Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2025 and Updates to the IRF Quality Reporting Program

Published date29 March 2024
Record Number2024-06550
Citation89 FR 22246
CourtCenters For Medicare & Medicaid Services
SectionProposed rules
Federal Register, Volume 89 Issue 62 (Friday, March 29, 2024)
[Federal Register Volume 89, Number 62 (Friday, March 29, 2024)]
                [Proposed Rules]
                [Pages 22246-22292]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2024-06550]
                [[Page 22245]]
                Vol. 89
                Friday,
                No. 62
                March 29, 2024
                Part II Department 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 2025 and Updates to the IRF Quality
                Reporting Program; Proposed Rule
                Federal Register / Vol. 89 , No. 62 / Friday, March 29, 2024 /
                Proposed Rules
                [[Page 22246]]
                -----------------------------------------------------------------------
                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                42 CFR Part 412
                [CMS-1804-P]
                RIN 0938-AV31
                Medicare Program; Inpatient Rehabilitation Facility Prospective
                Payment System for Federal Fiscal Year 2025 and Updates to the IRF
                Quality Reporting Program
                AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
                Health and Human Services (HHS).
                ACTION: Proposed rule.
                -----------------------------------------------------------------------
                SUMMARY: This rule proposes updates to the prospective payment rates
                for inpatient rehabilitation facilities (IRFs) for Federal fiscal year
                (FY) 2025. 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 2025. We
                are proposing updates to the Office of Management and Budget (OMB)
                market area delineations for the IRF prospective payment system (PPS)
                wage index and proposing to apply a 3-year phase-out of the rural
                adjustment. This rule also 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, by May 28, 2024.
                ADDRESSES: In commenting, please refer to file code CMS-1804-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 https://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-1804-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-1804-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:
                 Patricia Taft, (410) 786-4561, for general information.
                 Kim Schwartz, (410) 786-2571, for information about the IRF payment
                policies, payment rates and coverage policies.
                 Ariel Cress, (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: https://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 commenter will take actions to harm an 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.
                 Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
                plain language summary of this rule may be found at https://www.regulations.gov.
                I. Executive Summary
                A. Purpose
                 This proposed rule updates the prospective payment rates for IRFs
                for FY 2025 (that is, for discharges occurring on or after October 1,
                2024, and on or before September 30, 2025) 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), a description of the methodologies and data used in computing
                the prospective payment rates for FY 2025, and revised OMB core-based
                statistical area delineations from the July 21, 2023, OMB Bulletin (No.
                23-01) for the IRF PPS wage index. This proposed rule includes three
                proposals for the FY 2028 IRF QRP and two Requests for Information
                (RFIs).
                 This proposed rule proposes the collection of four new items as
                standardized patient assessment data elements and the modification of
                one item collected as a standardized patient assessment data element,
                in the IRF-Patient Assessment Instrument (IRF-PAI) beginning with the
                FY 2028 IRF QRP. This proposed rule also proposes to remove one
                assessment item from the IRF-PAI beginning October 1, 2026. In
                addition, this proposed rule requests information on quality measure
                concepts for the IRF QRP in future years and an IRF star rating system.
                B. Summary of Major Provisions
                 In this proposed rule, we use the methods described in the FY 2024
                IRF PPS final rule (88 FR 50956) to update the prospective payment
                rates for FY 2025 using updated FY 2023 IRF claims and the most recent
                available IRF cost report data, which is FY 2022 IRF cost report data.
                We are also proposing to use the revised OMB market area delineations
                from the July 21, 2023, OMB Bulletin (No. 23-01) for the IRF PPS wage
                index, and to apply a 3-year phase-out of the rural adjustment for
                those IRFs changing from rural to urban.
                 Beginning with the FY 2028 IRF QRP, we are proposing four new items
                as standardized patient assessment data elements to be collected and
                submitted using the IRF-PAI: one item for Living Situation, two items
                for Food, and one item for Utilities. Additionally, we are proposing to
                modify the current Transportation item, and to remove one item
                (Admission Class) from the IRF-PAI. Finally, we are seeking input from
                interested parties on future IRF QRP quality measure concepts and an
                IRF star rating system.
                C. Summary of Impact
                [[Page 22247]]
                [GRAPHIC] [TIFF OMITTED] TP29MR24.016
                II. Background
                A. Statutory Basis and Scope for IRF PPS Provisions
                 Section 1886(j) of the Act provides for the implementation of a
                per-discharge PPS for inpatient rehabilitation hospitals and inpatient
                rehabilitation units of a hospital (collectively, hereinafter referred
                to as IRFs). Payments under the IRF PPS encompass inpatient operating
                and capital costs of furnishing covered rehabilitation services (that
                is, routine, ancillary, and capital costs), but not direct graduate
                medical education costs, costs of approved nursing and allied health
                education activities, bad debts, and other services or items outside
                the scope of the IRF PPS. A complete discussion of the IRF PPS
                provisions appears in the original FY 2002 IRF PPS final rule (66 FR
                41316) and the FY 2006 IRF PPS final rule (70 FR 47880) and we provided
                a general description of the IRF PPS for FYs 2007 through 2019 in the
                FY 2020 IRF PPS final rule (84 FR 39055 through 39057). A general
                description of the IRF PPS for FYs 2020 through 2024, 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.
                 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 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 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). Any reference to the FY 2006 IRF PPS final
                rule in this final rule also includes the provisions effective in the
                correcting amendments. For a detailed discussion of the final key
                policy changes for FY 2006, please refer to the FY 2006 IRF PPS final
                rule.
                 In response to COVID-19 Public Health Emergency (PHE), we published
                two interim final rules with comment period affecting IRF payment and
                conditions for participation. The interim final rule with comment
                period (IFC) entitled ``Medicare and Medicaid Programs; Policy and
                Regulatory Revisions in Response to the COVID-19 Public Health
                Emergency,'' published on April 6, 2020 (85 FR 19230) (hereinafter
                referred to as the April 6, 2020 IFC), included certain changes to the
                IRF PPS medical supervision requirements at 42 CFR 412.622(a)(3)(iv)
                and 412.29(e) during the PHE for COVID-19. In addition, in the April 6,
                2020 IFC, we removed the post-admission physician evaluation
                requirement at Sec. 412.622(a)(4)(ii) for all
                [[Page 22248]]
                IRFs during the PHE for COVID-19. In the FY 2021 IRF PPS final rule, to
                ease documentation and administrative burden, we permanently removed
                the post-admission physician evaluation documentation requirement at
                Sec. 412.622(a)(4)(ii) 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) 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.
                CMS finalized these policies in the Calendar Year 2023 Hospital
                Outpatient Prospective Payment and Ambulatory Surgical Center Payment
                Systems final rule with comment period (87 FR 71748). Subsequently, on
                May 11, 2023, the U.S. Department of Health and Human Services
                (``HHS'') declared the expiration of the COVID-19 public health
                emergency. (See https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html.) As a result,
                the ``3-hour rule'' waiver at Sec. 412.622(a)(3)(ii), and other IRF
                flexibilities were terminated.
                ---------------------------------------------------------------------------
                 \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).
                ---------------------------------------------------------------------------
                 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 2024, is available on the CMS website at
                https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS.
                B. Provisions of the Affordable Care Act 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 (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 Patient Protection and Affordable Care Act,
                was enacted on March 30, 2010. In this proposed rule, we refer to the
                two statutes collectively as the ``Affordable Care Act'' or ``ACA''.
                 The ACA 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 ACA 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 2025 is discussed in
                section V.D. 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.
                 Section 3004(b) of the ACA 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 ACA 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 lower than 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 the FY 2010 IRF PPS correction notice (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 https://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
                [[Page 22249]]
                addition, once a MA patient is discharged, in accordance with the
                Medicare Claims Processing Manual, chapter 3, section 20.3 (Pub. 100-
                04), hospitals (including IRFs) must submit to their MAC an
                informational-only bill (type of bill (TOB) 111) that includes
                Condition Code 04. 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 https://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 https://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).
                III. Summary of Provisions of the Proposed Rule
                 In the FY 2025 IRF PPS proposed rule, we are proposing to update
                the IRF PPS for FY 2025 and the IRF QRP for FY 2028.
                 The proposed policy changes and updates to the IRF prospective
                payment rates for FY 2025 are as follows:
                 Update the CMG relative weights and average length of stay
                values for FY 2025, in a budget neutral manner, as discussed in section
                IV.
                 Update the IRF PPS payment rates for FY 2025 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.
                 Update the FY 2025 IRF PPS payment rates by the FY 2025
                wage index, describe the proposed adoption of the revised OMB market
                area delineations, the phase-out of the rural adjustment for those IRFs
                changing from rural to urban, and the labor-related share in a budget-
                neutral manner, as discussed in section V.
                 Describe the calculation of the IRF standard payment
                conversion factor for FY 2025, as discussed in section V.
                 Update the outlier threshold amount for FY 2025, as
                discussed in section VI.
                 Update the cost-to-charge ratio (CCR) ceiling and urban/
                rural average CCRs for FY 2025, as discussed in section VI.
                 We also propose updates to the IRF QRP beginning with the FY 2028
                IRF QRP and request information in section VII. of this proposed rule
                as follows:
                 Propose to adopt four items as standardized patient
                assessment data elements and modify one item collected as a
                standardized patient assessment data element in the IRF-PAI.
                 Remove the Admission Class item from the IRF-PAI.
                 Request information on IRF QRP quality measure and
                concepts.
                 Request information on an IRF QRP star rating system.
                IV. Proposed Update to the Case-Mix Group (CMG) Relative Weights and
                Average Length of Stay (ALOS) Values for FY 2025
                 As specified in Sec. 412.620(b)(1), we calculate a relative weight
                for each CMG that is proportional to the resources needed for 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 ALOS values for FY 2025. Typically, we use the most recent
                available data to update the CMG relative weights and ALOS values. For
                FY 2025, we are proposing to use the FY 2023 IRF claims and FY 2022 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 2023
                IRF cost report data is available for analysis, but the majority of the
                FY 2023 IRF claims data are available for analysis. We are proposing
                that if more recent data become available after the publication of the
                proposed rule and before the publication of the final rule, we would
                use such data to determine the FY 2025 CMG relative weights and ALOS
                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 ALOS values
                each FY since we implemented an update to the methodology. The detailed
                cost to charge ratio (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 Step 1.
                [[Page 22250]]
                 Step 3. We use the adjusted costs from Step 2 to calculate CMG
                relative weights, using the hospital-specific relative value method.
                 Step 4. We normalize the FY 2025 CMG relative weights using a
                normalization factor that results in the average CMG relative weights
                in FY 2025 being the same as the average CMG relative weights in the FY
                2024 IRF PPS final rule (88 FR 50956).
                 Consistent with the methodology that we have used to update the IRF
                classification system in each instance in the past, we are proposing to
                update the CMG relative weights for FY 2025 in such a way that total
                estimated aggregate payments to IRFs for FY 2025 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
                2025 CMG relative weights, we use the following steps:
                 Step 1. Calculate the estimated total amount of IRF PPS payments
                for FY 2025 (with no changes to the CMG relative weights).
                 Step 2. Calculate the estimated total amount of IRF PPS payments
                for FY 2025 by applying the 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
                0.9973 that would maintain the same total estimated aggregate payments
                in FY 2025 with and without the changes to the proposed CMG relative
                weights.
                 Step 4. Apply the budget neutrality factor from step 3 to the FY
                2025 IRF PPS standard payment amount after the application of the
                budget-neutral wage adjustment factor.
                 In section V. of this proposed rule, we discuss the use of the
                existing methodology to calculate the standard payment conversion
                factor for FY 2025.
                 In Table 2, ``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 ALOS values for each
                CMG and tier for FY 2025. The ALOS for each CMG is used to determine
                when an IRF discharge meets the definition of a short-stay transfer,
                which results in a per diem case level adjustment.
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                 Generally, updates to the CMG relative weights result in some
                increases and some decreases to the CMG relative weight values. Table 2
                shows how we estimate that the application of the proposed revisions
                for FY 2025 would affect particular CMG relative weight values, which
                would affect the overall distribution of payments within CMGs and
                tiers. We note that, because we implement the CMG relative weight
                revisions in a budget-neutral manner (as previously described), total
                estimated aggregate payments to IRFs for FY 2025 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.
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                 As shown in Table 3, 99.2 percent of all IRF cases are in CMGs and
                tiers that would experience less than a 5 percent change (either
                increase or decrease) in the CMG relative weight value as a result of
                the proposed revisions for FY 2025. The proposed changes in the ALOS
                values for FY 2025, compared with the FY 2024 ALOS 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 ALOS values for FY 2025.
                V. Proposed FY 2025 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 2025 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 data for both freestanding and hospital-
                based IRFs (80 FR 47049 through 47068). In 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. Beginning with FY 2024, we finalized a rebased and revised IRF
                market basket to reflect a 2021 base year. The FY 2024 IRF PPS final
                rule (88 FR 50966 through 50988) contains a complete discussion of the
                development of the 2021-based IRF market basket.
                B. Proposed FY 2025 Market Basket Update and Productivity Adjustment
                1. Proposed FY 2025 Market Basket Update
                 For FY 2025 (that is, beginning October 1, 2024, and ending
                September 30, 2025), 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 2025, we are proposing to use
                the same methodology described in the FY 2024 IRF PPS final rule (88 FR
                50982 through 50984).
                 Consistent with historical practice, we are proposing to estimate
                the market basket update for the IRF PPS for FY 2025 based on IHS
                Global Inc.'s (IGI's) forecast using the most recent available data.
                Based on IGI's fourth quarter 2023 forecast with historical data
                through the third quarter of 2023, the proposed 2021-based IRF market
                basket increase factor for FY 2025 is projected to be 3.2 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 or productivity adjustment), we would use such data, if
                appropriate, to determine the FY 2025 market basket update in the final
                rule.
                2. Proposed FY 2025 Productivity Adjustment
                 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 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 multifactor productivity
                (as projected by the Secretary for the 10-year period ending with the
                applicable FY, year, cost reporting period, or other annual period)
                (the ``productivity adjustment''). The U.S. Department of Labor's
                Bureau of Labor Statistics (BLS) publishes the official measures of
                productivity for the U.S. economy. We note that previously the
                productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the
                Act, was referred to by BLS as private nonfarm business multifactor
                productivity. Beginning with the November 18, 2021, release of
                productivity data, BLS replaced the term multifactor productivity (MFP)
                with total factor productivity (TFP). BLS noted that this is a change
                in terminology only and will not affect the data or methodology. As a
                result of this change, the productivity measure referenced in section
                1886(b)(3)(B)(xi)(II) is now published by BLS as private nonfarm
                business total factor productivity. However, as mentioned above, the
                data and methods are unchanged. Please see www.bls.gov for the BLS
                historical published TFP data. A complete description of IGI's TFP
                projection methodology is available on the CMS website at https://www.cms.gov/data-research/statistics-trends-and-reports/medicare-program-rates-statistics/market-basket-research-and-information. In
                addition, in the FY 2022 IRF final rule (86 FR 42374), we noted that
                effective with FY 2022 and forward, CMS changed the name of this
                adjustment to refer to it as the productivity adjustment rather than
                the MFP adjustment.
                 Using IGI's fourth quarter 2023 forecast, the 10-year moving
                average
                [[Page 22256]]
                growth of TFP for FY 2025 is projected to be 0.4 percent. In accordance
                with section 1886(j)(3)(C) of the Act, we are proposing to base the FY
                2025 market basket update, which is used to determine the applicable
                percentage increase for the IRF payments, on IGI's fourth quarter 2023
                forecast of the 2021-based IRF market basket. We are proposing to then
                reduce the market basket percentage increase by the estimated
                productivity adjustment for FY 2025 of 0.4 percentage point (the 10-
                year moving average growth of TFP for the period ending FY 2025 based
                on IGI's fourth quarter 2023 forecast). Therefore, the proposed FY 2025
                IRF update is equal to 2.8 percent (3.2 percent market basket
                percentage increase reduced by the 0.4 percentage point productivity
                adjustment). Furthermore, we are 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 percentage increase and/or productivity
                adjustment), we would use such data, if appropriate, to determine the
                FY 2025 market basket percentage increase and productivity adjustment
                in the final rule.
                 For FY 2025, the Medicare Payment Advisory Commission (MedPAC)
                recommends that we reduce IRF PPS payment rates by 5 percent.\3\ 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 2025 by the proposed IRF market basket update
                of 2.8 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 2025.
                ---------------------------------------------------------------------------
                 \3\ https://www.medpac.gov/wp-content/uploads/2025/03/Mar25_MedPAC_ReportToCongress_SEC.pdf.
                ---------------------------------------------------------------------------
                 We invite public comment on our proposals for the FY 2025 market
                basket percentage increase and productivity adjustment.
                C. Proposed Labor-Related Share for FY 2025
                 Section 1886(j)(6) of the Act specifies that the Secretary is to
                adjust the proportion (as estimated by the Secretary from time to time)
                of IRFs' costs that are attributable to wages and wage-related costs,
                of the prospective payment rates computed under section 1886(j)(3) of
                the Act, for area differences in wage levels by a factor (established
                by the Secretary) reflecting the relative hospital wage level in the
                geographic area of the rehabilitation facility compared to the national
                average wage level for such facilities. The labor-related share is
                determined by identifying the national average proportion of total
                costs that are related to, influenced by, or vary with the local labor
                market. We 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 2021-based IRF market basket, we are proposing to
                calculate the labor-related share for FY 2025 as the sum of the FY 2025
                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 2021-based IRF market basket. For more details
                regarding the methodology for determining specific cost categories for
                inclusion in the 2021-based IRF labor-related share, see the FY 2024
                IRF PPS final rule (88 FR 50985 through 50988).
                 The relative importance reflects the different rates of price
                change for these cost categories between the base year (2021) and FY
                2025. We calculate the labor-related relative importance from the IRF
                market basket, and it approximates the labor-related portion of the
                total costs after taking into account historical and projected price
                changes between the base year and FY 2025. The price proxies that move
                the different cost categories in the market basket do not necessarily
                change at the same rate, and the relative importance captures these
                changes. Based on IGI's fourth quarter 2023 forecast of the 2021-based
                IRF market basket, the sum of the FY 2025 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
                70.5 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 8.1 percent
                of the 2021-based IRF market basket for FY 2025, we are proposing to
                take 46 percent of 8.1 percent to determine the labor-related share of
                Capital-Related costs for FY 2025 of 3.7 percent. Therefore, we are
                proposing a total labor-related share for FY 2025 of 74.2 percent (the
                sum of 70.5 percent for the proposed labor-related share of operating
                costs and 3.7 percent for the proposed labor-related share of Capital-
                Related costs). We are proposing that if more recent data become
                available after publication of the proposed rule and before the
                publication of the final rule (for example, a more recent estimate of
                the labor-related share), we would use such data, if appropriate, to
                determine the FY 2025 IRF labor-related share in the final rule.
                 Table 4 shows the current estimate of the proposed FY 2025 labor-
                related share and the FY 2024 final labor-related share using the 2021-
                based IRF market basket relative importance.
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                 We invite public comments on the proposed labor-related share for
                FY 2025.
                D. Wage Adjustment for FY 2025
                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.
                 In the FY 2023 IRF PPS final rule (87 FR 47054 through 47056) we
                finalized a policy to apply a 5-percent cap on any decrease to a
                provider's wage index from its wage index in the prior year, regardless
                of the circumstances causing the decline. We amended IRF PPS
                regulations at Sec. 412.624(e)(1)(ii) to reflect this permanent cap on
                wage index decreases. Additionally, we finalized a policy that a new
                IRF would be paid the wage index for the area in which it is
                geographically located for its first full or partial FY with no cap
                applied because a new IRF would not have a wage index in the prior FY.
                A full discussion of the adoption of this policy is found in the FY
                2023 IRF PPS final rule.
                 For FY 2025, we propose to maintain the policies and methodologies
                described in the FY 2024 IRF PPS final rule (88 FR 50956) 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 2025
                pre-reclassification and pre-floor hospital wage index data. In
                accordance with section 1886(d)(3)(E) of the Act, the FY 2025 pre-
                reclassification and pre-floor hospital wage index is based on data
                submitted for hospital cost reporting periods beginning on or after
                October 1, 2020, and before October 1, 2021 (that is, FY 2021 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 2025 IRF
                PPS wage index. For FY 2025, the only rural area without wage index
                data available is North Dakota. We have determined that the borders of
                18 rural counties are local and contiguous with 8 urban counties.
                Therefore, under this methodology, the wage indexes for the counties of
                Burleigh/Morton/Oliver (CBSA 13900: 0.9020), Cass (CBSA 22020: 0.8763),
                Grand Forks (CBSA 24220: 0.7865), and McHenry/Renville/Ward (CBSA
                33500: 0.7686) are averaged, resulting in an imputed rural wage index
                of 0.8334 for rural North Dakota for FY 2025. In past years for rural
                Puerto Rico, we did not apply this methodology due to the distinct
                economic circumstances there; due to the close proximity of almost all
                of Puerto Rico's various urban and non-urban areas, this methodology
                would produce a wage index for rural Puerto Rico that is higher than
                that in half of its urban areas. However, because rural Puerto Rico now
                has hospital wage index data on which to base an area wage adjustment,
                we will not apply this policy for FY 2025. For urban areas without
                specific hospital wage index data, we will continue using the average
                wage indexes of all urban areas within the State to serve as a
                reasonable proxy for the wage index of that urban CBSA as proposed and
                finalized in FY 2006 (70 FR 47927). For FY 2025, the only urban area
                without wage index data available is CBSA 25980, Hinesville-Fort
                Stewart, GA.
                 We invite public comment on our proposal regarding the Wage
                Adjustment for FY 2025.
                2. Core-Based Statistical Areas (CBSAs) for the FY 2025 IRF Wage Index
                 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
                [[Page 22258]]
                for the IRF PPS beginning with FY 2016) are based on revised OMB
                delineations issued on February 28, 2013, in OMB Bulletin No. 13-01.
                OMB Bulletin No. 13-01 established revised delineations for
                Metropolitan Statistical Areas, Micropolitan Statistical Areas, and
                Combined Statistical Areas in the United States and Puerto Rico based
                on the 2010 Census and provided guidance on the use of the delineations
                of these statistical areas using standards published in the June 28,
                2010 Federal Register (75 FR 37246 through 37252). We refer readers to
                the FY 2016 IRF PPS final rule (80 FR 47068 through 47076) for a full
                discussion of our implementation of the OMB labor market area
                delineations beginning with the FY 2016 wage index.
                 Generally, OMB issues major revisions to statistical areas every 10
                years, based on the results of the decennial census. Additionally, OMB
                occasionally issues updates and revisions to the statistical areas in
                between decennial censuses to reflect the recognition of new areas or
                the addition of counties to existing areas. In some instances, these
                updates merge formerly separate areas, transfer components of an area
                from one area to another or drop components from an area. On July 15,
                2015, OMB issued OMB Bulletin No. 15-01, which provides minor updates
                to and supersedes OMB Bulletin No. 13-01 that was issued on February
                28, 2013. The attachment to OMB Bulletin No. 15-01 provides detailed
                information on the update to statistical areas since February 28, 2013.
                The updates provided in OMB Bulletin No. 15-01 are based on the
                application of the 2010 Standards for Delineating Metropolitan and
                Micropolitan Statistical Areas to Census Bureau population estimates
                for July 1, 2012, and July 1, 2013.
                 In the FY 2018 IRF PPS final rule (82 FR 36250 through 36251), we
                adopted the updates set forth in OMB Bulletin No. 15-01 effective
                October 1, 2017, beginning with the FY 2018 IRF wage index. For a
                complete discussion of the adoption of the updates set forth in OMB
                Bulletin No. 15-01, we refer readers to the FY 2018 IRF PPS final rule.
                In the FY 2019 IRF PPS final rule (83 FR 38527), we continued to use
                the OMB delineations that were adopted beginning with FY 2016 to
                calculate the area wage indexes, with updates set forth in OMB Bulletin
                No. 15-01 that we adopted beginning with the FY 2018 wage index.
                 On August 15, 2017, OMB issued OMB Bulletin No. 17-01, which
                provided updates to and superseded OMB Bulletin No. 15-01 that was
                issued on July 15, 2015. The attachments to OMB Bulletin No. 17-01
                provide detailed information on the update to statistical areas since
                July 15, 2015, and are based on the application of the 2010 Standards
                for Delineating Metropolitan and Micropolitan Statistical Areas to
                Census Bureau population estimates for July 1, 2014, and July 1, 2015.
                In the FY 2020 IRF PPS final rule (84 FR 39090 through 39091), we
                adopted the updates set forth in OMB Bulletin No. 17-01 effective
                October 1, 2019, beginning with the FY 2020 IRF wage index.
                 On April 10, 2018, OMB issued OMB Bulletin No. 18-03, which
                superseded the August 15, 2017 OMB Bulletin No. 17-01, and on September
                14, 2018, OMB issued OMB Bulletin No. 18-04, which superseded the April
                10, 2018 OMB Bulletin No. 18-03. These bulletins established revised
                delineations for Metropolitan Statistical Areas, Micropolitan
                Statistical Areas, and Combined Statistical Areas, and provided
                guidance on the use of the delineations of these statistical areas. A
                copy of this bulletin may be obtained at https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf.
                 To this end, as discussed in the FY 2021 IRF PPS proposed (85 FR
                22075 through 22079) and final (85 FR 48434 through 48440) rules, we
                adopted the revised OMB delineations identified in OMB Bulletin No. 18-
                04 (available at https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf) beginning October 1, 2020, including a 1-year
                transition for FY 2021 under which we applied a 5-percent cap on any
                decrease in an IRF's wage index compared to its wage index for the
                prior fiscal year (FY 2020). The updated OMB delineations more
                accurately reflect the contemporary urban and rural nature of areas
                across the country, and the use of such delineations allows us to
                determine more accurately the appropriate wage index and rate tables to
                apply under the IRF PPS. OMB issued further revised CBSA delineations
                in OMB Bulletin No. 20-01, on March 6, 2020 (available on the web at
                https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf). However, we 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, we did not propose to adopt the revised
                OMB delineations identified in OMB Bulletin No. 20-01 for FY 2022
                through FY 2024.
                 On July 21, 2023, OMB issued OMB Bulletin No. 23-01 (available at
                https://www.whitehouse.gov/wp-content/uploads/2023/07/OMB-Bulletin-23-01.pdf) which updates and supersedes OMB Bulletin No. 20-01 based upon
                the 2020 Standards for Delineating Core Based Statistical Areas (``the
                2020 Standards'') published by the Office of Management and Budget
                (OMB) on July 16, 2021 (86 FR 37770). OMB Bulletin No. 23-01 revised
                CBSA delineations which are comprised of counties and equivalent
                entities (for example, boroughs, a city and borough, and a municipality
                in Alaska, planning regions in Connecticut, parishes in Louisiana,
                municipios in Puerto Rico, and independent cities in Maryland,
                Missouri, Nevada, and Virginia). For FY 2025, we propose to adopt the
                revised OMB delineations identified in OMB Bulletin No. 23-01.
                a. Urban Counties Becoming Rural
                 As previously discussed, we are proposing to implement the new OMB
                statistical area delineations (based upon the 2020 decennial Census
                data) beginning in FY 2025 for the IRF PPS wage index. Our analysis
                shows that a total of 54 counties (and county equivalents) that are
                currently considered part of an urban CBSA would be considered located
                in a rural area, for IRF PPS payment beginning in FY 2025, if we adopt
                the new OMB delineations. Table 5 lists the 54 urban counties that
                would be rural if we finalize our proposal to implement the new OMB
                delineations.
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                 We are proposing that the wage data for all hospitals located in
                the counties listed in Table 5 now be considered rural when their
                respective State's rural wage index value is calculated. This rural
                wage index value would be used under the IRF PPS.
                b. Rural Counties Becoming Urban
                 Analysis of the new OMB delineations (based upon the 2020 decennial
                Census data) shows that a total of 54 counties (and county equivalents)
                that are currently located in rural areas would be in urban areas if we
                finalize our proposal to implement the new OMB delineations. Table 6
                lists the 54 rural counties that would be urban if we finalize this
                proposal.
                [[Page 22261]]
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                [[Page 22262]]
                [GRAPHIC] [TIFF OMITTED] TP29MR24.026
                 We are proposing that when calculating the area wage index, the
                wage data for hospitals located in these counties would be included in
                their new respective urban CBSAs.
                c. Urban Counties Moving to a Different Urban CBSA
                 In addition to rural counties becoming urban and urban counties
                becoming rural, several urban counties would shift from one urban CBSA
                to another urban CBSA under our proposal to adopt the new OMB
                delineations. In other cases, if we adopt the new OMB delineations,
                counties would shift between existing and new CBSAs, changing the
                constituent makeup of the CBSAs.
                 In one type of change, an entire CBSA would be subsumed by another
                CBSA. For example, CBSA 31460 (Madera, CA) currently is a single county
                (Madera, CA) CBSA. Madera County would be a part of CBSA 23420 (Fresno,
                CA) under the new OMB delineations.
                 In another type of change, some CBSAs have counties that would
                split off to become part of, or to form, entirely new labor market
                areas. For example, CBSA 29404 (Lake County-Kenosha County, IL-WI)
                currently is comprised of two counties (Lake County, IL and Kenosha
                County, WI). Under the new OMB delineations, Kenosha County would split
                off and form the new CBSA 28450 (Kenosha, WI), while Lake County would
                remain in CBSA 29404.
                 Finally, in some cases, a CBSA would lose counties to another
                existing CBSA if we adopt the new OMB delineations. For example, Meade
                County, KY, would move from CBSA 21060 (Elizabethtown-Fort Knox, KY) to
                CBSA 31140 (Louisville/Jefferson County, KY-IN). CBSA 21060 would still
                exist in the new labor market delineations with fewer constituent
                counties. Table 7 lists the urban counties that would move from one
                urban CBSA to another urban CBSA under the new OMB delineations.
                [[Page 22263]]
                [GRAPHIC] [TIFF OMITTED] TP29MR24.027
                [[Page 22264]]
                [GRAPHIC] [TIFF OMITTED] TP29MR24.028
                 If providers located in these counties move from one CBSA to
                another under the new OMB delineations, there may be impacts, both
                negative and positive, upon their specific wage index values.
                [[Page 22265]]
                 In other cases, adopting the revised OMB delineations would involve
                a change only in CBSA name and/or number, while the CBSA continues to
                encompass the same constituent counties. For example, CBSA 19430
                (Dayton-Kettering, OH) would experience a change to its name and become
                CBSA 19430 (Dayton-Kettering-Beavercreek, OH), while all of its three
                constituent counties would remain the same. We consider these proposed
                changes (where only the CBSA name and/or number would change) to be
                inconsequential changes with respect to the IRF PPS wage index. Table 8
                sets forth a list of such CBSAs where there would be a change in CBSA
                name and/or number only if we adopt the revised OMB delineations.
                [GRAPHIC] [TIFF OMITTED] TP29MR24.029
                [[Page 22266]]
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                [[Page 22267]]
                [GRAPHIC] [TIFF OMITTED] TP29MR24.031
                BILLING CODE 4120-01-C
                d. Change to County-Equivalents in the State of Connecticut
                 The June 6, 2022 Census Bureau Notice (87 FR 34235--34240), OMB
                Bulletin No. 23-01 replaced the 8 counties in Connecticut with 9 new
                ``Planning Regions.'' Planning regions now serve as county-equivalents
                within the CBSA system. We are proposing to adopt the planning regions
                as county equivalents for wage index purposes. We believe it is
                necessary to adopt this migration from counties to planning region
                county-equivalents in order to maintain consistency with OMB updates.
                We are providing the following crosswalk with the current and proposed
                FIPS county and county-equivalent codes and CBSA assignments.
                [GRAPHIC] [TIFF OMITTED] TP29MR24.032
                3. Transition Policy for FY 2025 Wage Index Changes
                 Overall, we believe that implementing the new OMB delineations
                would result in wage index values being more representative of the
                actual costs of labor in a given area. We recognize that some providers
                (10 percent) would have a higher wage index due to our proposed
                implementation of the new labor market area delineations. However, we
                also recognize that more providers (16 percent) would experience
                decreases in wage index values as a result of our proposed
                implementation of the new labor market area delineations. Our analysis
                for the FY 2025 proposed rule indicates that 16 IRFs will experience a
                change in either rural or urban designations. Of these, 8 facilities
                designated as rural in FY 2024 would be designated as urban in FY 2025.
                Based upon the CBSA delineations, those rural IRFs that change from
                rural to urban would lose the 14.9 percent rural adjustment. To
                mitigate the financial impacts of this loss, we are proposing a
                transition for these facilities, as discussed further below.
                 CMS recognizes that IRFs in certain areas may experience reduced
                payments due to the proposed adoption of the revised OMB delineations
                and has finalized transition policies to mitigate negative financial
                impacts and provide stability to year-to-year wage index variations. In
                the FY 2021 final rule (85 FR 48434), CMS finalized a wage index
                transition policy to apply a 5 percent cap for IRFs that may experience
                decreases in their final wage index from the prior fiscal year. In FY
                2023, the 5 percent cap policy was made permanent. This 5 percent cap
                on reductions policy is discussed in further detail in FY 2023 final
                rule at 87 FR 47054 through 47056. It is CMS's long held opinion that
                revised labor market delineations should be adopted as soon as is
                possible to maintain the integrity of the wage index system. We believe
                the 5- percent cap policy will sufficiently mitigate significant
                disruptive financial impacts on hospitals negatively affected by the
                proposed adoption of the revised OMB delineations. Besides the rural
                adjustment transition discussed immediately below, we do not believe
                any additional transition is necessary
                [[Page 22268]]
                considering that the current cap on wage index decreases, which was not
                in place when implementing prior decennial census updates in FY 2006
                and FY 2015, ensures that an IRFs wage index would not be less than 95
                percent of its final wage index for the prior year.
                 Consistent with the transition policy adopted in FY 2006 (70 FR
                47923 \4\ through 47927 \5\), we considered the appropriateness of
                applying a 3-year phase-out of the rural adjustment for IRFs located in
                rural counties that would become urban under the new OMB delineations,
                given the potentially significant payment impacts for these facilities.
                We continue to believe, as discussed in the FY 2006 IRF final rule (70
                FR 47880 \6\), that the phase-out of the rural adjustment transition
                period for these facilities specifically is appropriate because, as a
                group, we expect these IRFs would experience a steeper and more abrupt
                reduction in their payments compared to other IRFs. Therefore, we are
                proposing a budget neutral three-year phase-out of the rural adjustment
                for existing FY 2024 rural IRFs that will become urban in FY 2025 and
                that experience a loss in payments due to changes from the new CBSA
                delineations. Accordingly, the incremental steps needed to reduce the
                impact of the loss of the FY 2024 rural adjustment of 14.9 percent will
                be phased out over FYs 2025, 2026 and 2027. This policy will allow
                rural IRFs which would be classified as urban in FY 2025 to receive
                two-thirds of the 2024 rural adjustment for FY 2025. For FY 2026, these
                IRFs will receive the full FY 2026 wage index and one-third of the FY
                2024 rural adjustment. For FY 2027, these IRFs will receive the full FY
                2027 wage index without a rural adjustment. We believe a three-year
                budget-neutral phase-out of the rural adjustment for IRFs that
                transition from rural to urban status under the new CBSA delineations
                would best accomplish the goals of mitigating the loss of the rural
                adjustment for existing FY 2024 rural IRFs. The purpose of the gradual
                phase-out of the rural adjustment for these facilities is to alleviate
                the significant payment implications for existing rural IRFs that may
                need time to adjust to the loss of their FY 2024 rural payment
                adjustment or that experience a reduction in payments solely because of
                this redesignation. As stated, this policy is specifically for rural
                IRFs that become urban in FY 2025 and that experience a loss in
                payments due to changes from the new CBSA delineations. Thus, we are
                not implementing a transition policy for urban facilities that become
                rural in FY 2025 because these IRFs will receive the full rural
                adjustment of 14.9 percent beginning October 1, 2024.
                ---------------------------------------------------------------------------
                 \4\ https://www.federalregister.gov/citation/70-FR-47923.
                 \5\ https://www.federalregister.gov/citation/70-FR-47927.
                 \6\ https://www.federalregister.gov/citation/70-FR-47880.
                ---------------------------------------------------------------------------
                 We invite comments on our proposed implementation of revised labor
                market area delineations and on the proposed transition policy for
                rural IRFs that would be designated as urban under the new CBSA
                delineations. The proposed wage index applicable to FY 2025 is set
                forth in Table A available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRF-Rules-and-Related-Files.html. Table A provides a crosswalk between the
                FY 2024 wage index for a provider using the current OMB delineations in
                effect in FY 2024 and the FY 2025 wage index using the proposed revised
                OMB delineations.
                4. IRF Budget-Neutral Wage Adjustment Factor Methodology
                 To calculate the wage-adjusted facility payment for the proposed
                payment rates set forth in this proposed rule, we multiply the
                unadjusted Federal payment rate for IRFs by the FY 2025 labor-related
                share based on the 2021-based IRF market basket relative importance
                (74.2 percent) to determine the labor-related portion of the standard
                payment amount. (A full discussion of the calculation of the labor-
                related share appears in section VI.E. 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
                calculate a budget-neutral wage adjustment factor as established in the
                FY 2004 IRF PPS final rule (68 FR 45689) and codified at Sec.
                412.624(e)(1), as described in the steps below. We use the listed steps
                to ensure that the FY 2025 IRF standard payment conversion factor
                reflects the update to the wage indexes (based on the FY 2021 hospital
                cost report data) and the 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 2024 (as
                published in the FY 2024 IRF PPS final rule (88 FR 50956)).
                 Step 2. Calculate the total amount of estimated IRF PPS payments
                using the FY 2025 wage index values (based on updated hospital wage
                data and considering the permanent cap on wage index decreases policy)
                and the FY 2025 proposed labor-related share of 74.2 percent.
                 Step 3. Divide the amount calculated in step 1 by the amount
                calculated in step 2. The resulting quotient is the FY 2025 budget-
                neutral wage adjustment factor of 0.9928.
                 Step 4. Apply the budget neutrality factor from step 3 to the FY
                2025 IRF PPS standard payment amount after the application of the
                increase factor to determine the FY 2025 standard payment conversion
                factor.
                 We discuss the calculation of the standard payment conversion
                factor for FY 2025 in section VI.G. of this proposed rule.
                 We invite public comment on our proposals regarding the Wage
                Adjustment for FY 2025.
                G. Description of the Proposed IRF Standard Payment Conversion Factor
                and Payment Rates for FY 2025
                 To calculate the proposed standard payment conversion factor for FY
                2025, as illustrated in Table 10, we begin by applying the proposed
                increase factor for FY 2025, as adjusted in accordance with sections
                1886(j)(3)(C) of the Act, to the standard payment conversion factor for
                FY 2024 ($18,541). Applying the proposed 2.8 payment update for FY 2025
                to the standard payment conversion factor for FY 2024 of $18,541 yields
                a standard payment amount of $19,060. Then, we apply the proposed
                budget neutrality factor for the FY 2025 wage index (taking into
                account the policy placing a permanent cap on decreases in the wage
                index), and labor-related share of 0.9928, which results in a standard
                payment amount of $18,923. We next apply the proposed budget neutrality
                factor for the CMG relative weights of 0.9973, which results in the
                proposed standard payment conversion factor of $18,872 for FY 2025.
                 We invite public comment on the proposed FY 2025 standard payment
                conversion factor.
                [[Page 22269]]
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                 We then apply the proposed CMG relative weights described in
                section IV. of this proposed rule to the FY 2025 standard payment
                conversion factor ($18,872), to determine the unadjusted IRF
                prospective payment rates for FY 2025. The unadjusted prospective
                payment rates for FY 2025 are shown in Table 11.
                BILLING CODE 4120-01-P
                [[Page 22270]]
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                [[Page 22271]]
                [GRAPHIC] [TIFF OMITTED] TP29MR24.035
                BILLING CODE 4120-01-C
                H. Example of the Methodology for Adjusting the Prospective Payment
                Rates
                 Table 12 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 unadjusted prospective payment rate for CMG 0104 (without
                comorbidities) appears in Table 11.
                 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 0.8693, 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 0.9106, and a teaching status adjustment of
                0.0784.
                [[Page 22272]]
                 To calculate each IRF's labor and non-labor portion of the proposed
                prospective payment, we begin by taking the proposed FY 2025 unadjusted
                prospective payment rate for CMG 0104 (without comorbidities) from
                Table 11. Then, we multiply the proposed labor-related share for FY
                2025 (74.2 percent) described in section VI. of this proposed rule by
                the 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 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 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 12 illustrates the components of the
                adjusted payment calculation.
                [GRAPHIC] [TIFF OMITTED] TP29MR24.036
                 Thus, the proposed adjusted payment for Facility A would be
                $30,728.61, and the proposed adjusted payment for Facility B would be
                $30,597.28.
                VI. Proposed Update to Payments for High-Cost Outliers Under the IRF
                PPS for FY 2025
                A. Update to the Outlier Threshold Amount for FY 2025
                 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 2024 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, 85 FR 48444, 86 FR 42362, 87 FR 47038, and 88 FR 50956
                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
                [[Page 22273]]
                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 2025, we propose
                to use FY 2023 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 41362 through 41363), which is also the same methodology that we
                used to update the outlier threshold amounts for FYs 2006 through 2024.
                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 2025, we
                estimated the amount of FY 2025 IRF PPS aggregate and outlier payments
                using the most recent claims available (FY 2023) and the proposed FY
                2025 standard payment conversion factor, labor-related share, and wage
                indexes, incorporating any applicable budget-neutrality adjustment
                factors. The outlier threshold is adjusted either up or down in this
                simulation until the estimated outlier payments equal 3 percent of the
                estimated aggregate payments. Based on an analysis of the preliminary
                data used for the proposed rule, we estimated that IRF outlier payments
                as a percentage of total estimated payments would be approximately 3.2
                percent in FY 2024. Therefore, we propose to update the outlier
                threshold amount from $10,423 for FY 2024 to $12,158 for FY 2025 to
                maintain estimated outlier payments at approximately 3 percent of total
                estimated aggregate IRF payments for FY 2025.
                 We note that, as we typically do, we will update our data between
                the FY 2025 IRF PPS proposed and final rules to ensure that we use the
                most recent available data in calculating IRF PPS payments.
                 We invite public comment on the proposed update to the IRF outlier
                threshold for FY 2025.
                B. Proposed Update to the IRF Cost-to-Charge Ratio Ceiling and Urban/
                Rural Averages for FY 2025
                 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 FR45692 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 2025, 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 2025, as discussed below in this section.
                 Other IRFs for which accurate data to calculate an overall
                CCR are not available.
                 Specifically, for FY 2025, we propose to estimate a national
                average CCR of 0.492 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 0.406 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 2022). This
                includes all IRFs whose cost reporting periods begin on or after
                October 1, 2021, and before October 1, 2022. If, for any IRF, the FY
                2022 cost report was missing or had an ``as submitted'' status, we used
                data from a previous FY's (that is, FY 2004 through FY 2021) 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 2022 cost report data for this proposed
                rule, we estimate a national average CCR of 0.492 for rural IRFs, and a
                national average CCR of 0.406 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 proposed a national CCR ceiling of 1.52 for FY 2025. This
                means that, if an individual IRF's CCR were to exceed this ceiling of
                1.52 for FY 2025, 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 also propose 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 2025 national
                average rural and urban CCRs and the national CCR ceiling in the final
                rule. Using the FY 2022 cost report data for this proposed rule, we
                estimate a national average CCR ceiling of 1.52, using the same
                methodology.
                 We invite public comment on the proposed update to IRF CCR ceiling
                and the urban/rural averages for FY 2025.
                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. Section 1886(j)(7)(A)(i) of the Act requires the Secretary
                to reduce by 2 percentage points the annual increase factor for
                discharges occurring during a FY for any IRF that does not submit data
                in accordance with the IRF QRP requirements set forth in subparagraphs
                (C) and (F) of section 1886(j)(7) of the Act. We have codified our
                program requirements in our regulations at Sec. 412.634.
                 We are proposing to require IRFs to report four new items to the
                IRF-Patient Assessment Instrument (PAI) and modify one item on the IRF-
                PAI as described in section VII.C. of this proposed rule. We are also
                proposing to remove an item from the IRF-PAI as described in section
                VII.F.3. Finally, we are seeking information on future measure concepts
                for the IRF QRP and on an IRF star rating system.
                [[Page 22274]]
                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 IRF QRP
                 The IRF QRP currently has 18 adopted measures, which are listed in
                Table 13. For a discussion of the factors used to evaluate whether a
                measure should be removed from the IRF QRP, we refer readers to Sec.
                412.634(b)(2).
                BILLING CODE 4120-01-P
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                [[Page 22275]]
                BILLING CODE 4120-01-C
                 We are not proposing to adopt any new measures for the IRF QRP.
                C. Proposal To Collect Four New Items as Standardized Patient
                Assessment Data Elements and Modify One Item Collected as a
                Standardized Patient Assessment Data Element Beginning With the FY 2028
                IRF QRP
                 In this proposed rule, we are proposing to require IRFs to report
                the following four new items \7\ to be collected as standardized
                patient assessment data elements in the IRF-PAI under the social
                determinants of health (SDOH) category under the IRF QRP: one item for
                Living Situation; two items for Food; and one item for Utilities. We
                are also proposing to modify one of the current items collected as
                standardized patient assessment data under the SDOH category (the
                Transportation item), as described in section VII.C.5. of this proposed
                rule.
                ---------------------------------------------------------------------------
                 \7\ Items may also be referred to as ``data elements.''
                ---------------------------------------------------------------------------
                1. Definition of Standardized Patient Assessment Data
                 Section 1886(j)(7)(F)(ii) of the Act requires IRFs to submit
                standardized patient assessment data required under section 1899B(b)(1)
                of the Act. Section 1899B(b)(1)(A) of the Act requires post-acute care
                (PAC) providers to submit standardized patient assessment data under
                applicable reporting provisions (which, for IRFs, is the IRF QRP) with
                respect to the admission and discharge of an individual (and more
                frequently as the Secretary deems appropriate) using a standardized
                patient assessment instrument. Section 1899B(a)(1)(C) of the Act
                requires, in part, the Secretary to modify the PAC assessment
                instruments in order for PAC providers, including IRFs, to submit
                standardized patient assessment data under the Medicare program. IRFs
                are currently required to report standardized patient assessment data
                through the patient assessment instrument, referred to as the Inpatient
                Rehabilitation Facility-Patient Assessment Instrument (IRF-PAI).
                Section 1899B(b)(1)(B) of the Act describes standardized patient
                assessment data as data required for at least the quality measures
                described in section 1899B(c)(1) of the Act and that is with respect to
                the following categories: (1) functional status, such as mobility and
                self-care at admission to a PAC provider and before discharge from a
                PAC provider; (2) cognitive function, such as ability to express ideas
                and to understand, and mental status, such as depression and dementia;
                (3) special services, treatments, and interventions, such as need for
                ventilator use, dialysis, chemotherapy, central line placement, and
                total parenteral nutrition; (4) medical conditions and comorbidities,
                such as diabetes, congestive heart failure, and pressure ulcers; (5)
                impairments, such as incontinence and an impaired ability to hear, see,
                or swallow, and (6) other categories deemed necessary and appropriate
                by the Secretary.
                2. Social Determinants of Health Collected as Standardized Patient
                Assessment Data Elements
                 Section 1899B(b)(1)(B)(vi) of the Act authorizes the Secretary to
                collect standardized patient assessment data elements with respect to
                other categories deemed necessary and appropriate. Accordingly, we
                finalized the creation of the SDOH category of standardized patient
                assessment data elements in the FY 2020 IRF PPS final rule (84 FR 39149
                through 39161), and defined SDOH as the socioeconomic, cultural, and
                environmental circumstances in which individuals live that impact their
                health.\8\ According to the World Health Organization, research shows
                that the SDOH can be more important than health care or lifestyle
                choices in influencing health, accounting for between 30-55% of health
                outcomes.\9\ This is a part of a growing body of research that
                highlights the importance of SDOH on health outcomes. Subsequent to the
                FY 2020 IRF PPS final rule, we expanded our definition of SDOH: SDOH
                are the conditions in the environments where people are born, live,
                learn, work, play, worship, and age that affect a wide range of health,
                functioning, and quality-of-life outcomes and risks.10 11 12
                This update will align our definition of SDOH with the definition used
                by HHS agencies, including OASH, the Centers for Disease Control and
                Prevention (CDC), and the White House Office of Science and Technology
                Policy.13 14 We currently collect seven items in this SDOH
                category of standardized patient assessment data elements: ethnicity,
                race, preferred language, interpreter services, health literacy,
                transportation, and social isolation (84 FR 39149 through 39161).\15\
                ---------------------------------------------------------------------------
                 \8\ Office of the Assistant Secretary for Planning and
                Evaluation (ASPE). Second Report to Congress on Social Risk and
                Medicare's Value-Based Purchasing Programs. June 28, 2020. Available
                at: https://aspe.hhs.gov/reports/second-report-congress-social-risk-medicares-value-based-purchasing-programs.
                 \9\ World Health Organization. Social determinants of health.
                Available at: https://www.who.int/health-topics/social-determinants-of-health#tab=tab_1.
                 \10\ Using Z Codes: The Social Determinants of Health (SDOH).
                Data Journey to Better Outcomes. https://www.cms.gov/files/document/zcodes-infographic.pdf.
                 \11\ Improving the Collection of Social Determinants of Health
                (SDOH) Data with ICD-10-CM Z Codes. https://www.cms.gov/files/document/cms-2023-omh-z-code-resource.pdf.
                 \12\ CMS.gov. Measures Management System (MMS). CMS Focus on
                Health Equity. Health Equity Terminology and Quality Measures.
                https://mmshub.cms.gov/about-quality/quality-at-CMS/goals/cms-focus-on-health-equity/health-equity-terminology.
                 \13\ Centers for Disease Control and Prevention. Social
                Determinants of Health (SDOH) and PLACES Data. https://www.cdc.gov/places/social-determinants-of-health-and-places-data/.
                 \14\ ``U.S. Playbook To Address Social Determinants Of Health''
                from the White House Office Of Science And Technology Policy
                (November 2023).
                 \15\ These SDOH data are also collected for purposes outlined in
                section 2(d)(2)(B) of the Improving Medicare Post-Acute Care
                Transitions Act (IMPACT Act). For a detailed discussion on SDOH data
                collection under section 2(d)(2)(B) of the IMPACT Act, see the FY
                2020 IRF PPS final rule (84 FR 39149 through 39161).
                ---------------------------------------------------------------------------
                 In accordance with our authority under section 1899B(b)(1)(B)(vi)
                of the Act, we similarly finalized the creation of the SDOH category of
                standardized patient assessment data elements for Skilled Nursing
                Facilities (SNFs) in the FY 2020 SNF PPS final rule (84 FR 38805
                through 38817), for Long-Term Care Hospitals (LTCHs) in the FY 2020
                Inpatient Prospective Payment System (IPPS)/LTCH PPS final rule (84 FR
                42577 through 42588), and for Home Health Agencies (HHAs) in the
                Calendar Year (CY) 2020 HH PPS final rule (84 FR 60597 through 60608).
                We also collect the same seven SDOH items in these PAC providers'
                respective patient/resident assessment instruments (84 FR 38817, 84 FR
                42590, and 84 FR 60610, respectively).
                 Access to standardized data relating to SDOH on a national level
                permits us to conduct periodic analyses, and to assess their
                appropriateness as risk adjustors or in future quality measures. Our
                ability to perform these analyses and to make adjustments relies on
                existing data collection of SDOH items from PAC settings. We adopted
                these SDOH items using common standards and definitions across the four
                PAC providers to promote interoperable exchange of longitudinal
                information among these PAC providers, including IRFs, and other
                providers. We believe this information may facilitate coordinated care,
                continuity in care planning, and the discharge planning process from
                PAC settings.
                 We noted in our FY 2020 IRF PPS final rule that each of the items
                was identified in the 2016 National Academies of Sciences, Engineering,
                [[Page 22276]]
                and Medicine (NASEM) report as impacting care use, cost, and outcomes
                for Medicare beneficiaries (84 FR 39150 through 39151). At that time,
                we acknowledged that other items may also be useful to understand. The
                SDOH items we are proposing to adopt as standardized patient assessment
                data elements under the SDOH category in this proposed rule were also
                identified in the 2016 NASEM report \16\ or the 2020 NASEM report \17\
                as impacting care use, cost, and outcomes for Medicare beneficiaries.
                The items have the capacity to take into account treatment preferences
                and care goals of patients and their caregivers, to inform our
                understanding of patient complexity and SDOH that may affect care
                outcomes and ensure that IRFs are in a position to impact through the
                provision of services and supports, such as connecting patients and
                their caregivers with identified needs with social support programs.
                ---------------------------------------------------------------------------
                 \16\ Social Determinants of Health. Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health. (February 2019).
                 \17\ National Academies of Sciences, Engineering, and Medicine.
                2020. Leading Health Indicators 2030: Advancing Health, Equity, and
                Well-Being. Washington, DC: The National Academies Press. https://doi.org/10.17226/25682.
                ---------------------------------------------------------------------------
                 Health-related social needs (HRSNs) are the resulting effects of
                SDOH, which are individual-level, adverse social conditions that
                negatively impact a person's health or health care.\18\ Examples of
                HRSNs include lack of access to food, housing, or transportation, and
                have been associated with poorer health outcomes, greater use of
                emergency departments and hospitals, and higher health care costs.\19\
                Certain HRSNs can lead to unmet social needs that directly influence an
                individual's physical, psychosocial, and functional status. This is
                particularly true for food security, housing stability, utilities
                security, and access to transportation.\20\
                ---------------------------------------------------------------------------
                 \18\ Centers for Medicare & Medicaid Services. ``A Guide to
                Using the Accountable Health Communities Health-Related Social Needs
                Screening Tool: Promising Practices and Key Insights.'' August 2022.
                Available at: https://www.cms.gov/priorities/innovation/media/document/ahcm-screeningtool-companion.
                 \19\ Berkowitz, S.A., T.P. Baggett, and S.T. Edwards,
                ``Addressing Health-Related Social Needs: Value-Based Care or
                Values-Based Care?'' Journal of General Internal Medicine, vol. 34,
                no. 9, 2019, pp. 1916-1918, https://doi.org/10.1007/s11606-019-05087-3.
                 \20\ Hugh Alderwick and Laura M. Gottlieb, ``Meanings and
                Misunderstandings: A Social Determinants of Health Lexicon for
                Health Care Systems: Milbank Quarterly,'' Milbank Memorial Fund,
                November 18, 2019, https://www.milbank.org/quarterly/articles/meanings-and-misunderstandings-a-social-determinants-of-health-lexicon-for-health-care-systems/.
                ---------------------------------------------------------------------------
                 We are proposing to require IRFs collect and submit four new items
                in the IRF-PAI as standardized patient assessment data elements under
                the SDOH category because these items would collect information not
                already captured by the current SDOH items. Specifically, we believe
                the ongoing identification of SDOH would have three significant
                benefits. First, promoting screening for SDOH could serve as evidence-
                based building blocks for supporting healthcare providers in
                actualizing their commitment to address disparities that
                disproportionately impact underserved communities. Second, screening
                for SDOH improves health equity through identifying potential social
                needs so the IRF may address those with the patient, their caregivers,
                and community partners during the discharge planning process, if
                indicated.\21\ Third, these SDOH items could support our ongoing IRF
                QRP initiatives by providing data with which to stratify IRFs'
                performance on measures and or in future quality measures.
                ---------------------------------------------------------------------------
                 \21\ American Hospital Association. (2020). Health Equity,
                Diversity & Inclusion Measures for Hospitals and Health System
                Dashboards. December 2020. Accessed: January 18, 2022. Available at:
                https://ifdhe.aha.org/system/files/media/file/2020/12/ifdhe_inclusion_dashboard.pdf.
                ---------------------------------------------------------------------------
                 Additional collection of SDOH items would permit us to continue
                developing the statistical tools necessary to maximize the value of
                Medicare data and improve the quality of care for all beneficiaries.
                For example, we recently developed and released the Health Equity
                Confidential Feedback Reports, which provided data to IRFs on whether
                differences in quality measure outcomes are present for their patients
                by dual-enrollment status and race and ethnicity.\22\ We note that
                advancing health equity by addressing the health disparities that
                underlie the country's health system is one of our strategic pillars
                \23\ and a Biden-Harris Administration priority.\24\
                ---------------------------------------------------------------------------
                 \22\ In October 2023, we released two new annual Health Equity
                Confidential Feedback Reports to IRFs: The Discharge to Community
                (DTC) Health Equity Confidential Feedback Report and the Medicare
                Spending Per Beneficiary (MSPB) Health Equity Confidential Feedback
                Report. The PAC Health Equity Confidential Feedback Reports
                stratified the DTC and MSPB measures by dual-enrollment status and
                race/ethnicity. For more information on the Health Equity
                Confidential Feedback Reports, please refer to the Education and
                Outreach materials available on the IRF QRP Training web page at
                https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/irf-quality-reporting/irf-quality-reporting-training.
                 \23\ Brooks-LaSure, C. (2021). My First 100 Days and Where We Go
                from Here: A Strategic Vision for CMS. Centers for Medicare &
                Medicaid. Available at: https://www.cms.gov/blog/my-first-100-days-and-where-we-go-here-strategic-vision-cms.
                 \24\ The Biden-Harris Administration's strategic approach to
                addressing health related social needs can be found in The U.S.
                Playbook to Address Social Determinants of Health (SDOH) (2023):
                https://www.whitehouse.gov/wp-content/uploads/2023/11/SDOH-Playbook-3.pdf.
                ---------------------------------------------------------------------------
                3. Proposal To Collect Four New Items as Standardized Patient
                Assessment Data Elements Beginning With the FY 2028 IRF QRP
                 We are proposing to require IRFs to collect and submit four new
                items as standardized patient assessment data elements under the SDOH
                category using the IRF-PAI: one item for Living Situation, as described
                in section VII.3.(a) of this proposed rule; two items for Food, as
                described in section VII.3.(b) of this proposed rule; and one item for
                Utilities, as described in VII.3.(c) of this proposed rule.
                 We selected the proposed SDOH items from the Accountable Health
                Communities (AHC) HRSN Screening Tool developed for the AHC Model. The
                AHC HRSN Screening Tool is a universal, comprehensive screening for
                HRSNs that addresses five core domains as follows: (1) housing
                instability (for example, homelessness, poor housing quality), (2) food
                insecurity, (3) transportation difficulties, (4) utility assistance
                needs, and (5) interpersonal safety concerns (for example, intimate-
                partner violence, elder abuse, child maltreatment).\25\
                ---------------------------------------------------------------------------
                 \25\ More information about the AHC HRSN Screening Tool is
                available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
                ---------------------------------------------------------------------------
                 We believe that requiring IRFs to report new items that are
                currently included in the AHC HRSN Screening Tool would further
                standardize the screening of SDOH across quality programs. For example,
                our proposal would align, in part, with the requirements of the
                Hospital Inpatient Quality Reporting (IQR) Program and the Inpatient
                Psychiatric Facility Quality Reporting (IPFQR) Program. As of January
                2024, hospitals are required to report whether they have screened
                patients for the standardized SDOH categories of housing instability,
                food insecurity, utility difficulties, transportation needs, and
                interpersonal safety to meet the Hospital IQR Program requirements.\26\
                Additionally, beginning January 2025, IPFs will also be required
                [[Page 22277]]
                to report whether they have screened patients for the same set of SDOH
                categories.\27\ As we continue to standardize data collection across
                PAC settings, we believe using common standards and definitions for new
                items is important to promote interoperable exchange of longitudinal
                information between IRFs and other providers to facilitate coordinated
                care, continuity in care planning, and the discharge planning process.
                ---------------------------------------------------------------------------
                 \26\ Centers for Medicare & Medicaid Services, FY2023 IPPS/LTCH
                PPS final rule (87 FR 49191 through 49194).
                 \27\ Centers for Medicare & Medicaid Services, FY2024 Inpatient
                Psychiatric Prospective Payment System--Rate Update (88 FR 51107
                through 51121).
                ---------------------------------------------------------------------------
                 Below we describe each of the four proposed items in more detail.
                (a) Living Situation
                 Healthy People 2030 prioritizes economic stability as a key SDOH,
                of which housing stability is a component.28 29 Lack of
                housing stability encompasses several challenges, such as having
                trouble paying rent, overcrowding, moving frequently, or spending the
                bulk of household income on housing.\30\ These experiences may
                negatively affect one's physical health and access to health care.
                Housing instability can also lead to homelessness, which is housing
                deprivation in its most severe form.\31\ On a single night in 2023,
                roughly 653,100 people, or 20 out of every 10,000 people in the United
                States, were experiencing homelessness.\32\ Studies also found that
                people who are homeless have an increased risk of premature death and
                experience chronic disease more often than among the general
                population.\33\
                ---------------------------------------------------------------------------
                 \28\ https://health.gov/healthypeople/priority-areas/social-determinants-health.
                 \29\ Healthy People 2030 is a long-term, evidence-based effort
                led by the U.S. Department of Health and Human Services (HHS) that
                aims to identify nationwide health improvement priorities and
                improve the health of all Americans.
                 \30\ Kushel, M.B., Gupta, R., Gee, L., & Haas, J.S. (2006).
                Housing instability and food insecurity as barriers to health care
                among low-income Americans. Journal of General Internal Medicine,
                21(1), 71-77. doi: https://doi.org/10.1111/j.1525-1497.2005.00278.x.
                 \31\ Homelessness is defined as ``lacking a regular nighttime
                residence or having a primary nighttime residence that is a
                temporary shelter or other place not designed for sleeping.''
                Crowley, S. (2003). The affordable housing crisis: Residential
                mobility of poor families and school mobility of poor children.
                Journal of Negro Education, 72(1), 22-38. doi: https://doi.org/10.2307/3211288.
                 \32\ The 2023 Annual Homeless Assessment Report (AHAR) to
                Congress. The U.S. Department of Housing and Urban Development 2023.
                https://www.huduser.gov/portal/sites/default/files/pdf/2023-AHAR-Part-1.pdf.
                 \33\ Baggett, T.P., Hwang, S.W., O'Connell, J.J., Porneala,
                B.C., Stringfellow, E.J., Orav, E.J., Singer, D.E., & Rigotti, N.A.
                (2013). Mortality among homeless adults in Boston: Shifts in causes
                of death over a 15-year period. JAMA Internal Medicine, 173(3), 189-
                195. doi: https://doi.org/10.1001/jamainternmed.2013.1604. Schanzer,
                B., Dominguez, B., Shrout, P.E., & Caton, C.L. (2007). Homelessness,
                health status, and health care use. American Journal of Public
                Health, 97(3), 464-469. doi: https://doi.org/10.2105/ajph.2005.076190.
                ---------------------------------------------------------------------------
                 We believe that IRFs can use information obtained from the Living
                Situation item during a patient's discharge planning. For example, IRFs
                could work in partnership with community care hubs and community-based
                organizations to establish new care transition workflows, including
                referral pathways, contracting mechanisms, data sharing strategies, and
                implementation training that can track HRSNs to ensure unmet needs,
                such as housing, are successfully addressed through closed loop
                referrals and follow-up.\34\ IRFs could also take action to help
                alleviate a patient's other related costs of living, like food, by
                referring the patient to community-based organizations that would allow
                the patient's additional resources to be allocated towards housing
                without sacrificing other needs.\35\ Finally, IRFs could use the
                information obtained from the Living Situation item to better
                coordinate with other healthcare providers, facilities, and agencies
                during transitions of care, so that referrals to address a patient's
                housing stability are not lost during vulnerable transition periods.
                ---------------------------------------------------------------------------
                 \34\ U.S. Department of Health & Human Services (HHS), Call to
                Action, ``Addressing Health Related Social Needs in Communities
                Across the Nation.'' November 2023. https://aspe.hhs.gov/sites/default/files/documents/3e2f6140d0087435cc6832bf8cf32618/hhs-call-to-action-health-related-social-needs.pdf.
                 \35\ Henderson, K.A., Manian, N., Rog, D.J., Robison, E., Jorge,
                E., AlAbdulmunem, M. ``Addressing Homelessness Among Older Adults''
                (Final Report). Washington, DC: Office of the Assistant Secretary
                for Planning and Evaluation, U.S. Department of Health and Human
                Services. October 26, 2023.
                ---------------------------------------------------------------------------
                 Due to the potential negative impacts housing instability can have
                on a patient's health, we are proposing to adopt the Living Situation
                item as a new standardized patient assessment data element under the
                SDOH category. This proposed Living Situation item is based on the
                Living Situation item currently collected in the AHC HRSN Screening
                Tool,36 37 and was adapted from the Protocol for Responding
                to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE)
                tool.\38\ The proposed Living Situation item asks, ``What is your
                living situation today?'' The proposed response options are: (1) I have
                a steady place to live; (2) I have a place to live today, but I am
                worried about losing it in the future; (3) I do not have a steady place
                to live; (7) Patient declines to respond; and (8) Patient unable to
                respond. A draft of the proposed Living Situation item to be adopted as
                a standardized patient assessment data element under the SDOH category
                can be found in the Downloads section of the IRF-PAI and IRF-PAI Manual
                web page at https://www.cms.gov/medicare/quality/inpatient-rehabilitation-facility/irf-pai-and-irf-qrp-manual.
                ---------------------------------------------------------------------------
                 \36\ More information about the AHC HRSN Screening Tool is
                available on the website at https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf.
                 \37\ The AHC HRSN Screening Tool Living Situation item includes
                two questions. In an effort to limit IRF burden, we are only
                proposing the first question.
                 \38\ National Association of Community Health Centers and
                Partners, National Association of Community Health Centers,
                Association of Asian Pacific Community Health Organizations,
                Association OPC, Institute for Alternative Futures. ``PRAPARE.''
                2017. https://prapare.org/the-prapare-screening-tool/.
                ---------------------------------------------------------------------------
                (b) Food
                 The U.S. Department of Agriculture, Economic Research Service
                defines a lack of food security as a household-level economic and
                social condition of limited or uncertain access to adequate food.\39\
                Adults who are food insecure may be at an increased risk for a variety
                of negative health outcomes and health disparities. For example, a
                study found that food-insecure adults may be at an increased risk for
                obesity.\40\ Another study found that food-insecure adults have a
                significantly higher probability of death from any cause or
                cardiovascular disease in long-term follow-up care, in comparison to
                adults that are food secure.\41\
                ---------------------------------------------------------------------------
                 \39\ U.S. Department of Agriculture, Economic Research Service.
                (n.d.). Definitions of food security. Retrieved March 10, 2022, from
                https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-u-s/definitions-of-food-security/.
                 \40\ Hernandez, D.C., Reesor, L.M., & Murillo, R. (2017). Food
                insecurity and adult overweight/obesity: Gender and race/ethnic
                disparities. Appetite, 117, 373-378.
                 \41\ Banerjee, S., Radak, T., Khubchandani, J., & Dunn, P.
                (2021). Food Insecurity and Mortality in American Adults: Results
                From the NHANES-Linked Mortality Study. Health promotion practice,
                22(2), 204-214. https://doi.org/10.1177/1524839920945927.
                ---------------------------------------------------------------------------
                 While having enough food is one of many predictors for health
                outcomes, a diet low in nutritious foods is also a factor.\42\ The
                United States Department of Agriculture (USDA) defines nutrition
                security as ``consistent and equitable access to healthy, safe,
                affordable foods essential to optimal health and well-
                [[Page 22278]]
                being.'' \43\ Nutrition security builds on and complements long
                standing efforts to advance food security. Studies have shown that
                older adults struggling with food insecurity consume fewer calories and
                nutrients and have lower overall dietary quality than those who are
                food secure, which can put them at nutritional risk.\44\ Older adults
                are also at a higher risk of developing malnutrition, which is
                considered a state of deficit, excess, or imbalance in protein, energy,
                or other nutrients that adversely impacts an individual's own body
                form, function, and clinical outcomes.\45\ About 50 percent of older
                adults are affected by malnutrition, which is further aggravated by a
                lack of food security and poverty.\46\ These facts highlight why the
                Biden-Harris Administration launched the White House Challenge to End
                Hunger and Build Health Communities.\47\
                ---------------------------------------------------------------------------
                 \42\ National Center for Health Statistics. (2022, September 6).
                Exercise or Physical Activity. Retrieved from Centers for Disease
                Control and Prevention: https://www.cdc.gov/nchs/fastats/exercise.htm.
                 \43\ Ziliak, J.P., & Gundersen, C. (2019). The State of Senior
                Hunger in America 2017: An Annual Report. Prepared for Feeding
                America. Available at https://www.feedingamerica.org/research/senior-hunger-research/senior.
                 \44\ Ziliak, J.P., & Gundersen, C. (2019). The State of Senior
                Hunger in America 2017: An Annual Report. Prepared for Feeding
                America. Available at: https://www.feedingamerica.org/research/senior-hunger-research/senior.
                 \45\ The Malnutrition Quality Collaborative. (2020). National
                Blueprint: Achieving Quality Malnutrition Care for Older Adults,
                2020 Update. Washington, DC: Avalere Health and Defeat Malnutrition
                Today. Available at: https://defeatmalnutrition.today/advocacy/blueprint/.
                 \46\ Food Research & Action Center (FRAC). ``Hunger is a Health
                Issue for Older Adults: Food Security, Health, and the Federal
                Nutrition Programs.'' December 2019. https://frac.org/wp-content/uploads/hunger-is-a-health-issue-for-older-adults-1.pdf.
                 \47\ The White House Challenge to End Hunger and Build Health
                Communities (Challenge) was a nationwide call-to-action released on
                March 24, 2023, to stakeholders across all of society to make
                commitments to advance President Biden's goal to end hunger and
                reduce diet-related diseases by 2030--all while reducing
                disparities. More information on the White House Challenge to End
                Hunger and Build Health Communities can be found: https://www.whitehouse.gov/briefing-room/statements-releases/2023/03/24/fact-sheet-biden-harris-administration-launches-the-white-house-challenge-to-end-hunger-and-build-healthy-communities-announces-new-public-private-sector-actions-to-continue-momentum-from-hist/.
                ---------------------------------------------------------------------------
                 We believe that adopting items to collect and analyze information
                about a patient's food security at home could provide additional
                insight to their health complexity and help facilitate coordination
                with other healthcare providers, facilities, and agencies during
                transitions of care, so that referrals to address a patient's food
                security are not lost during vulnerable transition periods. For
                example, an IRF's dietitian or other clinically qualified nutrition
                professional could work with the patient and their caregiver to plan
                healthy, affordable food choices prior to discharge.\48\ IRFs could
                also refer a patient that indicates lack of food security to government
                initiatives such as the Supplemental Nutrition Assistance Program
                (SNAP) and food pharmacies (programs to increase access to healthful
                foods by making them affordable), two initiatives that have been
                associated with lower health care costs and reduced hospitalization and
                emergency department visits.\49\
                ---------------------------------------------------------------------------
                 \48\ Schroeder K., Smaldone A., Food Insecurity: A Concept
                Analysis. Nurse Forum. 2015 Oct-Dec; 50(4):274-84. doi: 10.1111/
                nuf.12118. Epub 2015 Jan 21. PMID: 25612146; PMCID: PMC4510041.
                 \49\ Tsega M., Lewis C., McCarthy D., Shah T., Coutts K., Review
                of Evidence for Health-Related Social Needs Interventions. July
                2019. The Commonwealth Fund. https://www.commonwealthfund.org/sites/default/files/2019-07/COMBINED_ROI_EVIDENCE_REVIEW_7.15.19.pdf.
                ---------------------------------------------------------------------------
                 We are proposing to adopt two Food items as new standardized
                patient assessment data elements under the SDOH Category. These
                proposed items are based on the Food items currently collected in the
                AHC HRSN Screening Tool, and were adapted from the USDA 18-item
                Household Food Security Survey (HFSS).\50\ The first proposed Food item
                states, ``Within the past 12 months, you worried that your food would
                run out before you got money to buy more.'' The second proposed Food
                item states, ``Within the past 12 months, the food you bought just
                didn't last and you didn't have money to get more.'' We propose the
                same response options for both items: (1) Often true; (2) Sometimes
                true; (3) Never True; (7) Patient declines to respond; and (8) Patient
                unable to respond. A draft of the proposed Food items to be adopted as
                standardized patient assessment data elements under the SDOH category
                can be found in the Downloads section of the IRF-PAI and IRF-PAI Manual
                web page at https://www.cms.gov/medicare/quality/inpatient-rehabilitation-facility/irf-pai-and-irf-qrp-manual.
                ---------------------------------------------------------------------------
                 \50\ More information about the HFSS tool can be found at
                https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-u-s/survey-tools/.
                ---------------------------------------------------------------------------
                (c) Utilities
                 A lack of energy (utility) security can be defined as an inability
                to adequately meet basic household energy needs.\51\ According to the
                United States Department of Energy, one in three households in the U.S.
                are unable to adequately meet basic household energy needs.\52\ The
                consequences associated with a lack of utility security are represented
                by three primary dimensions: economic, physical, and behavioral.
                Patients with low incomes are disproportionately affected by high
                energy costs, and they may be forced to prioritize paying for housing
                and food over utilities.\53\ Some patients may face limited housing
                options and therefore are at increased risk of living in lower-quality
                physical conditions with malfunctioning heating and cooling systems,
                poor lighting, and outdated plumbing and electrical systems.\54\
                Patients with a lack of utility security may use negative behavioral
                approaches to cope, such as using stoves and space heaters for
                heat.\55\ In addition, data from the Department of Energy's U.S. Energy
                Information Administration confirm that a lack of energy security
                disproportionately affects certain populations, such as low-income and
                African American households.\56\ The effects of a lack of utility
                security include vulnerability to environmental exposures such as
                dampness, mold, and thermal discomfort in the home, which have a direct
                impact on a person's health.\57\ For example, research has shown
                associations between a lack of energy security and respiratory
                conditions as well as mental health-related disparities and poor sleep
                quality in vulnerable populations such as the elderly, children, the
                socioeconomically disadvantaged, and the medically vulnerable.\58\
                ---------------------------------------------------------------------------
                 \51\ Hern[aacute]ndez D., Understanding `energy insecurity' and
                why it matters to health. Soc Sci Med. 2016 Oct; 167:1-10. Doi:
                10.1016/j.socscimed.2016.08.029. Epub 2016 Aug 21. PMID: 27592003;
                PMCID: PMC5114037.
                 \52\ U.S. Energy Information Administration. ``One in Three U.S.
                Households Faced Challenges in Paying Energy Bills in 2015.'' 2017
                Oct 13. https://www.eia.gov/consumption/residential/reports/2015/energybills/.
                 \53\ Hern[aacute]ndez D., ``Understanding `energy insecurity'
                and why it matters to health.'' Soc Sci Med. 2016; 167:1-10.
                 \54\ Hern[aacute]ndez D., Understanding 'energy insecurity' and
                why it matters to health. Soc Sci Med. 2016 Oct; 167:1-10. doi:
                10.1016/j.socscimed.2016.08.029. Epub 2016 Aug 21. PMID: 27592003;
                PMCID: PMC5114037.
                 \55\ Hern[aacute]ndez D., ``What `Merle' Taught Me About Energy
                Insecurity and Health.'' Health Affairs, VOL.37, NO.3: Advancing
                Health Equity Narrative Matters. March 2018. https://doi.org/10.1377/hlthaff.2017.1413.
                 \56\ U.S. Energy Information Administration. ``One in Three U.S.
                Households Faced Challenges in Paying Energy Bills in 2015.'' 2017
                Oct 13. https://www.eia.gov/consumption/residential/reports/2015/energybills/.
                 \57\ Hern[aacute]ndez D., Understanding 'energy insecurity' and
                why it matters to health. Soc Sci Med. 2016 Oct; 167:1-10. doi:
                10.1016/j.socscimed.2016.08.029. Epub 2016 Aug 21. PMID: 27592003;
                PMCID: PMC5114037.
                 \58\ Hern[aacute]ndez D., Siegel E., Energy insecurity and its
                ill health effects: A community perspective on the energy-health
                nexus in New York City. Energy Res Soc Sci. 2019 Jan; 47:78-83. doi:
                10.1016/j.erss.2018.08.011. Epub 2018 Sep 8. PMID: 32280598; PMCID:
                PMC7147484.
                ---------------------------------------------------------------------------
                 We believe adopting an item to collect information upon a patient's
                admission to an IRF about their utility security
                [[Page 22279]]
                would facilitate the identification of patients who may not have
                utility security and who may benefit from engagement efforts. For
                example, IRFs may be able to use the information on utility security to
                help connect some patients in need to programs that can help older
                adults pay for their home energy (heating/cooling) costs, like the Low-
                Income Home Energy Assistance Program (LIHEAP).\59\ IRFs may also be
                able to partner with community care hubs and community-based
                organizations to assist the patient in applying for these and other
                local utility assistance programs, as well as helping them navigate the
                enrollment process.\60\
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                 \59\ https://www.fcc.gov/broadbandbenefit.
                 \60\ National Council on Aging (NCOA). ``How to Make It Easier
                for Older Adults to Get Energy and Utility Assistance.'' Promising
                Practices Clearinghouse for Professionals. Jan 13, 2022. https://www.ncoa.org/article/how-to-make-it-easier-for-older-adults-to-get-energy-and-utility-assistance.
                ---------------------------------------------------------------------------
                 We are proposing to adopt a new item, Utilities, as a new
                standardized patient assessment data element under the SDOH category.
                This proposed item is based on the Utilities item currently collected
                in the AHC HRSN Screening Tool and was adapted from the Children's
                Sentinel Nutrition Assessment Program (C-SNAP) survey.\61\ The proposed
                Utilities item asks, ``In the past 12 months, has the electric, gas,
                oil, or water company threatened to shut off services in your home?''
                The proposed response options are: (1) Yes; (2) No; (3) Already shut
                off; (7) Patient declines to respond; and (8) Patient unable to
                respond. A draft of the proposed Utilities item to be adopted as a
                standardized patient assessment data element under the SDOH category
                can be found in the Downloads section of the IRF-PAI and IRF-PAI Manual
                web page at https://www.cms.gov/medicare/quality/inpatient-rehabilitation-facility/irf-pai-and-irf-qrp-manual.
                ---------------------------------------------------------------------------
                 \61\ This validated survey was developed as a clinical indicator
                of household energy security among pediatric caregivers. Cook, J.T.,
                D.A. Frank., P.H. Casey, R. Rose-Jacobs, M.M. Black, M. Chilton, S.
                Ettinger de Cuba, et al. ``A Brief Indicator of Household Energy
                Security: Associations with Food Security, Child Health, and Child
                Development in US Infants and Toddlers.'' Pediatrics, vol. 122, no.
                4, 2008, pp. e874-e875. https://doi.org/10.1542/peds.2008-0286.
                ---------------------------------------------------------------------------
                4. Stakeholder Input
                 We developed our proposal to add these items after considering
                feedback we received in response to our Health Equity Update in the FY
                2024 IRF PPS final rule. While there were commenters who urged CMS to
                balance reporting requirements so as not to create undue administrative
                burden and avoid making generalizations about differences in health and
                health care on certain data elements, it was also suggested CMS
                incentivize collection of data on SDOH such as housing stability and
                food security. Two commenters emphasized that any additional
                stratification of quality measures, including social risk factors and
                SDOH, would be of value to PAC providers, including IRFs. The FY 2024
                IRF PPS final rule (88 FR 51037 through 51039) includes a summary of
                the public comments that we received in response to the Health Equity
                Update and our responses to those comments.
                 Additionally, we considered feedback we received when we proposed
                the creation of the SDOH category of standardized patient assessment
                data elements in the FY 2020 IRF PPS proposed rule (84 FR 17319 through
                17326). Commenters were generally in favor of the concept of collecting
                SDOH items and stated that if implemented appropriately the data could
                be useful in identifying and addressing health care disparities, as
                well as refining the risk adjustment of outcome measures. One commenter
                specifically recommended CMS consider including data collection of
                housing status, since unmet housing needs can put patients at higher
                risk for readmission. The FY 2020 IRF PPS final rule (84 FR 39149
                through 39161) includes a summary of the public comments that we
                received and our responses to those comments. We incorporated this
                input into the development of this proposal.
                 We invite comment on the proposal to adopt four new items as
                standardized patient assessment data elements in the IRF-PAI under the
                SDOH category beginning with the FY 2028 IRF QRP: one Living Situation
                item; two Food items; and one Utilities item.
                5. Proposal To Modify the Transportation Item Beginning With the FY
                2028 IRF QRP
                 Beginning October 1, 2022, IRFs began collecting seven items
                adopted as standardized patient assessment data elements under the SDOH
                category on the IRF-PAI.\62\ One of these items, A1250. Transportation,
                collects data on whether a lack of transportation has kept a patient
                from getting to and from medical appointments, meetings, work, or from
                getting things they need for daily living. This item was adopted as a
                standardized patient assessment data element under the SDOH category in
                the FY 2020 IRF PPS final rule (84 FR 39160 through 39161). As we
                discussed in the FY 2020 IRF PPS final rule (84 FR 39158), we continue
                to believe that access to transportation for ongoing health care and
                medication access needs, particularly for those with chronic diseases,
                is essential to successful chronic disease management and the
                collection of a Transportation item would facilitate the connection to
                programs that can address identified needs.
                ---------------------------------------------------------------------------
                 \62\ The seven SDOH items are ethnicity, race, preferred
                language, interpreter services, health literacy, transportation, and
                social isolation (84 FR 39149 through 339161).
                ---------------------------------------------------------------------------
                As part of our routine item and measure monitoring work, we
                continually assess the implementation of the new SDOH items. We have
                identified an opportunity to improve the data collection for A1250.
                Transportation in the IRF-PAI by aligning it with the Transportation
                category collected in our other programs.63 64 Specifically,
                we are proposing to modify the current Transportation item in the IRF-
                PAI so that it aligns with a Transportation item collected on the AHC
                HRSN Screening Tool available to the IPFQR and Hospital IQR Programs.
                ---------------------------------------------------------------------------
                 \63\ Centers for Medicare & Medicaid Services, FY2024 Inpatient
                Psychiatric Prospective Payment System--Rate Update (88 FR 51107
                through 51121).
                 \64\ Centers for Medicate & Medicaid Services, FY2023 IPPS/LTCH
                PPS Final rule (87 FR 49202 through 49215).
                ---------------------------------------------------------------------------
                 A1250. Transportation currently collected in the IRF-PAI asks:
                ``Has lack of transportation kept you from medical appointments,
                meetings, work, or from getting things needed for daily living?'' The
                response options are: (A) Yes, it has kept me from medical appointments
                or from getting my medications; (B) Yes, it has kept me from non-
                medical meetings, appointments, work, or from getting things that I
                need; (C) No; (X) Patient unable to respond; and (Y) Patient declines
                to respond. The Transportation item collected in the AHC HRSN Screening
                Tool asks, ``In the past 12 months, has lack of reliable transportation
                kept you from medical appointments, meetings, work or from getting
                things needed for daily living?'' The two response options are: (1)
                Yes; and (2) No. Consistent with the AHC HRSN Screening Tool, we are
                proposing to modify the A1250. Transportation item currently collected
                in the IRF-PAI in two ways: (1) revise the look-back period for when
                the patient experienced lack of reliable transportation; and (2)
                simplify the response options.
                 First, the proposed modification of the Transportation item would
                use a defined 12-month look back period, while the current
                Transportation item uses a look back period of six to 12 months. We
                believe the distinction of a 12-month look back period would reduce
                ambiguity for both patients and
                [[Page 22280]]
                clinicians, and therefore improve the validity of the data collected.
                Second, we are proposing to simplify the response options. Currently,
                IRFs separately collect information on whether a lack of transportation
                has kept the patient from medical appointments or from getting
                medications, and whether a lack of transportation has kept the patient
                from non-medical meetings, appointments, work, or from getting things
                they need. Although transportation barriers can directly affect a
                person's ability to attend medical appointments and obtain medications,
                a lack of transportation can also affect a person's health in other
                ways, including accessing goods and services, obtaining adequate food
                and clothing, and social activities.\65\ The proposed modified
                Transportation item would collect information on whether a lack of
                reliable transportation has kept the patient from medical appointments,
                meetings, work, or from getting things needed for daily living, rather
                than collecting the information separately. As discussed previously, we
                believe reliable transportation services are fundamental to a person's
                overall health, and as a result, the burden of collecting this
                information separately outweighs its potential benefit.
                ---------------------------------------------------------------------------
                 \65\ Centers for Medicare & Medicaid Services, FY2024 Inpatient
                Psychiatric Prospective Payment System--Rate Update (88 FR 51107
                through 51121).
                ---------------------------------------------------------------------------
                 For the reasons stated previously, we are proposing to modify
                A1250. Transportation based on the Transportation item adopted for use
                in the AHC HRSN Screening Tool and adapted from the PRAPARE tool. The
                proposed Transportation item asks, ``In the past 12 months, has a lack
                of reliable transportation kept you from medical appointments,
                meetings, work or from getting things needed for daily living?'' The
                proposed response options are: (0) Yes; (1) No; (7) Patient declines to
                respond; and (8) Patient unable to respond. A draft of the proposed
                modified Transportation item can be found in the Downloads section of
                the IRF-PAI and IRF-PAI Manual web page at https://www.cms.gov/medicare/quality/inpatient-rehabilitation-facility/irf-pai-and-irf-qrp-manual.
                 We invite comment on the proposal to modify the current
                Transportation item previously adopted as a standardized patient
                assessment data element under the SDOH category beginning with the FY
                2028 IRF QRP.
                D. IRF QRP Quality Measure Concepts Under Consideration for Future
                Years--Request for Information (RFI)
                 We are seeking input on the importance, relevance, appropriateness,
                and applicability of each of the concepts under consideration listed in
                Table 13 for future years in the IRF QRP. In the FY 2024 IRF PPS
                proposed rule (88 FR 21000 through 21003), we published a request for
                information (RFI) on a set of principles for selecting and prioritizing
                IRF QRP measures, identifying measurement gaps, and suitable measures
                for filling these gaps. Within this proposed rule, we also sought input
                on data available to develop measures, approaches for data collection,
                perceived challenges or barriers, and approaches for addressing
                identified challenges. We refer readers to the FY 2024 IRF PPS final
                rule (88 FR 51036 through 51037) for a summary of the public comments
                we received in response to the RFI.
                 Subsequently, our measure development contractor convened a
                Technical Expert Panel (TEP) on December 15, 2023 to obtain expert
                input on the future measure concepts that could fill the measurement
                gaps identified in our FY 2024 RFI.\66\ The TEP discussed the alignment
                of PAC and Hospice measures with CMS' ``Universal Foundation'' of
                quality measures.\67\ The Universal Foundation aims to focus provider
                attention, reduce burden, identify disparities in care, prioritize
                development of interoperable, digital quality measures, allow for
                comparisons across programs, and help identify measurement gaps.
                ---------------------------------------------------------------------------
                 \66\ The Post-Acute Care (PAC) and Hospice Quality Reporting
                Program Cross-Setting TEP summary report will be published in early
                summer or as soon as technically feasible. IRFs can monitor the
                Partnership for Quality Measurement website at https://mmshub.cms.gov/get-involved/technical-expert-panel/updates for
                updates.
                 \67\ Centers for Medicare & Medicaid Services. Aligning Quality
                Measures Across CMS--the Universal Foundation. November 17, 2023.
                https://www.cms.gov/aligning-quality-measures-across-cms-universal-foundation.
                ---------------------------------------------------------------------------
                 In consideration of the feedback, we have received from interested
                parties through these activities, we are seeking input on three
                concepts for the IRF QRP. One is a composite of vaccinations,\68\ which
                could represent overall immunization status of patients such as the
                Adult Immunization Status measure \69\ in the Universal Foundation. A
                second concept on which we are seeking feedback is the concept of
                depression for the IRF QRP, which may be similar to the Clinical
                Screening for Depression and Follow-up measure \70\ in the Universal
                Foundation. Finally, we are seeking feedback on the concept of pain
                management.
                ---------------------------------------------------------------------------
                 \68\ A composite measure can summarize multiple measures through
                the use of one value or piece of information. More information can
                be found at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/mms/downloads/composite-measures.pdf.
                 \69\ CMS Measures Inventory Tool. Adult immunization status
                measure found at https://cmit.cms.gov/cmit/#/FamilyView?familyId=26.
                 \70\ CMS Measures Inventory Tool. Clinical Depression Screening
                and Follow-Up measure found at https://cmit.cms.gov/cmit/#/FamilyView?familyId=672.
                [GRAPHIC] [TIFF OMITTED] TP29MR24.038
                [[Page 22281]]
                 While we will not be responding to specific comments in response to
                this RFI in the FY 2025 IRF PPS final rule, we intend to use this input
                to inform our future measure development efforts.
                E. Future IRF Star Rating System: Request for Information (RFI)
                 Section 1886(j)(7)(E) of the Act requires that the Secretary
                establish procedures for making data submitted under the IRF QRP
                available to the public. Such procedures must ensure the IRFs
                participating in the IRF QRP have the opportunity to review the IRF-
                submitted data prior to such data being made public. The Secretary must
                publicly report quality measures that relate to services furnished in
                IRFs on the CMS website. We currently publicly report data we receive
                on measures under the IRF QRP on our Care Compare website.\71\
                ---------------------------------------------------------------------------
                 \71\ Centers for Medicare & Medicaid Services (CMS). Care
                Compare. 2023. https://www.medicare.gov/care-compare.
                ---------------------------------------------------------------------------
                 Care Compare displays star ratings for many provider types,
                specifically: doctors and clinicians, hospitals, nursing homes, home
                health, hospice, and dialysis facilities. Rating methodologies vary by
                provider type. Star ratings summarize performance using symbols to help
                consumers quickly and easily understand quality of care information.
                Star ratings are designed to enhance and supplement existing publicly
                reported quality information, and also serve to spotlight differences
                in health care quality and identify areas for improvement.\72\ Some
                providers receive ``overall star ratings,'' which are a composite score
                calculated using different data sources, such as quality measures or
                survey results. Others receive ``patient survey star ratings,'' a
                composite score derived from patient experience of care surveys.
                Depending on the provider type, some utilize one--or both--of these
                rating methodologies.
                ---------------------------------------------------------------------------
                 \72\ Centers for Medicare & Medicaid Services (CMS). Home Health
                Star Ratings. 2023. https://www.cms.gov/medicare/quality/home-health/home-health-star-ratings.
                ---------------------------------------------------------------------------
                 Star ratings serve an important function for patients, caregivers,
                and families, helping them to more quickly comprehend complex
                information about a health care providers' care quality and to easily
                assess differences among providers. This transparency serves an
                important educational function, while also helping to promote
                competition in health care markets. Informed patients and consumers are
                more empowered to select among health care providers, fostering
                continued quality improvement. CMS' commitment to establishing star
                ratings systems across health care settings is consistent with the
                Biden-Harris Administration's goal to promote an open, transparent, and
                competitive economy as outlined in Executive Order 14036, Promoting
                Competition in the American Economy (86 FR 36987, July 14, 2021).\73\
                ---------------------------------------------------------------------------
                 \73\ The White House. Executive Order on Promoting Competition
                in the American Economy. 2023. https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/.
                ---------------------------------------------------------------------------
                 We are seeking feedback on the development of a five-star
                methodology for IRFs that can meaningfully distinguish between quality
                of care offered by IRFs. Star ratings for IRFs would be designed to
                help consumers quickly identify differences in quality when selecting a
                provider. We are committed to developing a well-tested, data-driven
                methodology that encourages continuous quality improvement. We plan to
                engage with the IRF community and provide multiple opportunities for
                IRFs and other interested parties to give input on the development of a
                star rating system for IRFs. We note that IRFs would have the ability
                to preview their own facility's quality data before public posting of
                the IRF's star rating on the Care Compare website in accordance with
                section 1886(j)(7)(E) of the Act.
                 Specifically, we invite public comment on the following questions:
                 1. Are there specific criteria CMS should use to select measures
                for an IRF star rating system?
                 2. How should CMS present IRF star ratings information in a way
                that it is most useful to consumers?
                 While we will not be responding to specific comments in response to
                this RFI in the FY 2025 IRF PPS final rule, we intend to use this input
                to inform our future star rating development efforts. We intend to
                consider how a rating system would determine an IRF's star rating, the
                methods used for such calculations, and an anticipated timeline for
                implementation. We will consider comments in response to this RFI for
                future rulemaking.
                F. Form, Manner, and Timing of Data Submission Under the IRF QRP
                1. Background
                 We refer readers to the regulatory text at Sec. 412.634(b)(1) for
                information regarding the current policies for reporting specified data
                for the IRF QRP.
                2. Proposed Reporting Schedule for the Submission of Proposed New Items
                as Standardized Patient Assessment Data Elements and the Transportation
                Item Beginning With the FY 2028 IRF QRP
                 As discussed in sections VII.C.3. and VII.C.5. of this proposed
                rule, we are proposing to adopt four new items as standardized patient
                assessment data elements under the SDOH category (one Living Situation
                item, two Food items, and one Utilities item) and to modify the
                Transportation standardized patient assessment data element previously
                adopted under the SDOH category beginning with the FY 2028 IRF QRP.
                 We are proposing that IRFs would be required to report these new
                items and the transportation item using the IRF-PAI beginning with
                patients admitted on October 1, 2026, for purposes of the FY 2028 IRF
                QRP. Starting in CY 2027, IRFs would be required to submit data for the
                entire calendar year with the FY 2029 IRF QRP.
                 We are also proposing that IRFs that submit the Living Situation,
                Food, and Utilities items proposed for adoption as standardized patient
                assessment data elements under the SDOH category with respect to
                admission only would be deemed to have submitted those items with
                respect to both admission and discharge. We propose that IRFs would be
                required to submit these items at admission only (and not at discharge)
                because it is unlikely that the assessment of those items at admission
                would differ from the assessment of the same item at discharge. This
                would align the data collection for these proposed items with other
                SDOH items (that is, Race, Ethnicity, Preferred Language, and
                Interpreter Services) which are only collected at admission.\74\ A
                draft of the proposed items is available in the Downloads section of
                the IRF-PAI and IRF-PAI Manual web page at https://www.cms.gov/medicare/quality/inpatient-rehabilitation-facility/irf-pai-and-irf-qrp-manual.
                ---------------------------------------------------------------------------
                 \74\ FY 2020 IRF PPS final rule (84 FR 39161 through 339162).
                ---------------------------------------------------------------------------
                As we noted in section VII.C.5. of this proposed rule, we
                continually assess the implementation of the new SDOH items, including
                A1250. Transportation, as part of our routine item and measure
                monitoring work. We received feedback from stakeholders in response to
                the FY 2020 IRF PPS proposed rule (84 FR 39149 through 39161) noting
                their concern with the burden of collecting the Transportation item at
                admission and discharge. Specifically, commenters stated that a
                patient's access to transportation is unlikely to change between
                admission and discharge (84
                [[Page 22282]]
                FR 39159). We analyzed the data IRFs reported from October 1, 2022,
                through June 30, 2023 (Quarter 4 CY 2022 through Quarter 2 CY 2023),
                and found that patient responses do not significantly change from
                admission to discharge.\75\ Specifically, the proportion of patients
                \76\ who responded ``Yes'' to the Transportation item at admission
                versus at discharge differed by only 0.19 percentage points during this
                period. We find these results convincing, and therefore are proposing
                to require IRFs to collect and submit the proposed modified
                standardized patient assessment data element, Transportation, at
                admission only.
                ---------------------------------------------------------------------------
                 \75\ Due to data availability of IRF SDOH standardized patient
                assessment data elements, this is based on three quarters of
                Transportation data.
                 \76\ The analysis is limited to patients who responded to the
                Transportation item at both admission and discharge.
                ---------------------------------------------------------------------------
                 We invite public comment on our proposal to collect data on the
                following items proposed as standardized patient assessment data
                elements under the SDOH category at admission beginning October 1, 2026
                with the FY 2028 IRF QRP: (1) Living Situation as described in section
                VII.C.3.(a) of this proposed rule; (2) Food as described in section
                VII.C.3.(b) of this proposed rule; and (3) Utilities as described in
                section VII.C.3.(c) of this proposed rule. We also invite comment on
                our proposal to submit the proposed modified standardized patient
                assessment data element, Transportation, at admission only beginning
                October 1, 2026, with the FY 2028 IRF QRP as described in section
                VII.C.5. of this proposed rule.
                3. Proposal To Remove the Admission Class Item From the IRF-PAI
                Beginning October 1, 2026
                (a) Background
                 In the CY 2002 PPS for IRFs final rule (66 FR 41324 through 41342),
                we finalized the use of the IRF-PAI, through which IRFs are now
                required to collect and electronically submit patient data for all
                Medicare Part A FFS and Medicare Part C (Medicare Advantage) patients
                admitted and discharged from an IRF through September 30, 2024 \77\ and
                for all patients regardless of payer beginning October 1, 2024.\78\
                Item 14-Admission Class has been included on the IRF-PAI since the IRF-
                PAI was first implemented and is completed only at admission. The most
                recent version of the IRF-PAI is available for reference on the IRF-PAI
                and IRF QRP Manual web page at https://www.cms.gov/medicare/quality/inpatient-rehabilitation-facility/irf-pai-and-irf-qrp-manual. Item 14,
                Admission Class, includes the following response options: (i) Initial
                Rehab; (iii) Readmission; (iv) Unplanned Discharge; and (v) Continuing
                Rehabilitation.
                ---------------------------------------------------------------------------
                 \77\ In the FY 2010 IRF PPS final rule (74 FR 39798 through
                39800), CMS revised the regulation text in Sec. Sec. 412.604,
                412.606, 412.610, 412.614, and 412.618 to require that all IRFs
                submit IRF-PAI data on all of their Medicare Part C patients.
                 \78\ In the FY 2023 IRF PPS final rule (87 FR 47073 through
                47092), CMS revised the regulation text in Sec. Sec. 412.604,
                412.606, 412.610, 412.614, and 412.618 to require that all IRFs
                submit IRF-PAI data on each patient receiving care in an IRF,
                regardless of payer.
                ---------------------------------------------------------------------------
                (b) Removal of Item
                 We routinely review item sets for redundancies and identify
                opportunities to simplify data submission requirements. We propose to
                remove Item 14 entirely from the IRF-PAI, beginning October 1, 2026. We
                have identified this item is currently not used in the calculation of
                quality measures already adopted in the IRF QRP. It is also not used
                for previously established purposes unrelated to the IRF QRP, such as
                payment, survey, or care planning.
                 We invite public comment on our proposal to remove Item 14-
                Admission Class from the IRF-PAI, effective October 1, 2026.
                G. Policies Regarding Public Display of Measure Data for the IRF QRP
                 We are not proposing any new policies regarding the public display
                of measure data at this time. 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).
                VIII. Collection of Information Requirements
                 Under the Paperwork Reduction Act of 1995, 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 Office of Management and Budget (OMB) for review and approval. In
                order to fairly evaluate whether an information collection should be
                approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
                of 1995 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.
                 Recommendations to minimize the information collection
                burden on the affected public, including automated collection
                techniques.
                 This proposed rule refers to associated information collections
                that are not discussed in the regulation text contained in this
                document.
                A. Requirements for Updates Related to the IRF QRP Beginning With the
                FY 2028 IRF QRP
                 An IRF that does not meet the requirements of the IRF QRP for a
                fiscal year will receive a 2-percentage point reduction to its
                otherwise applicable annual increase factor for that fiscal year.
                 In section VII.C. of the proposed rule, we are proposing to adopt
                four items as standardized patient assessment data elements and modify
                one item collected as a standardized patient assessment data element
                beginning with the FY 2028 IRF QRP. In section VII.F.3. of the proposed
                rule, we are proposing to remove one item, Admission Class, from the
                IRF-PAI.
                 As stated in sections VII.C.3. and VII.C.5. of the preamble of this
                proposed rule, we are proposing to adopt four items as standardized
                patient assessment data elements and modify one item collected as a
                standardized patient assessment data element beginning with the FY 2028
                IRF QRP. The proposed and modified items would be collected using the
                IRF-PAI. The IRF-PAI, in its current form, has been approved under OMB
                control number 0938-0842.\79\ Four items would need to be added to the
                IRF-PAI at admission to allow for collection of these data, and one
                item would be modified. Additionally, as stated in section VII.F.2. of
                this proposed rule, we are proposing that IRFs would submit the four
                new items and one modified item at admission only. The net result of
                collecting four new items at admission, modifying one item currently
                collected at admission, and removing the collection of one item at
                discharge is an increase of 0.9 minutes or 0.015 hour of clinical staff
                time at admission [(4 items x 0.005 hour) minus (1 item x 0.005 hour)].
                We identified the staff type based on past IRF burden calculations, and
                our assumptions are based on the categories generally necessary to
                perform an assessment. We believe that the items would be completed
                equally by a Registered Nurse (RN) (50 percent of the time) and a
                Licensed Practical and Licensed Vocational Nurse (LPN/LVN) (50 percent
                of the time). However, IRFs determine the staffing resources necessary.
                ---------------------------------------------------------------------------
                 \79\ https://www.reginfo.gov/public/do/DownloadNOA?requestID=494186.
                ---------------------------------------------------------------------------
                [[Page 22283]]
                 For the purposes of calculating the costs associated with the
                collection of information requirements, we obtained median hourly wages
                for these staff from the U.S. Bureau of Labor Statistics' (BLS) May
                2022 National Occupational Employment and Wage Estimates.\80\ To
                account for other indirect costs and fringe benefits, we doubled the
                hourly wage. These amounts are detailed in Table 15. We established a
                composite cost estimate using our adjusted wage estimates. The
                composite estimate of $65.31/hr was calculated by weighting each
                adjusted hourly wage equally (that is, 50%) [($78.10/hr x 0.5) +
                ($52.52/hr x 0.5) = $65.31].
                ---------------------------------------------------------------------------
                 \80\ U.S. Bureau of Labor Statistics' (BLS) May 2022 National
                Occupational Employment and Wage Estimates. https://www.bls.gov/oes/current/oes_nat.htm.
                [GRAPHIC] [TIFF OMITTED] TP29MR24.039
                 We estimate that the burden and cost for IRFs for complying with
                requirements of the FY 2028 IRF QRP would increase under this proposal.
                Using FY 2023 data, we estimate a total of 571,151 admissions to and
                512,677 planned discharges from 1,154 IRFs annually for an increase of
                8,859.64 hours in burden for all IRFs [(571,151 x 0.02 hour)
                admissions-(512,677 x 0.005 hour) planned discharges]. Given 0.02 hour
                at $65.31 per hour to complete an average of 500 IRF-PAI admission
                assessments per IRF per year minus 0.005 at $65.31 per hour to complete
                an average of 449 IRF-PAI Planned Discharge assessments per IRF per
                year, we estimate the total cost would be increased by $501.41 per IRF
                annually, or $578,622.76 for all IRFs annually.
                 In section VII.F.3. of this proposed rule, we are proposing to
                remove one item, Admission Class, from the IRF-PAI beginning October 1,
                2026. We believe that the removal of Admission Class will result in a
                decrease of 18 seconds (0.3 minutes or 0.005 hours) of clinical staff
                time at admission beginning with the FY 2028 IRF QRP. We believe the
                IRF-PAI item, Admission Class, is completed equally by a Registered
                Nurse (RN) and a Licensed Practical and Licensed Vocational Nurse (LPN/
                LVN). Individual IRFs determine the staffing resources necessary.
                 We estimate that the burden and cost for IRFs for complying with
                requirements of the FY 2028 IRF QRP would decrease under this proposal
                in section VII.F.3. Specifically, we believe that there will be a 2.47
                hour decrease in clinical staff time to report data for each IRF-PAI
                completed at admission. Using data from FY 2023, we estimate 571,151
                admission assessments from 1,154 IRFs annually. This equates to a
                decrease of 2,855.76 hours in burden at admission for all IRFs (0.005
                hour x 571,151 admissions). Given 0.005 hour at $65.31 per hour to
                complete an average of 500 IRF-PAI admission assessments per IRF per
                year, we estimate the total cost will be decreased by $161.62
                ($186,509.36 total decrease/1,154 IRFs) per IRF annually, or
                $186,509.36 for all IRFs annually, based on the proposal to remove one
                item from the IRF-PAI.
                 In summary, under OMB control number 0938-0842, the changes to the
                IRF QRP will result in a burden increase of $339.79 per IRF
                ($392,113.40/1,154 IRFs). The total cost increase related to this
                proposed information collection is approximately $392,113.40 and is
                summarized in Table 16.
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                 We invite public comments on the proposed information collection
                requirements.
                IX. Regulatory Impact Analysis
                A. Statement of Need
                 This proposed rule updates the IRF prospective payment rates for FY
                2025 as required under section 1886(j)(3)(C) of the Act and in
                accordance with section 1886(j)(5) of the Act, which requires the
                Secretary to publish in the Federal Register on or before August 1
                before each FY, the classification and weighting factors for CMGs used
                under the IRF PPS for such FY and a description of the methodology and
                data used in computing the prospective payment rates under the IRF PPS
                for that FY. This proposed rule would also implement section
                1886(j)(3)(C) of the Act, which requires the Secretary to apply a
                productivity adjustment to the market basket percentage increase for FY
                2012 and subsequent years.
                 Furthermore, this proposed rule proposes to adopt policy changes to
                the IRF QRP under the statutory discretion afforded to the Secretary
                under section 1886(j)(7) of the Act. This rule proposes updates to the
                IRF QRP requirements beginning with the FY 2028 IRF QRP.
                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), Executive Order 14094 on Modernizing Regulatory
                Review (April 6, 2023), 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), and Executive Order 13132 on Federalism (August
                4, 1999).
                 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). Executive
                Order 14094 (Modernizing Regulatory Review) amends section 3(f)(1) of
                Executive Order 12866 (Regulatory Planning and Review). The amended
                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 $200 million or more in
                any 1 year (adjusted every 3 years by the Administrator of OMB's Office
                of Information and Regulatory Affairs (OIRA) for changes in gross
                domestic product), or adversely affect in a material way the economy, a
                sector of the economy, productivity, competition, jobs, the
                environment, public health or safety, or State, local, territorial, or
                Tribal governments or communities; (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) raise legal or policy issues for which
                centralized review would meaningfully further the President's
                priorities or the principles set forth in the Executive order, as
                specifically authorized in a timely manner by the Administrator of OIRA
                in each case.
                 A regulatory impact analysis (RIA) must be prepared for major rules
                with significant regulatory action/s and/or with significant effects as
                per section 3(f)(1) ($200 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 2025 with those in FY 2024.
                This analysis results
                [[Page 22285]]
                in an estimated $255 million increase for FY 2025 IRF PPS payments.
                Additionally, we estimate that costs associated with updating the
                reporting requirements under the IRF QRP result in an estimated
                $392,113.40 additional cost for IRFs in FY 2026 for purposes of meeting
                the FY 2028 IRF QRP. Based on our estimates, OMB's Office of
                Information and Regulatory Affairs has determined this rulemaking is
                significant per section 3(f)(1) as measured by the $200 million or more
                in any 1 year, and hence also a major rule under Subtitle E of the
                Small Business Regulatory Enforcement Fairness Act of 1996 (also known
                as the Congressional Review Act). 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 $ 9.0
                million to $ 47.0million 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 1,154 IRFs, of which approximately 50
                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 the proposed rule on all IRFs is to increase
                estimated payments by approximately 2.5 percent. The rates and policies
                proposed in this rule would not have a significant impact (not greater
                than 5 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 4.6 percent based on the data of the 130
                rural units and 13 rural hospitals in our database of 1,154 IRFs for
                which data were available. We estimate an overall impact for rural IRFs
                in all areas between 0.8 percent and 10.4 percent. As a result, we
                anticipate that this proposed rule will not have a significant negative
                impact on a substantial number of small entities.
                 Section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L.
                104-04, enacted 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 2024, that threshold is
                approximately $183 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 will not have a substantial
                effect on State and local governments, preempt State law, or otherwise
                have a federalism implication.
                2. Detailed Economic Analysis
                 This rule proposes updates to the IRF PPS rates contained in the FY
                2024 IRF PPS final rule (88 FR 509564). Specifically, this proposed
                rule proposes updates to the CMG relative weights and ALOS values, the
                wage index, and the outlier threshold for high-cost cases. This
                proposed rule would apply a productivity adjustment to the FY 2025 IRF
                market basket percentage increase 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 $255 million in
                payments to IRFs. The impact analysis in Table 17 of this proposed rule
                represents the projected effects of the proposed updates to IRF PPS
                payments for FY 2025 compared with the estimated IRF PPS payments in FY
                2024. 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 2025, we are proposing to implement
                the standard annual revisions described in this proposed rule (for
                example, the update to the wage index and market basket percentage
                increase used to adjust the Federal rates). We are also reducing the FY
                2025 IRF market basket percentage increase by a productivity adjustment
                in accordance with section 1886(j)(3)(C)(ii)(I) of the Act. We propose
                the estimate of the total increase in payments to IRFs in FY 2025,
                relative to FY 2024, would be approximately $255 million.
                 This estimate is derived from the application of the FY 2025 IRF
                market basket percentage increase, 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 $280
                million. However, there is an estimated $25 million decrease in
                aggregate payments to IRFs due to the update to the outlier threshold
                amount. Therefore,
                [[Page 22286]]
                we estimate that these proposed updates would result in a net increase
                in estimated payments of $255 million from FY 2024 to FY 2025.
                 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 3.2 percent to 3.0 percent of
                total estimated payments for FY 2025, consistent with section
                1886(j)(4) of the Act.
                 The effects of the proposed annual market basket update
                (using the 2021-based 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)(ii)(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, accounting for the permanent cap on wage index
                decreases when applicable.
                 The effects of the proposed budget-neutral changes to the
                CMG relative weights and ALOS values under the authority of section
                1886(j)(2)(C)(i) of the Act.
                 The total change in proposed estimated payments based on
                the FY 2025 payment changes relative to the estimated FY 2024 payments.
                3. Description of Table 17
                 Table 17 shows the overall impact on the 1,154 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 1,011 IRFs located in
                urban areas included in our analysis. Among these, there are 651 IRF
                units of hospitals located in urban areas and 360 freestanding IRF
                hospitals located in urban areas. There are 143 IRFs located in rural
                areas included in our analysis. Among these, there are 130 IRF units of
                hospitals located in rural areas and 13 freestanding IRF hospitals
                located in rural areas. There are 494 for-profit IRFs. Among these,
                there are 459 IRFs in urban areas and 35 IRFs in rural areas. There are
                564 non-profit IRFs. Among these, there are 475 urban IRFs and 89 rural
                IRFs. There are 96 government-owned IRFs. Among these, there are 77
                urban IRFs and 19 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 proposed
                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 2025 analysis file.
                 Column (3) shows the number of cases in each category in
                our FY 2025 analysis file.
                 Column (4) shows the estimated effect of the adjustment to
                the outlier threshold amount.
                 Column (5a) shows the estimated effect of the FY 2025
                update to the IRF labor-related share, the FY 2024 CBSA delineations,
                and FY 2025 wage index with the 5 percent cap, in a budget-neutral
                manner.
                 Column (5b) shows the estimated effect of the update to
                the IRF labor-related share, FY2025 CBSA delineations and wage index
                with the 5 percent cap, in a budget-neutral manner.
                 Column (6) shows the estimated effect of the update to the
                CMG relative weights and ALOS 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 2025 to our estimates of payments per discharge in FY 2024.
                 The average estimated increase for all IRFs is approximately 2.5
                percent. This estimated net increase includes the effects of the IRF
                market basket update for FY 2025 of 2.8 percent, which is based on a
                IRF market basket percentage increase of 3.2 percent, less a 0.4
                percentage point productivity adjustment, as required by section
                1886(j)(3)(C)(ii)(I) of the Act. It also includes the approximate 0.2
                percent overall decrease in estimated IRF outlier payments from the
                update to the outlier threshold amount. Since we are proposing to make
                updates to the IRF wage index, labor-related share and the CMG relative
                weights in a budget-neutral manner, we estimate there is no expected
                impact to total estimated IRF payments in aggregate. However, as
                described in more detail in each section, we estimate there will be
                expected impacts to the estimated distribution of payments among
                providers.
                BILLING CODE 4120-01-P
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                BILLING CODE 4120-01-C
                4. Impact of the Update to the Outlier Threshold Amount
                 The estimated effects of the update to the outlier threshold
                adjustment are presented in column 4 of Table 17.
                 For the FY 2025 proposed rule, we used FY 2023 IRF claims data and
                based on that analysis, we estimated that IRF outlier payments as a
                percentage of total estimated IRF payments would be 3.2 percent in FY
                2024. Thus, we are adjusting the outlier threshold amount in this
                proposed rule to maintain total estimated outlier payments equal to 3
                percent of total estimated payments in FY 2025.
                 The estimated change in total IRF payments for FY 2025, therefore,
                includes an approximate 0.2 percentage point decrease in payments
                because the estimated outlier portion of total payments is estimated to
                decrease from approximately 3.2 percent to 3.0 percent.
                 The impact of this update to the outlier threshold amount (as shown
                in column 4 of Table 17) is to decrease estimated overall payments to
                IRFs by 0.2 percentage point.
                5. Impact of the Wage Index, Labor-Related Share, and Wage Index Cap
                 In column 5a of Table 17, we present the effects of the budget-
                neutral update of the wage index and labor-related share, taking into
                account the permanent 5 percent cap on wage index decreases when
                applicable, without taking into account the updated FY2025 CBSA
                delineations, which are presented separately in the next column. The
                changes to the wage index and the labor-related share are discussed
                together because the wage index is applied to the labor-related share
                portion of payments, so the changes in the two have a combined effect
                on payments to providers. As discussed in section VI.E. of this
                proposed rule, we update the FY 2025 labor-related share from 74.1
                percent in FY 2024 to 74.2 percent in FY 2025.
                6. Impact of the Updated CBSA Delineations
                 In column 5b of Table 17, we present the effects of the revised
                FY2025 CBSA delineations. In aggregate, we do not estimate that these
                updates will affect overall estimated payments to IRFs. However, we do
                expect these updates to have small distributional effects. We estimate
                the largest decrease in payment from the update to the FY 2025 CBSA
                delineation and wage index and labor-related share (column 5b of Table
                17) to be a 1.0 percent decrease for IRFs in the Rural Middle Atlantic
                and the largest increase in payment to be a 1.6 percent increase for
                IRFs in the Rural South Atlantic.
                7. Impact of the Update to the CMG Relative Weights and ALOS Values
                 In column 6 of Table 17, we present the effects of the budget-
                neutral update of the CMG relative weights and ALOS values. In the
                aggregate, we do not estimate that these updates will affect overall
                estimated payments of IRFs. However, we do expect these updates to have
                small distributional effects between -0.1 to 0.1.
                8. Effects of Requirements for the IRF QRP Beginning With the FY 2028
                IRF QRP
                 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 IX.A. of the proposed rule, we discussed the method for
                applying the 2 percentage points reduction to IRFs that fail to meet
                the IRF QRP requirements.
                 As discussed in sections VII.C.3. and VII.C.5. of the preamble of
                this proposed rule, we are proposing to adopt four new items as
                standardized patient assessment data elements under the SDOH category
                and to modify one item currently collected as a standardized patient
                assessment data element. Although the proposed increase in burden will
                be accounted for in a revised information collection request under OMB
                control number (0938-0842), we are providing impact information. We
                believe the proposed items would be completed equally by a Registered
                Nurse (RN) (50 percent of the time) and a Licensed Practical and
                Vocational Nurses (LPN/LVN) (50 percent of the time). For the purposes
                of calculating the costs associated with the collection of information
                requirements, we obtained median hourly wages for these staff from the
                U.S. Bureau of Labor Statistics' (BLS) May 2022 National Occupational
                Employment and Wage
                [[Page 22290]]
                Estimates.\81\ To account for other indirect costs and fringe benefits,
                we doubled the hourly wage. These amounts are detailed in Table 18.
                ---------------------------------------------------------------------------
                 \81\ U.S. Bureau of Labor Statistics' (BLS) May 2022 National
                Occupational Employment and Wage Estimates. https://www.bls.gov/oes/current/oes_nat.htm.
                [GRAPHIC] [TIFF OMITTED] TP29MR24.060
                 With 571,151 admissions from 1,154 IRFs annually, we estimated an
                annual burden increase of 8,859.64 hours [(571,151 x 0.02 hour)
                admissions-(512,677 x 0.005 hour) planned discharges] and an increase
                of $578,622.76 [8,859.64 hours x $65.31/hr)]. For each IRF, we estimate
                an annual burden increase of 7.68 hours (8,859.64 hours/1,154 IRFs) for
                an annual increase of $501.41 ($578,622.76/1,154 IRFs).
                 As discussed in section VII.F.3. of this proposed rule, we are
                proposing to remove one item, Admission Class, from the IRF-PAI
                beginning October 1, 2026. We estimate the removal of this item would
                result in a decrease of 0.005 hour of clinical staff time beginning
                with admission assessments completed on October 1, 2026. Although the
                proposed decrease in burden will be accounted for in a revised
                information collection request under OMB control number 0938-0842, we
                are providing impact information. We estimate this item is completed
                equally by an RN (50 percent of the time) and by an LPN/LVN (50 percent
                of the time). For the purposes of calculating the costs associated with
                the collection of information requirements, we obtained median hourly
                wages for these staff from the U.S. Bureau of Labor Statistics' (BLS)
                May 2022 National Occupational Employment and Wage Estimates.\82\ To
                account for other indirect costs and fringe benefits, we doubled the
                hourly wage. These amounts are detailed in Table 18. With 571,151
                admissions from 1,154 IRFs annually, we estimate an annual burden
                decrease of 2,855.76 hours (571,151 admissions x 0.005 hour) and a
                decrease of $186,509.36 [2,855.76 hours x $65.31/hr)]. For each IRF we
                estimate an annual burden decrease of 2.47 hours (2,855.76 hours/1,154
                IRFs) for an annual decrease of $161.62 ($186,509.36/1,154 IRFs).
                ---------------------------------------------------------------------------
                 \82\ U.S. Bureau of Labor Statistics' (BLS) May 2022 National
                Occupational Employment and Wage Estimates. https://www.bls.gov/oes/current/oes_nat.htm.
                ---------------------------------------------------------------------------
                 In summary, under OMB control number 0938-0842, the proposed
                changes to the IRF QRP would result in an estimated increase in
                programmatic burden for 1,154 IRFs. The total burden increase is
                approximately $392,113.40 for all IRFs and $339.79 per IRF and is
                summarized in Table 19.
                [[Page 22291]]
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                 We invite public comments on the overall impact of the IRF QRP
                proposals for FY 2028.
                D. Alternatives Considered
                 The following is a discussion of the alternatives considered for
                the IRF PPS updates contained in this proposed rule.
                 As noted previously in the 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 and services included in the covered IRF
                services and section 1886(j)(3)(C)(ii)(I) of the Act requires the
                Secretary to apply a productivity adjustment to the market basket
                percentage increase for FY 2025. Thus, in accordance with section
                1886(j)(3)(C) of the Act, we are updating the IRF prospective payments
                in this proposed rule by 2.8 percent (which equals the 3.2 percent
                proposed IRF market basket percentage increase for FY 2025 reduced by a
                proposed 0.4 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 maintaining the existing CMG relative weights and
                average length of stay values for FY 2025. 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, we believe that it
                is appropriate to propose updates to the CMG relative weights and
                average length of stay values at this time to ensure that IRF PPS
                payments continue to reflect as accurately as possible the current
                costs of care in IRFs.
                 We considered maintaining the existing outlier threshold amount for
                FY 2025. However, analysis of updated FY 2024 data indicates that
                estimated outlier payments would be more than 3 percent of total
                estimated payments for FY 2025, unless we updated the outlier threshold
                amount. Consequently, we are proposing to adjust the outlier threshold
                amount to maintain estimated outlier payments at 3 percent of estimated
                aggregate payments in FY 2025.
                 With regard to the proposal to collect four new items as
                standardized patient assessment data elements under the SDOH category
                and modify one item collected as a standardized patient assessment data
                element under the SDOH category beginning with the FY 2028 IRF QRP, we
                believe these proposals would advance the CMS National Quality Strategy
                Goals of equity and engagement. We considered the alternative of
                delaying the proposal to collect these assessment items but given the
                fact they would encourage meaningful collaboration among healthcare
                providers, caregivers, and community-based organizations to address
                SDOH prior to discharge from the IRF, we believe further delay is
                unwarranted.
                 With regard to the proposal to remove one item, Admission Class,
                from the IRF-PAI, we routinely review the IRF-PAI for redundancies and
                opportunities to simplify data submission requirements. We have
                identified that this item is currently not used in the calculation of
                quality measures already adopted in the IRF QRP, payment, survey, or
                care planning, and therefore no alternatives were considered.
                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 2025 IRF PPS proposed rule will be the number of
                reviewers of last year's 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
                2024 IRF PPS proposed rule in detail, and it is also possible that some
                reviewers chose not to comment
                [[Page 22292]]
                on the FY 2024 proposed rule. For these reasons, we thought that the
                number of 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.
                 Using the national mean hourly wage data from the May 2022 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 $123.06 per hour, including overhead and fringe benefits
                (https://www.bls.gov/oes/current/oes_nat.htm). Assuming an average
                reading speed, we estimate that it would take approximately 3 hours for
                the staff to review half of proposed rule. For each reviewer of the
                rule, the estimated cost is $369.18 (3 hours x $123.06). Therefore, we
                estimate that the total cost of reviewing this regulation is $16,613.10
                ($369.18 x 45 reviewers).
                F. Accounting Statement and Table
                 As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf), in Table 20 we have prepared an accounting
                statement showing the classification of the expenditures associated
                with the provisions of this proposed rule. Table 20 provides our best
                estimate of the increase in Medicare payments under the IRF PPS as a
                result of the updates presented in this proposed rule based on the data
                for 1,154 IRFs in our database.
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                G. Conclusion
                 Overall, the estimated payments per discharge for IRFs in FY 2025
                are projected to increase by 2.5 percent, compared with the estimated
                payments in FY 2024, as reflected in column 7 of Table 17.
                 IRF payments per discharge are estimated to increase by 2.4 percent
                in urban areas and 4.6 percent in rural areas, compared with estimated
                FY 2024 payments. Payments per discharge to rehabilitation units are
                estimated to increase 1.8 percent in urban areas and 4.6 percent in
                rural areas. Payments per discharge to freestanding rehabilitation
                hospitals are estimated to increase 2.8 percent in urban areas and 4.7
                percent in rural areas.
                 Overall, IRFs are estimated to experience a net increase in
                payments as a result of the policies in this proposed rule. The largest
                payment increase is estimated to be a 10.4 percent increase for IRFs
                located in the Rural Middle 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.
                 Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
                Medicaid Services, approved this document on March 19, 2024.
                Xavier Becerra,
                Secretary, Department of Health and Human Services.
                [FR Doc. 2024-06550 Filed 3-27-24; 4:15 pm]
                BILLING CODE 4120-01-P
                

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