Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program
| Published date | 12 April 2021 |
| Citation | 86 FR 19086 |
| Record Number | 2021-07343 |
| Section | Proposed rules |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 86 Issue 68 (Monday, April 12, 2021)
[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Proposed Rules]
[Pages 19086-19126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07343]
[[Page 19085]]
Vol. 86
Monday,
No. 68
April 12, 2021
Part IIDepartment of Health and Human Services-----------------------------------------------------------------------Centers for Medicare & Medicaid Services-----------------------------------------------------------------------42 CFR Part 412Medicare Program; Inpatient Rehabilitation Facility Prospective Payment
System for Federal Fiscal Year 2022 and Updates to the IRF Quality
Reporting Program; Proposed Rule
Federal Register / Vol. 86 , No. 68 / Monday, April 12, 2021 /
Proposed Rules
[[Page 19086]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 412
[CMS-1748-P]
RIN 0938-AU38
Medicare Program; Inpatient Rehabilitation Facility Prospective
Payment System for Federal Fiscal Year 2022 and Updates to the IRF
Quality Reporting Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would update the prospective payment rates
for inpatient rehabilitation facilities (IRFs) for Federal fiscal year
(FY) 2022. As required by statute, this proposed 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. In
addition, this proposed rule includes proposals for the IRF Quality
Reporting Program (QRP).
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on June 7, 2021.
ADDRESSES: In commenting, please refer to file code CMS-1748-P.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1748-P, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1748-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
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.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
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 proposed rule
are available through the internet on the CMS Website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS.
We note that prior to 2020, each rule or notice issued under the
IRF PPS has included a detailed reiteration of the various regulatory
provisions that have affected the IRF PPS over the years. That
discussion, along with detailed background information for various
other aspects of the IRF PPS, is now available on the CMS Website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS.
I. Executive Summary
A. Purpose
This proposed rule would update 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 proposed 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 proposed rule
proposes to add one new measure to the IRF QRP and modify the
denominator for another measure currently under the IRF QRP beginning
with the FY 2023 IRF QRP. In addition, this proposed rule proposes to
modify the number of quarters used for publicly reporting certain IRF
QRP measures due to the public health emergency (PHE). Finally, we are
seeking comment on the use of Health Level Seven International
(HL7[supreg]) Fast Healthcare Interoperability Resources[supreg]
(FHIR)-based standards in post-acute care, specifically the IRF QRP,
and on our continued efforts to close the health equity gap.
B. Summary of Major Provisions
In this proposed 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 proposed rule proposes to update certain requirements for the IRF
QRP, and also makes requests for information.
C. Summary of Impact
[[Page 19087]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.000
II. Background
A. Statutory Basis and Scope
Section 1886(j) of the Act provides for the implementation of a
per-discharge PPS for inpatient rehabilitation hospitals and inpatient
rehabilitation units of a hospital (collectively, hereinafter referred
to as IRFs). Payments under the IRF PPS encompass inpatient operating
and capital costs of furnishing covered rehabilitation services (that
is, routine, ancillary, and capital costs), but not direct graduate
medical education costs, costs of approved nursing and allied health
education activities, bad debts, and other services or items outside
the scope of the IRF PPS. A complete discussion of the IRF PPS
provisions appears in the original FY 2002 IRF PPS final rule (66 FR
41316) and the FY 2006 IRF PPS final rule (70 FR 47880) and we provided
a general description of the IRF PPS for FYs 2007 through 2019 in the
FY 2020 IRF PPS final rule (84 FR 39055 through 39057).
Under the IRF PPS from FY 2002 through FY 2005, the prospective
payment rates were computed across 100 distinct CMGs, as described in
the FY 2002 IRF PPS final rule (66 FR 41316). We constructed 95 CMGs
using rehabilitation impairment categories (RICs), functional status
(both motor and cognitive), and age (in some cases, cognitive status
and age may not be a factor in defining a CMG). In addition, we
constructed five special CMGs to account for very short stays and for
patients who expire in the IRF.
For each of the CMGs, we developed relative weighting factors to
account for a patient's clinical characteristics and expected resource
needs. Thus, the weighting factors accounted for the relative
difference in resource use across all CMGs. Within each CMG, we created
tiers based on the estimated effects that certain comorbidities would
have on resource use.
We established the Federal PPS rates using a standardized payment
conversion factor (formerly referred to as the budget-neutral
conversion factor). For a detailed discussion of the budget-neutral
conversion factor, please refer to our FY 2004 IRF PPS final rule (68
FR 45684 through 45685). In the FY 2006 IRF PPS final rule (70 FR
47880), we discussed in detail the methodology for determining the
standard payment conversion factor.
We applied the relative weighting factors to the standard payment
conversion factor to compute the unadjusted prospective payment rates
under the IRF PPS from FYs 2002 through 2005. Within the structure of
the payment system, we then made adjustments to account for interrupted
stays, transfers, short stays, and deaths. Finally, we applied the
applicable adjustments to account for geographic variations in wages
(wage index), the percentage of low-income patients, location in a
rural area (if applicable), and outlier payments (if applicable) to the
IRFs' unadjusted prospective payment rates.
For cost reporting periods that began on or after January 1, 2002,
and before October 1, 2002, we determined the final prospective payment
amounts using the transition methodology prescribed in section
1886(j)(1) of the Act. Under this provision, IRFs transitioning into
the PPS were paid a blend of the Federal IRF PPS rate and the payment
that the IRFs would have received had the IRF PPS not been implemented.
This provision also allowed IRFs to elect to bypass this blended
payment and immediately be paid 100 percent of the Federal IRF PPS
rate. The transition methodology expired as of cost reporting periods
beginning on or after October 1, 2002 (FY 2003), and payments for all
IRFs now consist of 100 percent of the Federal IRF PPS rate.
Section 1886(j) of the Act confers broad statutory authority upon
the Secretary to propose refinements to the IRF PPS. In the FY 2006 IRF
PPS final rule (70 FR 47880) and in correcting amendments to the FY
2006 IRF PPS final rule (70 FR 57166), we finalized a number of
refinements to the IRF PPS case-mix classification system (the CMGs and
the corresponding relative weights) and the case-level and facility-
level adjustments. These refinements included the adoption of the
Office of Management and Budget's (OMB's) Core-Based Statistical Area
(CBSA) market definitions; modifications to the CMGs, tier
comorbidities; and CMG relative weights, implementation of a new
teaching status adjustment for IRFs; rebasing and revising the market
basket index used to update IRF payments, and updates to the rural,
low-income percentage (LIP), and high-cost outlier adjustments.
Beginning with the FY 2006 IRF PPS final rule (70 FR 47908 through
47917), the market basket index used to update IRF payments was a
market basket reflecting the operating and capital cost structures for
freestanding IRFs, freestanding inpatient psychiatric facilities
(IPFs), and long-term care hospitals (LTCHs) (hereinafter referred to
as the rehabilitation, psychiatric, and long-term care (RPL) market
basket). Any reference to the FY 2006 IRF PPS final rule in this
proposed rule also includes the provisions effective in the correcting
amendments. For a detailed discussion of the final key policy changes
for FY 2006, please refer to the FY 2006 IRF PPS final rule.
The regulatory history previously included in each rule or notice
issued under the IRF PPS, including a general description of the IRF
PPS for FYs 2007 through 2020, is available on the CMS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS.
In late 2019, 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
[[Page 19088]]
interim final rule with comment period (IFC) entitled, ``Medicare and
Medicaid Programs; Policy and Regulatory Revisions in Response to the
COVID-19 Public Health Emergency'', published on April 6, 2020 (85 FR
19230) (hereinafter referred to as the April 6, 2020 IFC), included
certain changes to the IRF PPS medical supervision requirements at 42
CFR 412.622(a)(3)(iv) and 412.29(e) during the PHE for COVID-19. In
addition, in the April 6, 2020 IFC, we removed the post-admission
physician evaluation requirement at Sec. 412.622(a)(4)(ii) for all
IRFs during the PHE for COVID-19. In the FY 2021 IRF PPS final rule, to
ease documentation and administrative burden, we also removed the post-
admission physician evaluation documentation requirement at 42 CFR
412.622(a)(4)(ii) permanently beginning in FY 2021.
A second IFC entitled, ``Medicare and Medicaid Programs, Basic
Health Program, and Exchanges; Additional Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency and Delay
of Certain Reporting Requirements for the Skilled Nursing Facility
Quality Reporting Program'' was published on May 8, 2020 (85 FR 27550)
(hereinafter referred to as the May 8, 2020 IFC). Among other changes,
the May 8, 2020 IFC included a waiver of the ``3-hour rule'' at Sec.
412.622(a)(3)(ii) to reflect the waiver required by section 3711(a) of
the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
(Pub. L. 116-136, enacted on March 27, 2020). In the May 8, 2020 IFC,
we also modified certain IRF coverage and classification requirements
for freestanding IRF hospitals to relieve acute care hospital capacity
concerns in states (or regions, as applicable) that are experiencing a
surge during the PHE for COVID-19. In addition to the policies adopted
in our IFCs, we responded to the PHE with numerous blanket waivers \1\
and other flexibilities,\2\ some of which are applicable to the IRF
PPS.
---------------------------------------------------------------------------
\1\ CMS, ``COVID-19 Emergency Declaration Blanket Waivers for
Health Care Providers,'' (updated Feb. 19 2021) (available at
https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf).
\2\ CMS, ``COVID-19 Frequently Asked Questions (FAQs) on
Medicare Fee-for-Service (FFS) Billing,'' (updated March 5, 2021)
(available at https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf).
---------------------------------------------------------------------------
B. 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
proposed 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 V.B. of this proposed 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.
C. Operational Overview of the Current IRF PPS
As described in the FY 2002 IRF PPS final rule (66 FR 41316), upon
the admission and discharge of a Medicare Part A fee-for-service (FFS)
patient, the IRF is required to complete the appropriate sections of a
Patient Assessment Instrument (PAI), designated as the IRF-PAI. In
addition, beginning with IRF discharges occurring on or after October
1, 2009, the IRF is also required to complete the appropriate sections
of the IRF-PAI upon the admission and discharge of each Medicare
Advantage (MA) patient, as described in the FY 2010 IRF PPS final rule
(74 FR 39762 and 74 FR 50712). All required data must be electronically
encoded into the IRF-PAI software product. Generally, the software
product includes patient classification programming called the Grouper
software. The Grouper software uses specific IRF-PAI data elements to
classify (or group) patients into distinct CMGs and account for the
existence of any relevant comorbidities.
The Grouper software produces a five-character CMG number. The
first character is an alphabetic character that indicates the
comorbidity tier. The last four characters are numeric characters that
represent the distinct CMG number. A free download of the Grouper
software is available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Software.html. The Grouper software is also embedded in the internet
Quality Improvement and Evaluation System (iQIES) User tool available
in iQIES at https://www.cms.gov/medicare/quality-safety-oversight-general-information/iqies.
Once a Medicare Part A FFS patient is discharged, the IRF submits a
Medicare claim as a Health Insurance Portability and Accountability Act
of 1996 (HIPAA) (Pub. L. 104-191, enacted on August 21, 1996) -
compliant electronic claim or, if the Administrative Simplification
Compliance Act of 2002 (ASCA) (Pub. L. 107-105, enacted on December 27,
2002) permits, a paper claim (a UB-04 or a CMS-1450 as appropriate)
using the five-character CMG number and sends it to the appropriate
Medicare Administrative Contractor (MAC). In addition, once a MA
patient is
[[Page 19089]]
discharged, in accordance with the Medicare Claims Processing Manual,
chapter 3, section 20.3 (Pub. 100-04), hospitals (including IRFs) must
submit an informational-only bill (type of bill (TOB) 111), which
includes Condition Code 04 to their MAC. This will ensure that the MA
days are included in the hospital's Supplemental Security Income (SSI)
ratio (used in calculating the IRF LIP adjustment) for FY 2007 and
beyond. Claims submitted to Medicare must comply with both ASCA and
HIPAA.
Section 3 of the ASCA amended section 1862(a) of the Act by adding
paragraph (22), which requires the Medicare program, subject to section
1862(h) of the Act, to deny payment under Part A or Part B for any
expenses for items or services for which a claim is submitted other
than in an electronic form specified by the Secretary. Section 1862(h)
of the Act, in turn, provides that the Secretary shall waive such
denial in situations in which there is no method available for the
submission of claims in an electronic form or the entity submitting the
claim is a small provider. In addition, the Secretary also has the
authority to waive such denial in such unusual cases as the Secretary
finds appropriate. For more information, see the ``Medicare Program;
Electronic Submission of Medicare Claims'' final rule (70 FR 71008).
Our instructions for the limited number of Medicare claims submitted on
paper are available at http://www.cms.gov/manuals/downloads/clm104c25.pdf.
Section 3 of the ASCA operates in the context of the administrative
simplification provisions of HIPAA, which include, among others, the
requirements for transaction standards and code sets codified in 45 CFR
part 160 and part 162, subparts A and I through R (generally known as
the Transactions Rule). The Transactions Rule requires covered
entities, including covered healthcare providers, to conduct covered
electronic transactions according to the applicable transaction
standards. (See the CMS program claim memoranda at http://www.cms.gov/ElectronicBillingEDITrans/ and listed in the addenda to the Medicare
Intermediary Manual, Part 3, section 3600).
The MAC processes the claim through its software system. This
software system includes pricing programming called the ``Pricer''
software. The Pricer software uses the CMG number, along with other
specific claim data elements and provider-specific data, to adjust the
IRF's prospective payment for interrupted stays, transfers, short
stays, and deaths, and then applies the applicable adjustments to
account for the IRF's wage index, percentage of low-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).
D. Advancing Health Information Exchange
The Department of Health and Human Services (HHS) has a number of
initiatives designed to encourage and support the adoption of
interoperable health information technology and to promote nationwide
health information exchange to improve health care and patient access
to their health information.
To further interoperability in post-acute care settings, CMS and
Office of the National Coordinator for Health Information Technology
(ONC) participate in the Post-Acute Care Interoperability Workgroup
(PACIO) (https://pacioproject.org/) to facilitate collaboration with
industry stakeholders to develop FHIR standards. These standards could
support the exchange and reuse of patient assessment data derived from
the minimum data set (MDS), inpatient rehabilitation facility patient
assessment instrument (IRF-PAI), long term care hospital continuity
assessment record and evaluation (LCDS), outcome and assessment
information set (OASIS), and other sources. The PACIO Project has
focused on FHIR implementation guides for functional status, cognitive
status and new use cases on advance directives and speech, and language
pathology. We encourage post-acute care (PAC) provider and health IT
vendor participation as these efforts advance.
The CMS Data Element Library (DEL) continues to be updated and
serves as the authoritative resource for PAC assessment data elements
and their associated mappings to health IT standards such as Logical
Observation Identifiers Names and Codes (LOINC) and Systematized
Nomenclature of Medicine Clinical Terms (SNOMED). The DEL furthers CMS'
goal of data standardization and interoperability. When combined with
digital information systems that capture and maintain these coded
elements, their standardized clinical content can reduce provider
burden by supporting exchange of standardized healthcare data;
supporting provider exchange of electronic health information for care
coordination, person-centered care; and supporting real-time, data
driven, clinical decision making. Standards in the Data Element Library
(https://del.cms.gov/DELWeb/pubHome) can be referenced on the CMS
website and in the ONC Interoperability Standards Advisory (ISA). The
2021 ISA is available at https://www.healthit.gov/isa.
The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted on
December 13, 2016) requires HHS to take new steps to enable the
electronic sharing of health information ensuring interoperability for
providers and settings across the care continuum. The Cures Act
includes a trusted exchange framework and common agreement (TEFCA)
provision \3\ that will enable the nationwide exchange of electronic
health information across health information networks and provide an
important way to enable bi-directional health information exchange in
the future. For more information on current developments related to
TEFCA, we refer readers to https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement and
https://rce.sequoiaproject.org/.
---------------------------------------------------------------------------
\3\ ONC, Draft 2 Trusted Exchange Framework and Common
Agreement, https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf.
---------------------------------------------------------------------------
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
[[Page 19090]]
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 invite 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 this proposed rule, we are proposing to update the IRF PPS 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 this proposed rule.
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 this proposed rule.
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 this proposed rule.
Describe the calculation of the IRF standard payment
conversion factor for FY 2022, as discussed in section V. of this
proposed rule.
Update the outlier threshold amount for FY 2022, as
discussed in section VI. of this proposed rule.
Update the cost-to-charge ratio (CCR) ceiling and urban/
rural average CCRs for FY 2022, as discussed in section VI. of this
proposed rule.
The proposed policy changes and updates to the IRF QRP for FYs 2022
and 2023 are as follows:
Propose revisions and updates to quality measures and
reporting requirements under the IRF QRP, as well as make requests for
information as discussed in section VII. of this proposed rule.
IV. Proposed Update to the Case-Mix Group (CMG) Relative Weights and
Average Length of Stay Values for FY 2022
As specified in Sec. 412.620(b)(1), we calculate a relative weight
for each CMG that is proportional to the resources needed by an average
inpatient rehabilitation case in that CMG. For example, cases in a CMG
with a relative weight of 2, on average, will cost twice as much as
cases in a CMG with a relative weight of 1. Relative weights account
for the variance in cost per discharge due to the variance in resource
utilization among the payment groups, and their use helps to ensure
that IRF PPS payments support beneficiary access to care, as well as
provider efficiency.
In this proposed rule, we propose to update the CMG relative
weights and average length of stay 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 are proposing 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 are proposing that if more recent data become
available after the publication of this proposed rule and before the
publication of the final rule, we would use such data to determine the
FY 2022 CMG relative weights and average length of stay values in the
final rule.
We are proposing to apply these data using the same methodologies
that we have used to update the CMG relative weights and average length
of stay 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
proposed rule is as follows:
Step 1. We estimate the effects that comorbidities have on costs.
Step 2. We adjust the cost of each Medicare discharge (case) to
reflect the effects found in the first step.
Step 3. We use the adjusted costs from the second step to calculate
CMG relative weights, using the hospital-specific relative value
method.
Step 4. We normalize the FY 2022 CMG relative weights to the same
average CMG relative weight from the CMG relative weights implemented
in the FY 2021 IRF PPS final rule (85 FR 48424).
Consistent with the methodology that we have used to update the IRF
classification system in each instance in the past, we propose 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. To calculate
the appropriate 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 proposed changes to the CMG relative
weights (as discussed in this proposed rule).
Step 3. Divide the amount calculated in step 1 by the amount
calculated in step 2 to determine the budget neutrality factor of
1.0000 that would maintain the same total estimated aggregate payments
in FY 2022 with and without the proposed changes to the CMG relative
weights.
[[Page 19091]]
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 V.E. of this proposed rule, we discuss the proposed use
of the existing methodology to calculate the proposed standard payment
conversion factor for FY 2022.
In Table 2, ``Proposed Relative Weights and Average Length of Stay
Values for Case-Mix Groups,'' we present the proposed CMGs, the
comorbidity tiers, the corresponding relative weights, and the average
length of stay values for each CMG and tier for FY 2022. The average
length of stay 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
[[Page 19092]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.001
[[Page 19093]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.002
[[Page 19094]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.003
[[Page 19095]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.004
BILLING CODE 4120-01-C
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 proposed 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 propose to implement the CMG relative
weight revisions in a budget-neutral manner (as previously described),
total estimated aggregate payments to IRFs for FY 2022 would not be
affected as a result of the proposed CMG relative weight revisions.
However, the proposed revisions would affect the distribution of
payments within CMGs and tiers.
[GRAPHIC] [TIFF OMITTED] TP12AP21.005
As shown in Table 3, 97.3 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 proposed revisions for FY 2022. The proposed changes in the average
length of stay values for FY 2022, compared with the FY 2021 average
length of stay values, are small and do not show any particular trends
in IRF length of stay patterns.
We invite public comment on our proposed updates to the CMG
relative weights and average length of stay values for FY 2022.
V. Proposed 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 this proposed rule,
we are proposing 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 IRF PPS final rule (84 FR 39071 through
39086) contains a complete discussion of the development of the 2016-
based IRF market basket.
B. Proposed FY 2022 Market Basket Update and Productivity Adjustment
For FY 2022 (that is, beginning October 1, 2021 and ending
September 30, 2022), we are proposing 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 are proposing 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 are proposing to use the iBoxx AAA
Corporate Bond Yield index instead of the Moody's AAA Corporate Bond
Yield index. Effective for December 2020, the Moody's AAA Corporate
Bond series is no longer available for use under license to IHS Global
Inc. (IGI), the nationally-recognized economic and financial
forecasting firm with which we contract to forecast the components of
the market baskets and multi-factor productivity (MFP). Since IGI is no
longer licensed to use and publish the Moody's series, IGI was required
to discontinue the publication of the associated historical data and
forecasts of this series. Therefore, IGI constructed a bond yield index
(iBoxx) that closely replicates the Moody's corporate bond yield
indices currently used in the market baskets.
We compared the iBoxx AAA Corporate Bond Yield index with the
[[Page 19096]]
Moody's AAA Corporate Bond Yield index and found that the average
growth rates in the history of the two series are very similar. Over
the historical time period of FY 2001 to FY 2020, the 4-quarter percent
change moving average growth in the iBoxx series was approximately 0.1
percentage point higher, on average, than the Moody's series. However,
given the relatively small weight for this cost category, replacing the
Moody's series with the iBoxx series does not impact the historical
top-line market basket increases when rounded to the nearest tenth of a
percentage point over the past ten fiscal years (FY 2011 to FY 2020).
Therefore, 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
believe that using the iBoxx AAA Corporate Bond Yield index is
technically appropriate to use in the 2016-based IRF market basket.
Consistent with historical practice, we are proposing to estimate
the market basket update for the IRF PPS for FY 2022 based on IGI's
forecast using the most 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 is projected to be 2.4 percent. We are also proposing that if more
recent data become available after the publication of the proposed rule
and before the publication of the final rule (for example, a more
recent estimate of the market basket update), we would use such data,
if appropriate, to determine the FY 2022 market basket update in the
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 ``MFP
adjustment''). The U.S. Department of Labor's Bureau of Labor
Statistics (BLS) publishes the official measure of private nonfarm
business MFP. Please see http://www.bls.gov/mfp for the BLS historical
published MFP data. A complete description of the MFP projection
methodology is available on the CMS website at https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/MarketBasketResearch.html.
Using IGI's fourth quarter 2020 forecast, the 10-year moving
average growth of MFP for FY 2022 is projected to be 0.2 percent. Thus,
in accordance with section 1886(j)(3)(C) of the Act, we are proposing
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
are proposing to then reduce this percentage increase by the estimated
MFP 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 is equal to 2.2 percent (2.4 percent market basket update less
0.2 percentage point MFP adjustment). Furthermore, if more recent data
become available after the publication of the proposed rule and before
the publication of the 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 MFP
adjustment in the final rule.
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 is proposing to update the IRF
PPS payment rates for FY 2022 by an adjusted market basket increase
factor which, based on the most recently available data, is 2.2
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 invite public comment on our proposals.
C. Proposed 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 which are attributable to wages and wage-related costs,
of the prospective payment rates computed under section 1886(j)(3) of
the Act, for area differences in wage levels by a factor (established
by the Secretary) reflecting the relative hospital wage level in the
geographic area of the rehabilitation facility compared to the national
average wage level for such facilities. The labor-related share is
determined by identifying the national average proportion of total
costs that are related to, influenced by, or vary with the local labor
market. We are proposing to continue to classify a cost category as
labor-related if the costs are labor-intensive and vary with the local
labor market.
Based on our definition of the labor-related share and the cost
categories in the 2016-based IRF market basket, we calculate the
proposed labor-related share for FY 2022 as the sum of the FY 2022
relative importance of Wages and Salaries, Employee Benefits,
Professional Fees: Labor-related, Administrative and Facilities Support
Services, Installation, Maintenance, and Repair Services, All Other:
Labor-related Services, and a portion of the Capital-Related relative
importance from the 2016-based IRF market basket. For more details
regarding the methodology for determining specific cost categories for
inclusion in the 2016-based IRF labor-related share, see the FY 2020
IRF PPS final rule (84 FR 39087 through 39089).
The relative importance reflects the different rates of price
change for these cost categories between the base year (2016) and FY
2022. Based on IGI's fourth quarter 2020 forecast of the 2016-based IRF
market basket, the sum of the FY 2022 relative importance for Wages and
Salaries, Employee Benefits, Professional Fees: Labor-related,
Administrative and Facilities Support Services, Installation
Maintenance & Repair Services, and All Other: Labor-related Services is
69.0 percent. We are proposing that the portion of Capital-Related
costs that are influenced by the local labor market is 46 percent.
Since the relative importance for Capital-Related costs is 8.4 percent
of the 2016-based IRF market basket for FY 2022, we are proposing to
take 46 percent of 8.4 percent to determine the labor-related share of
Capital-Related costs for FY 2022 of 3.9 percent. Therefore, we are
proposing 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
are proposing that if more recent data become available after
publication of this proposed rule and before the publication of the
final rule
[[Page 19097]]
(for example, a more recent estimate of the labor-related share), we
will use such data, if appropriate, to determine the FY 2022 IRF labor-
related share in the final rule.
Table 4 shows the current estimate of the proposed FY 2022 labor-
related share and the FY 2021 final labor-related share using the 2016-
based IRF market basket relative importance.
[GRAPHIC] [TIFF OMITTED] TP12AP21.006
D. Proposed 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 propose 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 propose 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 propose 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 calculation for the FY 2022 IRF
PPS wage index.
We invite public comment on our proposals.
2. Core-Based Statistical Areas (CBSAs) for the FY 2022 IRF Wage Index
a. Background
The wage index used for the IRF PPS is calculated using the pre-
reclassification and pre-floor inpatient PPS (IPPS) wage index data and
is assigned to the IRF on the basis of the labor market area in which
the IRF is geographically located. IRF labor market areas are
delineated based on the CBSAs established by the OMB. The CBSA
delineations (which were implemented for the IRF PPS beginning with FY
2016) are based on revised OMB delineations issued on February 28,
2013, in OMB Bulletin No. 13-01. OMB Bulletin No. 13-01 established
revised delineations for Metropolitan Statistical Areas, Micropolitan
Statistical Areas, and Combined Statistical Areas in the United States
and Puerto Rico based on the 2010 Census, and provided guidance on the
use of the delineations of these statistical areas using standards
published in the June 28, 2010 Federal Register (75 FR 37246 through
37252). We refer readers to the FY 2016 IRF PPS final rule (80 FR 47068
through 47076) for a full discussion of our implementation of the OMB
labor market area delineations beginning with the FY 2016 wage index.
Generally, OMB issues major revisions to statistical areas every 10
years, based on the results of the decennial census. Additionally, OMB
occasionally issues updates and revisions to the statistical areas in
between decennial censuses to reflect the recognition of new areas or
the addition of counties to existing areas. In some instances, these
updates merge formerly separate areas, transfer components of an area
from one area to another, or drop components from an area. On July 15,
2015, OMB issued OMB Bulletin No. 15-01, which provides minor updates
to and supersedes OMB Bulletin No. 13-01 that was issued on February
28, 2013. The attachment to OMB Bulletin No. 15-01 provides detailed
information on the update to statistical areas since February 28, 2013.
The updates provided in OMB Bulletin No. 15-01 are
[[Page 19098]]
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 delineations of these statistical areas. A
copy of this bulletin may be obtained at https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf.
To this end, as discussed in the FY 2021 IRF PPS proposed (85 FR
22075 through 22079) and final (85 FR 48434 through 48440) rules, we
adopted the revised OMB delineations identified in OMB Bulletin No. 18-
04 (available at https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf) beginning October 1, 2020, including a 1-year
transition for FY 2021 under which we applied a 5 percent cap on any
decrease in a hospital's wage index compared to its wage index for the
prior fiscal year (FY 2020). The updated OMB delineations more
accurately reflect the contemporary urban and rural nature of areas
across the country, and the use of such delineations allows us to
determine more accurately the appropriate wage index and rate tables to
apply under the IRF PPS.
OMB issued further revised CBSA delineations in OMB Bulletin No.
20-01, on March 6, 2020 (available on the web at https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf).
However, we have determined that the changes in OMB Bulletin No. 20-01
do not impact the CBSA-based labor market area delineations adopted in
FY 2021. Therefore, CMS is not proposing to adopt the revised OMB
delineations identified in OMB Bulletin No. 20-01 for FY 2022.
4. Proposed Wage Adjustment
To calculate the wage-adjusted facility payment for the proposed
payment rates set forth in this proposed rule, we would multiply the
proposed 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 V.C. of this proposed rule.
We would then multiply the labor-related portion by the applicable IRF
wage index. The wage index tables are available on the CMS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRF-Rules-and-Related-Files.html.
Adjustments or updates to the IRF wage index made under section
1886(j)(6) of the Act must be made in a budget-neutral manner. We
propose to calculate a budget-neutral wage adjustment factor as
established in the FY 2004 IRF PPS final rule (68 FR 45689), codified
at Sec. 412.624(e)(1), as described in the steps below. We propose to
use the listed steps to ensure that the FY 2022 IRF standard payment
conversion factor reflects the proposed update to the wage indexes
(based on the FY 2018 hospital cost report data) and the proposed
update to the labor-related share, in a budget-neutral manner:
Step 1. Calculate the total amount of estimated IRF PPS payments
using the labor-related share and the wage indexes from FY 2021 (as
published in the FY 2021 IRF PPS final rule (85 FR 48424)).
Step 2. Calculate the total amount of estimated IRF PPS payments
using the proposed FY 2022 wage index values (based on updated hospital
wage data) and the proposed 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 proposed FY 2022
budget-neutral wage adjustment factor of 1.0027.
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 proposed FY 2022 standard payment
conversion factor.
We discuss the calculation of the proposed standard payment
conversion factor for FY 2022 in section V.E. of this proposed rule.
We invite public comment on the proposed IRF wage adjustment for FY
2022.
E. Description of the Proposed IRF Standard Payment Conversion Factor
and Payment Rates for FY 2022
To calculate the proposed standard payment conversion factor for FY
2022, as illustrated in Table 5, we begin by applying the proposed
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 proposed 2.2 percent increase factor
for FY 2022 to the standard payment conversion factor for FY 2021 of
$16,856 yields a standard payment amount of $17,227. Then, we apply the
proposed budget neutrality factor for the FY 2022 wage index, and
labor-related share of 1.0027, which results in a standard payment
amount of $17,273. We next apply the proposed budget neutrality factor
for the CMG relative weights of 1.0000, which results in the standard
payment conversion factor of $17,273 for FY 2022.
We invite public comment on the proposed FY 2022 standard payment
conversion factor.
[[Page 19099]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.007
After the application of the proposed CMG relative weights
described in section IV. of this proposed rule to the proposed FY 2022
standard payment conversion factor ($17,273), the resulting unadjusted
IRF prospective payment rates for FY 2022 are shown in Table 6.
BILLING CODE 4120-01-P
[[Page 19100]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.008
[[Page 19101]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.009
BILLING CODE 4120-01-C
F. Example of the Methodology for Adjusting the Proposed Prospective
Payment Rates
Table 7 illustrates the methodology for adjusting the proposed
prospective payments (as described in section V. of this proposed
rule). The following examples are based on two hypothetical Medicare
beneficiaries, both classified into CMG 0104 (without comorbidities).
The proposed 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 0.8606, 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 0.8686, and a teaching status adjustment of
0.0784.
[[Page 19102]]
To calculate each IRF's labor and non-labor portion of the proposed
prospective payment, we begin by taking the unadjusted prospective
payment rate for CMG 0104 (without comorbidities) from Table 7. Then,
we multiply the proposed labor-related share for FY 2022 (72.9 percent)
described in section V.C. of this proposed rule by the proposed
unadjusted prospective payment rate. To determine the non-labor portion
of the proposed prospective payment rate, we subtract the labor portion
of the Federal payment from the proposed unadjusted prospective
payment.
To compute the proposed wage-adjusted prospective payment, we
multiply the labor portion of the proposed federal payment by the
appropriate wage index located in the applicable wage index table. This
table is available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRF-Rules-and-Related-Files.html.
The resulting figure is the wage-adjusted labor amount. Next, we
compute the proposed wage-adjusted Federal payment by adding the wage-
adjusted labor amount to the non-labor portion of the proposed Federal
payment.
Adjusting the proposed wage-adjusted Federal payment by the
facility-level adjustments involves several steps. First, we take the
wage-adjusted prospective payment and multiply it by the appropriate
rural and LIP adjustments (if applicable). Second, to determine the
appropriate amount of additional payment for the teaching status
adjustment (if applicable), we multiply the teaching status adjustment
(0.0784, in this example) by the wage-adjusted and rural-adjusted
amount (if applicable). Finally, we add the additional teaching status
payments (if applicable) to the wage, rural, and LIP-adjusted
prospective payment rates. Table 7 illustrates the components of the
adjusted payment calculation.
[GRAPHIC] [TIFF OMITTED] TP12AP21.010
Thus, the proposed adjusted payment for Facility A would be
$28,961.86, and the adjusted payment for Facility B would be
$28,072.62.
VI. Proposed Update to Payments for High-Cost Outliers Under the IRF
PPS for FY 2022
A. Proposed 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,
[[Page 19103]]
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 propose
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 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 estimate 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 estimate that IRF outlier payments as a percentage of
total estimated payments would be approximately 3.3 percent in FY 2021.
Therefore, we propose 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 invite public comment 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.
B. Proposed Update to the IRF Cost-to-Charge Ratio Ceiling and Urban/
Rural Averages for FY 2022
CCRs are used to adjust charges from Medicare claims to costs and
are computed annually from facility-specific data obtained from MCRs.
IRF specific CCRs are used in the development of the CMG relative
weights and the calculation of outlier payments under the IRF PPS. In
accordance with the methodology stated in the FY 2004 IRF PPS final
rule (68 FR 45674, 45692 through 45694), we propose to apply a ceiling
to IRFs' CCRs. Using the methodology described in that final rule, we
propose 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 propose 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 propose 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 proposed 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. Using updated FY 2019 cost report data for this proposed
rule, we estimate a national average CCR of 0.478 for rural IRFs, and a
national average CCR of 0.393 for urban IRFs.
In accordance with past practice, we propose to set the national
CCR ceiling at 3 standard deviations above the mean CCR. Using this
method, we propose 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.
We are also proposing that if more recent data become available
after the publication of this 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.
We invite public comment on the proposed update to the IRF CCR
ceiling and the urban/rural averages for FY 2022.
VII. 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),
[[Page 19104]]
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.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP12AP21.011
BILLING CODE 4120-01-C
C. IRF QRP Quality Measure Proposals 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 propose to adopt one new measure:
The COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) \4\
measure as an ``other'' measure under the resource use or other measure
domain under section
[[Page 19105]]
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.
---------------------------------------------------------------------------
\4\ The measure steward changed the name of the measure from
SARS-CoV-2 Vaccination Coverage among Healthcare Personnel to COVID-
19 Vaccination Coverage among Healthcare Personnel. There were no
changes to the measure itself, other than the name change.
---------------------------------------------------------------------------
In addition, we propose 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. Proposed 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 SARS-CoV-2, a novel
(new) coronavirus that causes a disease named ``coronavirus disease
2019'' (COVID-19).\5\ COVID-19 is a contagious respiratory infection
\6\ 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-19.7 8 As of March 31, 2021, the U.S. reported over 30
million cases of COVID-19 and over 548,000 COVID-19 deaths.\9\
Hospitals and health systems saw significant surges of COVID-19
patients as community infection levels increased.\10\ In December 2020
and January 2021, media outlets reported that more than 100,000
Americans were in the hospital with COVID-19.\11\
---------------------------------------------------------------------------
\5\ U.S. Dept of Health and Human Services, Office of the
Assistant Secretary for Preparedness and Response. (2020).
Determination that a Public Health Emergency Exists. Available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
\6\ Centers for Disease Control and Prevention. (2020). Your
Health: Symptoms of Coronavirus. Available at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
\7\ Centers for Disease Control and Prevention. (2020). Your
Health: Symptoms of Coronavirus. Available at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
\8\ Centers for Disease Control and Prevention (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.
\9\ Centers for Disease Control and Prevention. (2020). CDC
COVID Data Tracker. Available at https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days.
\10\ Associated Press. Tired to the Bone. Hospitals Overwhelmed
with Virus Cases. November 18, 2020. Accessed on December 16, 2020,
at https://apnews.com/article/hospitals-overwhelmed-coronavirus-cases-74a1f0dc3634917a5dc13408455cd895. Also see: New York Times.
Just how full are U.S. intensive care units? New data paints an
alarming picture. November 18, 2020. Accessed on December 16, 2020,
at https://www.nytimes.com/2020/12/09/world/just-how-full-are-us-intensive-care-units-new-data-paints-an-alarming-picture.html.
\11\ NPR. U.S. Hits 100,000 COVID-19 Hospitalizations, Breaks
Daily Death Record. Dec. 2, 2020. Accessed on December 17, 2020 at
https://www.npr.org/sections/coronavirus-live-updates/2020/12/02/941902471/u-s-hits-100-000-covid-19-hospitalizations-breaks-daily-death-record; The Wall Street Journal. Coronavirus Live Updates:
U.S. Hospitalizations, Newly Reported Cases, Deaths Edge Downward.
Accessed on January 11 at https://www.wsj.com/livecoverage/covid-2021-01-11.
---------------------------------------------------------------------------
Evidence indicates that COVID-19 primarily spreads when individuals
are in close contact with one another.\12\ 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.\13\ Experts believe that COVID-19 spreads less
commonly through contact with a contaminated surface \14\ (although
that is not thought to be a common way that COVID-19 spreads), and that
in certain circumstances, infection can occur through airborne
transmission.\15\ 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.\16\ Although personal protective equipment
(PPE) and other infection-control precautions can reduce the likelihood
of transmission in health care settings, COVID-19 can spread between
health care personnel (HCP) and patients given the close contact that
may occur during the provision of care.\17\ The CDC has emphasized that
health care settings, including IRFs, can be high-risk places for
COVID-19 exposure and transmission.\18\ Vaccination is a critical part
of the nation's strategy to effectively counter the spread of COVID-19
and ultimately help restore societal functioning.\19\
---------------------------------------------------------------------------
\12\ Centers for Disease Control and Prevention. (2021). COVID-
19. Your Health. Frequently Asked Questions. Accessed on January 11,
2021 at https://www.cdc.gov/coronavirus/2019-ncov/faq.html.
\13\ Centers for Disease Control and Prevention (2021). COVID-
19. Your Health. Frequently Asked Questions. Accessed on January 11,
2021 at https://www.cdc.gov/coronavirus/2019-ncov/faq.html.
\14\ Centers for Disease Control and Prevention (2021). COVID-
19. Your Health. Frequently Asked Questions. Accessed on January 11,
2021 at https://www.cdc.gov/coronavirus/2019-ncov/faq.html.
\15\ Centers for Disease Control and Prevention. (2020). Centers
for Disease Control Scientific Brief: SARS-CoV-2 and Potential
Airborne Transmission. Available at https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html.
\16\ Centers for Disease Control and Prevention. (2020).
Clinical Questions about COVID-19: Questions and Answers. Accessed
on December 2, 2020 at https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html.
\17\ Centers for Disease Control and Prevention. (2020). Interim
U.S. Guidance for Risk Assessment and Work Restrictions for
Healthcare Personnel with Potential Exposure to COVID-19. Accessed
on December 2 at https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.
\18\ 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.
\19\ Centers for Disease Control and Prevention. (2020). COVID-
19 Vaccination Program Interim Playbook for Jurisdiction Operations.
Accessed on December 18 at https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.
---------------------------------------------------------------------------
On December 11, 2020, the Food and Drug Administration (FDA) issued
the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in
the United States.\20\ 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.21 22 23
---------------------------------------------------------------------------
\20\ U.S. Food and Drug Administration. (2020). Pfizer-BioNTech
COVID-19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144412/download.
\21\ Ibid.
\22\ U.S. Food and Drug Administration. (2021). ModernaTX, Inc.
COVID-19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144636/download.
\23\ U.S. Food and Drug Administration (2020). Janssen Biotech,
Inc. COVID-19 Vaccine EUA Letter of Authorization. Available at
https://www.fda.gov/media/146303/download.
---------------------------------------------------------------------------
As part of its national strategy to address COVID-19, the current
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.\24\ Although the
goal of the U.S. government is to ensure that every
[[Page 19106]]
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),\25\ and individuals at highest risk for developing severe
illness from COVID-19.\26\ For example, the CDC's Advisory 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.\27\ Research suggests most states followed this
recommendation,\28\ and HCP began receiving the vaccine in mid-December
of 2020.\29\
---------------------------------------------------------------------------
\24\ The White House. Remarks by President Biden on the COVID-19
Response and the State of Vaccinations. March 29, 2021. Accessed at
https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/03/29/remarks-by-president-biden-on-the-covid-19-response-and-the-state-of-vaccinations/.
\25\ Centers for Disease Control and Prevention. Glossary of
Terms. https://cdc.gov/infectioncontrol/guidelines/healthcare-personnel/appendix/terminology.html.
\26\ Health and Human Services, Department of Defense. (2020)
From the Factory to the Frontlines: The Operation Warp Speed
Strategy for Distributing a COVID-19 Vaccine. Accessed December 18
at https://www.hhs.gov/sites/default/files/strategy-for-distributing-covid-19-vaccine.pdf; Centers for Disease Control
(2020). COVID-19 Vaccination Program Interim Playbook for
Jurisdiction Operations. Accessed December 18 at https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.
\27\ 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.
\28\ Kates, J, Michaud, J, Tolbert, J. ``How Are States
Prioritizing Who Will Get the COVID-19 Vaccine First?'' Kaiser
Family Foundation. December 14, 2020. Accessed on December 16 at
https://www.kff.org/policy-watch/how-are-states-prioritizing-who-will-get-the-covid-19-vaccine-first/.
\29\ Associated Press. `Healing is Coming:' U.S. Health Workers
Start Getting Vaccine. December 15, 2020. Accessed on December 16 at
https://apnews.com/article/us-health-workers-coronavirus-vaccine-56df745388a9fc12ae93c6f9a0d0e81f.
---------------------------------------------------------------------------
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, this rule proposes a new measure, COVID-19 Vaccination
Coverage among HCP to assess the proportion of an IRF's healthcare
workforce that has been vaccinated against COVID-19.
b. Stakeholder Input
In the development and specification of the measure, a transparent
process was employed to seek input from stakeholders and national
experts and engage in a process that allows for pre-rulemaking input on
each measure, under section 1890A of the Act.\30\ To meet this
requirement, the following opportunity was provided for stakeholder
input.
---------------------------------------------------------------------------
\30\ Centers for Medicare & Medicaid Services. Pre-rulemaking.
Accessed at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rulemaking.
---------------------------------------------------------------------------
The pre-rule making process includes making publicly available a
list of quality and efficiency measures, called the Measures Under
Consideration (MUC) List that the Secretary is considering adopting,
through federal rulemaking process, for use in Medicare program(s).
This allows multi-stakeholder groups to provide recommendations to the
Secretary on the measures included on the list. The COVID-19
Vaccination Coverage among Healthcare Personnel measure was included on
the publicly available ``List of Measures under Consideration for
December 21, 2020''.\31\ 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.
---------------------------------------------------------------------------
\31\ National Quality Forum. List of Measures Under
Consideration for December 21, 2020. Accessed at https://www.cms.gov/files/document/measures-under-consideration-list-2020-report.pdf on January 12, 2021.
---------------------------------------------------------------------------
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.\32\ 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.\33\
---------------------------------------------------------------------------
\32\ Measure Applications Partnership. MAP Preliminary
Recommendations 2020-2021. Accessed on February 3, 2021 at https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94650.
\33\ Ibid.
---------------------------------------------------------------------------
In its preliminary recommendations, the MAP PAC-LTC Workgroup did
not support this measure for rulemaking, subject to potential for
mitigation.\34\ To mitigate its concerns, the MAP believed that the
measure needed well-documented evidence, finalized specifications,
testing, and NQF endorsement prior to implementation.\35\ 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.
---------------------------------------------------------------------------
\34\ Ibid.
\35\ Ibid.
---------------------------------------------------------------------------
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,
[[Page 19107]]
CMS and CDC clarified the alignment of the COVID-19 Vaccination
Coverage among HCP with the Influenza Vaccination Coverage 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 Coverage among HCP measure.\36\
The 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.\37\
---------------------------------------------------------------------------
\36\ The Influenza Vaccination Coverage among Healthcare
Personnel (NQF #0431) measure which is NQF endorsed and was adopted
in the IRF QRP in the FY 2014 IRF PPS Final Rule (78 FR 47905
through 47906), and in the LTCH QRP in the FY 2013 IPPS/LTCH PPS
Final Rule (77 FR 53630 through 53631).
\37\ Centers for Disease Control and Preventions. Morbidity and
Mortality Weekly Report. March 29, 2021. Available at https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm?s_cid=mm7013e3_w.
---------------------------------------------------------------------------
Additionally, to support the measure's data element validity, CDC
conducted testing of the COVID-19 vaccination numerator using data
collected through the NHSN and independently reported through the
Federal Pharmacy Partnership for Long-term Care Program for delivering
vaccines to long-term care facilities. These are two completely
independent data collection systems. In initial analyses of the first
month of vaccination, the number of HCP vaccinated in approximately
1,200 facilities, which had data from both systems, the number of HCP
vaccinated was highly correlated between these two systems with a
correlation coefficient of nearly 90 percent in the second 2 weeks of
reporting. Of note, assessment of data element reliability may not be
required by NQF if data element validity is demonstrated.\38\ 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) \39\ 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.
---------------------------------------------------------------------------
\38\ National Quality Form. Key Points for Evaluating Scientific
Acceptability. Revised January 3, 2020. https://
www.qualityforum.org/Measuring_Performance/Scientific_Methods_Panel/
Docs/
Evaluation_Guidance.aspx#:~:text=NQF%20is%20not%20prescriptive%20abou
t,reliability%20or%20validity%20testing%20results.&text=Reliability%2
0and%20validity%20must%20be,source%20and%20level%20of%20analysis).
\39\ Ibid.
---------------------------------------------------------------------------
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 believe it is 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.\40\
---------------------------------------------------------------------------
\40\ Centers for Disease Control and Prevention. Interim
Clinical Considerations for Use of COVID-19 Vaccines Currently
Authorized in the United Sates, Appendix B. Accessed at https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Appendix-B.
---------------------------------------------------------------------------
The numerator would be the cumulative number of HCP eligible to
work in the IRF for at least one day during the reporting period and
who received a complete vaccination course against SARS-CoV-2. A
complete vaccination course may require one or more doses depending on
the specific vaccine used. The finalized measure specifications are
available on the CDC website at https://www.cdc.gov/nhsn/nqf/index.html.
We propose that IRFs would submit data for the measure through the
CDC/NHSN data collection and submission
[[Page 19108]]
framework.\41\ 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 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 one 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.
---------------------------------------------------------------------------
\41\ Centers for Disease Control and Prevention. Surveillance
for Weekly HCP COVID-19 Vaccination. Accessed at https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html on February 10,
2021.
---------------------------------------------------------------------------
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 this proposed rule.
We invite public comment on our proposal to add a new measure,
COVID-19 Vaccination Coverage among Healthcare Personnel measure, to
the IRF QRP beginning with the FY 2023 IRF QRP.
2. Proposed Update to the Transfer of Health (TOH) Information to the
Patient--Post-Acute Care (PAC) Measure Beginning With the FY 2023 IRF
QRP
This rule proposes to update the Transfer of Health Information to
the Patient--Post-Acute Care (PAC) measure 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 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, this rule proposes 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, this rule proposes to remove this location from the definition of
the denominator for the TOH-Patient measure. Therefore, we are
proposing to update the denominator for the TOH-Patient measure to only
discharges to a private home/apartment, board and care home, assisted
living, group home, or transitional living. For additional technical
information regarding the TOH-Patient measure, we refer readers to the
document titled ``Final Specifications for IRF QRP Quality Measures and
Standardized Patient Assessment Data Elements (SPADEs)'' available at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/Downloads/Final-Specifications-for-IRF-QRP-Quality-Measures-and-SPADEs.pdf.
We are inviting 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.
D. IRF QRP Quality Measures Under Consideration for Future Years:
Request for Information
We are seeking input on the importance, relevance, appropriateness,
and applicability of each of the measures and concepts under
consideration listed in Table 9 for future years in the IRF QRP.
[GRAPHIC] [TIFF OMITTED] TP12AP21.012
While we will not be responding to specific comments submitted in
response to this Request for Information in the FY 2022 IRF PPS final
rule, we intend to use this input to inform our future measure
development efforts.
[[Page 19109]]
E. Fast Healthcare Interoperability Resources (FHIR) in Support of
Digital Quality Measurement in Quality Programs--Request for
Information
1. Background
The IRF QRP is authorized by section 1886(j)(7) of the Act and
furthers our mission to improve the quality of health care for
beneficiaries through measurement, transparency, and public reporting
of data. The IRF QRP and CMS's other quality programs are foundational
for contributing to improvements in health care, enhancing patient
outcomes, and informing consumer choice.
In October 2017, we launched the Meaningful Measures Framework.
This framework captures our vision to address health care quality
priorities and gaps, including emphasizing digital quality measurement
(dQM), reducing measurement burden, and promoting patient perspectives,
while also focusing on modernization and innovation. The scope of the
Meaningful Measures Framework has evolved to accommodate the changes in
the health care environment, initially focusing on measure and burden
reduction to include the promotion of innovation and modernization of
all aspects of quality.\42\ There is a need to streamline our approach
to data collection, calculation, and reporting to fully leverage
clinical and patient-centered information for measurement, improvement,
and learning.
---------------------------------------------------------------------------
\42\ Meaningful Measures 2.0: Moving from Measure Reduction to
Modernization. Available at https://www.cms.gov/meaningful-measures-20-moving-measure-reduction-modernization.
---------------------------------------------------------------------------
In alignment with Meaningful Measures 2.0, we are seeking feedback
on our future plans to define digital quality measures (dQMs) for the
IRF QRP. We also are seeking feedback on the potential use of Fast
Healthcare Interoperable Resources (FHIR) for dQMs within the IRF QRP
aligning where possible with other quality programs. FHIR is a free and
open source standards framework (in both commercial and government
settings) created by Health Level Seven International (HL7[supreg])
that establishes a common language and process for all health
information technology.
2. Definition of Digital Quality Measures
We are considering adopting a standardized definition of Digital
Quality Measures (dQMs) in alignment across quality programs, including
the IRF QRP. We are considering in the future to propose the adoption
within the IRF QRP the following definition: Digital Quality Measures
(dQMs) are quality measures that use one or more sources of health
information that are captured and can be transmitted electronically via
interoperable systems.\43\ A dQM includes a calculation that processes
digital data to produce a measure score or measure scores. Data sources
for dQMs may include administrative systems, electronically submitted
clinical assessment data, case management systems, EHRs, instruments
(for example, medical devices and wearable devices), patient portals or
applications (for example, for collection of patient-generated health
data), health information exchanges (HIEs) or registries, and other
sources. As an example, the quality measures calculated from patient
assessment data submitted electronically to CMS would be considered
digital quality measures.
---------------------------------------------------------------------------
\43\ Definition taken from the CMS Quality Conference 2021.
---------------------------------------------------------------------------
3. Use of FHIR for Future dQMs in the IRF QRP
One of the first areas CMS has identified relative to improving our
digital strategy is through the use of Fast Healthcare Interoperability
Resources (FHIR)-based standards to exchange clinical information
through application programming interfaces (APIs), aligning with other
programs where possible, to allow clinicians to digitally submit
quality information one time that can then be used in many ways. We
believe that in the future proposing such a standard within the IRF QRP
could potentially enable collaboration and information sharing, which
is essential for delivering high-quality care and better outcomes at a
lower cost.
We are currently evaluating the use of FHIR based APIs to access
assessment data collected and maintained through the Quality
Improvement and Evaluation System (QIES) and internet QIES (iQIES)
health information systems and are working with healthcare standards
organizations to assure that their evolving standards fully support our
assessment instrument content. Further, as more IRFs are adopting EHRs,
we are evaluating using the FHIR interfaces for accessing patient data
(including standard assessments) directly from IRF EHRs. Accessing data
in this manner could also enable the exchange of data for purposes
beyond data reporting to CMS, such as care coordination further
increasing the value of EHR investments across the healthcare
continuum. Once providers map their EHR data to a FHIR API in standard
FHIR formats it could be possible to send/receive the data needed for
measures and other uses from their EHRs through FHIR APIs.
4. Future Alignment of Measures Across Reporting Programs, Federal and
State Agencies, and the Private Sector
We are committed to using policy levers and working with
stakeholders to achieve interoperable data exchange and to transition
to full digital quality measurement in our quality programs. We are
considering the future potential development and staged implementation
of a cohesive portfolio of dQMs across our quality programs (including
the IRF QRP), agencies, and private payers. This cohesive portfolio
would require, where possible, alignment of: (1) Measure concepts and
specifications including narrative statements, measure logic, and value
sets, and (2) the individual data elements used to build these measure
specifications and calculate the measures. Further, the required data
elements would be limited to standardized, interoperable elements to
the fullest extent possible; hence, part of the alignment strategy will
be the consideration and advancement of data standards and
implementation guides for key data elements. We would coordinate
closely with quality measure developers, federal and state agencies,
and private payers to develop and to maintain a cohesive dQM portfolio
that meets our programmatic requirements and that fully aligns across
federal and state agencies and payers to the extent possible.
We intend this coordination to be ongoing and allow for continuous
refinement to ensure quality measures remain aligned with evolving
healthcare practices and priorities (for example, patient reported
outcomes (PROs), disparities, care coordination), and track with the
transformation of data collection. This includes conformance with
standards and health IT module updates, future adoption of technologies
incorporated within the ONC Health IT Certification Program and may
also include standards adopted by ONC (for example, to enable
standards-based APIs). The coordination would build on the principles
outlined in HHS' National Health Quality Roadmap.\44\ It would focus on
the quality domains of safety, timeliness, efficiency, effectiveness,
equitability, and patient-centeredness. It would leverage several
existing federal and public-private efforts including our Meaningful
[[Page 19110]]
Measures 2.0 Framework; the Federal Electronic Health Record
Modernization (DoD/VA); the Core Quality Measure Collaborative, which
convenes stakeholders from America's Health Insurance Plans (AHIP),
CMS, NQF, provider organizations, private payers, and consumers and
develops consensus on quality measures for provider specialties; and
the NQF-convened Measure Applications Partnership (MAP), which
recommends measures for use in public payment and reporting programs.
We would coordinate with HL7's ongoing work to advance FHIR resources
in critical areas to support patient care and measurement such as
social determinants of health. Through this coordination, we would
identify which existing measures could be used or evolved to be used as
dQMs, in recognition of current healthcare practice and priorities.
---------------------------------------------------------------------------
\44\ Department of Health and Human Services. National Health
Quality Roadmap. May 15, 2020. Available at https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf.
---------------------------------------------------------------------------
This multi-stakeholder, joint federal, state, and industry effort,
made possible and enabled by the pending advances towards true
interoperability, would yield a significantly improved quality
measurement enterprise. The success of the dQM portfolio would be
enhanced by the degree to which the measures achieve our programmatic
requirements as well as the requirements of other agencies and payers.
5. Solicitation of Comments
We seek 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 plan to continue working with other agencies and stakeholders to
coordinate and to inform our transformation to dQMs leveraging health
IT standards. While we will not be responding to specific comments
submitted in response to this Request for Information in the FY 2022
IRF PPS final rule, 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. Background
Significant and persistent inequities in health outcomes exist in
the United States. In recognition of persistent health disparities and
the importance of closing the health equity gap, we request information
on revising several CMS programs to make reporting of health
disparities based on social risk factors and race and ethnicity more
comprehensive and actionable for providers and patients. Belonging to a
racial or ethnic minority group; living with a disability; being a
member of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+)
community; or being near or below the poverty level is often associated
with worse health outcomes.45 46 47 48 We are committed to
achieving health equity by improving data collection to better measure
and analyze disparities across programs and
policies.49 50 51 52 53 54 Such disparities in health
outcomes are the result of a number of factors, but importantly for CMS
programs, although not the sole determinant, poor access and provision
of lower quality health care contribute to health disparities. For
instance, numerous studies have shown that among Medicare
beneficiaries, racial and ethnic minority individuals often receive
lower quality of care, report lower experiences of care, and experience
more frequent hospital readmissions and operative
complications.55 56 57 58 59 60 Readmission rates for common
conditions in the Hospital Readmissions Reduction Program are higher
for black Medicare beneficiaries and higher for Hispanic Medicare
beneficiaries with Congestive Heart Failure and Acute Myocardial
Infarction.61 62 63 64 65 Studies have also
[[Page 19111]]
shown that African Americans are significantly more likely than white
Americans to die prematurely from heart disease and stroke.\66\ The
COVID-19 pandemic has further illustrated many of these longstanding
health inequities with higher rates of infection, hospitalization, and
mortality among black, Latino, and Indigenous and Native American
persons relative to white persons.67 68 As noted by the
Centers for Disease Control ``long-standing systemic health and social
inequities have put many people from racial and ethnic minority groups
at increased risk of getting sick and dying from COVID-19''.\69\ One
important strategy for addressing these important inequities is by
improving data collection to allow for better measurement and reporting
on equity across post-acute care programs and policies.
---------------------------------------------------------------------------
\45\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA. 2011;
305(7):675-681.
\46\ Lindenauer PK, Lagu T, Rothberg MB, et al. Income
Inequality and 30 Day Outcomes After Acute Myocardial Infarction,
Heart Failure, and Pneumonia: Retrospective Cohort Study. British
Medical Journal. 2013; 346.
\47\ Trivedi AN, Nsa W, Hausmann LRM, et al. Quality and Equity
of Care in U.S. Hospitals. New England Journal of Medicine. 2014;
371(24):2298-2308.
\48\ Polyakova, M., et al. Racial Disparities In Excess All-
Cause Mortality During The Early COVID-19 Pandemic Varied
Substantially Across States. Health Affairs. 2021; 40(2): 307-316.
\49\ Centers for Medicare & Medicaid Services. CMS Quality
Strategy. 2016. Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\50\ Report to Congress: Improving Medicare Post-Acute Care
Transformation (IMPACT) Act of 2014 Strategic Plan for Accessing
Race and Ethnicity Data. January 5, 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Research-Reports-2017-Report-to-Congress-IMPACT-ACT-of-2014.pdf.
\51\ Rural Health Research Gateway. Rural Communities: Age,
Income, and Health Status. Rural Health Research Recap. November
2018.
\52\ https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
\53\ www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
\54\ Poteat TC, Reisner SL, Miller M, Wirtz AL. COVID-19
Vulnerability of Transgender Women With and Without HIV Infection in
the Eastern and Southern U.S. Preprint. medRxiv.
2020;2020.07.21.20159327. Published 2020 Jul 24. doi:10.1101/
2020.07.21.20159327.
\55\ Martino, SC, Elliott, MN, Dembosky, JW, Hambarsoomian, K,
Burkhart, Q, Klein, DJ, Gildner, J, and Haviland, AM. Racial,
Ethnic, and Gender Disparities in Health Care in Medicare Advantage.
Baltimore, MD: CMS Office of Minority Health. 2020.
\56\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\57\ Singh JA, Lu X, Rosenthal GE, Ibrahim S, Cram P. Racial
disparities in knee and hip total joint arthroplasty: An 18-year
analysis of national Medicare data. Ann Rheum Dis. 2014
Dec;73(12):2107-15.
\58\ Rivera-Hernandez M, Rahman M, Mor V, Trivedi AN. Racial
Disparities in Readmission Rates among Patients Discharged to
Skilled Nursing Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672-
1679.
\59\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\60\ Tsai TC, Orav EJ, Joynt KE. Disparities in surgical 30-day
readmission rates for Medicare beneficiaries by race and site of
care. Ann Surg. Jun 2014;259(6):1086-1090.
\61\ Rodriguez F, Joynt KE, Lopez L, Saldana F, Jha AK.
Readmission rates for Hispanic Medicare beneficiaries with heart
failure and acute myocardial infarction. Am Heart J. Aug
2011;162(2):254-261 e253.
\62\ Centers for Medicare and Medicaid Services. Medicare
Hospital Quality Chartbook: Performance Report on Outcome Measures;
2014.
\63\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\64\ Prieto-Centurion V, Gussin HA, Rolle AJ, Krishnan JA.
Chronic obstructive pulmonary disease readmissions at minority-
serving institutions. Ann Am Thorac Soc. Dec 2013;10(6):680-684.
\65\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\66\ HHS. Heart disease and African Americans. (March 29, 2021).
https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
\67\ https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
\68\ Ochieng N, Cubanski J, Neuman T, Artiga S, and Damico A.
Racial and Ethnic Health Inequities and Medicare. Kaiser Family
Foundation. February 2021. Available at https://www.kff.org/medicare/report/racial-and-ethnic-health-inequities-and-medicare/.
\69\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
---------------------------------------------------------------------------
We are also committed to achieving equity in health care outcomes
for our beneficiaries by supporting providers in quality improvement
activities to reduce health inequities, enabling them to make more
informed decisions, and promoting provider accountability for health
care disparities.70 71 For the purposes of this rule, we are
using a definition of equity established in Executive Order 13985, as
``the consistent and systematic fair, just, and impartial treatment of
all individuals, including individuals who belong to underserved
communities that have been denied such treatment, such as Black,
Latino, and Indigenous and Native American persons, Asian Americans and
Pacific Islanders and other persons of color; members of religious
minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+)
persons; persons with disabilities; persons who live in rural areas;
and persons otherwise adversely affected by persistent poverty or
inequality.'' \72\ We note that this definition was recently
established by the current administration, and provides a useful,
common definition for equity across different areas of government,
although numerous other definitions of equity exist.
---------------------------------------------------------------------------
\70\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\71\ Report to Congress: Improving Medicare Post-Acute Care
Transformation (IMPACT) Act of 2014 Strategic Plan for Accessing
Race and Ethnicity Data. January 5, 2017. Available at https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Research-Reports-2017-Report-to-Congress-IMPACT-ACT-of-2014.pdf.
\72\ https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government.
---------------------------------------------------------------------------
Our ongoing commitment to closing the equity gap in CMS quality
programs is demonstrated by a portfolio of programs aimed at making
information on the quality of health care providers and services,
including disparities, more transparent to consumers and providers. The
CMS Equity Plan for Improving Quality in Medicare outlines a path to
equity which aims to support Quality Improvement Networks and Quality
Improvement Organizations (QIN-QIOs); federal, state, local, and tribal
organizations; providers; researchers; policymakers; beneficiaries and
their families; and other stakeholders in activities to achieve health
equity. The CMS Equity Plan includes three core elements: (1)
Increasing understanding and awareness of disparities; (2) developing
and disseminating solutions to achieve health equity; and (3)
implementing sustainable actions to achieve health equity.\73\ The CMS
Quality Strategy and Meaningful Measures Framework \74\ include
elimination of racial and ethnic disparities as a central principle.
Our ongoing commitment to closing the health equity gap in the IRF QRP
is demonstrated by the adoption of standardized patient assessment data
elements (SPADEs) which include several social determinants of health
(SDOH) that were finalized in the FY 2020 IRF PPS final rule for the
IRF QRP (84 FR 39149 through 39161).
---------------------------------------------------------------------------
\73\ Centers for Medicare & Medicaid Services Office of Minority
Health. The CMS Equity Plan for Improving Quality in Medicare.
https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
\74\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.
---------------------------------------------------------------------------
We continue to work with federal and private partners to better
leverage data on social risk to improve our understanding of how these
factors can be better measured in order to close the health equity gap.
Among other things, we have developed an Inventory of Resources for
Standardized Demographic and Language Data Collection \75\ and
supported collection of specialized International Classification of
Disease, 10th Edition, Clinical Modification (ICD-10-CM) codes for
describing the socioeconomic, cultural, and environmental determinants
of health. We continue to work to improve our understanding of this
important issue and to identify policy solutions that achieve the goals
of attaining health equity for all patients.
---------------------------------------------------------------------------
\75\ Centers for Medicare and Medicaid Services. Building an
Organizational Response to Health Disparities Inventory of Resources
for Standardized Demographic and Language Data Collection. 2020.
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Collection-Resources.pdf.
---------------------------------------------------------------------------
2. Solicitation of Public Comment
Under authority of the IMPACT Act and section 1886(j)(7) of the
Act, we are seeking 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 are inviting 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.\76\ 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.
---------------------------------------------------------------------------
\76\ 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.
---------------------------------------------------------------------------
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
[[Page 19112]]
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 \77\ 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)).
---------------------------------------------------------------------------
\77\ https://qualitynet.cms.gov/inpatient/measures/disparity-methods/methodology.
---------------------------------------------------------------------------
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.
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 Request for Information in the FY 2022 IRF PPS final
rule, we intend to use this input to inform future policy development.
We look forward to receiving feedback on these topics, and note for
readers that responses to the RFI should focus on how they could be
applied to the quality reporting program requirements. Please note that
any responses provided will not impact payment decisions.
G. Form, Manner, and Timing of Data Submission Under the IRF QRP
1. Background
We refer readers to the regulatory text at 42 CFR[thinsp]412.634(b)
for information regarding the current policies for reporting IRF QRP
data.
2. Proposed Schedule for Data Submission of the COVID-19 Vaccination
Coverage Among Healthcare Personnel Measure With the FY 2023 IRF QRP
As discussed in section VII.C.1 of this proposed rule, we are
proposing 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, this rule proposes an initial data
submission period from October 1, 2021 through December 31, 2021.
Starting in CY 2022, IRFs would be required to submit data for the
entire calendar year beginning with the FY 2024 IRF QRP.
IRFs would submit data for the measure through the CDC/NHSN web-
based surveillance system. IRFs currently utilize the NHSN for purposes
of meeting other IRF QRP requirements.\78\ 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 one week each month and the CDC would report to CMS quarterly.
---------------------------------------------------------------------------
\78\ Centers for Disease Control and Prevention. Surveillance
for Weekly HCP COVID-19 Vaccination. Accessed at https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html on February 10,
2021.
---------------------------------------------------------------------------
We invite public comment on this proposal.
H. Proposed 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. Proposal for Public Reporting of the COVID-19 Vaccination Coverage
Among Healthcare Personnel (HCP) Measure Beginning With the FY 2023 IRF
QRP
We propose 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).
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 invite public comment on the proposal for the public display of
the measure, COVID-19 Vaccination Coverage among HCP.
3. Proposals for 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.\79\ On March 27, 2020, we sent
a guidance memorandum under the subject title, ``Exceptions and
Extensions for Quality Reporting Requirements for Acute Care Hospitals,
PPS-Exempt Cancer Hospitals, Inpatient Psychiatric Facilities, Skilled
Nursing Facilities, Home Health Agencies, Hospices, Inpatient
Rehabilitation Facilities, Long-Term Care Hospitals, Ambulatory
Surgical Centers, Renal Dialysis Facilities, and MIPS Eligible
Clinicians Affected by COVID-19'' to the Medicare Learning Network
(MLN) Connects
[[Page 19113]]
Newsletter and Other Program-Specific Listserv Recipients,\80\
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.
---------------------------------------------------------------------------
\79\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
\80\ https://www.cms.gov/files/document/guidance-memo-exceptions-and-extensions-quality-reporting-and-value-based-purchasing-programs.pdf.
---------------------------------------------------------------------------
IRF quality measures are publicly reported on Care Compare. Care
Compare uses four quarters of data for IRF-PAI assessment-based
measures and eight quarters for claims-based measures. Table 10
displays the original schedule for public reporting of IRF QRP
measures.\81\
---------------------------------------------------------------------------
\81\ More information about the IRF QRP Public Reporting
schedule can be found on the IRF QRP Public Reporting website at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Public-Reporting.
---------------------------------------------------------------------------
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP12AP21.013
BILLING CODE 4120-01-C
During 2020, we conducted testing to inform decisions about
publicly reporting data for those refreshes, which include partially
and/or fully exempt data (discussed below). The testing helped us
develop a plan for posting data that are as up-to-date as possible and
that also meet acceptable standards for public reporting. We believe
that the plan allows us to provide consumers with helpful information
on the quality of IRF care, while also making the necessary adjustments
to accommodate the exemption provided IRFs. The following sections
provide the results of our testing, and explains how we used the
results to develop plans for accommodating exempt and partially-exempt
data in public reporting.
b. Exempted Quarters
In the March 27, 2020, Medicare Learning Network (MLN) Newsletter
on Exceptions and Extensions for Quality Reporting Program (QRP)
Requirements, we stated that we would not report any PAC quality data
that might be greatly impacted by the exemptions granted for Quarter 1
and Quarter 2 of 2020. Given the timing of the PHE onset, we determined
that we would not use IRF-PAI assessments or IRF claims from Quarter 1
and Quarter 2 of 2020 for public reporting, but that we would assess
the COVID-19 PHE impact on data from Quarter 4 2019. Before proceeding
with the December 2020 refresh, we conducted testing to ensure that,
despite the voluntary nature of reporting for that quarter, public
reporting would still meet our public reporting standards. We found the
level of reporting, measured in the number of eligible stays and
providers, and the reported outcomes, to be in line with
[[Page 19114]]
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 analyzed whether it would
be possible to use fewer quarters of data for one or more refreshes and
thus reduce the number of refreshes that continue to display December
2020 data. Using fewer quarters of more up-to-date data requires that:
(1) A sufficient percentage of IRFs would still likely have enough
assessment data to report quality measures (reportability); and (2)
fewer quarters would likely produce similar measure scores for
providers, with similar reliability, and thus not unfairly represent
the quality of care IRFs provide during the period reported in a given
refresh (reliability).
To assess these criteria, we conducted reportability and
reliability analysis using 3 quarters of data in a refresh, instead of
the standard 4 quarters of data for reporting assessment-based measures
and using 6 quarters instead of 8 for claims-based measures.
Specifically, we used historical data to calculate IRF-PAI assessment-
based and IRF claims-based measures under two scenarios:
(1) Standard Public Reporting (SPR) Base Scenario: We used four
quarters of CY 2019 data as a proxy alternative for the exempted
quarters in CY 2020 in order to compare results. For assessment-based
measures, the quarters used in this scenario are Q1 through Q4 2019.
For claims-based measures, the quarters used in this scenario are Q1
2018 through Q4 2019.
(2) COVID-19 Affected Reporting (CAR) Scenario: We calculated IRF
QRP measures using 3 quarters (Q2 2019 through Q4 2019) of IRF QRP data
for assessment-based measures, and 6 quarters (Q1 2018 through Q4 2018
and Q3 2019 through Q4 2019) for claims-based measures. The CAR
scenario uses the most recently available data to simulate the public
health emergency reality where quarters 1 and 2 of a calendar year must
be excluded from calculation. Quarterly trends in IRF-PAI assessment-
based and IRF claims-based measures indicate that these measures do not
exhibit substantial seasonal variation.
To assess performance in these scenarios, we calculated the
reportability as the percent of IRFs meeting the case minimum for
public reporting (the public reporting threshold). To test the
reliability of restricting the IRFs included in the SPR Base Scenario
to those included in the CAR Scenario, we performed three tests on the
set of IRFs included in both scenarios. First, we evaluated measure
correlation using the Pearson and Spearman correlation coefficients,
which assess the alignment of IRFs' provider scores. Second, for each
scenario, we conducted a split-half reliability analysis and estimated
intraclass correlation (ICC) scores, where higher scores imply better
internal reliability. Modest differences in ICC scores between both
scenarios would suggest that using fewer quarters of data does not
impact the internal reliability of the results. Third, we estimated
reliability scores where a higher value indicates that measure scores
are relatively consistent for patients admitted to the same IRF and
variation in the measure reflects true differences across providers. To
calculate the reliability results, we restricted the IRFs included in
the SPR scenario included in the CAR scenario.
Our testing indicated that the expected impact of using fewer
quarters of data on reportability and reliability of IRF-PAI
assessment-based measures and IRF claims-based measures is acceptable.
We are proposing to use the CAR scenario as the approach for the
following affected refreshes: For IRF-PAI assessment-based measures,
the affected refresh is the December 2021 refresh; for claims-based
measures, the affected refreshes occur from December 2021 through June
2023. For the earlier three affected refreshes (March, June, and
September 2021), we decided to hold constant the Care Compare website
with December 2020 data. We communicated this decision in a Public
Reporting Tip Sheet, which is located at https://www.cms.gov/files/document/irfqrp-covid19prtipsheet-october-2020.pdf.
Our proposal of the CAR approach for the affected refreshes would
allow us to begin displaying more recent data in December 2021, rather
than continue displaying December 2020 data (Q1 2019 through Q4 2019
for assessment-based measures, Q4 2017 through Q3 2019 for claims-based
measures). We believe that resuming public reporting refreshes starting
in December 2021 with fewer quarters of data can assist consumers by
providing more recent quality data as well as more actionable data for
IRF providers. Our testing results indicate we can achieve these
positive impacts with acceptable changes in reportability and
reliability. Table 11 summarizes the revised schedule (that is, frozen
data) and the proposed schedule (that is, using fewer quarters in the
affected refreshes) for assessment-based measures. Table 12 summarizes
the revised schedule (that is, frozen data) and the proposed schedule
(that is, using fewer quarters in the affected refreshes) for claims-
based measures.
We invite public comments on the proposal to use the CAR scenario
to publicly report IRF measures for the December 2021-June 2023
refreshes.
BILLING CODE 4120-01-P
[[Page 19115]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.014
[GRAPHIC] [TIFF OMITTED] TP12AP21.015
d. Update on Data Freeze and Proposal for 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.
[[Page 19116]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.016
[[Page 19117]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.017
BILLING CODE 4120-01-C
VIII. 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 proposed rule does not impose any new information collection
requirements as outlined in the regulation. However, this proposed 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 this proposed rule, for purposes of
calculating the IRF Annual Increase Factor (AIF), we propose 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
The data source for this quality measure is the Centers for Disease
Control and Prevention (CDC)/National Healthcare Safety Network (NHSN).
Data collection 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).\82\ However, we refer readers to section
X.C.7. of this proposed rule, where CMS has 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.
---------------------------------------------------------------------------
\82\ Section 321 of the NCVIA provides the PRA waiver for
activities that come under the NCVIA, including those in the NCVIA
at section 2102 of the Public Health Service Act (42 U.S.C. 300aa-
2). Section 321 is not codified in the U.S. Code, but can be found
in a note at 42 U.S.C. 300aa-1.
---------------------------------------------------------------------------
In section VII.C.2. of this proposed rule, we are proposing to
update the Transfer of Health (TOH) Information to the Patient--Post-
Acute Care (PAC) measure to exclude residents discharged 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 proposed update would not affect the
information collection burden already established.
If you comment on these information collection requirements, that
is, reporting, recordkeeping or third-party disclosure requirements,
please submit your comments as specified in the ADDRESSES section of
this proposed rule.
Comments must be received on/by June 7, 2021.
IX. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
X. Regulatory Impact Analysis
A. Statement of Need
This proposed rule would update 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
[[Page 19118]]
FY and a description of the methodology and data used in computing the
prospective payment rates under the IRF PPS for that FY. This proposed
rule would also implement section 1886(j)(3)(C) of the Act, which
requires the Secretary to apply a MFP adjustment to the market basket
increase factor for FY 2012 and subsequent years.
Furthermore, this proposed rule would adopt policy changes under
the statutory discretion afforded to the Secretary under section
1886(j) of the Act.
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
proposed rule by comparing the estimated payments in FY 2022 with those
in FY 2021. This analysis results in an estimated $160 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 $487,338.96 addition to costs in FY
2022 for IRFs. We estimate that this rulemaking is ``economically
significant'' as measured by the $100 million threshold, and hence also
a major rule under the Congressional Review Act. 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
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small
governmental jurisdictions. Most IRFs and most other providers and
suppliers are small entities, either by having revenues of $8.0 million
to $41.5 million or less in any 1 year depending on industry
classification, or by being nonprofit organizations that are not
dominant in their markets. (For details, see the Small Business
Administration's final rule that set forth size standards for health
care industries, at 65 FR 69432 at https://www.sba.gov/sites/default/files/2019-08/SBA%20Table%20of%20Size%20Standards_Effective%20Aug%2019%2C%202019_Rev.pdf, effective January 1, 2017 and updated on August 19, 2019.) Because
we lack data on individual hospital receipts, we cannot determine the
number of small proprietary IRFs or the proportion of IRFs' revenue
that is derived from Medicare payments. Therefore, we assume that all
IRFs (an approximate total of 1,109 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 proposed rule on all IRFs is to increase
estimated payments by approximately 1.8 percent. The rates and policies
set forth in this proposed 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.
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 603 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 proposed rule on rural IRFs is to increase estimated
payments by approximately 1.9 percent based on the data of the 133
rural units and 12 rural hospitals in our database of 1,109 IRFs for
which data were available. We estimate an overall impact for rural IRFs
in all areas between 0.4 percent and 3.4 percent. As a result, we
anticipate this proposed rule would have a positive impact on a
substantial number of small rural hospitals.
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 proposed 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 proposed rule would not have a
substantial effect on state and local governments, preempt state law,
or otherwise have a federalism implication.
2. Detailed Economic Analysis
This proposed rule would update the IRF PPS rates contained in the
FY 2021 IRF PPS final rule (85 FR 48424). Specifically, this proposed
rule would update the CMG relative weights and average length of stay
values, the wage
[[Page 19119]]
index, and the outlier threshold for high-cost cases. This proposed
rule would apply a MFP 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 proposed rule would be a net estimated increase of $160 million in
payments to IRF providers. The impact analysis in Table 17 of this
proposed 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 proposing standard annual
revisions described in this proposed rule (for example, the update to
the wage index and market basket increase factor used to adjust the
Federal rates). We are also implementing 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 the total increase
in payments to IRFs in FY 2022, relative to FY 2021, would be
approximately $160 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 $190
million. However, there is an estimated $30 million decrease in
aggregate payments to IRFs due to the proposed update to the outlier
threshold amount. Therefore, we estimate that these updates would
result in a net increase in estimated payments of $160 million from FY
2021 to FY 2022.
The effects of the proposed updates that impact IRF PPS payment
rates are shown in Table 17. The following proposed updates that affect
the IRF PPS payment rates are discussed separately below:
The effects of the proposed update to the outlier
threshold amount, from approximately 3.3 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 proposed 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 proposed budget-neutral labor-
related share and wage index adjustment, as required under section
1886(j)(6) of the Act.
The effects of the proposed budget-neutral changes to the
CMG relative weights and average LOS 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.
3. Description of Table 17
Table 17 shows the overall impact on the 1,109 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 964 IRFs located in
urban areas included in our analysis. Among these, there are 662 IRF
units of hospitals located in urban areas and 302 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 404 for-profit IRFs. Among these,
there are 370 IRFs in urban areas and 34 IRFs in rural areas. There are
597 non-profit IRFs. Among these, there are 507 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 proposed
adjustment to the outlier threshold amount.
Column (5) shows the estimated effect of the proposed
update to the IRF labor-related share and wage index, in a budget-
neutral manner.
Column (6) shows the estimated effect of the proposed
update to the CMG relative weights and average LOS values, in a budget-
neutral manner.
Column (7) compares our estimates of the payments per
discharge, incorporating all of the policies reflected in this proposed
rule for FY 2022 to our estimates of payments per discharge in FY 2021.
The average estimated increase for all IRFs is approximately 1.8
percent. This estimated net increase includes the effects of the
proposed IRF market basket increase factor for FY 2022 of 2.2 percent
update based on a IRF-specific
[[Page 19120]]
market basket estimate of 2.4 percent, less a 0.2 percentage point MFP
adjustment, as required by section 1886(j)(3)(C)(ii)(I) of the Act. It
also includes the approximate 0.3 percent overall decrease in estimated
IRF outlier payments from the proposed update to the outlier threshold
amount. Since we are making the updates to the IRF wage index, labor-
related share and the CMG relative weights in a budget-neutral manner,
they will not be expected to affect total estimated IRF payments in the
aggregate. However, as described in more detail in each section, they
will be expected to affect the estimated distribution of payments among
providers.
BILLING CODE 4120-01-P
[[Page 19121]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.018
BILLING CODE 4120-01-C
4. Impact of the Proposed Update to the Outlier Threshold Amount
The estimated effects of the proposed update to the outlier
threshold adjustment are presented in column 4 of Table 17.
For this proposed rule, we are using 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. Thus, we propose to adjust the outlier
threshold amount in this
[[Page 19122]]
proposed 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 0.3
percentage point decrease in payments because the estimated outlier
portion of total payments is estimated to decrease from approximately
3.3 percent to 3 percent.
The impact of this proposed outlier adjustment update (as shown in
column 4 of Table 17) is to decrease estimated overall payments to IRFs
by a 0.3 percentage point.
5. Impact of the Proposed Wage Index and Labor-Related Share
In column 5 of Table 17, we present the effects of the proposed
budget-neutral update of the wage index and labor-related share. The
proposed 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 proposed changes in the two
have a combined effect on payments to providers. As discussed in
section V.C. of this proposed rule, we are proposing to update the
labor-related share from 73.0 percent in FY 2021 to 72.9 percent in FY
2022.
6. Impact of the Proposed Update to the CMG Relative Weights and
Average LOS Values
In column 7 of Table 17, we present the effects of the proposed
budget-neutral update of the CMG relative weights and average LOS
values. In the aggregate, we do not estimate that these proposed
updates will affect overall estimated payments of IRFs. However, we do
expect these updates to have small distributional effects.
7. Effects of Proposed 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 proposed rule, we discuss the method for
applying the 2 percentage point reduction to IRFs that fail to meet the
IRF QRP requirements. As discussed in section VII.C. of this proposed
rule, we are proposing to add one measure to the IRF QRP beginning with
the FY 2023 IRF QRP: COVID-19 Vaccination Coverage among Healthcare
Personnel (HCP) measure.
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 proposed 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 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' May 2019
National Occupational Employment and Wage Estimates.\83\ To account for
overhead and fringe benefits, we have doubled the hourly wage. These
amounts are detailed in Table 18.
---------------------------------------------------------------------------
\83\ https://www.bls.gov/oes/current/oes_nat.htm. Accessed on
March 30, 2021.
[GRAPHIC] [TIFF OMITTED] TP12AP21.019
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 13,308 hours across all IRFs. The estimated
annual cost across all 1,109 IRFs in the U.S. for the submission of the
COVID-19 Vaccination Coverage among HCP measure would range from
$365,570.76 and $609,240.24 with an average of $487,338.96.
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 IRFs
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 outweigh the costs of
reporting. We welcome comments on the estimated time to collect data
and enter it into NHSN.
D. Alternatives Considered
The following is a discussion of the alternatives considered for
the IRF PPS updates contained in this proposed 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
[[Page 19123]]
and services included in the covered IRF services.
As noted previously in this proposed 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
propose to update the IRF prospective payments in this proposed rule by
2.2 percent (which equals the 2.4 percent estimated IRF market basket
increase factor for FY 2022 reduced by a 0.2 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 are
soliciting comment on the use of FY 2019 data to update the prospective
payment rates for FY 2022.
Table 19 shows the estimated effects of the use of FY 2019 data on
particular aspects of the proposed FY 2022 IRF PPS compared to those
utilizing FY 2020 data.
[GRAPHIC] [TIFF OMITTED] TP12AP21.020
A comparison of the estimated impacts, using FY 2019 data, as shown
in Table 20, or FY 2020 data, as shown in Table 17, indicates that
overall IRF PPS payments and payments to all subgroups of IRF providers
would increase if either data set is used. However, there will be
distributional payment effects across providers due to the difference
in estimated outlier payments under both scenarios. For more
information on the estimated effects of utilizing FY 2019 to update the
prospective payment rates for FY 2022, we refer readers to Table 20.
BILLING CODE 4120-01-P
[[Page 19124]]
[GRAPHIC] [TIFF OMITTED] TP12AP21.021
BILLING CODE 4120-01-C
We welcome comments from stakeholders regarding the use of FY 2019
claims data to update the prospective payment rates for FY 2022.
We considered maintaining the existing CMG relative weights and
average length of stay values for FY
[[Page 19125]]
2022. However, in light of recently available data and our desire to
ensure that the CMG relative weights and average length of stay 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 propose to
update the CMG relative weights and average length of stay 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 0.3 percent. Consequently, we propose adjusting the
outlier threshold amount in this proposed rule to reflect a 0.3 percent
decrease thereby setting the total outlier payments equal to 3 percent,
instead of 3.3 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 proposed 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 2021 IRF PPS proposed rule will be the number of
reviewers of this proposed rule. We acknowledge that this assumption
may understate or overstate the costs of reviewing this proposed rule.
It is possible that not all commenters reviewed the FY 2021 IRF PPS
proposed rule in detail, and it is also possible that some reviewers
chose not to comment on the FY 2021 proposed rule. For these reasons,
we thought that the number of past commenters would be a fair estimate
of the number of reviewers of this proposed rule.
We also recognize that different types of entities are in many
cases affected by mutually exclusive sections of this proposed 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 2019 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 $110.74 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 2 hours for
the staff to review half of this proposed rule. For each IRF that
reviews the rule, the estimated cost is $221.48 (2 hours x $110.74).
Therefore, we estimate that the total cost of reviewing this regulation
is $590,908.64 ($221.48 x 2,668 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 Table 21, we have prepared an accounting statement showing
the classification of the expenditures associated with the provisions
of this proposed rule. Table 21 provides our best estimate of the
increase in Medicare payments under the IRF PPS as a result of the
proposed updates presented in this proposed rule based on the data for
1,109 IRFs in our database.
[GRAPHIC] [TIFF OMITTED] TP12AP21.022
G. Conclusion
Overall, the estimated payments per discharge for IRFs in FY 2022
are projected to increase by 1.8 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 1.8 percent
in urban areas and 1.9 percent in rural areas, compared with estimated
FY 2021 payments. Payments per discharge to rehabilitation units are
estimated to increase 1.5 percent in urban areas and 1.7 percent in
rural areas. Payments per discharge to freestanding rehabilitation
hospitals are estimated to increase 2.1 percent in urban areas and
increase 2.7 percent in rural areas.
Overall, IRFs are estimated to experience a net increase in
payments as a result of the proposed policies in this proposed rule.
The largest payment increase is estimated to be a 3.4 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.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by OMB.
[[Page 19126]]
Dated: March 29, 2021.
Elizabeth Richter,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: April 6, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-07343 Filed 4-7-21; 4:15 pm]
BILLING CODE 4120-01-P
