[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Proposed Rules]
[Pages 39104-39907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14973]
[[Page 39103]]
Vol. 86
Friday,
No. 139
July 23, 2021
Part II
Book 2 of 2 Books
Pages 39103-39938
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 403, 405, et al.
Medicare Program; CY 2022 Payment Policies Under the Physician Fee
Schedule and Other Changes to Part B Payment Policies; Medicare Shared
Savings Program Requirements; Provider Enrollment Regulation Updates;
Provider and Supplier Prepayment and Post-Payment Medical Review
Requirements; Proposed Rule
Federal Register / Vol. 86 , No. 139 / Friday, July 23, 2021 /
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 405, 410, 411, 414, 415, 423, 424, and 425
[CMS-1751-P]
RIN 0938-AU42
Medicare Program; CY 2022 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment Policies; Medicare
Shared Savings Program Requirements; Provider Enrollment Regulation
Updates; Provider and Supplier Prepayment and Post-Payment Medical
Review Requirements.
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This major proposed rule addresses: Changes to the physician
fee schedule (PFS); other changes to Medicare Part B payment policies
to ensure that payment systems are updated to reflect changes in
medical practice, relative value of services, and changes in the
statute; Medicare Shared Savings Program requirements; updates to the
Quality Payment Program; Medicare coverage of opioid use disorder
services furnished by opioid treatment programs; updates to certain
Medicare provider enrollment policies; requirements for prepayment and
post-payment medical review activities; requirement for electronic
prescribing for controlled substances for a covered Part D drug under a
prescription drug plan, or a Medicare Advantage Prescription Drug (MA-
PD) plan; updates to the Medicare Ground Ambulance Data Collection
System; changes to the Medicare Diabetes Prevention Program (MDPP)
expanded model; and amendments to the physician self-referral law
regulations.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 13,
2021.
ADDRESSES: In commenting, please refer to file code CMS-1751-P.
Comments, including mass comment submissions, must be submitted in one
of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1751-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1751-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
FOR FURTHER INFORMATION CONTACT:
[email protected], for any issues not
identified below.
Michael Soracoe, (410) 786-6312, for issues related to practice
expense, work RVUs, conversion factor, and PFS specialty-specific
impacts.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Donta Henson, (410) 786-1947, Patrick Sartini, (410) 786-9252, and
Larry Chan, (410) 786-6864, for issues related to telehealth services
and other services involving communications technology.
Julie Adams, (410) 786-8932, for issues related to payment for
anesthesia services.
Sarah Leipnik, (410) 786-3933, for issues related to split (or
shared) services.
Christiane LaBonte, (410) 786-7237, for issues related to indirect
practice expense, PFS payment for critical care services, and PFS
payment for teaching physician services.
[email protected], for issues related to
payment for vaccine administration services.
Regina Walker-Wren, (410) 786-9160, for issues related to billing
for services of physician assistants.
Pamela West, (410) 786-2302, for issues related to PFS payment for
therapy services, medical nutrition therapy services, and services of
registered dieticians and nutrition professionals.
Liane Grayson, (410) 786-6583, and Donta Henson, (410) 786-1947,
for issues related to coinsurance for certain colorectal cancer
screening services.
Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs.
Laura Kennedy, (410) 786-3377, for issues related to drugs payable
under Part B.
Heather Hostetler, (410) 786-4515, and Elizabeth Truong, 410-786-
6005, for issues related to removal of select national coverage
determinations.
Sarah Fulton, (410) 786-2749, for issues related to Appropriate Use
Criteria for Advanced Diagnostic Imaging (AUC); and Pulmonary
Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac
Rehabilitation.
Rachel Katonak, (410) 786-8564, for issues related to Medical
Nutrition Therapy.
Fiona Larbi, (410) 786-7224, for issues related to the Medicare
Shared Savings Program (Shared Savings Program) Quality performance
standard and quality reporting requirements.
Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518,
or [email protected], for issues related to Shared
Savings Program beneficiary assignment, repayment mechanism
requirements, and benchmarking methodology.
Naseem Tarmohamed, (410) 786-0814, or
[email protected], for inquiries related to Shared
Savings Program application, compliance and beneficiary notification
requirements.
Amy Gruber, [email protected], for issues related
to the Medicare Ground Ambulance Data Collection System.
Juliana Tiongson, (410) 786-0342, for issues related to the
Medicare Diabetes Prevention Program (MDPP).
Laura Ashbaugh, (410) 786-1113, for issues related to Clinical
Laboratory Fee Schedule: Laboratory Specimen Collection and Travel
Allowance and Use of Electronic Travel Logs.
Frank Whelan, (410) 786-1302, for issues related to Medicare
provider enrollment regulation updates.
Thomas J. Kessler, (410) 786-1991, for issues related to provider
and supplier prepayment and post-payment medical review requirements.
Lindsey Baldwin, (410) 786-1694, and Michele Franklin, (410) 786-
9226, for issues related to Medicare coverage of opioid use disorder
treatment services furnished by opioid treatment programs.
Lisa O. Wilson, (410) 786-8852, or Meredith Larson, (410) 786-7923,
for inquiries related to the physician self-referral law.
Joella Roland, (410) 786-7638, for issues related to requirement
for electronic prescribing for controlled substances for a covered Part
D drug under a prescription drug plan or an MA-PD plan.
Kathleen Ott, (410) 786-4246, for issues related to open payments.
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Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
Brittany LaCouture, (410) 786-0481, for inquiries related to
Alternative Payment Models (APMs).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
Addenda Available Only Through the Internet on the CMS Website: The
PFS Addenda along with other supporting documents and tables referenced
in this proposed rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. Click on the link on the left side of the
screen titled, ``PFS Federal Regulations Notices'' for a chronological
list of PFS Federal Register and other related documents. For the CY
2022 PFS proposed rule, refer to item CMS-1751-P. Readers with
questions related to accessing any of the Addenda or other supporting
documents referenced in this proposed rule and posted on the CMS
website identified above should contact
[email protected].
CPT (Current Procedural Terminology) Copyright Notice: Throughout
this proposed rule, we use CPT codes and descriptions to refer to a
variety of services. We note that CPT codes and descriptions are
copyright 2020 American Medical Association. All Rights Reserved. CPT
is a registered trademark of the American Medical Association (AMA).
Applicable Federal Acquisition Regulations (FAR) and Defense Federal
Acquisition Regulations (DFAR) apply.
I. Executive Summary
This major proposed rule proposes to revise payment polices under
the Medicare PFS and makes other policy changes, including proposals to
implement certain provisions of the Consolidated Appropriations Act,
2021 (CAA, 2021) (Pub. L. 116-260, December 27, 2020), Bipartisan
Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018)
and the Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT
Act) (Pub. L. 115-271, October 24, 2018), related to Medicare Part B
payment. In addition, this major proposed rule includes proposals
regarding other Medicare payment policies described in sections III.
and IV.
A. Summary of the Major Provisions
The statute requires us to establish payments under the PFS, based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: Work,
practice expense (PE), and malpractice (MP) expense. In addition, the
statute requires that we establish each year by regulation the payment
amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major proposed rule, we are proposing to establish RVUs for
CY 2022 for the PFS to ensure that our payment systems are updated to
reflect changes in medical practice and the relative value of services,
as well as changes in the statute. This proposed rule also includes
discussions and provisions regarding several other Medicare Part B
payment policies.
Specifically, this proposed rule addresses:
Practice Expense RVUs (section II.B.)
Potentially Misvalued Services Under the PFS (section
II.C.)
Telehealth and Other Services Involving Communications
Technology (section II.D.)
Valuation of Specific Codes (section II.E.)
Evaluation and Management Visits (section II.F.)
Billing for Physician Assistant Services (section II.G.)
Therapy Services (section II.H.)
Changes to Beneficiary Coinsurance for Additional
Procedures Furnished During the Same Clinical Encounter as Certain
Colorectal Cancer Screening Tests (section II.I.)
Vaccine Administration Services (section II.J.)
Payment for Medical Nutrition Therapy Services and Related
Services (section II.K.)
Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (sections III.A., III.B., and III.C.)
Requiring Certain Manufacturers to Report Drug Pricing
Information for Part B and Determination of ASP for Certain Self-
administered Drug Products (sections III.D.1. and 2.)
Medicare Part B Drug Payment for Drugs Approved under
Section 505(b)(2) of the Federal Food, Drug, & Cosmetic Act (section
III.E.)
Appropriate Use Criteria for Advanced Diagnostic Imaging
(section III.F.)
Removal of Select National Coverage Determinations
(section III.G.)
Pulmonary Rehabilitation, Cardiac Rehabilitation and
Intensive Cardiac Rehabilitation (section III.H.)
Medical Nutrition Therapy (section III.I.)
Medicare Shared Savings Program (section III.J.)
Medicare Ground Ambulance Data Collection System (section
III.K.)
Medicare Diabetes Prevention Program (MDPP) (section
III.L.)
Clinical Laboratory Fee Schedule: Laboratory Specimen
Collection and Travel Allowance for Clinical Diagnostic Laboratory
Tests and Use of Electronic Travel Logs (section III.M.)
Medicare Provider and Supplier Enrollment Changes (section
III.N.1.)
Provider/Supplier Medical Review Requirements: Addition of
Provider/Supplier Requirements related to Prepayment and Post-payment
Reviews (section III.N.2.)
Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.O.)
Updates to the Physician Self-Referral Regulations
(section III.P.)
Requirement for Electronic Prescribing for Controlled
Substances for a Covered Part D Drug under a Prescription Drug Plan or
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.Q.)
Open Payments (section III.R.)
Updates to the Quality Payment Program (section IV.)
Collection of Information Requirements (section V.)
Response to Comments (section VI.)
Regulatory Impact Analysis (section VII.)
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3. Summary of Costs and Benefits
We have determined that this proposed rule is economically
significant. For a detailed discussion of the economic impacts, see
section VII., Regulatory Impact Analysis, of this proposed rule.
II. Provisions of the Proposed Rule for the PFS
A. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Social Security Act (the Act), ``Payment for
Physicians' Services.'' The PFS relies on national relative values that
are established for work, practice expense (PE), and malpractice (MP),
which are adjusted for geographic cost variations. These values are
multiplied by a conversion factor (CF) to convert the relative value
units (RVUs) into payment rates. The concepts and methodology
underlying the PFS were enacted as part of the Omnibus Budget
Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239, December 19,
1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
(Pub. L. 101-508, November 5, 1990). The final rule published in the
November 25, 1991 Federal Register (56 FR 59502) set forth the first
fee schedule used for payment for physicians' services.
We note that throughout this proposed rule, unless otherwise noted,
the term ``practitioner'' is used to describe both physicians and
nonphysician practitioners (NPPs) who are permitted to bill Medicare
under the PFS for the services they furnish to Medicare beneficiaries.
1. Development of the RVUs
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
implemented on January 1, 1992, were developed with extensive input
from the physician community. A research team at the Harvard School of
Public Health developed the original work RVUs for most codes under a
cooperative agreement with the Department of Health and Human Services
(HHS). In constructing the code-specific vignettes used in determining
the original physician work RVUs, Harvard worked with panels of
experts, both inside and outside the federal government, and obtained
input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work
component of physicians' services means the portion of the resources
used in furnishing the service that reflects physician time and
intensity. We establish work RVUs for new, revised and potentially
misvalued codes based on our review of information that generally
includes, but is not limited to, recommendations received from the
American Medical Association/Specialty Society Relative Value Scale
Update Committee (RUC), the Health Care Professionals Advisory
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC),
and other public commenters; medical literature and comparative
databases; as well as a comparison of the work for other codes within
the Medicare PFS, and consultation with other physicians and health
care professionals within CMS and the federal government. We also
assess the methodology and data used to develop the recommendations
submitted to us by the RUC and other public commenters, and the
rationale for their recommendations. In the CY 2011 PFS final rule with
comment period (75 FR 73328 through 73329), we discussed a variety of
methodologies and approaches used to develop work RVUs, including
survey data, building blocks, crosswalk to key reference or similar
codes, and magnitude estimation. More information on these issues is
available in that rule.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, October 31,
1994), amended by section 1848(c)(2)(C)(ii) of the Act and required us
to develop resource-based PE RVUs for each physicians' service
beginning in 1998. We were required to consider general categories of
expenses (such as office rent and wages of personnel, but excluding MP
expenses) comprising PEs. The PE RVUs continue to represent the portion
of these resources involved in furnishing PFS services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (BBA `97)
(Pub. L. 105-33, August 5, 1997) delayed implementation of the
resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA `97 provided for a 4-year transition period
from the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in the November 2, 1998 final rule (63 FR 58814), effective for
services furnished in CY 1999. Based on the requirement to transition
to a resource-based system for PE over a 4-year period, payment rates
were not fully based upon resource-based PE RVUs until CY 2002. This
resource-based system was based on two significant sources of actual PE
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's
Socioeconomic Monitoring System (SMS) data. These data sources are
described in greater detail in the CY 2012 PFS final rule with comment
period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some resource costs are borne by the
facility. Medicare's payment to the facility (such as the outpatient
prospective payment system (OPPS) payment to the HOPD) would reflect
costs typically incurred by the facility. Thus, payment associated with
those specific facility resource costs is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA)
(Pub. L. 106-113, November 29, 1999) directed the Secretary of Health
and Human Services (the Secretary) to establish a process under which
we accept and use, to the maximum extent practicable and consistent
with sound data practices, data collected or developed by entities and
organizations to supplement the data we normally collect in determining
the PE component. On May 3, 2000, we published the interim final rule
(65 FR 25664) that set forth the criteria for the submission of these
supplemental PE survey data. The criteria were modified in response to
comments received, and published in the Federal Register (65 FR 65376)
as part of a November 1, 2000 final rule. The PFS final rules published
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended
the period during which we would accept these supplemental data through
March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with
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comment period, we updated the practice expense per hour (PE/HR) data
that are used in the calculation of PE RVUs for most specialties (74 FR
61749). In CY 2010, we began a 4-year transition to the new PE RVUs
using the updated PE/HR data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA `97 amended section 1848(c) of the Act
to require that we implement resource-based MP RVUs for services
furnished on or after CY 2000. The resource-based MP RVUs were
implemented in the PFS final rule with comment period published
November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and
physician-owned insurers' MP insurance premium data from all the
states, the District of Columbia, and Puerto Rico.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently from one another. We
completed 5-year reviews of work RVUs that were effective for calendar
years 1997, 2002, 2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the 5-year reviews, beginning for CY 2009, CMS and
the RUC identified and reviewed a number of potentially misvalued codes
on an annual basis based on various identification screens. This annual
review of work and PE RVUs for potentially misvalued codes was
supplemented by the amendments to section 1848 of the Act, as enacted
by section 3134 of the Affordable Care Act, that require the agency to
periodically identify, review and adjust values for potentially
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
As described in section VII. of this proposed rule, the Regulatory
Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of
the Act, if revisions to the RVUs cause expenditures for the year to
change by more than $20 million, we will make adjustments to ensure
that expenditures do not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
To calculate the payment for each service, the components of the
fee schedule (work, PE, and MP RVUs) are adjusted by geographic
practice cost indices (GPCIs) to reflect the variations in the costs of
furnishing the services. The GPCIs reflect the relative costs of work,
PE, and MP in an area compared to the national average costs for each
component. Please refer to the CY 2020 PFS final rule for a discussion
of the last GPCI update (84 FR 62615 through 62623).
RVUs are converted to dollar amounts through the application of a
CF, which is calculated based on a statutory formula by CMS' Office of
the Actuary (OACT). The formula for calculating the Medicare PFS
payment amount for a given service and fee schedule area can be
expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
MP)] x CF
3. Separate Fee Schedule Methodology for Anesthesia Services
Section 1848(b)(2)(B) of the Act specifies that the fee schedule
amounts for anesthesia services are to be based on a uniform relative
value guide, with appropriate adjustment of an anesthesia CF, in a
manner to ensure that fee schedule amounts for anesthesia services are
consistent with those for other services of comparable value.
Therefore, there is a separate fee schedule methodology for anesthesia
services. Specifically, we establish a separate CF for anesthesia
services and we utilize the uniform relative value guide, or base
units, as well as time units, to calculate the fee schedule amounts for
anesthesia services. Since anesthesia services are not valued using
RVUs, a separate methodology for locality adjustments is also
necessary. This involves an adjustment to the national anesthesia CF
for each payment locality.
B. Determination of PE RVUs
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding MP expenses, as specified in section 1848(c)(1)(B) of the
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a
resource-based system for determining PE RVUs for each physicians'
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the 5-year review of work RVUs under the
PFS and proposed changes to the PE methodology CY 2007 PFS proposed
notice (71 FR 37242) and the CY 2007 PFS final rule with comment period
(71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty,
[[Page 39108]]
nationally representative, PE survey of both physicians and NPPs paid
under the PFS using a survey instrument and methods highly consistent
with those used for the SMS and the supplemental surveys. The PPIS
gathered information from 3,656 respondents across 51 physician
specialty and health care professional groups. We believe the PPIS is
the most comprehensive source of PE survey information available. We
used the PPIS data to update the PE/HR data for the CY 2010 PFS for
almost all of the Medicare-recognized specialties that participated in
the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file titled ``CY 2022 PFS proposed rule PE/HR'' on the
CMS website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2022, we have incorporated the available utilization data
for two new specialties, each of which became a recognized Medicare
specialty during 2020. These specialties are Micrographic Dermatologic
Surgery (MDS) and Adult Congenital Heart Disease (ACHD). We are
proposing to use proxy PE/HR values for these new specialties, as there
are no PPIS data for these specialties, by crosswalking the PE/HR as
follows from specialties that furnish similar services in the Medicare
claims data:
Micrographic Dermatologic Surgery (MDS) from Dermatology;
and
Adult Congenital Heart Disease (ACHD from Cardiology.
These updates are reflected in the ``CY 2022 PFS proposed rule PE/
HR'' file available on the CMS website under the supporting data files
for the CY 2022 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level based on the
direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion. The general
approach to developing the indirect portion of the PE RVUs is as
follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00,
[[Page 39109]]
the indirect portion of the PE RVUs of the first service would be twice
as great as the indirect portion of the PE RVUs for the second service.
Then, we incorporate the specialty-specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: Facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: A
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct readers to the file titled ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described in this proposed rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to a RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Codes with low Medicare service volume require special attention
since billing or enrollment irregularities for a given year can result
in significant changes in specialty mix assignment. We finalized a
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning specialty mix based on the specialties
of the practitioners reporting the services in the claims data, we use
the expected specialty that we identify on a list developed based on
medical review and input from expert stakeholders. We display this list
of expected specialty assignments as part of the annual set of data
files we make available as part of notice and comment rulemaking and
consider recommendations from the RUC and other stakeholders on changes
to this list on an annual basis. Services for which the specialty is
automatically assigned based on previously finalized policies under our
established methodology (for example, ``always therapy'' services) are
unaffected by the list of expected specialty assignments. We also
finalized in the CY 2018 PFS final rule (82 FR 52982 through 59283) a
policy to apply these service-level overrides for both PE and MP,
rather than one or the other category.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: the direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: Indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect
[[Page 39110]]
allocator is: Indirect PE percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs would be allocated
using the work RVUs, and for the TC service, indirect PEs would be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
titled ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the aggregate work RVUs scaled by the ratio of current
aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in
the PFS account for the fact that certain specialties are excluded from
the calculation of PE RVUs but included in maintaining overall PFS
budget neutrality. (See ``Specialties excluded from ratesetting
calculation'' later in this final rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased in
over a 2-year period. In implementing the phase-in, we consider a 19
percent reduction as the maximum 1-year reduction for any service not
described by a new or revised code. This approach limits the year one
reduction for the service to the maximum allowed amount (that is, 19
percent), and then phases in the remainder of the reduction. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE and MP RVUs, we exclude certain
specialties, such as certain NPPs paid at a percentage of the PFS and
low-volume specialties, from the calculation. These specialties are
included for the purposes of calculating the BN adjustment. They are
displayed in Table 1.
BILLING CODE 4120-01-P
[[Page 39111]]
[GRAPHIC] [TIFF OMITTED] TP23JY21.000
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 2 details the manner in which the
modifiers are applied.
[[Page 39112]]
[GRAPHIC] [TIFF OMITTED] TP23JY21.001
BILLING CODE 4120-01-C
We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (MPPRs). We note that
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
for multiple imaging procedures and multiple therapy services from the
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the development of the RVUs.
Beginning in CY 2022, section 1834(v)(1) of the Act requires that
we apply a 15 percent payment reduction for outpatient occupational
therapy services and outpatient physical therapy services that are
provided, in whole or in part, by a physical therapist assistant (PTA)
or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the
Act required CMS to establish modifiers to identify these services,
which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661),
creating the CQ and CO payment modifiers for services provided in whole
or in part by PTAs and OTAs, respectively. These payment modifiers are
required to be used on claims for services with dates of service
beginning January 1, 2020, as specified in the CY 2020 PFS final rule
(84 FR 62702 through 62708). We will apply the 15 percent payment
reduction to therapy services provided by PTAs (using the CQ modifier)
or OTAs (using the CO modifier), as required by statute. Under sections
1834(k) and 1848 of the Act, payment is made for outpatient therapy
services at 80 percent of the lesser of the actual charge or applicable
fee schedule amount (the allowed charge). The remaining 20 percent is
the beneficiary copayment. For therapy services to which the new
discount applies, payment will be made at 85 percent of the 80 percent
of allowed charges. Therefore, the volume discount factor for therapy
services to which the CQ and CO modifiers apply is: (0.20 + (0.80*
0.85), which equals 88 percent.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
final rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate)[and] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally 150,000 minutes.
usage = variable, see discussion below in this proposed rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this proposed
rule.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Useful Life: In the CY 2005 PFS final rule we stated that we
updated the useful life for equipment items primarily based on the
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets''
guidelines (69 FR 66246). The most recent edition of these guidelines
was published in 2018. This reference material provides an estimated
useful life for hundreds of different types of equipment, the vast
majority of which fall in the range of 5 to 10 years, and none of which
are lower than 2 years in duration. We believe that the updated
editions of this reference material remain the most accurate source for
estimating the useful life of depreciable medical equipment.
[[Page 39113]]
In the CY 2021 PFS final rule, we finalized a proposal to treat
equipment life durations of less than 1 year as having a duration of 1
year for the purpose of our equipment price per minute formula. In the
rare cases where items are replaced every few months, we noted that we
believe it is more accurate to treat these items as disposable supplies
with a fractional supply quantity as opposed to equipment items with
very short equipment life durations. For a more detailed discussion of
the methodology associated with very short equipment life durations, we
refer readers to the CY 2021 PFS final rule (85 FR 84482 through
84483).
Maintenance: We finalized the 5 percent factor for annual
maintenance in the CY 1998 PFS final rule with comment period (62 FR
33164). As we previously stated in the CY 2016 PFS final rule with
comment period (80 FR 70897), we do not believe the annual maintenance
factor for all equipment is precisely 5 percent, and we concur that the
current rate likely understates the true cost of maintaining some
equipment. We also noted that we believe it likely overstates the
maintenance costs for other equipment. When we solicited comments
regarding sources of data containing equipment maintenance rates,
commenters were unable to identify an auditable, robust data source
that could be used by CMS on a wide scale. We noted that we did not
believe voluntary submissions regarding the maintenance costs of
individual equipment items would be an appropriate methodology for
determining costs. As a result, in the absence of publicly available
datasets regarding equipment maintenance costs or another systematic
data collection methodology for determining a different maintenance
factor, we did not propose a variable maintenance factor for equipment
cost per minute pricing as we did not believe that we have sufficient
information at present. We noted that we would continue to investigate
potential avenues for determining equipment maintenance costs across a
broad range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment
period (77 FR 68902), we updated the interest rates used in developing
an equipment cost per minute calculation (see 77 FR 68902 for a
thorough discussion of this issue). The interest rate was based on the
Small Business Administration (SBA) maximum interest rates for
different categories of loan size (equipment cost) and maturity (useful
life). The Interest rates are listed in Table 3.
[GRAPHIC] [TIFF OMITTED] TP23JY21.002
We are not proposing any changes to the equipment interest rates
for CY 2022.
3. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2022 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2022 PFS
proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640 through 67641), we continue to make improvements to the direct
PE input database to provide the number of clinical labor minutes
assigned for each task for every code in the database instead of only
including the number of clinical labor minutes for the preservice,
service, and post service periods for each code. In addition to
increasing the transparency of the information used to set PE RVUs,
this level of detail would allow us to compare clinical labor times for
activities associated with services across the PFS, which we believe is
important to maintaining the relativity of the direct PE inputs. This
information would facilitate the identification of the usual numbers of
minutes for clinical labor tasks and the identification of exceptions
to the usual values. It would also allow for greater transparency and
consistency in the assignment of equipment minutes based on clinical
labor times. Finally, we believe that the detailed information can be
useful in maintaining standard times for particular clinical labor
tasks that can be applied consistently to many codes as they are valued
over several years, similar in principle to the use of physician
preservice time packages. We believe that setting and maintaining such
standards would provide greater consistency among codes that share the
same clinical labor tasks and could improve relativity of values among
codes. For example, as medical practice and technologies change over
time, changes in the standards could be updated simultaneously for all
codes with the applicable clinical labor tasks, instead of waiting for
individual codes to be reviewed.
In the CY 2016 PFS final rule with comment period (80 FR 70901), we
solicited comments on the appropriate standard minutes for the clinical
labor tasks associated with services that use digital technology. After
consideration of comments received, we finalized standard times for
clinical labor tasks associated with digital imaging at 2 minutes for
``Availability of prior images confirmed'', 2 minutes for ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'', 2
minutes for ``Review examination with interpreting MD'', and 1 minute
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS
system to generate billing process and to populate images into
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184
through 80186), we finalized a policy to establish a range of
appropriate standard minutes for the clinical labor activity,
``Technologist QCs images in PACS, checking for all images, reformats,
and dose page.'' These standard minutes will be applied to new and
revised
[[Page 39114]]
codes that make use of this clinical labor activity when they are
reviewed by us for valuation. We finalized a policy to establish 2
minutes as the standard for the simple case, 3 minutes as the standard
for the intermediate case, 4 minutes as the standard for the complex
case, and 5 minutes as the standard for the highly complex case. These
values were based upon a review of the existing minutes assigned for
this clinical labor activity; we determined that 2 minutes is the
duration for most services and a small number of codes with more
complex forms of digital imaging have higher values. We also finalized
standard times for a series of clinical labor tasks associated with
pathology services in the CY 2016 PFS final rule with comment period
(80 FR 70902). We do not believe these activities would be dependent on
number of blocks or batch size, and we believe that the finalized
standard values accurately reflect the typical time it takes to perform
these clinical labor tasks.
In reviewing the RUC-recommended direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical labor time traditionally
assigned to the ``Prepare room, equipment and supplies'' (CA013)
clinical labor activity were split into 2 minutes for the ``Prepare
room, equipment and supplies'' activity and 1 minute for the ``Confirm
order, protocol exam'' (CA014) activity. We proposed to maintain the 3
minutes of clinical labor time for the ``Prepare room, equipment and
supplies'' activity and remove the clinical labor time for the
``Confirm order, protocol exam'' activity wherever we observed this
pattern in the RUC-recommended direct PE inputs. Commenters explained
in response that when the new version of the PE worksheet introduced
the activity codes for clinical labor, there was a need to translate
old clinical labor tasks into the new activity codes, and that a prior
clinical labor task was split into two of the new clinical labor
activity codes: CA007 (Review patient clinical extant information and
questionnaire) in the preservice period, and CA014 (Confirm order,
protocol exam) in the service period. Commenters stated that the same
clinical labor from the old PE worksheet was now divided into the CA007
and CA014 activity codes, with a standard of 1 minute for each
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity
code and 1 minute for the CA014 activity code in situations where this
was the case. However, when reviewing the clinical labor for the
reviewed codes affected by this issue, we found that several of the
codes did not include this old clinical labor task, and we also noted
that several of the reviewed codes that contained the CA014 clinical
labor activity code did not contain any clinical labor for the CA007
activity. In these situations, we continue to believe that in these
cases, the 3 total minutes of clinical staff time would be more
accurately described by the CA013 ``Prepare room, equipment and
supplies'' activity code, and we finalized these clinical labor
refinements. For additional details, we direct readers to the
discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).
Following the publication of the CY 2020 PFS proposed rule, a
commenter expressed concern with the published list of common
refinements to equipment time. The commenter stated that these
refinements were the formulaic result of the applying refinements to
the clinical labor time and did not constitute separate refinements;
the commenter requested that CMS no longer include these refinements in
the table published each year. In the CY 2020 PFS final rule, we agreed
with the commenter that these equipment time refinements did not
reflect errors in the equipment recommendations or policy discrepancies
with the RUC's equipment time recommendations. However, we believed
that it was important to publish the specific equipment times that we
were proposing (or finalizing in the case of the final rule) when they
differed from the recommended values due to the effect that these
changes can have on the direct costs associated with equipment time.
Therefore, we finalized the separation of the equipment time
refinements associated with changes in clinical labor into a separate
table of refinements. For additional details, we direct readers to the
discussion in the CY 2020 PFS final rule (84 FR 62584).
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in developing and
submitting recommendations will help us to simplify and standardize the
hundreds of different clinical labor tasks currently listed in our
direct PE database. As we did in previous calendar years, to facilitate
rulemaking for CY 2022, we are continuing to display two versions of
the Labor Task Detail public use file: one version with the old listing
of clinical labor tasks, and one with the same tasks crosswalked to the
new listing of clinical labor activity codes. These lists are available
on the CMS website under downloads for the CY 2022 PFS proposed rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Technical Corrections to Direct PE Input Database and Supporting
Files
For CY 2022, we are proposing to address the following:
Following the publication of the CY 2021 PFS proposed
rule, several commenters questioned the proposed RVUs associated with
several occupational therapy evaluation procedures (CPT codes 97165
through 97167). Commenters stated that the PE valuation for these codes
appeared to be illogical as it was counterintuitive for the PE RVU to
go down as the level of complexity increased. Commenters stated that
the distribution of code usage has not changed in any manner to justify
a reduction in the code values and that all three evaluation codes
should reimburse at the same rate. In response to the commenters, we
noted that although the three codes in question shared the same work
RVU and the same direct PE inputs, they did not share the same
specialty distribution in the claims data and therefore would not
necessarily receive the same allocation of indirect PE. In the CY 2021
PFS final rule (85 FR 84490), we finalized the implementation of a
technical change intended to ensure that these three services received
the same allocation of indirect PE. We agreed with commenters that it
was important to avoid a potential rank order anomaly in which the
simple case for a service was valued higher than the complex case.
After the publication of the CY 2021 PFS final rule, stakeholders
stated their appreciation for the technical change made in the final
rule to ensure that the indirect PE allocation was the same for all
three levels of occupational therapy evaluation codes. However,
stakeholders expressed concern that the PE RVUs we finalized for CPT
codes
[[Page 39115]]
97165-97167 decreased as compared to the PE RVUs we proposed for CY
2021. Stakeholders stated that nothing had occurred in the past year
that would account for a reduction to the proposed PE for these codes,
especially in a year where the proposed PE increased for the
corresponding physical therapy evaluation procedures (CPT codes 97161-
97163), and stakeholders questioned whether there had been an error in
applying the indirect PE methodology.
We reviewed the indirect PE allocation for CPT codes 97165-97167 in
response to the stakeholder inquiry and we do not agree that there was
an error in applying the indirect PE methodology. We finalized a
technical change in the CY 2021 PFS final rule intended to ensure that
these three services received the same allocation of indirect PE, which
achieved its desired goal of assigning equivalent indirect PE to these
three services. However, by forcing CPT codes 97165-97167 to have the
same indirect PE allocation, the indirect PE values for these codes no
longer relied on the claims data, which ended up affecting the indirect
practice cost index for the wider occupational therapy specialty.
Because CPT codes 97165-97167 are high volume services, this resulted
in a lower indirect practice cost index for the occupational therapy
specialty and a smaller allocation of indirect PE for CY 2021 than
initially proposed.
We are addressing this issue for CY 2022 by proposing to assign all
claims data associated with CPT codes 97165-97167 to the occupational
therapy specialty. This should ensure that CPT codes 97165-97167 would
always receive the same indirect PE allocation as well as preventing
any fluctuations to the indirect practice cost index for the wider
occupational therapy specialty. This proposal is intended to avoid a
potential rank order anomaly in which the simple case for a service is
valued higher than the complex case. As the utilization for CPT codes
97165-97167 is overwhelmingly identified as performed by occupational
therapists, we do not anticipate that assigning all of the claims data
for these codes to the occupational therapy specialty will have a
noticeable effect on their valuation. We are soliciting public comments
regarding this proposal, and specifically on what commenters suggest as
the most appropriate method of assigning indirect PE allocation for
these services.
In the CY 2020 PFS final rule (84 FR 63102 through 63104),
we created two new HCPCS G codes, G2082 and G2083, effective January 1,
2020 on an interim final basis for the provision of self-administered
esketamine. In the CY 2021 PFS final rule, we finalized a proposal to
refine the values for HCPCS codes G2082 and G2083 using a building
block methodology that summed the values associated with several codes
(85 FR 84641 through 84642). Following the publication of the CY 2021
PFS final rule, stakeholders expressed their concern that the finalized
PE RVU had decreased for HCPCS codes G2082 and G2083 as compared to the
proposed valuation and as compared to the previous CY 2020 interim
final valuation. Stakeholders questioned whether there had been an
error in the PE allocation since CMS had finalized increases in the
direct PE inputs for the services.
We reviewed the indirect PE allocation for HCPCS codes G2082 and
G2083 in response to the stakeholder inquiry and discovered a technical
change that was applied in error. Specifically, we inadvertently
assigned a different physician specialty than we intended (``All
Physicians'') to HCPCS codes G2082 and G2083 for indirect PE allocation
in our ratesetting process during valuation of these codes in the CY
2020 PFS final rule, and continued that assignment into the CY 2021 PFS
proposed rule. This specialty assignment caused the PE value for these
services to be higher than anticipated for CY 2020. We intended to
revise the assigned physician specialty for these codes to ``General
Practice'' in the CY 2021 PFS final rule; however, we neglected to
discuss this change in the course of PFS rulemaking for CY 2021. Since
we initially applied this technical change in the CY 2021 PFS final
rule without providing an explanation, we issued a correction notice
(86 FR 14690) to remove this change from the CY 2021 PFS final rule,
and to instead maintain the All Physicians specialty assignment through
CY 2021. We apologize for any confusion this may have caused.
For CY 2022, we are proposing to maintain the currently assigned
physician specialty for indirect PE allocation for HCPCS codes G2082
and G2083. We are proposing to assign these two services to the All
Physicians specialty for indirect PE allocation which will maintain
payment consistency with the rates published in the CY 2020 PFS final
rule and the CY 2021 PFS proposed rule. Although we had previously
intended to assign the General Practice specialty to these codes,
stakeholders have provided additional information about these services
suggesting that maintaining the All Physicians specialty assignment for
these codes will help maintain payment stability and preserve access to
this care for beneficiaries. We are soliciting public comments to help
us discern which specialty would be the most appropriate to use for
indirect PE allocation for HCPCS codes G2082 and G2083. We note that
the PE methodology, which relies on the allocation of indirect costs
based on the magnitude of direct costs, should appropriately reflect
the typical costs for the specialty the commenters suggest. For
example, we do not believe it would be appropriate to assign the
Psychiatry specialty for these services given that HCPCS codes G2082
and G2083 include the high direct costs associated with esketamine
supplies. The Psychiatry specialty is an outlier compared to most other
specialties, allocating indirect costs at a 15:1 ratio based on direct
costs because psychiatry services typically have very low direct costs.
Assignment of most other specialties would result in allocation of
direct costs at roughly a 3:1 ratio. We request that commenters explain
in their comments how the indirect PE allocation would affect the
payment for these services. Specifically, to ensure appropriate payment
for HCPCS codes G2082 and G2083, we would like to get a better
understanding of the indirect costs associated with these services,
relative to other services furnished by the suggested specialty.
A stakeholder contacted us regarding a potential error
involving the intraservice work time for CPT code 35860 (Exploration
for postoperative hemorrhage, thrombosis or infection; extremity). The
stakeholder stated that the RUC recommended an intraservice work time
of 90 minutes for this code when it was last reviewed in the CY 2012
PFS final rule and we finalized the work time without refinement at 60
minutes (76 FR 73131). The stakeholder requested that the intraservice
work time for CPT code 35860 should be updated to 90 minutes.
We reviewed the intraservice work time for CPT code 35860 and found
that the RUC inadvertently recommended a time of 60 minutes for the
code, which we proposed and finalized without comment in rulemaking for
the CY 2012 PFS. As a result, we do not believe that this is a
technical error on our part. However, since the stakeholder has
clarified that the RUC intended to recommend 90 minutes of intraservice
work time for CPT code 35860 based on the surveyed median time, we are
proposing to update the intraservice work time to 90 minutes to match
the survey results.
[[Page 39116]]
c. Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2022,
we are proposing to update the price of six supplies and two equipment
items in response to the public submission of invoices. Since this is
the final year of the supply and equipment pricing update, the new
pricing for each of these supply and equipment items will take effect
for CY 2022 as there are no remaining years of the transition. The six
supply and equipment items with proposed updated prices are listed in
the valuation of specific codes section of the preamble under Table 16:
CY 2022 Invoices Received for Existing Direct PE Inputs.
(1) Market-Based Supply and Equipment Pricing Update
Section 220(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93, April 1, 2014) provides that the Secretary may
collect or obtain information from any eligible professional or any
other source on the resources directly or indirectly related to
furnishing services for which payment is made under the PFS, and that
such information may be used in the determination of relative values
for services under the PFS. Such information may include the time
involved in furnishing services; the amounts, types and prices of PE
inputs; overhead and accounting information for practices of physicians
and other suppliers, and any other elements that would improve the
valuation of services under the PFS.
As part of our authority under section 1848(c)(2)(M) of the Act, we
initiated a market research contract with StrategyGen to conduct an in-
depth and robust market research study to update the PFS direct PE
inputs (DPEI) for supply and equipment pricing for CY 2019. These
supply and equipment prices were last systematically developed in 2004-
2005. StrategyGen submitted a report with updated pricing
recommendations for approximately 1300 supplies and 750 equipment items
currently used as direct PE inputs. This report is available as a
public use file displayed on the CMS website under downloads for the CY
2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The StrategyGen team of researchers, attorneys, physicians, and
health policy experts conducted a market research study of the supply
and equipment items currently used in the PFS direct PE input database.
Resources and methodologies included field surveys, aggregate
databases, vendor resources, market scans, market analysis, physician
substantiation, and statistical analysis to estimate and validate
current prices for medical equipment and medical supplies. StrategyGen
conducted secondary market research on each of the 2,072 DPEI medical
equipment and supply items that CMS identified from the current DPEI.
The primary and secondary resources StrategyGen used to gather price
data and other information were:
Telephone surveys with vendors for top priority items
(Vendor Survey).
Physician panel validation of market research results,
prioritized by total spending (Physician Panel).
The General Services Administration system (GSA).
An aggregate health system buyers database with discounted
prices (Buyers).
Publicly available vendor resources, that is, Amazon
Business, Cardinal Health (Vendors).
The Federal Register, current DPEI data, historical
proposed and final rules prior to CY 2018, and other resources; that
is, AMA RUC reports (References).
StrategyGen prioritized the equipment and supply research based on
current share of PE RVUs attributable by item provided by CMS.
StrategyGen developed the preliminary Recommended Price (RP)
methodology based on the following rules in hierarchical order
considering both data representativeness and reliability.
(1) If the market share, as well as the sample size, for the top
three commercial products were available, the weighted average price
(weighted by percent market share) was the reported RP. Commercial
price, as a weighted average of market share, represents a more robust
estimate for each piece of equipment and a more precise reference for
the RP.
(2) If no data were available for commercial products, the current
CMS prices were used as the RP.
GSA prices were not used to calculate the StrategyGen recommended
prices, due to our concern that the GSA system curtails the number and
type of suppliers whose products may be accessed on the GSA Advantage
website, and that the GSA prices may often be lower than prices that
are available to non-governmental purchasers. After reviewing the
StrategyGen report, we proposed to adopt the updated direct PE input
prices for supplies and equipment as recommended by StrategyGen.
StrategyGen found that despite technological advancements, the
average commercial price for medical equipment and supplies has
remained relatively consistent with the current CMS price.
Specifically, preliminary data indicated that there was no
statistically significant difference between the estimated commercial
prices and the current CMS prices for both equipment and supplies. This
cumulative stable pricing for medical equipment and supplies appears
similar to the pricing impacts of non-medical technology advancements
where some historically high-priced equipment (that is, desktop PCs)
has been increasingly substituted with current technology (that is,
laptops and tablets) at similar or lower price points. However, while
there were no statistically significant differences in pricing at the
aggregate level, medical specialties would experience increases or
decreases in their Medicare payments if we were to adopt the pricing
updates recommended by StrategyGen. At the service level, there may be
large shifts in PE RVUs for individual codes that happened to contain
supplies and/or equipment with major changes in pricing, although we
note that codes with a sizable PE RVU decrease would be limited by the
requirement to phase in significant reductions in RVUs, as required by
section 1848(c)(7) of the Act. The phase-in requirement limits the
maximum RVU reduction for codes that are not new or revised to 19
percent in any individual calendar year.
We believe that it is important to make use of the most current
information available for supply and equipment pricing instead of
continuing to rely on pricing information that is more than a decade
old. Given the potentially significant changes in payment that would
occur, both for specific services and more broadly at the specialty
level, in the CY 2019 PFS proposed rule we proposed to phase in our use
of the new direct PE input pricing over a 4-year period using a 25/75
percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021),
and 100/0 percent (CY 2022) split between new and old pricing. This
approach is consistent with how we have previously incorporated
significant new data into the calculation of PE RVUs, such as the 4-
year transition period finalized in CY 2007 PFS final rule with comment
period when changing to the ``bottom-
[[Page 39117]]
up'' PE methodology (71 FR 69641). This transition period will not only
ease the shift to the updated supply and equipment pricing, but will
also allow interested parties an opportunity to review and respond to
the new pricing information associated with their services.
We proposed to implement this phase-in over 4 years so that supply
and equipment values transition smoothly from the prices we currently
include to the final updated prices in CY 2022. We proposed to
implement this pricing transition such that one quarter of the
difference between the current price and the fully phased-in price is
implemented for CY 2019, one third of the difference between the CY
2019 price and the final price is implemented for CY 2020, and one half
of the difference between the CY 2020 price and the final price is
implemented for CY 2021, with the new direct PE prices fully
implemented for CY 2022. An example of the transition from the current
to the fully-implemented new pricing is provided in Table 4.
[GRAPHIC] [TIFF OMITTED] TP23JY21.003
For new supply and equipment codes for which we establish prices
during the transition years (CYs 2019, 2020 and 2021) based on the
public submission of invoices, we proposed to fully implement those
prices with no transition since there are no current prices for these
supply and equipment items. These new supply and equipment codes would
immediately be priced at their newly established values. We also
proposed that, for existing supply and equipment codes, when we
establish prices based on invoices that are submitted as part of a
revaluation or comprehensive review of a code or code family, they will
be fully implemented for the year they are adopted without being phased
in over the 4-year pricing transition. The formal review process for a
HCPCS code includes a review of pricing of the supplies and equipment
included in the code. When we find that the price on the submitted
invoice is typical for the item in question, we believe it would be
appropriate to finalize the new pricing immediately along with any
other revisions we adopt for the code valuation.
For existing supply and equipment codes that are not part of a
comprehensive review and valuation of a code family and for which we
establish prices based on invoices submitted by the public, we proposed
to implement the established invoice price as the updated price and to
phase in the new price over the remaining years of the proposed 4-year
pricing transition. During the proposed transition period, where price
changes for supplies and equipment are adopted without a formal review
of the HCPCS codes that include them (as is the case for the many
updated prices we proposed to phase in over the 4-year transition
period), we believe it is important to include them in the remaining
transition toward the updated price. We also proposed to phase in any
updated pricing we establish during the 4-year transition period for
very commonly used supplies and equipment that are included in 100 or
more codes, such as sterile gloves (SB024) or exam tables (EF023), even
if invoices are provided as part of the formal review of a code family.
We would implement the new prices for any such supplies and equipment
over the remaining years of the proposed 4-year transition period. Our
proposal was intended to minimize any potential disruptive effects
during the proposed transition period that could be caused by other
sudden shifts in RVUs due to the high number of services that make use
of these very common supply and equipment items (meaning that these
items are included in 100 or more codes).
We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining
stability and allowing stakeholders the opportunity to address
potential concerns about changes in payment for particular items.
Updating the pricing of direct PE inputs for supplies and equipment
over a longer timeframe will allow more opportunities for public
comment and submission of additional, applicable data. We welcomed
feedback from stakeholders on the proposed updated supply and equipment
pricing, including the submission of additional invoices for
consideration.
We received many comments regarding the market-based supply and
equipment pricing proposal following the publication of the CY 2019 PFS
proposed rule. For a full discussion of these comments, we direct
readers to the CY 2019 PFS final rule (83 FR 59475 through 59480). In
each instance in which a commenter raised questions about the accuracy
of a supply or equipment code's recommended price, the StrategyGen
contractor conducted further research on the item and its price with
special attention to ensuring that the recommended price was based on
the correct item in question and the clarified unit of measure. Based
on the commenters' requests, the StrategyGen contractor conducted an
extensive examination of the pricing of any supply or equipment items
that any commenter identified as requiring additional review. Invoices
submitted by multiple commenters were greatly appreciated and ensured
that medical equipment and supplies were re-examined and clarified.
Multiple researchers reviewed these specified supply and equipment
codes for accuracy and proper pricing. In most cases, the contractor
also reached out to a team of nurses and their physician panel to
further validate the accuracy of the data and pricing information. In
some cases, the pricing for individual items needed further
clarification due to a lack of information or due to significant
variation in packaged items. After consideration of the comments and
this additional price research, we updated the recommended prices for
approximately 70 supply and equipment codes identified by the
commenters. Table 9 in the CY 2019 PFS final rule lists the supply and
equipment codes with price changes based on feedback from the
commenters and the resulting additional research into pricing (83 FR
59479 through 59480).
After consideration of the public comments, we finalized our
proposals
[[Page 39118]]
associated with the market research study to update the PFS direct PE
inputs for supply and equipment pricing. We continue to believe that
implementing the updated prices with a 4-year phase-in will improve
payment accuracy, while maintaining stability and allowing stakeholders
the opportunity to address potential concerns about changes in payment
for particular items. We continue to welcome feedback from stakeholders
on the updated supply and equipment pricing, including the submission
of additional invoices for consideration.
For CY 2022, we received invoice submissions from stakeholders for
approximately half a dozen supply and equipment codes as part of the
fourth year of the market-based supply and equipment pricing update. We
used these submitted invoices in many cases to supplement the pricing
originally proposed for the CY 2019 PFS rule cycle. We reviewed the
invoices, as well as our own data for the relevant supply/equipment
codes to make sure the item in the invoice was representative of the
supply/equipment item in question and aligned with past research. Based
on this review, we are proposing to update the prices of six supply
items listed in the valuation of specific codes section of the preamble
under Table 16: CY 2022 Invoices Received for Existing Direct PE
Inputs. Since this is the final year of the supply and equipment
pricing update, the new pricing for each of these supply and equipment
items would take effect immediately for CY 2022.
The proposed prices for the supply and equipment items listed in
Table 16 of CY 2022 were generally calculated following our standard
methodology of averaging together the prices on the submitted invoices.
In the case of the Liquid coverslip (Ventana 650-010) (SL479) supply,
we are proposing a price of $0.051 based on the median invoice due to
the presence of an outlier invoice that substantially increased the
pricing when using an average. We believe that the proposed price of
$0.051 would be more typical for the SL479 supply based on the pricing
information contained on the other submitted invoices. We also received
several invoices for the 3C patch system (SD343) supply; however, since
we established a price of $625.00 for this supply in last year's CY
2021 PFS final rule and the submitted invoices had an average price of
$612.50, we are not proposing to update the price. We believe that the
submitted invoices confirm that the current pricing of $625.00 is
typical for the SD343 supply.
(2) Invoice Submission
The full list of updated supply and equipment pricing as
implemented over the 4-year transition period will be made available as
a public use file displayed on the CMS website under downloads for the
CY 2022 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC-recommended values for the codes. To be included in a given
year's proposed rule, we generally need to receive invoices by the same
February 10th deadline we noted for consideration of RUC
recommendations. However, we will consider invoices submitted as public
comments during the comment period following the publication of the PFS
proposed rule, and would consider any invoices received after February
10th or outside of the public comment process as part of our
established annual process for requests to update supply and equipment
prices. Stakeholders are encouraged to submit invoices with their
public comments or, if outside the notice and comment rulemaking
process, via email at [email protected].
(3) Autologous Platelet-Rich Plasma (HCPCS Code G0460) Supply Inputs
We did not make any proposals associated with HCPCS code G0460
(Autologous platelet rich plasma for chronic wounds/ulcers, including
phlebotomy, centrifugation, and all other preparatory procedures,
administration and dressings, per treatment) in the CY 2021 PFS
proposed rule. Following publication of the rule, stakeholders
contacted CMS regarding the creation of a new 3C patch system supply,
which is topically applied for the management of exuding cutaneous
wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and
mechanically or surgically-debrided wounds. Stakeholders first sought
clarification on how CMS calculated the underlying nonfacility PE RVUs
for HCPCS code G0460. Stakeholders also stated that autologous platelet
rich plasma administration procedures furnished in clinical trials
(including the new 3C patch system) are reported using HCPCS code G0460
and requested that CMS revalue the service to reflect the PEs
associated with the new patch system supply. The stakeholders stated
that the use of the new 3C patch system will represent the typical case
for HCPCS code G0460, and suggested that, therefore, the cost inputs
for this supply should be used to establish the RVUs for this code, as
the current PFS payment rate is substantially less than the amount it
costs to furnish the 3C patch.
We want to clarify that the direct PE inputs for HCPCS code G0460
increased for CY 2021 as a result of the ongoing market-based supply
and equipment pricing update. However, there was also a minor decrease
in the indirect PE allocation associated with this service for CY 2021,
with the net result that the proposed PE RVU coincidentally ended up
remaining the same as in the previous year. We also clarify that HCPCS
code G0460 is not included in the Anticipated Specialty Assignment for
Low Volume Services list, and therefore, was unaffected by low
utilization in the claims data. In addition, as a contractor priced
service, HCPCS code G0460 is unaffected by inclusion or exclusion from
this list.
We share the concerns of the stakeholders that patient access to
the 3C patch could be materially impacted if CMS maintains the current
PE RVUs for HCPCS G0460. In the CY 2021 PFS final rule, we established
contractor pricing for HCPCS code G0460 for CY 2021. We believe that
the use of contractor pricing again for CY 2022 will allow us
additional time to consider the most appropriate resource inputs and PE
RVUs for HCPCS code G0460. We also added the 3C patch system to our
supply database under supply code SD343 at a price of $625.00 based on
an average of the submitted invoices. We are proposing to maintain
contractor pricing for CY 2022 for HCPCS code G0460 as we do not
currently have sufficient information to establish national pricing. It
remains unclear to us what the typical supply inputs would be for HCPCS
code G0460 and whether they would include the use of the new 3C patch
system. We believe that it would be more appropriate to maintain
contractor pricing for the service, which will allow for more
flexibility in pricing. We are soliciting any additional information
that commenters can supply that CMS should consider to establish
national payment for HCPCS code G0460.
d. Clinical Labor Pricing Update
Section 220(a) of the PAMA provides that the Secretary may collect
or obtain information from any eligible professional or any other
source on the resources directly or indirectly related to furnishing
services for which payment is made under the PFS, and
[[Page 39119]]
that such information may be used in the determination of relative
values for services under the PFS. Such information may include the
time involved in furnishing services; the amounts, types and prices of
PE inputs; overhead and accounting information for practices of
physicians and other suppliers, and any other elements that would
improve the valuation of services under the PFS.
Since 2019, we have been updating the supply and equipment prices
used for PE as part of a market-based pricing transition; CY 2022 will
be the final year of this 4-year transition. We initiated a market
research contract with StrategyGen to conduct an in-depth and robust
market research study to update the supply and equipment pricing for CY
2019, and we finalized a policy in CY 2019 to phase in the new pricing
over a period of 4 years. However, we did not propose to update the
clinical labor pricing, and the pricing for clinical labor has remained
unchanged during this pricing transition. Clinical labor rates were
last updated for CY 2002 using Bureau of Labor Statistics (BLS) data
and other supplementary sources where BLS data were not available; we
refer readers to the full discussion in the CY 2002 PFS final rule for
additional details (66 FR 55257 through 55262).
Stakeholders have raised concerns that the long delay since
clinical labor pricing was last updated has created a significant
disparity between CMS' clinical wage data and the market average for
clinical labor. In recent years, a number of stakeholders have
suggested that certain wage rates are inadequate because they do not
reflect current labor rate information. Some stakeholders have also
stated that updating the supply and equipment pricing without updating
the clinical labor pricing could create distortions in the allocation
of direct PE. Since the pool of aggregated direct PE inputs is budget
neutral, if these rates are not routinely updated, clinical labor may
become undervalued over time relative to equipment and supplies,
especially since the supply and equipment prices are in the process of
being updated. There has been considerable stakeholder interest in
updating the clinical labor rates, and when we solicited comment on
this topic in past rules, such as in the CY 2019 PFS final rule (83 FR
59480), stakeholders supported the idea.
Therefore, we are proposing to update the clinical labor pricing
for CY 2022, in conjunction with the final year of the supply and
equipment pricing update. We believe it is important to update the
clinical labor pricing to maintain relativity with the recent supply
and equipment pricing updates. We are proposing to use the methodology
outlined in the CY 2002 PFS final rule (66 FR 55257), which draws
primarily from BLS wage data, to calculate updated clinical labor
pricing. As we stated in the CY 2002 PFS final rule, the BLS'
reputation for publishing valid estimates that are nationally
representative led to the choice to use the BLS data as the main
source. We believe that the BLS wage data continues to be the most
accurate source to use as a basis for clinical labor pricing and this
data will appropriately reflect changes in clinical labor resource
inputs for purposes of setting PE RVUs under the PFS. We used the most
current BLS survey data (2019) as the main source of wage data for this
proposal.
We recognize that the BLS survey of wage data does not cover all
the staff types contained in our direct PE database. Therefore, we
crosswalked or extrapolated the wages for several staff types using
supplementary data sources for verification whenever possible. In
situations where the price wages of clinical labor types were not
referenced in the BLS data, we have used the national salary data from
the Salary Expert, an online project of the Economic Research Institute
that surveys national and local salary ranges and averages for
thousands of job titles using mainly government sources. (A detailed
explanation of the methodology used by Salary Expert to estimate
specific job salaries can be found at www.salaryexpert.com). We
previously used Salary Expert information as the primary backup source
of wage data during the last update of clinical labor pricing in CY
2002. If we did not have direct BLS wage data available for a clinical
labor type, we used the wage data from Salary Expert as a reference for
pricing, then crosswalked these clinical labor types to a proxy BLS
labor category rate that most closely matched the reference wage data,
similar to the crosswalks used in our PE/HR allocation. For example,
there is no direct BLS wage data for the Mammography Technologist
(L043) clinical labor type; we used the wage data from Salary Expert as
a reference and identified the BLS wage data for Respiratory Therapists
as the best proxy category. We calculated rates for the ``blend''
clinical labor categories by combining the rates for each labor type in
the blend and then dividing by the total number of labor types in the
blend.
As in the CY 2002 clinical labor pricing update, the proposed cost
per minute for each clinical staff type was derived by dividing the
average hourly wage rate by 60 to arrive at the per minute cost. In
cases where an hourly wage rate was not available for a clinical staff
type, the proposed cost per minute for the clinical staff type was
derived by dividing the annual salary (converted to 2021 dollars using
the Medicare Economic Index) by 2080 (the number of hours in a typical
work year) to arrive at the hourly wage rate and then again by 60 to
arrive at the per minute cost. To account for the employers' cost of
providing fringe benefits, such as sick leave, we used the same
benefits multiplier of 1.366 as employed in CY 2002. As an example of
this process, for the Physical Therapy Aide (L023A) clinical labor
type, the BLS data reflected an average hourly wage rate of $14.03,
which we multiplied by the 1.366 benefits modifier and then divided by
60 minutes to arrive at the proposed per-minute rate of $0.32.
Table 5 lists our proposed updates to the clinical labor prices.
The BLS occupational code used as a source of wage data is listed for
each clinical labor type; for the ``blend'' clinical labor types, this
may include multiple BLS occupational codes and other clinical labor
types which were calculated separately and then averaged together.
Clinical labor types without a direct BLS labor category where we are
employing a proxy BLS wage rate are indicated with an asterisk in Table
5.
BILLING CODE 4120-01-P
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We are proposing to use the 75th percentile of the average wage
data for the Medical Physicist (L152A) clinical labor type because we
believe this level
[[Page 39121]]
would most closely fit with the historic wage data for this clinical
labor type. A Medical Physicist is a specific type of physicist, and
the available BLS wage data describes the more general category of
physicist which is paid at a lower rate. In this specific case, the
75th percentile more accurately describes the clinical labor type in
question based on how it has historically been paid. We are also
proposing to maintain the current clinical labor pricing for the
Behavioral Health Care Manager (L057B) clinical labor type rather than
update it. Although the BLS data reflected a decreased clinical labor
rate for the Behavioral Health Care Manager labor type, we do not
believe that the typical wages have decreased for this clinical labor
type given that every other clinical labor type has increased over the
past 5 years since the Behavioral Health Care Manager clinical labor
type was created. The Behavioral Health Care Manager labor type was
initially established in the CY 2017 PFS final rule (81 FR 80350). It
seems more likely that we misidentified the proper BLS category for
this clinical labor type than that wages have decreased since 2017. We
believe that the clinical labor rate for the Behavioral Health Care
Manager should be held constant for CY 2022 pending additional public
feedback.
We are soliciting comments on the proposed updated clinical labor
pricing. We are particularly interested in additional wage data for the
clinical labor types for which we lacked direct BLS wage data and made
use of proxy labor categories for pricing. We understand that the
clinical labor undertaken by, for example, a Histotechnologist (L037B)
is not the same as the clinical labor provided by the Health
Information Technologist category of BLS wage data that we employed as
a proxy for pricing. Although these occupations are not directly
analogous to each other in terms of the work they do, we nonetheless
believe that the proposed crosswalks are appropriate in terms of the
resulting hourly wage data. We appreciate any additional information
that commenters can supply both in terms of direct wage data, as well
as identifying the most accurate types of BLS categories that could be
used as proxies to update pricing for clinical labor types that lack
direct BLS wage data. We isolated the anticipated effects of the
clinical labor pricing update on specialty payment impacts by comparing
the proposed CY 2022 PFS rates with and without the clinical labor
pricing updates in place:
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BILLING CODE 4120-01-C
The potential effects of the clinical labor pricing update on
specialty payment impacts are largely driven by the share that labor
costs represent of the direct PE inputs for each specialty. Specialties
with a substantially lower or higher than average share of direct costs
attributable to labor would experience significant declines or
increases, respectively, if this proposal is finalized. For example,
the Family Practice specialty has a higher share of direct costs
associated with clinical labor, and payments to services comprising the
specialty would be expected to increase as a result of this clinical
labor pricing update. In contrast, Diagnostic Testing Facilities have a
lower share of direct costs that are associated with clinical labor,
and payments to services comprising the specialty would be expected to
decrease. Other specialty-level payment impacts for the proposed
clinical labor pricing changes are driven by changes in wage rates for
a clinical labor category that affects a given specialty more than
average. One such example would be the proposed increase of 11 percent
for Oncology nurses as opposed to the average increase for nurses of 63
percent. We emphasize that these are not the projected impacts by
specialty of all the policies we are proposing in this proposed rule
for CY 2022, only the anticipated effect of the isolated clinical labor
pricing update, should this clinical labor pricing update be finalized
as proposed.
When updates to our payment methodology based on new data produce
significant shifts in payment, we often consider whether it would be
appropriate to implement the updates through a phased transition across
several calendar years. For example, we utilized a 4-year transition
for the market-based supply and equipment pricing update concluding in
CY 2022. We are considering the use of a similar 4-year transition to
implement the clinical labor pricing update. A multi-year transition
could smooth out the increases and decreases in payment caused by the
pricing update for affected stakeholders, promoting payment stability.
However, a phased transition would delay the full implementation of
updated pricing and continue to rely in part on outdated data for
clinical labor pricing. We discuss a potential 4-year transition for
the clinical labor pricing update as an alternative considered in the
Regulatory Impact Analysis (section VII.I) of this rule.
e. Proposal To Establish Values for Remote Retinal Imaging (CPT Code
92229), Comment Solicitation for Fractional Flow Reserve Derived From
Computed Tomography (CPT Code 0503T), and Comment Solicitation for
Codes Involving Innovative Technology
Rapid advances in innovative technology are having a profound
effect on every facet of the economy, including in the delivery of
health care. Emerging and evolving technologies are introducing
advances in treatment options that have the potential to increase
access to care for Medicare beneficiaries, improve outcomes, and reduce
overall costs to the program. While new services have emerged over the
last several years, it is possible that the COVID-19 public health
emergency (PHE) could be accelerating the supply and demand for these
innovations. Emerging and evolving technologies could be useful tools
for improving disparities in care that have been exacerbated by the
PHE. Some of these new applications have codes for which innovative
technology is substituting for and/or augmenting physician work. For
example, the CPT Editorial Panel created CPT code 92229 (Imaging of
retina for detection or monitoring of disease; point-of-care automated
analysis and report, unilateral or bilateral), a diagnostic test for
diabetic retinopathy that uses a software algorithm, and the RUC
provided valuation recommendations which included a retinal camera and
an analysis fee for remote imaging. In the CY 2021 PFS final rule (85
FR 84629 through 84630), we considered CPT code 92229 to be a
diagnostic service under the PFS, contractor-priced it, and stated that
we would have ongoing conversations with stakeholders. The following
section will discuss proposed policies to establish RVUs for CPT code
92229, solicit feedback to establish RVUs for CPT code 0503T
(Noninvasive estimated coronary fractional flow reserve (FFR) derived
from coronary computed tomography angiography data using computation
fluid dynamics physiologic simulation software analysis of functional
data to assess the severity of coronary artery disease; analysis of
fluid dynamics and simulated maximal coronary hyperemia, and generation
of estimated FFR model), and solicit feedback to help us better
understand the resource costs for services involving the use of
innovative technologies such as software algorithms and artificial
intelligence (AI).
In our discussion of CPT code 92229 in the CY 2021 PFS final rule
(85 FR 84629 through 84630), we wrote that as the data used in our PE
methodology have aged, and more services have begun to include
innovative technology such as software algorithms and AI, these
innovative applications are not well accounted for in our PE
methodology. As described earlier in this section, PE resources
involved in furnishing services are characterized as either direct or
indirect costs. Direct costs of the PE resources involved in furnish a
service are estimated for each code and include clinical labor, medical
supplies, and medical equipment. Indirect costs include administrative
labor, office expenses, and all other expenses. Indirect PE is
allocated to each service based on physician work, direct costs, and a
specialty-specific indirect percentage. The source of the specialty
specific indirect percentage was the Physician Practice Information
Survey (PPIS), last administered in 2007 and 2008, when emerging
technologies that rely primarily on software, licensing, and analysis
fees, with minimal costs in equipment and hardware may not have been
typical. Thus, these costs are not well accounted for in the PE
methodology.
Consistent with our PE methodology and as we have stated in past
PFS rulemaking (83 FR 59557), we have considered most computer software
and associated analysis and licensing fees to be indirect costs tied to
costs for associated hardware that is considered to be medical
equipment. In the case of CPT code 92229, the hardware is a retinal
camera used for remote imaging. Given that indirect costs are based on
physician work, direct costs, and
[[Page 39124]]
specialty-specific indirect percentages that can include high-cost
equipment, our concern is that if we were to consider an analysis fee
to be a supply cost, as was recommended by the RUC, it is possible that
we would inadvertently allocate too many indirect costs for a supply
item that may not require additional indirect expenses. Unlike a piece
of equipment, such as the retinal camera, an analysis fee for software
does not require physical space in an office or administrative staff
hours to maintain it.
However, increasingly, stakeholders have routinely expressed
concerns with our policy to consider analysis fees as indirect costs,
especially for evolving technologies that rely primarily on these fees
with minimal costs in equipment or hardware. In comments in the CY 2021
PFS final rule (85 FR 84629 through 84630) responding to our proposal
to price the analysis fee for remote imaging as an indirect cost,
stakeholders stated that there would be no service if the software was
not used. There are two aspects that distinguish CPT code 92229 from
other services. First, most of the RUC's recommended resource costs for
CPT code 92229 were for the analysis fee, rather than high-cost
equipment or other supplies that require commensurate indirect costs to
accommodate for space or administrative labor. Second, the innovative
technology incorporated into the service is a software algorithm, which
interprets data collected during the test, either augmenting the work
of the physician or NPP performing the test, or in some cases replacing
at least some work that a physician would typically furnish. In
general, it is possible that physician work time and intensity of
furnishing care to patients could be affected as more services that
involve innovative technologies such as software algorithms or AI
become available.
We finalized a policy to establish contractor pricing for CPT code
92229 (85 FR 84629 through 84630) because analysis fees for software
algorithms and AI applications are not well accounted for our PE
methodology, and to recognize that practitioners do incur resource
costs for purchase and ongoing use of the software. We stated that we
would continue to seek out new data sources and have ongoing
conversations with stakeholders while also considering other approaches
to reflect overall resource costs for these technologies in our PE
methodology.
As we described in the CY 2021 PFS final rule (85 FR 84498 through
84499), the RAND Corporation is currently studying potential
improvements to CMS' PE allocation methodology and the data that
underlie it. RAND has found that the PPIS data last collected in 2007-
2008 may no longer reflect the resource allocation, staffing
arrangements, and cost structures that describe practitioners' resource
requirements in furnishing services to Medicare beneficiaries, and
consequently may not accurately capture the indirect PE resources
required to furnish services to Medicare FFS beneficiaries. Our
experience with the challenge of accurately accounting for resource
costs for innovative and emerging technologies such as ongoing service-
specific software costs that are included in CPT code 92229 is another
reason we continue to be interested in potentially refining the PE
methodology and updating the data used to establish RVUs and payment
rates under the PFS. We commonly employ a crosswalk to recognize
resource costs when we lack the inputs that we would need to calculate
work, PE, and/or malpractice RVUs for a service otherwise. When we use
a crosswalk to value a service, we substitute the established RVUs for
other services with similar resource costs in the physician office
setting to set RVUs and the national payment rates for that particular
service.
For CY 2022, we are proposing to establish values for CPT code
92229 using our crosswalk approach, and thus this service would no
longer be contractor-priced. We continue to believe that the software
algorithm present in the analysis fee for CPT code 92229 is not well
accounted for in our PE methodology; however, we recognize that
practitioners are incurring resource costs for purchase of the software
and its ongoing use. We are proposing to use a crosswalk that reflects
the overall relative resource costs for this service while we continue
to consider potentially refining the PE methodology and updating the
data we use to establish PE RVUs under the PFS. Specifically, we are
proposing a crosswalk to CPT code 92325 (Modification of contact lens
(separate procedure), with medical supervision of adaptation), a PE-
only code used for the eye, as we believe it reflects overall resource
costs for CPT code 92229 in the physician office setting. We recognize
that the services described by CPT code 92325 are not the same as the
services in CPT code 92229; however, we believe that the total resource
costs would be similar across these two codes. We believe that
crosswalking the RVUs for CPT code 92229 to a code with similar
resource costs allows CMS to recognize that practitioners are incurring
resource costs for the purchase and ongoing use of the software
employed in CPT code 92229, which would not typically be considered
direct PE under our current methodology. We are also soliciting
comments on our proposal to crosswalk CPT code 92229 to CPT code 92325,
and whether other codes would provide a more appropriate crosswalk in
terms of resource costs. In addition, as discussed in section II.E of
this proposed rule, we are proposing to use our crosswalk approach for
CPT code 77X01 (Trabecular bone score (TBS), structural condition of
the bone microarchitecture; using dual X-ray absorptiometry (DXA) or
other imaging data on gray-scale variogram, calculation, with
interpretation and report on fracture risk) and CPT code 77X03
(Trabecular bone score (TBS), structural condition of the bone
microarchitecture; using dual X-ray absorptiometry (DXA) or other
imaging data on gray-scale variogram, calculation, with interpretation
and report on fracture risk, technical calculation only).
We are aware of other services that use similar innovative
technologies to those used for the diagnostic test for diabetic
retinopathy and trabecular bone score, and that those technologies also
are not well-accounted for in our PE methodology. For CY 2018, the AMA
CPT Editorial Panel established four new Category III CPT codes for
fractional flow reserve derived from computed tomography (FFRCT): CPT
code 0501T (Noninvasive estimated coronary fractional flow reserve
(FFR) derived from coronary computed tomography angiography data using
computation fluid dynamics physiologic simulation software analysis of
functional data to assess the severity of coronary artery disease; data
preparation and transmission, analysis of fluid dynamics and simulated
maximal coronary hyperemia, generation of estimated FFR model, with
anatomical data review in comparison with estimated FFR model to
reconcile discordant data, interpretation and report) CPT code 0502T
(Noninvasive estimated coronary fractional flow reserve (FFR) derived
from coronary computed tomography angiography data using computation
fluid dynamics physiologic simulation software analysis of functional
data to assess the severity of coronary artery disease; data
preparation and transmission); CPT code 0503T (Noninvasive estimated
coronary fractional flow reserve (FFR) derived from coronary computed
tomography angiography data using computation fluid dynamics
physiologic
[[Page 39125]]
simulation software analysis of functional data to assess the severity
of coronary artery disease; analysis of fluid dynamics and simulated
maximal coronary hyperemia, and generation of estimated FFR model); and
CPT code 0504T (Noninvasive estimated coronary fractional flow reserve
(FFR) derived from coronary computed tomography angiography data using
computation fluid dynamics physiologic simulation software analysis of
functional data to assess the severity of coronary artery disease;
anatomical data review in comparison with estimated FFR model to
reconcile discordant data, interpretation and report). FFRCT is a
noninvasive diagnostic service that allows physicians to measure
coronary artery disease in a patient through coronary CT scans. It uses
a proprietary data analysis process performed at a central facility to
develop a three-dimensional image of a patient's coronary arteries,
which allows physicians to identify the fractional flow reserve to
assess whether or not patients should undergo further invasive testing
or treatment (typically, a coronary angiogram). We understand that
FFRCT can show through non-invasive imaging whether a beneficiary has
coronary artery disease thereby potentially avoiding an invasive
coronary procedure. Medicare began payment for CPT code 0503T in the
hospital outpatient department setting under the Outpatient Prospective
Payment System (OPPS) in CY 2018 (82 FR 59284). For the PFS, we
typically assign contractor pricing for Category III codes since they
are temporary codes assigned to emerging technology and services. We
followed this established process for Category III codes by assigning
and listing them as contractor pricing in Appendix B in the CY 2018 PFS
final rule (available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/
CMS-1676-F). We have since been trying to understand the costs of the
PE resource inputs for CPT code 0503T in the physician office setting.
In the CY 2021 PFS final rule, we stated that we found FFRCT to be
similar to other technologies that use algorithms, artificial
intelligence, or other innovative forms of analysis to determine a
course of treatment, where the analysis portion of the service cannot
adequately be reflected under the PE methodology; and that our recent
reviews for the overall cost of CPT code 0503T have shown the costs in
the physician office setting to be similar to costs reflected in
payment under the OPPS (85 FR 84630). For the CY 2021 OPPS/ASC final
rule, we found that the geometric mean cost reported by hospital
outpatient departments for the service was $804.35 (85 FR 85943). We
believe the costs reported under the OPPS are instructive as they
reflect actual costs that hospitals incurred in furnishing the service
described by CPT code 0503T to Medicare beneficiaries, and, as we
stated in the CY 2021 PFS final rule, we believe that these costs would
be similar in the physician office setting. Using the geometric mean
costs under the OPPS as a proxy, we then searched for services paid
under the PFS that could potentially serve as a crosswalk.
Specifically, we looked for services paid under the PFS that include
only a technical component because CPT code 0503T is a technical
component-only service, and that have similar total costs to CPT code
0503T. We identified the following potential crosswalks, and seek
public comment on which, if any of them, would be appropriate: CPT code
93455 (Catheter placement in coronary artery(s) for coronary
angiography, including intraprocedural injection(s) for coronary
angiography, imaging supervision and interpretation; with catheter
placement(s) in bypass graft(s) (internal mammary, free arterial,
venous grafts) including intraprocedural injection(s) for bypass graft
angiography) and CPT code 93458 (Catheter placement in coronary
artery(s) for coronary angiography, including intraprocedural
injection(s) for coronary angiography, imaging supervision and
interpretation; with left heart catheterization including
intraprocedural injection(s) for left ventriculography, when
performed). We are also seeking comment on whether other codes would
provide a more appropriate crosswalk in terms of resource costs.
We are also more broadly soliciting public comment to help us
better understand the resource costs for services involving the use of
innovative technologies, including but not limited to software
algorithms and AI. Specifically, we are requesting commenters consider
the following questions:
To what extent are services involving innovative
technologies such as software algorithms and/or AI substitutes and/or
supplements for physician work? To what extent do these services
involving innovative technology inform, augment, or replace physician
work? For example, CPT code 92229 is a PE-only code in which the
software algorithm may be substituting for some work of an
ophthalmologist to diagnose/detect diabetic retinopathy. CPT code 77X01
is a service in which the trabecular bone score software may be
supplementing physician work to predict and detect fracture risk. CPT
code 0503T may be both substituting for, and supplementing physician
work to detect coronary artery disease.
How has innovative technology such as software algorithms
and/or AI affected physician work time and intensity of furnishing
services involving the use of such technology to Medicare
beneficiaries? For example, if a new software algorithm or AI
technology for a diagnostic test results in a reduction in the amount
of time that a practitioner spends reviewing and interpreting the
results of a diagnostic test that previously did not involve such
software algorithm or AI technology, and if the software algorithm or
AI could be considered in part a substitute for at least some physician
work, it may follow that the intensity of the service decreases. It is
also possible that a software algorithm for a diagnostic test that is
supplementing other tests to establish a diagnosis or treatment pathway
for a particular condition could result in an increase in the amount of
time that a practitioner spends explaining the test to a patient and
then reviewing the results.
How is innovative technology such as software algorithms
and/or AI changing cost structures in the physician office setting? As
discussed previously, the PPIS data that underlie the PE methodology
were last collected in 2007 and 2008, which was prior to the widespread
adoption of electronic health records and services that involve care
management, non-face-to-face and/or asynchronous remote care; the need
to use electronic clinical quality measure data to support quality
improvement, disparity identification and resolution, and value based
payment; and the emergence of software algorithms and/or AI and other
technologies that use data to inform, augment, or replace physician
work in the delivery of health care. Do costs for innovative technology
such as software algorithms and/or AI to furnish services to patients
involve a one-time investment and/or recurring costs? How should CMS
consider costs for software algorithms and/or AI that use patient data
that were previously collected as part of another service? As
technology adoption grows, do these costs decrease over time?
How is innovative technology affecting beneficiary access
to Medicare-covered services? How are services involving software
algorithms and/or AI being furnished to Medicare beneficiaries and what
is important for
[[Page 39126]]
CMS to understand as it considers how to accurately pay for services
involving software algorithms and/or AI? For example, it is possible
that services that involve software algorithms and/or AI may allow a
practitioner to more efficiently furnish care to more Medicare
beneficiaries, potentially increasing access to care. Additionally, to
what extent have services that involve innovative technology such as
software algorithms and/or AI affected access to Medicare-covered
services in rural and/or underserved areas, or for beneficiaries that
may face barriers (homelessness, lack of access to transportation,
lower levels of health literacy, lower rates of internet access, mental
illness, having a high number of chronic conditions/frailty, etc.) in
obtaining health care?
Compared to other services paid under the PFS, are
services that are driven by or supported by innovative technology such
as software algorithms and/or AI at greater risk of overutilization or
more subject to fraud, waste, and abuse? As we are considering
appropriate payment for services enabled by new technologies, there are
considerations for program integrity. For example, section 218(b) of
the PAMA required that we establish an Appropriate Use Criteria Program
to promote appropriate use of advanced diagnostic imaging services
provided to Medicare beneficiaries.\1\ To what extent do services
involving innovative technology require mechanisms such as appropriate
use criteria to guard against overutilization, fraud, waste, or abuse?
---------------------------------------------------------------------------
\1\ Appropriate Use Criteria Program. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program.
---------------------------------------------------------------------------
Compared to other services paid under the PFS, are
services driven by or supported by innovative technology such as
software algorithms and/or AI associated with improvements in the
quality of care or improvements in health equity? For example,
increased access to services to detect diabetic retinopathy such as the
service described by CPT code 92229 could eventually lead to fewer
beneficiaries losing their vision. Because CPT code 92229 can be
furnished in a primary care practice's office and may not require the
specialized services of an ophthalmologist, more beneficiaries could
have access to a test, including those who live in areas with fewer
ophthalmologists. Additionally, taking into consideration that a
software algorithm and/or AI may introduce bias into clinical decision
making that could influence outcomes for racial and ethnic minorities
and people who are socioeconomically disadvantaged, are there
guardrails, such as removing the source of bias in a software algorithm
and/or AI, that Medicare should require as part of considering payment
amounts for services enabled by software algorithm and/or AI?
Our proposals to use crosswalks to set values for codes
describing diabetic retinopathy and trabecular bone score would allow
us to account for overall resource costs involved in furnishing the
services. The possible crosswalks for FFRCT may also account for
overall resource costs involved in furnishing the service. We also
believe it is important to accurately account for resource costs for
innovative and emerging technologies such as ongoing service-specific
software costs and, as explained above, such costs are not well
accounted for in the PE methodology. We continue to be interested in
potentially refining the PE methodology and updating the underlying
data, including the PPIS data that are the data source that underpins
the indirect PE allocation. How might CMS consider updating such data
to reflect ongoing advances in technology so that we could establish
appropriate relative values without resorting to crosswalks? The RAND
Corporation laid out a number of issues for CMS to consider in two
reports. We refer readers to RAND's first phase of research, available
at https://www.rand.org/pubs/research_reports/RR2166.html, and RAND's
second phase of research, available at https://www.rand.org/pubs/research_reports/RR3248.html.
C. Potentially Misvalued Services Under the PFS
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the relative
value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of
the Act requires the Secretary to periodically identify potentially
misvalued services using certain criteria and to review and make
appropriate adjustments to the relative values for those services.
Section 1848(c)(2)(L) of the Act also requires the Secretary to develop
a process to validate the RVUs of certain potentially misvalued codes
under the PFS, using the same criteria used to identify potentially
misvalued codes, and to make appropriate adjustments.
As discussed in section II.E. of this proposed rule, Valuation of
Specific Codes, each year we develop appropriate adjustments to the
RVUs taking into account recommendations provided by the American
Medical Association (AMA) Resource-Based Relative Value Scale (RVS)
Update Committee (RUC), the Medicare Payment Advisory Commission
(MedPAC), and other stakeholders. For many years, the RUC has provided
us with recommendations on the appropriate relative values for new,
revised, and potentially misvalued PFS services. We review these
recommendations on a code-by-code basis and consider these
recommendations in conjunction with analyses of other data, such as
claims data, to inform the decision-making process as authorized by
statute. We may also consider analyses of work time, work RVUs, or
direct PE inputs using other data sources, such as Department of
Veteran Affairs (VA), National Surgical Quality Improvement Program
(NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based
Incentive Payment System (MIPS) data. In addition to considering the
most recently available data, we assess the results of physician
surveys and specialty recommendations submitted to us by the RUC for
our review. We also consider information provided by other
stakeholders. We conduct a review to assess the appropriate RVUs in the
context of contemporary medical practice. We note that section
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
other techniques to determine the RVUs for physicians' services for
which specific data are not available and requires us to take into
account the results of consultations with organizations representing
physicians who provide the services. In accordance with section 1848(c)
of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed
the importance of appropriately valuing physicians' services, noting
that misvalued services can distort the market for physicians'
services, as well as for other health care services that physicians
order, such as hospital services. In that same report, MedPAC
postulated that physicians' services under the PFS can become misvalued
over time. MedPAC stated, ``When a new service is added to the
physician fee schedule, it may be assigned a relatively high value
because of the time, technical skill, and psychological stress that are
often required to furnish that service. Over time, the work
[[Page 39127]]
required for certain services would be expected to decline as
physicians become more familiar with the service and more efficient in
furnishing it.'' We believe services can also become overvalued when PE
costs decline. This can happen when the costs of equipment and supplies
fall, or when equipment is used more frequently than is estimated in
the PE methodology, reducing its cost per use. Likewise, services can
become undervalued when physician work increases or PE costs rises.
As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since
MedPAC made the initial recommendations, CMS and the RUC have taken
several steps to improve the review process. Also, section
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
Secretary to specifically examine, as determined appropriate,
potentially misvalued services in the following categories:
Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in PE.
Codes that describe new technologies or services within an
appropriate time-period (such as 3 years) after the relative values are
initially established for such codes.
Codes which are multiple codes that are frequently billed
in conjunction with furnishing a single service.
Codes with low relative values, particularly those that
are often billed multiple times for a single treatment.
Codes that have not been subject to review since
implementation of the fee schedule.
Codes that account for the majority of spending under the
PFS.
Codes for services that have experienced a substantial
change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site
of service since the code was last valued.
Codes for which there is a significant difference in
payment for the same service between different sites of service.
Codes for which there may be anomalies in relative values
within a family of codes.
Codes for services where there may be efficiencies when a
service is furnished at the same time as other services.
Codes with high intraservice work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the
Secretary may use existing processes to receive recommendations on the
review and appropriate adjustment of potentially misvalued services. In
addition, the Secretary may conduct surveys, other data collection
activities, studies, or other analyses, as the Secretary determines to
be appropriate, to facilitate the review and appropriate adjustment of
potentially misvalued services. This section also authorizes the use of
analytic contractors to identify and analyze potentially misvalued
codes, conduct surveys or collect data, and make recommendations on the
review and appropriate adjustment of potentially misvalued services.
Additionally, this section provides that the Secretary may coordinate
the review and adjustment of any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well. Individuals and stakeholder groups may submit codes for review
under the potentially misvalued codes initiative to CMS in one of two
ways. Nominations may be submitted to CMS via email or through postal
mail. Email submissions should be sent to the CMS emailbox
[email protected], with the phrase ``Potentially
Misvalued Codes'' and the referencing CPT code number(s) and/or the CPT
descriptor(s) in the subject line. Physical letters for nominations
should be sent via the U.S. Postal Service to the Centers for Medicare
& Medicaid Services, Mail Stop: C4-01-26, 7500 Security Blvd.,
Baltimore, Maryland 21244. Envelopes containing the nomination letters
must be labeled ``Attention: Division of Practitioner Services,
Potentially Misvalued Codes''. Nominations for consideration in our
next annual rule cycle should be received by our February 10th
deadline. Since CY 2009, as a part of the annual potentially misvalued
code review and Five-Year Review process, we have reviewed over 1,700
potentially misvalued codes to refine work RVUs and direct PE inputs.
We have assigned appropriate work RVUs and direct PE inputs for these
services as a result of these reviews. A more detailed discussion of
the extensive prior reviews of potentially misvalued codes is included
in the Medicare Program; Payment Policies Under the Physician Fee
Schedule, Five-Year Review of Work Relative Value Units, Clinical
Laboratory Fee Schedule: Signature on Requisition, and Other Revisions
to Part B for CY 2012; final rule (76 FR 73052 through 73055)
(hereinafter referred to as the ``CY 2012 PFS final rule with comment
period''). In the CY 2012 PFS final rule with comment period (76 FR
73055 through 73958), we finalized our policy to consolidate the review
of physician work and PE at the same time, and established a process
for the annual public nomination of potentially misvalued services.
In the Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the
Requirement for Termination of Non-Random Prepayment Complex Medical
Review and Other Revisions to Part B for CY 2013 (77 FR 68892)
(hereinafter referred to as the ``CY 2013 PFS final rule with comment
period''), we built upon the work we began in CY 2009 to review
potentially misvalued codes that have not been reviewed since the
implementation of the PFS (so-called ``Harvard-valued codes''). In the
Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2009; and Revisions to
the Amendment of the E-Prescribing Exemption for Computer Generated
Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter
referred to as
[[Page 39128]]
the ``CY 2009 PFS proposed rule''), we requested recommendations from
the RUC to aid in our review of Harvard-valued codes that had not yet
been reviewed, focusing first on high-volume, low intensity codes. In
the fourth Five-Year Review (76 FR 32410), we requested recommendations
from the RUC to aid in our review of Harvard-valued codes with annual
utilization of greater than 30,000 services. In the CY 2013 PFS final
rule with comment period, we identified specific Harvard-valued
services with annual allowed charges that total at least $10,000,000 as
potentially misvalued. In addition to the Harvard-valued codes, in the
CY 2013 PFS final rule with comment period we finalized for review a
list of potentially misvalued codes that have stand-alone PE (codes
with physician work and no listed work time and codes with no physician
work that have listed work time). We continue each year to consider and
finalize a list of potentially misvalued codes that have or will be
reviewed and revised as appropriate in future rulemaking.
3. CY 2022 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606
through 67608), we modified this process whereby the public and
stakeholders may nominate potentially misvalued codes for review by
submitting the code with supporting documentation by February 10th of
each year. Supporting documentation for codes nominated for the annual
review of potentially misvalued codes may include the following:
Documentation in peer reviewed medical literature or other
reliable data that demonstrate changes in physician work due to one or
more of the following: Technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example, VA, NSQIP, the STS National Database,
and the MIPS data).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate for each nominated code whether we
agree with its inclusion as a potentially misvalued code. The public
has the opportunity to comment on these and all other proposed
potentially misvalued codes. In that year's final rule, we finalize our
list of potentially misvalued codes.
a. Public Nominations
In this proposed rule, we are soliciting comments regarding the
potentially misvalued codes nominated by the public to inform our
decision on whether to establish the codes as potentially misvalued in
the CY 2022 PFS final rule. We received public nominations for
potentially misvalued codes by February 10th. We display these public
nominations on our public website, including the submitter's name and
their associated organization to provide full transparency. Among the
public nominations that we received this year, one was a request for
CMS to review a PE-related input for a code. We refer readers to
section II.B. of this proposed rule, Determination of PE RVUs, for
further discussion on the PE-related submission. The summary of this
year's submissions under the potentially misvalued code initiative are
discussed below.
A stakeholder nominated CPT code 22551 (Fusion of spine bones with
removal of disc at upper spinal column, anterior approach, complex)
``and common related services'' as potentially misvalued. Citing the CY
2021 PFS final rule (84 FR 84501) where CMS agreed with the public
nomination of CPT code 22867 (Insertion of interlaminar/interspinous
process stabilization/distraction device, without fusion, including
image guidance when performed, with open decompression, lumbar; single
level) as potentially misvalued, and discussed the relationship between
CPT code 22867 and CPT code 63047 (Laminectomy, facetectomy and
foraminotomy (unilateral or bilateral with decompression of spinal
cord, cauda equina and/or nerve root[s], [e.g., spinal or lateral
recess stenosis]), single vertebral segment; lumbar), this stakeholder
suggests that there are additional CPT code values related to spine
procedures that are in need of contemporaneous review with CPT code
22867. The stakeholder believes that CMS has an interest in reviewing
associated anterior cervical discectomy and fusion (ACDF) procedures as
well, and suggests that CPT code 22551 ``and common related services''
can result in cumulative RVUs that do not sufficiently reflect
physician work, time, or outcomes.
In their submission, the stakeholder expressed concern that there
is a discrepancy between the typical total RVUs for codes billed for
vertebral fusion procedures performed using three synthetic cage
devices with plate and vertebral fusion procedures performed using
three allografts with plate. Both methods of vertebral fusion are
described by CPT code 22551 (includes a 90-day global period), which
has a work RVU of 25.00. Both methods of vertebral fusion involve two
units of CPT code 22552 (Arthrodesis, anterior interbody, including
disc space preparation, discectomy, osteophytectomy and decompression
of spinal cord and/or nerve roots; cervical below C2, each additional
interspace (List separately in addition to code for primary procedure)
(ZZZ global period)) with a total work RVU of 13.00 (6.50 x 2); and
both methods of vertebral fusion involve 1 unit of CPT code 22846
(Anterior instrumentation; 4 to 7 vertebral segments (List separately
in addition to code for primary procedure) (ZZZ global period)) with a
work RVU of 12.40. The vertebral fusion method employing three
synthetic cage devices with a plate would involve CPT code 22853
(Insertion of interbody biomechanical device(s) (e.g., synthetic cage,
mesh) with integral anterior instrumentation for device anchoring
(e.g., screws, flanges), when performed, to intervertebral disc space
in conjunction with interbody arthrodesis, each interspace (List
separately in addition to code for primary procedure) (ZZZ global
period)) for the insertion of synthetic cage devices for a total work
RVU of 12.75 (4.25 x 3), and CPT code 20930 (Allograft, morselized, or
[[Page 39129]]
placement of osteopromotive material, for spine surgery only (List
separately in addition to code for primary procedure)) with a work RVU
of 0.00 (because Medicare considers this code to be bundled into codes
for other services). The stakeholder stated that the total work RVUs
for the typical vertebral fusion employing three synthetic cage devices
with plate would be 63.15 work RVUs.
In contrast, the stakeholder asserted that the vertebral fusion
method employing three allografts with plate involves the same set of
services and codes (CPT code 22551 (090 global period) and CPT code
22846 (ZZZ global period)), but instead of CPT codes 22853 or 20930,
involve CPT code 20931 (Allograft, structural, for spine surgery only
(List separately in addition to code for primary procedure) (ZZZ global
period) with a work RVU of 1.81. Altogether, the total work RVUs for
CPT codes involved in this vertebral fusion method is 52.21. The
stakeholder suggested that this difference in total work RVUs, 63.15
versus 52.21, is evidence that these services are misvalued, and that
the total work RVUs do not reflect the differences in the amount of
work, resources, and intensity between the two vertebral fusion
methods.
This stakeholder's description of the potential misvaluation of CPT
code 22551 ``and common related services'' differs from the CMS
approach to identifying potentially misvalued services by using certain
criteria, as described in the beginning of this section. Our
determination that one or more codes are potentially misvalued
generally revolves around the specific RVUs assigned to an individual
code, or several codes within a family of codes. CMS generally does not
examine the summed differences in total RVUs based on billing patterns
using different codes in different scenarios, representing different
physician work, and then comparing the two methods of a procedure, in
this case, the use or non-use, of the synthetic cage devices in the
vertebral fusion with removal of the disc in the upper spinal column.
We do not believe that the stakeholder has provided support for the
premise that CPT code 22551 alone is misvalued, or that any of the
codes identified as common related services are misvalued. Therefore,
we are not inclined to propose this code as potentially misvalued.
However, we welcome additional comment, including any analysis or
studies demonstrating that one or more of these codes meet the criteria
listed above under ``Identification and Review of Potentially Misvalued
Services,'' particularly in regard to any changes in the resources to
providing a service, or are otherwise potentially misvalued.
A stakeholder nominated CPT code 49436 (Delayed creation of exit
site from embedded subcutaneous segment of intraperitoneal cannula or
catheter) as potentially misvalued, as it has not been valued for
payment in the non-facility/office setting. This stakeholder did not
include in their submission detailed recommendations for the items,
quantities, and unit costs for the supplies, equipment types, and
clinical labor (if any), that might be incurred in the non-facility/
office setting, all of which are key factors when determining potential
valuation or mis-valuation of a service. Medicare claims data for 2018,
2019, and 2020 show that CPT code 49436 is solely performed in the
facility ambulatory surgical center (ASC) setting. We are not inclined
to propose this code as potentially misvalued; however, we welcome
additional comment, including any analysis or studies demonstrating
that this code meets the criteria listed above under ``Identification
and Review of Potentially Misvalued Services,'' particularly in regard
to any changes in the resources to providing a service, or is otherwise
potentially misvalued.
A stakeholder nominated CPT code 55880 (Ablation of malignant
prostate tissue, transrectal, with high intensity-focused ultrasound
(HIFU), including ultrasound guidance) as potentially misvalued, as it
has not been valued in the non-facility/office setting. This
stakeholder also did not include in their submission detailed
recommendations for items, quantities, and unit costs for the supplies,
equipment types, and clinical labor (if any), that might be incurred in
the non-facility/office setting, all of which are key factors when
determining valuation or mis-valuation. This stakeholder stated that
the advances in High Intensity Focused Ultrasound (HIFU) technology
toward the destruction of cancerous tissues in the prostate gland have
matured to the point where this procedure is now equally as effective
and as safe as the cryoablation procedure described by CPT code 55873
(Cryosurgical ablation of the prostate (includes ultrasonic guidance
and monitoring)), which is currently valued in the non-facility/office
setting (186.69 total RVUs, approximately $6,514) and has been for
approximately 10 years. We note that CPT code 55880 was reviewed and
valued in the CY 2021 PFS final rule (85 FR 84614 through 84615) in the
facility setting only. Accordingly, we do not have enough claims data
for this code to make accurate comparisons to similar codes that may be
furnished in non-facility settings. There is no case presented here
that constitutes a misvaluation of CPT code 55880, and therefore, we
are not inclined to put this code forward as potentially misvalued for
CY 2022; however, we welcome additional comment, including any analysis
or studies demonstrating that this code meets the criteria listed above
under ``Identification and Review of Potentially Misvalued Services,''
particularly in regard to any changes in the resources to providing a
service, or is otherwise potentially misvalued.
A stakeholder nominated CPT code 59200 (Insertion cervical dilator
(e.g., laminaria, prostaglandin) as potentially misvalued because the
direct PE inputs do not include the supply item, Dilapan-S. This
stakeholder had sought to establish a Level II HCPCS code for Dilapan-
S, but CMS did not find sufficient evidence to support that request.
The stakeholder now submits Dilapan-S to be considered as PE supply
input to a Level I CPT code(s). This stakeholder seeks to add Dilapan-S
to the nonfacility/office PE inputs for CPT code 59200. Specifically,
the stakeholder recommends adding 4 rods of Dilapan-S at $80.00 per
unit, for a total of $320.00, as a replacement for the current PE
supply item, laminaria tent (a small rod of dehydrated seaweed that
when inserted in the cervix, rehydrates, absorbing the water from the
surrounding tissue in the woman's body), which is currently listed at
$4.0683 per unit, with a total of 3 units, for a total of $12.20. We
welcome additional comment, including any analysis or studies
demonstrating that this code meets the criteria listed above under
``Identification and Review of Potentially Misvalued Services,''
particularly in regard to any changes in the resources to providing a
service, or is otherwise potentially misvalued.
A stakeholder nominated CPT codes 66982 through 66986 as
potentially misvalued, as they have not been valued in the non-
facility/office setting. This stakeholder did not submit other details
or reasoning to support their nomination. We note that some of these
cataract-related procedures were initially reviewed and valued in CY
2020 PFS final rule (84 FR 62751), and that presently, additional codes
in this family are scheduled to be reviewed and valued in this CY 2022
PFS proposed rule (we refer readers to section II.E. of this proposed
rule, Valuation of Specific Codes). The highest utilization of these
cataract codes are CPT code 66982 (Extracapsular cataract removal with
insertion of intraocular lens prosthesis
[[Page 39130]]
(1-stage procedure), manual or mechanical technique (e.g., irrigation
and aspiration or phacoemulsification), complex, requiring devices or
techniques not generally used in routine cataract surgery (e.g., iris
expansion device, suture support for intraocular lens, or primary
posterior capsulorrhexis) or performed on patients in the amblyogenic
developmental stage; without endoscopic cyclophotocoagulation) and CPT
code 66984 (Extracapsular cataract removal with insertion of
intraocular lens prosthesis (1-stage procedure), manual or mechanical
technique (e.g., irrigation and aspiration or phacoemulsification);
without endoscopic cyclophotocoagulation). In 2018 and 2019, these
services were almost all performed in the ASC facility setting, but
based on 2020 claims, the most common setting appears to have shifted
to the hospital inpatient or hospital outpatient facility setting.
There is no case presented here that constitutes a misvaluation of CPT
codes 66982 to 66986, and therefore, we are not inclined to put this
code family forward as potentially misvalued for CY 2022; however, we
welcome additional comment, including any analysis or studies
demonstrating that one or more of these codes meet the criteria listed
above under ``Identification and Review of Potentially Misvalued
Services,'' particularly in regard to any changes in the resources to
providing a service, or are otherwise potentially misvalued.
[GRAPHIC] [TIFF OMITTED] TP23JY21.007
D. Telehealth and Other Services Involving Communications Technology,
and Interim Final Rule With Comment Period for Coding and Payment of
Virtual Check-In Services--Payment for Medicare Telehealth Services
Under Section 1834(m) of the Act
As discussed in prior rulemaking, several conditions must be met
for Medicare to make payment for telehealth services under the PFS. See
further details and full discussion of the scope of Medicare telehealth
services in the CY 2018 PFS final rule (82 FR 53006) and CY 2021 PFS
final rule (85 FR 84502) and in 42 CFR 410.78 and 414.65.
1. Payment for Medicare Telehealth Services Under Section 1834(m) of
the Act
a. Proposed Changes to the Medicare Telehealth Services List
In the CY 2003 PFS final rule with comment period (67 FR 79988), we
established a regulatory process for adding services to or deleting
services from the Medicare telehealth services list in accordance with
section 1834(m)(4)(F)(ii) of the Act (42 CFR 410.78(f)). This process
provides the public with an ongoing opportunity to submit requests for
adding services, which are then reviewed by us and assigned to
categories established through notice and comment rulemaking.
Specifically, we assign any submitted request to add to the Medicare
telehealth services list to one of the following two categories:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the Medicare telehealth services list. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
service; for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to those on the
current Medicare telehealth services list. Our review of these requests
includes an assessment of whether the service is accurately described
by the corresponding code when furnished via telehealth and whether the
use of a telecommunications system to furnish the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits. Some examples of other clinical benefits that we would
consider include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
Category 3: In the CY 2021 PFS final rule (85 FR 84507),
we created a third category of criteria for adding services to the
Medicare telehealth services list on a temporary basis following the
end of the PHE for the COVID-19 pandemic. This new category describes
services that were added to the Medicare telehealth services list
during the PHE for which there is likely to be clinical benefit when
furnished via telehealth, but there is not yet sufficient evidence
available to consider the services for permanent addition under the
Category 1 or Category 2 criteria. Services added on a temporary,
Category 3 basis would ultimately need to meet the criteria under
Category 1 or 2 in order to be permanently added to the Medicare
telehealth services list. To add specific services on a Category 3
basis, we conducted a clinical assessment to identify those services
for which we could foresee a reasonable potential likelihood of
clinical benefit
[[Page 39131]]
when furnished via telehealth. We considered the following factors:
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns for patient safety if the service is furnished as a
telehealth service.
++ Whether, outside of the circumstances of the PHE for COVID-19,
there are concerns about whether the provision of the service via
telehealth is likely to jeopardize quality of care.
++ Whether all elements of the service could fully and effectively
be performed by a remotely located clinician using two-way, audio/video
telecommunications technology.
In the CY 2021 PFS final rule (85 FR 84507), we also temporarily
added several services to the Medicare telehealth services list using
the Category 3 criteria described above. In this proposed rule, we are
considering additional requests to add services to the Medicare
telehealth services list on a Category 3 basis using the previously
described Category 3 criteria.
The Medicare telehealth services list, including the additions
described later in this section, is available on the CMS website at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
Beginning in CY 2019, we stated that for CY 2019 and onward, we
intend to accept requests through February 10, consistent with the
deadline for our receipt of code valuation recommendations from the RUC
(83 FR 59491). For CY 2022, requests to add services to the Medicare
telehealth services list must have been submitted and received by
February 10, 2021. Each request to add a service to the Medicare
telehealth services list must have included any supporting
documentation the requester wishes us to consider as we review the
request. Because we use the annual PFS rulemaking process as the
vehicle to make changes to the Medicare telehealth services list,
requesters are advised that any information submitted as part of a
request is subject to public disclosure for this purpose. For more
information on submitting a request in the future to add services to
the Medicare telehealth services list, including where to mail these
requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests To Add Services to the Medicare Telehealth Services List
for CY 2022
Under our current policy, we add services to the Medicare
telehealth services list on a Category 1 basis when we determine that
they are similar to services on the existing Medicare telehealth
services list for the roles of, and interactions among, the
beneficiary, physician (or other practitioner) at the distant site and,
if necessary, the telepresenter. As we stated in the CY 2012 PFS final
rule with comment period (76 FR 73098), we believe that the Category 1
criteria not only streamline our review process for publicly requested
services that fall into this category, but also expedite our ability to
identify codes for the Medicare telehealth services list that resemble
those services already on the Medicare telehealth services list.
We received several requests to permanently add various services to
the Medicare telehealth services list effective for CY 2022. We found
that none of the requests we received by the February 10th submission
deadline met our Category 1 or Category 2 criteria for permanent
addition to the Medicare telehealth services list. The requested
services are listed in Table 8.
BILLING CODE 4120-01-P
[[Page 39132]]
[GRAPHIC] [TIFF OMITTED] TP23JY21.008
[[Page 39133]]
[GRAPHIC] [TIFF OMITTED] TP23JY21.009
BILLING CODE 4120-01-C
We remind stakeholders that the criterion for adding services to
the Medicare telehealth list under Category 1 is that the requested
services are similar to professional consultations, office visits, and
office psychiatry services that are currently on the Medicare
telehealth services list, and that the criterion for adding services
under Category 2 is that there is evidence of clinical benefit if
provided as telehealth. As explained below, we find that none of the
requested services met the Category 1 criterion.
We received a request to permanently add CPT code 51741 (Complex
uroflowmetry (e.g., calibrated electronic equipment)) to the Medicare
telehealth services list. This CPT code describes the acquisition of
uroflowmetric information and analysis of that information. The code
includes a technical component and a professional component. The
technical component describes the acquisition of the uroflowmetric
information when billed as a standalone service. The professional
component describes the analysis for the uroflowmetric information when
it is billed as a standalone service. As we have explained in previous
rulemaking (see 83 FR 59483), the remote interpretation of diagnostic
tests is not considered to be a telehealth service under section
1834(m) of the Act or our regulation at Sec. 410.78. We do not believe
that the technical component, which would include acquisition of the
uroflowmetric
[[Page 39134]]
information, would meet the criterion to be added on a Category 1 basis
because it is not similar to other services on the Medicare telehealth
list. Moreover, we do not believe the uroflowmetric information can be
accurately and effectively collected using two-way, audio/video
communication technology to the degree that would make the results
clinically useful. We believe the patient would need to be in the same
location as the equipment; thus, making it impracticable to achieve via
telehealth. Due to these concerns, we do not believe that the submitted
information demonstrates sufficient clinical benefit to support the
addition of CPT code 51741 to the Medicare telehealth services list.
We received a request to permanently add several biofeedback,
services, CPT codes 90901, 90912, and 90913, to the Medicare telehealth
services list. We do not believe these services are similar to Category
1 services on the Medicare telehealth list in that these services
describe the application of electrodes directly to the patient's skin
and using them to monitor the patient's response. Therefore, we do not
believe they meet the criterion for addition to the Medicare telehealth
services list on a Category 1 basis. We also believe that proper
application of electrodes and monitoring of the patient's response
would require the furnishing practitioner to be in the same physical
location as the beneficiary. As such, we do not believe these services
would meet the criteria for addition to the Medicare telehealth list on
a Category 2 basis. When we reviewed these biofeedback services on a
Category 2 basis, we found that the information supplied with the
requests was not detailed enough to determine if the objective
functional outcomes (that is, Activities of Daily Living (ADLs) and
Instrumental Activities of Daily Living (IADLs) of the telehealth
patients) were similar to that of patients treated in person. Moreover,
we believe that the ADLs/IADLs alone are not sufficient to determine if
these services, when performed via telehealth, demonstrate a clinical
benefit to a patient. We would request that stakeholders supply a more
comprehensive set of objective data in order to fully illustrate any
benefits, to better enable us to evaluate all outcomes.
We received requests to permanently add Neuropsychological/
Psychological Testing services, CPT codes 96130-96133 and 96136-96139,
to the Medicare telehealth services list. We separately reviewed each
of the services in these two code families. In prior years' rulemaking,
we have declined to add these services on a Category 1 basis because,
in contrast to other services on the telehealth list these services
require close observation by the furnishing practitioner to monitor how
a patient responds and progresses through the testing (see 81 FR
80197). We continue to believe that this is the case. All of these
codes describe services that involve a very thorough observation and
testing process, and require the tester to observe the following: Speed
of responses; the ability to adjust focus; written, sometimes manual
tasks; following tasks that display the patients' visuospatial mapping
abilities, pattern recognition, abstraction, calculation--all while
appreciating that the patient may be distracted or aided by
environmental cues. The tester must also maintain some subjective
amount of flexibility to allow the patient to be in their environment.
Additionally, the tester has to maintain professional scrutiny through
dynamic tasks. Given all of the above, remote observation by the
furnishing practitioner to accomplish the testing in question seems
impractical and potentially creates the risk of inaccuracies in
diagnosis and subsequent treatment. We note that the information
supplied by stakeholders did not address these concerns, and as such,
we have concerns over patient safety and the ability of these services
to be accurately and thoroughly performed via telehealth to demonstrate
a clinical benefit to Medicare beneficiaries. Therefore, we do not
believe these services meet the Category 2 criteria for permanent
addition to the Medicare telehealth list of services. Consequently, we
are not proposing to add these services to the Medicare telehealth
services list. We encourage stakeholders to submit information
addressing the concerns we have stated in any future requests to have
these services added to the Medicare telehealth list of services.
We received requests to add Therapy Procedures, CPT codes 97110,
97112, 97116, 97150, and 97530; Physical Therapy Evaluations, CPT codes
97161-97164; Therapy Personal Care services, CPT codes 97535, 97537,
and 97542; and Therapy Tests and Measurements services, CPT codes
97750, 97755, and 97763, to the Medicare telehealth services list. In
the CY 2017 PFS final rule (81 FR 80198), we noted that section
1834(m)(4)(E) of the Act specifies the types of practitioners who may
furnish and bill for Medicare telehealth services as those
practitioners under section 1842(b)(18)(C) of the Act. Physical
therapists (PTs), occupational therapists (OTs), and speech-language
pathologists (SLPs) are not among the practitioners identified in
section 1842(b)(18)(C) of the Act. We also stated in the CY 2017 PFS
final rule that, because these services are predominantly furnished by
PTs, OTs, and SLPs, we did not believe it would be appropriate to add
them to the Medicare telehealth services list at that time. In a
subsequent request to consider adding these services for 2018, the
original requester suggested that we might propose these services be
added to the Medicare telehealth services list so that payment can be
made for them when furnished via telehealth by physicians or
practitioners who can serve as distant site practitioners. We stated
that, since the majority of the codes are furnished over 90 percent of
the time by therapy professionals who are not included on the statutory
list of eligible distant site practitioners, we believed that adding
therapy services to the Medicare telehealth services list could result
in confusion about who is authorized to furnish and bill for these
services when furnished via telehealth. We continue to believe this to
be true; however, we reviewed each therapy service separately, and have
categorized them together here for convenience as the same set of
information accompanied the request for each of these services.
We determined that these services did not meet the Category 1
criteria for addition to the Medicare telehealth services because they
are therapeutic in nature and in many instances involve direct physical
contact between the practitioner and the patient. In assessing the
evidence that was supplied by stakeholders in support of adding these
services to the Medicare telehealth services list on a Category 2
basis, we concluded that it did not provide sufficient detail to
determine whether all of the necessary elements of the service could be
furnished remotely, and whether the objective functional outcomes of
ADL and IADL for the telehealth patients were similar to those of
patients receiving the services in person. As we stated above when
discussing the request to add certain biofeedback services to the
telehealth list, we do not believe ADLs and IADLS alone are sufficient
to demonstrate clinical benefit to a Medicare beneficiary. We have
enumerated above some examples of the types of clinical benefits we
would consider when evaluating services using the Category 2 criterion.
Therefore, we do not believe the supplied information demonstrates
that the services meet either the Category 1 or the Category 2
criteria. We are not
[[Page 39135]]
proposing to add these services to the Medicare telehealth services
list. We continue to encourage commenters to supply sufficient data for
us to be able to see all measurements/parameters performed, so that we
may evaluate all outcomes.
We received requests to add the services in Table 9, and we note
that these services are generally not separately payable under the
Medicare PFS. Given that these services are not separately payable when
furnished in-person, they would not be separately payable when
furnished as telehealth. Section 1834(m)(2)(A) of the Act provides that
payment for a service when furnished as a telehealth services is equal
to the payment when the service is furnished in person. CPT code 90849
has a restricted payment status, indicating that claims must be
adjudicated on a case-by-case basis when furnished in-person.
Accordingly, any separate payment for that service would require
special consideration and not be routine. Therefore, we do not believe
this service should be added to the Medicare telehealth list. CPT codes
98960-98962 are bundled services, and therefore, payment for these
services is always bundled into payment of other services. For that
reason, we are not proposing to add them to the Medicare list of
telehealth services.
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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 10). In their submission, the
requestor noted they would conduct a future study and would submit the
study data to CMS at a later date. These services are on the expanded
telehealth services list for the PHE, but were not added by CMS on a
category 3 basis in the CY 2021 PFS final rule. We do not yet have
sufficient information to adjudicate whether these services are likely
to meet the category 1 or category 2 criteria given additional time on
the Medicare telehealth services list, without having evaluated the
full data, and we encourage commenters to submit all available
information, when available, for future consideration. As a result, we
are not proposing to add these services to the Medicare telehealth list
of services on a Category 3 basis at this time.
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c. Revised Timeframe for Consideration of Services Added to the
Telehealth List on a Temporary Basis
In the CY 2021 PFS final rule (85 FR 84506), in response to the PHE
for COVID-19, we created a third category of criteria for adding
services to the Medicare telehealth services list on a temporary basis.
We included in this category the services that were added during the
PHE for COVID-19 for which we believed there is likely to be clinical
benefit when furnished via telehealth, but for which there is not yet
sufficient evidence available to consider the services as permanent
additions under Category 1 or Category 2 criteria. We recognized that
the services we added on a temporary basis under Category 3 would
ultimately need to meet the criteria under Categories 1 or 2 in order
to be permanently added to the Medicare telehealth services list, and
that there was a potential for evidence development that could continue
through the Category 3 temporary addition period. We also stated that
any service added on a temporary basis under Category 3 would remain on
the Medicare telehealth services list through the end of the calendar
year in which the PHE for COVID-19 ends.
We added 135 services to the Medicare telehealth list in CY 2020 on
an interim basis in response to the PHE for COVID-19 through the
interim final rule with comment period (IFC) (March 31st COVID-19 IFC
(85 FR 19234-19243) and the subregulatory process established in the
May 8th COVID-19 IFC (85 FR 27550-27649). Since the publication of the
May 8th COVID-19 IFC, we have added several services to the Medicare
telehealth list of services using this subregulatory process (please
see https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes for the list of codes available for
telehealth under the PFS). As discussed in the CY 2021 PFS final rule
(FR 85 84507), at the conclusion of the PHE for COVID-19, associated
waivers and interim policies will expire, payment for Medicare
telehealth services will once again be limited by the requirements of
section 1834(m) of the Act, and we will return to the policies
established through the regular notice-and-comment rulemaking process,
including the previously established Medicare telehealth services list,
as modified by subsequent changes in policies and additions to the
telehealth services list adopted through rulemaking. Services that were
temporarily added on an interim basis during the PHE for COVID-19 would
not be continued on the list after the end of the PHE for COVID-19.
Numerous stakeholders have continued to note that there is
uncertainty about when the PHE for COVID-19 may end, and express
concerns that the services added to the telehealth list on a temporary
basis could be removed from the list before practitioners have had time
to compile
[[Page 39137]]
and submit evidence to support the permanent addition of these services
on a Category 1 or Category 2 basis. To respond to these continuing
concerns, we are proposing to revise the timeframe for inclusion of the
services we added to the Medicare telehealth services list on a
temporary, Category 3 basis. Extending the temporary inclusion of these
services on the telehealth list will allow additional time for
stakeholders to collect, analyze and submit data on those services to
support their consideration for permanent addition to the list on a
Category 1 or Category 2 basis.
We propose to retain all services added to the Medicare telehealth
services list on a Category 3 basis until the end of CY 2023. This will
allow us time to collect more information regarding utilization of
these services during the pandemic, and provide stakeholders the
opportunity to continue to develop support for the permanent addition
of appropriate services to the telehealth list through our regular
consideration process, which includes notice-and-comment rulemaking. By
keeping these services on the Medicare telehealth services list through
CY 2023, we will facilitate the submission of requests to add services
permanently to the Medicare telehealth services list for consideration
in the CY 2023 PFS rulemaking process and for consideration in the CY
2024 PFS rule.
See Table 11 for a list of services that were added to the Medicare
telehealth services list on an interim basis to respond to the PHE for
COVID-19, but were not extended on a temporary Category 3 basis in the
CY 2021 PFS final rule. Under our current policy, these services will
be removed from the Medicare telehealth services list as of the date
that the PHE for COVID-19 ends. We recognize that, during the time
between the publication of the CY 2021 PFS final rule and this proposed
rule, practitioners may have used that time to compile new evidence of
clinical benefit to support addition to the Medicare telehealth
services list on a category 3 basis, including information that
suggests that a certain service would likely meet the category 1 or
category 2 criteria if provided with more time. We are soliciting
comment on whether any of the services that were added to the Medicare
telehealth list for the duration of the PHE for COVID-19 should now be
added to the Medicare telehealth list on a Category 3 basis to allow
for additional data collection for submission for CMS to consider as
part of the rulemaking process described in prior paragraphs.
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BILLING CODE 4120-01-C
d. Implementation of Provisions of the Consolidated Appropriations Act,
2021 (CAA)
The Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116-260,
December 27, 2020) included a number of provisions pertaining to
Medicare telehealth services. The Medicare telehealth statute at
section 1834(m)(4)(C) of the Act generally limits the scope of
telehealth services to those furnished in rural areas and in certain
enumerated types of ``originating sites'' including physician offices,
hospitals, and other medical care settings. Section 1834(m)(7) of the
Act, (as added by section 2001(a) of the SUPPORT for Patients and
Communities Act (Pub. L. 115-271, October 24, 2018), specifies that the
geographic restrictions under section 1834(m)(4)(C)(i) of the Act do
not apply, and includes the patient's home as a permissible originating
site, for telehealth services furnished to a patient with a diagnosed
substance use disorder (SUD) for treatment of that disorder or a co-
occurring mental health disorder. Section 123(a) of Division CC of the
CAA amended section 1834(m)(7)(A) of the Act to broaden the scope of
services for which the geographic restrictions under section
1834(m)(4)(C)(i) of the Act do not apply and for which the patient's
home is a permissible originating site to include telehealth services
furnished for the purpose of diagnosis, evaluation, or treatment of a
mental health disorder, effective for services furnished on or after
the end of the PHE for COVID-19.\2\
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\2\ We note that neither the SUPPORT Act nor the CAA amended
section 1862 of the Act. Section 1862(a)(4) of the Act and our
corresponding regulation at 42 CFR 411.9 prohibit Medicare payment
for services that are not furnished within the United States. Both
the originating site and the distant site are subject to the
statutory payment exclusion.
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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 in-person item or
service applies only for telehealth services furnished for purposes of
diagnosis, evaluation, or treatment of a mental health disorder other
than for treatment of a diagnosed SUD or co-occurring mental health
disorder, and only in locations that do not meet the geographic
requirements in section 1834(m)(4)(C)(i) of the Act or when the
originating site is the home of the patient, regardless of geography.
We are seeking comment on whether we
[[Page 39146]]
should adopt a claims-based mechanism to distinguish between the mental
health telehealth services that are within the scope of the CAA
amendments and those that are not (in other words, the services for
which payment was newly authorized by the CAA amendments, and those for
which payment was authorized before the CAA amendments), and if so,
what that mechanism should be. In the event that we need to distinguish
between the mental health telehealth services that are within the scope
of the CAA amendments and those that are not we are also seeking
comment on whether a clarification should be added to the regulation at
Sec. 410.78 as follows (which would take into account the other
amendments we are proposing to Sec. 410.78):
The requirement that the physician or practitioner must furnish an
item or service in person, without the use of telehealth, within a
specified time frame shall not apply to telehealth services furnished
for treatment of a diagnosed substance use disorder or co-occurring
mental health disorder, or to services furnished in an originating site
described in paragraphs (b)(3)(i) through (viii) or (xiii) that meets
the geographic requirements specified in paragraph (b)(4) other than
(b)(4)(iv)(D).
As we noted above, section 123(a) of the CAA amends section
1834(m)(7)(B)(i)(I) of the Act to prohibit payment for telehealth
services under that paragraph unless the physician or practitioner
furnished an item or service to the patient in person, without the use
of telehealth, within 6 months before the first telehealth service.
Thereafter, section 1834(m)(7)(B)(i)(II) of the Act leaves the
Secretary discretion to specify the times or intervals at which an in-
person, non-telehealth service is required as a condition of payment
for these telehealth services. Therefore, in order to implement the new
statutory requirement to specify when an in-person service is required,
we propose that, as a condition of payment for a mental health
telehealth service described in section 1834(m)(7)(A) of the Act other
than services described in section 1834(m)(7)(B)(ii) of the Act (that
is, services for which payment was authorized before the CAA
amendments), the billing physician or practitioner must have furnished
an in-person, non-telehealth service to the beneficiary within the 6-
month period before the date of the telehealth service.
We are also seeking comment on whether the required in-person, non-
telehealth service could also be furnished by another physician or
practitioner of the same specialty and same subspecialty within the
same group as the physician or practitioner who furnishes the
telehealth service. We note that the language in the CAA states that
the physician or practitioner furnishing the in-person, non-telehealth
service must be the same person as the practitioner furnishing the
telehealth service. There are several circumstances, however, under
which we have historically treated the billing practitioner and other
practitioners of the same specialty or subspecialty in the same group
as if they were the same individual. For instance, for purposes of
deciding whether a patient is a new or established patient, or whether
to bill for initial or subsequent visit, practitioners of the same
specialty/subspecialty in the same group are treated as the same
person. For example, when Physician A and Physician B are of the same
specialty and subspecialty and in the same group, if Physician A
furnishes an initial critical care service to a patient, and Physician
B subsequently furnishes additional critical care services to the same
beneficiary for the same condition on the same day, Physician B would
bill for a subsequent critical care service rather than an initial
critical care visit. As we explain in in section II.F.2 of this
proposed rule, because practitioners in the same specialty and same
group often cover for one another to provide concurrent services, we
believe the total time for critical care services furnished to a
patient on the same day by the practitioners in the same group with the
same specialty should be reflected as if it were a single set of
critical care services furnished to the patient. See section II.F.2 of
this proposed rule for further discussion of our current and proposed
policies for billing critical care services. Similarly, if Physician A
furnished a service to a patient, and then Physician B furnished a
service to the patient a few months later, that patient would be
considered an established patient with respect to both Physician A and
Physician B. For example, Physician B could initiate care management
services for the patient as an established patient. An example of
guidance to this effect can be found in the Medicare Claims Processing
Manual (IOM Pub. 100-04, Chapter 12, Sec. 30.6.7), which defines ``new
patient'' as a patient who has not received any professional services,
that is, E/M service or other face-to-face service (for example,
surgical procedure) from the physician or physician group (same
physician specialty) within the previous 3 years, for E/M services.
We note that this manual provision is also consistent with CPT
guidance on whether a patient is a new or established patient.\3\
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\3\ American Medical Association. (2020). CPT 2021 professional
edition. Chicago, Ill.: American Medical Association.
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We are interested in comments regarding the extent to which a
patient routinely receiving mental health services from one
practitioner in a group might have occasion to see a different
practitioner of the same specialty in that group for treatment of the
same condition. This might occur when practitioners in a group cover
for each other when a particular practitioner is unavailable or when a
practitioner has left the group, but the beneficiary continues to
receive services furnished by the group. In addition, fee-for-time
compensation arrangements (formerly referred to as locum tenens
arrangements), as described in section 1842(b)(6)(D) of the Act, allow
for payment to be made to a physician for physicians' services (and
services furnished incident to such services) furnished by a second
physician to patients of the first physician if the first physician is
unavailable to provide the services, and the services are furnished
pursuant to an arrangement that is either informal and reciprocal, or
involves per diem or other fee-for-time compensation for such services.
Recognizing the importance of ensuring access to mental health
telehealth services to beneficiaries who are unable to see the same
practitioner who furnished the prerequisite in-person services due to
the practitioner's unavailability, we are seeking comments on an
alternative policy to also allow the prerequisite in-person, non-
telehealth service for certain mental health telehealth services to be
furnished by a practitioner in the same specialty/subspecialty in the
same group when the physician or practitioner who furnishes the
telehealth service is unavailable or the two professionals are
practicing as a team.
As amended by the CAA, section 1834(m)(7)(B)(i)(II) of the Act
specifies that for subsequent mental health telehealth service, an in-
person, non-telehealth service is required at such times as the
Secretary determines appropriate. We are proposing to require that an
in-person, non-telehealth service must be furnished by the physician or
practitioner at least once within 6 months before each telehealth
service furnished for the diagnosis, evaluation, or treatment of mental
health disorders by the same practitioner, other than for
[[Page 39147]]
treatment of a diagnosed SUD or co-occurring mental health disorder,
and that the distinction between the telehealth and non-telehealth
services must be documented in the patient's medical record. We
distinguish between mental health services furnished for a diagnosed
SUD or co-occurring mental health disorder and those furnished to
beneficiaries without a SUD diagnosis on the basis of ICD-10 diagnosis
codes included on claims when the services are billed. We chose this
interval because we are concerned that an interval less than 6 months
may impose potentially burdensome travel requirements on the
beneficiary, but that an interval greater than 6 months could result in
the beneficiary not receiving clinically necessary in-person care/
observation. The proposed 6-month interval also matches the specified
statutory interval for the initial telehealth service. We believe that
a 6-month interval strikes an appropriate balance between these
competing considerations, but are seeking comment on whether a
different interval, whether shorter, such as 3-4 months or longer, such
as 12 months, may be appropriate to balance program integrity and
patient safety concerns with increased access to care. However, we note
that regardless of the time interval we establish, the practitioner is
not precluded from scheduling in-person visits at a more frequent
interval should such visit be determined to be clinically appropriate
or preferred by the patient.
As discussed below in this section of this proposed rule, ``e.
Payment for Medicare Telehealth Services Furnished Using Audio-Only
Communication Technology,'' we are proposing to revise our regulatory
definition of ``interactive telecommunications system'' to permit use
of audio-only communications technology for mental health telehealth
services under certain conditions when provided to beneficiaries
located in their home. Therefore, we are also seeking comment on
whether it would be appropriate to establish a different interval for
these telehealth services, for the diagnosis, evaluation, or treatment
of mental health disorders, other than for treatment of diagnosed SUD
or co-occurring mental health disorder, when furnished as permitted
through audio-only communications technology.
In any event, we propose that there would need to be an in-person
visit within 6 months of any telehealth service furnished for the
diagnosis, evaluation, or treatment of mental health disorders (other
than for treatment of a diagnosed SUD or co-occurring mental health
disorder), and the in-person visit would need to be documented in the
patient's medical record. Payment would not be made for these
telehealth services unless the required in-person service was furnished
within 6 months of the telehealth service.
Given the addition of the home of the individual as a permissible
originating site for telehealth services for purposes of diagnosis,
evaluation, or treatment of a mental health disorder, we are proposing
to revise our regulation at Sec. 410.78(b)(3) to add a new paragraph
(xiv) to identify the home of a beneficiary as an originating site for
telehealth services for the diagnosis, evaluation, or treatment of a
mental health disorder, effective for services furnished on or after
the first day after the end of the PHE as defined Sec. 400.200 of our
regulations; and to provide that payment will not be made for a
telehealth service furnished under this paragraph unless the physician
or practitioner has furnished an item or service in person, without the
use of telehealth, for which Medicare payment was made (or would have
been made if the patient were entitled to, or enrolled for, Medicare
benefits at the time the item or service is furnished) within 6 months
of the telehealth service. We are also proposing to revise our
regulation at Sec. 410.78(b)(4)(iv)(D) to specify that the geographic
restrictions in Sec. 410.78(b)(4) do not apply to telehealth services
furnished for the diagnosis, evaluation, or treatment of a mental
health disorder, effective for services furnished on or after the first
day after the end of the PHE as defined in our regulation at Sec.
400.200.
In addition, section 125(c) of the CAA amended section
1834(m)(4)(C)(ii) of the Act to add to the list of permissible
telehealth originating sites a rural emergency hospital, which is a new
Medicare provider type added by section 125 of the CAA effective
beginning in CY 2023.
We are also proposing to amend our regulation at Sec. 410.78,
Telehealth services, to conform with the statutory change to include
rural emergency hospitals as telehealth originating sites beginning in
CY 2023. In accordance with section 1834(m)(4)(C)(ii)(XI) of the Act,
as added by section 125(c) of the CAA, we propose to revise Sec.
410.78(b)(3) of our regulations to add a rural emergency hospital, as
defined in section 1861(kkk)(2) of the Act, as a permissible
originating site for telehealth services furnished on or after January
1, 2023.
e. Payment for Medicare Telehealth Services Furnished Using Audio-Only
Communication Technology
Section 1834(m) of the Act outlines the requirements for Medicare
payment for telehealth services that are furnished via a
``telecommunications system,'' and specifies that, only for purposes of
Medicare telehealth services through a federal telemedicine
demonstration program conducted in Alaska or Hawaii, the term
``telecommunications system'' includes asynchronous, store-and-forward
technologies. We further defined the term, ``telecommunications
system,'' in the regulation at Sec. 410.78(a)(3) to mean an
interactive telecommunications system, which is defined as multimedia
communications equipment that includes, at a minimum, audio and video
equipment permitting two-way, real-time interactive communication
between the patient and distant site physician or practitioner.
During the PHE for COVID-19, we used waiver authority under section
1135(b)(8) of the Act to temporarily waive the requirement, for certain
behavioral health and/or counseling services and for audio-only
evaluation and management (E/M) visits, that telehealth services must
be furnished using an interactive telecommunications system that
includes video communications technology. Therefore, for certain
services furnished during the PHE for COVID-19, we make payment for
these telehealth services when they are furnished using audio-only
communications technology. Emergency waiver authority is no longer
available after the PHE for COVID-19 ends, and telehealth services will
again be subject to all statutory and regulatory requirements.
In the CY 2021 PFS final rule (85 FR 84535), we noted that we
continued to believe that our longstanding regulatory definition of
``telecommunications system'' reflected the intent of statute and that
the term should continue to be defined as including two way, real-time,
audio/video communication technology.
Historically, we have not proposed any permanent modifications to
the definition of ``interactive telecommunications system'' to allow
for use of audio-only communications technology due to our
interpretation of the statutory requirements, as well as concerns over
program integrity and quality of care. Specifically, we were concerned
that the use of audio-only communications technology for Medicare
telehealth services could lead to inappropriate overutilization, and
believed that video visualization of the patient generally was
necessary to fulfill
[[Page 39148]]
the full scope of service elements of the codes included on the
Medicare telehealth list. We believe it is reasonable to reassess these
concerns, given the now widespread utilization during the PHE for
COVID-19 of Medicare telehealth services furnished using audio-only
communication technology. Based upon an initial review of claims data
collected during the PHE for COVID-19, which describe audio-only
telephone E/M services, we observed that the audio-only E/M visits have
been some of the most commonly performed telehealth services during the
PHE, and that most of the beneficiaries receiving these services were
receiving them for treatment of a mental health condition. Given the
generalized shortage of mental health care professionals (https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/technical-documentation-health-workforce-simulation-model.pdf), and the
existence of areas and populations where there is limited access to
broadband due to geographic or socioeconomic challenges, we believe
beneficiaries may have come to rely upon the use of audio-only
communication technology in order to receive mental health services,
and that a sudden discontinuation of this flexibility at the end of the
PHE could have a negative impact on access to care.
As explained above, section 123 of the CAA removes the geographic
restrictions for Medicare telehealth services for the diagnosis,
evaluation, or treatment of a mental health disorder, and adds the
patient's home as a permissible originating site for these telehealth
services. We also believe that mental health services are different
from most other services on the Medicare telehealth services list in
that many of the services primarily involve verbal conversation where
visualization between the patient and furnishing physician or
practitioner may be less critical to provision of the service. While we
continue to believe that two-way, audio/video communications technology
is the appropriate, general standard for telehealth services, and that
there may be particular instances where visual cues may help a
practitioner's ability to assess and treat patients with mental health
disorders, especially where opioids or other mental health medications
are involved (for example, visual cues as to patient hygiene, or
indicators of self-destructive behavior), we note that stakeholders
have suggested to us that the availability of telehealth services for
mental health care via audio-only communications technology would
increase access to care. This is especially true in areas with poor
broadband infrastructure and among patient populations that do not wish
to use, do not have access to, and/or are unable to utilize devices
that permit a two-way, audio/video interaction. Our preliminary
analysis of Medicare claims data, as well as information provided to us
by stakeholders on the popularity of these services, indicates that use
of interactive communication technology for mental health care would
likely continue to be high even beyond the circumstances of the COVID-
19 pandemic. According to our analysis of Medicare Part B claims data
for services furnished via Medicare telehealth during the PHE for
COVID-19, utilization of telehealth for many professional services
spiked around April 2020 and has diminished over the ensuing months. In
contrast, preliminary analysis of Medicare claims data suggest that,
for many mental health services that were permanently and temporarily
added to the Medicare Telehealth list, there is a steady utilization
trend from April 2020 and thereafter. Furthermore, as described above,
according to preliminary analysis of claims data which examined
utilization by diagnosis, the codes for audio-only E/M services have
been highly utilized during the PHE, particularly for beneficiaries
with mental health conditions.
Given these considerations, we now believe that it would be
appropriate to revisit our regulatory definition of ``interactive
telecommunications system'' beyond the circumstances of the PHE to
allow for the inclusion of audio-only services under certain
circumstances. Therefore, we are proposing to amend our regulation at
Sec. 410.78(a)(3) to define interactive telecommunications system to
include audio-only communications technology when used for telehealth
services for the diagnosis, evaluation, or treatment of mental health
disorders furnished to established patients when the originating site
is the patient's home. We believe this proposal is consistent with the
expansion of at-home access to mental health telehealth services in
section 1834(m)(7) of the Act, as amended by section 123 of the CAA,
which required that the beneficiary must have received a Medicare-paid
(or payable), in-person item or service from the physician or
practitioner furnishing the mental health services through telehealth
within 6 months of the first mental health telehealth service. We are
proposing to adopt a similar ongoing requirement that an in-person item
or service must be furnished within 6 months of such a mental health
telehealth service. We reiterate that our proposed policy to permit
audio-only telehealth services is limited to services where the home is
the originating site. This is because the other enumerated telehealth
originating sites are medical settings that are far more likely to have
access to reliable broadband internet service. When a patient is
located at one of these originating sites, access to care is far less
likely to be limited by access to broadband that facilitates a video
connection. In contrast, access to broadband, devices, and user
expertise to enable a video connection is less likely to be available
in the patient's home. As described in prior paragraphs, we also
believe that mental health services are distinct from other kinds of
services on the Medicare telehealth list in that many of the services
do not necessarily require visualization of the patient to fulfill the
full scope of service elements.
We are also proposing to limit payment for audio-only services to
services furnished by physicians or practitioners who have the capacity
to furnish two-way, audio/video telehealth services but are providing
the mental health services via audio-only communication technology in
an instance where the beneficiary is unable to use, does not wish to
use, or does not have access to two-way, audio/video technology. We
believe that this requirement will ensure that mental health services
furnished via telehealth are only conducted using audio-only
communication technology in instances where the use of audio-only
technology is facilitating access to care that would be unlikely to
occur otherwise, given the patient's technological limitations or
preferences. In the interests of monitoring utilization and program
integrity concerns for audio-only telehealth services furnished under
the terms of this proposed exception, we are proposing to create a
service-level modifier that would identify these mental health
telehealth services furnished to a beneficiary in their home using
audio-only communications technology. The use of this modifier would
also serve to certify that the audio-only telehealth service meets the
requirements for the exception specified in proposed on Sec.
410.78(a)(3), including that the furnishing physician or practitioner
has the capacity to furnish the service using interactive two-way,
real-time audio/video communication technology, but instead used audio-
only
[[Page 39149]]
technology under the conditions specified in the regulation.
We are proposing to amend our regulation at Sec. 410.78(a)(3) to
specify that an interactive telecommunications system can include
interactive, real-time, two-way audio-only technology for telehealth
services furnished for the diagnosis, evaluation, or treatment of a
mental health disorder as described under paragraph (b)(4)(D), under
the following conditions: The patient is located in their home at the
time of service as described at Sec. 410.78 (b)(3)(xiv); the distant
site physician or practitioner has the technical capability at the time
of the service to use an interactive telecommunications system that
includes video; and the patient is not capable of, or does not consent
to, the use video technology for the service.
We are seeking comment on these proposals, as well as what, if any,
additional documentation should be required in the patient's medical
record to support the clinical appropriateness of providing audio-only
telehealth services for mental health in the event of an audit or
claims denial. Additional required documentation could include
information about the patient's level of risk and any other guardrails
that are appropriate to demonstrate clinical appropriateness, and
minimize program integrity and patient safety concerns.
We are also seeking comment on whether, for purposes of the
proposed audio-only mental health telehealth services exception, we
should exclude certain higher-level services, such as level 4 or 5 E/M
visit codes, when furnished alongside add-on codes for psychotherapy,
or codes that describe psychotherapy with crisis. We are seeking
comment on whether the full scope of service elements for these codes
could be performed via audio-only communication technology. However, we
also note that maintaining the availability of these services through
audio-only communication technology might give patients access to care
needed to address their higher level or acute mental health needs in
instances where they are unable to access two-way, audio/video
communication technology.
2. Other Non-Face-to-Face Services Involving Communications Technology
Under the PFS
a. Expiration of PHE Flexibilities for Direct Supervision Requirements
Under section 1861 of the Act and at Sec. 410.32(b)(3) of the
regulations, Medicare requires certain types of services to be
furnished under specific levels of supervision of a physician or
practitioner, including diagnostic tests, services incident to
physician services, and other services. For professional services
furnished incident to the services of a billing physician or
practitioner (see Sec. 410.26) and many diagnostic tests (see Sec.
410.32), direct supervision is required. Additionally, for pulmonary
rehabilitation services (see Sec. 410.47) and for cardiac
rehabilitation and intensive cardiac rehabilitation services (see Sec.
410.49), requirements for immediate availability and accessibility of a
physician are considered to be satisfied if the physician meets the
requirements for direct supervision for physician office services at
Sec. 410.26 and for hospital outpatient services at Sec. 410.27.
Outside the circumstances of the PHE, direct supervision requires the
immediate availability of the supervising physician or other
practitioner, but the professional need not be present in the same room
during the service, and we have interpreted this ``immediate
availability'' requirement to mean in-person, physical, not virtual,
availability.
Through the March 31st COVID-19 IFC, we changed the definition of
``direct supervision'' during the PHE for COVID-19 (85 FR 19245 through
19246) as it pertains to supervision of diagnostic tests, physicians'
services, and some hospital outpatient services, to allow the
supervising professional to be immediately available through virtual
presence using real-time audio/video technology, instead of requiring
their physical presence. In the CY 2021 PFS final rule (85 FR 84538
through 84540), we finalized continuation of this policy through the
later of the end of the calendar year in which the PHE for COVID-19
ends or December 31, 2021. In that rule, we also solicited comment on
issues related to the policy allowing virtual provision of direct
supervision, specifically whether there should be any additional
guardrails or limitations put in place to ensure patient safety/
clinical appropriateness, beyond typical clinical standards, and
whether we should consider potential restrictions to prevent fraud or
inappropriate use. We also stated that we will consider this and other
information as we contemplate future policy regarding use of
communication technology to satisfy supervision requirements, as well
as the best approach for safeguarding patient safety while promoting
use of technology to enhance access.
We also note that the temporary exception to allow immediate
availability for direct supervision through virtual presence
facilitates the provision of telehealth services by clinical staff of
physicians and other practitioners incident to their own professional
services. This is discussed in the March 31st COVID-19 IFC (85 FR
19246). This is especially relevant for services such as physical
therapy, occupational therapy, and speech language pathology services,
since those practitioners can only bill Medicare directly for
telehealth services under telehealth waivers that are effective only
during the PHE for COVID-19. We note that sections 1834(m)(4)(D) and
(E) of the Act specifies the types of clinicians who may furnish and
bill for Medicare telehealth services, and include only physicians as
defined in section 1861(r) of the Act and practitioners described in
section 1842(b)(18)(C) of the Act.
We continue to seek information on whether this flexibility should
be continued beyond the later of the end of the PHE for COVID-19 or CY
2021. Specifically, we are seeking comment on the extent to which the
flexibility to meet the immediate availability requirement for direct
supervision through the use of real-time, audio/video technology is
being used during the PHE, and whether physicians and practitioners
anticipate relying on this flexibility after the end of the PHE. We are
seeking comment on whether this flexibility should potentially be made
permanent, meaning that we would revise the definition of ``direct
supervision'' at Sec. 410.32(b)(3)(ii) to include immediate
availability through the virtual presence of the supervising physician
or practitioner using real-time, interactive audio/video communications
technology without limitation after the PHE for COVID-19, or if we
should continue the policy in place for a short additional time to
facilitate a gradual sunset of the policy. We are soliciting comment on
whether the current timeframe for continuing this flexibility at Sec.
410.32(b)(3)(ii), which is currently the later of the end of the year
in which the PHE for COVID-19 ends or December 31, 2021, remains
appropriate, or if this timeframe should be extended through some later
date to facilitate the gathering of additional information in
recognition that, due to the on-going nature of the PHE for COVID-19,
practitioners may not yet have had time to assess the implications of a
permanent change in this policy. We also seek comment regarding the
possibility of permanently allowing immediate availability for direct
supervision through virtual presence using real-time audio/video
technology for only a subset of services, as we recognize that it may
be inappropriate to allow direct
[[Page 39150]]
supervision without physical presence for some services, due to
potential concerns over patient safety if the practitioner is not
immediately available in-person. We are also seeking comment on, were
this policy to be made permanent, if a service level modifier should be
required to identify when the requirements for direct supervision were
met using two-way, audio/video communications technology.
b. Interim Final Provisions in the CY 2021 PFS Final Rule
In the CY 2021 PFS final rule (85 FR 84536), we finalized the
establishment of HCPCS code G2252 (Brief communication technology-based
service, e.g., virtual check-in service, by a physician or other
qualified health care professional who can report evaluation and
management services, provided to an established patient, not
originating from a related E/M service provided within the previous 7
days nor leading to an E/M service or procedure within the next 24
hours or soonest available appointment; 11-20 minutes of medical
discussion) on an interim basis. We stated that, given the widespread
concerns expressed by commenters about the continuing need for audio-
only conversations with patients and our determination that we would
not continue to pay for audio-only E/M visits after the conclusion of
the PHE (see 85 FR 84533 through 84535 for further discussion of that
policy), we believed it would be expedient to establish additional
coding and payment for an extended virtual check-in, which could be
furnished using any form of synchronous communication technology,
including audio-only, on an interim basis for CY 2021. We stated that
we believed establishing payment for this service on an interim basis
will support access to care for beneficiaries who may be reluctant to
return to in-person visits unless absolutely necessary, and allow us to
consider whether this policy should be adopted on a permanent basis. In
that rule, we finalized a direct crosswalk to CPT code 99442, the value
of which we believe most accurately reflects the resources associated
with a longer service delivered via synchronous communication
technology, which can include audio-only communication. Commenters
supported the creation and interim final adoption of this service.
Commenters stated that, as beneficiaries and practitioners may be
reluctant to return to primarily in-person services post-PHE, payment
for a longer virtual check-in would be necessary to account for
circumstances where more time is spent determining whether an in-person
visit is needed beyond the 5-10 minutes accounted for by HCPCS code
G2012 (Brief communication technology-based service, e.g., virtual
check-in, by a physician or other qualified health care professional
who can report evaluation and management services, provided to an
established patient, not originating from a related e/m service
provided within the previous 7 days nor leading to an e/m service or
procedure within the next 24 hours or soonest available appointment; 5-
10 minutes of medical discussion). Commenters also supported valuing
HCPCS code G2252 through a direct crosswalk to CPT code 99442. We agree
with commenters that additional time may be needed to assess the
necessity of an in-person service given concerns over exposure to
illnesses beyond the duration of the PHE for COVID-19 and that current
coding may not accurately reflect that time. Based on support from
commenters, we are proposing to permanently adopt coding and payment
for CY 2022, HCPCS code G2252 as described in the CY 2021 PFS final
rule.
E. Valuation of Specific Codes
1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since the inception of the PFS,
it has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year
review process, revisions in RVUs were proposed and finalized via
rulemaking. In addition to the 5-year reviews, beginning with CY 2009,
CMS and the RUC identified a number of potentially misvalued codes each
year using various identification screens, as discussed in section
II.C. of this proposed rule, Potentially Misvalued Services under the
PFS. Historically, when we received RUC recommendations, our process
had been to establish interim final RVUs for the potentially misvalued
codes, new codes, and any other codes for which there were coding
changes in the final rule with comment period for a year. Then, during
the 60-day period following the publication of the final rule with
comment period, we accepted public comment about those valuations. For
services furnished during the calendar year following the publication
of interim final rates, we paid for services based upon the interim
final values established in the final rule. In the final rule with
comment period for the subsequent year, we considered and responded to
public comments received on the interim final values, and typically
made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period (79 FR 67547), we
finalized a new process for establishing values for new, revised and
potentially misvalued codes. Under the new process, we include proposed
values for these services in the proposed rule, rather than
establishing them as interim final in the final rule with comment
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
new process was applicable to all codes, except for new codes that
describe truly new services. For CY 2017, we proposed new values in the
CY 2017 PFS proposed rule for the vast majority of new, revised, and
potentially misvalued codes for which we received complete RUC
recommendations by February 10, 2016. To complete the transition to
this new process, for codes for which we established interim final
values in the CY 2016 PFS final rule with comment period (81 FR 80170),
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period (80 FR 70886), and re-proposed values for those codes in the CY
2017 PFS proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process, we
will adopt interim final values only in the case of wholly new services
for which there are no predecessor codes or values and for which we do
not receive recommendations in time to propose values.
As part of our obligation to establish RVUs for the PFS, we
thoroughly review and consider available information including
recommendations and supporting information from the RUC, the Health
Care Professionals Advisory Committee (HCPAC), public commenters,
medical literature, Medicare claims data, comparative databases,
comparison with other codes within the PFS, as well as consultation
with other physicians and healthcare professionals within CMS and the
[[Page 39151]]
federal government as part of our process for establishing valuations.
Where we concur that the RUC's recommendations, or recommendations from
other commenters, are reasonable and appropriate and are consistent
with the time and intensity paradigm of physician work, we proposed
those values as recommended. Additionally, we continually engage with
stakeholders, including the RUC, with regard to our approach for
accurately valuing codes, and as we prioritize our obligation to value
new, revised, and potentially misvalued codes. We continue to welcome
feedback from all interested parties regarding valuation of services
for consideration through our rulemaking process.
2. Methodology for Establishing Work RVUs
For each code identified in this section, we conduct a review that
includes the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our reviews of recommended work RVUs and time
inputs generally include, but have not been limited to, a review of
information provided by the RUC, the HCPAC, and other public
commenters, medical literature, and comparative databases, as well as a
comparison with other codes within the PFS, consultation with other
physicians and health care professionals within CMS and the federal
government, as well as Medicare claims data. We also assess the
methodology and data used to develop the recommendations submitted to
us by the RUC and other public commenters and the rationale for the
recommendations. In the CY 2011 PFS final rule with comment period (75
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation (see the CY 2011 PFS final rule with comment period (75 FR
73328 through 73329) for more information). When referring to a survey,
unless otherwise noted, we mean the surveys conducted by specialty
societies as part of the formal RUC process.
Components that we use in the building block approach may include
preservice, intraservice, or postservice time and post-procedure
visits. When referring to a bundled CPT code, the building block
components could include the CPT codes that make up the bundled code
and the inputs associated with those codes. We use the building block
methodology to construct, or deconstruct, the work RVU for a CPT code
based on component pieces of the code. Magnitude estimation refers to a
methodology for valuing work that determines the appropriate work RVU
for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we frequently utilize an incremental methodology in
which we value a code based upon its incremental difference between
another code and another family of codes. Section 1848(c)(1)(A) of the
Act specifically defines the work component as the resources that
reflect time and intensity in furnishing the service. Also, the
published literature on valuing work has recognized the key role of
time in overall work. For particular codes, we refine the work RVUs in
direct proportion to the changes in the best information regarding the
time resources involved in furnishing particular services, either
considering the total time or the intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently, there are preservice time packages for
services typically furnished in the facility setting (for example,
preservice time packages reflecting the different combinations of
straightforward or difficult procedure, and straightforward or
difficult patient). Currently, there are three preservice time packages
for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value
services appropriately when they have common billing patterns. In cases
where a service is typically furnished to a beneficiary on the same day
as an E/M service, we believe that there is overlap between the two
services in some of the activities furnished during the preservice
evaluation and postservice time. Our longstanding adjustments have
reflected a broad assumption that at least one-third of the work time
in both the preservice evaluation and postservice period is duplicative
of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we adjust the work RVU and/or times to account
for the overlap. The work RVU for a service is the product of the time
involved in furnishing the service multiplied by the intensity of the
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which
means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU.
Therefore, in many cases when we remove 2 minutes of preservice
time and 2 minutes of postservice time from a procedure to account for
the overlap with the same day E/M service, we also remove a work RVU of
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
time had already been accounted for in the work RVU. The RUC has
recognized this valuation policy and, in many cases, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
The following paragraphs contain a general discussion of our
approach to reviewing RUC recommendations and developing proposed
values for specific codes. When they exist we also include a summary of
stakeholder reactions to our approach. We note that many commenters and
stakeholders have expressed concerns over the years with our ongoing
adjustment of work RVUs based on changes in the best information we had
regarding the time resources involved in furnishing individual
services. We have been particularly concerned with the RUC's and
various specialty societies' objections to our approach given the
significance of their recommendations to our process for valuing
services and since much of the information we used to make the
adjustments is derived from their survey process. We are obligated
under the statute to consider both time and intensity in establishing
work RVUs for PFS services. As explained in the CY 2016 PFS final rule
with comment period (80 FR 70933), we recognize that adjusting work
RVUs for changes in time is not always a straightforward process, so we
have applied various methodologies to identify several potential work
values for individual codes.
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been the
case for a significant portion of codes for which we recently
established or proposed work RVUs that are based on refinements to the
RUC-recommended values. When we have adjusted work
[[Page 39152]]
RVUs to account for significant changes in time, we have started by
looking at the change in the time in the context of the RUC-recommended
work RVU. When the recommended work RVUs do not appear to account for
significant changes in time, we have employed the different approaches
to identify potential values that reconcile the recommended work RVUs
with the recommended time values. Many of these methodologies, such as
survey data, building block, crosswalks to key reference or similar
codes, and magnitude estimation have long been used in developing work
RVUs under the PFS. In addition to these, we sometimes use the
relationship between the old time values and the new time values for
particular services to identify alternative work RVUs based on changes
in time components.
In so doing, rather than ignoring the RUC-recommended value, we
have used the recommended values as a starting reference and then
applied one of these several methodologies to account for the
reductions in time that we believe were not otherwise reflected in the
RUC-recommended value. If we believe that such changes in time are
already accounted for in the RUC's recommendation, then we do not make
such adjustments. Likewise, we do not arbitrarily apply time ratios to
current work RVUs to calculate proposed work RVUs. We use the ratios to
identify potential work RVUs and consider these work RVUs as potential
options relative to the values developed through other options.
We do not imply that the decrease in time as reflected in survey
values should always equate to a one-to-one or linear decrease in newly
valued work RVUs. Instead, we believe that, since the two components of
work are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, significant decreases in time should be reflected in
decreases to work RVUs. If the RUC's recommendation has appeared to
disregard or dismiss the changes in time, without a persuasive
explanation of why such a change should not be accounted for in the
overall work of the service, then we have generally used one of the
aforementioned methodologies to identify potential work RVUs, including
the methodologies intended to account for the changes in the resources
involved in furnishing the procedure.
Several stakeholders, including the RUC, have expressed general
objections to our use of these methodologies and deemed our actions in
adjusting the recommended work RVUs as inappropriate; other
stakeholders have also expressed general concerns with CMS refinements
to RUC-recommended values in general. In the CY 2017 PFS final rule (81
FR 80272 through 80277), we responded in detail to several comments
that we received regarding this issue. In the CY 2017 PFS proposed rule
(81 FR 46162), we requested comments regarding potential alternatives
to making adjustments that would recognize overall estimates of work in
the context of changes in the resource of time for particular services;
however, we did not receive any specific potential alternatives. As
described earlier in this section, crosswalks to key reference or
similar codes are one of the many methodological approaches we have
employed to identify potential values that reconcile the RUC-recommend
work RVUs with the recommended time values when the RUC-recommended
work RVUs did not appear to account for significant changes in time.
In response to comments, in the CY 2019 PFS final rule (83 FR
59515), we clarified that terms ``reference services'', ``key reference
services'', and ``crosswalks'' as described by the commenters are part
of the RUC's process for code valuation. These are not terms that we
created, and we do not agree that we necessarily must employ them in
the identical fashion for the purposes of discussing our valuation of
individual services that come up for review. However, in the interest
of minimizing confusion and providing clear language to facilitate
stakeholder feedback, we will seek to limit the use of the term,
``crosswalk,'' to those cases where we are making a comparison to a CPT
code with the identical work RVU. We also occasionally make use of a
``bracket'' for code valuation. A ``bracket'' refers to when a work RVU
falls between the values of two CPT codes, one at a higher work RVU and
one at a lower work RVU.
We look forward to continuing to engage with stakeholders and
commenters, including the RUC, as we prioritize our obligation to value
new, revised, and potentially misvalued codes; and will continue to
welcome feedback from all interested parties regarding valuation of
services for consideration through our rulemaking process. We refer
readers to the detailed discussion in this section of the valuation
considered for specific codes. Table 13 contains a list of codes and
descriptors for which we are proposing work RVUs; this includes all
codes for which we received RUC recommendations by February 10, 2021.
The proposed work RVUs, work time and other payment information for all
CY 2022 payable codes are available on the CMS website under downloads
for the CY 2022 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, and consultation with physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC's recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, are consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended PE inputs to better reflect our estimate of the PE
resources required for the service. We also confirm whether CPT codes
should have facility and/or nonfacility direct PE inputs and refine the
inputs accordingly.
Our review and refinement of the RUC-recommended direct PE inputs
includes many refinements that are common across codes, as well as
refinements that are specific to particular services. Table 14 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this proposed rule, Determination
of Practice Expense Relative Value Units (PE RVUs), we addressed
certain refinements that would be common across codes. Refinements to
particular codes are addressed in the portions of that section that are
dedicated to particular codes. We noted that for each refinement, we
[[Page 39153]]
indicated the impact on direct costs for that service. We noted that,
on average, in any case where the impact on the direct cost for a
particular refinement is $0.35 or less, the refinement has no impact on
the PE RVUs. This calculation considers both the impact on the direct
portion of the PE RVU, as well as the impact on the indirect allocator
for the average service. We also noted that many of the refinements
listed in Table 14 result in changes under the $0.35 threshold and are
unlikely to result in a change to the RVUs.
We also noted that the direct PE inputs for CY 2022 are displayed
in the CY 2022 direct PE input files, available on the CMS website
under the downloads for the CY 2022 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs
displayed there have been used in developing the CY 2022 PE RVUs as
displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We appreciate the RUC's willingness to provide
us with these additional inputs as part of its PE recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We clarified this principle
over several years of rulemaking, indicating that we consider equipment
time as the time within the intraservice period when a clinician is
using the piece of equipment plus any additional time that the piece of
equipment is not available for use for another patient due to its use
during the designated procedure. For those services for which we
allocate cleaning time to portable equipment items, because the
portable equipment does not need to be cleaned in the room where the
service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up
postoperative visits included in the global period for a service, the
equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also note that we believe these same assumptions would
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question would be available if the
room is not being occupied by a particular patient. For additional
information, we refer readers to our discussion of these issues in the
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there is a standardized number of minutes, depending on the type
of procedure, its typical setting, its global period, and the other
procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice clinical labor
tasks to avoid duplicative inputs and to reflect the resource costs of
furnishing the typical service.
We refer readers to section II.B. of this proposed rule,
Determination of Practice Expense Relative Value Units (PE RVUs), for
more information regarding the collaborative work of CMS and the RUC in
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC's
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. However, some recommendations include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2022 we received invoices for several new supply and
equipment items. Tables 16 and 17 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this proposed rule, Determination of Practice Expense Relative
Value Units, we encourage stakeholders to review the prices associated
with these new and existing items to determine whether these prices
appear to be accurate. Where prices appear inaccurate, we encourage
stakeholders to submit invoices or other information to improve the
accuracy of pricing for these items in the direct PE database by
February 10th of the following year for consideration in future
rulemaking, similar to our process for consideration of RUC
recommendations.
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We remind stakeholders that due to the relativity inherent in the
development of RVUs, reductions in existing prices for any items in the
direct PE database increase the pool of direct PE RVUs available to all
other PFS services. Tables 16 and 17 also include the number of
invoices received and the number of nonfacility allowed services for
procedures that use these equipment items. We provide the nonfacility
allowed services so that stakeholders will note the impact the
particular price might have on PE relativity, as well as to identify
items that are used frequently, since we believe that stakeholders are
more likely to have better pricing information for items used more
frequently. A single invoice may not be reflective of typical costs and
we encourage stakeholders to provide additional invoices so that we
might identify and use accurate prices in the development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we include the item in the direct PE input database without any
associated price. Although including the item without an associated
price means that the item does not contribute to the calculation of the
final PE RVU for particular services, it facilitates our ability to
incorporate a price once we obtain information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our direct PE inputs do not include clinical
labor minutes assigned to the service period because the cost of
clinical labor during the service period for a procedure in the
facility setting is not considered a resource cost to the practitioner
since Medicare makes separate payment to the facility for these costs.
We address code-specific refinements to clinical labor in the
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the list of services for the upcoming calendar year
that are subject to the MPPR on diagnostic cardiovascular services,
diagnostic imaging services, diagnostic ophthalmology services, and
therapy services; and the list of procedures that meet the definition
of imaging under section 1848(b)(4)(B) of the Act, and therefore, are
subject to the OPPS cap; are displayed in the public use files for the
PFS proposed and final rules for each year. The public use files for CY
2022 are available on the CMS website under downloads for the CY 2022
PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For more information regarding the history of the MPPR policy, we refer
readers to the CY 2014 PFS final rule with comment period (78 FR 74261
through 74263).
Effective January 1, 2007, section 5102(b)(1) of the Deficit
Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section
1848(b)(4) of the Act to require that, for imaging services, if--(i)
The technical component (including the technical component portion of a
global fee) of the service established for a year under the fee
schedule without application of the geographic adjustment factor,
exceeds (ii) The Medicare OPD fee schedule amount established under the
prospective payment system (PPS) for hospital outpatient department
services under section 1833(t)(3)(D) of the Act for such service for
such year, determined without regard to geographic adjustment under
paragraph (t)(2)(D) of such section, the Secretary shall substitute the
amount described in clause (ii), adjusted by the geographic adjustment
factor [under the PFS], for the fee schedule amount for such technical
component for such year. As required by the section 1848(b)(4)(A) of
the statute, for imaging services furnished on or after January 1,
2007, we cap the TC of the PFS payment amount for the year (prior to
geographic adjustment) by the Outpatient Prospective Payment System
(OPPS) payment amount for the service (prior to geographic adjustment).
We then apply the PFS geographic adjustment to the capped payment
amount. Section 1848(b)(4)(B) of the Act defines imaging services as
``imaging and computer-assisted imaging services, including X-ray,
ultrasound (including echocardiography), nuclear medicine (including
PET), magnetic resonance imaging (MRI), computed tomography (CT), and
fluoroscopy, but excluding diagnostic and screening mammography.'' For
more information regarding the history of the cap on the TC of the PFS
payment amount under the DRA (the ``OPPS cap''), we refer readers to
the CY 2007 PFS final rule with comment period (71 FR 69659 through
69662).
For CY 2022, we identified new and revised codes to determine which
services meet the definition of ``imaging services'' as defined above
for purposes of this cap. Beginning for CY 2022, we are proposing to
include the following services on the list of codes to which the OPPS
cap applies: CPT codes 0633T (Computed tomography, breast, including 3D
rendering, when performed, unilateral; without contrast material),
0634T (Computed tomography, breast, including 3D rendering, when
performed, unilateral; with contrast material(s)), 0635T (Computed
tomography, breast, including 3D rendering, when performed, unilateral;
without contrast, followed by contrast material(s)), 0636T (Computed
tomography, breast, including 3D rendering, when performed, bilateral;
without contrast material(s)), 0637T (Computed tomography, breast,
including 3D rendering, when performed, bilateral; with contrast
material(s)), 0638T (Computed tomography, breast, including 3D
rendering, when performed, bilateral; without contrast, followed by
contrast material(s)), 0648T (Quantitative magnetic resonance for
analysis of tissue composition (e.g., fat, iron, water content),
including multiparametric data acquisition, data preparation and
transmission, interpretation and report, obtained without diagnostic
MRI examination of the same anatomy (e.g., organ, gland, tissue, target
structure) during the same session), 0649T (Quantitative magnetic
resonance for analysis of tissue composition (e.g., fat, iron, water
content), including multiparametric data acquisition, data preparation
and transmission, interpretation and report, obtained with diagnostic
MRI examination of the same anatomy (e.g., organ, gland, tissue, target
structure) (List separately in addition to code for primary
procedure)), 77X01 (Trabecular bone score (TBS), structural condition
of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or
other imaging data on gray-scale variogram, calculation, with
interpretation and report on fracture risk), 77X02
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(Trabecular bone score (TBS), structural condition of the bone
microarchitecture; using dual X-ray absorptiometry (DXA) or other
imaging data on gray-scale variogram, calculation, with interpretation
and report on fracture risk, technical preparation and transmission of
data for analysis to be performed elsewhere), 77X03 (Trabecular bone
score (TBS), structural condition of the bone microarchitecture; using
dual X-ray absorptiometry (DXA) or other imaging data on gray-scale
variogram, calculation, with interpretation and report on fracture
risk, technical calculation only), 77X04 (Trabecular bone score (TBS),
structural condition of the bone microarchitecture; using dual X-ray
absorptiometry (DXA) or other imaging data on gray-scale variogram,
calculation, with interpretation and report on fracture risk
interpretation and report on fracture risk only, by other qualified
health care professional), 9111X (Gastrointestinal tract imaging,
intraluminal (e.g., capsule endoscopy), colon, with interpretation and
report), and 933X0 (3D echocardiographic imaging and postprocessing
during transesophageal echocardiography or transthoracic
echocardiography for congenital cardiac anomalies for the assessment of
cardiac structure(s) (e.g., cardiac chambers and valves, left atrial
appendage, intraterial septum, interventricular septum) and function,
when performed). We believe these codes meet the definition of imaging
services under section 1848(b)(4)(B) of the Act, and thus, should be
subject to the OPPS cap.
4. Proposed Valuation of Specific Codes for CY 2022
(1) Anesthesia for Cardiac Electrophysiologic Procedures (CPT Code
00537)
In October 2019, the RUC reviewed CPT code 00537 (Anesthesia for
cardiac electrophysiologic procedures including radiofrequency
ablation) and recommended that the code be surveyed for the October
2020 meeting. This service was identified by the RUC via the high
volume growth screen for services with total Medicare utilization of
10,000 or more that have increased by at least 100 percent from 2009
through 2014. Additionally, at the October 2019 RUC meeting, the RUC
approved an anesthesia reference service list (RSL) and a method to
assess the relativity among services on the anesthesia fee schedule
that uses a revised building block methodology and a regression line
analysis. The RUC has stated that the revised building block
methodology generates ``proxy RVUs'' that are then compared against the
RSL regression line to assess relativity among anesthesia services. The
RUC has indicated that their primary and approved method for anesthesia
base unit valuation continues to be the anesthesia survey results, and
that the building block and regression line analysis are used as a
supplemental validation measure.
The RUC recommended a valuation of 12 base units for CPT code
00537.We disagree with the RUC-recommended valuation of 12 base units
for CPT code 00537. After performing a RUC database search of codes
with similar total times and post-induction period procedure anesthesia
(PIPPA) times, 12 base units appears to be on the very high range. We
are proposing a valuation of 10 base units supported by reference codes
CPT code 00620 (anesthesia for procedures on the thoracic spine and
cord, not otherwise specified) and CPT code 00600 (Anesthesia for
procedures on cervical spine and cord; not otherwise specified), which
both have a valuation of 10 base units. CPT code 00620 has a very
similar total time of 235 minutes and CPT code 00600 has a higher total
time of 257 minutes and the same base unit value of 10, which indicates
that this is an appropriate valuation. Additionally, we note that the
survey total time for CPT code 00537 increased from 150 to 238 minutes,
resulting in a survey result 25th percentile valuation of 10 base
units.
We are proposing the RUC-recommended direct PE inputs for CPT code
00537.
(2) Anesthesia Services for Image-Guided Spinal Procedures (CPT Codes
01XX2, 01XX3, 01XX4, 01XX5, 01XX6, and 01XX7)
In 2017, the RUC identified CPT code 01936 (Anesthesia for
percutaneous image guided procedures on the spine and spinal cord;
therapeutic) as possibly needing refinement due to inaccurate reporting
via the high volume growth screen. The Relativity Assessment Workgroup
reviewed data on what procedures were reported with this anesthesia
code. In October 2019, the Workgroup reviewed this service and
recommended that it be referred to the CPT Editorial Panel to create
more granular codes. In October 2020, the CPT Editorial Panel replaced
CPT codes 01935 and 01936 with six new codes to report percutaneous
image-guided spine and spinal cord anesthesia procedures. These CPT
codes are 01XX2 (Anesthesia for percutaneous image-guided injection,
drainage or aspiration procedures on the spine or spinal cord; cervical
or thoracic), 01XX3 (Anesthesia for percutaneous image guided
injection, drainage or aspiration procedures on the spine or spinal
cord; lumbar or sacral), 01XX4 (Anesthesia for percutaneous image
guided destruction procedures by neurolytic agent on the spine or
spinal cord; cervical or thoracic), 01XX5 (Anesthesia for percutaneous
image guided destruction procedures by neurolytic agent on the spine or
spinal cord; lumbar or sacral), 01XX6 (Anesthesia for percutaneous
image guided neuromodulation or intravertebral procedures (e.g.,
Kyphoplasty, vertebroplasty) on the spine or spinal cord; cervical or
thoracic) and 01XX7 (Anesthesia for percutaneous image guided
neuromodulation or intravertebral procedures (e.g., Kyphoplasty,
vertebroplasty) on the spine or spinal cord; lumbar or sacral).
We are proposing the RUC-recommended valuation of 4 base units for
CPT codes 01XX2, 01XX3, 01XX4, and 01XX5.
We disagree with the RUC-recommend valuation of 6 base units for
CPT codes 01XX6 and 01XX7. After performing a RUC database search of
codes with similar total times and post-induction period procedure
anesthesia (PIPPA) times, 6 base units for CPT codes 01XX6 and 01XX7
appears to be a high valuation. We are proposing a valuation of 5 base
units for both codes supported by a reference code, CPT code 00813
(Anesthesia for combined upper and lower gastrointestinal endoscopic
procedures, endoscope introduced both proximal to and distal to the
duodenum). CPT code 00813 has a valuation of 5 base units with a higher
PIPPA time of 40 minutes as well as a higher total time of 70 minutes.
The RUC notes that CPT codes 01XX6 and 01XX7 should have a higher base
unit valuation than the other similar codes within this family due to
the complex nature of these procedures that have a more intensive
anesthesia process. The RUC supports their recommendation with a
crosswalk code, CPT code 00732 (Anesthesia for upper gastrointestinal
endoscopic procedures, endoscope introduced proximal to duodenum;
endoscopic retrograde cholangiopancreatography (ECRP)). CPT code 00732
has a valuation of 6 base units, a total time of 100 minutes, and a
PIPPA time of 65 minutes. CPT codes 01XX6 and 01XX7 have a total time
of 58 minutes and a PIPPA time of 20 minutes. We agree that a more
complex procedure may require a higher base unit valuation within a
code family; however, given the disparity in total and PIPPA time, we
disagree with the use of
[[Page 39156]]
this crosswalk code to support a valuation of 6 base units and instead
propose a valuation of 5 base units supported by reference CPT code
00813, which has higher times and the same base unit valuation.
We are proposing the RUC-recommended direct PE inputs for all six
codes in the family.
(3) Closed Treatment of Nasal Bone Fracture (CPT Codes 21315 and 21320)
We agree with the RUC's recommendation to change CPT codes 21315
(Closed treatment of nasal bone fracture; without stabilization) and
21320 (Closed treatment of nasal bone fracture; with stabilization) to
000-day global period codes from 010-day global period codes to account
for the degree of swelling within 10 days post-procedure, and because
the patient can remove their own splint at home for CPT code 21320. For
CPT codes 21315 and 21320, we disagree with the RUC-recommended work
RVUs of 2.00 and 2.33, respectively, as we believe these values do not
adequately reflect the surveyed reductions in physician time and the
change to a 000-day global period from a 010-day global period for
these CPT codes. We are proposing a work RVU of 0.96 for CPT code 21315
and 1.59 for CPT code 21320 based on the reverse building block
methodology to remove the RVUs associated with the 010-day global
period and the surveyed reductions in physician time. We believe that
the proposed work RVU of 0.96 for CPT code 21315 adequately accounts
for the 50 percent decrease in intraservice and postservice time, a 31-
minute decrease in total time, and a change to a 000-day global period
which will allow for separately billable E/M visits as medically
necessary. We believe that the proposed work RVU of 1.59 for CPT code
21320 adequately accounts for the 5-minute decrease in intraservice
time, 3-minute decrease in total time, and 48 percent decrease in
postservice time. Absent an explicitly stated rationale for an
intensity increase for CPT codes 21315 and 21320, we are proposing to
adjust the work RVU to reflect significant decreases in surveyed
physician time.
The global period changes from 010-day to 000-day allow for
separately billable E/M visits relating to CPT codes 21315 and 21320,
therefore we removed RVUs that we believed were attributable to the
currently bundled E/M visits totaling 1.30 RVUs for CPT code 21315 and
0.35 RVUs for CPT code 21320. CPT code 21315 is currently bundled with
one post-operative follow up office visit, CPT code 99213 (Office or
other outpatient visit for the evaluation and management of an
established patient, which requires a medically appropriate history
and/or examination and low level of medical decision making. When using
time for code selection, 20-29 minutes of total time is spent on the
date of the encounter). CPT code 21320 is currently bundled with half
of a post-operative follow up office visit, CPT code 99212 (Office or
other outpatient visit for the evaluation and management of an
established patient, which requires a medically appropriate history
and/or examination and straightforward medical decision making. When
using time for code selection, 10-19 minutes of total time is spent on
the date of the encounter). We do not believe the RUC adequately
accounted for the loss of these E/M visits in their recommended work
RVUs for CPT codes 21315 and 21320. The RUC's recommendations also seem
to dismiss the significant changes in surveyed physician time, without
a persuasive explanation of a significant increase in IWPUT that
results from the RUC's recommended work RVUs for CPT codes 21315 and
21320. We believe the surveyed decreases in physician time in
conjunction with the loss of the post-operative visits for CPT codes
21315 and 21320 merit decreases in the work RVUs from the current work
RVUs.
We considered using a modified total time ratio methodology given
the age and potentially flawed methodology used to arrive at the
current valuation. The modified total time ratio calculation does not
include the loss of 8 minutes of post-operative time attributable to
the change from a 010-day global period to a 000-day global period for
CPT code 21320 and loss of 23 minutes of post-operative time for CPT
code 23215. This modified time ratio methodology reflects how the
physician time is changing in the pre-, intra-, and postservice periods
when a code's global period is changing, given that E/M services can be
billed as medically necessary and appropriate for a 000-day global
code. The total time ratio between the current and proposed total times
for CPT code 21315, excluding the 23 minutes of post-operative time in
the current total time, equals 1.64. We arrived at 1.64 by modifying
the original total time ratio equation to equal the proposed new total
time divided by the current time, less any time attributable to the
post-operative global period, then multiplied by the current work RVU.
The current total time for CPT code 21315 without the 23 minutes of
post-operative time that will be lost by going from a 010-day to a 000-
day global period code is 76 minutes, therefore, the modified total
time ratio = (68 minutes/(99 minutes-23 minutes)) * 1.83 = 1.64. When
using the original total time ratio methodology for CPT code 21315, it
shows a 31 percent decrease in total time [(68 minutes-99 minutes)/99
minutes = -0.31], whereas the modified methodology shows that there is
only an 11 percent decrease in newly proposed pre-, intra-, and
postservice time from the current times [(68 minutes-76 minutes)/76
minutes = -0.11]. The same modified total time ratio methodology could
be applicable to CPT code 21320. The current total time for CPT code
21320 without the 8 minutes of post-operative time that will be lost by
going from a 010-day to a 000-day global period code is 70 minutes,
therefore, the modified total time ratio = (75 minutes/(78 minutes-8
minutes) * 1.88 = 2.01. The modified methodology shows that the pre-,
intra-, and postservice time is increasing by 7 percent for CPT code
21320, whereas the original methodology, which accounts for the loss of
the 8 post-operative minutes in the total time ratio, shows a 4 percent
decrease in total time that would indicate the need for a work RVU
decrease. We recognize that we have not previously used a modified
total time approach to consider work RVU values when there is a change
in the global period for a service in conjunction with significant
surveyed changes to the pre-, intra-, and postservice times; therefore,
we are seeking comment on application of the modified total time ratio
approach to value services that have a global period change and
significant surveyed physician time changes. We believe this
methodology may account for the loss of post-operative visits and the
surveyed changes in the pre-, intra-, and postservice times in this
unique situation, given the potentially flawed methodology used to
arrive at the current valuations for CPT codes 21315 and 21320 that are
used in the total time ratios.
We are also proposing the RUC-recommended direct PE inputs without
refinements and the surveyed physician times for CPT codes 21315 and
21320.
(4) Insertion of Interlaminar/Interspinous Device (CPT Code 22867)
We are proposing the RUC-recommended work RVU of 15.00 for CPT code
22867 (Insertion of interlaminar/interspinous process stabilization/
distraction device, without fusion, including image guidance when
performed, with open decompression, lumbar; single level). The RUC is
not recommending changes to the current
[[Page 39157]]
PE inputs, and CMS is not proposing any changes to the current PE
inputs.
(5) Treatment of Foot Infection (CPT Codes 28001, 28002, and 28003)
Through a screen of codes with 010-day global period service with
more than one post-operative follow-up office visit, the RUC identified
this family of major surgical codes that did not have consistent global
periods. The RUC conducted a survey of these codes as 000-day globals
for their April 2020 meeting, and the review was postponed until
October 2020. CPT code 28001 (Incision and drainage, bursa, foot) (work
RVU of 2.78 with 31 minutes of intraservice time) currently has a 010-
day global period with one post-operative follow-up office visit, CPT
code 99212 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires at least 2 of
these 3 key components: A problem focused history; A problem focused
examination; Straightforward medical decision making. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are self limited or minor. Typically, 10 minutes
are spent face-to-face with the patient and/or family). Survey results
from podiatrists and orthopedic surgeons yielded a median work RVU of
2.00 with 17 minutes of preservice evaluation time, 3 minutes of
preservice positioning time, 5 minutes of preservice scrub/dress/wait
time, 20 minutes intraservice time, and 15 minutes immediate
postservice time for a total of 60 minutes total time. We are proposing
the RUC-recommended work RVU of 2.00 and the surveyed physician times
for this 000-day global code.
CPT code 28002 (Incision and drainage below fascia, with or without
tendon sheath involvement, foot; single bursal space) (work RVU of 5.34
with 30 minutes of intraservice time) currently has a 010-day global
period with two post-operative follow-up office visits, CPT code 99213
(Office or other outpatient visit for the evaluation and management of
an established patient, which requires at least 2 of these 3 key
components: An expanded problem focused history; An expanded problem
focused examination; Medical decision making of low complexity.
Counseling and coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and/or
family's needs. Usually, the presenting problem(s) are of low to
moderate severity. Typically, 15 minutes are spent face-to-face with
the patient and/or family); and a half day hospital discharge CPT code
99238 (Hospital discharge day management; 30 minutes or less). For CPT
code 28002, the RUC recommended 30 minutes of preservice evaluation
time, 5 minutes of preservice positioning time, 15 minutes of
preservice scrub/dress/wait time, 30 minutes of intraservice time, and
20 minutes of immediate postservice time, for a total of 100 minutes
total time. The RUC recommended a work RVU of 3.50 and the surveyed
physician times for this 000-day global code.
We note that the result from the survey's 50th percentile work RVU
was 3.73 and that the survey's 25th percentile work RVU was 2.80. As
this CPT code is converting from a 010-day global to a 000-day global
we find the reference CPT code 43193 (Esophagoscopy, rigid, transoral;
with biopsy, single or multiple) as a more suitable value of 2.79 work
RVUs with a similar 30 minutes of intraservice physician time and 106
minutes of total time. We are proposing a work RVU of 2.79 for CPT code
28002 and we are proposing the RUC surveyed physician times for this
000-day global code.
CPT code 28003 (Incision and drainage below fascia, with or without
tendon sheath involvement, foot; multiple areas) currently has a 090-
day global period with two post-operative follow-up office visits, CPT
code 99212 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires at least 2 of
these 3 key components: A problem focused history; A problem focused
examination; Straightforward medical decision making. Counseling and/or
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are self limited or minor. Typically, 10 minutes
are spent face-to-face with the patient and/or family); three post-
operative follow-up office visits, CPT code 99213 (Office or other
outpatient visit for the evaluation and management of an established
patient, which requires at least 2 of these 3 key components: An
expanded problem focused history; An expanded problem focused
examination; Medical decision making of low complexity. Counseling and
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and/or family's needs. Usually, the
presenting problem(s) are of low to moderate severity. Typically, 15
minutes are spent face-to-face with the patient and/or family.); one
post-operative CPT code 99231 (Subsequent hospital care, per day, for
the evaluation and management of a patient, which requires at least 2
of these 3 key components: A problem focused interval history; A
problem focused examination; Medical decision making that is
straightforward or of low complexity. Counseling and/or coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and/or family's needs. Usually, the patient is
stable, recovering or improving. Typically, 15 minutes are spent at the
bedside and on the patient's hospital floor or unit); one post-
operative CPT code 99232 (Subsequent hospital care, per day, for the
evaluation and management of a patient, which requires at least 2 of
these 3 key components: An expanded problem focused interval history;
An expanded problem focused examination; Medical decision making of
moderate complexity. Counseling and/or coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and/or family's needs. Usually, the patient is responding inadequately
to therapy or has developed a minor complication. Typically, 25 minutes
are spent at the bedside and on the patient's hospital floor or unit),
and one hospital discharge CPT code 99238 (Hospital discharge day
management; 30 minutes or less), for a total of eight post op follow-up
visits, across five types of E/M and hospital care codes. For CPT code
28003, the RUC recommends 40 minutes of preservice evaluation time, 10
minutes of preservice positioning time, 15 minutes of preservice scrub/
dress/wait time, 45 minutes of intraservice time, and 20 minutes of
immediate postservice time, for a total time of 130 minutes. We are
proposing the RUC-recommended work RVU of 5.28 and surveyed physician
times for this 000-day global code.
In order to complete the adjustments for making these Treatment of
Foot Infection codes consistent as 000-day global codes, the RUC
adjusted the PE inputs for these codes to reflect their proposed global
periods from 010 and 090-day globals to 000-day global, and to reflect
the use of more typical supplies, equipment, and clinical labor
[[Page 39158]]
employed now, than what was necessary a decade ago. Some relatively
small valued supply items were removed, while other items were added,
and clinical labor times were largely adjusted to remove minutes from
the post-operative follow-up office visit times in the 010 and 090-day
global codes. We are proposing all of the PE refinements as recommended
by the RUC for these codes, which can be found in section II.B. of this
proposed rule, under the Determination of Practice Expense RVUs.
(6) Percutaneous Cerebral Embolic Protection (CPT Codes 33XXX)
CPT code 33XXX (Transcatheter placement and subsequent removal of
cerebral embolic protection device(s), including arterial access,
catheterization, imaging, and radiological supervision and
interpretation, percutaneous (List separately in addition to code for
primary procedure)) was created in October 2020, by the CPT Editorial
Panel as a new add-on code to report transcatheter placement and
subsequent removal of cerebral embolic protection device(s). The CPT
Editorial Panel also added instructions to report the new code in the
Aortic Valve guidelines. The RUC reviewed the survey results for the
new add-on code and noted that the survey respondents likely overvalued
the physician work involved in performing this service, with a 25th
percentile work value of 3.43. The RUC recommends a work RVU of 2.50
for CPT code 33XXX.
We are proposing the RUC-recommended work RVU of 2.50 for CPT code
33XXX. This is a facility-based add-on code with no direct PE inputs.
(7) Exclusion of Left Atrial Appendage (CPT Codes 33XX3, 33XX4, and
33XX5)
In May 2020, the CPT Editorial Panel approved the creation of three
new codes to describe open and thoracoscopic left atrial appendage
management procedures when performed as stand-alone procedures or in
conjunction with other procedures. The codes represent new technology
and surgical techniques that may be used to treat atrial fibrillation
at the time of another surgical procedure and include CPT code 33XX3
(Exclusion of left atrial appendage, open, any method (e.g., excision,
isolation via stapling, oversewing, ligation, plication, clip), CPT
code 33XX4 (Exclusion of left atrial appendage, open, performed at the
time of other sternotomy or thoracotomy procedure(s), any method (e.g.,
excision, isolation via stapling, oversewing, ligation, plication,
clip) (List separately in addition to code for primary procedure)), and
CPT code 33XX5 (Exclusion of left atrial appendage, thoracoscopic, any
method (e.g., excision, isolation via stapling, oversewing, ligation,
plication, clip). CPT codes 33XX3 and 33XX5 are 090-day global codes
while CPT code 33XX4 is a ZZZ global code.
In October 2020, the RUC reviewed and recommended work and PE
values for the three new codes. Recommended work values include 18.50
RVUs for CPT code 33XX3, 2.50 work RVUs for CPT code 33XX4, and 14.31
work RVUs for CPT code 33XX5.
We are proposing the RUC-recommended work RVUs for the three new
codes. We are also proposing the RUC-recommended direct PE inputs for
CPT codes 33XX3 and 33XX5. We note that CPT code 33XX4 has no direct PE
inputs.
(8) Endovascular Repair of Aortic Coarctation (CPT Codes 338X1, 338X2,
and 338X0)
In October 2020, the CPT Editorial Panel created CPT codes 338X1
(Endovascular stent repair of coarctation of the ascending, transverse,
or descending thoracic or abdominal aorta, involving stent placement;
across major side branches) and 338X2 (Endovascular stent repair of
coarctation of the ascending, transverse, or descending thoracic or
abdominal aorta, involving stent placement; not crossing major side
branches) to report endovascular stent repair of coarctation of the
thoracic or abdominal aorta; and CPT code 338X0 (Percutaneous
transluminal angioplasty of native or recurrent coarctation of the
aorta) to report trans-liminal angioplasty for repair of native or
recurrent percutaneous coarctation of the aorta. For CY 2022, the RUC
recommended a work RVU of 21.70 for CPT code 338X1, a work RVU 17.97
for CPT code 338X2, and a work RVU 14.00 for CPT code 338X0.
We disagree with the RUC-recommended work RVUs for the CPT code
family of 338X1, 338X2, and 338X0. We found that the recommended work
RVUs for these CPT codes were high when compared to other codes with
similar time values. Therefore, we are proposing the RUC survey 25th
percentile of 18.27 as the work RVU for 338X1, we are proposing a work
RVU of 14.54 for 338X2, and we are proposing a work RVU of 10.81 for
338X0.
When we reviewed CPT code 338X1, we found that the recommended work
RVU was high compared to other codes with similar time values. The RUC
survey 25th percentile of 18.27 falls within the range of RVUs with
similar intra service time. This is supported by the reference CPT
codes we compared to CPT code 338X1 with intra service time similar to
the 134 minutes of intra service time for CPT code 338X1; reference CPT
code 37231 (Revascularization, endovascular, open or percutaneous,
tibial, peroneal artery, unilateral, initial vessel; with transluminal
stent placement(s) and atherectomy, includes angioplasty within the
same vessel, when performed) has a work RVU of 14.75 with 135 minutes
of intra service time, and CPT code 93590 (Percutaneous transcatheter
closure of paravalvular leak; initial occlusion device, mitral valve)
has a work RVU of 21.70 with 135 minutes of intra service time. We note
that the RUC-recommended RVU of 21.70 is a crosswalk from CPT code
93590 and is the highest value code within the range of reference codes
we reviewed with similar intra service time. Again, we believe the RUC
survey 25th percentile of 18.27 is a more appropriate value overall
than 21.70 when compared to the range of codes with similar intra
service time.
The RUC-recommended RVU of 17.97 for CPT code 338X2 was higher than
other codes with the same 120 minutes of intra service time and similar
total time. Although we disagree with the RUC-recommended work RVU for
338X2, we concur that the relative difference in work between CPT codes
338X1 and 338X2 is equivalent to the RUC-recommended interval of 3.73
RVUs. We believe the use of an incremental difference between these CPT
codes is a valid methodology for setting values, especially in valuing
services within a family of codes where it is important to maintain an
appropriate intra-family relativity. Therefore, we are proposing a work
RVU of 14.54 for CPT code 338X2, based on the RUC-recommended interval
of 3.73 RVUs below our proposed work RVU of 18.27 for CPT code 338X1.
The RUC-recommended work RVU of 14.00 for CPT code 338X0 was higher
than other codes with the same 90 minutes of intra service time and
similar total time and we believe it would be more accurate to propose
a work RVU that maintains the 3.73 incremental difference between the
codes in this family. Therefore, for CPT code 338X0, we propose a work
RVU of 10.81 which also continues the 3.73 incremental difference used
between CPT codes 338X1 and 338X2, instead of the RUC incremental
difference of 3.97 between CPT codes 338X2 and 338X0. Although
[[Page 39159]]
the work RVU of 10.81 we are proposing for CPT code 338X0 is lower than
the RUC recommendation, the 3.73 incremental difference between CPT
codes 338X2 and 338X0 we are proposing is more generous than the RUC
incremental difference of 3.97 between CPT codes 338X2 and 338X0.
We are proposing no direct PE inputs for the CPT code family of
338X1, 338X2, and 338X0, as recommended by the RUC. These services are
provided exclusively in the facility setting.
(9) Harvest of Upper Extremity Artery (CPT Codes 35XX0 and 35600)
In May 2020, the CPT Editorial Panel created CPT code 35XX0
(Harvest of upper extremity artery, 1 segment, for coronary artery
bypass procedure, endoscopic) to describe endoscopic radial artery
harvest via an endoscopic approach, and CPT code 35600 (Harvest of
upper extremity artery, 1 segment, for coronary artery bypass
procedure, open) was modified to only include an open approach for the
upper extremity harvesting procedure. The RUC also stated that CPT
codes 35XX0 and 35600 are almost always exclusively performed in
conjunction with coronary artery bypass grafting (CABG) procedures. For
CY 2022, the RUC-recommended a work RVU of 3.75 for CPT code 35XX0 and
a work RVU of 4.00 for CPT code 35600.
We disagree with the RUC-recommended RVUs for the CPT code family
of 35XX0 and 35600. We found that the recommended work RVUs for these
CPT codes were high when compared to other codes with similar time
values. Therefore, we are proposing 3.34 as the work RVU for 35XX0 and
we are proposing a work RVU of 3.59 for 35600.
We disagree with the RUC-recommended work RVU for CPT code 35XX0
and are proposing an RVU of 3.34 which is a direct work RVU crosswalk
from CPT code 35686 (Creation of distal arteriovenous fistula during
lower extremity bypass surgery (non-hemodialysis) (List separately in
addition to code for primary procedure)). The RUC-recommended value of
3.75 is higher than other codes with similar intra service time and
total time. This is supported by the reference CPT codes we compared to
CPT code 35XX0 with the same 35 minutes of intra service time and 35
minutes of total time as CPT code 35XX0; reference CPT code 74713
(Magnetic resonance (e.g., proton) imaging, fetal, including placental
and maternal pelvic imaging when performed; each additional gestation
(List separately in addition to code for primary procedure)) has a work
RVU of 1.85, and CPT code 35686 has a work RVU of 3.34.
Although we disagree with the RUC-recommended work RVU for CPT code
35600, we concur that the relative difference in work between CPT codes
35XX0 and 35600 is equivalent to the RUC-recommended interval of 0.25
RVUs. We believe the use of an incremental difference between these CPT
codes is a valid methodology for setting values, especially in valuing
services within a family of codes where it is important to maintain an
appropriate intra-family relativity. Therefore, we are proposing a work
RVU of 3.59 for CPT code 35600, based on the RUC-recommended interval
of 0.25 RVUs above our proposed work RVU of 3.34 for CPT code 35XX0.
We are proposing no direct PE inputs for the CPT code family of
35XX0 and 35600 as recommended by the RUC. These services are provided
exclusively in the facility setting.
The RUC acknowledged that CPT codes 35XX0 and 35600 are almost
always exclusively performed in conjunction with coronary artery bypass
grafting (CABG) procedures. Such codes are designated as add-on
procedures and are assigned a ZZZ-day global period (that is, code
related to another service and is always included in the global period
of the other service). The RUC also requested that the global period
for both CPT codes 35XX0 and 35600 be an XXX-day global period (that
is, global concept does not apply) and not a ZZZ-day global period as
is customary for add-on codes. The RUC stated that an XXX-day global
period would allow the individual that performs the harvest of upper
extremity artery procedure (often separate from the surgeon performing
the base CABG procedure) to report it under their own provider number.
The RUC noted that it is often a nurse practitioner (NP) or physician's
assistant (PA) who performs the harvest procedure. However, the RUC
surveyed CPT codes 35XX0 and 35600 using reference codes with the ZZZ-
day global period. Therefore, we believe it is appropriate to use that
same ZZZ-day global period for CPT codes 35XX0 and 35600, and we are
proposing to assign the ZZZ-day global period to CPT codes 35XX0 and
35600 for CY 2022. Through our scrutiny of comparing the code
descriptions of codes with matching intra service times, we find much
more clinically coherent similarities with codes with a ZZZ-day global
period (procedures complementary, and sometimes necessary, to complete
a larger procedure) than codes with an XXX-day global period.
However, we are compelled to understand more about the billing
circumstances presented by the RUC and stakeholders that have presented
this approach for CPT codes 35XX0 and 35600 to CMS for consideration.
We are seeking comments and requesting information that may inform why
CPT codes 35XX0 and 35600 should have an XXX-day global period instead
of the ZZZ-day global period that is customary for add-on codes.
(10) Needle Biopsy of Lymph Nodes (CPT Code 38505)
CPT code 38505 (Biopsy or excision of lymph node(s); by needle,
superficial (e.g., cervical, inguinal, axillary)) was identified in
October 2019 as Harvard Valued with a utilization of over 30,000
claims. In January 2020, the RUC recommended that the code be surveyed
for October 2020 RUC meeting. The RUC recommended increasing the work
RVU to 1.59 which is the survey 25th percentile, acknowledging a change
in the service, which now involves larger tissue samples as well as a
change in technology, and a change in the dominant specialty now
reporting the service.
We are proposing the RUC-recommended work RVU of 1.59 for CPT code
38505. We are also proposing the RUC-recommended direct PE inputs for
this code.
(11) Drug Induced Sleep Endoscopy (CPT Codes 42XXX)
CPT code 42XXX (Drug induced sleep endoscopy; with dynamic
evaluation of velum, pharynx, tongue base, and larynx for evaluation of
sleep disordered breathing; flexible, diagnostic) is a new code created
to report drug induced sleep endoscopy (DISE) flexible, diagnostic. The
RUC recommended, and we agree, that the survey 25th percentile for the
work RVU of 1.90 accurately reflects the typical physician work
necessary to perform this service.
Since this is a drug induced sleep endoscopy, we are proposing CPT
code 31575 (Diagnostic laryngoscopy) as the endoscopic base code for
CPT code 42XXX because the description of the proposed CPT code is the
same as what is described for CPT code 31575 with the additional
component of the patient being sedated. The procedure is performed with
a flexible endoscope or laryngoscope. CPT code 42XXX is not an add-on
code, it has a 0-day global period. The endoscopic base code that it is
using is a specific type of multiple procedure discount that applies to
some endoscopy codes.
We are proposing the RUC-recommended work RVU of 1.90 for
[[Page 39160]]
CPT code 42XXX. We are also proposing the RUC-recommended direct PE
inputs for this code.
(12) Per-Oral Endoscopic Myotomy (POEM) (CPT Codes 434XX)
In May 2020, the CPT Editorial Panel created a new CPT code 434XX
(Lower esophageal myotomy, transoral (i.e., peroral endoscopic myotomy
[POEM])) to describe a Per-Oral Endoscopic Myotomy (POEM), which
involves the visualization and dissection of the esophageal muscle
layers via an endoscope to treat esophageal motility disorders such as
achalasia. This procedure accomplishes a comparable myotomy to what
traditional open and laparoscopic myotomy (Heller) accomplishes. POEM
utilizes an endoscope and specially designed dissecting, cutting, and
cauterizing instruments to create a long submucosal tunnel beginning in
the mid-esophagus and extending several centimeters into the cardia.
For CY 2022, the RUC recommended a work RVU of 15.50 for CPT code
434XX.
We disagree with the RUC-recommended work RVU for CPT code 434XX
and are proposing a work RVU of 13.29 based on a direct work RVU
crosswalk from CPT code 36819 (Arteriovenous anastomosis, open; by
upper arm basilic vein transposition). CPT code 36819 has the same 120
minutes of intra service time as CPT code 434XX, and has 283 minutes of
total time, which is 2 minutes more than the 281 minutes of total time
than for 434XX. The RUC used CPT codes 43279 (Laparoscopy, surgical,
esophagomyotomy (Heller type), with fundoplasty, when performed) and
43180 (Esophagoscopy, rigid, transoral with diverticulectomy of
hypopharynx or cervical esophagus (e.g., Zenker's diverticulum), with
cricopharyngeal myotomy, includes use of telescope or operating
microscope and repair, when performed) as reference codes for CPT code
434XX. However, the intra service time of 150 minutes and total time of
404 minutes for the RUC reference CPT code 43279, and intra service
time of 60 minutes and total time of 201 minutes for the RUC reference
CPT code 43180, are not adequate comparisons since they do not have
similar time values to those of CPT code 434XX. Therefore, we believe
the proposed work RVU of 13.29 for CPT code 434XX based on a direct
work RVU crosswalk from CPT code 36819 is a better representation of
the work being performed and is more appropriate based on the same
intra service time and similar total time.
We are proposing the RUC-recommended direct PE inputs for CPT code
434XX without refinement.
(13) Placement-Removal of Seton (CPT Codes 46020 and 46030)
For CPT codes 46020 (Placement of seton) and 46030 (Removal of anal
seton, other marker), we disagree with the RUC-recommended work RVUs of
3.50 and 2.00, respectively, as we believe these values do not
adequately reflect the surveyed reductions in physician time for CPT
code 46020 and the change to a 000-day global period from a 010-day
global period for these CPT codes. Instead, we are proposing a work RVU
of 1.86 for CPT code 46020 and 1.48 for CPT code 46030 based on a
reverse building block methodology.
The survey showed that total time and intraservice time are
decreasing for CPT code 46020 by 26 minutes and 5 minutes,
respectively. We believe the surveyed decreases in physician time in
conjunction with the loss of the post-operative visits for CPT code
46020 merit a decrease in work RVU from the current work RVU.
We note that the proposed work RVU of 1.48 for CPT code 46030 falls
between CPT code 57410 (Pelvic examination under anesthesia (other than
local)), which has a work RVU of 1.75, and CPT code 64487 (Transversus
abdominis plane (TAP) block (abdominal plane block, rectus sheath
block) unilateral; by continuous infusion(s) (includes imaging
guidance, when performed)), which has a work RVU of 1.48. Both of these
bracketing reference codes have identical intraservice times and
similar total time values. While we understand that total time is going
up for CPT code 46030, this increase is a result of significant
increases to evaluation, positioning, and scrub, dress, wait preservice
times, which is mostly low-intensity physician work.
We agree with the RUC's recommendation to change CPT codes 46020
and 46030 to 000-day global period codes from 010-day global period
codes to account for the highly variable follow-up care for these
services, but we note that the differences in RUC-recommended work RVUs
and our proposed work RVUs largely reflect the change in global period
and loss of physician time to provide the E/M services. The global
period changes from 010-day to 000-day allow for separately billable E/
M visits relating to CPT codes 46020 and 46030, therefore we removed
RVUs that we believed were attributable to the currently bundled E/M
visits totaling 2.04 RVUs for CPT code 46020 and 0.35 RVUs for CPT code
46030. CPT code 46020 is currently bundled with two post-operative
follow up office visits, CPT code 99212 (Office or other outpatient
visit for the evaluation and management of an established patient,
which requires a medically appropriate history and/or examination and
straightforward medical decision making. When using time for code
selection, 10-19 minutes of total time is spent on the date of the
encounter), and a half hospital discharge CPT code 99238 (Hospital
discharge day management; 30 minutes or less). CPT code 46030 is
currently bundled with half of a post-operative follow up office visit,
CPT code 99212 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and straightforward medical
decision making. When using time for code selection, 10-19 minutes of
total time is spent on the date of the encounter). We do not believe
the RUC adequately accounted for the loss of these E/M visits in their
recommended work RVUs for CPT codes 46020 and 46030.
The RUC proposed the standard 090-day preservice times for the
clinical labor activities CA001, CA002, CA003, CA004, and CA005 for CPT
code 46020 in the facility. We note that the RUC recommended 090-day
preservice clinical labor times despite surveying the service as a 000-
day service. We disagree with the RUC-recommended 090-day preservice
clinical labor times as we believe 000-day services should have times
consistent with 000-day services, not 090-day services. However, we
recognize there is time needed to coordinate this service. Therefore,
we are proposing the following standard clinical labor times for
extensive use of clinical staff for a 000-day global code:
Complete preservice diagnostic and referral forms (CA001)
5 minutes.
Coordinate pre-surgery services (including test results)
(CA002) 10 minutes.
Schedule space and equipment in facility (CA003) 5
minutes.
Provide preservice education/obtain consent (CA004) 7
minutes.
Complete pre-procedure phone calls and prescription
(CA005) 3 minutes.
We are also proposing to refine the direct PE input for Coordinate
post-procedure services (CA038) to 0 minutes from the RUC-recommended 3
minutes to align with 000-day standards instead of 090-day standards
for CPT code 46020.
For CPT code 46030, the RUC recommended the standard 000-day
[[Page 39161]]
extensive use of clinical staff preservice times for clinical
activities CA001, CA002, CA003, CA004, and CA005 in the facility and
non-facility settings. Preservice times for 000-day codes are presumed
to be zero unless there is sufficient justification that preservice
time is warranted. We do not agree that sufficient justification was
presented to warrant preservice time in the non-facility setting,
therefore, we are proposing the following standard clinical labor times
for use of clinical staff in the non-facility setting. We are also
proposing the standards for minimal use of clinical staff in the
facility setting, as we recognize there is time needed to coordinate
this service for CPT code 46030:
Complete preservice diagnostic and referral forms (CA001)
0 minutes for non-facility and 3 minutes for facility.
Coordinate pre-surgery services (including test results)
(CA002) 0 minutes for non-facility and 3 minutes for facility.
Schedule space and equipment in facility (CA003) 0 minutes
for non-facility and 3 minutes for facility.
Provide preservice education/obtain consent (CA004) 0
minutes for non-facility and 3 minutes for facility.
Complete pre-procedure phone calls and prescription
(CA005) 0 minutes for non-facility and 3 minutes for facility.
We are also proposing to refine the direct PE input for Coordinate
post-procedure services (CA038) to 0 minutes from the RUC-recommended 3
minutes to align with 000-day standards instead of 090-day standards
for CPT code 46030.
(14) Periurethral Balloon Continence Device Procedures (CPT Codes
53XX1, 53XX2, 53XX3, and 53XX4)
In October 2020, the CPT Editorial Panel replaced four CPT Category
III codes with four new CPT Category I codes to report periurethral
adjustable balloon continence devices. Given the low utilization and
the low survey response rate for the four new codes, the RUC
recommended that CMS assign contractor pricing to these procedures. We
agree with the RUC and we are proposing contractor pricing for all four
codes in the family, CPT codes 53XX1 (Periurethral transperineal
adjustable balloon continence device; bilateral insertion, including
cystourethroscopy and imaging guidance), 53XX2 (Periurethral
transperineal adjustable balloon continence device; unilateral
insertion, including cystourethroscopy and imaging guidance), 53XX3
(Periurethral transperineal adjustable balloon continence device;
removal, each balloon) and 53XX4 (Periurethral transperineal adjustable
balloon continence device; percutaneous adjustment of balloon(s) fluid
volume).
(15) Intracranial Laser Interstitial Thermal Therapy (LITT) (CPT Codes
617X1 and 617X2)
In October 2020, the CPT Editorial Panel approved the addition of
two codes to report laser interstitial thermal therapy (LITT) of
lesion, intracranial, including burr hole(s), with magnetic resonance
(MR) imaging guidance for a single trajectory for 1 simple lesion and
multiple trajectories for multiple or complex lesion(s). LITT is a
novel procedure that involves multiple steps and movements of the
patient through the hospital for different stages of the procedure. The
typical facility does not have an interoperative MRI suite (a small
minority of academic medical centers may), so patient transport is
necessary.
The RUC recommended a work RVU of 20.00 for CPT code 617X1 (Laser
interstitial thermal therapy (LITT) of lesion, intracranial, including
burr hole(s), with magnetic resonance imaging guidance, when performed;
single trajectory for 1 simple lesion) based on the survey median
response. CPT code 617X1 was surveyed with having one subsequent
hospital visit, CPT code 99232 (sbsq hospital care/day 25 minutes) and
40 minutes of immediate postservice time. The RUC noted that although
the survey median immediate postservice time was 40 minutes, for 617X1,
the CMS 23-Hour Stay Outpatient Surgical Services with Subsequent
Hospital Visits Policy was applied which resulted in the 99232 visit
being removed and its 20 minutes of intraservice time being applied to
the 40 minutes of immediate postservice time resulting in 60 minutes of
immediate postservice time. See the 2011 PFS final rule (75 FR 73226)
for an in-depth explanation of the 23-hour policy. We believe the RUC
partially applied the 23-hr policy when it applied the policy to the
immediate post service time but not to the work RVU. We believe the 23-
hour policy in its entirety should be applied to 671X1, which includes
the work RVUs along with the immediate postservice time.
Following the valuation methodology we established for 23-hour stay
services in the CY 2011 PFS final rule, 617X1 would have a work RVU of
19.06.
The steps are as follows:
Step (1): CPT code 617X1 does not have a hospital
discharge day management service; therefore, we would skip this step.
Step (2): 20 - 1.39** = 18.61.
Step (3): 18.61 + (20 minutes x 0.0224)*** = 19.06 RVUs.
* Value associated with 1/2 hospital discharge day management
service.
** Value associated with an inpatient hospital visit, CPT code
99232.
*** Value associated with the reallocated intraservice time
multiplied by the postservice intensity of the 23-hour stay code.
Therefore, for CY 2022 we are proposing a work RVU of 19.06 for CPT
code 671X1.
In reviewing the RUC-recommended direct PE inputs for 671X1 we
noticed the RUC proposed the standard 090-day preservice times for the
following clinical labor activities:
Complete preservice diagnostic and referral forms (CA001)
5 minutes.
Coordinate pre-surgery services (including test results)
(CA002) 20 minutes.
Schedule space and equipment in facility (CA003) 8
minutes.
Provide preservice education/obtain consent (CA004) 20
minutes.
Complete pre-procedure phone calls and prescription (CA005) 7
minutes.
We note that the RUC recommended 090-day preservice times despite
surveying the service as a 000-day service. We disagree with the RUC-
recommended 090-day times as we believe this is a 000-day service and
should have times consistent with 000-day services. However, we
recognize there is time needed to coordinate this service. Therefore,
for CY 2022 we are proposing the following standard clinical labor
times for a 000-day extensive:
Complete preservice diagnostic and referral forms (CA001)
5 minutes.
Coordinate pre-surgery services (including test results)
(CA002) 10 minutes.
Schedule space and equipment in facility (CA003) 5
minutes.
Provide preservice education/obtain consent (CA004) 7
minutes.
Complete pre-procedure phone calls and prescription
(CA005) 3 minutes.
For CPT code 617X2 (Laser interstitial thermal therapy (LITT) of
lesion, intracranial, including burr hole(s), with magnetic resonance
imaging guidance, when performed; multiple trajectories for multiple or
complex lesion(s)), the RUC recommended a work RVU of 24.00 which is
the survey median. The RUC's recommendation also included 40 minutes of
immediate postservice time and one hospital visit, CPT code 99233 (sbsq
hospital care/day visit 35 minutes). We believe it would be appropriate
to apply the 23-hr policy to CPT code 617X2 as well.
[[Page 39162]]
The steps are as follows:
Step (1): CPT code 617X2 does not have a hospital
discharge day management service. Therefore, we would skip this step.
Step (2): 24 - 2** = 22
Step (3): 22 + (30 minutes x 0.0224)*** = 22.67 RVUs
* Value associated with 1/2 hospital discharge day management
service.
** Value associated with an inpatient hospital visit, CPT code
99233.
*** Value associated with the reallocated intraservice time
multiplied by the postservice intensity of the 23-hour stay code.
This results in a work RVU of 22.67, and an immediate post service
time of 70 minutes. Therefore, for CY 2022 we a proposing a work RVU of
22.67 and 70 minutes of immediate postservice time for CPT code 617X2.
For the direct PE, the RUC proposed identical preservice times for
CPT codes 617X1 and 617X2. For the reasons stated above concerning the
direct PE inputs for CPT code 671X1, we are proposing the standard
clinical labor times associated with a 000-day extensive for CPT code
617X2 for CY 2022.
(16) Arthrodesis Decompression (CPT Codes 630XX and 630X1)
For CPT codes 630XX (Laminectomy, facetectomy, or foraminotomy
(unilateral or bilateral with decompression of spinal cord, cauda
equina and/or nerve root[s] [eg, spinal or lateral recess stenosis]),
during posterior interbody arthrodesis, lumbar; single vertebral
segment (List separately in addition to code for primary procedure))
and 630X1 (Laminectomy, facetectomy, or foraminotomy (unilateral or
bilateral with decompression of spinal cord, cauda equina and/or nerve
root[s] [eg, spinal or lateral recess stenosis]), during posterior
interbody arthrodesis, lumbar; each additional segment (List separately
in addition to code for primary procedure)), we disagree with the RUC-
recommended work RVUs of 5.55 and 4.44, respectively, because these
values are anomalously high in comparison to other similar add-on codes
that have longer intraservice times, and we are proposing a work RVU of
3.08 for CPT code 630XX and a work RVU of 2.31 for CPT code 630X1.
CPT codes 630XX and 630X1 are new add-on codes to report
decompression when performed in conjunction with posterior interbody
arthrodesis at the same interspace. The proposed work RVU for CPT code
630XX is based on an intraservice time ratio between the proposed 40
minutes of intraservice time for CPT code 630XX and the 45 minutes of
intraservice time for CPT code 63048 (Laminectomy, facetectomy and
foraminotomy (unilateral or bilateral with decompression of spinal
cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess
stenosis]), single vertebral segment; each additional segment,
cervical, thoracic, or lumbar (List separately in addition to code for
primary procedure)). We believe that CPT code 63048 is a stronger
reference code for CPT code 630XX than the RUC-recommended reference
CPT codes 33924 (Ligation and takedown of a systemic-to-pulmonary
artery shunt, performed in conjunction with a congenital heart
procedure (List separately in addition to code for primary procedure))
and 22614 (Arthrodesis, posterior or posterolateral technique, single
level; each additional vertebral segment (List separately in addition
to code for primary procedure)) because of the similarities in the long
descriptors, physician time, and intensity of intraservice work for CPT
codes 630XX and 63048. The intraservice time ratio between CPT codes
63048 and 630XX equals a work RVU of 3.08 for CPT code 630XX ((40
minutes/45 minutes) * 3.47 = 3.08). Therefore, we are proposing a work
RVU of 3.08 for CPT code 630XX. The intraservice time ratio between CPT
codes 63048 and 630XX was selected to value CPT code 630XX because of
the similarities in the descriptions of intraservice work provided in
the RUC's summary of recommendations for CPT code 630XX and the RUC
Database for CPT code 63048. We are proposing a work RVU of 2.31 for
CPT code 630X1 based on an intraservice time ratio between the proposed
30 minutes of intraservice time for CPT code 630X1 and the proposed 40
minutes of intraservice time for CPT code 630XX ((30 minutes/40
minutes) * 3.08 = 2.31), given that the RUC contends that there are
some efficiencies in providing an additional level of decompression,
evidenced by the 10 minutes less of intraservice time for CPT code
630X1 compared to CPT code 630XX. These work RVU proposals are further
supported by brackets of other 30 and 40 minute ZZZ codes.
We note that the proposed work RVU for CPT code 630XX falls between
CPT code 19294 (Preparation of tumor cavity, with placement of a
radiation therapy applicator for intraoperative radiation therapy
(IORT) concurrent with partial mastectomy (List separately in addition
to code for primary procedure)), which has a work RVU of 3.00, and CPT
code 37185 (Primary percutaneous transluminal mechanical thrombectomy,
noncoronary, non-intracranial, arterial or arterial bypass graft,
including fluoroscopic guidance and intraprocedural pharmacological
thrombolytic injection(s); second and all subsequent vessel(s) within
the same vascular family (List separately in addition to code for
primary mechanical thrombectomy procedure)), which has a work RVU of
3.28. Both of these bracketing reference codes have identical
intraservice times as CPT code 630XX. The proposed work RVU for CPT
code 630X1 falls between CPT code 43273 (Endoscopic cannulation of
papilla with direct visualization of pancreatic/common bile duct(s)
(List separately in addition to code(s) for primary procedure)), which
has a work RVU of 2.24, and CPT code 22870 (Insertion of interlaminar/
interspinous process stabilization/distraction device, without open
decompression or fusion, including image guidance when performed,
lumbar; second level (List separately in addition to code for primary
procedure)), which has a work RVU of 2.34. Both of these bracketing
reference codes have identical intraservice times as CPT code 630X1.
When we compared the RUC-recommended work RVU of 5.55 for CPT code
630XX and 4.44 for CPT code 630X1 to other spinal add-on codes in the
63000 CPT code series in the RUC database, we found that CPT code 630XX
would have the highest work RVU and the second shortest intraservice
time (with CPT code 630X1 having the shortest intraservice time), and
CPT code 630X1 would have the third highest work RVU and shortest
intraservice time compared to the 10 other nationally-priced spinal
add-on codes in the 63000 CPT code series. We do not agree that
decompression when performed in conjunction with posterior interbody
arthrodesis at the same interspace should have an anomalously high work
value in comparison to other similar add-on codes that have longer
intraservice times. We believe that our proposed work RVUs of 3.08 for
CPT code 630XX and 2.31 for CPT code 630X1 better serve the interests
of relativity. We note that the specialty societies did not survey the
two new add-on codes with the base codes, which is a standard to
provide assurance that the respondents followed instruction to only
consider the work of the add-on codes. CPT codes 630XX and 630X1 were
reviewed again with their base codes at the April 2021 RUC meeting.
There were also revisions to the base codes' definitions, guidelines,
and parenthetical instructions, which
[[Page 39163]]
were approved by the CPT Editorial Panel for CY 2022.
The RUC did not recommend any direct PE inputs for these codes and
we are not proposing any direct PE inputs.
(17) Hypoglossal Nerve Stimulator Services (CPT Codes 645X1, 645X2, and
645X3)
In October 2020, the CPT Editorial Panel added three new CPT
Category I codes to report open implantation, revision or replacement,
and removal of hypoglossal nerve stimulator array. These new CPT codes
replaced three CPT Category III codes which were reported with CPT
codes 64568 (Incision for implantation of cranial nerve (eg, vagus
nerve) neurostimulator electrode array and pulse generator), 64569
(Revision or replacement of cranial nerve (eg, vagus nerve)
neurostimulator electrode array, including connection to existing pulse
generator) and 64570 (Removal of cranial nerve (eg, vagus nerve)
neurostimulator electrode array and pulse generator).
CPT code 645X1 (Open implantation of hypoglossal nerve
neruostimulator array, pulse generator, and distal respiratory sensor
electrode or electrode array) was previously reported using the now
deleted Category III CPT code 0466T (Insertion of chest wall
respiratory sensor electrode or electrode array, including connection
to pulse generator (List separately in addition to code for primary
procedure)) along with CPT code 64568. We are not proposing the RUC-
recommendation to use the survey median work RVU of 16.00 for CPT code
645X1. We are proposing a work RVU of 14.00 based on the intraservice
time ratio of CPT code 64568 compared to the RUC-recommended
intraservice time for CPT code 645X1. CPT code 64568 has a work RVU of
9.00, intraservice time of 90 minutes and total time of 275 minutes.
CPT code 645X1 has a RUC-recommended work RVU of 16.00, intraservice
time of 140 minutes and total time of 294 minutes. Additionally, when
we reviewed CPT code 645X1, we found that the RUC-recommended work RVU
was higher than other global 90-day codes with similar time values. We
do not agree that it would be typical to value this code so much higher
than services with similar work time values. Additionally, we note that
the proposed work RVU of 14.00 is also the survey 25th percentile.
Therefore, as previously stated, we believe 14.00 is a more appropriate
value overall than 16.00 when compared to the range of codes with
similar work times.
We are not proposing the RUC-recommended work value of 16.50 for
CPT code 645X2 (Revision or replacement of hypoglossal nerve
neruostimulator array and distal respiratory sensor electrode or
electrode array, including connection to an existing pulse generator),
rather we are proposing a work RVU of 14.50. Although we disagree with
the RUC-recommended work RVU, we concur that the relative difference in
work between CPT codes 645X1 and 645X2 is equivalent to the recommended
increment of 0.50 RVUs. Therefore, we are proposing a work RVU of 14.50
for CPT code 645X2 based on the recommended increment of 0.50
additional RVUs above our proposed work RVU of 14.00 for CPT code
645X1. We believe the use of an incremental difference between these
CPT codes is a valid methodology for setting values, especially in
valuing services within a family of codes where it is important to
maintain an appropriate intra-family relativity. Additionally, we note
that the proposed work RVU of 14.50 is also nearly identical to the
25th percentile survey value for CPT code 645X2 of 14.63. Therefore, as
previously stated, we believe 14.50 is a more appropriate value than
16.50 to maintain an appropriate intra-family relativity.
We are not proposing the RUC-recommended work value of 14.00 for
CPT code 645X3 (Removal of hypoglossal nerve neruostimulator array,
pulse generator, and distal respiratory sensor electrode or electrode
array), rather we are proposing a work RVU of 12.00. Although we
disagree with the RUC-recommended work RVU, we concur that the relative
difference in work between CPT codes 645X1 and 645X3 is equivalent to
the recommended increment of -2.0 RVUs. We believe the use of an
incremental difference between these CPT codes is a valid methodology
for setting values, especially in valuing services within a family of
codes where it is important to maintain an appropriate intra-family
relativity. Therefore, we are proposing a work RVU of 12.00 for CPT
code 645X3 based on the recommended increment of 2.0 RVUs below our
proposed work RVU of 14.00 for CPT code 645X1. Additionally, we note
that the proposed work RVU of 12.00 is also the RUC 25th percentile
survey value for CPT code 645X3.
We are proposing the RUC-recommended direct PE inputs without
refinements for CPT codes 645X1, 645X2 and 645X3.
(18) Destruction by Neurolytic Agent (CPT Codes 64633, 64634, 64635,
and 64636)
In September 2014, the Relativity Assessment Workgroup identified a
work neutrality issue for CPT codes 64633 (Destruction by neurolytic
agent, paravertebral facet joint nerve(s), with imaging guidance
(fluoroscopy or CT); cervical or thoracic, single facet joint), 64634
(Destruction by neurolytic agent, paravertebral facet joint nerve(s),
with imaging guidance (fluoroscopy or CT); cervical or thoracic, each
additional facet joint (List separately in addition to code for primary
procedure)), 64635 (Destruction by neurolytic agent, paravertebral
facet joint nerve(s), with imaging guidance (fluoroscopy or CT); lumbar
or sacral, single facet joint), and 64636 (Destruction by neurolytic
agent, paravertebral facet joint nerve(s), with imaging guidance
(fluoroscopy or CT); lumbar or sacral, each additional facet joint
(List separately in addition to code for primary procedure)) related to
incorrect coding relative to how the services were originally valued.
In May 2015, the CPT Editorial Panel revised the parenthetical
instructions for the five codes describing paravertebral facet joint
nerve destruction to clarify that these codes are reported per joint,
not nerve. Due to the extensive growth and original incorrect
assumptions about distribution of reporting, the RUC recommended that
CPT codes 64633-64636 be surveyed. We are proposing the RUC-recommended
work RVU of 1.32 for CPT code 64634 and the RUC-recommended work RVU of
1.16 for CPT code 64636.
For CPT codes 64633 and 64635, we are not proposing the RUC-
recommended work RVU of 3.42 for both codes, as we believe this value
understates the decrease in physician work time for these codes. An
analysis of all 010-day global period codes indicates that these
proposed values would place these codes among the highest valued for
codes with similar time values. We are instead using a total-time ratio
methodology to propose work RVUs of 3.31 for CPT code 64633 and 3.32
for CPT code 64635. We support these values by noting that they fall
between CPT codes 54164 (Frenulotomy of penis), with a work RVU of
2.82, and CPT code 68371 (Harvesting conjunctival allograft, living
donor), with a work RVU of 5.09; these reference codes have total time
values that are similar to, and intraservice time values that are
identical to those recommended for CPT codes 64633 and 64635.
[[Page 39164]]
We are proposing the RUC-recommended direct PE inputs without
refinement.
(19) Destruction of Intraosseous Basivertebral Nerve (CPT Codes 646X0
and 646X1)
In October 2020, the CPT Editorial Panel added two Category I codes
to report thermal destruction of intraosseous basivertebral nerve,
inclusive of all imaging guidance for the first two vertebral bodies
(lumbar or sacral) and for each additional vertebral body (lumbar or
sacral).
We are not proposing the RUC-recommended work value of 8.25 for CPT
code 646X0 (Thermal destruction of intraosseous basivertebral nerve,
inclusive of all imaging guidance; first two vertebral bodies, lumbar
or sacral). When we reviewed CPT code 646X0, we found that the RUC-
recommended work RVU was higher than codes with the same 10-day global
period, same intraservice time and similar total times. The RUC-
recommended work RVU of 8.25 would value CPT code 646X0 at the 90th
percentile of comparable 10-day globals and we do not agree that it
would be typical to value this code so much higher than services with
similar work time values. We believe it would be more accurate to
propose a work RVU of 7.15 based on a crosswalk to CPT code 63650
(Percutaneous implantation of neurostimulator electrode array,
epidural) with a work RVU of 7.15, identical intraservice time of 60,
and similar total time of 170. We believe the crosswalk to CPT code
63650 serves as a more accurate valuation for CPT code 646X0.
We also are not proposing the RUC-recommended work value of 4.87
for CPT code 646X1 (Thermal destruction of intraosseous basivertebral
nerve, inclusive of all imaging guidance; each additional vertebral
body, lumbar or sacral (List separately in addition to code for primary
procedure)). Although we disagree with the RUC-recommended work RVU, we
concur that the relative difference in work between CPT codes 646X0 and
646X1 is equivalent to the recommended increment of -3.38 RVUs.
However, since the recommended work RVU of code 646X0 was higher than
other codes with the same 10-day global period, same intraservice time,
and similar total times, we refined the work RVU for code 646X1 to
preserve the incremental difference between the two codes. We believe
that these refinements maintain the relationship between the two codes
in the family while better preserving relativity with other similar 10-
day global codes on the wider PFS. We believe the use of an incremental
difference between these CPT codes is a valid methodology for setting
values, especially in valuing services within a family of codes where
it is important to maintain an appropriate intra-family relativity.
Therefore, we are proposing a work RVU of 3.77 for CPT code 646X1 based
on the recommended increment of 3.38 RVUs below our proposed work RVU
of 7.15 for CPT code 646X0.
We are proposing the RUC-recommended direct PE inputs without
refinements for CPT code 646X0. CPT code 646X1 is an add-on code and
does not have any direct PE inputs.
(20) Dilation of Aqueous Outflow Canal (CPT Codes 66174 and 66175)
These services were identified through the New Technology/New
Services List. In January 2020, the specialty societies submitted an
action plan and the RUC recommended referral to the CPT Editorial Panel
in 2020 to possibly revise the descriptor and add exclusionary
parentheticals for CPT code 66174 (Transluminal dilation of aqueous
outflow canal; without retention of device or stent). In October 2020,
the CPT Editorial Panel revised this code to add a parenthetical to
restrict reporting this code in conjunction with CPT code 65820
(Goniotomy).
We are not proposing the RUC-recommended work RVUs of 8.53 for CPT
code 66174 and 10.25 for CPT code 66175 (Transluminal dilation of
aqueous outflow canal; with retention of device or stent), as we
believe these values do not adequately reflect the surveyed reductions
in physician time. These RVUs would rank these codes among the highest
valued 090-day global period codes of similar time values. We are
proposing a work RVU of 9.34 for CPT code 66175 using a reverse
building block methodology. We then subtract the incremental difference
between the two RUC-recommended work RVUs, an increment of 1.72, from
our proposed work RVU of 9.34 for CPT code 66175 to propose a work RVU
of 7.62 for CPT code 66174. We believe this approach is consistent with
the RUC's assumption that the intensity and complexity of CPT code
66174 is the same as that of CPT code 66175, the only difference
between the two procedures being the additional intraservice time
associated with placement of the stent. As further support for these
values, we note that they fall between CPT code 66984 (Extracapsular
cataract removal with insertion of intraocular lens prosthesis (1 stage
procedure), manual or mechanical technique (eg, irrigation and
aspiration or phacoemulsification); without endoscopic
cyclophotocoagulation), with 7.35 work RVUs, and CPT code 15150 (Tissue
cultured skin autograft, trunk, arms, legs; first 25 sq cm or less),
with 9.39 work RVUs.
We are proposing the RUC-recommended PE inputs without refinement.
(21) Cataract Removal With Drainage Device Insertion (CPT Codes 669X1,
669X2, 66982, 66984, 66987, 66988, and 0X12T)
The RUC identified CPT code 0191T (Insertion of anterior segment
aqueous drainage device, without extraocular reservoir, internal
approach, into the trabecular meshwork; initial insertion) via the
Category III codes with High Utilization screen (2018 estimated
Medicare utilization over 1,000). In January 2020, the RUC recommended
that the specialty societies develop a coding application for Category
I status for CPT code 0191T and CPT code 0376T (each additional device
insertion (List separately in addition to code for primary procedure).
In October 2020, the CPT Editorial Panel replaced two Category III
codes (CPT codes 0191T and 0376T) with two new codes, CPT codes 669X1
and 669X2, to report extracapsular cataract removal with insertion of
intraocular lens prosthesis and one Category III code to report
insertion of anterior segment aqueous drainage device without
concomitant cataract removal.
The RUC recommended a work RVU of 12.13 for CPT code 669X1
(Extracapsular cataract removal with insertion of intraocular lens
prosthesis (1-stage procedure), manual or mechanical technique (eg,
irrigation and aspiration or phacoemulsification), complex, requiring
devices or techniques not generally used in routine cataract surgery
(eg, iris expansion device, suture support for intraocular lens, or
primary posterior capsulorrhexis) or performed on patients in the
amblyogenic developmental stage; with insertion of intraocular (eg,
trabecular meshwork, supraciliary, suprachoroidal) anterior segment
aqueous drainage device, without extraocular reservoir, internal
approach, one or more) based on the survey 25th percentile.
In its recommendation, the RUC noted that the recommended
intraservice time of 28 minutes for CPT code 669X1 is 2 minutes less
than the intraservice time of 30 minutes associated with CPT code 66982
(Extracapsular cataract removal with insertion of intraocular lens
prosthesis (1-stage procedure), manual
[[Page 39165]]
or mechanical technique (eg, irrigation and aspiration or
phacoemulsification), complex, requiring devices or techniques not
generally used in routine cataract surgery (eg, iris expansion device,
suture support for intraocular lens, or primary posterior
capsulorrhexis) or performed on patients in the amblyogenic
developmental stage; without endoscopic cyclophotocoagulation). The RUC
further noted this should not be the case, as the insertion of the
intraocular lens prosthesis should take the same amount of time and be
represented by the same relative work for both procedures and that it
is counterintuitive that the intraservice time for CPT code 669X1 would
be lower than the intraservice time for CPT code 66982, as CPT code
669X1 includes both complex cataract surgery and the insertion of the
intraocular anterior segment aqueous drainage device. The specialty
society that surveyed the codes explained that this is likely because
the early adopters of this new technology service are highly skilled
surgeons who would likely perform these procedures quickly. They stated
that as this procedure diffuses into the wider population of
ophthalmologic surgeons over the next few years, the intraservice time
will likely rise above the intraservice time associated with CPT codes
66982 and 66984 and will come in line for both CPT codes 669X1 and
669X2.
CPT code 69982 has a work RVU of 10.25, 125 minutes of total time
and 30 minutes of intraservice time. CPT code 669X1 has a RUC-
recommended work RVU of 12.13, 176 minutes of total time and 28 minutes
of intraservice time. We agree with the RUC assessment that both
procedures, CPT code 66982 and CPT code 669X1, are almost identical in
time and intensity. However, we disagree with the RUC-recommended work
RVU of 12.13 for CPT code 669X1 noting that CPT code 66982 has a work
RUV of 10.25. We are proposing a work RVU of 10.31 based on the current
total time ratio of CPT code 66982 compared to the RUC-recommended
total time for CPT code 669X1.
For CPT code 669X2, the RUC recommended a work RVU of 9.23. The RUC
determined that it would be appropriate to use the increment between
the 25th percentile work RVU value for CPT code 669X1 and the current
RUC-reviewed work RVU value for CPT code 66982 to build a work RVU
recommendation for CPT code 669X2. The RUC determined that the
increment between the 25th percentile work RVU value for CPT code 669X1
(work RVU = 12.13) and the current RUC-reviewed work RVU value for CPT
code 66982 (work RVU = 10.25) would yield an increment between those
two codes of 1.88. The RUC added the 1.88 increment to 7.35, the
current work RVU for 66984, which yields a RUC-recommended work RVU
value of 9.23. This comparison results in a work RVU recommendation of
9.23 for CPT code 669X2. We are proposing a work RVU of 7.41, which is
the increment between the current RUC-reviewed work RVU value for CPT
code 66982 and CPT code 66984. The increment between CPT code 66982
(work RVU = 10.25) and CPT code 66984 (work RVU = 7.35) yields a work
RUV of 2.90. We subtracted this 2.90 increment from 10.31, to determine
our proposed work RVU of 7.41 for CPT code 669X1.
We are proposing the RUC-recommended indirect PE values for CPT
codes 669X1 and 669X2.
We are not proposing any new valuations but reaffirming the work
RVUs and direct PE inputs that we previously finalized for CPT codes
66982 (Extracapsular cataract removal with insertion of intraocular
lens prosthesis (1-stage procedure), manual or mechanical technique
(eg, irrigation and aspiration or phacoemulsification), complex,
requiring devices or techniques not generally used in routine cataract
surgery (eg, iris expansion device, suture support for intraocular
lens, or primary posterior capsulorrhexis) or performed on patients in
the amblyogenic developmental stage; without endoscopic
cyclophotocoagulation) and 66984 (Extracapsular cataract removal with
insertion of intraocular lens prosthesis (1 stage procedure), manual or
mechanical technique (eg, irrigation and aspiration or
phacoemulsification); without endoscopic cyclophotocoagulation). For
CPT codes 66987 (Extracapsular cataract removal with insertion of
intraocular lens prosthesis (1-stage procedure), manual or mechanical
technique (eg, irrigation and aspiration or phacoemulsification),
complex, requiring devices or techniques not generally used in routine
cataract surgery (eg, iris expansion device, suture support for
intraocular lens, or primary posterior capsulorrhexis) or performed on
patients in the amblyogenic developmental stage; with endoscopic
cyclophotocoagulation) and 66988 (Extracapsular cataract removal with
insertion of intraocular lens prosthesis (1 stage procedure), manual or
mechanical technique (eg, irrigation and aspiration or
phacoemulsification); with endoscopic cyclophotocoagulation) we
continue to believe these services should be contractor priced.
(22) Retinal Detachment Prophylaxis (CPT Codes 67141 and 67145)
CPT code 67145 (Prophylaxis of retinal detachment (eg, retinal
break, lattice degeneration) without drainage, 1 or more sessions;
photocoagulation (laser or xenon arc)) was identified in October 2019
as a Harvard Valued service with utilization over 30,000. In January
2020, the RUC agreed with the specialty societies that surveyed the
service and recommended that CPT code 67145, as well as its parent CPT
code 67141 (Prophylaxis of retinal detachment (eg, retinal break,
lattice degeneration) without drainage, 1 or more sessions;
cryotherapy, diathermy), be referred to the CPT Editorial Panel for a
descriptor and global period change. The codes were edited to remove
the reference to ``1 or more sessions'' so that the services may be
valued as a 010-day procedure versus the current 090-day global. At the
May 2020 CPT Editorial Panel meeting, the Panel approved revision of
the two codes to remove ``1 or more sessions'' from the descriptors and
deletion of the Eye and Ocular Adnexa Prophylaxis guidelines.
For CY 2022, we are proposing the RUC-recommended work RVU of 2.53
for CPT codes 67141 and 67145. We are also proposing the RUC-
recommended direct PE inputs without refinements.
(23) Strabismus Surgery (CPT Codes 67311, 67312, 67314, 67316, 67318,
67320, 67331, 67332, 67334, 67335, and 67340)
In April 2020, The RUC recommend that add-on CPT codes 67320,
67331, 67332, 67334, 67335, and 67340 be surveyed along with the base
codes in which these services are typically reported (CPT codes 67311,
67312, 67314, 67316 and 67318). When AMA staff compiled a list of 010-
day and 090-day services for increases in physician work and time
during the surgical global period, they noticed that several low volume
codes that were converted to ZZZ global periods in 1999 still included
office visits (specifically CPT codes 67320, 67331, 67332, 67334,
67340). It appeared that these office visits may not be appropriate for
these services. This issue was deferred until October 2020.
We are proposing the RUC-recommended work RVUs for all base codes
within this family. This includes a work RVU of 5.93 for CPT code 67311
(Strabismus surgery, recession or resection procedure; 1 horizontal
muscle), 9.50 for CPT code 67312
[[Page 39166]]
(Strabismus surgery, recession or resection procedure; 2 horizontal
muscles), 5.93 for CPT code 67314 (Strabismus surgery, recession or
resection procedure; 1 vertical muscle (excluding superior oblique),
10.31 for CPT code 67316 (Strabismus surgery, recession or resection
procedure; 2 or more vertical muscles (excluding superior oblique)),
and 9.80 for CPT code 67318 (Strabismus surgery, any procedure,
superior oblique muscle).
We are also proposing the RUC-recommend work RVUs for all of the
add-on codes within this family. This includes a work RVU of 3.00 for
CPT code 67320 (Transposition procedure (eg, for paretic extraocular
muscle), any extraocular muscle (specify) (List separately in addition
to code)), 2.00 for CPT code 67331 (Strabismus surgery on patient with
previous eye surgery or injury that did not involve the extraocular
muscles (List separately in addition to code for primary procedure)),
3.50 for CPT code 67332 (Strabismus surgery on patient with scarring of
extraocular muscles (eg, prior ocular injury, strabismus or retinal
detachment surgery) or restrictive myopathy (eg, dysthyroid
opthalmopathy) (List separately in addition to code for primary
procedure)), 2.06 for CPT code 67334 (Strabismus surgery by posterior
fixation suture technique, with or without muscle recession (List
separately in addition to code for primary procedure)), 3.23 for CPT
code 67335 (Strabismus surgery by posterior fixation suture technique,
with or without muscle recession (List separately in addition to code
for primary procedure)), and 5.00 for CPT code 67340 (Strabismus
surgery by posterior fixation suture technique, with or without muscle
recession (List separately in addition to code for primary procedure)).
We are proposing the RUC-recommended direct PE inputs for this code
family without refinements.
(24) Lacrimal Canaliculus Drug Eluding Implant Insertion (CPT Codes
68XXX)
CPT code 68XXX (Insertion of drug-eluting implant, including
punctal dilation, when performed, into lacrimal canaliculus, each) was
recommended for RUC review in October 2020 since the CPT Editorial
Panel replaced CPT Category III (temporary) code 0356T with a new CPT
Category I code to report the insertion of a drug eluting implant into
the lacrimal canaliculus. We are proposing the RUC-recommended work RVU
of 0.49 for CPT code 68XXX.
For the direct PE inputs, we are proposing to refine the equipment
time for the ``lane, screening (oph)'' (EL006) from the RUC-recommended
9 minutes of equipment time to the 5 minute equipment standard for CPT
code 68XXX. Five minutes is the standard equipment time associated with
EL006 for this procedure. The recommended materials for this code
family from the RUC state that the screening lane is used for the
duration of setup, procedure, cleaning, and counselling post procedure
and that the standard formulas are applied. We believe that the RUC
inadvertently failed to update the equipment time associated with this
procedure when CPT code 68XXX was reviewed. The recommended materials
for CPT code 68XXX state the standard equipment time formula would be
typical for this service, which would be 5 minutes in this case (the
CA013 and CA024 equipment times are included but not the CA035
equipment time). We are proposing to refine the equipment time for the
equipment item lane, screening (oph) (EL006) from 9 minutes to 5
minutes to match this change in equipment time and are seeking
additional comment from stakeholders regarding the RUC-recommended non-
standard equipment time of 9 minutes. We do not agree that it would be
typical for CPT code 68XXX to require an additional 4 minutes of
equipment time totaling 9 minutes.
(25) Transcutaneous Passive Implant-Temporal Bone (CPT Codes 69714,
69717, 69X50, 69X51, 69X52, and 69X53)
In October 2020, the CPT Editorial Panel deleted two codes used for
mastoidectomy and replaced them with four new codes for magnetic
transcutaneous attachment to external speech processor. The CPT
Editorial Panel made additional revisions to differentiate
implantation, removal, and replacement of the implants.
We are proposing the RUC-recommended work RVU for all six of the
codes in this family. We are proposing a work RVU of 8.69 for CPT code
69714 (Implantation, osseointegrated implant, skull; with percutaneous
attachment to external speech processor), a work RVU of 9.77 for CPT
code 69X50 (Implantation, osseointegrated implant, skull; with magnetic
transcutaneous attachment to external speech processor), a work RVU of
8.80 for CPT code 69717 (Revision/replacement (including removal of
existing device), osseointegrated implant, skull; with percutaneous
attachment to external speech processor), a work RVU of 9.77 for CPT
code 69X51 (Revision/replacement (including removal of existing
device), osseointegrated implant, skull; with magnetic transcutaneous
attachment to external speech processor), a work RVU of 5.93 for CPT
code 69X52 (Removal, osseointegrated implant, skull; with percutaneous
attachment to external speech processor), and a work RVU of 7.13 for
CPT code 69X53 (Removal, osseointegrated implant, skull; with magnetic
transcutaneous attachment to external speech processor).
For the direct PE inputs, we are proposing to refine the clinical
labor time for the ``Post-operative visits (total time)'' (CA039)
activity from the RUC-recommended 108 minutes to 99 minutes for CPT
codes 69714 and 69717. 99 minutes is the clinical labor time associated
with one Level 2 postoperative office visit and two Level 3
postoperative office visits; we believe that the RUC inadvertently
failed to update the clinical labor time associated with these
postoperative office visits when CPT codes 69714 and 69717 were
reviewed. We are also proposing to refine the equipment time for all
equipment items other than the basic instrument pack (EQ137) from 108
minutes to 99 minutes to match this change in clinical labor time.
(26) X-Rays at Surgery Add-On (CPT Code 74301)
The RUC recommended that CPT code 74301 (Cholangiography and/or
pancreatography; additional set intraoperative, radiological
supervision and interpretation (List separately in addition to code for
primary procedure)) be deleted for October 2020. The specialty
societies that typically bill for this service submitted a code change
application to delete CPT code 74301 at the February 2020 CPT meeting.
However, the specialty societies withdrew the deletion request after
receiving feedback from the dominant provider of CPT code 74301
(general surgery), indicating the code is still necessary and should
not be deleted. The RUC recommended to maintain the work RVU of 0.21
for CPT code 74301. The specialty societies did not resurvey CPT code
74301 due to its low utilization (2019 Medicare utilization = 63) and
the difficulty of obtaining 30 survey responses from providers with
experience in the past 12 months. Since there was no survey done, there
is no new information and the RUC recommended to maintain the current
value. The work RVU suggested by the RUC is a reaffirmation of the
current value.
We are proposing the RUC-recommended work RVU of 0.21 for
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CPT code 74301. This is an add-on code with no direct PE inputs.
(27) Trabecular Bone Score (TBS) (CPT Codes 77X01, 77X02, 77X03, and
77X04)
We are proposing the RUC-recommended work RVUs of 0.20 for CPT
codes 77X01 (Trabecular bone score (TBS), structural condition of the
bone microarchitecture; using dual X-ray absorptiometry (DXA) or other
imaging data on gray-scale variogram, calculation, with interpretation
and report on fracture risk) and 77X04 (Trabecular bone score (TBS),
structural condition of the bone microarchitecture; using dual X-ray
absorptiometry (DXA) or other imaging data on gray-scale variogram,
calculation, with interpretation and report on fracture risk
interpretation and report on fracture risk only, by other qualified
health care professional). CPT codes 77X02 (Trabecular bone score
(TBS), structural condition of the bone microarchitecture; technical
preparation and transmission of data for analysis to be performed
elsewhere) and 77X03 (Trabecular bone score (TBS), structural condition
of the bone microarchitecture; technical calculation only) are PE only
codes; the RUC did not recommend and we are not proposing a work RVU
for these codes.
The RUC PE recommendations for CPT codes 77X01 and 77X03 include a
new ``TBS iNsight Software'' supply input. The submitted invoice for
this supply indicates that it is a licensing fee associated with the
use of the software, which is not typically considered to be a form of
direct PE under our methodology. Historically, we have considered most
computer software and associated licensing fees to be indirect costs
tied to associated costs for hardware considered to be medical
equipment. However, as we noted in section II.B. of this proposed rule
(the PE section), stakeholders have routinely expressed concerns with
this policy, especially for evolving technologies that rely primarily
on software and licensing fees with minimal costs in equipment or
hardware. Most of the recommended resource costs for CPT codes 77X01
and 77X03 are for this analysis fee and these costs are not well
accommodated by the PE methodology since these sorts of technological
applications did not exist when the data that underlie the PE
allocation was last collected in 2007 through 2008.
We are therefore proposing to value the PE for CPT codes 77X01 and
77X03 through the use of a crosswalk to a comparable service, CPT code
71101 (Radiologic examination, ribs, unilateral; including
posteroanterior chest, minimum of 3 views), which, for CY 2021, had a
PE RVU of 0.94. We are proposing that the PE RVU for CPT code 77X03
equals the PE RVU from code 77X01 minus the PE RVU from codes 77X02 and
77X04 so that the three codes sum to the valuation of code 77X01. (CPT
code 77X01 is the global code in this family and CPT codes 77X02,
77X03, and 77X04 must sum together to equal the value of 77X01.) CPT
code 71101 is another type of bone imaging procedure that we believe
reflects codes 77X01 and 77X03 similar direct PE resource costs as CPT
codes 77X01 and 77X03. We recognize that the services being performed
in this crosswalk code are not the same as the services in CPT codes
77X01 and 77X03, however we believe that the direct resource costs
would typically be analogous across these codes. We believe that this
is the most accurate way to incorporate the costs of the software
employed in CPT codes 77X01 and 77X03 which would not typically be
considered direct PE under our current methodology. We are soliciting
comments, both on the specific proposal for the Trabecular Bone Score
codes as well as our broader discussion of this topic in section II.B.
of this proposed rule.
(28) Pathology Clinical Consult (CPT Codes 80XX0, 80XX1, 80XX2, and
80XX3)
The Relativity Assessment Workgroup identified CPT code 80500
(Clinical pathology consultation; limited, without review of patient's
history and medical records) via the CMS/Other source codes with the
Medicare utilization over 20,000 screen. In October 2019, the RUC
referred this issue to the CPT Editorial Panel to define this service
more specifically as the current descriptor is vague. In October 2020,
the CPT Editorial Panel replaced CPT codes 80500 and 80502 (Clinical
pathology consultation; comprehensive, for a complex diagnostic
problem, with review of patient's history and medical records) with
four new codes, CPT codes 80XX0 (Pathology clinical consultation; for a
clinical problem with limited review of patient's history and medical
records and straightforward medical decision making. When using time
for code selection, 5-20 minutes of total time is spent on the date of
the consultation. (For consultations involving the examination and
evaluation of the patient, see 99241, 99242, 99243, 99244, 99245,
99251, 99252, 99253, 99254, 99255)), 80XX1 (for a moderately complex
clinical problem, with review of patient's history and medical records
and moderate level of medical decision making. When using time for code
selection, 21-40 minutes of total time is spent on the date of the
consultation), 80XX2 (for a highly complex clinical problem, with
comprehensive review of patient's history and medical records and high
level of medical decision making. When using time for code selection,
41-60 minutes of total time is spent on the date of the consultation),
and 80XX3 (prolonged service, each additional 30 minutes (List
separately in addition to code for primary procedure) (Use 80XX3 in
conjunction with 80XX2) (Do not report 80XX0, 80XX1, 80XX2, 80XX3 in
conjunction with 88321, 88323, 88325) (Prolonged pathology clinical
consultation service of less than 15 additional minutes is not reported
separately) (For consultations involving the examination and evaluation
of the patient, see 99241-99255)) to report pathology clinical
consultation and creation of guidelines to select and document the
appropriate level of service.
The RUC recommended a work RVU of 0.50 for CPT code 80XX0 based on
the 25th percentile of the survey. The RUC-recommended 15 minutes of
intraservice and total times for CPT code 80XX0 are 2 minutes above the
current instraservice and total times for CPT code 80500. This
represents a 15 percent increase in the respective times. However, the
RUC-recommended work RVU of 0.50 is 35 percent higher than the current
work RVU of 0.37 for CPT code 80500. We believe that the increase or
decrease in times should be commensurate with the increase or decrease
in the work RVU. Therefore, we are proposing a work RVU of 0.43. This
represents the ratio of total time between the current total time of
CPT code 80500 and the proposed total time of CPT code 80XX0 (0.15)
applied to the current value of CPT code 80500 (0.37 x 0.15 = 0.43).
We are proposing the RUC-recommended work RVU of 0.91 without
refinements for CPT code 80XX1.
The RUC recommended a work RVU of 1.80 for CPT code 80XX2 based on
the 25th percentile of the survey. The current intraservice and total
times for CPT code 80502 are 42 minutes. The RUC-recommended times for
CPT code 80XX2 are 54 minutes. Similar to the scenario described above
for CPT code 80XX0, the intraservice and total times for CPT code 80XX2
increased 28.6 percent while the work RVU increased 35 percent. As
stated above, we believe the increase or decrease in time should be
commensurate with the increase or
[[Page 39168]]
decrease in the work RVU. Therefore, for CPT code 80XX2 we are
proposing a work RVU of 1.71, which is the current total time ratio of
CPT code 80502 compared to the RUC-recommended total time for CPT code
80XX2.
We are proposing the RUC-recommended work RVU of 0.80 for CPT code
80XX3 without refinement.
For the direct PE inputs of CPT codes 80XX0, 80XX1, and 80XX2, we
are proposing to refine the time associated with the clinical labor
activity PA001 (Accession and enter information) from the RUC-
recommended time of 4 minutes to 0 minutes as we believe the time is
duplicative with clinical labor activity PA008 (File specimen,
supplies, and other materials).
The RUC recommended 15, 30, 54, and 30 minutes of equipment time
for EP024 (microscope, compound) for CPT codes 80XX0, 80XX1, 80XX2, and
80XX3, respectively. We note that there is no indication from the code
descriptors that the pathologist is reviewing physical slides. The code
descriptor and description of work indicate that the pathologist is
reviewing paper records and/or EHR and therefore we are proposing to
remove the equipment time associated with EP024 (microscope, compound)
from CPT codes 80XX0, 80XX1, 80XX2, and 80XX3.
Additionally, the proposed Levels of Decision Making for Table for
Pathology Clinical Consult codes includes ``Assessment requiring an
independent historian(s)'' as an element of ``Amount and/or Complexity
of Data to be Reviewed and Analyzed *--Each unique test, order, or
document contributes to the combination of 2 or combination of 3 in
Category 1 below.'' Neither the code descriptors nor the descriptions
of work indicate that this type of assessment is typical in a pathology
clinical consult as was discussed for the office visit Levels of
Decision Making table. For these reasons, CMS proposes that this
element not be included as an element that CMS would recognize as an
element of medical decision making. We note that CMS will monitor the
use of these replacement codes per our usual practice to ensure
appropriate billing and inform future rulemaking as needed. We are also
seeking comment on how these replacement codes would most typically be
billed relative to use of existing pathology coding. Such information
would also inform future rulemaking as needed.
(29) Revaluing End Stage Renal Disease (ESRD) Monthly Capitation
Payment Services (MCP) (CPT Code 90954)
In the CY 2021 PFS final rule (85 FR 84551 through 84554), we
revalued most, but not all, of the ESRD MCP services. We finalized an
increase in valuations for those ESRD MCP codes with values tied to the
values of Outpatient/Office Evaluation and Management (O/O E/M) codes.
We did not revalue CPT code 90954 (End-stage renal disease (ESRD)
related services monthly, for patients 2-11 years of age to include
monitoring for the adequacy of nutrition, assessment of growth and
development, and counseling of parents; with 4 or more face-to-face
visits by a physician or other qualified health care professional per
month) because it was originally valued by a crosswalk.
Stakeholders stated that CPT code 90954 was different from the
other ESRD MCP codes. Rather than using an O/O E/M code building block
methodology as had been used originally to value the other ESRD MCP
codes, CPT code 90954 was valued based upon a crosswalk to CPT code
99293 (Inpatient pediatric critical care provided for children age 29
days through 24 months old, per day). When CPT code 99293 was deleted,
the value of CPT code 90954 was crosswalked to a replacement code, CPT
code 99471 (Initial inpatient pediatric critical care, per day, for the
evaluation and management of a critically ill infant or young child, 29
days through 24 months of age). By crosswalking CPT code 90954 to CPT
code 99471, the rank order across the ESRD MCP code family at that time
was preserved.
Since we finalized the revalued ESRD MCP values for CY 2021,
stakeholders have requested that we revalue CPT code 90954 because by
not updating it, we created a rank order anomaly for work RVUs and time
within the ESRD MCP code family. A stakeholder suggested that we
address the rank order anomaly by revaluing CPT code 90954 based upon a
new crosswalk to CPT code 33977 (Removal of a ventricular assist
device; extracorporeal, single ventricle). The stakeholder stated that
CPT code 33977 more appropriately represented the time and effort of
the service provided over one month than the existing crosswalk to CPT
code 99471 relative to the revalued services within the MCP code
family.
In response to stakeholder requests to update the value of CPT code
90954, we are proposing to increase the value of CPT code 90954, a
global code with a current work RVU of 15.98, by crosswalking it to CPT
code 33977, a 090-day procedural code with a work RVU of 20.86 to
preserve relativity within the ESRD MCP family. We are also seeking
comment on our proposal to increase the value of CPT code 90954.
(30) Colon Capsule Endoscopy (CPT Codes 91110, 91111, and 9111X)
In October 2020, the CPT Editorial Panel replaced Category III code
0355T (Gastrointestinal tract imaging, intraluminal (eg, capsule
endoscopy), colon, with interpretation and report) with a new Category
I code 9111X (Gastrointestinal tract imaging, intraluminal (eg, capsule
endoscopy), colon, with interpretation and report) to report
gastrointestinal tract imaging. CPT codes 91110 (Gastrointestinal tract
imaging, intraluminal (eg, capsule endoscopy), esophagus through ileum,
with interpretation and report) and 91111 (Gastrointestinal tract
imaging, intraluminal (eg, capsule endoscopy), esophagus with
interpretation and report) were added as part of the family and
surveyed for the January 2021 RUC meeting.
We are proposing the RUC-recommended work RVU for two of the codes
in this family. We are proposing a work RVU of 2.24 for CPT code 91110
and a work RVU of 2.41 for CPT code 9111X as recommended by the RUC in
both cases. For CPT code 91111, we disagree with the RUC-recommended
work RVU of 1.00 and we are proposing a work RVU of 0.90 based on a
crosswalk to CPT code 95923 (Testing of autonomic nervous system
function; sudomotor, including 1 or more of the following: Quantitative
sudomotor axon reflex test (QSART), silastic sweat imprint,
thermoregulatory sweat test, and changes in sympathetic skin
potential). CPT code 95923 is an autonomic nervous system testing
procedure that shares the identical intraservice work time of 15
minutes with CPT code 91111 and has 5 additional minutes of immediate
postservice work time. When we reviewed CPT code 91111, we noted that
the surveyed intraservice work time had decreased by 3 minutes, from 18
minutes to 15 minutes, while the RUC recommended maintaining the
current work RVU of 1.00. Although we do not imply that the decrease in
time as reflected in survey values must equate to a one-to-one or
linear decrease in the valuation of work RVUs, we believe that since
the two components of work are time and intensity, decreases in time
should typically be reflected in decreases to work RVUs. In the case of
CPT code 91111, we believe that it would be more accurate to propose a
work RVU of 0.90 based on a crosswalk
[[Page 39169]]
to CPT code 95923 to account for these decreases in the surveyed work
time.
For the direct PE inputs, we are proposing to refine the clinical
labor time for the ``Prepare, set-up and start IV, initial positioning
and monitoring of patient'' (CA016) activity from the RUC-recommended 9
minutes to 6 minutes for CPT code 91111. The recommended materials for
this code family state that the 6 minutes for the CA016 activity are
used to connect the equipment, fit belt to patient, put data recorder
on patient, and sync capsule to each sensor on belt. This description
of this clinical labor activity is identical for CPT codes 91110 and
9111X and each code has the same recommended time of 6 minutes.
However, the recommended materials for CPT code 91111 state that 6
minutes are used to connect the equipment, fit belt, put data recorder
on patient, sync capsule to each sensor and then an additional 3
minutes are used to position the patient (assist patient onto table
lying down on right side and then into a sitting position after the
capsule is swallowed). We do not agree that it would be typical for CPT
code 91111 to require an additional 3 minutes for positioning as
compared with the other codes in the family, particularly in light of
the clinical similarities between these services. We are refining the
clinical labor time to 6 minutes for CPT code 91111 to maintain
relativity within the family.
We are also proposing to refine the equipment time for the capsule
endoscopy recorder kit (EQ146) from 64 minutes to 61 minutes and the
exam table (EF023) from 44 minutes to 41 minutes to match this change
in clinical labor time for CPT code 91111.
(31) External Cardiovascular Device Monitoring (CPT Codes 93228 and
93229)
For CPT code 93228 (External mobile cardiovascular telemetry with
electrocardiographic recording, concurrent computerized real time data
analysis and greater than 24 hours of accessible ECG data storage
(retrievable with query) with ECG triggered and patient selected events
transmitted to a remote attended surveillance center for up to 30 days;
review and interpretation with report by a physician or other qualified
health care professional), we disagree with the RUC-recommended work
RVU of 0.52, and we are proposing a work RVU of 0.43. The proposed work
RVU is based on an intraservice time ratio between the current and RUC-
recommended intraservice times for CPT code 93228 ((10 minutes/12
minutes)*0.52), yielding a work RVU of 0.43. This proposed work RVU
reflects the decrease in total time and is a direct work RVU crosswalk
to CPT code 93290 (Interrogation device evaluation (in person) with
analysis, review and report by a physician or other qualified health
care professional, includes connection, recording and disconnection per
patient encounter; implantable cardiovascular physiologic monitor
system, including analysis of 1 or more recorded physiologic
cardiovascular data elements from all internal and external sensors).
CPT code 93290 has the same pre-, intra-, and postservice times as the
survey times for CPT code 93228 and was reviewed in October 2016. While
we recognize that the number of ECG tracings and daily reports have
increased because of the increase in average wear time from 14 days to
20 days, the specialty societies and the RUC contend that this is
offset by technology advancements, integrations with EHRs, and online
portals that make it easier to manage and review the data in a
chronological and efficient manner. Therefore, we are recommending a
work RVU that accounts for decrease in total time to provide this
service, given that the increased tracings and daily reports are offset
by the efficiencies gained by technological advancements.
The RUC recommended 10 minutes for ``Provide education/obtain
consent'' (CA011) for CPT code 93228, based on a direct crosswalk and
duplication of CPT code 93229 (External mobile cardiovascular telemetry
with electrocardiographic recording, concurrent computerized real time
data analysis and greater than 24 hours of accessible ECG data storage
(retrievable with query) with ECG triggered and patient selected events
transmitted to a remote attended surveillance center for up to 30 days;
review and interpretation with report by a physician or other qualified
health care professional). We disagree with the RUC-recommended
duplication of clinical labor to provide education that the patient
will hear for a second time from the IDTF technician. While we
understand that the duplication is by design, we do not agree with a
direct crosswalk from CPT code 93229, because the provider of CPT code
93229 will likely have more in-depth education, specific to the
patient, including materials and instructions for the patient to
review. Therefore, we are proposing the standard 2 minutes for CA011 in
the non-facility for CPT code 93228.
The RUC recommended the addition of 24 minutes for quality
assurance ``overread'' done by a second, senior technician, Clinical
Activity Code CA021, Line 67 on the RUC-recommended PE Spreadsheet, for
CPT code 93229. This is a new clinical activity for CPT code 93228, and
we are seeking public comment about the typicality of a second senior
technician. We are requesting additional information about the IDTF's
current quality assurance measures and parameters within the ECG
recording program that should act as some degree of quality assurance.
We are also seeking additional information from IDTFs about the current
error rate for improperly transmitted tracings to the physician that
would indicate that it is typical for a second, senior technician to
perform ``overread.'' We are proposing 0 minutes for Clinical Activity
Code CA021, Line 67 on the RUC-recommended PE Spreadsheet, unless
commenters can provide compelling information that a second, senior
technician typically performs quality assurance measures. Otherwise, we
agree with the RUC-recommended direct PE inputs and are proposing the
refinements as recommended.
In addition to the proposed work RVU and direct PE input
refinements, we are requesting additional information about the
acquisition costs for equipment item EQ340 Patient Worn Telemetry
System. Due to the proprietary nature of this equipment, invoices were
unattainable to update this equipment item. Substantial technological
improvements have been made to these devices since the last update in
2008, but they are proprietary devices, owned and manufactured for each
IDTF. We are seeking public comment on the manufacturing costs and
other information to help update the equipment item for CY 2022.
Second, we are requesting additional information about the useful
lifetime of EQ340. CMS currently assigns 3 years of useful life to
EQ340, but the RUC notes that this is the only equipment item and CPT
code 93228 is the only CPT code with an equipment item that has more
than 500 minutes of equipment time and a useful life of 3 years or
less. We are seeking public comment to help update the useful life of
EQ340, as it has not been updated since 2008, and the device has
experienced significant technological changes.
(32) Electrophysiologic Evaluation (CPT Code 93621)
In October 2019, the RUC identified CPT code 93621 (Comprehensive
electrophysiologic evaluation including insertion and repositioning of
multiple electrode catheters with induction or attempted induction of
arrhythmia; with left atrial pacing and recording from coronary sinus
or left atrium (List separately in addition to code for
[[Page 39170]]
primary procedure) as a high-growth service. It is an add-on code that
can be used with several different procedures--base codes or other add-
on codes, diagnostic as well as therapeutic. CPT code 93621 is
furnished in the facility only and thus has no direct PE inputs.
We disagree with the RUC-recommended work RVU of 1.75 based on a
crosswalk to CPT code 36483 (Endovenous ablation therapy of incompetent
vein, extremity, by transcatheter delivery of a chemical adhesive (eg,
cyanoacrylate) remote from the access site, inclusive of all imaging
guidance and monitoring, percutaneous; subsequent vein(s) treated in a
single extremity, each through separate access sites (List separately
in addition to code for primary procedure). We are proposing a work RVU
of 1.50 based on a crosswalk to CPT code 16036 (Escharotomy; each
additional incision). CPT code 16036 is also an add-on code for a
surgical incision that shares both an identical intraservice work time
and a total time of 20 minutes with CPT code 93621. While the RUC's
recommended crosswalk code also has 20 minutes of intraservice and
total time, CPT code 36483 is more intense than CPT code 93621, whereas
CPT code 16036 has a similar level of intensity as CPT code 93621.
The RUC did not recommend and we are not proposing any direct PE
inputs for CPT code 93621.
(33) Cardiac Ablation Services Bundling (CPT Codes 93653, 93654, 93655,
93656, and 93657)
The technologies and clinical practices associated with Cardiac
Ablation Services have changed enough over the past decade (since 2011
when they were first developed) that the specialty societies
recommended referring theses codes to CPT Editorial Panel to have the
code descriptors for Cardiac Ablation Services updated to create new
and more complete descriptors reflecting the fact that many of these
services are commonly performed together and should be incorporated and
bundled. In October 2020, the CPT Editorial Panel revised the three
existing cardiac ablation codes to be bundled with 3D mapping and to
include ``induction or attempted induction of an arrhythmia with right
atrial pacing and recording, and catheter ablation of arrhythmogenic
focus,'' and ``left atrial pacing and recording from coronary sinus or
left atrium'' and ``intracardiac echocardiography including imaging
supervision and interpretation'' into their descriptors.
A survey of the Cardiac Ablation Services was sent out using the
newly revised CPT code descriptors asking cardiac electrophysiologists
about the revised language in the existing CPT codes. From the survey
results, the RUC advisory committee believes that many of the survey
respondents may not have realized that the code descriptors had been
substantially revised and that they may not have read the updated code
descriptors thoroughly enough to understand that services that are
separately billed, were now combined into the existing codes (since CPT
did not issue new codes for the revised descriptors). The RUC
recommended that these services be valued as interim to allow for re-
survey and subsequent review at the April 2021 RUC meeting.
CPT code 93653 (Comprehensive electrophysiologic evaluation with
insertion and repositioning of multiple electrode catheters, induction
or attempted induction of an arrhythmia with right atrial pacing and
recording, and catheter ablation of arrhythmogenic focus, including
intracardiac electrophysiologic 3-dimensional mapping, right
ventricular pacing and recording, left atrial pacing and recording from
coronary sinus or left atrium, and His bundle recording, when
performed; treatment of supraventricular tachycardia by ablation of
fast or slow atrioventricular pathway, accessory atrioventricular
connection, cavo-tricuspid isthmus or other single atrial focus or
source of atrial re-entry)(previous work RVU of 14.75 with 000-day
global) is now bundled with the add-on CPT codes 93613 (Intracardiac
electrophysiologic 3-dimensional mapping (List separately in addition
to code for primary procedure))(work RVU of 5.23 with 90 minutes of
intraservice time) and the add-on CPT code 93621 (Comprehensive
electrophysiologic evaluation including insertion and repositioning of
multiple electrode catheters with induction or attempted induction of
arrhythmia; with left atrial pacing and recording from coronary sinus
or left atrium (List separately in addition to code for primary
procedure))(work RVU of 2.10 with 30 minutes of intraservice time). The
RUC-recommended work RVU for CPT code 93653 is 18.49, with 40 minutes
of preservice evaluation, 3 minutes of preservice positioning, 15
minutes of preservice scrub/dress/wait time, 125 minutes of
intraservice time and 30 minutes of immediate postservice time.
Since the two add-on codes are combined with the primary CPT code
93653, one would expect the intraservice time to have increased or
remained similar to the current 180 minutes. Instead, the RUC-
recommended intraservice time has decreased to 125 minutes. Accounting
for changes in technologies and clinical practices from over 10 years
since this code family's last review, we would expect better
efficiencies and reductions in work times, but with the addition of two
add-on codes whose work is mostly, if not all, added to the
intraservice time, one would not expect a net decrease in minutes. This
is not what the collected responses from this survey show and it is a
concern. Some of CPT code 93653 add-on service times may have shifted
over to the increases in preservice times, but there does appear to be
a collective misunderstanding in the survey's work RVUs and physician
work time responses.
In light of the RUC's intention to resurvey and re-review CPT code
93653 (and this family of codes) at the April 2021 RUC meeting, and to
resolve any flaws from the initial survey, such as survey respondents
probably not realizing that a new descriptor describing the inclusion
of services is now bundled to the existing CPT code (and not a newly
issued CPT code), we are proposing to maintain the current physician
times and current work RVU of 14.75, until the AMA RUC returns with a
more definitive and accurate valuation.
For CPT code 93654 (Comprehensive electrophysiologic evaluation
with insertion and repositioning of multiple electrode catheters,
induction or attempted induction of an arrhythmia with right atrial
pacing and recording, and catheter ablation of arrhythmogenic focus,
including intracardiac electrophysiologic 3-dimensional mapping, right
ventricular pacing and recording, left atrial pacing and recording from
coronary sinus or left atrium, and His bundle recording, when
performed; with treatment of ventricular tachycardia or focus of
ventricular ectopy including left ventricular pacing and recording,
when performed) (work RVU of 19.75), the RUC recommends 40 minutes of
preservice evaluation, 3 minutes of preservice positioning, 20 minutes
of preservice scrub/dress/wait time, 240 minutes of intraservice time
and 33 minutes of immediate postservice time for a total of 336
minutes, an increase to the code's current 309 total minutes. Unlike
CPT codes 93653 and 93656, CPT code 93654 already accounts for the work
RVUs and physician times for 3-dimensional mapping of add-on CPT code
93613. The RUC recommended maintaining the current work RVU
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value of 19.75. We are proposing the RUC-recommended updates to the
physician times (net increase in total minutes) and to maintain the
same work RVUs for CPT code 93654 for CY 2022.
CPT code 93655 (Intracardiac catheter ablation of a discrete
mechanism of arrhythmia which is distinct from the primary ablated
mechanism, including repeat diagnostic maneuvers, to treat a
spontaneous or induced arrhythmia (List separately in addition to code
for primary procedure)) has a current work RVU of 7.50 with a physician
intraservice time of 90 minutes. The RUC recommended a revised
intraservice time of 60 minutes and 6.50 work RVUs. The primary change
to CPT code 93655 is the reduction of the intraservice time of about 67
percent, which we use as a guide to determine a work RVU. We compare
add-on CPT code 22854 (Insertion of intervertebral biomechanical
device(s) (e.g., synthetic cage, mesh) with integral anterior
instrumentation for device anchoring (e.g., screws, flanges), when
performed, to vertebral corpectomy(ies) (vertebral body resection,
partial or complete) defect, in conjunction with interbody arthrodesis,
each contiguous defect (List separately in addition to code for primary
procedure)) also with 60 minutes of intraservice and total time and a
work RVU of 5.50 to CPT code 93655 and we believe that this is a more
accurate valuation than the RUC's work RVU crosswalk to CPT code 34709
(Placement of extension prosthesis(es) distal to the common iliac
artery(ies) or proximal to the renal artery(ies) for endovascular
repair of infrarenal abdominal aortic or iliac aneurysm, false
aneurysm, dissection, penetrating ulcer, including pre-procedure sizing
and device selection, all nonselective catheterization(s), all
associated radiological supervision and interpretation, and treatment
zone angioplasty/stenting, when performed, per vessel treated (List
separately in addition to code for primary procedure)) with a work RVU
of 6.50 and an intraservice and total time of 60 minutes because the
proportional reduction in physician time should also reflect a similar
proportional reduction in work RVUs. We are proposing the RUC-
recommended 60 minutes of intraservice and total time, but instead
propose a work RVU of 5.50 for CPT code 93655.
CPT code 93656 (Comprehensive electrophysiologic evaluation
including transseptal catheterizations, insertion and repositioning of
multiple electrode catheters with intracardiac catheter ablation of
atrial fibrillation by pulmonary vein isolation, including intracardiac
electrophysiologic 3-dimensional mapping, intracardiac echocardiography
including imaging supervision and interpretation, induction or
attempted induction of an arrhythmia including left or right atrial
pacing/recording, right ventricular pacing/recording, and His bundle
recording, when performed) is now bundled with the add-on CPT codes
93613 (Intracardiac electrophysiologic 3-dimensional mapping (List
separately in addition to code for primary procedure)) (work RVU of
5.23 with 90 minutes of intraservice time) and the add-on CPT code
93662 (Intracardiac echocardiography during therapeutic/diagnostic
intervention, including imaging supervision and interpretation (List
separately in addition to code for primary procedure) (work RVU
currently carrier-priced with 25 minutes of intraservice time) which
previously were separately reported add-on services, similar to above
CPT code 93653 and its add-on codes.
The RUC-recommended work RVU for CPT code 93656 is 20.00, with 40
minutes of preservice evaluation, 3 minutes of preservice positioning,
20 minutes of preservice scrub/dress/wait time, 210 minutes of
intraservice time and 33 minutes of immediate postservice time, for a
total of 306 minutes. The current physician times for CPT code 93656
are 23 minutes of preservice evaluation, 1 minutes of preservice
positioning, 5 minutes of preservice scrub/dress/wait time, 240 minutes
of intraservice time, and 40 minutes of immediate postservice time, for
a total of 309 minutes, which is a net difference of 3 minutes less in
the total proposed minutes, and the RUC is recommending a work RVU of
20.00, which is 0.23 more work RVUs than the current work RVU of 19.77.
In light of the RUC's intention to resurvey and review CPT code
93653 (and this family of codes) with its new bundling at their April
2021 RUC meeting to resolve any flaws from the initial survey, where
many of the survey respondents may not have realized that the code
descriptors had been substantially revised and that they may not have
read the updated code descriptors thoroughly enough to respond
correctly, we believe CPT code 93656 is in the same situation with its
new bundling thus, we are proposing the RUC-recommended updates to the
physician times (a net decrease of 3 minutes in total time) and to
maintain the current work RVU of 19.77.
From the survey of CPT code 93657 (Additional linear or focal
intracardiac catheter ablation of the left or right atrium for
treatment of atrial fibrillation remaining after completion of
pulmonary vein isolation (List separately in addition to code for
primary procedure)), a value of 8.00 work RVUs was obtained at the 25th
percentile for this add-on code. The RUC recommended a work RVU of
6.50, for the 60 minutes of intraservice and total physician time. The
current work RVU is 7.50, for 90 minutes of intraservice and total
physician time.
We compare add-on CPT code 22854 (Insertion of intervertebral
biomechanical device(s) (e.g., synthetic cage, mesh) with integral
anterior instrumentation for device anchoring (e.g., screws, flanges),
when performed, to vertebral corpectomy(ies) (vertebral body resection,
partial or complete) defect, in conjunction with interbody arthrodesis,
each contiguous defect (List separately in addition to code for primary
procedure)) with 60 minutes of intraservice and total time and 5.50
work RVUs to CPT code 93657 and we believe that this is a more accurate
valuation, since the primary change to CPT code 93657 is the reduction
of the intraservice time of about 67 percent, which we use as a guide
to determining a work RVU. The RUC-recommended work RVU is crosswalked
from CPT code 34709 (Placement of extension prosthesis(es) distal to
the common iliac artery(ies) or proximal to the renal artery(ies) for
endovascular repair of infrarenal abdominal aortic or iliac aneurysm,
false aneurysm, dissection, penetrating ulcer, including pre-procedure
sizing and device selection, all nonselective catheterization(s), all
associated radiological supervision and interpretation, and treatment
zone angioplasty/stenting, when performed, per vessel treated (List
separately in addition to code for primary procedure)) with a work RVU
of 6.50 and an intraservice and total time of 60 minutes, does not
reflect the proportional reductions to the intraservice time and work.
For CPT code 93657, we are proposing the RUC-recommended 60 minutes of
intraservice and total time, and a work RVU of 5.50, crosswalked from
CPT code 22854. There are no direct PE inputs for these facility-only
CPT codes.
(34) 3D Imaging of Cardiac Structures (CPT Codes 933X0)
In May 2020, the CPT Editorial Panel created one new add-on code to
describe the 3D echocardiographic imaging and postprocessing during
transesophageal or transthoracic echocardiography for congenital
cardiac anomalies for the assessment of cardiac
[[Page 39172]]
structure(s). The 3D imaging could be performed as a follow-up to a 2D
transthoracic echocardiogram.
We are proposing the RUC-recommended work RVU of 0.50 for CPT code
93XX0 (3D echocardiographic imaging and postprocessing during
transesophageal echocardiography, or during transthoracic
echocardiography for congenital cardiac anomalies, for the assessment
of cardiac structure(s) (eg, cardiac chambers and valves, left atrial
appendage, interatrial septum, interventricular septum) and function,
when performed (List separately in addition to code for
echocardiographic imaging).
While we are proposing no refinements to the direct PE inputs, we
are requesting additional information about the 3D echocardiography
probe equipment item. The RUC recommended that a 3D probe was required
in addition to the base echocardiography machine. We received an
invoice for $31,754.30 for this equipment item. It was unclear if the
invoice reflected both the 3D probe and the base echocardiography
machine or only the probe itself. We are seeking additional information
to know if this equipment item reflected both the 3D probe and the base
echocardiography machine or only the probe.
(35) Cardiac Catheterization for Congenital Defects (CPT Codes 93X1X,
93X2X, 93X3X, 93X4X, 93X5X, and 93X6X)
In May 2020, the CPT Editorial Panel replaced a family of four
cardiac catheterization codes with five new codes (CPT codes 93X1X-
93X5X) to describe cardiac catheterization for congenital cardiac
defect(s). The CPT Editorial Panel also replaced two cardiac output
measurement codes with one new add-on code (CPT code 93X6X) to report
cardiac output measurement(s), performed during cardiac catheterization
for congenital cardiac defects.
We are proposing the RUC-recommended work RVU for two of the codes
in this family. We are proposing a work RVU of 3.99 for CPT code 93X1X
(Right heart catheterization for congenital heart defect(s) including
imaging guidance by the proceduralist to advance the catheter to the
target zone; normal native connections) and a work RVU of 6.10 for CPT
code 93X2X (Right heart catheterization for congenital heart defect(s)
including imaging guidance by the proceduralist to advance the catheter
to the target zone; abnormal native connections) as recommended by the
RUC in both cases.
For CPT code 93X3X (Left heart catheterization for congenital heart
defect(s) including imaging guidance by the proceduralist to advance
the catheter to the target zone, normal or abnormal native
connections), we disagree with the RUC-recommended work RVU of 6.00 and
we are instead proposing a work RVU of 5.50 based on a crosswalk to CPT
code 32607 (Thoracoscopy; with diagnostic biopsy(ies) of lung
infiltrate(s) (eg, wedge, incisional), unilateral). CPT code 32607 is a
thorascopy procedure with three fewer minutes of intraservice work time
(45 minutes) than CPT code 93X3X but a higher total work time of 178
minutes. CPT code 93X3X has similar surveyed work time to CPT code
93X1X but the RUC recommended a work RVU of 3.99 for the first code in
the family as compared to 6.00 for CPT code 93X3X. While we agree that
CPT code 93X3X is a more intensive procedure, we do not agree that it
should be valued more than two full RVUs higher as compared to the
first code in the family. We believe that it would be more accurate to
propose a work RVU of 5.50 based on the aforementioned crosswalk to CPT
code 32607. We note that the intensity of CPT code 93X3X remains higher
than the first two codes in the family at the proposed work RVU of
5.50.
For CPT code 93X4X (Right and left heart catheterization for
congenital heart defect(s) including imaging guidance by the
proceduralist to advance the catheter to the target zone(s); normal
native connections), we disagree with the RUC-recommended work RVU of
7.91 and we are instead proposing a work RVU of 6.84 based on a
crosswalk to CPT code 32608 (Thoracoscopy; with diagnostic biopsy(ies)
of lung nodule(s) or mass(es) (eg, wedge, incisional), unilateral). CPT
code 32608 is another thorascopy procedure from the same family as CPT
code 32607, with the same 60 minutes of intraservice work time as CPT
code 93X4X and a higher total work time of 195 minutes. In the same
fashion as the previous code, CPT code 93X4X has similar surveyed work
time to CPT code 93X2X but the RUC recommended a work RVU of 6.10 for
the second code in the family as compared to 7.91 for CPT code 93X4X.
While we agree that CPT code 93X4X is a more intensive procedure, we do
not agree that it should be valued almost two full RVUs higher as
compared to the second code in the family. We believe that it would be
more accurate to propose a work RVU of 6.84 based on the aforementioned
crosswalk to CPT code 32608. We note that the intensity of CPT code
93X4X remains the highest among the first four codes in the family at
the proposed work RVU of 6.84. We believe that our proposed RVUs for
CPT codes 93X3X and 93X4X better preserve relativity both within the
family and also with other services on the PFS.
For CPT code 93X5X (Right and left heart catheterization for
congenital heart defect(s) including imaging guidance by the
proceduralist to advance the catheter to the target zone(s); abnormal
native connections), we disagree with the RUC-recommended work RVU of
9.99 and we are instead proposing a work RVU of 8.88 based on the
median work RVU from the survey. The RUC's recommendation of a work RVU
of 9.99, based on maintaining the prior work RVU of deleted CPT code
93532 (Combined right heart catheterization and transseptal left heart
catheterization through intact septum with or without retrograde left
heart catheterization, for congenital cardiac anomalies), was nearly
equal to the 75th percentile work RVU from the survey at 10.00. Since
the RUC recommended the survey median work RVU for the other four non-
measurement codes in the family, we do not understand the
recommendation of a value for CPT code 93X5X that sits within 0.01 RVUs
of the survey 75th percentile. The survey for CPT code 93X5X also
revealed that it typically requires far less work time to perform as
compared with predecessor code 93532 (83 minutes of intraservice work
time as compared to 175 minutes for the predecessor code). Although we
agree that CPT code 93X5X is a more intensive procedure than its
predecessor code, we do not believe that the work RVU should remain
unchanged given the greatly reduced work time in the new procedure.
Since the two components of work are time and intensity, we believe
that decreases in time should typically be reflected in decreases to
work RVUs. We are therefore proposing a work RVU of 8.88 for CPT code
93X5X based on the survey median outcome. We believe that our proposed
RVU more accurately accounts for these changes in surveyed work time
and better preserves relativity with the rest of the family.
For CPT code 93X6X (Cardiac output measurement(s), thermodilution
or other indicator dilution method, performed during cardiac
catheterization for the evaluation of congenital heart defects), we
disagree with the RUC-recommended work RVU of 1.75 and we are instead
proposing a work RVU of 1.44 based on a crosswalk
[[Page 39173]]
to CPT code 37253 (Intravascular ultrasound (noncoronary vessel) during
diagnostic evaluation and/or therapeutic intervention, including
radiological supervision and interpretation; each additional
noncoronary vessel). CPT code 37253 is an intravascular ultrasound
procedure that shares the same intraservice work time of 20 minutes as
CPT code 93X6X and has 1 additional minute of immediate postservice
time. We note that the intensity of CPT code 93X6X as recommended by
the RUC at a work RVU of 1.75 would be the second-highest in the
family, higher than CPT code 93X5X for example. We do not agree that
this cardiac output measurement code would typically be more intensive
to perform than the two types of heart catheterization taking place in
CPT code 93X5X.
We also note that the recommended work RVU for CPT code 93X6X was
higher than the sum of its two predecessor codes. Former CPT codes
93561 (Indicator dilution studies such as dye or thermodilution,
including arterial and/or venous catheterization; with cardiac output
measurement) and 93562 (Indicator dilution studies such as dye or
thermodilution, including arterial and/or venous catheterization;
subsequent measurement of cardiac output) had CY 2021 work RVUs of 0.95
and 0.77 respectively. These two codes sum together to a work RVU of
1.72 which would be lower than the RUC's recommendation of 1.75 for CPT
code 93X6X. The RUC's recommendation suggests that there would be no
efficiencies gained or savings created in the process of creating CPT
code 93X6X; we believe that the survey for the new code indicates
otherwise, as the predecessor codes had work times of 15 minutes and 12
minutes respectively (27 minutes total) as compared to 20 minutes of
surveyed work time for the new code. This lower work time suggests that
the creation of CPT code 93X6X has led to greater efficiencies in the
service which, under the resource-based nature of the RVU system, lends
further support for a reduction in the work RVU as compared to a sum of
the predecessor codes. We therefore believe that it would be more
accurate to propose a work RVU of 1.44 based on the aforementioned
crosswalk to CPT code 37253.
The RUC did not recommend any direct PE inputs for these six codes
and we are not proposing any direct PE inputs.
(36) Outpatient Pulmonary Rehabilitation Services (CPT Codes 946X1 and
946X2)
CPT code 946X1 (Physician or other qualified health care
professional services for outpatient pulmonary rehabilitation; without
continuous oximetry monitoring (per session)) and CPT code 946X2
(Physician or other qualified health care professional services for
outpatient pulmonary rehabilitation; with continuous oximetry
monitoring (per session) (Do not report 946X1, 946X2 in conjunction
with 94760, 94761)) are two new codes created by the CPT Editorial
Panel to take the place of the HCPCS G-code G0424 (Pulmonary
rehabilitation, including exercise (includes monitoring), one hour, per
session, up to two sessions per day) which was created in 2010. The RUC
recommended work RVUs for CPT codes 946X1 and 946X2 of 0.55 and 0.69
respectively. We disagree with the RUC-recommended work RVUs for both
CPT code 946X1 and 946X2. Although the pulmonary rehab service as
described by these new codes have not changed, the RUC recommendation
included an increase in intraservice and total time for the services.
As the survey time increased for the pulmonary rehabilitation codes, an
increase in work value may be appropriate.
Based on a comparison of intraservice time for the current code
relative the recommended values, we are proposing a work RVU of 0.36
for CPT code 946X1 and a work RVU of 0.56 for CPT code 946X2, which is
an increase to the work RVU from the HCPCS G-code G0424 that these two
codes are replacing and reflects a commensurate increase in work
relative to the increase in intraservice time.
For the direct PE inputs, we are proposing to refine the clinical
labor time for the ``Provide education/obtain consent'' (CA011)
activity from the RUC-recommended 15 minutes to 2 minutes for both CPT
codes 946X1 and 946X2. The recommended materials for this code family
state that the 15 minutes for the CA011 activity are used for education
which is an integral component of pulmonary rehabilitation programs.
There is education provided at each separate session following a
curriculum outlined in the guideline and covers both educational topics
concerning self-management and educational topics concerning advance
care planning which is different at every session.
We do not agree that it would be typical for CPT codes 946X1 and
946X2 to require an additional 13 minutes for education and consent
given the patient is seen two to three times a week for pulmonary
rehabilitation and the education can be covered during those sessions.
We are refining the clinical labor time to 2 minutes for both CPT codes
946X1 and 946X2 to maintain relativity, particularly in light of the
clinical similarities between these services. The education would be
done during the ``Perform procedure/service--NOT directly related to
physician work time'' (CA021), as stated above, as the patient is seen
two to three times a week for pulmonary rehabilitation.
We are also proposing to refine the equipment time and lower the
pulse oximeter w-printer (EQ211) and exercise equipment (treadmill,
bike, stepper, UBE, pulleys, balance board) (EQ118) equipment times
from 93 minutes to 80 minutes to match this change in clinical labor
time for CPT codes 946X1 and 946X2.
Additionally, we are proposing to revise the utilization that we
would use to set rates for CPT code 946X2 to reflect our understanding
that pulmonary rehabilitation is always done with pulse oximetry. Thus,
we are proposing to update our analytic crosswalk to reflect our belief
that 100 percent of the utilization for the pulmonary rehabilitation
services currently billed using HCPCS code G0424 will now be billed
using CPT code 946X2. We believe that it is unlikely that these
services would typically be billed using CPT code 946X1 since it is our
understanding that pulmonary rehabilitation is typically provided with
pulse oximetry, and therefore, we expect little to no utilization for
CPT code 946X1. We are seeking comment from stakeholders on our
understanding and proposal to revise the utilization as stated.
(37) Remote Therapeutic Monitoring (CPT Codes 989X1, 989X2, 989X3,
989X4, and 989X5)
Remote Therapeutic Monitoring (RTM) is a family of five codes
created by the CPT Editorial Panel in October 2020 and valued by the
RUC at its January 2021 meeting. The RTM family includes three PE-only
codes and two codes that include professional work.
In recent years, we have finalized seven codes in the Remote
Physiological Monitoring (RPM) family that include services similar to
the new RTM codes. (See the CY 2021 PFS final rule at 85 FR 84542
through 84546 for more information.) Based upon our analysis, the
services and code structure of RTM resemble those of RPM. For example,
the RTM codes reflect similar staff and
[[Page 39174]]
physician work, although the specific equipment used is different.
While there are notable similarities between the two sets of code
descriptors, there are two primary differences. One difference is that
according to RUC documents, primary billers of RTM codes are projected
to be nurses and physical therapists. Stakeholders have suggested that
the new RTM coding was created to allow practitioners who cannot bill
RPM codes to furnish and bill for services that look similar to those
of RPM. RPM services are considered to be E/M services and physical
therapists, for example, are practitioners who cannot bill E/M
services. The RTM codes, instead, are general medicine codes.
In our review of the new codes, we identified an issue that
disallows physical therapists and other practitioners, who are not
physicians or NPPs, to bill the RTM codes. By modeling the new RTM
codes on the RPM codes, ``incident to'' services became part of the
three direct practice expense-only (PE-only) codes (that is, CPT codes
989X1, 989X2, and 989X3) as well as the two professional work codes
(that is, CPT codes 989X4 and 989X5). As a result, the RTM codes as
constructed currently cannot be billed by, for example, physical
therapists. We describe ``incident to'' services in the CMS Medicare
Benefit Policy Manual, Chapter 15, beginning at section 60 and note
that only physicians and certain other practitioners are authorized to
furnish and bill ``incident to'' services. Incident to services are:
An integral, although incidental, part of the physician's
professional service (see Sec. 60.1);
Commonly rendered without charge or included in the
physician's bill (see Sec. 60.1A);
Of a type that are commonly furnished in physician's
offices or clinics (see Sec. 60.1A); and
Furnished by the physician or by auxiliary personnel under
the physician's direct supervision (see Sec. 60.1B).
Additionally, we designated the treatment management RPM codes
(that is, CPT codes 99457 and 99458) as care management services (84 FR
62697 through 62698), which allow general supervision rather than
direct supervision for incident to services. The treatment management
RTM codes (CPT codes 989X4 and 989X5), because they are not E/M codes,
cannot be designated as care management services. As a result, we are
seeking comment on how we might remedy the issues related to the RTM
code construction in order to permit practitioners who are not
physicians or NPPs to bill the RTM codes.
The second primary difference between the RTM and RPM codes is the
nature of the data to be collected and how it is collected. According
to the code descriptors, RTM codes monitor health conditions, including
musculoskeletal system status, respiratory system status, therapy
(medication) adherence, and therapy (medication) response, and as such,
allow non-physiologic data to be collected. Reportedly, data also can
be self-reported as well as digitally uploaded. RPM requires that data
be physiologic and be digitally uploaded. We note that, for both sets
of codes, the device used must meet the FDA definition of a medical
device as described in section 201(h) of the Federal Food, Drug and
Cosmetic Act (FFDCA). We are seeking comment on the typical type of
device(s) and associated costs of the device(s) that might be used to
collect the various kinds of data included in the code descriptors (for
example, respiratory system status, musculoskeletal status, medication
adherence, pain) for the RTM services.
For CY 2022, we are proposing the RUC-recommended work RVU of 0.62
for CPT code 989X4 (Remote therapeutic monitoring treatment management
services, physician/other qualified health care professional time in a
calendar month requiring at least one interactive communication with
the patient/caregiver during the calendar month; first 20 minutes) and
the RUC-recommended work RVU of 0.61 for its add-on code, CPT code
989X5 (Remote therapeutic monitoring treatment management services,
physician/other qualified health care professional time in a calendar
month requiring at least one interactive communication with the
patient/caregiver during the calendar month; each additional 20 minutes
(List separately in addition to code for primary procedure)) as a means
of maintaining parity with the two RPM treatment management codes (CPT
codes 99457 and 99458) upon which the two RTM codes are based. We also
are proposing the RUC-recommended direct PE inputs for the two
treatment management codes, CPT codes 989X4 and 989X5, without
refinement.
We are proposing to refine the direct PE inputs for the three PE-
only codes: CPT code 989X1 (Remote therapeutic monitoring (e.g.,
respiratory system status, musculoskeletal system status, therapy
adherence, therapy response); initial set-up and patient education on
use of equipment), CPT code 989X2 (Remote therapeutic monitoring (e.g.,
respiratory system status, musculoskeletal system status, therapy
adherence, therapy response); device(s) supply with scheduled (e.g.,
daily) recording(s) and/or programmed alert(s) transmission to monitor
respiratory system, each 30 days), and CPT code 989X3 (Remote
therapeutic monitoring (e.g., respiratory system status,
musculoskeletal system status, therapy adherence, therapy response);
device(s) supply with scheduled (e.g., daily) recording(s) and/or
programmed alert(s) transmission to monitor musculoskeletal system,
each 30 days). We are proposing to value the PE for CPT code 989X1 by
crosswalking to the PE RVU for RPM code 99453 upon which the new RTM
code was based. We also are proposing to value the PE for CPT codes
989X2 and 989X3 by crosswalking to the PE RVU for comparable RPM code
99454, a code that includes payment for the medical device used to
collect and transmit data. We note that the only input to CPT code
989X2 is a monthly fee of $25, which would not be paid as a direct cost
under the PFS. Historically, we have considered most computer software
and associated licensing fees to be indirect costs. However, as we
noted in section II.B. of this proposed rule (the PE section),
stakeholders have routinely expressed concerns with this policy,
especially for evolving technologies that rely primarily on software
and licensing fees with minimal costs in equipment or hardware.
(38) Principal Care Management and Chronic Care Management (CPT Codes
99490, 99439, 99491, 99X21, 99487, 99489, 99X22, 99X23, 99X24, and
99X25)
In recent years, we have engaged in efforts to update and improve
the relative value of care management and coordination services within
the PFS by identifying gaps in payment and coding. One of those PFS
services is Chronic Care Management (CCM). CCM services, which include
management and support services provided by clinical staff under the
supervision of a physician or NPP or services provided personally by a
physician or NPP, have received ongoing refinements related to payment
and coding since CY 2013.
Beginning in the CY 2014 PFS final rule (78 FR 74414 through
74427), we noted that physicians and NPPs who furnish care to patients
with multiple chronic conditions require greater resources than are
required to support patient care in a typical E/M service. In response,
we finalized a separately payable HCPCS code, GXXX1 (Chronic Care
Management (CCM) services
[[Page 39175]]
furnished to patients with multiple (2 or more) chronic condition
expected to last at least 12 months, or until the death of the patient;
20 minutes or more per in 30 days of chronic care management services
provided by clinical staff and directed by a physician or other
qualified health care practitioner). For CY 2015 (79 FR 67715 through
67730), we refined aspects of the existing CCM policies and adopted
separate payment for CCM services under CPT code 99490 (Chronic care
management services (CCM), at least 20 minutes of clinical staff time
directed by a physician or other qualified health professional, per
calendar month, with the following required elements: Multiple (two or
more) chronic conditions expected to last at least 12 months, or until
the death of the patient; Chronic conditions place the patient at
significant risk of death, acute exacerbation/decompensation, or
functional decline; Comprehensive care plan established, implemented,
revised, or monitored). For CY 2017 (81 FR 80244), we adopted CPT codes
99487 (Complex chronic care management (CCCM) services with the
following required elements: Multiple (two or more) chronic conditions
expected to last at least 12 months, or until the death of the patient,
chronic conditions place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline, comprehensive
care plan established, implemented, revised, or monitored, moderate or
high complexity medical decision making; first 60 minutes of clinical
staff time directed by a physician or other qualified health care
professional, per calendar month) and 99489 (Complex chronic care
management (CCCM) services with the following required elements:
Multiple (two or more) chronic conditions expected to last at least 12
months, or until the death of the patient, chronic conditions place the
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, comprehensive care plan
established, implemented, revised, or monitored, moderate or high
complexity medical decision making; each additional 30 minutes of
clinical staff time directed by a physician or other qualified health
care professional, per calendar month (List separately in addition to
code for primary procedure)). Then, in the CY 2019 PFS final rule (83
FR 59577), we adopted a new CPT code, 99491 (Chronic care management
services, provided personally by a physician or other qualified health
care professional, at least 30 minutes of physician or other qualified
health care professional time, per calendar month, with the following
required elements: Multiple (two or more) chronic conditions expected
to last at least 12 months, or until the death of the patient; chronic
conditions place the patient at significant risk of death, acute
exacerbation/decompensation, or functional decline; comprehensive care
plan established, implemented, revised, or monitored), to describe at
least 30 minutes of CCM services performed personally by a physician or
NPP. In the CY 2020 PFS final rule (84 FR 62690), we established
payment for an add-on code to CPT code 99490 by creating HCPCS code
G2058 (Chronic care management services, each additional 20 minutes of
clinical staff time directed by a physician or other qualified
healthcare professional, per calendar month). We also created two new
HCPCS G codes, G2064 and G2065 (84 FR 62692 through 62694),
representing comprehensive services for a single high-risk disease
(that is, principal care management). In the CY 2021 PFS final rule (85
FR 84639), we finalized a RUC-recommended replacement code for HCPCS
code G2058, CPT code 99439, which was given the same valuation and the
identical descriptor as G2058.
For CY 2022, the RUC resurveyed the CCM code family, including
Complex Chronic Care Management (CCCM) and Principal Care Management
(PCM), and added five new CPT codes: 99X21 (Chronic care management
services each additional 30 minutes by a physician or other qualified
health care professional, per calendar month (List separately in
addition to code for primary procedure)), 99X22 (Principal care
management services for a single high-risk disease first 30 minutes
provided personally by a physician or other qualified health care
professional, per calendar month), 99X23 (Principal care management
services for a single high-risk disease each additional 30 minutes
provided personally by a physician or other qualified health care
professional, per calendar month (List separately in addition to code
for primary procedure), 99X24 (Principal care management services, for
a single high-risk disease first 30 minutes of clinical staff time
directed by physician or other qualified health care professional, per
calendar month), and 99X25 (Principal care management services, for a
single high-risk disease each additional 30 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month (List separately in addition to code
for primary procedure)). The CCM/CCCM/PCM code family now includes five
sets of codes, each set with a base code and an add-on code. The sets
vary by the degree of complexity of care (that is, CCM, CCCM, or PCM),
who furnishes the care (that is, clinical staff or the physician or
NPP), and the time allocated for the services. The RUC-recommended
values for work RVUs and direct PE inputs for CY 2022 derive from the
recent RUC specialty society survey (see Table 12).
We reviewed the RUC-recommended values for the 10 codes in the CCM
family and are proposing to accept the recommended work values for the
codes. We are proposing the RUC-recommended direct PE inputs without
refinements. We believe that proposing to accept these updated values
is consistent with our goals of ensuring continued and consistent
access to these crucial care management services and acknowledges our
longstanding concern about undervaluation of care management under the
PFS. We are seeking comment, however, on whether keeping professional
PCM and CCM at the same value creates an incentive to bill CCM instead
of billing PCM when appropriate.
In addition to the proposals on the values for CCM codes, we are
interested in understanding more about the standard practice used by
practitioners to obtain beneficiary consent for these services. We have
received questions from stakeholders regarding the consent requirements
for CCM services. We believe that these questions have arisen because
of the many flexibilities allowed in response to the PHE for COVID-19.
In particular, during the PHE for COVID-19, we allowed stakeholders to
obtain beneficiary consent for certain services under general
supervision (85 FR 19230, April 6, 2020). Before the PHE for COVID-19,
we required that beneficiary consent be obtained either by or under the
direct supervision of the primary care practitioner. This requirement
is consistent with the conditions of payment for this service under the
PFS. As we consider what policies implemented during the PHE for COVID-
19 should remain in effect beyond the PHE, we are interested in
understanding how billing practitioners furnishing CCM at different
service sites (for example, physician office settings, RHCs, FQHCs)
have been obtaining beneficiary consent over the past year and how
different levels of supervision impact this activity. We welcome public
comment on the issue, specifically on what levels of supervision are
necessary to obtain beneficiary consent when furnishing CCM services
and will
[[Page 39176]]
consider such comments in future rulemaking.
We also are proposing to adopt CPT codes 99X22 (PCM First 30
minutes provided personally by a physician or other qualified health
care professional, per calendar month) and 99X24 (PCM First 30 minutes
of clinical staff time directed by physician or other qualified health
care professional, per calendar month) to replace HCPCS codes G2064 and
G2065 in the calculation of the rate for HCPCS code G0511 for General
Care Management services billed by RHCs and FQHCs. The payment rate for
HCPCS code G0511 is calculated based on the average of the national
non-facility PFS payment rate for care management and general
behavioral health integration codes (CPT codes 99484, 99487, 99490, and
99491) as well as HCPCS codes G2064 and G2065 which describe PCM
services billed under the PFS. The payment rate for HCPCS code G0511 is
updated annually based on the PFS amounts for these codes.
[GRAPHIC] [TIFF OMITTED] TP23JY21.020
(39) Moderate Sedation (HCPCS Code G0500)
Following the publication of the CY 2021 PFS final rule, a
stakeholder contacted us regarding what they believed to be an error in
the intraservice work time for HCPCS code G0500 (Moderate sedation
services provided by the same physician or other qualified health care
professional performing a gastrointestinal endoscopic service that
sedation supports, requiring the presence of an independent trained
observer to assist in the monitoring of the patient's level of
consciousness and physiological status; initial 15 minutes of intra-
service time; patient age 5 years or older (additional time may be
reported with 99153, as appropriate)). We established HCPCS code G0500
in CY 2017 to more accurately capture the work of administering
moderate sedation for gastrointestinal endoscopic procedures for
patients 5 years of age or older. We based the physician work and time
for HCPCS code G0500 on data from the 100 gastroenterologists who
completed the survey of CPT code 99152 (Moderate sedation services
provided by the same physician or other qualified health care
professional performing the diagnostic or therapeutic service that the
sedation supports, requiring the presence of an independent trained
observer to assist in the monitoring of the patient's level of
consciousness and physiological status; initial 15 minutes of
intraservice time, patient age 5 years or older) presented at the
October 2015 RUC meeting. The survey data for CPT code 99152 showed a
significant bimodal distribution with data from gastroenterologists
performing endoscopic procedures demonstrating a markedly different and
lesser amount of physician work for moderate sedation compared to other
specialties. The stakeholder stated that the finalization of 12 minutes
of intraservice work time for HCPCS G0500 appeared to be an error and
asked CMS to correct it to reflect the 5 minutes of intraservice work
time indicated by survey data when gastroenterologists performed
endoscopic procedures.
While we appreciate the feedback from the stakeholder, we disagree
that the finalization of 12 minutes of intraservice work time for HCPCS
code G0500 (matching CPT code 99152) was an error. The work time for
HCPCS code G0500 was proposed and finalized at 12 minutes in CY 2017,
with the intention that it would match the work time for CPT code
99152. This was the rationale behind the descriptor for HCPCS code
G0500 listing that the code was intended for the initial 15 minutes of
intraservice time. Furthermore, several commenters questioned the work
time for HCPCS code G0500 in the CY 2017 PFS final rule (81 FR 80341)
and we stated in response that we expected that practitioners would
report the appropriate CPT or HCPCS code that most accurately described
the services performed during a patient encounter, including those
services performed concurrently and in support of a procedural service
consistent with CPT guidance. We noted that the commenters referred to
the time for moderate sedation in the survey data, while the time
thresholds for the moderate sedation codes were intended to match the
intraservice time of the procedure itself. For a full discussion of
this topic, we refer readers to the CY
[[Page 39177]]
2017 PFS final rule (81 FR 80339 through 80349).
Although we are not proposing a change in the work time for HCPCS
code G0500, we are soliciting comments on this issue in the interest of
gaining additional information about the typical use of this procedure.
(40) Payment for Synthetic Skin Substitutes (HCPCS Codes GXXAB, GXXAC,
GXXAD, GXXAE, GXXAF, GXXAG, GXXAH, and GXXAI)
On July 1, 2020, Medicare implemented HCPCS code C1849 (Skin
substitute, synthetic, resorbable, per square centimeter) and made it
payable under the OPPS. In the CY 2021 OPPS final rule (85 FR 86064
through 86067) Medicare finalized payment for C1849--and the associated
synthetic skin substitute products--allowing it to be billed with graft
skin substitute procedure CPT codes 15271 through 15278. We note that
under the OPPS, payment for C1849 is packaged into the payment for the
graft skin substitute procedure, and its costs are reflected in the
development of the payment rates for those services. The creation of
the C-code and the CY 2021 OPPS rulemaking addressed the need for a
mechanism to pay for graft skin substitute application services
performed with synthetic graft substitute products in the outpatient
hospital setting, which is comparable to how Medicare pays for graft
skin substitute application services performed with graft skin
substitutes that are regulated by the Food and Drug Administration
(FDA) under its regulatory framework at section 361 of the Public
Health Service (PHS) Act for human cells, tissues, and cellular and
tissue-based products (HCT/Ps). We want to clarify that the
availability of a HCPCS code for a particular HCT/P does not mean that
the product is appropriately regulated solely under section 361 of the
PHS Act and the FDA regulations in 21 CFR part 1271. Manufacturers of
HCT/Ps should consult with the FDA Tissue Reference Group (TRG) or
obtain a determination through a Request for Designation (RFD) on
whether their HCT/Ps are appropriately regulated solely under section
361 of the PHS Act and the regulations in 21 CFR part 1271 (85 FR
86058). We note that in a response to the CY 2021 OPPS proposal, a
commenter noted that the use of a C-code meant that synthetic graft
skin substitute products would only be payable under the OPPS, and
would not be able to be reported for graft skin substitute services
using a synthetic product in the physician office setting (85 FR
86066).
Currently, graft skin substitute application services are paid
separately from the (HCT/Ps) skin substitutes under the PFS.
Specifically, when a physician or NPP furnishes a surgical service to
apply a (HCT/Ps) skin substitute in a non-facility setting, they may
bill Medicare for the surgical service (as described by CPT codes 15271
through 15278), and separately bill for the (HCT/Ps) skin substitute.
For CY 2022, in order to reconcile the gap in payment for synthetic
products in the physician office setting, we are proposing to create
eight HCPCS codes (parallel to the aforementioned existing surgical
codes) that would include the synthetic graft skin substitute product
as a supply cost in determining the PFS rate. We believe that it would
be appropriate to consider these products as incident to supplies in
the office setting, and as such they should be built in as a supply
cost in calculating the PFS rate. Therefore, we are proposing to
consider these products as incident to supplies in the office setting.
The codes and long descriptors for the proposed synthetic graft
skin substitute services are:
HCPCS Code GXXAB: Application of synthetic skin substitute
graft to trunk, arms, legs, total wound surface area up to 100 sq cm,
including provision of synthetic skin substitute; first 25 sq cm or
less wound surface area.
HCPCS Code GXXAC: Application of synthetic skin substitute
graft to trunk, arms, legs, total wound surface area up to 100 sq cm,
including provision of synthetic skin substitute; each additional 25 sq
cm wound surface area, or part thereof (List separately in addition to
code for primary procedure).
HCPCS Code GXXAD: Application of synthetic skin substitute
graft to trunk, arms, legs, total wound surface area greater than or
equal to 100 sq cm, including provision of synthetic skin substitute;
first 100 sq cm wound surface area, or 1% of body area of infants and
children.
HCPCS Code GXXAE: Application of synthetic skin substitute
graft to trunk, arms, legs, total wound surface area greater than or
equal to 100 sq cm, including provision of synthetic skin substitute;
each additional 100 sq cm wound surface area, or part thereof, or each
additional 1% of body area of infants and children, or part thereof
(List separately in addition to code for primary procedure).
HCPCS Code GXXAF: Application of synthetic skin substitute
graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits, total wound surface area up to 100
sq cm, including provision of synthetic skin substitute; first 25 sq cm
or less wound surface area.
HCPCS Code GXXAG: Application of synthetic skin substitute
graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits, total wound surface area up to 100
sq cm, including provision of synthetic skin substitute; each
additional 25 sq cm wound surface area, or part thereof (List
separately in addition to code for primary procedure).
HCPCS Code GXXAH: Application of synthetic skin substitute
graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits, total wound surface area greater
than or equal to 100 sq cm, including provision of synthetic skin
substitute; first 100 sq cm wound surface area, or 1% of body area of
infants and children.
HCPCS Code GXXAI: Application of synthetic skin substitute
graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia,
hands, feet, and/or multiple digits, total wound surface area greater
than or equal to 100 sq cm, including provision of synthetic skin
substitute; each additional 100 sq cm wound surface area, or part
thereof, or each additional 1% of body area of infants and children, or
part thereof (List separately in addition to code for primary
procedure).
We are proposing contractor pricing for these codes for CY 2022; we
note that there is limited data available on the cost of synthetic skin
substitute products in physician offices, so we are also seeking
comment and documentation regarding the appropriate values for these
services for consideration of national pricing in future rulemaking.
Though we are proposing contractor pricing in the interim, we also
considered an alternative approach that would use crosswalks to value
these services in the physician office setting in a way that is
commensurate with the rates paid under the OPPS. Though limited data
exists on the cost of graft synthetic skin substitute products in
physician offices, hospitals began reporting costs associated with
synthetic skin substitute products in CY 2020 after C1849 became
effective and payable under the OPPS starting in July, 2020. We
analyzed CY 2020 OPPS claims data and estimate hospital outpatient
department costs for graft synthetic skin substitute products averaged
$1,500. We note that under the OPPS, outpatient departments are paid
separately for the primary surgical application codes (CPT codes 15271,
15273, 15275, 15277), and the costs associated with the synthetic
products
[[Page 39178]]
as well as the add-on services (described by CPT codes 15272, 15274,
15276, 15278) are packaged into the payment for the primary procedure.
Under this alternative, we considered following an approach similar
to that under the OPPS where the cost of the supply would be included
in the primary codes (described by HCPCS GXXAB, GXXAD, GXXAF, and
GXXAH) and not the add-on codes (described by HCPCS GXXAC, GXXAE,
GXXAG, and GXXAI), though the add-on would continue to be reported and
paid separately. Specifically, we would use direct crosswalks for the
work RVUs, MP RVUs, and facility PE RVUs from the current surgical
application codes (that is, CPT codes 15271 through 15278) as we
believe that these payment components for the synthetic graft skin
substitute services, described by the aforementioned HCPCS codes, would
be similar.
However, with regards to the non-facility PE RVUs, we recognize
that there are significant supply costs associated with synthetic skin
substitute products. As described previously, we estimate that
hospitals face average costs associated with synthetic skin substitute
products of $1,500. We note that the PE methodology, which relies on
the allocation of indirect costs based on the magnitude of direct
costs, may not be appropriate for these types of services because the
specialists that typically furnish these types of services do not
typically have significant supply costs within the methodology. As
such, we used the hospital reported costs and we looked to other codes
where specialists frequently have similarly high supply costs in order
to crosswalk the non-facility PE RVUs. We considered services that have
a significant proportion of supply costs and are furnished by
specialists who typically have higher supply costs as potential
crosswalks for the non-facility PE RVUs. For example, we considered a
crosswalk to CPT code 21461 (Open treatment of mandibular fracture;
without interdental fixation) for HCPCS codes GXXAB and GXXAF, and a
crosswalk to CPT code 21462 (Open treatment of mandibular fracture;
with interdental fixation) for HCPCS codes GXXAD and GXXAH. As an
estimate of non-facility PE, we believe these would be appropriate
codes for crosswalking non-facility PE RVUs. As previously discussed,
for the purposes of the work RVUs, MP RVUs, and facility PE RVUs, we
believe direct crosswalks to the current surgical application codes
would be appropriate as those values would generally not be impacted by
the addition of a synthetic skin substitute product. We realize this
alternative considered would follow a similar coding and payment
approach established under the OPPS, and that potential adoption of
this alternative would mean that the cost of the products is included
in the primary codes and not included in the add-on codes. We welcome
feedback on our proposal to treat synthetic skin substitute products as
incident to supplies in the physician office, the proposal to have
contractor pricing for these codes, and other ways we could obtain
detailed and reliable cost information on synthetic skin substitutes
that are furnished in the non-facility setting. We are also seeking
comment on the alternative approach that we considered (using
crosswalks to value these services in the physician office setting).
Additionally, we are seeking comment on potential ways to reconcile
these coding and payment differences across settings to yield a more
consistent and rational payment approach for synthetic and HCT/P graft
skin substitutes.
(41) External Extended ECG Monitoring (CPT Codes 93241, 93242, 93243,
93244, 93245, 93246, 93247, and 93248)
In the CY 2021 PFS proposed rule (85 FR 50164), we proposed to
adopt the RUC recommendations for CPT codes 93241 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; includes recording, scanning
analysis with report, review and interpretation), 93242 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; recording (includes connection
and initial recording)), 93243 (External electrocardiographic recording
for more than 48 hours up to 7 days by continuous rhythm recording and
storage; scanning analysis with report), 93244 (External
electrocardiographic recording for more than 48 hours up to 7 days by
continuous rhythm recording and storage; review and interpretation),
93245 (External electrocardiographic recording for more than 7 days up
to 15 days by continuous rhythm recording and storage; includes
recording, scanning analysis with report, review and interpretation),
93246 (External electrocardiographic recording for more than 7 days up
to 15 days by continuous rhythm recording and storage; recording
(includes connection and initial recording)), 93247 (External
electrocardiographic recording for more than 7 days up to 15 days by
continuous rhythm recording and storage; scanning analysis with
report), and 93248 (External electrocardiographic recording for more
than 7 days up to 15 days by continuous rhythm recording and storage;
review and interpretation).
We noted that the recommendations for this family of codes contain
one new supply item, the ``extended external ECG patch, medical
magnetic tape recorder'' (SD339). We did not receive a traditional
invoice to establish a price for this supply item. Instead we received
pricing information from two sources: A weighted median of claims data
with the cost of the other direct PE inputs removed, and a top-down
approach calculating the cost of the supply per service based on
summing the total costs of the health care provider and dividing by the
total number of tests furnished. The former methodology yielded a
supply price of approximately $440 while the latter methodology
produced an estimated supply price of $416.85. Stakeholders also
submitted a series of invoices from the clinical study marketplace with
a price of $595, which we rejected as we typically require an invoice
representative of commercial market pricing to establish a national
price for a new supply or equipment item.
After consideration of the information, we proposed to employ a
crosswalk to an existing supply for use as a proxy price until we
received pricing information to use for the ``extended external ECG
patch, medical magnetic tape recorder'' item. We proposed to use the
``kit, percutaneous neuro test stimulation'' (SA022) supply as our
proxy item at a price of $413.24. We believed the kit to be the closest
match from a pricing perspective to employ as a proxy until we would be
able to arrive at an invoice that is representative of commercial
market pricing. We welcomed the submission of invoices or other
additional information for use in pricing the ``extended external ECG
patch, medical magnetic tape recorder'' supply. In response to our
proposal, we received conflicting information from commenters and in
the CY 2021 PFS final rule (85 FR 84631), we ultimately finalized
contractor pricing for CY 2021 for the four codes that include this
supply input (CPT codes 93241, 93243, 93245, and 93247) to allow
additional time to receive more pricing information.
We note that stakeholders have continued to engage with CMS and the
MACs on payment for this service. We remain concerned that we continue
to hear that the supply costs as initially considered in our CY 2021
PFS proposal are much higher than they should be. At the same time we
also have heard that
[[Page 39179]]
the resource costs, as reflected in the contractor based payments do
not adequately cover the incurred cost for the SD339 supply that is
used to furnish these services. In consideration of continued access to
these services for Medicare beneficiaries, we are once again seeking
public comment and information to support CMS' future rulemaking to
establish a uniform national payment that appropriately reflects the PE
that are used to furnish these services. As previously stated, invoices
or other additional information, including for example, which proxy
supply items could be used to establish cost for the SD339 supply,
information on use/application and potential alternatives (as
appropriate) to the supply items, would be ideal for us to use in
establishing fair and stable pricing for these services. We note that
in the absence of such additional and actionable information (that is,
information that provides further context to information that has
already been considered) we are proposing to maintain contractor
pricing for these services.
(42) Comment Solicitation for Impact of Infectious Disease on Codes and
Ratesetting
During the PHE for COVID-19, several stakeholders have contacted
CMS with concerns about the additional costs borne by physician and
NPPs due to the pandemic that may impact the professional services
furnished to Medicare beneficiaries. For example, we have heard from
stakeholders about higher costs due to additional supplies, such as
personal protective equipment, and increased time that physicians, NPPs
and their clinical staff may spend with patients to mitigate further
spread of infection when, for example, stakeholders are working to rule
out a COVID-19 infection, or furnishing other services to a patient
with a confirmed COVID-19 infection. While costs such as these may
diffuse into Medicare payment rates over a period of time, our payment
systems, including the PFS, are not generally designed to accommodate
more acute increases in resource costs, even if they are widespread. We
acknowledge the circumstances stakeholders have identified that may
lead to additional costs borne by physicians and NPPs during the PHE,
and we have developed and implemented policies, as appropriate and
where possible, to maintain beneficiary access to necessary services
during the PHE. CMS is continuing to think broadly about the concerns
raised, and specifically about the types of resource costs that may not
be fully reflected in payment rates for existing services, or costs
that could be accounted for by establishing new payment rates for new
services. We are interested in feedback from stakeholders about
additional strategies to account for PHE-related costs, including
feedback on the specific types of services and costs that may benefit
from further review, such as infectious disease control measures,
research-related activities and services, or PHE-related preventive or
therapeutic counseling services. We are interested in detailed feedback
from stakeholders to help inform whether we should consider making
changes to payments for services or develop separate payments for such
services in future rulemaking.
(43) Comment Solicitation on Separate PFS Coding and Payment for
Chronic Pain Management
Adequate treatment of pain is a significant public health
challenge. Centers for Disease Control and Prevention (CDC) data
indicate 50 million adults in the United States have chronic daily
pain, with nearly 20 million experiencing high impact pain that
interferes with daily life or work. Pain is the most common reason
individuals seek medical care, and more than 20 percent of office
visits are associated with pain.\4\ In the United States, 42.6 percent
of adults report having pain on some days in the past 6 months,\5\ and
chronic pain and high-impact chronic pain are experienced by 20.4
percent and 8 percent of adults, respectively.\6\ The high prevalence
of pain exacts a substantial economic toll: Medical expenditures and
lost productivity related to pain result in a cost to the United States
estimated at up to $635 billion.\7\
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\4\ Daubresse M, Chang HY, Yu Y, Viswanathan S, Shah ND,
Stafford RS, Kruszewski SP, Alexander GC. Ambulatory diagnosis and
treatment of non-malignant pain in the United States, 2000-2010.
Medical care. 2013 Oct;51(10).
\5\ Erratum: Vol. 66, No. 29. MMWR Morb Mortal Wkly Rep
2017;66:1238. DOI: http://dx.doi.org/10.15585/mmwr.mm6644a10external
icon.
\6\ Dahlhamer J, Lucas J, Zelaya, C, et al. Prevalence of
Chronic Pain and High-Impact Chronic Pain Among Adults--United
States, 2016. MMWR Morb Mortal Wkly Rep 2018;67:1001-1006. DOI:
http://dx.doi.org/10.15585/mmwr.mm6736a2.
\7\ Gaskin DJ, Richard P. The economic costs of pain in the
United States. The Journal of Pain. 2012 Aug 1;13(8):715-24.
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In 2010, HHS, through the National Institutes of Health (NIH),
contracted with the Institute of Medicine to make recommendations ``to
increase the recognition of pain as a significant public health problem
in the United States.'' In its 2011 report entitled Relieving Pain in
America: A Blueprint for Transforming Prevention, Care, Education, and
Research, the Institute of Medicine, through a study mandated by
Congress, recommended significant improvements in pain prevention,
care, education, and research and development of a population health-
level strategy to address pain care.\8\ The report described that the
unique experience of pain requires a combination of person-centered
therapies and coping techniques influenced by genes, cultural
attitudes, stress, depression, ability to understand health
information, and other behavioral, cultural, and emotional factors. It
noted that individualized care can require adequate extra time to
counsel patients and caregivers, promote self-management, and consult
with other providers, but current reimbursement systems are not
designed to efficiently pay for this approach. HHS subsequently
convened an expert committee to oversee creation of the National Pain
Strategy (NPS), issued in 2016.\9\ The NPS addressed six key areas of
care: Population research, prevention and care, disparities, service
delivery and payment, professional education and training, and public
education/communication. In this report, NPS' vision is to ``decrease
the prevalence of pain across its continuum from acute to high-impact
chronic pain and its associated morbidity and disability across the
lifespan,'' and aim ``to reduce the burden of pain for individuals,
their families, and society as a whole.''
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\8\ https://www.nap.edu/catalog/13172/relieving-pain-in-america-a-blueprint-for-transforming-prevention-care.
\9\ https://www.iprcc.nih.gov/national-pain-strategy-overview/national-pain-strategy-report.
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This work was followed by HHS's 2019 release of its Pain Management
Best Practices Inter-Agency Task Force Report: Updates, Gaps,
Inconsistencies, and Recommendations (PMTF Report).\10\ The PMTF Report
focuses on the development of patient-centered pain treatment plans to
establish diagnosis and set measurable outcomes such as improvements in
quality of life, function, and activities of daily living. It
emphasized multi-modal, multi-disciplinary approaches that include
various modalities for acute and chronic pain. The PMTF Report also
identified five broad treatment categories: Medications including
opioids and non-opioids, restorative therapies, interventional
approaches, behavioral approaches, and complementary and integrative
health. It stressed the importance of special populations including
older adults and persons with
[[Page 39180]]
relapsing conditions, Veterans, and people who receive palliative care.
The PMTF Report recognized the importance of proper opioid stewardship
for individuals who need opioids to effectively manage their pain. As
the Task Force noted, there are ongoing concerns regarding suicide and
suicidal ideation due to pain, and a lack of access to pain treatment,
including appropriate access to opioid medications. The PMTF Report
noted that management of pain conditions often requires
multidisciplinary coordination among health care professionals, and
that the experience of pain can intensify other health issues such as
delayed recovery from surgery, or exacerbate behavioral health
conditions. Many health care professionals, including primary care
providers, have opted out entirely in treating pain, worsening an
existing shortage of pain specialists and making chronic pain care hard
to access, including for people who frequently experience disparities
in pain care such as rural dwellers, racial/ethnic minorities, and
people with disabilities. The COVID-19 Public Health Emergency has also
had an impact on the ability of many older adults and people with
disabilities' access to care, although telehealth modalities have shown
promise in broadening access to services and supports.
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\10\ https://www.hhs.gov/sites/default/files/pmtf-final-report-2019-05-23.pdf.
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At the same time individuals are experiencing difficulties finding
pain care, the country is also coping with a worsening opioid and SUD
crisis. The current environment involves shifting ``waves'' of overdose
deaths associated with heroin, synthetic opioids, and prescription
drugs, and intensifying stimulant and polysubstance use. Preliminary
Centers for Disease Control and Prevention data released in April 2021
show a 29 percent rise in overdose deaths from October 2019 through
September 2020--the most recent data available--compared with the
previous 12-month period.\11\ Illicitly manufactured fentanyl and other
synthetic opioids were the primary drivers, although many fatal
overdoses have also involved stimulant drugs, particularly
methamphetamine. In December 2020, the Substance Abuse and Mental
Health Services Administration (SAMHSA) released a preliminary report
from its Drug Abuse Warning Network, which captures data on emergency
department (ED) visits related to recent substance use and misuse such
as alcohol use, illicit drug use, suicide attempts, and nonmedical use
of pharmaceuticals. Most commonly associated with ED visits in the
participating hospitals are illicit substances and central nervous
system agents. Among illicit drugs, stimulants (including
methamphetamine and illicit amphetamine) are the most common, followed
by cannabinoids (including marijuana and synthetic cannabinoids).\12\
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\11\ https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
\12\ https://www.samhsa.gov/data/report/preliminary-dawn-data-review.
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The PMTF Report urged clinicians to use a comprehensive,
individualized, person-centered approach to the diagnosis and treatment
of pain featuring multiple therapeutic modalities. The uptake of this
approach is an urgent concern as growing numbers of older adults are
enrolling in Medicare. Some estimates indicate about half of older
adults have pain that interferes with function. Primary care clinicians
and specialists are already facing challenges in treating pain and
associated chronic disease in the Medicare population, where conditions
such as arthritis, bone/joint disorders, back and neck pain, cancer and
other conditions that inform and at times inhibit employing the full
spectrum of pain management therapies are common. We believe untreated
and inappropriately treated pain may translate to increased costs to
the Medicare program as more beneficiaries experience functional
decline, incapacitation, and frailty. Additional risks in untreated
pain include individuals using illicit drugs such as cannabis;
inadequate treatment of mental disorders such as depression and
anxiety, misuse of prescription drugs, alcohol and other drug use
disorder, and increased suicide risk and suicide.
In 2019 HHS issued the Guide for Clinicians on the Appropriate
Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics (the
Guide) to support the thoughtful, deliberative, and measured
discontinuation of long-term opioid analgesics, and mitigate harm and
risk to patients who are working with their clinicians to undergo
appropriate tapering or discontinuation.\13\ The Guide notes that
decisions to continue or reduce opioid medications for pain should be
collaborative and based on the individual patient's goals and
circumstances and clinicians should consider, for example, whether
opioid medications continue to support patients meeting treatment
goals; if opioids are exposing the person to an increased risk for
serious adverse events or an opioid use disorder; and whether benefits
continue to outweigh risks of opioids. Whether or not opioids are used
in treatment, safe and effective non-opioid treatments can be
integrated into patients' pain management plans based on an
individualized assessment of benefits and risks, and considering the
patient's diagnosis, goals and circumstances.\14\ Unique needs and
coordination across the health care team is critical and clinicians and
care teams have a responsibility to provide, or arrange for,
coordinated management of patients' pain including any medication-
related issues. The system of care should not ultimately result in
patient abandonment. The FDA issued a safety announcement in 2019,
advising that health care professionals should not abruptly discontinue
opioids in patients who are physically dependent and that patient-
specific plans should be created to gradually taper off opioids, in
part due to the risk of adverse events including abrupt withdrawal
symptoms, increased pain, mood changes, mental health impact,
psychosocial impact, and importantly, suicide risk.\15\
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\13\ https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf.
\14\ https://www.cdc.gov/drugoverdose/pdf/assessing_benefits_harms_of_opioid_therapy-a.pdf.
\15\ https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes.
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In 2020 the National Academy of Medicine, as part of its ``Action
Collaborative to Countering the U.S. Opioid Epidemic,'' began an effort
to understand more about the state of chronic pain management, and to
bring greater awareness to any intended and unintended consequences of
opioid prescribing metrics as they pertain to the delivery, access, and
coordination of chronic pain management and care. CMS is one of the
sponsors of this work. The aim of this project is to visually
illustrate the chronic pain management journey and accelerate the
uptake of a range of pain treatments by outlining approaches to
effective communication that leads to strong clinical relationships and
optimal quality of life for people with pain.\16\
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\16\ https://nam.edu/event/living-with-chronic-pain-perspectives-from-persons-with-lived-experience/.
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The SUPPORT Act (Pub. L. 115-271, October 24, 2018) outlines
national strategies to help address America's opioid and substance use
disorders (SUD) crisis, and advances policies to improve the treatment
of pain and SUD. The SUPPORT Act recognizes the importance of opioid-
related medication management, as well as the overall need to identify
SUD in the Medicare
[[Page 39181]]
beneficiary population. Sections 2002 and 6086 of the SUPPORT Act are
of particular importance regarding pain management. For beneficiaries
with chronic pain, section 2002 of the SUPPORT Act amended sections
1861(ww) and (hhh)(2) of the Act to include a review of any current
opioid prescriptions in conjunction with the initial preventive
physical examination (the ``Welcome to Medicare'' visit) and annual
wellness visit (AWV). The opioid prescription review is to include a
review of the potential risk factors to the individual for opioid use
disorder, an evaluation of the individual's pain severity and current
treatment plan, the provision of information on non-opioid treatment
options, and referral to a specialist, if appropriate. Section 2002
also amended sections 1861(ww) and (hhh)(2) of the Act to add a
screening for potential SUDs to the Welcome to Medicare visit and the
AWV, and to add referral to a specialist, as appropriate, to the AWV.
Section 6086 of the SUPPORT Act, the Dr. Todd Graham Pain
Management Study, will provide HHS and CMS with key information about
services delivered to Medicare beneficiaries with acute or chronic
pain, help in understanding the current landscape of pain relief
options for Medicare beneficiaries, and inform decisions around payment
and coverage for pain management interventions, including those that
minimize the risk of SUD. CMS has worked with the Agency for Healthcare
Research and Quality, which has undertaken three topic briefs and two
systematic reviews to inform Medicare coverage for the treatment of
acute and chronic pain. CMS has also worked with HHS's Office of the
Secretary for Planning and Evaluation to write a Report on the Study,
which will be submitted to Congress. CMS will post a completed copy of
the Report on our website. The Report will address questions regarding
coverage and payment for evidence-based interventions for acute and
chronic pain in Medicare, barriers to access, costs and benefits of
expanding or revising benefits not currently covered, and legislative
and administrative options to improve pain interventions.
We believe it is important to highlight the role of a person-
centered approach to pain care. The National Quality Forum, which as
its core work defines measures and health care practices as the best,
evidence-based approaches to improving care, has defined person-
centered planning as ``a facilitated, individual-directed, positive
approach to the planning and coordination of a person's services and
supports based on individual aspirations, needs, preferences, and
values,'' and stated that the ``goal of person-centered planning is to
create a plan that would optimize the person's self-defined quality of
life, choice, and control, and self-determination through meaningful
exploration and discovery of unique preferences and needs and wants in
areas including, but not limited to, health and well-being,
relationships, safety, communication, residence, technology, community,
resources, and assistance.'' \17\ These general principles should also
apply in the treatment of individuals with pain, where clinicians
confirm and affirm the individual's recovery and/or maintenance goals,
and focus on those, where treatment is a means to an end.\18\ For
example, one goal might be to not rely on aiming to reduce a simple
pain score, such as a numeric or visual score, but to evaluate function
for example, through a tool such as the Defense and Veterans Pain
Rating scale,\19\ which integrates functional status, and then aim to
optimize physical function and mental function in the beneficiary with
chronic pain.
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\17\ https://www.qualityforum.org/Home.aspx.
\18\ https://www.qualityforum.org/ProjectMaterials.aspx?projectID=89422.
\19\ https://www.va.gov/painmanagement/resources.asp.
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We recognize that there are no existing codes that specifically
describe the work of the clinician involved in performing the tasks
necessary to perform pain management care. We believe there are
complexities in treating pain management patients that could include
lifestyle discussion, ongoing medication management (such as opioid
tapering or discontinuation, when appropriate), behavioral health care,
preparation and updating of a care plan, consideration of federal and
other opioid prescribing limits and guidelines, Prescription Drug
Monitoring Program checks, electronic prescribing requirements, special
licensing requirements (controlled substance licenses; buprenorphine
``X-waivers''), interdisciplinary interactions, prescription drug
coverage, CMS high-prescriber oversight, consideration of out-of-pocket
costs, and other issues. As one example, decreasing or discontinuing
opioid treatment requires careful, person-centered consideration of all
of these aspects of providing care. These unique challenges often
adversely impact the delivery of care, and subsequent access to care,
for beneficiaries with chronic pain. Current Medicare payment
methodologies such as Chronic Care Management (CCM) support chronic
disease management, though may not provide adequate payment to health
care providers or systems to holistically care for beneficiaries with
chronic pain; we believe the complexity and resources required for safe
and effective pain management may not be adequately captured and paid
through these codes.
We believe that creating separate or add-on payment for care and
management for people with pain might provide opportunities to better
leverage services furnished using telecommunications technology and non
face-to-face care while expanding access to treatment for pain. Such an
additional payment could potentially be effective in preventing or
reducing the need for acute services such as fall avoidance, and reduce
the need for treatment for mental disorders such as depression,
anxiety, and sleep disorders which may occur in some individuals with
pain. There is also reason to believe that addressing chronic pain (for
example, pain that lasts more than 3 months) early in its course may
result in averting the development of ``high-impact'' chronic pain in
some individuals, where they experience at least one major activity
restriction (for example, unable to work, go to school, perform
household chores). These individuals report more severe pain, more
difficulty with self-care, and higher health care use than others with
chronic pain. From a social determinants of health perspective, Blacks,
Native Americans, persons of Asian/Indian descent, older adults, and
people with less education, and single individuals report more high
impact chronic pain.\20\
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\20\ https://www.nccih.nih.gov/research/research-results/prevalence-and-profile-of-high-impact-chronic-pain.
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In 2019, 12.2 million individuals were enrolled in both Medicaid
and Medicare, including people age 65 and older and younger
beneficiaries with disabilities. Many have multiple chronic conditions,
physical disabilities, behavioral health conditions, and cognitive
impairments and on average, use more services and supports than those
enrolled in only Medicaid or Medicare, with higher per capita costs.
Dually eligible beneficiaries often have multiple social risk factors
such as housing insecurity and homelessness, food insecurity,
inadequate access to transportation, and low health literacy. A 2019
study \21\ on dually eligible beneficiaries using ``high dose'' opioids
to treat pain between 2006 through 2015
[[Page 39182]]
indicated that the common conditions in beneficiaries studied were
chronic pain, migraine, rheumatoid arthritis, osteoporosis, HIV/AIDS,
viral hepatitis, and SUD.\22\
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\21\ https://www.macpac.gov/wp-content/uploads/2020/06/Chapter-1-Integrating-Care-for-Dually-Eligible-Beneficiaries-Background-and-Context.pdf.
\22\ https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/DataStatisticalResources/Downloads/OpioidsDataBrief_2006-2015_10242018.pdf.
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We are soliciting comment on whether we should consider creating
separate coding and payment for medically necessary activities involved
with chronic pain management and achieving safe and effective dose
reduction of opioid medications when appropriate, or whether the
resources involved in furnishing these services are appropriately
recognized in current coding and payment. These activities could
include, but are not limited to the following:
Diagnosis;
Assessment and monitoring;
Administration of a validated rating scale(s);
Development and maintenance of a person-centered care
plan;
Overall treatment management;
Facilitation and coordination of any needed behavioral
health treatment;
Medication management;
Patient education and self-management;
Crisis care;
Specialty care coordination such as complementary and
integrative pain care, and SUD care; and
Other aspects of pain and/or behavioral health services,
including care rendered through telehealth modalities.
We are interested in feedback regarding whether the resource costs
involved in furnishing these activities would be best captured through
an add-on code to be billed with an E/M visit or a standalone code. To
price such a code, we could consider using a crosswalk to the valuation
and inputs for reference codes such as CPT code 99483 (Assessment of
and care planning for a patient with cognitive impairment), HCPCS code
G2064 (Comprehensive care management services for a single high-risk
disease, e.g., principal care management, at least 30 minutes of
physician or other qualified health care professional time per calendar
month), HCPCS code G0108 (Diabetes outpatient self-management training
services, individual, per 30 minutes), or other services paid under the
PFS with similar resource costs.
We also seek information on which healthcare settings and stages in
treatment these transitions from opioid dependence are occurring, as
well as what types of practitioners furnish these services. We are
soliciting comments on whether the specific activities we identify
above are appropriate, and whether there are other activities that
should be included. We are interested in stakeholder feedback regarding
how we could define and value separate coding or an E/M add-on code. We
also seek comment on whether any components of the service could be
provided ``incident to'' the services of the billing physician who is
managing the beneficiary's overall care similar to the structure of the
Behavioral Health Integration (BHI) codes, which can include BHI
services that are not delivered personally by the billing practitioner
and delivered by other members of the care team (except the
beneficiary), under the direction of the billing practitioner on an
incident to basis (as an integral part of services delivered by the
billing practitioner), subject to applicable state law, licensure, and
scope of practice. The other care team members are either employees or
working under contract to the practitioner who bills for BHI services.
We welcome feedback from stakeholders and the public on potential
separate coding or an E/M add-on code for chronic pain management for
our consideration for CY 2022 or for future rulemaking.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
F. Evaluation and Management (E/M) Visits
Over the past several years, CMS has engaged with the AMA and other
stakeholders in a process to update coding and payment for office/
outpatient evaluation and management (E/M) visits, with recent changes
taking effect January 1, 2021 (see 85 FR 84548 through 84574). In light
of these changes, we are engaged in an ongoing review of other E/M
visit code sets and are proposing a number of refinements to our
current policies. The following section will discuss proposed policies
regarding split (or shared) visits, critical care services, and
teaching physician visits.
1. Split (or Shared) Visits
a. Background
A split (or shared) visit refers to an E/M visit that is performed
(``split'' or ``shared'') by both a physician and a NPP who are in the
same group. Because the Medicare statute provides a higher PFS payment
rate for services furnished by physicians than services furnished by
NPPs, we need to address whether and when the physician can bill for
split (or shared) visits. For visits in the non-facility (for example,
office) setting for which the physician and NPP each perform portions
of the visit, the physician can bill for the visit rather than the NPP
as long as the visit meets the conditions of payment in our regulations
at Sec. 410.26(b)(1) for services furnished ``incident to'' a
physician's professional services. However, for visits furnished under
similar circumstances in facility settings (for example, in a
hospital), our current regulations provide for payment only to the
physician or NPP who personally performs all elements of the service,
and no payment is made for services furnished ``incident to'' the
billing professional's services.
As stated in our regulation at Sec. 410.26(b)(1), Medicare Part B
pays for services and supplies furnished ``incident to'' a physician's
(or other practitioner's) professional services if those services and
supplies are furnished in a noninstitutional setting to
noninstitutional patients. In certain institutional (or ``facility'')
settings, our longstanding split (or shared) billing
[[Page 39204]]
policy allows a physician to bill for an E/M visit when both the
billing physician and an NPP in their group each perform portions of
the visit, but only if the physician performs a substantive portion of
the visit. When the physician bills for such a split (or shared) visit,
in accordance with section 1833(a)(1)(N) of the Act, the Medicare Part
B payment is equal to 80 percent of the payment basis under the PFS
which, under section 1848(a)(1) of the Act, is the lesser of the actual
charge or the fee schedule amount for the service. In contrast, if the
physician does not perform a substantive portion of such a split (or
shared) visit and the NPP bills for it, in accordance with section
1833(a)(1)(O) of the Act, the Medicare Part B payment is equal to 80
percent of the lesser of the actual charge or 85 percent of the fee
schedule rate.
Previously, our policy for billing these split (or shared) visits
was reflected in several provisions of our Medicare Claims Policy
Manual (sections 30.6.1(B), 30.6.12, and 30.6.13(H)) which were
withdrawn effective May 9, 2021, in response to a petition under the
Department's Good Guidance regulations at 45 CFR 1.5 (see Transmittal
10742 available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Transmittals/r10742cp). In the
absence of these manual provisions, the Medicare statute and various
broadly applicable regulations continue to apply. In addition to
withdrawing the manual provisions, we issued our response to the
petition and an accompanying enforcement instruction on May 26, 2021,
available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Evaluation-and-Management-Visits). In those documents, we indicated that we intend to address
split (or shared) visits and critical care services (addressed below)
through rulemaking; and that until we do, we will limit review to the
applicable statutory and regulatory requirements for purposes of
assessing payment compliance.
The list of applicable statutory and regulatory requirements
includes the CY 2021 PFS final rule (85 FR 84549), where CMS generally
adopted new CPT prefatory language and code descriptors for office/
outpatient E/M visits. The new CPT guidelines for E/M services
introduced a CPT definition of a split (or shared) visit for the first
time, effective January 1, 2021. This new CPT definition was part of
CPT's new guidelines indicating how to select the visit level based on
time, which can be done for all office/outpatient E/M visits starting
in 2021. The CPT guidelines that we are referring to are published in
the CPT Codebook, in a section titled ``Evaluation and Management
Services (E/M) Guidelines.'' \23\ In this section of our proposed rule,
we use the term ``CPT E/M Guidelines'' to refer to this material.
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\23\ 2021 CPT Codebook, p. 5.
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In the CY 2021 PFS final rule (85 FR 84549), we stated that we are
generally adopting the CPT E/M Guidelines for the new office/outpatient
E/M visit codes. However, the CPT E/M Guidelines do not address many
issues that arise in the context of PFS payment for split (or shared)
visits, such as which practitioner should report the visit when
elements of the visit are performed by different practitioners; whether
a substantive portion of the visit must be performed by the billing
practitioner; whether practitioners must be in the same group to bill
for a split (or shared) visit; or the settings of care where split (or
shared) visits may be furnished and billed. The CPT E/M Guidelines
simply state, ``A split or shared visit is defined as a visit in which
a physician and other qualified health care professional(s) jointly
provide the face-to-face and non-face-to-face work related to the
visit. When time is being used to select the appropriate level of
services for which time-based reporting of shared or split visits is
allowed, the time personally spent by the physicians and other
qualified health care professional(s) assessing and managing the
patient on the date of the encounter is summed to define total time.
Only distinct time should be summed for split or shared visits (that
is, when two or more individuals jointly meet with or discuss the
patient, only the time of one individual should be counted).'' \24\
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\24\ 2021 CPT Codebook, p. 7.
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In contrast, to ensure appropriate PFS payment, our policy for
split (or shared) visits, as expressed in the recently withdrawn manual
provisions, is that the physician may bill for a split (or shared)
visit only if they perform a substantive portion of the visit, and the
practitioners must be in the same group and furnishing the visit in
specified settings in order to bill for a split (or shared) visit. Our
manual also limited billing for split (or shared) visits to services
furnished to established patients. In this proposed rule, we are making
a number of proposals to address the recently withdrawn manual sections
and improve transparency and clarity regarding our policies on billing
for split (or shared) visits, to update them to account for recent
revisions to E/M visit coding and payment, and to revise our
regulations to reflect these policies.
b. Definition of Split (or Shared) Visits
We are proposing to define a split (or shared) visit as an E/M
visit in the facility setting that is performed in part by both a
physician and an NPP who are in the same group, in accordance with
applicable laws and regulations. We propose to add this definition to a
new section of our regulations at Sec. 415.140.
Additionally, we propose to define split (or shared) visits as
those that:
Are furnished in a facility setting by a physician and an
NPP in the same group, where the facility setting is defined as an
institutional setting in which payment for services and supplies
furnished incident to a physician or practitioner's professional
services is prohibited under our regulation at Sec. 410.26(b)(1).
Are furnished in accordance with applicable law and
regulations, including conditions of coverage and payment, such that
the E/M visit could be billed by either the physician or the NPP if it
were furnished independently by only one of them in the facility
setting (rather than as a split (or shared) visit).
We are proposing to revise our regulations at Sec. 415.140 to
codify this definition.
We believe that limiting the definition of split (or shared) visits
to include only E/M visits in institutional settings, for which
``incident to'' payment is not available, will allow for improved
clarity, and clearly distinguish, the policies applicable to split (or
shared) visits, from the policies applicable to services furnished
incident to the professional services of a physician. We do not see a
need for split (or shared) visit billing in the office setting, because
the ``incident to'' regulations govern situations where an NPP works
with a physician who bills for the visit, rather than billing under the
NPP's own provider number.
We are also proposing to modify our policy to allow physicians and
NPPs to bill for split (or shared) visits for both new and established
patients, and for critical care and certain Skilled Nursing Facility/
Nursing Facility (SNF/NF) E/M visits. We are proposing these
modifications to the current policy and conditions of payment for split
(or shared) visits, discussed below, to account for changes that have
occurred in medical practice patterns, including
[[Page 39205]]
the evolving role of NPPs as part of the medical team.
c. Definition of Substantive Portion
(1) More Than Half of the Total Time
As stated earlier, only the physician or NPP who performs the
substantive portion of the split (or shared) visit would bill for the
visit. We are proposing to define ``substantive portion'' as more than
half of the total time spent by the physician and non-physician
practitioner performing the visit. We note that our withdrawn manual
instructions contained a few definitions of ``substantive portion.''
For example, one section defined substantive portion as any face-to-
face portion of the visit, while another section defined it as one of
the three key components of an E/M visit--either the history of present
illness (HPI), physical exam, and/or medical decision-making (MDM).
Given recent changes in the CPT E/M Guidelines, HPI and physical exam
are no longer necessarily included in all E/M visits, because as noted
above, for office/outpatient E/M visits, the visit level can now be
selected based on either MDM or time, and history and exam are
performed only as medically appropriate. Accordingly, defining
``substantive portion'' as one of these three key components is no
longer a viable approach. Similarly, MDM is not easily attributed to a
single physician or NPP when the work is shared, because MDM is not
necessarily quantifiable and can depend on patient characteristics (for
example, risk). We believe that time is a more precise factor than MDM
to use as a basis for deciding which practitioner performs the
substantive portion of the visit.
We also do not believe it would be appropriate to consider the
performance of any portion of the visit--with or without direct patient
contact--as a substantive portion. For instance, we do not believe it
would be appropriate to consider a brief or minor interaction, with or
without direct patient contact, such as where the physician merely
``pokes their head'' into the room, to be a substantive portion of the
visit. Therefore, we are proposing to define ``substantive portion'' as
more than half of the total time spent by the physician and NPP
performing the split (or shared) visit. We are proposing to revise our
regulation at Sec. 415.140 to codify this definition.
We recognize that the billing practitioner, who would be the
practitioner providing the substantive portion of the visit, could
select the level for the split (or shared) visit based on MDM, but we
nonetheless propose to base the definition of substantive portion on
the amount of time spent by the physician and NPP providing the visit.
We recognize that this policy would necessitate the practitioners'
tracking and documenting the time they spent for these visits. However,
we believe that practitioners are likely to increasingly time their
visits for purposes of visit level selection independent of our split
(or shared) visit policies, given recent changes to the CPT E/M
Guidelines, and the fact that critical care visits are already timed.
Accordingly, we do not believe this would comprise a substantial new
burden.
(2) Distinct Time
We propose that the distinct time of service spent by each
physician or NPP furnishing a split (or shared) visit would be summed
to determine total time and who provided the substantive portion (and
therefore bills for the visit). This would be consistent with the CPT
E/M Guidelines stating that, for split (or shared) visits, when two or
more individuals jointly meet with or discuss the patient, only the
time of one individual should be counted).\25\ For example, if the NPP
first spent 10 minutes with the patient and the physician then spent
another 15 minutes, their individual time spent would be summed to
equal a total of 25 minutes. The physician would bill for this visit
since they spent more than half of the total time (15 of 25 total
minutes). If, in the same situation, the physician and NPP met together
for five additional minutes (beyond the 25 minutes) to discuss the
patient's treatment plan, that overlapping time could only be counted
once for purposes of establishing total time and who provided the
substantive portion of the visit. The total time would be 30 minutes,
and the physician would bill for the visit since they spent more than
half of the total time (20 of 30 total minutes).
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\25\ 2021 CPT Codebook (Evaluation and Management (E/M) Services
Guidelines), p.7.
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(3) Qualifying Time
Drawing on the CPT E/M Guidelines, we are proposing a listing of
activities that could count toward total time for purposes of
determining the substantive portion. For visits that are not critical
care services, we are proposing the same listing of activities that can
count when time is used to select E/M visit level, specifically the
following activities, when performed and regardless of whether or not
they involve direct patient contact:
Preparing to see the patient (for example, review of
tests).
Obtaining and/or reviewing separately obtained history.
Performing a medically appropriate examination and/or
evaluation.
Counseling and educating the patient/family/caregiver.
Ordering medications, tests, or procedures.
Referring and communicating with other health care
professionals (when not separately reported).
Documenting clinical information in the electronic or
other health record.
Independently interpreting results (not separately
reported) and communicating results to the patient/family/caregiver.
Care coordination (not separately reported).
Practitioners would not count time spent on the following:
The performance of other services that are reported
separately.
Travel.
Teaching that is general and not limited to discussion
that is required for the management of a specific patient.\26\
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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 are proposing a
different listing of qualifying activities, discussed in our section
below on split (or shared) critical care services. Additionally, we are
seeking public comment on whether there should be a different listing
of qualifying activities for purposes of determining the total time and
substantive portion of split (or shared) emergency department visits,
since those visits also have a unique construct.
(4) Application to Prolonged Services
For office/outpatient E/M visits, as discussed in our CY 2021 PFS
final rule (85 FR 84572), HCPCS code G2212 can be used to report
prolonged services in 15-minute increments of time beyond the maximum
time for a level 5 office/outpatient E/M visit. For all other E/M
visits (except critical care and emergency department visits), CPT
codes 99354-9 can be used to report prolonged time with or without
direct patient contact, when required time increments above the typical
time is spent (see CY 2017 PFS final rule, 81 FR 80228-80230 and the
Medicare Claims Processing Manual (Pub. 100-02), chapter 12, section
30.6.15 available on our website at https://www.cms.gov/
[[Page 39206]]
Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
Our withdrawn manual provisions instructed that practitioners
cannot bill prolonged services as a split (or shared) visit. Having
reviewed this policy, we believe that codes that are billed as add-on
codes for prolonged service time for an E/M visit, which could be
furnished and billed as a split (or shared) visit under our proposed
policy, should be considered to be part of that E/M visit. Therefore,
we are proposing to change our policy to allow a practitioner to bill
for a prolonged E/M visit as a split (or shared) visit. Specifically,
the physician or practitioner who spent more than half the total time
(that is, performed the substantive portion described above) would bill
for the primary E/M visit and the prolonged service code(s) when the
service is furnished as a split (or shared) visit, if all other
requirements to bill for the services were met. The physician and NPP
would sum their time together, and whomever furnished more than half of
the total time, including prolonged time, (that is, the substantive
portion) would report both the primary service code and the prolonged
services add-on code(s), assuming the time threshold for reporting
prolonged services is met. We note that for critical care visits, the
practitioner would not bill prolonged E/M services because the
practitioners would instead aggregate their time, as proposed below, to
report additional units of critical care services.
d. New and Established Patients, and Initial and Subsequent Visits
Our withdrawn manual provisions stated that when an E/M service is
furnished as a split or shared encounter, between a physician and an
NPP (that is, an NP, PA, CNS or CNM), the service is considered to have
been performed ``incident to'' if the requirements for ``incident to''
are met and the patient is an established patient. This provision was
generally interpreted to mean that split (or shared) visits cannot be
billed for new patients. The withdrawn manual provisions also did not
specify whether the practitioner who bills for the split or shared
visit could bill for initial, versus subsequent, split (or shared)
visits in the facility setting. After conducting an internal review,
including consulting our medical officers, we believe that the practice
of medicine has evolved toward a more team-based approach to care, and
greater integration in the practice of physicians and NPPs,
particularly when care is furnished by practitioners in the same group
in the facility setting. Given this evolution in medical practice, the
concerns that may have been present when we issued the manual
instructions may no longer be as relevant. We understand that there
have been changes in the practice of medicine over the past several
years, some facilitated by the advent of electronic health records
(EHRs) and other systems, toward a more team-based approach to care.
There has also been an increase in alternative payment models that
employ a more team-based approach to care. After considering and
reevaluating our policy, we see no reason to preclude the physician or
NPP from billing for split (or shared) visits for a new patient, in
addition to an established patient, or for initial and subsequent split
(or shared) visits. Therefore, we are proposing to permit the physician
or NPP to bill for split (or shared) visits for both new and
established patients, as well as for initial and subsequent visits. We
believe this approach is also consistent with the CPT E/M Guidelines
for split (or shared) visits, which does not exclude these types of
visits from being billed when furnished as split (or shared) services.
e. Settings of Care
The concept of split (or shared) visits was developed as an analog
in the facility setting to payment policies for services and supplies
furnished incident to a physician's or an NPP's professional services
in the non-institutional setting. Section 410.26(a)(6) of our
regulations defines the non-institutional setting as all settings other
than a hospital or SNF. We are proposing to allow billing of split (or
shared) visits, including critical care visits, when they are performed
in any institutional setting and are proposing to codify the definition
of facility setting in the regulation at Sec. 415.140. We discuss our
proposals regarding billing for critical care split (or shared) E/M
services below (see section II.F. of this proposed rule).
Our withdrawn manual provisions did not allow practitioners to bill
for split (or shared) visits that are critical care services or SNF/NF
visits. The manual stated that the split (or shared) E/M policy did not
apply to critical care services or procedures, and that a split (or
shared) E/M service performed by a physician and a qualified NPP of the
same group (or employed by the same employer) cannot be reported as a
critical care service. It also stated that a split (or shared) E/M
visit cannot be reported in the SNF/NF setting. We propose to define
split (or shared) visits to be limited to services furnished in
institutional settings, as discussed above. As discussed below, we do
not see any reason to preclude billing for split (or shared) visits for
critical care services, although we are seeking public comment on this
issue in particular. We understand that there have been changes in the
practice of medicine over the past several years, some facilitated by
the advent of EHRs and other systems, toward a more team-based approach
to care. There has also been an increase in alternative payment models
that employ a more team-based approach to care. Where a physician and
NPP in the same group take a team approach to furnishing care, as would
be the case for split (or shared) visits, even for new patients,
initial visits, critical care visits, or SNF/NF visits, we are less
concerned about potential disruptions in continuity of care than we
might once have been. Rather, we believe that when a visit is shared
between a physician and an NPP in the same group, there would be close
coordination and an element of collaboration in providing care to the
beneficiary.
We do not see any reason to preclude billing for split (or shared)
visits for the subset of SNF/NF visits that are not required by our
regulations to be performed in their entirety by a physician. Under our
current policy, no E/M services can be furnished and billed as split
(or shared) visits in the SNF setting. We refer readers to our
Conditions of Participation in 42 CFR 483.30 for information regarding
the SNF/NF visits that are required to be performed in their entirety
by a physician. That regulation requires that certain SNF/NF visits
must be furnished directly and solely by a physician. If finalized, our
proposal would not apply to the SNF/NF visits that are required to be
performed in their entirety by a physician; any SNF/NF visit that is
required to be performed in its entirety by a physician cannot and
would not be able to be billed as a split (or shared) visit. However,
for other visits to which the regulation at Sec. 483.30 does not
apply, there is no requirement for a physician to directly and solely
perform the visit. We propose that those visits could be furnished and
billed as split (or shared) visits.
f. Same Group
In accordance with the current policy outlined in the withdrawn
manual provisions, we are proposing that a physician and NPP must be in
the same group in order for the physician and NPP to bill for a split
(or shared) visit. We believe that in circumstances when a split or
(shared) visit is appropriately billed, a physician and NPP are working
jointly to furnish all of the work related to the visit with the
patient. However, if a physician and NPP are in different groups, we
would expect the physician
[[Page 39207]]
and NPP to bill independently, and only for the services they
specifically and fully furnish. Further, consistent with our withdrawn
manual guidance, we note that Medicare does not pay for partial
physician's visits, so CPT modifier -52 (reduced services) could not be
used to report split (or shared) visits. Thus, if a physician and an
NPP who are in different groups each furnish part of an E/M service,
but not all of it, then we would not consider either service to be a
billable service. Similarly, if two physicians, each in their own
private practice, both saw the same patient in the hospital, but
neither one fully furnished a billable service--there would be no basis
on which to combine their efforts or minutes of service into one
billable E/M visit.
We are seeking public comment on whether we should further define
``group'' for purposes of split (or shared) visit billing. While we are
not proposing a definition in this proposed rule, we have considered
several options, such as requiring that the physician and NPP must be
in the same clinical specialty, in which case we would use the approach
outlined in the CPT E/M Guidelines; that is the NPP is considered to be
in the same specialty and subspecialty as the physician with whom they
are working.\27\ We are also considering an approach under which we
would align the definition of ``group'' with the definition of
``physician organization'' at Sec. 411.351. The term ``physician
organization'' is defined at Sec. 411.351 for purposes of section 1877
of the Act and our regulations in 42 CFR part 411, subpart J
(collectively, the physician self-referral law), and explained further
in frequently asked questions available on the CMS website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Downloads/FAQs-Physician-Self-Referral-Law.pdf. Another approach would be to
consider practitioners with the same billing tax identification number
as being in the same group. We are concerned that this particular
approach may be too broad in multi-specialty groups or health care
systems that include many practitioners who do not typically work
together to furnish care to patients in the facility setting. We note
that some of these approaches may not align with the definition of
``group'' used for purposes of Medicare enrollment.
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\27\ 2021 CPT Codebook, p. 6, ``When advanced practice nurses
and physician assistants are working with physicians, they are
considered as working in the exact same specialty and exact same
subspecialties as the physician.''
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g. Medical Record Documentation
To ensure program integrity and quality of care, we are proposing
that documentation in the medical record must identify the two
individual practitioners who performed the visit. The individual who
performed the substantive portion (and therefore bills the visit) would
be required to sign and date the medical record. We are proposing to
revise our regulation at Sec. 415.140 to reflect the conditions of
payment for split (or shared) visits as discussed in this section.
h. Claim Identification
We are proposing to create a modifier to describe split (or shared)
visits, and we are proposing to require that the modifier must be
appended to claims for split (or shared) visits, whether the physician
or NPP bills for the visit. Currently, we cannot identify through
claims that a visit was performed as a split (or shared) visit, which
means that we could know that a visit was performed as a split (or
shared) visit only through medical record review. We believe it is
important for program integrity and quality considerations to have a
way to identify who is providing which E/M services, and how often we
are paying at the physician rate for services provided in part by NPPs.
(Please see the documentation section below for additional
information). The proposed modifier, if finalized, would give CMS
insight, directly through our claims data instead of only through
medical record review, into the specific circumstances under which
these split (or shared) visits are furnished. Such information would be
helpful to CMS for program integrity purposes, and could be instructive
in considering whether we may need to offer additional clarification to
the public, or further revise the policy for these E/M visits in future
rulemaking.
We are proposing to revise our regulation at Sec. 415.140 to
reflect the conditions of payment for split (or shared) visits as
discussed in this section.
Consistent with our current policy, Medicare does not pay for
partial E/M visits for which all elements of the service are not
furnished. Therefore, we are proposing that the modifier identified by
CPT for purposes of reporting partial services (modifier -52 (reduced
services)) could not be used to report partial E/M visits, including
any partial services furnished as split (or shared) visits. We are also
considering whether it is necessary to amend our regulations to
explicitly state that Medicare does not pay for partial E/M visits and
are interested in public comments on this issue.
2. Critical Care Services (CPT Codes 99291-99292)
As stated previously, in light of updates that we previously
finalized for coding and payment for office/outpatient E/M visits, we
are proposing a number of refinements to other E/M code sets.
Historically, our policy for billing critical care services was
reflected in several provisions of the Medicare Claims Processing
Manual (sections 30.6.1(B), 30.6.12, and 30.6.13(H)) which were
withdrawn effective May 9, 2021, in response to a petition under the
Department's Good Guidance regulation at 45 CFR 1.5 (see Transmittal
10742 available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Transmittals/r10742cp). In the
absence of these manual provisions, the Medicare statute and various
broadly applicable regulations continue to apply. In addition to
withdrawing the manual provisions, we issued our response to the
petition and accompanying enforcement instruction issued on May 26,
2021, available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Evaluation-and-Management-Visits. In those documents, we indicated that we intend to
address split (or shared) visits (addressed above) and critical care
services (addressed below) through rulemaking; and that until we do, we
will limit review to the applicable statutory and regulatory
requirements for purposes of assessing payment compliance. The list of
applicable statutory and regulatory requirements includes the CY 2021
PFS final rule (85 FR 84549), where CMS generally adopted new CPT
prefatory language and code descriptors for office/outpatient E/M
visits. Therefore, in this section of the proposed rule, we are
proposing to update our critical care E/M visit policies to improve
transparency and clarity, and to account for recent revisions to E/M
visit coding and payment.
The CPT 2021[supreg] Professional Codebook (hereafter, CPT
Codebook) provides guidelines for critical care services in the CPT E/M
Guidelines on pp. 5-9 and in prefatory language, code descriptors, and
parentheticals on pp. 31-33. We are proposing to adopt the CPT
prefatory language for critical care services as currently described in
the CPT Codebook, except as otherwise specified in this section of the
proposed rule. Should CPT make changes to the guidance for critical
care services in a
[[Page 39208]]
subsequent edition of the CPT Codebook, we could revisit these policies
in future rulemaking.
We are also proposing to clarify our definition of critical care
visits, and the requirements governing how critical care visits are
reported when more than one practitioner or specialty is involved in
furnishing critical care services to a patient. Further, we are
proposing to prohibit a practitioner that reports critical care
services furnished to a patient from also reporting any other E/M visit
for that same patient on the same calendar day that the critical care
services are furnished to that patient, and vice versa. Additionally,
we are proposing to prohibit practitioners from reporting critical care
visits during the same time-period as a procedure with a global
surgical period.
a. Definition of Critical Care
Critical care visits are described by CPT codes 99291 (Critical
care, evaluation and management of the critically ill or critically
injured patient; first 30-74 minutes) and 99292 (each additional 30
minutes (List separately in addition to code for primary service). As
stated above, the CPT Codebook defines critical care services in
prefatory language on pp. 31-33.
Critical care services were defined in the withdrawn provisions of
the Medicare Claims Processing Manual, and that definition tracked
closely with the CPT prefatory language regarding critical care
services. To improve transparency and clarity, we are proposing to
adopt the CPT prefatory language as the definition of critical care
services. The CPT prefatory language states that critical care is the
direct delivery by a physician(s) or other qualified healthcare
professional (QHP) of medical care for a critically ill/injured patient
in which there is acute impairment of one or more vital organ systems,
such that there is a probability of imminent or life-threatening
deterioration of the patient's condition.\28\ It involves high
complexity decision-making to treat single or multiple vital organ
system failure and/or to prevent further life-threatening deterioration
of the patient's condition. We continue to believe that the CPT
Codebook appropriately delineates coding and definitions for critical
care services in order to distinguish them as more intense services
that are valued relatively higher than other E/M services. Thus, we are
proposing to adopt the CPT prefatory language as the definition of
critical care services, and refer readers to the CPT Codebook for
additional details.
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\28\ 2021 CPT Codebook, p. 31.
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Under current Medicare policy, a QHP is an individual who is
qualified by education, training, licensure/regulation (when
applicable), facility privileging (when applicable), and the applicable
Medicare benefit category to perform a professional service within
their scope of practice and independently report that service (see, for
example, 80 FR 70957; 85 FR 84543, 84593). Because the CPT Codebook
provides that critical care services can be delivered by a physician or
QHP, we are proposing that critical care services may be reported by a
physician or NPP who is a QHP as explained above.
The CPT prefatory language specifies that critical care may be
furnished on multiple days, and is typically furnished in a critical
care area, which can include an intensive care unit or emergency care
facility. CPT prefatory language also states that critical care
requires the full attention of the physician or NPP, and therefore, for
any given time-period spent providing critical care services, the
practitioner cannot provide services to any other patient during the
same period of time. We are proposing to adopt this CPT prefatory
language to improve transparency and clarity of our policy for this
service for Medicare billing purposes.
CPT prefatory language and billing and coding guidance bundles
several services into critical care visits furnished by a given
practitioner when performed during the critical period by the
practitioners providing critical care. We are proposing to adopt CPT's
listing of bundled services that are part of critical care visits to
improve transparency and clarity of our policy for this service.
Therefore, we are proposing that the following services would be
bundled into critical care visits: Interpretation of cardiac output
measurements (93561, 93562), chest X rays (71045, 71046), pulse
oximetry (94760, 94761, 94762), blood gases, and collection and
interpretation of physiologic data (for example, ECGs, blood pressures,
hematologic data); gastric intubation (43752, 43753); temporary
transcutaneous pacing (92953); ventilator management (94002-94004,
94660, 94662); and vascular access procedures. As a result, these codes
would not be separately billable by a practitioner during the time-
period when the practitioner is providing critical care for a given
patient. We are also proposing to adopt the CPT prefatory language
stating that time spent performing separately reportable procedures or
services should be reported separately and should not be included in
the time reported as critical care time.
b. Critical Care by a Single Physician or NPP
Our withdrawn manual provisions and the prefatory language in the
CPT Codebook cited above both describe the time duration for the
correct reporting of critical care services by a single physician or
NPP. To improve transparency and clarity of our policy for this
service, we are proposing to adopt the CPT prefatory language. Under
our proposal, the physician or NPP would report CPT code 99291 for the
first 30-74 minutes of critical care services provided to a patient on
a given date. Thereafter, they would report CPT code 99292 for
additional 30-minute time increments provided to the same patient. We
refer readers to the CPT Codebook for examples of the total duration of
critical care visits.\29\ The prefatory language states that CPT codes
99291 and 99292 are used to report the total duration of time spent by
the physician or QHP providing critical care services to a critically
ill or critically injured patient, even if the time spent by the
practitioner on that date is not continuous; and that non-continuous
time for medically necessary critical care services may be aggregated.
The CPT Codebook indicates that CPT code 99291 is used to report the
first 30-74 minutes of critical care on a given date, and that the code
should be used only once per date even if the time spent by the
practitioner is not continuous on that date. We are proposing to adopt
this rule for critical care services furnished by a single physician or
NPP. We note that the prefatory language does not indicate how
practitioners should report critical care when a service lasts beyond
midnight. We are seeking comment about how practitioners should report
CPT codes 99291 and 99292 when a service extends beyond midnight to the
following calendar day.
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\29\ CPT Codebook, p. 32.
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c. Critical Care Services Furnished Concurrently by Different
Specialties
The CPT Codebook does not provide any special instructions
regarding how to report critical care furnished by more than one
physician or practitioner, whether in a split (or shared) visit context
or other contexts that might be relevant given the unique nature of
critical care and the long timeframes over which patients may receive
these services. The CPT E/M Guidelines state broadly that concurrent
care is the provision of similar services (for
[[Page 39209]]
example, hospital visits) to the same patient by more than one
physician or other QHP on the same day. The CPT E/M Guidelines state
that when concurrent care is provided, no special reporting is
required.\30\ The CPT E/M Guidelines also state broadly that when time
is being used to select the appropriate level of services for which
time-based reporting of split (or shared) visits is allowed, the time
personally spent by the physician and other QHP(s) assessing and
managing the patient on the date of the encounter is summed to define
total time; and that only distinct time should be summed for split (or
shared) visits (that is, when two or more individuals jointly meet with
or discuss the patient, only the time of one individual should be
counted).\31\
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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
overlap. Consistent with our current policy, and to improve
transparency and clarity of our policy for critical care services, we
are proposing that concurrent care occurs where more than one physician
or qualified NPP furnishes services to the same patient on the same
day. In general, concurrent care is covered when the services of each
practitioner are medically necessary, and not duplicative. For example,
concurrent care may be medically necessary because of the existence of
more than one medical condition requiring diverse specialized medical
services, that is, more than one specialty (which can include a
qualified NPP as a specialty). In the context of critical care
services, a critically ill patient may have more than one medical
condition requiring diverse specialized medical services and thus
requiring more than one practitioner having different specialties to
play an active role in the patient's treatment. Thus, we are proposing
that critical care services may be furnished as concurrent care (or
concurrently) to the same patient on the same day by more than one
practitioner in more than one specialty (for example, an internist and
a surgeon, allergist and a cardiologist, neurosurgeon and NPP),
regardless of group affiliation, if the service meets the definition of
critical care and is not duplicative of other services. However, as for
most Medicare-covered services, these critical care services would need
to be medically reasonable and necessary for the diagnosis or treatment
of illness or injury or to improve the functioning of a malformed body
member. We are seeking comment on this proposal to better understand
current clinical practice for critical care, and when it would be
appropriate for more than one physician or NPP of the same or different
specialties, and within the same or a different group, to provide
critical care services.
d. Critical Care Furnished Concurrently by Practitioners in the Same
Specialty and Same Group (Follow-Up Care)
Physician(s) or NPP(s) in the same specialty and in the same group
may provide concurrent follow-up care, such as a critical care visit
subsequent to another practitioner's critical care visit. This may be
as part of continuous staff coverage or follow-up care to critical care
services furnished earlier in the day on the same calendar date.
According to CPT coding and billing conventions that we generally
acknowledge, a practitioner who furnishes a timed service such as
critical care would typically need to report the primary service or
procedure code before reporting an add-on code. However, we are
proposing that when critical care is furnished concurrently by two or
more practitioners in the same specialty and in the same group to the
same patient on the same day, the individual physician(s) or NPP(s)
providing the follow-up or subsequent care would report their time
using the code for subsequent time intervals (CPT code 99292), and
would not report the primary service code (CPT code 99291). CPT code
99291 would not be reported more than once for the same patient on the
same day by these practitioners. This proposal recognizes that multiple
practitioners in the same specialty and the same group can maintain
continuity of care by providing follow-up care for the same patient on
the same day, and is consistent with our current policy as described in
the withdrawn manual provisions. Because practitioners in the same
specialty and same group cover for one another to provide concurrent
critical care services, we believe the total time for critical care
services furnished to a patient on the same day by the practitioners in
the same group with the same specialty should be reflected as if it
were a single set of critical care services furnished to the patient.
The practitioner furnishing the initial critical care service would
report CPT code 99291, and the practitioner(s) reporting subsequent
critical care service time would report CPT code 99292.
Under our current policy, the initial critical care service must be
performed by a single physician or qualified NPP. In considering and
reevaluating this policy, we believe it would better reflect current
medical practice to allow critical care service time spent by more than
one practitioner in the same group with the same specialty to be added
together for the purposes of meeting the time requirement to bill for
the initial critical care service using CPT code 99291. We are
proposing this policy for two main reasons. First, we believe this
proposal would appropriately recognize that multiple practitioners in
the same specialty and group can concurrently furnish critical care
services to a patient on a single day. Second, this proposal would
conform our policy for the initial critical care service with our
proposal described above for multiple practitioners in the same
specialty and same group to report CPT code 99292 for their cumulative
critical care service time. Thus, we are proposing that where one
practitioner begins furnishing the initial critical care service but
does not meet the time required to report CPT code 99291, and another
practitioner in the same specialty and group continues to deliver
critical care to the same patient on the same day, the time spent by
those practitioners could be aggregated to meet the time requirement to
bill CPT code 99291. Under our proposal, once the cumulative required
critical care service time is met to report CPT code 99291, CPT code
99292 would not be reported by the practitioner or another practitioner
in the same specialty and group unless and until an additional 30
minutes of critical care services are furnished to the same patient on
the same day (114 total minutes). Finally, consistent with our current
policy, we are proposing that the aggregated time spent on critical
care visits must be medically necessary and each visit must meet the
definition of critical care in order to add the times for purposes of
meeting the time requirement to bill CPT code 99291. We are seeking
comment on this proposal to better understand current clinical practice
for critical care, and when it would be appropriate for more than one
physician or NPP of the same or different specialties, and within the
same or a different group, to provide
[[Page 39210]]
critical care services to a patient on a single day.
e. Split (or Shared) Critical Care Services
Under current CMS policy, critical care services cannot be billed
as split (or shared) E/M services. As previously discussed in section
II.F.1. of this proposed rule for split (or shared) visits, we believe
the practice of medicine has evolved toward a more team-based approach
to care, and greater integration in the practice of physicians and
NPPs, particularly when care is furnished by clinicians in the same
group in the facility setting. Given this evolution in medical
practice, the concerns that may have been present when we issued
current policy may no longer be as relevant. We understand that there
have been changes in the practice of medicine over the past several
years, some facilitated by the advent of EHRs and other systems, toward
a more team-based approach to care. There has also been an increase in
alternative payment models that employ a more team-based approach to
care. In considering and reevaluating this policy, we believe it would
be appropriate to revise our policy to allow critical care services to
be reported when furnished as split (or shared) services. Therefore, we
are proposing that critical care visits may be furnished as split (or
shared) visits. The proposals described in section II.F.1. of this
proposed rule for split (or shared) visits would apply (with one
exception discussed below), and service time would be counted for CPT
code 99292 in the same way as for prolonged E/M services. In other
words, we are proposing that the total critical care service time
provided by a physician and NPP in the same group on a given calendar
date to a patient would be summed, and the practitioner who furnishes
the substantive portion of the cumulative critical care time would
report the critical care service(s).
In section II.F.1. of this proposed rule, drawing on the CPT E/M
Guidelines, we proposed a list of activities that could count toward
total time for purposes of determining the substantive portion. We
stated that since critical care services can include additional
activities that are bundled into the critical care visits code(s), we
are proposing a different listing of qualifying activities for split
(or shared) critical care. These qualifying activities are described in
prefatory language on pp. 31-32 of the CPT Codebook. Thus, when
critical care services are furnished as a split (or shared) visit, we
are proposing to define the substantive portion as more than half the
cumulative total time in qualifying activities that are included in CPT
codes 99291 and 99292. Additionally, the billing practitioner would
first report CPT code 99291 and, if 75 or more cumulative total minutes
were spent providing critical care, one or more units of CPT code
99292. We would require practitioners to include the proposed split (or
shared) visit modifier on the claim, and we are proposing that the
documentation and other rules proposed in section II.F.1. of this
proposed rule for split (or shared) visits would apply to split
critical care services. We note that, in contrast to our proposals
regarding concurrent critical care services above, we are proposing
that when a critical care service is furnished as a split (or shared)
visit, when two or more practitioners spend time jointly meeting with
or discussing the patient, the time may be counted only once for
purposes of reporting the split (or shared) critical care visit. This
proposed policy accords with our proposed policy for all split (or
shared) visits. It also accords with the CPT E/M Guidelines stating
that, for split (or shared) visits, when two or more individuals
jointly meet with or discuss the patient, only the time of one
individual should be counted).\32\
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\32\ 2021 CPT Codebook (Evaluation and Management (E/M) Services
Guidelines), p.7.
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We are seeking comment on these proposals to ensure they reflect a
clinically appropriate approach, and intend to assess whether we should
instead require that an individual physician or NPP directly perform
the entirety of each critical care visit. We are seeking comment on
this proposal to better understand current clinical practice for
critical care, and when it would be appropriate for more than one
physician or NPP of the same or different specialties, and within the
same or a different group, to provide critical care to a patient.
f. Critical Care Visits and Same-Day Emergency Department, Inpatient or
Office/Outpatient Visits
The CPT Codebook states that critical care and other E/M services
may be provided to the same patient on the same date by the same
individual. However, our general policy as described in the Medicare
Claims Processing Manual states that physicians in the same group who
are in the same specialty must bill and be paid for services under the
PFS as though they were a single physician. If more than one E/M visit
is provided on the same day to the same patient by the same physician,
or by more than one physician in the same specialty in the same group,
only one E/M service may be reported unless the E/M services are for
unrelated problems. Instead of billing separately, the physicians
should select a level of service representative of the combined visits
and submit the appropriate code for that level.\33\ This policy is
intended to ensure that multiple E/M visits for a patient on a single
day are medically necessary and not duplicative. With respect to
office/outpatient E/M visits specifically, our current manual
instructs, ``As for all other E/M services except where specifically
noted, the Medicare Administrative Contractors (MACs) may not pay two
E/M office visits billed by a physician (or physician of the same
specialty from the same group) for the same beneficiary on the same day
unless the physician documents that the visits were for unrelated
problems in the office, off campus-outpatient hospital, or on campus-
outpatient hospital setting which could not be provided during the same
encounter.'' \34\ With respect to hospital visits, hospital ED visits,
and critical care services furnished on the same day, the Medicare
Claims Processing Manual states, ``When a hospital inpatient or office/
outpatient E/M service are furnished on a calendar date at which time
the patient does not require critical care and the patient subsequently
requires critical care both the critical care services (CPT codes 99291
and 99292) and the previous E/M service may be paid on the same date of
service. Hospital ED services are not paid for the same date as
critical care services when provided by the same physician to the same
patient.'' \35\
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\33\ Medicare Claims Processing Manual (Pub. 100-02), Chapter
12, Section 30.6.5, Physicians In Group Practice.
\34\ Pub. 100-04, Medicare Claims Processing Manual, Chapter 12,
Section 30.6.7.B., available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf.
\35\ Pub. 100-04, Medicare Claims Processing Manual, Chapter 12,
Section 30.6.9.B., available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf.
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We are concerned that adopting the CPT rule that critical care and
other E/M visits may be furnished to the same patient on the same date
by the same practitioner could have unintended consequences for the
Medicare program. We have previously expressed concerns that multiple
E/M visits by the same practitioner, or by practitioners in the same
specialty within a group, on the same day as another E/M service
ordinarily would not be medically necessary (83 FR 59639). It is
possible that adopting the CPT rule allowing billing for critical care
and other E/M
[[Page 39211]]
visits on the same day, by practitioners in the same group and of the
same specialty, could lead to duplicative payment, particularly given
the frequently long duration of critical care services, the CPT
prefatory language indicating that time spent furnishing critical care
may be non-continuous, and the relatively higher valuation of critical
care services compared to other E/M services. Thus, we are proposing
that no other E/M visit can be billed for the same patient on the same
date as a critical care service when the services are furnished by the
same practitioner, or by practitioners in the same specialty in the
same group.
There are possible alternative approaches to address our concerns
about medical necessity and duplicative payment for E/M services
furnished to a patient on the same day by the same practitioner or a
practitioner in the same group. We have previously considered a
Multiple Procedure Payment Reduction (MPPR) for standalone office/
outpatient E/M visits that occur on the same day as a procedure to
address efficiencies (for example, in preservice and postservice
clinician work and PE) that are not accounted for in the current
payment rates (83 FR 59639). These visits could be identified on the
claim with modifier -25 (significant, separately identifiable E/M
service by the same physician on the same day of the procedure or other
service) and CMS could assign a reduced payment rate to one of the
visits. CMS could also use documentation requirements to support the
medical necessity and non-duplicative nature of a claim for critical
care services on the same calendar date as another E/M visit provided
to a patient by the same practitioner or practitioner of the same
specialty in a group. We also recognize that our proposal not to allow
an E/M visit to be billed for the same patient on the same date as a
critical care service when the services are furnished by the same
practitioner, or by practitioners in the same specialty within a group,
may be appropriate only in certain clinical situations. For example, it
may be possible that a patient would not require critical care services
at the time of an ED visit, but then be admitted to the hospital on the
same calendar date as the ED visit and require care that meets the
definition of critical care services. It may also be possible that the
practitioner who furnished the ED visit later provided critical care
services to the same patient on the same calendar date. Thus, we are
seeking comment on this proposal to better understand clinical practice
for critical care, whether and how CMS could pay for E/M services
furnished on the same date as critical care services when provided by
the same practitioner, or practitioners in the same specialty within a
group, while also reducing the potential for duplicative payment.
g. Critical Care Visits and Global Surgery
Critical care services may be needed on the on the same calendar
date as a procedure code with a global surgical period. In many cases,
preoperative and postoperative critical care visits are included in
procedure codes that have a global surgical period. In the CY 2015 PFS
final rule, we discussed the challenges of accurately accounting for
the number of visits included in the valuation of 10- and 90-day global
packages (79 FR 67548, 67582). The 10- and 90-day global packages can
include critical care visits. We finalized a policy to change all
global periods to 0-day global periods, and to allow separate payment
for post-operative E/M visits. Our concerns were based on a number of
key points including: The lack of sufficient data on the number of
visits typically furnished during the global periods, questions about
whether we will be able to adjust values on a regular basis to reflect
changes in the practice of medicine and health care delivery, and
concerns about how our global payment policies could affect the
services that are actually furnished. Section 1848(c)(8)(B) of the Act,
which was added by section 523(a) of the Medicare Access and CHIP
Reauthorization Act (MACRA), required us to collect data to value
surgical services. Because critical care visits are included in some
10- and 90-day global packages, we are proposing to bundle critical
care visits with procedure codes that have a global surgical period. We
note that this proposal contrasts with the current policy as described
in the Medicare Claims Processing Manual which states that critical
care visits are unbundled from procedures with a global surgical period
as long as the critical care service was unrelated to the
procedure.\36\ As we have made clear in previous rulemaking, we are
continuing to assess values for global surgery procedures (84 FR 2452),
including in particular the number and level of preoperative and
postoperative visits, which can include critical care services. Because
this work is still ongoing, we are proposing to bundle critical care
visits with procedure codes that have a global surgical period.
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\36\ Pub. 100-04, Medicare Claims Processing Manual, Chapter 12,
Section 40.2.9, available on the CMS website.
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h. Documentation Requirements
Because critical care is a time-based service, we are proposing to
require practitioners to document in the medical record the total time
that critical care services were provided by each reporting
practitioner (not necessarily start and stop times). The documentation
would also need to indicate that the services furnished to the patient,
including any concurrent care by the practitioners, were medically
reasonable and necessary for the diagnosis or treatment of illness or
injury or to improve the functioning of a malformed body member. To
support coverage and payment determinations regarding concurrent care,
services would need to be sufficiently documented to allow a medical
reviewer to determine the role each practitioner played in the
patient's care (that is, the condition or conditions for which the
practitioner treated the patient). To support coverage and payment
determinations regarding split (or shared) critical care services, the
documentation requirements proposed above for all split (or shared) E/M
visits would also apply to critical care visits (see section II.F. of
this proposed rule).
3. Payment for the Services of Teaching Physicians
As part of the CPT office/outpatient E/M visit coding framework
that we finalized beginning for CY 2021 (85 FR 84548 through 84574),
practitioners can select the office/outpatient E/M visit level to bill,
based either on the total time personally spent by the reporting
practitioner or MDM. Stakeholders have asked us how teaching physicians
who involve residents in furnishing care should consider time spent by
the resident in selecting the office/outpatient E/M visit level.
For teaching physicians, section 1842(b) of the Act specifies that
in the case of physicians' services furnished to a patient in a
hospital with a teaching program, the Secretary shall not provide
payment for such services unless the physician renders sufficient
personal and identifiable physicians' services to the patient to
exercise full, personal control over the management of the portion of
the case for which payment is sought.
Regulations regarding PFS payment for teaching physician services
are codified in 42 CFR part 415. In general, under Sec. 415.170,
payment is made under the PFS for services furnished in a teaching
hospital setting if the services are personally furnished by a
physician
[[Page 39212]]
who is not a resident, or the services are furnished by a resident in
the presence of a teaching physician, with exceptions as specified in
subsequent regulatory provisions in part 415. Medicare separately pays
for the time spent by the resident through direct graduate medical
education (GME) under Medicare Part A.
a. General Policy for Evaluation and Management Visits
Under our regulation at Sec. 415.172 and absent a public health
emergency (PHE), if a resident participates in a service furnished in a
teaching setting, a teaching physician can bill for the service only if
they are present for the key or critical portion of the service. For
residency training sites that are located outside a metropolitan
statistical area, PFS payment may also be made if a teaching physician
is present through audio/video real-time communications technology
(that is, ``virtual presence''). In the case of E/M services, the
teaching physician must be present during the portion of the service
that determines the level of service billed.
We are proposing that when total time is used to determine the
office/outpatient E/M visit level, only the time that the teaching
physician was present can be included. We believe it is appropriate to
include only the time of the teaching physician because the Medicare
program makes separate payment for the program's share of the
resident's graduate medical training program, which includes time spent
by a resident furnishing services with a teaching physician, under
Medicare Part A. During the PHE, the time of the teaching physician
when they are present through audio/video real-time communications
technology may also be included in the total time considered for visit
level selection. We note that, outside the circumstances of the COVID-
19 PHE, the teaching physician presence requirement can be met
virtually, through audio/video real-time communications technology,
only in residency training sites that are located outside of a
metropolitan statistical area.
This proposal is consistent with our previously finalized policy
that practitioners can use total time personally spent by the reporting
practitioner to select office/outpatient E/M visit level. It is also
consistent with our regulation at Sec. 415.172 that states that PFS
payment is made when a teaching physician involves a resident in
providing care only if the teaching physician is present for the key or
critical portions of the service, including the portion that is used to
select the visit level.
b. Primary Care Exception Policy
The regulation at Sec. [thinsp]415.174 sets forth an exception to
the conditions for PFS payment for services furnished in teaching
settings in the case of certain E/M services furnished in certain
primary care centers. Under the so-called ``primary care exception,''
Medicare makes PFS payment in certain teaching hospital primary care
centers for certain services of lower and mid-level complexity
furnished by a resident without the physical presence of a teaching
physician. We expanded the list of services that residents could
furnish without the physical presence of the teaching physician for the
duration of the PHE to include all levels of an office/outpatient E/M
visit, among other services. Upon the conclusion of the PHE, levels 4-5
office/outpatient E/M visits will no longer be included in the primary
care exception (85 FR 84585 through 84590).
Section 415.174(a)(3) requires that the teaching physician must not
direct the care of more than four residents at a time, and must direct
the care from such proximity as to constitute immediate availability
(that is, provide direct supervision), and must review with each
resident during or immediately after each visit, the beneficiary's
medical history, physical examination, diagnosis, and record of tests
and therapies. Section 415.174(a)(3) also requires that the teaching
physician must have no other responsibilities at the time, assume
management responsibility for the beneficiaries seen by the residents,
and ensure that the services furnished are appropriate.
We are proposing that under the primary care exception, only MDM
can be used to select office/outpatient E/M visit level. The intent of
the primary care exception as described in Sec. [thinsp]415.174 is
that E/M visits of lower and mid-level complexity furnished by
residents are simple enough to permit a teaching physician to be able
to direct and manage the care of up to four residents at any given time
and direct the care from such proximity as to constitute immediate
availability. In the context of teaching hospital primary care centers
that are staffed by residents and teaching physicians, we believe that
MDM would be a more accurate indicator of the complexity of the visit
as opposed to time. Because residents are in training, they may need
more time than is reflected in the code descriptor to furnish a visit
that has a low-level of medical decision making. For example, CPT code
99213 (Office or other outpatient visit for the evaluation and
management of an established patient, which requires a medically
appropriate history and/or examination and low level of medical
decision making. When using time for code selection, 20-29 minutes of
total time is spent on the date of the encounter) involves a low level
of MDM and between 20-29 minutes of total time. If time was used for
level selection instead of MDM, it is possible that residents may need
more than 20-29 minutes of time, including any conferring with the
teaching physician, to furnish CPT code 99213. Thus, residents may be
less efficient relative to a teaching physician in furnishing care.
Office/outpatient E/M visits requiring 30 or more minutes of total
time are described by visit levels 4-5. After the expiration of the
COVID-19 PHE, office/outpatient levels 4-5 will no longer be included
in the primary care exception. In the CY 2021 PFS final rule, we
expressed concern that the teaching physician may not be able to
maintain sufficient personal involvement in all of the care to warrant
PFS payment for the services being furnished by up to four residents
when some or all of the residents might be furnishing services that are
more than lower and mid-level complexity. We noted that when the
teaching physician is directing the care of a patient that requires
moderate or higher medical decision-making, the ability to be
immediately available to other residents could be compromised,
potentially putting patients at risk (85 FR 84586). Thus, to guard
against the possibility of residents furnishing visits that are of more
than lower and mid-level complexity, we are proposing that only MDM may
be used for office/outpatient E/M visit level selection for services
furnished by residents under the primary care exception.
We acknowledge that under the new CPT office/outpatient E/M visit
coding framework, it is possible that time is an accurate indicator of
the complexity of the visit. Thus, we are seeking comment on this
proposal, including our assumption that MDM is a more accurate
indicator of the appropriate level of the visit relative to time in the
context of the primary care exception for services furnished by
residents and billed by teaching physicians in primary care centers. We
are also seeking comment on whether time is an accurate indicator of
the complexity of the visit and how teaching physicians might select
office/outpatient E/M visit level using time when directing the care of
a patient that is being furnished by a resident in the context of the
primary care exception.
[[Page 39213]]
G. Billing for Physician Assistant (PA) Services
Under the respective Medicare statutory benefit categories for
services of Physician assistants (PAs), nurse practitioners (NPs), and
clinical nurse specialists (CNSs), these practitioners are authorized
to furnish services that would be physicians' services if they were
furnished by a physician, and which they are legally authorized to
perform by the state in which the services are furnished; and such
services that are furnished incident to the practitioners' professional
services (but only if no facility or other provider charges or is paid
any amount for the services). Additionally, the payment amount for the
services of PAs, NPs, and CNSs, as specified under section
1833(a)(1)(O) of the Act, is equal to 80 percent of the lesser of the
practitioner's actual charge or 85 percent of the amount that would be
paid to a physician under the PFS. However, while NPs and CNSs are
authorized to bill the Medicare program and be paid directly for their
professional services, section 1842(b)(6)(C)(i) of the Act has required
since the inception of the PA benefit (with a narrow exception not
relevant here) that payment for PA services must be made to the PA's
employer. Accordingly, our regulation at Sec. 410.74(a)(2)(v)
specifies that PA services are covered under Medicare Part B only when
billed by the PA's employer. Our regulation that addresses to whom
Medicare Part B payment is made, at Sec. 410.150(b)(15), further
provides that payment is made to the qualified employer of a PA, and
specifies that the PA could furnish services under a W-2 employment
relationship, an employer-employee relationship, or as an independent
contractor through a 1099 employment relationship. The regulation also
specifies that a group of PAs that incorporate to bill for their
services is not a qualified employer. Given the statutory requirement
that we make payment to the PA's employer, PAs are precluded from
directly billing the Medicare program and receiving payment for their
services, and do not have the ability to reassign Medicare payment
rights for their services to any employer, facility, or billing agent.
Section 403 of the Consolidated Appropriations Act, 2021 (CAA)
(Pub. L. 116-260, December 27, 2020), amends section 1842(b)(6)(C)(i)
of the Act to remove the requirement to make payment for PA services
only to the employer of a PA effective January 1, 2022. With the
removal of this requirement, PAs will be authorized to bill the
Medicare program and be paid directly for their services in the same
way that NPs and CNSs do. Effective with this amendment, PAs also may
reassign their rights to payment for their services, and may choose to
incorporate as a group comprised solely of practitioners in their
specialty and bill the Medicare program, in the same way that NPs and
CNSs may do. We note that the amendment made by section 403 of the CAA
changed only the statutory billing construct for PA services. It
neither changed the statutory benefit category for PA services,
including the requirement that PA services are performed under
physician supervision, at section 1861(s)(2)(K)(i) of the Act, nor did
it change the statutory payment percentage applicable to PA services
specified in section 1833(a)(1)(O) of the Act.
We are proposing to amend pertinent sections of our regulations to
reflect the amendment made by section 403 of the CAA. Specifically, we
are proposing to amend Sec. 410.74(a)(2)(v) to specify that the
current requirement that PA services must be billed by the PA's
employer in order to be covered under Medicare Part B is effective only
until January 1, 2022. We are also proposing to amend Sec. 410.150(b)
to redesignate the current requirements in paragraph (b)(15) as Sec.
410.150(b)(15)(i), and to amend that paragraph to provide that Medicare
payment is made for PA services to the qualified employer of the PA for
services furnished prior to January 1, 2022. In Sec. 410.150, we
further propose to add a new paragraph (b)(15)(ii) to state that,
effective for services furnished on or after January 1, 2022, payment
is made to a PA for their professional services, including services and
supplies furnished incident to their services. We would conform this
new paragraph with the regulation at Sec. 410.150(b)(16) regarding to
whom payment is made for NP or CNS services. As such, the proposed new
paragraph at Sec. 410.150(b)(15)(ii) would provide that payment will
be made to a PA for professional services furnished by a PA in all
settings in both rural and non-rural areas; and that payment is made
only if no facility or other provider charges or is paid any amount for
services furnished by a PA. We also intend to update our program manual
instructions to reflect the statutory change made by section 403 of the
CAA and the changes to our regulations.
H. Therapy Services
We are implementing the third and final part of the amendments made
by section 53107 of the Bipartisan Budget Act (BBA of 2018) (Pub. L.
115-123, February 9, 2018). The BBA of 2018 added a new section 1834(v)
of the Act. Section 1834(v)(1) of the Act requires CMS to make a
reduced payment for physical therapy and occupational therapy services
furnished in whole or in part by physical therapist assistants (PTAs)
and occupational therapy assistants (OTAs) at 85 percent of the
otherwise applicable Part B payment for the service, effective January
1, 2022.
Section 1834(v)(2) of the Act requires that: (1) By January 1,
2019, CMS must establish a modifier to indicate that a therapy service
was furnished in whole or in part by a PTA or OTA; and, (2) beginning
January 1, 2020, each claim for a therapy service furnished in whole or
in part by a PTA or an OTA must include the modifier. Section
1834(v)(3) of the Act requires CMS to implement these amendments
through notice and comment rulemaking.
In the CY 2019 PFS final rule (83 FR 59654 through 59660), we
established the CQ and CO modifiers that were required to be used by
the billing practitioner or therapy provider to identify therapy
services provided in whole or in part by PTAs and OTAs, respectively,
beginning January 1, 2020. We require these payment modifiers to be
appended on claims for therapy services, alongside the GP and GO
therapy modifiers which are used to indicate the services are furnished
under a physical therapy or occupational therapy plan of care,
respectively. The payment modifiers are defined as follows:
CQ modifier: Physical therapy services furnished in whole
or in part by PTAs.
CO modifier: Occupational therapy services furnished in
whole or in part by OTAs. In the CY 2019 PFS final rule (83 FR 59654
through 59660), we did not finalize our proposed definition of
``furnished in whole or in part by a PTA or OTA'' as a service for
which any minute of a therapeutic service is furnished by a PTA or OTA.
Instead, in response to public comments, we finalized a de minimis
standard under which a service is considered to be furnished in whole
or in part by a PTA or OTA when more than 10 percent of the service is
furnished by the PTA or OTA.
In the CY 2019 PFS proposed and final rules (83 FR 35850 through
35852, and 83 FR 59654 through 59660, respectively), we explained that
the CQ and CO modifiers would not apply to claims for outpatient
therapy services that are furnished by, or incident to, the services
of, physicians or NPPs including NPs, PAs, and CNSs. This is because
our outpatient physical and
[[Page 39214]]
occupational therapy services regulations require that the individual
who performs outpatient therapy services incident to the services of a
physician or NPP must meet the qualifications and standards for a
therapist (other than state licensure). As such, only therapists, and
not therapy assistants, can perform outpatient therapy services
incident to the services of a physician or NPP (83 FR 59655 through
59656); and the modifiers to describe services furnished in whole or in
part by a PTA or OTA are not applicable to the claim for a therapy
service billed by a physician or NPP incident to their professional
services. We indicated that we would add this distinction in the
provision of the Medicare Benefit Policy Manual (MBPM) Chapter 15 that
discusses therapy services furnished incident to the physician's or
NPP's services at section 230.5, as well as the sections that discuss
PTA and OTA services at sections 230.1 and 230.2, respectively.
In the CY 2020 PFS proposed and final rules (84 FR 40558 through
40564 and 62702 through 62708, respectively), we explained that the CQ/
CO modifiers and the de minimis policy would apply to both untimed and
timed codes. The untimed codes are evaluation and reevaluation codes,
group therapy and supervised modalities, and when these are billed,
only one unit is reflected in the ``units'' portion of the claim. When
the PTA/OTA provides more than 10 percent of the service, the code is
billed with a CQ/CO modifier. For timed codes, that is, those codes
defined in 15-minute increments, the services are typically performed
in multiple units of the same and/or different codes for a patient on
one treatment day. We explained that under our policy, the therapist or
therapy assistant needs to find the total time of all these 15-minute
timed codes in order to determine the number of units that can be
billed for that day. For example, if the PT/OT and/or the PTA/OTA, as
appropriate, furnished between 8 minutes through 22 minutes, one unit
can be billed; if 23 minutes through 37 minutes are provided, 2 units
can be billed; if 38 minutes through 52 minutes are furnished, 3 units
can be billed. Once the total number of units to bill is determined,
the qualified professional (therapist or assistant) then needs to
decide whether the CQ/CO modifier is applicable.
In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we
proposed that the time the PTA/OTA spent together with the PT/OT in
performing a service, as well as the time the PTA/OTA spent independent
of the PT/OT treating the patient, is considered time for which the
service is furnished in whole or in part by the PTA/OTA. As explained
in the CY 2020 PFS final rule (84 FR 62702 through 62708), many
commenters objected to our proposal to include as time that the therapy
service is furnished ``in whole or in part'' by the PTA/OTA both the
minutes spent by the PTA/OTA concurrently with and separately from the
therapist. These commenters also expressed concerns that this policy
would unfairly discount services that are fully furnished by
therapists, and in which the therapy assistant supports them while they
provide a service. We were persuaded by commenters to finalize a policy
to not include as minutes furnished in whole or in part by a PTA/OTA
the minutes in which the PTA/OTA worked concurrently with the PT/OT. We
agreed with the commenters that when a therapy assistant and therapist
furnish care to a patient at the same time, the patient requires both
professionals, and this reflects a clinical scenario where the
assistant is helping the therapist to provide a highly skilled
procedure or one in which both professionals are needed for safety
reasons. We modified our proposed regulation text at Sec. Sec. 410.59
(outpatient occupational therapy), 410.60 (physical therapy), and
410.105 (for PT and OT CORF services) accordingly.
For purposes of deciding whether the 10 percent de minimis standard
is exceeded, we offered two different ways to compute this.
The simple method: Divide the total of the PTA/OTA + PT/OT
minutes by 10, round to the nearest integer then add 1 minute to get
the number of minutes needed to exceed the de minimis standard at and
above which the CQ/CO modifier applies.
The percentage method: Divide the PTA/OTA minutes by the
sum of the PTA/OTA and therapist minutes and then multiply this number
by 100 to calculate the percentage of the service that involves the
PTA/OTA, if this number is greater than 10 percent the CQ/CO modifier
applies.
Hypothetical examples of each of these methods are included later
in this section. In response to our proposal that all the units of one
service needed to be considered when determining if the de minimis is
applied, commenters requested that we consider each 15-minute unit
instead--noting that they would be able to apply the CQ/CO modifier on
one claim line for a service that was provided by the PTA/OTA and
report another claim line without the CQ/CO for the service provided by
the PT/OT. We were persuaded by stakeholders, and finalized a policy
under which the de minimis standard is applied for each 15-minute unit
of a service. This allows the separate reporting, on two different
claim lines, of the number of 15-minute units of a code to which the
therapy assistant modifiers do not apply, and the number of 15-minute
units of a code to which the therapy assistant modifiers do apply.
However, we neglected to modify the text of our regulations to reflect
this final policy for applying the de minimis standard; therefore, we
are proposing to revise our regulation text to specify that the de
minimis rule is applied to each 15-minute unit of a service, rather
than to all the units of a service at Sec. Sec. 410.59(a)(4)(iii)(B),
410.60(a)(4)(iii)(B), and 410.105(d)(3)(ii). The specific proposed
revisions are discussed below.
To recap, we finalized a de minimis standard to identify when the
CQ/CO modifiers apply and when they do not apply as follows:
Portions of a service furnished by the PTA/OTA independent
of the physical therapist/occupational therapist, as applicable, that
do not exceed 10 percent of the total service (or 15-minute unit of a
service) are not considered to be furnished in whole or in part by a
PTA/OTA, so are not subject to the payment reduction;
Portions of a service that exceed 10 percent of the total
service (or 15-minute unit of a service) when furnished by the PTA/OTA
independent of the therapist must be reported with the CQ/CO modifier,
alongside of the corresponding GP/GO therapy modifier; are considered
to be furnished in whole or in part by a PTA/OTA, and are subject to
the payment reduction; and
Portions of a service provided by the PTA/OTA together
with the physical therapist/occupational therapist are considered for
this purpose to be services provided by the therapist.
In the CY 2020 PFS proposed rule (84 FR 40558 through 40564), we
proposed to adopt a documentation requirement that a short phrase or
statement must be added to the daily treatment note to explain whether
the therapy assistant modifier was or was not appended for each therapy
service furnished. We also sought comment on whether it would be
appropriate to also require documentation of the minutes spent by the
therapist or therapy assistant along with the CQ/CO modifier
explanation as a means to avoid possible additional burden associated
with a contractor's medical review process conducted for these
services. Many commenters stated that: (1) The statute does not require
documentation to explain why a
[[Page 39215]]
modifier was or was not applied for each code; (2) the proposed
documentation requirements are exceedingly burdensome and conflict with
the agency's ``Patients over Paperwork Initiative''; (3) the proposed
documentation requirement that calls for a narrative phrase in the
treatment note and requires documentation of the minutes is duplicative
of current requirements that requires adding the total timed code
minutes and total treatment time (includes timed and untimed codes) to
the daily treatment note; and, (4) the Medicare Benefit Policy Manual
(MBPM) already includes extensive documentation requirements. In
response to the feedback, we did not finalize the proposed
documentation requirement; nor did we finalize a requirement that the
therapist and therapy assistant minutes be included in the
documentation. Instead, we reminded therapists and therapy providers
that correct billing requires sufficient documentation in the medical
record to support the codes and units reported on the claim, including
those reported with and without an assistant modifier. Further, in
agreement with many commenters, we clarified that we would expect the
documentation in the medical record to be sufficient to know whether a
specific service was furnished independently by a therapist or a
therapist assistant, or was furnished ``in part'' by a therapist
assistant, in sufficient detail to permit the determination of whether
the 10 percent standard was exceeded.
In the CY 2020 PFS proposed rule, we also provided multiple typical
clinical billing scenarios to illustrate when the CQ/CO modifier would
and would not be applicable. Because these clinical scenarios did not
convey our finalized policies as modified in response to public
comments, we indicated in the CY 2020 PFS final rule that we would
provide further detail regarding the clinical scenario examples to
illustrate how to use the therapy assistant modifiers through
information we would post on the cms.gov website. We clarified that our
revised finalized policy applied generally in the same way as
illustrated in those examples, except for the difference in the minutes
of time that are counted toward the 10 percent standard (not counting
the minutes furnished together by a therapist and therapy assistant),
the application of the 10 percent standard to each billed unit of a
timed code rather than to all billed units of a timed code, and the
billing on two separate claim lines of the units of a timed code to
which the therapy assistant modifiers do and do not apply.
In early March 2021, we posted on our Therapy Services website at
https://www.cms.gov/Medicare/Billing/TherapyServices general guidance
on how to assign the CQ/CO modifiers for multiple billing scenarios. In
the guidance, we provided general examples for 8 different billing
scenarios in which multiple units of 15-minute codes are provided by
PTs/OTs and PTAs/OTAs and one billing example that used the untimed
code for group therapy performed for equal minutes by a PT and a PTA.
We noted that prior to applying our rules to determine appropriate
application of the CQ/CO modifiers, the PTA/OTA or PT/OT first needs to
determine how many 15-minute units can be billed in a single treatment
day for a patient. For information on this topic, we referred readers
to the chart in section 20.2.C of Chapter 5 of the Medicare Claims
Processing Manual (MCPM) that describes how to count minutes for timed
codes defined by 15-minute units, since the therapist or assistant
should use the same counting rule, commonly known as the ``8-minute
rule,'' that they have used previously.
Once the therapist or therapy assistant has identified the number
of 15-minute units that can be billed for a patient on a single
treatment day, we provided the following information to clarify how to
apply our policy for application of the CQ and CO modifiers, as
follows:
Step 1. Identify the Timed HCPCS Codes Furnished for 15 Minutes or
More: List the code numbers of each of the services furnished along
with the number of minutes in total done by the PT, PTA, OT, or OTA.
When a PT, PTA, OT, or OTA provides at least 15 minutes and less than
30 minutes of a service on a single treatment day, assign 1 unit; when
multiples of 15 minutes are furnished, for example, 30 minutes (assign
2 units) and 45 minutes (assign 3 units), etc. This needs to be the
first step whenever it is applicable to the billing scenario. When any
of these services, that is, full 15-minute increments, are provided by
a PTA/OTA, the CQ/CO modifiers apply.
Step 2. Identify Services for Which the PT/OT and PTA/OTA Provide
Minutes of the Same HCPCS Code: After applying Step 1, where
applicable, identify any minutes (including remaining minutes from Step
1) performed by a PT/OT and PTA/OTA for the same service/code. Add the
minutes furnished by the PT/OT and the PTA/OTA together, then divide
the total by 10 and round to the nearest integer--this is the 10
percent de minimis time standard. Then add 1 minute to get the fewest
number of minutes performed by the PTA/OTA that would exceed the 10
percent time standard for that service--if the PTA/OTA minutes meet or
exceed this number, the CQ/CO modifier would be appended. This is the
``simple'' method for calculating the de minimis number of minutes.
Step 3. Identify Services Where the PT/OT and PTA/OTA Furnish
Services of Two Different Timed HCPCS Codes: After applying Step 1 for
each service, compare the remaining minutes furnished by the PT/OT for
one service with the remaining minutes furnished by the PTA/OTA for a
different service. Assign the CQ/CO modifier to the service provided by
the PTA/OTA when the time they spent is greater than the time spent by
the PT/OT performing the different service. The CQ/CO modifier does not
apply when the minutes spent delivering a service by the PT/OT are
greater than the minutes spent by the PTA/OTA delivering a different
service.
Step 4. Identify the Different HCPCS Codes Where the PT/OT and the
PTA/OTA Each Independently Furnish the Same Number of Minutes: Once
Step 1 is completed for each service (when applicable), and when the
remaining minutes for each service--one provided by the PT/OT and the
other provided by the PTA/OTA--are the same, either service may be
billed. If the service provided by the PT/OT is billed, the CQ/CO
modifier does not apply. However, if the service provided by the PTA/
OTA is billed, the CQ/CO modifier does apply.
The below two examples are taken from our guidance on the CMS
website. These are examples of when the PT and PTA provide minutes of
the same service:
Example #1
PTA--23 minutes 97110
PT--13 minutes 97110
PT--30 minutes 97140
Total = 66 minutes--qualifies for billing 4 units (53 minutes
through 67 minutes).
Billing Explanation:
First Step: Assign units to services based on those that
have at least 15 minutes or codes that were provided in multiples of 15
minutes. For 97110, assign one unit of 97110 with the CQ modifier
because the PTA furnished at least 15 minutes of 97110 (therapeutic
exercise). Then, assign two units of 97140 without the modifier,
because the PT furnished the full 30 minutes of manual therapy.
Second Step: Determine if the PTA furnished more than 10
percent of the remaining minutes of the 97110 service. To do this via
the simple method: Add
[[Page 39216]]
the PTA's 8 remaining minutes to the PT's 13 minutes for a total time
of 21 minutes. Divide the total by 10 to get 2.1 minutes and round to
the nearest integer, which is 2 minutes (the 10 percent time standard
for this service). Add 1 minute to find the threshold number of minutes
that would exceed the de minimis standard, which in this example is 3
minutes. Using the percentage method, divide the PTA's remaining 8
minutes by the total 21 minutes of the service (8 PTA + 13 PT = 21
minutes) to get 0.38, then multiply the result x 100 = 38 percent.
Final Step: Because 8 minutes meets or exceeds the 3-minute
threshold, and 38 percent is greater than 10 percent, a second unit of
97110 is billed with the CQ modifier.
Example #2
PTA--19 minutes of 97110
PT--10 minutes of 97110
Total = 29 minutes--two units of 97110 can be billed (23 minutes
through 37 minutes).
Billing Explanation:
First Step: Bill one unit of 97110 with the CQ modifier
because a full 15 minutes was provided by the PTA, with 4 minutes
remaining.
Second Step: Determine if the PTA's 4 remaining minutes
exceed the 10 percent de minimis standard. Simple method: Add together
the PTA's 4 remaining minutes and the 10 PT minutes to get the total
time of 14 minutes and divide by ten to get 1.4 minutes and round to
the nearest integer = 1 minute to get the 10 percent de minimis
standard. Then add 1 minute to get a threshold minimum of 2 minutes for
PTA time. If the PTA minutes are at or above the threshold, the CQ
modifier applies. Percentage method: Divide the PTA's 4 remaining
minutes by the total time of 14 to get 0.29 then multiply by 100 = 29
percent. If the resulting percentage is greater than 10 percent, the
PTA modifier applies.
Final Step: Bill another unit of 97110 with the CQ
modifier since 4 minutes is greater than the 2-minute threshold minimum
and 29 percent is greater than 10 percent.
After reviewing the information posted on the CMS Therapy Services
web page, therapy stakeholders reached out to CMS to express concern
that certain aspects of the billing scenarios described in the guidance
contradict their interpretation of our de minimis policy, especially as
it applies to a final unit of a multiple-unit timed service. The
therapy stakeholders suggested that the guidance we offered would lead
to confusion for the same-service billing scenarios (including examples
#1 and #2 above). We consider the unit of measure for a timed therapy
service code to be 15 minutes. In billing scenarios with multiple
units, we would consider the combined time for same or different
services in 15-minute unit increments.
The stakeholders agree that the de minimis standard is applied to
the last unit of a timed therapy service code in two separate cases.
The first case happens when the PTA/OTA and the PT/OT each furnish less
than 8 minutes for that final unit of a service. For example, if the
PTA/OTA provided 7 minutes and the PT/OT furnished 5 minutes--using the
simple method: 12 minutes divided by 10 equals 1.2, rounded to the
nearest integer is 1, plus 1 equals 2--if the PTA/OTA provides 2 or
more minutes, the CQ/CO modifier is applied. The second case occurs
when the PTA/OTA provides 8 or more minutes and the PT/OT furnishes
less than 8 minutes--in which event, the de minimis standard is
exceeded and the CQ/CO modifier is applied.
We note that the therapy stakeholders' interpretation of when the
de minimis policy applies for a final 15-minute unit of a multiple unit
timed service is based on what is commonly termed the ``8-minute rule''
which recognizes a unit of a 15-minute timed therapy service code as 8
minutes (more than the midpoint of the service or 7.5 minutes), but
only when it applies to the final unit billed. Applied to the above two
examples, the stakeholders informed us that they believe the second
unit of CPT code 97110 in both examples should not be billed with an
assistant modifier because the therapist provided enough minutes of the
service on their own, that is, 8 minutes or more, to bill for the last
unit without the assistant's additional minutes. The stakeholders
indicated that the therapist would have a financial incentive to not
have the PTA/OTA provide the additional minutes at all if the CQ or CO
modifier would apply. We note that, in addition to the two cases
discussed above, there is another billing scenario to address in the
context of our de minimis policy--specifically, where the PT/OT and
PTA/OTA each furnish between 9 and 14 minutes of a 15-minute timed
service when the total time of therapy services furnished in
combination by the PTA/OTA and PT/OT is at least 23 but no more than 28
minutes, and there are two remaining units left to be billed. These
``two remaining unit'' cases with time ranges between 9 and 14 minutes
include the following PTA/OTA:PT/OT (or vice versa) time splits: 9:14,
10:13, 11:12, 12:12, 12:13, 12:14, 13:13; 13:14; and 14:14.
We believe that the stakeholder's interpretation of the de minimis
standard is not consistent with the de minimis policy we finalized in
the CY 2020 PFS final rule (84 FR 62702 through 62708). However, in
working through the billing scenarios with the stakeholders, we
identified where we could make refinements to our policy to address
some of the confusion and concerns expressed by stakeholders and to
address the ``two remaining unit'' cases noted above. These refinements
may also avoid implementing a payment policy that could be perceived to
penalize the provision of additional care by a therapy assistant when
those minutes of service would lead to a reduced payment for a unit of
a service. The stakeholders criticized the finalized de minimis policy
because they believed it provides an inherent financial incentive for
the therapist to ensure that PTAs/OTAs provide services in exactly 15-
minute intervals--to avoid any leftover PTA/OTA minutes that could
necessitate application of the CQ/CO modifier, and reduced payment, for
the service that the therapist is also providing--without regard to the
clinical needs of the individual patient. The stakeholders suggested
that if we were to recognize their ``8-minute rule'' and recommended
policy, we would remove the incentive for the therapist to avoid
providing appropriate minutes of therapy services performed by the PTA/
OTA.
To address the concerns expressed by the stakeholders and the ``two
remaining unit'' cases we identified in our review, we propose to
modify our existing policy, specifically for billing scenarios when
only one unit of a timed therapy service remains to be billed (the
majority of all billing scenarios) and the ``two remaining unit'' cases
described above. As shown in Table 19, this proposal would require
application of the CQ/CO modifier when the PTA/OTA provides at least 8
minutes or more and the PT/OT provides less than 8 minutes of the
service; or, when both the PT/OT and the PTA/OTA provide less than 8
minutes of the same service.
[[Page 39217]]
[GRAPHIC] [TIFF OMITTED] TP23JY21.042
Under this proposed modification, the CQ/CO modifier would not
apply when the PT/OT furnishes 8 minutes or more, or both the PT/OT and
the PTA/OTA furnish 8 minutes or more, of a timed service. This
proposed ``midpoint rule'' policy was suggested to us by the therapy
stakeholders. We agree that since, in this circumstance, the PT/OT
provided enough minutes of the service on their own to bill the last
unit of the service, the additional minutes of service performed by the
PTA/OTA are not material, and thus, should be disregarded, as shown in
the examples in Table 20.
[GRAPHIC] [TIFF OMITTED] TP23JY21.043
With these proposed policy adjustments, the CQ/CO modifiers apply
when the PTA/OTA provides all the minutes of a timed service, and to
some services (as illustrated in Table 19) when the PTA/OTA and PT/OT
each, independent of the other, furnish portions of the same timed
service. The CQ/CO modifiers also apply if the portion of an untimed
code furnished by the PTA/OTA exceeds the de minimis standard. The CQ/
CO modifiers do not apply when the PTA/OTA and the PT/OT furnish
different services. Time spent by the PT/OT and PTA/OTA providing
services together is considered time spent by the PT/OT for purposes of
applying the de minimis standard. Finally, we propose to modify our
policy so that the CQ/CO modifiers would not apply when the PT/OT
provides enough minutes of the service on their own to bill for the
last unit of a timed service, (more minutes than the midpoint or 8
minutes of a 15-minute timed code) regardless of any additional minutes
for the service provided by the PTA/OTA.
Examples of Billing Scenarios using the CQ/CO modifiers when the de
minimis standard applies, and the proposed policy for the last billed
unit of a service:
Example #A:
PTA--10 minutes of 97110
PT--5 minutes of 97110
Total = 15 minutes--qualifies to bill one 15-minute unit (8
minute to 22 minutes).
Analysis: Bill one unit of 97110 with the CQ modifier because the
PTA provided 8 minutes or more and the PT provided less than 8 minutes.
The de minimis standard applies in these cases.
Example #B:
PTA--5 minutes of 97110
PT--6 minutes of 97110
Total = 11 minutes--qualifies to bill one 15-minute unit (8
minute through 22 minutes).
Analysis: Bill one unit of 97110 with the CQ modifier because the
PTA and the PT both provided less than 8 minutes. In this case, the PT
provided 6 minutes and the PTA furnished 5 minutes independent of each
other. The de minimis standard applies in these cases.
Example #C:
PTA-22 minutes of 97110
PT--23 minutes of 97110
Total = 45 minutes--qualifies to bill three 15-minute units (38
minutes through 52 minutes).
Analysis:
Apply Step One of the general policy rules and bill one
unit of 97110 with the CQ modifier because the PTA provided 15 full
minutes with 7 minutes remaining.
Apply Step One to the PT's 23 minutes and bill one unit
without the assistant modifier with 8 minutes remaining.
The third unit of 97110 is billed without the assistant
modifier because the therapist provided enough minutes (8 or more
minutes) without the PTAs minutes to bill the final unit.
[[Page 39218]]
Example #D--also see the below regulatory proposal using this `two
remaining unit' example.
PT--12 minutes of 97110
PTA--14 minutes of 97110
PT--20 minutes of 97140
Total = 46 minutes--qualifies to bill three units (38 minutes
through 52 minutes).
Analysis:
Apply Step One of the general policy rules and bill one
unit of 97140 without the CQ modifier because the PT provided 15 full
minutes of one unit with 5 minutes remaining.
Two units remain to be billed and the PT and the PTA each
provided between 9 and 14 minutes independent of one another with a
total time between 23 and 28 minutes--in these ``two remaining unit''
scenarios, one unit is billed with the CQ modifier for the PTA and the
other unit is billed without it for the PT.
The PT's 5 remaining minutes of 97140 are counted towards
the total timed minutes but are not billable in this scenario.
Example #E
OTA--11 minutes of 97535
OT--11 minutes of 97530
Total = 22 minutes--qualifies to bill one (1) unit (8 minutes
through 22 minutes).
Billing Analysis:
Since two different services were furnished for an equal number of
minutes--the ``tie-breaker'' scenario applies. Either code 97530 by the
OT or code 97535 by the OTA can be billed in accordance with a billing
example in the MCPM, Chapter 5, section 20.2.C. Either one unit of
97530 is billed without the CO modifier or one unit of 97535 is billed
with the CO modifier.
Example #F: Untimed code--1 unit is billed for all untimed codes
including evaluations, reevaluations, supervised modalities, and group
therapy.
OTA--20 minutes 97150 independent of the OT
OT--20 minutes 97150 independent of the OTA
Total = 40 minutes of Group Therapy = 1 unit of 97150 is billed
for each group member.
Billing Analysis: One unit of group therapy 97150 is billed with
the CO modifier because the OTA provided more than the 10 percent time
standard in this example. Either method can be used to determine if the
OTA's time exceeded the 10 percent time standard for this clinical
scenario, see below:
The simple method: First add the OTA's 20 minutes to the
OT's 20 minutes to get 40, then divide by 10 to get 4.0 and add 1 to
equal 5 minutes. The OTA's 20 minutes is equal to or greater than 5
minutes so the CO modifier is required on the claim.
The percentage method: Divide the number of minutes that
an OTA independently furnished a service by the total number of minutes
the service was furnished as a whole--20 divided by 40 equals 0.50.
Then multiple by 100 to get 50 percent, which is greater than 10
percent. The CO modifier is applied to 97150.
Tie breaker: The tie breaker does not apply in this
scenario because the example does not contain two different timed codes
described in 15-minute intervals. For ``tie breaker'' see Example #F
above.
As noted above and illustrated in Example #D, there are a finite
number of cases where there are two 15-minute units left to bill. In
these ``two remaining unit'' cases, the PTA/OTA and the PT/OT each
provide between 9 and 14 minutes with a total time of at least 23
minutes through 28 minutes. Under our proposed policy, one unit of the
service would be billed with the CQ/CO modifier for the minutes
furnished by the PTA/OTA (who furnished between 9 and 14 minutes of the
service), and one unit would be billed without the CQ/CO modifier for
the service provided by the PT/OT (who also furnished between 9 and 14
minutes of the same service). This is because the PTA/OTA and the PT/OT
each independently furnished part of each unit of the same service, and
these cases are not addressed by the proposed midpoint rule that would
apply when there is only one single unit left to bill. We are proposing
to amend our regulation to address the scenario where there are two
remaining 15-minute units of the same service for which the PTA/OTA and
the PT/OT each provided between 9 and 14 minutes with a total time of
at least 23 minutes and no more than 28 minutes. In this scenario, we
propose that one unit of the service would be billed with the CQ/CO
modifier and the other unit of the service would be billed without the
assistant modifier. We are proposing to add this policy to our
regulations at Sec. Sec. 410.59(a)(4)(v) and 410.60(a)(4)(v) for
outpatient occupational therapy and physical therapy services,
respectively and at Sec. 410.105(d)(3)(iv) for Comprehensive
Outpatient Rehabilitation Facility (CORF) services.
As noted above, when we finalized the policy to consider each 15-
minute unit of a service for purposes of determining whether the de
minimis standard applies, we neglected to revise our regulations at
Sec. Sec. 410.59, 410.60 and 410.105 to reflect this change. As such,
we are proposing to amend the regulations at Sec. Sec.
410.59(a)(4)(iii)(B) and 410.60(a)(4)(iii)(B) for outpatient
occupational therapy and physical therapy services, respectively, and
at Sec. 410.105(d)(3)(ii) for CORF services to specify that we
consider a service to be furnished in part by a PTA or an OTA when the
PTA/OTA furnishes a portion of a service, or in the case of a 15-minute
timed code, a portion of a unit of a service, separately from the
portion of the service or unit of service furnished by the therapist
such that the minutes for that portion of a service or a unit of a
service furnished by the PTA/OTA exceed 10 percent of the total minutes
for that service or unit of a service.
To accommodate the proposed refinement of the de minimis policy, we
are proposing to amend the same regulations at Sec. Sec.
410.59(a)(4)(iv) and 410.60(a)(4)(iv) for outpatient occupational
therapy and physical therapy services, respectively, and at Sec.
410.105(d)(3)(iii) for CORF services to provide that, for the final 15-
minute unit billed for a patient for a date of service, when the PT/OT
provides more than the midpoint (at least 8 minutes) of a service such
that they could bill for the service without any additional minutes
being furnished by the PTA/OTA, the service may be billed without a CQ
or CO modifier, and any remaining minutes of service furnished by the
PTA/OTA are considered immaterial.
Beginning January 1, 2022, therapy services furnished in whole or
in part by a PTA or OTA will be identified based on the inclusion by
the billing therapy services provider (whether a therapist in private
practice or therapy provider) of the CQ or CO modifier, respectively,
on claim lines for therapy services, and the payment for those services
will be adjusted as required by section 1834(v)(1) of the Act. Per our
usual system update process, we plan to issue instructions in a change
request to prepare our shared systems and Medicare Administrative
Contractors (MACs) to pay the reduced amount for therapy services
furnished in whole or in part by a PTA or OTA. We will issue an MLN
article once the CR is released, after the CY 2022 PFS final rule is
issued.
We are seeking comment on all of our proposals.
I. Changes to Beneficiary Coinsurance for Additional Procedures
Furnished During the Same Clinical Encounter as Certain Colorectal
Cancer Screening Tests
Section 122 of the Consolidated Appropriations Act (CAA) of 2021,
Waiving Medicare Coinsurance for
[[Page 39219]]
Certain Colorectal Cancer Screening Tests, amends section 1833(a) of
the Act to offer a special coinsurance rule for screening flexible
sigmoidoscopies and screening colonoscopies, regardless of the code
that is billed for the establishment of a diagnosis as a result of the
test, or for the removal of tissue or other matter or other procedure,
that is furnished in connection with, as a result of, and in the same
clinical encounter as the colorectal cancer screening test. The reduced
coinsurance will be phased-in beginning January 1, 2022. Currently, the
addition of any procedure beyond a planned colorectal cancer screening
test (for which there is no coinsurance), results in the beneficiary
having to pay coinsurance.
Section 1861(pp) of the Act defines ``colorectal cancer screening
tests'' and, under sections 1861(pp)(1)(B) and (C) of the Act,
identifies ``screening flexible sigmoidoscopy'' and ``screening
colonoscopy'' as two of the recognized procedures. During the course of
either one of these two procedures, removal of tissue or other matter
may become necessary for diagnostic purposes. Among other things,
section 1861(pp)(1)(D) of the Act authorizes the Secretary to include
in the definition other tests or procedures and modifications to the
tests and procedures described under this subsection, with such
frequency and payment limits as the Secretary determines appropriate,
in consultation with appropriate organizations. Section 1861(s)(2)(R)
of the Act includes colorectal cancer screening tests in the definition
of the medical and other health services that fall within the scope of
Medicare Part B benefits described in section 1832(a)(1) of the Act.
Section 1861(ddd)(3) of the Act includes colorectal cancer screening
tests within the definition of ``preventive services.'' In addition,
section 1833(a)(1)(Y) of the Act provides for payment for a preventive
service under the PFS at 100 percent of the lesser of the actual charge
or the fee schedule amount for these colorectal cancer screening tests,
and under the OPPS at 100 percent of the OPPS payment amount, when the
preventive service is recommended by the United States Preventive
Services Task Force (USPSTF) with a grade of A or B. As such, there is
no beneficiary coinsurance for recommended colorectal cancer screening
tests as defined in section 1861(pp)(1) of the Act.
Under these statutory provisions, we have issued regulations
governing payment for colorectal cancer screening tests at Sec.
410.152(l)(5). We pay 100 percent of the Medicare payment amount
established under the applicable payment methodology for the setting
for providers and suppliers, and beneficiaries are not required to pay
Part B coinsurance for colorectal cancer screening tests (except for
barium enemas, which are not recommended by the USPSTF with a grade of
A or B).\37\
---------------------------------------------------------------------------
\37\ We refer readers to the CY 2022 OPPS proposed rule for a
detailed discussion of Changes to Beneficiary Coinsurance for
Colorectal Cancer Screening Tests in outpatient and ambulatory
surgical settings.
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In addition to colorectal cancer screening tests, which typically
are furnished to patients in the absence of signs or symptoms of
illness or injury, Medicare also covers various diagnostic tests (see
Sec. 410.32). In general, diagnostic tests must be ordered by the
physician or practitioner who is treating the beneficiary and who uses
the results of the diagnostic test in the management of the patient's
specific medical condition. Under Part B, Medicare may cover flexible
sigmoidoscopies and colonoscopies as diagnostic tests when those tests
are reasonable and necessary as specified in section 1862(a)(1)(A) of
the Act. When these services are furnished as diagnostic tests rather
than as screening tests, patients are responsible for the Part B
coinsurance (20 or 25 percent depending upon the setting) associated
with these services.
We define colorectal cancer screening tests in our regulation at
Sec. 410.37(a)(1) to include ``flexible screening sigmoidoscopies''
and ``screening colonoscopies, including anesthesia furnished in
conjunction with the service.'' Under our current regulations, we
exclude from the definition of colorectal screening services,
colonoscopies and sigmoidoscopies that begin as screening services, but
where a polyp or other growth is found and removed as part of the
procedure. The exclusion of these services from the definition of
colorectal cancer screening tests is based upon longstanding provisions
under sections 1834(d)(2)(D) and (d)(3)(D) of the Act dealing with the
detection of lesions or growths during procedures (see CY 1998 PFS
final rule at 62 FR 59048, 59082 for a more detailed explanation).
Prior to the enactment of section 122 of the CAA, section
1834(d)(2)(D) of the Act provided that if, during the course of a
screening flexible sigmoidoscopy, a lesion or growth is detected which
results in a biopsy or removal of the lesion or growth, payment under
Medicare Part B shall not be made for the screening flexible
sigmoidoscopy, but shall be made for the procedure classified as a
flexible sigmoidoscopy with such biopsy or removal. Similarly, prior to
the recent legislative change, section 1834(d)(3)(D) of the Act
provided that if, during the course of a screening colonoscopy, a
lesion or growth is detected that results in a biopsy or removal of the
lesion or growth, payment under Medicare Part B shall not be made for
the screening colonoscopy but shall be made for the procedure
classified as a colonoscopy with such biopsy or removal. In these
situations, Medicare pays for the flexible sigmoidoscopy and
colonoscopy tests as diagnostic tests rather than as screening tests
and the 100 percent payment rate for recommended preventive services
under section 1833(a)(1)(Y) of the Act, as codified in our regulation
at Sec. 410.152(l)(5), has not applied. As such, beneficiaries
currently are responsible for the usual coinsurance that applies to the
services (20 or 25 percent of the cost of the services depending upon
the setting).
Under section 1833(b) of the Act, before making payment under
Medicare Part B for expenses incurred by a beneficiary for covered Part
B services, beneficiaries must first meet the applicable deductible for
the year. Section 4104 of the Affordable Care Act (that is, the Patient
Protection and Affordable Care Act (Pub L. 111-148, March 23, 2010),
and the Health Care and Education Reconciliation Act of 2010 (Pub. L.
111-152, March 30, 2010), collectively referred to as the ``Affordable
Care Act'') amended section 1833(b)(1) of the Act to make the
deductible inapplicable to expenses incurred for certain preventive
services that are recommended with a grade of A or B by the USPSTF,
including colorectal cancer screening tests as defined in section
1861(pp) of the Act. Section 4104 of the Affordable Care Act also added
a sentence at the end of section 1833(b)(1) of the Act specifying that
the exception to the deductible shall apply with respect to a
colorectal cancer screening test regardless of the code that is billed
for the establishment of a diagnosis as a result of the test, or for
the removal of tissue or other matter or other procedure that is
furnished in connection with, as a result of, and in the same clinical
encounter as the screening test. Although amendments made by the
Affordable Care Act addressed the applicability of the deductible in
the case of a colorectal cancer screening test that involves biopsy or
tissue removal, they did not alter the coinsurance provision in section
1833(a) of the Act for such procedures. Public commenters encouraged
the agency to eliminate the coinsurance in these circumstances;
[[Page 39220]]
however, the agency found that statute did not provide for elimination
of the coinsurance (75 FR 73170 at 73431).
Beneficiaries have continued to contact us noting their concern
that a coinsurance percentage applies (20 or 25 percent depending upon
the setting) under circumstances where they expected to receive only a
colorectal screening test to which coinsurance does not apply. Instead,
these beneficiaries received what Medicare considers to be a diagnostic
procedure because, for example, polyps were discovered and removed
during the procedure. Similarly, physicians have expressed concern
about the reactions of beneficiaries when they are informed that they
will be responsible for coinsurance if polyps are discovered and
removed during a procedure that they had expected to be a screening
procedure to which coinsurance does not apply.
Section 122 of the CAA addresses this coinsurance issue by
successively reducing, over a period of years, the percentage amount of
coinsurance for which the beneficiary is responsible. Ultimately, for
services furnished on or after January 1, 2030, the coinsurance will be
zero.
To implement the amendments made by section 122 of the CAA, we are
proposing to modify our regulations to reflect the changes to Medicare
statute. As amended, the statute effectively provides that, for
services furnished on or after January 1, 2022, a flexible
sigmoidoscopy or a colonoscopy can be considered a screening flexible
sigmoidoscopy or a screening colonoscopy test even if an additional
procedure is furnished to remove tissue or other matter during the
screening test. Specifically, section 122(a)(3) of the CAA added a
sentence to the end of section 1833(a) of the Act to include as
colorectal screening tests described in section 1833(a)(1)(Y) of the
Act, a colorectal cancer screening test, regardless of the code that is
billed for the establishment of a diagnosis as a result of the test, or
for the removal of tissue or other matter or other procedure that is
furnished in connection with, as a result of, and in the same clinical
encounter as the screening test. We note that only flexible screening
sigmoidoscopies and screening colonoscopies are recognized currently as
colorectal cancer screening tests that might involve removal of tissue
or other matter. This new sentence added under section 1833(a) of the
Act uses the same language that was used to amend the statute at
section 1833(b)(1) of the Act and to broaden the scope of colorectal
cancer screening tests to which a deductible does not apply. Section
122(b)(1) of the CAA then limits application of the 100 percent
Medicare payment rate (that is, no beneficiary coinsurance) under
section 1833(a)(1)(Y) of the Act for the additional colorectal cancer
screening tests (those that are not screening tests ``but for'' the new
sentence at the end of section 1833(a) of the Act) by making payment
for them subject to a new section 1833(dd) of the Act. Section 1833(dd)
of the Act provides for a series of increases in the Medicare payment
rate percentage for those services over successive periods of years
through CY 2029. Thereafter, section 1833(dd) of the Act has no effect,
so payment for all colorectal cancer screening tests would be made at
100 percent under section 1833(a)(1)(Y) of the Act.
To codify the amendments made by section 122 of the CAA in our
regulations, we are proposing to make two modifications to current
regulations.
At Sec. 410.37, we propose to modify our regulation where we
define conditions for and limitations on coverage for colorectal cancer
screening tests by adding a new paragraph (j). That paragraph would
provide that, effective January 1, 2022, when a planned colorectal
cancer screening test, that is, screening flexible sigmoidoscopy or
screening colonoscopy test, requires a related procedure, including
removal of tissue or other matter, furnished in connection with, as a
result of, and in the same clinical encounter as the screening test, it
is considered to be a colorectal cancer screening test.
At Sec. 410.152(l)(5), we also propose to modify our regulation.
Here we describe payment for colorectal cancer screening tests.
Effective January 1, 2022, we propose to provide for an increase in the
Medicare payment percentage that is phased in over time. As the
Medicare payment percentage increases, the beneficiary coinsurance
percentage decreases. We propose to revise Sec. 410.152(l)(5) to
provide that Medicare payment in a specified year is equal to a
specified percent of the lesser of the actual charge for the service or
the amount determined under the fee schedule that applies to the test.
The phased in Medicare payment percentages for colorectal cancer
screening services described in the proposed regulation at Sec.
410.37(j) (and the corresponding reduction in coinsurance) are as
follows:
80 percent payment for services furnished during CY 2022
(with coinsurance equal to 20 percent);
85 percent payment for services furnished during CY 2023
through CY 2026 (with coinsurance equal to 15 percent);
90 percent payment for services furnished during CY 2027
through CY 2029 (with coinsurance equal to 10 percent); and
100 percent payment for services furnished from CY 2030
onward (with coinsurance equal to zero percent).
Thus, between CYs 2022 and 2030, the coinsurance required of
Medicare beneficiaries for planned colorectal cancer screening tests
that result in additional procedures furnished in the same clinical
encounter will be reduced over time from the current 20 or 25 percent
to zero percent in CY 2030 and will remain at zero percent for these
services furnished beginning in CY 2030 and thereafter.
J. Vaccine Administration Services: Comment Solicitation: Medicare
Payments for Administering Preventive Vaccines
On January 31, 2020, under section 319 of the Public Health Service
(PHS) Act (42 U.S.C. 247d), the Secretary of the Department of Health
and Human Services (the Secretary) determined that a public health
emergency (PHE) as a result of confirmed cases of 2019 Novel
Coronavirus exists nationwide and has existed since January 27, 2020
(hereafter referred to as the PHE for COVID-19). The Secretary has
since renewed this declaration for successive 90-day periods, the
latest on April 15, 2021.
The PHE for COVID-19 has reinforced the important and positive
impact that preventive vaccines can have on the health of Medicare
beneficiaries and the broader public. At the time of publishing this
proposed rule, the PHE for COVID-19 declaration is still in effect and
the United States is in the middle of a national effort to vaccinate as
many people against COVID-19 as quickly as possible. This national
effort has at least temporarily altered the landscape for vaccines and
vaccine administration by, for example, encouraging existing providers
and suppliers to dramatically expand their vaccination capabilities and
by encouraging new (and new types) of providers and suppliers to
furnish vaccines.
Over the past several years, stakeholders have expressed concerns
about the reduction in Medicare payment rates for the service to
administer preventive vaccines covered by Medicare Part B under section
1861(s)(10) of the Act, including the influenza, pneumococcal, and
hepatitis B virus (HBV) vaccines. In the last two PFS rulemaking cycles
(that is, for CY 2020 and CY 2021), we have attempted
[[Page 39221]]
to address some of these concerns and these efforts are discussed in
more detail below. However, CY 2021 payment rates for administration of
these vaccines by suppliers including physicians, NPPs, and mass
immunizers remain the same as in CY 2019: A national average rate of
$16.94, which is geographically adjusted. In this section, we are
seeking feedback on how we should update the payment rate for
administration of these preventive vaccines under Medicare Part B.
1. Medicare Part B Payment for Vaccines
Under section 1861(s)(10) of the Act, Medicare Part B covers both
the vaccine and its administration for the preventive vaccines
specified--the influenza, pneumococcal, HBV, and COVID-19 vaccines.
Under sections 1833(a)(1)(B) and (b)(1) of the Act, there is no
applicable beneficiary coinsurance, and the annual Part B deductible
does not apply for these vaccinations or the services to administer
them. In CY 2021, payment for these vaccines is based on 95 percent of
the Average Wholesale Price (AWP) for a particular vaccine product
except where furnished in the settings for which payment is based on
reasonable cost, such as a hospital outpatient department, rural health
clinic (RHC), or federally qualified health center (FQHC). For example,
for the 2020-2021 influenza season, payment limits for adult influenza
vaccine products range from about $19 to $61 per adult dose. We note
that most other preventive vaccines not specified for Medicare Part B
coverage under section 1861(s)(10) of the Act, such as the shingles
vaccine, are covered and paid for under Medicare Part D.
Section 3713 of the Coronavirus Aid, Relief, and Economic Security
Act (CARES Act) (Pub. L. 116-136) added the COVID-19 vaccine and its
administration to section 1861(s)(10)(A) of the Act in the same
subparagraph as the influenza and pneumococcal vaccines and their
administration. To implement this section, we issued an interim final
rule with comment period (November 4th COVID-19 IFC (85 FR 71145
through 71150)) which established that payments for COVID-19 vaccines
and vaccine administration would be made in the same manner as payments
for the influenza and pneumococcal vaccines. The IFC specifically
amended Sec. Sec. 414.707(a)(2)(iii) and 414.904(e)(1) to include the
COVID-19 vaccine in the list of vaccines with payment limits calculated
using 95 percent of the AWP (85 FR 71147). We note that Medicare does
not pay providers and suppliers for the vaccine product when the
federal government purchases it and gives it to the provider or
suppliers for free, as has been the case for all COVID-19 vaccines as
of the publication of this proposed rule.
We note that the vaccine administration services described under
1861(s)(10) of the Act are not technically valued or paid under the
PFS, as they are not included within the statutory definition of
physicians' services in section 1848(j)(3) of the Act. Despite this, we
have historically based payment rates for the administration of these
preventive vaccines by suppliers such as physicians, NPPs, and mass
immunizers on an evaluation of the resource costs involved in
furnishing the service, which is similar to the methodology that we use
to establish payment rates for the PFS. We note further that we also
assign a payment rate for administering these preventive vaccines under
the Outpatient Prospective Payment System (OPPS), and those payment
rates are for hospitals and home health agencies for preventive vaccine
administration. Certain other types of providers and suppliers, such as
RHCs, FQHCs and critical access hospitals (CAHs), are paid based on
reasonable cost for vaccine administration. We also note that these
payments are geographically adjusted based on the provider's wage
index.
As discussed in the CY 2021 PFS proposed rule (85 CFR 50162), many
stakeholders raised concerns about the reductions in payment rates for
the preventive vaccine administration services that had occurred over
the past several years. We generally have established payment rates for
the three Healthcare Common Procedural Coding System (HCPCS) codes
G0008, G0009, and G0010--which describe the services to administer an
influenza, pneumococcal and HBV vaccines, respectively, based on a
direct crosswalk to the PFS payment rate for CPT code 96372
(Therapeutic, prophylactic, or diagnostic injection (specify substance
or drug); subcutaneous or intramuscular). Because we proposed and
finalized reductions in valuation for that code for CY 2018, the
payment rate for the vaccine administration codes was concurrently
reduced. Further, because the reduction in RVUs for CPT code 96372 was
significant enough to be required to be phased in over several years
under section 1848(c)(7) of the Act, the reductions in overall
valuation for the vaccine administration codes were likewise subject to
reductions over several years. As noted in Table 21, the national
payment rate for administering these preventive vaccines has declined
more than 30 percent since 2015.
[[Page 39222]]
[GRAPHIC] [TIFF OMITTED] TP23JY21.044
We have attempted to address the reduction in payment rates for
these vaccine administration HCPCS codes in the last two PFS rulemaking
cycles. In the CY 2020 PFS final rule, we acknowledged that it is in
the public interest to ensure appropriate resource costs are reflected
in the valuation of the immunization administration services that are
used to deliver these vaccines, and noted that we planned to review the
valuations for these services in future rulemaking. For CY 2020, we
maintained the CY 2019 national payment amount for immunization
administration services described by HCPCS codes G0008, G0009 and
G0010.
In the CY 2021 PFS proposed rule, we proposed to crosswalk G0008,
G0009 and G0010 to CPT code 36000 (Introduction of needle or
intracatheter, vein) (85 FR 50163). In the proposed rule, we noted that
CPT code 36000 is a service with a similar clinical vignette, and that
the additional clinical labor, supply, and equipment resources
associated with furnishing CPT code 36000 were similar to costs
associated with these vaccine administration codes. We also noted that
this crosswalk would have resulted in payment rates for vaccine
administration services at a rate that is approximately the same as the
CY 2017 rate (as noted in Table 21) that was in place prior to the
revaluation of CPT code 96372 (the original crosswalk code). In the CY
2021 PFS final rule, we did not finalize the proposed policy, and
instead finalized a policy to maintain the CY 2019 payment amount for
G0008, G0009 and G0010 (85 FR 84628). In the final rule, we also noted
that we continued to seek additional information that specifically
identifies the resource costs and inputs that should be considered to
establish payment for vaccine administration services on a long-term
basis.
As noted above, section 3713 of the CARES Act added the COVID-19
vaccine and its administration to the preventive vaccines covered under
Medicare Part B under section 1861(s)(10)(A) of the Act in the same
subparagraph as the influenza and pneumococcal vaccines and their
administration. Section 3713 of the CARES Act allows us to implement
the amendments made by that section through ``program instruction or
otherwise.'' In the November 4th COVID-19 IFC (85 FR 71147)
implementing section 3713 of the CARES Act, we indicated that we would
establish specific coding and payment rates for the COVID-19 vaccine
and vaccine administration through technical direction to Medicare
Administrative Contractors (MACs) and information posted publicly on
CMS' website.
In December 2020, we publicly posted the applicable CPT codes for
the Pfizer-BioNTech and Moderna COVID-19 vaccines and initial Medicare
payment rates for administration of these vaccines upon the FDA's
authorization of these vaccines. We announced an initial Medicare
payment rate for COVID-19 vaccine administration of $28.39 to
administer single-dose vaccines. For a COVID-19 vaccine requiring a
series of two or more doses--for example, for both the Pfizer-BioNTech
and Moderna products--we announced a payment rate for administration of
the initial dose(s) of $16.94, which was based on the Medicare payment
rate for administering the other preventive vaccines under section
1861(s)(10) of the Act. We also announced a payment rate for
administering the second dose of $28.39, which was based on the payment
rate that was proposed, but not finalized, for administration of the
other preventive vaccines under section 1861(s)(10) of the Act in the
CY 2021 PFS proposed rule, discussed in more detail above.
On March 15, 2021, we announced an increase in the payment rate for
administering a COVID-19 vaccine to $40 per dose, effective for doses
administered on or after March 15, 2021, which means the payment rate
is $40 to administer a single dose product, and $40 each to administer
the first and second dose in a two-dose regime ($80 total).
[[Page 39223]]
[GRAPHIC] [TIFF OMITTED] TP23JY21.045
As discussed above, payment rates for suppliers such as physicians,
NPPs, and mass immunizers for administering the Part B covered
preventive vaccines have generally been based on a direct crosswalk to
CPT code 96372 (Therapeutic, prophylactic, or diagnostic injection
(specify substance or drug); subcutaneous or intramuscular). This
crosswalk code is paid under the PFS, and Medicare's process to value
codes under the PFS relies in part on recommended resource inputs
provided by the AMA RUC and steps to translate those recommended inputs
into national RVUs.
In 2020, the RUC resubmitted its 2009 valuation recommendation for
vaccine administration services described by CPT codes, including CPT
codes 90460 (Administration of first vaccine or toxoid component
through 18 years of age with counseling), 90471 (Administration of 1
vaccine), and 90473 (Administration of 1 nasal or oral vaccine). The
AMA RUC also recently provided valuation recommendations for the CPT
codes that describe the service to administer the COVID-19 vaccines.
As noted earlier, we also assign a payment rate for administering
preventive vaccines under the OPPS by assigning an ambulatory payment
classification (APC) to each service based on clinical and resource
cost similarity to other services assigned to the APC. Geometric mean
costs, which are generally used in establishing the prospective OPPS
payments for each APC, are calculated using historical claims and cost
report information. In CY 2021, CMS assigned HCPCS codes G0008, G0009
and G0010 to APC 5691 (level 1 drug administration), which has a
national payment rate of $40 for CY 2021.
Our practice of setting payment rates for preventive vaccine
administration services described by HCPCS codes G0008, G0009 and G0010
for physicians, NPPs, and mass immunizers by using the PFS approach
(for example, a crosswalk to an existing CPT code) means that costs
incorporated into the rate primarily reflect costs of furnishing the
service in a physician office setting. It also means that the payment
rate can be affected by other aspects of the PFS rate-setting
methodology, such as the allocation of indirect PE, and broader changes
to PFS codes and rates, including the multi-year phase-in of
significant reductions in RVUs discussed earlier. We note that we have
not historically collected or used information from other providers and
suppliers, including pharmacies which are commonly enrolled as mass
immunizers to furnish vaccines and vaccine administration services, for
purposes of establishing a rate for these codes.
We are requesting feedback from stakeholders that would support the
development of an accurate and stable payment rate for administration
of the preventive vaccines described in section 1861(s)(10) of the Act
for physicians, NPPs, mass immunizers and certain other providers and
suppliers. We are interested in detailed feedback on the following
questions, which we believe would assist us in establishing payment
rates for these services that could be appropriate for use on a long-
term basis.
What are the different types of providers and suppliers
that furnish preventive vaccines, and have these types of providers/
suppliers changed as a result of the PHE for COVID-19? (We note that
our claims data reflect the type of Medicare enrollment for those
billing for the vaccine administration, but we are particularly
interested in understanding additional, specific characteristics of the
providers and suppliers that may not be distinguishable under the more
general Medicare enrollment data.) We are also interested in whether
different providers and suppliers furnish different aspects of the
vaccine administration for the same beneficiary.
What are the differences in incurred costs of furnishing
flu, pneumonia and HBV vaccines compared to furnishing COVID-19
vaccines? Are there differences in the costs (per dose or otherwise) of
furnishing a one-dose vaccine product vs. a two-dose vaccine product?
Also, are there differences in cost of administering preventive
vaccines furnished under the Part D benefit, such as the shingles
vaccines, compared to those furnished under Part B?
What are the resource costs that physicians, NPPs, mass
immunizers and certain other suppliers incur when furnishing vaccines
safely and effectively? We are interested in specific information on
costs related to staffing/labor, infrastructure, patient onboarding/
enrollment, vaccine storage and handling, vaccine procurement and
coordination, supplies, CDC and state reporting requirements, patient
counseling about safety and efficacy, and other costs we may not have
considered. We are also interested in specific resource costs per
vaccine dose within each cost category, if that is available.
What are the impacts of the PHE for COVID-19 on resource
costs incurred by vaccination providers, and do stakeholders envision
that these impacts will continue after the PHE has ended? Following the
end of the PHE, do you expect that the same types of vaccination
providers and suppliers will continue to administer vaccines, or do you
envision that this will change (if so, how, and what would be the
primary factors driving the change)?
As described previously, Medicare has generally relied on
the PFS methodology for setting payment rates for HCPCS codes G0008,
G0009 and
[[Page 39224]]
G0010. How should Medicare assess costs associated with furnishing
these preventive vaccines outside of the physician office setting, such
as in pharmacies, mass immunization sites, mobile vaccine clinics or
other locations? In addition, we understand that there could be
administrative burden associated with the routine collection of cost
data to support more accurate rate-setting for suppliers that are
vaccinating patients. Are there other ways to update and validate costs
for a broader range of entities using existing data?
Payment rates for vaccine administration currently vary by
setting. For HCPCS codes G0008, G0009 and G0010, the CY 2021 national
average payment rate for physicians, practitioners and other suppliers
is $16.94, which is geographically adjusted, while for hospital
outpatient departments it is $40. However, for COVID-19 vaccine
administration, Medicare now pays $40 per administration in all
settings, unless the vaccine in administered under certain
circumstances in the beneficiary's home or residence (as discussed in
more detail below). Should Medicare continue to pay differently for
non-COVID-19 preventive vaccines furnished in certain settings or under
certain conditions? If not, what factors contribute to higher costs for
administration of non-COVID-19 vaccines that are not currently
reflected in the Medicare payment rates?
Should CMS use a different process to update the payment
rates for administration of the preventive vaccines described in
section 1861(s)(10) of the Act on an annual basis?
In the last few years we have also crosswalked vaccine
administration CPT codes 90460 (Administration of first vaccine or
toxoid component through 18 years of age with counseling), 90461
(Administration of vaccine or toxoid component through 18 years of age
with counseling), 90471 (Administration of 1 vaccine), 90472
(Administration of vaccine), 90473 (Administration of 1 nasal or oral
vaccine), and 90474 (Administration of nasal or oral vaccine) to the
same rate used by G0008, G0009 and G0010. How should Medicare address
payment rates for these CPT codes under the PFS?
Are there major differences between what Medicare pays
physicians, NPPs and mass immunizers for non-COVID-19 preventive
vaccine administration and what commercial insurers pay? To the extent
possible we are also interested in feedback on specific rates used by
other insurers.
2. Payment for COVID-19 Vaccine Administration in the Home
Effective June 8, 2021, we announced a new add-on payment with a
national rate of $35.50 when a COVID-19 vaccine is administered in the
beneficiary's home.\38\ Under this new policy, providers and suppliers
that administer a COVID-19 vaccine in a beneficiary's home under
certain circumstances can bill Medicare for one of the existing COVID-
19 vaccine administration CPT codes (0001A, 0002A, 0011A, 0012A, 0031A)
along with HCPCS code M0201 (COVID-19 vaccine administration inside a
patient's home; reported only once per individual home per date of
service when only COVID-19 vaccine administration is performed at the
patient's home). Providers and suppliers administering a COVID-19
vaccine in the home will be paid a national average payment $75.50
dollars per dose ($40 for COVID-19 vaccine administration and $35.50
for the additional payment for administration in the home, and both
payments are geographically adjusted).
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\38\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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In establishing the additional payment for COVID-19 vaccine
administration in the beneficiary's home, we also established certain
conditions for the add-on payment described by HCPCS code M0201. More
specifically, for purposes of this additional payment for
administration of the COVID-19 vaccine in the beneficiary's home, we
established that Medicare will make this payment when either of these
situations applies:
The patient has difficulty leaving the home to get the
vaccine, which could mean any of these:
(1) They have a condition, due to an illness or injury, that
restricts their ability to leave home without a supportive device or
help from a paid or unpaid caregiver;
(2) They have a condition that makes them more susceptible to
contracting a pandemic disease like COVID-19; or
(3) They are generally unable to leave the home, and if they do
leave home, it requires a considerable and taxing effort;
The patient is hard-to-reach because they have a
disability or face clinical, socioeconomic, or geographical barriers to
getting a COVID-19 vaccine in settings other than their home. These
patients face challenges that significantly reduce their ability to get
vaccinated outside the home, such as challenges with transportation,
communication, or caregiving.
We also specified that payment is made for HCPCS code M0201 if the
sole purpose of the visit is to administer the COVID-19 vaccine.
However, Medicare will not pay the additional amount if the provider or
supplier furnished another Medicare covered service in the same home on
the same date.
For purposes of this add-on payment for in-home COVID-19 vaccine
administration, we announced that a home can be a private residence
temporary lodging (for example, a hotel or motel, campground, hostel,
or homeless shelter), an apartment in an apartment complex or a unit in
an assisted living facility or group home, or a patient's home that is
made provider-based to a hospital during the PHE for COVID-19. As such,
a home may be a domiciliary or rest home, meaning a facility, which
provides room, board, and other personal assistance services (for
example, an assisted living facility).
We also announced that the following locations are not considered
to be the patient's home for purposes of the add-on payment for COVID-
19 vaccine administration: Communal spaces of a multi-unit living
arrangement; hospitals; Medicare SNFs, and Medicaid NFs, regardless of
whether they are the patient's permanent residence; assisted living
facilities participating in the CDC's Pharmacy Partnership for Long-
Term Care Program when their residents are vaccinated through this
program. We are clarifying that an institution is not considered to be
a patient's home if the institution meets the requirements of sections
1861(e)(1), 1819(a)(1), or 1919(a)(1) of the Act, which includes
hospitals and skilled nursing facilities, as well as most nursing
facilities under Medicaid.\39\
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\39\ 42 CFR 409.42(a).
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Additionally, we established that assisted living facilities
participating in the CDC Pharmacy Partnership for Long-Term Care
Program partnership would not be eligible for this higher payment for
COVID-19 vaccine administration in the home when their residents were
vaccinated through this program.
In addition, the COVID-19 vaccine administration service must be
furnished inside an individual's home. An individual unit in a multi-
dwelling building is considered a home. For example, an individual
apartment in an apartment complex or an individual bedroom inside an
assisted living facility or group home is considered a home. We
established that communal spaces of, or related to, congregate living
arrangements (such as a communal area of an apartment or condominium
complex, assisted living facility, group
[[Page 39225]]
home) are not considered a home for purposes of this add-on payment
because multiple people could be vaccinated and monitored either
simultaneously or in tandem in such communal spaces.
As noted in the code descriptor for HCPCS code M0201, this code can
be billed only once per individual home per date of service. In
situations where more than one Medicare beneficiary lives in the same
individual home, the additional payment for COVID-19 vaccine
administration in the home is limited to one time in that home on that
day, while any additional COVID-19 vaccine administration services for
other individuals in that same home would be paid at the generally
applicable rate of approximately $40 without the additional in-home
add-on payment amount.
We established the payment amount for HCPCS code M0201 for in-home
vaccination to reflect the additional costs associated with
administering the vaccine in the home, such as upfront administration
costs like scheduling, the additional clinical time needed for post
administration monitoring of a single patient, and public health
reporting requirements. To identify an appropriate payment rate for
HCPCS code M0201, we used the home health low utilization payment
adjustment add-on factor for skilled nursing as a proxy for the
increased resource costs, above those reflected in the base payment
rate for COVID-19 vaccine administration, involved in arranging and
furnishing COVID-19 vaccine administration services in the home. For
home health services, we make a low utilization payment adjustment
(LUPA) when, during a 30-day period of home health care (or prior to
January 1, 2020, a 60-day episode of home health care) a patient
receives minimal services (less visits than a predetermined threshold)
and the home health agency is paid per visit rather than the full 30-
day (previously 60-day) bundled payment amount (see 42 CFR 484.230). As
stated in the CY 2008 HH PPS proposed rule, after the HH PPS went into
effect we received comments and correspondence stating that the LUPA
per-visit payment rates do not adequately account for the front-loading
of costs in an episode. Commenters suggested that because of the small
number of visits in a LUPA episode, HHAs have little opportunity to
spread the costs of lengthy initial visits over a full episode (72 FR
25424). As such, under the Medicare home health payment system, LUPA
add-on payments are made to account for the upfront fixed costs and
prolonged visit lengths in a LUPA period/episode compared to those for
non-LUPA periods/episodes. We believe the LUPA add-on factor for
skilled nursing is an appropriate proxy for the upfront fixed costs and
prolonged visit lengths that exemplify and constitute the increased
resource costs involved in arranging and furnishing COVID-19 vaccine
administration services in the home.
The CY 2021 LUPA add-on factor for skilled nursing is 1.8451, and
we applied this to the base rate for COVID-19 vaccine administration of
$40 per dose (effective March 15, 2021). This calculation results in a
total proxy payment rate for in-home COVID-19 vaccine administration of
approximately $74. Subtracting the $40 base rate for COVID-19 vaccine
administration, which applies across most other settings, results in an
additional proxy payment rate of roughly $34. To expedite access to
this service and ensure consistency in payment rates for HCPCS code
M0201 between health care professionals, other suppliers, and
institutional providers, we established a payment rate that corresponds
to the proxy we calculated based on the LUPA add-on factor using a
reference to another proxy payment rate under the hospital OPPS.
Specifically, we looked to APC payment amounts under the hospital OPPS
that were similar to the $34 proxy amount and could be implemented with
speed under the COVID-19 vaccine benefit (which relies on both
institutional and professional claims processing systems). We
identified New Technology APC 1494 under the hospital OPPS with a
national payment rate of $35.50 as an appropriate reference payment
amount for this service for most providers and suppliers, and
established that amount as the national payment rate for HCPCS code
M0201. That is, the national payment rate for HCPCS code M0201 is
$35.50 for all providers and suppliers not paid reasonable cost.
In announcing the add-on payment for in-home COVID-19 vaccine
administration, we noted that we established these policies on a
``preliminary basis to ensure access to COVID-19 vaccines during the
public health emergency'' and that ``we continue to evaluate the needs
of Medicare patients and these policies, and will address them in the
future, as needed''.\40\ We are using this proposed rule as a way to
collect feedback on these policies and potential future changes.
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\40\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
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We are interested in feedback on our requirements,
including the definition of the ``home'' and the types of clinical and
non-clinical circumstances that make it difficult for a beneficiary to
receive a COVID-19 vaccine outside the home. Do these requirements
strike the appropriate balance of ensuring access to vaccines for
vulnerable beneficiaries while also protecting against potential fraud?
Should we maintain these requirements during the PHE as-is, and if not,
what changes should we consider? Outside of the circumstances of the
PHE that create a need for beneficiaries to be vaccinated as quickly
and broadly as possible, under what circumstances do health care
providers, suppliers, or others find particular need to vaccinate
people at home rather than periodically in association with routine in-
person visits?
As noted, we established an add-on payment of $35.50,
which is based on applying the LUPA add-on factor for skilled nursing
to the national $40 payment rate for the base service as a proxy to
reflect the additional resources involved in furnishing services in the
home setting. We are interested in detailed feedback on the costs
associated with furnishing COVID-19 vaccines in the home, and how these
costs differ from costs of furnishing vaccines in traditional
locations, such as a physician's office or mass immunization site.
What other steps should we take related to program
integrity and beneficiary protection with this new add-on payment for
administering the COVID-19 vaccine in the home? What documentation
should providers and suppliers that furnish vaccines in the home be
required to maintain and/or provide?
We note that this add-on payment of $35.50 only applies when
providers or suppliers furnish the COVID-19 vaccine in the
beneficiary's home, and is not billable when providers and suppliers
furnish a different preventive vaccine (influenza, pneumonia, HBV) in
the home. We believe the additional payment is only appropriate for
COVID-19 vaccines due to the unique circumstances of the PHE, as well
as the upfront fixed costs and prolonged visit lengths that exemplify
and constitute the increased resource costs involved in arranging and
furnishing COVID-19 vaccine administration services in the home.
However, we are interested in feedback on whether the same barriers
that could prevent a beneficiary from obtaining a COVID-19 vaccine
would also prevent them from obtaining other preventive vaccines,
whether Medicare should make a similar add-on vaccine administration
payment in those
[[Page 39226]]
circumstances, and whether the costs to furnish other preventive
vaccines in the beneficiary's home would be consistent with the costs
to furnish the COVID-19 vaccine.
3. Monoclonal Antibodies Used To Treat COVID-19
On November 10, 2020, the FDA issued an Emergency Use Authorization
(EUA) for bamlanivimab monotherapy.\41\ On November 21, 2020 the FDA
issued an EUA for casirivimab and imdevimab, which are administered
together.\42\ On February 9, 2021, the FDA issued an EUA for
bamlanivimab and etesevimab, which are also administered together.\43\
On April 16, 2021, the FDA revoked the EUA for bamlanivimab
monotherapy.\44\ On May 26, 2021, the FDA issued an EUA for sotrovimab
monotherapy.\45\ On June 3, 2021, the FDA revised the EUA for
casirivimab and imdevimab, which revised the dosing regimen from 2400mg
(1200 mg of casirivimab and 1200 mg of imdevimab) to 1200mg (600 mg of
casirivimab and 600 mg of imdevimab), authorized the addition of a new
presentation consisting of a single vial of casirivimab and imdevimab
co-formulated in a 1:1 ratio, and also authorized casirivimab and
imdevimab to be administered together via subcutaneous injection in
certain limited circumstances.\46\ On June 24, 2021, the FDA issued an
EUA for tocilizumab monotherapy.\47\ Under the EUAs, for all of these
products except for tocilizumab, they can be used for certain high-risk
patients with mild-to-moderate COVID-19 with the goal of preventing
further deterioration and hospitalization. Tocilizumab is authorized
for hospitalized patients who are receiving systemic corticosteroids
and require supplemental oxygen, non-invasive or invasive mechanical
ventilation, or extracorporeal membrane oxygenation (ECMO).
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\41\ https://www.fda.gov/media/143602/download.
\42\ https://www.fda.gov/media/143891/download.
\43\ https://www.fda.gov/media/145801/download.
\44\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab.
\45\ https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19.
\46\ https://www.regeneron.com/downloads/treatment-covid19-eua-fda-letter.pdf.
\47\ https://www.fda.gov/media/150319/download.
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When these products were authorized during the PHE for COVID-19, we
made the determination to cover and pay for them under the COVID-19
vaccine benefit in section 1861(s)(10) of the Act. When we announced
this approach, we also indicated that we would address ``potential
refinements to payment for administering monoclonal antibody products
to treat COVID-19 through future notice-and-comment rulemaking''.\48\
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\48\ https://www.cms.gov/medicare/covid-19/monoclonal-antibody-covid-19-infusion.
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We make a separate payment for the products (when not given to the
provider or supplier for free by the government) and for the service to
administer them. We note that as of June 30, 2021, the monoclonal
antibody products authorized by the FDA under an EUA include two
products involving drugs administered together, casirivimab and
imdevimab and bamlanivimab and etesevimab, the sotrovimab monotherapy,
and the tocilizumab monotherapy. All four products may be administered
through intravenous (IV) infusion, and casirivimab and imdevimab may be
administered via subcutanoues injection in certain limited
circumstances under the updated June 3rd EUA.
Initially, we established a national payment rate of $309.10 for
the service to administer (through IV infusion only at the time) these
products, which was based on one hour of infusion and post-infusion
monitoring in the hospital outpatient setting. We note that while these
products are typically infused over a period of roughly one hour, the
EUA for casirivimab and imdevimab allows the product to be infused over
a shorter time-period, such as 20 minutes, when appropriate. We note
that, as of June 15, 2021, the EUAs require at least one hour of post
infusion monitoring for all of the products available. On May 6, 2021,
we increased the payment rate for administration to $450.00 and
established a separate payment rate of $750.00 when a monoclonal
antibody product used to treat COVID-19 is administered in a home or
residence.\49\
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\49\ https://www.cms.gov/newsroom/press-releases/cms-increases-medicare-payment-covid-19-monoclonal-antibody-infusions.
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The decision to cover and pay for monoclonal antibody products used
to treat COVID-19 under the COVID-19 vaccine benefit prioritized access
to these products during the COVID-19 pandemic by allowing almost all
Medicare enrolled providers and suppliers, as permitted by state law
and consistent with the terms of the EUA, to furnish and bill for
administering these products across settings of care. Covering and
paying for these services under the COVID-19 vaccine benefit also means
that beneficiaries are not responsible for any cost sharing for the
product or the service to administer it. We note that Medicare
considers other monoclonal antibody products--that is, monoclonal
antibody products used in the treatment of other health conditions--
``biologicals'' and pays for them based on the methodology in section
1847A of the Act when they are furnished in physician offices,
ambulatory infusion clinics and under a similar methodology under the
hospital OPPS. We also note that, for these care settings, we typically
rely on the applicable AMA CPT codes to describe and pay for drug
administration services performed by providers and suppliers.
As noted above, bamlanivimab monotherapy and casirivimab and
imdevimab, administered together, were authorized in late 2020, we made
the determination to cover and pay for them under the vaccine benefit
in section 1861(s)(10) of the Act, and this decision prioritized
beneficiary access for purposes of addressing the PHE for COVID-19.
Since that time, the EUA for bamlanivimab monotherapy has been revoked,
the EUA for casirivimab and imdevimab administered together has been
revised to include a new presentation, a new dosing regimen, and a new
route of administration (in certain limited circumstances), the
sotrovimab monotherapy has been authorized and the tocilizumab
monotherapy has been authorized. It is also becoming clear that, as
more products enter the market, the federal government may not purchase
them for distribution to providers and suppliers for free, as is the
case with sotrovimab monotherapy and tocilizumab monotherapy. Given
these fast-moving changes, we are seeking feedback on our approach to
coverage and payment for COVID-19 monoclonal antibody products under
the COVID-19 vaccine benefit. We are considering whether we should
align payment and coverage for these products with our approach for
other monoclonal antibody products following the end of the PHE. We
believe that the context in which these products are furnished to
beneficiaries after the end of the PHE may more closely resemble the
circumstances under which similar drugs and biologics are ordinarily
furnished, specifically to a more targeted patient population outside
of a pandemic. Outside the context of the PHE, we believe treating
these products like other drugs and biologics paid under section 1847A
of the Act may better align Medicare coverage and payment policies for
COVID-19 monoclonal antibody products with other monoclonal antibody
products, which are purchased by providers and suppliers through
[[Page 39227]]
similar channels and administered using similar modalities. As noted
above, coverage and payment for COVID-19 monoclonal antibodies under
the COVID-19 vaccine benefit has meant that Medicare beneficiaries are
not responsible for any cost-sharing, which is typically 20 percent of
the allowed amount in most settings. We note that if Medicare were to
pay for COVID-19 monoclonal antibody products under the methodologies
in 1847A of the Act, it would mean that beneficiary co-insurance would
apply, similar to how it applies to other drugs and biologics that are
not paid for under a preventive vaccine benefit.
We also note that tocilizumab--typically sold under the brand name
Actemra--was previously approved by the FDA for several
indications.\50\ As a result, during the PHE for COVID-19, Medicare has
separate coding and payment rules for tocilizumab when it is furnished
to patients with COVID-19 and in a manner consistent with the terms of
the EUA, and for when tocilizumab is used for other clinical purposes.
This may be confusing for hospital providers and we believe that
treating these monoclonal antibody products like other drugs and
biologics paid under section 1847A of the Act may help clarify these
inconsistencies. We are interested in feedback on these issues.
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\50\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125472s044lbl.pdf.
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We are also interested in additional feedback on the resource costs
to administer COVID-19 monoclonal antibody products, such as costs
associated with infrastructure, clinical labor, and equipment,
including personal protective equipment. We recognize that
administering monoclonal antibodies used to treat COVID-19 may be
complex due the need to interact with beneficiaries that have active
infections and manage the potential for spreading disease. We are
interested in information on how the costs to furnish monoclonal
antibodies used to treat COVID-19 compare with infusions of other
complex biologics, and how the costs to furnish these products may be
different when these products are administered in the home.
4. Summary
We have taken several steps to promote timely access to COVID-19
vaccines including monoclonal antibody products during the PHE for
COVID-19. As explained above, we increased the payment rates we
initially established for services to administer a COVID-19 injected
vaccine and a COVID-19 infused or injected monoclonal antibody product.
We also developed specific payment rates when these products are
administered in the beneficiary's home. Taken together, these efforts
signal our understanding of the importance of COVID-19 vaccines for the
health of the individual beneficiary and the public. We also believe
these efforts, and the PHE broadly, provide an opportunity to consider
a more rational payment framework for the other preventive vaccines
covered under Medicare Part B. We are encouraged by stakeholder
engagement on these important issues and continue to seek information
that reflects the resource costs that we should consider for vaccine
administration services. We are interested in detailed feedback and
verifiable data from the public to help inform whether we should
consider making changes to payments for administering preventive
vaccines, or develop separate payments for vaccine administration in
the home.
We appreciate feedback from the public on these important issues
regarding preventive vaccine administration, vaccine administration in
the home, and monoclonal antibodies used to treat COVID-19.
K. Payment for Medical Nutrition Therapy Services and Related Services
Section 105 of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554,
December 21, 2000) added section 1861(vv)(1) to the Act which provided
Medicare coverage under Part B for Medical Nutrition Therapy (MNT)
services when performed by registered dietitians and nutrition
professionals pursuant to a referral from a physician.
Under section 1842(b)(18)(C) of the Act, registered dietitians and
nutrition professionals are included in the list of NPPs that may bill
Medicare and be paid directly for their services, effective January 1,
2002. To submit claims for MNT services, the registered dietitian or
nutrition professional must enroll as such in accordance with our
regulations at 42 CFR 414.64 and 424.510. Like other NPPs listed in
section 1842(b)(18)(C) of the Act, registered dietitians and nutrition
professionals who are employees or independent contractors of hospitals
or physician groups may reassign their benefits to that hospital or
physician group, as appropriate. The Medicare specialty code for
``dietitian/nutritionist'' is 71.
Under section 1833(a)(1)(T) of the Act, we were originally required
to pay for MNT services at 80 percent of the lesser of the actual
charge for the services or 85 percent of the amount determined under
the PFS for the same services if the services had been furnished by a
physician. We established payment regulations for MNT in our regulation
at Sec. 414.64 in the CY 2002 PFS final rule (66 FR 55278 through
55281 and 55332).
MNT services are defined as services that are furnished by a
registered dietitian or nutrition professionals. These practitioners
use three CPT[supreg] codes to bill for MNT assessment and intervention
services with the referral of a physician. In cases where there is a
second physician referral for MNT for the same patient within a
calendar year (for example, based on a change in the patient's
condition, diagnosis, or treatment regimen), the furnishing
practitioner uses two other HCPCS codes to report these episodes. We
have worked with stakeholders over the years to establish values for
the services described by the five MNT codes.
The importance of MNT services for managing diabetes or renal
disease, as well as the underutilization of the benefit by Medicare
beneficiaries is discussed in this proposed rule at section III.H. More
recently, stakeholders who are concerned about the low utilization rate
for the services have requested that CMS make changes geared toward
making MNT services more accessible to Medicare beneficiaries. These
stakeholders believe the underutilization of MNT services is due to
multiple factors. Some of these factors and our proposal to address
them are discussed elsewhere in this rule (see section III.H.),
including proposals to remove the requirement that the MNT referral be
made by the ``treating physician'' and update the glomerular filtration
rate (GFR) to reflect current medical practice. And, some factors are
being considered here. First, stakeholders recommend that we modify the
Medicare Claims Processing Manual (MCPM) to increase the visibility of
MNT services by moving the provisions that address these services to
appear near the provisions addressing other preventive services. (We
note that MNT services are included in the definition of preventive
services under section 1861(ddd)(3)(A) of the Act). Second, the
stakeholders recommend that we revise our Medicare Benefit Policy
Manual to address registered dietitians and nutrition professionals,
and the MNT services they furnish, in a way that aligns with the
provisions addressing other types of practitioners and the services
they furnish.
[[Page 39228]]
We established the MNT regulations in the CY 2002 PFS final rule at
Sec. 410.130 through Sec. 410.134 and Sec. 414.64. There have since
been two significant changes to payment for MNT services, which are
discussed in more detail below: (1) We added MNT services to the
Medicare telehealth services list and recognized that registered
dietitians and nutrition professionals can furnish and bill for these
services as distant site practitioners; and (2) section 4104 of the
Affordable Care Act (ACA) amended the statute to remove application of
the Medicare Part B deductible and coinsurance for MNT services
effective January 1, 2011. In the CY 2006 PFS final rule (70 FR 70155
through 70157), we amended our regulation to add registered dietitians
and nutrition professionals to the list of distant site practitioners
for telehealth services at Sec. 410.78(b)(2)(viii), and to add the
three individual MNT services to the Medicare telehealth services list
by adding ``individual medical nutrition therapy'' to Sec.
414.65(a)(1). In the CY 2011 PFS final rule, we also added one of the
group MNT codes (97804) to the Medicare telehealth services list (75 FR
73314 through 73315).
In the CY 2011 PFS final rule, (75 FR 73412 through 73430), we
implemented the amendments made by section 4104 of the ACA, which were
designed to remove financial barriers that may have prevented
beneficiaries from obtaining certain preventive services. Section 4104
of the ACA amended section 1833(a)(1) of the Act by adding a new
subparagraph (Y), which provides for Medicare Part B payment at 100
percent for preventive services described in section 1861(ddd)(3)(A) of
the Act that are recommended with a grade of A or B by the United
States Preventive Services Task Force (USPSTF); and, amended section
1833(b)(1) of the Act to specify that the annual Medicare Part B
deductible does not apply to preventive services with a recommended
grade of A or B by the USPSTF. Section 1861(ddd)(3) of the Act defines
``preventive services'' and includes MNT services as a preventive
service through a cross references section 1861(ww)(2) of the Act.
Additionally, section 4104 of the ACA amended section 1833(a)(1)(T) of
the Act to specify that Medicare Part B payment is made at 100 percent
(instead of 80 percent) of the lesser of the actual charge or 85
percent of the PFS payment amount for these services if they are
recommended with an A or B rating by the USPSTF, thereby removing
beneficiary coinsurance for these services. In the CY 2011 PFS final
rule, we listed all preventive services and their recommended ratings
from the USPSTF in Table 66 (66 FR 73420 through 73430), noting that
all 5 MNT services received a grade of B from the USPSTF; and the last
column in the table noted that the coinsurance and deductible are not
applicable to these services beginning January 1, 2011. We codified the
coinsurance exception for MNT services at Sec. 410.152(l)(7) to
indicate that Medicare Part B pays 100 percent of the Medicare payment
amount, and the exception for the Medicare Part B deductible at Sec.
410.160(b)(11).
At that time, the preventive services coinsurance and deductible
changes were implemented through Change Request 7012 (Transmittal 864);
however, we neglected to update the payment regulation for MNT services
at Sec. 414.64(a). As a result, we are now proposing to modify to the
requirement at Sec. 414.64(a) for payment of MNT services to reflect
that MNT services, with their USPSTF recommended B rating, are paid at
100 percent of the lesser of the actual charges or 85 percent of the
PFS amount.
Because the registered dietitian and nutrition professional are the
only practitioners listed at section 1842(b)(18)(C) of the Act without
a specific regulatory provision addressing them as a type of
practitioner and specifying payment policies for their services, we are
proposing to create a new section at Sec. 410.72 to reflect these
policies. We are proposing to include in the regulation at Sec. 410.72
a cross reference to the regulation at Sec. 410.134 that addresses the
qualifications for registered dietitians and nutrition professionals.
For covered services described at Sec. 410.72(b), we are proposing as
a condition of coverage to refer to medical nutrition therapy services
as defined at Sec. 410.130, and also to refer to the conditions for
coverage of MNT services at Sec. 410.132(a). Section 410.132(a)
requires a referral for MNT services from a physician (an M.D. or
D.O.), and that MNT services are personally performed by the registered
dietitian or nutrition professional in a face-to-face encounter except
when those services are furnished as a telehealth service as provided
in Sec. 410.78 of our regulations.
Because registered dietitians and nutrition professionals are also
the primary specialty that furnishes diabetes self-management training
(DSMT) services, we are proposing to include DSMT at Sec. 410.72(b)(2)
as an ``other service'' that registered dietitians and nutrition
professionals can provide in cases where the registered dietitian or
nutrition professional is a certified provider of DSMT services as
specified at section 1861(qq)(2)(A) of the Act; and they have submitted
necessary documentation to, and are accredited by, a CMS-approved
accreditation organization, as specified in Sec. 410.141(e) for DSMT
services. We also propose to address in the regulation at Sec.
410.72(b)(2) the current requirement that, as specified in the
regulation at Sec. 410.141(b)(1), DSMT services require a referral
from the physician or qualified NPP (as defined in Sec. 410.32(a)(2))
who is treating the beneficiary's diabetes condition. We also propose
to specify in the regulation at Sec. 410.72(b)(3) that MNT and DSMT
services cannot be furnished together on the same date of service as
detailed in the national coverage determination for MNT services (see
https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=252); and, that neither MNT nor DSMT services can be
furnished incident to the professional services of a physician or other
practitioner. For MNT services, we are proposing to clarify that MNT
services cannot be provided incident to the services of a billing
physician. As a distinct, stand-alone benefit under Medicare Part B at
section 1861(s)(2)(V) of the Act, MNT services cannot be furnished
incident to a physician's professional service that is separately
specified at section 1861(s)(2)(A) of the Act. Further, if a physician
also meets the qualifications to bill Medicare as a registered
dietitian or nutrition professional (although not necessarily enrolled
as one), they would have to personally provide any MNT services as
explained above, meaning that those services could not be furnished by
auxiliary personnel incident to their own professional services. For
DSMT services, we are also proposing to clarify that DSMT services
cannot be provided incident to the services of a billing physician or
practitioner. DSMT is a distinct benefit under Medicare Part B, as
specified in a stand-alone statutory provision at section 1861(s)(2)(S)
of the Act. Approved DSMT entities are separately recognized programs,
rather than individuals or practitioners, that provide DSMT services in
accordance with their accreditation from a CMS-approved organization
under Sec. 410.142, indicating that the entity meets a set of quality
standards described in Sec. 410.144. Even when the DSMT services are
billed by a physician or other practitioner, such as the DSMT certified
provider, the physician or other practitioner could not provide
[[Page 39229]]
DSMT services directly, unless they themselves are also an approved
DSMT entity. If a physician or practitioner is an approved entity, the
DSMT services must be provided in accordance with the requirements to
furnish such services. For these reasons, we are adding at Sec.
410.72(b)(3)(ii) that neither MNT nor DSMT may be furnished and billed
incident to the professional services of a physician or practitioner,
where applicable.
As such, we are proposing to add at 410.72(d) that the registered
dietitian or nutrition professional can be paid for their professional
services only if those services have been personally performed by them.
Section 1861(vv) of the Act clearly indicates that MNT services are
only provided by registered dietitians and nutrition professionals; and
this was reiterated at Sec. 410.134 in the CY 2002 PFS final rule (66
FR 55331). In addition, in the CY 2002 PFS final rule, we established a
regulation at Sec. 410.132(a) that requires registered dietitians and
nutrition professionals to provide MNT services and that those services
consist of face-to-face nutritional assessments and interventions in
accordance with nationally accepted dietary or nutritional protocols.
Both of these provisions were codified in our regulations at Sec. Sec.
410.132(a) and 410.134.
In the CY 2001 PFS final rule, we discussed that registered
dietitians and nutrition professionals who are enrolled in Medicare
could furnish services in various settings including private practices
and outpatient hospitals, but that payment for MNT services would not
be made when beneficiaries are inpatients in Part A stays in hospitals
and skilled nursing facilities (SNFs) (66 FR 55279). We explained that
our payment to hospitals and SNFs includes payment for MNT services. We
established these regulations at Sec. 414.64(c). We are proposing to
add these rules to our regulation at Sec. 410.72(c)(1) and (2), as on
payment for services of registered dietitians and nutrition
professionals when beneficiaries are inpatients of hospitals and SNFs.
Also, in the CY 2001 PFS final rule, we finalized, in accordance with
section 1861(s)(2)(V)(ii) of the Act, that there is no coverage for MNT
services available for beneficiaries who are receiving maintenance
dialysis for which payment is made under section 1881 of the Act, that
is, services from an end-stage renal disease (ESRD) facility. This was
codified at Sec. 410.132(b). We are proposing to add this non-covered
service to our regulation at Sec. 410.72(c)(3) and note its cross
reference to Sec. 410.132(b).
In accordance with section 1842(b)(18)(B) of the Act, the
registered dietitian or nutrition professional must accept assignment,
meaning that they must accept the payment amount Medicare approves as
payment in full and collect nothing from the beneficiaries for those
services for which Medicare pays 100 percent of the Medicare approved
amount or only collect the difference between the Medicare approved
amount and the Medicare Part B payment in accordance with Sec. 424.55.
We are proposing to add at Sec. 410.72(f) that the services of a
registered dietitian or nutrition professional are provided on an
assignment-related basis. Because Medicare pays 100 percent of the
Medicare approved amount for MNT covered services, this means that
beneficiaries cannot be billed any amount for MNT covered services. For
other services, including DSMT, for which the Medicare Part B
coinsurance percentage is 20 percent, a registered dietitian or
nutrition professional must not collect amounts in excess of the limits
specified in Sec. 424.55 of our regulation, and if they do, they must
refund the full amount of the impermissible charge to the beneficiary.
Finally, we note that the proposed regulatory text for Sec. 410.72(f)
is consistent with the text in existing Sec. Sec. 410.74(d)(2),
410.75(e)(2), 410.76(e)(2) and 410.77(d)(2). We are also considering
whether alternate regulatory text that cross-refers to the assignment
requirements in Sec. 424.55 would provide additional clarity.
Specifically, we are considering whether to specify restrictions at
Sec. 410.72(f) to specify that the services of a registered dietitian
or nutrition professional are provided on an assignment-related basis,
and the registered dietitian or nutrition professional may not charge a
beneficiary in excess of the amounts permitted under 42 CFR 424.55. In
addition, if a beneficiary has made payment for a service in excess of
these limits, the registered dietitian or nutrition professional must
refund the full amount of the impermissible charge to the beneficiary.
To ensure maximum consistency in our regulations, if we finalize
the alternate regulatory text for Sec. 410.72(f), we would also make
corresponding revisions to Sec. Sec. 410.74(d)(2), 410.75(e)(2),
410.76(e)(2) and 410.77(d)(2). We seek public comments on the clearest
language to describe the assignment requirements.
We are seeking comment on our proposals.
III. Other Provisions of the Proposed Rule
A. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)
1. Background
a. RHC and FQHC Payment Methodologies
As discussed in 42 CFR part 405, subpart X, RHC and FQHC visits
generally are face-to-face encounters between a patient and one or more
RHC or FQHC practitioners during which one or more RHC or FQHC
qualifying services are furnished. RHC and FQHC practitioners are
physicians, nurse practitioners (NPs), physician assistants (PA),
certified nurse midwives (CNMs), clinical psychologists (CPs), and
clinical social workers, and under certain conditions, a registered
nurse or licensed practical nurse furnishing care to a homebound RHC or
FQHC patient in an area with a shortage of home health agencies. A
Transitional Care Management (TCM) service can also be an RHC or FQHC
visit. In addition, a Diabetes Self-Management Training (DSMT) service
or a Medical Nutrition Therapy (MNT) service furnished by a certified
DSMT or MNT program may also be considered an FQHC visit. Only
medically necessary medical, mental health, or qualified preventive
health services that require the skill level of an RHC or FQHC
practitioner are RHC or FQHC billable visits. Services furnished by
auxiliary personnel (for example, nurses, medical assistants, or other
clinical personnel acting under the supervision of the RHC or FQHC
practitioner) are considered incident to the visit and are included in
the per-visit payment.
RHCs generally are paid an all-inclusive rate (AIR) for all
medically necessary medical and mental health services and qualified
preventive health services furnished on the same day (with some
exceptions). The AIR is subject to a payment limit, meaning that an RHC
will not receive any payment beyond the specified limit amount. As of
April 1, 2021, all RHCs are subject to a payment limit for the AIR, and
this limit will be determined for each RHC in accordance with section
130 of the Consolidated Appropriations Act, 2021, described below.
FQHCs were paid under the same AIR methodology until October 1,
2014. Beginning that date, in accordance with section 1834(o) of the
Act (as added by section 10501(i)(3) of the Affordable
[[Page 39230]]
Care Act), they began to transition to an FQHC PPS system in which they
are paid based on the lesser of the FQHC PPS rate or their actual
charges. The FQHC PPS rate is adjusted for geographic differences in
the cost of services by the FQHC PPS geographic adjustment factor
(GAF). The rate is increased by 34 percent when an FQHC furnishes care
to a patient that is new to the FQHC, or to a beneficiary receiving an
initial preventive physical examination (IPPE) or has an annual
wellness visit (AWV).
Both the RHC AIR and FQHC PPS payment rates were designed to
reflect the cost of all services and supplies that an RHC or FQHC
furnishes to a patient in a single day. The rates are not adjusted for
the complexity of the patient health care needs, the length of the
visit, or the number or type of practitioners involved in the patient's
care.
2. Payment Methodology for RHCs
a. Background
As we discussed previously, under Medicare Part B, payment to RHCs
for services (defined in Sec. 405.2411) furnished to beneficiaries is
made on the basis of an all-inclusive payment methodology subject to a
maximum payment per-visit (discussed in section III.A.3. of this
proposed rule) and annual reconciliation. Our regulations, at Sec.
405.2470 provides that RHCs are required to submit cost reports to
allow the Medicare Administrative Contractor (MAC) to determine payment
in accordance with 42 CFR part 405, subpart X, and instructions issued
by CMS. The statutory payment requirements for RHC services are set
forth at section 1833(a)(3) of the Act, (as amended by the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 \51\),
which states that RHCs are paid reasonable costs ``* * * less the
amount a provider may charge as described in clause of section
1866(a)(2)(A), but in no case may the payment exceed 80 percent of such
costs. The beneficiary is responsible for the Medicare Part B
deductible and coinsurance amounts. Section 1866(a)(2)(A)(ii) of the
Act and implementing regulations at Sec. 405.2410(b) establish
beneficiary coinsurance at an amount not to exceed 20 percent of the
clinic's reasonable charges for covered services.
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We explain in Sec. 405.2464(a) the AIR is determined by the MAC at
the beginning of the cost reporting period. The MAC calculates the AIR
that will apply for the upcoming cost reporting period for each RHC by
dividing the estimated total allowable costs by estimated total visits
for RHC services. The MAC also periodically reviews the AIR throughout
the cost reporting period to assure that payments approximate actual
allowable costs and visits and may adjust the rate. Productivity,
payment limits, and other factors are also considered in the
calculation. Allowable costs must be reasonable and necessary and may
include practitioner compensation, overhead, equipment, space,
supplies, personnel, and other costs incident to the delivery of RHC
services (Sec. 405.2468).
Medicare payment for RHC services are ultimately determined at cost
report settlement. That is, during the annual reconciliation as
explained in Sec. 405.2466, MACs determine the total reimbursement
amount due the RHC for covered services furnished to Medicare
beneficiaries based on the reporting period. The total reimbursement
amount due is compared with total payments made to the RHC for the
reporting period, and the difference constitutes the amount of the
reconciliation. If the total reimbursement due the RHC exceeds the
payments made for the reporting period, the MAC makes a lump-sum
payment to the RHC to bring total payments into agreement with total
reimbursement due the RHC. If the total payments made to an RHC for the
reporting period exceed the total reimbursement due the RHC for the
period, the MAC arranges with the RHC for repayment.
In the event a new RHC is in its initial reporting period, and the
MAC does not have a cost report to set its AIR, the RHC provides the
MAC an estimate of what it expects its costs to be for its initial
reporting period. In the Provider Reimbursement Manual (Pub. 15-2),
chapter 46, section 4600,\52\ we explain that for an RHC's initial
reporting period, the clinic completes the cost report's worksheets
with estimates of costs and visits and other information required by
the reports. The MAC uses these estimates to determine an interim rate
of payment for the RHC. This interim rate may be adjusted throughout
the reporting period. Following the end of the RHC's reporting period,
the RHC is required to submit its worksheets, using data based on its
actual experience for the reporting period. The AIR for the following
year will then be based on the RHC's actual experience.
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As discussed in Pub. 100-02, Chapter 13, section 80.2,\53\ when
RHCs are part of the same organization with more than one RHC, they may
elect to file consolidated cost reports rather than individual cost
reports. Under this type of reporting, each RHC in the organization
need not file individual cost reports. Rather, the group of RHCs may
file a single report that accumulates the costs and visits for all RHCs
in the organization. In order to qualify for consolidation reporting,
all RHCs in the group must be owned, leased, or through any other
agreement, controlled by one organization.
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3. RHC Payment Limit Per-Visit
a. Background
Prior to the Balanced Budget Act of 1997 \54\ (BBA), the payment
methodology for an RHC depended on whether it was ``provider-based'' or
``independent.'' Specifically, payment to provider-based RHCs for
services furnished to Medicare beneficiaries was made on a reasonable
cost basis by the provider's MAC in accordance with the regulations at
42 CFR part 413; whereas payment to independent RHCs for services
furnished to Medicare beneficiaries was made on the basis of a uniform
all-inclusive rate payment methodology in accordance with 42 CFR part
405, subpart X. In addition, payment to independent RHCs also was
subject to a maximum payment per visit (also referred to as a ``payment
limit per-visit'', ``upper payment limit per-visit'', or ``cap'') as
set forth in section 1833(f) of the Act. This national statutory
payment limit was set at $46 and was adjusted annually based on the
Medicare Economic Index (MEI) described in section 1842(b)(3) of the
Act.
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Section 1833(f) of the Act was further amended by section 4205(a)
of the BBA) (Pub. L. 105-33) to permit an exception to the national
statutory payment limit for RHCs based in rural hospitals with less
than 50 beds. Our guidance directed Medicare intermediaries to use the
bed definition at Sec. 412.105(b) and the rural definition at Sec.
412.62(f)(1) to determine which RHCs are eligible for the exception.
The hospital bed definition was based on available bed days and the
rural definition was based on the Office of Management and Budget's
[[Page 39231]]
metropolitan statistical area (MSA) method.
Section 224 of the Medicare, Medicaid and SCHIP Benefits
Improvement and Protection Act of 2000 (Appendix F of Consolidated
Appropriations Act of 2001) (BIPA) \55\ (Pub. L. 106-554, December 21,
2000) further amended section 1833(f) of the Act by expanding the
eligibility criteria for receiving an exception to the national
statutory payment limit for RHCs. Specifically, this section of BIPA
extended the exemption to RHCs based in small, urban hospitals.
Effective July 1, 2001, all hospitals of less than 50 beds were
eligible to receive an exception from the per visit payment limit for
their RHCs.
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As discussed in Change Request 1958, Transmittal A-01-138 issued on
December 6, 2001, following the implementation of the BBA provision,
CMS announced an alternative bed size definition for very rural, sole
community hospitals with seasonal fluctuations in patient census. The
MAC reviews the number of beds twice a year to determine whether the
provider-based RHC meets the exception, during the Desk Review process
and during the interim rate process (that is, determining the RHC's
AIR). The provider-based RHC continues to receive the exception until
the hospital which they are affiliated with submits a cost report with
more than 50 beds. However, in the May 8, 2020 Federal Register, in
response to the PHE for COVID-19, we published the ``Medicare and
Medicaid Programs, Basic Health Program, and Exchanges; Additional
Policy and Regulatory Revisions in Response to the COVID-19 Public
Health Emergency and Delay of Certain Reporting Requirements for the
Skilled Nursing Facility Quality Reporting Program'' interim final rule
with comment period (85 FR 27550) (May 8, 2020 IFC). In the May 8, 2020
IFC, we implemented, on an interim basis, a change to the period of
time used to determine the number of beds in a hospital at Sec.
412.105(b) for purposes of determining which provider-based RHCs are
subject to the payment limit (85 FR 27569). That is, for the duration
of the PHE, we adopted an interim final policy to use the number of
beds from the cost reporting period prior to the start of the PHE as
the official hospital bed count for application of this policy. As
such, RHCs with provider-based status that were exempt from the
national statutory payment limit in the period prior to the effective
date of the PHE (January 27, 2020) would continue to be exempt from the
bed count requirement for the duration of the PHE for the COVID-19
pandemic, as defined at Sec. 400.200, even if the hospital raised its
bed count above 50. Once the PHE for COVID-19 ends, hospitals need to
lower their bed count to less than 50 beds to utilize an RHC policy
that has such a requirement.
b. Section 130 of the Consolidated Appropriations Act, 2021
Section 130 of the Consolidated Appropriations Act, 2021 (CAA 2021)
(Pub. L. 116-260, December 27, 2020) updated section 1833(f) of the Act
by restructuring the payment limits for RHCs beginning April 1, 2021.
We note that section 2 of H.R. 1868 (Pub. L. 117-7), enacted April 14,
2021, provided a technical correction to section 1833(f) of the Act.
The amendments made by this technical correction take effect as if
included in the enactment of the Consolidated Appropriations Act of
2021 (Pub. L. 116-260).
Section 1833(f)(2) of the Act, as added by section 130 of the CAA
2021, states that beginning April 1, 2021, RHCs will begin to receive
an increase in their payment limit per visit over an 8-year period,
with a prescribed amount for each year from 2021 through 2028. Then, in
a subsequent year, at the limit established for the previous year
increased by the percentage increase in the MEI applicable to primary
care services furnished as of the first of such subsequent year. This
provision also subjects all new RHCs (including provider-based RHCs in
a hospital with less than 50 beds and enrolled in Medicare after
December 31, 2020) to the national statutory payment limit.
The national statutory payment limit for RHCs over an 8-year period
is as follows:
In 2021, after March 31, at $100 per visit;
In 2022, at $113 per visit;
In 2023, at $126 per visit;
In 2024, at $139 per visit;
In 2025, at $152 per visit;
In 2026, at $165 per visit;
In 2027, at $178 per visit; and
In 2028, at $190 per visit.
Beginning April 1, 2021, provider-based RHCs that meet the
qualifications in section 1833(f)(3)(B) of the Act, as added by section
130 of the CAA 2021 and amended by Public Law 117-7, are entitled to
special payment rules, as described in section 1833(f)(3)(B) of the
Act. That is, a provider-based RHC must meet the following criteria to
have its payment limit established based on its per visit payment
amount (or AIR):
As of December 31, 2020, was in a hospital with less than
50 beds and after December 31, 2020 in a hospital that continues to
have less than 50 beds (not taking into account any increase in the
number of beds pursuant to a waiver during the PHE for COVID-19); and
one of the following circumstances:
++ As of December 31, 2020, was enrolled in Medicare (including
temporary enrollment during the PHE for COVID-19); or
++ Submitted an application for enrollment in Medicare (or a
request for temporary enrollment during the PHE for COVID-19) that was
received not later than December 31, 2020.
Specifically, beginning April 1, 2021, for provider-based RHCs that
had a per visit payment amount (or AIR) established for services
furnished in 2020, the payment limit per visit shall be set at an
amount equal to the greater of: (1) The per visit payment amount
applicable to such RHC for services furnished in 2020, increased by the
percentage increase in the MEI applicable to primary care services
furnished as of the first day of 2021; or (2) the national statutory
payment limit for RHCs per visit. The details of the most recent MEI
rebasing and revising is discussed in the CY 2011 PFS final rule with
comment period (75 FR 73262). The MEI increase for an update year is
based on historical data through the second quarter of the prior
calendar year. For example, the 2021 update reflects data through the
second quarter 2020. We note that the MEI percentage increase for CY
2021 is 1.4 percent, which reflects historical MEI data through the 2nd
quarter 2020 and historical multifactor productivity (MFP) data through
2019. IGI is a nationally recognized economic and financial forecasting
firm with which we contract to forecast the components of the MEI and
other CMS market baskets, https://ihsmarkit.com/index.html.
In a subsequent year (that is, after 2021), the provider-based
RHC's payment limit per visit shall be set at an amount equal to the
greater of: (1) The payment limit per visit established for the
previous year, increased by the percentage increase in the MEI
applicable to primary care services furnished as of the first day of
such subsequent year; or (2) the national statutory payment limit for
RHCs. The proposed CY 2022 MEI update is 1.8 percent based on the IGI
1st quarter 2021 forecast of the MEI and productivity adjustment, which
reflects historical MEI data through 4th quarter 2020 and historical
MFP data through 2019. As is our general practice, we are
[[Page 39232]]
proposing that if more recent data become available after the
publication of this proposed rule and before the publication of the
final rule (for example, a more recent estimate of the MEI percentage
increase or productivity adjustment), we would use such data, if
appropriate, to determine the final CY 2022 MEI update.
For provider-based RHCs that meet certain requirements, but did not
have a per visit payment amount (or AIR) established for services
furnished in 2020, the payment limit per visit shall be at an amount
equal to the greater of: (1) The per visit payment amount applicable to
the provider-based RHC for services furnished in 2021; or (2) the
national statutory payment limit for RHCs.
In a subsequent year (that is, after 2022), the provider-based RHCs
payment limit per visit will be the greater of: (1) The payment limit
per visit established for the previous year, increased by the
percentage increase in MEI applicable to primary care services
furnished as of the first day of such subsequent year; or (2) the
national statutory payment limit for RHCs.
A provider-based RHC that meets the qualifications of section
1833(f)(3)(B) of the Act, as corrected by Public Law 117-7 will lose
this designation if the hospital does not continue to have less than 50
beds, beyond the exemptions provided for the PHE for COVID-19. If this
occurs, the provider-based RHC will be subject to the statutory payment
limit per visit applicable for such year and not able to regain the
specified provider-based payment limit.
Provider-based RHCs that are newly enrolled beginning January 1,
2021, and after are subject to the national statutory payment limit
applicable for such year for RHCs.
c. Implementation of Section 130 of the Consolidated Appropriations
Act, 2021
As we stated above, RHCs began to receive an increase in the
national statutory payment limit over an 8-year period, with a
prescribed amount for each year from 2021 through 2028. Prior to this
legislation, the CY 2020 national statutory payment limit for RHCs was
$86.31. Then for calendar year 2021, there are two sets of payment
rules for RHCs. For the period before March 31, 2021, independent RHCs
and provider-based RHCs that did not meet specified requirements were
subject to the payment limit of $87.52 that CMS announced in Change
Request 12035, Transmittal 10413 issued on October 29, 2020.\56\
Provider-based RHCs that met specified requirements were not subject to
a payment limit for the first quarter of calendar year 2021. However,
beginning April 1, 2021, in accordance with section 130 of the CAA
2021, all RHCs are now subject to a payment limit. For example,
beginning April 1, 2021 through December 31, 2021 the national
statutory payment limit for RHCs is $100.00. To prepare for this change
in payment limits during the calendar year, Change Request 12185,
Transmittal 10679 was issued on March 16, 2021, to implement an
increase in the RHC statutory payment limit per visit and establish the
provider-based RHC payment limits per visit, which went in effect on
April 1, 2021. We note, Change Request 12185, Transmittal 10679 was
rescinded and replaced by Transmittal 10780 issued on May 4, 2021 to
reflect the technical corrections in section 2 of H.R. 1868 (Pub. L.
117-7). We also note that this provision does not impact the way
beneficiary coinsurance is calculated as described in Sec.
405.2410(b)(1).
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i. Specified Provider-Based RHCs
In section III.A.3.b. of this proposed rule, we discuss the
qualifications specified in section 1833(f)(3)(B) of the Act, as
amended by Public Law 117-7, that determine if a provider-based RHC is
entitled to the special payment rules described in section
1833(f)(3)(A) of the Act. To determine if an RHC was in a hospital with
less than 50 beds as of December 31, 2020, we will review each
provider-based RHC using the existing bed count review process, as
described above, to determine if this criterion is met. In addition,
this process generally includes ongoing review by the MACs two times a
year. The beds to be counted for purposes of this criterion are
described in Sec. 412.105(b), in accordance with existing policy.
In continuing with our existing policy and in accordance with
section 1833(f)(3)(B)(i) of the Act which states that ``as of December
31, 2020, was in a hospital with less than 50 beds and after such date
such hospital continues to have less than 50 beds'' an RHC will retain
its specified provider-based status until the hospital which they are
affiliated submits a cost report with more than 50 beds. An RHC will no
longer retain its specified provider-based status nor be eligible for
specified status in the future once the hospital which they are
affiliated submits a cost report with more than 50 beds. However, in
response to the PHE for COVID-19 and in accordance with section
1833(f)(3)(B)(I) of the Act, we will apply the policy that allows for
increased hospital bed counts, as described in the May 8, 2020 IFC, for
purposes of determining this bed count criterion for specified
provider-based RHC status. That policy specifies that for the duration
of the PHE, we will use the number of beds from the cost reporting
period prior to the start of the PHE as the official hospital bed
count. We note that the criteria specified in section 1833(f)(3)(B)(i)
of the Act specifies ``in a hospital with less than 50 beds''
therefore, beginning April 1, 2021, we will apply the bed definition at
Sec. 412.105(b) exclusively.
Section 1833(f)(3)(B)(ii) of the Act, as added by section 2 of
Public Law 117-7, requires that these specified provider-based RHCs as
of December 31, 2020 are ``enrolled under 1866(j) (including temporary
enrollment during such emergency period for such emergency period),''
or ``submitted an application for enrollment under section 1866(j) of
the Act (or a request for such a temporary enrollment for such
emergency period) that was received not later than December 31, 2020.''
We propose that the RHC's effective date of enrollment (as established
under existing regulations) would be used in our determination as to
whether an RHC is enrolled under section 1866(j) of the Act as of
December 31, 2020. In addition, with regard to an application for
enrollment under section 1866(j) of the Act or a request for temporary
enrollment, we propose to use the date an application or request was
received to determine if the RHC met the qualification. RHCs that
established temporary locations for the purpose of responding to the
PHE for COVID-19, in accordance with their state pandemic response
plan, are permitted to enroll and receive temporary Medicare billing
privileges. When the PHE for COVID-19 ends, an RHC that had been
temporarily enrolled under the flexibilities described above must
submit a complete CMS-855 enrollment application in order to establish
full Medicare billing privileges. Failure to do so will result in the
deactivation of the RHC's temporary billing privileges. No payments can
be made for services provided while the temporary billing privileges
are deactivated. For RHCs enrolled through the temporary enrollment
process that will need to submit a complete CMS-855 enrollment
application, we propose, regardless of when the temporarily enrolled
RHC is fully enrolled, that the RHC would be entitled to the special
payment rules as long as it was
[[Page 39233]]
temporarily enrolled as of December 31, 2020 or a temporary enrollment
request was received by December 31, 2020, and it meets the bed count
requirement.
As stated above, section 1833(f)(3)(A) of the Act instructs
Medicare to set payment limits per visit for these specified provider-
based RHCs under certain payment rules. Specifically, beginning April
1, 2021, a payment limit per visit shall be set at an amount equal to
the greater of: (1) The per visit payment amount applicable to such RHC
for services furnished in 2020, increased by the percentage increase in
the MEI applicable to primary care services furnished as of the first
day of 2021; or (2) the statutory payment limit per visit as described
in section 1833(f)(2) of the Act. For subsequent years, in accordance
with section 1833(f)(3)(A)(ii) of the Act, that payment amount is
increased by the percentage increase in the MEI or the statutory
payment limit described in section 1833(f)(2) of the Act, whichever is
greater.
We interpret the ``per visit payment amount'' to align with the
interim rate process the MACs use in determining an RHC's AIR
(discussed above in section III.A.2. of this proposed rule). That is,
as explained in Sec. 405.2464(a) the AIR is determined by the MAC
using the most recently available cost report. Therefore, with regard
to ``services furnished in 2020'' we interpret this to mean the period
at which the services were furnished in 2020 and that costs for those
services were reported. We understand that there may be more than one
cost report that reports costs for services furnished in calendar year
2020. However, since section 130 of the CAA 2021 states that the ``per
visit payment amount'' is to be increased by the CY 2021 MEI, if a
provider has a cost reporting period that differs from a calendar year
time-period then the MACs should use data based on the relevant cost
report period ending in 2020.
Finally, we understand that certain RHCs file consolidated cost
reports, as described above. For specified provider-based RHCs,
existing RHCs that are independent, and existing RHCs that are in a
hospital with greater than 50 beds, we will continue to use the parent
RHCs' cost reports to determine the payment limit per visit (for multi-
facility RHC systems), as consolidated cost reporting reduces the
reporting burden and cost report preparation time for RHCs. Combining
multiple individual RHC cost reports into a consolidated cost report
allows RHCs to take advantage of administrative efficiencies and
economies of scale that do not exist otherwise.
However, in accordance with section 1833(f)(2) of the Act, all new
provider-based RHCs and independent RHCs enrolled, as of January 1,
2021, shall have a payment limit established at the national statutory
payment limit for RHCs. Therefore, beginning with RHCs enrolled in
Medicare as of January 1, 2021, we will no longer allow new RHCs to
file consolidated cost reports.
ii. All Other RHCs
While there are criteria that allow for specified provider-based
RHCs to be eligible for certain payment rules, all other RHCs are
subject to payment limits as described in section 1833(f)(2) of the
Act. While there may be new RHCs that are ``in a hospital with less
than 50 beds'' and ``enrolled under section 1866(j)'', they will not
have met these criteria by December 31, 2020. Thus, any new RHCs will
also be subject to the national statutory payment limits as described
in section 1833(f)(2) of the Act.
Though the payment limit is described, these RHCs will still have
an AIR per visit determined based on their allowable costs for each
year going forward. However, the payment limit that is established will
be the maximum amount that an RHC will be paid by Medicare per visit.
As discussed above, at the time of reconciliation, if an RHC's costs
per visit are above the AIR, they will be paid an amount that reflects
these additional costs, not to exceed the payment limit. If an RHC's
costs per visit are below the AIR, then CMS will collect any
overpayment for that visit. To implement this provision beginning April
1, 2021, CMS instructed the MACs to increase the payment limits to $100
per visit.
Although the payment limit per-visit as set forth in section
1833(f) of the Act has already been implemented in administrative
instructions issued to the MACs in Change Request 12185, we are
proposing revisions to Sec. 405.2462 to reflect the provisions set
forth in section 1833(f)(2) and (3) of the Act. We solicit comment on
these revisions and on our proposals regarding the implementation of
section 130 of the CAA 2021.
3. Payment for Attending Physician Services Furnished by RHCs or FQHCs
to Hospice Patients
a. Background
In the Fiscal Year (FY) 2021 Hospice Payment Rate Update final rule
(85 FR 47070) we explain that hospice care is a comprehensive, holistic
approach to treatment that recognizes the impending death of a
terminally ill individual and warrants a change in the focus from
curative care to palliative care for relief of pain and for symptom
management. Palliative care is at the core of hospice philosophy and
care practices, and is a critical component of the Medicare hospice
benefit. The goal of hospice care is to help terminally ill individuals
continue life with minimal disruption to normal activities while
remaining primarily in the home environment.
A hospice uses an interdisciplinary approach to deliver medical,
nursing, social, psychological, emotional, and spiritual services
through a collaboration of professionals and other caregivers, with the
goal of making the beneficiary as physically and emotionally
comfortable as possible. As referenced in our regulations at Sec.
418.22(b)(1), to be eligible for Medicare hospice services, the
patient's attending physician (if any) and the hospice medical director
must certify that the individual is ``terminally ill,'' as defined in
section 1861(dd)(3)(A) of the Act and our regulations at Sec. 418.3;
that is, the individual's prognosis is for a life expectancy of 6
months or less if the terminal illness runs its normal course.
Section 1861(dd)(3)(B) of the Act defines the term ``attending
physician'' to mean, with respect to an individual, the physician, the
NP or PA who may be employed by a hospice program, whom the individual
identifies as having the most significant role in the determination and
delivery of medical care to the individual at the time the individual
makes an election to receive hospice care.
As explained in Pub. 100-02, chapter 9, section 20.1,\57\ the
attending physician is a doctor of medicine or osteopathy who is
legally authorized to practice medicine or surgery by the state in
which he or she performs that function, an NP, or PA, and is identified
by the individual, at the time he or she elects to receive hospice
care, as having the most significant role in the determination and
delivery of the individual's medical care. An NP is defined as a
registered nurse who performs such services as legally authorized to
perform (in the state in which the services are performed) in
accordance with state law (or state regulatory mechanism provided by
state law) and who meets training, education, and experience
requirements described in Sec. 410.75. A PA is defined as a
professional who has graduated from an accredited PA educational
program who
[[Page 39234]]
performs such services as he or she is legally authorized to perform
(in the state in which the services are performed) in accordance with
state law (or state regulatory mechanism provided by state law) and who
meets the training, education, and experience requirements as the
Secretary may prescribe. The PA qualifications for eligibility for
furnishing services under the Medicare program can be found in the
regulations at Sec. 410.74 (c).
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\57\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c09.pdf.
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RHCs and FQHCs are not authorized under the statute to serve in the
role of an attending physician. However, a physician, NP, or PA who
works for an RHC or FQHC may provide hospice attending physician
services during a time when they are not working for the RHC or FQHC
(unless prohibited by their RHC or FQHC contract or employment
agreement). These services would not be considered RHC or FQHC
services, since they are not being provided by an RHC or FQHC
practitioner during RHC or FQHC hours. The physician, NP, or PA would
bill for services under Part B using their own provider number/NPI. In
addition, any service provided to a hospice beneficiary by an RHC or
FQHC practitioner must comply with Medicare prohibitions on
commingling. Further information regarding commingling is available in
Pub. 100-02, Chapter 13, section 100.\58\
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\58\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c13.pdf.
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b. Section 132 of the Consolidated Appropriations Act 2021
Section 132 of the CAA 2021 amended section 1834(o) of the Act and
added a new section 1834(y) to the Act, to provide the authority for
both FQHCs and RHCs, respectively, to receive payment for hospice
attending physician services. Specifically, when a designated attending
physician employed by or working under contract with an FQHC or RHC
furnishes hospice attending physician services (as described in section
1812(d)(2)(A)(ii) of the Act) on or after January 1, 2022, the FQHC or
RHC is eligible to receive payment under the FQHC PPS or RHC AIR,
respectively.
Therefore, beginning January 1, 2022, a physician, NP, or PA who is
employed by or working under contract with an RHC or FQHC may provide
hospice attending physician services during a time when they are
working for the RHC or FQHC. The RHC or FQHC would bill for these
services as they would for any other qualified service to be paid the
RHC AIR or the FQHC PPS rate, respectively. When the RHC/FQHC furnishes
a hospice attending physician service that has a technical component,
the provider furnishing the technical component would go to the hospice
for payment as discussed in the Medicare Claims Processing Manual at
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c11.pdf.
We propose to codify the new statutory provisions as described in
section 132 of the CAA 2021 in 42 CFR 405, subpart X, specifically:
At Sec. 405.2411, Scope of benefits, we are amending
Sec. 405.2411(b) to reflect that hospice attending physician services
are covered when furnished during a patient's hospice election only
when provided by an RHC/FQHC physician, NP, or PA designated by the
patient at the time of hospice election as his or her attending
physician and employed or under contract with the RHC or FQHC at the
time the services are furnished.
At Sec. 405.2446, Scope of services, we are amending
Sec. 405.2446(c) to include that FQHC services are covered when they
are hospice attending physician services furnished during a hospice
election.
4. Concurrent Billing for Chronic Care Management Services (CCM) and
Transitional Care Management (TCM) Services for RHCs and FQHCs
a. Background
In the CY 2013 PFS final rule (77 FR 68978 through 68994), Medicare
payment for TCM services furnished by an RHC or FQHC practitioner was
effective January 1, 2013, consistent with the effective date of
payment for TCM services under the PFS. We adopted two CPT codes (99495
and 99496) to report physician or qualifying NPP care management
services for a patient following a discharge from an inpatient hospital
or SNF, an outpatient hospital stay for observation or partial
hospitalization services, or partial hospitalization in a community
mental health center. As a condition for receiving TCM payment, a face-
to-face visit was required.
In the CY 2016 PFS final rule with comment period (80 FR 71080
through 71088), we finalized policies for payment of CCM services in
RHCs and FQHCs. Payment for CCM services in RHCs and FQHCs was
effective beginning on January 1, 2016, for RHCs and FQHCs that furnish
a minimum of 20 minutes of qualifying CCM services during a calendar
month to patients with multiple (two or more) chronic conditions that
are expected to last at least 12 months or until the death of the
patient, and that would place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline. Payment was
made for CCM services when CPT code 99490 was billed alone or with
other payable services on an RHC or FQHC claim, and the rate was based
on the PFS national average non-facility payment rate. The requirement
that RHC or FQHC services be furnished face-to-face was waived for CCM
services furnished to an RHC or FQHC patient because CCM describes non
face-to-face services.
In the CY 2018 PFS final rule, (82 FR 53172 through 53180), we
finalized payment for CCM, general Behavioral Health Integration (BHI),
and the psychiatric collaborative care model (CoCM) services furnished
by RHCs or FQHCs on or after January 1, 2018, described by HCPCS codes
G0511 and G0512. HCPCS code G0511 is a General Care Management code for
use by RHCs or FQHCs when at least 20 minutes of qualified CCM or
general BHI services are furnished to a patient in a calendar month.
HCPCS code G0512 is a psychiatric CoCM code for use by RHCs or FQHCs
when at least 70 minutes of initial psychiatric CoCM services or 60
minutes of subsequent psychiatric CoCM services are furnished to a
patient in a calendar month. The payment amount for HCPCS code G0511 is
set at the average of the three national non-facility PFS payment rates
for the CCM and general BHI codes and updated annually based on the PFS
rates. The three codes are CPT code 99490 (20 minutes or more of CCM
services), CPT code 99487 (60 minutes or more of complex CCM services),
and CPT code 99484 (20 minutes or more of BHI services). The payment
amount for HCPCS code G0512 is set at the average of the two national
non-facility PFS payment rates for the CoCM codes and is updated
annually based on the PFS rates. The two codes are CPT code 99492 (70
minutes or more of initial psychiatric CoCM services) and CPT code
99493 (60 minutes or more of subsequent psychiatric CoCM services).
In the CY 2019 PFS final rule (83 FR 59687), we finalized that
effective January 1, 2019, the payment rate for HCPCS code G0511
(General Care Management Services) is set at the average of the
national non-facility PFS payment rates for CPT codes 99490, 99487,
99484, and 99491.
In the CY 2020 PFS final rule with comment period (84 FR 62692), we
added HCPCS code G2064 (30 minutes of PCM services furnished by
physicians or NPPs) and G2065 (30 minutes or more of PCM services
furnished by
[[Page 39235]]
clinical staff under the direct supervision of a physician or NPP) as a
general care management service and included it in the calculation of
HCPCS code G0511. Beginning January 1, 2021, the payment for HCPCS code
G0511 is set at the average of the national non-facility PFS payment
rates for CPT codes 99490, 99487, 99484, and 99491, and HCPCS codes
G2064 and G2065, and is updated annually based on the PFS rates.
Additional information on CCM requirements is available on the CMS Care
Management web page \59\ and on the CMS RHC \60\ and FQHC \61\ web
pages.
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\59\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
\60\ https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html.
\61\ https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
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Currently, RHCs and FQHCs may not bill for TCM services for a
beneficiary if another practitioner or facility has already billed for
CCM services for the same beneficiary during the same time-period.
b. Concurrent Billing for Chronic Care Management Services and TCM
Services for RHCs and FQHCs
In the CY 2020 PFS final rule (84 FR 62687), we finalized a policy
allowing suppliers paid under the PFS to concurrently bill care
management codes that were previously restricted from being billed with
TCM for services billed under the PFS. This included allowing
concurrent billing of TCM with 14 HCPCS codes, as well as CPT codes
99490 and 99491, which describe CCM services furnished under the PFS.
However, we did not extend this policy to care management services
furnished in RHCs or FQHCs at that time.
Consistent with changes made in the CY 2020 PFS final rule for care
management services billed under the PFS, for CY 2022, we are proposing
to allow RHCs and FQHCs to bill for TCM and other care management
services furnished for the same beneficiary during the same service
period, provided that all requirements for billing each code are met.
This would include the services described by HCPCS codes G0511 (General
Care Management for RHCs and FQHCs only) and G0512 (Psychiatric CoCM
code for RHCs and FQHCs only), which both describe a service period of
one calendar month. We believe that when medically necessary, these
services may complement each other rather than substantially
overlapping or duplicating services since TCM services are furnished
once within 30 days of a patient's discharge, whereas CCM services
require a more comprehensive care management plan, care coordination
and ongoing clinical care, and CoCM services describe care management
services specifically for behavioral health conditions. We note that
under this proposal, time and effort could not be counted more than
once.
4. Proposed Conforming Technical Changes to 42 CFR 405.2466
In the November 6, 2020 Federal Register, we published the
``Additional Policy and Regulatory Revisions in Response to the COVID-
19 Public Health Emergency'' interim final rule with request for
comment (85 FR 71145 through 71147) (hereinafter referred to as the
November 6, 2020 IFC). In the November 6, 2020 IFC, we implemented
section 3713 of the CARES Act (Pub. L 116-136, March 27, 2020), which
established Medicare Part B coverage and payment for a COVID-19 vaccine
and its administration.
As we discussed in that rule (85 FR 71147), section 3713 of the
CARES Act added the COVID-19 vaccine and administration to section
1861(s)(10)(A) of the Act in the same subparagraph as the influenza and
pneumococcal vaccines and their administration. Therefore, the Medicare
allowed amount and billing processes for COVID-19 vaccinations are
similar to those in place for influenza and pneumococcal vaccinations
across provider/supplier settings. The amendments made to section
1861(s)(10)(A) of the Act were effective on the date of enactment, that
is, March 27, 2020, and apply to a COVID-19 vaccine beginning on the
date that such vaccine is licensed under section 351 of the PHS Act (42
U.S.C. 262). A list of vaccines and their effective dates are updated
as they are available and located on the CMS website at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies. Although there were regulations
updated to reflect the changes set forth by the CARES Act, we
inadvertently did not revise the specific regulation text that applies
to RHCs and FQHCs.
Therefore, consistent with the changes described above, we are
proposing to make conforming technical changes to the applicable RHC
and FQHC regulations in 42 CFR part 405, subpart X, specifically:
At Sec. 405.2466, Annual reconciliation, we are proposing
to amend paragraph (b)(1)(iv) to include the COVID-19 vaccine in the
list of vaccines and their administration that would be paid at 100
percent of Medicare reasonable cost.
B. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)--Telecommunications Technology
1. Revising the Definition of an RHC and FQHC Mental Health Visit
a. Payment Rules for RHC and FQHC Visits and for Medicare Telehealth
Services
Section 1861(aa)(1) of the Act defines RHC services as physicians'
services and such services and supplies that are furnished as an
incident to a physician's professional service, and items and services
as well as certain vaccines and their administration. It also includes
services furnished by a PA, NP, clinical psychologist, or clinical
social worker and services and supplies furnished as incident to these
services as would otherwise be covered if furnished by a physician or
incident to a physician's service. In the case of an RHC in an area
with a home health agency shortage, part-time or intermittent nursing
care and related medical supplies may be furnished by a registered
professional nurse or licensed practical nurse to a homebound
individual under certain conditions. Section 1861(aa)(3) of the Act
defines FQHC services to include the specified RHC services and
preventive services as well as required primary preventive health
services.
As previously stated, RHC and FQHC visits are defined as medically-
necessary, face-to-face encounters between a patient and an RHC or FQHC
practitioner, during which time one or more RHC or FQHC qualifying
services are furnished. Services furnished must be within the
practitioner's state scope of practice, and only services that require
the skill level of the RHC or FQHC practitioner are considered RHC or
FQHC visits. The RHC and FQHC payment is based on the costs of all
services, except in certain circumstances, such as vaccines and their
administration.
RHCs are paid an all-inclusive rate (AIR) for medically-necessary
primary health care services, and qualified preventive health services,
furnished by an RHC practitioner. Medicare pays 80 percent of the RHC
AIR, subject to a payment limit. Services furnished incident to an RHC
professional service are included in the AIR and are not billed as a
separate visit. The professional component of a procedure is usually a
covered service, but is not a stand-alone billable visit. The costs of
covered services provided incident to a
[[Page 39236]]
billable visit may be included on the RHC cost report.
FQHCs are paid 80 percent of the lesser of the FQHC's charge or the
FQHC PPS payment rate. Except for grandfathered tribal FQHCs, the FQHC
PPS payment rate reflects a base rate that is the same for all FQHCs, a
geographic adjustment based on the location where services are
furnished, and other applicable adjustments. The FQHC PPS rate was
established based on the aggregate of FQHC total costs, and is updated
yearly by the FQHC market basket.
Under the PFS, Medicare makes payment to professionals and other
suppliers for physician's services, certain diagnostic tests, and some
preventive services. Section 1834(m) of the Act specifies for Medicare
telehealth services paid under the PFS, the payment amounts and
circumstances under which Medicare makes payment for a discrete set of
services, all of which must ordinarily be furnished in-person, when
they are instead furnished using interactive, real-time
telecommunication technology. When furnished under the telehealth
rules, many of these specified Medicare telehealth services are still
reported using codes that describe ``face-to-face'' services but are
furnished using audio/video, real-time communication technology instead
of in-person (82 FR 53006). Section 1834(m) of the Act also specifies
conditions related to which professionals can be paid by Medicare for
their professional services furnished via telehealth (referred to as
distant site practitioners) and the originating site (both setting of
care and geography) where a beneficiary is located while receiving
telehealth services furnished remotely by the physician or practitioner
through a telecommunications system. The regulation text at 42 CFR
410.78 describes a process for adding or deleting services to the list
of Medicare telehealth services through the annual PFS rulemaking
process and defines what technology may be used to furnish the service.
Under the permanent authority provided under section
1834(m)(4)(C)(ii) of the Act, RHCs and FQHCs, like hospitals, physician
offices, and other sites, are authorized to serve as originating sites
for eligible telehealth services. As defined in section
1834(m)(4)(C)(i) of the Act, the originating site is where the eligible
telehealth individual is located at the time the service is furnished
via a telecommunications system. As defined in section 1834(m)(4)(A) of
the Act, the distant site is where the physician or practitioner is
located at the time the service is provided via a telecommunications
system. Originating sites are paid an originating site facility fee
that is billed using HCPCS code Q3014 and is assigned a rate of $27.02
for CY 2021.
Section 3704 of the Coronavirus Aid, Relief, and Economic Security
Act (the CARES Act) (Pub. L. 116-136, March 27, 2020) directs the
Secretary to establish Medicare payment for telehealth services when
RHCs and FQHCs serve as the distant site during the public health
emergency (PHE) for COVID-19. Separately, section 3703 of the CARES Act
expanded CMS' emergency waiver authority to allow for a waiver of any
of the statutory telehealth payment requirements under section 1834(m)
of the Act for telehealth services furnished during the PHE.
Specifically, section 1834(m)(8)(B) of the Act, as added by the CARES
Act, requires that the Secretary develop and implement payment methods
for FQHCs and RHCs that serve as a distant site during the PHE for the
COVID-19 pandemic. The payment methodology outlined in the CARES Act
requires that rates shall be based on rates that are similar to the
national average payment rates for comparable telehealth services under
the Medicare PFS. CMS established rates based on the average amount for
all PFS telehealth services on the telehealth list, weighted by volume.
RHCs and FQHCs bill for these Medicare telehealth services using HCPCS
code G2025 and the rate for CY 2021 is $99.45. The temporary authority
under section 1834(m)(8) of the Act to pay RHCs and FQHCs for
furnishing distant site Medicare telehealth services expires when the
PHE for the COVID-19 pandemic is terminated. While they will continue
to be able to serve as an originating site for Medicare telehealth
services, the payment mechanism for the professional services of RHC
and FQHC practitioners will be FQHC and RHC payments under the
established methodology, that is the RHC AIR or the FQHC PPS.
b. Adoption of Telehealth Technologies for Mental Health Care
While not specific to RHC and FQHC telehealth services provided
during the PHE, according to MedPAC's report, Telehealth in Medicare
after the Coronavirus Public Health Emergency,\62\ there were 8.4
million telehealth services paid under the PFS in April 2020, compared
with 102,000 in February 2020. MedPAC also reported that during focus
groups held in the summer of 2020, clinicians and beneficiaries
supported continued access to telehealth visits with some combination
of in-person visits. They cited benefits of telehealth, including
improved access to care for those with physical impairments, increased
convenience from not traveling to an office, and increased access to
specialists outside of a local area. In their annual beneficiary
survey, over 90 percent of respondents who had a telehealth visit
reported being ``somewhat'' or ``very satisfied'' with their video or
audio visit, and nearly two-thirds reported being ``very satisfied.''
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\62\ http://medpac.gov/docs/default-source/reports/mar21_medpac_report_ch14_sec.pdf?sfvrsn=0.
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Widespread use of telecommunications technology to furnish services
during the PHE has illustrated interest within the medical community
and among Medicare beneficiaries in furnishing and receiving care
through the use of technology beyond the PHE. During the PHE for COVID-
19 pandemic, RHCs and FQHCs, much like other provider types, have had
to change how they furnish care in order to meet the needs of their
patients, and use of the temporary authority to bill Medicare for PFS
telehealth services has been widely utilized by RHCs and FQHCs during
the PHE. This shift in how care is furnished has prompted us to
reevaluate the regulations regarding visit requirements for encounters
between an RHC or FQHC patient and an RHC or FQHC practitioner to
ensure that they reflect contemporary medical practice.
Recently enacted legislation modified the circumstances under which
Medicare makes payment for mental health services furnished via
telehealth technology under the PFS following the PHE. Division CC,
section 123 of the Consolidated Appropriations Act of 2021 (CAA) (Pub.
L. 116-260, December 27, 2020) removed the domestic geographic
originating site restrictions and added the home of the individual as a
permissible originating site for telehealth services billed under the
PFS when furnished for the purposes of diagnosis, evaluation, or
treatment of a mental health disorder. This change correlates with a
growing acceptance of the use of technology in the provision of mental
health care. Clinicians furnishing telepsychiatry services at
Massachusetts General Hospital Department of Psychiatry during the PHE
observed several advantages of the virtual format for furnishing
psychiatric services, noting that patients with psychiatric pathologies
that interfere with their ability to leave home (for example,
immobilizing depression,
[[Page 39237]]
anxiety, agoraphobia, and/or time-consuming obsessive-compulsive
rituals) were able to access care more consistently since eliminating
the need to travel to a psychiatry clinic can increase privacy, and
therefore, decrease stigma-related barriers to treatment, potentially
bringing care to many more patients in need, as well as enhanced ease
of scheduling, decreased rate of no-shows, increased understanding of
family and home dynamics, and protection for patients and practitioners
with underlying health conditions.\63\
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\63\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7347331/.
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These findings are consistent with our analysis of Medicare claims
data that indicate that use of interactive communication technology for
mental health care is likely to continue to be in broad use beyond the
circumstances of the pandemic. According to our analysis of Medicare
Part B claims data for services furnished via Medicare telehealth under
the PFS during the PHE, use of telehealth for many professional
services spiked in utilization around April 2020 and diminished over
time; however, utilization was still higher than it was prior to the
PHE. In contrast, Medicare claims data suggests that for mental health
services both permanently and temporarily added to the Medicare
Telehealth list, subsequent to April 2020, the trend is toward
maintaining a steady state of usage over time. Given this information,
broad acceptance in the public and medical community, and the
relatively stable Medicare utilization of services during the entire
COVID-19 pandemic, we believe use of interactive communication
technology in furnishing mental health care is becoming an established
part of medical practice, very likely to persist well after the COVID-
19 pandemic, and available across the country under Medicare statute
for the range of professionals furnishing mental health care and paid
under the PFS.
c. Revising the Definition of an RHC and FQHC Mental Health Visit
We believe beneficiaries receiving mental health services from RHC
and FQHC practitioners should have the same access to mental health
care delivered via telecommunications technology as beneficiaries
receiving services from practitioners paid under the PFS. We also
believe that disruptions in access to mental health care from trusted
practitioners can be particularly problematic for Medicare
beneficiaries, especially when it results in fragmented care. However,
absent changes in the definition of mental health visits, RHCs and
FQHCs would no longer be paid by Medicare for mental health care
services delivered via telecommunications technology and would likely
resume furnishing solely in-person, face-to-face mental health visits
after the PHE, thereby removing the ability for beneficiaries to be
able to receive these services from RHC/FQHC practitioners if furnished
via interactive communication technology.
Because the definitions of RHC and FQHC services, as specified in
sections 1861(aa)(1) and (3) of the Act, respectively, refer
specifically to physicians' services, and services that would be
physicians' services, but are instead furnished by certain other types
of practitioners, we believe it would be consistent to align policies
to provide access to services furnished by RHCs and FQHCs similar to
PFS services, where appropriate and within statutory requirements. To
ensure that beneficiaries can access services furnished by RHCs and
FQHCs in a manner similar to mental health services under the PFS after
the PHE, we believe it is appropriate to consider modifying our
regulatory definition of a mental health visit to provide for remote
access to RHC and FQHC services. Therefore, to avoid both the
inequities in access to modes of care, and to avoid potentially
problematic interruptions to care or the negative consequences of
fragmented care, for CY 2022, we are proposing to revise the regulatory
requirement that an RHC or FQHC mental health visit must be a face-to-
face (that is, in person) encounter between an RHC or FQHC patient and
an RHC or FQHC practitioner to also include encounters furnished
through interactive, real-time telecommunications technology, but only
when furnishing services for the purposes of diagnosis, evaluation, or
treatment of a mental health disorder.
Additionally, similar to the discussion of proposals for mental
health services furnished under the PFS, as described in section II.D.
of this proposed rule, we believe that mental health telehealth
services furnished via audio-only communications technology would
increase access to care, especially in areas with poor broadband
infrastructure and among patient populations that either are not
capable of, or do not consent to, the use of devices that permit a two-
way, audio/video interaction. Therefore, in order to align with
proposals related to use of audio-only telecommunications technology to
furnish similar mental health services under the PFS, we are proposing
to allow RHCs and FQHCs to furnish mental health visits using audio-
only interactions in cases where beneficiaries are not capable of, or
do not consent to, the use of devices that permit a two-way, audio/
video interaction. We note that the decision related to a service being
furnished via telecommunications technology should be a patient-
centered choice and that providers/practitioners should not force or
impose services being furnished via telecommunications technology on
beneficiaries who prefer to receive the services in-person.
Additionally, some patients may prefer a hybrid whereby some mental
health services are in person, but other times they are done using
telecommunications technology. We believe that this decision should be
based on the clinical judgment of the practitioner, in consideration of
patient needs and preferences.
This proposed change would allow RHCs and FQHCs to report and be
paid for mental health visits furnished via real-time,
telecommunication technology in the same way they currently do when
these services are furnished in-person. This proposed expansion of
payable modes of mental health services furnished by RHCs and FQHCs
corresponds with the expanded availability for professionals paid for
Medicare Telehealth services under the PFS authorized by section 123 of
the CAA and using the technology available for use for corollary
services when paid under the PFS. This proposed revision would not
allow RHCs or FQHCs to report visits furnished using asynchronous
communications like email exchanges. Rather, RHCs and FQHCs would
continue to report and be paid for furnishing medically necessary
virtual communications services in accordance with the requirements for
HCPCS code G0071 (83 FR 59686). Also, this proposed change would not
allow RHCs and FQHCs to report Medicare telehealth services under
section 1834(m) of the Act or be paid under the PFS since RHCs and
FQHCs are not authorized to serve as distant site practitioners for
Medicare telehealth services once the PHE for the COVID-19 pandemic has
been terminated. In order to track utilization of mental health visits
furnished using communication technology, we are proposing that RHCs
and FQHCs would append the 95 modifier (Synchronous Telemedicine
Service Rendered via Real-Time Interactive Audio and Video
Telecommunications System) in instances where the service was furnished
using audio-video communication technology or a new
[[Page 39238]]
service level modifier in cases where the service was furnished audio-
only.
Additionally, we note that section 123 of the CAA also requires
that there be an in-person service within 6 months prior to the
furnishing of the telehealth service and at intervals thereafter as
specified by the Secretary for mental health services furnished via
Medicare telehealth under the PFS. We are seeking comment on whether we
should consider a similar requirement for mental health services
furnished by RHCs and FQHCs via telecommunications technology, or
whether this requirement may be especially burdensome for beneficiaries
receiving treatment at RHCs and FQHCs, particularly in rural areas. If
we were to establish a similar requirement for RHC and FQHC mental
health services, we could consider the proposal for Medicare telehealth
services described in section II.D. of this proposed rule that there be
an in-person service within 6 months prior to the furnishing of the
telecommunications service and that an in-person service (without the
use of telecommunications technology) be provided at least every 6
months while the beneficiary is receiving services furnished via
telecommunications technology for diagnosis, evaluation, or treatment
of mental health disorders, which would be documented in the patient's
medical record, or whether we should defer to the clinical judgment of
the practitioner on how often an in-person visit would be appropriate.
d. Regulatory Changes
We are proposing to revise the regulation at Sec. 405.2463, to
revise paragraph (a)(1)(i) to state that a mental health visit is a
face-to-face (that is, in person) encounter (or, for mental health
visits only, an encounter that meets the requirements under paragraph
(b)(3)) between an RHC patient and an RHC practitioner. We are
proposing to revise paragraph (b)(3) to define a mental health visit as
a face-to-face encounter or an encounter where services are furnished
using interactive, real-time, audio and video telecommunications
technology or audio-only interactions in cases where beneficiaries are
not capable of, or do not consent to, the use of devices that permit a
two-way, audio/video interaction for the purposes of diagnosis,
evaluation or treatment of a mental health disorder. We are also
proposing to revise Sec. 405.2469, FQHC supplemental payments, to
revise paragraph (d) by adding that a supplemental payment required
under this section is made to the FQHC when a covered face-to-face
(that is, in-person) encounter or an encounter where services are
furnished using interactive, real-time, telecommunications technology
or audio-only interactions in cases where beneficiaries do not wish to
use or do not have access to devices that permit a two-way, audio/video
interaction for the purposes of diagnosis, evaluation or treatment of a
mental health disorder occurs between a MA enrollee and a practitioner
as set forth in Sec. 405.2463.
C. Federally Qualified Health Centers (FQHCs) Payment for Tribal
FQHCs--Comment Solicitation
1. Health Services to American Indians and Alaska Natives (AI/AN)
There is a special government-to-government relationship between
the federal government and federally recognized tribes based on U.S.
treaties, laws, Supreme Court decisions, Executive Orders and the U.S.
Constitution. This government-to-government relationship forms the
basis for federal health services to American Indians/Alaska Natives
(AI/AN) in the U.S. In 1976, the Indian Health Care Improvement Act
(IHCIA) (Pub. L. 94-437, September 30, 1976) amended the statute to
permit payment by Medicare and Medicaid for services provided to AI/ANs
in Indian Health Service (IHS) and tribal health care facilities that
meet the applicable requirements. Under this authority, Medicare
services to AI/ANs may be furnished by IHS operated facilities and
programs and tribally-operated facilities and programs under Title I or
Title V of the Indian Self Determination Education Assistance Act, as
amended (ISDEAA) (Pub. L 93-638, January 4, 1975). According to the IHS
Profile,\64\ the IHS healthcare delivery system currently consists of
46 hospitals, with 24 of those hospitals operated by the IHS and 22 of
them operated by tribes under the ISDEAA, as well as 492 health
centers, 75 operated by IHS and 417 operated by tribes under the
ISDEAA.
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\64\ https://www.ihs.gov/newsroom/factsheets/ihsprofile/.
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Payment rates for outpatient medical care (also referred to as
outpatient hospital services) furnished by the IHS and tribal
facilities is set annually by the IHS under the authority of sections
321(a) and 322(b) of the Public Health Service Act (the PHS Act) (42
U.S.C. 248 and 249(b)) (Pub. L. 83-568 (42 U.S.C. 2001(a)), and the
IHCIA, based on the previous year cost reports from federal and tribal
hospitals. The IHCIA provided the authority for CMS (then HCFA) to pay
IHS and tribal facilities for its outpatient hospital services to
Medicare eligible patients, using an outpatient per visit rate (also
referred to as the Medicare all-inclusive payment rate (AIR).
2. Federally Qualified Health Centers (FQHCs) Prospective Payment
System (PPS)
FQHCs were established in 1990 by section 4161 of the Omnibus
Budget Reconciliation Act of 1990 (OBRA 90) (Pub. L. 101- 508, November
5, 1990), and were effective beginning on October 1, 1991. They are
facilities that furnish services that are typically furnished in an
outpatient clinic setting. There are many FQHCs operated by IHS and
tribes. The statutory requirements that FQHCs must meet to furnish
services to Medicare beneficiaries are in section 1861(aa)(4) of the
Act. All FQHCs are subject to Medicare regulations at 42 CFR part 405,
subpart X, and 42 CFR part 491. Based on these provisions, the
following three types of organizations that are eligible to enroll in
Medicare as FQHCs:
Health Center Program grantees: Organizations receiving
grants under section 330 of the PHS Act (42 U.S.C. 254b).
Health Center Program ``lookalikes'': Organizations that
have been identified by the Health Resources and Services
Administration as meeting the requirements to receive a grant under
section 330 of the PHS Act, but which do not receive section 330 grant
funding.
Outpatient health programs or facilities operated by a
Tribe or tribal organization under the ISDEAA, or by an urban Indian
organization receiving funds under Title V of the IHCIA.
FQHCs are also entities that were treated by the Secretary, for
purposes of Medicare Part B, as a comprehensive federally funded health
center as of January 1, 1990 (see section 1861(aa)(4)(C) of the Act).
Section 1834 of the Act was amended in 2010 by section 10501(i)(3)(A)
of the Affordable Care Act by adding a new subsection (o),
``Development and Implementation of Prospective Payment System'' for
FQHCs. Section 1834(o)(1)(A) of the Act requires that the system
include a process for appropriately describing the services furnished
by FQHCs, and establish payment rates based on such descriptions of
services, taking into account the type, intensity, and duration of
services furnished by FQHCs. It also stated that the new system may
include adjustments (such as geographic adjustments) as determined
appropriate by the Secretary. Section 1833(a)(1)(Z) of the Act, as
added by the Affordable Care
[[Page 39239]]
Act, requires that Medicare payment for FQHC services under section
1834(o) of the Act be 80 percent of the lesser of the actual charge or
the PPS amount determined under section 1834(o) of the Act.
In accordance with the requirements in the statute, as amended by
the Affordable Care Act, beginning on October 1, 2014, payment to FQHCs
is based on the lesser of the national encounter-based FQHC PPS rate,
or the FQHC's total charges, for primary health services and qualified
preventive health services furnished to Medicare beneficiaries. The
FQHC PPS rate is adjusted by the FQHC geographic adjustment factor
(GAF), which is based on the Geographic Practice Cost Index used under
the PFS. The FQHC PPS rate is also adjusted when the FQHC furnishes
services to a patient that is new to the FQHC, and when the FQHC
furnishes an IPPE or an AWV. Payment to the FQHC for a Medicare visit
is the lesser of the FQHC's charges (as established by the G-code), or
the PPS rate. The CY 2021 FQHC PPS rate is $176.45.
3. Grandfathered Tribal FQHCs
In the November 16, 2015 Federal Register, we published a final
rule, entitled ``Medicare Program; Revisions to Payment Policies Under
the Physician Fee Schedule and Other Revisions to Part B for CY 2016
(referred to as CY 2016 PFS final rule). In that rule, we discuss the
payment methodology and requirements finalized for grandfathered tribal
FQHCs (80 FR 71089 through 71096). We stated that tribal facilities
that met the conditions of Sec. 413.65(m) on or before April 7, 2000,
and had a change in their status on or after April 7, 2000, from IHS to
tribal operation, or vice versa, or the realignment of a facility from
one IHS or tribal hospital to another IHS or tribal hospital, such that
the organization no longer met the Medicare Conditions of Participation
(CoPs) for Medicare-participating hospitals at Sec. 482.12, the
``governing body'' of the facility could nevertheless seek to become
certified as a grandfathered tribal FQHC.
In CY 2016 PFS final rule, we explained that a different structure
was needed to maintain access to care for AI/AN populations served by
the hospitals and clinics impacted by the provider-based rules at Sec.
413.65, while also ensuring that the tribal clinics are in compliance
with our health and safety rules. We recognized that a tribal clinic
billing under an IHS hospital's CMS Certification Number (CCN), without
any additional administrative or clinical relationship with the IHS
hospital, could put that hospital at risk for noncompliance with their
CoPs because the clinic had a separate governing body although still
provider-based. We explained that the FQHC program provided an
alternative structure that met the needs of these tribal clinics and
the populations they served, while also ensuring the IHS hospitals were
not at risk of being cited for non-compliance with the requirements
with their CoPs (80 FR 71090).
As stated in Sec. 405.2462(d)(1) a ``grandfathered tribal FQHC''
is a FQHC that is operated by a tribe or tribal organization under the
ISDEAA; was billing as if it were provider-based to an IHS hospital on
or before April 7, 2000 and is not currently operating as a provider-
based department of an IHS hospital. We refer to these tribal FQHCs as
``grandfathered tribal FQHCs'' to distinguish them from freestanding
tribal FQHCs that are currently being paid the lesser of their charges
or the adjusted national FQHC PPS rate, and from provider-based tribal
clinics that may have begun operations subsequent to April 7, 2000.
There are 7 ``grandfathered tribal FQHCs''.
Under the authority in section 1834(o) of the Act to include
adjustments determined appropriate by the Secretary, we revised
Sec. Sec. 405.2462 and 405.2464 to pay these grandfathered tribal
FQHCs on the Medicare outpatient per visit rate as set annually by the
IHS, that is, the AIR and not the FQHC PPS payment rates (80 FR 71089).
Payment rates for outpatient medical care (also referred to as
outpatient hospital services) furnished by the IHS and tribal
facilities is set annually by the IHS under the authority of sections
321(a) and 322(b) of the Public Health Service Act (the PHS Act) (42
U.S.C. 248 and 249(b)) (Pub. L. 83-568 (42 U.S.C. 2001(a)), and the
IHCIA, based on the previous year cost reports from federal and tribal
hospitals. The outpatient per visit rate is only applicable for those
IHS or tribal facilities that meet the definition of a provider-based
department as described at Sec. 413.65(m), or a ``grandfathered''
tribal FQHC as described at Sec. 405.2462(d)(1). There is an
outpatient per visit AIR for Medicare visits in Alaska and a separate
outpatient per visit AIR for Medicare visits in the lower 48 states.
For CY 2021, the outpatient per visit rate for Medicare visits in
Alaska is $662 and $414 in the lower 48 states (85 FR 86940). There are
no grandfathered tribal FQHCs in Alaska because the tribes operate the
hospitals, not IHS. We note that IHS does not operate any hospitals or
facilities in Hawaii or the territories, and thus no rates are set, in
those localities.
As we discussed in CY 2016 PFS final rule, the payment rate is not
adjusted by the FQHC GAF; for new patients, annual wellness visits, or
initial preventive physical examinations; or annually by the FQHC PPS
market basket, as further adjustments would be unnecessary and/or
duplicative of adjustments already made by IHS in deriving the rate.
Comparatively, the FQHC PPS rate established by CMS is $176.45. The
reimbursement is the lesser of the charges or the IHS AIR rate. We
stated as part of the CY 2016 PFS final rule that we would monitor
future costs and claims data of these tribal clinics and reconsider
options as appropriate.
4. Paying all IHS- and Tribally-Operated Outpatient Clinics the AIR
CMS established a Tribal Technical Advisory Group (TTAG) in 2004 to
provide advice and input to CMS on policy and program issues impacting
AI/AN populations served by CMS programs. Although not a substitute for
formal consultation with Tribal leaders, the TTAG enhances the
government-to-government relationship and improves increased
understanding between CMS and Tribes. The TTAG has subject specific
subcommittees that meet on a regular basis in order to be more
effective and perform in-depth analysis of Medicare, Medicaid, CHIP,
and the Health Insurance Marketplace policies that have Tribal
implications. The TTAG is comprised of 17 representatives: An elected
Tribal leader, or an appointed representative from each of the 12
geographic areas of the IHS delivery system and a representative from
each of the national Indian organizations headquartered in Washington
DC--the National Indian Health Board, the National Congress of American
Indians, and the Tribal Self-Governance Advisory Group. The American
Recovery and Reinvestment Act of 2009 section 5006(e)(1), which became
effective July 1, 2009, mandates that TTAG shall be maintained within
CMS and added two new representative's positions: A representative and
alternate from a national urban Indian health organization (National
Council of Urban Indian Health) and a representative and alternate from
the IHS.
The TTAG has requested \65\ that CMS amend its Medicare regulations
to make all IHS and tribally-operated outpatient
[[Page 39240]]
facilities eligible for payment at the IHS Medicare outpatient per
visit rate/AIR. The TTAG explained that outpatient clinics, which are
otherwise similar to grandfathered tribal FQHCs, are paid at different
rates depending upon whether they meet the requirements as a ``provider
based facility,'' a ``grandfathered tribal FQHC,'' a non-grandfathered
tribal FQHC, or none of the above. They believe that the rates vary
based on the Medicare regulatory definition, rather than the actual
costs of the outpatient clinic. There are varying payment differentials
among Medicare enrolled providers and suppliers under the authorities
of the SSA. For example, Ambulatory Surgical Centers are paid
differently than hospital outpatient departments; which are paid
differently whether they're under the under the outpatient prospective
payments system or a located in a critical access hospital.
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\65\ https://www.nihb.org/tribalhealthreform/wp-content/uploads/2020/06/TTAG-letter-to-CMS-requesting-IHS-rate-for-all-tribal-clinics-06.10.2020.pdf.
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The TTAG also questioned the need for grandfathered tribal FQHCs to
file cost reports. Specifically, the TTAG stated that the FQHC cost
reports have no relationship to the IHS Medicare outpatient per visit
rate/AIR paid to grandfathered tribal FQHCs, as they use hospital cost
reports in setting the rate. Therefore, they stated, the FQHCs should
only need to file a cost report to the extent necessary to support
payment for non-FQHC services that are reimbursed outside the Medicare
outpatient per visit rate/AIR. We note that under section 1815(a) of
the Act, providers participating in the Medicare program are required
to submit financial and statistical information to achieve settlement
of costs relating to health care services rendered to Medicare
beneficiaries. Under the FQHC PPS, Medicare payment for FQHC services
is the lesser of the FQHC PPS rate or the charges on the claim. In the
establishment of the FQHC PPS, the statute does not exempt FQHCs from
submitting cost reports. In addition, Medicare payments for the
reasonable costs of the influenza and pneumococcal vaccines and their
administration, allowable graduate medical education costs, and bad
debts are determined and paid through the cost report. The FQHC market
basket also uses information from the FQHC cost report to determine the
cost share weights, which reflect the relative costs of input expenses
that FQHCs face in order to provide FQHC services. Having a full
picture of the costs of providing care by grandfathered FQHCs is
important so that CMS can be sure that payments are adequate.
5. Comment Solicitation
We appreciate the TTAG's concerns with ensuring that CMS make
appropriate payments among the clinics for similar services and the
impact this has on tribal Medicare beneficiaries and ensuring that
access to healthcare is available and equitable and we take these
concerns seriously. However, we have insufficient information necessary
to evaluate the costs and benefits of potential changes to these
policies. Therefore, we would like to solicit comment on the TTAG's
request for CMS to amend its Medicare regulations to make all IHS- and
tribally-operated outpatient facilities/clinics eligible for payment at
the Medicare outpatient per visit rate/AIR, regardless of whether they
were owned, operated, or leased by IHS.
We seek information on the kinds of and number of facilities or
clinics that could potentially enroll in Medicare as an FQHC, or are
already an FQHC paid under the FQHC PPS, and if these clinics are
freestanding or provider-based to expand on information provided by the
IHS Profile. We seek information regarding the relative operating costs
of IHS- and tribally-operated outpatient clinics compared to non-tribal
FQHCs, stakeholder feedback and supporting evidence to address whether
or why payment set at the IHS AIR would be more appropriate than
payment rate under the FQHC PPS. Further, we seek comment on how the
IHS AIR, which is based upon a limited number of hospital cost reports,
relates to costs in such clinics and the kinds of services that the
clinics furnish. Finally, we seek comment on the concerns that the AI/
AN community may have on issues regarding access or inequity care in
situations where a payment differential exists.
While, we have information on grandfathered tribal FQHCs and the
outpatient hospital cost reports, we do not have any information
specific to the composition of IHS and tribal facilities. For example,
if the facility is not enrolled in Medicare as an FQHC or is not
provider based to a hospital, is it a physician practice? It would be
helpful to know how the facilities are organized and related. Are there
other options for enrolling as different types of providers or
suppliers?
As increasing the rate would increase payments from the Medicare
Trust Fund, we are also seeking comment on the magnitude of that
payment change and whether any program integrity concerns would be
present with the increased payment. We also request comments on FQHC
services that are paid through the cost report, like influenza,
pneumococcal, and COVID-19 vaccinations and GME and how that impacts
the request to not file cost reports. As stated above, having a full
picture of the costs of providing care is important so that CMS can be
sure that payments are adequate. Are these services included in the
IHS/AIR?
We are also seeking input on other potential uses of the adjustment
authority under section 1834(o)(1)(A) of the Act which provides that
the FQHC PPS may include adjustments determined appropriate by the
Secretary. For example, we could consider TTAG's request on the
expansion of the payment policy finalized in the CY 2016 PFS final rule
for grandfathered tribal FQHCs to all Tribally-operated outpatient
clinics. Alternatively, we could develop a payment adjustment
applicable to IHS- and tribally-operated outpatient clinics based on
the cost differential reported in their cost reports when compared to
non-IHS outpatient clinics, or non-provider-based clinics, if such
differentials exist and would be interested in specific comments about
appropriate adjustments to the FQHC PPS rate for clinics that are
enrolled as FQHCs. We seek comment on other potential ways to determine
whether the costs associated with furnishing services to AI/AN are
uniquely greater than other clinics within the confines of the FQHC PPS
outlined in section 1834(o)(1) of the Act.
D. Requiring Certain Manufacturers To Report Drug Pricing Information
for Part B and Determination of ASP for Certain Self-Administered Drug
Products
1. Requiring Certain Manufacturers To Report Drug Pricing Information
for Part B (Sec. Sec. 414.802 and 414.806)
a. Overview and Summary
Section 1927(b)(3)(A)(iii)(I) of the Act requires manufacturers
with a Medicaid drug rebate agreement to report Average Sales Price
(ASP) data as specified in section 1847A of the Act. Some manufacturers
without Medicaid drug rebate agreements voluntarily submit ASP data for
their single source drugs or biologicals that are payable under Part B;
however, other manufacturers without Medicaid drug rebate agreements do
not voluntarily submit such data. Without manufacturer reported ASP
data, CMS cannot calculate the ASP payment limit, and consequently,
payment is typically based on Wholesale Acquisition Cost (WAC).
Consistent with section 1847A(c)(3) of the Act and our regulations
at
[[Page 39241]]
Sec. 414.804(a)(2), the ASP is net of price concessions. However,
consistent with the definition of WAC at section 1847A(c)(6)(B) of the
Act, the WAC is not net of price concessions, and thus, is nearly
always, and sometimes, significantly, higher than ASP. Drugs with
payment allowances based on WAC may have greater ``spreads'' between
acquisition costs and payment than drugs for which there is an ASP-
based payment allowance, which, in turn, may: (1) Incent the use of the
drug based on its spread rather than on purely clinical considerations;
(2) result in increased payments under Medicare Part B; and (3)
increase beneficiary cost sharing.
Section 401 of Division CC, Title IV of the CAA, 2021 (for the
purposes of this section of this proposed rule, hereinafter is referred
to as ``section 401'') amended section 1847A of the Act to add new
section 1847A(f)(2) of the Act, which requires manufacturers without a
Medicaid drug rebate agreement to report ASP information to CMS for
calendar quarters beginning on January 1, 2022, for drugs or
biologicals payable under Medicare Part B and described in sections
1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including
items, services, supplies, and products that are payable under Part B
as a drug or biological. Section 401(b)(2) also amended section
1847A(c)(6)(A) of the Act to permit the Secretary to exclude
repackagers \66\ from the definition of ``manufacturer'' for purposes
of the ASP reporting requirement in section 1847A(f)(2) of the Act, if
the Secretary determines appropriate.
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\66\ The FDA has defined ``repackag[ing],'' for purposes of drug
establishment registration, as ``the act of taking a finished drug
product or unfinished drug from the container in which it was placed
in commercial distribution and placing it into a different container
without manipulating, changing, or affecting the composition or
formulation of the drug.'' 21 CFR 207.1. The FDA has defined
``repack[ager]'' for purposes of drug establishment registration as
the person who owns or operates an establishment that repacks a drug
or drug package.'' Id. For more information about repackaging,
please see FDA guidance documents, including a January 2017 Guidance
for Industry titled, ``Repackaging of Certain Human Drug Products by
Pharmacies and Outsourcing Facilities,'' available at https://www.fda.gov/media/90978/download and the FDA's January 2018 Guidance
for Industry titled, ``Mixing, Diluting, or Repackaging Biological
Products Outside the Scope of an Approved Biologics License
Application,'' available at https://www.fda.gov/files/drugs/published/Mixing-Diluting-or-Repackaging-Biological-Products-Outside-the-Scope-of-an-Approved-Biologics-License-Application.pdf.
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Section 401(b)(1) also adds provisions to section 1847A of the Act
addressing confidentiality, audit and verification provisions; civil
money penalties for misrepresentation, late reporting, and reporting of
false information; and increasing oversight and enforcement provisions.
These provisions largely track the statutory provisions in section
1927(b) of the Act that apply to the reporting of ASP by manufacturers
with Medicaid drug rebate agreements. Additionally, section 401(d)
requires HHS Office of the Inspector General (OIG) to submit a report
on the accuracy of ASP submissions to Congress by January 1, 2023.
Finally, section 401 amended section 1927(b) of the Act to clarify
that for Part B ASP reporting, drugs would include items, services,
supplies, and products that are payable under Medicare Part B as a drug
or biological.
We are proposing regulatory changes to implement the new reporting
requirements at 42 CFR, part 414, subpart J.
b. Reporting Requirements for Manufacturers Without a Medicaid Drug
Rebate Agreement
Starting with calendar quarters beginning on January 1, 2022,
manufacturers will be required to report ASP for drugs and biologicals
payable under Medicare Part B consistent with the statutory
requirements of section 1847A(f) of the Act, regardless of whether they
have Medicaid drug rebate agreements. Our existing regulations at 42
CFR part 414, subpart J implement the ASP reporting requirements
referenced in section 1847A(f)(1) of the Act, that is, the requirements
of section 1927(b)(3) of the Act. Thus, the existing regulations at 42
CFR part 414, subpart J already set forth requirements for
manufacturers with Medicaid drug rebate agreements to report their ASP
information (and if required to make payment, WAC) each quarter.
Many manufacturers without Medicaid drug rebate agreements
voluntarily submit ASP data consistent with these requirements. Whether
obligated to report or voluntarily reporting, manufacturers are
accustomed to the existing regulatory requirements at 42 CFR part 414
subpart J, and indeed, the methodology for reporting ASP reflected in
these regulations does not currently distinguish between manufacturers
with Medicaid drug rebate agreements and those without these
agreements.
Because new section 1847A(f)(2) of the Act, as noted previously,
largely parallels section 1927(b)(3) of the Act, and thus both
manufacturers with Medicaid drug rebate agreements, as well as those
without such agreements, will be subject to requirements already
reflected in the existing regulations at subpart J, we do not believe
it is necessary to propose substantial changes to the regulation text.
For these reasons, our proposal to amend the regulations to reflect the
new requirements of section 1847A(f)(2) of the Act seeks to preserve
the status quo to the extent possible.
c. Definitions
As noted previously, the new section 1847A(f)(2) of the Act, as
added by section 401(a), requires manufacturers without a Medicaid drug
rebate agreement to report ASP information to CMS for calendar quarters
beginning on January 1, 2022 for drugs or biologicals payable under
Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or
1881(b)(14)(B) of the Act, including items, services, supplies, and
products that are payable under Part B as a drug or biological. Section
401 also made a conforming amendment to the ASP reporting requirements
applicable to manufacturers with Medicaid drug rebate agreements at
section 1927(b)(3)(A)(iii) of the Act to specify that those reporting
requirements also apply to items, services, supplies, and products that
are payable under Part B as a drug or biological.
To implement this change, we propose to amend the definition of the
term ``drug'' at Sec. 414.802 to mean a drug or biological, and
includes an item, service, supply, or product that is payable under
Medicare Part B as a drug or biological.
Section 1847A(c)(6)(A) of the Act incorporates the definition of
manufacturer at section 1927(k)(5) of the Act, except that section
401(b)(2) permits the Secretary to exempt repackagers from the
definition of manufacturer, as determined appropriate, for purposes of
section 1847A(f)(2) of the Act. However, no such exemption is provided
for manufacturers with Medicaid drug rebate agreements (see the
definition of manufacturer at Sec. 447.502). Consequently, the current
ASP data reporting includes submissions by repackagers.
To confirm the Medicare Payment Advisory Commission's (MedPAC's)
assertion in their June 2017 report (available at http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf) that many repackagers
currently do not report ASP data, and thus inform our consideration of
whether we should propose to exclude repackagers from the definition of
manufacturers for purposes of section 1847A(f)(2) of the Act, we
conducted an analysis to estimate the proportion of repackaged products
in our existing ASP data. If our existing ASP data do not contain an
appreciable
[[Page 39242]]
proportion of repackaged products, it may be appropriate to exclude
repackagers from the definition of manufacturer for this limited
purpose. However, if repackaged products comprise an appreciable
proportion of our existing ASP data, we would reasonably anticipate
this trend to follow under the new requirements, and in such a
scenario, it would not be appropriate to exclude repackagers from the
definition of manufacturer for purposes of section 1847A(f)(2) of the
Act because excluding their sales could distort the ASP.
To effectuate this analysis, we obtained a list of National Drug
Codes (NDCs) of repackaged drugs from the United States Food and Drug
Administration (FDA).\67\ We also obtained a list of labeler codes for
which the manufacturers have Medicaid drug rebate agreements.\68\ We
then performed a crosswalk both of these to our composite file of ASP
data submissions to segregate our composite file of ASP data
submissions into four categories:
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\67\ https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory. We note that this list only included
prescription drugs approved under a New Drug Application (NDA) or
Abbreviated NDA (ANDA) and did not include biological products
approved under a Biologics License Application (BLA) or devices.
\68\ https://data.medicaid.gov/Uncategorized/Drug-Manufacturer-Contacts/uex2-n56q/data. This link has all labeler codes with
effective date and termination date, if applicable. If there is a
termination date, the code was not active as of that date.
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(1) Repackaged products for which ASP data submissions were
required (that is, manufacturers with Medicaid drug rebate agreements);
(2) Repackaged products for which ASP data submissions were
voluntary (that is, for manufacturers without Medicaid drug rebate
agreements);
(3) Non-repackaged products for which ASP data submissions were
required; and
(4) Non-repackaged products for which ASP data submissions were
voluntary.
We estimate that, of all 6319 products for which we currently
receive ASP data submissions (the sum of categories (1)-(4) above),
repackaged products accounted for 271 (4.29 percent) of these products.
Additionally, repackaged products accounted for 137 (2.51 percent of)
products for which ASP data submissions were required, and 134 (15.23
percent of) products for which ASP data were voluntarily submitted.
Additionally, we conducted another analysis to estimate: (1) The
number of new ASP submissions we can expect as a result of the new
requirements under section 401; and (2) the proportion of those
submissions that involve repackaged products. To effectuate this
analysis, we obtained a crosswalk of NDCs and Healthcare Common
Procedure Coding System (HCPCS) codes that includes the NDCs and HCPCS
codes of items for which ASP reporting is not currently required.\69\
We supplemented this crosswalk by adding HCPCS codes with NDCs that are
payable under Part B, but not already reflected in the crosswalk.\70\
We then identified \71\ and removed from the crosswalk all of the
products contained in our composite file of ASP data submissions and
those HCPCS codes that are non-covered under Medicare Part B. Adding
the results of this analysis to the results of categories two and four
from the prior analysis (that is, repackaged and non-repackaged
products for which ASP submissions were voluntary), we estimate there
will be 6994 total products for which manufacturers will now be
required to submit ASP data. We then compared this number to the FDA's
list of repackaged products in the previous analysis, and found that of
the 6994 products for which manufacturers will be required to submit
ASP data, 223 (3.19 percent) are repackaged products. Further, we
estimate 6114 products for which their manufacturers did not previously
(voluntarily) submit ASP data and will now be required to do so under
the new reporting requirements of section 401. Of these, 89 (1.46
percent) are repackaged products.
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\69\ https://www.dmepdac.com/palmetto/PDACv2.nsf/DID/FFYLYC1WVL
Accessed April 12, 2021, using the April 2021 files.
\70\ We note that such products were spread across the second
and fourth categories in the prior analysis.
\71\ We used the April 2021 Alpha-Numeric HCPCS codes files
available at https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update. We selected HCPCS codes
with a coverage code of S (column AE), which indicates that the
product is non-covered by the Medicare statute.
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These data do not persuade us that it is necessary to exempt
repackagers from the new reporting requirements under section 401 at
this time. Our current operational process to verify the accuracy of
manufacturers' reported ASP data does not distinguish: (1) Products on
the basis of repackaging, and (2) manufacturers who are required to
report ASP data from those who do so voluntarily.
Each month, CMS reviews ASP data submissions at the NDC level (and
for products without NDCs, the manufacturer's product code).
Previously, we have not required manufacturers to identify which
products are repackaged as part of these submissions. Exempting
repackagers from the new requirements of section 1847A(f)(2) of the Act
would significantly increase our administrative burden because we would
have to undergo an additional quality check for each NDC from a
different database for which data are submitted as part of our
operational process to verify the accuracy of manufacturers' reported
ASP data. Moreover, for products without NDCs, our ability to determine
if these products are repackaged (without manufacturer attestation) to
that effect is significantly limited. Finally, any such attestation
would require a data source for us to verify the accuracy of the
attestation, and no such data source currently exists.
These additional checks could, in turn, significantly increase the
time it takes for us to calculate and display on our website the
volume-weighted ASP payment limits. Additionally, we are concerned that
exempting repackagers from the new reporting requirements could lead to
a gap in ASP reporting, meaning that ASPs could be distorted to the
extent that certain sales are carved out of the reporting requirement
through the use of repackagers. Consequently, in order to maintain
consistency and integrity of the ASP data for those manufacturers with
and without Medicaid drug rebate agreements, we do not believe it is
appropriate to exclude repackagers from the requirements of section 401
at this time. However, we may propose to exempt repackagers in the
future, if warranted.
We solicit comment on this approach.
In summary, we propose to modify the definition of drug at Sec.
414.802 to include any item, service, supply or product that is payable
under Part B as a drug or biological. We are not proposing to exclude
repackagers from the definition of manufacturer for purposes of the
reporting requirements at section 1847A(f)(2) of the Act.
d. Civil Money Penalties
As amended by section 401(b), section 1847A(d)(4)(A) of the Act
specifies the penalties associated with misrepresentations in the
reporting of the manufacturer's ASP for a drug or biological.
Consistent with our existing regulation at Sec. 414.806, if the
Secretary determines that a manufacturer has made a misrepresentation
in the reporting of ASP data, a civil money penalty in an amount of up
to $10,000 may be applied for each price misrepresentation and for each
day in which the price misrepresentation was applied.
New sections 1847A(d)(4)(B) and (C) of the Act, as added by section
401(b),
[[Page 39243]]
apply civil money penalties for failure to report timely and accurate
ASP data for manufacturers without Medicaid drug rebate agreements,
consistent with the civil money penalties found at sections
1927(b)(3)(C)(i) and (ii) of the Act for manufacturers with Medicaid
drug rebate agreements. Our current regulations at Sec. 414.806 refer
to section 1927(b)(3)(C) of the Act, as amended by section 303(i)(4) of
the Medicare Prescription Drug, Improvement, and Modernization Act
(MMA) of 2003 (Pub. L. 108-173, December 8, 2003), as specifying the
penalties associated with a manufacturer's failure to submit timely
information or the submission of false information.
We propose to amend Sec. 414.806 to reflect the new provisions
specifying penalties for manufacturers without Medicaid drug rebate
agreements and to provide some technical changes to streamline the
regulations text. Specifically, we propose to do the following:
Add paragraph (a), labeled as ``Misrepresentation'',
moving the existing regulatory language at Sec. 414.806 specific to
misrepresentation to this paragraph;
Remove the sentence which reads, ``If the Secretary
determines that a manufacturer has made a misrepresentation in the
reporting of ASP data, a civil money penalty in an amount of up to
$10,000 may be applied for each price misrepresentation and for each
day in which the price misrepresentation was applied,'' since the
previous sentence in the regulations text already references the
statutory provision for this language;
Add paragraph (b), labeled as ``Failure to provide timely
information or the submission of false information'';
Add paragraph (b)(1) to clarify that the existing language
at Sec. 414.806 regarding civil money penalties for failure to submit
timely information or for the submission of false information applies
to manufacturers with a Medicaid drug rebate agreement;
Remove the phrase ``as amended by section 303(i)(4) of the
MMA''; and
Add paragraph (b)(2) to reflect new sections
1847A(d)(4)(B) and (C) of the Act regarding civil money penalties for
failure to submit timely information or for the submission of false
information for manufacturers without a Medicaid drug rebate agreement.
We welcome comments on these proposals.
e. Summary of all Proposals
In summary, to implement the new reporting requirements for
manufacturers without Medicaid drug rebate agreements, we are proposing
to modify:
The definition of drug at Sec. 414.802; and
The regulations describing civil money penalties at Sec.
414.806.
We welcome comments on these proposals.
2. Determination of ASP for Certain Self-Administered Drug Products
(Sec. 414.904)
a. Background
Drugs and biologicals payable under Medicare Part B fall into three
general categories: those furnished incident to a physician's services
(hereinafter referred to as ``incident to'') (section 1861(s)(2) of the
Act), those administered via a covered item of durable medical
equipment (DME) (section 1861(s)(6) of the Act), and others as
specified by statute (for example, certain vaccines described in
sections 1861(10)(A) and (B) of the Act). Payment limits for most drugs
and biologicals separately payable under Medicare Part B are determined
using the methodology in section 1847A of the Act, and in many cases,
payment is based on the Average Sales Price (ASP) plus a statutorily
mandated 6 percent add-on. Most drugs payable under Part B are paid
under the ``incident to'' benefit under section 1861(s)(2) of the Act,
which includes drugs and biologicals not usually self-administered by
the patient.
Paragraphs (4)(A) and (6) of sections 1847A(b) of the Act require
that the Medicare Part B payment amount for a single-source drug or
biological be determined using all of the NDCs assigned to it. Section
1847A(b)(5) of the Act further states that the payment limit shall be
determined without regard to any special packaging, labeling, or
identifiers on the dosage form or product or package. In 2007, CMS
issued a program instruction (available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf), as permitted under section
1847A(c)(5)(C) of the Act, stating that the payment limit for a single
source drug or biological will be based on the pricing information for
products produced or distributed under the applicable FDA approval
(such as a New Drug Application (NDA) or Biologics License Application
(BLA)). Therefore, all versions of a single source drug or biological
product (or NDCs) marketed under the same FDA approval number (for
example, NDA or BLA, including supplements) are considered the same
drug or biological, for payments made under section 1847A of the Act
and are crosswalked to the same billing and payment code. This means
that a self-administered version marketed under the same FDA approval
is subject to the ASP reporting requirements and is not excluded from
the payment limit calculation, even though Medicare does not make
separate Part B payment for it. This is consistent with our
longstanding policy on the scope of the ASP reporting requirements.
(Please see our final rule titled, ``Medicare Program; Revisions to
Payment Policies, Five-Year Review of Work Relative Value Units,
Changes to the Practice Expense Methodology Under the Physician Fee
Schedule, and Other Changes to Payment Under Part B; Revisions to the
Payment Policies of Ambulance Services Under the Fee Schedule for
Ambulance Services; and Ambulance Inflation Factor Update for CY
2007,'' published in the December 1, 2006 Federal Register (71 FR
69675)). The price of a drug or biological product that may be
administered by the patient (that is, self-administered) may differ
from versions that are administered incident to a physician's service,
which may affect the ASP-based payment limit for drug or biological
product's billing and payment code.
The HHS OIG conducted studies \72\ \73\ of payment-limit
calculations for certain drugs paid under section 1847A of the Act. The
OIG identified two highly utilized biological products for which there
are both Part-B-covered (versions administered incident to a
physician's service) and non-covered versions (those identified to be
self-administered) for which the NDCs were marketed under the same FDA
approval number. OIG's studies found that when the ASPs of the self-
administered versions are included in the payment limit calculation,
the resulting payment limit is substantially higher than if the ASPs of
only the incident-to versions had been included.
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\72\ https://www.oig.hhs.gov/oei/reports/oei-12-17-00260.pdf,
accessed March 15, 2021.
\73\ https://www.oig.hhs.gov/oei/reports/OEI-BL-20-00100.pdf,
accessed March 15, 2021.
---------------------------------------------------------------------------
The OIG studies concluded that as a result, Medicare payment
amounts were inflated, causing the program and its beneficiaries to pay
an additional $366 million from 2014 through 2016 and $497 million from
2017 through 2018. They recommended that legislative changes be made to
provide CMS the flexibility to determine when certain versions of a
drug identified to be self-administered should be included in ASP
payment limit calculations.
Section 405 of Division CC, Title IV of the CAA, 2021, amended
section 1847A of the Act by redesignating
[[Page 39244]]
existing subsection (g) as subsection (h) and adding new subsection
(g), which describes the Medicare Part B ASP payment-limit adjustment
for certain drugs and biological products for which NDCs have been
identified by the OIG to be self-administered and not covered under
Medicare Part B. The new section 1847A(g)(1) of the Act directs OIG to
conduct periodic studies to identify NDCs for drug or biological
products that are identified to be self-administered for which payment
may not be made under Part B pursuant to section 1861(s)(2) of the Act
and that OIG determines should be excluded from the determination of
the payment amount under section 1847A of the Act.
New section 1847A(g)(2) of the Act specifies that if the OIG
identifies an NDC under section 1847A(g)(1) of the Act, it must inform
the Secretary at such times as the Secretary may specify. Then the
Secretary shall, to the extent appropriate, apply as the payment limit
for the applicable billing and payment code the lesser of: (1) The
payment allowance that would be determined under section 1847A of the
Act if the NDC for the identified drug or biological product were
excluded from the calculation; or (2) the payment limit otherwise
determined under section 1847A of the Act without application of
section 1847A(g) of the Act. In other words, the Medicare payment limit
for a drug or biological product's billing and payment code in these
circumstances would be the lesser of the payment limit determined
including the NDCs identified to be self-administered and the payment
limit determined after excluding the NDCs identified to be self-
administered (hereinafter referred to as the ``lesser-of payment
methodology'').
Although section 1847A(g)(1) of the Act provides us with discretion
in whether to apply the lesser-of methodology to billing and payment
codes that include self-administered versions identified by the OIG
(because we are directed to apply the methodology to the extent deemed
appropriate), new section 1847A(g)(3) of the Act, requires the
application of the lesser-of methodology to the two billing and payment
codes identified in the OIG's July 2020 report titled, ``Loophole in
Drug Payment Rule Continues To Cost Medicare and Beneficiaries Hundreds
of Millions of Dollars,'' (available at https://oig.hhs.gov/oei/reports/OEI-BL-20-00100.asp) (hereinafter referred to as ``OIG's July
2020 report'')) beginning July 1, 2021. To meet the implementation date
required by this provision, we applied the lesser-of methodology to the
payment limit calculations for the billing and payment codes
representing Cimzia[supreg] (certolizumab pegol) and Orencia[supreg]
(abatacept), details on these calculations are described in this
section. In a memorandum providing supplemental information on the OIG
July 2020 report, the OIG provided specific NDCs that the report
identified: 00003-2188-11, 00003-2188-51, 00003-2814-11, 00003-2818-11,
50474-0710-79, 50474-0710-81. The lesser-of methodology was applied to
these billing and payment codes for the July 2021 ASP Drug Pricing
Files and crosswalks along with program instructions in a change
request (CR) at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files.
We propose to codify the new requirements of section 1847A(g) of
the Act at Sec. 414.904. Our proposals described in the next section
specify when the application of the lesser-of methodology would be
appropriate, describe how we will apply the lesser-of payment
methodology to billing and payment codes that OIG has identified
pursuant to studies described in section 1847A(g)(1) of the Act, and
codify the approach we used for the certolizumab pegol and abatacept
billing and payment codes.
b. Identification of Billing and Payment Codes to Which the Lesser-of
Policy Will Be Applied
As noted previously, section 1847A(g)(1) of the Act directs OIG to
conduct periodic studies to identify NDCs for drug or biological
products that are self-administered and for which payment is not made
under Part B. Section 1847A(g)(2) of the Act specifies that if OIG
makes an identification under section 1847A(g)(1) of the Act, OIG
informs CMS at such times as we may specify, and in such an event, we
apply the lesser-of methodology to the extent deemed appropriate. We
propose that when the OIG conducts a periodic study, OIG informs us at
the time the study becomes are publicly available. CMS will obtain the
NDCs identified by the OIG study described in section 1847A(g)(1) of
the Act. However, if the specific NDCs are not available in the OIG
study report, we will request OIG provide documentation of the
identified NDCs to CMS.
To allow operational time for assessment and application of the
lesser-of methodology, we believe it is reasonable that the application
of the lesser-of methodology be reflected beginning in the ASP pricing
file two quarters following the OIG study publication. For example, if
the OIG study becomes available to the public in the first quarter of
the calendar year, the lesser-of methodology would be applied to the
payment limit calculation of the applicable billing and payment code in
the third quarter ASP pricing file (in other words, the July ASP
pricing file) and each quarter thereafter.
c. Calculation of Payment Allowance Using the Lesser-of Payment
Methodology
Sections 1847A(g)(2) and (g)(3) of the Act set forth the lesser-of
payment methodology for applicable billing and payment codes with NDCs
for certain drug or biological products identified by the OIG as self-
administered products for which payment may not be made under this part
because such products are not covered under section 1861(s)(2) of the
Act. In this section, we describe how we propose to apply the lesser-of
methodology. We propose to codify this methodology, which we currently
use for the billing and payment codes that describe certolizumab pegol
and abatacept, and which we propose to use for billing and payment
codes for which OIG identifies a drug or biological product with NDCs
identified to be self-administered as described in section 1847A(g)(1)
of the Act.
The ASP payment limit calculation is described in section
1847A(b)(6) of the Act and codified at Sec. 414.904(b)(2)(ii) and
(c)(2)(ii), which specifies that for a billing and payment code, the
volume-weighted average of the average sales prices reported by the
manufacturer is determined by:
Computing the sum of the products (for each NDC assigned
to such drug products) of:
++ The manufacturer's average sales price determined by the
Secretary without dividing such price by the total number of billing
units for the NDC for the billing and payment code; and
++ The total number of units sold; and
Dividing the sum determined under (A) by the sum of by the
sum of the products (for each NDC assigned to such drug products) of
++ The total number of units specified sold; and
++ The total number of billing units for the NDC for the billing
and payment code.
When applying the lesser-of methodology described in 1847A(g)(2)
and (g)(3) of the Act, we propose to make two calculations as described
in section 1847A(b)(6) of the Act: (1) The ASP payment limit for the
billing and payment code, excluding the NDCs that have been identified
by the OIG study (that is, excluding the ASPs for those NDCs as well as
the units of such NDCs
[[Page 39245]]
sold in the quarter); and (2) the ASP payment limit for the billing and
payment code, including such NDCs' ASPs and units sold. The calculation
resulting in the lower payment limit will be used as the payment limit
for the applicable billing and payment code for that quarter's ASP
pricing files. We propose to apply the lesser-of methodology to the
billing and payment codes containing OIG-identified products each
quarter when determining ASP payment limits.
New section 1847A(g) of the Act does not change ASP reporting
requirements, and consistent with section 1847A(f)(1) of the Act and,
beginning January 1, 2022, section 1847A(f)(2) of the Act,
manufacturers must continue to report ASP data for all NDCs of the drug
or biological product. Under new section 1847A(g) of the Act, ASP data
for all NDCs under the same FDA approval application (for example, NDA
or BLA, including any supplements) are required to carry out the
lesser-of calculations for the purposes of determining the payment
limit for the billing and payment code. Even if the resulting payment
limit does not reflect the ASPs or units sold of self-administered
versions of a product identified by the OIG, the manufacturer must
continue to report those versions' ASPs and units sold to the
Secretary.
The implementation of the lesser-of methodology is not expected to
be associated with substantial administrative costs. We plan to
incorporate methodology in the current operational process that is used
to determine ASP payment limits each quarter. The OIG found that
Medicare and its beneficiaries would have saved a combined $497 million
on certolizumab pegol and abatacept over 2 years (2017-2018) if such a
methodology had been in place.
d. Exceptions
We further propose that the application of the lesser-of
methodology is deemed appropriate in all cases in which OIG identifies
a drug or biological product in a periodic study described in section
1847A(g)(1) of the Act and made publicly available, unless the drug or
biological product is in short supply.\74\ As stated in the OIG's July
2020 report, CMS expressed concern about potential impact on
beneficiary access if certain versions identified to be self-
administered were excluded from the ASP payment limit calculation.
Because of potential for drug shortages that may affect patient care,
beneficiary and provider access, and drug prices for providers, we
would consider it not appropriate to apply the lesser-of methodology
when a product is in short supply. Similar to the average manufacturer
price (AMP) price substitution provision in section 1847A(d)(3)(C) of
the Act (codified in Sec. [thinsp]414.904(d)(3)), we propose to add
Sec. 414.904(d)(4)(ii) to specify that we will not apply the lesser-of
methodology (that is, we will determine the payment allowance including
all NDCs of the drug or biological product) if the drug and dosage
form(s) represented by the billing and payment code are reported by the
Drug Shortage list established under section 506E of the Federal Food,
Drug, and Cosmetic Act (FFDCA) at the time that ASP payment limits are
being finalized for the next quarter. However, we propose that this
exception to the application of the lesser-of methodology would not
apply in the case of the billing and payment codes for certolizumab
pegol and abatacept because section 1847A(g)(3) of the Act does not
provide us with the same discretion as section 1847A(g)(2) of the Act.
Thus, for these applicable billing and payment codes we will always
apply the lesser-of methodology. We recognize that NDCs identified by
an OIG study described in section 1847A(g)(1) or (g)(3) of the Act may
change, for example, because of a manufacturer change. In the event
that the manufacturer of an OIG-identified product simply redesignates
the NDC for its product, we believe the new NDC also would meet the
same criteria defined in the OIG study. In this circumstance, we expect
that the product labeling would not contain substantial changes
regarding the redesignated NDC. Therefore, we propose to add Sec.
414.904(d)(4)(iv) to codify the application of the lesser-of
methodology such that the manufacturer-reported pricing data associated
with redesignated NDCs will be used in the lesser-of methodology in the
same way as the original OIG-identified NDC.
---------------------------------------------------------------------------
\74\ Our regulation at Sec. 414.904(d)(3)(ii)(C) in reference
to AMP price substitution refers to drugs ``identified by FDA as
being in short supply.'' The current AMP price substitution policy
for shortages is consistent with the policy discussed here, as we
interpret the phrase ``identified by FDA as being in short supply''
at Sec. 414.904(d)(3)(ii)(C) to mean the list in effect under
section 506E of the Federal Food, Drug, and Cosmetic Act.
---------------------------------------------------------------------------
Once an OIG study identifies self-administered versions of a drug
or biological product, there may be subsequent FDA approvals of other
products with the same active ingredient, such as new syringe sizes,
new types of injector syringes, generic formulations, biosimilar
biological products, or interchangeable biological products. For
example, this would include the situation in which the current
manufacturer of certolizumab pegol or abatacept obtains a supplemental
FDA approval for a new version of the product. Similarly, this would
also include the situation in which another manufacturer gains FDA
approval of a product with the same active ingredient as an OIG-
identified self-administered version. We believe that provisions at new
section 1847A(g) of the Act would require a new OIG study as described
in section 1847A(g)(1) of the Act in order for us to apply the lesser-
of methodology to the drug or biological product.
e. Summary
In summary, to implement new section 1847A(g) of the Act, we are
proposing to:
Add Sec. 414.904(d)(4) to codify the lesser-of payment
methodology and define when the application of the lesser-of
methodology would first be reflected in the ASP pricing file following
the OIG study publication; and
Describe the lesser of methodology at Sec.
414.904(d)(4)(iv).
Describe exceptions to application of the lesser-of
methodology at Sec. 414.904(d)(4)(ii).
Clarify application of the lesser-of methodology for
billing and payment code described under section 1847A(g)(3) of the Act
at Sec. 414.904(d)(4)(iii).
Describe the application of the lesser-of methodology to
redesignated NDCs of those identified in the OIG studies at Sec.
414.904(d)(4)(v).
We welcome comments on these proposals.
E. Medicare Part B Payment for Drugs Approved Through the Pathway
Established Under Section 505(b)(2) of the Federal Food, Drug, &
Cosmetic Act
1. Background
For most drugs that are payable under Medicare Part B, payment-
limit amounts are determined using the methodology in section 1847A of
the Act. In many cases, the payment-limit amount is based on the
Average Sales Price (ASP) plus a statutorily mandated 6 percent add-on.
Additionally, small molecule drugs payable under Medicare Part B using
the methodology in section 1847A of the Act fall into two broad,
mutually exclusive categories: (1) Multiple source drugs, and (2)
single source drugs. These terms are defined in sections 1847A(c)(6)(C)
and (D) of the Act, respectively.
[[Page 39246]]
In most cases, the distinction between multiple source drugs and
single source drugs is straightforward. We published program
instructions in 2007 (available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf) that address
how these distinctions are made. However, a subset of drugs that are
approved by the FDA under New Drug Applications (NDAs) are approved
through the pathway established under section 505(b)(2) of the FFDCA
(Pub. L. 75-717, June 25, 1938) (hereinafter referred to as ``section
505(b)(2) drug products''). For section 505(b)(2) drug products, the
distinction between multiple source drugs and single source drugs can
be less straightforward.
The drug approval pathway established under section 505(b)(2) of
the FFDCA (hereinafter referred to as ``the section 505(b)(2)
pathway'') provides an avenue for applications that contain full
reports of investigations of safety and effectiveness, where at least
some of the information needed for an approval comes from studies not
conducted by or for the applicant, and for which the applicant has not
obtained a right of reference or use.\75\ An application submitted
under the section 505(b)(2) pathway (hereinafter referred to as a
``section 505(b)(2) application'') may rely either on the FDA's
findings of safety, effectiveness, or both, for an already-FDA-approved
drug product or on published literature, provided that: (1) Such
reliance is scientifically justified, and (2) the section 505(b)(2)
application complies with applicable statutory and regulatory
requirements, including, but not limited to, patent certification, if
appropriate. Unlike a generic drug product approved under an
Abbreviated New Drug Application (ANDA), a section 505(b)(2) drug
product is not required to have the same FDA-approved labeling as the
labeling for the already-FDA-approved drug product(s) upon which the
section 505(b)(2) application relied. (For more information, see the
FDA's May 2019 guidance titled, ``Determining Whether to Submit an ANDA
or a 505(b)(2) Application,'' available at https://www.fda.gov/media/124848/download.)
---------------------------------------------------------------------------
\75\ Regulations at 21 CFR 314.3 define ``Right of Reference or
Use'' to mean the authority to rely upon, and otherwise use, an
investigation for the purpose of obtaining approval of an NDA,
including the ability to make available the underlying raw data from
the investigation for FDA audit, if necessary.
---------------------------------------------------------------------------
The number of section 505(b)(2) drug products approved each year
has been growing, from about 40 per year from 2011 to 2016, to about 60
to 70 per year from 2017 to 2020. Approximately 10 to 20 percent of
these section 505(b)(2) drug products are payable under Medicare Part
B. Of these, some section 505(b)(2) drug products share substantial
portions of the FDA-approved labeling with the approved drug product(s)
upon which the section 505(b)(2) application relied, for example
prescribing information on safety, efficacy, and pharmacokinetics. In
some cases, the section 505(b)(2) drug product even shares substantial
portions of labeling with generic drug products that are payable under
Part B as multiple source drugs. Medicare Part B claims data from 2020
indicate that spending for some of these section 505(b)(2) drug
products (that is, those that could be assigned to a multiple source
drug code under the framework described below, but are instead
currently assigned to a single source drug code) is substantially
greater than that for the corresponding generic drug products assigned
to a multiple source drug code. One example is a sterile injectable
drug that was first approved as a lyophilized powder for reconstitution
in a vial and later was approved through the section 505(b)(2) pathway
as a concentrated liquid in a vial. Another example is a drug available
as a lyophilized powder for reconstitution in a vial that was then
approved through the section 505(b)(2) pathway as a ready-to-use
intravenous (IV) solution in a bag. Analysis of 2020 claims data for
the separately coded section 505(b)(2) drug product (that is, the
ready-to-use IV solution) shows that Medicare spending per service unit
was approximately eight times that of the corresponding products in the
multiple source drug code. Moreover, in the July 2021 ASP Pricing File
(available at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files), the payment limit for
the section 505(b)(2) drug product is 17.2 times the payment limit for
the multiple source code, when adjusted for the different dose
descriptors of each code. In another example, there were approximately
7.54 million allowed service units, representing approximately $1.38
million of allowed charges, for a multiple source drug code, but for
the separately coded section 505(b)(2) drug product, over the same
time-period there were approximately 1.08 million allowed service
units, representing approximately $2.13 million in allowed charges.
Calculating the allowed charges per allowed service unit, each service
unit of the section 505(b)(2) drug product cost Medicare 10.78 times
that of the corresponding products assigned to the multiple source drug
code, costing Medicare an additional $1.93 million. In the July 2021
ASP Pricing File, the payment limit for the section 505(b)(2) drug
product is 21.3 times the payment limit for the multiple source code.
Based on these observed data points, we are planning an additional
analysis of spending on section 505(b)(2) drug products and potential
savings to Medicare and Medicare beneficiaries that may be realized if
certain section 505(b)(2) drug products were to be assigned to multiple
source drug codes based on the framework described in section 3 of this
preamble.
2. CY 2021 Proposal
In the CY 2021 PFS proposed rule, we proposed to codify our long-
standing approach to determine whether a section 505(b)(2) drug product
is described by an existing multiple source drug code, or if the
section 505(b)(2) drug product would be assigned to a single source
drug code. In that proposal, we explained generally how information
about the section 505(b)(2) drug product's active ingredient(s), drug
product name (this refers to nomenclature of the drug product as found
in the United States Pharmacopeia--National Formulary (USP-NF) and
nomenclature as found in title of the FDA-approved labeling), and
description; labeling information; and ordering (prescribing) and
clinical use would factor into a determination. Commenters on our
proposal in the CY 2021 PFS proposed rule (primarily manufacturers)
stated that the proposal conflicted with both the Medicare statute and
the FDA's therapeutic equivalence (TE) ratings,76 77 and
would impair access for patients, underpay providers, and stifle
innovation. Several commenters from beneficiary advocate and provider
organizations generally repeated the same points, although some
commenters expressed support for curbing drug prices, particularly if
the proposal did not affect patient access. Several commenters appeared
to take a middle ground that conditionally supported the proposals,
particularly if more detail could be provided and if effects on patient
access were considered. Several commenters supported the proposals
without conditions. Several commenters expressed that we should provide
more
[[Page 39247]]
detail about the decision framework and the determination process.
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\76\ As published in the FDA's ``Orange Book: Approved Drug
Products with Therapeutic Equivalence Evaluations'' available at
https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
\77\ See also 21 CFR 314.3(b) for definitions of ``therapeutic
equivalents'' and related terms, as well as https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface.
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Some commenters on the CY 2021 PFS proposed rule requested that we
provide more details about the process by which certain section
505(b)(2) drug products would be assigned to multiple source drug
codes. Commenters requested that we include more detail on how factors
described in the CY 2021 PFS proposal, (for example, differences in the
active ingredient and labeling) may be interpreted and which drug
products might be affected. Commenters also requested that we provide
the public more time to assess a more detailed proposal as well as an
opportunity, such as through future rulemaking, for public input both
on the proposal and on decisions about specific drug products.
Several commenters stated that if we move forward with the CY 2021
proposal, we should exclude products with ``meaningful differences''
from the policy and encouraged us to continue an approach ``that allows
for innovation, competition, and ultimately more therapeutic choices
for Medicare beneficiaries.'' We recognize that some section 505(b)(2)
drug products have clear differences in factors such as safety,
efficacy, or pharmacokinetics, which would not result in the assignment
of the product to the existing multiple source drug code. The framework
discussed in the next section would address situations in which a
section 505(b)(2) drug product is not described by an existing multiple
source drug code, and therefore, would not be assigned to the existing
multiple source drug code.
In response to commenters' requesting more detail about our
proposed approach and to delay finalizing a decision, we did not
finalize our proposals in the CY 2021 PFS proposed rule regarding
section 505(b)(2) drug products. We stated that the delay would allow
time for CMS to further consider this issue. As part of our further
consideration, we are soliciting comment on a more detailed framework
(hereinafter referred to as ``the framework'') for determining when a
section 505(b)(2) drug product is a multiple source drug under section
1847A(c)(6)(C) of the Act.
The framework is consistent with program instruction published in
2007, which addressed how we would assign ``single source drugs'' and
``biological products'' using a multi-step process. However, this
program instruction did not expressly address how we would assign
multiple source drugs. The program instruction uses the term ``drug''
at the billing and payment code level when discussing single source
drugs in the same way that the discussion in this preamble uses the
term ``drug'' in reference to multiple source drugs. Development of
standards for identifying multiple source drugs (that is, the
framework) would add to the 2007 program instruction and provide detail
about an approach to Medicare Part B payment for section 505(b)(2) drug
products.
The framework described in the next section aims to build off the
current CMS policy for assigning drug products to billing and payment
codes by describing detailed standards for determining whether a
section 505(b)(2) drug product corresponds to an existing multiple
source drug code. We are not proposing to adopt the framework at this
time. Rather, we are seeking comment on the framework to inform future
policy making.
3. The Framework
The framework is a determination process to identify when section
505(b)(2) drug products without an FDA TE rating to an existing drug
product payable under Part B correspond to an existing multiple source
drug code for the purpose of payment under Medicare Part B. The
framework would provide additional detail about the decision-making
process and increase transparency about potential determinations
resulting from the framework.
The first portion of the framework would compare certain qualities
of the section 505(b)(2) drug product with drug products already
assigned to an existing multiple source drug code.\78\ This includes
comparison of the: (1) Active ingredient(s); (2) dosage form (if part
of the drug product name); (3) salt form; and (4) other ingredients in
the drug product formulation. The drug product assessment could result
in a match or non-match designation. Section 505(b)(2) drug products
receiving a match designation in the first portion of the framework
would continue to a verification step. This step would compare the
pharmacokinetic and clinical studies of the section 505(b)(2) drug
product's FDA-approved labeling with those of the drug products already
assigned to an existing multiple source code. Finally, a determination
would be made as to whether the section 505(b)(2) drug product could be
assigned to the existing multiple source code.
---------------------------------------------------------------------------
\78\ These assignments are published as part of the ASP NDC-
HCPCS Crosswalk Files available at https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2021-asp-drug-pricing-files.
---------------------------------------------------------------------------
For full details on the framework, please see https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.
We are soliciting comment on:
The framework and how it aligns with the statutory
definitions of single source and multiple source drugs in section
1847A(c)(6)(C) and (D) of the Act, respectively;
How the framework distinguishes situations in which a
section 505(b)(2) drug product is not described by an existing multiple
source drug code; and
The potential impacts of the framework on Medicare
beneficiaries, the government, and other stakeholders.
F. Appropriate Use Criteria for Advanced Diagnostic Imaging
Section 218(b) of the Protecting Access to Medicare Act (Pub. L.
113-93, April 1, 2014) (PAMA) amended Title XVIII of the Act to add
section 1834(q) of the Act directing us to establish a program to
promote the use of appropriate use criteria (AUC) for advanced
diagnostic imaging services. We have taken steps to implement this
program over several years, and codified the AUC program in our
regulations at 42 CFR 414.94. In CY 2020, we began conducting an
educational and operations testing period for the claims-based
reporting of AUC consultation information, which has been extended
through CY 2021.
The CY 2016 PFS final rule with comment period (80 FR 70886)
addressed the initial component of the new Medicare AUC program,
specifying applicable AUC. In the CY 2016 PFS final rule with comment
period, we established an evidence-based process and transparency
requirements for the development of AUC, defined provider-led entities
(PLEs) and established the process by which PLEs may become qualified
to develop, modify or endorse AUC. The first list of qualified PLEs was
posted on the CMS website at the end of June 2016 at which time their
AUC libraries became specified applicable AUC for purposes of section
1834(q)(2)(A) of the Act.
The CY 2017 PFS final rule (81 FR 80170) addressed the second
component of this program, specification of qualified clinical decision
support mechanisms (CDSMs). In the CY 2017 PFS final rule, we defined
CDSM, identified the requirements CDSMs must meet for qualification,
including preliminary qualification for mechanisms documenting how and
when each requirement is reasonably
[[Page 39248]]
expected to be met, and established a process by which CDSMs may become
qualified. We also defined applicable payment systems under this
program, specified the first list of priority clinical areas, and
identified exceptions to the requirement that ordering professionals
consult specified applicable AUC when ordering applicable imaging
services. The first list of qualified CDSMs was posted on the CMS
website in July 2017.
The CY 2018 PFS final rule (82 FR 53190) addressed the third
component of this program, the consultation and reporting requirements.
In the CY 2018 PFS final rule, we established the start date of January
1, 2020 for the Medicare AUC program for advanced diagnostic imaging
services. Specifically, for services ordered on and after January 1,
2020, we established that ordering professionals must consult specified
applicable AUC using a qualified CDSM when ordering applicable imaging
services, and furnishing professionals must report AUC consultation
information on the Medicare claim. We further specified that the AUC
program will begin on January 1, 2020 with a year-long educational and
operations testing period during which time AUC consultation
information is expected to be reported on claims, but claims would not
be denied for failure to include proper AUC consultation information.
We also established a voluntary period from July 2018 through the end
of 2019 that ordering professionals who are ready to participate in the
AUC program may consult specified applicable AUC through qualified
CDSMs and communicate the results to furnishing professionals; and
furnishing professionals who are ready to do so may report AUC
consultation information on the claim at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10481.pdf.
Additionally, to incentivize early use of qualified CDSMs to
consult AUC, we established in the CY 2018 Updates to the Quality
Payment Program; and Quality Payment Program: Extreme and
Uncontrollable Circumstances Policy for the Transition Year final rule
with comment period and interim final rule (hereinafter ``CY 2018
Quality Payment Program final rule''), a high-weight improvement
activity for ordering professionals who consult specified AUC using a
qualified CDSM for the Merit-based Incentive Payment System (MIPS)
performance period that began January 1, 2018 (82 FR 54193).
In the CY 2019 PFS final rule (83 FR 59452), we made further
additions and clarifications to the AUC program requirements. We added
independent diagnostic testing facility (IDTF) to the definition of
applicable settings under Sec. 414.94(b). We also clarified that the
furnishing professionals (including provider or supplier entities
furnishing advanced diagnostic imaging services in an applicable
setting, paid for under an applicable payment system) are required to
report AUC consultation information on the claims as specified under
Sec. 414.94(k). We established significant hardship exception criteria
and process under Sec. 414.94(i)(3) to be specific to the AUC program
and independent of other Medicare programs. We specified under Sec.
414.94(j)(2) that when delegated by the ordering professional, clinical
staff under the direction of the ordering professional may perform the
AUC consultation with a qualified CDSM. Finally, we announced our
intention to use G-codes and modifiers to report AUC consultation
information on the Medicare claims. In 2020, in response to the Public
Health Emergency (PHE) for the Coronavirus Disease 2019 (COVID-19) (PHE
for COVID-19), the educational and operations testing period was
extended through CY 2021.
1. Background
AUC present information in a manner that links a specific clinical
condition or presentation; one or more services; and an assessment of
the appropriateness of the service(s). Evidence-based AUC for imaging
can assist clinicians in selecting the imaging study that is most
likely to improve health outcomes for patients based on their
individual clinical presentation. For purposes of this program, AUC is
a set or library of individual AUC. Each individual criterion is an
evidence-based guideline for a particular clinical scenario based on a
patient presenting symptoms or condition.
AUC need to be integrated as seamlessly as possible into the
clinical workflow. CDSMs are the electronic portals through which
clinicians access the AUC during the patient workup. They can be
standalone applications that require direct entry of patient
information, but may be more effective when they are integrated into
electronic health records (EHRs). Ideally, practitioners would interact
directly with the CDSM through their primary user interface, thus
minimizing interruption to the clinical workflow.
2. Statutory Authority
Section 218(b) of the PAMA added a new section 1834(q) of the Act
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging
Services,'' which directed the Secretary to establish a program to
promote the use of AUC. Section 1834(q)(4) of the Act requires ordering
professionals to consult with specified applicable AUC through a
qualified CDSM for applicable imaging services furnished in an
applicable setting and paid for under an applicable payment system; and
payment for such service may only be made if the claim for the service
includes information about the ordering professional's consultation of
specified applicable AUC through a qualified CDSM.
3. Discussion of Statutory Requirements
There are four major components of the AUC program under section
1834(q) of the Act, and each component has its own implementation date:
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of
the Act); (2) identification of mechanisms for consultation with AUC by
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by
ordering professionals, and reporting on AUC consultation by January 1,
2017 (section 1834(q)(4) of the Act); and (4) annual identification of
outlier ordering professionals for services furnished after January 1,
2017 (section 1834(q)(5) of the Act). We did not identify mechanisms
for consultation by April 1, 2016. Therefore, we did not require
ordering professionals to consult CDSMs or furnishing professionals to
report information on the consultation by the January 1, 2017 date.
a. Establishment of AUC
In the CY 2016 PFS final rule with comment period, we addressed the
first component of the Medicare AUC program under section 1834(q)(2) of
the Act--the requirements and process for establishment and
specification of applicable AUC, along with relevant aspects of the
definitions under section 1834(q)(1) of the Act. This included defining
the term ``provider-led entity'' and finalizing requirements for the
rigorous, evidence-based process by which a PLE would develop AUC, upon
which qualification is based, as provided in section 1834(q)(2)(B) of
the Act and in the CY 2016 PFS final rule with comment period. Using
this process, once a PLE is qualified by us, the AUC that are
developed, modified or endorsed by the qualified PLE are considered to
be specified applicable AUC under section 1834(q)(2)(A) of the Act. We
defined PLE to include national professional medical societies, health
systems, hospitals, clinical practices and collaborations of such
entities such as the High Value Healthcare Collaborative or the
National Comprehensive Cancer Network.
[[Page 39249]]
Qualified PLEs may collaborate with third parties that they believe add
value to their development of AUC, provided such collaboration is
transparent. We expect qualified PLEs to have sufficient
infrastructure, resources, and the relevant experience to develop and
maintain AUC according to the rigorous, transparent, and evidence-based
processes detailed in the CY 2016 PFS final rule with comment period.
In the same rule, we established a timeline and process under Sec.
414.94(c)(2) for PLEs to apply to become qualified. Qualified PLEs are
listed at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html (OMB
Control Number 0938-1288).
b. Mechanism for AUC Consultation
In the CY 2017 PFS final rule, we addressed the second major
component of the Medicare AUC program--the specification of qualified
CDSMs for use by ordering professionals for consultation with specified
applicable AUC under section 1834(q)(3) of the Act, along with relevant
aspects of the definitions under section 1834(q)(1) of the Act. This
included defining the term CDSM and finalizing functionality
requirements of mechanisms, upon which qualification is based, as
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS
final rule. We defined CDSM as an interactive, electronic tool for use
by clinicians that communicates AUC information to the user and assists
them in making the most appropriate treatment decision for a patient's
specific clinical condition. Tools may be modules within or available
through certified EHR technology (as defined in section 1848(o)(4) of
the Act) or private sector mechanisms independent from certified EHR
technology or a mechanism established by the Secretary.
In the CY 2017 PFS final rule, we established a timeline and
process in Sec. 414.94(g)(2) for CDSM developers to apply to have
their CDSMs qualified. Qualified CDSMs are listed at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html (OMB Control
Number 0938-1315).
c. AUC Consultation and Reporting
In the CY 2018 PFS final rule, we addressed the third major
component of the Medicare AUC program--consultation with applicable AUC
by the ordering professional and reporting of such consultations under
section 1834(q)(4) of the Act. We established a January 1, 2020
effective date for the AUC consultation and reporting requirements for
this program. We also established a voluntary period during which early
adopters could begin reporting limited consultation information on
Medicare claims from July 2018 through December 2019. During the
voluntary period, there is no requirement for ordering professionals to
consult AUC or furnishing professionals to report information related
to the consultation. On January 1, 2020, the program began with an
educational and operations testing period and during this time, we have
continued to pay claims whether or not they correctly include AUC
consultation information. Ordering professionals must consult specified
applicable AUC through qualified CDSMs for applicable imaging services
furnished in an applicable setting, paid for under an applicable
payment system and ordered on or after January 1, 2020; and furnishing
professionals must report the AUC consultation information on the
Medicare claim for these services ordered on or after January 1, 2020.
Consistent with section 1834(q)(4)(B) of the Act, we also
established that the following information must be reported on Medicare
claims for advanced diagnostic imaging services as specified in section
1834(q)(1)(C) of the Act and defined in Sec. 414.94(b), furnished in
an applicable setting as defined in section 1834(q)(1)(D) of the Act,
paid for under an applicable payment system as defined in section
1834(q)(4)(D) of the Act, and ordered on or after January 1, 2020: (1)
The qualified CDSM consulted by the ordering professional; (2) whether
the service ordered would or would not adhere to specified applicable
AUC, or whether the specified applicable AUC consulted was not
applicable to the service ordered; and (3) the NPI of the ordering
professional (if different from the furnishing professional).
Section 1834(q)(4)(C) of the Act provides for exceptions to the AUC
consultation and reporting requirements in the case of: A service
ordered for an individual with an emergency medical condition, a
service ordered for an inpatient and for which payment is made under
Medicare Part A, and a service ordered by an ordering professional for
whom the Secretary determines that consultation with applicable AUC
would result in a significant hardship. In the CY 2017 PFS final rule,
we adopted a regulation at Sec. 414.94(h)(1)(i) to specify the
circumstances under which AUC consultation and reporting requirements
are not applicable and in the CY 2019 PFS final rule, we updated the
significant hardship exception criteria to be specific to the AUC
program and independent of other programs. An ordering professional
experiencing any of the following when ordering an advanced diagnostic
imaging service is not required to consult AUC using a qualified CDSM,
and the claim for the applicable imaging service is not required to
include AUC consultation information. Significant hardship exceptions
under Sec. 414.94(i)(3) include: Insufficient internet access; EHR or
CDSM vendor issues; or extreme and uncontrollable circumstances.
We remind readers that, consistent with section 1834(q)(4)(A) of
the Act, ordering professionals must consult AUC for every applicable
imaging service furnished in an applicable setting and paid under an
applicable payment system unless a statutory exception applies.
Section 1834(q)(4)(D) of the Act specifies the applicable payment
systems for which AUC consultation and reporting requirements apply. In
the CY 2017 PFS final rule, we defined applicable payment system to
reflect the statutory requirements in Sec. 414.94(b) as: (1) The PFS
established under section 1848(b) of the Act; (2) the PPS for hospital
outpatient department services under section 1833(t) of the Act; and
(3) the ambulatory surgical center payment system under section 1833(i)
of the Act.
Section 1834(q)(1)(D) of the Act specifies the applicable settings
in which AUC consultation and reporting requirements apply: A
physician's office, a hospital outpatient department (including an
emergency department), an ambulatory surgical center, and any other
``provider-led outpatient setting determined appropriate by the
Secretary.'' In the CY 2017 PFS final rule, we added this definition to
Sec. 414.94(b). As noted above, we expanded that definition to add an
IDTF in the CY 2019 PFS final rule.
d. Identification of Outliers
The fourth component of the Medicare AUC program is specified in
section 1834(q)(5) of the Act, Identification of Outlier Ordering
Professionals. The identification of outlier ordering professionals
under this paragraph facilitates a prior authorization requirement that
applies for outlier professionals beginning January 1, 2020, as
specified under section 1834(q)(6) of the Act. Because we established a
start date of January 1, 2020 for AUC consultation and reporting
requirements, we did not identify any outlier ordering professionals by
that date. As such,
[[Page 39250]]
implementation of the prior authorization component is delayed.
However, we did finalize in the CY 2017 PFS final rule the first list
of priority clinical areas to guide identification of outlier ordering
professionals as follows:
Coronary artery disease (suspected or diagnosed).
Suspected pulmonary embolism.
Headache (traumatic and non-traumatic).
Hip pain.
Low back pain.
Shoulder pain (to include suspected rotator cuff injury).
Cancer of the lung (primary or metastatic, suspected or
diagnosed).
Cervical or neck pain.
We will use future rulemaking to establish the methodology for the
identification of outlier ordering professionals who would eventually
be subject to a prior authorization process when ordering advanced
diagnostic imaging services.
4. Proposals for Continuing Implementation
a. Proposed Clarification of AUC Program Scope
i. Modified Orders
Updates or modifications to orders for advanced diagnostic imaging
services may be warranted in certain situations once the beneficiary is
under the care of the furnishing professional. Unless they are also
serving as the ordering professional, furnishing professionals may not
consult AUC on behalf of or in place of the ordering professional. The
Medicare Benefit Policy Manual (BPM) (Pub. L. 100-02) addresses
situations where the furnishing professional performs imaging services
that differ from ordered services in chapter 15, sections 80.6.1-4.
These BPM sections on modified orders state that when an interpreting
physician determines that a different or additional imaging service not
included on the order should be performed, the interpreting physician
or testing facility generally may not perform the test until a new
order from the treating physician/practitioner has been received. If
the treating physician/practitioner cannot be reached to change or
obtain a new order, the interpreting physician or testing facility may
furnish the additional imaging service under the following
circumstances, as documented in the patient's medical record: The
treating physician/practitioner could not be reached, the ordered test
is performed and an additional diagnostic test is medically necessary
because of the abnormal result of that test, delaying performance of
the additional test would have an adverse effect on the patient's care,
the result of the additional test is communicated to and used by the
treating physician/practitioner in the patient's treatment, and the
interpreting physician/practitioner documents in the report the reasons
for the additional testing.
When the furnishing professional performs additional imaging
services not reflected on the order under these circumstances, we do
not believe it would be appropriate to consider them to be acting as an
ordering professional such that an AUC consultation would be needed.
Instead, we believe the furnishing professional in these situations is
the interpreting physician/practitioner who is exercising their
professional judgment to provide the ordering professional with
additional diagnostic test results for use in managing the patient's
care. Additionally, they are doing so only because, after performing
the ordered test and determining that additional testing is expedient
given the results of that test, the ordering professional cannot be
reached to request a modified or additional order. Given the conditions
under which these additional imaging services are performed, we propose
that when the furnishing professional for an advanced diagnostic
imaging service performs one or more additional services under the
circumstances described in chapter 15, section 80.6.2-4 of the BPM,
neither the ordering professional nor the furnishing professional are
required to consult AUC for the additional service(s). In these
situations, the AUC consultation information from the original order is
to be reported on the claim line for the additional service(s). Where
the furnishing professional modifies the order for an advanced
diagnostic imaging service without obtaining a new order from the
ordering professional, the AUC consultation information provided by the
ordering professional with the original order should be reflected on
the Medicare claim to demonstrate that the requisite AUC consultation
occurred. Because the BPM instructions state that the interpreting
physician or testing facility generally may not perform a modified or
new test until a new order from the treating physician/practitioner has
been received, we expect situations where AUC consultations do not
occur for new or modified orders to be infrequent.
ii. Extreme and Uncontrollable Circumstances Hardship Exception
In the CY 2019 PFS final rule, we describe extreme and
uncontrollable circumstances to include disasters, natural or man-made,
that have a significant negative impact on healthcare operations, area
infrastructure or communication systems. We also explain these may
include areas where events occur that have been designated by FEMA as a
major disaster or a public health emergency declared by the Secretary.
To further clarify, these circumstances are events that are entirely
outside the control of the ordering professional that prevent the
ordering professional from consulting AUC through a qualified CDSM. We
believe the hardship criteria under this program are similar to other
programs such as the Promoting Interoperability performance category of
the Merit-based Incentive Payment System (MIPS), particularly the
flexibility that is given to clinicians to identify what they consider
to be extreme and uncontrollable circumstances.
The PHE for COVID-19 has been in effect since January 27, 2020.
Stakeholders have described challenges in continuing to prepare for the
payment penalty phase of the AUC program due to resource reallocation
resulting from the PHE. Some stakeholders have explained that all
health technology projects unrelated to the PHE were halted, including
projects that impact establishing or updating health IT systems that
enable AUC consultation through qualified CDSMs. Stakeholders have also
indicated that human resources were reallocated to focus on responding
to the PHE. Additionally, we recognize that practitioners have been
heavily impacted in their own practice of medicine to respond to the
PHE and provide treatment to patients which may have prevented them
from focusing on and participating in the educational and operations
testing period to prepare for the payment penalty phase. While we are
continuing to move forward in implementing the AUC program, we want to
assure stakeholders that they may attest to a significant hardship
under the AUC program due to extreme and uncontrollable circumstances
due to the PHE for COVID-19, and such an attestation may be used as
needed by ordering practitioners throughout the PHE. Furthermore, as
the AUC program progresses into the payment penalty phase, self-
attestation for a significant hardship exception will continue to be
available for ordering professionals experiencing extreme and
uncontrollable circumstances due to the PHE. We also recognize that
ordering professionals may experience significant
[[Page 39251]]
hardships related to or resulting from the PHE that extend beyond the
date the PHE expires and note that AUC program exceptions will continue
to be available for such significant hardships as defined at Sec.
414.94(i)(3).
b. Claims Processing
As we move ahead to implement the payment penalty phase of this
program, we must address additional operational and administrative
issues. We explain these issues here, and our assessments and proposals
for addressing them. We are soliciting comments on whether additional
scenarios require our consideration, and whether the proposed solutions
adequately address issues raised by stakeholders. We are soliciting any
additional information stakeholders may offer to assist us in
developing claims processing system edits or other measures to ensure
that only appropriate claims are subject to AUC claims processing
edits. The AUC program will be fully implemented when we have the
necessary edits established in the claims processing system and we
begin using those edits to deny Medicare claims that fail to report the
required AUC consultation information. Therefore, we need to find
workable solutions that allow the AUC program to accurately pay and
deny claims using the information available on Medicare claims, while
working within the limitations of the Medicare claims processing
system. The identification of claims that are or are not subject to the
Medicare AUC Program must be precise to avoid inadvertently denying
claims that should be paid. Because implementation of this program
establishes edits for advanced diagnostic imaging claims, the
inadvertent denial of claims would disproportionately impact
radiologists, hospital outpatient departments and freestanding imaging
centers. Also, as we have noted previously, the AUC program is unique
in that the burden of consulting AUC and providing AUC consultation
information to the furnishing professional falls on the ordering
professional, yet the claims that are denied for failing to report AUC
consultation information are for services furnished and billed by the
professionals and facilities that furnish advance diagnostic imaging.
Two main Medicare claim types are subject to claims processing
edits in the AUC program. These are the CMS-1500 and its electronic
equivalent (referred to here as the practitioner claim) submitted by
physicians and practitioners, ASCs, and IDTFs, and the UB-04, also
called the CMS-1450, (referred to here as the institutional claim)
submitted by hospital outpatient departments and on-campus and off-
campus provider-based departments. These claim types differ in the data
elements they contain; therefore, claims processing edits will not be
identical across claim types.
We have already issued partial claims processing instructions
(CR11268, Transmittal 2404) \79\ to support the educational and
operations testing period. We established HCPCS Level III G-codes for
furnishing professionals to report which CDSM was consulted. We also
established HCPCS modifiers for furnishing professionals to report
adherence, non-adherence and not applicable AUC consultation responses
on the same claim line as the corresponding G-code. Both G-codes and
modifiers are applicable to practitioner and institutional claims. We
established additional HCPCS modifiers for furnishing professionals to
report situations in which the ordering professional is not required to
consult AUC. These modifiers are reported on the same claim line as the
code for the advanced diagnostic imaging procedure since a G-code would
not be reported. We also established a procedure code list that
identifies the advanced diagnostic imaging codes that are subject to
the AUC program. Based on a review of CY 2020 Medicare claims (noting
for readers that during this year the AUC program was only in the
education and operations testing phase with no payment penalties), we
estimate between 9-10 percent of all claims subject to the AUC program
reported information sufficient to be considered compliant with the
program, which means that 90-91 percent of claims would not be
considered compliant with AUC program requirements. In other words, if
the claims processing systems edits had been in place for the payment
penalty phase, only 9-10 percent of claims subject to the AUC program
would have been paid as opposed to being denied or rejected. An
additional 6-7 percent of claims subject to the AUC program included
some relevant information, which demonstrates an awareness of the AUC
program among these billing entities; but the claims did not include
all of the necessary AUC consultation information that will ultimately
be required for the claim to be paid.
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\79\ https://www.cms.gov/files/document/r2404otn.pdf.
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i. Ordering Professional NPI
There are locations on both the practitioner and institutional
claim types to report the NPI of the ordering professional. The
institutional claim uses the K3 segment and the practitioner claim uses
the referring professional field. However, to fully implement the AUC
program, we must establish a claims processing edit to require these
fields to be populated on all advanced diagnostic imaging claims
subject to the AUC program.
In addition, there currently are situations in which multiple
advanced diagnostic imaging services ordered by more than one ordering
professional may be reported on a single claim. This would not be
workable for purposes of reporting AUC consultation information because
the referring professional field is reported at the claim-level and not
at the claim line- or service-level for professional claims. Therefore,
the furnishing professional will need to submit separate claims for the
services ordered by each referring or ordering professional. In other
words, only one ordering professional can be reported per claim.
ii. Critical Access Hospitals
As discussed in the CY 2018 PFS final rule with comment period (82
FR 53192), advanced diagnostic imaging services furnished in an
outpatient department of a critical access hospital (CAH) are not
subject to the AUC program because, in accordance with section
1833(q)(1)(D) of the Act, a CAH is not an applicable setting under the
program. Therefore, we must identify these advanced diagnostic imaging
services and allow them to bypass the AUC program claims processing
edits. For institutional claims, we intend to apply the AUC program
claims processing edits to type of bill 13x, which is used only for
outpatient hospital settings. CAHs submit outpatient claims using type
of bill 85x, rather than type of bill 13x.
In the CY 2019 PFS final rule (83 FR 59694), we further explained
that because section 1834(q)(4)(B) of the Act clearly includes all
claims paid under applicable payment systems without exclusion, the
claims from both furnishing professionals and facilities must include
AUC consultation information. We revised our regulation at Sec.
414.94(k) to specify that AUC consultation information must be reported
on Medicare claims for advanced diagnostic imaging services furnished
in an applicable setting and paid under an applicable payment system.
Prior to this revision, Sec. 414.94(k) required furnishing
professionals to report AUC consultation on the claim, without also
specifying that facility claims must include the AUC consultation
[[Page 39252]]
information. In the CY 2019 PFS final rule, we explained that the AUC
consultation information would be included on the practitioner's claim
for the professional component (PC) of the service and on the
provider's or supplier's claim for the facility portion or technical
component (TC) of the service. Under Sec. 414.94(k), the requirement
to report AUC consultation information on the claim applies to both the
PC and TC of the imaging services that are furnished in an applicable
setting and paid under an applicable payment system. Section
1834(q)(4)(B) of the Act further specifies that the requirement to
report AUC consultation information is specific to claims for advanced
diagnostic imaging services furnished in an applicable setting and paid
under an applicable payment system. We believe that all claims for
advanced diagnostic imaging services, both the PC and TC, must include
the AUC consultation information when they are furnished both in an
applicable setting and paid under an applicable payment system.
However, if advanced diagnostic imaging services are not entirely
furnished in an applicable setting, we believe that neither the PC nor
TC claim should be required to include AUC consultation information.
This ensures consistent application of the AUC consultation
requirements across claims submitted for advanced diagnostic imaging
services even when the PC and TC components of the service are
furnished by different furnishing professionals. As such, we propose
that claims submitted by physicians or practitioners for the PC of an
advanced diagnostic imaging service when the TC was not furnished in an
applicable setting would not be subject to the AUC program since the
setting where the TC of the imaging service is furnished is not subject
to the AUC program consultation and reporting requirements. If a
physician or practitioner submits a claim for the PC of an advanced
imaging service for which the TC was performed as an outpatient CAH
service, there currently is not a systems-based way for us to recognize
that the TC of the service was furnished by a CAH. Place of service
codes reported on practitioner claims are not specific enough. We have
not yet identified a way to segregate these claims and automatically
allow them to bypass AUC program claims processing edits. Therefore, as
discussed below, we propose to establish a separate HCPCS modifier that
will be used to identify practitioner claims for advanced diagnostic
imaging services that are not subject to the AUC program and that are
not otherwise identified using the other AUC program modifiers
designated to identify specific situations where the claims are not
subject to the AUC program.
iii. Maryland Total Cost of Care Model
Section 1834(q)(4)(D) of the Act specifies that the applicable
payment systems for which AUC consultation and reporting requirements
apply are the PFS, the hospital OPPS and the ambulatory surgical center
payment system. We define applicable payment system consistent with
statute at Sec. 414.94(b) and, as noted above, require AUC
consultation information to be reported on Medicare claims for advanced
diagnostic imaging services, both the PC and TC, furnished in an
applicable setting and paid under an applicable payment system at Sec.
414.94(k). Section 1834(q)(4)(B) of the Act specifies that the
requirement to report AUC consultation information is specific to
claims for advanced diagnostic imaging services furnished in an
applicable setting and paid under an applicable payment system. We
believe that all claims for the advanced diagnostic imaging services,
both the PC and TC, must include the AUC consultation information when
they are furnished both in an applicable setting and paid under an
applicable payment system. Therefore, if both the PC and TC for
advanced diagnostic imaging services are not paid under an applicable
payment system, neither the PC nor TC claim is required to include AUC
consultation information. This ensures consistent application of the
AUC consultation requirements across claims submitted for advanced
diagnostic imaging services even when the PC and TC components of the
service are furnished by different furnishing professionals. Similar to
claims for the PC of services for which the TC is furnished outside of
an applicable setting, and because both practitioner and institutional
claims are subject to the AUC program as discussed above, when the
practitioner or institutional claim for the advanced imaging service is
not subject to the AUC program (for example, payment is not made under
an applicable payment system), the corresponding practitioner or
institutional claim for the same imaging service is also not subject to
the AUC program.
Stakeholders alerted CMS to concerns about whether advanced
diagnostic imaging services furnished in hospitals participating in the
Maryland Total Cost of Care Model would be subject to the AUC program.
We appreciate that this has been brought to our attention and we seek
comments on other models. Advanced diagnostic imaging services
furnished in outpatient departments of Maryland hospitals that
participate in the Hospital Payment Program within the Maryland Total
Cost of Care Model are not subject to the AUC program because these
services are not paid under an applicable payment system (Maryland
hospitals that receive payments under the Hospital Payment Program
within the Maryland Total Cost of Care Model are not paid under the
OPPS). Because these services are not subject to the AUC program
requirements when furnished in a hospital paid under the Hospital
Payment Program within the Maryland Total Cost of Care Model, as
opposed to an applicable payment system, we propose that the PCs of
these advanced diagnostic imaging services, when billed separately, are
also not required to include AUC consultation information. We believe
we can identify all institutional claims from a hospital that is paid
under the Hospital Payment Program within the Maryland Total Cost of
Care Model based on their CMS Certification Number (CCN) and allow
those claims to bypass AUC program claims processing edits. We
understand that when the TC and PC of advanced diagnostic imaging
services are billed separately, the professional claim must identify in
box 32 the location where the TC of the imaging service was furnished
to the patient. Therefore, we believe we will have the ability to
identify situations in which the imaging service was furnished in a
hospital that is paid under the Hospital Payment Program within the
Maryland Total Cost of Care Model and exclude those claims from being
subject to AUC program claims processing edits. We believe this can be
accomplished by using the CCN and will continue to work to determine if
a list of CCNs can be used as the source of our edits in addition to
determining the frequency that the list will be updated.
Note that advanced diagnostic imaging services furnished in
applicable settings in the state of Maryland and paid under an
applicable payment system are subject to the AUC program--the above
discussion applies only to the outpatient departments of hospitals that
are paid under the Hospital Payment Program within the Maryland Total
Cost of Care Model.
iv. Inpatients Converted to Outpatients
While uncommon, there are situations in which a beneficiary's
hospital inpatient status is changed to outpatient. Certain criteria
must be met for this to occur and, if met, condition
[[Page 39253]]
code 44 (inpatient admission changed to outpatient) is appended to the
institutional claim (https://www.cms.gov/regulations-and-guidance/guidance/transmittals/downloads/r299cp.pdf). We propose to allow
institutional claims with condition code 44 to bypass AUC claims
processing edits. We make this proposal because, at the time advanced
diagnostic imaging services were ordered and furnished, they were
ordered for and furnished to a beneficiary who was in inpatient status.
As such, the AUC consultation requirement would not have applied at
that time. We believe that any professional claims would include place
of service code 21 (inpatient hospital) since the expectation, until
just prior to discharge, would be that the patient is in an inpatient
status. We expect less than half of one percent of claims will include
condition code 44.
v. Deny or Return Claims That Fail AUC Claims Processing Edits
As discussed above, claims that do not properly include AUC
consultation information will not be paid once we fully implement the
AUC claims processing edits. We are considering whether claims that do
not pass the AUC claims processing edits, and therefore will not be
paid, should be initially returned to the health care provider so they
can be corrected and resubmitted, or should be denied so they can be
appealed. On one hand, we expect there will be some errors in reporting
AUC consultation information on claims, especially early on, and health
care providers might find it helpful to have the opportunity to correct
claims. However, there may be situations in which the health care
provider would prefer the claim be denied so they have an earlier
opportunity to appeal. We are requesting comments to help us better
understand which path would be most appropriate once we fully implement
the AUC program claims edits. Additionally, we are requesting comments
on whether the payment penalty phase should begin first with returning
claims and then transition to denying claims after a period of time,
which may be helpful to furnishing professionals and facilities as they
become more proficient in submitting claims under the AUC program.
vi. Medicare as a Secondary Payer
We understand based on feedback from stakeholders that, in some
EHRs, the primary payer information is readily available and known to
the ordering professional; however, secondary payer information
typically is not available. Additionally, it is possible that when
Medicare is the secondary payer that no Medicare payment would be made
at all after the primary payer makes payment. Medicare is reported as
the secondary payer for approximately 1.5 percent of advanced
diagnostic imaging services that are subject to the AUC program.
Because the secondary payer information for a patient generally is not
available to the ordering professional, and because no Medicare payment
may be involved at all when Medicare is the secondary payer, we propose
to exclude claims that identify Medicare as the secondary payer from
application of the AUC consultation and reporting requirements.
Specifically, we propose to allow claims that identify Medicare as the
secondary payer (using block 1 or the electronic equivalent of the
practitioner claims and using FL 50/51 or the electronic equivalent of
institutional claims) to bypass the AUC program claims processing
edits.
vii. Date of Service and Date of Order
We will specify a start date for the AUC program claims processing
edits to take effect. Medicare claims include a date of service but do
not allow for the date of an imaging order to be recorded. Because we
cannot identify the order date for an advanced imaging service based on
claims, we propose that the AUC program claims processing edits for the
payment penalty phase will be applicable for advanced imaging services
furnished on or after the effective date of the claims edits. For
imaging services ordered prior to, but furnished on or after the
effective date of the AUC program claims processing edits, the
furnishing professional would apply the separate HCPCS modifier
discussed in section III.F.4.b.ii. (Critical Access Hospitals) of this
proposed rule to indicate that the claim is not subject to the AUC
claims processing edits.
viii. HCPCS Modifiers
We established two primary sets of HCPCS modifiers for this
program. One set is to be included on the same claim line as the G-code
identifying the CDSM that was consulted, and reports whether the
imaging service adheres to the AUC (modifier ME), does not adhere to
the AUC (modifier MF), or the qualified CDSM does not contain AUC that
applies to the order (modifier MG). We intend for these modifiers to
continue to be used when the program enters the payment penalty phase.
Additionally, reporting of these modifiers should be limited to one per
qualified CDSM G-code since these modifiers are mutually exclusive.
The second set of HCPCS modifiers is available for use when the
ordering professional does not consult a qualified CDSM. On these
claims, providers would not add a G-code for a CDSM because a
consultation did not take place, and the HCPCS modifier would be
included on the same line as the procedure code for the advanced
diagnostic imaging service that was furnished. These HCPCS modifiers
include the three that were created to describe significant hardship
exceptions (insufficient internet access (modifier MB), EHR or CDSM
vendor issues (modifier MC) and extreme and uncontrollable
circumstances (modifier MD)). Additionally, section 1834(q)(4)(C) of
the Act includes an exception for services ordered for an individual
with an emergency medical condition and modifier MA is available to
identify claims for patients with a suspected or confirmed emergency
medical condition. This set of codes is mutually exclusive and we
expect only one to be reported per procedure code-level claim line.
Modifier QQ was created for use during the voluntary period, before
more detailed modifiers and codes were created, to indicate that an
ordering professional consulted a qualified CDSM for the service and
related data was provided to the furnishing professional. The
descriptor for this code explains that the ordering professional
consulted a qualified CDSM for this service and the related information
was provided to the furnishing professional. Modifier QQ continues to
be available for use through the educational and operations testing
period, but we intend to end the use of that modifier and not carry it
forward into the payment penalty phase since we have established and
will require the use of distinct modifiers to communicate specific AUC
consultation information.
Modifier MH was created for use during the educational and
operations testing phase to identify claims for which AUC consultation
information was not provided to the furnishing professional and
furnishing facility. When the AUC program enters the payment penalty
phase, we will no longer have a need for this modifier because claims
will be required to include AUC consultation information or indicate a
reason the information is not required in order to avoid AUC program
claims processing edits. Beginning for services furnished on and after
the effective date of the AUC program claims processing edits, we
propose to redefine modifier MH to describe situations in which the
[[Page 39254]]
ordering professional is not required to consult AUC and the claim is
not required to report AUC consultation information. For example, we
would repurpose modifier MH to be used in the scenarios described in
sections III.F.4.b.ii. (Critical Access Hospitals), III.F.4.b.iii
(Maryland Total Cost of Care Model) if other options to identify claims
are not feasible, and III.F.4.b.vii. (Date of Service and Date of
Order) of this proposed rule as those scenarios would fall outside the
scope of the AUC program requirements.
ix. Additional Claims Processing Information
Section 1834(q)(1)(D) of the Act specifies the applicable settings
for the AUC program as a physician's office, a hospital outpatient
department (including an emergency department), and ambulatory surgical
center and any other provider-led outpatient setting determined
appropriate by the Secretary. As discussed in the CY 2019 PFS final
rule (83 FR 59690 and 59691), we added IDTFs to the definition of
applicable setting at Sec. 414.94(b) to the three applicable settings
specified in statute because it is a provider-led outpatient setting in
which advanced diagnostic imaging services are furnished by licensed,
certified nonphysician personnel under appropriate physician
supervision. To identify these settings through the Medicare claims
system we evaluated type of bill and place of service codes to identify
those aligned with applicable settings under the AUC program. For
institutional claims, we propose to limit AUC program claims processing
edits to apply only to type of bill 13x (hospital outpatient). This
claim type code encompasses the hospital outpatient department and the
emergency department which represent all applicable settings under the
program that would bill Medicare using institutional claims. For
practitioner claims, we propose to limit the edits to claims with place
of service codes 11 (office), 15 (mobile unit), 19 (off campus
outpatient hospital), 22 (on campus outpatient hospital), 23 (emergency
room) and 24 (ASC). These place of service codes should encompass all
applicable settings under the AUC program as defined at Sec.
414.94(b). Because these type of bill and place of service codes
reflect the applicable settings within which advanced diagnostic
imaging services must be furnished to be subject to the AUC program
requirements, we believe setting these parameters will allow us to more
accurately pay claims while avoiding the need for other types of
professionals and facilities to append modifiers to their claims.
x. Claims Processing Summary
We have presented above some of the scenarios that CMS and
stakeholders have identified as being potentially challenging or
impracticable for application of the AUC program claims processing
edits for purposes of the payment penalty phase. We request feedback on
whether additional scenarios require consideration and whether the
proposed claims processing solutions will adequately address the issues
raised. We also request feedback on areas that stakeholders believe
need more education to inform our ongoing outreach and education
efforts. While much of the discussion is about identifying claims that
are not subject to the AUC program, we note that physicians and other
practitioners, or providers submitting claims for advanced imaging
services that are not subject to the AUC program can voluntarily report
AUC consultation information. We intend to allow those claims to
process through the system. We request commenters to provide additional
information to assist us in developing edits that ensure only
appropriate claims are subject to AUC claims processing edits.
c. Timing of Payment Penalties
We have previously announced in August 2020, via the CMS AUC
website, that the education and operations testing period of the AUC
program would be extended through 2021 and the payment penalty phase
would begin in January 2022. However, given the many complexities
around the scope and application of AUC program claims processing
edits, we believe that notice and comment rulemaking is the most
appropriate means for us to discuss the implementation and claims
processing issues, the start date of the payment penalty phase, and to
obtain stakeholder feedback before subsequently finalizing a course of
action in the final rule. This process will help ensure that we will
appropriately identify claims for denial when the payment penalty phase
of the program begins. In addition, we acknowledge the circumstances of
physicians and other practitioners, and providers, due to the PHE for
COVID-19 and that additional time may be needed to prepare for the
payment penalty phase given the challenges and practice disruptions
they have experienced while responding to the PHE.
The earliest that our claims processing system can begin screening
claims using the AUC program claims processing edits for the payment
penalty phase is October 2022. This is because it would not be possible
for us to finalize implementation and claims processing plans in this
final rule (typically published on or before November 1) and make those
decisions effective any earlier than the 3rd calendar quarter of 2022.
Implementing the types of claims processing edits necessary for this
program generally requires a long lead time. However, we note that an
effective date for the claims processing edits in October 2022 may be
misaligned with typical annual updates to the systems used by the
health care providers that are subject to the AUC program such as EHR,
CDSM or claims submission systems. Therefore, we believe the earliest
practicable effective date for the AUC program claims processing edits
and payment penalty phase is January 1, 2023.
While the above date takes into account technical system and
programming concerns, it does not expressly take into the account the
impact that the PHE for COVID-19 has had, and may yet have, on
practitioners, providers and beneficiaries. Therefore, we are proposing
a flexible effective date for AUC program claims processing edits and
payment penalty phase to begin the later of January 1, 2023, or the
January 1 that follows the declared end of the PHE for COVID-19.
We acknowledge that the AUC program has been significantly delayed.
We seek public comment on this proposal for the payment penalty phase
to begin, and whether we have appropriately taken into account the PHE
for COVID-19 and other factors. We recognize that some practitioners
and institutions have already invested in qualified CDSMs, while others
have had to redirect their resources during the PHE. We seek
information from the public on the state of readiness of practitioners,
facilities, and EHR and CDSM vendors.
5. Summary
In summary, we are providing clarifications and proposals around
the scope of the AUC program specifically pertaining to updates or
modifications to orders for advanced diagnostic imaging services and
the extreme and uncontrollable circumstances significant hardship
exception. We are also proposing several claims processing solutions to
ensure accurate identification of claims that are and are not subject
to the AUC program requirements. These proposals address special
circumstances related to: Services furnished by a CAH, services paid
under the Maryland Total Cost of
[[Page 39255]]
Care Model, inpatients converted to outpatients, situations when
Medicare is the secondary payer, and imaging services ordered prior to
the payment penalty phase but furnished on or after the start of the
payment penalty phase. We also discuss identifying the ordering
professional on practitioner claims for the imaging service and request
feedback on whether it is more appropriate to deny or return claims
that fail AUC claims processing edits. We are also proposing to begin
the AUC claims processing systems edits and payment penalty phase of
the program on the later of January 1, 2023, or the January 1 of the
year after the year in which the PHE for COVID-19 ends. We invite the
public to submit comments on these clarifications and proposals.
We will continue to post information on our website for this
program, accessible at www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html.
G. Removal of Selected National Coverage Determinations
CMS periodically identifies and removes National Coverage
Determinations (NCDs) that no longer contain clinically pertinent and
current information, in other words those items and services that no
longer reflect current medical practice, or that involve items or
services that are used infrequently by beneficiaries. Clinical science
and technology evolves and items and services that were once considered
state-of-the-art or cutting edge and experimental may be established as
reasonable and necessary for Medicare beneficiaries or replaced by more
beneficial technologies or clinical paradigms.
In the CY 2021 PFS final rule (85 FR 84472), we established
rulemaking as an appropriate vehicle for receiving public comment on
removing outdated NCDs, replacing the prior subregulatory
administrative process used on two occasions in 2013 and 2015. Using
rulemaking under section 1871(a)(2) of the Act allows us to consider
removal of several NCDs at once as compared to the public comment
process established in section 1862(l) of the Act, to be used in making
and reconsidering individual NCDs.
Eliminating an NCD that provides national coverage for items and
services means that the item or service will no longer be automatically
covered by Medicare (42 CFR 405.1060). Instead, the initial coverage
determinations for those items and services will be made by local
Medicare Administrative Contractors (MACs). On the other hand, removing
an NCD that bars coverage for an item or service under title XVIII
(that is, national noncoverage NCD), allows MACs to cover the item or
service if the MAC determines that such action is appropriate under the
statute. Removing a national non-coverage NCD may permit more immediate
access to technologies that may now be beneficial for some uses. As the
scientific community continues to conduct research, which produces new
evidence, the evidence base we previously reviewed may have evolved to
support other policy conclusions.
In the CY 2021 PFS final rule, we did not establish an exclusive
list of criteria that we would use for identifying and evaluating NCDs
for removal. Instead, based on recommendations in public comments, and
to be more flexible and nimble, we added considerations to the six
factors established in 2013 to guide our decision making process. In
addition to the six factors listed below, we also consider the general
age of an NCD, changes in medical practice/standard of care, the pace
of medical technology development since the last determination, and
availability and quality of clinical evidence and information to
support removal of an NCD. We would consider proposing the removal of
an NCD if:
We believe that allowing local contractor discretion to
make a coverage decision better serves the needs of the Medicare
program and its beneficiaries.
The technology is generally acknowledged to be obsolete
and is no longer marketed.
In the case of a noncoverage NCD based on the experimental
status of an item or service, the item or service in the NCD is no
longer considered experimental.
The NCD has been superseded by subsequent Medicare policy.
The national policy does not meet the definition of an
``NCD'' as defined in sections 1862(l) or 1869(f) of the Act.
The benefit category determination is no longer consistent
with a category in the statute.
When we evaluate particular NCDs for removal, we take into account
information gathered from stakeholders, the claims data for those items
and services, and factors such as whether there may be documentation
requirements within the NCD that are outdated and create a barrier to
coverage. The rulemaking process provides an opportunity to consider
public input before the NCD would be removed. We could decide to retain
those NCDs after considering public comments.
In Table 23, we list the NCDs that we propose to remove. In
addition to conducting an internal review to identify appropriate NCDs
for removal, we receive removal requests from a variety of external
stakeholders, such as medical specialty societies, device
manufacturers, beneficiaries, physicians and providers, and other
interested individuals. Additionally, sometimes topics are brought to
our attention by the MAC medical directors. Also, we received comments
to the NCD Removal proposal in response to the CY 2021 PFS proposed
rule suggesting another seven NCDs for CMS to consider removing. After
reviewing those comments and considering other available evidence and
information, we are proposing to remove one of those seven NCDs in this
rulemaking cycle. We have opened a national coverage analysis (NCA)
using the NCD process for one and believe the other five NCDs should be
retained.
We solicit comment on the two NCDs discussed in Table 23, as well
as comments recommending other NCDs for CMS to consider for removal in
a future rulemaking or through the NCD process.
[GRAPHIC] [TIFF OMITTED] TP23JY21.046
The following outlines each NCD and provides a summary of the
rationale for removal. Each of the current NCDs below is available in
the Medicare National Coverage Determinations Manual located at https:/
/www.cms.gov/
[[Page 39256]]
Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-
Items/CMS014961.
1. NCD 180.2 Enteral and Parenteral Nutritional Therapy (July 11, 1984)
Circumstances/Factor: We believe that allowing local
contractor discretion to make a coverage decision better serves the
needs of the Medicare program and its beneficiaries.
Rationale: External stakeholders suggested that portions
of this NCD are outdated. Enteral nutrition is the delivery of food to
a patient with a functioning gastrointestinal tract who, due to
pathology to, or non-function of the structures that normally permit
food to reach the digestive tract, cannot maintain weight and strength.
Enteral nutrition is provided through a nasogastric, jejunostomy, or
gastrostomy tube. Parenteral nutrition is provided intravenously to the
patient with pathology of the alimentary tract severe enough, that it
does not allow for absorption of sufficient nutrients. This NCD does
not provide as a matter of course, for pharmacy prepared parental
solutions, which would increase patient safety. It also unnecessarily
adds to patient and provider burden as it requires repeated reviews of
medical necessity for those individuals who need enteral or parenteral
nutrition services as a result of chronic diseases that affect the
ability to eat or to digest/absorb nutrition. Local contractors have
proposed LCDs that, if finalized, would provide parenteral and enteral
nutrition coverage for certain Medicare beneficiaries. Therefore, we
believe that removing this NCD would better serve the needs of the
Medicare program and its beneficiaries.
2. NCD 220.6 Positron Emission Tomography (PET) Scans (September 3,
2013)
Circumstances/Factor: We believe that allowing local
contractor discretion to make a coverage decision better serves the
needs of the Medicare program and its beneficiaries.
Rationale: External stakeholders suggested this NCD may be
outdated. NCD 220.6 established broad national non-coverage for non-
oncologic indications of PET and was established in 2000. Thus we
required that every non-oncologic indication for PET must have its own
NCD in order to receive coverage. In 2013, we reconsidered the NCD to
allow coverage for diagnostic PET imaging for oncologic uses not
already determined by an NCD, to be made at the discretion of local
Medicare administrative contractors (MACs), due to ``various
improvements in the technical, regulatory and professional aspects of
PET imaging for diagnosis.'' Since the 2013 reconsideration, new non-
oncologic PET agents have been approved by the FDA and multiple
professional medical societies have published guidelines relevant to
appropriate use of these agents. We believe that local contractor
discretion provides an immediate avenue to potential coverage in
appropriate candidates for non-oncologic indications. Therefore, we are
proposing to eliminate subsection 220.6 to remove the broad national
bar to coverage of PET scans for non-oncologic indications, thus
allowing local Medicare contractors to make a coverage determination
under section 1862(a)(1)(A) of the Act for beneficiaries. We believe
this framework better serves the needs of the Medicare program and its
beneficiaries. For clarity, we are not proposing to change any other
subsections of 220.6. Thus, the NCDs listed at 220.6.1 through 220.6.20
would not be changed by this proposal.
In summary, we solicit comment on the proposal to remove the two
NCDs, as well as comments recommending other NCDs for CMS to consider
for future removal. We request commenters include a rationale to
support their comments. We will use the public comments to help inform
our decision to take one of three actions on the three NCDs proposed
for removal:
Remove the NCD, as proposed, allowing for coverage to be
determined by the MACs.