Rule2021-16310
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program; Payment for Complex Rehabilitative Wheelchairs and Related Accessories (Including Seating Systems) and Seat and Back Cushions Furnished in Connection With Such Wheelchairs
Primary source
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Published
August 4, 2021
Effective
October 1, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2022. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2022. This final rule also includes updates for the IRF Quality Reporting Program (QRP). In addition, we are finalizing a Medicare provision adopted in an interim final rule with comment period (IFC) issued on May 11, 2018 related to fee schedule adjustments for wheelchair accessories (including seating systems) and seat and back cushions furnished in connection with group 3 or higher complex rehabilitative power wheelchairs as well as changes to the regulations related to the Further Consolidated Appropriations Act, 2020 governing payment for these and other items.
Full Text
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<title>Federal Register, Volume 86 Issue 147 (Wednesday, August 4, 2021)</title>
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[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Rules and Regulations]
[Pages 42362-42422]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16310]
[[Page 42361]]
Vol. 86
Wednesday,
No. 147
August 4, 2021
Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 414
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment
System for Federal Fiscal Year 2022 and Updates to the IRF Quality
Reporting Program; Payment for Complex Rehabilitative Wheelchairs and
Related Accessories (Including Seating Systems) and Seat and Back
Cushions Furnished in Connection With Such Wheelchairs; Final Rule
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 /
Rules and Regulations
[[Page 42362]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 414
[CMS-1748-F, CMS-1687-IFC, and CMS-1738-F]
RIN 0938-AU38, 0938-AT21, and 0938-AU17
Medicare Program; Inpatient Rehabilitation Facility Prospective
Payment System for Federal Fiscal Year 2022 and Updates to the IRF
Quality Reporting Program; Payment for Complex Rehabilitative
Wheelchairs and Related Accessories (Including Seating Systems) and
Seat and Back Cushions Furnished in Connection With Such Wheelchairs
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This final rule updates the prospective payment rates for
inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY)
2022. As required by statute, this final rule includes the
classification and weighting factors for the IRF prospective payment
system's case-mix groups and a description of the methodologies and
data used in computing the prospective payment rates for FY 2022. This
final rule also includes updates for the IRF Quality Reporting Program
(QRP). In addition, we are finalizing a Medicare provision adopted in
an interim final rule with comment period (IFC) issued on May 11, 2018
related to fee schedule adjustments for wheelchair accessories
(including seating systems) and seat and back cushions furnished in
connection with group 3 or higher complex rehabilitative power
wheelchairs as well as changes to the regulations related to the
Further Consolidated Appropriations Act, 2020 governing payment for
these and other items.
DATES:
Effective date: These regulations are effective on October 1, 2021.
Applicability dates: The updated IRF prospective payment rates are
applicable for IRF discharges occurring on or after October 1, 2021,
and on or before September 30, 2022 (FY 2022).
FOR FURTHER INFORMATION CONTACT:
Gwendolyn Johnson, (410) 786-6954, for general information.
Catie Cooksey, (410) 786-0179, for information about the IRF
payment policies and payment rates.
Kadie Derby, (410) 786-0468, for information about the IRF coverage
policies.
Ariel Adams, (410) 786-8571, for information about the IRF quality
reporting program.
<a href="/cdn-cgi/l/email-protection#dd9990988d928e9dbeb0aef3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="d99d949c89968a99bab4aaf7b1b1aaf7beb6af">[email protected]</span></a> or Alexander Ullman, (410) 786-9671, for issues
related to the DMEPOS payment policy.
SUPPLEMENTARY INFORMATION:
Availability of Certain Information Through the Internet on the CMS
Website
The IRF prospective payment system (IRF PPS) Addenda along with
other supporting documents and tables referenced in this final rule are
available through the internet on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS</a>.
We note that prior to 2020, each rule or notice issued under the
IRF PPS has included a detailed reiteration of the various regulatory
provisions that have affected the IRF PPS over the years. That
discussion, along with detailed background information for various
other aspects of the IRF PPS, is now available on the CMS website at
<a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS</a>.
I. Executive Summary
A. Purpose
This final rule updates the prospective payment rates for IRFs for
FY 2022 (that is, for discharges occurring on or after October 1, 2021,
and on or before September 30, 2022) as required under section
1886(j)(3)(C) of the Social Security Act (the Act). As required by
section 1886(j)(5) of the Act, this final rule includes the
classification and weighting factors for the IRF PPS's case-mix groups
(CMGs) and a description of the methodologies and data used in
computing the prospective payment rates for FY 2022. This final rule
adds one new measure to the IRF QRP and modifies the denominator for
another measure currently under the IRF QRP beginning with the FY 2023
IRF QRP. In addition, this final rule modifies the number of quarters
used for publicly reporting certain IRF QRP measures due to the public
health emergency (PHE). In this final rule, we summarize comments we
sought on the use of Health Level Seven International (HL7[supreg])
Fast Healthcare Interoperability Resources[supreg] (FHIR)-based
standards in post-acute care, specifically the IRF QRP, and on our
continued efforts to close the health equity gap. This final rule also
finalizes a Medicare provision adopted in an interim final rule with
comment period (IFC) published in the May 11, 2018 Federal Register
entitled ``Medicare Program; Durable Medical Equipment Fee Schedule
Adjustments to Resume the Transitional 50/50 Blended Rates to Provide
Relief in Rural Areas and Non-Contiguous Areas'' (83 FR 21912) that
excludes the fee schedule amounts for wheelchair accessories (including
seating systems) and seat and back cushions furnished in connection
with group 3 or higher complex rehabilitative power wheelchairs from
adjustments based on information from the Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding
Program (CBP). In response to public comments on the IFC published in
the May 11, 2018 Federal Register, we are also finalizing an extension
of this policy to wheelchair accessories (including seating systems)
and seat and back cushions furnished in connection with complex
rehabilitative manual wheelchairs in this final rule. In addition, this
rule finalizes a Medicare provision that was included in the proposed
rule published in the November 4, 2020 Federal Register entitled
``Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics,
and Supplies (DMEPOS) Policy Issues and Level II of the Healthcare
Common Procedure Coding System (HCPCS)'' (85 FR 70358). The provision
implements section 106(a) of division N, title I of the Further
Consolidated Appropriations Act, 2020 (FCAA) (Pub. L. 116-94, December
20, 2019) by modifying a regulatory definition in order to exclude
complex rehabilitative manual wheelchairs and certain other manual
wheelchairs and related accessories when furnished in connection with
these wheelchairs from the DMEPOS CBP.
[[Page 42363]]
B. Summary of Major Provisions
In this final rule, we use the methods described in the FY 2021 IRF
PPS final rule (85 FR 48424) to update the prospective payment rates
for FY 2022 using updated FY 2020 IRF claims and the most recent
available IRF cost report data, which is FY 2019 IRF cost report data.
This final rule updates certain requirements for the IRF QRP. In
addition, this final rule addresses fee schedule adjustments for
wheelchair accessories (including seating systems) and seat and back
cushions furnished in connection with Group 3 or higher complex
rehabilitative power wheelchairs and complex rehabilitative manual
wheelchairs. This final rule also revises the definition of ``item''
under the DMEPOS CBP at 42 CFR 414.402 to exclude complex
rehabilitative manual wheelchairs and certain other manual wheelchairs
and related accessories from the DMEPOS CBP, as required by section
106(a) of the FCAA.
C. Summary of Impact
[GRAPHIC] [TIFF OMITTED] TR04AU21.192
II. Background
A. Statutory Basis and Scope for IRF PPS Provisions
Section 1886(j) of the Act provides for the implementation of a
per-discharge PPS for inpatient rehabilitation hospitals and inpatient
rehabilitation units of a hospital (collectively, hereinafter referred
to as IRFs). Payments under the IRF PPS encompass inpatient operating
and capital costs of furnishing covered rehabilitation services (that
is, routine, ancillary, and capital costs), but not direct graduate
medical education costs, costs of approved nursing and allied health
education activities, bad debts, and other services or items outside
the scope of the IRF PPS. A complete discussion of the IRF PPS
provisions appears in the original FY 2002 IRF PPS final rule (66 FR
41316) and the FY 2006 IRF PPS final rule (70 FR 47880) and we provided
a general description of the IRF PPS for FYs 2007 through 2019 in the
FY 2020 IRF PPS final rule (84 FR 39055 through 39057).
Under the IRF PPS from FY 2002 through FY 2005, the prospective
payment rates were computed across 100 distinct CMGs, as described in
the FY 2002 IRF PPS final rule (66 FR 41316). We constructed 95 CMGs
using rehabilitation impairment categories (RICs), functional status
(both motor and cognitive), and age (in some cases, cognitive status
and age may not be a factor in defining a CMG). In addition, we
constructed five special CMGs to account for very short stays and for
patients who expire in the IRF.
For each of the CMGs, we developed relative weighting factors to
account for a patient's clinical characteristics and expected resource
needs. Thus, the weighting factors accounted for the relative
difference in resource use across all CMGs. Within each CMG, we created
tiers based on the estimated effects that certain comorbidities would
have on resource use.
We established the Federal PPS rates using a standardized payment
conversion factor (formerly referred to as the budget-neutral
conversion factor). For a detailed discussion of the budget-neutral
conversion factor, please refer to our FY 2004 IRF PPS final rule (68
FR 45684 through 45685). In the FY 2006 IRF PPS final rule (70 FR
47880), we discussed in detail the methodology for determining the
standard payment conversion factor.
We applied the relative weighting factors to the standard payment
conversion factor to compute the unadjusted prospective payment rates
under the IRF PPS from FYs 2002 through 2005. Within the structure of
the payment system, we then made adjustments to account for interrupted
stays, transfers, short stays, and deaths. Finally, we applied the
applicable adjustments to account for geographic variations in wages
(wage index), the percentage of low-income patients, location in a
rural area (if applicable), and outlier payments (if applicable) to the
IRFs' unadjusted prospective payment rates.
For cost reporting periods that began on or after January 1, 2002,
and before October 1, 2002, we determined the final prospective payment
amounts using the transition methodology prescribed in section
1886(j)(1) of the Act. Under this provision, IRFs transitioning into
the PPS were paid a blend of the Federal IRF PPS rate and the payment
that the IRFs would have received had the IRF PPS not been implemented.
This provision also allowed IRFs to elect to bypass this blended
payment and immediately be paid 100 percent of the Federal IRF PPS
rate. The transition methodology expired as of cost reporting periods
beginning on or after October 1, 2002 (FY 2003), and payments for all
IRFs now consist of 100 percent of the Federal IRF PPS rate.
Section 1886(j) of the Act confers broad statutory authority upon
the Secretary to propose refinements to the IRF PPS. In the FY 2006 IRF
PPS final rule (70 FR 47880) and in correcting amendments to the FY
2006 IRF PPS final rule (70 FR 57166), we finalized a number of
refinements to the IRF PPS case-mix classification system (the CMGs and
the corresponding relative weights) and the case-level and facility-
level adjustments. These refinements included the adoption of the
Office of Management and Budget's (OMB's) Core-Based Statistical Area
(CBSA) market definitions; modifications to the CMGs, tier
comorbidities; and CMG relative weights, implementation of a new
teaching status adjustment for IRFs; rebasing and revising the market
basket
[[Page 42364]]
index used to update IRF payments, and updates to the rural, low-income
percentage (LIP), and high-cost outlier adjustments. Beginning with the
FY 2006 IRF PPS final rule (70 FR 47908 through 47917), the market
basket index used to update IRF payments was a market basket reflecting
the operating and capital cost structures for freestanding IRFs,
freestanding inpatient psychiatric facilities (IPFs), and long-term
care hospitals (LTCHs) (hereinafter referred to as the rehabilitation,
psychiatric, and long-term care (RPL) market basket). Any reference to
the FY 2006 IRF PPS final rule in this final rule also includes the
provisions effective in the correcting amendments. For a detailed
discussion of the final key policy changes for FY 2006, please refer to
the FY 2006 IRF PPS final rule.
The regulatory history previously included in each rule or notice
issued under the IRF PPS, including a general description of the IRF
PPS for FYs 2007 through 2020, is available on the CMS website at
<a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS</a>.
In late 2019,\1\ the United States began responding to an outbreak
of a virus named ``SARS-CoV-2'' and the disease it causes, which is
named ``coronavirus disease 2019'' (abbreviated ``COVID-19''). Due to
our prioritizing efforts in support of containing and combatting the
PHE for COVID-19, and devoting significant resources to that end, we
published two interim final rules with comment period affecting IRF
payment and conditions for participation. The interim final rule with
comment period (IFC) entitled, ``Medicare and Medicaid Programs; Policy
and Regulatory Revisions in Response to the COVID-19 Public Health
Emergency'', published on April 6, 2020 (85 FR 19230) (hereinafter
referred to as the April 6, 2020 IFC), included certain changes to the
IRF PPS medical supervision requirements at 42 CFR 412.622(a)(3)(iv)
and 412.29(e) during the PHE for COVID-19. In addition, in the April 6,
2020 IFC, we removed the post-admission physician evaluation
requirement at Sec. 412.622(a)(4)(ii) for all IRFs during the PHE for
COVID-19. In the FY 2021 IRF PPS final rule, to ease documentation and
administrative burden, we also removed the post-admission physician
evaluation documentation requirement at 42 CFR 412.622(a)(4)(ii)
permanently beginning in FY 2021.
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\1\ Patel A, Jernigan DB. Initial Public Health Response and
Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak--
United States, December 31, 2019--February 4, 2020. MMWR Morb Mortal
Wkly Rep 2020;69:140-146. DOI <a href="http://dx.doi.org/10.15585/mmwr.mm6905e1">http://dx.doi.org/10.15585/mmwr.mm6905e1</a>.
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A second IFC entitled, ``Medicare and Medicaid Programs, Basic
Health Program, and Exchanges; Additional Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency and Delay
of Certain Reporting Requirements for the Skilled Nursing Facility
Quality Reporting Program'' was published on May 8, 2020 (85 FR 27550)
(hereinafter referred to as the May 8, 2020 IFC). Among other changes,
the May 8, 2020 IFC included a waiver of the ``3-hour rule'' at Sec.
412.622(a)(3)(ii) to reflect the waiver required by section 3711(a) of
the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
(Pub. L. 116-136, enacted on March 27, 2020). In the May 8, 2020 IFC,
we also modified certain IRF coverage and classification requirements
for freestanding IRF hospitals to relieve acute care hospital capacity
concerns in states (or regions, as applicable) that are experiencing a
surge during the PHE for COVID-19. In addition to the policies adopted
in our IFCs, we responded to the PHE with numerous blanket waivers \2\
and other flexibilities,\3\ some of which are applicable to the IRF
PPS.
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\2\ CMS, ``COVID-19 Emergency Declaration Blanket Waivers for
Health Care Providers,'' (updated Feb. 19 2021) (available at
<a href="https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf">https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf</a>).
\3\ CMS, ``COVID-19 Frequently Asked Questions (FAQs) on
Medicare Fee-for-Service (FFS) Billing,'' (updated March 5, 2021)
(available at <a href="https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf">https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf</a>).
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B. Statutory Basis and Scope for DMEPOS Provisions
Section 1847(a) of the Act, as amended by section 302(b)(1) of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(Pub. L. 108-173, December 8, 2003), requires CMS to implement the
Medicare Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Competitive Bidding Program (CBP) for contract award
purposes in order to furnish certain competitively priced DMEPOS items
and services subject to the CBP. Such items and services include:
<bullet> Off-the-shelf (OTS) orthotics, for which payment would
otherwise be made under section 1834(h) of the Act;
<bullet> Enteral nutrients, equipment, and supplies described in
section 1842(s)(2)(D) of the Act; and
<bullet> Certain DME and medical supplies, which are covered items
(as defined in section 1834(a)(13) of the Act) for which payment would
otherwise be made under section 1834(a) of the Act.
Section 1834(a)(1)(F)(ii) of the Act requires the Secretary to use
information on the payment determined under the Medicare DMEPOS CBP to
adjust the fee schedule amounts for DME items and services furnished in
all non-CBAs on or after January 1, 2016. Section 1834(a)(1)(F)(iii) of
the Act requires the Secretary to continue to make these adjustments as
additional covered items are phased in under the CBP or information is
updated as new CBP contracts are awarded.
Section 2 of the Patient Access and Medicare Protection Act of 2015
(Pub. L. 114-115, December 28, 2015) excluded the accessories furnished
in connection with Group 3 complex rehabilitative power wheelchairs
from the fee schedule adjustments under section 1834(a)(1)(F)(ii) of
the Act from January 1 through December 31, 2016. Congress then
extended this exclusion through June 2017 under section 16005 of the
21st Century Cures Act of 2016 (Pub. L. 114-255, December 13, 2016). In
June 2017, we elected to continue this policy through program
instructions, followed by interim final rule in 2018, entitled
``Medicare Program; Durable Medical Equipment Fee Schedule Adjustments
to Resume the Transitional 50/50 Blended Rates to Provide Relief in
Rural Areas and Non-Contiguous Areas'' (83 FR 21912). On April 26,
2021, we announced the continuation of effectiveness of the 2018
interim final rule and the extension of the timeline for publication of
the final rule (86 FR 21949).
Section 106(a) of the FCAA excludes complex rehabilitative manual
wheelchairs and certain other manual wheelchairs and wheelchair
accessories and seat and back cushions when furnished in connection
with these wheelchairs from the DMEPOS CBP. Section 106(b) of the FCAA
excludes these items from fee schedule adjustments based on information
from the DMEPOS CBP through June 30, 2021. We address section
1834(a)(1)(F)(ii) of the Act and payment for these items in this final
rule.
We issued a proposed rule on November 4, 2020 (85 FR 70358) to make
conforming changes to the regulations to reflect section 106(a) of the
FCAA. This rule proposed to revise the definition of ``item'' under the
CBP at 42 CFR 414.402 to exclude complex rehabilitative manual
wheelchairs and certain other manual wheelchairs and related
accessories when furnished in connection with such wheelchairs from the
CBP as required by section 106(a) of the FCAA.
[[Page 42365]]
C. Provisions of the PPACA and the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA) Affecting the IRF PPS in FY 2012
and Beyond
The Patient Protection and Affordable Care Act (PPACA) (Pub. L.
111-148) was enacted on March 23, 2010. The Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152), which amended and revised
several provisions of the PPACA, was enacted on March 30, 2010. In this
final rule, we refer to the two statutes collectively as the ``Patient
Protection and Affordable Care Act'' or ``PPACA''.
The PPACA included several provisions that affect the IRF PPS in
FYs 2012 and beyond. In addition to what was previously discussed,
section 3401(d) of the PPACA also added section 1886(j)(3)(C)(ii)(I) of
the Act (providing for a ``productivity adjustment'' for FY 2012 and
each subsequent FY). The productivity adjustment for FY 2022 is
discussed in section VI.B. of this final rule. Section
1886(j)(3)(C)(ii)(II) of the Act provides that the application of the
productivity adjustment to the market basket update may result in an
update that is less than 0.0 for a FY and in payment rates for a FY
being less than such payment rates for the preceding FY.
Sections 3004(b) of the PPACA and section 411(b) of the MACRA (Pub.
L. 114-10, enacted on April 16, 2015) also addressed the IRF PPS.
Section 3004(b) of PPACA reassigned the previously designated section
1886(j)(7) of the Act to section 1886(j)(8) of the Act and inserted a
new section 1886(j)(7) of the Act, which contains requirements for the
Secretary to establish a QRP for IRFs. Under that program, data must be
submitted in a form and manner and at a time specified by the
Secretary. Beginning in FY 2014, section 1886(j)(7)(A)(i) of the Act
requires the application of a 2 percentage point reduction to the
market basket increase factor otherwise applicable to an IRF (after
application of paragraphs (C)(iii) and (D) of section 1886(j)(3) of the
Act) for a FY if the IRF does not comply with the requirements of the
IRF QRP for that FY. Application of the 2 percentage point reduction
may result in an update that is less than 0.0 for a FY and in payment
rates for a FY being less than such payment rates for the preceding FY.
Reporting-based reductions to the market basket increase factor are not
cumulative; they only apply for the FY involved. Section 411(b) of the
MACRA amended section 1886(j)(3)(C) of the Act by adding paragraph
(iii), which required us to apply for FY 2018, after the application of
section 1886(j)(3)(C)(ii) of the Act, an increase factor of 1.0 percent
to update the IRF prospective payment rates.
D. Operational Overview of the Current IRF PPS
As described in the FY 2002 IRF PPS final rule (66 FR 41316), upon
the admission and discharge of a Medicare Part A fee-for-service (FFS)
patient, the IRF is required to complete the appropriate sections of a
Patient Assessment Instrument (PAI), designated as the IRF-PAI. In
addition, beginning with IRF discharges occurring on or after October
1, 2009, the IRF is also required to complete the appropriate sections
of the IRF-PAI upon the admission and discharge of each Medicare
Advantage (MA) patient, as described in the FY 2010 IRF PPS final rule
(74 FR 39762 and 74 FR 50712). All required data must be electronically
encoded into the IRF-PAI software product. Generally, the software
product includes patient classification programming called the Grouper
software. The Grouper software uses specific IRF-PAI data elements to
classify (or group) patients into distinct CMGs and account for the
existence of any relevant comorbidities.
The Grouper software produces a five-character CMG number. The
first character is an alphabetic character that indicates the
comorbidity tier. The last four characters are numeric characters that
represent the distinct CMG number. A free download of the Grouper
software is available on the CMS website at <a href="http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Software.html">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Software.html</a>. The Grouper software is also embedded in the internet
Quality Improvement and Evaluation System (iQIES) User tool available
in iQIES at <a href="https://www.cms.gov/medicare/quality-safety-oversight-general-information/iqies">https://www.cms.gov/medicare/quality-safety-oversight-general-information/iqies</a>.
Once a Medicare Part A FFS patient is discharged, the IRF submits a
Medicare claim as a Health Insurance Portability and Accountability Act
of 1996 (HIPAA) (Pub. L. 104-191, enacted on August 21, 1996)-compliant
electronic claim or, if the Administrative Simplification Compliance
Act of 2002 (ASCA) (Pub. L. 107-105, enacted on December 27, 2002)
permits, a paper claim (a UB-04 or a CMS-1450 as appropriate) using the
five-character CMG number and sends it to the appropriate Medicare
Administrative Contractor (MAC). In addition, once a MA patient is
discharged, in accordance with the Medicare Claims Processing Manual,
chapter 3, section 20.3 (Pub. L. 100-04), hospitals (including IRFs)
must submit an informational-only bill (type of bill (TOB) 111), which
includes Condition Code 04 to their MAC. This will ensure that the MA
days are included in the hospital's Supplemental Security Income (SSI)
ratio (used in calculating the IRF LIP adjustment) for FY 2007 and
beyond. Claims submitted to Medicare must comply with both ASCA and
HIPAA.
Section 3 of the ASCA amended section 1862(a) of the Act by adding
paragraph (22), which requires the Medicare program, subject to section
1862(h) of the Act, to deny payment under Part A or Part B for any
expenses for items or services for which a claim is submitted other
than in an electronic form specified by the Secretary. Section 1862(h)
of the Act, in turn, provides that the Secretary shall waive such
denial in situations in which there is no method available for the
submission of claims in an electronic form or the entity submitting the
claim is a small provider. In addition, the Secretary also has the
authority to waive such denial in such unusual cases as the Secretary
finds appropriate. For more information, see the ``Medicare Program;
Electronic Submission of Medicare Claims'' final rule (70 FR 71008).
Our instructions for the limited number of Medicare claims submitted on
paper are available at <a href="http://www.cms.gov/manuals/downloads/clm104c25.pdf">http://www.cms.gov/manuals/downloads/clm104c25.pdf</a>.
Section 3 of the ASCA operates in the context of the administrative
simplification provisions of HIPAA, which include, among others, the
requirements for transaction standards and code sets codified in 45 CFR
part 160 and part 162, subparts A and I through R (generally known as
the Transactions Rule). The Transactions Rule requires covered
entities, including covered healthcare providers, to conduct covered
electronic transactions according to the applicable transaction
standards. (See the CMS program claim memoranda at <a href="http://www.cms.gov/ElectronicBillingEDITrans/">http://www.cms.gov/ElectronicBillingEDITrans/</a> and listed in the addenda to the Medicare
Intermediary Manual, Part 3, section 3600).
The MAC processes the claim through its software system. This
software system includes pricing programming called the ``Pricer''
software. The Pricer software uses the CMG number, along with other
specific claim data elements and provider-specific data, to adjust the
IRF's prospective payment for interrupted stays, transfers, short
stays, and deaths, and then applies the applicable adjustments to
account for the IRF's wage index, percentage of low-
[[Page 42366]]
income patients, rural location, and outlier payments. For discharges
occurring on or after October 1, 2005, the IRF PPS payment also
reflects the teaching status adjustment that became effective as of FY
2006, as discussed in the FY 2006 IRF PPS final rule (70 FR 47880).
E. Advancing Health Information Exchange
The Department of Health and Human Services (HHS) has a number of
initiatives designed to encourage and support the adoption of
interoperable health information technology and to promote nationwide
health information exchange to improve health care and patient access
to their health information.
To further interoperability in post-acute care settings, CMS and
Office of the National Coordinator for Health Information Technology
(ONC) participate in the Post-Acute Care Interoperability Workgroup
(PACIO) (<a href="https://pacioproject.org/">https://pacioproject.org/</a>) to facilitate collaboration with
industry stakeholders to develop FHIR standards. These standards could
support the exchange and reuse of patient assessment data derived from
the minimum data set (MDS), inpatient rehabilitation facility patient
assessment instrument (IRF-PAI), long term care hospital continuity
assessment record and evaluation (LCDS), outcome and assessment
information set (OASIS), and other sources. The PACIO Project has
focused on FHIR implementation guides for functional status, cognitive
status and new use cases on advance directives and speech, and language
pathology. We encourage post-acute care (PAC) provider and health IT
vendor participation as these efforts advance.
The CMS Data Element Library (DEL) continues to be updated and
serves as the authoritative resource for PAC assessment data elements
and their associated mappings to health IT standards such as Logical
Observation Identifiers Names and Codes (LOINC) and Systematized
Nomenclature of Medicine Clinical Terms (SNOMED). The DEL furthers CMS'
goal of data standardization and interoperability. When combined with
digital information systems that capture and maintain these coded
elements, their standardized clinical content can reduce provider
burden by supporting exchange of standardized healthcare data;
supporting provider exchange of electronic health information for care
coordination, person-centered care; and supporting real-time, data
driven, clinical decision making. Standards in the Data Element Library
(<a href="https://del.cms.gov/DELWeb/pubHome">https://del.cms.gov/DELWeb/pubHome</a>) can be referenced on the CMS
website and in the ONC Interoperability Standards Advisory (ISA). The
2021 ISA is available at <a href="https://www.healthit.gov/isa">https://www.healthit.gov/isa</a>.
The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted on
December 13, 2016) requires HHS to take new steps to enable the
electronic sharing of health information ensuring interoperability for
providers and settings across the care continuum. The Cures Act
includes a trusted exchange framework and common agreement (TEFCA)
provision \4\ that will enable the nationwide exchange of electronic
health information across health information networks and provide an
important way to enable bi-directional health information exchange in
the future. For more information on current developments related to
TEFCA, we refer readers to <a href="https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement">https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement</a> and
<a href="https://rce.sequoiaproject.org/">https://rce.sequoiaproject.org/</a>.
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\4\ ONC, Draft 2 Trusted Exchange Framework and Common
Agreement, <a href="https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf">https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf</a>.
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The ONC final rule entitled, ``21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program'' final rule (85 FR 25642) published in the May
1, 2020 Federal Register (hereinafter ``ONC Cures Act Final Rule'')
implemented policies related to information blocking required under
section 4003 of the 21st Century Cures Act. Information blocking is
generally defined as a practice by a health IT developer of certified
health IT, health information network, health information exchange, or
health care provider that, except as required by law or specified by
the Secretary of Health and Human Services (HHS) as a reasonable and
necessary activity, is likely to interfere with access, exchange, or
use of electronic health information. The definition of information
blocking includes a knowledge standard, which is different for health
care providers than for health IT developers of certified health IT and
health information networks or health information exchanges. A
healthcare provider must know that the practice is unreasonable as well
as likely to interfere with access, exchange, or use of electronic
health information. To deter information blocking, health IT developers
of certified health IT, health information networks and health
information exchanges whom the HHS Inspector General determines,
following an investigation, have committed information blocking, are
subject to civil monetary penalties of up to $1 million per violation.
Appropriate disincentives for health care providers need to be
established by the Secretary through rulemaking. Stakeholders can learn
more about information blocking at <a href="https://www.healthit.gov/curesrule/final-rule-policy/information-blocking">https://www.healthit.gov/curesrule/final-rule-policy/information-blocking</a>. ONC has posted information
resources including fact sheets (<a href="https://www.healthit.gov/curesrule/resources/fact-sheets">https://www.healthit.gov/curesrule/resources/fact-sheets</a>), frequently asked questions (<a href="https://www.healthit.gov/curesrule/resources/information-blocking-faqs">https://www.healthit.gov/curesrule/resources/information-blocking-faqs</a>), and
recorded webinars (<a href="https://www.healthit.gov/curesrule/resources/webinars">https://www.healthit.gov/curesrule/resources/webinars</a>).
We invited providers to learn more about these important
developments and how they are likely to affect IRFs.
III. Summary of Provisions of the Proposed Rule
In the FY 2022 IRF PPS proposed rule, we proposed to update the IRF
PPS for FY 2022 and the IRF QRP for FYs 2022 and 2023.
The proposed policy changes and updates to the IRF prospective
payment rates for FY 2022 are as follows:
<bullet> Update the CMG relative weights and average length of stay
values for FY 2022, in a budget neutral manner, as discussed in section
IV. of the FY 2022 IRF PPS proposed rule (86 FR 19086, 19090 through
19095).
<bullet> Update the IRF PPS payment rates for FY 2022 by the market
basket increase factor, based upon the most current data available,
with a productivity adjustment required by section 1886(j)(3)(C)(ii)(I)
of the Act, as described in section V. of the FY 2022 IRF PPS proposed
rule (86 FR 19086, 19095 through 19096).
<bullet> Update the FY 2022 IRF PPS payment rates by the FY 2022
wage index and the labor-related share in a budget-neutral manner, as
discussed in section V. of the FY 2022 IRF PPS proposed rule (86 FR
19086, 19096 through 19098).
<bullet> Describe the calculation of the IRF standard payment
conversion factor for FY 2022, as discussed in section V. of the FY
2022 IRF PPS proposed rule (86 FR 19086, 19098 through 19099).
<bullet> Update the outlier threshold amount for FY 2022, as
discussed in section VI. of the FY 2022 IRF PPS proposed rule (86 FR
19086, 19102 through 19103).
<bullet> Update the cost-to-charge ratio (CCR) ceiling and urban/
rural average CCRs for FY 2022, as discussed in
[[Page 42367]]
section VI. of the FY 2022 IRF PPS proposed rule (86 FR 19086, 19103).
We also proposed policy changes and updates to the IRF QRP for FYs
2022 and 2023 as follows:
<bullet> Updates to quality measures and reporting requirements
under the IRF QRP, as well as requests for information discussed in
section VII. of the FY 2022 IRF PPS proposed rule (86 FR 19086, 19103
through 19116).
In a separate 2018 interim final rule with comment period (IFC),
entitled ``Medicare Program; Durable Medical Equipment Fee Schedule
Adjustments To Resume the Transitional 50/50 Blended Rates To Provide
Relief in Rural Areas and Non-Contiguous Areas'' (hereinafter 2018
interim final rule), we:
<bullet> Excluded accessories furnished in connection with group 3
or higher complex rehabilitative power wheelchairs from fee schedule
adjustments based on payments determined under the DMEPOS CBP (83 FR
21912 through 21925). In a 2021 notice of continuation, we announced
the continuation of effectiveness of the 2018 interim final rule and
the extension of the timeline for publication of the final rule (86 FR
21949).
Finally, in a separate proposed rule published on November 4, 2020,
entitled ``Medicare Program; Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS) Policy Issues and Level II of the
Healthcare Common Procedure Coding System (HCPCS),'' we:
<bullet> Proposed to make changes to the definition of ``item'' at
42 CFR 414.402 to reflect that complex rehabilitative manual
wheelchairs, certain other manual wheelchairs, and accessories
furnished in connection with these wheelchairs are excluded from the
DMEPOS CBP by section 106(a) of the FCAA (85 FR 70405). This is a
conforming change to the regulations to implement section 106(a) of the
FCAA. We are finalizing this change to 42 CFR 414.402 as part of this
final rule.
IV. Analysis of and Responses to Public Comments
A. FY 2022 IRF PPS Proposed Rule
In response to the FY 2022 IRF PPS proposed rule (86 FR 19086), we
received 50 timely responses from the public. We received comments from
various trade associations, inpatient rehabilitation facilities,
individual physicians, therapists, clinicians, health care industry
organizations, and health care consulting firms. The following
sections, arranged by subject area, include a summary of the public
comments that we received, and our responses.
B. 2018 Interim Final Rule
The 2018 interim final rule (83 FR 21912) included changes in fee
schedule adjustments for accessories (including seating systems) and
seat and back cushions furnished in connection with group 3 or higher
complex rehabilitative power wheelchairs. We received 5 timely
responses from wheelchair suppliers, manufacturers, and a patient
advocacy organization related to fee schedule adjustments for
accessories (including seating systems) and seat and back cushions
furnished in connection with complex rehabilitative wheelchairs.
C. DMEPOS/HCPCS Proposed Rule
The November 2020 proposed rule (85 FR 70358) included a provision
to revise the definition of ``item'' under the CBP at 42 CFR 414.402 to
exclude complex rehabilitative manual wheelchairs, certain other manual
wheelchairs and accessories furnished in connection with these
wheelchairs from the DMEPOS CBP. We received 11 timely responses from
wheelchair suppliers, manufacturers, and a national coalition of
consumers and clinicians regarding excluding complex rehabilitative
manual wheelchairs, certain other manual wheelchairs and related
accessories furnished in connection with these wheelchairs from the
CBP.
V. Update to the Case-Mix Group (CMG) Relative Weights and Average
Length of Stay (ALOS) Values for FY 2022
As specified in Sec. 412.620(b)(1), we calculate a relative weight
for each CMG that is proportional to the resources needed by an average
inpatient rehabilitation case in that CMG. For example, cases in a CMG
with a relative weight of 2, on average, will cost twice as much as
cases in a CMG with a relative weight of 1. Relative weights account
for the variance in cost per discharge due to the variance in resource
utilization among the payment groups, and their use helps to ensure
that IRF PPS payments support beneficiary access to care, as well as
provider efficiency.
We proposed to update the CMG relative weights and ALOS values for
FY 2022. Typically, we use the most recent available data to update the
CMG relative weights and average lengths of stay. As such, section
1886(j) of the Act confers broad statutory authority upon the Secretary
to propose refinements to the IRF PPS. For FY 2022, we proposed to use
the FY 2020 IRF claims and FY 2019 IRF cost report data. These data are
the most current and complete data available at this time. Currently,
only a small portion of the FY 2020 IRF cost report data are available
for analysis, but the majority of the FY 2020 IRF claims data are
available for analysis. We also proposed that if more recent data
become available after the publication of the proposed rule and before
the publication of the final rule, we would use such data to determine
the FY 2022 CMG relative weights and ALOS values in the final rule.
We proposed to apply these data using the same methodologies that
we have used to update the CMG relative weights and ALOS values each FY
since we implemented an update to the methodology. The detailed CCR
data from the cost reports of IRF provider units of primary acute care
hospitals is used for this methodology, instead of CCR data from the
associated primary care hospitals, to calculate IRFs' average costs per
case, as discussed in the FY 2009 IRF PPS final rule (73 FR 46372). In
calculating the CMG relative weights, we use a hospital-specific
relative value method to estimate operating (routine and ancillary
services) and capital costs of IRFs. The process to calculate the CMG
relative weights for this final rule is as follows:
Step 1. We estimate the effects that comorbidities have on costs.
Step 2. We adjust the cost of each Medicare discharge (case) to
reflect the effects found in the first step.
Step 3. We use the adjusted costs from the second step to calculate
CMG relative weights, using the hospital-specific relative value
method.
Step 4. We normalize the FY 2022 CMG relative weights to the same
average CMG relative weight from the CMG relative weights implemented
in the FY 2021 IRF PPS final rule (85 FR 48424).
Consistent with the methodology that we have used to update the IRF
classification system in each instance in the past, we proposed to
update the CMG relative weights for FY 2022 in such a way that total
estimated aggregate payments to IRFs for FY 2022 are the same with or
without the changes (that is, in a budget-neutral manner) by applying a
budget neutrality factor to the standard payment amount. We note that,
as we typically do, we updated our data between the FY 2022 IRF PPS
proposed and final rules to ensure that we use the most recent
available data in calculating IRF PPS payments. This updated data
reflects a more complete set of claims for FY 2020 and additional cost
report data for FY 2019. To calculate the appropriate
[[Page 42368]]
budget neutrality factor for use in updating the FY 2022 CMG relative
weights, we use the following steps:
Step 1. Calculate the estimated total amount of IRF PPS payments
for FY 2022 (with no changes to the CMG relative weights).
Step 2. Calculate the estimated total amount of IRF PPS payments
for FY 2022 by applying the changes to the CMG relative weights (as
discussed in this final rule).
Step 3. Divide the amount calculated in step 1 by the amount
calculated in step 2 to determine the budget neutrality factor of
1.0005 that would maintain the same total estimated aggregate payments
in FY 2022 with and without the changes to the CMG relative weights.
Step 4. Apply the budget neutrality factor from step 3 to the FY
2022 IRF PPS standard payment amount after the application of the
budget-neutral wage adjustment factor.
In section VI.E. of this final rule, we discuss the use of the
existing methodology to calculate the standard payment conversion
factor for FY 2022.
In Table 2, ``Relative Weights and Average Length of Stay Values
for Case-Mix Groups,'' we present the CMGs, the comorbidity tiers, the
corresponding relative weights, and the ALOS values for each CMG and
tier for FY 2022. The ALOS for each CMG is used to determine when an
IRF discharge meets the definition of a short-stay transfer, which
results in a per diem case level adjustment.
BILLING CODE 4120-01-P
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Generally, updates to the CMG relative weights result in some
increases and some decreases to the CMG relative weight values. Table 2
shows how we estimate that the application of the revisions for FY 2022
would affect particular CMG relative weight values, which would affect
the overall distribution of payments within CMGs and tiers. We note
that, because we implement the CMG relative weight revisions in a
budget-neutral manner (as previously described), total estimated
aggregate payments to IRFs for FY 2022 are not affected as a result of
the CMG relative weight revisions. However, the revisions affect the
distribution of payments within CMGs and tiers.
[GRAPHIC] [TIFF OMITTED] TR04AU21.197
BILLING CODE 4120-01-C
As shown in Table 3, 97.2 percent of all IRF cases are in CMGs and
tiers that would experience less than a 5 percent change (either
increase or decrease) in the CMG relative weight value as a result of
the revisions for FY 2022. The changes in the ALOS values for FY 2022,
compared with the FY 2021 ALOS values, are small and do not show any
particular trends in IRF length of stay patterns.
The comments we received on our proposed updates to the CMG
relative weights and ALOS values for FY 2022 and our responses are
summarized below.
Comment: Several commenters supported the proposed updates to the
CMG relative weights and ALOS values using the latest available data
(the FY 2020 claims and FY 2019 cost report data). These commenters
noted that applying Functional Independence Measure<SUP>TM</SUP>
(FIM<SUP>TM</SUP>)-based FY 2019 claims data in FY 2022 will not
reflect effects of numerous changes that occurred during the COVID-19
PHE. These changes include enhanced use of personal protective
equipment (PPE), increased staffing costs, COVID-19 testing for staff
and patients, and other infection control protocols, to name just a few
examples. However, the commenters requested more details of the
analysis for determining how the COVID-19-related claims affect the
relative weight and ALOS calculations.
Response: We appreciate the commenters' support for the proposed
updates. The annual updates to the CMG relative weights, which include
both increases and decreases to the CMG relative weights, are intended
to ensure that IRF payments are aligned as closely as possible with the
current costs of care. The relative weights for each of the CMGs and
tiers represent the relative costliness of patients in those CMGs and
tiers compared with patients in other CMGs and tiers. Using FY 2020
claims data does not result in significantly different CMG relative
weight values than the relative weight values obtained using FY 2019
claims data. The relative weight budget neutrality factor would be
1.0005 using FY 2020 claims in comparison to 0.9998 using FY 2019
claims.
Additionally, with regard to providing additional analysis of the
ALOS values, we found that the variation in the ALOS values between FY
2019 and FY 2020 was similar to the year-to-year fluctuations in these
values that we typically see. In addition, we note that a decline in
ALOS values, which the commenter expresses concern about, would
actually have the effect of slightly increasing IRF PPS payments to
providers, as more patients would qualify for full IRF PPS payments
instead of reduced short-stay transfer payments, and the reduced short-
stay transfer payments would be slightly higher (because we divide by
the ALOS values in calculating the short-stay transfer per diem payment
amounts). We note, also, that changes in ALOS values have no effect on
IRF coverage, as these values are not used in determining coverage of
IRF claims. In the IRF PPS, ALOS values are only used in determining
which cases qualify for the short-stay transfer policy. Thus, we
believe that the ALOS values that we are finalizing in this final rule
are appropriate and will not result in any unintended consequences.
As stated in the FY 2022 IRF PPS proposed rule, the FY 2020 claims
data is the most current and complete data available for updating
payments. As most recently discussed in detail in the FY 2021 IRF PPS
final rule (85 FR 48424), we believe that these data
[[Page 42373]]
accurately reflect the severity of the IRF patient population and the
associated costs of caring for these patients in the IRF setting. We
believe using the FY 2020 claims-based calculation reflects as
accurately as possible the current costs of care in IRFs. Therefore, we
believe it is appropriate to use the FY 2020 claims data to update the
CMG relative weights and ALOS values for FY 2022 to ensure the case mix
system is as reflective as possible of recent changes in IRF
utilization and case mix. With regard to the additional request for
further analysis to be provided on the use of FY 2020 claims data, CMS
examined the relative weight values calculated both including and
excluding cases associated with a COVID-19 ICD-10 diagnosis code. This
analysis indicated that for the majority of CMGs relative weight values
would change by less than 1 percent when such COVID cases were removed.
In addition, we do not believe removing COVID-19 related claims from
the analysis provides the best prediction of FY 2022 data because as
most commenters said, we will likely still be seeing evidence of the
PHE in the data for FY 2022.
Comment: Some commenters requested that CMS provide analyses of how
the COVID-19 PHE would affect the IRF PPS payment rates in FY 2022.
Some commenters suggested that, despite the progress being made with
vaccinations and other infection control efforts, IRFs are likely to
continue to treat COVID-19 survivors as well as ``Long COVID'' patients
for the foreseeable future.
Response: We appreciate the commenters' suggestions and will
consider providing additional analyses in future rule updates. However,
we agree with most commenters, that we will be seeing evidence of the
PHE in the data for FY 2022 and beyond. We believe future evaluation
and impact from the PHE will generate a more robust data set for
analysis giving greater insight on IRF impacts as they relate to CMG
relative weights.
Comment: A few commenters stated CMS should evaluate and
incorporate adjustments to the FY 2020 data for any major reductions in
volumes and surgical admissions due to the PHE, which they stated
resulted in a significantly different case mix from a normal year. The
commenters recommended that CMS should use a blended approach (that is,
blending the relative weights obtained using the FY 2019 and FY 2020
data) in determining the relative weight updates, which may mean that a
larger payment increase is warranted.
Response: We appreciate the commenters' suggestions regarding
changes to the methodology used to establish the CMG relative weights
for the IRF PPS payments. We will continue to monitor the CMG relative
weight updates to ensure that they continue to compensate IRFs
appropriately. However, we disagree that a blended approach would
result in the most accurate CMG relative weights, as this blended
approach would not fully reflect the most recent available data (the FY
2020 IRF claims data). We believe the utilization of the FY 2020 claims
data accurately reflects the severity of the IRF patient population and
the associated costs of caring for these patients in the IRF setting.
Comment: One commenter expressed concerns about the underlying
construction of the CMGs, specifically the commenter stated that the
proposed adjustments neither account for newer coding practices nor
provide adequate coverage and payment for severe patients who benefit
from IRF services, thus leading to CMS relative weights and ALOS values
that do not reflect current clinical practice. The commenter expressed
particular concern that CMS proposed to reduce the relative weight
values for patients with a stroke, traumatic brain injury, and
traumatic spinal cord injury. The commenter stated that the proposed
updates would decrease the relative weights for 18 of the 24 stroke
CMGs, 19 of the 20 traumatic brain injury CMGs, and 16 of the 28
traumatic spinal cord injury CMGs.
Response: CMG relative weights are updated in a budget neutral
manner, thus leading to increases in some relative weights and
corresponding decreases in other CMG relative weights. We have
carefully examined all of the decreases and increases in the CMG
relative weights for FY 2022, and we believe that these changes
accurately reflect our best estimates of the relative costs of caring
for different types of patients in the IRF in FY 2022. As the commenter
notes, the relative weights in the stroke, traumatic brain injury, and
traumatic spinal cord injury conditions included both increases and
decreases, and the variation for FY 2022 is similar to the typical
year-to-year variation that we observe. The increases and decreases
also appear to be related to severity, with the increases concentrated
in the CMGs for more severe patients and the decreases concentrated in
the CMGs for less severe patients. We believe that this is appropriate
and reflects the most current and complete information that we have for
estimating the FY 2022 relative costs of care.
Therefore, we believe that these updates more closely align IRF PPS
payments with the costs of caring for different types of patients, and
more closely align the average lengths of stay with the actual lengths
of stay for patients in the various CMGs. As indicated previously, the
magnitude of the updates for FY 2022 is similar to the changes we see
in a typical year.
Regarding the updates to ``new coding practices'', we are not
certain what the commenter means, but if, as we suspect, they may be
referring to the changes in the CMGs and the data used to assign those
CMGs, then our analysis indicates the FY 2020 IRF claims and the FY
2019 IRF cost report data provides the best available data for setting
the CMS relative weights for FY 2022.
After consideration of the comments we received, we are finalizing
our proposal to update the CMG relative weights and ALOS values for FY
2022, as shown in Table 2 of this final rule. These updates are
effective for FY 2022, that is, for discharges occurring on or after
October 1, 2021 and on or before September 30, 2022.
VI. FY 2022 IRF PPS Payment Update
A. Background
Section 1886(j)(3)(C) of the Act requires the Secretary to
establish an increase factor that reflects changes over time in the
prices of an appropriate mix of goods and services for which payment is
made under the IRF PPS. According to section 1886(j)(3)(A)(i) of the
Act, the increase factor shall be used to update the IRF prospective
payment rates for each FY. Section 1886(j)(3)(C)(ii)(I) of the Act
requires the application of the productivity adjustment described in
section 1886(b)(3)(B)(xi)(II) of the Act. Thus, in the FY 2022 IRF PPS
proposed rule, we proposed to update the IRF PPS payments for FY 2022
by a market basket increase factor as required by section 1886(j)(3)(C)
of the Act based upon the most current data available, with a
productivity adjustment as required by section 1886(j)(3)(C)(ii)(I) of
the Act.
We have utilized various market baskets through the years in the
IRF PPS. For a discussion of these market baskets, we refer readers to
the FY 2016 IRF PPS final rule (80 FR 47046).
In FY 2016, we finalized the use of a 2012-based IRF market basket,
using Medicare cost report (MCR) data for both freestanding and
hospital-based IRFs (80 FR 47049 through 47068). Beginning with FY
2020, we finalized a rebased and revised IRF market basket to reflect a
2016 base year. The FY 2020
[[Page 42374]]
IRF PPS final rule (84 FR 39071 through 39086) contains a complete
discussion of the development of the 2016-based IRF market basket.
B. FY 2022 Market Basket Update and Productivity Adjustment
For FY 2022 (that is, beginning October 1, 2021 and ending
September 30, 2022), we proposed to update the IRF PPS payments by a
market basket increase factor as required by section 1886(j)(3)(C) of
the Act, with a productivity adjustment as required by section
1886(j)(3)(C)(ii)(I) of the Act. For FY 2022, we proposed to use the
same methodology described in the FY 2021 IRF PPS final rule (85 FR
48432 through 48433), with one proposed modification to the 2016-based
IRF market basket.
For the price proxy for the For-profit Interest cost category of
the 2016-based IRF market basket, we proposed to use the iBoxx AAA
Corporate Bond Yield index instead of the Moody's AAA Corporate Bond
Yield index. Effective for December 2020, the Moody's AAA Corporate
Bond series is no longer available for use under license to IHS Global
Inc. (IGI), the nationally-recognized economic and financial
forecasting firm with which we contract to forecast the components of
the market baskets and multi-factor productivity (MFP). Since IGI is no
longer licensed to use and publish the Moody's series, IGI was required
to discontinue the publication of the associated historical data and
forecasts of this series. Therefore, IGI constructed a bond yield index
(iBoxx) that closely replicates the Moody's corporate bond yield
indices currently used in the market baskets.
In the FY 2022 IRF PPS proposed rule, we stated that because the
iBoxx AAA Corporate Bond Yield index captures the same technical
concept as the current corporate bond proxy and tracks similarly to the
current measure that is no longer available, we believed that the iBoxx
AAA Corporate Bond Yield index is technically appropriate to use in the
2016-based IRF market basket.
Consistent with historical practice, we proposed to estimate the
market basket update for the IRF PPS for FY 2022 based on IGI's
forecast using more recent available data. Based on IGI's fourth
quarter 2020 forecast with historical data through the third quarter of
2020, the proposed 2016-based IRF market basket increase factor for FY
2022 was projected to be 2.4 percent. We also proposed that if more
recent data became available after the publication of the proposed rule
and before the publication of this final rule (for example, a more
recent estimate of the market basket update or MFP), we would use such
data, if appropriate, to determine the FY 2022 market basket update in
this final rule.
According to section 1886(j)(3)(C)(i) of the Act, the Secretary
shall establish an increase factor based on an appropriate percentage
increase in a market basket of goods and services. Section
1886(j)(3)(C)(ii) of the Act then requires that, after establishing the
increase factor for a FY, the Secretary shall reduce such increase
factor for FY 2012 and each subsequent FY, by the productivity
adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.
Section 1886(b)(3)(B)(xi)(II) of the Act sets forth the definition of
this productivity adjustment. The statute defines the productivity
adjustment to be equal to the 10-year moving average of changes in
annual economy-wide, private nonfarm business MFP (as projected by the
Secretary for the 10-year period ending with the applicable FY, year,
cost reporting period, or other annual period) (the ``productivity
adjustment''). The U.S. Department of Labor's Bureau of Labor
Statistics (BLS) publishes the official measure of private nonfarm
business MFP. Please see <a href="http://www.bls.gov/mfp">http://www.bls.gov/mfp</a> for the BLS historical
published MFP data. A complete description of the MFP projection
methodology is available on the CMS website at <a href="https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/MarketBasketResearch.html">https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/MarketBasketResearch.html</a>. We note that
effective with FY 2022 and forward, CMS is changing the name of this
adjustment to refer to it as the productivity adjustment rather than
the MFP adjustment. We note that this is not a change in policy as the
methodology for deriving the adjustment relies on the same underlying
data and methodology. This change in terminology results in a title
more consistent with the statutory language described in section
1886(j)(3)(C)(ii) of the Act.
Using IGI's fourth quarter 2020 forecast, the 10-year moving
average growth of MFP for FY 2022 was projected to be 0.2 percent.
Thus, in accordance with section 1886(j)(3)(C) of the Act, we proposed
to base the FY 2022 market basket update, which is used to determine
the applicable percentage increase for the IRF payments, on IGI's
fourth quarter 2020 forecast of the 2016-based IRF market basket. We
proposed to then reduce this percentage increase by the estimated
productivity adjustment for FY 2022 of 0.2 percentage point (the 10-
year moving average growth of MFP for the period ending FY 2022 based
on IGI's fourth quarter 2020 forecast). Therefore, the proposed FY 2022
IRF update was equal to 2.2 percent (2.4 percent market basket update
reduced by the 0.2 percentage point productivity adjustment).
Furthermore, we proposed that if more recent data became available
after the publication of the proposed rule and before the publication
of this final rule (for example, a more recent estimate of the market
basket and/or MFP), we would use such data, if appropriate, to
determine the FY 2022 market basket update and productivity adjustment
in this final rule.
Based on the more recent data available for this FY 2022 IRF final
rule (that is, IGI's second quarter 2021 forecast of the 2016-based IRF
market basket with historical data through the first quarter of 2021),
we estimate that the IRF FY 2022 market basket update is 2.6 percent.
Based on the more recent data available from IGI's second quarter 2021
forecast, the current estimate of the productivity adjustment for FY
2022 is 0.7 percentage point. Therefore, the current estimate of the FY
2022 IRF increase factor is equal to 1.9 percent (2.6 percent market
basket update reduced by 0.7 percentage point productivity adjustment).
For FY 2022, the Medicare Payment Advisory Commission (MedPAC)
recommends that we reduce IRF PPS payment rates by 5 percent. As
discussed, and in accordance with sections 1886(j)(3)(C) and
1886(j)(3)(D) of the Act, the Secretary proposed to update the IRF PPS
payment rates for FY 2022 by a productivity-adjusted IRF market basket
increase factor of 2.2 percent. Based on more recent data, the current
estimate of the productivity-adjusted IRF market basket increase factor
is 1.9 percent. Section 1886(j)(3)(C) of the Act does not provide the
Secretary with the authority to apply a different update factor to IRF
PPS payment rates for FY 2022.
We invited public comment on our proposals for the FY 2022 market
basket update and productivity adjustment. The following is a summary
of the public comments received on the proposed FY 2022 market basket
update and productivity adjustment and our responses:
Comment: One commenter supported the change to the iBoxx AAA
Corporate Bond Yield index for use in the IRF market basket price proxy
for the For-profit interest cost category in lieu of the Moody's AAA
Corporate Bond Yield Index that is no longer available.
[[Page 42375]]
Response: We appreciate the commenter's support of the use of the
iBoxx AAA Corporate Bond Yield index as the replacement price proxy for
the for-profit interest cost category in the 2016-based IRF market
basket.
Comment: A few commenters noted their appreciation for the proposed
increase in IRF payments as a result of the productivity-adjusted
market basket update. Several commenters supported CMS continuing to
update the market basket and productivity factor using the latest
available data in the IRF PPS final rule.
Response: We appreciate the commenters' support for the use of the
productivity-adjusted market basket to annually update IRF PPS
payments. As proposed, we are using the latest available data to
determine the FY 2022 IRF market basket update and productivity
adjustment.
Comment: Several commenters expressed concern that the impact of
the PHE due to COVID-19 is not factored into the payment rate update.
One commenter stated that the PHE has required and continues to require
IRFs to increase their labor costs through increased use of contract
labor; incurrence of substantial additional paid time off for nurses
and therapists who have contracted COVID-19 or been quarantined due to
potential exposure to this disease; increased operating costs related
to purchases of additional PPE; increases in purchases of other supply
costs; and increased costs of cleaning supplies, among other cost
increases. The commenters also stated that while many of these new or
increased costs will likely extend into FY 2022, the current market
basket update factors do not have these costs embedded into the
underlying payment rate update. Commenters encouraged CMS to consider
these factors and embed an additional update to account for this added
cost to IRFs. Another commenter stated that while they appreciate the
modest increase to the IRF payment rate, they believe it is
insufficient to offset the negative financial impact of cost inflation
and the COVID-19 pandemic and encouraged CMS to consider additional
funding opportunities in the final rule. One commenter requested that
CMS measure the impacts of COVID-19 and include them in the analysis
for the final IRF rule.
Response: For this final rule, we have incorporated more recent
historical data and forecasts provided by IGI to capture the price and
wage pressures facing IRFs. By incorporating the more recent estimates
available of the market basket update and productivity adjustment, we
believe these data reflect the best available projection of input price
inflation faced by IRFs for FY 2022, adjusted for economy-wide
productivity, which is required by statute.
The current IRF market basket cost weights are based on Medicare
cost report data from 2016. Typically, a market basket is rebased every
4 to 5 years. However, we continually monitor the cost weights in the
market baskets to ensure they are reflecting the mix of inputs used in
providing services. We do not yet have cost report data available to
determine the impact of COVID-19 on IRF cost structures. When complete
Medicare cost report data covering the full impact of the PHE become
available, we plan to review this information for future rulemaking.
Any future rebasing or revising of the IRF market basket will be
proposed and subject to public comments in future rulemaking.
While the update factor for IRFs for FY 2022 use data that reflect
the best available projection of input price inflation faced by IRFs,
we acknowledge the commenters' concern that the rate update may not
reflect certain additional costs incurred during the COVID-19 PHE.
However, we note that Medicare providers, may be eligible for payments
from the Provider Relief Fund (as authorized by Division B, Title VIII
of the CARES Act, Division B, Title I of the Paycheck Protection
Program and Health Care Enhancement Act (Pub. L. 116-139, enacted April
24, 2020), and Division M Title III of the Consolidated Appropriations
Act, 2021 (Pub. L. 116-260, enacted December 27, 2020) or the American
Rescue Plan Act (ARPA) Rural Distribution (as authorized by section
9911 of the American Rescue Plan Act of 2021) (Pub. L. 117-2, enacted
March 11, 2021) to cover health-care related expenses and lost revenues
attributed to COVID-19. The total appropriation for the Provider Relief
Fund is $178 billion. These payments are intended to help healthcare
providers respond to the productivity losses and extra expenses caused
by the PHE.
IRFs are eligible to apply for reimbursement for providing COVID-19
testing, treatment, or vaccine administration to uninsured people.
These payments are available from the COVID-19 Claims Reimbursement to
Health Care Providers and Facilities for Testing, Treatment and Vaccine
Administration for the Uninsured Program (additional information about
the Uninsured Program can be found at <a href="https://www.hrsa.gov/coviduninsuredclaim">https://www.hrsa.gov/coviduninsuredclaim</a>). IRFs are also eligible to apply to the HRSA
COVID-19 Coverage Assistance Fund (CAF) for reimbursement for
administering COVID-19 vaccines to underinsured individuals, defined as
those whose health plan either does not cover vaccines, or covers them
with patient cost-sharing (additional information about the CAF can be
found at <a href="https://www.hrsa.gov/covid19-coverage-assistance">https://www.hrsa.gov/covid19-coverage-assistance</a>.)
In accordance with statutory requirements, the Provider Relief Fund
and ARPA Rural payments may not be used to reimburse expenses or losses
that have been reimbursed from other sources or that other sources are
obligated to reimburse. Likewise, we do not believe that it is
appropriate to account for PHE-related costs in our IRF rate setting to
the extent that such costs were actually reimbursed by the Provider
Relief Fund or may be reimbursed by the ARPA Rural Distribution
program.
Comment: One commenter expressed concerns about the continued
application of the productivity adjustment to IRFs. The commenter also
stated that while it understands that CMS is bound by statute to reduce
the market basket update by a productivity adjustment factor in
accordance with the ACA, it remains concerned that IRFs will not have
the ability to generate additional productivity gains at a pace
matching the productivity of the economy at large on an ongoing,
consistent basis as contemplated by the ACA. The commenter further
stated that recent developments related to the PHE due to COVID-19 have
resulted in further productivity challenges for IRFs and a loss of
productivity efficiencies. The commenter stated that hospitals have
been impacted by the additional costs and administrative processes
associated with the PHE and various guidance and requirements issued by
federal, state, and local health authorities arising as a result of it,
such as--but by no means limited to--screening or testing of all
employees, visitors, and vendors coming through the doors for COVID-19;
revamping housekeeping processes and schedules; increased provision of
in-room therapy; reorienting the patients and employees to new food/
meal service processes, which includes in-room only meals for patients;
the clinical inefficiencies of donning and doffing of PPE; the
quarantining of employees with known or possible detection of COVID-19;
purchasing of in-house COVID-19 testing devices; and the tracking and
reporting of COVID-19 cases, tests, and vaccines administered, among
other reporting requirements. The commenter
[[Page 42376]]
stated that it is not clear when or whether these and other process
changes will end. The commenter further stated that the PHE has caused
disruption to staffing efficiencies, required staff to quarantine, and
required them to alter their treatment patterns to care for COVID-19
positive patients. They noted that the PHE has underscored the concern
that year-over-year productivity gains are unattainable and do not
track with actual IRF operational experience. The commenter requested
CMS monitor the impact that the productivity adjustments will have on
the rehabilitation hospital sector and provide feedback to Congress as
appropriate, and reduce the productivity adjustment.
Response: As the commenter acknowledged, section
1886(j)(3)(C)(ii)(I) of the Act requires the application of a
productivity adjustment to the IRF PPS market basket increase factor.
In response to the commenter's request to reduce the productivity
adjustment, we note that we are required by statute to use an economy-
wide productivity measure to derive this productivity adjustment. The
current projection of the productivity adjustment for FY 2022 is
provided by an independent contractor, IGI, and reflects their recent
expectations regarding the 10-year moving average growth in private
nonfarm business MFP for the period ending FY 2022. As requested by the
commenter, we will continue to monitor the impact of the payment
updates on IRF Medicare payment adequacy as well as beneficiary access
to care.
We also note that the Provider Relief Fund and ARPA Rural
Distribution payments discussed above are intended to help providers,
including IRFs, respond to additional expenses and productivity losses
caused by the PHE. We do not believe that the COVID-19 expenses that
the commenter discusses in any way alter CMS' responsibility to
estimate and apply a multifactor productivity adjustment to the IRF
increase factor, as required by section 1886(j)(3)(C)(ii)(I) of the
Act.
As stated in the FY 2020 IRF PPS final rule (84 FR 39087) and the
FY 2021 IRF PPS final rule (85 FR 48443), we would be interested in
better understanding IRF-specific productivity, including any insights
into available data at the level required to estimate IRF-specific
multi-factor productivity that would allow this analysis.
Comment: Several commenters recommended that CMS continue to
examine productivity factors for health care providers and hospitals
and provide findings to Congress in order to implement a more
appropriate, healthcare specific productivity adjustment. One commenter
recommended that CMS recommend to Congress a more specific productivity
adjustment that would properly reflect the nature of healthcare
services, and in particular, hospital services.
Response: We have estimated hospital-sector multi-factor
productivity and regularly publish updated findings at <a href="https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/Downloads/ProductivityMemo2016.pdf">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/Downloads/ProductivityMemo2016.pdf</a>. As more
recent data become available regarding hospital-sector productivity, we
plan to continue updating these estimates and reporting this
information on our website. In addition, we note that MedPAC annually
monitors various factors for Medicare providers in terms of
profitability and beneficiary access to care and reports the findings
to Congress on an annual basis. In chapter 9 of its March 2021 report
to Congress, MedPAC has recommended that payments to IRF facilities be
reduced because the Commission determined that Medicare's current
payment rates for IRFs appear to be more than adequate. As noted
previously, section 1886(j)(3)(C)(ii)(I) of the Act requires the
application of a productivity adjustment based on the economy-wide
productivity measure to the IRF PPS market basket increase factor.
Comment: MedPAC commented that while it understands that CMS is
required to implement the statutory payment update; it noted that
MedPAC determined that Medicare's current payment rates for IRFs appear
to be more than adequate and recommended that the Congress reduce the
IRF payment rate by 5 percent for FY 2022.
Response: We are required to update IRF PPS payments by the market
basket update adjusted for productivity, as directed by section
1886(j)(3)(C) of the Act. Any change to the productivity adjusted-
market basket update would need to be made through legislation.
Comment: One commenter noted that FY 2021 was the second year in a
row where MedPAC has recommended a decrease in payments and CMS did not
accept the recommendation. The commenter stated that MedPAC's
recommendation was flawed for several reasons. The commenter disagreed
that the metrics utilizing case-mix groups (CMG) payments are site
neutral since one for-profit company alone controls one third of the
U.S. Medicare IRF market, resulting in statistical bias. The commenter
also stated that the proposed rule, with regards to the proposed
increase for payments to IRF providers, should be withdrawn and
reconsidered.
Response: We appreciate the commenter's concern regarding the
payment increase for IRFs; however, we do not have the statutory
authority to implement MedPAC's recommendation. As discussed, and in
accordance with sections 1886(j)(3)(C), the Secretary is updating IRF
PPS payment rates for FY 2022 by an adjusted market basket increase
factor of 1.9 percent, as section 1886(j)(3)(C) of the Act does not
provide the Secretary with the authority to apply a different update
factor to IRF PPS payment rates for FY 2022. The CMGs utilized under
the IRF PPS were implemented in accordance with statute and incorporate
case-level and facility-level adjustments to best align IRF prospective
payments with the expected costs of treating patients in the IRF
setting.
After consideration of the comments we received, we are finalizing
a FY 2022 IRF update equal to 1.9 percent based on the most recent data
available.
C. Labor-Related Share for FY 2022
Section 1886(j)(6) of the Act specifies that the Secretary is to
adjust the proportion (as estimated by the Secretary from time to time)
of IRFs' costs that are attributable to wages and wage-related costs,
of the prospective payment rates computed under section 1886(j)(3) of
the Act, for area differences in wage levels by a factor (established
by the Secretary) reflecting the relative hospital wage level in the
geographic area of the rehabilitation facility compared to the national
average wage level for such facilities. The labor-related share is
determined by identifying the national average proportion of total
costs that are related to, influenced by, or vary with the local labor
market. We proposed to continue to classify a cost category as labor-
related if the costs are labor-intensive and vary with the local labor
market.
Based on our definition of the labor-related share and the cost
categories in the 2016-based IRF market basket, we proposed to
calculate the labor-related share for FY 2022 as the sum of the FY 2022
relative importance of Wages and Salaries, Employee Benefits,
Professional Fees: Labor-related, Administrative and Facilities Support
Services, Installation, Maintenance, and Repair Services, All Other:
Labor-related Services, and a portion of the Capital-Related relative
importance from the 2016-based IRF market basket. For more details
regarding the methodology for determining specific cost categories for
inclusion in the 2016-based IRF labor-
[[Page 42377]]
related share, see the FY 2020 IRF PPS final rule (84 FR 39087 through
39089).
The relative importance reflects the different rates of price
change for these cost categories between the base year (2016) and FY
2022. Based on IGI's fourth quarter 2020 forecast of the 2016-based IRF
market basket, the sum of the FY 2022 relative importance for Wages and
Salaries, Employee Benefits, Professional Fees: Labor-related,
Administrative and Facilities Support Services, Installation
Maintenance & Repair Services, and All Other: Labor-related Services
was 69.0 percent. We proposed that the portion of Capital-Related costs
that are influenced by the local labor market is 46 percent. Since the
relative importance for Capital-Related costs was 8.4 percent of the
2016-based IRF market basket for FY 2022, we proposed to take 46
percent of 8.4 percent to determine the labor-related share of Capital-
Related costs for FY 2022 of 3.9 percent. Therefore, we proposed a
total labor-related share for FY 2022 of 72.9 percent (the sum of 69.0
percent for the labor-related share of operating costs and 3.9 percent
for the labor-related share of Capital-Related costs). We proposed that
if more recent data became available after publication of the proposed
rule and before the publication of this final rule (for example, a more
recent estimate of the labor-related share), we would use such data, if
appropriate, to determine the FY 2022 IRF labor-related share in the
final rule.
Based on IGI's second quarter 2021 forecast of the 2016-based IRF
market basket, the sum of the FY 2022 relative importance for Wages and
Salaries, Employee Benefits, Professional Fees: Labor-related,
Administrative and Facilities Support Services, Installation
Maintenance & Repair Services, and All Other: Labor-related Services is
69.0 percent. Since the relative importance for Capital-Related costs
is 8.4 percent of the 2016-based IRF market basket for FY 2022, we take
46 percent of 8.4 percent to determine the labor-related share of
Capital-Related costs for FY 2022 of 3.9 percent. Therefore, the
current estimate of the total labor-related share for FY 2022 is equal
to 72.9 percent (the sum of 69.0 percent for the labor-related share of
operating costs and 3.9 percent for the labor-related share of Capital-
Related costs).
Table 4 shows the current estimate of the FY 2022 labor-related
share and the FY 2021 final labor-related share using the 2016-based
IRF market basket relative importance.
[GRAPHIC] [TIFF OMITTED] TR04AU21.198
We invited public comment on the proposed labor-related share for
FY 2022.
We did not receive any comments on the proposed revisions to the
labor related share for FY 2022 and, therefore, we are finalizing the
use of the sum of the FY 2022 relative importance for the labor-related
cost categories based on the most recent forecast (IGI's second quarter
2021 forecast) of the 2016-based IRF market basket labor-related share
cost weights, as proposed.
D. Wage Adjustment for FY 2022
1. Background
Section 1886(j)(6) of the Act requires the Secretary to adjust the
proportion of rehabilitation facilities' costs attributable to wages
and wage-related costs (as estimated by the Secretary from time to
time) by a factor (established by the Secretary) reflecting the
relative hospital wage level in the geographic area of the
rehabilitation facility compared to the national average wage level for
those facilities. The Secretary is required to update the IRF PPS wage
index on the basis of information available to the Secretary on the
wages and wage-related costs to furnish rehabilitation services. Any
adjustment or updates made under section 1886(j)(6) of the Act for a FY
are made in a budget-neutral manner.
For FY 2022, we proposed to maintain the policies and methodologies
described in the FY 2021 IRF PPS final rule (85 FR 48435) related to
the labor market area definitions and the wage index methodology for
areas with wage data. Thus, we proposed to use the core based
statistical areas (CBSAs) labor market area definitions and the FY 2022
pre-reclassification and pre-floor hospital wage index data. In
accordance with section 1886(d)(3)(E) of the Act, the FY 2022 pre-
reclassification and pre-floor hospital wage index is based on data
submitted for hospital cost reporting periods beginning on or after
October 1, 2017, and before October 1, 2018 (that is, FY 2018 cost
report data).
The labor market designations made by the OMB include some
geographic areas where there are no hospitals and, thus, no hospital
wage index data on which to base the calculation of the IRF PPS wage
index. We proposed to continue to use the same methodology discussed in
the FY 2008 IRF PPS final rule (72 FR 44299) to address those
geographic areas where there are no hospitals and, thus, no hospital
wage index data on which to base the
[[Page 42378]]
calculation for the FY 2022 IRF PPS wage index.
We invited public comment on our proposals regarding the Wage
Adjustment for FY 2022.
The following is a summary of the public comments received on the
proposed revisions to Wage Adjustment for FY 2022 and our responses:
Comment: Some commenters who were supportive of using the
concurrent year's IPPS wage data requested that CMS adopt other IPPS
wage index methodologies for the IRF PPS, including geographic
reclassification and the imposition of a rural floor.
Response: We appreciate the commenters' support for the continued
use of the concurrent year's IPPS wage data. However, we note that the
IRF PPS does not account for geographic reclassification under sections
1886(d)(8) and (d)(10) of the Act, and does not apply the ``rural
floor'' under section 4410 of the Balanced Budget Act of 1997 (BBA)
(Pub. L. 105-33, enacted August 5, 1997). Furthermore, as we do not
have an IRF-specific wage index, we are unable to determine the degree,
if any, to which a geographic reclassification adjustment or a rural
floor policy under the IRF PPS would be appropriate. The rationale for
our current wage index policies was most recently published in the FY
2021 IRF PPS final rule (85 FR 48435 through 48436) and fully described
in the FY 2006 IRF PPS final rule (70 FR 47880, 47926 through 47928).
Comment: Several commenters requested that we apply a 5 percent
wage index cap to ensure that wage index values do not change by more
than 5 percent from year-to-year to protect IRFs from larger payment
volatility.
Response: We note that certain changes to wage index policy may
significantly affect Medicare payments. These changes may arise from
revisions to the OMB delineations of statistical areas resulting from
the decennial census data, periodic updates to the OMB delineations in
the years between the decennial censuses, or other wage index policy
changes. While we consider how best to address these potential
scenarios in a consistent and thoughtful manner, we reiterate that our
policy principles with regard to the wage index include generally using
the most current data and information available and providing that data
and information, as well as any approaches to addressing any
significant effects on Medicare payments resulting from these potential
scenarios, in notice and comment rulemaking. We also note that any
hospital wage data used to derive the IRF PPS wage index would be
available from the CMS IPPS wage index website for each respective FY,
which can be accessed from <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index</a>.
Comment: Several commenters requested that we provide additional
wage index data that relate to changes for low-wage index areas that
were finalized in the FY 2021 IPPS final rule.
Response: Data pertaining to the FY 2021 IPPS final rule are
available at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index</a>. We do not have any additional data on
this for the IRF PPS.
After considering the comments received, for the reasons discussed
above and in the FY 2022 IRF PPS proposed rule (86 FR 19097), we are
finalizing our proposal to continue to use the updated hospital
inpatient wage data, exclusive of the occupational mix and floor
adjustments, to develop the IRF PPS wage index.
2. Core-Based Statistical Areas (CBSAs) for the FY 2022 IRF Wage Index
a. Background
The wage index used for the IRF PPS is calculated using the pre-
reclassification and pre-floor inpatient PPS (IPPS) wage index data and
is assigned to the IRF on the basis of the labor market area in which
the IRF is geographically located. IRF labor market areas are
delineated based on the CBSAs established by the OMB. The CBSA
delineations (which were implemented for the IRF PPS beginning with FY
2016) are based on revised OMB delineations issued on February 28,
2013, in OMB Bulletin No. 13-01. OMB Bulletin No. 13-01 established
revised delineations for Metropolitan Statistical Areas, Micropolitan
Statistical Areas, and Combined Statistical Areas in the United States
and Puerto Rico based on the 2010 Census, and provided guidance on the
use of the delineations of these statistical areas using standards
published in the June 28, 2010 Federal Register (75 FR 37246 through
37252). We refer readers to the FY 2016 IRF PPS final rule (80 FR 47068
through 47076) for a full discussion of our implementation of the OMB
labor market area delineations beginning with the FY 2016 wage index.
Generally, OMB issues major revisions to statistical areas every 10
years, based on the results of the decennial census. Additionally, OMB
occasionally issues updates and revisions to the statistical areas in
between decennial censuses to reflect the recognition of new areas or
the addition of counties to existing areas. In some instances, these
updates merge formerly separate areas, transfer components of an area
from one area to another, or drop components from an area. On July 15,
2015, OMB issued OMB Bulletin No. 15-01, which provides minor updates
to and supersedes OMB Bulletin No. 13-01 that was issued on February
28, 2013. The attachment to OMB Bulletin No. 15-01 provides detailed
information on the update to statistical areas since February 28, 2013.
The updates provided in OMB Bulletin No. 15-01 are based on the
application of the 2010 Standards for Delineating Metropolitan and
Micropolitan Statistical Areas to Census Bureau population estimates
for July 1, 2012 and July 1, 2013.
In the FY 2018 IRF PPS final rule (82 FR 36250 through 36251), we
adopted the updates set forth in OMB Bulletin No. 15-01 effective
October 1, 2017, beginning with the FY 2018 IRF wage index. For a
complete discussion of the adoption of the updates set forth in OMB
Bulletin No. 15-01, we refer readers to the FY 2018 IRF PPS final rule.
In the FY 2019 IRF PPS final rule (83 FR 38527), we continued to use
the OMB delineations that were adopted beginning with FY 2016 to
calculate the area wage indexes, with updates set forth in OMB Bulletin
No. 15-01 that we adopted beginning with the FY 2018 wage index.
On August 15, 2017, OMB issued OMB Bulletin No. 17-01, which
provided updates to and superseded OMB Bulletin No. 15-01 that was
issued on July 15, 2015. The attachments to OMB Bulletin No. 17-01
provide detailed information on the update to statistical areas since
July 15, 2015, and are based on the application of the 2010 Standards
for Delineating Metropolitan and Micropolitan Statistical Areas to
Census Bureau population estimates for July 1, 2014 and July 1, 2015.
In the FY 2020 IRF PPS final rule (84 FR 39090 through 39091), we
adopted the updates set forth in OMB Bulletin No. 17-01 effective
October 1, 2019, beginning with the FY 2020 IRF wage index.
On April 10, 2018, OMB issued OMB Bulletin No. 18-03, which
superseded the August 15, 2017 OMB Bulletin No. 17-01, and on September
14, 2018, OMB issued OMB Bulletin No. 18-04, which superseded the April
10, 2018 OMB Bulletin No. 18-03. These bulletins established revised
delineations for Metropolitan Statistical Areas, Micropolitan
Statistical Areas, and Combined Statistical Areas, and provided
guidance on the use of the
[[Page 42379]]
delineations of these statistical areas. A copy of this bulletin may be
obtained at <a href="https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf">https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf</a>.
To this end, as discussed in the FY 2021 IRF PPS proposed (85 FR
22075 through 22079) and final (85 FR 48434 through 48440) rules, we
adopted the revised OMB delineations identified in OMB Bulletin No. 18-
04 (available at <a href="https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf">https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf</a>) beginning October 1, 2020, including a 1-year
transition for FY 2021 under which we applied a 5 percent cap on any
decrease in an IRF's wage index compared to its wage index for the
prior fiscal year (FY 2020). The updated OMB delineations more
accurately reflect the contemporary urban and rural nature of areas
across the country, and the use of such delineations allows us to
determine more accurately the appropriate wage index and rate tables to
apply under the IRF PPS.
OMB issued further revised CBSA delineations in OMB Bulletin No.
20-01, on March 6, 2020 (available on the web at <a href="https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf">https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf</a>).
However, we have determined that the changes in OMB Bulletin No. 20-01
do not impact the CBSA-based labor market area delineations adopted in
FY 2021. Therefore, CMS did not propose to adopt the revised OMB
delineations identified in OMB Bulletin No. 20-01 for FY 2022.
4. Wage Adjustment
To calculate the wage-adjusted facility payment for the payment
rates set forth in this final rule, we multiply the unadjusted Federal
payment rate for IRFs by the FY 2022 labor-related share based on the
2016-based IRF market basket relative importance (72.9 percent) to
determine the labor-related portion of the standard payment amount. A
full discussion of the calculation of the labor-related share is
located in section VI.C. of this final rule. We then multiply the
labor-related portion by the applicable IRF wage index. The wage index
tables are available on the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRF-Rules-and-Related-Files.html">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRF-Rules-and-Related-Files.html</a>.
Adjustments or updates to the IRF wage index made under section
1886(j)(6) of the Act must be made in a budget-neutral manner. We
proposed to calculate a budget-neutral wage adjustment factor as
established in the FY 2004 IRF PPS final rule (68 FR 45689), codified
at Sec. 412.624(e)(1), as described in the steps below. We proposed to
use the listed steps to ensure that the FY 2022 IRF standard payment
conversion factor reflects the proposed update to the wage indexes
(based on the FY 2018 hospital cost report data) and the proposed
update to the labor-related share, in a budget-neutral manner:
Step 1. Calculate the total amount of estimated IRF PPS payments
using the labor-related share and the wage indexes from FY 2021 (as
published in the FY 2021 IRF PPS final rule (85 FR 48424)).
Step 2. Calculate the total amount of estimated IRF PPS payments
using the FY 2022 wage index values (based on updated hospital wage
data) and the FY 2022 labor-related share of 72.9 percent.
Step 3. Divide the amount calculated in step 1 by the amount
calculated in step 2. The resulting quotient is the FY 2022 budget-
neutral wage adjustment factor of 1.0032.
Step 4. Apply the budget neutrality factor from step 3 to the FY
2022 IRF PPS standard payment amount after the application of the
increase factor to determine the FY 2022 standard payment conversion
factor.
We discuss the calculation of the standard payment conversion
factor for FY 2022 in section VI.E. of this final rule.
We did not receive any comments on the proposed revisions to the
IRF wage adjustment for FY 2022, and therefore, we are finalizing the
revisions as proposed.
E. Description of the IRF Standard Payment Conversion Factor and
Payment Rates for FY 2022
To calculate the standard payment conversion factor for FY 2022, as
illustrated in Table 5, we begin by applying the increase factor for FY
2022, as adjusted in accordance with sections 1886(j)(3)(C) of the Act,
to the standard payment conversion factor for FY 2021 ($16,856).
Applying the 1.9 percent increase factor for FY 2022 to the standard
payment conversion factor for FY 2021 of $16,856 yields a standard
payment amount of $17,176. Then, we apply the budget neutrality factor
for the FY 2022 wage index, and labor-related share of 1.0032, which
results in a standard payment amount of $17,231. We next apply the
budget neutrality factor for the CMG relative weights of 1.0005, which
results in the standard payment conversion factor of $17,240 for FY
2022.
We invited public comment on the proposed FY 2022 standard payment
conversion factor.
We did not receive any comments on the proposed revisions to the FY
2022 standard payment conversion factor, and therefore, we are
finalizing the revisions as proposed.
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After the application of the CMG relative weights described in
section V. of the proposed rule to the proposed FY 2022 standard
payment conversion factor ($17,240), the resulting unadjusted IRF
prospective payment rates for FY 2022 are shown in Table 6.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
F. Example of the Methodology for Adjusting the Prospective Payment
Rates
Table 7 illustrates the methodology for adjusting the prospective
payments (as described in section VI. of this final rule). The
following examples are based on two hypothetical Medicare
beneficiaries, both classified into CMG 0104 (without comorbidities).
The unadjusted prospective payment rate for CMG 0104 (without
comorbidities) appears in Table 7.
Example: One beneficiary is in Facility A, an IRF located in rural
Spencer County, Indiana, and another beneficiary is in Facility B, an
IRF located in urban Harrison County, Indiana. Facility A, a rural non-
teaching hospital has a Disproportionate Share Hospital (DSH)
percentage of 5 percent (which would result in a LIP adjustment of
1.0156), a wage index of 0.8594, and a rural adjustment of 14.9
percent. Facility B, an urban teaching hospital, has a DSH percentage
of 15 percent (which would result in a LIP adjustment of 1.0454
percent), a wage index of 0.8695, and a teaching status adjustment of
0.0784.
To calculate each IRF's labor and non-labor portion of the
prospective payment, we begin by taking the unadjusted prospective
payment rate for
[[Page 42382]]
CMG 0104 (without comorbidities) from Table 7. Then, we multiply the
labor-related share for FY 2022 (72.9 percent) described in section
VI.C. of this final rule by the unadjusted prospective payment rate. To
determine the non-labor portion of the prospective payment rate, we
subtract the labor portion of the Federal payment from the unadjusted
prospective payment.
To compute the wage-adjusted prospective payment, we multiply the
labor portion of the federal payment by the appropriate wage index
located in the applicable wage index table. This table is available on
the CMS website at <a href="https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRF-Rules-and-Related-Files.html">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRF-Rules-and-Related-Files.html</a>.
The resulting figure is the wage-adjusted labor amount. Next, we
compute the wage-adjusted Federal payment by adding the wage-adjusted
labor amount to the non-labor portion of the Federal payment.
Adjusting the wage-adjusted Federal payment by the facility-level
adjustments involves several steps. First, we take the wage-adjusted
prospective payment and multiply it by the appropriate rural and LIP
adjustments (if applicable). Second, to determine the appropriate
amount of additional payment for the teaching status adjustment (if
applicable), we multiply the teaching status adjustment (0.0784, in
this example) by the wage-adjusted and rural-adjusted amount (if
applicable). Finally, we add the additional teaching status payments
(if applicable) to the wage, rural, and LIP-adjusted prospective
payment rates. Table 7 illustrates the components of the adjusted
payment calculation.
[GRAPHIC] [TIFF OMITTED] TR04AU21.202
Thus, the adjusted payment for Facility A would be $28,876.57, and
the adjusted payment for Facility B would be $28,037.56.
VII. Update to Payments for High-Cost Outliers Under the IRF PPS for FY
2022
A. Update to the Outlier Threshold Amount for FY 2022
Section 1886(j)(4) of the Act provides the Secretary with the
authority to make payments in addition to the basic IRF prospective
payments for cases incurring extraordinarily high costs. A case
qualifies for an outlier payment if the estimated cost of the case
exceeds the adjusted outlier threshold. We calculate the adjusted
outlier threshold by adding the IRF PPS payment for the case (that is,
the CMG payment adjusted by all of the relevant facility-level
adjustments) and the adjusted threshold amount (also adjusted by all of
the relevant facility-level adjustments). Then, we calculate the
estimated cost of a case by multiplying the IRF's overall CCR by the
Medicare allowable covered charge. If the estimated cost of the case is
higher than the adjusted outlier threshold, we make an outlier payment
for the case equal to 80 percent of the difference between the
estimated cost of the case and the outlier threshold.
In the FY 2002 IRF PPS final rule (66 FR 41362 through 41363), we
discussed our rationale for setting the outlier threshold amount for
the IRF PPS so that estimated outlier payments would equal 3 percent of
total estimated payments. For the FY 2002 IRF PPS final rule, we
analyzed various outlier policies using 3, 4, and 5 percent of the
total estimated payments, and we concluded that an outlier policy set
at 3 percent of total estimated payments would optimize the extent to
which we could reduce the financial risk to IRFs of caring for high-
cost patients, while still providing for adequate payments for all
other (non-high cost outlier) cases.
Subsequently, we updated the IRF outlier threshold amount in the
FYs 2006 through 2021 IRF PPS final rules and the FY 2011 and FY 2013
notices (70 FR 47880, 71 FR 48354, 72 FR 44284, 73 FR 46370, 74 FR
39762, 75 FR 42836, 76 FR 47836, 76 FR 59256, 77 FR 44618, 78 FR 47860,
79 FR 45872, 80 FR 47036, 81 FR 52056, 82 FR 36238, 83 FR 38514, 84 FR
39054, and 85 FR 48444, respectively) to maintain estimated outlier
payments at 3 percent of total estimated payments. We also stated in
the FY 2009 final rule (73 FR 46370 at 46385) that we would continue to
analyze the estimated outlier payments for subsequent years and adjust
the outlier threshold amount as appropriate to maintain the 3 percent
target.
To update the IRF outlier threshold amount for FY 2022, we proposed
to use FY 2020 claims data and the same methodology that we used to set
the initial outlier threshold amount in the FY 2002 IRF PPS final rule
(66 FR 41316 and 41362 through 41363), which is also the same
methodology that we used to update the outlier threshold amounts for
FYs 2006 through 2021. The outlier
[[Page 42383]]
threshold is calculated by simulating aggregate payments and using an
iterative process to determine a threshold that results in outlier
payments being equal to 3 percent of total payments under the
simulation. To determine the outlier threshold for FY 2022, we
estimated the amount of FY 2022 IRF PPS aggregate and outlier payments
using the most recent claims available (FY 2020) and the proposed FY
2022 standard payment conversion factor, labor-related share, and wage
indexes, incorporating any applicable budget-neutrality adjustment
factors. The outlier threshold is adjusted either up or down in this
simulation until the estimated outlier payments equal 3 percent of the
estimated aggregate payments. Based on an analysis of the preliminary
data used for the proposed rule, we estimated that IRF outlier payments
as a percentage of total estimated payments would be approximately 3.3
percent in FY 2021. Therefore, we proposed to update the outlier
threshold amount from $7,906 for FY 2021 to $9,192 for FY 2022 to
maintain estimated outlier payments at approximately 3 percent of total
estimated aggregate IRF payments for FY 2022.
We note that, as we typically do, we updated our data between the
FY 2022 IRF PPS proposed and final rules to ensure that we use the most
recent available data in calculating IRF PPS payments. This updated
data includes a more complete set of claims for FY 2020. Based on our
analysis using this updated data, we continue to estimate that IRF
outlier payments as a percentage of total estimated payments are
approximately 3.4 percent in FY 2021. Therefore, we will update the
outlier threshold amount from $7,906 for FY 2021 to $9,491 for FY 2022
to account for the increases in IRF PPS payments and estimated costs
and to maintain estimated outlier payments at approximately 3 percent
of total estimated aggregate IRF payments for FY 2022.
The comments received on the proposed update to the FY 2022 outlier
threshold amount to maintain estimated outlier payments at
approximately 3 percent of total estimated IRF payments and our
responses are summarized below.
Comment: Commenters were generally supportive of the update to the
outlier threshold. However, one commenter suggested that CMS consider
policies that would better target outlier payments, such as placing a
10 percent cap on the amount of outlier payments any IRF could receive
or lowering the 3 percent outlier pool. Additionally, another commenter
suggested that any outlier change should be limited to no more than
plus or minus 5 percent in any given year.
Response: We thank the commenters for their support of the update
to the outlier threshold. We continue to believe that maintaining the
outlier pool at 3 percent of aggregate IRF payments optimizes the
extent to which we can reduce financial risk to IRFs of caring for
highest-cost patients, while still providing for adequate payments for
all other nonoutlier cases. However, as we did not propose changes to
this methodology, these comments are outside the scope of this final
rule. We will continue to monitor our IRF outlier policies to ensure
that they continue to compensate IRFs appropriately. We refer readers
to the FY 2002 IRF PPS final rule (66 FR 41316, 41362 through 41363)
for more information regarding the rationale for setting the outlier
threshold amount for the IRF PPS so that estimated outlier payments
would equal 3 percent of total estimated payments.
Comment: One commenter asked CMS to provide further analysis and
expand upon the relationship between COVID-19 related claims in the
outlier calculations so that stakeholders could better understand CMS's
perspective on the continuing impact of public health emergency claims
from both the prior and current fiscal years on FY 2022 payments and
beyond.
Response: We thank the commenter and appreciate the suggestion
regarding further analysis to be conducted on outlier payments and
COVID-19 claim interactions. We examined the relative weight values
calculated both including and excluding cases associated with a COVID-
19 ICD-10 diagnosis code. This analysis indicated that the majority of
the changes in relative weight value would be less than 1 percent when
COVID cases were removed.
Comment: Several commenters expressed concerns that the use of 2020
data in establishing the fixed-loss threshold would result in an
excessively high fixed loss threshold that may be disconnected from the
expected characteristics of patients in FY 2022 as the pandemic
continues to subside. These commenters noted that the net result would
be a substantial underpayment of outliers. The commenters requested
that CMS freeze the fixed-loss threshold amount at the FY 2021 level,
which was based on FY 2019 claims.
Response: We do not believe that freezing the fixed-loss threshold
at the FY 2021 level is appropriate because to do so would fail to
address the fact that we estimate for FY 2021 that we are overpaying by
0.4 percent the established outlier pool of 3 percent for the IRF PPS.
As discussed previously, providers have access to Provider Relief Funds
to assist with COVID-19 related costs, and it is unclear why IRFs would
have incurred higher costs during the pandemic that were not COVID-19
related. We issued several IRF waivers to assist with the COVID-19
pandemic that, if anything, would have significantly lowered the costs
of caring for patients in the IRF setting. Thus, we do not find any
justification for continuing to overpay the established outlier pool of
3 percent.
Further, in FY 2022, we believe that IRFs, as the leader in
rehabilitation services, will be very involved in treating the sequela
of the COVID-19 infection in patients. Also, we believe that many of
the infection control measures, such as personal protective equipment,
private room and isolation protocols, and provision of therapies in a
patient's room rather than a group setting, will continue to be used
throughout IRFs in FY 2022 as new variants of COVID-19 emerge.
Comparing the outlier threshold adjustments in prior years, we
continue to believe that maintaining the outlier pool at 3 percent of
aggregate IRF payments optimizes the extent to which we can reduce
financial risk to IRFs of caring for highest-cost patients, while still
providing for adequate payments for all other non-outlier cases.
We will continue to monitor our IRF outlier policies to ensure that
they continue to compensate IRFs appropriately. If we find any
overpayments or underpayments in IRF outliers, we will continue to
adjust the IRF outlier threshold amount appropriately to maintain IRF
outlier payments at 3 percent of total IRF payments in future
rulemaking cycles.
After consideration of the comments received and taking into
account the most recent available data, we are finalizing the outlier
threshold amount of $9,491 to maintain estimated outlier payments at
approximately 3 percent of total estimated aggregate IRF payments for
FY 2022.
B. Update to the IRF Cost-to-Charge Ratio Ceiling and Urban/Rural
Averages for FY 2022
CCRs are used to adjust charges from Medicare claims to costs and
are computed annually from facility-specific data obtained from MCRs.
IRF specific CCRs are used in the development of the CMG relative
weights and the calculation of outlier payments under the IRF PPS. In
[[Page 42384]]
accordance with the methodology stated in the FY 2004 IRF PPS final
rule (68 FR 45674, 45692 through 45694), we proposed to apply a ceiling
to IRFs' CCRs. Using the methodology described in that final rule, we
proposed to update the national urban and rural CCRs for IRFs, as well
as the national CCR ceiling for FY 2022, based on analysis of the most
recent data available. We apply the national urban and rural CCRs in
the following situations:
<bullet> New IRFs that have not yet submitted their first MCR.
<bullet> IRFs whose overall CCR is in excess of the national CCR
ceiling for FY 2022, as discussed below in this section.
<bullet> Other IRFs for which accurate data to calculate an overall
CCR are not available.
Specifically, for FY 2022, we proposed to estimate a national
average CCR of 0.478 for rural IRFs, which we calculated by taking an
average of the CCRs for all rural IRFs using their most recently
submitted cost report data. Similarly, we proposed to estimate a
national average CCR of 0.393 for urban IRFs, which we calculated by
taking an average of the CCRs for all urban IRFs using their most
recently submitted cost report data. We apply weights to both of these
averages using the IRFs' estimated costs, meaning that the CCRs of IRFs
with higher total costs factor more heavily into the averages than the
CCRs of IRFs with lower total costs. For this final rule, we have used
the most recent available cost report data (FY 2019). This includes all
IRFs whose cost reporting periods begin on or after October 1, 2018,
and before October 1, 2019. If, for any IRF, the FY 2019 cost report
was missing or had an ``as submitted'' status, we used data from a
previous FY's (that is, FY 2004 through FY 2018) settled cost report
for that IRF. We do not use cost report data from before FY 2004 for
any IRF because changes in IRF utilization since FY 2004 resulting from
the 60 percent rule and IRF medical review activities suggest that
these older data do not adequately reflect the current cost of care. We
proposed that if more recent data become available after the
publication of the proposed rule and before the publication of the
final rule, we would use such data to determine the FY 2022 national
average rural and urban CCRs and the national CCR ceiling in the final
rule. Using updated FY 2019 cost report data for this final rule, we
estimate a national average CCR of 0.478 for rural IRFs, and a national
average CCR of 0.394 for urban IRFs.
In accordance with past practice, we proposed to set the national
CCR ceiling at 3 standard deviations above the mean CCR. Using this
method, we proposed a national CCR ceiling of 1.34 for FY 2022. This
means that, if an individual IRF's CCR were to exceed this ceiling of
1.34 for FY 2022, we will replace the IRF's CCR with the appropriate
proposed national average CCR (either rural or urban, depending on the
geographic location of the IRF). We calculated the proposed national
CCR ceiling by:
Step 1. Taking the national average CCR (weighted by each IRF's
total costs, as previously discussed) of all IRFs for which we have
sufficient cost report data (both rural and urban IRFs combined).
Step 2. Estimating the standard deviation of the national average
CCR computed in step 1.
Step 3. Multiplying the standard deviation of the national average
CCR computed in step 2 by a factor of 3 to compute a statistically
significant reliable ceiling.
Step 4. Adding the result from step 3 to the national average CCR
of all IRFs for which we have sufficient cost report data, from step 1.
Using the updated FY 2019 cost report data for this final rule, we
estimate a national average CCR ceiling of 1.35, using the same
methodology.
We invited public comment on the proposed update to the IRF CCR
ceiling and the urban/rural averages for FY 2022.
However, we did not receive any comments on the proposed revisions
to the IRF CCR ceiling and the urban/rural averages for FY 2022, and
therefore, we are finalizing the national average urban CCR at 0.394,
the national average rural CCR at 0.478, and the national average CCR
ceiling at 1.35 for FY 2022.
VIII. Inpatient Rehabilitation Facility (IRF) Quality Reporting Program
(QRP)
A. Background and Statutory Authority
The Inpatient Rehabilitation Facility Quality Reporting Program
(IRF QRP) is authorized by section 1886(j)(7) of the Act, and it
applies to freestanding IRFs, as well as inpatient rehabilitation units
of hospitals or Critical Access Hospitals (CAHs) paid by Medicare under
the IRF PPS. Under the IRF QRP, the Secretary must reduce by 2
percentage points the annual increase factor for discharges occurring
during a fiscal year for any IRF that does not submit data in
accordance with the IRF QRP requirements established by the Secretary.
For more information on the background and statutory authority for the
IRF QRP, we refer readers to the FY 2012 IRF PPS final rule (76 FR
47873 through 47874), the CY 2013 Hospital Outpatient Prospective
Payment System/Ambulatory Surgical Center (OPPS/ASC) Payment Systems
and Quality Reporting Programs final rule (77 FR 68500 through 68503),
the FY 2014 IRF PPS final rule (78 FR 47902), the FY 2015 IRF PPS final
rule (79 FR 45908), the FY 2016 IRF PPS final rule (80 FR 47080 through
47083), the FY 2017 IRF PPS final rule (81 FR 52080 through 52081), the
FY 2018 IRF PPS final rule (82 FR 36269 through 36270), the FY 2019 IRF
PPS final rule (83 FR 38555 through 38556), and the FY 2020 IRF PPS
final rule (84 FR 39054 through 39165).
B. General Considerations Used for the Selection of Measures for the
IRF QRP
For a detailed discussion of the considerations we use for the
selection of IRF QRP quality, resource use, or other measures, we refer
readers to the FY 2016 IRF PPS final rule (80 FR 47083 through 47084).
1. Quality Measures Currently Adopted for the FY 2022 IRF QRP
The IRF QRP currently has 17 measures for the FY 2022 program year,
which are set out in Table 8.
[[Page 42385]]
[GRAPHIC] [TIFF OMITTED] TR04AU21.203
C. IRF QRP Quality Measures Beginning With the FY 2023 IRF QRP
Section 1899B(h)(1) of the Act permits the Secretary to remove,
suspend, or add quality measures or resource use or other measures
described in sections 1899B(c)(1) and section 1899B(d)(1) of the Act
respectively, so long as the Secretary publishes in the Federal
Register (with a notice and comment period) a justification for such
removal, suspension, or addition. We proposed to adopt one new measure:
The COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) \5\
measure as an ``other'' measure under the resource use or other measure
domain under section 1899B(d)(1) of the Act beginning with the FY 2023
IRF QRP. In accordance with section 1899B(a)(1)(B) of the Act, the data
used to calculate this measure is standardized and interoperable. The
proposed measure supports the Meaningful Measures domain of Promote
Effective Prevention and Treatment of Chronic Disease. CMS identified
the measure's concept as a priority in response to the current public
health crisis. This process measure was developed with the Centers for
Disease Control and Prevention (CDC) to track COVID-19 vaccination
Coverage among HCP in the IRF setting. This measure is described in
more detail below.
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\5\ The measure steward changed the name of the measure from
SARS-CoV-2 Vaccination Coverage among Healthcare Personnel to COVID-
19 Vaccination Coverage among Healthcare Personnel. There were no
changes to the measure itself, other than the name change.
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In addition, we proposed to update the denominator for one measure,
the Transfer of Health (TOH) Information to the Patient-Post-Acute Care
(PAC) measure to exclude patients discharged home under the care of an
organized home health service or hospice.
1. COVID-19 Vaccination Coverage Among Healthcare Personnel (HCP)
Measure Beginning With the FY 2023 IRF QRP
a. Background
On January 31, 2020, the Secretary of the U.S. Department Health
and Human Services declared a public health emergency (PHE) for the
United States in response to the global outbreak of
[[Page 42386]]
SARS-CoV-2, a novel (new) coronavirus that causes a disease named
``coronavirus disease 2019'' (COVID-19).\6\ COVID-19 is a contagious
respiratory infection \7\ that can cause serious illness and death.
Older individuals, racial and ethnic minorities, and those with
underlying medical conditions are considered to be at higher risk for
more serious complications from COVID-19.<SUP>8 9</SUP> As stated in
the proposed rule, as of March 31, 2021, the U.S. reported over 30
million cases of COVID-19 and over 548,000 COVID-19 deaths.\10\
Hospitals and health systems saw significant surges of COVID-19
patients as community infection levels increased.\11\ In December 2020
and January 2021, media outlets reported that more than 100,000
Americans were in the hospital with COVID-19.\12\ As of July 21, 2021,
the U.S. has reported over 33 million cases of COVID-19 and over
600,000 COVID-19 deaths.\13\
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\6\ U.S. Dept. of Health and Human Services, Office of the
Assistant Secretary for Preparedness and Response. (2020).
Determination that a Public Health Emergency Exists. Available at
<a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx</a>.
\7\ Centers for Disease Control and Prevention. (2020). Your
Health: Symptoms of Coronavirus. Available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html">https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html</a>.
\8\ Centers for Disease Control and Prevention. (2020). Your
Health: Symptoms of Coronavirus. Available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html">https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html</a>.
\9\ Centers for Disease Control and Prevention (2021). Health
Equity Considerations and Racial and Ethnic Minority Groups.
Available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html">https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html</a>.
\10\ Centers for Disease Control and Prevention. (2020). CDC
COVID Data Tracker. Available at <a href="https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days">https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days</a>.
\11\ Associated Press. Tired to the Bone. Hospitals Overwhelmed
with Virus Cases. November 18, 2020. Accessed on December 16, 2020,
at <a href="https://apnews.com/article/hospitals-overwhelmed-coronavirus-cases-74a1f0dc3634917a5dc13408455cd895">https://apnews.com/article/hospitals-overwhelmed-coronavirus-cases-74a1f0dc3634917a5dc13408455cd895</a>. Also see: New York Times.
Just how full are U.S. intensive care units? New data paints an
alarming picture. November 18, 2020. Accessed on December 16, 2020,
at <a href="https://www.nytimes.com/2020/12/09/world/just-how-full-are-us-intensive-care-units-new-data-paints-an-alarming-picture.html">https://www.nytimes.com/2020/12/09/world/just-how-full-are-us-intensive-care-units-new-data-paints-an-alarming-picture.html</a>.
\12\ NPR. U.S. Hits 100,000 COVID-19 Hospitalizations, Breaks
Daily Death Record. Dec. 2, 2020. Accessed on December 17, 2020 at
<a href="https://www.npr.org/sections/coronavirus-live-updates/2020/12/02/941902471/u-s-hits-100-000-covid-19-hospitalizations-breaks-daily-death-record">https://www.npr.org/sections/coronavirus-live-updates/2020/12/02/941902471/u-s-hits-100-000-covid-19-hospitalizations-breaks-daily-death-record</a>; The Wall Street Journal. Coronavirus Live Updates:
U.S. Hospitalizations, Newly Reported Cases, Deaths Edge Downward.
Accessed on January 11 at <a href="https://www.wsj.com/livecoverage/covid-2021-01-11">https://www.wsj.com/livecoverage/covid-2021-01-11</a>.
\13\ Centers for Disease Control and Prevention. (2020). CDC
COVID Data Tracker. Available at <a href="https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days">https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days</a>.
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Evidence indicates that COVID-19 primarily spreads when individuals
are in close contact with one another.\14\ The virus is typically
transmitted through respiratory droplets or small particles created
when someone who is infected with the virus coughs, sneezes, sings,
talks or breathes.\15\ Experts believe that COVID-19 spreads less
commonly through contact with a contaminated surface.\16\
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\14\ Centers for Disease Control and Prevention. (2021). COVID-
19. Your Health. Frequently Asked Questions. Accessed on January 11,
2021 at <a href="https://www.cdc.gov/coronavirus/2019-ncov/faq.html">https://www.cdc.gov/coronavirus/2019-ncov/faq.html</a>.
\15\ Centers for Disease Control and Prevention (2021). COVID-
19. Your Health. Frequently Asked Questions. Accessed on January 11,
2021 at <a href="https://www.cdc.gov/coronavirus/2019-ncov/faq.html">https://www.cdc.gov/coronavirus/2019-ncov/faq.html</a>.
\16\ Centers for Disease Control and Prevention (2021). COVID-
19. Your Health. Frequently Asked Questions. Accessed on January 11,
2021 at <a href="https://www.cdc.gov/coronavirus/2019-ncov/faq.html">https://www.cdc.gov/coronavirus/2019-ncov/faq.html</a>.
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According to the CDC, those at greatest risk of infection are
persons who have had prolonged, unprotected close contact (that is,
within 6 feet for 15 minutes or longer) with an individual with
confirmed SARS-CoV-2 infection, regardless of whether the individual
has symptoms.\17\ Subsequent to the publication of the proposed rule,
the CDC has confirmed that the three main ways that COVID-19 is spread
are: (1) Breathing in air when close to an infected person who is
exhaling small droplets and particles that contain the virus; (2)
Having these small droplets and particles that contain virus land on
the eyes, nose, or mouth, especially through splashes and sprays like a
cough or sneeze; and (3) Touching eyes, nose, or mouth with hands that
have the virus on them.\18\ Personal protective equipment (PPE) and
other infection-control precautions can reduce the likelihood of
transmission in health care settings, but COVID-19 can still spread
between health care personnel (HCP) and patients given the close
contact that may occur during the provision of care.\19\ The CDC has
emphasized that health care settings, including IRFs, can be high-risk
places for COVID-19 exposure and transmission.\20\ Vaccination is a
critical part of the nation's strategy to effectively counter the
spread of COVID-19 and ultimately help restore societal
functioning.\21\
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\17\ Centers for Disease Control and Prevention. (2020).
Clinical Questions about COVID-19: Questions and Answers. Accessed
on December 2, 2020 at <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html</a>.
\18\ Centers for Disease Control and Prevention. (2021). How
COVID-19 Spreads. Accessed on July 15, 2021 at <a href="https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html">https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html</a>.
\19\ Centers for Disease Control and Prevention. (2020). Interim
U.S. Guidance for Risk Assessment and Work Restrictions for
Healthcare Personnel with Potential Exposure to COVID-19. Accessed
on December 2 at <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html</a>.
\20\ Dooling, K, McClung, M, et al. ``The Advisory Committee on
Immunization Practices' Interim Recommendations for Allocating
Initial Supplies of COVID-19 Vaccine--United States, 2020.'' Morb
Mortal Wkly Rep. 2020; 69(49): 1857-1859.
\21\ Centers for Disease Control and Prevention. (2020). COVID-
19 Vaccination Program Interim Playbook for Jurisdiction Operations.
Accessed on December 18 at <a href="https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf">https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf</a>.
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On December 11, 2020, the Food and Drug Administration (FDA) issued
the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in
the United States.\22\ Subsequently, the FDA issued EUAs for additional
COVID-19 vaccines. In issuing these EUAs, the FDA determined that it
was reasonable to conclude that the known and potential benefits of
each vaccine, when used as authorized to prevent COVID-19, outweighed
its known and potential risks.<SUP>23 24 25</SUP>
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\22\ U.S. Food and Drug Administration. (2021). Pfizer-BioNTech
COVID-19 Vaccine. Available at <a href="https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine">https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine</a>.
\23\ Ibid.
\24\ U.S. Food and Drug Administration. (2021). ModernaTX, Inc.
COVID-19 Vaccine EUA Letter of Authorization. Available at <a href="https://www.fda.gov/media/144636/download">https://www.fda.gov/media/144636/download</a>.
\25\ U.S. Food and Drug Administration (2021). Janssen Biotech,
Inc. COVID-19 Vaccine EUA Letter of Authorization. Available at
<a href="https://www.fda.gov/media/146303/download">https://www.fda.gov/media/146303/download</a>.
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As part of its national strategy to address COVID-19, the Biden
administration stated that it would work with states and the private
sector to execute an aggressive vaccination strategy and has outlined a
goal of administering 200 million shots in 100 days.\26\ Although the
goal of the U.S. government is to ensure that every American who wants
to receive a COVID-19 vaccine can receive one, federal agencies
recommended that early vaccination efforts focus on those critical to
the PHE response, including healthcare personnel (HCP),\27\ and
individuals at highest risk for developing severe illness from COVID-
19.\28\ For example, the CDC's Advisory
[[Page 42387]]
Committee on Immunization Practices (ACIP) recommended that HCP should
be among those individuals prioritized to receive the initial, limited
supply of the COVID-19 vaccination, given the potential for
transmission in health care settings and the need to preserve health
care system capacity.\29\ Research suggests most states followed this
recommendation,\30\ and HCP began receiving the vaccine in mid-December
of 2020.\31\ Subsequent to the publication of the IRF PPS proposed
rule, on June 3, 2021 the White House confirmed that there was
sufficient vaccine supply for all Americans.\32\
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\26\ The White House. Remarks by President Biden on the COVID-19
Response and the State of Vaccinations. March 29, 2021. Accessed at
<a href="https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/03/29/remarks-by-president-biden-on-the-covid-19-response-and-the-state-of-vaccinations/">https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/03/29/remarks-by-president-biden-on-the-covid-19-response-and-the-state-of-vaccinations/</a>.
\27\ Centers for Disease Control and Prevention. Glossary of
Terms. <a href="https://cdc.gov/infectioncontrol/guidelines/healthcare-personnel/appendix/terminology.html">https://cdc.gov/infectioncontrol/guidelines/healthcare-personnel/appendix/terminology.html</a>.
\28\ Health and Human Services, Department of Defense. (2020)
From the Factory to the Frontlines: The Operation Warp Speed
Strategy for Distributing a COVID-19 Vaccine. Accessed December 18
at <a href="https://www.hhs.gov/sites/default/files/strategy-for-distributing-covid-19-vaccine.pdf">https://www.hhs.gov/sites/default/files/strategy-for-distributing-covid-19-vaccine.pdf</a>; Centers for Disease Control
(2020). COVID-19 Vaccination Program Interim Playbook for
Jurisdiction Operations. Accessed December 18 at <a href="https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf">https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf</a>.
\29\ Dooling, K, McClung, M, et al. ``The Advisory Committee on
Immunization Practices' Interim Recommendations for Allocating
Initial Supplies of COVID-19 Vaccine--United States, 2020.'' Morb.
Mortal Wkly Rep. 2020; 69(49): 1857-1859. ACIP also recommended that
long-term care residents be prioritized to receive the vaccine,
given their age, high levels of underlying medical conditions, and
congregate living situations make them high risk for severe illness
from COVID-19.
\30\ Kates, J, Michaud, J, Tolbert, J. ``How Are States
Prioritizing Who Will Get the COVID-19 Vaccine First?'' Kaiser
Family Foundation. December 14, 2020. Accessed on December 16 at
<a href="https://www.kff.org/policy-watch/how-are-states-prioritizing-who-will-get-the-covid-19-vaccine-first/">https://www.kff.org/policy-watch/how-are-states-prioritizing-who-will-get-the-covid-19-vaccine-first/</a>.
\31\ Associated Press. `Healing is Coming:' US Health Workers
Start Getting Vaccine. December 15, 2020. Accessed on December 16 at
<a href="https://apnews.com/article/us-health-workers-coronavirus-vaccine-56df745388a9fc12ae93c6f9a0d0e81f">https://apnews.com/article/us-health-workers-coronavirus-vaccine-56df745388a9fc12ae93c6f9a0d0e81f</a>.
\32\ Press Briefing by White House COVID-19 Response Team and
Public Health Officials [verbar] The White House. Accessed on July
21, 2021 at <a href="https://www.whitehouse.gov/briefing-room/press-briefings/2021/06/03/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-40/">https://www.whitehouse.gov/briefing-room/press-briefings/2021/06/03/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-40/</a>.
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HCP are at risk of carrying COVID-19 infection to patients,
experiencing illness or death as a result of COVID-19 themselves, and
transmitting it to their families, friends, and the general public. We
believe it is important to require that IRFs report COVID-19 HCP
vaccination in order to assess whether they are taking steps to limit
the spread of COVID-19 among their HCP, reduce the risk of transmission
of COVID-19 within their facilities, and to help sustain the ability of
IRFs to continue serving their communities throughout the PHE and
beyond.
We also believe that publishing facility level COVID-19 HCP
vaccination rates on Care Compare would be helpful to many patients,
including those who are at high-risk for developing serious
complications from COVID-19, as they choose facilities from which to
seek treatment. Under CMS' Meaningful Measures framework, the COVID-19
Vaccination Coverage among Healthcare Personnel measure addresses the
quality priority of ``Promote Effective Prevention & Treatment of
Chronic Disease'' through the Meaningful Measures Area of ``Preventive
Care.''
Therefore, we proposed a new measure, COVID-19 Vaccination Coverage
among HCP to assess the proportion of an IRF's healthcare workforce
that has been vaccinated against COVID-19.
b. Stakeholder Input
In the development and specification of the measure, a transparent
process was employed to seek input from stakeholders and national
experts and engage in a process that allows for pre-rulemaking input on
each measure, under section 1890A of the Act.\33\ To meet this
requirement, the following opportunity was provided for stakeholder
input.
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\33\ Centers for Medicare & Medicaid Services. Pre-rulemaking.
Accessed at <a href="https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rulemaking">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rulemaking</a>.
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The pre-rule making process includes making publicly available a
list of quality and efficiency measures, called the Measures Under
Consideration (MUC) List that the Secretary is considering adopting,
through federal rulemaking process, for use in Medicare program(s).
This allows multi-stakeholder groups to provide recommendations to the
Secretary on the measures included on the list. The COVID-19
Vaccination Coverage among Healthcare Personnel measure was included on
the publicly available ``List of Measures under Consideration for
December 21, 2020''.\34\ Five comments were received from industry
stakeholders during the pre-rulemaking process on the COVID-19
Vaccination Coverage among HCP measure, and support was mixed.
Commenters generally supported the concept of the measure. However,
there was concern about the availability of the vaccine and measure
definition for HCP, and some commenters encouraged CMS to continue to
update the measure as new evidence comes in.
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\34\ National Quality Forum. List of Measures Under
Consideration for December 21, 2020. Accessed at <a href="https://www.cms.gov/files/document/measures-under-consideration-list-2020-report.pdf">https://www.cms.gov/files/document/measures-under-consideration-list-2020-report.pdf</a> on January 12, 2021.
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c. Measure Applications Partnership (MAP) Review
When the Measure Applications Partnership (MAP) Post-Acute Care/
Long-Term Care (PAC-LTC) Workgroup convened on January 11, 2021, it
reviewed the MUC List and the COVID-19 Vaccination Coverage among HCP
measure. The MAP recognized that the proposed measure represents a
promising effort to advance measurement for an evolving national
pandemic and that it would bring value to the IRF QRP measure set by
providing transparency about an important COVID-19 intervention to help
limit COVID-19 infections.\35\ The MAP also stated that collecting
information on COVID-19 vaccination Coverage among healthcare personnel
and providing feedback to facilities would allow facilities to
benchmark coverage rates and improve coverage in their facility, and
that reducing rates of COVID-19 in healthcare personnel may reduce
transmission among patients and reduce instances of staff shortages due
to illness.\36\
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\35\ Measure Applications Partnership. MAP Preliminary
Recommendations 2020-2021. Accessed on February 3, 2021 at <a href="https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94650">https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94650</a>.
\36\ Ibid.
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In its preliminary recommendations, the MAP PAC-LTC Workgroup did
not support this measure for rulemaking, subject to potential for
mitigation.\37\ To mitigate its concerns, the MAP believed that the
measure needed well-documented evidence, finalized specifications,
testing, and NQF endorsement prior to implementation.\38\ Subsequently,
the MAP Coordinating Committee met on January 25, 2021, and reviewed
the COVID-19 Vaccination Coverage among Healthcare Personnel measure.
In the 2020-2021 MAP Final Recommendations, the MAP offered conditional
support for rulemaking contingent on CMS bringing the measures back to
the MAP once the specifications are further clarified. The final MAP
report is available at <a href="http://www.qualityforum.org/Publications/2021/03/MAP_2020-2021_Considerations_for_Implementing_Measures_Final_Report_-_Clinicians,_Hospitals,_and_PAC-LTC.aspx">http://www.qualityforum.org/Publications/2021/03/MAP_2020-2021_Considerations_for_Implementing_Measures_Final_Report_-_Clinicians,_Hospitals,_and_PAC-LTC.aspx</a>.
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\37\ Ibid.
\38\ Ibid.
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In response to the MAP request for CMS to bring the measure back
once the specifications were further clarified, CMS met with the MAP
Coordinating Committee on March 15, 2021. First, CMS and CDC clarified
the alignment of the COVID-19 Vaccination Coverage among HCP with the
Influenza Vaccination among HCP (NQF #0431), an NQF-endorsed measure
since 2012. The COVID-19 Vaccination Coverage among HCP measure is
calculated using the same approach as the Influenza Vaccination among
HCP measure.\39\ The
[[Page 42388]]
approach to identifying HCPs eligible for the COVID-19 vaccination is
analogous to those used in the NQF endorsed flu measure which underwent
rigorous review from technical experts about the validity of that
approach and for which ultimately received NQF endorsement. More
recently, prospective cohorts of health care personnel, first
responders, and other essential and frontline workers over 13 weeks in
eight U.S. locations confirmed that authorized COVID-19 vaccines are
highly effective in real-world conditions. Vaccine effectiveness of
full immunization with two doses of vaccines was 90 percent.\40\
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\39\ The Influenza Vaccination Coverage among Healthcare
Personnel (NQF #0431) measure which is NQF endorsed and was adopted
in the IRF QRP in the FY 2014 IRF PPS Final Rule (78 FR 47905
through 47906), and in the LTCH QRP in the FY 2013 IPPS/LTCH PPS
Final Rule (77 FR 53630 through 53631).
\40\ Centers for Disease Control and Preventions. Morbidity and
Mortality Weekly Report. March 29, 2021. Available at <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm?s_cid=mm7013e3_w">https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm?s_cid=mm7013e3_w</a>.
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Additionally, to support the measure's data element validity, CDC
conducted testing of the COVID-19 vaccination numerator using data
collected through the NHSN and independently reported through the
Federal Pharmacy Partnership for Long-term Care Program for delivering
vaccines to long-term care facilities. These are two completely
independent data collection systems. In initial analyses of the first
month of vaccination, the number of HCP vaccinated in approximately
1,200 facilities, which had data from both systems, the number of HCP
vaccinated was highly correlated between these two systems with a
correlation coefficient of nearly 90 percent in the second 2 weeks of
reporting. Of note, assessment of data element reliability may not be
required by NQF if data element validity is demonstrated.\41\ In
addition, for assessing the validity of new performance measure score
(in this case, percentage COVID-19 vaccination coverage), NQF allows
assessment by face validity (subjective determination by experts that
the measure appears to reflect quality of care, done through a
systematic and transparent process) \42\ and the MAP concurred with
face validity of the measure of COVID-19 vaccination coverage.
Materials from the March 15, 2021 MAP Coordinating Committee meeting
are on the NQF website at <a href="https://www.qualityforum.org/ProjectMaterials.aspx?projectID=75367">https://www.qualityforum.org/ProjectMaterials.aspx?projectID=75367</a>.
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\41\ National Quality Form. Key Points for Evaluating Scientific
Acceptability. Revised January 3, 2020. https://
www.qualityforum.org/Measuring_Performance/Scientific_Methods_Panel/
Docs/Evaluation_Guidance.aspx#:~:text.
\42\ Ibid.
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This measure is not NQF endorsed, but CMS, in collaboration with
the CDC, plans to submit the measure for NQF endorsement in the future.
d. Competing and Related Measures
Section 1886(j)(7)(D)(i) of the Act requires that, absent an
exception under section 1886(j)(7)(D)(ii) of the Act, measures
specified by the Secretary under section 1886(j)(7)(D) of the Act be
endorsed by the entity with a contract under section 1890(a) of the
Act, currently the National Quality Forum (NQF). In the case of a
specified area or medical topic determined appropriate by the Secretary
for which a feasible and practical measure has not been endorsed,
section 1886(j)(7)(D)(ii) of the Act permits the Secretary to specify a
measure that is not so endorsed, as long as due consideration is given
to the measures that have been endorsed or adopted by a consensus
organization identified by the Secretary. Section 1899B(e)(2)(A) of the
Act requires that, subject to section 1899B(e)(2)(B) of the Act, each
measure specified by the Secretary under section 1899B of the Act be
endorsed by the entity with a contract under section 1890(a) of the
Act. However, in the case of a specified area or medical topic
determined appropriate by the Secretary for which a feasible and
practical measure has not been endorsed by the entity with a contract
under section 1890(a) of the Act, the Secretary may specify a measure
that is not so endorsed as long as due consideration is given to
measures that have been endorsed or adopted by a consensus organization
identified by the Secretary.
The proposed COVID-19 Vaccination Coverage among HCP measure is not
currently NQF endorsed and has not been submitted to the NQF for
consideration, so we considered whether there are other available
measures that assess COVID-19 vaccinations among HCP. After review of
the NQF's consensus-endorsed measures, we were unable to identify any
NQF endorsed measures for IRFs focused on capturing COVID-19
vaccination coverage of HCP and we found no other feasible and
practical measure on the topic of COVID-19 vaccination Coverage among
HCP, and we found no other feasible and practical measure on the topic
of COVID-19 vaccination Coverage among HCP. The only other vaccination
coverage of HCP measure found was the Influenza Vaccination Coverage
among Healthcare Personnel (NQF #0431) measure which is NQF endorsed
and was adopted in the IRF QRP in the FY 2014 IRF PPS Final Rule (78 FR
47905 through 47906).
Given the novel nature of the SARS-CoV-2 virus, and the significant
and immediate risk it poses in IRFs, we believed it was necessary to
propose the measure as soon as possible. Therefore, after consideration
of other available measures that assess COVID-19 vaccination rates
among HCP, we believe the exception under section 1899B(e)(2)(B) of the
Act applies. This proposed measure has the potential to generate
actionable data on vaccination rates that can be used to target quality
improvement among IRF providers.
e. Quality Measure Calculation
The COVID-19 Vaccination Coverage among Healthcare Personnel (HCP)
measure is a process measure developed by the CDC to track COVID-19
vaccination Coverage among HCP in facilities such as IRFs. Since this
proposed measure is a process measure, rather than an outcome measure,
it does not require risk-adjustment.
The denominator would be the number of HCP eligible to work in the
IRF for at least one day during the reporting period, excluding persons
with contraindications to COVID-19 vaccination, that are described by
the CDC.\43\
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\43\ Centers for Disease Control and Prevention. Interim
Clinical Considerations for Use of COVID-19 Vaccines Currently
Authorized in the United Sates, Appendix B. Accessed at <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Appendix-B">https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Appendix-B</a>.
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The numerator would be the cumulative number of HCP eligible to
work in the IRF for at least one day during the reporting period and
who received a complete vaccination course against SARS-CoV-2. A
complete vaccination course may require one or more doses depending on
the specific vaccine used. The finalized measure specifications are
available on the CDC website at <a href="https://www.cdc.gov/nhsn/nqf/index.html">https://www.cdc.gov/nhsn/nqf/index.html</a>.
We proposed that IRFs would submit data for the measure through the
CDC/NHSN data collection and submission framework.\44\ This framework
is currently used for reporting the CAUTI (NQF #0138) and Influenza
Vaccination Coverage among Healthcare Personnel (NQF #0431) measures.
IRFs would use the COVID-19 vaccination data reporting module in the
NHSN Healthcare Personnel Safety (HPS) Component to report the number
of HCP eligible who have worked at the facility
[[Page 42389]]
that week (denominator) and the number of those HCP who have received a
completed COVID-19 vaccination course (numerator). IRFs would submit
COVID-19 vaccination data for at least 1 week each month. If IRFs
submit more than one week of data in a month, the most recent week's
data would be used for measure calculation purposes. Each quarter, the
CDC would calculate a summary measure of COVID-19 vaccination coverage
from the three monthly modules reported for the quarter. This quarterly
rate would be publicly reported on the Care Compare website. Subsequent
to the first refresh, one additional quarter of data would be added to
the measure calculation during each advancing refresh, until the point
four full quarters of data is reached. Thereafter, the measure would be
reported using four rolling quarters of data on Care Compare.
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\44\ Centers for Disease Control and Prevention. Surveillance
for Weekly HCP COVID-19 Vaccination. Accessed at <a href="https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html">https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html</a> on February 10,
2021.
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For purposes of submitting data to CMS for the FY 2023 IRF QRP,
IRFs would be required to submit data for the period October 1, 2021
through December 31, 2021. Following the data submission quarter for
the FY 2023 IRF QRP, subsequent compliance for the IRF QRP would be
based on four quarters of such data submission. For more information on
the measure's proposed public reporting period, we refer readers to
section VII.G.2 of the proposed rule.
We invited public comment on our proposal to add a new measure,
COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) measure,
to the IRF QRP beginning with the FY 2023 IRF QRP.
The following is a summary of the public comments received on the
proposed revisions to add a new measure, COVID-19 Vaccination Coverage
among HCP measure, to the IRF QRP beginning with the FY 2023 IRF QRP,
and our responses:
Comment: A number of organizations, including provider associations
and patient advocacy groups, supported the proposal to adopt the COVID-
19 Vaccination Coverage among HCP measure for the IRF QRP. Commenters
agreed that the measure is vitally important to protect the health and
well-being of older adults in IRFs and reporting of this measure
through the NHSN would help to ensure transparency and accountability
in community infection prevention and control efforts. The commenters
supported the idea that reporting of HCP vaccination rates helps inform
patient and caregiver choices when considering IRFs from which to seek
care, particularly for those at high risk for developing serious
complications from COVID-19. Another commenter noted that reporting
COVID-19 HCP vaccination rates would provide greater transparency to
federal officials and other stakeholders seeking to effectively target
vaccine hesitancy and resources related to the COVID-19 vaccines. One
commenter noted that vaccinations are particularly important because
the nature of care settings like IRFs makes other COVID-19 transmission
mitigation strategies (for example, social distancing) much less
effective.
Response: We thank the commenters for their support and agree that
the COVID-19 Vaccination Coverage among HCP measure is critically
important to the protection of health and well-being of older adults in
IRFs, and that reporting this measure will help to ensure transparency
and accountability in community infection prevention and control
efforts. We also agree that the nature of care settings like IRFs makes
other COVID-19 transmission mitigation strategies less effective, which
makes COVID-19 vaccinations of HCP in this setting especially
important. The CDC has also emphasized that healthcare settings,
including IRFs, can be high-risk places for COVID-19 exposure and
transmission and notes that COVID-19 can spread between HCP and
patients given the close contact that may occur during the provision of
care.\45\
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\45\ Dooling, K, McClung, M, et al. ``The Advisory Committee on
Immunization Practices' Interim Recommendations for Allocating
Initial Supplies of COVID-19 Vaccine--United States, 2020.'' Morb
Mortal Wkly Rep. 2020; 69(49): 1857-1859.
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Although we received a number of comments in support of the
measure's concept as well as the need to encourage widespread
vaccination among HCP, some commenters expressed concerns with the
measure, including administrative burden, lack of access to the
vaccine, concerns that staff may be intimidated into receiving the
vaccine, the lack of certainty about whether a booster vaccination will
be necessary, concern that the vaccinations have not received full FDA
approval, and finally that the measure is not NQF endorsed. We will
address each of these comments below.
Comment: Several commenters expressed concern over the potential
for inequality among providers because vaccines are not equally
available across the nation. They point out that the type of vaccine
available to them is out of their control and since the availability of
the single-dose vaccines may be different across the country, some
providers would be at a disadvantage because of the 4-week waiting
period between doses of the two-dose vaccines to reach complete
vaccination status. Some providers were concerned about vaccine
availability. These commenters pointed out that at times the COVID-19
vaccine supply chain has been disrupted and believe the measure should
not be implemented until there is a more definitive understanding of
the future supply of vaccines.
Response: As part of its national strategy to address COVID-19, the
current administration stated that it would work with states and the
private sector to execute an aggressive vaccination strategy. The goal
of the U.S. government is to ensure that every American who wants to
receive a COVID-19 vaccine can receive one. While we acknowledge that
vaccine supply was initially limited, more than 20 states are no longer
ordering all the vaccine doses allocated to them due to decline in
demand,\46\ and more than 1,000 counties are reporting a surplus of
vaccine appointments.\47\ We understand that vaccine availability may
vary based on location, and vaccination and medical staff authorized to
administer the vaccination may not be readily available in all areas.
Supply distribution is the responsibility of each state, and IRFs
should continue to consult state and local health departments to
understand the range of options for how vaccines can be made available
to patients and staff.
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\46\ CBS News. More than 20 States Not Ordering All Available
Doses as COVID-19 Vaccinations Slow. May 3, 2021. Available at
<a href="https://www.cbsnews.com/news/covid-19-vaccine-doses-states/">https://www.cbsnews.com/news/covid-19-vaccine-doses-states/</a>.
Accessed June 24, 2021.
\47\ GoodRx. From Shortage to Surplus: A Growing Number of U.S.
Counties Have Vacant COVID-19 Vaccine Appointments. April 20, 2021.
Available at <a href="https://www.goodrx.com/">https://www.goodrx.com/</a>;blog/covid-19-vaccine-surplus-
vacant-appointments/. Accessed June 24, 2021.
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As discussed in section VIII.C.1.e of this final rule, we proposed
that IRFs would submit data for the COVID-19 vaccination Coverage among
HCP measure data for at least 1 week each month. If IRFs submit more
than 1 week of data in a month, the most recent week's data would be
used for measure calculation purposes. Each quarter, the CDC would
calculate a summary measure of COVID-19 vaccination coverage from the
three monthly modules reported for the quarter. This quarterly rate
would be publicly reported on the Care Compare website. As a result,
there will be time within the quarter for persons receiving the two-
dose vaccine to reach complete vaccination status.
Comment: Several commenters were concerned about the effect
potential booster shots could have on the definition of a ``complete
vaccination course,'' and raised questions about
[[Page 42390]]
whether a booster shot would be needed, the timing of such a shot, and
at what intervals. They pointed out that it could complicate the
tracking of the measure, while others questioned how booster shots
would factor into reporting requirements. Commenters requested that CMS
clarify how the potential need for ``booster'' vaccinations would be
accounted for in IRFs going forward. A commenter noted that in the FY
2022 Inpatient Prospective Payment System (IPPS) proposed rule, CMS
states that the numerator would be calculated based on HCP who received
a completed vaccination course ``since the vaccine was first available
or on a repeated interval if revaccination is recommended.'' Since this
language is not included in the FY 2022 IRF PPS proposed rule, they
requested clarification on how evolving vaccine recommendations will be
accounted for in this proposed measure.
Response: The COVID-19 Vaccination Coverage among HCP measure is a
measure of a completed COVID-19 vaccination course as defined in
section VIII.C.1.e. of this final rule. A complete vaccination course
may require one or more doses depending on the specific vaccine used.
Currently, the need for COVID-19 booster doses has not been
established, and no additional doses are currently recommended for
HCP.\48\ However, we believe that the numerator is sufficiently broad
to include potential future boosters as part of a ``complete
vaccination course'' and therefore the measure is sufficiently
specified to address boosters.
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\48\ Centers for Disease Control and Prevention. Vaccine
Administration. Available at <a href="https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html">https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html</a>. Accessed June 25,
2021.
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Comment: We received several comments posing questions about the
uncertainty the provider community believes about the future of the
COVID-19 vaccination. Commenters voiced concern about the uncertainty
of how long the vaccines confer immunity. They point to the amount of
misinformation that has been and is still currently being spread about
COVID-19 and the vaccinations.
Response: We acknowledge the science relating to the SARS-CoV-2
virus continues to evolve. It is another reason the COVID-19
Vaccination Coverage among HCP measure is so important. Population
immunity means that enough people in a community are protected from
getting a disease because they have already had the disease or because
they have been vaccinated. Population immunity makes it hard for the
disease to spread from person to person.\49\
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\49\ Centers for Disease Control and Prevention. Population
Immunity. Available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html">https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html</a>. Accessed June 25, 2021.
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We are still learning how effective the vaccines are against new
variants of the virus that causes COVID-19. Current evidence suggests
that the COVID-19 vaccines authorized for use in the United States
offer protection against most variants currently spreading in the
United States.\50\ The CDC will continue to monitor how vaccines are
working to see if variants have any impact on how well COVID-19
vaccines work in real-world conditions.
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\50\ Centers for Disease Control and Prevention. Covid-19
vaccines and new variants. Available at https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/effectiveness/
work.html#:~:text=COVID%2D19%20vaccines%20and%20new%20variants%20of%2
0the%20virus&text=Current%20data%20suggest%20that%20COVID,after%20the
y%20are%20fully%20vaccinated. Accessed June 25, 2021.
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Comment: Because the vaccine is new, several commenters suggested
that CMS not adopt the measure until more is known about SARS-CoV-2.
Other commenters urged CMS to either make the measure voluntary for the
FY 2023 program, or delay implementation by at least 1 year.
Response: We believe it is important that all IRFs report COVID-19
Vaccination Coverage among HCP as soon as possible in order to assess
the potential spread of COVID-19 among their HCP and within their
facilities to help sustain the ability of IRFs to continue serving
their communities throughout the PHE and beyond. Allowing IRFs to
voluntarily report may result in selective reporting among high-
performing facilities, which would reduce the usefulness of the
publicly reported data. Because of the ongoing PHE for COVID-19 and
risk of infection transmissions in the IRF population, this measure
will be informative to beneficiaries and consumers who receive
inpatient rehabilitation services from IRFs.
Comment: Commenters pointed out that there is still a degree of
vaccine hesitancy remaining among the general population as well as
hospital staff. They believe the lack of certainty could create an
unnecessary burden on IRFs until the vaccines receive FDA approval or
there is some equivalent guidance from the federal government
clarifying how IRFs should proceed with mandating vaccinations.
Response: We reiterate that the COVID-19 vaccines are authorized by
FDA for use through Emergency Use Authorizations (EUAs). We refer
readers to the FDA website for additional information related to FDA's
process for evaluating an EUA request at <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained">https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained</a>. Additionally, two of the three vaccines authorized for
emergency use are shown to be 90 to 95 percent effective in preventing
COVID-19 in persons without prior infection, and are equally effective
across a variety of characteristics, including age, gender, race,
ethnicity, and body mass index or presence of other medical
conditions.\51\ In clinical trials, the Pfizer vaccine was 100 percent
effective at preventing severe disease. The third vaccine authorized
for emergency use demonstrates it is 93.1 percent effective at
preventing COVID-19 hospitalization and 75 percent effective against
all-cause death.\52\ The FDA is closely monitoring the safety of the
COVID-19 vaccines authorized for emergency use.
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\51\ Effectiveness of Pfizer-BioNTech and Moderna Vaccines
Against COVID-19 Among Hospitalized Adults Aged >=65 Years--United
States, January-March 2021. Morbidity and Mortality Weekly Report
(MMWR). May 7, 2021. Available at <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e1.htm?s_cid=mm7018e1_w">https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e1.htm?s_cid=mm7018e1_w</a>. Accessed July 19, 2021.
\52\ The Advisory Committee on Immunization Practices' Interim
Recommendation for Use of Janssen COVID-19 Vaccine--United States,
February 2021. Morbidity and Mortality Weekly Report (MMWR). March
5, 2021. Available at <a href="https://www.cdc.gov/mmwr/volumes/70/wr/mm7009e4.htm">https://www.cdc.gov/mmwr/volumes/70/wr/mm7009e4.htm</a>. Accessed July 19, 2021.
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We believe it is critical to measure staff vaccination rates among
IRFs even as vaccinations become more common, especially in light of
the vaccine hesitancy the commenters have pointed out. As reported by
Medscape Medical News on June 28, 2021,\53\ federal data show that one
in four hospital workers across the United states are still
unvaccinated, and only one in every three hospital workers are
vaccinated in the nation's 50 largest health systems. Moreover, the
adoption of this measure does not mandate or require that HCP complete
a COVID-19 vaccination course. Even if IRFs have limited control over
the vaccination status of their employees, the information collected by
this measure is vitally important and useful to stakeholders.
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\53\ Medscape. Disturbing Number of Hospital Workers Still
Unvaccinated. Available at <a href="https://www.medscape.com/viewarticle/953871">https://www.medscape.com/viewarticle/953871</a>. Accessed July 13, 2021.
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Comment: We received several comments stating that while the COVID-
19 Vaccination Coverage among HCP measure does not directly compel IRFs
to ensure that their employees are vaccinated, publicly reporting
performance on this measure might
[[Page 42391]]
incent IRFs to adopt mandatory vaccination policies for their
personnel. As a result, commenters suggest the measure has the
potential to jeopardize an already challenged workforce, exacerbating
critical workforce issues, if IRFs attempt to produce a positive
performance by either mandating vaccination and/or not hiring or
letting go of staff who choose not to be vaccinated. One commenter
noted that multiple states have introduced or passed legislation
prohibiting discrimination based on COVID-19 vaccination status.
Several state legislatures have considered legislation that would
prohibit an employer from forcing employees to be vaccinated for COVID-
19. Other state legislatures are considering legislation to
specifically authorize employer-mandated vaccinations. Commenters
cautioned that IRFs unable to mandate the vaccine could be at a
systematic performance disadvantage on the measure.
Response: We believe that the unprecedented risks associated with
the COVID-19 PHE warrant direct attention, especially because HCP are
working directly with and in close proximity to patients, but are
clarifying that the COVID-19 Vaccination Coverage among HCP measure
does not require providers to adopt mandatory vaccination policies. To
support a comprehensive vaccine administration strategy, we encourage
IRFs to voluntarily engage in the provision of appropriate and
accessible education and vaccine-offering activities. Many IRFs across
the country are educating staff, patients, and patient representatives,
participating in vaccine distribution programs, and voluntarily
reporting vaccine administration. The CDC has a number of resources
\54\ available to providers to assist in building vaccine confidence.
CMS also has a web page to help providers, including IRFs, find
resources related to the COVID-19 vaccines.\55\ There are a number of
toolkits and videos providers can use to stay informed and to educate
their employees, patients and communities about the COVID-19 vaccines.
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\54\ Centers for Disease Control and Prevention. Building
Confidence in COVID-19 Vaccines. Available at <a href="https://www.cdc.gov/vaccines/covid-19/vaccinate-with-confidence.html">https://www.cdc.gov/vaccines/covid-19/vaccinate-with-confidence.html</a>.
\55\ Centers for Medicare and Medicaid Services. Coronovirus
(COVID-19) Partner Resources. Available at <a href="https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-resources">https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-resources</a>.
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Consistent vaccination reporting by IRFs via the NHSN will help
patients and their caregivers identify IRFs that have potential issues
with vaccine confidence or slow uptake among staff. Implementation of
voluntary COVID-19 vaccine education and vaccination programs in IRFs
will help protect patients and staff, allowing for an expedited return
to more normal routines, including timely preventive healthcare;
family, caregiver, and community visitation; and group and individual
activities.\56\
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\56\ Centers for Disease Control and Prevention. Updated
Healthcare Infection Prevention and Control Recommendations in
Response to COVID-19 Vaccination. Available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-after-vaccination.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-after-vaccination.html</a>.
Accessed June 26, 2021.
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Regarding concerns over discrimination based on COVID-19
vaccination status, the Equal Employment Opportunity Commission (EEOC)
released updated and expanded technical assistance on May 28, 2021,\57\
stating that federal equal employment opportunity (EEO) laws do not
prevent an employer from requiring all employees physically entering
the workplace to be vaccinated for COVID-19, so long as the employer
complies with the reasonable accommodation provisions of the Americans
with Disabilities Act (ADA) and Title VII of the Civil Rights Act of
1964 and other EEO considerations.
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\57\ U.S. Equal Employment Opportunity Commission. What You
Should Know About COVID-19 and the ADA, the Rehabilitation Act, and
Other EEO Laws. Available at <a href="https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws">https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws</a>. Accessed June 25, 2021.
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Comment: One commenter referenced new state laws restricting an
employer's ability to obtain information regarding an employee's
vaccination status unless it is for the purpose of determining whether
the facility should implement reasonable accommodation measures to
protect health and safety.
Response: We acknowledge the commenter's concern regarding state
laws prohibiting providers from obtaining information regarding an
employee's COVID-19 vaccination status except in certain circumstances
related to health and safety. We believe, however, that obtaining
COVID-19 vaccination status information is important for determining
reasonable measures to protect the health and safety of not only the
patients it serves, but other staff working within the facility. Within
the NHSN reporting module, there is an option to select ``unknown
COVID-19 vaccination status'' and providers should utilize this
response for employees who choose not to disclose their status.
Additionally, as mentioned in the previous comment response, the EEOC
released updated and expanded technical assistance on May 28, 2021,\58\
stating that federal EEO laws do not prevent an employer from requiring
all employees physically entering the workplace to be vaccinated for
COVID-19, so long as the employer complies with the reasonable
accommodation provisions of the Americans with Disabilities Act (ADA)
and Title VII of the Civil Rights Act of 1964 and other EEO
considerations.
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\58\ U.S. Equal Employment Opportunity Commission. What You
Should Know About COVID-19 and the ADA, the Rehabilitation Act, and
Other EEO Laws. Available at <a href="https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws">https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws</a>. Accessed June 25, 2021.
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Comment: One commenter questioned whether the proposal was in
conflict with guidance from the EEOC, which states employers must
provide a reasonable accommodation if an employee's sincerely held
religious belief, practice, or observance prevents them from receiving
the vaccination.
Response: We believe the commenter is referring to the updated and
expanded technical assistance the EEOC issued on May 28, 2021.\59\ CMS
disagrees that the proposal conflicts with the EEOC's guidance.
Specifically, the EEOC stated the federal EEO laws do not prevent an
employer from requiring all employees physically entering the workplace
to be vaccinated for COVID-19, so long as the employer complies with
the reasonable accommodation provisions of the Americans with
Disabilities Act (ADA) and Title VII of the Civil Rights Act of 1964
and other EEO considerations. This measure is intended to report the
number of HCP who have received a COVID-19 vaccination, but it does not
mandate HCP to receive a COVID-19 vaccination.
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\59\ U.S. Equal Employment Opportunity Commission. What You
Should Know About COVID-19 and the ADA, the Rehabilitation Act, and
Other EEO Laws. Available at <a href="https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws">https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws</a>. Accessed June 25, 2021.
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Comment: One commenter questioned why this information would be
used in a quality measure that impacts payments when providers cannot
mandate their staff to become vaccinated. Another commenter pointed out
that the potential for interstate regulatory differences raises
concerns about a future employee vaccination metric in a pay-for-
performance program.
Response: We proposed the COVID-19 Vaccination Coverage among HCP
measure beginning with the FY 2023 IRF QRP. The IRF QRP is a pay-for-
reporting program under which IRFs are not financially penalized based
on measure performance, but rather on
[[Page 42392]]
their adherence to the reporting requirements.
Comment: A few commenters raised the issue of the possibility of
legal risk to their organization if HCP experience an adverse event
related to a vaccine, given the vaccines are not FDA-approved. They
point out that this creates ethical and legal challenges to the
organization.
Response: It is unclear what legal and ethical challenges the
commenters are referring to, as the COVID-19 Vaccination Coverage among
HCP measure does not require HCP to be vaccinated. In addition, all of
the COVID-19 vaccines have been authorized by the FDA for widespread
use through an EUA. We refer readers to the FDA website for additional
information related to the process of vaccination vetting and approval
found here: <a href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained">https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained</a>.
Comment: A number of commenters stated that it is premature to
begin tracking COVID-19 vaccinations because the COVID-19 vaccines are
authorized through an EUA and do not have full FDA approval at this
time. One provider acknowledged that they were confident in the safety
and efficacy of the three current vaccine products but still find it to
be incongruous to adopt a measure into federal quality reporting
programs that assesses the use of a product that has not yet received
full federal approval.
Response: We believe there is still risk of transmitting infections
in the IRF population. COVID-19 vaccines are a crucial tool for slowing
the spread of disease and death among residents, staff, and the general
public. Based on the FDA's review, evaluation of the data, and its
decision to authorize three vaccines for emergency use, these vaccines
meet FDA's standards for an EUA for safety and effectiveness to prevent
COVID-19 disease and related serious outcomes, including
hospitalization and death. The combination of vaccination, universal
source control (wearing masks), social distancing, and handwashing
offers further protection from COVID-19.\60\ Given the emergency use
authorization by the FDA and the continued PHE for COVID-19, we
disagree with the commenter, and believe our proposal to add the COVID-
19 Vaccination Coverage among HCP measure to the IRF QRP is appropriate
and necessary for patient safety.
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\60\ Centers for Disease Control and Prevention. Guidance for
Unvaccinated People: How to Protect Yourself & Others. June 11,
2021. Available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html">https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html</a>. Accessed June 24, 2021.
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Comment: We received numerous comments requesting that CMS delay
the adoption of the COVID-19 Vaccination Coverage among HCP measure
until it has received NQF endorsement. These commenters expressed
concern that since the measure has not been fully specified, tested, or
endorsed by the NQF, it may not be thoroughly tested and vetted. They
urged CMS, in addition to seeking NQF endorsement, to fully develop and
test the measure for reliability and validity before implementing it in
the IRF QRP.
Response: Given the novel nature of the SARS-CoV-2 virus, and the
significant and immediate health risk it poses in IRFs, we believe it
is necessary to propose the measure as soon as possible. Additionally,
given the results from CDC's preliminary validity testing of the data
elements required for the measure numerator (described further in
section VIII.C.1.c. of this final rule), the alignment between the
denominator of this measure and the denominator of the Influenza
Vaccination among HCP measure (which is NQF-endorsed), and the MAP's
determination that the measure has face validity, CMS believes it is
appropriate to propose the COVID-19 Vaccination Coverage among HCP
measure for the FY 2023 QRP. The CDC, in collaboration with CMS, are
planning to submit the measure for consideration in the NQF Fall 2021
measure cycle.
Comment: One commenter expressed concern that the measure was
developed for public health tracking during a PHE, not for quality
assessment or payment purposes.
Response: This measure was developed for quality assessment
purposes. COVID-19 is a contagious respiratory infection \61\ that can
cause serious illness and death. As of June 25, 2021, the U.S. reported
over 33 million cases of COVID-19 and over 600,000 COVID-19 deaths.\62\
Immunization has a significant role in reducing the incidence and
prevalence--as well as the morbidity and mortality--of vaccine-
preventable diseases.\63\ Over the past decade, there has been
increased focus on improving adult immunization rates. In 2010, the
Department of Health & Human Services (HHS) published a National
Vaccination Plan which provided a strategic approach for preventing
infectious diseases and improving the public's health through
vaccination.\64\ More recently, a 2014 NQF report emphasized addressing
adult immunization measures outside of those addressing influenza and
pneumococcal disease and offered recommendations to advance
measurement, including a composite of all Advisory Committee on
Immunization Practices (ACIP) of the CDC (ACIP/CDC) recommended
vaccinations for HCP.\65\ The measure was developed in collaboration
with the CDC because we believe it is important to require that IRFs
report COVID-19 HCP vaccination to assess the potential spread of
COVID-19 among their HCP and the risk of transmission of COVID-19
within their facilities, and to help sustain the ability of IRFs to
continue serving their communities throughout the PHE and beyond.
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\61\ Centers for Disease Control and Prevention. (2021).
Symptoms of COVID-19. Available at <a href="https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html">https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html</a>. Accessed June 24, 2021.
\62\ Centers for Disease Control and Prevention. (2020). CDC
COVID Data Tracker. Available at <a href="https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days">https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days</a>. Accessed June 24, 2021.
\63\ Vaccinate Your Family website. Vaccines are cost saving.
Available at <a href="https://vaccinateyourfamily.org/why-vaccinate/vaccine-benefits/costs-of-disease-outbreaks/">https://vaccinateyourfamily.org/why-vaccinate/vaccine-benefits/costs-of-disease-outbreaks/</a>. Accessed June 25, 2021.
\64\ U.S. Department of Health & Human Services. 2010 National
Vaccine Plan. Available at <a href="https://www.hhs.gov/sites/default/files/nvpo/vacc_plan/2010-Plan/nationalvaccineplan.pdf">https://www.hhs.gov/sites/default/files/nvpo/vacc_plan/2010-Plan/nationalvaccineplan.pdf</a>. Accessed June 25,
2021.
\65\ National Quality Forum. Priority Setting for Healthcare
Performance Measurement: Addressing Performance Measure Gaps for
Adult Immunizations. Available at <a href="https://www.qualityforum.org/Publications/2014/08/Priority_Setting_for_Healthcare_Performance_Measurement_Addressing_Performance_Measure_Gaps_for_Adult_Immunizations.aspx">https://www.qualityforum.org/Publications/2014/08/Priority_Setting_for_Healthcare_Performance_Measurement_Addressing_Performance_Measure_Gaps_for_Adult_Immunizations.aspx</a>. Accessed June
25, 2021.
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Comment: We received a comment asking CMS not to finalize the
COVID-19 Vaccination Coverage among HCP measure due to the burden
associated with it. The commenter pointed to the reasons previously
cited in 2018 for removing the Influenza vaccination measures through
NHSN as justification.
Response: We presume the commenter is referring to the removal of
the Percent of Residents of Patients Who Were Assessed and
Appropriately Given the Seasonal Influenza Vaccine (Short Stay) (NQF
#0680), which was removed from the IRF QRP in the FY 2019 IRF PPS final
rule (83 FR 38559 to 38560). The reason the measure was removed was not
because of the burden associated with collecting it. We use measure
removal factors (Sec. 412.634(b)(2)) to determine when measures should
be removed from the IRF QRP. The Percent of Residents of Patients Who
Were Assessed and Appropriately Given the Seasonal Influenza Vaccine
(Short Stay) (NQF #0680) measure performance among
[[Page 42393]]
IRFs was so high and unvarying that meaningful distinctions in
improvements in performance could no longer be made. Therefore, it met
the standard for measure removal Factor 1 (set forth at Sec.
412.634(b)(2)(i)) of the IRF QRP regulations and was removed.
Comment: Several commenters who were concerned about the burden on
IRFs stated that the measure would divert resources currently being
used to combat the COVID-19 pandemic since their IT systems must be
updated to accommodate changes to the IRF QRP. The commenters
recommended that CMS delay this measure for at least one full calendar
year following the conclusion of the COVID-19 PHE declaration. They
believe a delay in adding this new measure to the IRF QRP is needed to
avoid imposing an additional burden on IRFs.
Response: We believe it is important to require that IRFs report
COVID-19 HCP vaccination as soon as possible to assess the potential
spread of COVID-19 among their HCP and the risk of transmission of
COVID-19 within their facilities, and to help sustain the ability of
IRFs to continue serving their communities throughout the PHE and
beyond. Additionally, consistent vaccination reporting by IRFs via the
NHSN will help CMS to identify additional resources and tools IRFs may
need to address the challenges of the PHE. Accordingly, we do not
believe that a delayed reporting effective date is appropriate.
Comment: We received several comments related to the burden of
tracking vaccination records. One commenter attributed the burden of
reporting the measure to the fact that they keep employee health
records outside of their electronic health record (EHR) due to health
privacy concerns. Therefore, attempting to identify and collect data on
employee vaccine adherence is inherently difficult and burdensome.
Another commenter noted the challenges inherent in monitoring and
tracking employees who receive multi-dose courses on varying schedules.
Still other commenters pointed to the fact that many vaccination sites,
including federally run mass vaccination sites, do not communicate with
all registries, and that some states do not maintain a registry. We
received several comments asking CMS to consider easing the reporting
frequency for the COVID-19 Vaccination Coverage among HCP measure. Some
commenters stated that reporting vaccinations one week per month rather
than one time per quarter is burdensome, while others raise concern
that it could cause fluctuations in vaccination rates.
Response: IRFs are currently required to submit data for the
Influenza Vaccination among HCP (NQF #0431) measure to the CDC's NHSN
Healthcare Personnel Safety Component (HPS) annually. While IRFs will
not have the burden of registering and learning how to use the NHSN, we
acknowledge there will be burden with collecting the required
information. However, we believe it will be minimal because IRFs
already have experience successfully reporting information using the
NHSN reporting modules. We refer readers to section XIII.C.7. of this
final rule for an estimate of burden related to the COVID-19
Vaccination Coverage among HCP measure. The data sources for the number
of HCP who have received COVID-19 vaccines may include HCP health
records and paper and/or electronic documentation of vaccination given
at the healthcare facility, pharmacy, or elsewhere. Further, HCP
receiving vaccination elsewhere may provide documentation of
vaccination. Additionally, the CDC has provided a number of resources
including a tool called the Data Tracking Worksheet for COVID-19
Vaccination among Healthcare Personnel to help IRFs log and track the
number of healthcare personnel (HCP) who are vaccinated for COVID-19.
IRFs would enter COVID vaccination data for each HCP in the tracking
worksheet, and select a reporting week, the data to be entered into the
NHSN will automatically be calculated on the Reporting Summary.\66\
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\66\ Data Tracking Worksheet for COVID-19 Vaccination among
Healthcare Personnel at <a href="https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html">https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html</a>.
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Comment: One commenter pointed to the fact that for IRFs within
acute care hospitals, separating out which HCP may have had contact
with the IRF unit may present a substantial reporting burden while
providing little useful information that could not be gleaned from the
hospital-wide reports already submitted. Rather than creating an
additional reporting requirement applying solely to IRFs, the agency
should leverage existing COVID-19 vaccination rate reporting to achieve
the agency's goals.
Response: The IRF QRP is a separate reporting program from the
Hospital Inpatient Quality Reporting (IQR) Program. Section
1886(b)(3)(B)(viii) of the Act requires subsection (d) hospitals to
submit quality measure data to the Secretary. Separately, section
1886(j)(7) of the Act requires the Secretary, among other things, to
specify reporting requirements for IRFs. Each distinct Medicare
provider reports separately to CMS to meet its reporting obligations
for their respective quality programs, as applicable. Because the IRF
QRP and the Hospital IQR are separate programs, any HCP who is eligible
to work one day during the reporting period in the IRF would be counted
for purposes of the IRF QRP COVID-19 Vaccination Coverage among HCP
measure, regardless of whether those HCP work in another facility that
is also reporting the same measure.
Comment: A few commenters commented on CMS' statement that the
COVID-19 Vaccination Coverage among HCP measure was modeled after the
Influenza Vaccination among HCP measure. They believe that there are
key differences between the two measures, such as how the vaccines are
administered and data are collected. They stated that it is common for
influenza vaccinations to be administered by the facility itself,
whereas COVID-19 vaccination administration has been varied depending
on the state and locality the provider is located in. They also point
to the fact that the influenza vaccine is administered one time for the
entire flu season with a numerator and denominator that can be
calculated with relative ease. Another commenter listed the different
reporting requirements for the numerator for the COVID-19 vaccination
as compared to the influenza vaccination.
Response: We agree that there are key differences between the
Influenza Vaccination among HCP measure and the COVID-19 Vaccination
Coverage among HCP measure. We acknowledge that even though the CDC
modeled the COVID-19 Vaccination Coverage among HCP measure after the
Influenza Vaccination among HCP measure, FDA-approved influenza
vaccines and the authorized COVID-19 vaccines differ in multiple ways.
The reporting requirements for the numerator of the COVID-19
Vaccination Coverage among HCP measure that one commenter listed are
due to the fact that some COVID-19 vaccines require two doses to reach
full vaccination status, while some COVID-19 vaccines require only one
dose. The measures are aligned with respect to the reporting mechanism
used to report data (the NHSN) and key components of the measure
specifications (for example, the definition of the denominator), but
the measures allow for important differences to reflect the reality
that the circumstances around vaccine administration (that the
commenter points out) are not identical.
[[Page 42394]]
Comment: One commenter disagreed with the proposal of adopting the
COVID-19 Vaccination Coverage among HCP measure to the IRF QRP, citing
the fact that any new measure added to the IRF QRP creates another
basis for CMS to financially penalize IRFs for even the smallest
infractions of the multitudinous guidance documents concerning not only
the reporting of the quality data itself, but the many technical
elements required by the CDC's NHSN system for quality data to be
processed and transferred to CMS. The commenters stated providers
should never be financially penalized if they report all their quality
data by the reporting deadlines, but especially when the quality
measure concerns an ongoing global pandemic. Other commenters stated
that the COVID-19 measure should be outside of the IRF QRP and not be
subject to the 2 percent payment penalty or used for payment decisions.
Response: Section 1886(j)(7)(A)(i) of the Act requires the
Secretary to apply a 2 percent payment penalty under the IRF QRP to
IRFs that fail to meet the IRF QRP reporting requirements during a
fiscal year. IRFs that submit IRF QRP data according to the program's
requirements during a fiscal year will not receive the 2 percent
payment for the fiscal year.
We received comments about the measure in general, but also
specific to the numerator and denominator. We address those comments
here.
Comment: Several commenters pointed to the fact that providers have
many questions about the specifics of the COVID-19 Vaccination Coverage
among HCP measure such as what the long-term plans for using the
measure in the IRF QRP are. Another commenter believes the measure
seemed unnecessary based on the current vaccination push and the fact
that due to the Federal Vaccination Schedule, healthcare workers would
already have received the vaccination. This commenter did not believe
that the measure addressed many of the unknowns still ahead regarding
the virus.
Response: We interpret the commenter's reference to the ``Federal
Vaccination Schedule'' to be referring to the eligibility criteria
during the initial rollout of the COVID-19 vaccine. When the U.S.
supply of COVID-19 vaccine was limited, CDC provided recommendations to
federal, state, and local governments about who should be vaccinated
first. While CDC made recommendations for who should be offered the
COVID-19 vaccines first, each state had its own plan. CMS acknowledges
that healthcare workers were given priority in receiving the vaccine,
but as reported by Medscape Medical News on June 28, 2021,\67\ federal
data show that one in four hospital workers across the United states
are still unvaccinated, and only one in every three hospital workers
are vaccinated in the nation's 50 largest health systems. We believe it
is critical to measure staff vaccination rates among IRFs even as
vaccinations become more common, especially in light of the vaccine
hesitancy other commenters have pointed out. As with all measures
within the IRF QRP, this measure will be routinely monitored and
evaluated, and if substantive changes are necessary, it will be re-
specified through the rulemaking process.
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\67\ Medscape. Disturbing Number of Hospital Workers Still
Unvaccinated. Available at <a href="https://www.medscape.com/viewarticle/953871">https://www.medscape.com/viewarticle/953871</a>. Accessed July 13, 2021.
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In response to the comment questioning the long-term plans for
using the measure, as described in sections VIII.C.1.e and VIII.H.2. of
this final rule, we proposed to adopt the COVID-19 Vaccination Coverage
among HCP measure into the IRF QRP and publicly report on IRF
performance. Once a measure is adopted under the IRF QRP, the measure
will remain in effect until CMS proposes that it be removed, suspended,
or replaced. We refer readers to the CY 2013 Hospital Outpatient
Prospective Payment System/Ambulatory Surgical Center (OPPS/ASC)
Payment Systems and Quality Reporting Programs final rule (77 FR 68500
through 68507) for details on this policy.
Comment: One commenter had questions on what ``fully vaccinated''
meant.
Response: The term ``fully vaccinated'' is not used in the proposed
COVID-19 Vaccine Coverage among HCP measure. We proposed the numerator
for the COVID-19 Vaccination Coverage among HCP measure to include
[…truncated; see source link]Indexed from Federal Register on August 4, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.