Rule2021-23972
Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-Payment Medical Review Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 19, 2021
Effective
January 1, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This major final rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare provider enrollment policies; requirements for prepayment and post- payment medical review activities; requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan, or a Medicare Advantage Prescription Drug (MA- PD) plan; updates to the Medicare Ground Ambulance Data Collection System; changes to the Medicare Diabetes Prevention Program (MDPP) expanded model; and amendments to the physician self-referral law regulations.
Full Text
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[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Rules and Regulations]
[Pages 64996-66031]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23972]
[[Page 64995]]
Vol. 86
Friday,
No. 221
November 19, 2021
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 403, 405, 410, et al.
Medicare Program; CY 2022 Payment Policies Under the Physician Fee
Schedule and Other Changes to Part B Payment Policies; Medicare Shared
Savings Program Requirements; Provider Enrollment Regulation Updates;
and Provider and Supplier Prepayment and Post-Payment Medical Review
Requirements; Final Rule
Federal Register / Vol. 86 , No. 221 / Friday, November 19, 2021 /
Rules and Regulations
[[Page 64996]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 405, 410, 411, 414, 415, 423, 424, and 425
[CMS-1751-F]
RIN 0938-AU42
Medicare Program; CY 2022 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment Policies; Medicare
Shared Savings Program Requirements; Provider Enrollment Regulation
Updates; and Provider and Supplier Prepayment and Post-Payment Medical
Review Requirements
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This major final rule addresses: Changes to the physician fee
schedule (PFS); other changes to Medicare Part B payment policies to
ensure that payment systems are updated to reflect changes in medical
practice, relative value of services, and changes in the statute;
Medicare Shared Savings Program requirements; updates to the Quality
Payment Program; Medicare coverage of opioid use disorder services
furnished by opioid treatment programs; updates to certain Medicare
provider enrollment policies; requirements for prepayment and post-
payment medical review activities; requirement for electronic
prescribing for controlled substances for a covered Part D drug under a
prescription drug plan, or a Medicare Advantage Prescription Drug (MA-
PD) plan; updates to the Medicare Ground Ambulance Data Collection
System; changes to the Medicare Diabetes Prevention Program (MDPP)
expanded model; and amendments to the physician self-referral law
regulations.
DATES: These regulations are effective on January 1, 2022.
FOR FURTHER INFORMATION CONTACT:
<a href="/cdn-cgi/l/email-protection#36725f405f455f5958595066445755425f425f59585344655344405f55534576555b45185e5e4518515940"><span class="__cf_email__" data-cfemail="b9fdd0cfd0cad0d6d7d6dfe9cbd8dacdd0cdd0d6d7dccbeadccbcfd0dadccaf9dad4ca97d1d1ca97ded6cf">[email protected]</span></a>, for any issues not
identified below.
Michael Soracoe, (410) 786-6312, or
<a href="/cdn-cgi/l/email-protection#1b5f726d7268727475747d4b697a786f726f7274757e69487e696d72787e685b78766835737368357c746d"><span class="__cf_email__" data-cfemail="9bdff2edf2e8f2f4f5f4fdcbe9faf8eff2eff2f4f5fee9c8fee9edf2f8fee8dbf8f6e8b5f3f3e8b5fcf4ed">[email protected]</span></a>, for issues related to
practice expense, work RVUs, conversion factor, and PFS specialty-
specific impacts.
Larry Chan, (410) 786-6864, for issues related to potentially
misvalued services under the PFS.
Patrick Sartini, (410) 786-9252, and Larry Chan, (410) 786-6864,
for issues related to telehealth services and other services involving
communications technology.
Julie Adams, (410) 786-8932, for issues related to payment for
anesthesia services.
Sarah Leipnik, (410) 786-3933, or
<a href="/cdn-cgi/l/email-protection#4f0b2639263c26202120291f3d2e2c3b263b2620212a3d1c2a3d39262c2a3c0f2c223c6127273c61282039"><span class="__cf_email__" data-cfemail="8cc8e5fae5ffe5e3e2e3eadcfeedeff8e5f8e5e3e2e9fedfe9fefae5efe9ffccefe1ffa2e4e4ffa2ebe3fa">[email protected]</span></a>, for issues related to split
(or shared) services.
Michelle Cruse, (410) 786-7540, and Michael Konieczny, (410) 786-
0825, for issues related to payment for vaccine administration
services.
Regina Walker-Wren, (410) 786-9160, for issues related to billing
for services of physician assistants and PFS payment for teaching
physician services.
Pamela West, (410) 786-2302, for issues related to PFS payment for
therapy services, medical nutrition therapy services, and services of
registered dietitians and nutrition professionals.
Liane Grayson, (410) 786-6583, for issues related to coinsurance
for certain colorectal cancer screening services and PFS payment for
critical care services.
Lisa Parker, (410) 786-4949, and Michele Franklin, (410) 786-9226,
for issues related to RHCs and FQHCs.
Laura Kennedy, (410) 786-3377, for issues related to drugs payable
under Part B.
Heather Hostetler, (410) 786-4515, and Elizabeth Truong, 410-786-
6005, for issues related to removal of selected national coverage
determinations.
Sarah Fulton, (410) 786-2749, for issues related to Appropriate Use
Criteria for Advanced Diagnostic Imaging (AUC); and Pulmonary
Rehabilitation, Cardiac Rehabilitation and Intensive Cardiac
Rehabilitation.
Rachel Katonak, (410) 786-8564, for issues related to Medical
Nutrition Therapy.
Sabrina Ahmed, (410) 786-7499, for issues related to the Medicare
Shared Savings Program (Shared Savings Program) quality reporting
requirements and quality performance standard.
Janae James, (410) 786-0801, Elizabeth November, (410) 786-4518, or
<a href="/cdn-cgi/l/email-protection#b8ebd0d9cadddcebd9ced1d6dfcbe8cad7dfcad9d5f8dbd5cb96d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="89dae1e8fbeceddae8ffe0e7eefad9fbe6eefbe8e4c9eae4faa7e1e1faa7eee6ff">[email protected]</span></a>, for issues related to Shared Savings
Program beneficiary assignment, repayment mechanism requirements, and
benchmarking methodology.
Naseem Tarmohamed, (410) 786-0814, or
<a href="/cdn-cgi/l/email-protection#a9fac1c8dbcccdfac8dfc0c7cedaf9dbc6cedbc8c4e9cac4da87c1c1da87cec6df"><span class="__cf_email__" data-cfemail="5c0f343d2e39380f3d2a35323b2f0c2e333b2e3d311c3f312f7234342f723b332a">[email protected]</span></a>, for inquiries related to Shared
Savings Program application, compliance and beneficiary notification
requirements.
Amy Gruber, <a href="/cdn-cgi/l/email-protection#e7a68a85928b86898482a3869386a4888b8b8284938e8889a7848a94c98f8f94c9808891"><span class="__cf_email__" data-cfemail="acedc1ced9c0cdc2cfc9e8cdd8cdefc3c0c0c9cfd8c5c3c2eccfc1df82c4c4df82cbc3da">[email protected]</span></a>, for issues related
to the Medicare Ground Ambulance Data Collection System.
Juliana Tiongson, (410) 786-0342, for issues related to the
Medicare Diabetes Prevention Program (MDPP).
Laura Ashbaugh, (410) 786-1113, for issues related to Clinical
Laboratory Fee Schedule: Laboratory Specimen Collection and Travel
Allowance and Use of Electronic Travel Logs.
Frank Whelan, (410) 786-1302, for issues related to Medicare
provider enrollment regulation updates.
Katie Mucklow, (410) 786-0537, for issues related to provider and
supplier prepayment and post-payment medical review requirements.
Lindsey Baldwin, (410) 786-1694, and Michele Franklin, (410) 786-
9226, for issues related to Medicare coverage of opioid use disorder
treatment services furnished by opioid treatment programs.
Lisa O. Wilson, (410) 786-8852, or Meredith Larson, (410) 786-7923,
for inquiries related to the physician self-referral law.
Joella Roland, (410) 786-7638, for issues related to requirement
for electronic prescribing for controlled substances for a covered Part
D drug under a prescription drug plan or an MA-PD plan.
Kathleen Ott, (410) 786-4246, for issues related to open payments.
Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
Brittany LaCouture, (410) 786-0481, for inquiries related to
Alternative Payment Models (APMs).
SUPPLEMENTARY INFORMATION:
Addenda Available Only Through the Internet on the CMS Website: The
PFS Addenda along with other supporting documents and tables referenced
in this final rule are available on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/index.html">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/index.html</a>. Click on the link on the left side of the
screen titled, ``PFS Federal Regulations Notices'' for a chronological
list of PFS Federal Register and other related documents. For the CY
2022 PFS final rule, refer to item CMS-1751-F. Readers with questions
related to accessing any of the Addenda or other supporting documents
referenced in this final rule and posted on the CMS website identified
above should contact <a href="/cdn-cgi/l/email-protection#99ddf0eff0eaf0f6f7f6ffc9ebf8faedf0edf0f6f7fcebcafcebeff0fafcead9faf4eab7f1f1eab7fef6ef"><span class="__cf_email__" data-cfemail="81c5e8f7e8f2e8eeefeee7d1f3e0e2f5e8f5e8eeefe4f3d2e4f3f7e8e2e4f2c1e2ecf2afe9e9f2afe6eef7">[email protected]</span></a>.
CPT (Current Procedural Terminology) Copyright Notice:
[[Page 64997]]
Throughout this final rule, we use CPT codes and descriptions to refer
to a variety of services. We note that CPT codes and descriptions are
copyright 2020 American Medical Association. All Rights Reserved. CPT
is a registered trademark of the American Medical Association (AMA).
Applicable Federal Acquisition Regulations (FAR) and Defense Federal
Acquisition Regulations (DFAR) apply.
I. Executive Summary
This major final rule revises payment polices under the Medicare
PFS and makes other policy changes, including to the implementation of
certain provisions of the Consolidated Appropriations Act, 2021 (CAA,
2021) (Pub. L. 116-260, December 27, 2020), Bipartisan Budget Act of
2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) and the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L. 115-
271, October 24, 2018), related to Medicare Part B payment. In
addition, this major final rule includes revisions to other Medicare
payment policies described in sections III. and IV.
B. Summary of the Major Provisions
The statute requires us to establish payments under the PFS based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: Work,
practice expense (PE), and malpractice (MP) expense. In addition, the
statute requires that we establish each year by regulation the payment
amounts for physicians' services paid under the PFS, including
geographic adjustments to reflect the variations in the costs of
furnishing services in different geographic areas.
In this major final rule, we are establishing RVUs for CY 2022 for
the PFS to ensure that our payment systems are updated to reflect
changes in medical practice and the relative value of services, as well
as changes in the statute. This final rule also includes discussions
and provisions regarding several other Medicare Part B payment
policies.
Specifically, this final rule addresses:
<bullet> Practice Expense RVUs (section II.B.)
<bullet> Potentially Misvalued Services Under the PFS (section II.C.)
<bullet> Telehealth and Other Services Involving Communications
Technology (section II.D.)
<bullet> Valuation of Specific Codes (section II.E.)
<bullet> Evaluation and Management Visits (section II.F.)
<bullet> Billing for Physician Assistant Services (section II.G.)
<bullet> Therapy Services (section II.H.)
<bullet> Changes to Beneficiary Coinsurance for Additional Procedures
Furnished During the Same Clinical Encounter as Certain Colorectal
Cancer Screening Tests (section II.I.)
<bullet> Vaccine Administration Services (section II.J.)
<bullet> Payment for Medical Nutrition Therapy Services and Related
Services (section II.K.)
<bullet> Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs) (sections III.A., III.B., and III.C.)
<bullet> 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.)
<bullet> Medicare Part B Drug Payment for Drugs Approved under Section
505(b)(2) of the Federal Food, Drug, & Cosmetic Act (section III.E.)
<bullet> Appropriate Use Criteria for Advanced Diagnostic Imaging
(section III.F.)
<bullet> Removal of Selected National Coverage Determinations (section
III.G.)
<bullet> Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive
Cardiac Rehabilitation (section III.H.)
<bullet> Medical Nutrition Therapy (section III.I.)
<bullet> Medicare Shared Savings Program (section III.J.)
<bullet> Medicare Ground Ambulance Data Collection System (section
III.K.)
<bullet> Medicare Diabetes Prevention Program (MDPP) (section III.L.)
<bullet> Clinical Laboratory Fee Schedule: Laboratory Specimen
Collection and Travel Allowance for Clinical Diagnostic Laboratory
Tests and Use of Electronic Travel Logs (section III.M.)
<bullet> Medicare Provider and Supplier Enrollment Changes (section
III.N.1.)
<bullet> Provider/Supplier Medical Review Requirements: Addition of
Provider/Supplier Requirements related to Prepayment and Post-payment
Reviews (section III.N.2.)
<bullet> Modifications Related to Medicare Coverage for Opioid Use
Disorder (OUD) Treatment Services Furnished by Opioid Treatment
Programs (OTPs) (section III.O.)
<bullet> Updates to the Physician Self-Referral Regulations (section
III.P.)
<bullet> 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.)
<bullet> Open Payments (section III.R.)
<bullet> Updates to the Quality Payment Program (section IV.)
<bullet> Collection of Information Requirements (section V.)
<bullet> Regulatory Impact Analysis (section VI.)
3. Summary of Costs and Benefits
We have determined that this final rule is economically
significant. For a detailed discussion of the economic impacts, see
section VI., Regulatory Impact Analysis, of this final rule.
II. Summary of the Proposed Provisions, Analysis of and Response to
Public Comments, and the Provisions of the Final Rule for the PFS
A. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Social Security Act (the Act), ``Payment for
Physicians' Services.'' The PFS relies on national relative values that
are established for work, practice expense (PE), and malpractice (MP),
which are adjusted for geographic cost variations. These values are
multiplied by a conversion factor (CF) to convert the RVUs into payment
rates. The concepts and methodology underlying the PFS were enacted as
part of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89) (Pub.
L. 101-239, December 19, 1989), and the Omnibus Budget Reconciliation
Act of 1990 (OBRA '90) (Pub. L. 101-508, November 5, 1990). The final
rule published in the November 25, 1991 Federal Register (56 FR 59502)
set forth the first fee schedule used for payment for physicians'
services.
We note that throughout this final rule, unless otherwise noted,
the term ``practitioner'' is used to describe both physicians and
nonphysician practitioners (NPPs) who are permitted to bill Medicare
under the PFS for the services they furnish to Medicare beneficiaries.
1. Development of the RVUs
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
implemented on January 1, 1992, were developed with extensive input
from the physician community. A research team at the Harvard School of
Public Health developed the original work RVUs for most codes under a
cooperative agreement with the Department of Health and Human Services
(HHS). In constructing the code-specific vignettes used in
[[Page 64998]]
determining the original physician work RVUs, Harvard worked with
panels of experts, both inside and outside the Federal Government, and
obtained input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work
component of physicians' services means the portion of the resources
used in furnishing the service that reflects physician time and
intensity. We establish work RVUs for new, revised and potentially
misvalued codes based on our review of information that generally
includes, but is not limited to, recommendations received from the
American Medical Association/Specialty Society Relative Value Scale
Update Committee (RUC), the Health Care Professionals Advisory
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC),
and other public commenters; medical literature and comparative
databases; as well as a comparison of the work for other codes within
the Medicare PFS, and consultation with other physicians and health
care professionals within CMS and the Federal Government. We also
assess the methodology and data used to develop the recommendations
submitted to us by the RUC and other public commenters, and the
rationale for their recommendations. In the CY 2011 PFS final rule with
comment period (75 FR 73328 through 73329), we discussed a variety of
methodologies and approaches used to develop work RVUs, including
survey data, building blocks, crosswalk to key reference or similar
codes, and magnitude estimation. More information on these issues is
available in that rule.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, October 31,
1994), amended by section 1848(c)(2)(C)(ii) of the Act and required us
to develop resource-based PE RVUs for each physicians' service
beginning in 1998. We were required to consider general categories of
expenses (such as office rent and wages of personnel, but excluding MP
expenses) comprising PEs. The PE RVUs continue to represent the portion
of these resources involved in furnishing PFS services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (BBA `97)
(Pub. L. 105-33, August 5, 1997) delayed implementation of the
resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA `97 provided for a 4-year transition period
from the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in the November 2, 1998 final rule (63 FR 58814), effective for
services furnished in CY 1999. Based on the requirement to transition
to a resource-based system for PE over a 4-year period, payment rates
were not fully based upon resource-based PE RVUs until CY 2002. This
resource-based system was based on two significant sources of actual PE
data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's
Socioeconomic Monitoring System (SMS) data. These data sources are
described in greater detail in the CY 2012 PFS final rule with comment
period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some resource costs are borne by the
facility. Medicare's payment to the facility (such as the outpatient
prospective payment system (OPPS) payment to the HOPD) would reflect
costs typically incurred by the facility. Thus, payment associated with
those specific facility resource costs is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA)
(Pub. L. 106-113, November 29, 1999) directed the Secretary of Health
and Human Services (the Secretary) to establish a process under which
we accept and use, to the maximum extent practicable and consistent
with sound data practices, data collected or developed by entities and
organizations to supplement the data we normally collect in determining
the PE component. On May 3, 2000, we published the interim final rule
(65 FR 25664) that set forth the criteria for the submission of these
supplemental PE survey data. The criteria were modified in response to
comments received, and published in the Federal Register (65 FR 65376)
as part of a November 1, 2000 final rule. The PFS final rules published
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended
the period during which we would accept these supplemental data through
March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA `97 amended section 1848(c) of the Act
to require that we implement resource-based MP RVUs for services
furnished on or after CY 2000. The resource-based MP RVUs were
implemented in the PFS final rule with comment period published
November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and
physician-owned insurers' MP insurance premium data from all the
States, the District of Columbia, and Puerto Rico.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently from one another. We
completed 5-year reviews of work RVUs that were effective for calendar
years 1997, 2002, 2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the 5-year reviews, beginning for CY 2009, CMS and
the RUC identified and reviewed a number of potentially misvalued codes
on an annual basis based on various identification screens. This annual
review of work and PE RVUs for
[[Page 64999]]
potentially misvalued codes was supplemented by the amendments to
section 1848 of the Act, as enacted by section 3134 of the Affordable
Care Act, that require the agency to periodically identify, review and
adjust values for potentially misvalued codes.
e. Application of BN to Adjustments of RVUs
As described in section VI. of this final rule, the Regulatory
Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of
the Act, if revisions to the RVUs cause expenditures for the year to
change by more than $20 million, we make adjustments to ensure that
expenditures do not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
To calculate the payment for each service, the components of the
fee schedule (work, PE, and MP RVUs) are adjusted by geographic
practice cost indices (GPCIs) to reflect the variations in the costs of
furnishing the services. The GPCIs reflect the relative costs of work,
PE, and MP in an area compared to the national average costs for each
component. Please refer to the CY 2020 PFS final rule for a discussion
of the last GPCI update (84 FR 62615 through 62623).
RVUs are converted to dollar amounts through the application of a
CF, which is calculated based on a statutory formula by CMS' Office of
the Actuary (OACT). The formula for calculating the Medicare PFS
payment amount for a given service and fee schedule area can be
expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
MP)] x CF
3. Separate Fee Schedule Methodology for Anesthesia Services
Section 1848(b)(2)(B) of the Act specifies that the fee schedule
amounts for anesthesia services are to be based on a uniform relative
value guide, with appropriate adjustment of an anesthesia CF, in a
manner to ensure that fee schedule amounts for anesthesia services are
consistent with those for other services of comparable value.
Therefore, there is a separate fee schedule methodology for anesthesia
services. Specifically, we establish a separate CF for anesthesia
services and we utilize the uniform relative value guide, or base
units, as well as time units, to calculate the fee schedule amounts for
anesthesia services. Since anesthesia services are not valued using
RVUs, a separate methodology for locality adjustments is also
necessary. This involves an adjustment to the national anesthesia CF
for each payment locality.
B. Determination of PE RVUs
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding MP expenses, as specified in section 1848(c)(1)(B) of the
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a
resource-based system for determining PE RVUs for each physicians'
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the 5-year review of work RVUs under the
PFS and proposed changes to the PE methodology CY 2007 PFS proposed
notice (71 FR 37242) and the CY 2007 PFS final rule with comment period
(71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked, in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the PE/HR by specialty that was obtained from the AMA's
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
Physician Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and NPPs paid under the PFS using a survey instrument and methods
highly consistent with those used for the SMS and the supplemental
surveys. The PPIS gathered information from 3,656 respondents across 51
physician specialty and health care professional groups. We believe the
PPIS is the most comprehensive source of PE survey information
available. We used the PPIS data to update the PE/HR data for the CY
2010 PFS for almost all of the Medicare-recognized specialties that
participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
[[Page 65000]]
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and comment rulemaking and are
available in the file titled ``CY 2022 PFS final rule PE/HR'' on the
CMS website under downloads for the CY 2022 PFS final rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
For CY 2022, we have incorporated the available utilization data
for two new specialties, each of which became a recognized Medicare
specialty during 2020. These specialties are Micrographic Dermatologic
Surgery (MDS) and Adult Congenital Heart Disease (ACHD). We proposed to
use proxy PE/HR values for these new specialties, as there are no PPIS
data for these specialties, by crosswalking the PE/HR as follows from
specialties that furnish similar services in the Medicare claims data:
<bullet> Micrographic Dermatologic Surgery (MDS) from Dermatology; and
<bullet> Adult Congenital Heart Disease (ACHD) from Cardiology
These updates are reflected in the ``CY 2022 PFS final rule PE/HR''
file available on the CMS website under the supporting data files for
the CY 2022 PFS final rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
We received public comments on our proposal to use proxy PE/HR
values for MDS and ACHD. The following is a summary of the comments we
received and our responses.
Comment: One commenter stated that they appreciated and supported
the proposal incorporating the available utilization data for MDS to
establish an indirect PE/HR for their newly designated specialty. The
commenter stated that they also agreed with the proposal to use a proxy
PE/HR value by crosswalking to the PE/HR for Dermatology and urged CMS
to finalize this policy.
Response: We appreciate the support from the commenter for our
proposed PE/HR crosswalk.
Comment: Several commenters questioned the assigned specialty
crosswalk to use for indirect PE when it comes to home PT/INR
monitoring services. Commenters stated that they appreciated that CMS
acknowledged their concerns last year and agreed to update the indirect
factors for home PT/INR monitoring by crosswalking to the General
Practice specialty which helped address the on-going substantial
reductions in payment for home PT/INR monitoring. However, the
commenters stated that the predominant code for PT/INR monitoring
(HCPCS code G0249) will again be significantly and negatively impacted
by the proposed changes in the clinical labor rates which will
completely negate any benefit from the crosswalk to General Practice.
The commenters requested CMS change the crosswalk for home PT/INR
monitoring services to All Physicians which would partially offset the
proposed reduction that HCPCS code G0249 is facing due to changes in
the clinical labor rates.
Response: We finalized a crosswalk to the General Practice
specialty for home PT/INR monitoring services (HCPCS codes G0248,
G0249, and G0250) in the CY 2021 PFS final rule (85 FR 84477-84478).
The data submitted by the commenters indicated that the direct-to-
indirect cost percentages to furnish home PT/INR monitoring are in the
range of 31:69, similar to the ratio associated with the General
Practice specialty. We disagree that these home PT/INR monitoring
services should now be reassigned to a different specialty that is less
reflective of the cost structure for these services to offset
reductions in payment for the services that result from an unrelated
policy proposal (the clinical labor pricing update). Additionally, we
did not propose to change the assigned specialty for PT/INR services.
As such, this comment is outside the scope of the proposed rule.
Therefore, we are not finalizing any changes to the assigned specialty
for PT/INR services. We note however that, recognizing the changing
practice of medicine and increasing use of innovative technologies and
supplies to furnish certain services, we are reviewing our underlying
data as part of a comprehensive review of our PE inputs and overall
methodology. We continue to engage with stakeholders on this crucial
topic of updating the PE data, for example, at our recent PE town hall
this year.
After consideration of the comments, we are finalizing our proposed
PE/HR crosswalks for the new MDS and ACHD specialties.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
We allocate the indirect costs at the code level based on the
direct costs specifically associated with a code and the greater of
either the clinical labor costs or the work RVUs. We also incorporate
the survey data described earlier in the PE/HR discussion. The general
approach to developing the indirect portion of the PE RVUs is as
follows:
<bullet> For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represent 25 percent of total costs for the specialties that
furnish the service, the initial indirect allocator would be calculated
so that it equals 75 percent of the total PE RVUs. Thus, in this
example, the initial indirect allocator would equal 6.00, resulting in
a total PE RVU of 8.00
[[Page 65001]]
(2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
<bullet> Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
<bullet> Then, we incorporate the specialty-specific indirect PE/HR
data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, we establish two
PE RVUs: Facility and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: A
professional component (PC); and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct readers to the file titled ``Calculation
of PE RVUs under Methodology for Selected Codes'' which is available on
our website under downloads for the CY 2022 PFS final rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html</a>. This file
contains a table that illustrates the calculation of PE RVUs as
described in this final rule for individual codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the projected aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, use the CF to
calculate a direct PE scaling adjustment to ensure that the aggregate
pool of direct PE costs calculated in Step 3 does not vary from the
aggregate pool of direct PE costs for the current year. Apply the
scaling adjustment to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to an RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs as long as the same CF is used in Step 4
and Step 5. Different CFs would result in different direct PE scaling
adjustments, but this has no effect on the final direct cost PE RVUs
since changes in the CFs and changes in the associated direct scaling
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Codes with low Medicare service volume require special attention
since billing or enrollment irregularities for a given year can result
in significant changes in specialty mix assignment. We finalized a
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
the most recent year of claims data to determine which codes are low
volume for the coming year (those that have fewer than 100 allowed
services in the Medicare claims data). For codes that fall into this
category, instead of assigning specialty mix based on the specialties
of the practitioners reporting the services in the claims data, we use
the expected specialty that we identify on a list developed based on
medical review and input from expert stakeholders. We display this list
of expected specialty assignments as part of the annual set of data
files we make available as part of notice and comment rulemaking and
consider recommendations from the RUC and other stakeholders on changes
to this list on an annual basis. Services for which the specialty is
automatically assigned based on previously finalized policies under our
established methodology (for example, ``always therapy'' services) are
unaffected by the list of expected specialty assignments. We also
finalized in the CY 2018 PFS final rule (82 FR 52982 through 52983) a
policy to apply these service-level overrides for both PE and MP,
rather than one or the other category.
[[Page 65002]]
We did not make any proposals associated with the list of expected
specialty assignments for low volume services, however we received
public comments on this topic from stakeholders. The following is a
summary of the comments we received and our responses.
Comment: Several commenters stated that they had performed an
analysis to identify all codes that meet the criteria to receive a
specialty override under this CMS policy and drafted updated
recommendations for CY 2022. Commenters stated that the purpose of
assigning a specialty to these codes was to avoid the major adverse
impact on MP RVUs that result from errors in specialty utilization data
magnified in representation (percentage) by small sample size. These
commenters submitted a lengthy list of low volume HCPCS codes with
recommended expected specialty assignments. One commenter requested
changing the override specialty for a series of codes from thoracic
surgery to cardiac surgery based on whether the procedures in question
are performed on the heart and surrounding structures versus performed
on the lungs, esophagus, chest wall and mediastinum.
Response: We appreciate the submission of expected specialty
assignments for additional low volume HCPCS codes. After reviewing the
information provided by the commenters to determine that the submitted
specialty assignments were appropriate for the service in question, we
are finalizing the additions in Table 1 to the list of expected
specialty assignments for low volume services.
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Commenters recommended an expected specialty assignment of
interventional cardiology for CPT codes 33018, 33741, 33745, 33746,
92975, and 93565 and an expected specialty assignment of cardiac
electrophysiology for CPT code 33275. However, we do not have PE/HR
data for the interventional cardiology and cardiac electrophysiology
specialties as they were not part of the PPIS when it was conducted in
2007. These specialties both use the cardiology specialty for their PE/
HR data, and therefore, we have also crosswalked the CPT codes in
question to the cardiology specialty on the list of expected specialty
assignments for low volume services.
Based on the information provided by the commenters, we are
finalizing the changes in expected specialty assignment for the five
CPT codes in Table 2 which were already included on the list.
[GRAPHIC] [TIFF OMITTED] TR19NO21.004
We are not finalizing the recommended changes in expected specialty
assignment for the CPT codes in Table 3 associated with the thoracic
surgery specialty.
[[Page 65007]]
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[[Page 65008]]
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Commenters requested that the expected specialty assignment for the
CPT codes in this group be changed from the thoracic surgery specialty
to the cardiac surgery specialty. We did not finalize this same request
in previous rulemaking cycles in both CY 2020 (84 FR 62576) and CY 2021
(85 FR 84479) for the same group of CPT codes. We finalized a proposal
in CY 2020 to update the expected specialty list to accurately reflect
a previously finalized crosswalk to thoracic surgery for the services
in question. As we stated at the time, we did not finalize a proposal
to assign the codes in question to the cardiac surgery specialty.
Instead, we finalized a proposal to update the incorrect documentation
in our expected specialty list to accurately reflect a previously
finalized crosswalk to thoracic surgery for these services. The
previously finalized assignment of the cardiac surgery specialty to
these services has been in place since the CY 2012 rule cycle, and we
believe that the expected specialty list should be updated to reflect
the correct specialty assignment. We have previously considered and
declined to make the changes suggested by commenters, and we are not
finalizing such changes in this CY 2022 PFS final rule. We direct
readers to the discussion of this topic in the CY 2020 PFS final rule
(84 FR 62574 through 62578) and we reiterate that we do not anticipate
this finalized proposal from CY 2020 having a discernible effect on the
valuation of the affected codes due to the similarity between the
cardiac surgery and thoracic surgery specialties.
We also note for commenters that each HCPCS code that appears on
the list of expected specialty assignments for low volume services
remains on the list from year to year, even if the volume
[[Page 65009]]
for the code in question rises to over 100 services for an individual
calendar year. The HCPCS codes and expected specialty assignment remain
on the list, and will be applied should the volume fall below 100
services in any calendar year; there is no need to ``reactivate''
individual codes as some commenters indicated in their submissions.
Comment: Several commenters stated that in previous years, CMS has
applied the expected specialty override to services with fewer than 100
allowed services in a 3-year average of Medicare claims data without
adjusting the utilization to interpret any CPT modifiers. Although
commenters agreed with the use of a 3-year average to identify low
volume services for expected specialty assignment, commenters stated
that not adjusting for certain modifiers will result in undercounting
or overcounting of certain services. For example, commenters stated
that if a single procedure is performed by both a primary surgeon and
an assistant at surgery, this service should only be counted once even
though each of the practitioners would report the service on a separate
claim. Commenters recommended that CMS should set the frequency to zero
for post-operative only (modifier '55') and assistant at surgery
(modifier '80') records, multiply the frequency by 2 for bilateral
surgery records (modifier '50'), and divide the frequency by 2 for co-
surgery records (modifier '62').
Response: We do not agree that it would be more appropriate to make
the adjustments to utilization as described by the commenters to
determine low volume status. As we stated in the CY 2020 PFS final rule
(84 FR 62576), we finalized a policy in the CY 2018 PFS final rule (82
FR 52982 through 59283) to use claims data to determine which codes are
low volume for the coming year, defining ``low volume'' as those that
had fewer than 100 allowed services in the Medicare claims data. We did
not finalize a policy to discount this utilization based on modifiers
that identify certain circumstances, and we do not believe that it
would be more appropriate to do so, as a service is still furnished and
billed in each case, even if payment is discounted. Additionally, we
did not make any proposals concerning the methodology used to identify
low volume services in the proposed rule, and therefore, we are not
finalizing any changes to this methodology.
After consideration of the public comments, we are finalizing the
updates to the list of expected specialty assignments for low volume
services as detailed above.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: Indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
<bullet> 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.
<bullet> If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs would be allocated
using the work RVUs, and for the TC service, indirect PEs would be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
titled ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
<bullet> The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
<bullet> The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 to the aggregate work RVUs scaled by the ratio of current
aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in
the PFS account for the fact that certain specialties are excluded from
the calculation of PE RVUs but included in maintaining overall PFS BN.
(See ``Specialties excluded from ratesetting calculation'' later in
this final rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
[[Page 65010]]
associated adjustment. Section 1848(c)(7) of the Act specifies that for
services that are not new or revised codes, if the total RVUs for a
service for a year would otherwise be decreased by an estimated 20
percent or more as compared to the total RVUs for the previous year,
the applicable adjustments in work, PE, and MP RVUs shall be phased in
over a 2-year period. In implementing the phase-in, we consider a 19
percent reduction as the maximum 1-year reduction for any service not
described by a new or revised code. This approach limits the year one
reduction for the service to the maximum allowed amount (that is, 19
percent), and then phases in the remainder of the reduction. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
(e) Setup File Information
<bullet> Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE and MP RVUs, we exclude certain
specialties, such as certain NPPs paid at a percentage of the PFS and
low-volume specialties, from the calculation. These specialties are
included for the purposes of calculating the BN adjustment. They are
displayed in Table 4.
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<bullet> Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
<bullet> Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
<bullet> 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).
<bullet> Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 5 details the manner in which the
modifiers are applied.
[GRAPHIC] [TIFF OMITTED] TR19NO21.008
We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (MPPRs). We note that
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
for multiple imaging procedures and multiple therapy services from the
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the development of the RVUs.
Beginning in CY 2022, section 1834(v)(1) of the Act requires that
we apply a 15 percent payment reduction for outpatient occupational
therapy services and outpatient physical therapy services that are
provided, in whole or in part, by a physical therapist assistant (PTA)
or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the
Act required CMS to establish modifiers to identify these services,
which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661),
creating the CQ and CO payment modifiers for services provided in whole
or in part by PTAs and OTAs, respectively. These payment modifiers are
required to be used on claims for services with dates of service
beginning January 1, 2020, as specified in the CY 2020 PFS final rule
(84 FR 62702 through 62708). We will apply the 15 percent payment
reduction to therapy services provided by PTAs (using the CQ modifier)
or OTAs (using the CO modifier), as required by statute. Under sections
1834(k) and 1848 of the Act, payment is made for outpatient therapy
services at 80 percent of the lesser of the actual charge or applicable
fee schedule amount (the allowed charge). The remaining 20 percent is
the beneficiary copayment. For therapy services to which the new
discount applies, payment will be made at 85 percent of the 80 percent
of allowed charges. Therefore, the volume discount factor for therapy
services to which the CQ and CO modifiers apply is: (0.20 + (0.80*
0.85), which equals 88 percent.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a
[[Page 65012]]
time adjustment of 33 percent is made only for medical direction of two
to four cases since that is the only situation where a single
practitioner is involved with multiple beneficiaries concurrently, so
that counting each service without regard to the overlap with other
services would overstate the amount of time spent by the practitioner
furnishing these services.
<bullet> Work RVUs: The setup file contains the work RVUs from this
final rule.
(6) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate) [caret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally, 150,000 minutes
usage = variable, see discussion below in this final rule
price = price of the particular piece of equipment
life of equipment = useful life of the particular piece of equipment
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this final rule
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Useful Life: In the CY 2005 PFS final rule we stated that we
updated the useful life for equipment items primarily based on the
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets''
guidelines (69 FR 66246). The most recent edition of these guidelines
was published in 2018. This reference material provides an estimated
useful life for hundreds of different types of equipment, the vast
majority of which fall in the range of 5 to 10 years, and none of which
are lower than 2 years in duration. We believe that the updated
editions of this reference material remain the most accurate source for
estimating the useful life of depreciable medical equipment.
In the CY 2021 PFS final rule, we finalized a proposal to treat
equipment life durations of less than 1 year as having a duration of 1
year for the purpose of our equipment price per minute formula. In the
rare cases where items are replaced every few months, we noted that we
believe it is more accurate to treat these items as disposable supplies
with a fractional supply quantity as opposed to equipment items with
very short equipment life durations. For a more detailed discussion of
the methodology associated with very short equipment life durations, we
refer readers to the CY 2021 PFS final rule (85 FR 84482 through
84483).
<bullet> 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.
<bullet> Interest Rate: In the CY 2013 PFS final rule with comment
period (77 FR 68902), we updated the interest rates used in developing
an equipment cost per minute calculation (see 77 FR 68902 for a
thorough discussion of this issue). The interest rate was based on the
Small Business Administration (SBA) maximum interest rates for
different categories of loan size (equipment cost) and maturity (useful
life). The Interest rates are listed in Table 6.
[GRAPHIC] [TIFF OMITTED] TR19NO21.009
We did not propose any changes to the equipment interest rates for
CY 2022.
3. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2022 direct PE input public use files, which are
available on the CMS website under downloads for the CY 2022 PFS final
rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
a. Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640 through 67641), we continue to make improvements to the direct
PE input database to provide the number of clinical labor minutes
assigned for each task for every code in the database instead of only
including the number of
[[Page 65013]]
clinical labor minutes for the preservice, service, and post service
periods for each code. In addition to increasing the transparency of
the information used to set PE RVUs, this level of detail would allow
us to compare clinical labor times for activities associated with
services across the PFS, which we believe is important to maintaining
the relativity of the direct PE inputs. This information would
facilitate the identification of the usual numbers of minutes for
clinical labor tasks and the identification of exceptions to the usual
values. It would also allow for greater transparency and consistency in
the assignment of equipment minutes based on clinical labor times.
Finally, we believe that the detailed information can be useful in
maintaining standard times for particular clinical labor tasks that can
be applied consistently to many codes as they are valued over several
years, similar in principle to the use of physician preservice time
packages. We believe that setting and maintaining such standards would
provide greater consistency among codes that share the same clinical
labor tasks and could improve relativity of values among codes. For
example, as medical practice and technologies change over time, changes
in the standards could be updated simultaneously for all codes with the
applicable clinical labor tasks, instead of waiting for individual
codes to be reviewed.
In the CY 2016 PFS final rule with comment period (80 FR 70901), we
solicited comments on the appropriate standard minutes for the clinical
labor tasks associated with services that use digital technology. After
consideration of comments received, we finalized standard times for
clinical labor tasks associated with digital imaging at 2 minutes for
``Availability of prior images confirmed'', 2 minutes for ``Patient
clinical information and questionnaire reviewed by technologist, order
from physician confirmed and exam protocoled by radiologist'', 2
minutes for ``Review examination with interpreting MD'', and 1 minute
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS
system to generate billing process and to populate images into
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184
through 80186), we finalized a policy to establish a range of
appropriate standard minutes for the clinical labor activity,
``Technologist QCs images in PACS, checking for all images, reformats,
and dose page.'' These standard minutes will be applied to new and
revised codes that make use of this clinical labor activity when they
are reviewed by us for valuation. We finalized a policy to establish 2
minutes as the standard for the simple case, 3 minutes as the standard
for the intermediate case, 4 minutes as the standard for the complex
case, and 5 minutes as the standard for the highly complex case. These
values were based upon a review of the existing minutes assigned for
this clinical labor activity; we determined that 2 minutes is the
duration for most services and a small number of codes with more
complex forms of digital imaging have higher values. We also finalized
standard times for a series of clinical labor tasks associated with
pathology services in the CY 2016 PFS final rule with comment period
(80 FR 70902). We do not believe these activities would be dependent on
number of blocks or batch size, and we believe that the finalized
standard values accurately reflect the typical time it takes to perform
these clinical labor tasks.
In reviewing the RUC-recommended direct PE inputs for CY 2019, we
noticed that the 3 minutes of clinical labor time traditionally
assigned to the ``Prepare room, equipment and supplies'' (CA013)
clinical labor activity were split into 2 minutes for the ``Prepare
room, equipment and supplies'' activity and 1 minute for the ``Confirm
order, protocol exam'' (CA014) activity. We proposed to maintain the 3
minutes of clinical labor time for the ``Prepare room, equipment and
supplies'' activity and remove the clinical labor time for the
``Confirm order, protocol exam'' activity wherever we observed this
pattern in the RUC-recommended direct PE inputs. Commenters explained
in response that when the new version of the PE worksheet introduced
the activity codes for clinical labor, there was a need to translate
old clinical labor tasks into the new activity codes, and that a prior
clinical labor task was split into two of the new clinical labor
activity codes: CA007 (Review patient clinical extant information and
questionnaire) in the preservice period, and CA014 (Confirm order,
protocol exam) in the service period. Commenters stated that the same
clinical labor from the old PE worksheet was now divided into the CA007
and CA014 activity codes, with a standard of 1 minute for each
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity
code and 1 minute for the CA014 activity code in situations where this
was the case. However, when reviewing the clinical labor for the
reviewed codes affected by this issue, we found that several of the
codes did not include this old clinical labor task, and we also noted
that several of the reviewed codes that contained the CA014 clinical
labor activity code did not contain any clinical labor for the CA007
activity. In these situations, we continue to believe that in these
cases, the 3 total minutes of clinical staff time would be more
accurately described by the CA013 ``Prepare room, equipment and
supplies'' activity code, and we finalized these clinical labor
refinements. For additional details, we direct readers to the
discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).
Following the publication of the CY 2020 PFS proposed rule, one
commenter expressed concern with the published list of common
refinements to equipment time. The commenter stated that these
refinements were the formulaic result of the applying refinements to
the clinical labor time and did not constitute separate refinements;
the commenter requested that CMS no longer include these refinements in
the table published each year. In the CY 2020 PFS final rule, we agreed
with the commenter that these equipment time refinements did not
reflect errors in the equipment recommendations or policy discrepancies
with the RUC's equipment time recommendations. However, we believed
that it was important to publish the specific equipment times that we
were proposing (or finalizing in the case of the final rule) when they
differed from the recommended values due to the effect that these
changes can have on the direct costs associated with equipment time.
Therefore, we finalized the separation of the equipment time
refinements associated with changes in clinical labor into a separate
table of refinements. For additional details, we direct readers to the
discussion in the CY 2020 PFS final rule (84 FR 62584).
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning with its recommendations for CY
2019, the RUC has mandated the use of a new PE worksheet for purposes
of their recommendation development process that standardizes the
clinical labor tasks and assigns them a clinical labor activity code.
We believe the RUC's use of the new PE worksheet in
[[Page 65014]]
developing and submitting recommendations will help us to simplify and
standardize the hundreds of different clinical labor tasks currently
listed in our direct PE database. As we did in previous calendar years,
to facilitate rulemaking for CY 2022, we are continuing to display two
versions of the Labor Task Detail public use file: One version with the
old listing of clinical labor tasks, and one with the same tasks
crosswalked to the new listing of clinical labor activity codes. These
lists are available on the CMS website under downloads for the CY 2022
PFS final rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
b. Technical Corrections to Direct PE Input Database and Supporting
Files
For CY 2022, we proposed to address the following:
<bullet> Following the publication of the CY 2021 PFS proposed
rule, several commenters questioned the proposed RVUs associated with
several occupational therapy evaluation procedures (CPT codes 97165
through 97167). Commenters stated that the PE valuation for these codes
appeared to be illogical as it was counterintuitive for the PE RVU to
go down as the level of complexity increased. Commenters stated that
the distribution of code usage has not changed in any manner to justify
a reduction in the code values and that all three evaluation codes
should reimburse at the same rate. In response to the commenters, we
noted that although the three codes in question shared the same work
RVU and the same direct PE inputs, they did not share the same
specialty distribution in the claims data, and therefore, would not
necessarily receive the same allocation of indirect PE. In the CY 2021
PFS final rule (85 FR 84490), we finalized the implementation of a
technical change intended to ensure that these three services received
the same allocation of indirect PE. We agreed with commenters that it
was important to avoid a potential rank order anomaly in which the
simple case for a service was valued higher than the complex case.
After the publication of the CY 2021 PFS final rule, stakeholders
stated their appreciation for the technical change made in the final
rule to ensure that the indirect PE allocation was the same for all
three levels of occupational therapy evaluation codes. However,
stakeholders expressed concern that the PE RVUs we finalized for CPT
codes 97165-97167 decreased as compared to the PE RVUs we proposed for
CY 2021. Stakeholders stated that nothing had occurred in the past year
that would account for a reduction to the proposed PE for these codes,
especially in a year where the proposed PE increased for the
corresponding physical therapy evaluation procedures (CPT codes 97161-
97163), and stakeholders questioned whether there had been an error in
applying the indirect PE methodology.
We reviewed the indirect PE allocation for CPT codes 97165-97167 in
response to the stakeholder inquiry and we do not agree that there was
an error in applying the indirect PE methodology. We finalized a
technical change in the CY 2021 PFS final rule intended to ensure that
these three services received the same allocation of indirect PE, which
achieved its desired goal of assigning equivalent indirect PE to these
three services. However, by forcing CPT codes 97165-97167 to have the
same indirect PE allocation, the indirect PE values for these codes no
longer relied on the claims data, which ended up affecting the indirect
practice cost index for the wider occupational therapy specialty.
Because CPT codes 97165-97167 are high volume services, this resulted
in a lower indirect practice cost index for the occupational therapy
specialty and a smaller allocation of indirect PE for CY 2021 than
initially proposed.
We proposed to address this issue for CY 2022 by assigning all
claims data associated with CPT codes 97165-97167 to the occupational
therapy specialty. This should ensure that CPT codes 97165-97167 will
always receive the same indirect PE allocation, as well as prevent any
fluctuations to the indirect practice cost index for the wider
occupational therapy specialty. This is intended to avoid a potential
rank order anomaly in which the simple case for a service is valued
higher than the complex case. As the utilization for CPT codes 97165-
97167 is overwhelmingly identified as performed by occupational
therapists, we do not anticipate that assigning all of the claims data
for these codes to the occupational therapy specialty will have a
noticeable effect on their valuation. We solicited public comments
regarding this proposal, and specifically on what commenters suggest as
the most appropriate method of assigning indirect PE allocation for
these services.
The following is a summary of the comments we received on our
proposal and our responses.
Comment: Several commenters stated that they appreciated CMS taking
steps to review the PE calculations and make the correction to maintain
the PE values equally for CPT codes 97165, 97166 and 97167. The
commenters stated that they appreciated and agreed with the correction
in calculation. The commenters also urged CMS to review this policy
again if and when the evaluation codes are stratified because the
current rank order anomaly caused by indirect PE when the codes are
paid the same will not exist in the future when the code values are
stratified based on complexity level.
Response: We appreciate the support for our proposal from the
commenters.
After consideration of the public comments, we are finalizing our
proposal to assign all claims data associated with CPT codes 97165-
97167 to the occupational therapy specialty.
In the CY 2020 PFS final rule (84 FR 63102 through 63104), we
created two new HCPCS G codes, G2082 and G2083, effective January 1,
2020 on an interim final basis for the provision of self-administered
esketamine. In the CY 2021 PFS final rule, we finalized a proposal to
refine the values for HCPCS codes G2082 and G2083 using a building
block methodology that summed the values associated with several codes
(85 FR 84641 through 84642). Following the publication of the CY 2021
PFS final rule, stakeholders expressed concerns that the finalized PE
RVU had decreased for HCPCS codes G2082 and G2083 as compared to the
proposed valuation and as compared to the previous CY 2020 interim
final valuation. Stakeholders questioned whether there had been an
error in the PE allocation since CMS had finalized increases in the
direct PE inputs for the services.
We reviewed the indirect PE allocation for HCPCS codes G2082 and
G2083 in response to the stakeholder inquiry and discovered a technical
change that was applied in error. Specifically, we inadvertently
assigned a different physician specialty than we intended (``All
Physicians'') to HCPCS codes G2082 and G2083 for indirect PE allocation
in our ratesetting process during valuation of these codes in the CY
2020 PFS final rule, and continued that assignment into the CY 2021 PFS
proposed rule. This specialty assignment caused the PE value for these
services to be higher than anticipated for CY 2020. We intended to
revise the assigned physician specialty for these codes to ``General
Practice'' in the CY 2021 PFS final rule; however, we neglected to
discuss this change in the course of PFS rulemaking for CY 2021. Since
we initially applied this technical change in the CY 2021 PFS final
rule without providing an explanation, we
[[Page 65015]]
issued a correction notice (86 FR 14690) to remove this change from the
CY 2021 PFS final rule, and to instead maintain the All Physicians
specialty assignment through CY 2021. We apologize for any confusion
this may have caused.
For CY 2022, we proposed to maintain the currently assigned
physician specialty for indirect PE allocation for HCPCS codes G2082
and G2083. We proposed to assign these two services to the All
Physicians specialty for indirect PE allocation which will maintain
payment consistency with the rates published in the CY 2020 PFS final
rule and the CY 2021 PFS proposed rule. Although we had previously
intended to assign the General Practice specialty to these codes,
stakeholders have provided additional information about these services
suggesting that maintaining the All Physicians specialty assignment for
these codes will help maintain payment stability and preserve access to
this care for beneficiaries. We solicited public comments to help us
discern which specialty would be the most appropriate to use for
indirect PE allocation for HCPCS codes G2082 and G2083. We note that
the PE methodology, which relies on the allocation of indirect costs
based on the magnitude of direct costs, should appropriately reflect
the typical costs for the specialty the commenters suggest. For
example, we do not believe it would be appropriate to assign the
Psychiatry specialty for these services given that HCPCS codes G2082
and G2083 include the high direct costs associated with esketamine
supplies. The Psychiatry specialty is an outlier compared to most other
specialties, allocating indirect costs at a 15:1 ratio based on direct
costs because psychiatry services typically have very low direct costs.
Assignment of most other specialties would result in allocation of
direct costs at roughly a 3:1 ratio. We requested that commenters
explain in their comments how the indirect PE allocation would affect
the payment for these services. Specifically, to ensure appropriate
payment for HCPCS codes G2082 and G2083, we would like to get a better
understanding of the indirect costs associated with these services,
relative to other services furnished by the suggested specialty.
The following is a summary of the comments we received on our
proposal and our responses.
Comment: Several commenters supported the proposal to maintain the
currently assigned physician specialty (All Physicians) for indirect PE
allocation for HCPCS codes G2082 and G2083. Commenters thanked CMS for
making technical corrections to restore the payment levels for services
related to self-administered esketamine to their CY 2020 amounts. One
commenter encouraged CMS to maintain the current rates to ensure
payment stability and beneficiary access to this evidence- based
treatment option. Another commenter urged CMS either to maintain its
current approach by allowing continued use of the all-physician
specialty designation or to provide a blend of the Psychiatry (\2/3\)
and All Physicians (\1/3\) designations.
Response: We appreciate the support for our proposed policies from
the commenters.
Comment: Several commenters stated that esketamine services were
best identified as procedures assigned to the specialty of Psychiatry.
Commenters stated that approximately 95 percent of the providers
administering esketamine are psychiatric professionals and that
utilization data from CMS demonstrated that nearly 75 percent of
providers in the non-facility setting fall within the Psychiatry
specialty for both codes. Commenters stressed the high costs to the
provider of administering esketamine which result in more risk due to
up-front supply costs, and several commenters requested assigning HCPCS
codes G2082 and G2083 to the Psychiatry specialty to offset potential
decreases in valuation resulting from the proposed clinical labor
pricing update. One commenter requested a specialty blend of three-
fourths Psychiatry and one-fourth ``All Physicians'' which the
commenter stated was clinically coherent, consistent with the data
available, and would result in the total non-facility national average
reimbursement amount that most closely approximates CY 2021 levels.
Response: We appreciate the feedback from the commenters regarding
the costs associated with administering esketamine. However, we
continue to believe that the All Physicians specialty most accurately
captures the indirect PE allocation associated with these services. We
do not assign a blended combination of specialties for any other
services and the commenters did not provide new data to support a
change in specialty assignment aside from noting that many providers in
the non-facility setting fall within the Psychiatry specialty for both
codes. We continue to believe that it would not be accurate to assign
the Psychiatry specialty for HCPCS codes G2082 and G2083 due to its
outlier status amongst specialties, whereby Psychiatry allocates
indirect costs at a 15:1 ratio based on direct costs as compared to
most other specialties having approximately a 3:1 ratio. We do not
believe that this would be an accurate specialty designation for HCPCS
codes G2082 and G2083 given the high direct costs associated with
esketamine (which would translate into disproportionately high indirect
PE allocation at said 15:1 ratio).
As we noted in the CY 2021 PFS final rule (85 FR 84498 through
84499) and again in this rule, the RAND Corporation is currently
studying potential improvements to our PE allocation methodology and
the data that underlie it. We are interested in exploring ways that the
PE methodology can be updated, which could include improvements to the
indirect PE methodology to address unusual codes like G2082 and G2083
which have a direct to indirect ratio that does not match their most
commonly billed specialties. Under the current PE methodology, however,
we agree with the commenters who supported the proposal to maintain the
currently assigned physician specialty (All Physicians) for indirect PE
allocation.
After consideration of the public comments, we are finalizing our
proposal to maintain the All Physicians specialty for indirect PE
allocation for HCPCS codes G2082 and G2083.
A stakeholder contacted us regarding a potential error involving
the intraservice work time for CPT code 35860 (Exploration for
postoperative hemorrhage, thrombosis or infection; extremity). The
stakeholder stated that the RUC recommended an intraservice work time
of 90 minutes for this code when it was last reviewed in the CY 2012
PFS final rule and we finalized the work time without refinement at 60
minutes (76 FR 73131). The stakeholder requested that the intraservice
work time for CPT code 35860 should be updated to 90 minutes.
We reviewed the intraservice work time for CPT code 35860 and found
that the RUC inadvertently recommended a time of 60 minutes for the
code, which we proposed and finalized without comment in rulemaking for
the CY 2012 PFS. As a result, we do not believe that this is a
technical error on our part. However, since the stakeholder has
clarified that the RUC intended to recommend 90 minutes of intraservice
work time for CPT code 35860 based on the surveyed median time, we
proposed to update the intraservice work time to 90 minutes to match
the survey results.
We did not receive public comments on our proposal to update the
intraservice work time for CPT code 35860, and we are finalizing as
proposed.
We did not make any proposals specifically associated with the
utilization crosswalk file or public use
[[Page 65016]]
file as described below, however we received a public comment on these
topics from one stakeholder. The following is a summary of the comments
we received and our responses.
Comment: One stakeholder contacted CMS identifying what appeared to
be duplicate data in the utilization crosswalk file. The stakeholder
stated that the first 15,875 rows of the file appeared to almost
exclusively contain duplicate lines in sets of two, and requested
clarification on whether the utilization file was in error.
Response: Due to a technical error, the utilization for anesthesia
services was unintentionally duplicated in the files associated with
the proposed rule. We have corrected this error for the final rule and
we apologize for any confusion which may have resulted from this
inadvertent mistake in the utilization crosswalk file.
Comment: One commenter stated that they believed the public use
files contain an error in the clinical labor portion of the PE RVU
calculation. The commenter stated that the CY 2022 PE RVU summary file
provided the pre-, intra-, and post-service costs for CPT codes 65778
and 65779. The commenter stated that this file showed no cost for pre-
service activities or post-service activities, however the accompanying
Clinical Labor New Activity Detail public use file showed a series of
staff activities associated with CPT codes 65778 and 65779. The
commenter requested that CMS review the pre-service and post-service
costs and correct or update the clinical labor values for these codes
accordingly. The commenter also stated that the patient contact time
reflected in the public use file is understated by approximately 50
percent for CPT codes 65778 and 65779 and encouraged CMS to evaluate
whether the public use file values should be updated prior to
implementation of the PFS for CY 2022.
Response: We reviewed the public use files described by the
commenter and we can confirm that there was no error in the calculation
of the rates for these services. The clinical labor tasks described by
the commenter for CPT codes 65778 and 65779 all take place during the
intra-service period, not the pre-service or post-service period, and
the Clinical Labor New Activity Detail public use file correctly lists
the clinical labor for these services. If the commenter has reason to
believe that the clinical labor is undervalued for these services, we
encourage them to nominate CPT codes 65778 and 65779 as potentially
misvalued for additional review.
c. Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2022,
we proposed to update the price of six supplies and two equipment items
in response to the public submission of invoices. Since this is the
final year of the supply and equipment pricing update, the new pricing
for each of these supply and equipment items will take effect for CY
2022 as there are no remaining years of the transition. The six supply
and equipment items with proposed updated prices are listed in the
valuation of specific codes section of the preamble under Table 23, CY
2022 Invoices Received for Existing Direct PE Inputs.
(1) Market-Based Supply and Equipment Pricing Update
Section 220(a) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93, April 1, 2014) provides that the Secretary may
collect or obtain information from any eligible professional or any
other source on the resources directly or indirectly related to
furnishing services for which payment is made under the PFS, and that
such information may be used in the determination of relative values
for services under the PFS. Such information may include the time
involved in furnishing services; the amounts, types and prices of PE
inputs; overhead and accounting information for practices of physicians
and other suppliers, and any other elements that would improve the
valuation of services under the PFS.
As part of our authority under section 1848(c)(2)(M) of the Act, we
initiated a market research contract with StrategyGen to conduct an in-
depth and robust market research study to update the PFS direct PE
inputs (DPEI) for supply and equipment pricing for CY 2019. These
supply and equipment prices were last systematically developed in 2004-
2005. StrategyGen submitted a report with updated pricing
recommendations for approximately 1300 supplies and 750 equipment items
currently used as direct PE inputs. This report is available as a
public use file displayed on the CMS website under downloads for the CY
2019 PFS final rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
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:
<bullet> Telephone surveys with vendors for top priority items
(Vendor Survey).
<bullet> Physician panel validation of market research results,
prioritized by total spending (Physician Panel).
<bullet> The General Services Administration system (GSA).
<bullet> An aggregate health system buyers database with discounted
prices (Buyers).
<bullet> Publicly available vendor resources, that is, Amazon
Business, Cardinal Health (Vendors).
<bullet> The Federal Register, current DPEI data, historical
proposed and final rules prior to CY 2018, and other resources; that
is, AMA RUC reports (References).
StrategyGen prioritized the equipment and supply research based on
current share of PE RVUs attributable by item provided by CMS.
StrategyGen developed the preliminary Recommended Price (RP)
methodology based on the following rules in hierarchical order
considering both data representativeness and reliability.
(1) If the market share, as well as the sample size, for the top
three commercial products were available, the weighted average price
(weighted by percent market share) was the reported RP. Commercial
price, as a weighted average of market share, represents a more robust
estimate for each piece of equipment and a more precise reference for
the RP.
(2) If no data were available for commercial products, the current
CMS prices were used as the RP.
GSA prices were not used to calculate the StrategyGen recommended
prices, due to our concern that the GSA system curtails the number and
type of suppliers whose products may be accessed on the GSA Advantage
website, and that the GSA prices may often be lower than prices that
are
[[Page 65017]]
available to non-governmental purchasers. After reviewing the
StrategyGen report, we proposed to adopt the updated direct PE input
prices for supplies and equipment as recommended by StrategyGen.
StrategyGen found that despite technological advancements, the
average commercial price for medical equipment and supplies has
remained relatively consistent with the current CMS price.
Specifically, preliminary data indicated that there was no
statistically significant difference between the estimated commercial
prices and the current CMS prices for both equipment and supplies. This
cumulative stable pricing for medical equipment and supplies appears
similar to the pricing impacts of non-medical technology advancements
where some historically high-priced equipment (that is, desktop PCs)
has been increasingly substituted with current technology (that is,
laptops and tablets) at similar or lower price points. However, while
there were no statistically significant differences in pricing at the
aggregate level, medical specialties would experience increases or
decreases in their Medicare payments if we were to adopt the pricing
updates recommended by StrategyGen. At the service level, there may be
large shifts in PE RVUs for individual codes that happened to contain
supplies and/or equipment with major changes in pricing, although we
note that codes with a sizable PE RVU decrease would be limited by the
requirement to phase in significant reductions in RVUs, as required by
section 1848(c)(7) of the Act. The phase-in requirement limits the
maximum RVU reduction for codes that are not new or revised to 19
percent in any individual calendar year.
We believe that it is important to make use of the most current
information available for supply and equipment pricing instead of
continuing to rely on pricing information that is more than a decade
old. Given the potentially significant changes in payment that would
occur, both for specific services and more broadly at the specialty
level, in the CY 2019 PFS proposed rule we proposed to phase in our use
of the new direct PE input pricing over a 4-year period using a 25/75
percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021),
and 100/0 percent (CY 2022) split between new and old pricing. This
approach is consistent with how we have previously incorporated
significant new data into the calculation of PE RVUs, such as the 4-
year transition period finalized in CY 2007 PFS final rule with comment
period when changing to the ``bottom-up'' PE methodology (71 FR 69641).
This transition period will not only ease the shift to the updated
supply and equipment pricing, but will also allow interested parties an
opportunity to review and respond to the new pricing information
associated with their services.
We proposed to implement this phase-in over 4 years so that supply
and equipment values transition smoothly from the prices we currently
include to the final updated prices in CY 2022. We proposed to
implement this pricing transition such that one quarter of the
difference between the current price and the fully phased-in price is
implemented for CY 2019, one third of the difference between the CY
2019 price and the final price is implemented for CY 2020, and one half
of the difference between the CY 2020 price and the final price is
implemented for CY 2021, with the new direct PE prices fully
implemented for CY 2022. An example of the transition from the current
to the fully-implemented new pricing is provided in Table 7.
[GRAPHIC] [TIFF OMITTED] TR19NO21.010
For new supply and equipment codes for which we establish prices
during the transition years (CYs 2019, 2020 and 2021) based on the
public submission of invoices, we proposed to fully implement those
prices with no transition since there are no current prices for these
supply and equipment items. These new supply and equipment codes would
immediately be priced at their newly established values. We also
proposed that, for existing supply and equipment codes, when we
establish prices based on invoices that are submitted as part of a
revaluation or comprehensive review of a code or code family, they will
be fully implemented for the year they are adopted without being phased
in over the 4-year pricing transition. The formal review process for a
HCPCS code includes a review of pricing of the supplies and equipment
included in the code. When we find that the price on the submitted
invoice is typical for the item in question, we believe it would be
appropriate to finalize the new pricing immediately along with any
other revisions we adopt for the code valuation.
For existing supply and equipment codes that are not part of a
comprehensive review and valuation of a code family and for which we
establish prices based on invoices submitted by the public, we proposed
to implement the established invoice price as the updated price and to
phase in the new price over the remaining years of the proposed 4-year
pricing transition. During the proposed transition period, where price
changes for supplies and equipment are adopted without a formal review
of the HCPCS codes that include them (as is the case for the many
updated prices we proposed to phase in over the 4-year transition
period), we believe it is important to include them in the remaining
transition toward the updated price. We also proposed to phase in any
updated pricing we establish during the 4-year transition period for
very commonly used supplies and equipment that are included in 100 or
more codes, such as sterile gloves (SB024) or exam tables (EF023), even
if invoices are provided as part of the formal review of a code family.
We would implement the new prices for any such supplies and equipment
over the remaining years of the proposed 4-year transition period. Our
proposal was intended to minimize any potential disruptive effects
during the proposed transition period that could be caused by other
sudden shifts in RVUs due to the high number of services that make
[[Page 65018]]
use of these very common supply and equipment items (meaning that these
items are included in 100 or more codes).
We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining
stability and allowing stakeholders the opportunity to address
potential concerns about changes in payment for particular items.
Updating the pricing of direct PE inputs for supplies and equipment
over a longer timeframe will allow more opportunities for public
comment and submission of additional, applicable data. We welcomed
feedback from stakeholders on the proposed updated supply and equipment
pricing, including the submission of additional invoices for
consideration.
We received many comments regarding the market-based supply and
equipment pricing proposal following the publication of the CY 2019 PFS
proposed rule. For a full discussion of these comments, we direct
readers to the CY 2019 PFS final rule (83 FR 59475 through 59480). In
each instance in which one commenter raised questions about the
accuracy of a supply or equipment code's recommended price, the
StrategyGen contractor conducted further research on the item and its
price with special attention to ensuring that the recommended price was
based on the correct item in question and the clarified unit of
measure. Based on the commenters' requests, the StrategyGen contractor
conducted an extensive examination of the pricing of any supply or
equipment items that any commenter identified as requiring additional
review. Invoices submitted by multiple commenters were greatly
appreciated and ensured that medical equipment and supplies were re-
examined and clarified. Multiple researchers reviewed these specified
supply and equipment codes for accuracy and proper pricing. In most
cases, the contractor also reached out to a team of nurses and their
physician panel to further validate the accuracy of the data and
pricing information. In some cases, the pricing for individual items
needed further clarification due to a lack of information or due to
significant variation in packaged items. After consideration of the
comments and this additional price research, we updated the recommended
prices for approximately 70 supply and equipment codes identified by
the commenters. Table 9 in the CY 2019 PFS final rule lists the supply
and equipment codes with price changes based on feedback from the
commenters and the resulting additional research into pricing (83 FR
59479 through 59480).
After consideration of the public comments, we finalized our
proposals associated with the market research study to update the PFS
direct PE inputs for supply and equipment pricing. We continue to
believe that implementing the updated prices with a 4-year phase-in
will improve payment accuracy, while maintaining stability and allowing
stakeholders the opportunity to address potential concerns about
changes in payment for particular items. We continue to welcome
feedback from stakeholders on the updated supply and equipment pricing,
including the submission of additional invoices for consideration.
For CY 2022, we received invoice submissions from stakeholders for
approximately half a dozen supply and equipment codes as part of the
fourth year of the market-based supply and equipment pricing update. We
used these submitted invoices in many cases to supplement the pricing
originally proposed for the CY 2019 PFS rule cycle. We reviewed the
invoices, as well as our own data for the relevant supply/equipment
codes to make sure the item in the invoice was representative of the
supply/equipment item in question and aligned with past research. Based
on this review, we proposed to update the prices of six supply items
listed in the valuation of specific codes section of the preamble under
Table 23: CY 2022 Invoices Received for Existing Direct PE Inputs.
Since this is the final year of the supply and equipment pricing
update, the new pricing for each of these supply and equipment items
would take effect immediately for CY 2022.
The proposed prices for the supply and equipment items listed in
Table 23 of CY 2022 were generally calculated following our standard
methodology of averaging together the prices on the submitted invoices.
In the case of the Liquid coverslip (Ventana 650-010) (SL479) supply,
we proposed a price of $0.051 based on the median invoice due to the
presence of an outlier invoice that substantially increased the pricing
when using an average. We believe that the price of $0.051 will be more
typical for the SL479 supply based on the pricing information contained
on the other submitted invoices. We also received several invoices for
the 3C patch system (SD343) supply; however, since we established a
price of $625.00 for this supply in last year's CY 2021 PFS final rule
and the submitted invoices had an average price of $612.50, we did not
propose to update the price. We believe that the submitted invoices
confirm that the current pricing of $625.00 is typical for the SD343
supply.
We received public comments on the fourth and final year of the
market-based supply and equipment pricing update. The following is a
summary of the comments we received and our responses.
Comment: One commenter urged CMS to update prices for negative
pressure wound therapy (NPWT) devices given the context of the clinical
labor pricing update. The commenter stated that while one database
reported typical costs of $400-$600 for single-use disposable NPWT
devices, further prices provided by a medical equipment distributor
show lower costs incurred by providers paying for PICO, Smith+Nephew's
single-use disposable NPWT device. The commenter submitted five
invoices for the negative pressure wound therapy, disposable kit
(SA131) supply and stated that these updated prices for single-use NPWT
devices could be used in future updates of direct cost inputs, which
would strengthen the accuracy of Medicare pricing.
Response: We appreciate the submission of invoices from the
commenter to update the pricing of the SA131 supply. This kit is
currently priced at $208 and we are finalizing an update to a price of
$263.25 based on the median of the five submitted invoices from one
commenter. We believe that the median value is more reflective of the
typical price than the average value as there was a clear outlier
amongst the five invoice prices ($248.33, $252.00, $263.25, $284.50,
and $340.20).
Comment: Several commenters stated their concerns regarding
significant price reductions for several types of radiation therapy
equipment: The IMRT treatment planning system (ED033), the HDR
Afterload System Nucletron--Oldelft (ER003), and the SRS system SBRT
(ER083). Commenters stated that they appreciated CMS' efforts to
acquire current pricing information but believed that the recommended
prices for these equipment items are below industry standards.
Commenters stated that undervaluing equipment inputs has the potential
to create access to care issues and potentially reduce the utilization
of services that provide high quality patient outcomes.
Response: Although we share the concerns of the commenters about
the importance of ensuring accuracy in pricing and beneficiary access
to care, the commenters did not submit invoices or provide any other
pricing information for the three equipment items in question. In the
absence of other pricing
[[Page 65019]]
data, we continue to believe that the equipment pricing we established
for these items based on our past market-based research reflects the
most accurate information for the equipment items in question.
Comment: An anonymous commenter submitted an invoice that they
stated could be used to update the pricing of the endovascular laser
treatment kit (SA074) supply. The commenter stated that the PE may be
overvalued for CPT code 36478, and the cost of $205.00 per kit detailed
in this invoice may be more accurately reflective of SA074 kit costs.
Response: We appreciate the invoice submission from the anonymous
commenter. The SA074 supply has a current CY 2022 price of $438.60
based on invoices submitted in last year's CY 2021 rulemaking cycle.
The new invoice submission is less than half of this price, and when we
compared the specific kit in question on the invoices, they described
two different products. The CY 2021 invoices described a 65 cm kit
while the CY 2022 invoice described a 45 cm version of the same kit. We
believe that this explains the disparity in pricing between the
different invoices. Since it is unclear to us which of these two
products is more typical for use in CPT code 36478, we are maintaining
the current CY 2022 price of $438.60 pending availability of additional
information. We encourage stakeholders to submit additional invoices to
assist in the pricing of the SA074 supply. These invoices can be
submitted with public comments in next year's CY 2023 rulemaking cycle
or, if outside the notice and comment rulemaking process, via email at
<a href="/cdn-cgi/l/email-protection#3c6c79636c4e555f596375524c494863694c585d48597c5f514f1254544f125b534a"><span class="__cf_email__" data-cfemail="cf9f8a909fbda6acaa9086a1bfbabb909abfabaebbaa8faca2bce1a7a7bce1a8a0b9">[email protected]</span></a>.
Comment: One commenter requested that CMS establish a national
physician payment rate for Category III CPT code 0583T, also known as
tympanostomy under local anesthesia (Tula). The commenter stated that
this device-intensive procedure has inappropriately low physician MAC-
posted rates resulting from crosswalks to ENT codes that do not involve
use of single-use implantable medical devices provided in the physician
office setting. The commenter suggested work RVUs and direct PE inputs
for Category III code 0583T to be used in national pricing of the
service, and separately submitted six invoices showing prices paid by
physicians for the tympanostomy under local anesthesia (Tula)
implantable device and related supplies. The commenter requested a
price of $995 for the Tula implantable device.
Response: We appreciate the submission of invoices and other
pricing information from the commenter regarding Category III CPT code
0583T, but we did not propose to establish national pricing for this
service. Category III CPT codes are typically contractor priced since
they describe new and emerging technologies. We will review the
materials provided by the commenter for potential use in future
rulemaking; however, we are not finalizing national pricing for
Category III CPT code 0583T or establishing a price for the Tula
implantable device at this time.
After consideration of the public comments, we are finalizing the
supply and equipment prices as detailed individually above. We note
that the supply and equipment prices finalized for CY 2022 represent
the fourth and final year of the market-based supply and equipment
pricing update.
(2) Invoice Submission
The full list of updated supply and equipment pricing as
implemented over the 4-year transition period will be made available as
a public use file displayed on the CMS website under downloads for the
CY 2022 PFS final rule at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysisianFeeSched/PFS-Federal-Regulation-Notices.html</a>.
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 <a href="/cdn-cgi/l/email-protection#7020352f20021913152f391e0005042f25001411041530131d035e1818035e171f06"><span class="__cf_email__" data-cfemail="4010051f10322923251f092e3035341f15302421342500232d336e2828336e272f36">[email protected]</span></a>.
(3) Autologous Platelet-Rich Plasma (HCPCS Code G0460) Supply Inputs
We did not make any proposals associated with HCPCS code G0460
(Autologous platelet rich plasma for chronic wounds/ulcers, including
phlebotomy, centrifugation, and all other preparatory procedures,
administration and dressings, per treatment) in the CY 2021 PFS
proposed rule. Following publication of the rule, stakeholders
contacted CMS regarding the creation of a new 3C patch system supply,
which is topically applied for the management of exuding cutaneous
wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and
mechanically or surgically-debrided wounds. Stakeholders first sought
clarification on how CMS calculated the underlying nonfacility PE RVUs
for HCPCS code G0460. Stakeholders also stated that autologous platelet
rich plasma administration procedures furnished in clinical trials
(including the new 3C patch system) are reported using HCPCS code G0460
and requested that CMS revalue the service to reflect the PEs
associated with the new patch system supply. The stakeholders stated
that the use of the new 3C patch system will represent the typical case
for HCPCS code G0460, and suggested that, therefore, the cost inputs
for this supply should be used to establish the RVUs for this code, as
the current PFS payment rate is substantially less than the amount it
costs to furnish the 3C patch.
We want to clarify that the direct PE inputs for HCPCS code G0460
increased for CY 2021 as a result of the ongoing market-based supply
and equipment pricing update. However, there was also a minor decrease
in the indirect PE allocation associated with this service for CY 2021,
with the net result that the proposed PE RVU coincidentally ended up
remaining the same as in the previous year. We also clarify that HCPCS
code G0460 is not included in the Anticipated Specialty Assignment for
Low Volume Services list, and therefore, was unaffected by low
utilization in the claims data. In addition, as a contractor priced
service, HCPCS code G0460 is unaffected by inclusion or exclusion from
this list.
We share the concerns of the stakeholders that patient access to
the 3C patch could be materially impacted if CMS maintains the current
PE RVUs for HCPCS G0460. In the CY 2021 PFS final rule, we established
contractor pricing for HCPCS code G0460 for CY 2021. We believe that
the use of contractor pricing again for CY 2022 will allow us
additional time to consider the most appropriate resource inputs and PE
RVUs for HCPCS code G0460. We also added the 3C patch system to our
supply database under supply code SD343 at a price of $625.00 based on
an average of the submitted invoices. We proposed to maintain
contractor pricing for CY 2022 for HCPCS code G0460 as we do not
currently have sufficient information to establish national pricing. It
remains
[[Page 65020]]
unclear to us what the typical supply inputs would be for HCPCS code
G0460 and whether they would include the use of the new 3C patch
system. We believe that it would be more appropriate to maintain
contractor pricing for the service, which will allow for more
flexibility in pricing. We solicited any additional information that
commenters can supply that CMS should consider to establish national
payment for HCPCS code G0460.
We did not receive public comments on this proposal and are
finalizing contractor pricing for HCPCS code G0460 for CY 2022 as
proposed.
d. Clinical Labor Pricing Update
Section 220(a) of the PAMA provides that the Secretary may collect
or obtain information from any eligible professional or any other
source on the resources directly or indirectly related to furnishing
services for which payment is made under the PFS, and that such
information may be used in the determination of relative values for
services under the PFS. Such information may include the time involved
in furnishing services; the amounts, types and prices of PE inputs;
overhead and accounting information for practices of physicians and
other suppliers, and any other elements that would improve the
valuation of services under the PFS.
Since 2019, we have been updating the supply and equipment prices
used for PE as part of a market-based pricing transition; CY 2022 will
be the final year of this 4-year transition. We initiated a market
research contract with StrategyGen to conduct an in-depth and robust
market research study to update the supply and equipment pricing for CY
2019, and we finalized a policy in CY 2019 to phase in the new pricing
over a period of 4 years. However, we did not propose to update the
clinical labor pricing, and the pricing for clinical labor has remained
unchanged during this pricing transition. Clinical labor rates were
last updated for CY 2002 using Bureau of Labor Statistics (BLS) data
and other supplementary sources where BLS data were not available; we
refer readers to the full discussion in the CY 2002 PFS final rule for
additional details (66 FR 55257 through 55262).
Stakeholders have raised concerns that the long delay since
clinical labor pricing was last updated has created a significant
disparity between CMS' clinical wage data and the market average for
clinical labor. In recent years, a number of stakeholders have
suggested that certain wage rates are inadequate because they do not
reflect current labor rate information. Some stakeholders have also
stated that updating the supply and equipment pricing without updating
the clinical labor pricing could create distortions in the allocation
of direct PE. Since the pool of aggregated direct PE inputs is budget
neutral, if these rates are not routinely updated, clinical labor may
become undervalued over time relative to equipment and supplies,
especially since the supply and equipment prices are in the process of
being updated. There has been considerable stakeholder interest in
updating the clinical labor rates, and when we solicited comment on
this topic in past rules, such as in the CY 2019 PFS final rule (83 FR
59480), stakeholders supported the idea.
Therefore, we proposed to update the clinical labor pricing for CY
2022, in conjunction with the final year of the supply and equipment
pricing update. We believe it is important to update the clinical labor
pricing to maintain relativity with the recent supply and equipment
pricing updates. We proposed to use the methodology outlined in the CY
2002 PFS final rule (66 FR 55257), which draws primarily from BLS wage
data, to calculate updated clinical labor pricing. As we stated in the
CY 2002 PFS final rule, the BLS' reputation for publishing valid
estimates that are nationally representative led to the choice to use
the BLS data as the main source. We believe that the BLS wage data
continues to be the most accurate source to use as a basis for clinical
labor pricing and this data will appropriately reflect changes in
clinical labor resource inputs for purposes of setting PE RVUs under
the PFS. We used the most current BLS survey data (2019) as the main
source of wage data for this proposal.
We recognize that the BLS survey of wage data does not cover all
the staff types contained in our direct PE database. Therefore, we
crosswalked or extrapolated the wages for several staff types using
supplementary data sources for verification whenever possible. In
situations where the price wages of clinical labor types were not
referenced in the BLS data, we have used the national salary data from
the Salary Expert, an online project of the Economic Research Institute
that surveys national and local salary ranges and averages for
thousands of job titles using mainly government sources. (A detailed
explanation of the methodology used by Salary Expert to estimate
specific job salaries can be found at <a href="http://www.salaryexpert.com">www.salaryexpert.com</a>). We
previously used Salary Expert information as the primary backup source
of wage data during the last update of clinical labor pricing in CY
2002. If we did not have direct BLS wage data available for a clinical
labor type, we used the wage data from Salary Expert as a reference for
pricing, then crosswalked these clinical labor types to a proxy BLS
labor category rate that most closely matched the reference wage data,
similar to the crosswalks used in our PE/HR allocation. For example,
there is no direct BLS wage data for the Mammography Technologist
(L043) clinical labor type; we used the wage data from Salary Expert as
a reference and identified the BLS wage data for Respiratory Therapists
as the best proxy category. We calculated rates for the ``blend''
clinical labor categories by combining the rates for each labor type in
the blend and then dividing by the total number of labor types in the
blend.
As in the CY 2002 clinical labor pricing update, the proposed cost
per minute for each clinical staff type was derived by dividing the
average hourly wage rate by 60 to arrive at the per minute cost. In
cases where an hourly wage rate was not available for a clinical staff
type, the proposed cost per minute for the clinical staff type was
derived by dividing the annual salary (converted to 2021 dollars using
the Medicare Economic Index) by 2080 (the number of hours in a typical
work year) to arrive at the hourly wage rate and then again by 60 to
arrive at the per minute cost. To account for the employers' cost of
providing fringe benefits, such as sick leave, we used the same
benefits multiplier of 1.366 as employed in CY 2002. As an example of
this process, for the Physical Therapy Aide (L023A) clinical labor
type, the BLS data reflected an average hourly wage rate of $14.03,
which we multiplied by the 1.366 benefits modifier and then divided by
60 minutes to arrive at the proposed per-minute rate of $0.32.
Table 8 lists our updates to the clinical labor prices. The BLS
occupational code used as a source of wage data is listed for each
clinical labor type; for the ``blend'' clinical labor types, this may
include multiple BLS occupational codes and other clinical labor types
which were calculated separately and then averaged together. Clinical
labor types without a direct BLS labor category where we are employing
a proxy BLS wage rate are indicated with an asterisk in Table 8.
BILLING CODE 4120-01-P
[[Page 65021]]
[GRAPHIC] [TIFF OMITTED] TR19NO21.011
BILLING CODE 4120-01-C
We proposed to use the 75th percentile of the average wage data for
the Medical Physicist (L152A) clinical labor type because we believe
this level
[[Page 65022]]
will most closely fit with the historic wage data for this clinical
labor type. A Medical Physicist is a specific type of physicist, and
the available BLS wage data describes the more general category of
physicist which is paid at a lower rate. In this specific case, the
75th percentile more accurately describes the clinical labor type in
question based on how it has historically been paid. We also proposed
to maintain the current clinical labor pricing for the Behavioral
Health Care Manager (L057B) clinical labor type rather than update it.
Although the BLS data reflected a decreased clinical labor rate for the
Behavioral Health Care Manager labor type, we do not believe that the
typical wages have decreased for this clinical labor type given that
every other clinical labor type has increased over the past 5 years
since the Behavioral Health Care Manager clinical labor type was
created. The Behavioral Health Care Manager labor type was initially
established in the CY 2017 PFS final rule (81 FR 80350). It seems more
likely that we misidentified the proper BLS category for this clinical
labor type than that wages have decreased since 2017. We believe that
the clinical labor rate for the Behavioral Health Care Manager should
be held constant for CY 2022 pending additional public feedback.
We solicited comments on the updated clinical labor pricing. We
were particularly interested in additional wage data for the clinical
labor types for which we lacked direct BLS wage data and made use of
proxy labor categories for pricing. We understand that the clinical
labor undertaken by, for example, a Histotechnologist (L037B) is not
the same as the clinical labor provided by the Health Information
Technologist category of BLS wage data that we employed as a proxy for
pricing. Although these occupations are not directly analogous to each
other in terms of the work they do, we nonetheless believe that the
proposed crosswalks are appropriate in terms of the resulting hourly
wage data. We indicated that we would appreciate any additional
information that commenters could supply both in terms of direct wage
data, as well as identifying the most accurate types of BLS categories
that could be used as proxies to update pricing for clinical labor
types that lack direct BLS wage data. We isolated the anticipated
effects of the clinical labor pricing update on specialty payment
impacts by comparing the proposed CY 2022 PFS rates with and without
the clinical labor pricing updates in place as shown in Table 9.
BILLING CODE 4120-01-P
[[Page 65023]]
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[[Page 65024]]
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BILLING CODE 4120-01-C
The potential effects of the clinical labor pricing update on
specialty payment impacts were largely driven by the share that labor
costs represent of the direct PE inputs for each specialty. Specialties
with a substantially lower or higher than average share of direct costs
attributable to labor would experience significant declines or
increases, respectively, if this proposal is finalized. For example,
the Family Practice specialty had a higher share of direct costs
associated with clinical labor, and payments to services comprising the
specialty would be expected to increase as a result of this clinical
labor pricing update. In contrast, Diagnostic Testing Facilities had a
lower share of direct costs that are associated with clinical labor,
and payments to services comprising the specialty would be expected to
decrease. Other specialty-level payment impacts for the proposed
clinical labor pricing changes were driven by changes in wage rates for
a clinical labor category that affects a given specialty more than
average. One such example would be the proposed increase of 11 percent
for Oncology nurses as opposed to the average increase for nurses of 63
percent. We emphasized that these are not the projected impacts by
specialty of all the policies we proposed in the proposed rule for CY
2022, only the anticipated effect of the isolated clinical labor
pricing update, should this clinical labor pricing update be finalized
as proposed.
When updates to our payment methodology based on new data produce
significant shifts in payment, we often consider whether it would be
appropriate to implement the updates through a phased transition across
several calendar years. For example, we utilized a 4-year transition
for the market-based supply and equipment pricing update concluding in
CY 2022. We are considering the use of a similar 4-year transition to
implement the clinical labor pricing update. A multi-year transition
could smooth out the increases and decreases in payment caused by the
pricing update for affected stakeholders, promoting payment stability.
However, a phased transition would delay the full implementation of
updated pricing and continue to rely in part on outdated data for
clinical labor pricing. We discuss a potential 4-year transition for
the clinical labor pricing update as an alternative considered in the
Regulatory Impact Analysis (section VI.I of this final rule).
We received public comments on our proposal to update the clinical
labor pricing. The following is a summary of the comments we received
and our responses.
Comment: Many commenters supported the proposal to update the
clinical labor pricing. Commenters overwhelmingly agreed that the BLS
was the most accurate source of wage data and the best source to use
for updating the clinical labor pricing. Commenters stated that CMS
needs recurring and accurate sources of data to keep PE RVUs up to date
and that such data sources should capture the prices of equipment and
supplies, wage rates for clinical staff, the types and quantities of
direct PE inputs, and specialties' practice costs. Commenters stated
that inaccurate prices for PE inputs could lead to distortions in the
PE RVUs; for example, updating prices for equipment and supplies but
not clinical labor could lead to undervaluing of services that use a
high share of clinical labor. Several commenters stated that, after
almost 20 years, an update to clinical labor pricing was long overdue.
Several commenters urged CMS to update the prices for clinical labor
immediately because inaccurate payment rates distort the market for
clinician services and further prolonging the necessary improvement in
CMS' PE RVU methodology will result in additional, unnecessary delays
for an already overdue pricing update. These commenters recognized that
this update may negatively impact certain specialties and procedures,
but stated that the lack of pricing updates has likely disadvantaged
services that rely heavily on clinical labor, such as family medicine,
for several years.
Response: We appreciate the support for our proposed policies from
the commenters.
Comment: Many commenters supported the proposal to update the
clinical labor pricing, but stated that the update should be phased in
using a 4-year transition. Commenters stated that the use of a 4-year
transition would be consistent with previous PE updates such as the
market-based supply and equipment pricing update and the implementation
of the bottom-up PE methodology. Commenters stated that the phased in
approach would help minimize the reimbursement reductions to specific
services which rely heavily on supply and equipment costs that
otherwise could prove detrimental to Medicare beneficiary access to
services. Commenters stated that these PE decreases coupled with the
3.75 percent reduction in the conversion factor resulting from the
expiration of the temporary increase provided under the CY 2021
Consolidated Appropriations Act are difficult for practices to absorb
as the country struggles to contain the COVID-19 pandemic, and that
mitigating the effects of the clinical labor pricing update through the
use of a 4-year transition would help maintain payment stability.
Response: We appreciate the support for the proposed clinical labor
update from the commenters, with the additional request that we
implement it using a 4-year transition. After consideration of the
comments, we agree that the use of a multi-year transition will help
smooth out the changes in payment resulting from the clinical labor
pricing update, avoiding potentially disruptive changes in payment for
affected stakeholders, and promoting payment stability from year-to-
year. We believe it would be appropriate to use a 4-year transition, as
we have for several other broad-based updates or methodological
changes. While we recognize that using a 4-year transition to implement
the update means that we will continue to rely in part on outdated data
for clinical labor pricing until the change is fully completed in CY
2025, we agree with the commenters that these significant updates to PE
valuation should be implemented in the same way, and for the same
reasons, as for other major updates to pricing such as the recent
supply and equipment update. We believe that the use of a 4-year
transition in implementing the clinical labor pricing update will help
to maintain payment stability, particularly given the ongoing public
health emergency (PHE) for COVID-19.
We are finalizing the implementation of the clinical labor pricing
update over 4 years to transition from current prices
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to the final updated prices in CY 2025. We considered, as an
alternative to our proposal, implementing this pricing transition over
4 years, such that one quarter of the difference between the current
price and the fully phased-in price is implemented for CY 2022, one
third of the difference between the CY 2022 price and the final price
is implemented for CY 2023, and one half of the difference between the
CY 2023 price and the final price is implemented for CY 2024, with the
new direct PE prices fully implemented for CY 2025. An example of the
transition from the current to the fully-implemented new pricing that
we are finalizing is provided in Table 10.
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Comment: A few commenters requested the use of a 2-year transition
as a timetable that they stated would be more equitable to all impacted
providers. These commenters stated that if a 2-year timetable was not
feasible, they would support a 4-year transition over a 1-year
transition.
Response: While we appreciate the support from the commenters for
the proposed clinical labor pricing update and the suggestion from some
that we use a 2-year transition, we believe that a 4-year transition,
which is consistent with the way we have implemented prior significant
updates to resource input pricing and the PE methodology, would meet
the need to update clinical labor pricing while providing the health
care provider community time to adjust to the resulting shifts in
payments, especially during the ongoing PHE.
Comment: Many commenters disagreed with the proposal to update
clinical labor pricing and urged that the policy should not be
finalized, with or without a 4-year transition. These commenters
objected to proposed reductions in payment for many types of services,
such as but not limited to services in the fields of radiation
oncology, peripheral arterial disease, PT/INR home monitoring, flow
cytometry, cardiovascular disease, and many others. Commenters stated
that the clinical labor pricing update will limit access to care for
Medicare patients and will force many Medicare beneficiaries into the
facility-based system at a significantly higher cost to the Medicare
program and its patients. Commenters stated that this shift in care to
the facility-based hospital settings will cause great burdens on an
already overwhelmed hospital system, exacerbate market consolidation,
and will adversely affect physicians' ability to provide the right care
to the right patient at the right time. Commenters stated that patients
may have to travel farther and wait longer for care, as well as pay
more out-of-pocket since every single case shifted to the facility
setting means higher cost-sharing for the affected beneficiary.
Commenters emphasized the benefits of office-based care for a variety
of services and argued that clinical labor pricing should not be
updated as we proposed to help maintain access to office-based care.
Several commenters stated that the proposed decrease in payment for
certain services will disproportionately affect women's health and
racial minorities, with a negative impact on some of the most
vulnerable of Medicare's beneficiaries.
Response: We share the concerns expressed by the commenters about
the need to ensure continued access to quality and affordable care for
all beneficiaries, in both the office and hospital settings. Under
section 1848 of the Act, we are required to base payment for services
under the PFS on relative resource costs. To accomplish that, it is
necessary periodically to update the information on which we base
relative values. We believe, and commenters overwhelmingly agreed, that
the BLS wage data is the best source to use for clinical labor pricing,
and commenters did not identify alternative sources of data that could
be used to update pricing. Although we recognize that payment for some
services will be reduced as a result of the pricing update due to the
BN requirements of the PFS, we do not believe that this is a reason to
refrain from updating clinical labor pricing to reflect changes in
resource costs over time as suggested by some commenters. There are
also other services, such as those primarily furnished by family
practice and internal medicine specialties, that will be positively
affected by the pricing update, which we anticipate will increase
access to care for disadvantaged groups such as women and racial
minorities. We also note that for many services that involve
proportionally more clinical labor, payment rates were reduced as a
result of the prior market-based supply and equipment pricing update,
and payment rates will increase with the clinical labor pricing update,
due to the same PFS BN requirements. We believe that the ongoing trend
of market consolidation and site of service differentials highlight the
need to update the overall PE data comprehensively, including a full
accounting of indirect/overhead costs, to account for current trends in
the delivery of health care, especially with regard to independent
versus facility-based practices. We believe that CMS efforts to improve
pricing accuracy would improve the sustainability of the Medicare PFS
and the broader health system, improve access to care, and reduce
inequitable disparities. We believe that the use of a 4-year transition
in implementing the clinical labor pricing update will help to maintain
payment stability and mitigate potential negative effects on healthcare
providers by gradually phasing in the changes over a period of time. We
believe that this transition period is also important given that the
PHE for COVID-19 is ongoing and industry recovery is likely to take
time.
Comment: Many commenters discussed the direct scaling factor used
in the calculation of PE RVUs. Commenters stated that updating the
clinical labor rates is estimated to increase direct PE costs by 30
percent which would equate to approximately $3.5 billion in total
additional direct costs. Commenters noted that the direct scaling
factor was proposed to decrease by 24 percent as a result, from 0.5916
in 2021 to 0.4468 in 2022, with the net
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effect that Medicare will now reimburse 44 cents on the dollar instead
of 59 cents on the dollar for direct costs. Commenters stated that many
services require the use of expensive supplies with considerable
capital costs that need to be stocked and readily available. Commenters
stated that they did not believe the cost of this labor rate update
should be borne disproportionately by equipment and supply-heavy
services, which are the services least able to accommodate sharp and
sudden payment reductions since equipment costs are fixed. Many
commenters stated that the proposed policy would place a huge and
unfair burden on specialties that require expensive supplies and
equipment; commenters stated that the high costs of maintaining this
equipment remain the same whether or not the equipment is used.
Commenters stated that the proposed policy would result in wildly
fluctuating shifts in reimbursement, violating a core principle of the
resource-based relative value system which is to stabilize RVUs and
reduce fluctuations in year-to-year payments. Commenters stated that if
payments change drastically, there is no way to accommodate those
shifts through operating expenses without cuts elsewhere, including to
staff and services offered. Commenters stated that CMS should explore
options to adjust the scaling factor(s) in order to more appropriately
reimburse for expenses incurred to treat their beneficiaries.
Response: We appreciate the estimate provided by commenters of the
additional spending on direct costs as a result of the proposed
clinical labor pricing update. However, we disagree with the commenters
that updating the clinical labor pricing to make use of current wage
data constitutes an unfair burden or has an inappropriate
disproportionate impact on certain services. The PFS is a resource-
based relative value payment system that necessarily relies on accuracy
in the pricing of resource inputs. Continuing to use clinical labor
cost data that are nearly 2 decades old would create distortions in
relativity that undervalue many services which involve a higher
proportion of clinical labor. As noted previously, payment for services
that involve a higher proportion of clinical labor resources was
negatively affected by the prior market-based supply and equipment
pricing update as a result of the same BN requirements and will now be
positively affected by the clinical labor pricing update. We do not
agree that updates to pricing for the three categories of direct PE
(clinical labor, supplies and equipment), create an unfair burden for
individual services. We do agree with commenters that the impact of the
proposed clinical labor pricing update is substantial, which is why we
believe it is appropriate to use a 4-year transition to implement the
pricing update. We believe the use of this transition will help address
the concerns of the commenters about stabilizing RVUs and reducing
large fluctuations in year-to-year payments.
Comment: Several commenters requested that CMS maintain the CY 2021
direct scaling factor of 0.5916 if the agency chooses to finalize the
clinical labor pricing update.
Response: Under our current PE methodology, we calculate a direct
PE scaling adjustment to ensure that the aggregate pool of direct PE
costs does not vary from the aggregate pool of direct PE costs for the
current year. (This calculation is described in more detail in the ``PE
RVU Methodology'' section earlier in this rule.) In other words, the
direct scaling adjustment ensures that the share of direct PE remains
constant from year to year. If we continued to maintain the direct
scaling factor from a previous calendar year, without making any
adjustment to account for the total direct costs increasing as a result
of the clinical labor pricing update, the amount of PFS spending
allocated to direct PE would increase at the expense of all other
spending. This would negatively affect the valuation of many services
that have few or no direct PE inputs. It would also result in a
substantial negative adjustment to the conversion factor under the
statute's BN requirements as the total number of PE RVUs would increase
and would need to be offset through the conversion factor. We do not
agree that it would be appropriate to maintain the direct scaling
factor from a previous calendar year; we did not propose to update our
PE methodology and we are not finalizing any changes in the
methodology.
Comment: Several commenters suggested that CMS spread the cost of
the clinical labor update across both the direct and indirect PE pools.
Commenters stated that this suggestion would allocate approximately 27
percent of the additional costs to the direct cost pool and 73 percent
to the indirect cost pool. Commenters stated that this change would
result in minimal changes in allowed charges for specialties such as
general practice and family medicine, as compared with the changes that
would result from the proposed approach.
Response: We disagree with the commenters that it would be
appropriate to spread the increased spending from the clinical labor
pricing update across both the direct and indirect PE pools, as opposed
to solely the direct pool as proposed. This suggested change to the PE
methodology would have an effect similar to continuing to maintain the
direct scaling factor from previous calendar years, that is, the amount
of PFS spending allocated to direct PE would increase at the expense of
all other spending. In particular, services that have a higher
proportion of indirect PE would be negatively affected as increases in
the direct PE pool would be subsidized by the indirect PE pool. We do
not believe that this would appropriately carry out the statute's
directive to value services based on relative resource costs. We did
not propose to update our PE methodology and we are not finalizing any
changes in the methodology.
Comment: Several commenters suggested that CMS consider scaling the
clinical labor and equipment/supply components of the direct PE pool
separately. Commenters stated that based on the CY 2014 PFS final rule,
it appeared that the clinical labor component of the pool should be
weighted at 4.636 percent of PFS expenditures, and should not exceed
about 66 percent of the direct cost pool.
Response: We disagree with the commenter that the three components
of direct PE (clinical labor, supplies, and equipment) should be should
be scaled separately instead of together. This would have the effect of
freezing the portion of direct PE allocated to each of the three
components; if we were to make this change to the PE methodology,
updating the clinical labor pricing would not allocate any additional
valuation to clinical labor at all. It would merely shift the
relationship between the individual clinical labor types as they were
re-priced. The clinical labor component of direct PE has not been
updated since 2002, while supply and equipment pricing has been updated
more recently. The commenters' suggested change to the PE methodology
would lock in place the relativity between direct PE components at a
particular time. We believe that this would be inconsistent with the
statute's directive to value services based on relative resource costs.
As noted above, we did not propose to modify our PE methodology, and we
are not finalizing any changes in the methodology.
Comment: Several commenters stated that they had performed an
analysis suggesting that the proportion of PFS expenditures allocated
to direct PE may have shrunk from the proportion
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adopted in 2014. Commenters requested that CMS examine whether, and to
what extent, the total PE pool has been reduced over time, and, if so,
requested that it be restored.
Response: As explained above, the direct scaling adjustment ensures
that the share of direct PE (and therefore, also indirect PE) remains
constant from year to year. We can confirm for the commenters that our
application of BN adjustments, which is required by statute, has
maintained the total PE pool over time.
Comment: Several commenters referred to the decrease in the direct
scaling factor and stated that this would cause huge second order
effects that are not being considered by CMS. Commenters stated that
the result would be a PFS that is ever more out of touch with reality
as conversion factors, direct adjustment factors, and other factors
make the PFS less and less reflective of what it actually takes to
provide services in the office.
Response: We disagree with the commenters that our proposed
clinical labor update makes the PFS less reflective of the real-world
cost of providing services. We believe that updating clinical labor
rates to reflect current pricing has the opposite effect, appropriately
improving recognition of current clinical labor costs in the PFS
methodology.
Comment: Several commenters stated that the PPIS data which
underlie the share of PE allocated to direct PE and indirect PE are
outdated, and that it was unreasonable to cap updated direct costs
based on direct/indirect cost splits from 2006. Commenters stated that
if the updated clinical labor pricing had been in effect in 2006, then
direct costs undoubtedly would have constituted a larger proportion of
the overall PE pool.
Response: We have no doubt that if the clinical labor pricing in
2006 had been based on BLS wage data from 2019, direct costs would have
constituted a larger proportion of the overall PE pool. However, it is
inappropriate to make use of wage data from 2019 and compare it to the
direct/indirect cost splits from 2006 without also acknowledging that
indirect costs such as administrative expenses and office rent have
also greatly increased over the intervening span of time. While we
share the concerns of the commenters that the PPIS data used in the PE
methodology date back more than a decade, we have no evidence at
present to indicate that direct costs have increased faster than
indirect costs since 2006, or vice versa. As we noted in the CY 2021
PFS final rule (85 FR 84498 through 84499) and again in this rule, the
RAND corporation is currently studying potential improvements to our PE
allocation methodology and the data that underlie it. We are interested
in exploring ways that the PPIS data can be updated; however, we do not
believe that this constitutes a reason to refrain from updating the
clinical labor pricing.
Comment: Several commenters referenced the BN requirements for the
PFS that are included in the statute. Commenters stated that no
adjustments to the $20 million threshold for BN have been made to
account for new technology in over 30 years. Commenters stated that CMS
should publish how the annual $20 million restriction on changes to
expenditures could have played a role in the clinical labor updates.
Response: Section 1848(c)(2)(B)(ii)(II) of the Act requires that
increases or decreases in RVUs may not cause the amount of expenditures
for the year to differ by more than $20 million from what expenditures
would have been in the absence of these changes. If this threshold is
exceeded, we make adjustments to preserve BN. As this is a statutory
requirement of the PFS, we are required by law to apply BN adjustments
to offset the spending impact of any changes exceeding $20 million;
given the roughly $100 billion in spending associated with the PFS,
this threshold is exceeded each calendar year by a wide margin. A BN
adjustment would be avoided only if updating the clinical labor pricing
failed to reach this $20 million threshold. We found that the estimated
effect of the proposed clinical labor pricing update was approximately
$3.5 billion, with our analysis matching the figure supplied by
commenters, which far exceeds the $20 million threshold. Therefore, we
were required by statute to make BN adjustments to reflect the expected
effects of the clinical labor pricing update. We also note that as the
BN requirement is statutory in nature, we do not have discretion to
adjust it for new technology or other changes that may have taken
place.
Comment: Several commenters urged CMS to use its discretion to
waive BN in implementing the proposed update to clinical labor pricing.
Other commenters urged CMS to hold harmless the specialties that are
bearing the brunt of this proposal and consider alternative ways to
update clinical labor pricing. Several commenters stated that updated
clinical labor pricing should not be done within the confines of a
budget neutral system, unless there were concomitant inflationary
updates to the entire fee schedule.
Response: As mentioned above, BN adjustments are a statutory
requirement of the PFS. We do not have discretion within the terms of
the statute to waive BN or hold individual specialties harmless in
implementing the clinical labor pricing update.
Comment: One commenter stated that while CMS has broad discretion
to determine and adjust RVUs for physician services, CMS cannot make
arbitrary changes to RVUs. The commenter stated that CMS must give a
reasoned explanation for adjustments it makes for certain codes, and
those explanations must relate to the relative resource use for a
particular service. The commenter stated that the requirement to
maintain BN does not authorize the agency to ignore the general rule
that RVUs, and their individual components, must be based on relative
resource use. The commenter stated that unless CMS can articulate how
the relative cost of the other PE inputs--like supplies and medical
equipment--has gone down, the agency is not authorized to decrease the
value of those inputs. The commenter stated that CMS is only authorized
to apply a BN adjustment across all RVUs and the BN provisions do not
authorize CMS to manipulate the inputs to the two RVU components.
Response: We disagree with the commenter that we have proposed
arbitrary changes to the valuation of individual services; we detailed
the methodology behind our proposed clinical labor pricing update and
provided an opportunity for commenters to submit feedback through
notice and comment rulemaking. We believe that updating the clinical
labor pricing makes the relative resource use basis dictated by the
statute more accurate, not less accurate, for the valuation of
services. While the relative resource cost of the other non-clinical
labor direct PE inputs, such as supplies and equipment, would in fact
decrease for CY 2022 based on our proposed update to clinical labor
pricing, they have only decreased in relative terms because the PFS is
based on the use of RVUs as part of a budget neutral methodology. We
note again that the use of a 4-year transition in implementing the
clinical labor pricing update should help to mitigate potential
negative effects of these shifts in relative resource costs by
spreading them out over a longer period of time.
Comment: Several commenters stated that the specialty impacts
tables isolating the effects of the clinical labor pricing update in
the CY 2022 PFS proposed rule were misleading. Commenters stated that
in reality the negative impact for many services was
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much greater than displayed on these tables. Commenters stated that it
would be more transparent to share impacts for individual services when
they had a potentially large negative effect on providers of office-
based procedures with high supply and equipment costs.
Response: Although we share the concerns of commenters regarding
the importance of providing transparency in the published data, we
disagree that the specialty impacts tables included in the CY 2022 PFS
proposed rule were misleading, or that commenters lacked sufficient
information about the pricing of individual services. We noted in the
CY 2022 PFS proposed rule (86 FR 39532) that the impact tables are for
illustrative purposes for aggregate impacts on specialties, and are not
meant to be code specific; therefore, they are averages, and may not
necessarily be representative of what is happening to the particular
services furnished by a single practitioner within any given specialty.
This has been a feature of the specialty impact tables published in the
PFS for many years, and we believe it is generally well understood by
stakeholders. We also note that the proposed RVUs for every HCPCS code
were published in Addendum B as part of the CY 2022 PFS proposed rule
to allow stakeholders the opportunity to provide comment on the
proposed valuations for each code. Due to the thousands of HCPCS codes
affected by the clinical labor pricing update, we did not publish a
service-level analysis of the pricing update in the preamble, but did
include this information in Addendum B for consideration by
stakeholders. We will consider suggestions to improve the information
available to stakeholders for future rulemaking.
Comment: Many commenters noted that 14 of the 32 clinical labor
staff types had proposed valuations using a BLS crosswalk because an
exact match was not available. Commenters stated that to maintain
transparency CMS should publish the ``other sources'' wage data details
for these clinical labor types. Commenters stated that CMS should
update specific clinical labor wage rates based on stakeholder comments
and data.
Response: We agree with the commenters that stakeholder comments
and data will be valuable in updating the clinical labor pricing, and
we share the concerns of the commenters regarding transparency in the
data used for pricing. As we stated in the proposed rule, we used the
national salary data from the Salary Expert as a reference for pricing,
then crosswalked these clinical labor types to a proxy BLS labor
category rate that most closely matched the reference wage data. For
example, there is no direct BLS wage data for the Mammography
Technologist (L043) clinical labor type; we used the wage data from
Salary Expert for Mammography Technologists as a reference and
identified the BLS wage data for Respiratory Therapists as the best
proxy category. In the interest of transparency, Table 11 lists the
Salary Expert wage data used for the clinical labor types which did not
have direct BLS matches.
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Comment: Many commenters stated that CMS proposed to utilize the
mean wage data to establish updated clinical labor rates, while the
majority of the data inputs for the PFS are based on the median value.
Commenters used as an example how RUC recommendations for work RVUs,
work times, and direct PE inputs were based on the median or typical
case. Commenters requested that CMS use the median wage data, instead
of mean wage data, to more accurately capture typical wage rates and to
be consistent with the median statistic used for clinical staff time.
Response: We appreciate the feedback from the commenters regarding
the use of mean versus median wage data in updating the clinical labor
pricing. Based on the feedback from the commenters, we agree that the
use of median BLS wage data would be more appropriate than average or
mean wage data. We agree that the median value is less susceptible to
outlier values, and therefore, better captures the ``typical'' case. We
will use the median wage data when finalizing the pricing for the
clinical labor update.
Comment: Many commenters disagreed with the proposal to use the
same fringe benefits multiplier of 1.366 that was utilized during the
previous clinical labor pricing in CY 2002. Commenters stated that
using the fringe benefits multiplier rate from 20 years ago was not
consistent with CMS' premise for updating the clinical labor pricing
which was to maintain relativity
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with the recent supply and equipment pricing updates. Commenters stated
that the BLS publishes benefits data routinely and that CMS should use
a current fringe benefits multiplier; many commenters suggested using a
multiplier of 1.296 from the most recent available BLS data.
Response: We agree with the commenters that it would be appropriate
to use a more current fringe benefits multiplier as opposed to our
proposal to use the same multiplier from 2002. According to a BLS
release from June 17, 2021 (USDL-21-1094), the current fringe benefits
multiplier for employees in private industry is 1.296, as noted and
requested by the commenters. We believe that this will be more
appropriate than the proposed fringe benefits multiplier of 1.366 from
2002.
Comment: Many commenters requested that CMS should delay the
implementation of the clinical labor pricing update for one year, or
finalize a 5-year transition with no update in the first year which was
functionally the same request. Commenters stated that the current
clinical labor proposal requires additional analysis and modifications
prior to implementation and there was further work to be done by both
CMS and stakeholders to ensure accurate data are used and appropriate
methodological steps are taken for implementation. Some commenters
stated that CMS should wait until after the market-based supply and
equipment pricing update was concluded before beginning the process of
updating clinical labor pricing. Many commenters mentioned the negative
impacts of the ongoing COVID-19 PHE and the finalization of updated
values for E/M visits in last year's CY 2021 PFS final rule as reasons
to delay the clinical labor pricing update for a year.
Response: We disagree that the clinical labor pricing update should
be delayed for another year before beginning the 4-year implementation
timeline. We do not agree that delaying the pricing update will provide
meaningful improvements in our data; commenters overwhelmingly agreed
that BLS data was the best choice and did not suggest alternative
sources of wage data which would have required additional research. In
places where we made use of crosswalks to value individual clinical
labor types, commenters provided helpful feedback (see discussion
below) and will continue to have the opportunity to provide further
engagement over the course of the 4-year implementation timeline. It is
not clear to us what further work the commenters believe must be done
to ensure appropriate clinical labor pricing given the near-universal
support for the use of BLS wage data for the update. While we share the
concerns of commenters regarding the effects of the ongoing COVID-19
pandemic, we believe that the use of a 4-year transition in
implementing the clinical labor pricing update will help to maintain
payment stability and mitigate potential negative effects on healthcare
providers. Given that the statute requires PFS payment to be based on
relative resource costs, and that the proposed update to clinical labor
wages using the latest available BLS data was overwhelmingly supported
by commenters, we do not believe that we should delay the transition
from outdated pricing from 2002. All of the same issues concerning
redistribution of payments through BN will still remain in place
whether the clinical labor pricing update begins in CY 2022 or CY 2023.
Comment: One commenter stated that CMS should delay any repricing
of clinical labor until it can also collect the latest prices paid for
medical equipment and supplies. The commenter stated that this would
ensure all updated prices for direct cost inputs used in setting PE
payment are factored into Medicare physician rates concurrently.
Response: CY 2022 is the final year of the market-based supply and
equipment pricing transition; we proposed to begin implementing the
update to clinical labor pricing in this calendar year so that it could
take place in conjunction with a portion of the supply and equipment
pricing update. We agree with the commenter that it is important to
update the clinical labor pricing to maintain relativity with the
recent supply and equipment pricing updates.
Comment: Several commenters stated that CMS is currently
considering more significant future changes to the PE methodology as
explained at a June 16, 2021 Town Hall meeting (further details
available on the CMS website at <a href="https://www.cms.gov/medicare/physician-fee-schedule/practice-expense-data-methods">https://www.cms.gov/medicare/physician-fee-schedule/practice-expense-data-methods</a>). Commenters stated that
given the potential for significant future updates to the data or PE
methodology that could also have major impacts, CMS should postpone the
update to clinical labor pricing until those changes can be analyzed in
combination with other major changes to the PE methodology.
Response: As we noted in the CY 2021 PFS final rule (85 FR 84498
through 84499) and again in this rule, the RAND corporation is
currently studying potential improvements to CMS' PE allocation
methodology and the data that underlie it. We are interested in
exploring ways that the PE methodology can be updated; however, we do
not believe that this constitutes a reason to refrain from updating the
clinical labor pricing or delay the implementation of the pricing
update. We will employ a 4-year transition period for the clinical
labor pricing update in order to provide payment stability and soften
the effects of the pricing update in each calendar year.
Comment: Several commenters stated that the BLS is planning an
update to the estimation methodology for the Occupational Employment
and Wage Statistics (OEWS) survey next year that may impact their wage
data. Commenters stated that although they could not predict the impact
of these modifications, it is possible the revised BLS methodology will
result in important changes to the hourly wage estimates that CMS
proposed to use to update clinical labor pricing. Several commenters
requested delaying the implementation of the clinical labor pricing
update for one year to make use of updated BLS wage data.
Response: We appreciate the feedback from the commenters regarding
ongoing improvements to the BLS methodology for the OEWS. However, we
do not agree that this is a sufficient justification for continuing to
maintain current clinical labor prices for another year. The BLS
routinely updates its wage data and searches for ways to improve the
survey methodology. We also note that the commenters who brought this
issue to our attention stated that they could not predict the impact of
these BLS methodological changes which we believe argues against
delaying the pricing update for another year. We believe that the 2019
wage data from the BLS will certainly be an improvement over the
current 2002 data, and we will continue to review and evaluate future
BLS wage data to consider whether it would be appropriate to propose to
incorporate them into the clinical labor pricing update during the
course of the 4-year transition period or otherwise through future
rulemaking.
Comment: One commenter stated that CMS appeared to have used only
the BLS OEWS survey; however, when CMS last updated these data in 2002,
CMS also leveraged the BLS National Compensation Survey (NCS). The
commenter stated that while the OEWS survey can produce estimates at
metropolitan statistical areas (MSAs), the NCS can produce estimates at
the national and census region level. The commenter stated that OEWS
wage estimates represent only wages and salaries and do not include
nonwage
[[Page 65030]]
benefits, such as health insurance, retirement contributions, and
bonuses; whereas NCS data also includes nonwage benefits. The commenter
stated that CMS used the national median wage across all employer types
rather than the wage for physician office employers, and the commenter
believed that CMS should use the physician office setting of care where
possible rather than a median (or average) across all employer types.
Response: We appreciate the feedback from the commenters regarding
additional aspects of the wage data provided by the BLS. We are aware
that OEWS wage estimates represent only wages and salaries and do not
include nonwage benefits, which is why we included a fringe benefits
multiplier in our clinical labor pricing update as discussed above. We
disagree with the commenter that using the physician office setting of
care rather than a median across all employer types would be more
accurate for clinical labor pricing; clinical labor is employed in many
different sites of service, not solely in the physician office setting.
We encourage commenters to submit additional information regarding
clinical labor pricing, especially wage data for individual clinical
labor types, during future rulemaking, especially over the course of
the 4-year transition period for the update to clinical labor pricing.
Comment: Many commenters requested that CMS update pricing data on
a more frequent basis for all inputs so that adjustments will not be as
dramatic. Commenters stated that more frequent updates would prevent
significant redistributive effects to specialties in the future and
help ensure stability in payments. Commenters stated that CMS should
make year-to-year payment stability a goal of the PFS, and large
redistributive impacts on payment should occur infrequently.
Response: We agree with the commenters that the pricing data that
underlie the PE methodology should be updated frequently to ensure its
accuracy. For this reason, we believe that it is important to begin the
transition process of updating the clinical labor pricing for CY 2022.
We agree that more frequent updates to all direct PE inputs, clinical
labor and supplies and equipment, would help to maintain payment
stability across the PFS.
Comment: Several commenters recommended that CMS address the
problems related to high-cost supplies by establishing Healthcare
Common Procedure Coding System (HCPCS) Level II codes for supplies that
exceed $500. Commenters stated that the establishment of individual
coding for high cost supplies would help maintain patient access to
care in the office setting by offsetting the projected decreases in
payment from the clinical labor pricing update.
Response: We did not make any proposals to establish HCPCS Level II
codes for high cost supplies. We have received in previous rulemaking
cycles a number of prior requests from stakeholders, including the RUC,
to implement separately billable alpha-numeric Level II HCPCS codes to
allow practitioners to be paid for high cost disposable supplies per
patient encounter instead of in connection with payment for the CPT
code with which the supplies are furnished. We stated at the time, and
we continue to believe, that this option presents a series of potential
problems that we have addressed previously in the context of the
broader challenges regarding our ability to price high cost disposable
supply items. (For a discussion of this issue, we direct the reader to
our discussion in the CY 2011 PFS final rule with comment period (75 FR
73251)).
Comment: One commenter stated that, as participating practitioners
in the Medicare program, audiologists should not be included in the
proposed clinical labor pricing update. The commenter stated that they
are performing professional services for which they are billing
Medicare independently, and should not be assigned any additional
clinical labor time for their efforts. The commenter stated that this
oversight has created significant rank order anomalies within the
audiology code family as included in the proposed rule. The commenter
identified several CPT codes which they stated contained significant
rank order anomalies and requested again that audiologists be removed
from the labor update pool.
Response: We would like to clarify for the commenter that we are
proposing to update the rates for individual clinical labor types, not
updating the pricing for individual specialties. The statute requires
that valuation under the PFS is to be based on relative resource costs;
as such, we do not believe that an individual clinical labor type could
be priced at one rate when billed by some specialties and at a
different rate when billed by other specialties. If the commenter
believes that certain CPT codes have rank order anomalies in their
valuation, we encourage them to nominate those codes as potentially
misvalued for our additional review; see section II.C of this final
rule (Potentially Misvalued Services under the PFS) for additional
information.
After consideration of the comments detailed above, we are
finalizing our proposal to implement the clinical labor pricing update
through the use of a 4-year transition, with modifications. Rather than
using the proposed BLS fringe benefits multiplier and the BLS mean wage
data, in response to public comments, we will apply the BLS private
industry fringe benefits multiplier for 2019 and use the BLS median
wage data.
We also received a number of comments regarding the pricing of
individual clinical labor types which are summarized along with our
responses below. We note that, given our final policy to use the BLS
median wage data instead of mean as we had proposed, we refer in our
responses below to the median wage data.
Comment: Several commenters stated that they supported the proposal
to use BLS category 19-1040 (Medical Scientist) for the Vascular
Technologist (L054A) clinical labor type. Commenters stated that both
vascular technologists and medical dosimetrists play critical roles in
independently providing clinically accurate, reproducible and high-
quality data for physician decision making. Commenters stated that
although they did not have additional wage data to offer, they believed
that the proposed crosswalk for the L054A clinical labor type is
appropriate in terms of the resulting hourly wage rate and level of
technical skill, physical and mental effort, judgment and stress
relative to other professions utilizing ultrasound.
Response: We appreciate the support from the commenters for our
proposed pricing of the Vascular Technologist (L054A) clinical labor
type.
Comment: One commenter stated that they supported the proposed
pricing of the Mammography Technologist (L043A), CT Technologist
(L046A), and Vascular Technologist (L054A) clinical labor types based
on their individual BLS categories.
Response: We appreciate the support from the commenter for our
proposed clinical labor pricing.
Comment: Several commenters noted that the Angio Technician (L035A)
clinical labor type does not have a direct BLS labor category and CMS
proposed using BLS category 29-9000 (Other Healthcare Practitioners and
Technical Occupations) at $27.20 as the proxy BLS wage rate. Commenters
stated that they believed the Angio Technician was best represented by
an advanced level VI certified Radiologic Technologist or an MR
technologist. Commenters stated that according to the BLS, the median
annual wage for magnetic resonance
[[Page 65031]]
imaging technologists was $74,690 in May 2020, and the median annual
wage for radiologic technologists and technicians was $61,900 in May
2020. Commenters recommended using BLS category 29-2035 Magnetic
Resonance Imaging (MRI) Technologist as the proxy BLS wage rate for the
Angio Technician clinical labor type.
Response: We appreciate the additional information provided by the
commenters concerning the pricing of the Angio Technician (L035A)
clinical labor type. However, we disagree that a Magnetic Resonance
Imaging (MRI) Technologist described under BLS category 29-2035 would
be the most appropriate choice to use in pricing the L035A clinical
labor type. The median hourly wage for a Magnetic Resonance Imaging
(MRI) Technologist under this BLS category is $35.30 while the hourly
wage data for an Angio Technician that we have from Salary Expert is
only $26.81. As such, we disagree that MRI Technologist would be an
appropriate crosswalk for valuation. However, in response to the
additional certification information provided by the commenters for
this occupation, we are modifying our proposed crosswalk. We will
instead crosswalk the Angio Technician to the Lab Tech/
Histotechnologist (L035A) clinical labor type with a median hourly rate
of $26.63 (or an annual rate of $55,390). We believe that this
crosswalk better matches the wage data that we have available from
Salary Expert for Angio Technicians.
Comment: Several commenters stated that CMS updated the RN/OCN
(L056A) clinical labor type in CY 2004, which had been previously
updated in 2002, with survey data provided by the American Society of
Clinical Oncology (ASCO). Commenters noted that the proposed pricing
for the L056A clinical labor type increased by only 11 percent, the
third lowest increase among the 50 clinical labor types proposed in the
update; and the commenters were concerned that the ASCO wage data were
not appropriately captured in the proposed update. Commenters stated
that the RN/OCN clinical labor type, which was proposed at a rate only
3.5 percent higher than the regular RN (L051A) clinical labor type, is
clearly undervalued and should receive an upward adjustment prior to
finalizing the clinical labor pricing update. Commenters urged CMS to
delay implementation of the labor price update until they could work
with the agency to establish an accurate methodology and labor price
inputs for current RN/OCN labor.
Response: We appreciate the additional information provided by the
commenter regarding the historical pricing of the RN/OCN (L056A)
clinical labor type, and we will be happy to consider any wage data
that they can provide. However, we did not receive any additional data
from the commenter to be used in pricing the L056A clinical labor type,
and in the absence of other information on current wage rates, we
believe that our proposed use of BLS category 29-2033 (Nuclear Medicine
Technologists) at $37.48 remains the most appropriate accurate pricing
for L056A. We welcome the submission of additional pricing data for the
RN/OCN clinical labor type in future rulemaking cycles, particularly
over the course of the 4-year transition period.
Comment: One commenter provided recommendations on the pricing of
several clinical labor types, as indicated in the next 13 comment
summaries and responses. The commenter disagreed that BLS category 29-
9098 (Health Information Technologists, Medical Registrars, Surgical
Assistants, and Healthcare Practitioners and Technical Workers, All
Other) at an hourly rate of $28.17 was the correct crosswalk for the
Histotechnologist (L037B) clinical labor type. The commenter stated
that BLS category 29-2010 (Clinical Laboratory Technologists and
Technicians) more accurately describes the clinical staff type
associated with Histotechnologists.
Response: We appreciate the additional information provided by this
commenter concerning the pricing of the Histotechnologist (L037B)
clinical labor type and the others that follow. We reviewed the request
from the commenter and we agree that BLS category 29-2010 is a more
appropriate crosswalk for the L037B clinical labor type, which has an
updated median hourly wage of $25.54. This BLS category is a close
match for the wage data that we have from the Salary Expert reference
information that we discussed above.
Comment: The same commenter disagreed that BLS category 21-1023
(Mental Health and Substance Abuse Social Workers) at an hourly rate of
$24.84 was the correct crosswalk for the Child Life Specialist (L037E)
clinical labor type. The commenter stated that a child life specialist
was described as a professional armed with a strong background in child
development and family systems who promotes effective coping through
play, preparation, education, and self-expression activities--not child
mental health or substance abuse treatment. The commenter stated that
that BLS category 21-1021 (Child, Family, and School Social Workers)
more accurately describes the clinical staff type associated with
Orthoptists.
Response: We reviewed the request from the commenter and we agree
that BLS category 21-1021 is a more appropriate crosswalk for the L037E
clinical labor type, which has an updated median hourly wage of $22.78.
This BLS category is a close match for the wage data that we have from
the Salary Expert reference information that we discussed above.
Comment: The commenter disagreed that BLS category 31-2011
(Occupational Therapy Assistants) at an hourly rate of $29.75 was the
correct crosswalk for the Cardiovascular Technician (L038B) clinical
labor type. The commenter stated that BLS category 29-2031
(Cardiovascular Technologists and Technicians) was a direct crosswalk
for the L038B clinical labor type.
Response: We reviewed the request from the commenter and we agree
that BLS category 29-2031 is a more appropriate crosswalk for the L038B
clinical labor type, which has an updated median hourly wage of $27.75.
This BLS category is a close match for the wage data that we have from
the Salary Expert reference information that we discussed above.
Comment: The commenter disagreed that BLS category 29-1126
(Respiratory Therapists) at an hourly rate of $30.75 was the correct
crosswalk for the Mammography Technologist (L043A) clinical labor type.
The commenter stated that BLS category 29-2034 (Radiologic
Technologists and Technicians) more accurately describes the clinical
staff type associated with Mammography Technologists.
Response: We reviewed the request from the commenter and we agree
that BLS category 29-2034 is a more appropriate crosswalk for the L043A
clinical labor type, which has an updated median hourly wage of $29.09.
This BLS category is a close match for the wage data that we have from
the Salary Expert reference information that we discussed above.
Comment: The commenter disagreed with crosswalking the Certified
Surgical Technician (CST) to BLS category 19-4010 (Agricultural and
Food Science Technicians) at an hourly rate of $21.37 as part of the
blended COMT/COT/RN/CST (L038A) clinical labor type. The commenter
stated that BLS category 29-2055 (Surgical Technologist) was a direct
crosswalk for the L038A clinical labor type.
Response: We believe that there may have been a misunderstanding on
the part of the commenter; we proposed to crosswalk Certified Surgical
[[Page 65032]]
Technicians to BLS category 29-2061, not BLS category 19-4010, at a
median hourly rate of $22.83. There may have been some confusion
regarding the COT and CST clinical labor types in this blend.
Nevertheless, we reviewed the request from the commenter and we agree
that BLS category 29-2055 is a more appropriate crosswalk for the CST
portion of the L038A clinical labor type. This BLS category has a
median hourly rate of $23.22 which was very similar to our previous
pricing of $22.83. After we ran this updated rate for the CST through
the blended methodology for the L038A clinical labor type, the per-
minute pricing (including the fringe benefits multiplier) remained
unchanged at $0.52.
Comment: The commenter disagreed that BLS category 29-2010
(Clinical Laboratory Technologists and Technicians) at an hourly rate
of $26.34 was the correct crosswalk for the Certified Retinal
Angiographer (L039A) clinical labor type. The commenter stated that BLS
category 29-9000 (Other Healthcare Practitioners and Technical
Occupations) or BLS category 29-2057 (Ophthalmic Medical Technician)
more accurately described the clinical staff type associated with
Certified Retinal Angiographers.
Response: We reviewed the request from the commenter and we agree
that BLS category 29-9000 is a more appropriate crosswalk for the L039A
clinical labor type, which has an updated median hourly wage of $23.93.
The other suggested crosswalk to BLS category 29-2057 had a median
hourly wage of $17.76, which did not fit with the data that we had from
Salary Expert for Certified Retinal Angiographers; we believe the
crosswalk to BLS category 29-9000 is a more appropriate choice.
Comment: The commenter disagreed that BLS category 29-1141
(Registered Nurses) at an hourly rate of $37.24 was the correct
crosswalk for the Orthoptist (L037C) clinical labor type. The commenter
stated that that BLS category 29-2057 (Ophthalmic Medical Technician)
more accurately describes the clinical staff type associated with
Orthoptists. The commenter also stated that the L037C clinical labor
type is incorrectly assigned to the CPT code 62304. The commenter
stated that the correct clinical labor type for CPT code 62304 should
be L037D (RN/LPN/MTA), not L037C.
Response: We disagree with the commenter that an Ophthalmic Medical
Technician described under BLS category 29-2057 would be the most
appropriate choice to use in pricing the L037C clinical labor type. The
median hourly wage for an Ophthalmic Medical Technician under this BLS
category is $17.76 while the hourly wage data for an Orthoptist that we
have from Salary Expert is substantially higher at $37.41. We continue
to believe that our crosswalk to BLS category 29-1141 is a more
appropriate choice for valuation. While we appreciate the feedback from
the commenter, we reviewed CPT code 62304 and we did not find any
errors in its clinical labor inputs. We did not propose to change the
clinical labor type for CPT code 62304 and we are not finalizing any
changes to the clinical labor types of this CPT code at this time.
Comment: The commenter disagreed that BLS category 21-1029 (Social
Workers, All Other) at an hourly rate of $29.69 was the correct
crosswalk for the Psychometrist (L039C) clinical labor type. The
commenter stated that BLS category 31-1133 (Psychiatric Aide) more
accurately describes the clinical staff type associated with
Psychometrists.
Response: We disagree with the commenter that a Psychiatric Aide
described under BLS category 31-1133 would be the most appropriate
choice to use in pricing the L039C clinical labor type. The median
hourly wage for a Psychiatric Aide under this BLS category is $14.96
while the hourly wage data for a Psychometrist that we have from Salary
Expert is substantially higher at $29.29. We continue to believe that
our crosswalk to BLS category 21-1029 is a more accurate choice for
valuation.
Comment: The commenter disagreed that BLS category 29-9000 (Other
Healthcare Practitioners and Technical Occupations) at an hourly rate
of $27.22 was the correct crosswalk for the Angio Technician (L041A)
clinical labor type. The commenter stated that BLS category 29-2034
(Radiologic Technologists and Technicians) was the previous BLS
crosswalk used during the 2002 pricing of clinical labor and remains
the correct crosswalk for an angiography technician.
Response: We disagree with the commenter that a Radiologic
Technologist described under BLS category 29-2034 would be the most
appropriate choice to use in pricing the L041A clinical labor type. The
median hourly wage for a Radiologic Technologist under this BLS
category is $29.09 and, as we discussed above, the hourly wage data for
an Angio Technician that we have from Salary Expert is only $26.81. We
are instead crosswalking the Angio Technician to the Lab Tech/
Histotechnologist (L035A) clinical labor type with a median hourly rate
of $26.63 as described above. We believe that this crosswalk better
matches the wage data that we have available from Salary Expert for
Angio Technicians. The previous BLS crosswalk may have been the most
appropriate choice in 2002 but we have data from Salary Expert
suggesting that it is no longer the best option.
Comment: The commenter disagreed that BLS category 29-2035
(Magnetic Resonance Imaging Technologists) at an hourly rate of $35.70
was the correct crosswalk for the Cytotechnologist (L045A) clinical
labor type. The commenter stated that BLS category 29-2010 (Clinical
Laboratory Technologists and Technicians) was the previous BLS
crosswalk used during the 2002 pricing of clinical labor and remains
the correct crosswalk for a cytotechnologist.
Response: We disagree with the commenter that the Clinical
Laboratory Technologists described under BLS category 29-2010 would be
the most accurate choice to use in pricing the L045A clinical labor
type. The median hourly wage for a Clinical Laboratory Technologist
under this BLS category is $25.54 while the hourly wage data for a
Cytotechnologist that we have from Salary Expert is substantially
higher at $36.19. We continue to believe that our proposed crosswalk to
BLS category 29-2035 is a more appropriate choice for valuation. The
previous BLS crosswalk we used in 2002 was based on available
information at that time, but we have data suggesting that it is no
longer the best option.
Comment: The commenter disagreed that BLS category 29-1124
(Radiation Therapists) at an hourly rate of $44.05 was the correct
crosswalk for the Electron Microscopy Technologist (L045B) clinical
labor type. The commenter stated that BLS category 29-2010 (Clinical
Laboratory Technologists and Technicians) more accurately describes the
clinical staff type associated with Electron Microscopy Technologists.
Response: We disagree with the commenter that the Clinical
Laboratory Technologists described under BLS category 29-2010 would be
the most appropriate choice to use in pricing the L045B clinical labor
type. The median hourly wage for a Clinical Laboratory Technologist
under this BLS category is $25.54 while the hourly wage data for an
Electron Microscopy Technologist that we have from Salary Expert is
substantially higher at $44.90. We continue to believe that our
crosswalk to BLS category 29-1124 is a more appropriate choice for
valuation.
Comment: The commenter disagreed that BLS category 19-1040 (Medical
Scientists) at an hourly rate of $46.95 was the correct crosswalk for
the
[[Page 65033]]
Medical Dosimetrist (L063A) clinical labor type. The commenter stated
that BLS category 29-2098 (Medical Dosimetrists, Medical Records
Specialists, and Health Technologists and Technicians, All Other) more
accurately describes the clinical staff type associated with Medical
Dosimetrists.
Response: We disagree with the commenter that the clinical labor
described under BLS category 29-2098 would be the most appropriate
choice to use in pricing the L045B clinical labor type. The median
hourly wage under this BLS category is $20.50 while the hourly wage
data for a Medical Dosimetrist that we have from Salary Expert is
substantially higher at $48.31. We recognize that BLS category 29-2098
includes Medical Dosimetrists in its heading, however this is an
aggregated category that also includes many other miscellaneous types
of technicians. If we were to use this category for pricing Medical
Dosimetrists, the clinical labor type would be priced significantly
lower than its 2002 valuation ($27.67) which we do not believe would be
accurate for this profession, especially in the context of the wage
data that we have from Salary Expert for the profession. We continue to
believe that our crosswalk to BLS category 19-1040 is a more
appropriate choice for valuation.
Comment: The commenter disagreed that the 75th percentile of BLS
category 19-2012 (Physicists) at an hourly rate of $78.95 was the
correct crosswalk for the Medical Physicist (L152A) clinical labor
type. The commenter stated that the rationale to use the 75th
percentile was based on maintaining the historical wage level for
clinical labor type L152A which defeats the purpose of updating
clinical labor rates. The commenter stated that BLS category 19-2012
(Physicist) was the highest of several options and would suffice as a
crosswalk without using the 75th percentile rate.
Response: We disagree with the commenter that the Physicists
described under BLS category 19-2012 would be the most accurate choice
to use in pricing the L152A clinical labor type. The median hourly wage
for a Physicist under this BLS category is $59.06 while the hourly wage
data for a Medical Physicist that we have from Salary Expert is
substantially higher at $66.90. While we also have our reservations
about the use of 75th percentile wage data from the BLS, we continue to
believe that it is a more accurate choice for valuation than BLS
category 19-2012.
Comment: Several commenters stated that the BLS wage data for a
Physicist are not equivalent or representative of a Medical Physicist,
even at the CMS proposed 75th percentile labor rate. Commenters stated
that the sophistication and complexity of radiation therapy technology
has increased exponentially in the past few decades and as radiation
treatments have become more targeted and precise, they have
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