[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 [www.gpo.gov]
[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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS.
    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 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS.

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 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS.
    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 http://dx.doi.org/10.15585/mmwr.mm6905e1.
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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 
https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf).
    \3\ CMS, ``COVID-19 Frequently Asked Questions (FAQs) on 
Medicare Fee-for-Service (FFS) Billing,'' (updated March 5, 2021) 
(available at https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf).
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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 http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Software.html. The Grouper software is also embedded in the internet 
Quality Improvement and Evaluation System (iQIES) User tool available 
in iQIES at https://www.cms.gov/medicare/quality-safety-oversight-general-information/iqies.
    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 http://www.cms.gov/manuals/downloads/clm104c25.pdf.
    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 http://www.cms.gov/ElectronicBillingEDITrans/ 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) (https://pacioproject.org/) 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 
(https://del.cms.gov/DELWeb/pubHome) can be referenced on the CMS 
website and in the ONC Interoperability Standards Advisory (ISA). The 
2021 ISA is available at https://www.healthit.gov/isa.
    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 https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement and 
https://rce.sequoiaproject.org/.
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    \4\ ONC, Draft 2 Trusted Exchange Framework and Common 
Agreement, https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf.
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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 https://www.healthit.gov/curesrule/final-rule-policy/information-blocking. ONC has posted information 
resources including fact sheets (https://www.healthit.gov/curesrule/resources/fact-sheets), frequently asked questions (https://www.healthit.gov/curesrule/resources/information-blocking-faqs), and 
recorded webinars (https://www.healthit.gov/curesrule/resources/webinars).
    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

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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.
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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

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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 http://www.bls.gov/mfp for the BLS historical 
published MFP data. A complete description of the MFP projection 
methodology is available on the CMS website at https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/MarketBasketResearch.html. 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.

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    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 https://www.hrsa.gov/coviduninsuredclaim). 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 https://www.hrsa.gov/covid19-coverage-assistance.)
    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 https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/Downloads/ProductivityMemo2016.pdf. 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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.
    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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index. 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 https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf.
    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 https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf) 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 https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf). 
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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRF-Rules-and-Related-Files.html.
    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.
[GRAPHIC] [TIFF OMITTED] TR04AU21.199

    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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[GRAPHIC] [TIFF OMITTED] TR04AU21.200


[[Page 42381]]


[GRAPHIC] [TIFF OMITTED] TR04AU21.201

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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRF-Rules-and-Related-Files.html.
    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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 
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
    \7\ Centers for Disease Control and Prevention. (2020). Your 
Health: Symptoms of Coronavirus. Available at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
    \8\ Centers for Disease Control and Prevention. (2020). Your 
Health: Symptoms of Coronavirus. Available at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
    \9\ Centers for Disease Control and Prevention (2021). Health 
Equity Considerations and Racial and Ethnic Minority Groups. 
Available at https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
    \10\ Centers for Disease Control and Prevention. (2020). CDC 
COVID Data Tracker. Available at https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days.
    \11\ Associated Press. Tired to the Bone. Hospitals Overwhelmed 
with Virus Cases. November 18, 2020. Accessed on December 16, 2020, 
at https://apnews.com/article/hospitals-overwhelmed-coronavirus-cases-74a1f0dc3634917a5dc13408455cd895. 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 https://www.nytimes.com/2020/12/09/world/just-how-full-are-us-intensive-care-units-new-data-paints-an-alarming-picture.html.
    \12\ NPR. U.S. Hits 100,000 COVID-19 Hospitalizations, Breaks 
Daily Death Record. Dec. 2, 2020. Accessed on December 17, 2020 at 
https://www.npr.org/sections/coronavirus-live-updates/2020/12/02/941902471/u-s-hits-100-000-covid-19-hospitalizations-breaks-daily-death-record; The Wall Street Journal. Coronavirus Live Updates: 
U.S. Hospitalizations, Newly Reported Cases, Deaths Edge Downward. 
Accessed on January 11 at https://www.wsj.com/livecoverage/covid-2021-01-11.
    \13\ Centers for Disease Control and Prevention. (2020). CDC 
COVID Data Tracker. Available at https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \14\ Centers for Disease Control and Prevention. (2021). COVID-
19. Your Health. Frequently Asked Questions. Accessed on January 11, 
2021 at https://www.cdc.gov/coronavirus/2019-ncov/faq.html.
    \15\ Centers for Disease Control and Prevention (2021). COVID-
19. Your Health. Frequently Asked Questions. Accessed on January 11, 
2021 at https://www.cdc.gov/coronavirus/2019-ncov/faq.html.
    \16\ Centers for Disease Control and Prevention (2021). COVID-
19. Your Health. Frequently Asked Questions. Accessed on January 11, 
2021 at https://www.cdc.gov/coronavirus/2019-ncov/faq.html.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \17\ Centers for Disease Control and Prevention. (2020). 
Clinical Questions about COVID-19: Questions and Answers. Accessed 
on December 2, 2020 at https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html.
    \18\ Centers for Disease Control and Prevention. (2021). How 
COVID-19 Spreads. Accessed on July 15, 2021 at https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
    \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 https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.
    \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 https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.
---------------------------------------------------------------------------

    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>
---------------------------------------------------------------------------

    \22\ U.S. Food and Drug Administration. (2021). Pfizer-BioNTech 
COVID-19 Vaccine. Available at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine.
    \23\ Ibid.
    \24\ U.S. Food and Drug Administration. (2021). ModernaTX, Inc. 
COVID-19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144636/download.
    \25\ U.S. Food and Drug Administration (2021). Janssen Biotech, 
Inc. COVID-19 Vaccine EUA Letter of Authorization. Available at 
https://www.fda.gov/media/146303/download.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \26\ The White House. Remarks by President Biden on the COVID-19 
Response and the State of Vaccinations. March 29, 2021. Accessed at 
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/.
    \27\ Centers for Disease Control and Prevention. Glossary of 
Terms. https://cdc.gov/infectioncontrol/guidelines/healthcare-personnel/appendix/terminology.html.
    \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 https://www.hhs.gov/sites/default/files/strategy-for-distributing-covid-19-vaccine.pdf; Centers for Disease Control 
(2020). COVID-19 Vaccination Program Interim Playbook for 
Jurisdiction Operations. Accessed December 18 at https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.
    \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 
https://www.kff.org/policy-watch/how-are-states-prioritizing-who-will-get-the-covid-19-vaccine-first/.
    \31\ Associated Press. `Healing is Coming:' US Health Workers 
Start Getting Vaccine. December 15, 2020. Accessed on December 16 at 
https://apnews.com/article/us-health-workers-coronavirus-vaccine-56df745388a9fc12ae93c6f9a0d0e81f.
    \32\ Press Briefing by White House COVID-19 Response Team and 
Public Health Officials [verbar] The White House. Accessed on July 
21, 2021 at 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/.
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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.
---------------------------------------------------------------------------

    \33\ Centers for Medicare & Medicaid Services. Pre-rulemaking. 
Accessed at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rulemaking.
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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 https://www.cms.gov/files/document/measures-under-consideration-list-2020-report.pdf 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 https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94650.
    \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 http://www.qualityforum.org/Publications/2021/03/MAP_2020-2021_Considerations_for_Implementing_Measures_Final_Report_-_Clinicians,_Hospitals,_and_PAC-LTC.aspx.
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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 https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm?s_cid=mm7013e3_w.
---------------------------------------------------------------------------

    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 https://www.qualityforum.org/ProjectMaterials.aspx?projectID=75367.
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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 https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Appendix-B.
---------------------------------------------------------------------------

    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 https://www.cdc.gov/nhsn/nqf/index.html.
    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.
---------------------------------------------------------------------------

    \44\ Centers for Disease Control and Prevention. Surveillance 
for Weekly HCP COVID-19 Vaccination. Accessed at https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \46\ CBS News. More than 20 States Not Ordering All Available 
Doses as COVID-19 Vaccinations Slow. May 3, 2021. Available at 
https://www.cbsnews.com/news/covid-19-vaccine-doses-states/. 
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 https://www.goodrx.com/;blog/covid-19-vaccine-surplus-
vacant-appointments/. Accessed June 24, 2021.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \48\ Centers for Disease Control and Prevention. Vaccine 
Administration. Available at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html. 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 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html. 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.
---------------------------------------------------------------------------

    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 https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained. 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 https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e1.htm?s_cid=mm7018e1_w. 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 https://www.cdc.gov/mmwr/volumes/70/wr/mm7009e4.htm. Accessed July 19, 2021.
---------------------------------------------------------------------------

    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 https://www.medscape.com/viewarticle/953871. 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 https://www.cdc.gov/vaccines/covid-19/vaccinate-with-confidence.html.
    \55\ Centers for Medicare and Medicaid Services. Coronovirus 
(COVID-19) Partner Resources. Available at https://www.cms.gov/outreach-education/partner-resources/coronavirus-covid-19-partner-resources.
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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 https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-after-vaccination.html. 
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 https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. 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.
---------------------------------------------------------------------------

    \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 https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. 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 https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. Accessed June 25, 2021.
---------------------------------------------------------------------------

    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: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained.
    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 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. 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 https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Accessed June 24, 2021.
    \62\ Centers for Disease Control and Prevention. (2020). CDC 
COVID Data Tracker. Available at https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days. Accessed June 24, 2021.
    \63\ Vaccinate Your Family website. Vaccines are cost saving. 
Available at https://vaccinateyourfamily.org/why-vaccinate/vaccine-benefits/costs-of-disease-outbreaks/. Accessed June 25, 2021.
    \64\ U.S. Department of Health & Human Services. 2010 National 
Vaccine Plan. Available at https://www.hhs.gov/sites/default/files/nvpo/vacc_plan/2010-Plan/nationalvaccineplan.pdf. Accessed June 25, 
2021.
    \65\ National Quality Forum. Priority Setting for Healthcare 
Performance Measurement: Addressing Performance Measure Gaps for 
Adult Immunizations. Available at https://www.qualityforum.org/Publications/2014/08/Priority_Setting_for_Healthcare_Performance_Measurement_Addressing_Performance_Measure_Gaps_for_Adult_Immunizations.aspx. 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 https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html.
---------------------------------------------------------------------------

    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 https://www.medscape.com/viewarticle/953871. 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 a 
complete vaccination course as defined in section VIII.C.1.e of this 
final rule. We refer the commenter to the CDC's website at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html where 
the term ``fully vaccinated'' is defined.
    Comment: One commenter requested that once the pandemic subsided, 
that CMS restructure the reporting of this measure to be more similar 
to the influenza measure.
    Response: The Influenza Vaccination among HCP (NQF #0431) measure 
reports the percentage of HCP who receive the influenza vaccination 
during the time from October 1 (or when the vaccine is available) 
through March 31 of the following year,\68\ and is reported annually. 
CMS will continually monitor and evaluate this measure to ensure it 
remains clinically valid. If substantive revisions are needed in the 
future, such revisions would be proposed through the notice and comment 
rulemaking process.
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    \68\ National Quality Forum. Influenza Vaccination Coverage 
among Healthcare Personnel. Available at https://qualityforum.org/QPS/QPSTool.aspx?Exact=fase&Keyword=0431#. Accessed June 26, 2021.
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    Comment: Commenters pointed out that the Influenza Vaccination 
among HCP (NQF #0431) measure utilizes providers working in the 
facility for the denominator, whereas the proposed COVID-19 metric 
utilizes providers eligible to work in the facility. Several commenters 
requested that CMS revise the denominator to include eligible providers 
who have worked at the facility during the period being measured, 
similar to the influenza measure. They believe this would be important 
due to differences across states as to whom would be considered 
``eligible'' to work due to laws such as the Family Medical Leave Act 
(FMLA) and state-level laws associated with defining employee status.
    Response: The COVID-19 Vaccination Coverage among HCP measure 
includes in its calculation HCP who work regularly in an IRF. At times 
HCP who work in a facility may be temporarily absent from the facility 
for any reason including illness, injury, vacation, or leave. The 
Influenza Vaccination among HCP measurement period is the entire 6-
month influenza season so such temporary absences will not affect the 
influenza measure denominator. However, the COVID-19 vaccination 
Coverage among HCP measure has a measurement period of only 1 week, 
which is shorter than the timeframe covered by the influenza 
vaccination measure. This difference accounts for a HCP who works at an 
IRF who may be absent during this shortened period. Therefore, HCP who 
work in the IRF, but may be temporarily absent from the facility for up 
to 2 weeks, are still to be included in the measure denominator.\69\
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    \69\ National Healthcare Safety Network. Instructions for 
Completion of the Weekly Healthcare Personnel COVID-19 Cumulative 
Vaccination Summary Form for Non-Long-Term Care Facilities (57.220, 
Rev 3). Available at https://www.cdc.gov/nhsn/forms/instr/57.220-toi-508.pdf. Accessed June 26, 2021.
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    Comment: Several providers and provider organizations sent in 
comments about the vaccine's contraindications. Several commenters

[[Page 42395]]

stated that contraindications are poorly defined, continue to change, 
and vary depending on the vaccine administered. They point out that 
misinterpretation could lead to fluctuations in the denominator. They 
acknowledge that CDC has narrowed the list of contraindications, but 
``precautions'' still exist, and they are uncertain how precautions 
should be taken into account for reporting purposes.
    Response: Since authorized for emergency use by the FDA, over 300 
million doses of the COVID-19 vaccine have been administered in the 
United States.\70\ These vaccines have undergone the most intensive 
safety monitoring for a vaccine in U.S. history.\71\ This monitoring 
includes using both established and new safety monitoring systems to 
make sure that COVID-19 vaccines are safe. Contraindications are listed 
in the FDA patient and provider Fact Sheets and in the Interim Clinical 
Considerations for Use of COVID-19 Vaccines Currently Authorized in the 
United States at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html. Information may be updated 
based on data from safety monitoring systems at any time. 
Contraindications and other clinical considerations, while rare, are 
accounted for in the COVID-19 Vaccination Coverage among HCP measure. 
However, the precautions listed should not be reported as 
contraindications, as these are not measure exclusions.
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    \70\ Centers for Disease Control and Prevention. COVID Data 
Tracker. Available at https://covid.cdc.gov/covid-data-tracker/#vaccinations. Accessed June 26, 2021.
    \71\ Centers for Disease Control and Prevention. Safety of 
COVID-19 Vaccines. Available at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html. Accessed June 26, 
2021.
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    Comment: One commenter questioned whether immunization sites are 
currently capturing all immunization activity, which could lead to 
lapses in and inaccurate reporting.
    Response: We are unclear what issue the commenter is referring to 
and how it impacts the proposal to adopt the COVID-19 Vaccination 
Coverage among HCP measure into the IRF QRP. 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. HCP receiving 
vaccination elsewhere should provide documentation of vaccination.\72\
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    \72\ National Healthcare Safety Network. Instructions for 
Completion of the Weekly Healthcare Personnel COVID-19 Cumulative 
Vaccination Summary Form for Non-Long-Term Care Facilities (57.220, 
Rev 3). Available at https://www.cdc.gov/nhsn/forms/instr/57.220-toi-508.pdf. Accessed June 26, 2021.
---------------------------------------------------------------------------

    Comment: Several commenters shared their opinion that refining the 
measure and timeline would be appropriate before full implementation. 
They stated that adopting the measure into the QRP should hinge upon 
full approval by the FDA across all existing submitted vaccines under 
the EUA. They stated that feedback from the field is needed to ensure 
that the measure reflects the most current knowledge and evidence. They 
stated that there is still much unknown regarding the long-term 
effectiveness of the current COVID-19 vaccine under the EUA, and 
whether there will be the need for periodic re-inoculation to maintain 
immunity. They urged CMS to remain flexible on the proposed measure and 
adjust it accordingly based on the need to revaccinate.
    Response: We appreciate that there are unanswered questions related 
to the SARS-CoV-2 virus and COVID-19 vaccinations. We will routinely 
monitor and evaluate this measure to ensure it remains valid, reliable, 
and useful to consumers, and if substantive revisions are needed in the 
future, such revisions would be proposed through the notice and comment 
rulemaking process. In the meantime, we believe that the measure 
specifications as proposed are appropriate, and should be implemented 
in a manner that provides stakeholders with timely information about 
staff vaccination rates.
    Comment: We received several comments raising concerns that the 
vaccination rates collected for this measure could vary significantly 
from the time of data submission to the time they are publicly 
reported. They believe the time between data submission and reporting 
will not provide patients with accurate data on the vaccination status 
of HCP in a specific IRF. They question whether the definition of a 
fully vaccinated individual could change between the data submission 
and public reporting of the data, which would provide an even more 
incomplete window into HCP vaccination rates.
    Response: We acknowledge the commenters' concern with regard to 
timely display of publicly reported data. CMS believes it is important 
to make the most up-to-date data available to beneficiaries, which will 
aid them in making essential decisions about health care. In the FY 
2016 IRF PPS final rule (80 FR 47126 through 47127), we finalized our 
procedures for making available to the public information regarding the 
performance of individual IRFs with respect to the measures required 
under section 1899B of the Act. The IRF QRP's public display policy 
allows 4.5 months beyond the end of each calendar year quarter for a 
number of administrative tasks to occur in sequential order, including 
allowing sufficient time for IRFs to be able to submit data, review 
data, make corrections to the data, and view their performance prior to 
public reporting. Subsequently, a number of administrative tasks must 
then occur in sequential order between the time IRF QRP data are 
submitted and they are reported in Care Compare to ensure the validity 
of the data. We have streamlined the process as much as possible, but 
must take these steps to ensure we post IRF QRP data accurately. 
Additionally, the COVID-19 Vaccination Coverage among HCP measure will 
be one of several measures on Care Compare that patients and caregivers 
can use to make informed healthcare decisions.
    Comment: Several commenters stated that because IRFs would be 
dependent upon the HCP's permission to allow reporting their 
vaccination status, it would result in an undercounting of vaccinated 
HCP for a facility since they could choose not to share this 
information.
    Response: We understand that obtaining information about a person's 
vaccination status is dependent upon the HCP sharing that information, 
which is why we encourage providers to voluntarily engage in the 
provision of appropriate and accessible education and vaccine-offering 
activities. Many facilities, including IRFs, across the country are 
educating staff, patients, and patient representatives, and voluntarily 
reporting vaccine administration. The CDC has a number of resources 
\73\ available to providers to assist in building vaccine confidence. 
The Department of Health and Human Services (HHS) has launched a 
national initiative, the ``We Can Do This'' Campaign, to increase 
public confidence in and uptake of COVID-19 vaccines while reinforcing 
basic prevention measures such as mask wearing and social distancing. 
There are a number of resources and toolkits available on the website 
at https://wecandothis.hhs.gov/resources, and the COVID-19 Community 
Corps is available for communities to participate in to help build 
vaccine confidence in your

[[Page 42396]]

community. Additionally, the EEOC has guidance \74\ that states 
requesting documentation or other confirmation showing that an employee 
received a COVID-19 vaccination in the community is not a disability-
related inquiry covered by the Americans with Disabilities Act (ADA) 
and that the federal EEO laws do not prevent an employer from requiring 
all employees physically entering the workplace to be vaccinated for 
COVID-19, subject to the reasonable accommodation provisions of Title 
VII and the ADA.
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    \73\ Centers for Disease Control and Prevention. Building 
Confidence in COVID-19 Vaccines. Available at https://www.cdc.gov/vaccines/covid-19/vaccinate-with-confidence.html. Accessed June 24, 
2021.
    \74\ 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 https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. Accessed June 25, 2021.
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    Comment: A few commenters stated there is no evidence that these 
measures are reliable, valid, or differentiate between providers. As a 
result, they have concern that the data informing the measure are not 
reliable for public consumption. They believe that because of the 
number of challenges associated with reporting, the data reported are 
unlikely to be reliable and could therefore unfairly skew a hospital's 
score on this safety and quality measure.
    Response: There is evidence that this measure can identify 
clinically important differences between providers. As of June 14, 
2021, based on reporting to NHSN, there are facilities which reported 
HCP COVID-19 vaccination coverage rates approaching 100 percent and 
other facilities which reported HCP COVID-19 vaccination coverage rates 
below 50 percent (COVID-19 Nursing Home Data [bond] Data.CMS.gov). We 
expect the same level of differentiation to translate to IRFs. This 
measure was judged to have face validity by the MAP Coordinating 
Committee, which recognized the unique role that measurement plays in 
meeting the COVID-19 healthcare crisis through direct measurement of 
vaccination rates and noted that direct measurement of vaccination for 
patients and HCP is a key approach to addressing a national healthcare 
challenge.\75\ 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, was 
highly correlated between these two systems with a correlation 
coefficient of nearly 90 percent in the second 2 weeks of 
reporting.\76\ We expect similar validity to translate to IRFs. 
Finally, we proposed the measure's denominator to use the same 
identification and categorization as the existing Influenza Vaccination 
among HCP measure,\77\ an NQF-endorsed measure since 2012, which was 
adopted for the IRF QRP in the FY 2014 IRF PPS final rule (78 FR 
47859).
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    \75\ National Quality Forum. Measure Applications Partnership 
2020-2021 Considerations for Implementing Measures in Federal 
Programs: Clinician, Hospital & PAC/LTC. Final Report. March 11, 
2021. Available at http://www.qualityforum.org/Projects/i-m/MAP/MAP_2020-2021_Considerations_for_Implementing_Measures_Final_Report.aspx. 
Accessed June 26, 2021.
    \76\ Geller, et al. Surveillance of COVID-19 vaccination in US 
nursing homes, December 2020-April 2021. Medrxiv.org. Available at 
https://www.medrxiv.org/content/10.1101/2021.05.14.21257224v1.full.pdf. Accessed June 26, 2021.
    \77\ National Quality Forum. Influenza Vaccination Coverage 
among Healthcare Personnel. Available at https://qualityforum.org/QPS/QPSTool.aspx?Exact=fase&Keyword=0431#. Accessed June 26, 2021.
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    Comment: Two commenters urged CMS to delay adopting the measure 
until at least a full calendar year following the COVID-19 PHE has 
ended. They believe the additional time would allow CMS and relevant 
stakeholders the opportunity to discuss and address the challenges, 
avoid negative unintended consequences, and ensure the data captured 
allow accurate reporting that can be trusted by patients and their 
families. Other commenters recommended that CMS either delay adoption 
of the measure for at least one year or adopt the measure for voluntary 
reporting for at least the first year, but any voluntarily reported 
data should not be publicly reported.
    Response: We believe that the unprecedented risks associated with 
the COVID-19 PHE warrant direct attention. Data show that eight out of 
every 10 deaths related to COVID-19 have been in adults 65 years of age 
and older. When compared to 18- to 29-year-olds, adults over 65 have a 
five to eight times higher risk of being hospitalized from COVID-19 and 
those older than 75 have a 220 times higher risk of dying.\78\ 
Moreover, many common chronic conditions raise the risks associated 
with contracting COVID-19, including hypertension, obesity, chronic 
obstructive pulmonary disease, heart disease, diabetes, and chronic 
kidney disease.\79\
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    \78\ National Institute for Health Care Management (NIHCM). 
Aging & COVID-19: Vaccination, Mental and Physical Health, and 
Isolation. Updated February 17, 2021. Available at https://nihcm.org/publications/aging-covid-19-vaccination-mental-and-physical-health-and-isolation. Accessed June 26, 2021.
    \79\ Centers for Disease Control and Prevention. Science Brief: 
Evidence used to update the list of underlying medical conditions 
that increase a person's risk of severe illness from COVID-19. 
Available at https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/underlying-evidence-table.html. Accessed June 26, 
2021.
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    We believe consistent vaccination reporting by IRFs via the NHSN 
and public reporting of this information on Care Compare will assist 
Medicare beneficiaries to make informed choices when selecting IRF 
care. Further, this measure would facilitate patient care and care 
coordination during the discharge planning process. A discharging 
hospital/facility, in collaboration with the patient and family, can 
use this measure to coordinate care and ensure patient preferences are 
considered in the discharge plan. Patients at high risk for negative 
outcomes due to COVID-19 (perhaps due to underlying conditions) can use 
healthcare provider vaccination rates when they are selecting an IRF 
for next-level care. While we have taken into consideration comments 
suggesting that we delay implementation of this measure, we do not 
believe we can delay monitoring and publicly reporting the COVID-19 
Vaccination Coverage among HCP measure. Therefore, we believe it is 
important to begin publicly reporting this measure as proposed. CMS 
will routinely monitor and evaluate this measure to identify unintended 
consequences and to ensure it remains valid, reliable, and useful to 
consumers. The CDC, in collaboration with CMS are planning to submit 
the measure for consideration in the NQF Fall 2021 measure cycle.
    After careful consideration of the public comments, we are 
finalizing our proposal to adopt the COVID-19 Vaccination Coverage 
among HCP measure to the IRF QRP beginning with the FY 2023 IRF QRP.
2. Update to the Transfer of Health (TOH) Information to the Patient--
Post-Acute Care (PAC) Measure Beginning With the FY 2023 IRF QRP
    We proposed to update the Transfer of Health (TOH) Information to 
the Patient--Post-Acute Care (PAC) measure (TOH-Patient) denominator to 
exclude patients discharged home under the care of an organized home 
health service or hospice. This measure assesses for and reports on the 
timely transfer of health information, specifically transfer of a 
medication list. We adopted this

[[Page 42397]]

measure in the FY 2020 IRF PPS final rule (84 FR 39099 through 39107) 
beginning with the FY 2022 IRF QRP. It is a process-based measure that 
evaluates for the transfer of information when a patient is discharged 
from his or her current PAC setting to a private home/apartment, board 
and care home, assisted living, group home, transitional living, or 
home under the care of an organized home health service organization or 
hospice.
    This measure, adopted under section 1899B(c)(1)(E) of the Act, was 
developed to be a standardized measure for the IRF QRP, LTCH QRP, SNF 
QRP, and Home Health (HH) QRP. The measure is calculated by one 
standardized data element that asks, ``At the time of discharge, did 
the facility provide the patient's current reconciled medication list 
to the patient, family, and/or caregiver?'' The discharge location is 
captured by items on the Inpatient Rehabilitation Facility-Patient 
Assessment Instrument (IRF-PAI).
    Specifically, we proposed to update the measure denominator. 
Currently the measure denominators for both the TOH-Patient and the 
TOH-Provider measure assess the number of patients discharged home 
under the care of an organized home health service organization or 
hospice. In order to align the measure with the SNF QRP, LTCH QRP, and 
HH QRP and avoid counting the patient in both TOH measures in the IRF 
QRP, we proposed to remove this location from the definition of the 
denominator for the TOH-Patient measure. Therefore, we proposed to 
update the denominator for the TOH-Patient measure to only discharges 
to a private home/apartment, board and care home, assisted living, 
group home, or transitional living. For additional technical 
information regarding the TOH-Patient measure, we refer readers to the 
document titled ``Final Specifications for IRF QRP Quality Measures and 
Standardized Patient Assessment Data Elements (SPADEs)'' available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/Downloads/Final-Specifications-for-IRF-QRP-Quality-Measures-and-SPADEs.pdf.
    We invited public comment on our proposal to update the denominator 
of the Transfer of Health (TOH) Information to the Patient--Post-Acute 
Care (PAC) measure beginning with the FY 2023 IRF QRP.
    The following is a summary of the public comments received on our 
proposal to update the denominator of the TOH-Patient measure beginning 
with the FY 2023 IRF QRP and our responses:
    Comment: We received overwhelming support for our proposal to 
update the TOH-Patient measure's denominator to remove the inclusion of 
``home under care of an organized home health service organization or 
hospice.'' Commenters agreed that the update will further improve the 
validity and usefulness of the measure, while reducing provider burden. 
Some commenters stated that while they recognize the burden the PHE has 
had on all healthcare facility types, an accurate medication list is 
important to continuity of care. One commenter urged CMS to seek 
endorsement from the NQF on this measure, since it is not currently 
endorsed for use in PAC settings, including IRFs.
    Response: We appreciate the commenter's support. We plan to submit 
the measure for NQF endorsement.
    Comment: One provider noted disappointment that the measure has 
been delayed for at ``least two full fiscal years after the end of the 
PHE.''
    Response: We refer the commenter to the CY 2022 HH PPS proposed 
rule (86 FR 35874) where we proposed to revise the compliance date for 
the collection of data on the Transfer of Health Information to 
Provider-PAC measure and Transfer of Health Information to Patient-PAC 
measure and certain Standardized Patient Assessment Data Elements under 
the IRF QRP beginning October 1, 2022 and invite public comment on the 
proposal.
    After careful consideration of the public comments, we are 
finalizing our proposal to update the denominator of the Transfer of 
Health (TOH) Information to the Patient--Post Acute Care (PAC) measure 
beginning with the FY 2023 IRF QRP.

D. IRF QRP Quality Measures Under Consideration for Future Years: 
Request for Information

    We solicited input on the importance, relevance, appropriateness, 
and applicability of each of the measures and concepts under 
consideration listed in Table 9 for future years in the IRF QRP.
[GRAPHIC] [TIFF OMITTED] TR04AU21.204

    We received several comments on this RFI, which are summarized 
below:
    Comment: Several commenters supported the inclusion of all the 
proposed measures listed in Table 9. One commenter stated that all of 
the measures and measure concepts are important and relevant for 
assessing quality of care delivered to IRF patients. Another commenter 
stated that the concepts should generate valuable data points to 
consider.
    Many commenters supported the concept of frailty, and one commenter 
stated they are encouraged to see frailty included since a frailty 
diagnosis can be linked to a risk for falls and subsequent adverse 
clinical events. Several commenters, however, did not recommend a 
measure of frailty be included in the IRF QRP. Another commenter 
thought that the term ``frailty'' is non-specific and is a concept that 
may not be well understood or applied.
    Many commenters supported the measure concept of the shared 
decision-making process while others questioned how it could be 
captured in the IRF QRP. One commenter stated that while shared 
decision-making is a very important component of patient-

[[Page 42398]]

centered care, IRFs are unique settings that are not well-suited for 
inclusion in certain shared decision-making performance measures since 
shared decision-making requires that multiple options of the same 
clinical value be presented to the patient. Other commenters stated 
that since informed decision making is already part of the CMS 
Conditions of Participation (CoP), this would likely not add any value 
to providers or patients, and they do not support adding what they 
believe would likely be another process measure.
    Several commenters supported the concept of patient-reported 
outcomes (PROs). One commenter stressed the importance of PROs since 
they determine outcomes based on information obtained directly from 
patients, and therefore provide greater insight into patients' 
experience of the outcomes of care. Some commenters did not support the 
concept of PROs because they believe many patients treated in the IRF 
are unable to verbalize and/or lack the cognitive capacity to 
accurately express themselves.
    Several commenters were supportive of the inclusion of pain 
management quality measures, while others were concerned about the 
reporting of opioid use and frequency as a quality measure due to the 
potential for over- or under-prescribing of opioids. One commenter 
stated that because pain is often an inherent part of intensive 
rehabilitation therapy, and is already frequently assessed, it is not 
an appropriate quality reporting measure for the IRF QRP. Several 
commenters stated that a more meaningful pain measure in the IRF 
setting would be designed to assess whether staff are responsive to and 
help manage patients' pain.
    Commenters were generally supportive of the concept of health 
equity in quality measurement. They agree that closing the health 
equity gap is essential to ensure optimal health services and outcomes 
to all Americans regardless of individual characteristics.
    A couple of commenters encouraged CMS to remove topped-out measures 
and low-occurrence measures to ensure the IRF QRP remains relevant to 
quality and performance, and another commenter suggested removal of two 
of the IRF QRP measures currently reported. Finally, one commenter did 
not support any additional measures or measure concepts due to the 
burden associated with adding measures to the IRF QRP.
    Commenters also suggested other concepts for quality measurement in 
the IRF QRP such as quality of life, mental health, and nutritional 
status.
    Response: We appreciate the input provided by commenters. While we 
will not be responding to specific comments submitted in response to 
this RFI in this final rule, we intend to use this input to inform our 
future measure development efforts.

E. Fast Healthcare Interoperability Resources (FHIR) in Support of 
Digital Quality Measurement in Quality Programs--Request for 
Information

1. Solicitation of Comments
    We sought input on the following steps that would enable 
transformation of CMS' quality measurement enterprise to be fully 
digital:
    <bullet> What EHR/IT systems do you use and do you participate in a 
health information exchange (HIE)?
    <bullet> How do you currently share information with other 
providers?
    <bullet> In what ways could we incentivize or reward innovative 
uses of health information technology (IT) that could reduce burden for 
post-acute care settings, including but not limited to IRFs?
    <bullet> What additional resources or tools would post-acute care 
settings, including but not limited to IRFs, and health IT vendors find 
helpful to support the testing, implementation, collection, and 
reporting of all measures using FHIR standards via secure APIs to 
reinforce the sharing of patient health information between care 
settings?
    <bullet> Would vendors, including those that service post-acute 
care settings, such as IRFs, be interested in or willing to participate 
in pilots or models of alternative approaches to quality measurement 
that would align standards for quality measure data collection across 
care settings to improve care coordination, such as sharing patient 
data via secure FHIR API as the basis for calculating and reporting 
digital measures?
    We received a number of comments and appreciate the time commenters 
took to respond. We plan to continue working with other agencies and 
stakeholders to coordinate and to inform our transformation to dQMs 
leveraging health IT standards. We will actively consider all input as 
we develop future regulatory proposals or future subregulatory policy 
guidance. Any updates to specific program requirements related to 
quality measurement and reporting provisions would be addressed through 
separate and future notice-and-comment rulemaking, as necessary.

F. Closing the Health Equity Gap in Post-Acute Care Quality Reporting 
Programs--Request for Information

1. Solicitation of Public Comment
    Under authority of the IMPACT Act and section 1886(j)(7) of the 
Act, we sought comment on the possibility of revising measure 
development, and the collection of other SPADEs that address gaps in 
health equity in the IRF QRP. Any potential health equity data 
collection or measure reporting within a CMS program that might result 
from public comments received in response to this solicitation would be 
addressed through a separate notice-and-comment rulemaking in the 
future.
    Specifically, we invited public comment on the following:
    <bullet> Recommendations for quality measures or measurement 
domains that address health equity, for use in the IRF QRP.
    <bullet> As finalized in the FY 2020 IRF PPS Final Rule (84 FR 
39149 through 39161), IRFs must report certain standardized patient 
assessment data (SPADEs) on SDOH, including race, ethnicity, preferred 
language, interpreter services, health literacy, transportation and 
social isolation.\80\ CMS is seeking guidance on any additional items, 
including SPADEs that could be used to assess health equity in the care 
of IRF patients, for use in the IRF QRP.
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    \80\ In response to the COVID-19 PHE, CMS released an Interim 
Final Rule (85 FR 27595 through 27597) which delayed the compliance 
date for the collection and reporting of the SDOH for at least one 
full fiscal year after the end of the PHE.
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    <bullet> Recommendations for how CMS can promote health equity in 
outcomes among IRF patients. For example, we are interested in feedback 
regarding whether including facility-level quality measure results 
stratified by social risk factors and social determinants of health 
(for example, dual eligibility for Medicare and Medicaid, race) in 
confidential feedback reports could allow facilities to identify gaps 
in the quality of care they provide. (For example, methods similar or 
analogous to the CMS Disparity Methods \81\ which provide hospital-
level confidential results stratified by dual eligibility for 
condition-specific readmission measures which are currently included in 
the Hospital Readmission Reduction Program (see 84 FR 42496 through 
42500)).
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    \81\ https://qualitynet.cms.gov/inpatient/measures/disparity-methods/methodology.
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    <bullet> Methods that commenters or their organizations use in 
employing data to reduce disparities and improve patient outcomes, 
including the source(s) of data used, as appropriate.

[[Page 42399]]

    <bullet> Given the importance of structured data and health IT 
standards for the capture, use, and exchange of relevant health data 
for improving health equity, the existing challenges providers 
encounter for effective capture, use, and exchange of health 
information, such as data on race, ethnicity, and other social 
determinants of health, to support care delivery and decision making.
    While we will not be responding to specific comments submitted in 
response to this Health Equity RFI in this final rule, we appreciate 
all of the comments and interest in this topic. We will continue to 
take all concerns, comments, and suggestions into account as we 
continue work to address and develop policies on this important topic. 
It is our hope to provide additional stratified information to 
providers related to race and ethnicity if feasible. The provision of 
stratified measure results will allow IRFs to understand how they are 
performing with respect to certain patient risk groups, to support 
these providers in their efforts to ensure equity for all of their 
patients and to identify opportunities for improvements in health 
outcomes.

G. Form, Manner, and Timing of Data Submission Under the IRF QRP

1. Background
    We refer readers to the regulatory text at 42 CFR 412.634(b) for 
information regarding the current policies for reporting IRF QRP data.
2. Schedule for Data Submission of the COVID-19 Vaccination Coverage 
Among Healthcare Personnel Measure Beginning With the FY 2023 IRF QRP
    As discussed in section VII.C.1 of the proposed rule, we proposed 
to adopt the COVID-19 Vaccination Coverage among HCP measure beginning 
with the FY 2023 IRF QRP. Given the time-sensitive nature of this 
measure in light of the PHE, we proposed an initial data submission 
period from October 1, 2021 through December 31, 2021. Starting in CY 
2022, IRFs would be required to submit data for the entire calendar 
year beginning with the FY 2024 IRF QRP.
    IRFs would submit data for the measure through the CDC/NHSN web-
based surveillance system. IRFs currently utilize the NHSN for purposes 
of meeting other IRF QRP requirements.\82\ IRFs would use the COVID-19 
vaccination data reporting module in the NHSN Healthcare Personnel 
Safety (HPS) Component to report the cumulative number of HCP eligible 
to work in the healthcare facility for at least 1 day during the 
reporting period, excluding persons with contraindications to COVID-19 
vaccination (denominator) and the cumulative number of HCP eligible to 
work in the IRF for at least 1 day during the reporting period and who 
received a complete vaccination course against COVID-19 (numerator). 
IRFs would submit COVID-19 vaccination data through the NHSN for at 
least 1 week each month and the CDC would report to CMS quarterly.
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    \82\ Centers for Disease Control and Prevention. Surveillance 
for Weekly HCP COVID-19 Vaccination. Accessed at https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html on February 10, 
2021.
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    We invited public comment on this proposal.
    The following is a summary of the public comments received on the 
proposed revisions to the Form, Manner, and Timing of Data Submission 
under the IRF QRP and our responses:
    Comment: A number of commenters wrote to CMS about the 
administrative burden associated with reporting of the measure through 
NHSN. They pointed to other reporting systems being used around the 
country and stated that this would be duplicative reporting. Several 
commenters referenced the Department of Health and Human Services 
TeleTracking system, VaccineFinder, and various state agencies and 
databases. They stated that having to utilize these systems with 
different reporting periods in addition to the NHSN and its reporting 
period utilizes additional resources and will require multiple tracking 
strategies to keep up. They urged CMS to use data from these systems 
without requiring additional data collection in the NHSN. Several of 
these commenters requested that if the measure is finalized, that CMS 
utilize the data submitted through the TeleTracking system.
    Response: The TeleTracking system was one system that was used to 
manage the critical first months of the COVID-19 PHE, as it was 
critical that the federal government received data to facilitate 
planning, monitoring, and resource allocation during the PHE for COVID-
19. The TeleTracking system collects a number of data points, such as 
ventilators in the facility, ventilators in use, ICU beds available, 
and ICU beds occupied. However, the TeleTracking system was not used 
for the IRF QRP. We have proposed to use the NHSN COVID-19 Modules for 
tracking COVID-19 Vaccination Coverage among HCP across all sites of 
service, including IRFs, as most of the state Immunization Information 
Systems do not include the information needed to calculate the COVID-19 
Vaccination Coverage among HCP.
    For meeting the requirements of the IRF QRP, we do not prescribe 
which day of the week the data for the COVID-19 vaccinations must be 
submitted. We refer readers to section VIII.G.2 describing the proposal 
for data submission to the NHSN for more detail.
    Comment: Another commenter encouraged CMS to evaluate both methods 
of how data are submitted (that is, the TeleTracking system and the 
NHSN) and select just one standardized data reporting system and 
process. This commenter was in favor of using the NHSN to report the 
COVID-19 Vaccination Coverage among HCP measure because all care 
settings are using it to report the Influenza Vaccination Coverage 
among HCP and discontinuing COVID-19 vaccination reporting to the HHS 
tracking system. Another commenter urged CMS to use the TeleTracking 
system since the data fields collected in it are less detailed than 
what is required in the NHSN.
    Response: We proposed to use the NHSN COVID-19 Modules for tracking 
COVID-19 Vaccination Coverage among HCP across all sites of service, 
including IRFs. IRFs are familiar with NHSN since they use it to submit 
information for other CDC measures and this system facilitates 
calculation of the COVID-19 Vaccination Coverage among HCP measure so 
CMS can meet its public reporting obligations to provide information to 
beneficiaries seeking care from IRFs.
    Comment: One commenter stated that the reporting burden would be 
high depending on how reporting for the COVID-19 Vaccination Coverage 
among HCP measure interacts with other COVID-19 data reporting 
requirements, and adding this measure would require adjustments in 
workflow for which CMS would need to provide significant technical 
support.
    Response: IRFs are currently required to submit data for the 
Influenza Vaccination among HCP measure (NQF #0431) to the CDC's NHSN 
Healthcare Personnel Safety Component (HPS) annually. Therefore, we 
believe the burden for adding the COVID-19 Vaccination Coverage among 
HCP measure will be minimal for IRFs, since IRFs already have 
experience successfully reporting information using the NHSN reporting 
modules.
    Comment: We received several comments requesting that CMS consider 
reducing the reporting frequency for the COVID-19 Vaccination Coverage 
among HCP measure. They stated that reporting COVID-19 vaccinations 1 
week per month, rather than one time per quarter

[[Page 42400]]

is burdensome. They recommended CMS use quarterly reporting periods to 
align with the influenza vaccination reporting schedule.
    Response: The COVID-19 Vaccination Coverage among HCP measure 
measurement period is only 1 week, considerably shorter than the time 
period covered by the Influenza Vaccination among HCP measure (NQF 
#0431). Additionally, the reporting schedule of 1 week per month was 
chosen to provide vaccination coverage data on a more timely basis than 
the Influenza Vaccination among HCP measure (NQF #0431), while also 
reducing the burden on IRFs that weekly reporting of this information 
would have been.
    Comment: A couple of commenters were concerned that allowing IRFs 
to select which week of the month they will report could lead to IRFs 
selecting the week in which the highest number of employees completed a 
vaccination course. They were also concerned about having only 1 week 
out of the month represent a full month because it might add a 
confounding variable to the data and potentially reduce the value to 
healthcare consumers.
    Response: We proposed to allow IRFs to select which week of the 
month to report for additional flexibility. We note that counts 
reported during a given week should reflect the cumulative number of 
eligible HCP (as defined in the COVID-19 Vaccination Coverage among HCP 
measure specifications \83\) during the reporting period. Thus, IRFs 
have the flexibility to select a week that they determine is 
sufficiently representative of the month. The amount of burden 
reduction by reporting 1 week a month vs. every week a month is 
expected to outweigh any confounding variable that the commenters may 
be referring to. While the reporting experience during the PHE may not 
reflect the experience after the PHE, it is not expected the week -to -
week variation will significantly change vaccination coverage rates, 
particularly as the denominator of HCP consists of those who regularly 
work in the facility, including HCP who may be on temporary (less than 
2-week) leave.
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    \83\ Centers for Disease Control and Prevention. Measure 
Specification: NHSN COVID-19 Vaccination Coverage Updated March 
2021. Available at https://www.cdc.gov/nhsn/pdfs/nqf/covid-vax-hcpcoverage-508.pdf. Accessed June 27, 2021.
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    Comment: A few commenters were concerned about having a shortened 
reporting period of October 1, 2021 through December 31, 2021 to assess 
reporting requirements for the FY 2023 IRF QRP.
    Response: In the FY 2016 IRF PPS Final Rule (80 FR 47122 to 47123), 
CMS revised the data collection time frame for the IRF QRP to a 
calendar year, unless there is a clinical reason for an alternative 
data collection time frame.\84\ We believe this simplifies the data 
collection and submission time frame under the IRF QRP for IRFs, and 
also eliminates the situation in which data collection during a quarter 
in the same calendar year can affect two different years of annual 
payment update determination.\85\ Therefore this proposed data 
collection and submission time frame is consistent with the IRF QRP, 
and we are confident in IRFs' ability to meet the reporting period 
since they have demonstrated their ability to do so since FY 2016.
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    \84\ The NHSN Influenza Vaccination among HCP measure's (NQF 
#0431) data collection period is tied to the influenza vaccination 
season.
    \85\ We refer readers to Section IX.H.3. of the FY 2016 IRF PPS 
Final Rule (80 FR 47122 to 47123). Available at https://www.federalregister.gov/documents/2015/08/06/2015-18973/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal. Accessed June 26, 2021.
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    Comment: A couple of commenters are also concerned about having 
different reporting timelines for the COVID-19 Vaccination Coverage 
among HCP measure and the Influenza Vaccination among HCP measure (NQF 
#0431). They raised the question of whether providers would only have 6 
weeks after the end of the quarter to submit data for the COVID-19 
Vaccination Coverage among HCP measure, since this is the deadline for 
the Influenza Vaccination among HCP measure (NQF #0431). Some 
commenters recommended that CMS use the reporting deadlines used for 
the influenza measures, while others recommended CMS set the deadline 
for reporting the proposed COVID-19 Vaccination Coverage among HCP 
measure data consistent with existing NHSN requirements.
    Response: We thank the commenter for the question. While both 
measures assess vaccination rates among HCP, they are operationalized 
differently. The shortened deadline for the Influenza Vaccination among 
HCP measure (NQF #0431) is necessary to make the data available in the 
public reporting cycle more timely. Since the influenza vaccination 
season ends March 31, a 6-week reporting period is necessary in order 
to publish the measure in the next available public reporting refresh. 
Because the transmission of SARS-CoV-2 virus currently has no 
established seasonality, we proposed 4.5 months after the end of the 
quarter for IRFs to report the data. Additionally, since the measure 
will not be publicly reported until the Fall of 2022, we are able to 
allow the standard review and correct time periods.
    Comment: One commenter stated that since the measure requires 
COVID-19 vaccination rates to be reported monthly, using 1 week of 
data, it would mean that reporting IRFs will need to recalculate the 
numerator and denominator every reporting period in order to submit an 
accurate report. They stated it would require outreach to all 
employees, and a weekly review of the employee roster to ensure ongoing 
accuracy, since the number could potentially change daily.
    Response: IRFs do not need to recalculate the numerator and 
denominator every reporting period. IRFs complete the weekly COVID-19 
cumulative vaccination counts among HCP using the NHSN module, and the 
CDC reports the data to CMS quarterly.
    After careful consideration of the public comments, we are 
finalizing our proposal to require IRFs to submit COVID-19 Vaccination 
Coverage among HCP measure data through the NHSN for at least 1 week 
each month for the CDC to report to CMS quarterly.

H. Policies Regarding Public Display of Measure Data for the IRF QRP

1. Background
    Section 1886(j)(7)(E) of the Act requires the Secretary to 
establish procedures for making the IRF QRP data available to the 
public after ensuring that IRFs have the opportunity to review their 
data prior to public display. IRF QRP measure data are currently 
displayed on the Inpatient Rehabilitation Facilities website within 
Care Compare and the Provider Data Catalog. Both Care Compare and the 
Provider Data Catalog replaced IRF Compare and Data.Medicare.gov, which 
were both retired in December 2020. For a more detailed discussion 
about our policies regarding public display of IRF QRP measure data and 
procedures for the opportunity to review and correct data and 
information, we refer readers to the FY 2017 IRF PPS final rule (81 FR 
52125 through 52131).
2. Public Reporting of the COVID-19 Vaccination Coverage Among 
Healthcare Personnel (HCP) Measure Beginning With the FY 2023 IRF QRP
    We proposed to publicly report the COVID-19 Vaccination Coverage 
among Healthcare Personnel (HCP) measure beginning with the September 
2022 Care Compare refresh or as soon as technically feasible based on 
data

[[Page 42401]]

collected for Q4 2021 (October 1, 2021 through December 31, 2021). If 
finalized as proposed, an IRF's HCP COVID-19 vaccination coverage rates 
would be displayed based on one quarter of data updated quarterly. 
Subsequent to this, 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.
    We invited public comment on the proposal for the public display of 
the measure, COVID-19 Vaccination Coverage among HCP.
    The following is a summary of the public comments received on our 
proposal for the public display of the measure, COVID-19 Vaccination 
Coverage among HCP and our responses:
    Comment: One commenter voiced concern that it was premature to 
publicly report this measure at this time due the fact the measure 
would need to be reported for several years and the underlying evidence 
needed time to become more stable. Another commenter stated that the 
measure is not mature enough for use in a payment program at this time, 
and questions the value this outdated, and potentially incomplete 
information would bring in FY 2023.
    Response: The global outbreak of SARS-CoV-2, which resulted in the 
declaration of a PHE, took a significant toll on institutionalized 
patients, including those in IRFs, who are often at higher risk for 
more serious complications from the virus. We acknowledge that the 
science relating to SARS-CoV-2 virus is continuing to evolve, and we 
are still learning how effective the vaccines are against new variants 
of the virus that causes COVID-19. However, current information 
suggests that COVID-19 vaccines authorized for use in the United States 
offer protection against most variants in the United States.\86\
---------------------------------------------------------------------------

    \86\ 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.
---------------------------------------------------------------------------

    Furthermore, we do not believe that the public reporting of this 
information should be delayed because patients should have access to 
vaccination information when selecting an IRF in which they will 
receive care. CMS will be actively monitoring this measure and the 
evolving circumstances around the PHE. If substantive revisions to this 
measure are needed in the future, such revisions would be proposed 
through the notice and comment rulemaking process at that time.
    Comment: Several commenters stated that if CMS adopted the COVID-19 
Vaccination Coverage among HCP measure, then the data will be publicly 
displayed on Care Compare without proper context. They are concerned 
the public will not understand the legal issues providers feel 
pressured and/or constrained by, nor the information concerning FDA 
approval.
    Response: The comments concerning legal risks are vague and we are 
not clear about the legal risks that commenters are referring to. 
Commenters have raised these concerns related to the vaccine's FDA 
approval and the inability to require their HCP to receive a COVID-19 
vaccination. The COVID-19 vaccinations received Emergency Use 
Authorization (EUA) by the FDA. We refer readers to the FDA website for 
additional information related to the process of vaccination vetting 
and approval at https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained. The EEOC released 
updated and expanded technical assistance on May 28, 2021.\87\ 
Specifically the EEOC stated the 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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    \87\ 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 https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. Accessed June 25, 2021.
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    Comment: Several commenters questioned whether the COVID-19 
Vaccination Coverage among HCP measure data will be of value in 2023 
and beyond given the time associated with data collection, submission, 
and validation. While they support the rights of consumers to access 
real-time meaningful data to help inform healthcare decision-making, 
they believe that the use of a single, dated measure is not a true 
reflection of the safety or quality of care delivered at the IRF.
    Response: We proposed the COVID-19 Vaccination Coverage among HCP 
measure be reported beginning with the September 2022 Care Compare 
refresh or as soon as technically feasible, rather than 2023. However, 
we acknowledge the commenters' concern with regard to timely display of 
publicly reported data. We believe it is important to make the most up-
to-date data available to beneficiaries, which will support them in 
making essential decisions about health care. Based on these concerns, 
we believe it is appropriate to revise the measure's public reporting 
policy to use quarterly reporting, as opposed to averaging over four 
rolling quarters, which would allow the most recent quarter data to be 
displayed without combining it with older quarters of data. This 
revision would not affect the data collection schedule we proposed for 
submitting data to NHSN for the COVID-19 vaccination Coverage among HCP 
measure. This revision would simply update the way the measure's data 
are displayed for public reporting purposes. As always, IRFs will be 
given the chance to preview their COVID-19 Vaccination Coverage among 
HCP measure score, prior to the public posting of these data.
    CMS will closely monitor this measure over the next year, and 
consider any adjustments that are needed with respect to the status of 
and the circumstances surrounding the PHE at that time. If substantive 
revisions are needed in the future, such revisions would be proposed 
through the notice and comment rulemaking process. Additionally, 
reporting of a new or revised measure would be addressed at the time of 
the notice and comment rulemaking process.
    Comment: Commenters had different opinions on whether the 
information obtained from the COVID-19 Vaccination Coverage among HCP 
measure would be helpful to consumers. Some stated that it does little 
to guide patients and their caregivers in the discharge planning 
process or to distinguish IRFs from one another. Another commenter 
acknowledged the value of this information for public health and 
educational purposes, but still believes it would not be appropriate at 
this time to report publicly on the COVID-19 Vaccination Coverage among 
HCP measure for the purposes of assessing IRF quality performance.
    Response: We believe remaining COVID-19- free while receiving IRF 
care is critically important for Medicare beneficiaries, and therefore 
would be helpful to consumers. We regularly perform consumer testing on 
measures that are available on Care Compare to ensure that Care Compare 
supports patients and caregivers in making

[[Page 42402]]

informed choices about critical dimensions of quality. Public reporting 
of this measure will inform patients and caregivers on IRFs' response 
to the PHE.
    We also disagree that the measure does little to guide the 
discharge planning process, but rather this measure would facilitate 
patient care and care coordination during the discharge planning 
process. A discharging hospital/facility, in collaboration with the 
patient and family, can use this measure to coordinate care and ensure 
patient preferences are considered in the discharge plan. Patients at 
high risk for negative outcomes due to COVID-19 (perhaps due to 
underlying conditions) can use healthcare provider vaccination rates 
when they are selecting an IRF for next-level care.
    After careful consideration of the public comments, we are 
finalizing our proposal to publicly report the COVID-19 Vaccination 
Coverage among Healthcare Personnel (HCP) measure beginning with the 
September 2022 Care Compare refresh or as soon as technically feasible 
based on data collected for Q4 2021 (October 1, 2021 through December 
31, 2021) with the modification that we will not finalize our plan to 
add one additional quarter of data during each advancing refresh, until 
the point that four full quarters of data is reached and then report 
the measure using four rolling quarters of data. We will instead only 
report the most recent quarter of data.
3. Public Reporting of Quality Measures in the IRF QRP With Fewer 
Quarters Due to COVID-19 Public Health Emergency (PHE) Exemptions
a. COVID-19 Public Health Emergency Temporary Exemptions
    Under the authority of section 319 of the Public Health Service 
Act, the Secretary of Health and Human Services declared a public 
health emergency (PHE) effective as of January 27, 2020. On March 13, 
2020, subsequent to a presidential declaration of national emergency 
under the Stafford Act, the Secretary invoked section 1135(b) of the 
Act (42 U.S.C. 1320b-5) to waive or modify the requirements of titles 
XVIII, XIX, and XXI of the Act and regulations related to the PHE for 
COVID-19, effective as of March 1, 2020.\88\ On March 27, 2020, we sent 
a guidance memorandum under the subject title, ``Exceptions and 
Extensions for Quality Reporting Requirements for Acute Care Hospitals, 
PPS-Exempt Cancer Hospitals, Inpatient Psychiatric Facilities, Skilled 
Nursing Facilities, Home Health Agencies, Hospices, Inpatient 
Rehabilitation Facilities, Long-Term Care Hospitals, Ambulatory 
Surgical Centers, Renal Dialysis Facilities, and MIPS Eligible 
Clinicians Affected by COVID-19'' to the Medicare Learning Network 
(MLN) Connects Newsletter and Other Program-Specific Listserv 
Recipients,\89\ hereafter referred to as the March 27, 2020 CMS 
Guidance Memo. In that memo we granted an exception to the IRF QRP 
reporting requirements from Q4 2019 (October 1, 2019-December 31, 
2019), Q1 2020 (January 1, 2020-March 31, 2020), and Q2 2020 (April 1, 
2020-June 30, 2020). We also stated that we would not publicly report 
any IRF QRP data that might be greatly impacted by the exceptions from 
Q1 and Q2 of 2020. This exception impacted the schedule for public 
reporting that would have included those two quarters of data.
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    \88\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
    \89\ https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
---------------------------------------------------------------------------

    IRF quality measures are publicly reported on Care Compare. Care 
Compare uses four quarters of data for IRF-PAI assessment-based 
measures and eight quarters for claims-based measures. Table 10 
displays the original schedule for public reporting of IRF QRP 
measures.\90\
---------------------------------------------------------------------------

    \90\ More information about the IRF QRP Public Reporting 
schedule can be found on the IRF QRP Public Reporting website at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Public-Reporting.

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[[Page 42403]]

[GRAPHIC] [TIFF OMITTED] TR04AU21.205

    During 2020, we conducted testing to inform decisions about 
publicly reporting data for those refreshes, which include partially 
and/or fully exempt data (discussed below). The testing helped us 
develop a plan for posting data that are as up-to-date as possible and 
that also meet acceptable standards for public reporting. We believe 
that the plan allows us to provide consumers with helpful information 
on the quality of IRF care, while also making the necessary adjustments 
to accommodate the exemption provided IRFs. The following sections 
provide the results of our testing, and explains how we used the 
results to develop plans for accommodating exempt and partially-exempt 
data in public reporting.
b. Exempted Quarters
    In the March 27, 2020, Medicare Learning Network (MLN) Newsletter 
on Exceptions and Extensions for Quality Reporting Program (QRP) 
Requirements, we stated that we would not report any PAC quality data 
that might be greatly impacted by the exemptions granted for Quarter 1 
and Quarter 2 of 2020. Given the timing of the PHE onset, we determined 
that we would not use IRF-PAI assessments or IRF claims from Quarter 1 
and Quarter 2 of 2020 for public reporting, but that we would assess 
the COVID-19 PHE impact on data from Quarter 4 2019. Before proceeding 
with the December 2020 refresh, we conducted testing to ensure that, 
despite the voluntary nature of reporting for that quarter, public 
reporting would still meet our public reporting standards. We found the 
level of reporting, measured in the number of eligible stays and 
providers, and the reported outcomes, to be in line with levels and 
trends observed in FY 2018 and FY 2019. We note that Quarter 4 2019 
ended before the onset of the COVID-19 pandemic in the United States. 
Thus, we proceeded with including these data in IRF QRP measure 
calculations for the December 2020 refresh.
c. Update on Data Freeze and Proposal for December 2021 Public 
Reporting Methodology for IRF Claims-Based and IRF-PAI Assessment-Based 
Measures
    In addition to the March 2021 refresh, there are several other 
forthcoming refreshes for which the original public reporting schedules 
included exempted quarters of IRF QRP data. The impacted refreshes for 
IRF-PAI assessment and claims based measures are outlined above (Table 
10). We determined that freezing the data displayed on the website with 
the December 2020 refresh values--that is, hold data constant after the 
December 2020 refresh data on the website without subsequent update--
would be the most straightforward, efficient, and equitable approach 
for IRFs. Thus, we decided that, for as many refreshes as necessary, we 
would hold data constant on the website with the December 2020 data, 
and communicate this decision to the public.
    Because December 2020 refresh data will become increasingly out-of-
date and thus less useful for consumers, we

[[Page 42404]]

analyzed whether it would be possible to use fewer quarters of data for 
one or more refreshes and thus reduce the number of refreshes that 
continue to display December 2020 data. Using fewer quarters of more 
up-to-date data requires that: (1) A sufficient percentage of IRFs 
would still likely have enough assessment data to report quality 
measures (reportability); and (2) fewer quarters would likely produce 
similar measure scores for providers, with similar reliability, and 
thus not unfairly represent the quality of care IRFs provide during the 
period reported in a given refresh (reliability).
    To assess these criteria, we conducted reportability and 
reliability analysis using 3 quarters of data in a refresh, instead of 
the standard 4 quarters of data for reporting assessment-based measures 
and using 6 quarters instead of 8 for claims-based measures. 
Specifically, we used historical data to calculate IRF-PAI assessment-
based and IRF claims-based measures under two scenarios:
    (1) Standard Public Reporting (SPR) Base Scenario: We used four 
quarters of CY 2019 data as a proxy alternative for the exempted 
quarters in CY 2020 in order to compare results. For assessment-based 
measures, the quarters used in this scenario are Q1 through Q4 2019. 
For claims-based measures, the quarters used in this scenario are Q1 
2018 through Q4 2019.
    (2) COVID-19 Affected Reporting (CAR) Scenario: We calculated IRF 
QRP measures using 3 quarters (Q2 2019 through Q4 2019) of IRF QRP data 
for assessment-based measures, and 6 quarters (Q1 2018 through Q4 2018 
and Q3 2019 through Q4 2019) for claims-based measures. The CAR 
scenario uses the most recently available data to simulate the public 
health emergency reality where quarters 1 and 2 of a calendar year must 
be excluded from calculation. Quarterly trends in IRF-PAI assessment-
based and IRF claims-based measures indicate that these measures do not 
exhibit substantial seasonal variation.
    To assess performance in these scenarios, we calculated the 
reportability as the percent of IRFs meeting the case minimum for 
public reporting (the public reporting threshold). To test the 
reliability of restricting the IRFs included in the SPR Base Scenario 
to those included in the CAR Scenario, we performed three tests on the 
set of IRFs included in both scenarios. First, we evaluated measure 
correlation using the Pearson and Spearman correlation coefficients, 
which assess the alignment of IRFs' provider scores. Second, for each 
scenario, we conducted a split-half reliability analysis and estimated 
intraclass correlation (ICC) scores, where higher scores imply better 
internal reliability. Modest differences in ICC scores between both 
scenarios would suggest that using fewer quarters of data does not 
impact the internal reliability of the results. Third, we estimated 
reliability scores where a higher value indicates that measure scores 
are relatively consistent for patients admitted to the same IRF and 
variation in the measure reflects true differences across providers. To 
calculate the reliability results, we restricted the IRFs included in 
the SPR scenario included in the CAR scenario.
    Our testing indicated that the expected impact of using fewer 
quarters of data on reportability and reliability of IRF-PAI 
assessment-based measures and IRF claims-based measures is acceptable.
    We proposed to use the CAR scenario as the approach for the 
following affected refreshes: For IRF-PAI assessment-based measures, 
the affected refresh is the December 2021 refresh; for claims-based 
measures, the affected refreshes occur from December 2021 through June 
2023. For the earlier three affected refreshes (March, June, and 
September 2021), we decided to hold constant the Care Compare website 
with December 2020 data. We communicated this decision in a Public 
Reporting Tip Sheet, which is located at https://www.cms.gov/files/document/irfqrp-covid19prtipsheet-october-2020.pdf.
    Our proposal of the CAR approach for the affected refreshes would 
allow us to begin displaying more recent data in December 2021, rather 
than continue displaying December 2020 data (Q1 2019 through Q4 2019 
for assessment-based measures, Q4 2017 through Q3 2019 for claims-based 
measures). We believe that resuming public reporting refreshes starting 
in December 2021 with fewer quarters of data can assist consumers by 
providing more recent quality data as well as more actionable data for 
IRF providers. Our testing results indicate we can achieve these 
positive impacts with acceptable changes in reportability and 
reliability. Table 11 summarizes the revised schedule (that is, frozen 
data) and the proposed schedule (that is, using fewer quarters in the 
affected refreshes) for assessment-based measures. Table 12 summarizes 
the revised schedule (that is, frozen data) and the proposed schedule 
(that is, using fewer quarters in the affected refreshes) for claims-
based measures.
    We invited public comments on the proposal to use the CAR scenario 
to publicly report IRF measures for the December 2021-June 2023 
refreshes.
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BILLING CODE 4120-01-C
    The following is a summary of the public comments received on the 
proposed revisions to use the CAR scenario to publicly report IRF 
measures for the December 2021-June 2023 refreshes and our responses:
    Comment: We received a few comments on the COVID-19 Affected 
Reporting (CAR) scenario methodology proposed. Two commenters stated 
that the CAR scenario appeared to adequately ensure data reportability 
and reliability and also requested that CMS continue to monitor the 
modified Care Compare refreshes until normal reporting resumes to 
ensure the CAR scenario produces valid and reliable results. One 
commenter recommended that CMS continue using the Standard Public 
Reporting (SPR) base scenario, stating that it is more consistent and 
logical to use a continuous time-period rather than a mixture of time 
periods. Three commenters who disagreed with the CAR methodology did 
not provide specific alternative methods. However, they encouraged CMS 
to engage with stakeholders to determine alternative methods for 
updating Care Compare.
    Response: We thank the commenters for their support. Regarding the 
use of the SPR scenario, the use of only continuous time periods would 
have the effect of excluding one or more quarters of data (beyond the 
already excluded Q1 and Q2 2020 quarters) from measure calculations, 
resulting in a longer freeze of the measures on Care Compare. Thus, we 
believe the CAR scenario to be a more appropriate choice moving 
forward. We agree that it will be critical to monitor measures to 
identify any concerning trends, and we will continue to do so as part 
of its routine monitoring activities to regularly assess measure 
performance, reliability, and reportability for all data submitted for 
the IRF QRP.
    Comment: Most commenters expressed their appreciation for the 
flexibility that CMS offered to IRFs during the early months of the 
COVID-19 PHE in granting an exception to the IRF QRP reporting 
requirements from

[[Page 42406]]

Q1 2020 (January 1, 2020 through March 31, 2020) and Q2 2020 (April 1, 
2020 through June 30, 2020). However, a number of commenters raised 
concerns with CMS' proposal to utilize fewer than the standard number 
of quarters for public reporting of quality measures on Care Compare, 
since it will still include Q3 2020 (July 1, 2020 through September 30, 
2020) and Q4 2020 (October 1, 2020 through December 31, 2020). Several 
commenters are concerned that the proposed public reporting schedule 
would utilize data submitted while the country was still under a PHE, 
particularly during the proposed Q3 2020 and Q4 2020 timeframes. A few 
commenters pointed out that the pandemic community infection rate 
surged repeatedly across different regions of the country. One 
commenter noted in some parts of the country the highest infection 
rates occurred after IRFs resumed collecting QRP data in Q3 2020. 
Another commenter raised concern that with fewer quarters being 
reported, more weight would be assigned to data reported for Q3 and Q4 
2020. Several commenters urged CMS to exclude the entire calendar year 
2020 data.
    Response: While we understand that there are concerns related to 
the use of Q3 and Q4 2020 data, we do not believe that further 
exempting providers from QRP reporting requirements, nor the continued 
suspension of public reporting, are actionable solutions. We granted a 
6-month exception to IRF QRP reporting requirements related to the PHE 
for COVID-19 under 42 CFR 412.634(c)(4)(i) of our regulations, a 
sufficient timeframe for IRFs to adjust to the change in care patterns 
associated with the PHE for COVID-19. We further believe that the 
public display of quality data is extremely important, and the 
continued need for access to IRF quality data on Care Compare by CMS 
beneficiaries outweighs any potential provider impacts.
    We conducted testing to inform our decisions about publicly 
reporting data for refreshes using Q3 and Q4 2020 As discussed in 
section VII.H.3.c of the FY 2021 IRF PPS proposed rule (86 FR 19114 
through 19115), the testing helped us develop a plan that we believe 
meets acceptable standards for public reporting. IRFs that believe they 
were disproportionately affected by the PHE may apply for an individual 
exception or extension to the IRF QRP reporting requirement for Q3 and/
or Q4 2020. We direct readers to our regulations at 42 CFR 412.634(c). 
Instructions for requesting an extraordinary circumstances exemption 
(ECE) may be found on the IRF QRP Reconsideration and Exception and 
Extension web page at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Reconsideration-and-Exception-and-Extension.
    Comment: One commenter stated that public reporting should be 
frozen until the first quarter after the end of the PHE.
    Response: We disagree with the commenter about freezing the data 
until after the first quarter of the end of the PHE. Care Compare 
provides a single user-friendly interface that patients and caregivers 
can use to make informed decisions about healthcare based on cost, 
quality of care, volume of services, and other data. COVID-19 has 
caused CMS to take a number of actions to further protect IRF patients. 
Resuming public reporting will inform patients and families of more 
recent information on quality of care provided in IRFs. As we progress, 
CMS will analyze the quality measures for any significant changes, and 
take any actions needed to continue the improvement and protection of 
patient health and safety.
    Comment: One commenter requested that CMS include a notation on 
Care Compare to explain the temporary adjustments made for the PHE. 
Another commenter expressed concern that the public would not have the 
necessary context required to interpret the data that were collected 
during the pandemic.
    Response: We will notify consumers of the use of fewer quarters of 
data reported on Care Compare when the website is refreshed. However, 
we do not believe that posting additional explanation on how IRF 
measure scores may or may not be affected by the ongoing PHE would be 
helpful. Such messages would give the impression the data posted on 
Care Compare are inaccurate or cannot be used when making informed 
healthcare decisions, which is not the case given the extensive testing 
CMS conducts.
    Comment: One commenter suggested that CMS conduct a complete review 
and update the entire Care Compare platform and its reporting metrics 
while the website is in a data freeze, including removing measures that 
are outdated.
    Response: On September 3, 2020, we announced the launch of Care 
Compare, a streamlined redesign of eight legacy CMS healthcare compare 
tools that were available on Medicare.gov, including Inpatient 
Rehabilitation Facility Compare. We will continue to enhance the 
information available to patients, families, and consumers, so they can 
more easily learn about the quality of care nursing homes provide.
    After careful consideration of the public comments, we are 
finalizing our proposal to use the CAR scenario to publicly report IRF 
measures for the December 2021-June 2023 refreshes as proposed without 
modification.
d. Update on Data Freeze and December 2021 Public Reporting Methodology 
for NHSN-Based Measures
    CDC recommends using the four most recent non-contiguous non-
exempted quarters of data for NHSN reporting in the IRF QRP. This non-
contiguous compilation of quarterly reporting would continue until the 
time when four contiguous quarters of reporting resumes (based on CDC's 
review, this would occur in July 2022). Tables 13 and 14 display the 
original schedules for public reporting of IRF CDI NHSN and CAUTI NHSN 
measures and the HCP Influenza NHSN measure, respectively. Tables 15 
and 16 summarize the revised schedule and the proposed schedules for 
IRF CDI and CAUTI NHSN measures and the HCP Influenza measure, 
respectively.
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[[Page 42408]]


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BILLING CODE 4120-01-C
    The following is a summary of the public comments received on the 
proposed schedules for IRF CDI and CAUTI NHSN measures and the HCP 
Influenza measure and our responses:
    Comment: We received one comment regarding the appropriateness of 
reporting Q3 and Q4 2020 data, where the commenter believes that using 
Q3 and Q4 2020 data is problematic and an alternative methodology is 
required.
    Response: As described above in our response to comments regarding 
the general use of Q3 and Q4 2020 data, we do not believe that further 
exempting providers from QRP reporting requirements, nor the continued 
suspension of public reporting, are actionable solutions. We further 
believe that the public display of quality data is extremely important, 
and the continued need for access to provider quality data on Care 
Compare by CMS beneficiaries outweighs any potential provider impacts.
    After careful consideration of the public comment received, we are 
finalizing our proposal to publicly report the IRF CDI and CAUTI NHSN 
measures and the HCP Influenza measure using the four most recent non-
contiguous non-exempted quarters of data until the time when four 
contiguous quarters of reporting resumes.

IX. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 
(DMEPOS) Policy Issues

A. 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 and Complex 
Rehabilitative Manual Wheelchairs

1. Background
    For additional details on Medicare fee schedule payments for DMEPOS 
and specifically for wheelchairs and wheelchair accessories, see the 
interim final rule with comment period 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 through 21925).
a. Medicare Coding and Payment for Wheelchairs
    In 1989, Medicare began making payment for durable medical 
equipment (DME) using fee schedule amounts calculated from supplier 
charges for furnishing the equipment during the 1980s, increased by 
annual update factors specified under the statute. In 1994, CMS in 
collaboration with the wheelchair manufacturing industry and national 
associations representing wheelchair suppliers and manufacturers 
replaced all Healthcare Common Procedure Coding System (HCPCS) codes 
and statutorily-mandated fee schedule amounts for wheelchairs with new 
codes and fee schedule amounts for wheelchair ``bases'' and separate 
codes for ``options'' or accessories furnished in connection with the 
various wheelchair bases. For example, a separate HCPCS code K0040 and 
payment was created for an adjustable angle footplate used on the 
various wheelchair bases. The fee schedule amounts for the separately 
paid and covered wheelchair options/accessories did not vary based on 
the type of wheelchair base furnished with the option/accessory.
    Complex rehabilitative wheelchairs are generally used by patients 
with severe impairments. Such wheelchairs may have features such as 
specialty seating systems that can tilt the patient into various 
positions and special controls such as sip and puff versus a standard 
joystick. In general, the first codes for complex rehabilitative manual 
wheelchairs, which include adult and pediatric size wheelchairs with 
special seating systems, were added to the HCPCS in January 2003, 
although code K0005 for ultralight-weight manual wheelchairs was added 
to the HCPCS in 1994 and was later classified as a complex 
rehabilitative wheelchair in 2012. The first codes for complex 
rehabilitative power wheelchairs were added to the HCPCS in November 
2006. These wheelchairs are further separated into ``Group 2'' and 
``Group 3'' wheelchair bases based on performance capabilities such as 
speed, distance, and obstacle clearance. The fee schedule amounts 
initially established for the separately coded features such as power 
seating systems and sip and puff controls did not vary depending on 
whether they were furnished in connection with a Group 2 complex 
rehabilitative power wheelchair or a Group 3 complex rehabilitative 
power wheelchair.

[[Page 42409]]

b. DMEPOS Competitive Bidding Program (CBP)
    Section 1847(a) of the Act mandates the implementation of the 
Medicare DMEPOS CBP in competitive bidding areas (CBAs) throughout the 
United States for contract award purposes for the furnishing of 
competitively priced items and services falling under three main 
categories specified in paragraph (2) of such section of the Act:
    <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.
    Certain DME items are excluded from the DMEPOS CBP in section 
1847(a)(2)(A), including certain complex rehabilitative power 
wheelchairs recognized by the Secretary as classified within group 3 or 
higher (and related accessories when furnished in connection with such 
wheelchairs). More recently, section 106(a) of the FCAA excluded 
complex rehabilitative manual wheelchairs (as determined by the 
Secretary), and certain manual wheelchairs (identified, as of October 
1, 2018, by HCPCS codes E1235, E1236, E1237, E1238, and K0008 or any 
successor to such codes) and related accessories when furnished in 
connection with such wheelchairs from the DMEPOS CBP.
    Wheelchair accessories frequently furnished in connection with 
manual wheelchairs include adjustable armrests, headrests, anti-tipping 
devices, safety belts and harnesses, adjustable angle footplates, and 
seat and back cushions. These accessories were included under the CBP 
when furnished in connection with standard manual wheelchairs from July 
2013 through December 2018. Wheelchair accessories frequently furnished 
in connection with power wheelchairs include batteries, adjustable 
armrests, headrests, elevating leg rests, safety belts and harnesses, 
and seat and back cushions. These accessories were included under the 
CBP when furnished in connection with standard power wheelchairs from 
January 2011 through December 2018 and when furnished in connection 
with Group 2 complex rehabilitative power wheelchairs from January 2011 
through December 2013. Wheelchair accessories frequently furnished 
uniquely in connection with complex rehabilitative power wheelchairs 
include power seating systems, special interface controls (for example, 
sip and puff versus joystick), and expandable controllers and other 
special electronics. These accessories were included under the CBP when 
furnished in connection with Group 2 complex rehabilitative power 
wheelchairs from January 2011 through December 2013. Complex 
rehabilitative manual wheelchairs have never been included in the CBP.
c. Group 3 or Higher Complex Rehabilitative Power Wheelchairs and 
Related Accessories Excluded From the CBP
    Complex rehabilitative power wheelchairs classified as groups 2 and 
3 were included in Round 1 of the DMEPOS CBP. Section 154(a)(1)(A) of 
Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 
(Pub. L. 110-275) amended section 1847(a)(1) of the Act to add 
paragraph (D) which terminated Round 1 of the DMEPOS CBP and required 
rebidding Round 1 for the same items and services and the same areas 
with some changes. Section 154(a)(1)(B) of MIPPA amended section 
1847(a)(2)(A) of the Act to exclude group 3 or higher complex 
rehabilitative power wheelchairs and related accessories when furnished 
in connection with such wheelchairs from the DMEPOS CBP. Since we 
included group 2 complex rehabilitative power wheelchairs and related 
accessories (including seating systems) and seat and back cushions in 
Round 1 of the DMEPOS CBP, we were required to include those 
wheelchairs and accessories in the Round 1 Rebid of the DMEPOS CBP. The 
accessories (including seating systems) and seat and back cushions 
furnished in connection with group 2 complex rehabilitative power 
wheelchairs (HCPCS codes K0835 through K0843) are the same items 
furnished in connection with group 3 complex rehabilitative power 
wheelchairs (HCPCS codes K0848 through K0864). Standard power 
wheelchairs and related accessories were also included in the Round 1 
Rebid and included accessories such as batteries that are used in both 
complex rehabilitative and standard power wheelchairs but did not 
include accessories that are only used with complex rehabilitative 
power wheelchairs such as power seating systems and specialty interface 
controls (for example, sip and puff).
    The contract performance period and single payment amounts under 
the Round 1 Rebid of the DMEPOS CBP became effective on January 1, 
2011, in the nine Round 1 Rebid areas. Therefore, contract suppliers 
received the single payment amounts established under the CBP for 
furnishing group 1 and 2 standard power wheelchair bases, group 2 
complex rehabilitative power wheelchair bases, and the interchangeable 
accessories used with the different bases (for example, batteries used 
with all power wheelchairs and power seating systems used with both 
group 2 and 3 complex rehabilitative power wheelchairs) in the Round 1 
Rebid areas. As noted above, we did not competitively bid group 3 
complex rehabilitative power wheelchairs or accessories used with a 
group 3 complex rehabilitative power wheelchair in the Round 1 Rebid of 
the DMEPOS CBP, as such items were excluded from the CBP under section 
1847(a)(2)(A) of the Act. Although group 2 complex rehabilitative power 
wheelchair bases and accessories furnished in connection with these 
wheelchairs were included in the Round 1 Rebid of the DMEPOS CBP, these 
items were not included in subsequent rounds of the DMEPOS CBP due to 
the low number of claims and expenditures associated with these items 
and our determination that including these items under the DMEPOS CBP 
would not result in significant savings. However, these items could be 
included in future rounds of the DMEPOS CBP if the number of claims and 
expenditures associated with these items increases.
d. Fee Schedule Adjustments
    Section 1834(a)(1)(F)(ii) of the Act mandates that in the case of 
``covered items'' furnished on or after January 1, 2016, information on 
the payment determined under the CBP shall be used to adjust the fee 
schedule amounts for an area that is not a competitive bidding area. 
Section 1834(a)(13) of the Act defines covered items as durable medical 
equipment and medical supplies. The ``Medicare Program; End-Stage Renal 
Disease Prospective Payment System, Quality Incentive Program, and 
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies'' final 
rule establishing the methodology for using CBP payments to adjust fee 
schedule amounts was issued on November 6, 2014 (79 FR 66120). We 
issued a specific rule under Sec.  414.210(g)(5) for accessories used 
with different types of wheelchair base equipment, such as batteries 
furnished in connection with standard power wheelchairs, as well as 
Group 2 complex rehabilitative power wheelchairs (79 FR 66223 through 
66233). Our intent was that this standard fee schedule adjustment 
methodology would apply to both

[[Page 42410]]

wheelchair accessories furnished in connection with wheelchairs that 
were not included under the CBP, such as batteries or power seating 
systems furnished in connection with Group 3 complex rehabilitative 
power wheelchairs, as well as wheelchair accessories furnished in 
connection with wheelchairs that were included in the CBP. In that 
rulemaking, we stated the Agency's belief that it would be 
unnecessarily burdensome to have different fee schedule amounts for the 
same item (HCPCS code) when it is used with similar, but different 
types of base equipment, and that the costs of furnishing the accessory 
should not vary significantly based on the type of base equipment it is 
used with (79 FR 66230). We began adjusting the fee schedule amounts 
for these common wheelchair accessories based on the rules in 42 CFR 
414.210(g) effective on January 1, 2016.
    Section 2 of the Patient Access and Medicare Protection Act of 2015 
(Pub. L. 114-115) delayed the fee schedule adjustments for accessories 
(including seating systems) and seat and back cushions when furnished 
in connection with group 3 complex rehabilitative power wheelchairs 
until January 1, 2017. Subsequently, section 16005 of the Cures Act 
extended this delay in the fee schedule adjustments based on 
competitive bidding information from January 1, 2017 until July 1, 
2017. Since Congress has acted twice to address the issue, we stated in 
the ``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'' interim final rule 
with comment period (83 FR 21912 through 21925) (hereinafter referred 
to as the ``May 2018 IFC'') that these legislative actions highlighted 
a general concern regarding access to this specialized equipment by the 
vulnerable patient population that depends on this equipment and 
technology (83 FR 21919).
    We discussed in the May 2018 IFC that complex rehabilitative power 
wheelchairs are used by patients needing functionality, such as head or 
sip and puff controls, power tilt or recline seating, or ventilators 
mounted to the wheelchair, which are not available on standard power 
wheelchairs. The ability and performance of the wheelchair in meeting 
the patients' specialized needs is critical, and most patients use 
wheelchair bases with group 3 level performance to meet these needs. 
Far fewer use group 2 wheelchair bases, which are the bases that the 
accessories were included with under Round 1 of the DMEPOS CBP.
    Section 1847(a)(2)(A) of the Act provides the categories of items 
that are subject to the CBP and excludes certain complex rehabilitative 
power wheelchairs recognized by the Secretary as classified within 
group 3 or higher (and related accessories when furnished in connection 
with such wheelchairs). We stated in the May 2018 IFC that this 
statutory exclusion should inform our implementation of section 
1834(a)(1)(F) of the Act such that the fee schedule amounts for 
wheelchair accessories and back and seat cushions used in conjunction 
with group 3 complex rehabilitative power wheelchairs should not be 
adjusted based on the methodologies set forth in Sec.  414.210(g)(5). 
Therefore, as we announced in guidance available on the CMS website in 
June 2017 (located at https://www.cms.gov/Center/Provider-Type/Durable-Medical-Equipment-DME-Center.html), we stated in the May 2018 IFC that 
the fee schedule amounts for wheelchair accessories and back and seat 
cushions used in conjunction with group 3 power wheelchairs would 
continue to be based on the unadjusted fee schedule amounts updated by 
the covered item update specified in section 1834(a)(14) of the Act. In 
the May 2018 IFC (83 FR 21919) and continuation notice in 2021 (86 FR 
21949), we stated that the fee schedule amounts for all other 
accessories and cushions used with other wheelchairs would continue to 
be adjusted based on information from the CBP. We are changing our 
position in this final rule; this payment policy for wheelchair 
accessories and back and seat cushion used in conjunction with group 3 
power wheelchairs would also apply for accessories used in conjunction 
with complex rehabilitative manual wheelchairs for the reasons 
articulated below.
    We note that recently section 106(a) of the FCAA excluded complex 
rehabilitative manual wheelchairs and (as determined by the Secretary), 
and certain manual wheelchairs (identified, as of October 1, 2018, by 
HCPCS codes E1235, E1236, E1237, E1238, and K0008 or any successor to 
such codes) and related accessories from the DMEPOS CBP. In addition, 
section 106(b) of this Act excluded accessories (including seating 
systems) and seat and back cushions when furnished in connection with 
these manual wheelchairs from fee schedule adjustments based on 
information from the DMEPOS CBP from January 1, 2020, through June 30, 
2021. On June 23, 2021, we announced in guidance that we would continue 
the unadjusted fee schedule rates for these manual wheelchair 
accessories through the quarter beginning July 1, 2021. We stated in 
the guidance that we would continue these payment rates based on 
several factors. Beneficiaries with disabilities such as amyotrophic 
lateral sclerosis, cerebral palsy, multiple sclerosis, muscular 
dystrophy, spinal cord injury, and traumatic brain injury often rely on 
complex rehabilitative wheelchairs and accessories to maximize their 
function and independence. It is important to avoid any potential 
operational difficulties for suppliers, our partners in the Medicaid 
program, or private payers that have elected to rely on the DMEPOS fee 
schedule that could result from frequent updates to the Medicare fee 
schedules. Finally, this action is consistent with prior Medicare 
program policy actions related to similar accessories for complex power 
rehabilitative wheelchairs as described in section 2 of the Patient 
Access and Medicare Protection Act of 2015.
    We received 5 timely pieces of correspondence containing comments 
on the May 2018 IFC regarding fee schedule adjustments for accessories 
(including seating systems) and seat and back cushions for Group 3 or 
higher complex rehabilitative power wheelchairs. The comments were from 
wheelchair suppliers and manufacturers as well as a patient advocacy 
organization.
    The following is a summary of the public comments received on the 
Fee Schedule Amounts for Accessories Used with Group 3 Complex 
Rehabilitative Power Wheelchairs policy included in the May 2018 IFC 
and our responses:
    Comment: All of the commenters supported the policy to continue 
paying unadjusted fee schedule amounts for accessories (including 
seating systems) and seat and back cushions furnished in connection 
with group 3 or higher complex rehabilitative power wheelchairs and 
recommended that the same policy be applied to wheelchair accessories 
(including seating systems) and seat and back cushions furnished in 
connection with complex rehabilitative manual wheelchairs. Commenters 
stated that this would ensure access to complex rehabilitative 
wheelchair technology Medicare beneficiaries with significant 
disabilities depend on for functionality and that these needs are just 
as important for manual wheelchair users as they are for power 
wheelchair users. One commenter stated that the functionality that 
complex rehabilitative technology provides enhances lives and prevents 
painful, costly and wholly preventable hospital visits and is as

[[Page 42411]]

needed by a person using a manual wheelchair as it is by a person using 
a power wheelchair. One commenter noted that Congress has acted several 
times to protect complex rehabilitative wheelchair technology from 
payment reductions and that CMS should use its authority to do the 
same. One commenter stated that applying competitive bidding pricing to 
accessories used in connection with complex rehabilitative manual 
wheelchairs and not to accessories used in connection with complex 
rehabilitative power wheelchairs creates a disparity in that people 
with disabilities who use complex rehabilitative manual wheelchairs 
have less access to needed accessories than those using complex 
rehabilitative power wheelchairs and that there should be equal access 
for all beneficiaries who use complex rehabilitative wheelchairs.
    One commenter indicated that complex rehabilitative wheelchair 
accessories are designed to meet a unique clinical need and are 
costlier to provide than standard wheelchair accessories. They also 
indicated that since these special accessories are not used on standard 
wheelchair bases, they are not items that have been included in the CBP 
because only standard wheelchair bases and related accessories have 
been included in the CBP. They stated that CMS is using information 
obtained through the competitive bidding of accessories used on 
standard wheelchairs and inappropriately applying that pricing to 
complex rehabilitative accessories that were not part of the CBP. This 
commenter indicated that the June 2017 policy clarification posted on 
the CMS website regarding application of competitive bidding pricing on 
accessories for complex rehabilitative power wheelchairs should have 
also applied to accessories for complex rehabilitative manual 
wheelchairs as well.
    Response: We agree with the commenters that the issues faced by 
wheelchair users with significant disabilities who depend on complex 
rehabilitative wheelchair technology for functionality and to avoid 
adverse health outcomes is vitally important for this special 
population of wheelchair users and that this issue is no different for 
users of complex rehabilitative manual wheelchairs than it is for users 
of complex rehabilitative power wheelchairs. As noted above by a 
commenter, Congress has acted several times with regards to both manual 
and power complex rehabilitative wheelchair technology to exempt such 
technology from pricing reductions stemming from the CBP, specifically 
fee schedule adjustments based on competitive bidding pricing for 
accessories (including seating systems) and seat and back cushions when 
furnished with either Group 3 or higher complex rehabilitative power 
wheelchairs or complex rehabilitative manual wheelchairs. We believe 
that we should be consistent in applying our policies regarding pricing 
of accessories (including seating systems) and seat and back cushions 
when furnished with either Group 3 or higher complex rehabilitative 
power wheelchairs and complex rehabilitative manual wheelchairs to 
safeguard beneficiaries with significant disabilities who rely on this 
technology to function independently on a daily basis.
    After consideration of the public comments received, we are 
finalizing our policy to exempt accessories (including seating systems) 
and seat and back cushions furnished in connection with Group 3 or 
higher complex rehabilitative power wheelchairs from the fee schedule 
adjustments using prices for these items when furnished with standard 
power wheelchairs or Group 2 complex rehabilitative power wheelchairs 
under the CBP.
    Further, in light of the comments that we believe correctly point 
out that this issue is the same for complex rehabilitative manual 
wheelchairs as it is for Group 3 or higher complex rehabilitative power 
wheelchairs, we are extending this policy to also exempt accessories 
(including seating systems) and seat and back cushions furnished in 
connection with complex rehabilitative manual wheelchairs and other 
complex manual wheelchairs described by HCPCS codes E1235, E1236, 
E1237, E1238, and K0008 from the fee schedule adjustments based on 
information from the CBP. We agree with commenters that these 
accessories (including seating systems) and seat and back cushions are 
different items when furnished in connection with Group 3 or higher 
complex rehabilitative power wheelchairs or complex rehabilitative 
manual wheelchair bases, and that if these wheelchairs are excluded 
from the CBP by statute, then the wheelchairs and related accessories 
should also be excluded from the fee schedule adjustments. We believe 
that the combination of the more complex wheelchair bases and 
accessories and seat and back cushions furnished with those bases make 
up a completely different covered DME item than the combination of the 
less complex wheelchair bases and accessories and seat and back 
cushions. In addition, the statute excludes both related accessories 
furnished in connection with Group 3 or higher complex rehabilitative 
power wheelchair bases and more recently complex rehabilitative manual 
wheelchair bases from the CBP. Complex rehabilitative manual 
wheelchairs and manual wheelchairs described by HCPCS codes E1235, 
E1236, E1237, E1238, and K0008 and related accessories were not 
included in previous rounds of the DMEPOS CBP, and therefore, single 
payment amounts from the DMEPOS CBP are not available for these items. 
In light of comments received on this general issue, we now believe it 
would not be accurate or appropriate to rely on single payment amounts 
established under the DMEPOS CBP based on bids submitted by suppliers 
who are not required to use assistive technology providers to adjust 
the fee schedule amounts for more complex wheelchairs for patients with 
significant disabilities who depend on these important items to 
function every hour of the day.
    Therefore, we are finalizing an exemption for accessories 
(including seating systems) and seat and back cushions furnished in 
connection with Group 3 or higher complex rehabilitative power 
wheelchairs from the fee schedule adjustments under section 
1834(a)(1)(F) of the Act. In light of comments received in response to 
the May 2018 IFC, and out of an abundance of caution, we are also 
extending this exemption to accessories (including seating systems) and 
seat and back cushions furnished in connection with complex 
rehabilitative manual wheelchairs. We agree with commenters that we 
should treat these accessories (including seating systems) and seat and 
back cushions the same whether they are furnished in connection with 
Group 3 or higher complex rehabilitative power wheelchair or complex 
rehabilitative manual wheelchair bases. We note that these items are 
excluded from the CBP and therefore the fee schedule amounts should not 
be adjusted based on information from the CBP. We also note again that 
Congress has acted several times to delay or prohibit fee schedule 
adjustments for these items, and this final rule will continue to 
protect these items from fee schedule adjustments based on information 
from the DMEPOS CBP. Notably, such information from the CBP (single 
payment amounts) was calculated based on bids from suppliers who 
furnished these cushions and accessories in connection with different 
wheelchair bases, so we now believe this information is inapplicable in 
the context of payment for complex

[[Page 42412]]

rehabilitative manual wheelchairs and their cushions and accessories.

B. Exclusion of Complex Rehabilitative Manual Wheelchairs and Certain 
Other Manual Wheelchairs From the DMEPOS Competitive Bidding Program 
(CBP)

    Section 106(a) of the FCAA amended section 1847(a)(2)(A) of the Act 
to exclude complex rehabilitative manual wheelchairs, (as determined by 
the Secretary), certain manual wheelchairs described by HCPCS codes 
E1235, E1236, E1237, E1238, and K0008 or any successor codes, and 
related accessories from the DMEPOS CBP. Therefore, as part of the 
``Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics, 
and Supplies (DMEPOS) Policy Issues and Level II of the Healthcare 
Common Procedure Coding System (HCPCS)'' proposed rule (85 FR 70358 
through 70414) (hereinafter referred to as the ``November 2020 proposed 
rule''), we proposed to make conforming changes to the definition of 
``item'' under Sec.  414.402 to reflect that these wheelchairs and 
related accessories are excluded from the DMEPOS CBP. We proposed to 
edit the definition of item in Sec.  414.402 to exclude ``power 
wheelchairs, complex rehabilitative manual wheelchairs, manual 
wheelchairs described by HCPCS codes E1235, E1236, E1237, E1238, and 
K0008, and related accessories when furnished in connection with such 
wheelchairs.''
    In addition, section 106(b) of the FCAA mandated that, during the 
period beginning on January 1, 2020 and ending June 30, 2021, CMS not 
adjust the Medicare fee schedule amounts for wheelchair accessories 
(including seating systems) and seat and back cushions furnished in 
connection with complex rehabilitative manual wheelchairs (determined 
by the Secretary as HCPCS codes E1161, E1231, E1232, E1233, E1234 and 
K0005) and certain manual wheelchairs currently described by HCPCS 
codes E1235, E1236, E1237, E1238, and K0008 based on information from 
the CBP. We implemented the changes to the fee schedule amounts for 
these items through program instructions based on the discretion 
provided by the FCAA.
    We received 11 timely comments on the November 2020 proposed rule 
regarding excluding complex rehabilitative manual wheelchairs, certain 
other manual wheelchairs, and related accessories furnished in 
connection with these wheelchairs from the CBP. The comments were from 
wheelchair suppliers and manufacturers, as well as a national coalition 
of consumers and clinicians advocating for access to and coverage of 
assistive devices and technologies for persons with injuries, 
illnesses, disabilities, and chronic conditions of all ages.
    The following is a summary of the public comments received on our 
proposal to revise the definition of ``item'' under Sec.  414.402 to 
reflect that complex rehabilitative manual wheelchairs and related 
accessories are excluded from the DMEPOS CBP and our responses:
    Comment: All commenters supported the exclusion of the complex 
rehabilitative manual wheelchairs, other manual wheelchairs and related 
accessories furnished in connection with these wheelchairs from the 
DMEPOS CBP.
    Response: We thank the commenters for supporting the provisions of 
the proposed rule.
    Comment: Several commenters stated that the accessories for these 
wheelchairs should also be permanently excluded from fee schedule 
adjustments based on pricing for the accessories when furnished in 
connection with other wheelchairs included under the CBP. Commenters 
stated that section 1834(a)(1)(F) of the Act requires CMS to adjust the 
fee schedule rates for ``covered items,'' defined as DMEPOS included in 
the CBP, when the same items are furnished outside of CBAs. The 
commenters noted that Congress excluded complex rehabilitative manual 
wheelchairs and related accessories from the CBP, and therefore, they 
cannot be ``covered items'' as defined by section 1834(a)(1)(F) of the 
Act that can be subject to CBP-based adjustments. They stated that 
complex rehabilitative manual wheelchairs and related accessories are 
not CBP items, and therefore, CMS has no data from the CBP for these 
covered items that they can use to adjust the fee schedule amounts for 
such items when furnished outside of competitive bidding areas. 
Commenters also stated that in 2017, CMS recognized the same 
implication in the context of complex rehabilitative power wheelchairs 
and related accessories, which Congress excluded from the CBP and, by 
extension, prohibited any CBP-based adjustments to their fee schedule 
amounts. Commenters noted that CMS, via subregulatory guidance posted 
on its website, stated that the statutory exclusion of complex 
rehabilitative power wheelchairs and related accessories under section 
1847(a)(2)(A) of the Act should ``inform [the agency's] implementation 
of section 1834(a)(1)(F) . . . such that fee schedule amounts for 
wheelchair accessories and seat cushions used in conjunction with group 
3 complex rehabilitative power wheelchairs would not be adjusted based 
on the methodologies in Sec.  414.210(g)(5).'' The commenters noted 
that this same rationale supports a permanent exemption for complex 
rehabilitative manual wheelchairs and related accessories because of 
the enactment of section 106(a) of the FCAA and the corresponding 
exclusion of complex rehabilitative manual wheelchairs and related 
accessories from the CBP.
    Response: We agree with the commenters that complex rehabilitative 
manual wheelchairs and certain other complex manual wheelchairs 
described by HCPCS codes E1235, E1236, E1237, E1238, and K0008 and 
related accessories should be exempt from the fee schedule adjustments 
under section 1834(a)(1)(F) of the Act and address this issue in detail 
under section III of this final rule.
    After consideration of the public comments we received, we are 
finalizing the proposal to revise the definition of ``item'' under 
Sec.  414.402 to conform with section 106(a) of the FCAA. The new 
definition of item appears in the regulation text of this final rule. 
In addition, as discussed in section III. of this final rule, based on 
public comments we received in response to the May 2018 IFC, we are 
finalizing a fee schedule adjustment exemption for accessories 
(including seating systems) and cushions used with complex manual 
wheelchairs and other complex manual wheelchairs described by HCPCS 
codes E1235, E1236, E1237, E1238, and K0008. We agree with commenters 
that we should treat these accessories (including seating systems) and 
seat and back cushions the same whether they are furnished in 
connection with a Group 3 or higher complex rehabilitative power 
wheelchair or complex rehabilitative manual wheelchair bases. We note 
that these items are excluded from the CBP and therefore the fee 
schedule amounts should not be adjusted based on information from the 
CBP.

X. Miscellaneous Comments

    Comment: We received several additional comments that were outside 
the scope of the FY 2022 IRF PPS proposed rule. Specifically, we 
received comments regarding the facility-level adjustment factors, the 
inclusion of recreational therapy, and rehabilitation physician 
training and experience.
    Response: We thank the commenters for bringing these issues to our 
attention, and will take these comments

[[Page 42413]]

into consideration for potential policy refinements.
    Comment: We received a comment in response to the proposed adoption 
of the COVID-19 Vaccination Coverage among HCP measure for the IRF QRP 
recommending CMS assess Immunization Information Systems (IIS).
    Response: This comment falls outside the scope of the FY 2022 IRF 
PPS proposed rule.
    Comment: One commenter provided a document that included a series 
of proposed Care Compare reforms. Another commenter provided comments 
relative to documentation requirements, therapy requirements, prior 
authorization of managed care organizations, burden in the appeals 
process, regulatory flexibility for participation in alternative 
payment models, improving PAC navigability, and changes for specialty 
hospitals.
    Response: We thank the commenter for these suggestions, and will 
take these comments into consideration for potential Care Compare 
refinements.

XI. Provisions of the Final Regulations

    In this final rule, we are adopting the provisions set forth in the 
FY 2022 IRF PPS proposed rule (86 FR 19086), specifically:
    <bullet> We will update the CMG relative weights and average length 
of stay values for FY 2022, in a budget neutral manner, as discussed in 
section V. of this final rule.
    <bullet> We will 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 VI. of this 
final rule.
    <bullet> We will 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 VI. of this final rule.
    <bullet> We will calculate the final IRF standard payment 
conversion factor for FY 2022, as discussed in section VI. of this 
final rule.
    <bullet> We will update the outlier threshold amount for FY 2022, 
as discussed in section VII. of this final rule.
    <bullet> We will update the cost-to-charge ratio (CCR) ceiling and 
urban/rural average CCRs for FY 2022, as discussed in section VII. of 
this final rule.
    The policy changes and updates to the IRF QRP for FYs 2022 and 2023 
are as follows:
    <bullet> Updates to quality measures and reporting requirements 
under the IRF QRP.
    In this final rule, we are also adopting certain policy changes and 
provisions set forth in the interim final rule with comment period 
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 through 
21925) and the proposed rule 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 through 70414) as follows:
    <bullet> Changes to exclude complex rehabilitative manual 
wheelchairs, certain other manual wheelchairs, and accessories 
furnished in connection with these wheelchairs from the DMEPOS CBP.
    <bullet> Changes to exclude Group 3 or higher CRT power wheelchairs 
and accessories furnished in connection with these wheelchairs from the 
fee schedule adjustments under section 1834(a)(1)(F) of the Act.
    In this final rule, we are also extending the fee schedule 
adjustment exclusion for Group 3 or higher CRT power wheelchairs and 
accessories furnished in connection with these wheelchairs to complex 
rehabilitative manual wheelchairs, certain other manual wheelchairs, 
and accessories furnished in connection with these wheelchairs as well.

XII. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the OMB for review and approval. To fairly evaluate whether an 
information collection should be approved by OMB, section 3506(c)(2)(A) 
of the PRA requires that we solicit comment on the following issues:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency;
    <bullet> The accuracy of our estimate of the information collection 
burden;
    <bullet> The quality, utility, and clarity of the information to be 
collected; and
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    This final rule does not impose any new information collection 
requirements as outlined in the regulation. However, this final rule 
does make reference to an associated information collection that is not 
discussed in the regulation text contained in this document. The 
following is a discussion of this information collection, which has 
already received OMB approval.
    As stated in section VII.C. of the FY 2022 IRF PPS proposed rule, 
for purposes of calculating the IRF Annual Increase Factor (AIF), we 
proposed that IRFs submit data on one new quality measure: COVID-19 
Vaccination Coverage among Healthcare Personnel (HCP) beginning with 
the FY 2023 IRF QRP. The aforementioned measure will be collected via 
the following means.

A. COVID-19 Vaccination Coverage Among Healthcare Personnel (HCP) 
Measure

    IRFs will submit data for this quality measure using the Centers 
for Disease Control and Prevention (CDC)/National Healthcare Safety 
Network (NHSN). Data submission by the NHSN occurs via a web-based tool 
hosted by the CDC. This reporting service is provided free of charge to 
healthcare facilities, including IRFs. IRFs currently utilize the NHSN 
for purposes of meeting other IRF QRP requirements.
    We note that the CDC would account for the burden associated with 
the COVID-19 Vaccination Coverage among HCP measure collection under 
OMB control number 0920-1317 (expiration 1/31/2024). Currently, the CDC 
does not estimate burden for COVID-19 vaccination reporting under the 
CDC PRA package currently approved under OMB control number 0920-1317 
because the agency has been granted a waiver under section 321 of the 
National Childhood Vaccine Injury Act of 1986 (Pub. L. 99-660, enacted 
on November 14, 1986 (NCVIA)).\91\ However, we refer readers to section 
X.C.7. of the FY 2022 IRF PPS proposed rule, where we provided an 
estimate of the burden and cost to IRFs, and the CDC will include it in 
a revised information collection request for 0920-1317.
---------------------------------------------------------------------------

    \91\ Section 321 of the NCVIA provides the PRA waiver for 
activities that come under the NCVIA, including those in the NCVIA 
at section 2102 of the Public Health Service Act (42 U.S.C. 300aa-
2). Section 321 is not codified in the U.S. Code, but can be found 
in a note at 42 U.S.C. 300aa-1.
---------------------------------------------------------------------------

    In section VII.C.2. of the proposed rule, we proposed to update the 
Transfer of Health (TOH) Information to the Patient--Post-Acute Care 
(PAC) measure to exclude residents discharged

[[Page 42414]]

home under the care of an organized home health service or hospice. 
This measure was adopted in the FY 2020 IRF PPS final rule (84 FR 39099 
through 39107) and burden accounted for in OMB control number 0938-0842 
(expiration December 31, 2022). The finalized update to the measure's 
denominator does not affect the information collection burden already 
established.

XIII. Regulatory Impact Analysis

A. Statement of Need

    This final rule updates the IRF prospective payment rates for FY 
2022 as required under section 1886(j)(3)(C) of the Act and in 
accordance with section 1886(j)(5) of the Act, which requires the 
Secretary to publish in the Federal Register on or before August 1 
before each FY, the classification and weighting factors for CMGs used 
under the IRF PPS for such FY and a description of the methodology and 
data used in computing the prospective payment rates under the IRF PPS 
for that FY. This final rule also implements section 1886(j)(3)(C) of 
the Act, which requires the Secretary to apply a productivity 
adjustment to the market basket increase factor for FY 2012 and 
subsequent years.
    Furthermore, this final rule adopts policy changes under the 
statutory discretion afforded to the Secretary under section 1886(j) of 
the Act. We are also finalizing updates to quality measures and 
reporting requirements under the IRF QRP. In addition, this final rule 
finalizes 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 implementation of section 106(a) of the FCAA.

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in Executive Order 12866.
    Section (6)(a) of Executive Order 12866 provides that a regulatory 
impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We estimate the total impact of the policy updates described in this 
final rule by comparing the estimated payments in FY 2022 with those in 
FY 2021. This analysis results in an estimated $130 million increase 
for FY 2022 IRF PPS payments. Additionally, we estimate that costs 
associated with the proposal to update the reporting requirements under 
the IRF QRP result in an estimated $489,536.16 addition to costs in FY 
2022 for IRFs. We also estimate a $170 million dollar increase in 
Medicare payments for the provisions related to paying higher rates for 
wheelchair accessories used with complex power and manual wheelchairs 
for the period from FY 2022 to FY 2026. Based on our estimates OMB's 
Office of Information and Regulatory Affairs has determined that this 
rulemaking is ``economically significant'' as measured by the $100 
million threshold, and hence also a major rule under Subtitle E of the 
Small Business Regulatory Enforcement Fairness Act of 1996 (also known 
as the Congressional Review Act).
    Note that the Medicare DMEPOS provisions related to wheelchair 
accessories are assumed to add a total of $170 million dollars in 
increased Medicare payments to the overall impact of the rule from FY 
2022 to FY 2026.
    Also, the rule has been reviewed by OMB. Accordingly, we have 
prepared an RIA that, to the best of our ability, presents the costs 
and benefits of the rulemaking.

C. Anticipated Effects

1. Effects on IRFs and DME Suppliers
a. Effects on IRFs
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, small entities 
include small businesses, nonprofit organizations, and small 
governmental jurisdictions. Most IRFs and most other providers and 
suppliers are small entities, either by having revenues of $8.0 million 
to $41.5 million or less in any 1 year depending on industry 
classification, or by being nonprofit organizations that are not 
dominant in their markets. (For details, see the Small Business 
Administration's final rule that set forth size standards for health 
care industries, at 65 FR 69432 at https://www.sba.gov/sites/default/files/2019-08/SBA%20Table%20of%20Size%20Standards_Effective%20Aug%2019%2C%202019_Rev.pdf, effective January 1, 2017 and updated on 
August 19, 2019.) Because we lack data on individual hospital receipts, 
we cannot determine the number of small proprietary IRFs or the 
proportion of IRFs' revenue that is derived from Medicare payments. 
Therefore, we assume that all IRFs (an approximate total of 1,114 IRFs, 
of which approximately 54 percent are nonprofit facilities) are 
considered small entities and that Medicare payment constitutes the 
majority of their revenues. HHS generally uses a revenue impact of 3 to 
5 percent as a significance threshold under the RFA. As shown in Table 
17, we estimate that the net revenue impact of this final rule on all 
IRFs is to increase estimated payments by approximately 1.5 percent. 
The rates and policies set forth in this final rule will not have a 
significant impact (not greater than 3 percent) on a substantial number 
of small entities. The estimated impact on small entities is shown in 
Table 17. MACs are not considered to be small entities. Individuals and 
states are not included in the definition of a small entity.

[[Page 42415]]

    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area and has fewer 
than 100 beds. As shown in Table 17, we estimate that the net revenue 
impact of this final rule on rural IRFs is to increase estimated 
payments by approximately 1.6 percent based on the data of the 133 
rural units and 12 rural hospitals in our database of 1,114 IRFs for 
which data were available. We estimate an overall impact for rural IRFs 
in all areas between -0.1 percent and 3.0 percent. The Secretary hereby 
certifies that this final rule will not have a significant impact on a 
substantial number of small entities.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-04, enacted on March 22, 1995) (UMRA) also requires that agencies 
assess anticipated costs and benefits before issuing any rule whose 
mandates require spending in any 1 year of $100 million in 1995 
dollars, updated annually for inflation. In 2021, that threshold is 
approximately $158 million. This final rule does not mandate any 
requirements for State, local, or tribal governments, or for the 
private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has federalism 
implications. As stated, this final rule will not have a substantial 
effect on state and local governments, preempt state law, or otherwise 
have a federalism implication.
b. Effects on DME Suppliers
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. The DMEPOS provisions of this rule are not 
considered to have a significant impact on a substantial number of 
small entities as payments continue at their current levels.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. The DMEPOS provisions of 
this rule are not considered to have a significant impact on the 
operations of a substantial number of small rural hospitals.
    Section 202 of the UMRA also requires that agencies assess 
anticipated costs and benefits before issuing any rule whose mandates 
require spending in any 1 year of $100 million in 1995 dollars, updated 
annually for inflation. In 2021, that threshold is approximately $158 
million. The DMEPOS provisions of this rule do not mandate any 
requirements for State, local, or tribal governments, or for the 
private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has federalism 
implications. As stated, the DMEPOS provisions of this final rule will 
not have a substantial effect on state and local governments, preempt 
state law, or otherwise have a federalism implication.
2. Detailed Economic Analysis
    This final rule will update the IRF PPS rates contained in the FY 
2021 IRF PPS final rule (85 FR 48424). Specifically, this final rule 
will update the CMG relative weights and ALOS values, the wage index, 
and the outlier threshold for high-cost cases. This final rule will 
apply a productivity adjustment to the FY 2022 IRF market basket 
increase factor in accordance with section 1886(j)(3)(C)(ii)(I) of the 
Act.
    We estimate that the impact of the changes and updates described in 
this final rule would be a net estimated increase of $130 million in 
payments to IRF providers. The impact analysis in Table 17 of this 
final rule represents the projected effects of the updates to IRF PPS 
payments for FY 2022 compared with the estimated IRF PPS payments in FY 
2021. We determine the effects by estimating payments while holding all 
other payment variables constant. We use the best data available, but 
we do not attempt to predict behavioral responses to these changes, and 
we do not make adjustments for future changes in such variables as 
number of discharges or case-mix.
    We note that certain events may combine to limit the scope or 
accuracy of our impact analysis, because such an analysis is future-
oriented and, thus, susceptible to forecasting errors because of other 
changes in the forecasted impact time period. Some examples could be 
legislative changes made by the Congress to the Medicare program that 
would impact program funding, or changes specifically related to IRFs. 
Although some of these changes may not necessarily be specific to the 
IRF PPS, the nature of the Medicare program is such that the changes 
may interact, and the complexity of the interaction of these changes 
could make it difficult to predict accurately the full scope of the 
impact upon IRFs.
    In updating the rates for FY 2022, we are implementing the standard 
annual revisions described in this final rule (for example, the update 
to the wage index and market basket increase factor used to adjust the 
Federal rates). We are also reducing the FY 2022 IRF market basket 
increase factor by a productivity adjustment in accordance with section 
1886(j)(3)(C)(ii)(I) of the Act. We estimate the total increase in 
payments to IRFs in FY 2022, relative to FY 2021, would be 
approximately $130 million.
    This estimate is derived from the application of the FY 2022 IRF 
market basket increase factor, as reduced by a productivity adjustment 
in accordance with section 1886(j)(3)(C)(ii)(I) of the Act, which 
yields an estimated increase in aggregate payments to IRFs of $160 
million. However, there is an estimated $30 million decrease in 
aggregate payments to IRFs due to the update to the outlier threshold 
amount. Therefore, we estimate that these updates would result in a net 
increase in estimated payments of $130 million from FY 2021 to FY 2022.
    The effects of the updates that impact IRF PPS payment rates are 
shown in Table 17. The following updates that affect the IRF PPS 
payment rates are discussed separately below:
    <bullet> The effects of the update to the outlier threshold amount, 
from approximately 3.4 percent to 3.0 percent of total estimated 
payments for FY 2022, consistent with section 1886(j)(4) of the Act.
    <bullet> The effects of the annual market basket update (using the 
IRF market basket) to IRF PPS payment rates, as required by sections 
1886(j)(3)(A)(i) and (j)(3)(C) of the Act, including a productivity 
adjustment in accordance with section 1886(j)(3)(C)(i)(I) of the Act.
    <bullet> The effects of applying the budget-neutral labor-related 
share and wage index adjustment, as required under section 1886(j)(6) 
of the Act.
    <bullet> The effects of the budget-neutral changes to the CMG 
relative weights and ALOS values under the authority of section 
1886(j)(2)(C)(i) of the Act.
    <bullet> The total change in estimated payments based on the FY 
2022 payment changes relative to the estimated FY 2021 payments.

[[Page 42416]]

3. Description of Table 17
    Table 17 shows the overall impact on the 1,114 IRFs included in the 
analysis.
    The next 12 rows of Table 17 contain IRFs categorized according to 
their geographic location, designation as either a freestanding 
hospital or a unit of a hospital, and by type of ownership; all urban, 
which is further divided into urban units of a hospital, urban 
freestanding hospitals, and by type of ownership; and all rural, which 
is further divided into rural units of a hospital, rural freestanding 
hospitals, and by type of ownership. There are 969 IRFs located in 
urban areas included in our analysis. Among these, there are 665 IRF 
units of hospitals located in urban areas and 304 freestanding IRF 
hospitals located in urban areas. There are 145 IRFs located in rural 
areas included in our analysis. Among these, there are 133 IRF units of 
hospitals located in rural areas and 12 freestanding IRF hospitals 
located in rural areas. There are 407 for-profit IRFs. Among these, 
there are 373 IRFs in urban areas and 34 IRFs in rural areas. There are 
599 non-profit IRFs. Among these, there are 509 urban IRFs and 90 rural 
IRFs. There are 108 government-owned IRFs. Among these, there are 87 
urban IRFs and 21 rural IRFs.
    The remaining four parts of Table 17 show IRFs grouped by their 
geographic location within a region, by teaching status, and by DSH 
patient percentage (PP). First, IRFs located in urban areas are 
categorized for their location within a particular one of the nine 
Census geographic regions. Second, IRFs located in rural areas are 
categorized for their location within a particular one of the nine 
Census geographic regions. In some cases, especially for rural IRFs 
located in the New England, Mountain, and Pacific regions, the number 
of IRFs represented is small. IRFs are then grouped by teaching status, 
including non-teaching IRFs, IRFs with an intern and resident to 
average daily census (ADC) ratio less than 10 percent, IRFs with an 
intern and resident to ADC ratio greater than or equal to 10 percent 
and less than or equal to 19 percent, and IRFs with an intern and 
resident to ADC ratio greater than 19 percent. Finally, IRFs are 
grouped by DSH PP, including IRFs with zero DSH PP, IRFs with a DSH PP 
less than 5 percent, IRFs with a DSH PP between 5 and less than 10 
percent, IRFs with a DSH PP between 10 and 20 percent, and IRFs with a 
DSH PP greater than 20 percent.
    The estimated impacts of each policy described in this rule to the 
facility categories listed are shown in the columns of Table 17. The 
description of each column is as follows:
    <bullet> Column (1) shows the facility classification categories.
    <bullet> Column (2) shows the number of IRFs in each category in 
our FY 2022 analysis file.
    <bullet> Column (3) shows the number of cases in each category in 
our FY 2022 analysis file.
    <bullet> Column (4) shows the estimated effect of the adjustment to 
the outlier threshold amount.
    <bullet> Column (5) shows the estimated effect of the update to the 
IRF labor-related share and wage index, in a budget-neutral manner.
    <bullet> Column (6) shows the estimated effect of the update to the 
CMG relative weights and ALOS values, in a budget-neutral manner.
    <bullet> Column (7) compares our estimates of the payments per 
discharge, incorporating all of the policies reflected in this final 
rule for FY 2022 to our estimates of payments per discharge in FY 2021.
    The average estimated increase for all IRFs is approximately 1.5 
percent. This estimated net increase includes the effects of the IRF 
market basket increase factor for FY 2022 of 1.9 percent update based 
on an IRF market basket update of 2.6 percent, less a 0.7 percentage 
point productivity adjustment, as required by section 
1886(j)(3)(C)(ii)(I) of the Act. It also includes the approximate 0.4 
percent overall decrease in estimated IRF outlier payments from the 
update to the outlier threshold amount. Since we are making the updates 
to the IRF wage index, labor-related share and the CMG relative weights 
in a budget-neutral manner, they will not be expected to affect total 
estimated IRF payments in the aggregate. However, as described in more 
detail in each section, they will be expected to affect the estimated 
distribution of payments among providers.
BILLING CODE 4120-01-P

[[Page 42417]]

[GRAPHIC] [TIFF OMITTED] TR04AU21.212


[[Page 42418]]


[GRAPHIC] [TIFF OMITTED] TR04AU21.213

BILLING CODE 4120-01-C
4. Impact of the Update to the Outlier Threshold Amount
    The estimated effects of the update to the outlier threshold 
adjustment are presented in column 4 of Table 17.
    For the FY 2022 proposed rule, we used preliminary FY 2020 IRF 
claims data, and, based on that preliminary analysis, we estimated that 
IRF outlier payments as a percentage of total estimated IRF payments 
would be 3.3 percent in FY 2022. As we typically do between the 
proposed and final rules each year, we updated our FY 2020 IRF claims 
data to ensure that we are using the most recent available data in 
setting IRF payments. Therefore, based on updated analysis of the most 
recent IRF claims data for this final rule, we estimate that IRF 
outlier payments as a percentage of total estimated IRF payments are 
3.4 percent in FY 2022. Thus, we are adjusting the outlier threshold 
amount in this final rule to maintain total estimated outlier payments 
equal to 3 percent of total estimated payments in FY 2022. The 
estimated change in total IRF payments for FY 2022, therefore, includes 
an approximate 0.4 percentage point decrease in payments because the 
estimated outlier portion of total payments is estimated to decrease 
from approximately 3.4 percent to 3 percent.
    The impact of this outlier adjustment update (as shown in column 4 
of Table 17) is to decrease estimated overall payments to IRFs by 0.4 
percentage point.
5. Impact of the Wage Index and Labor-Related Share
    In column 5 of Table 17, we present the effects of the budget-
neutral update of the wage index and labor-related share. The changes 
to the wage index and the labor-related share are discussed together 
because the wage index is applied to the labor-related share portion of 
payments, so the changes in the two have a combined effect on payments 
to providers. As discussed in section VI.C. of this final rule, we are 
updating the labor-related share from 73.0 percent in FY 2021 to 72.9 
percent in FY 2022.
6. Impact of the Update to the CMG Relative Weights and ALOS Values.
    In column 7 of Table 17, we present the effects of the budget-
neutral update of the CMG relative weights and ALOS values. In the 
aggregate, we do not estimate that these updates will affect overall 
estimated payments of IRFs. However, we do expect these updates to have 
small distributional effects.
7. Effects of Requirements for the IRF QRP for FY 2022
    In accordance with section 1886(j)(7)(A) of the Act, the Secretary 
must reduce by 2 percentage points the annual market basket increase 
factor otherwise applicable to an IRF for a fiscal year if the IRF does 
not comply with the requirements of the IRF QRP for that fiscal year. 
In section VII.A of this final rule, we discussed the method for 
applying the 2 percentage point reduction to IRFs that fail to meet the 
IRF QRP requirements. As discussed in section VIII C. of this final 
rule, we are finalizing the adoption of one measure to the IRF QRP 
beginning with the FY 2023 IRF QRP, the COVID-19 Vaccination Coverage 
among Healthcare Personnel (HCP) measure, and finalizing our proposal 
to update the denominator of the Transfer of Health (TOH) Information 
to the Patient--Post-Acute Care (PAC) measure beginning with the FY 
2023 IRF QRP. As discussed in section VIII.G. of this final rule, we 
are finalizing the CDC/NHSN web-based surveillance system for data 
submission for the COVID-19 Vaccination Coverage among HCP measure. As 
discussed in section VIII.H., we are finalizing two public reporting 
policies. The first is to publicly report the COVID-19 Vaccination 
Coverage among Healthcare Personnel (HCP) measure beginning with the 
September 2022 Care Compare refresh or as soon as technically feasible 
based on data collected for Q4 2021 (October 1, 2021 through December 
31, 2021) using the most recent quarter of data. Second, we are 
finalizing use of the CAR scenario to publicly report IRF QRP measures 
for the December 2021-June 2023 refreshes and to publicly report the 
NHSN Facility-wide Inpatient Hospital-onset Clostridium difficile 
Infection (CDI) Outcome Measure (NQF #1717), the NHSN Catheter 
Associated Urinary Tract Infection (CAUTI) Outcome Measure (NQF #0138), 
and the NHSN Influenza Vaccination among HCP (NQF #0431) measure using 
the four most recent non-contiguous non-exempted quarters of data until 
the time when four contiguous quarters of reporting resumes.
    We believe that the burden associated with the IRF QRP is the time 
and effort associated with complying with the requirements of the IRF 
QRP. The finalized IRF QRP requirements add no additional burden to the 
active collection under OMB control number 0938-0842 (expiration 12/31/
2022). Currently, the CDC does not estimate burden for COVID-19 
vaccination reporting under the CDC PRA package currently approved 
under OMB control number 0920-1317 because the agency has been granted 
a waiver under section 321 of the NCVIA. However, CMS has provided an 
estimate of burden and cost for IRFs here, and the CDC will include it 
in a revised information collection request for 0920-1317. Consistent 
with the CDC's experience of collecting data

[[Page 42419]]

using the NHSN, we estimate that it would take each IRF an average of 1 
hour per month to collect data for the COVID-19 Vaccination Coverage 
among HCP measure and enter it into NHSN. We have estimated the time to 
complete this entire activity, since it could vary based on provider 
systems and staff availability. We believe it would take an 
administrative assistant from 45 minutes up to 1 hour and 15 minutes to 
enter this data into NHSN. For the purposes of calculating the costs 
associated with the collection of information requirements, we obtained 
mean hourly wages from the U.S. Bureau of Labor Statistics' (BLS) May 
2019 National Occupational Employment and Wage Estimates.\92\ To 
account for overhead and fringe benefits, we have doubled the hourly 
wage. These amounts are detailed in Table 18.
---------------------------------------------------------------------------

    \92\ https://www.bls.gov/oes/current/oes_nat.htm. Accessed on 
March 30, 2021.
[GRAPHIC] [TIFF OMITTED] TR04AU21.214

    Based on the time range, it would cost each IRF between $27.47 and 
$45.78 each month or an average cost of $36.62 each month, and between 
$329.64 and $549.36 each year. We believe the data submission for the 
COVID-19 Vaccination Coverage among HCP measure would cause IRFs to 
incur additional average burden of 12 hours per year for each IRF and a 
total annual burden of 13,368 hours across all IRFs. The estimated 
annual cost across all 1,114 IRFs in the U.S. for the submission of the 
COVID-19 Vaccination Coverage among HCP measure would range from 
$367,218.96 and $611,987.04 with an average of $489,536.16.
    We recognize that many IRFs may also be reporting other COVID-19 
data to HHS. However, we believe the benefits of reporting data on the 
COVID-19 Vaccination Coverage among HCP measure to assess whether the 
potential spread of COVID-19 among their HCP, and the risk of 
transmission of COVID-19 within IRFs, and to help sustain the ability 
of IRFs to continue serving their communities throughout the PHE and 
beyond outweigh the costs of reporting. We received no comments on the 
estimated time to collect data and enter it into NHSN.
8. Effects of Requirements for the DMEPOS Provisions
a. 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 and Complex 
Rehabilitative Manual Wheelchairs
    In this final rule, we are finalizing a policy exempting wheelchair 
accessories furnished in connection with Group 3 complex rehabilitative 
power wheelchairs from fee schedule adjustments based on information 
from the DMEPOS CBP. The cost of this provision is estimated to be $130 
million dollars in increased Medicare payments with $30 million dollars 
in increased beneficiary copayments from FY 2022 to FY 2026. This cost 
can be considered in the FY 2022 President's budget baseline. We are 
also finalizing a policy exempting wheelchair accessories furnished in 
connection with complex rehabilitative manual wheelchairs from fee 
schedule adjustments based on information from the DMEPOS CBP. This 
policy was not reflected in the FY 2022 President's budget baseline and 
has an estimated cost of $40 million dollars in increased Medicare 
payments with $10 million dollars in increased beneficiary copayments 
from FY 2022 to FY 2026.
b. Exclusion of Complex Rehabilitative Manual Wheelchairs and Certain 
Other Manual Wheelchairs From the DMEPOS CBP
    This rule finalizes conforming changes to the regulations at 42 CFR 
414.402 to revise the definition of ``item'' at 42 CFR 414.402 under 
the CBP to exclude complex rehabilitative manual wheelchairs and 
certain other wheelchairs from the CBP and is estimated to have no 
fiscal impact and is considered in the baseline of the FY 2022 
President's Budget.

D. Alternatives Considered

    The following is a discussion of the alternatives considered for 
the IRF PPS updates contained in this final rule.
    Section 1886(j)(3)(C) of the Act requires the Secretary to update 
the IRF PPS payment rates by an increase factor that reflects changes 
over time in the prices of an appropriate mix of goods and services 
included in the covered IRF services.
    As noted previously in this final rule, section 
1886(j)(3)(C)(ii)(I) of the Act requires the Secretary to apply a 
productivity adjustment to the market basket increase factor for FY 
2022. Thus, in accordance with section 1886(j)(3)(C) of the Act, we 
update the IRF prospective payments in this final rule by 1.9 percent 
(which equals the 2.6 percent estimated IRF market basket increase 
factor for FY 2022 reduced by a 0.7 percentage point productivity 
adjustment as determined under section 1886(b)(3)(B)(xi)(II) of the Act 
(as required by section 1886(j)(3)(C)(ii)(I) of the Act)).
    We considered utilizing FY 2019 claims data to update the 
prospective payment rates for FY 2022 due to the potential effects of 
the PHE on the FY 2020 IRF claims data. However, it has been our long-
standing practice to utilize the most recent full fiscal year of data 
to update the prospective payment rates, as this data is generally 
considered to be the best overall predictor of experience in the 
upcoming fiscal year. Additionally, the FY 2019 data does not reflect 
any of the changes to the CMG definitions or the data used to classify 
IRF patients into CMGs that became effective in FY 2020 and will 
continue to be used in FY 2022. As such, we believe it would be 
appropriate to utilize FY 2020 data to update the prospective payment 
rates for FY 2022 at this time. While we believe maintaining our 
existing methodology of utilizing the most recent available IRF data to 
update the prospective payment rates for FY 2022 is appropriate, we 
solicited comment in the FY 2020 proposed rule on the use of FY 2019 
data to update the prospective payment rates for FY 2022.

[[Page 42420]]

For more information on the proposed FY 2022 estimated impacts 
utilizing FY 2019 claims data, we refer readers to the FY 2022 IRF PPS 
proposed rule (86 FR 19086). As the comments received in response to 
this solicitation are pertinent to the updates in this final rule, we 
are providing a summary of the feedback we received from stakeholders 
regarding this solicitation in this final rule.
    The following is a summary of the comments received on the use of 
FY 2019 data to update the prospective rates for FY 2022 and our 
responses:
    Comment: In general, the majority of commenters supported the use 
of FY 2020 data to update the prospective payment rates for FY 2022. 
Several commenters suggested that FY 2020 data should be used to update 
the payment rates for FY 2022 as these data reflect changes in IRF care 
related to the pandemic and will therefore be more likely to reflect 
IRF utilization in FY 2022, as COVID-19 will continue to impact IRFs in 
the future. Additionally, these commenters supported the use of FY 2020 
data noting that it reflects changes to the CMG definitions that were 
implemented in FY 2020 and that will continue to be used in FY 2022. In 
contrast, a few commenters expressed concern with the proposed use of 
FY 2020 data to update the prospective payment rates for FY 2020 and 
recommended that CMS use FY 2019 data for this purpose. These 
commenters stated that they believe the FY 2020 data was heavily 
impacted by the pandemic and would result in skewed relative weights 
and an inflated outlier threshold and suggested that FY 2019 data would 
be more likely to reflect IRF utilization in FY 2022 as the pandemic 
continues to subside. A few of these commenters requested that CMS use 
FY 2019 claims data to update the relative weights and the outlier 
threshold while other commenters requested that CMS maintain the 
relative weights and outlier threshold at the current FY 2021 levels 
for FY 2022.
    Response: We appreciate the commenters' support of using FY 2020 
data to update the prospective payment rates for FY 2022. It has been 
our longstanding practice to use the most recent full fiscal year of 
claims data available to update the prospective payment rates as we 
believe this data is reflective of the current Medicare IRF population 
and is generally the best overall predictor of experience in the 
upcoming fiscal year. We also agree with the commenters' recommendation 
to use FY 2020 data for rate setting purposes as this data reflects the 
changes to the CMG definitions that were implemented in FY 2020 and 
that will continue to be used in FY 2022.
    We appreciate the commenters' feedback regarding how the PHE has 
impacted individual facilities and acknowledge that the PHE impacted 
many aspects of IRF operations. However, we disagree with the 
commenters' assertions that the FY 2020 claims data were impacted by 
the PHE to the extent that they would be unsuitable to use for payment 
updates under the IRF PPS. An analysis of FY 2020 IRF claims data 
indicates that admissions under the IRF PPS dropped by approximately 7 
percent overall compared to FY 2019. Decreased admissions were observed 
across almost all conditions in the IRF setting, with the largest 
declines occurring among patients treated for lower-extremity joint 
replacements and pain syndrome. However, there were only slight changes 
observed in the share of IRF admissions across all RICs in FY 2020 
compared to FY 2019. For example, the share of IRF admissions for 
lower-extremity joint replacements dropped from 3.7 percent in FY 2019 
to 3.0 percent in FY 2020, while the share of IRF admissions for pain 
syndrome dropped from 0.3 percent in FY 2019 to 0.2 percent in FY 2020.
    Additionally, we attempted to approximate changes in IRF 
utilization in the FY 2020 IRF claims data that could be attributable 
to the PHE. When the PHE for COVID-19 was declared, we announced a 
number of waivers to provide regulatory flexibilities to IRF providers. 
When submitting claims under these waivers, IRFs billed Medicare using 
a ``DR'' condition code on the claim. To approximate the number of IRF 
stays for admissions that would not have been expected in the absence 
of the PHE, we identified claims that included a COVID-19 ICD-10 
diagnosis code and claims that could be considered waiver admissions, 
as identified by the presence of a ``DR'' condition code on the claim. 
While we are not able to definitively identify claims that are solely 
attributable to the PHE based on the presence of a COVID-19 diagnosis 
code or waiver code on the claim, this methodology allows us to 
understand the overall utilization of the waivers and the overall 
frequency of COVID-19 diagnoses among the IRF population. This analysis 
indicated that approximately 1.0 percent of IRF stays included a COVID-
19 ICD-10 diagnosis code, while 4.2 percent of IRF stays could be 
considered waiver admissions. This would suggest that the FY 2020 IRF 
claims data were not disproportionally impacted by the PHE, as the 
overwhelming majority of IRF beneficiaries entered into IRF stays in FY 
2020 as they would have in any other year. Therefore, we believe this 
data is representative of typical IRF utilization of the current 
Medicare population and would therefore be appropriate to use when 
updating the prospective payment rates for FY 2022, as well as updates 
to the outlier threshold and the relative weights.
    We do not believe it would be appropriate to freeze the outlier 
threshold and the relative weights at their current FY 2021 levels for 
FY 2022. The annual updates to the outlier threshold and the relative 
weights are intended to better align IRF payments with the costs of 
caring for IRF patients and to ensure that IRFs will be appropriately 
compensated for treating unusually high-cost patients while taking into 
account changes in IRF utilization as well as changes in estimated 
costs and payments from year to year. Therefore, we believe it is 
appropriate to update these values for FY 2022 using FY 2020 claims 
data, as proposed in the FY 2022 proposed rule.
    Comment: One commenter suggested that CMS try to isolate the 
effects of the PHE in the IRF setting and recommended that CMS exclude 
claims with a COVID-19 diagnosis and claims considered to be wavier 
admissions from the 2020 data when setting the outlier threshold as 
these claims may be atypical.
    Response: As discussed above, we are not able to definitively 
identify claims that are directly attributable to the PHE, such as IRF 
stays that would not qualify for IRF level services in the absence of 
the PHE, solely based on the presence of a COVID-19 diagnosis code or 
waiver code on the claim. Additional information beyond the presence of 
these codes would be necessary to determine if the stay would qualify 
for IRF level services through review of IRF medical records. However, 
given the significant amount of resources that would be required to 
complete a comprehensive review of the medical records for these cases 
by both IRFs and CMS contractors we do not believe this undertaking is 
feasible at this time. As such, we do not believe it would be 
appropriate to exclude claims from, or otherwise apply adjustments to, 
the underlying pool of claims data that is used to determine 
adjustments to the IRF prospective payment rates. We also agree with 
the commenters' assertion that IRFs will continue to be impacted by the 
PHE in the near future and therefore it would be appropriate to 
maintain claims with a COVID-19 ICD-10 diagnosis code in the 
methodology used to determine adjustments under

[[Page 42421]]

the IRF PPS as IRFs will continue to treat patients with a COVID-19 
diagnosis in the near future.
    Comment: A few commenters noted analysis presented in other 
proposed payment rules related to other Medicare settings and indicated 
that the proposal to use FY 2020 data to update the IRF prospective 
payment rates for FY 2022 was inconsistent with CMS' proposed policies 
in other Medicare settings. Some commenters requested that additional 
data and analysis be shared with stakeholders to allow them to more 
fully assess the effects of the pandemic in the IRF setting and 
encouraged us to continue evaluating the effects of the PHE and to 
provide additional analysis in future years.
    Response: The proposed use of FY 2020 claims data to update the 
prospective payment rates for FY 2022 was based on analysis of both FY 
2019 and FY 2020 IRF claims data. As discussed above, we did not 
observe increases and decreases in IRF utilization in the FY 2020 
claims data of the same magnitude observed in other Medicare settings 
and described in other Medicare proposed rules. As such, we believe it 
would be appropriate to use the FY 2020 IRF claims data to update the 
prospective payment rates for FY 2022. We appreciate the commenters' 
feedback regarding the types of information that would be most useful 
to them in assessing the effects of the PHE in the IRF setting. We also 
appreciate the commenters' concerns regarding the impacts of the PHE in 
the IRF setting and will continue to monitor the IRF data to ensure 
that IRF payments are appropriately aligned with costs of care.
    After careful consideration of the comments we received in response 
to this solicitation, we are finalizing the use of FY 2020 claims data, 
as described in the FY 2022 proposed rule, to update the prospective 
rates for FY 2022.
    We considered maintaining the existing CMG relative weights and 
ALOS values for FY 2022. However, in light of recently available data 
and our desire to ensure that the CMG relative weights and ALOS values 
are as reflective as possible of recent changes in IRF utilization and 
case mix, at this time we believe that it is appropriate to update the 
CMG relative weights and ALOS values using FY 2020 claims data to 
ensure that IRF PPS payments continue to reflect as accurately as 
possible the current costs of care in IRFs.
    We also considered maintaining the existing outlier threshold 
amount for FY 2022. As outlier payments are a redistribution of 
payment, it is important to adjust the outlier threshold amount to 
maintain the targeted 3 percent outlier pool as closely as possible. 
Maintaining an outlier threshold that would yield estimated outlier 
payments greater than 3 percent would leave less payment available to 
cover the costs of non-outlier cases. Therefore, analysis of updated FY 
2020 data indicates that estimated outlier payments would be greater 
than 3 percent of total estimated payments for FY 2022, by 
approximately 0.4 percent. Consequently, we are adjusting the outlier 
threshold amount in this final rule to reflect a 0.4 percentage point 
decrease thereby setting the total outlier payments equal to 3 percent, 
instead of 3.4 percent, of aggregate estimated payments in FY 2022.

E. Regulatory Review Costs

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this final rule, we 
should estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on the FY 2022 IRF PPS proposed rule will be the number of 
reviewers of this final rule. We acknowledge that this assumption may 
understate or overstate the costs of reviewing this final rule. It is 
possible that not all commenters reviewed the FY 2022 IRF PPS proposed 
rule in detail, and it is also possible that some reviewers chose not 
to comment on the FY 2022 proposed rule. For these reasons, we thought 
that the number of commenters would be a fair estimate of the number of 
reviewers of this final rule.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this final rule, and 
therefore, for the purposes of our estimate we assume that each 
reviewer reads approximately 50 percent of the rule. We sought comments 
on this assumption.
    Using the national mean hourly wage data from the May 2020 BLS for 
Occupational Employment Statistics (OES) for medical and health service 
managers (SOC 11-9111), we estimate that the cost of reviewing this 
rule is $114.24 per hour, including overhead and fringe benefits 
(https://www.bls.gov/oes/current/oes_nat.htm). Assuming an average 
reading speed, we estimate that it would take approximately 3 hours for 
the staff to review half of this final rule. For each reviewer of the 
rule, the estimated cost is $342.72 (3 hours x $114.24). Therefore, we 
estimate that the total cost of reviewing this regulation is 
$1,137,144.96 ($342.72 x (2,668 IRF reviewers and 650 DME reviewers).

F. Accounting Statement and Table

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Tables 19, 20, and 21, we have prepared accounting 
statements showing the classification of the expenditures associated 
with the provisions of this final rule. Table 19 provides our best 
estimate of the increase in Medicare payments under the IRF PPS as a 
result of the updates presented in this final rule based on the data 
for 1,114 IRFs in our database. Tables 20 and 21 provides our best 
estimate of the impacts associated with the DME provisions in this 
final rule.
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[[Page 42422]]


[GRAPHIC] [TIFF OMITTED] TR04AU21.216

[GRAPHIC] [TIFF OMITTED] TR04AU21.217

G. Conclusion

    Overall, the estimated payments per discharge for IRFs in FY 2022 
are projected to increase by 1.5 percent, compared with the estimated 
payments in FY 2021, as reflected in column 7 of Table 17.
    IRF payments per discharge are estimated to increase by 1.5 percent 
in urban areas and 1.6 percent in rural areas, compared with estimated 
FY 2021 payments. Payments per discharge to rehabilitation units are 
estimated to increase 1.2 percent in urban areas and 1.4 percent in 
rural areas. Payments per discharge to freestanding rehabilitation 
hospitals are estimated to increase 1.8 percent in urban areas and 
increase 2.3 percent in rural areas.
    Overall, IRFs are estimated to experience a net increase in 
payments as a result of the policies in this final rule. The largest 
payment increase is estimated to be a 3.0 percent increase for rural 
IRFs located in the rural South Atlantic region. The analysis above, 
together with the remainder of this preamble, provides an RIA.
    The Medicare DMEPOS provisions will continue payments for affected 
items at the current levels.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by OMB.

Chiquita Brooks-LaSure,

Administrator of the Centers for Medicare & Medicaid Services, 
approved this document on July 21, 2021.

List of Subjects in 42 CFR Part 414

    Administrative practice and procedure, Biologics, Diseases, Drugs, 
Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR Chapter IV as follows:

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER SERVICES

0
1. The authority citation for part 414 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).


0
2. In Sec.  414.402 amend the definition of ``Item'' by revising 
paragraph (1) introductory text to read as follows:


Sec.  414.402  Definitions.

* * * * *
    Item * * *
    (1) Durable medical equipment (DME) other than class III devices 
under the Federal Food, Drug and Cosmetic Act, as defined in Sec.  
414.202, group 3 complex rehabilitative power wheelchairs, complex 
rehabilitative manual wheelchairs, manual wheelchairs described by 
HCPCS codes E1235, E1236, E1237, E1238, and K0008, and related 
accessories when furnished in connection with such wheelchairs, and 
further classified into the following categories:
* * * * *

    Dated: July 27, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-16310 Filed 7-29-21; 4:15 pm]
BILLING CODE 4120-01-P


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