42362 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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. 

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. 

DMEPOS@cms.hhs.gov 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-Feefor-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®) Fast Healthcare Interoperability 

Resources® (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. 


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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 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 

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 budgetneutral 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 facilitylevel 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 


lotter on DSK11XQN23PROD with RULES2ER04AU21.192</GPH>

TABLE 1: Cost and Benefit 

Provision Description Transfers/Costs 

[FY 2022 IRF PPS payment rate The overall economic impact of this final rule is an estimated $130 million in increased 

update tpayments from the Federal Government to IRFs during FY 2022. 

[FY 2022 IRF QRP changes The overall economic impact of this final rule is an estimated increase in cost to IRFs of 

$503,100.00 beginning with 2022. 

OC)MEPOS Complex Power The overall economic impact of this final rule is an estimated $130 million in increased 

!Wheelchair Accessories tpayments from the Federal Government to DME suppliers from FY 2022 to FY 2026. 

PMEPOS Complex Manual The overall economic impact of this final rule is an estimated $40 million in increased 

!Wheelchair tpayments from the Federal Government to DME suppliers from FY 2022 to FY 2026 
42364 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

1Patel 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. 

2CMS, ‘‘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). 

3CMS, ‘‘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). 

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 longterm 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-ServicePayment/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 postadmission physician evaluation 

requirement at § 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 postadmission physician evaluation 

documentation requirement at 42 CFR 

412.622(a)(4)(ii) permanently beginning 

in FY 2021. 

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 

§ 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. 

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: 

• Off-the-shelf (OTS) orthotics, for 

which payment would otherwise be 

made under section 1834(h) of the Act; 

• Enteral nutrients, equipment, and 

supplies described in section 

1842(s)(2)(D) of the Act; and 

• 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. 


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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 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 fivecharacter 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-ServicePayment/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/qualitysafety-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 lowVerDate Sep<11>2014 20:04 Aug 03, 2021 Jkt 253001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2

lotter on DSK11XQN23PROD with RULES2
42366 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

4ONC, Draft 2 Trusted Exchange Framework and 

Common Agreement, https://www.healthit.gov/ 

sites/default/files/page/2019-04/FINAL

TEFCAQTF41719508version.pdf. 

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 postacute 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-andcommon-agreement and https://

rce.sequoiaproject.org/. 

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: 

• 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). 

• 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). 

• 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). 

• 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). 

• 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). 

• 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: 

• 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: 

• 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: 

• 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 § 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 hospitalspecific 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 


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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 CaseMix Groups,’’ we present the CMGs, the 

comorbidity tiers, the corresponding 

relative weights, and the ALOS values 

for each CMG and tier for FY 2022. The 

ALOS for each CMG is used to 

determine when an IRF discharge meets 

the definition of a short-stay transfer, 

which results in a per diem case level 

adjustment. 

BILLING CODE 4120–01–P 


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TABLE 2 R : ea I f 1ve W e1e: . ht s an dA verae:e L ene: th 0 f St av V a I ues I or th e C ase-M" IX G roups 

Relative Wei2ht A vera2e Len 2th of Stav 

CMG Description No No 

CMG Comor- Tier Tier Tier Comor- (M=motor, A=age) Tier 1 Tier 2 Tier 3 bidity 1 2 3 bidity 

Tier Tier 

0101 Stroke M >=72.50 0.9741 0.8649 0.7846 0.7481 9 10 9 9 

0102 Stroke M >=63.50 and M <72.50 1.2657 1.1238 1.0194 0.9720 12 12 11 11 

0103 Stroke M >=50.50 and M <63.50 1.6201 1.4385 1.3049 1.2442 14 15 14 14 

0104 Stroke M >=41.50 and M <50.50 2.0824 1.8489 1.6773 1.5993 18 19 18 18 

0105 Stroke M <41.50 and A >=84.50 2.4437 2.1697 1.9683 1.8768 22 23 21 20 

0106 Stroke M <41.50 and A <84.50 2.8656 2.5444 2.3082 2.2008 26 26 24 23 

0201 Traumatic brain iniurv M >=73.50 1.0720 0.8842 0.8033 0.7549 11 12 9 9 

0202 Traumatic brain injury M >=61.50 and 1.3914 1.1477 1.0427 0.9799 13 13 12 11 

M <73.50 

0203 Traumatic brain injury M >=49.50 and 1.7032 1.4048 1.2763 1.1994 14 15 14 13 

M <61.50 

0204 Traumatic brain injury M >=35.50 and 2.0405 1.6830 1.5291 1.4370 18 18 16 16 

M <49.50 

0205 Traumatic brain iniurv M <35.50 2.6440 2.1808 1.9812 1.8619 28 23 20 19 

0301 Non-traumatic brain injury M >=65.50 1.2322 0.9699 0.8979 0.8465 11 10 10 10 

0302 Non-traumatic brain injury M >=52.50 1.5841 1.2469 1.1543 1.0883 13 13 12 12 

andM <65.50 

0303 Non-traumatic brain injury M >=42.50 1.8983 1.4943 1.3833 1.3042 16 15 14 14 

andM<52.50 

0304 Non-traumatic brain injury M <42.50 2.1743 1.7115 1.5844 1.4938 19 18 16 16 

and A >=78.50 

0305 Non-traumatic brain injury M <42.50 2.3954 1.8856 1.7456 1.6457 21 20 17 17 

and A <78.50 

0401 Traumatic spinal cord injury M 1.4043 1.1100 1.0628 0.9638 13 12 12 11 

>=56.50 

0402 Traumatic spinal cord injury M 1.8739 1.4811 1.4182 1.2861 18 16 14 15 

>=47.50 andM <56.50 

0403 Traumatic spinal cord injury M 2.1673 1.7130 1.6402 1.4875 19 18 17 17 

>=41.50 and M <47.50 

0404 Traumatic spinal cord injury M <31.50 3.3567 2.6531 2.5403 2.3037 36 30 25 22 

and A <61.50 

0405 Traumatic spinal cord injury M 2.7525 2.1756 2.0831 1.8891 25 22 22 20 

>=31.50 and M <41.50 

0406 Traumatic spinal cord injury M 3.6825 2.9106 2.7869 2.5273 34 30 30 26 

>=24.50 andM <31.50 and A >=61.50 

0407 Traumatic spinal cord injury M <24.50 4.6790 3.6982 3.5410 3.2113 49 37 34 36 

and A >=61.50 

0501 Non-traumatic spinal cord injury M 1.3110 0.9874 0.9279 0.8476 11 11 10 10 

>=60.50 

0502 Non-traumatic spinal cord injury M 1.6517 1.2439 1.1691 1.0678 15 13 13 12 

>=53.50 and M <60.50 

0503 Non-traumatic spinal cord injury M 1.8945 1.4268 1.3409 1.2248 16 15 14 14 

>=48.50 and M <53.50 

0504 Non-traumatic spinal cord injury M 2.2349 1.6831 1.5818 1.4448 20 17 17 16 

>=39.50 and M <48.50 

0505 Non-traumatic spinal cord injury M 3.1292 2.3566 2.2148 2.0230 28 24 23 21 

<39.50 

0601 Neurological M >=64.50 1.3639 1.0311 0.9648 0.8616 11 11 10 10 

0602 Neurological M >=52.50 and M <64.50 1.6723 1.2642 1.1829 1.0563 13 13 12 12 

0603 Neurological M >=43.50 and M <52.50 1.9892 1.5038 1.4071 1.2565 16 15 14 14 

0604 Neurological M <43.50 2.4216 1.8306 1.7129 1.5297 20 18 17 16 

0701 Fracture of lower extremity M >=61.50 1.1983 0.9559 0.9162 0.8354 11 11 10 10 
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Relative Weight Average Length of Stay 

CMG Description No No 

CMG Comor- Tier Tier Tier Comor- (M=motor, A=age) Tier 1 Tier 2 Tier3 bidity 1 2 3 bidity 

Tier Tier 

0702 Fracture oflower extremity M >=52.50 1.5211 1.2134 1.1630 1.0605 13 13 13 12 

andM <61.50 

0703 Fracture oflower extremity M >=41.50 1.8607 1.4844 1.4227 1.2973 16 16 15 14 

andM <52.50 

0704 Fracture oflower extremity M <41.50 2.2462 1.7918 1.7173 1.5660 18 18 18 17 

0801 Replacement of lower-extremity joint 1.1454 0.8842 0.8163 0.7612 11 10 9 9 

M>=63.50 

0802 Replacement of lower-extremity joint 1.3402 1.0345 0.9551 0.8907 11 11 10 10 

M >=57.50 and M <63.50 

0803 Replacement of lower-extremity joint 1.5058 1.1624 1.0732 1.0007 13 13 12 11 

M >=51.50 and M <57 .50 

0804 Replacement of lower-extremity joint 1.7026 1.3143 1.2134 1.1315 15 14 13 12 

M >=42.50 and M <51.50 

0805 Replacement of lower-extremity joint 2.1052 1.6251 1.5003 1.3991 17 16 16 15 

M <42.50 

0901 Other orthopedic M >=63.50 1.2474 0.9589 0.8979 0.8143 11 11 10 9 

0902 Other orthopedic M >=51.50 and M 1.5739 1.2099 1.1329 1.0274 13 13 12 12 

<63.50 

0903 Other orthopedic M >=44.50 and M 1.8513 1.4232 1.3325 1.2085 15 15 14 13 

<51.50 

0904 Other orthopedic M <44.5 2.1697 1.6679 1.5617 1.4164 18 17 16 15 

1001 Amputation lower extremity M 1.2459 1.0582 0.9377 0.8663 12 12 10 10 

>=64.50 

1002 Amputation lower extremity M 1.5267 1.2966 1.1490 1.0616 14 14 13 12 

>=55.50 and M <64.50 

1003 Amputation lower extremity M 1.8234 1.5486 1.3723 1.2678 15 17 15 14 

>=47.50 and M <55.50 

1004 Amputation lower extremity M <47.50 2.2745 1.9317 1.7118 1.5815 19 19 18 17 

1101 Amputation non-lower extremity M 1.3521 1.1226 1.0535 0.8753 13 12 11 10 

>=58.50 

1102 Amputation non-lower extremity M 1.6736 1.3896 1.3040 1.0834 14 13 14 10 

>=52.50 and M <58.50 

1103 Amputation non-lower extremity M 1.9117 1.5873 1.4896 1.2375 16 16 15 14 

<52.50 

1201 Osteoarthritis M >=61.50 1.4828 0.9160 0.9160 0.8199 12 10 10 10 

1202 Osteoarthritis M >=49.50 and M 1.9197 1.1859 1.1859 1.0614 15 12 13 12 

<61.50 

1203 Osteoarthritis M <49.50 and A >=74.50 2.3223 1.4346 1.4346 1.2840 17 16 16 14 

1204 Osteoarthritis M <49.50 and A <74.50 2.4163 1.4927 1.4927 1.3360 17 14 16 14 

1301 Rheumatoid other arthritis M >=62.50 1.2075 1.0436 0.8887 0.8225 10 12 9 10 

1302 Rheumatoid other arthritis M >=51.50 1.5071 1.3025 1.1092 1.0265 12 12 12 11 

andM <62.50 

1303 Rheumatoid other arthritis M >=44.50 1.8204 1.5733 1.3398 1.2399 14 16 14 13 

and M <51.50 and A >=64.50 

1304 Rheumatoid other arthritis M <44.50 2.1663 1.8722 1.5944 1.4755 16 24 16 16 

and A >=64.50 

1305 Rheumatoid other arthritis M <51.50 2.2382 1.9343 1.6473 1.5244 15 17 17 15 

and A <64.50 

1401 Cardiac M >=68.50 1.1149 0.8988 0.8348 0.7613 10 10 9 9 

1402 Cardiac M >=55.50 and M <68.50 1.4206 1.1453 1.0637 0.9701 12 12 11 11 

1403 Cardiac M >=45.50 and M <55.50 1.7213 1.3877 1.2888 1.1754 15 14 13 13 

1404 Cardiac M <45.50 2.0967 1.6904 1.5699 1.4318 18 17 16 15 

1501 Pulmonarv M >=68.50 1.2747 1.0575 0.9778 0.9192 12 11 10 9 

1502 Pulmonarv M >=56.50 and M <68.50 1.5560 1.2909 1.1935 1.1220 13 12 12 11 
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Relative Weight Average Length of Stay 

CMG Description No No 

CMG Comor- Tier Tier Tier Comor- (M=motor, A=age) Tier 1 Tier 2 Tier3 bidity 1 2 3 bidity 

Tier Tier 

1503 Pulmonarv M >=45.50 and M <56.50 1.8145 1.5054 1.3918 1.3084 15 15 14 13 

1504 Pulmonarv M <45.50 2.1401 1.7755 1.6416 1.5432 20 17 16 15 

1601 Pain svndrome M >=65.50 1.1148 0.8650 0.8650 0.7766 10 10 9 9 

1602 Pain syndrome M >=58.50 and M 1.3201 1.0244 1.0244 0.9197 11 11 11 11 

<65.50 

1603 Pain syndrome M >=43.50 and M 1.6241 1.2602 1.2602 1.1314 14 13 14 13 

<58.50 

1604 Pain svndrome M <43.50 1.9087 1.4811 1.4811 1.3297 14 14 16 14 

1701 Major multiple trauma without brain or 1.4001 1.0483 0.9743 0.9013 11 12 11 11 

spinal cord injurv M >=57.50 

Major multiple trauma without brain or 1.7185 1.2867 1.1958 1.1062 16 14 13 12 

1702 spinal cord injury M >=50.50 and M 

<57.50 

Major multiple trauma without brain or 2.0076 1.5031 1.3970 1.2923 17 16 15 14 

1703 spinal cord injury M >=41.50 and M 

<50.50 

Major multiple trauma without brain or 2.3366 1.7494 1.6259 1.5040 19 19 17 16 

1704 spinal cord injury M >=36.50 and M 

<41.50 

1705 Major multiple trauma without brain or 2.5888 1.9383 1.8014 1.6664 21 20 19 18 

spinal cord injurv M <36.50 

1801 Major multiple trauma with brain or 1.2417 0.9614 0.8857 0.8129 13 11 11 10 

spinal cord injury M >=67.50 

Major multiple trauma with brain or 1.5169 1.1745 1.0820 0.9931 14 13 12 11 

1802 spinal cord injury M >=55.50 and M 

<67.50 

Major multiple trauma with brain or 1.8886 1.4622 1.3471 1.2364 17 17 14 14 

1803 spinal cord injury M >=45.50 and M 

<55.50 

Major multiple trauma with brain or 2.2243 1.7222 1.5865 1.4562 25 18 17 16 

1804 spinal cord injury M >=40.50 and M 

<45.50 

Major multiple trauma with brain or 2.6686 2.0661 1.9034 1.7470 26 21 20 19 

1805 spinal cord injury M >=30.50 and M 

<40.50 

1806 Major multiple trauma with brain or 3.6837 2.8521 2.6275 2.4116 38 29 24 28 

spinal cord injury M <30.50 

1901 Guillain-Barre M >=66.50 1.0699 0.8960 0.8326 0.8265 11 11 10 10 

1902 Guillain-Barre M >=51.50 and M 1.5832 1.3259 1.2321 1.2230 15 14 14 14 

<66.50 

1903 Guillain-Barre M >=38.50 and M 2.2805 1.9099 1.7748 1.7617 20 21 19 20 

<51.50 

1904 Guillain-Barre M <38.50 3.5683 2.9884 2.7770 2.7565 39 29 29 29 

2001 Miscellaneous M >=66.50 1.2066 0.9647 0.8933 0.8155 11 10 10 9 

2002 Miscellaneous M >=55.50 and M 1.4890 1.1904 1.1023 1.0064 13 12 12 11 

<66.50 

2003 Miscellaneous M >=46.50 and M 1.7562 1.4041 1.3001 1.1869 15 15 14 13 

<55.50 

2004 Miscellaneous M <46.50 and A 2.0661 1.6518 1.5295 1.3963 18 17 16 15 

>=77.50 

2005 Miscellaneous M <46.50 and A <77.50 2.2267 1.7802 1.6484 1.5049 19 18 16 16 

2101 Burns M >=52.50 1.9303 1.3203 1.1699 1.1137 19 14 13 12 

2102 Burns M <52.50 2.7884 1.9072 1.6900 1.6088 24 21 16 17 

5001 Short-stay cases, length of stay is 3 0.1660 3 

days or fewer 
42372 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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. 

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 

MeasureTM (FIMTM)-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 


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Relative Wei2ht A vera2e Len2th of Stay 

CMG Description No No 

CMG Comor- Tier Tier Tier Comor- (M=motor, A=age) Tier 1 Tier2 Tier3 bidity 1 2 3 bidity 

Tier Tier 

5101 Expired, orthopedic, length of stay is 13 0.6930 7 

days or fewer 

5102 Expired, orthopedic, length of stay is 14 2.0491 19 

days or more 

5103 Expired, not orthopedic, length of stay 0.9096 9 

is 15 days or fewer 

5104 Expired, not orthopedic, length of stay 2.2526 21 

is 16 days or more 

TABLE 3 : D' IS t rI 'b U t' IODa I Efi ec t so fth e Ch anges t 0 th e CMG R ea I f ive W e1g . ht s 

Percentage Change in CMG Relative Number of Cases Affected Percentage of Cases 

Wei2hts Affected 

Increased by 15% or more 29 0.0% 

Increased by between 5% and 15% 4,392 1.2% 

Changed by less than 5% 367,212 97.2% 

Decreased by between 5% and 15% 6,058 1.6% 

Decreased by 15% or more 38 0.0% 
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 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 nationallyrecognized 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-StatisticsDataand-Systems/Statistics-TrendsandReports/ 

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 productivityadjusted 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 Forprofit 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-coverageassistance.) 

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 


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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-overyear 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 economywide 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 multifactor 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/ResearchStatistics-Data-and-Systems/StatisticsTrends-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 facilitylevel 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 laborrelated 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 laborrelated if the costs are labor-intensive 

and vary with the local labor market. 

Based on our definition of the laborrelated 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 CapitalRelated 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 laborVerDate Sep<11>2014 20:04 Aug 03, 2021 Jkt 253001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2

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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: Laborrelated Services was 69.0 percent. We 

proposed that the portion of CapitalRelated costs that are influenced by the 

local labor market is 46 percent. Since 

the relative importance for CapitalRelated 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 laborrelated 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 laborrelated 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. 

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 


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TABLE 4: FY 2022 IRF Labor-Related Share and FY 2021 IRF Labor-Related Share 

FY 2022 Labor-Related FY 2021 Final Labor 

Share 1 Related Share 2 

Wages and Salaries 48.3 48.6 

Employee Benefits 11.4 11.4 

Professional Fees: Labor-Related 3 5.0 5.0 

Administrative and Facilities Sunnort Services 0.8 0.7 

Installation, Maintenance, and Repair Services 1.6 1.6 

All Other: Labor-Related Services 1.9 1.8 

Subtotal 69.0 69.1 

Labor-related portion of Capital-Related ( 46%) 3.9 3.9 

Total Labor-Related Share 72.9 73.0 

1 Based on the 2016-based IRF market basket relative importance, IGI 2nd quarter 2021 forecast. 

2 Based on the 2016-based IRF market basket relative importance as published in the Federal Register 

(85 FR 48434). 

3 Includes all contract advertising and marketing costs and a portion of accounting, architectural, engineering, 

legal, management consulting, and home office contract labor costs. 
42378 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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-Feefor-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 prereclassification 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 


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delineations of these statistical areas. A 

copy of this bulletin may be obtained at 

https://www.whitehouse.gov/wpcontent/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/wpcontent/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/wpcontent/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-Feefor-Service-Payment/ 

InpatientRehabFacPPS/IRF-Rules-andRelated-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 § 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 budgetneutral 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. 

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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TABLE 5 C I : a cu If a ions t D t 0 e ermme th e FY 2022 St an d d P ar aymen tC onvers1on F ac t or 

Explanation for Adjustment Calculations 

Standard Pavment Conversion Factor for FY 2021 $16,856 

Market Basket Increase Factor for FY 2022 (2.6 %), reduced by 0.7 percentage point for the 

productivity adjustment as required by section 1886(i)(3)(C)(ii)(I) of the Act X 1.019 

Budget Neutrality Factor for the Updates to the Wage Index and Labor-Related Share X 1.0032 

Budget Neutrality Factor for the Revisions to the CMG Relative Weiclits X 1.0005 

FY 2022 Standard Payment Conversion Factor = $17,240 
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TABLE 6 : FY 2022 P aymen t R a t es 

CMG Payment Rate Tier 1 Payment Rate Tier 2 Payment Rate Tier 3 Payment Rate No Comorbidity 

0101 $16,793.48 $14,910.88 $13,526.50 $12,897.24 

0102 $21,820.67 $19,374.31 $17,574.46 $16,757.28 

0103 $27,930.52 $24,799.74 $22,496.48 $21,450.01 

0104 $35,900.58 $31,875.04 $28,916.65 $27,571.93 

0105 $42,129.39 $37,405.63 $33,933.49 $32,356.03 

0106 $49,402.94 $43,865.46 $39,793.37 $37,941.79 

0201 $18,481.28 $15,243.61 $13,848.89 $13,014.48 

0202 $23,987.74 $19,786.35 $17,976.15 $16,893.48 

0203 $29,363.17 $24,218.75 $22,003.41 $20,677.66 

0204 $35,178.22 $29,014.92 $26,361.68 $24,773.88 

0205 $45,582.56 $37,596.99 $34,155.89 $32,099.16 

0301 $21,243.13 $16,721.08 $15,479.80 $14,593.66 

0302 $27,309.88 $21,496.56 $19,900.13 $18,762.29 

0303 $32,726.69 $25,761.73 $23,848.09 $22,484.41 

0304 $37,484.93 $29,506.26 $27,315.06 $25,753.11 

0305 $41,296.70 $32,507.74 $30,094.14 $28,371.87 

0401 $24,210.13 $19,136.40 $18,322.67 $16,615.91 

0402 $32,306.04 $25,534.16 $24,449.77 $22,172.36 

0403 $37,364.25 $29,532.12 $28,277.05 $25,644.50 

0404 $57,869.51 $45,739.44 $43,794.77 $39,715.79 

0405 $47,453.10 $37,507.34 $35,912.64 $32,568.08 

0406 $63,486.30 $50,178.74 $48,046.16 $43,570.65 

0407 $80,665.96 $63,756.97 $61,046.84 $55,362.81 

0501 $22,601.64 $17,022.78 $15,997.00 $14,612.62 

0502 $28,475.31 $21,444.84 $20,155.28 $18,408.87 

0503 $32,661.18 $24,598.03 $23,117.12 $21,115.55 

0504 $38,529.68 $29,016.64 $27,270.23 $24,908.35 

0505 $53,947.41 $40,627.78 $38,183.15 $34,876.52 

0601 $23,513.64 $17,776.16 $16,633.15 $14,853.98 

0602 $28,830.45 $21,794.81 $20,393.20 $18,210.61 

0603 $34,293.81 $25,925.51 $24,258.40 $21,662.06 

0604 $41,748.38 $31,559.54 $29,530.40 $26,372.03 

0701 $20,658.69 $16,479.72 $15,795.29 $14,402.30 

0702 $26,223.76 $20,919.02 $20,050.12 $18,283.02 

0703 $32,078.47 $25,591.06 $24,527.35 $22,365.45 

0704 $38,724.49 $30,890.63 $29,606.25 $26,997.84 

0801 $19,746.70 $15,243.61 $14,073.01 $13,123.09 

0802 $23,105.05 $17,834.78 $16,465.92 $15,355.67 

0803 $25,959.99 $20,039.78 $18,501.97 $17,252.07 

0804 $29,352.82 $22,658.53 $20,919.02 $19,507.06 

0805 $36,293.65 $28,016.72 $25,865.17 $24,120.48 

0901 $21,505.18 $16,531.44 $15,479.80 $14,038.53 

0902 $27,134.04 $20,858.68 $19,531.20 $17,712.38 

0903 $31,916.41 $24,535.97 $22,972.30 $20,834.54 

0904 $37,405.63 $28,754.60 $26,923.71 $24,418.74 

1001 $21,479.32 $18,243.37 $16,165.95 $14,935.01 

1002 $26,320.31 $22,353.38 $19,808.76 $18,301.98 

1003 $31,435.42 $26,697.86 $23,658.45 $21,856.87 

1004 $39,212.38 $33,302.51 $29,511.43 $27,265.06 

1101 $23,310.20 $19,353.62 $18,162.34 $15,090.17 

1102 $28,852.86 $23,956.70 $22,480.96 $18,677.82 

1103 $32,957.71 $27,365.05 $25,680.70 $21,334.50 

1201 $25,563.47 $15 791.84 $15 791.84 $14 135.08 

1202 $33,095.63 $20 444.92 $20 444.92 $18 298.54 

1203 $40,036.45 $24 732.50 $24 732.50 $22 136.16 

1204 $41.657.01 $25 734.15 $25 734.15 $23 032.64 
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 42381 

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 nonlabor portion of the prospective 

payment, we begin by taking the 

unadjusted prospective payment rate for 


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CMG Payment Rate Tier 1 Payment Rate Tier 2 Payment Rate Tier 3 Payment Rate No Comorbidity 

1301 $20,817.30 $17,991.66 $15,321.19 $14,179.90 

1302 $25,982.40 $22,455.10 $19,122.61 $17,696.86 

1303 $31,383.70 $27,123.69 $23,098.15 $21,375.88 

1304 $37,347.01 $32,276.73 $27,487.46 $25,437.62 

1305 $38,586.57 $33,347.33 $28,399.45 $26,280.66 

1401 $19,220.88 $15,495.31 $14,391.95 $13,124.81 

1402 $24,491.14 $19,744.97 $18,338.19 $16,724.52 

1403 $29,675.21 $23,923.95 $22,218.91 $20,263.90 

1404 $36,147.11 $29,142.50 $27,065.08 $24,684.23 

1501 $21,975.83 $18,231.30 $16,857.27 $15,847.01 

1502 $26,825.44 $22,255.12 $20,575.94 $19,343.28 

1503 $31,281.98 $25,953.10 $23,994.63 $22,556.82 

1504 $36,895.32 $30,609.62 $28,301.18 $26,604.77 

1601 $19,219.15 $14,912.60 $14,912.60 $13,388.58 

1602 $22,758.52 $17,660.66 $17,660.66 $15,855.63 

1603 $27,999.48 $21,725.85 $21,725.85 $19,505.34 

1604 $32,905.99 $25,534.16 $25,534.16 $22,924.03 

1701 $24,137.72 $18,072.69 $16,796.93 $15,538.41 

1702 $29,626.94 $22,182.71 $20,615.59 $19,070.89 

1703 $34,611.02 $25,913.44 $24,084.28 $22,279.25 

1704 $40,282.98 $30,159.66 $28,030.52 $25,928.96 

1705 $44,630.91 $33,416.29 $31,056.14 $28,728.74 

1801 $21,406.91 $16,574.54 $15,269.47 $14,014.40 

1802 $26,151.36 $20,248.38 $18,653.68 $17,121.04 

1803 $32,559.46 $25,208.33 $23,224.00 $21,315.54 

1804 $38,346.93 $29,690.73 $27,351.26 $25,104.89 

1805 $46,006.66 $35,619.56 $32,814.62 $30,118.28 

1806 $63,506.99 $49,170.20 $45,298.10 $41,575.98 

1901 $18,445.08 $15,447.04 $14,354.02 $14,248.86 

1902 $27,294.37 $22,858.52 $21,241.40 $21,084.52 

1903 $39,315.82 $32,926.68 $30,597.55 $30,371.71 

1904 $61,517.49 $51,520.02 $47,875.48 $47,522.06 

2001 $20,801.78 $16,631.43 $15,400.49 $14,059.22 

2002 $25,670.36 $20,522.50 $19,003.65 $17,350.34 

2003 $30,276.89 $24,206.68 $22,413.72 $20,462.16 

2004 $35,619.56 $28,477.03 $26,368.58 $24,072.21 

2005 $38,388.31 $30,690.65 $28,418.42 $25,944.48 

2101 $33,278.37 $22,761.97 $20,169.08 $19,200.19 

2102 $48,072.02 $32,880.13 $29,135.60 $27,735.71 

5001 $ - $ - $ - $2,861.84 

5101 $ - $ - $ - $11,947.32 

5102 $ - $ - $ - $35,326.48 

5103 $ - $ - $ - $15,681.50 

5104 $ - $ - $ - $38,834.82 
42382 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

CMG 0104 (without comorbidities) from 

Table 7. Then, we multiply the laborrelated 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 nonlabor 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-andRelated-Files.html. 

The resulting figure is the wageadjusted 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 wageadjusted and rural-adjusted amount (if 

applicable). Finally, we add the 

additional teaching status payments (if 

applicable) to the wage, rural, and LIPadjusted prospective payment rates. 

Table 7 illustrates the components of 

the adjusted payment calculation. 

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 


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TABLE 7 E : xamp I e o fC ompu f me: th e FY 2022 IRF P rospec f ive p aymen t 

Steps Rural Facility A Urban Facility B 

(Spencer Co., IN) (Harrison Co., IN) 

1 Unadjusted Payment $27,571.93 $27,571.93 

2 Labor Share X 0.729 X 0.729 

3 Labor Portion of Payment = $20,099.94 = $20,099.94 

4 CBSA-Based Wage Index\ X 0.8594 X 0.8695 

5 Wage-Adjusted Amount = $17,273.89 = $17,476.90 

6 Non-Labor Amount + $7,471.99 + $7,471.99 

7 Wage-Adjusted Payment = $24,745.88 = $24,948.89 

8 Rural Adjustment X 1.149 X 1.000 

9 Wage- and Rural-Adjusted Payment = $28,433.01 = $24,948.89 

10 LIP Adjustment X 1.0156 X 1.0454 

11 Wage-, Rural- and LIP-Adjusted Payment = $28,876.57 = $26,081.57 

12 Wage- and Rural-Adjusted Payment $28.433.01 $24,948.89 

13 Teaching Status Adjustment X 0 X 0.0784 

14 Teaching Status Adjustment Amount = $0.00 = $1,955.99 

15 Wage-, Rural-, and LIP-Adjusted Payment + $28,876.57 + $26,081.57 

16 Total Adjusted Payment = $28,876.57 = $28,037.56 
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 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 facilityspecific 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 


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42384 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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: 

• New IRFs that have not yet 

submitted their first MCR. 

• IRFs whose overall CCR is in excess 

of the national CCR ceiling for FY 2022, 

as discussed below in this section. 

• 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. 


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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 42385 

5The 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. 

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. 

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 


lotter on DSK11XQN23PROD with RULES2ER04AU21.203</GPH>

TABLE 8: 

Application of Functional 

Assessment 

Change in Mobility 

Discharge Mobility Score 

Change in Self-Care 

Discharge Self-Care Score 

DRR 

TOH-Provider* 

CAUTI 

CDI 

DTC 

PPR30 day 

PPR Within Stay 

Application of Percent of Residents Experiencing One or More Falls with Major 

1n· Lon Sta . 

Application of Percent of Long-Term Care Hospital (L TCH) Patients with an 

Admission and Discharge Functional Assessment and a Care Plan That Addresses 

Function F #2631 . 

IRF Functional Outcome Measure: Change in Mobility Score for Medical 

Rehabilitation Patients F #2634 . 

IRF Functional Outcome Measure: Discharge Mobility Score for Medical 

Rehabilitation Patients F #2636 . 

IRF Functional Outcome Measure: Change in Self-Care Score for Medical 

Rehabilitation Patients F #2633 . 

IRF Functional Outcome Measure: Discharge Self-Care Score for Medical 

Rehabilitation Patients (NQF #2635). 

Drug Regimen Review Conducted With Follow-Up for Identified Issues-Post 

Acute Care (PAC) Inpatient Rehabilitation Facility (IRF) Quality Reporting 

Pro ram RP. 

Transfer of Health Information to the Provider-Post-Acute Care 

National Healthcare Safety Network (NHSN) Catheter-Associated Urinary Tract 

Infection Outcome Measure . 

National Healthcare Safety Network (NHSN Facility-wide Inpatient Hospital-onset 

Clostridium ome Meas 

Medicare Spending Per Beneficiary (MSPB}-Post Acute Care (PAC) IRF QRP 

F #3561 . 

F #3479. 

Potentially Preventable 30-Day Post-Discharge Readmission Measure for IRF 

QRP. 

Potentially Preventable Within Stay Readmission Measure for IRFs. 

*In response to the public health emergency (PHE) for the Coronavirus Disease 2019 (COVID-19), CMS released an interim 

final rule (85 FR 27595 through 27596) which delayed the compliance date for the collection and reporting of the Transfer of 

Health Information measures for at least 1 full fiscal year after the end of the PHE. 
42386 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

6U.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. 

7Centers for Disease Control and Prevention. 

(2020). Your Health: Symptoms of Coronavirus. 

Available at https://www.cdc.gov/coronavirus/2019- 

ncov/symptoms-testing/symptoms.html. 

8Centers for Disease Control and Prevention. 

(2020). Your Health: Symptoms of Coronavirus. 

Available at https://www.cdc.gov/coronavirus/2019- 

ncov/symptoms-testing/symptoms.html. 

9Centers 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. 

10Centers for Disease Control and Prevention. 

(2020). CDC COVID Data Tracker. Available at 

https://covid.cdc.gov/covid-data-tracker/#cases_

casesper100klast7days. 

11Associated Press. Tired to the Bone. Hospitals 

Overwhelmed with Virus Cases. November 18, 

2020. Accessed on December 16, 2020, at https:// 

apnews.com/article/hospitals-overwhelmedcoronavirus-cases-74a1f0dc3634917a5dc

13408455cd895. 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-fullare-us-intensive-care-units-new-data-paints-analarming-picture.html. 

12NPR. 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. 

13Centers for Disease Control and Prevention. 

(2020). CDC COVID Data Tracker. Available at 

https://covid.cdc.gov/covid-data-tracker/#cases_

casesper100klast7days. 

14Centers 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. 

15Centers 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. 

16Centers 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. 

17Centers 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. 

18Centers 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. 

19Centers 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. 

21Centers 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/imzmanagers/downloads/COVID-19-VaccinationProgram-Interim_Playbook.pdf. 

22U.S. Food and Drug Administration. (2021). 

Pfizer-BioNTech COVID–19 Vaccine. Available at 

https://www.fda.gov/emergency-preparedness-andresponse/coronavirus-disease-2019-covid-19/pfizerbiontech-covid-19-vaccine. 

23 Ibid. 

24U.S. Food and Drug Administration. (2021). 

ModernaTX, Inc. COVID–19 Vaccine EUA Letter of 

Authorization. Available at https://www.fda.gov/ 

media/144636/download. 

25U.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. 

26The 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/speechesremarks/2021/03/29/remarks-by-president-bidenon-the-covid-19-response-and-the-state-ofvaccinations/. 

27Centers for Disease Control and Prevention. 

Glossary of Terms. https://cdc.gov/infectioncontrol/ 

guidelines/healthcare-personnel/appendix/ 

terminology.html. 

28Health 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-fordistributing-covid-19-vaccine.pdf; Centers for 

Disease Control (2020). COVID–19 Vaccination 

Program Interim Playbook for Jurisdiction 

Operations. Accessed December 18 at https:// 

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–19.8 9 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

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

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 infectioncontrol 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

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.23 24 25

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 


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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 42387 

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-statesprioritizing-who-will-get-the-covid-19-vaccine-first/. 

31Associated 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-coronavirusvaccine-56df745388a9fc12ae93c6f9a0d0e81f. 

32Press Briefing by White House COVID–19 

Response Team and Public Health Officials | 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/. 

33Centers for Medicare & Medicaid Services. Prerulemaking. Accessed at https://www.cms.gov/ 

Medicare/Quality-Initiatives-Patient-AssessmentInstruments/QualityMeasures/Pre-Rulemaking. 

34National 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. 

35Measure 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. 

37 Ibid. 

38 Ibid. 

39The Influenza Vaccination Coverage among 

Healthcare Personnel (NQF #0431) measure which 

Continued 

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

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 prerulemaking input on each measure, 

under section 1890A of the Act.33 To 

meet this requirement, the following 

opportunity was provided for 

stakeholder input. 

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 multistakeholder 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. 

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

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 welldocumented 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. 

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 


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42388 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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). 

40Centers 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. 

41National 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. 

43Centers 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. 

44Centers 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. 

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

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 Longterm 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. 

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

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 


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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. 

46CBS 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-vaccinesurplus-vacant-appointments/. Accessed June 24, 

2021. 

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. 

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

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. 

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 twodose 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 


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48Centers for Disease Control and Prevention. 

Vaccine Administration. Available at https://

www.cdc.gov/vaccines/covid-19/clinicalconsiderations/covid-19-vaccines-us.html. Accessed 

June 25, 2021. 

49Centers for Disease Control and Prevention. 

Population Immunity. Available at https://

www.cdc.gov/coronavirus/2019-ncov/vaccines/ 

keythingstoknow.html. Accessed June 25, 2021. 

50Centers 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%20

and%20new%20variants%20of

%20the%20virus&text=Current%20data%20

suggest%20that%20COVID,after%20they%20

are%20fully%20vaccinated. Accessed June 25, 

2021. 

51Effectiveness 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. 

52The 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. 

53Medscape. Disturbing Number of Hospital 

Workers Still Unvaccinated. Available at https://

www.medscape.com/viewarticle/953871. Accessed 

July 13, 2021. 

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. 

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

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 realworld conditions. 

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 highperforming 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-authorizationvaccines-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 allcause death.52 The FDA is closely 

monitoring the safety of the COVID–19 

vaccines authorized for emergency use. 

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. 

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 


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54Centers for Disease Control and Prevention. 

Building Confidence in COVID–19 Vaccines. 

Available at https://www.cdc.gov/vaccines/covid19/vaccinate-with-confidence.html. 

55Centers for Medicare and Medicaid Services. 

Coronovirus (COVID–19) Partner Resources. 

Available at https://www.cms.gov/outreacheducation/partner-resources/coronavirus-covid-19- 

partner-resources. 

56Centers 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-aftervaccination.html. Accessed June 26, 2021. 

57U.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-aboutcovid-19-and-ada-rehabilitation-act-and-other-eeolaws. Accessed June 25, 2021. 

58U.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-aboutcovid-19-and-ada-rehabilitation-act-and-other-eeolaws. Accessed June 25, 2021. 

59U.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-aboutcovid-19-and-ada-rehabilitation-act-and-other-eeolaws. Accessed June 25, 2021. 

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 vaccineoffering 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. 

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

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. 

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. 

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. 

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-forreporting program under which IRFs are 

not financially penalized based on 

measure performance, but rather on 


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60Centers 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. 

61Centers 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. 

62Centers 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/vaccinebenefits/costs-of-disease-outbreaks/. Accessed June 

25, 2021. 

64U.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. 

65National 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. 

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 FDAapproved. 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/vaccinesblood-biologics/vaccines/emergencyuse-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. 

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. 

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 

(§ 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 


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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. 

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 § 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

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, FDAapproved 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. 


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67Medscape. Disturbing Number of Hospital 

Workers Still Unvaccinated. Available at https://

www.medscape.com/viewarticle/953871. Accessed 

July 13, 2021. 

68National Quality Forum. Influenza Vaccination 

Coverage among Healthcare Personnel. Available at 

https://qualityforum.org/QPS/QPSTool.

aspx?Exact=fase&Keyword=0431#. Accessed June 

26, 2021. 

69National 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: 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. 

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. 

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

Comment: Several providers and 

provider organizations sent in 

comments about the vaccine’s 

contraindications. Several commenters 


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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 42395 

70Centers for Disease Control and Prevention. 

COVID Data Tracker. Available at https://

covid.cdc.gov/covid-data-tracker/#vaccinations. 

Accessed June 26, 2021. 71Centers 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. 

72National 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. 

73Centers for Disease Control and Prevention. 

Building Confidence in COVID–19 Vaccines. 

Available at https://www.cdc.gov/vaccines/covid19/vaccinate-with-confidence.html. Accessed June 

24, 2021. 

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. 

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

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 reinoculation 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 


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42396 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

74U.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-aboutcovid-19-and-ada-rehabilitation-act-and-other-eeolaws. Accessed June 25, 2021. 

75National 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. 

77National Quality Forum. Influenza Vaccination 

Coverage among Healthcare Personnel. Available at 

https://qualityforum.org/QPS/QPSTool.aspx?

Exact=fase&Keyword=0431#. Accessed June 26, 

2021. 

78National 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-mentaland-physical-health-and-isolation. Accessed June 

26, 2021. 

79Centers 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-evidencetable.html. Accessed June 26, 2021. 

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. 

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 | 

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 Longterm 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). 

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

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—PostAcute 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 


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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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/ 

Downloads/Final-Specifications-for-IRFQRP-Quality-Measures-andSPADEs.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. 

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 decisionmaking 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 patientVerDate Sep<11>2014 20:04 Aug 03, 2021 Jkt 253001 PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2

lotter on DSK11XQN23PROD with RULES2ER04AU21.204</GPH>

TABLE 9: Future Measures and Measure Concepts Under Consideration for the IRF 

QRP 
42398 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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. 

81https://qualitynet.cms.gov/inpatient/measures/ 

disparity-methods/methodology. 

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 underprescribing 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: 

• What EHR/IT systems do you use 

and do you participate in a health 

information exchange (HIE)? 

• How do you currently share 

information with other providers? 

• 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? 

• 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? 

• 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: 

• Recommendations for quality 

measures or measurement domains that 

address health equity, for use in the IRF 

QRP. 

• 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. 

• 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)). 

• 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. 


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82Centers 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. 

• 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 webbased 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. 

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 


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42400 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

83Centers 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. 

84The NHSN Influenza Vaccination among HCP 

measure’s (NQF #0431) data collection period is 

tied to the influenza vaccination season. 

85We 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/medicareprogram-inpatient-rehabilitation-facilityprospective-payment-system-for-federal-fiscal. 

Accessed June 26, 2021. 

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. 

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. 

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 


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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 42401 

86Centers 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%20

and%20new%20variants%20of%20the%20

virus&text=Current%20data%20suggest%20

that%20COVID,after%20they%20are%20fully%20

vaccinated. Accessed June 25, 2021. 

87U.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-aboutcovid-19-and-ada-rehabilitation-act-and-other-eeolaws. Accessed June 25, 2021. 

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

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-authorizationvaccines-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. 

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 


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88https://www.phe.gov/emergency/news/ 

healthactions/section1135/Pages/covid19- 

13March20.aspx. 

89https://www.cms.gov/files/document/guidancememo-exceptions-and-extensions-quality-reportingand-value-based-purchasing-programs.pdf. 

90More 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-AssessmentInstruments/IRF-Quality-Reporting/IRF-QualityPublic-Reporting. 

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, LongTerm 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. 

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


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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 partiallyexempt 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 


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TABLE 10: IRF Quarters in Care Compare Original Schedule for Refreshes 

Affected b COVID-19 PHE Exem tions - Assessment and Claims Based Measures 

Quarter Refresh IRF Quarters in Original Schedule for Care 

Com are 

Actual December 2020 IRF-PAI: QI 2019 -Q4 2019 (4 quarters)* 

on Care Com are Claims: 4 2017 - 3 2019 8 uarters 

Original December 2020 IRF-PAI: Q2 2019-Ql 2020 (4 quarters) 

Claims: 4 2017 - 3 2019 8 uarters 

March 2021 IRF-PAI: Q3 2019-Q2 2020 (4 quarters) 

Claims: 4 2017 - 3 2019 8 uarters 

June 2021 IRF-PAI: Q4 2019 - Q3 2020 (4 quarters) 

Claims: 4 2017 - 3 2019 8 uarters 

September 2021 IRF-PAI: Ql 2020-Q4 2020 (4 quarters) 

Claims: 4 2018 - 3 2020 8 uarters 

December 2021 IRF-PAI: Q2 2020-Ql 2021 (4 quarters) 

Claims: 4 2018 - 3 2020 8 uarters 

March 2022 IRF-PAI: Q3 2020-Q2 2021 (4 quarters) 

Claims: 4 2018 - 3 2020 8 uarters 

June 2022 IRF-PAI: Q4 2020-Q3 2021 (4 quarters) 

Claims: 4 2018 - 3 2020 8 uarters 

September 2022 IRF-PAI: Ql 2021-Q4 2021 (4 quarters) 

Claims: Q4 2019 - Q3 2021 8 uarters 

December 2022 IRF-PAI: Q2 2021-Ql 2022 (4 quarters) 

Claims: Q4 2019 - Q3 2021 8 uarters 

March 2023 IRF-PAI: Q3 2021-Q2 2022 (4 quarters) 

Claims: Q4 2019 - Q3 2021 8 uarters 

June 2023 IRF-PAI: Q4 2021 - Q3 2022 (4 quarters) 

Claims: Q4 2019 - Q3 2021 8 uarters 

* The September 2020 refresh was postponed to December 2020 for technical 

reasons. The period of performance listed here reflects the data that was originally 

scheduled to be used to calculate provider performance for the December 2020 

refresh. 
42404 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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 claimsbased 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/irfqrpcovid19prtipsheet-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 assessmentbased 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 


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TABLE 11: Schedule for Refreshes Affected by COVID-19 PHE Exemptions for IRF-PAI 

Assessment--based QMs 

Quarter Refresh 

December 2020 

March 2021 

June 2021 

September 2021 

December 2021 

March 2022 

IRF-PAI Assessment Quarters in 

Revised/Proposed Schedule for 

Care Compare (number of 

quarters) 

Ql 2019- Q4 2019 (4) 

Q3 2020- Ql 2021 (3) 

Q3 2020- Q2 2021 (4)* 

*Normal reporting resumes with 4 

quarters of data. 

Note: The shaded cells represent data held constant due to PHE related to 

COVID-19. 

TABLE 12: Schedule for Refreshes Affected by COVID-19 PHE Exemptions for IRF 

Claims--based QMs 

Quarter Refresh Claims-based Quarters in Schedule for 

Care Compare (number of quarters) 

December 2020 Q4 2017 - Q3 2019 (8) 

March 2021 Q4 2017 - Q3 2019 (8) 

,_J_u_n_e_20_2_1 _____ Q4 2017 - Q3 2019 (8) 

September 2021 

December 2021 

March 2022 

June 2022 

September 2022 

December 2022 

March 2023 

June 2023 

September 2023 

Q4 2018 - Q4 2019, Q3 2020 (6) 

Q4 2018 - Q4 2019, Q3 2020 (6) 

Q4 2018 - Q4 2019, Q3 2020 (6) 

Q4 2019, Q3 2020- Q3 2021 (6) 

Q4 2019, Q3 2020- Q3 2021 (6) 

Q4 2019, Q3 2020- Q3 2021 (6) 

Q4 2019, Q3 2020- Q3 2021 (6) 

Q4 2020 - Q3 2022 (8)* 

*Normal reporting resumes with 8 

quarters of data. 

Note: The shaded cells represent data held constant due to PHE 

related to COVID-19. 
42406 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Reconsideration-andException-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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TABLE 13: IRF Quarters in Care Compare Original Schedule for Refreshes Affected by 

COVID -19 PHE E xemp f 10ns- CDI an d CAUTI NHSN M eas ures 

Quarter Refresh CDI and CAUTI Quarters in Original 

Schedule for Care Compare (number 

of quarters) 

Actual December 2020 Q4 2018 - Q3 2019 {4)* 

(on Care Compare) 

Original December 2020 Ql 2019 - Q4 2019 (4) 

March 2021 Q2 2019 - Ql 2020 (4) 

June 2021 Q3 2019 - Q2 2020 (4) 

September 2021 Q4 2019 - Q3 2020 (4) 

December 2021 Ql 2020- Q4 2020 (4) 

March 2022 Q2 2020- Ql 2021 (4) 

June 2022 Q3 2020 - Q2 2021 (4) 

*The September 2020 refresh was postponed to December 2020 for 

technical reasons. 

TABLE 14: IRF Quarters in Care Compare Original Schedule for Refreshes Affected by 

COVID -19 PHE E xemp f 10ns- HCP I n fl uenza M easure 

Quarter Refresh HCP Influenza Quarters in Original 

Schedule for Care Compare 

(number of quarters) 

Actual December 2020 Q4 2017 - Ql 2018 {2)* 

(on Care Compare) 

Original December 2020 Q4 2018 - Ql 2019 (2) 

March 2021 Q4 2018 - Ql 2019 (2) 

June 2021 Q4 2018 - Ql 2019 (2) 

September 2021 Q4 2018 - Ql 2019 (2) 

December 2021 Q4 2019 - Ql 2020 (2) 

March 2022 Q4 2019 - Ql 2020 (2) 

June 2022 Q4 2019 - Ql 2020 (2) 

September 2022 Q4 2019 - Ql 2020 (2) 

December 2022 Q4 2020- Ql 2021 (2) 

*The September 2020 refresh was postponed to December 2020 for 

technical reasons. 

TABLE 15: Schedule for Refreshes Affected by COVID-19 PHE Exemptions for the CDI 

and CAUTI NHSN Measures 

Quarter Refresh 

December 2020 

March2021 

June 2021 

Se tember 2021 

December 2021 

March2022 

CDI and CAUTI Quarters in 

Revised/Proposed Schedule for 

Care Compare (number of 

uarters 

Q2 2019 - Q4 2019, Q3 2020 4 

Q3 2020 - Q2 2021 

* Normal reporting resumes with 

June 2022* 4 conti uous uarters of data. 

Note: The shaded cells represent data held constant due to PHE related 

to COVID-19. 
42408 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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 noncontiguous 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. 


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TABLE 16: Schedule for Refreshes Affected by COVID-19 PHE Exemptions for the 

HCP Influenza NHSN Measure 

Quarter Refresh 

December 2020 

March202I 

June 2021 

Se tember 2021 

December 2021 

March2022 

June 2022 

Se tember 2022 

December 2022 

HCP Influenza Quarters in Schedule 

for Care Compare (number of 

uarters 

Q4 2018 - QI 2019 (2) 

Q4 2018 - QI 2019 (2) 

Q4 2018 - Ql 2019 (2) 

Q4 2018 - Ql 2019 (2) 

Q4 2020-Ql 2021 (2)* 

* Normal re ortin resumes. 

Note: The shaded cells represent data held constant due to PHE related to COVID-19. 
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 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: 

• Off-the-shelf (OTS) orthotics, for 

which payment would otherwise be 

made under section 1834(h) of the Act; 

• Enteral nutrients, equipment, and 

supplies described in section 

1842(s)(2)(D) of the Act; and 

• 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; EndStage 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 

§ 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 


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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 NonContiguous 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 

§ 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/ProviderType/Durable-Medical-Equipment-DMECenter.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 


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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 


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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 § 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 § 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 § 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 

§ 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 § 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 


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91Section 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. 

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: 

• 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. 

• 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. 

• 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. 

• We will calculate the final IRF 

standard payment conversion factor for 

FY 2022, as discussed in section VI. of 

this final rule. 

• We will update the outlier 

threshold amount for FY 2022, as 

discussed in section VII. of this final 

rule. 

• 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: 

• 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 NonContiguous 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: 

• Changes to exclude complex 

rehabilitative manual wheelchairs, 

certain other manual wheelchairs, and 

accessories furnished in connection 

with these wheelchairs from the 

DMEPOS CBP. 

• 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: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency; 

• The accuracy of our estimate of the 

information collection burden; 

• The quality, utility, and clarity of 

the information to be collected; and 

• 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. 

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 


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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%20 

Size%20Standards_Effective%20 

Aug%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. 


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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: 

• 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. 

• 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. 

• The effects of applying the budgetneutral labor-related share and wage 

index adjustment, as required under 

section 1886(j)(6) of the Act. 

• 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. 

• The total change in estimated 

payments based on the FY 2022 

payment changes relative to the 

estimated FY 2021 payments. 


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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 forprofit 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: 

• Column (1) shows the facility 

classification categories. 

• Column (2) shows the number of 

IRFs in each category in our FY 2022 

analysis file. 

• Column (3) shows the number of 

cases in each category in our FY 2022 

analysis file. 

• Column (4) shows the estimated 

effect of the adjustment to the outlier 

threshold amount. 

• Column (5) shows the estimated 

effect of the update to the IRF laborrelated share and wage index, in a 

budget-neutral manner. 

• Column (6) shows the estimated 

effect of the update to the CMG relative 

weights and ALOS values, in a budgetneutral manner. 

• 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 budgetneutral 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 


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TABLE 17: IRF Impact Table for FY 2022 Columns 4 throw?:h 7 in percentae:e) 

FY22 

Wage Index Total 

Number Number and Labor CMG Percent 

Facility Classification ofIRFs of Cases Outlier Share Weights Change 1 

(1) (2) (3) (4) (5) (6) (7) 

Total I, 114 381,770 -0.4 0.0 0.0 1.5 

-0.6 0.1 -0.2 1.2 

Urban unit 665 150,120 

Rural unit 133 19,484 -0.6 0.4 -0.3 1.4 

207,312 -0.2 -0.1 0.2 1.8 

Urban hospital 304 

Rural hospital 12 4,854 -0.1 0.4 0.1 2.3 

200,172 -0.2 0.0 0.2 1.9 

Urban For-Profit 373 

Rural For-Profit 34 7,988 -0.2 0.3 0.0 2.0 

137,347 -0.6 -0.1 -0.2 1.0 

Urban Non-Profit 509 

Rural Non-Profit 90 13,571 -0.7 0.5 -0.3 1.4 

Urban Government 87 19,913 -0.6 0.5 -0.3 1.5 

Rural Government 21 2 779 -0.4 0.3 -0.3 1.5 

-0.4 0.0 0.0 1.5 

Urban 969 357,432 

Rural 145 24,338 -0.5 0.4 -0.2 1.6 

Urban bv region 

Urban New England 31 14,531 -0.3 -0.6 -0.2 0.8 

43,217 -0.4 -1.0 0.0 0.5 

Urban Middle Atlantic 125 

Urban South Atlantic 154 74,192 -0.3 0.5 0.0 2.2 

Urban East North Central 157 45,939 -0.4 0.0 -0.1 1.4 

25,615 -0.2 0.0 0.1 1.8 

Urban East South Central 55 

20,395 -0.4 0.7 -0.2 2.0 

Urban West North Central 75 

80,374 -0.3 -0.3 0.2 1.5 

Urban West South Central 191 

28,228 -0.2 0.1 0.0 1.7 

Urban Mountain 82 

Urban Pacific 99 24,941 -0.7 0.5 -0.2 1.5 

Rural bv region 

Rural New England 5 1,264 -0.5 -0.2 -0.4 0.7 

10 -1.0 1.0 -0.4 1.6 

Rural Middle Atlantic 989 

Rural South Atlantic 16 3,976 -0.2 1.1 0.2 3.0 

Rural East North Central 23 3,931 -0.5 0.6 -0.2 1.8 

Rural East South Central 21 3,702 -0.3 0.1 -0.3 1.4 

Rural West North Central 20 2,872 -0.7 0.0 -0.4 0.8 

Rural West South Central 42 6,760 -0.5 0.3 -0.2 1.5 

5 -0.9 0.7 -0.5 1.2 

Rural Mountain 486 

Rural Pacific 3 358 -1.4 0.1 -0.7 -0.1 

Teaching status 

Non-teaching 1,008 337,505 -0.3 0.0 0.0 1.6 

-0.4 0.1 0.0 1.6 

Resident to ADC less than 10% 59 29,605 

13,318 -0.7 -0.4 -0.2 0.5 

Resident to ADC 10%-19% 36 

Resident to ADC greater than 19% 11 1,342 -0.4 0.0 -0.4 1.1 

Disproportionate share patient percentage (DSH PP) 
42418 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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 LaborRelated 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 nonexempted 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 


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FY22 

Wage Index Total 

Number Number and Labor CMG Percent 

Facility Classification ofIRFs of Cases Outlier Share Weiehts Chanee 1 

-0.6 -0.9 0.1 0.5 

DSHPP=0o/o 49 8,050 

-0.3 -0.2 0.1 1.5 

DSHPP<5% 143 52,695 

116,312 -0.3 0.1 0.1 1.8 

DSH PP 5%-10% 280 

387 -0.4 -0.1 0.0 1.4 

DSH PP 10%-20% 139,160 

-0.5 0.2 -0.1 1.5 

DSH PP greater than 20% 255 65,553 

1This column includes the impact of the updates in columns (4), (5), and (6) above, and of the IRF market basket update for 

FY 2022 (2.6 percent), reduced by 0.7 percentage point for the productivity adjustment as required by section 1886U)(3)(C)(ii)(I) 

of the Act. Note, the products of these impacts may be different from the percentage changes shown here due to rounding effects. 
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 42419 

92https://www.bls.gov/oes/current/oes_nat.htm. 

Accessed on March 30, 2021. 

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. 

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. 


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TABLE 18: U.S. Bureau of Labor and Statistics' May 2019 National Occupational 

E mp 1 oymen t d W an a1?;e Et· s 1ma t es 

Occupation title Occupation Mean Hourly Wage Overhead and Fringe Adjusted Hourly 

code ($/hr) Benefit ($/hr) Wa2e ($/hr) 

Administrative 43-6013 $18.31 $18.31 $36.62 

Assistant 
42420 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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 


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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 × 

$114.24). Therefore, we estimate that 

the total cost of reviewing this 

regulation is $1,137,144.96 ($342.72 × 

(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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Change in Estimated Transfers from FY 

2021 IRF PPS to FY 2022 IRF PPS 

Change in Estimated Costs from 

FY2021 IRF QRP to FY 2022 IRF QRP 

Estimated Costs Associated with 

Review Cost for FY 2022 IRF PPS 

Statement: Classification of Estimated Ex enditure 

Annualized Monetized Transfers 

From Whom to Whom? 

Annualized monetized cost in FY 2022 

for IRFs due to new quality reporting 

ro am re uirements 

Cost associated with regulatory review 

cost 

$130 million 

Federal Government to IRF 

Medicare Providers 

$489,536.16 

$1,137,144.96 
42422 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations 

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 

■ 1. The authority citation for part 414 

continues to read as follows: 

Authority: 42 U.S.C. 1302, 1395hh, and 

1395rr(b)(l). 

■ 2. In § 414.402 amend the definition 

of ‘‘Item’’ by revising paragraph (1) 

introductory text to read as follows: 

§ 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 § 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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TABLE 20: DME Provision: Complex Power Wheelchair Accessories Annualization 

Period 2022 to 2026 

Category Transfer 

Annualized Monetized Transfer on Program Cost Estimate Year Dollar Discount Rate 

Sharing (in $Millions) $20 2022 7% 

$20 2022 3% 

From Whom to Whom? Federal Government to Medicare suooliers 

Annualized Monetized Transfer on Beneficiary Estimate Year Dollar Discount Rate 

Cost Sharing (in $millions) $6 2022 7% 

$6 2022 3% 

From Whom to Whom? Beneficiaries to Medicare suppliers 

TABLE21 : C omp IM ex anua lWh ee lh' c air A ccessories A nnua I' iza f 10n P . erio d 2022 t 0 2026 

Category Transfer 

Annualized Monetized Transfer on Program Cost Estimate Year Dollar Discount Rate 

Sharing (in $Millions) $8 2022 7% 

$8 2022 3% 

From Whom to Whom? Federal Government to Medicare suooliers 

Annualized Monetized Transfer on Beneficiary Estimate Year Dollar Discount Rate 

Cost Sharing (in $millions) $0 2022 7% 

$0 2022 3% 

From Whom to Whom? Beneficiaries to Medicare suppliers