Medicare Program; FY 2025 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update

Published date03 April 2024
Record Number2024-06764
Citation89 FR 23146
CourtCenters For Medicare & Medicaid Services
SectionProposed rules
Federal Register, Volume 89 Issue 65 (Wednesday, April 3, 2024)
[Federal Register Volume 89, Number 65 (Wednesday, April 3, 2024)]
                [Proposed Rules]
                [Pages 23146-23224]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2024-06764]
                [[Page 23145]]
                Vol. 89
                Wednesday,
                No. 65
                April 3, 2024
                Part IIIDepartment of Health and Human Services-----------------------------------------------------------------------Centers for Medicare & Medicaid Services-----------------------------------------------------------------------42 CFR Part 412Medicare Program; FY 2025 Inpatient Psychiatric Facilities Prospective
                Payment System--Rate Update; Proposed Rule
                Federal Register / Vol. 89, No. 65 / Wednesday, April 3, 2024 /
                Proposed Rules
                [[Page 23146]]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                42 CFR Part 412
                [CMS-1806-P]
                RIN 0938-AV32
                Medicare Program; FY 2025 Inpatient Psychiatric Facilities
                Prospective Payment System--Rate Update
                AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
                Health and Human Services (HHS).
                ACTION: Proposed rule.
                -----------------------------------------------------------------------
                SUMMARY: This rulemaking proposes to update the prospective payment
                rates, the outlier threshold, and the wage index for Medicare inpatient
                hospital services provided by Inpatient Psychiatric Facilities (IPF),
                which include psychiatric hospitals and excluded psychiatric units of
                an acute care hospital or critical access hospital. This rulemaking
                also proposes to revise the patient-level adjustment factors, the
                Emergency Department adjustment, and the payment amount for
                electroconvulsive therapy. These proposed changes would be effective
                for IPF discharges occurring during the fiscal year beginning October
                1, 2024 through September 30, 2025 (FY 2025). In addition, this
                proposed rule seeks to adopt a new quality measure and modify reporting
                requirements under the IPF Quality Reporting Program beginning with the
                FY 2027 payment determination. Furthermore, this proposed rule solicits
                comments through Requests for Information (RFIs) regarding potential
                future revisions to the IPF PPS facility-level adjustments and
                regarding the development of a standardized IPF Patient Assessment
                Instrument.
                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-1806-P.
                 Comments, including mass comment submissions, must be submitted in
                one of the following three ways (please choose only one of the ways
                listed):
                 1. Electronically. You may submit electronic comments on this
                regulation to http://www.regulations.gov. Follow the ``Submit a
                comment'' instructions.
                 2. By regular mail. You may mail written comments to the following
                address ONLY: Centers for Medicare & Medicaid Services, Department of
                Health and Human Services, Attention: CMS-1806-P, P.O. Box 8010,
                Baltimore, MD 21244-8010.
                 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-1806-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:
                 Nick Brock (410) 786-5148, for information regarding the inpatient
                psychiatric facilities prospective payment system (IPF PPS).
                 Kaleigh Emerson (470) 890-4141, for information regarding the
                inpatient psychiatric facilities quality reporting program (IPFQR).
                SUPPLEMENTARY INFORMATION:
                 Inspection of Public Comments: All comments received before the
                close of the comment period are available for viewing by the public,
                including any personally identifiable or confidential business
                information that is included in a comment. We post all comments
                received before the close of the comment period on the following
                website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
                view public comments. CMS will not post on Regulations.gov public
                comments that make threats to individuals or institutions or suggest
                that the 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/.
                Availability of Certain Tables Exclusively Through the Internet on the
                CMS Website
                 Addendum A to this proposed rule summarizes the proposed FY 2025
                Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS)
                payment rates, outlier threshold, cost of living adjustment factors for
                Alaska and Hawaii, national and upper limit cost-to-charge ratios, and
                adjustment factors. In addition, Addendum B to this proposed rule shows
                the complete listing of ICD-10 Clinical Modification and Procedure
                Coding System codes, the FY 2025 IPF PPS comorbidity adjustment, and
                electroconvulsive therapy procedure codes. The A and B Addenda are
                available on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/tools.html.
                 Tables setting forth the FY 2025 Wage Index for Urban Areas Based
                on Core-Based Statistical Area Labor Market Areas, the FY 2025 Wage
                Index Based on CBSA Labor Market Areas for Rural Areas, and a county-
                level crosswalk of the FY 2024 CBSA Labor Market Areas to the FY 2025
                CBSA Labor Market Areas are available exclusively through the internet,
                on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/IPFPPS/WageIndex.html.
                I. Executive Summary
                A. Purpose
                 This proposed rule would update the prospective payment rates, the
                outlier threshold, and the wage index for Medicare inpatient hospital
                services provided by Inpatient Psychiatric Facilities (IPFs) for
                discharges occurring during fiscal year (FY) 2025, (beginning October
                1, 2024 through September 30, 2025). We are proposing to adopt the
                Core-Based Statistical Area (CBSA) Labor Market Areas for the IPF PPS
                wage index as defined in the Office of Management and Budget (OMB)
                Bulletin 23-01. In addition, this rule includes a proposal to refine
                the patient-level adjustment factors and increase the payment amount
                for electroconvulsive therapy (ECT) treatments. We are not proposing
                changes to the facility-level adjustment factors for FY 2025; however,
                this proposed rule presents the results of our latest analysis and
                includes a request for information relating to those results. This rule
                also includes a clarification of the eligibility criteria for an IPF to
                be approved to file all-inclusive cost reports. In addition, this
                proposed rule includes a request for information regarding the creation
                of a patient assessment instrument (PAI) as mandated by Section 4125 of
                the Consolidated Appropriations Act (CAA), 2023 (hereafter referred to
                as CAA, 2023) (Pub. L. 117-328). Lastly, this proposed rule discusses
                quality measures and reporting requirements under the Inpatient
                Psychiatric
                [[Page 23147]]
                Facilities Quality Reporting (IPFQR) Program.
                B. Summary of the Major Provisions
                1. Inpatient Psychiatric Facilities Prospective Payment System (IPF
                PPS)
                 For the IPF PPS, we are:
                 Proposing to revise the patient-level IPF PPS adjustment
                factors and increase the ECT per treatment payment amount.
                 Proposing to update the IPF PPS wage index to use the
                CBSAs defined within OMB Bulletin 23-01.
                 Clarifying the eligibility criteria for an IPF to be
                approved to file all-inclusive cost reports. Only a government-owned or
                tribally owned facility will be able to satisfy these criteria and will
                be eligible to file its cost report using an all-inclusive rate or no
                charge structure.
                 Soliciting comments to inform elements to be included in
                the IPF patient assessment instrument, which the CAA, 2023 requires the
                Centers for Medicare & Medicaid Services (CMS) to develop for FY 2028.
                 Soliciting comments to inform future refinements to the
                IPF PPS facility-level adjustment factors.
                 Making technical rate setting updates: The IPF PPS payment
                rates are adjusted annually for inflation, as well as statutory and
                other policy factors. This rule proposes to update:
                 ++ The IPF PPS Federal per diem base rate from $895.63 to $874.93.
                 ++ The IPF PPS Federal per diem base rate for providers who failed
                to report quality data to $857.89.
                 ++ The ECT payment per treatment from $385.58 to $660.30.
                 ++ The ECT payment per treatment for providers who failed to report
                quality data to $647.45.
                 ++ The labor-related share from 78.7 percent to 78.8 percent.
                 ++ The wage index budget neutrality factor to 0.9998. This proposed
                rule would apply a refinement standardization factor of 0.9514.
                 ++ The fixed dollar loss threshold amount from $33,470 to $35,590,
                to maintain estimated outlier payments at 2 percent of total estimated
                aggregate IPF PPS payments.
                2. Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program
                 For the IPFQR Program, we are proposing to:
                 Adopt the 30-Day Risk-Standardized All-Cause Emergency
                Department (ED) Visit Following an IPF Discharge measure beginning with
                the FY 2027 payment determination; and
                 Modify reporting requirements to require IPFs to submit
                patient-level data on a quarterly basis.
                 We also refer readers to our RFI in which we solicit comments to
                inform elements to be included in the IPF patient assessment
                instrument, which the CAA, 2023 requires the Centers for Medicare &
                Medicaid Services (CMS) to develop and implement for Rate Year (RY)
                2028.
                C. Summary of Impacts
                [GRAPHIC] [TIFF OMITTED] TP03AP24.000
                II. Background
                A. Overview of the Legislative Requirements of the IPF PPS
                 Section 124 of the Medicare, Medicaid, and State Children's Health
                Insurance Program Balanced Budget Refinement Act of 1999 (BBRA) (Pub.
                L. 106-113) required the establishment and implementation of an IPF
                PPS. Specifically, section 124 of the BBRA mandated that the Secretary
                of the Department of Health and Human Services (the Secretary) develop
                a per diem payment perspective system (PPS) for inpatient hospital
                services furnished in psychiatric hospitals and excluded psychiatric
                units including an adequate patient classification system that reflects
                the differences in patient resource use and costs among psychiatric
                hospitals and excluded psychiatric units. ``Excluded psychiatric unit''
                means a psychiatric unit of an acute care hospital or of a Critical
                Access Hospital (CAH), which is excluded from payment under the
                Inpatient Prospective Payment System (IPPS) or CAH payment system,
                respectively. These excluded psychiatric units will be paid under the
                IPF PPS.
                 Section 405(g)(2) of the Medicare Prescription Drug, Improvement,
                and Modernization Act of 2003 (MMA) (Pub. L. 108-173) extended the IPF
                PPS to psychiatric distinct part units of CAHs.
                 Sections 3401(f) and 10322 of the Patient Protection and Affordable
                Care Act (Pub. L. 111-148) as amended by section 10319(e) of that Act
                and by section 1105(d) of the Health Care and Education Reconciliation
                Act of 2010 (Pub. L. 111-152) (hereafter referred to jointly as ``the
                Affordable Care Act'') added subsection (s) to section 1886 of the Act.
                 Section 1886(s)(1) of the Act titled ``Reference to Establishment
                and Implementation of System,'' refers to section 124 of the BBRA,
                which relates to the establishment of the IPF PPS.
                 Section 1886(s)(2)(A)(i) of the Act requires the application of the
                productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of
                the Act to the IPF PPS for the rate year (RY) beginning in 2012 (that
                is, a RY that coincides with a FY) and each subsequent RY.
                 Section 1886(s)(2)(A)(ii) of the Act required the application of an
                ``other adjustment'' that reduced any update to an IPF PPS base rate by
                a percentage point amount specified in section 1886(s)(3) of the Act
                for the RY beginning in 2010 through the RY beginning in 2019. As noted
                in the FY 2020 Inpatient Psychiatric Facilities Prospective Payment
                System and Quality Reporting Updates for fiscal year Beginning October
                1, 2019 final rule, for the RY beginning in 2019,
                [[Page 23148]]
                section 1886(s)(3)(E) of the Act required that the other adjustment
                reduction be equal to 0.75 percentage point; that was the final year
                the statute required the application of this adjustment. Because FY
                2021 was a RY beginning in 2020, FY 2021 was the first year section
                1886(s)(2)(A)(ii) of the Act did not apply since its enactment.
                 Sections 1886(s)(4)(A) through (D) of the Act require that for RY
                2014 and each subsequent RY, IPFs that fail to report required quality
                data with respect to such a RY will have their annual update to a
                standard Federal rate for discharges reduced by 2.0 percentage points.
                This may result in an annual update being less than 0.0 for a RY, and
                may result in payment rates for the upcoming RY being less than such
                payment rates for the preceding RY. Any reduction for failure to report
                required quality data will apply only to the RY involved, and the
                Secretary will not consider such reduction in computing the payment
                amount for a subsequent RY. Additional information about the specifics
                of the current IPFQR Program is available in the FY 2020 Inpatient
                Psychiatric Facilities Prospective Payment System and Quality Reporting
                Updates for fiscal year Beginning October 1, 2019 (FY 2020) final rule
                (84 FR 38459 through 38468).
                 Section 4125 of the Consolidated Appropriations Act, 2023 (CAA,
                2023) (Pub. L. 117-328), which amended section 1886(s) of the Act,
                requires CMS to revise the Medicare prospective payment system for
                psychiatric hospitals and psychiatric units. Specifically, section
                4125(a) of the CAA, 2023 added section 1886(s)(5)(A) of the Act to
                require the Secretary to collect data and information, as the Secretary
                determines appropriate, to revise payments under the IPF PPS. CMS
                discussed this data collection last year in the FY 2024 IPF PPS final
                rule, as CMS was required to begin collecting this data and information
                not later than October 1, 2024. As discussed in that rule, the Agency
                has already been collecting data and information consistent with the
                types set forth in the CAA, 2023 as part of our extensive and years-
                long analyses and consideration of potential payment system
                refinements. We refer readers to the FY 2024 Inpatient Psychiatric
                Facilities Prospective Payment System--Rate Update (FY 2024 IPF PPS)
                final rule (88 FR 51095 through 51098) where we discussed existing data
                collection and requested information to inform future IPF PPS
                revisions.
                 In addition, section 1886(s)(5)(D) of the Act, as added by section
                4125(a) of the CAA, 2023 requires that the Secretary implement
                revisions to the methodology for determining the payment rates under
                the IPF PPS for psychiatric hospitals and psychiatric units, effective
                for RY 2025 (FY 2025). The revisions may be based on a review of the
                data and information collected under section 1886(s)(5)(A) of the Act.
                As discussed in section III.C of this FY 2025 IPF PPS proposed rule, we
                are proposing revisions to the IPF PPS patient-level adjustment factors
                based on a review of cost and claims data.
                 Section 4125(b) of the CAA, 2023 amended section 1886(s)(4) of the
                Act by inserting a new subparagraph (E), which requires IPFs
                participating in the IPFQR Program to collect and submit to the
                Secretary standardized patient assessment data, using a standardized
                patient assessment instrument, for RY 2028 (FY 2028) and each
                subsequent rate year. IPFs must submit such data with respect to at
                least the admission and discharge of an individual, or more frequently
                as the Secretary determines appropriate. For IPFs to meet this new data
                collection and reporting requirement for RY 2028 and each subsequent
                rate year, the Secretary must implement a standardized patient
                assessment instrument that collects data with respect to the following
                categories: functional status; cognitive function and mental status;
                special services, treatments, and interventions; medical conditions and
                comorbidities; impairments; and other categories as determined
                appropriate by the Secretary. This patient assessment instrument must
                enable comparison of such patient assessment data that IPFs submit
                across all such IPFs to which such data are applicable.
                 Section 4125(b) of the CAA, 2023 further amended section 1886(s) of
                the Act by adding a new subparagraph (6) that requires the Secretary to
                implement revisions to the methodology for determining the payment
                rates for psychiatric hospitals and psychiatric units (that is, payment
                rates under the IPF PPS), effective for RY 2031 (FY 2031), as the
                Secretary determines to be appropriate, to take into account the
                patient assessment data described in paragraph (4)(E)(ii).
                 To implement and periodically update the IPF PPS, we have published
                various proposed and final rules and notices in the Federal Register.
                For more information regarding these documents, we refer readers to the
                CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/index.html?redirect=/
                InpatientPsychFacilPPS/.
                B. Overview of the IPF PPS
                 On November 15, 2004, we published the RY 2005 IPF PPS final rule
                in the Federal Register (69 FR 66922). The RY 2005 IPF PPS final rule
                established the IPF PPS, as required by section 124 of the BBRA and
                codified at 42 CFR part 412, subpart N. The RY 2005 IPF PPS final rule
                set forth the Federal per diem base rate for the implementation year
                (the 18-month period from January 1, 2005 through June 30, 2006) and
                provided payment for the inpatient operating and capital costs to IPFs
                for covered psychiatric services they furnish (that is, routine,
                ancillary, and capital costs, but not costs of approved educational
                activities, bad debts, and other services or items that are outside the
                scope of the IPF PPS). Covered psychiatric services include services
                for which benefits are provided under the fee-for-service Part A
                (Hospital Insurance Program) of the Medicare program.
                 The IPF PPS established the Federal per diem base rate for each
                patient day in an IPF derived from the national average daily routine
                operating, ancillary, and capital costs in IPFs in FY 2002. The average
                per diem cost was updated to the midpoint of the first year under the
                IPF PPS, standardized to account for the overall positive effects of
                the IPF PPS payment adjustments, and adjusted for budget neutrality.
                 The Federal per diem payment under the IPF PPS is comprised of the
                Federal per diem base rate described previously and certain patient-
                and facility-level payment adjustments for characteristics that were
                found in the regression analysis to be associated with statistically
                significant per diem cost differences, with statistical significance
                defined as p less than 0.05. A complete discussion of the regression
                analysis that established the IPF PPS adjustment factors can be found
                in the RY 2005 IPF PPS final rule (69 FR 66933 through 66936).
                 The patient-level adjustments include age, Diagnosis-Related Group
                (DRG) assignment, and comorbidities, as well as adjustments to reflect
                higher per diem costs at the beginning of a patient's IPF stay and
                lower costs for later days of the stay. Facility-level adjustments
                include adjustments for the IPF's wage index, rural location, teaching
                status, a cost-of-living adjustment for IPFs located in Alaska and
                Hawaii, and an adjustment for the presence of a qualifying emergency
                department (ED).
                 The IPF PPS provides additional payment policies for outlier cases,
                interrupted stays, and a per treatment
                [[Page 23149]]
                payment for patients who undergo ECT. During the IPF PPS mandatory 3-
                year transition period, stop-loss payments were also provided; however,
                since the transition ended as of January 1, 2008, these payments are no
                longer available.
                C. Annual Requirements for Updating the IPF PPS
                 Section 124 of the BBRA did not specify an annual rate update
                strategy for the IPF PPS and was broadly written to give the Secretary
                discretion in establishing an update methodology. Therefore, in the RY
                2005 IPF PPS final rule, we implemented the IPF PPS using the following
                update strategy:
                 Calculate the final Federal per diem base rate to be
                budget neutral for the 18- month period of January 1, 2005 through June
                30, 2006.
                 Use a July 1 through June 30 annual update cycle.
                 Allow the IPF PPS first update to be effective for
                discharges on or after July 1, 2006 through June 30, 2007.
                 The RY 2005 final rule (69 FR 66922) implemented the IPF PPS. In
                developing the IPF PPS, and to ensure that the IPF PPS can account
                adequately for each IPF's case-mix, we performed an extensive
                regression analysis of the relationship between the per diem costs and
                certain patient and facility characteristics to determine those
                characteristics associated with statistically significant cost
                differences on a per diem basis. That regression analysis is described
                in detail in our RY 2004 IPF proposed rule (68 FR 66923; 66928 through
                66933) and our RY 2005 IPF final rule (69 FR 66933 through 66960). For
                characteristics with statistically significant cost differences, we
                used the regression coefficients of those variables to determine the
                size of the corresponding payment adjustments.
                 In the RY 2005 IPF final rule, we explained the reasons for
                delaying an update to the adjustment factors, derived from the
                regression analysis, including waiting until we have IPF PPS data that
                yields as much information as possible regarding the patient-level
                characteristics of the population that each IPF serves. We indicated
                that we did not intend to update the regression analysis and the
                patient-level and facility-level adjustments until we complete that
                analysis. Until that analysis is complete, we stated our intention to
                publish a notice in the Federal Register each spring to update the IPF
                PPS (69 FR 66966).
                 On May 6, 2011, we published a final rule in the Federal Register
                titled, ``Inpatient Psychiatric Facilities Prospective Payment System--
                Update for Rate Year Beginning July 1, 2011 (RY 2012)'' (76 FR 26432),
                which changed the payment rate update period to a RY that coincides
                with a FY update. Therefore, final rules are now published in the
                Federal Register in the summer to be effective on October 1st. When
                proposing changes in IPF payment policy, a proposed rule is issued in
                the spring, and the final rule in the summer to be effective on October
                1st. For a detailed list of updates to the IPF PPS, we refer readers to
                our regulations at 42 CFR 412.428. Beginning October 1, 2012, we
                finalized that we would refer to the 12-month period from October 1
                through September 30 as a ``fiscal year'' (FY) rather than a RY (76 FR
                26435). Therefore, in this final rule we refer to rules that took
                effect after RY 2012 by the FY, rather than the RY, in which they took
                effect.
                 The most recent IPF PPS annual update was published in a final rule
                on August 2, 2023 in the Federal Register titled, ``Medicare Program;
                FY 2024 Inpatient Psychiatric Facilities Prospective Payment System--
                Rate Update'' (88 FR 51054), which updated the IPF PPS payment rates
                for FY 2024. That final rule updated the IPF PPS Federal per diem base
                rates that were published in the FY 2023 IPF PPS Rate Update final rule
                (87 FR 46846) in accordance with our established policies.
                III. Provisions of the Proposed Regulations
                A. Proposed FY 2025 Market Basket Update and Productivity Adjustment
                for the IPF PPS
                1. Background
                 Originally, the input price index used to develop the IPF PPS was
                the Excluded Hospital with Capital market basket. This market basket
                was based on 1997 Medicare cost reports for Medicare-participating
                inpatient rehabilitation facilities (IRFs), IPFs, long-term care
                hospitals (LTCHs), cancer hospitals, and children's hospitals. Although
                ``market basket'' technically describes the mix of goods and services
                used in providing health care at a given point in time, this term is
                also commonly used to denote the input price index (that is, cost
                category weights and price proxies) derived from that market basket.
                Accordingly, the term ``market basket,'' as used in this document,
                refers to an input price index.
                 Since the IPF PPS inception, the market basket used to update IPF
                PPS payments has been rebased and revised to reflect more recent data
                on IPF cost structures. We last rebased and revised the IPF market
                basket in the FY 2024 IPF PPS rule, where we adopted a 2021-based IPF
                market basket, using Medicare cost report data for both Medicare
                participating freestanding psychiatric hospitals and psychiatric units.
                We refer readers to the FY 2024 IPF PPS final rule for a detailed
                discussion of the 2021-based IPF PPS market basket and its development
                (88 FR 51057 through 51081). References to the historical market
                baskets used to update IPF PPS payments are listed in the FY 2016 IPF
                PPS final rule (80 FR 46656).
                2. Proposed FY 2025 IPF Market Basket Update
                 For FY 2025 (beginning October 1, 2024 and ending September 30,
                2025), we are proposing to update the IPF PPS payments by a market
                basket increase factor with a productivity adjustment as required by
                section 1886(s)(2)(A)(i) of the Act. Consistent with historical
                practice, we are proposing to estimate the market basket update for the
                IPF PPS based on the most recent forecast available at the time of
                rulemaking from IHS Global Inc. (IGI). IGI is a nationally recognized
                economic and financial forecasting firm with which CMS contracts to
                forecast the components of the market baskets and productivity
                adjustment. For the proposed rule, based on IGI's fourth quarter 2023
                forecast with historical data through the third quarter of 2023, the
                2021-based IPF market basket increase factor for FY 2025 is 3.1
                percent.
                 Section 1886(s)(2)(A)(i) 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 (MFP) (as projected by the Secretary for the 10-year
                period ending with the applicable FY, year, cost reporting period, or
                other annual period) (the ``productivity adjustment''). The United
                States Department of Labor's Bureau of Labor Statistics (BLS) publishes
                the official measures of productivity for the United States economy. We
                note that previously the productivity measure referenced in section
                1886(b)(3)(B)(xi)(II) of the Act was published by BLS as private
                nonfarm business MFP. Beginning with the November 18, 2021 release of
                productivity data, BLS replaced the
                [[Page 23150]]
                term ``multifactor productivity'' 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 the BLS name change, the
                productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the
                Act is now published by BLS as private nonfarm business TFP. However,
                as mentioned previously, the data and methods are unchanged. We refer
                readers to 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 IPF final rule
                (86 FR 42611), 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.
                 Section 1886(s)(2)(A)(i) of the Act requires the application of the
                productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of
                the Act to the IPF PPS for the RY beginning in 2012 (a RY that
                coincides with a FY) and each subsequent RY. For this proposed rule,
                based on IGI's fourth quarter 2023 forecast, the proposed productivity
                adjustment for FY 2025 (the 10-year moving average of TFP for the
                period ending FY 2025) is projected to be 0.4 percent. Accordingly, we
                are proposing to reduce the 3.1 percent IPF market basket increase by
                this 0.4 percentage point productivity adjustment, as mandated by the
                Act. This results in a proposed FY 2025 IPF PPS payment rate update of
                2.7 percent (3.1-0.4 = 2.7). We are also proposing that if more recent
                data become available, we would use such data, if appropriate, to
                determine the FY 2025 IPF market basket increase and productivity
                adjustment for the final rule.
                 We solicit comment on the proposed IPF market basket increase and
                productivity adjustment for FY 2025.
                3. Proposed FY 2025 IPF Labor-Related Share
                 Due to variations in geographic wage levels and other labor-related
                costs, we believe that payment rates under the IPF PPS should continue
                to be adjusted by a geographic wage index, which would apply to the
                labor-related portion of the Federal per diem base rate (hereafter
                referred to as the labor-related share). 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 IPF market basket, we are proposing to
                continue to include in the labor-related share the sum of the 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 IPF market basket. For more details
                regarding the methodology for determining specific cost categories for
                inclusion in the labor-related share based on the 2021-based IPF market
                basket, we refer readers to the FY 2024 IPF PPS final rule (88 FR 51078
                through 51081).
                 The relative importance reflects the different rates of price
                change for these cost categories between the base year (FY 2021) and FY
                2025. Based on IGI's fourth quarter 2023 forecast of the 2021-based IPF
                market basket, the sum of the FY 2025 relative importance moving
                average 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 is 75.7 percent. We are proposing, consistent with
                prior rulemaking, 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 6.8 percent of the 2021-based
                IPF market basket for FY 2025, we are proposing to take 46 percent of
                6.8 percent to determine a labor-related share of Capital-Related costs
                for FY 2025 of 3.1 percent. Therefore, we are proposing a total labor-
                related share for FY 2025 of 78.8 percent (the sum of 75.7 percent for
                the labor-related share of operating costs and 3.1 percent for the
                labor-related share of Capital-Related costs). We are also proposing
                that if more recent data become available, we would use such data, if
                appropriate, to determine the FY 2025 labor-related share for the final
                rule. For more information on the labor-related share and its
                calculation, we refer readers to the FY 2024 IPF PPS final rule (88 FR
                51078 through 51081).
                 Table 1 shows the proposed FY 2025 labor-related share and the
                final FY 2024 labor-related share using the 2021- based IPF market
                basket relative importance.
                [[Page 23151]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.001
                 We solicit comment on the proposed labor-related share for FY 2025.
                B. Proposed Revisions to the IPF PPS Rates for FY Beginning October 1,
                2024
                 The IPF PPS is based on a standardized Federal per diem base rate
                calculated from the IPF average per diem costs and adjusted for budget
                neutrality in the implementation year. The Federal per diem base rate
                is used as the standard payment per day under the IPF PPS and is
                adjusted by the patient-level and facility-level adjustments that are
                applicable to the IPF stay. A detailed explanation of how we calculated
                the average per diem cost appears in the RY 2005 IPF PPS final rule (69
                FR 66926).
                1. Determining the Standardized Budget Neutral Federal per Diem Base
                Rate
                 Section 124(a)(1) of the BBRA required that we implement the IPF
                PPS in a budget neutral manner. In other words, the amount of total
                payments under the IPF PPS, including any payment adjustments, must be
                projected to be equal to the amount of total payments that would have
                been made if the IPF PPS were not implemented. Therefore, we calculated
                the budget neutrality factor by setting the total estimated IPF PPS
                payments to be equal to the total estimated payments that would have
                been made under the Tax Equity and Fiscal Responsibility Act of 1982
                (TEFRA) (Pub. L. 97-248) methodology had the IPF PPS not been
                implemented. A step-by-step description of the methodology used to
                estimate payments under the TEFRA payment system appears in the RY 2005
                IPF PPS final rule (69 FR 66926).
                 Under the IPF PPS methodology, we calculated the final Federal per
                diem base rate to be budget neutral during the IPF PPS implementation
                period (that is, the 18-month period from January 1, 2005 through June
                30, 2006) using a July 1 update cycle. We updated the average cost per
                day to the midpoint of the IPF PPS implementation period (October 1,
                2005), and this amount was used in the payment model to establish the
                budget neutrality adjustment.
                 Next, we standardized the IPF PPS Federal per diem base rate to
                account for the overall positive effects of the IPF PPS payment
                adjustment factors by dividing total estimated payments under the TEFRA
                payment system by estimated payments under the IPF PPS. The information
                concerning this standardization can be found in the RY 2005 IPF PPS
                final rule (69 FR 66932) and the RY 2006 IPF PPS final rule (71 FR
                27045). We then reduced the standardized Federal per diem base rate to
                account for the outlier policy, the stop loss provision, and
                anticipated behavioral changes. A complete discussion of how we
                calculated each component of the budget neutrality adjustment appears
                in the RY 2005 IPF PPS final rule (69 FR 66932 through 66933) and in
                the RY 2007 IPF PPS final rule (71 FR 27044 through 27046). The final
                standardized budget neutral Federal per diem base rate established for
                cost reporting periods beginning on or after January 1, 2005 was
                calculated to be $575.95.
                 The Federal per diem base rate has been updated in accordance with
                applicable statutory requirements and 42 CFR 412.428 through
                publication of annual notices or proposed and final rules. A detailed
                discussion on the standardized budget neutral Federal per diem base
                rate and the ECT payment per treatment appears in the FY 2014 IPF PPS
                update notice (78 FR 46738 through 46740). These documents are
                available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/index.html.
                 As discussed in section III.B.2 of this proposed rule, we are
                proposing to revise the patient-level adjustment factors and increase
                the ECT payment amount for FY 2025. Section 1866(s)(5)(D)(iii) of the
                Act, as added by section 4125(a) of the CAA, 2023, requires that
                revisions to the IPF PPS adjustment factors must be made budget-
                neutrally. Therefore, as discussed in section III.F of this proposed
                rule, we are proposing to apply a standardization factor to the FY 2025
                base rate that takes these refinements into account to keep total IPF
                PPS payments budget neutral.
                2. Proposed Increase in the Electroconvulsive Therapy (ECT) Payment per
                Treatment
                a. Background
                 In the RY 2005 IPF PPS final rule (69 FR 66951), we analyzed the
                costs of IPF stays that included ECT treatment using the FY 2002 MedPAR
                data. based on comments we received on the RY 2005
                [[Page 23152]]
                IPF PPS proposed rule. Consistent with the comments we received about
                ECT, our analysis and review indicated that cases with ECT treatment
                are substantially more costly than cases without ECT treatment. Based
                on this analysis, in that final rule we finalized an additional payment
                for each ECT treatment furnished during the IPF stay. This ECT payment
                per treatment is made in addition to the per diem and outlier payments
                under the IPF PPS. To receive the payment per ECT treatment, IPFs must
                indicate on their claims the revenue code and procedure code for ECT
                (Rev Code 901; procedure code 90870) and the number of units of ECT,
                that is, the number of ECT treatments the patient received during the
                IPF stay.
                 To establish the ECT per treatment payment, we used the pre-scaled
                and pre-adjusted median cost for procedure code 90870 developed for the
                Hospital Outpatient Prospective Payment System (OPPS), based on
                hospital claims data. We explained in the RY 2005 IPF PPS final rule
                that we used OPPS data because after a careful review and analysis of
                IPF claims, we were unable to separate out the cost of a single ECT
                treatment (69 FR 66922). We used the unadjusted hospital claims data
                under the OPPS because we did not want the ECT payment under the IPF
                PPS to be affected by factors that are relevant to OPPS, but not
                specifically applicable to IPFs. The median cost was then standardized
                and adjusted for budget neutrality. We also adjusted the ECT rate for
                wage differences in the same manner that we adjust the per diem rate.
                 Since the ECT payment rate was established in the RY 2005 IPF PPS
                rule, it has been updated annually by application of each year's market
                basket, productivity adjustment, and wage index budget neutrality
                factor to the previous year's ECT payment rate (referred to as our
                ``standard methodology'' in this section). While the ECT payment rate
                has been updated each year by these factors, we have not recalculated
                the ECT payment per treatment based on more recent cost data since the
                establishment of the IPF PPS.
                b. Proposed Increase to the Electroconvulsive Therapy Payment per
                Treatment
                 For this FY 2025 IPF PPS proposed rule, we analyzed data in both
                the IPF PPS and the OPPS. In the IPF PPS setting, our analysis of
                recent IPF PPS data indicates that IPF costs have increased for stays
                that include ECT treatments. As discussed in the next paragraph, our
                analysis of these costs leads us to consider whether the current
                payment per treatment for ECT is aligned with the additional costs
                associated with stays that include ECT treatments. We began by
                analyzing IPF stays with ECT treatment using the CY 2022 Medicare
                Provider and Analysis Review (MedPAR) data. IPF stays with ECT
                treatment comprised about 1.7 percent of all stays, which is a decrease
                from the FY 2002 MedPAR data discussed in the RY 2005 IPF PPS final
                rule, where stays with ECT treatment were 6.0 percent of all IPF stays.
                A total of 288 IPF facilities had stays with ECT treatment in 2022,
                with an average 6.7 units of ECT per stay. We compared the total cost
                for stays with and without ECT treatment, and found that IPF stays with
                ECT treatment were approximately three times more costly than IPF stays
                without ECT treatment ($44,687.50 per stay vs. $15,432.30 per stay).
                Most of the variance in cost was due to differences in the IPF length
                of stay (LOS) (28.00 days for stays with ECT treatment vs. 13.43 days
                for stays without ECT treatment). We note that the IPF PPS makes
                additional per diem payments for longer lengths of stay, which makes
                the total payment larger for a longer stay. However, we also observed
                that there are differences in the per-day cost for stays with and
                without ECT. We calculated the average cost per day for stays with and
                without ECT treatment and found that stays with ECT treatment have an
                average cost per day of $1,595.76, while stays without ECT treatment
                have an average cost per day of $1,149.51.
                 Furthermore, as we discuss in section III.C.3.d.(2) of this
                proposed rule, our latest regression analysis includes a control
                variable to account for the presence of ECT during an IPF stay. That
                control variable indicates that, holding all other patient-level and
                facility-level factors constant, there is a statistically significant
                increase in cost per day for IPF stays that include ECT, further
                demonstrating that resource use is higher for IPF stays with ECT than
                those without ECT. As we previously noted in the RY 2005 IPF PPS final
                rule (69 FR 66922), IPF claims and cost data are not sufficiently
                granular to identify the per-treatment cost of ECT. Therefore, we
                examined the difference in ancillary costs for IPF stays with and
                without ECT treatment. In the CY 2022 MedPAR data, the ancillary costs
                per IPF stay with ECT treatment were $7,116.85 higher than ancillary
                costs per IPF stay without ECT treatment. The ancillary costs were
                calculated as follows: for each ancillary department (for example,
                drugs or labs), the charges were multiplied by the department-level
                CCR, and those department-level costs were summed across departments
                for each stay. The average ancillary costs per stay were calculated
                accordingly for stays with and without ECT treatment, revealing that
                average ancillary costs per day are three times higher for stays with
                ECT treatment: $99.36 for stays without ECT treatment versus $301.77
                for stays with ECT treatment. Accounting for differences in length of
                stay between stays with and without ECT, the average additional
                ancillary cost per ECT unit was approximately $849.72.
                 Application of our standard methodology for updating the ECT
                payment would result in an FY 2025 payment of $377.54 per ECT treatment
                (based on the FY 2024 ECT payment amount of $385.58, increased by the
                market basket update of 2.7 percent and reduced by the FY 2025 wage
                index budget neutrality factor of 0.9998 and a refinement
                standardization factor of 0.9536, which is the standardization factor
                that would account for all other proposed refinements without
                increasing the ECT per treatment). As we noted above, this ECT payment
                would be added to the per diem and any applicable outlier payments for
                the entire stay. CMS considered this rate in proposing to adjust the
                ECT per treatment rate. However, the analysis of ancillary costs for
                IPF stays with ECT treatment suggested that a further increase to the
                current ECT payment amount per treatment could better align IPF PPS
                payments with the increased costs of furnishing ECT. The ancillary cost
                data show that costs for furnishing ECT have risen by a factor greater
                than the standard methodology for updating the rate would adjust for.
                 It continues to be the case that, as we discussed in the RY 2005
                IPF PPS final rule, current IPF cost and claims data are not
                sufficiently granular to identify the per-treatment cost of ECT. We
                believe that using the costs in the OPPS setting are the most accurate
                for purposes of updating the ECT per treatment rate because we believe
                this treatment requires comparable resources when performed in
                outpatient and inpatient settings. Thus, we analyzed the most recent
                OPPS cost information to consider changes to the ECT payment per
                treatment for FY 2025.
                 The original methodology for determining the ECT payment per
                treatment was based on the median cost for procedure code 90870
                developed for the OPPS, as discussed in the RY 2005 IPF PPS final rule
                (69 FR 66951). Since that time, the OPPS has adopted certain changes to
                its methodology for calculating costs. In the CY 2013 OPPS/ASC final
                rule with comment period (77
                [[Page 23153]]
                FR 68259 through 68270), CMS finalized a methodology for developing the
                relative payment weights for Ambulatory Payment Classifications using
                geometric mean costs instead of median costs. We explained that
                geometric means better capture the range of costs associated with
                providing services, including those cases where very efficient
                hospitals have provided services at much lower costs. While medians and
                geometric means both capture the impact of uniform changes, that is,
                those changes that influence all providers, only geometric means
                capture cost changes that are introduced slowly into the system on a
                case-by-case or hospital-by-hospital basis, allowing us to detect
                changes in the cost of services earlier.
                 We believe the rationale for using geometric mean cost in the OPPS
                setting as the underpinning methodology for establishing payments
                applies equally to the costs of providing ECT on a per treatment basis
                under the IPF PPS. Therefore, in considering changes for the IPF PPS
                ECT payment per treatment for FY 2025, we compared the costs observed
                in the IPF setting to the geometric mean cost for an ECT treatment
                posted as part of the CY 2024 OPPS/ASC update, which is based on CY
                2022 outpatient hospital claims. Although we are proposing to increase
                the ECT payment with reference to the CY 2024 OPPS ECT geometric mean
                cost for FY 2025, we are not proposing to adopt the OPPS rate (which is
                distinct from the geometric mean cost) for the ECT payment per
                treatment for FY 2025 because the final OPPS rates include policy
                decisions and payment rate updates that are specific to the OPPS. We
                intend to continue to monitor the costs associated with ECT treatment
                and may propose adjustments in the future as needed.
                 The pre-scaled and pre-adjusted CY 2024 OPPS geometric mean cost
                for ECT is $675.93. Comparatively, the FY 2024 IPF ECT payment rate was
                $385.58 (88 FR 51054). As discussed in the prior paragraphs, our
                analysis of updated ancillary cost data indicates that the IPF PPS ECT
                payment rate per treatment, when updated according to the standard
                methodology alone, has not kept pace with the cost of furnishing the
                treatment in the IPF setting. As we stated previously, we believe this
                treatment requires comparable resources when performed in outpatient
                and inpatient settings. Therefore, we are proposing to use the pre-
                scaled and pre-adjusted CY 2024 OPPS geometric mean cost of $675.93 as
                the basis for the IPF PPS ECT payment per treatment in FY 2025, as
                discussed below. We are proposing to update $675.93 by the FY 2025 IPF
                PPS payment rate update of 2.7 percent (3.1 percent IPF market basket
                increase, reduced by the 0.4 percentage point productivity adjustment),
                and the wage index budget neutrality factor of 0.9998 for FY 2025, in
                alignment with our current standard methodology.
                 To account for budget neutrality, as discussed in section III.F of
                this proposed rule, we are proposing to apply a refinement
                standardization factor to the FY 2025 IPF PPS Federal per diem base
                rate and to the ECT payment amount per treatment to account for this
                proposed change to the ECT payment amount per treatment and all
                proposed changes to the patient-level adjustment factors and to the ED
                adjustment factor for FY 2025. We note that this proposed increase to
                the ECT per treatment amount would be associated with a minor decrease
                to the IPF Federal per diem base rate as a result of the refinement
                standardization factor (0.9514 instead of 0.9536). We estimate that
                this change would increase payments for IPFs that provide ECT, and
                would decrease payments for IPFs that do not provide ECT. However, the
                decrease in payments associated with this change would be no more than
                approximately 0.2 percent, which would be offset by various other
                proposed changes such as the proposed wage index changes, proposed
                revisions to the IPF PPS patient-level adjustments, and the proposed
                market basket increase for FY 2025.
                 We note that we have monitored the provision of ECT through
                analysis of claims data since the beginning of the IPF PPS, and have
                not observed any indicators that payment is inappropriately
                incentivizing the provision of ECT to IPF patients. We intend to
                continue monitoring the provision of ECT through further analysis of
                IPF PPS claims data.
                 A detailed discussion of the distributional impacts of this
                proposed change is found in section VIII.C of this proposed rule. We
                welcome comments regarding our analysis, including any comments that
                could inform our understanding of where ECT costs are allocated in cost
                reports in order to potentially inform improved collection of data on
                ECT treatment costs in the IPF setting. We also welcome comments on
                whether it may be appropriate to collect additional ECT-specific costs
                on the hospital cost report. Lastly, we are proposing that if more
                recent data become available, we would use such data, if appropriate,
                to determine the FY 2025 Federal per diem base rate and ECT payment per
                treatment for the FY 2025 IPF PPS final rule.
                 IPFs must include a valid procedure code for ECT services provided
                to IPF beneficiaries to bill for ECT services, as described in our
                Medicare Claims Processing Manual, Chapter 3, Section 190.7.3
                (available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c03.pdf). There were no changes to the ECT
                procedure codes used on IPF claims in the final update to the ICD-10-
                PCS code set for FY 2024. Addendum B to this proposed rule shows the
                ECT procedure codes for FY 2025 and is available on the CMS website at
                https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/tools.html.
                3. Proposed Update of the Federal per Diem Base Rate and
                Electroconvulsive Therapy Payment per Treatment
                 The current (FY 2024) Federal per diem base rate is $895.63 and the
                ECT payment per treatment is $385.58. For the proposed FY 2025 Federal
                per diem base rate, we applied the payment rate update of 2.7
                percent,--that is, the proposed 2021-based IPF market basket increase
                for FY 2025 of 3.1 percent reduced by the proposed productivity
                adjustment of 0.4 percentage point--the proposed wage index budget
                neutrality factor of 0.9998 (as discussed in section III.D.1 of this
                proposed rule), and a proposed refinement standardization factor of
                0.9514 (as discussed in section III.F of this proposed rule) to the FY
                2024 Federal per diem base rate of $895.63, yielding a proposed Federal
                per diem base rate of $874.93 for FY 2025. As discussed in section
                III.B.2 of this proposed rule, we are proposing to increase the ECT
                payment per treatment for FY 2025 in addition to our routine updates to
                the rate. We applied the proposed 2.7 percent payment rate update, the
                proposed 0.9998 wage index budget neutrality factor, and the proposed
                0.9514 refinement standardization factor to the proposed payment per
                treatment based on the CY 2024 OPPS geometric mean cost of $675.93,
                yielding a proposed ECT payment per treatment of $660.30 for FY 2025.
                 Section 1886(s)(4)(A)(i) of the Act requires that for RY 2014 and
                each subsequent RY, in the case of an IPF that fails to report required
                quality data with respect to such RY, the Secretary will reduce any
                annual update to a standard Federal rate for discharges during the RY
                by 2.0 percentage points. Therefore, we are applying a 2.0 percentage
                point reduction to the annual update to the Federal per diem
                [[Page 23154]]
                base rate and the proposed ECT payment per treatment as follows:
                 For IPFs that fail to report required data under the IPFQR
                Program, we would apply a 0.7 percent payment rate update--that is, the
                proposed IPF market basket increase for FY 2025 of 3.1 percent reduced
                by the proposed productivity adjustment of 0.4 percentage point for an
                update of 2.7 percent, and further reduced by 2.0 percentage points in
                accordance with section 1886(s)(4)(A)(i) of the Act. We would also
                apply the proposed refinement standardization factor of 0.9514 and the
                proposed wage index budget neutrality factor of 0.9998 to the FY 2024
                Federal per diem base rate of $895.63, yielding a proposed Federal per
                diem base rate of $857.89 for FY 2025.
                 For IPFs that fail to report required data under the IPFQR
                Program, we would apply the proposed 0.7 percent annual payment rate
                update, the proposed 0.9514 refinement standardization factor, and the
                proposed 0.9998 wage index budget neutrality factor to the proposed
                payment per treatment based on the CY 2024 OPPS geometric mean cost of
                $675.93, yielding a proposed ECT payment per treatment of $647.45 for
                FY 2025.
                 We are proposing that if more recent data become available, we
                would use such data, if appropriate, to determine the FY 2025 Federal
                per diem base rate and ECT payment per treatment for the FY 2025 IPF
                final rule.
                C. Proposed Updates and Revisions to the IPF PPS Patient-Level
                Adjustment Factors
                1. Overview of the IPF PPS Adjustment Factors and Proposed Revisions
                 The current (FY 2024) IPF PPS payment adjustment factors were
                derived from a regression analysis of 100 percent of the FY 2002
                Medicare Provider and Analysis Review (MedPAR) data file, which
                contained 483,038 cases. For a more detailed description of the data
                file used for the regression analysis, we refer readers to the RY 2005
                IPF PPS final rule (69 FR 66935 through 66936).
                 For FY 2025, we are proposing to implement revisions to the
                methodology for determining payment rates under the IPF PPS. As we
                noted earlier in this FY 2025 IPF PPS proposed rule, section
                1886(s)(5)(D) of the Act, as added by section 4125(a) of the CAA, 2023
                requires that the Secretary implement revisions to the methodology for
                determining the payment rates under the IPF PPS for psychiatric
                hospitals and psychiatric units, effective for RY 2025 (FY 2025). The
                revisions may be based on a review of the data and information
                collected under section 1886(s)(5)(A) of the Act. Accordingly, we are
                proposing to revise the patient-level IPF PPS payment adjustment
                factors as discussed in section III.C.4. of this proposed rule,
                effective for FY 2025. We have developed proposed adjustment factors
                based on a regression analysis of IPF cost and claims data, which is
                discussed in greater detail in the following sections of this proposed
                rule. The primary sources of this analysis are CY 2019 through 2021
                MedPAR files and Medicare cost report data (CMS Form 2552-10, OMB No.
                0938-0050) \1\ from the FY 2019 through 2021 Hospital Cost Report
                Information System (HCRIS). For each year (2019 through 2021), if a
                provider did not have a Medicare cost report for that year, we used the
                provider's most recent available Medicare cost report prior to the year
                for which a Medicare cost report was missing, going back to as early as
                2018. Section III.C.3 of this proposed rule discusses the development
                of the proposed revised case-mix adjustment regression.
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                 \1\ https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202206-0938-017.
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                2. History of IPF PPS Cost and Claims Analyses
                 In the FY 2023 IPF PPS proposed rule (87 FR 19428 through 19429),
                we briefly discussed past analyses and areas of interest for future
                refinement, about which we previously solicited comments. CMS also
                released a technical report posted to the CMS website \2\ accompanying
                the rule, summarizing these analyses. In that same proposed rule, we
                described the results of the agency's latest analysis of the IPF PPS
                and solicited comments on certain topics from the report. We summarized
                the considerations and findings related to our analyses of the IPF PPS
                adjustment factors in the FY 2023 IPF PPS final rule (46864 through
                46865).
                ---------------------------------------------------------------------------
                 \2\ https://www.cms.gov/files/document/technical-report-medicare-program-inpatient-psychiatric-facilities-prospective-payment-system.pdf.
                ---------------------------------------------------------------------------
                 In the FY 2024 IPF PPS proposed rule (88 FR 21269 through 21272),
                we requested information from the public to inform revisions to the IPF
                PPS required by the CAA, 2023. Specifically, we sought information
                about which data and information would be most appropriate and useful
                for the purposes of refining IPF PPS payments. We requested information
                related to the specific types of data and information mentioned in the
                CAA, 2023. We also solicited comments on the reporting of ancillary
                charges, such as labs and drugs, on IPF claims. Lastly, we presented
                and solicited comments on the latest results of our analysis of social
                drivers of health (SDOH).
                 In response to the requests for information, commenters offered a
                number of suggestions for further analysis, including recommendations
                to consider adjusting payment for patients with sleep apnea, violent
                behavior, and patients that transfer from an acute care unit. We
                discuss the analysis conducted and our findings, as related to patient-
                level adjustment factors, in section III.C.3 of this proposed rule.
                 The primary goal in refining the IPF PPS payment adjustment factors
                is to pay each IPF an appropriate amount for the efficient delivery of
                care to Medicare beneficiaries. The system must be able to account
                adequately for each IPF's case-mix to allow for both fair distribution
                of Medicare payments and access to adequate care for those
                beneficiaries who require more costly care. As required by section
                1886(s)(5)(D)(iii) of the Act, as added by section 4125(a) of the CAA,
                2023, proposed revisions to the IPF PPS adjustment factors must be
                budget neutral. As discussed in section III.F of this proposed rule, we
                are applying a refinement standardization factor to the proposed IPF
                PPS payment rates to maintain budget neutrality for FY 2025.
                3. Development of the Proposed Revised Case-Mix Adjustment Regression
                 To ensure that the IPF PPS continues to account adequately for each
                IPF's case-mix, we performed an extensive regression analysis of the
                relationship between the per diem costs and both patient and facility
                characteristics to identify those characteristics associated with
                statistically significant cost differences. We discuss the results of
                this regression analysis in section III.C.3.e. of this proposed rule.
                We further discuss proposed revisions to the IPF PPS patient-level
                adjustment factors based on this regression analysis in section III.C.4
                of this proposed rule.
                 As discussed in greater detail in section III.C.3.c. of this
                proposed rule, we computed a per diem cost for each Medicare inpatient
                psychiatric stay, including routine operating, ancillary, and capital
                components using information from the CY 2019 through CY 2021 MedPAR
                files and data from the 2019 through 2021 Medicare cost reports,
                backfilling with Medicare cost reports from the most recent prior year
                when necessary.
                 We began with a 100 percent sample of the CY 2019 through CY 2021
                MedPAR data files, which contain a
                [[Page 23155]]
                total of 1,111,459 stays from 1,684 IPFs. As discussed in section
                III.C.3.b. of this proposed rule, we applied several data restrictions
                and exclusions to obtain the set of data used for our regression
                analysis. The MedPAR data files used for this regression analysis
                contain a total of 806,611 stays from 1,643 IPFs, which reflect the
                removal of 41 providers and 304,848 stays with missing or erroneous
                data. To include as many IPFs as possible in the regression, we used
                the cost report information for each provider corresponding to the year
                of claims, when available, and substituted the most recent prior
                available cost report information for routine cost and ancillary cost
                to charge ratios if the corresponding year's data was not available.
                a. Data Sources
                 For the regression analysis, we chose to use a combined set of CY
                2019 through 2021 MedPAR data. Our analysis showed that using a
                combined set of data from multiple years yields the most stable and
                consistent result. When we looked at the results for each year
                individually, we found that some DRGs and comorbidity categories were
                not statistically significant due in part to small sample size. In
                addition, during FY 2020, the U.S. healthcare system undertook an
                unprecedented response to the Public Health Emergency (PHE) declared by
                the Secretary of the Department of Health and Human Services on January
                31, 2020 in response to the outbreak of respiratory disease caused by a
                novel (new) coronavirus that has been named ``SARS CoV 2'' and the
                disease it causes, which has been named ``coronavirus disease 2019''
                (abbreviated ``COVID-19''). We believe the aggregated three-year
                regression serves to smooth the impact of changes in utilization driven
                by the COVID-19 PHE, as well as significant changes in staffing and
                labor costs that commenters noted in response to the FY 2023 and FY
                2024 IPF PPS proposed rules. As discussed earlier in this proposed
                rule, we used 2019 through 2021 Medicare cost report data to retain as
                many records as possible for analysis.
                 We also used several other data sources to identify the IPF
                population for analysis and to construct variables in the regression
                model:
                 Provider of Services (POS) File: The POS file contains
                facility characteristics including name, address, and types of services
                provided.
                 Provider Specific Data for Public Use Files for the IPF
                PPS: The Provider Specific File (PSF) contains data used to calculate
                COLA factors and identify the Core-Based Statistical Area (CBSA). CBSA
                is used to match providers with corresponding wage index data, which is
                used to adjust the calculation of the Federal per diem base rate to
                account for geographic differences in costs.
                 Common Working File (CWF) Inpatient Claims Data: The CWF
                contains data regarding ECT treatments provided during an IPF stay.
                 Among the 1,643 providers included in the regression analysis
                sample, the majority had their most recent Medicare cost report
                information corresponding to the year of the MedPAR data file.
                Specifically, for the CY 2019 MedPAR data file, 99.5 percent (1,551
                providers) used FY 2019 Medicare cost reports, and 0.5 percent (8
                providers) used FY 2018 Medicare cost reports. For CY 2020, 99.7
                percent (1,523 providers) used FY 2020 Medicare cost reports, and 0.3
                percent (5 providers) used FY 2019 Medicare cost reports. For CY 2021,
                97.6 percent (1,435 providers) used FY 2021 Medicare cost reports, and
                2.4 percent (35 providers) used FY 2020 Medicare cost reports. This
                approach allowed us to use the most current and relevant cost report
                data, ensuring the robustness and accuracy of our analysis.
                b. Trims and Assumptions
                 To identify the IPF population for analysis, we matched MedPAR
                records to facility-level information from Medicare cost reports, the
                POS file, and the PSF. We included MedPAR stays that met the following
                criteria:
                 Hospital CMS Certification Number (CCN) contains ``40,''
                ``41,'' ``42,'' ``43,'' or ``44'' in the third and fourth position or a
                special unit code of ``S'' or ``M'' for psychiatric unit or psychiatric
                unit in a critical access hospital.
                 Beneficiary primary payer code is equal to ``Z'' or blank,
                indicating Medicare is the primary payer.
                 Group Health Organization (GHO) paid code is equal to zero
                or blank, indicating that a GHO has not paid the facility for the stay.
                 National Claims History (NCH) claim type code is equal to
                ``60,'' an inpatient claim.
                 Number of utilization days was greater than zero.
                 To promote the accuracy and completeness of data included in the
                regression model, we completed a series of trimming steps to remove
                missing and outlier data. Before any trims or exclusions were applied,
                there were 1,684 providers in the MedPAR data file. First, we matched
                facilities from the MedPAR dataset to the most recent Medicare cost
                report file available from CY 2018 to CY 2021, and excluded facilities
                that did not have a Medicare cost report available from 2018 to 2021.
                If facilities had more than one Medicare cost report in a given year,
                we used the Medicare cost report representing the longest time span. We
                identified 1 provider in CY 2019, 5 providers in CY 2020, and 4
                providers in CY 2021 that had no available Medicare cost report
                information. In total, we excluded data from 5 unique providers that
                had no available Medicare cost report information from CY 2019 to CY
                2021.
                 Next, we trimmed facilities with extraordinarily high or low costs
                per day. We removed facilities with outlier routine per diem costs,
                defined as those falling outside of the range of the mean logarithm of
                routine costs per diem plus or minus 3.00 standard deviations. We also
                removed stays with outlier total per diem costs, defined as those
                falling outside the range of the mean per diem cost by facility type
                (psychiatric hospitals and psychiatric units) plus or minus 3.00
                standard deviations. The average and standard deviations of the total
                per diem cost (routine and ancillary costs) were computed separately
                for stays in psychiatric hospitals and psychiatric units because we did
                not want to systematically exclude a larger proportion of cases from
                one type of facility. In applying these trims across all three data
                years used in our regression model, there were 104 providers with
                routine per diem costs outside 3.00 standard deviations from the mean,
                and 47 providers with total per diem costs outside 3.00 standard
                deviations from the mean. Specifically, this includes 24 providers in
                CY 2019, 41 providers in CY 2020, and 39 providers in CY 2021 excluded
                for outlier routine per diem costs. We identified 25 providers in CY
                2019, 1 provider in CY 2020, and 21 providers in CY 2021 that we
                excluded for outlier total per diem costs. In total, we excluded data
                from 23 unique providers with outlier routine per diem costs and 8
                unique providers with outlier total per diem costs.
                 We also removed stays at providers without a POS file or PSF. There
                were 5 providers without a POS file or PSF during the period CY 2019 to
                CY 2021; therefore, we are excluding data from these 5 providers. Only
                1 unique provider was entirely excluded with no POS file or PSF from CY
                2019 to CY 2021. Additionally, 1 provider was excluded because no stays
                had one of the recognized IPF PPS DRGs assigned.
                 In summary, the application of these data preparation steps
                resulted in excluding 5 providers because they did not have a cost
                report available from 2018 to 2021, 23 providers with routine per diem
                costs outside 3.00 standard
                [[Page 23156]]
                deviations from the mean, and 8 providers with total per diem costs
                outside 3.00 standard deviations from the mean. We also excluded 1
                provider without a POS file or PSF, 1 provider with no stays with IPF
                PPS DRGs, and 3 providers based on IPF stays restrictions. In total,
                the exclusion of these 41 providers resulted in the removal of 304,848
                stays from our original total of 1,111,459 stays.
                 We considered trimming stays from facilities where 95 percent or
                more of stays had no ancillary charges because we assumed that the cost
                data from these facilities were inaccurate or incomplete. This is the
                trimming methodology that we applied to the analysis described in the
                technical report released along with the FY 2023 IPF PPS proposed rule.
                As previously discussed, the IPF PPS regression model uses the sum of
                routine and ancillary costs as the dependent variable, and we assumed
                that data from facilities without ancillary charge data would be
                inadequate to capture variation in costs. When we examined the claims
                from 2018, which we used for prior analysis, this trimming step
                resulted in removing almost one-quarter of total stays from the
                unrestricted 2018 MedPAR dataset (82,491 out of 364,080 total stays).
                This trimming step also resulted in disproportionate exclusion of
                certain types of facilities, particularly freestanding psychiatric
                hospitals that were for-profit or government-operated, as well as all-
                inclusive rate providers. Approximately 55 percent of stays from
                freestanding facilities would be removed, compared to just 0.3 percent
                of stays in psychiatric units. In the analysis described in the FY 2023
                IPF PPS proposed rule (87 FR 19429), we attempted to address this
                disproportionate removal of stays by facility type by applying weights
                by facility type and ownership in the regression model to account for
                excluded providers and to avoid biasing the sample towards stays from
                providers in psychiatric units.
                 In response to the analysis described in the FY 2023 IPF PPS
                proposed rule (87 FR 19429), commenters raised concerns about the large
                number of stays excluded from the regression analysis, and questioned
                whether the ancillary charge data were truly missing, as all-inclusive
                rate providers are not required to report separate ancillary charges.
                We agree that this trimming step reduces the representativeness of the
                IPF population used in the regression model and may increase the
                potential for bias of the regression coefficients used for payment
                adjustments. Furthermore, as discussed in section III.E.4. of this
                proposed rule, we are clarifying cost reporting requirements and
                implementing operational changes that we believe will increase the
                accuracy of the cost information reported in the future. Specifically,
                CMS will issue instructions to the MACs and put in place edits for cost
                reporting periods beginning on or after October 1, 2024, ensuring that
                only government-owned or tribally owned IPF hospitals will be permitted
                to file an all-inclusive cost report. All other IPF hospitals would be
                required to have a charge structure and to report ancillary costs and
                charges on their cost reports. We expect that this proposed change
                would support increased accuracy of future payment refinements to the
                IPF PPS.
                 When we examined the claims from CY 2019 to CY 2021, this trimming
                step would have resulted in a loss of a significant number of providers
                (324 providers in CY 2019, 330 providers in CY 2020, and 336 providers
                in CY 2021). Due to the concerns that commenters previously raised
                (which we summarized in the FY 2024 IPF PPS final rule (88 FR 51097
                through 51098)), and to include as many claims as possible in the
                regression analysis, we have not trimmed stays from facilities with
                zero or minimal ancillary charges. As a result, we observed a
                significant reduction in data loss when comparing our latest regression
                model with the model described in the FY 2023 IPF PPS proposed rule. By
                including, rather than trimming, facilities with low or no ancillary
                charge data, we prevented the loss of 288 providers across the three
                years, allowing for a more inclusive analysis. These providers
                accounted for approximately 194,673 stays included in our data set.
                 We present our regression results in section III.C.3.e. of this
                proposed rule without the application of any trimming or subsequent
                weighting to account for the removal of stays from facilities with zero
                or minimal ancillary charges.
                c. Calculation of the Dependent Variable
                 The IPF PPS regression model uses the natural logarithm of per diem
                total cost as the dependent variable. We computed a per diem cost for
                each Medicare inpatient psychiatric stay, including routine operating,
                ancillary, and capital components, using information from the combined
                CY 2019 through 2021 MedPAR file and data from the 2018 through 2021
                Medicare cost reports. For each MedPAR CY, we examined the
                corresponding Medicare cost report, and if a provider's cost-to-charge
                ratio was missing from the matching year's cost report, we looked at
                the provider's cost report from the prior year to obtain the most
                recent cost-to-charge value for the provider. We applied a prior-year
                cost-to-charge ratio to 8 providers from the CY 2019 MedPAR claims, 5
                providers from the CY 2020 MedPAR claims, and 35 providers from the CY
                2021 MedPAR claims.
                 To calculate the total cost per day for each inpatient psychiatric
                stay, routine costs were estimated by multiplying the routine cost per
                day from the IPF's Medicare cost report (Worksheet D-1, Part II, column
                1, line 38) by the number of Medicare covered days in the MedPAR stay
                record. Ancillary costs were estimated by multiplying each departmental
                cost-to-charge ratio (calculated by dividing the amount obtained from
                Worksheet C, columns 5, by the sum of Worksheet C, columns 6 and 7) by
                the corresponding ancillary charges in the MedPAR stay record. The
                total cost per day was calculated by summing routine and ancillary
                costs for the stay and dividing it by the number of Medicare covered
                days for each day of the stay.
                 To address extreme cost-to-charge ratios, we winsorized the
                distributions of the 17 ancillary cost centers from Worksheet C of the
                cost report at the 2nd and 98th percentiles. That is, if the cost-to-
                charge ratio was missing and there was a charge on the claim, the cost-
                to-charge ratio was imputed to the calculated median value for each
                respective cost center.
                 The total cost per day (also referred to as per diem cost) was
                adjusted for differences in cost across geographic areas using the FY
                2019 through 2021 IPF wage index and COLA corresponding to each MedPAR
                data year. We adjusted the labor-related portion of the per diem cost
                using the IPF wage index to account for geographic differences in labor
                cost and adjusted the non-labor portion of the per diem cost by the
                COLA adjustment factors for IPFs in Alaska and Hawaii. We used IPF PPS
                labor-related share and non-labor-related share finalized for each
                year, FY 2019 through FY 2021, to determine the amount of the per diem
                cost that is adjusted by the wage index and the COLA, respectively. We
                calculated the adjusted cost using the following formula:
                Wage adjusted per diem cost = per diem cost/(wage index * labor-related
                share + COLA * (1-labor-related share)).
                d. Independent Variables
                 Independent variables in the regression model are patient-level and
                facility-level characteristics that affect
                [[Page 23157]]
                the dependent variable in the model, which is per diem cost. As
                discussed in the following sections, the updated regression model for
                this proposed rule includes adjustment-related variables and control
                variables. Adjustment related variables are used for adjusting payment,
                and as we discuss in section III.C.4 of this proposed rule, we are
                proposing to revise the IPF PPS patient-level adjustment factors based
                on the regression results for many of the adjustment-related variables
                in the model. Control variables are used to account for variation in
                the dependent variable that is associated with factors outside the
                adjustment factors of the payment model.
                (1) Adjustment-Related Variables
                 Patient-level adjustment-related variables included in the
                regression model are variables for DRG assignment, comorbidity
                categories, age, and length of stay. We note that facility-level
                adjustment-related variables for rural status and teaching status are
                also included in the model; however, we are not proposing revisions to
                the rural or teaching adjustments for FY 2025. We discuss the latest
                results of the regression analysis for facility-level adjustments in
                greater detail in section IV.A. of this proposed rule.
                (2) Control Variables
                 The regression model used to determine IPF PPS payment adjustments
                in the RY 2005 IPF PPS final rule (69 FR 66922) included control
                variables to account for facilities' occupancy rate, a control variable
                to indicate if the patient received ECT, and a control variable for
                IPFs that do not bill for ancillary charges. In the updated regression
                model for this FY 2025 IPF PPS proposed rule, we have removed the
                occupancy control variables and the control variable for IPFs that do
                not bill for ancillary charges. In addition, we have retained the
                control variable for patients receiving ECT and added control variables
                for the data year. We also added a control variable for the presence of
                ED charges on the claim. We discuss considerations related to these
                control variables and others in the following paragraphs.
                 The 2004 regression model included two control variables for
                occupancy rate. One was a continuous variable for the facility's
                logarithmic-transformed occupancy rate. The other was a categorical
                variable indicating a facility had an occupancy rate below 30 percent.
                Both of these variables were found to be associated with statistically
                significant increases in cost. In the RY 2005 IPF PPS final rule, we
                adopted the structural approach and included these control variables in
                the regression. We explained that it was appropriate to control for
                variations in the occupancy rate in estimating the effects of the
                payment variables on per diem cost to avoid compensating facilities for
                inefficiency associated with underutilized fixed costs (69 FR 66934).
                As we discussed in the FY 2023 IPF PPS proposed rule, our analysis
                found that the occupancy control variables were associated with rural
                status. We solicited comments on the potential removal of the occupancy
                control variables from the model (87 FR 19429). In response, we
                received several comments in support of removing the occupancy control
                variables, due to the relationship between these control variables and
                the rural adjustment (87 FR 46865). Commenters cited the importance of
                rural IPFs as the primary points of care and access for many Medicare
                beneficiaries who cannot travel to urban areas for mental health
                services. We considered the potential negative impact to rural
                facilities of retaining the occupancy control variables in the
                regression model. We agree with the commenters who noted the importance
                of maintaining stability in payments for rural IPFs; therefore, we did
                not include any occupancy control variables in our regression model.
                 In addition, we considered including a control variable for IPFs
                that do not bill for ancillary services. As we discussed in the RY 2005
                IPF PPS final rule (69 FR 66936), we included variables in the
                regression to control for psychiatric hospitals that do not bill
                ancillary costs. However, at that time, the number of IPFs who did not
                bill for ancillary costs was relatively small and consisted mostly of
                government-operated facilities. As we discuss later in section III.E.4
                of this proposed rule, an increasing number of IPFs have stopped
                reporting ancillary charges on their claims, which means that ancillary
                cost information is not available for stays at these IPFs.
                 We considered whether to include a control variable for facilities
                that do not report ancillary charges. We considered that the inclusion
                of a control variable would only account for differences in the level
                of cost between IPFs with and without reported ancillary costs and
                would not facilitate comparison of costs between all IPFs in our
                sample. In addition, we found that facilities that did not report
                ancillary charges also tended to have lower routine costs; that is, our
                analysis showed that these facilities would have overall lower costs
                per day, regardless of whether ancillary costs were considered in the
                cost variable. We considered that the inclusion of a control variable
                in the regression model would account for these differences in overall
                cost, which would impact the size of payment-related adjustment factors
                that are correlated with the prevalence of missing ancillary charge
                data. For this reason, in developing a regression model for proposing
                revisions to the IPF PPS, we did not include a control variable to
                account for facilities that report zero or minimal ancillary charges.
                 As noted earlier, the original model also included a control
                variable for the presence of ECT. This is because ECT is paid on a per-
                treatment basis under the IPF PPS. As discussed in more detail in
                section III.B.2. of this FY 2025 IPF PPS proposed rule, we continue to
                observe that IPF stays with ECT have significantly higher costs per
                day. We are proposing to continue paying for ECT on a per-treatment
                basis; therefore, we included a control variable to account for the
                additional costs associated with ECT, which would continue to be paid
                for outside the regression model.
                 Similarly, we included a control variable for stays with emergency
                department (ED)-related charges. The original model did not include an
                ED control variable, because ED costs were excluded from the dependent
                variable of IPF per diem costs. Our regression model for this FY 2025
                IPF PPS proposed rule includes all costs associated with each IPF stay,
                including ED costs. As discussed in section III.D.4. of this proposed
                rule, we are proposing to calculate the ED adjustment in accordance
                with our longstanding methodology, separate from the regression model.
                However, we included a control variable for stays with ED charges to
                control for the additional costs associated with ED admissions, which
                are paid under the ED adjustment outside the regression model.
                 Lastly, we included control variables for the data year. Because
                the model used a combined set of data from 3 years, these control
                variables are included in the model to account for differences in cost
                levels between 2019, 2020, and 2021, which would be driven by economic
                inflation and other external factors unrelated to the independent
                variables in the regression model.
                e. Regression Results
                 Table 2 presents the results of our regression model. We discuss
                these results and our related proposals to
                [[Page 23158]]
                revise the IPF PPS patient-level adjustment factors in section III.C.4
                of this proposed rule.
                 This regression model includes a total of 806,611 stays, and the r-
                squared value of the model is 0.32340, meaning that the independent
                variables included in the regression model can explain approximately
                32.3 percent of the variation in per diem cost among IPF stays.
                 Except for the teaching variable, each of the adjustment factors in
                Table 2 is the exponentiated regression coefficient of our regression
                model, which as we previously noted uses the natural logarithm of per
                diem total cost as the dependent variable. We present the exponentiated
                regression results, as these most directly translate to the way that
                IPF PPS adjustment factors are calculated for payment purposes. That
                is, the exponentiated adjustment factors presented below represent a
                percentage increase or decrease in per diem cost for IPF stays with
                each characteristic. In the case of the teaching variable, the result
                in Table 2 is the un-exponentiated regression coefficient. As discussed
                in section III.D of this proposed rule, the current IPF PPS teaching
                adjustment is calculated as 1 + a facility's ratio of interns and
                residents to beds, raised to the power of 0.5150. The coefficient for
                teaching status presented in Table 2 can be interpreted in the same
                way.
                 For certain categorical variables, including DRG, age, length of
                stay, and the year control variables, results for the reference groups
                are not shown in Table 2. The DRG reference group is DRG 885, because
                this DRG represents the majority of IPF PPS stays. The age reference
                group is the Under 45 category, because this group is associated with
                the lowest costs after accounting for all other patient characteristics
                in the model. The reference group for length of stay is 10 days, which
                corresponds to the reference group used in the original regression
                model from the RY 2005 IPF PPS final rule. Lastly, the year control
                reference group is CY 2021. Each of these reference groups not shown in
                Table 2 effectively has an adjustment factor of 1.00 in the regression
                model.
                 As shown in Column 5 of Table 2, we considered the regression
                factors to be statistically significant when the p-value was less than
                or equal to the significance level of 0.05 (*), 0.01 (**), and 0.001
                (***). Columns 6 and 7 of Table 2 show the lower and upper bounds of
                the 95-percent confidence interval (CI).
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                4. Proposed Updates and Revisions to the IPF PPS Patient-Level
                Adjustments
                 The IPF PPS includes payment adjustments for the following patient-
                level characteristics: Medicare Severity Diagnosis Related Groups (MS-
                DRGs) assignment of the patient's principal diagnosis, selected
                comorbidities, patient age, and the variable per diem adjustments. As
                discussed in section III.C.3. of this proposed rule, we are proposing
                to derive updated IPF PPS adjustment factors for FY 2025 using a
                regression analysis of data from the CY 2019 through 2021 MedPAR data
                files and Medicare cost report data from the 2018 through FY 2021
                Hospital Cost Report Information System (HCRIS). However, we have used
                more recent claims (specifically, the December, 2023 update of the FY
                2023 IPF PPS MedPAR claims) and cost data from the January, 2024 update
                of the provider-specific file (PSF) to simulate payments to finalize
                the outlier fixed dollar loss threshold amount and to assess the impact
                of the IPF PPS updates. More information about the data used for the
                impact simulations is found in section VIII.C of this FY 2025 IPF PPS
                proposed rule. As discussed in section III.C.3. of this proposed rule,
                by adjusting for DRGs, comorbidities, age, and length of the stay,
                along with the facility-level variables and control variables in the
                model, we were able to explain approximately 32.3 percent of the
                variation in per diem cost among IPF stays.
                 In addition, we are proposing routine coding updates for FY 2025
                for our longstanding code first and IPF PPS comorbidities. Furthermore,
                as discussed in section III.C.4.a.(2) of this proposed rule, we are
                proposing to adopt a sub-regulatory process for future routine coding
                updates.
                a. Proposed Updated and Revisions to MS-DRG Assignment
                (1) Background
                 We believe it is important to maintain for IPFs the same diagnostic
                coding and DRG classification used under the IPPS for providing
                psychiatric care. For this reason, when the IPF PPS was implemented for
                cost reporting periods beginning on or after January 1, 2005, we
                adopted the same diagnostic code set (ICD-9-CM) and DRG patient
                classification system (MS-DRGs) that were utilized at the time under
                the IPPS. In the RY 2009 IPF PPS notice (73 FR 25709), we discussed
                CMS's effort to better recognize resource use and the severity of
                illness among patients. CMS adopted the new MS-DRGs for the IPPS in the
                FY 2008 IPPS final rule with comment period (72 FR 47130). In the RY
                2009 IPF PPS notice (73 FR 25716), we provided a crosswalk to reflect
                changes that were made under the IPF PPS to adopt the new MS-DRGs. For
                a detailed description of the mapping changes from the original DRG
                adjustment categories to the current MS-DRG adjustment categories, we
                refer readers to the RY 2009 IPF PPS notice (73 FR 25714).
                 The IPF PPS includes payment adjustments for designated psychiatric
                DRGs assigned to the claim based on the patient's principal diagnosis.
                The DRG adjustment factors were expressed relative to the most
                frequently reported psychiatric DRG in FY 2002, that is, DRG 430
                (psychoses). The coefficient values and adjustment factors were derived
                from the regression analysis discussed in detail in the RY 2004 IPF
                proposed rule (68 FR 66923; 66928 through 66933) and the RY 2005 IPF
                final rule (69 FR 66933 through 66960). Mapping the DRGs to the MS-DRGs
                resulted in the current 17 IPF MS-DRGs, instead of the original 15
                DRGs, for which the IPF PPS provides an adjustment.
                 In the FY 2015 IPF PPS final rule published August 6, 2014 in the
                Federal Register titled, ``Inpatient Psychiatric Facilities Prospective
                Payment System--Update for FY Beginning October 1, 2014 (FY 2015)'' (79
                FR 45945 through 45947), we finalized conversions of the ICD-9-CM-based
                MS-DRGs to ICD-10-CM/PCS-based MS-DRGs, which were implemented on
                October 1, 2015. Further information on the ICD-10-CM/PCS MS-DRG
                conversion project can be found on the CMS ICD-10-CM website at https://www.cms.gov/medicare/coding-billing/icd-10-codes/icd-10-ms-drg-conversion-project.
                [[Page 23162]]
                (2) Proposal To Adopt Sub-Regulatory Process for Publication of Coding
                Changes
                 As discussed in the FY 2015 IPF PPS proposed rule (79 FR 26047)
                every year, changes to the ICD-10-CM and the ICD-10-PCS coding system
                have been addressed in the IPPS proposed and final rules. The changes
                to the codes are effective October 1 of each year and must be used by
                acute care hospitals as well as other providers to report diagnostic
                and procedure information. In accordance with Sec. 412.428(e), we have
                historically described in the IPF PPS proposed and final rules the ICD-
                10-CM coding changes and DRG classification changes that have been
                discussed in the annual proposed and final hospital IPPS regulations.
                This has typically involved a discussion in the proposed rule about
                coding updates to be effective October 1 of each year, with a summary
                of comments in the final rule along with a description of additional
                finalized codes for October.
                 In the FY 2022 IPPS/LTCH PPS final rule (86 FR 44950 through
                44956), we adopted an April 1 implementation date for ICD-10-CM
                diagnosis and ICD-10-PCS procedure code updates in addition to the
                annual October 1 update of ICD-10-CM diagnosis and ICD-10-PCS procedure
                codes, beginning with April 1, 2022. In that rule, we noted the intent
                of this April 1 implementation date is to allow flexibility in the ICD-
                10 code update process. Currently, as noted earlier in this proposed
                rule, the IPF PPS uses the IPPS DRG assignments, which are applied to
                IPF PPS claims; these DRG assignments reflect the change in process
                that the IPPS adopted for FY 2022. To maintain consistency with IPPS
                policy, we are proposing to follow the same process beginning in FY
                2025. This means that for routine coding updates that incorporate new
                or revised codes, we are proposing to adopt these changes through a
                sub-regulatory process. Beginning in FY 2025, we would operationalize
                such coding changes in a Transmittal/Change Request, which would align
                with the way coding changes are announced under the IPPS.
                 For example, we are proposing that for April 2025, we would adopt
                routine coding updates for the IPF PPS comorbidity categories, code
                first policy, ECT code list, and DRG assignment via sub-regulatory
                guidance. These coding updates would take effect April 1, 2025. In
                accordance with Sec. 412.428(e), we would describe these coding
                changes, along with any coding updates that would be effective for
                October 1, 2025, in the FY 2026 IPF PPS proposed rule. We would
                summarize and respond to any comments on these April and October coding
                changes in the FY 2026 IPF PPS final rule.
                 The proposed update aims to allow flexibility in the ICD-10 code
                update process for the IPF PPS and reduces the lead time for making
                routine coding updates to the IPF PPS code first list, comorbidities,
                and ECT coding categories. In addition, the IPPS sub-regulatory process
                continues to manage DRG assignment changes which apply to the DRG
                assignments used in the IPF PPS. Finally, we are clarifying that we
                would only apply this sub-regulatory process for routine coding
                updates. Any future substantive revisions to the IPF PPS DRG
                adjustments, comorbidities, code first policy, or ECT payment policy
                would be proposed through notice and comment rulemaking. We solicit
                public comments on this proposal.
                (3) Routine Coding Updates for DRG Assignments
                 The diagnoses for each IPF MS-DRG will be updated as of October 1,
                2024, using the final IPPS FY 2025 ICD-10-CM/PCS code sets. The FY 2025
                IPPS/LTCH PPS final rule will include tables of the changes to the ICD-
                10-CM/PCS code sets that underlie the proposed FY 2025 IPF MS-DRGs.
                Both the FY 2025 IPPS final rule and the tables of final changes to the
                ICD-10-CM/PCS code sets, which underlie the FY 2025 MS-DRGs, will be
                available on the CMS IPPS website at https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps.
                (4) Code First
                 As discussed in the ICD-10-CM Official Guidelines for Coding and
                Reporting, certain conditions have both an underlying etiology and
                multiple body system manifestations due to the underlying etiology. For
                such conditions, the ICD-10-CM has a coding convention that requires
                the underlying condition be sequenced first, followed by the
                manifestation. Wherever such a combination exists, there is a ``use
                additional code'' note at the etiology code, and a ``code first'' note
                at the manifestation code. These instructional notes indicate the
                proper sequencing order of the codes (etiology followed by
                manifestation). In accordance with the ICD-10-CM Official Guidelines
                for Coding and Reporting, when a primary (psychiatric) diagnosis code
                has a code first note, the provider will follow the instructions in the
                ICD-10-CM Tabular List. The submitted claim goes through the CMS
                processing system, which will identify the principal diagnosis code as
                non-psychiatric and search the secondary codes for a psychiatric code
                to assign a DRG code for adjustment. The system will continue to search
                the secondary codes for those that are appropriate for comorbidity
                adjustment. For more information on the code first policy, we refer
                readers to the RY 2005 IPF PPS final rule (69 FR 66945). We also refer
                readers to sections I.A.13 and I.B.7 of the FY 2020 ICD-10-CM Coding
                Guidelines, which is available at https://www.cdc.gov/nchs/data/icd/10cmguidelinesFY2020_final.pdf. In the FY 2015 IPF PPS final rule, we
                provided a code first table for reference that highlights the same or
                similar manifestation codes where the code first instructions apply in
                ICD-10-CM that were present in ICD-10-CM (79 FR 46009). In FY 2018, FY
                2019, and FY 2020, there were no changes to the final ICD-10-CM codes
                in the IPF Code First table. For FY 2021 and FY 2022, there were 18
                ICD-10-CM codes deleted from the final IPF Code First table. For FY
                2023, there were 2 ICD-10-CM codes deleted and 48 ICD-10-CM codes added
                to the IPF Code First table. For FY 2024, there were no proposed
                changes to the Code First Table.
                 We are proposing to continue our existing code first policy. As
                outlined in our proposal to incorporate a sub-regulatory process for
                the publication of coding changes, we are proposing to adopt a sub-
                regulatory approach to handle the coding updates, which removes the
                requirement to discuss coding updates in the Federal Register during
                regulatory updates prior to implementation, which would mirror the
                approach taken by the IPPS. The proposed FY 2025 Code First table is
                shown in Addendum B on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-forServicePayment/InpatientPsychFacilPPS/tools.html.
                (5) Proposed Revisions to MS-DRG Adjustment Factors
                 For FY 2025, we are proposing to revise the payment adjustments for
                designated psychiatric DRGs assigned to the claim based on the
                patient's principal diagnosis, following our longstanding policy of
                using the ICD-10-CM/PCS-based MS-DRG system. As discussed in the
                following paragraphs, we are proposing to maintain DRG adjustments for
                15 of the existing 17 IPF MS-DRGs for which we currently adjust payment
                in FY 2024. We are proposing to replace two existing DRGs with two new
                DRGs to reflect changes in coding practices over time and proposing to
                add two DRGs that are associated with poisoning. We are also proposing
                to
                [[Page 23163]]
                revise the adjustment factors for the DRG adjustments as described in
                Table 3, based on the results of our latest regression analysis
                described in Section III.C.3 of this proposed rule. Addendum A is
                available on the CMS website at https://www.cms.gov/medicare/payment/prospective-payment-systems/inpatient-psychiatric-facility/tools-and-worksheets. The website includes the proposed DRG adjustment factors
                for FY 2025. In accordance with our longstanding policy, we are
                proposing that psychiatric principal diagnoses that do not group to one
                of the 19 proposed designated MS-DRGs would still receive the Federal
                per diem base rate and all other applicable adjustments; however, the
                payment would not include an MS-DRG adjustment.
                (a) Proposed Replacement of DRGs
                 We are proposing to remove DRGs 080 (Nontraumatic stupor & coma w
                MCC) and 081 (Nontraumatic stupor & coma w/o MCC), and to replace these
                with DRGs 947 (Signs and Symptoms w MCC) and 948 (Signs and Symptoms w/
                out MCC). As previously discussed, we observed that the number of cases
                in DRGs 080 and 081 have decreased significantly since 2004. We
                selected DRGs 947 and 948 as the most clinically appropriate
                replacements, because most of the ICD-10-CM codes that previously
                grouped to DRGs 080 or 081 now group to DRGs 947 or 948. Table 3
                compares the current adjustment factors for DRGs 080 and 081 to the
                regression-derived adjustment factors for DRGs 947 and 948. As shown in
                Table 3, the proposed adjustment factors for DRGs 947 and 948 would
                each be greater than the current DRG adjustment for DRGs 080 and 081.
                Therefore, we are proposing that claims with DRGs 080 or 081 would
                still receive the Federal per diem base rate and all other applicable
                adjustments; however, the payment would not include an MS-DRG
                adjustment.
                 As discussed in section III.F of this proposed rule, we are
                proposing to implement this revision to the DRG adjustments budget-
                neutrally. A detailed discussion of the distributional impacts of this
                proposed change is found in section VIII.C of this proposed rule.
                Lastly, we are proposing that if more recent data become available, we
                would use such data, if appropriate, to determine the FY 2025 DRG
                adjustment factors.
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                (b) Proposed Additions of DRGs
                 We are proposing to recognize DRG adjustments for two DRGs
                associated with poisoning; specifically, DRG 917 (Poisoning and toxic
                effects of drugs w MCC) and 918 (Poisoning and toxic effects of drugs
                w/out MCC). As discussed earlier in this proposed rule, we have
                identified that a small but increasing number of IPF stays contain
                these poisoning-related DRG assignments, and that stays with these DRGs
                have increased costs per day that are statistically significant. Table
                4 summarizes the frequency of these stays and the proposed adjustment
                factors for FY 2025. As discussed in section III.F of this proposed
                rule, we are proposing to implement this revision to the DRG
                adjustments budget-neutrally. A detailed discussion of the
                distributional impacts of this proposed change is found in section
                VIII.C of this proposed rule.
                 Lastly, we are proposing that if more recent data become available,
                we would use such data, if appropriate, to determine the FY 2025 DRG
                adjustment factors.
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                (c) Proposed Revisions to Adjustment Factors for Existing DRG
                Adjustments
                 We are proposing to revise the adjustment factors for the remaining
                15 of the existing 17 DRGs that currently receive a DRG adjustment in
                FY 2024. These proposed revisions are based on the results of our
                latest regression analysis described in section III.C.3 of this
                proposed rule.
                 As previously discussed, our analysis found that some of the
                adjustment factors in the regression model for DRGs that currently
                receive an adjustment are no longer statistically significant.
                Specifically, we found that the adjustment factors for DRG 882
                (Neuroses except depressive), DRG 887 (Other mental disorder
                diagnoses), and DRG 896 (Alcohol, Drug Abuse or Dependence w/out rehab
                therapy w MCC) were not statistically significant. For each of these
                DRGs, we examined whether the current adjustment factor falls within
                the confidence interval for our latest regression analysis. The current
                adjustment for DRG 882 is 1.02, and this falls within the confidence
                interval of 0.96798 to 1.07811 for the latest regression model
                discussed in section III.C.3 of this proposed rule. We believe it would
                be appropriate to maintain the current adjustment factor of 1.02 for
                DRG 882, because the latest regression results indicate that the
                current adjustment factor would be a reasonable approximation of the
                increased costs associated with DRG 882. For DRGs 887 and 896; however,
                the current adjustment factors (0.92 and 0.88, respectively) do not
                fall within the confidence interval for each of these DRGs. Therefore,
                we are proposing to apply an adjustment factor of 1.00 for IPF stays
                with these DRGs.
                 Table 5 summarizes the frequency of these stays and the proposed
                adjustment factors for FY 2025. As discussed in section III.F of this
                proposed rule, we are proposing to implement this revision to the DRG
                adjustments budget-neutrally. A detailed discussion of the
                distributional impacts of this proposed change is found in section
                VIII.C of this proposed rule.
                 Lastly, we are proposing that if more recent data become available,
                we would use such data, if appropriate, to determine the FY 2025 DRG
                adjustment factors.
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                b. Proposed Payment for Comorbid Conditions
                (1) Proposed Revisions to Comorbidity Adjustments
                 The intent of the comorbidity adjustments is to recognize the
                increased costs associated with comorbid conditions by providing
                additional payments for certain existing medical or psychiatric
                conditions that are expensive to treat.
                 Comorbidities are specific patient conditions that are secondary to
                the patient's principal diagnosis and that require treatment during the
                stay. Diagnoses that relate to an earlier episode of care and have no
                bearing on the current hospital stay are excluded and must not be
                reported on IPF claims. Comorbid conditions must exist at the time of
                admission or develop subsequently, and affect the treatment received,
                LOS, or both treatment and LOS.
                 The current comorbidity adjustments were determined based on the
                regression analysis using the diagnoses reported by IPFs in FY 2002.
                The principal diagnoses were used to establish the DRG adjustments and
                were not accounted for in establishing the comorbidity category
                adjustments, except where ICD-9-CM code first instructions applied. In
                a code first situation, the submitted claim goes through the CMS
                processing system, which identifies the principal diagnosis code as
                non-psychiatric and searches the secondary codes for a psychiatric code
                to assign an MS-DRG code for adjustment. The system continues to search
                the secondary codes for those that are appropriate for a comorbidity
                adjustment.
                 In our RY 2012 IPF PPS final rule (76 FR 26451 through 26452), we
                explained that the IPF PPS includes 17 comorbidity categories and
                identified the new, revised, and deleted ICD-9-CM diagnosis codes that
                generate a comorbid condition payment adjustment under the IPF PPS for
                RY 2012 (76 FR 226451).
                As discussed in section C.4.a.(1) of this proposed rule, it is our
                policy to
                [[Page 23166]]
                maintain the same diagnostic coding set for IPFs that is used under the
                IPPS for providing the same psychiatric care. The 17 comorbidity
                categories formerly defined using ICD-9-CM codes were converted to ICD-
                10-CM/PCS in our FY 2015 IPF PPS final rule (79 FR 45947 through
                45955). The goal for converting the comorbidity categories is referred
                to as replication, meaning that the payment adjustment for a given
                patient encounter is the same after ICD-10-CM implementation as it
                would be if the same record had been coded in ICD-9-CM and submitted
                prior to ICD-10-CM/PCS implementation on October 1, 2015. All
                conversion efforts were made with the intent of achieving this goal.
                 For each claim, an IPF may receive only one comorbidity adjustment
                within a comorbidity category, but it may receive an adjustment for
                more than one comorbidity category. Current billing instructions for
                discharge claims, on or after October 1, 2015, require IPFs to enter
                the complete ICD-10-CM codes for up to 24 additional diagnoses if they
                co-exist at the time of admission, or develop subsequently and impact
                the treatment provided.
                 As previously discussed in section III.C.4.a.(2) of this proposed
                rule, we are proposing to adopt an April 1 implementation date for ICD-
                10-CM diagnosis and ICD-10-PCS procedure code updates, in addition to
                the annual October 1 update, beginning with April 1, 2025 for the IPF
                PPS. For FY 2025 and future years, coding updates related to the IPF
                PPS comorbidity categories would be adopted following a sub-regulatory
                process as discussed earlier in this proposed rule.
                 For FY 2025, we are proposing to revise the comorbidity adjustment
                factors based on the results of the 2019 through 2021 regression
                analysis described in section III.C.3.e. of this proposed rule. We are
                also proposing additions and changes to the comorbidity categories for
                which we adjust payment based on our analysis of ICD-10-CM codes
                currently included in each category as well as public comments received
                in response to the FY 2022 and FY 2023 IPF PPS proposed rules.
                 Based on analysis of the ICD-10-CM codes, we considered the
                statistical significance of the adjustment factor and whether the
                current (FY 2024) adjustment factor fell within the confidence interval
                in the 2019 through 2021 regression to determine the FY 2025 IPF PPS
                proposed comorbidity categories and adjustment factors. As previously
                discussed for the DRG adjustment factors, when the regression factor is
                not statistically significant, but the current adjustment factor is
                within the confidence interval, we are proposing to maintain the
                current adjustment factor. When a regression factor is not
                statistically significant and the current adjustment factor is not
                within the confidence interval, we are proposing to remove the
                comorbidity category.
                 Specifically, we are proposing to increase the adjustment factors
                for the Gangrene, Severe Protein Malnutrition, Oncology Treatment,
                Poisoning, and Tracheostomy comorbidity categories based on the
                adjustment factors derived from the regression analysis discussed in
                section III.C.3 of this proposed rule. For these comorbidity
                categories, the regression results produced a statistically significant
                increase in the adjustment factors.
                 We are proposing to remove the comorbidity categories for the
                Coagulation Factor Deficit, Drug/Alcohol Induced Mental Disorders, and
                Infectious Diseases adjustment factors because the regression factor
                for the ICD-10-CM codes associated with Coagulation Factor Deficit and
                Infectious Diseases were not statistically significant, and the current
                adjustment factors did not fall within the confidence intervals in the
                2019 through 2021 regression.
                 The current adjustment factor for Drug/Alcohol Induced Mental
                Disorders is 1.03; however, the adjustment factor derived from our
                latest regression results was statistically significant at 0.96084,
                meaning payments would be reduced if we applied the regression-derived
                adjustment factor as a comorbidity adjustment for this category. In
                order to understand the drivers of changing costs for the Drug/Alcohol
                Induced Mental Disorders comorbidity category, we examined a subset of
                ICD-10-CM codes within the comorbidity category associated with opioid
                disorders which make up the majority of stays that qualify for the
                current Drug/Alcohol Induced Mental Disorders comorbidity adjustment.
                These opioid disorder codes are listed in Table 6. When we separately
                analyzed these codes associated with opioid disorder, the results
                suggested that patients with opioid disorder are significantly less
                expensive than patients without opioid disorder. Because stays with
                opioid disorders make up the majority of stays in the Drug/Alcohol
                Induced Mental Disorders comorbidity category, we observe a
                statistically-significant negative adjustment factor for the
                comorbidity category overall. The application of a comorbidity
                adjustment derived from our latest regression analysis would result in
                reduced payments for all stays in this comorbidity category. We do not
                believe it is appropriate to apply negative adjustment factors (that
                is, adjustment factors less than 1.00) for comorbidities because that
                would result in reduced rather than increased payments. Although we
                apply adjustment factors less than 1.00 for DRGs, this is because the
                DRG adjustment reflects the cost of stays relative to stays with the
                baseline DRG 885. In contrast, comorbidity adjustments reflect the cost
                relative to a stay with no comorbidities. A negative payment adjustment
                would not be consistent with the intent of a comorbidity adjustment,
                which is intended to provide additional payments to providers to
                account for the costs of treating patients with comorbid conditions.
                Therefore, we have not historically included any negative adjustment
                factors for comorbid conditions.
                 Therefore, we are proposing to remove the Drug/Alcohol Induced
                Mental Disorders comorbidity category beginning in FY 2025. IPF stays
                that include these codes as a non-principal diagnosis would no longer
                receive the current Drug/Alcohol Induced Mental Disorders comorbidity
                category adjustment factor of 1.03; nor would they receive a reduction
                in payment. However, many IPF stays that include these ICD-10-CM
                diagnosis codes as a principal diagnosis would continue to receive a
                DRG adjustment. We refer readers to section III.C.3.a of this proposed
                rule for a detailed discussion of proposed DRG adjustments under the
                IPF PPS.
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                 We believe removal of the Drug/Alcohol Induced Mental Disorders
                comorbidity category under the IPF PPS would more appropriately align
                payment with resource use, as reflected in the latest regression
                results. As previously discussed in section III.F of this proposed
                rule, all of these proposed revisions would be applied budget-
                neutrally. Therefore, we believe the removal of the Drug/Alcohol
                Induced Mental Disorders comorbidity adjustment would appropriately
                increase the IPF PPS Federal per diem base rate and thereby increase
                payment for IPF stays that are costlier. However, we are soliciting
                comments on whether a lack of ancillary charge data may be contributing
                to the results of our regression analysis as it relates to opioid
                disorders. We note that our analysis of the ICD-10-CM codes associated
                with opioid disorder also indicates that there is significant overlap
                between facility characteristics and stays including opioid disorder
                diagnoses. In particular, for-profit freestanding IPFs were found to
                serve the majority of patients with opioid disorders. As discussed in
                section III.E.4 of this proposed rule, our ongoing analysis has found
                an increase in the number of for-profit freestanding IPFs that are
                consistently reporting no ancillary charges or very minimal ancillary
                charges on their cost report. As a result, we have previously noted
                that data that is necessary for accurate Medicare ratesetting is
                excluded from the information these facilities are reporting.
                 As stated previously, the regression factor for Drug/Alcohol
                Induced Mental Disorders was statistically significant, but is less
                than 1, meaning payments would be reduced if we applied it as a
                comorbidity adjustment. We are interested in understanding whether
                there is data and information that could better inform our
                understanding of the costs of treating these conditions. In addition,
                we are interested in understanding whether commenters believe it may be
                more appropriate to maintain the existing Drug/Alcohol Induced Mental
                Disorders comorbidity category adjustment factor of 1.03, given that
                many providers that treat these patients also report minimal or no
                ancillary charges on their claims and cost reports. We note that if we
                were to maintain the adjustment factor of 1.03 for these IPF stays, we
                expect it would have a negative impact on the refinement
                standardization factor, thereby slightly reducing the IPF PPS Federal
                per diem base rate and ECT per treatment amount.
                 We are also proposing to modify the Eating and Conduct Disorders
                comorbidity category and redesignate it as the Eating Disorders
                comorbidity category. That is, we are proposing to remove conduct
                disorders from the codes eligible for a comorbidity adjustment. When we
                separately analyzed the ICD-10-CM codes for eating disorders
                (specifically, F5000 Anorexia nervosa, unspecified, F5001
                [[Page 23168]]
                Anorexia nervosa, restricting type, F5002 Anorexia nervosa, binge
                eating/purging type, and F509 Eating disorder, unspecified) and conduct
                disorders (F631 Pyromania, F6381 Intermittent explosive disorder, and
                F911 Conduct disorder, childhood-onset type), our regression results
                identified a positive, statistically significant adjustment factor
                associated with eating disorders. In contrast, conduct disorders had a
                negative and non-significant factor. These results suggest that eating
                disorders are associated with an increased level of resource use
                compared to conduct disorders, and that only eating disorders have an
                increase resource use at a level that is statistically significant.
                Based on these findings, we are proposing to remove conduct disorders
                from the proposed newly designated Eating Disorders comorbidity
                category.
                 In addition, we are proposing to modify the Chronic Obstructive
                Pulmonary Disease comorbidity category to include ICD-10-CM codes
                associated with sleep apnea (specifically, G4733 Obstructive sleep
                apnea (adult) (pediatric), 5A09357 Assistance with Respiratory
                Ventilation, <24 Hrs, CPAP, Z9981 Dependence on supplemental oxygen,
                and Z9989 Dependence on other enabling machines and devices). In
                response to the FY 2023 and FY 2024 IPF PPS proposed rules, commenters
                requested that CMS analyze the additional cost associated with patients
                with sleep apnea. Patients with sleep apnea often need to use a
                continuous positive airway pressure (CPAP) machine with a cord to
                manage their condition. Based on the clinical expertise of CMS Medical
                Officers, we determined that patients with sleep apnea in the IPF
                setting would have increased ligature risk (that is, anything that
                could be used to attach a cord, rope, or other material for the purpose
                of hanging or strangulation), similar to the risk associated with
                patients in the IPF setting that have chronic obstructive pulmonary
                disease. We expect the additional staffing resources involved in
                treating IPF patients with sleep apnea would be similar to the
                resources involved in treating IPF patients with chronic obstructive
                pulmonary disease, as patients with chronic obstructive pulmonary
                disease may also require the presence of an additional device with a
                cord in the patient's room, such as a bilevel positive airway pressure
                (BiPAP) machine. We evaluated adding codes associated with sleep apnea
                to our regression model, on the basis of our expectation that we would
                observe higher costs associated with these codes that would be
                comparable to the costs associated with chronic obstructive pulmonary
                disease. The results of our 2019 through 2021 regression model suggest
                that sleep apnea is in fact associated with an increased level of
                resource use. Therefore, we are proposing to redesignate the Chronic
                Obstructive Pulmonary Disease category as the Chronic Obstructive
                Pulmonary Disease and Sleep Apnea comorbidity category.
                 Further, we analyzed costs associated with the ICD-10-CM codes in
                Table 7 that indicate high-risk behavior. In response to the FY 2023
                and FY 2024 IPF PPS proposed rules, commenters requested that CMS
                analyze the additional cost associated with patients exhibiting violent
                behavior during their stay in an IPF. We considered these comments in
                coordination with CMS Medical Officers, and determined that patients
                exhibiting violent behavior would require more intensive management
                during an IPF stay. We determined that certain ICD-10-CM codes could
                describe the types of high-risk behaviors that require intensive
                management during an IPF stay. These could include patients exhibiting
                violent behavior as well as other high-risk, non-violent behaviors. We
                examined ICD-10-CM codes in the R45 code family (Symptoms and Signs
                Related to Emotional State) that could indicate high-risk behavior
                during an IPF stay, which would lead to increased resource use. The
                regression analysis found that several codes, R451 Restlessness and
                agitation, R454 Irritability and anger, and R4584 Anhedonia codes are
                associated with a statistically significant adjustment factor. In other
                words, patients presenting with restlessness and agitation,
                irritability and anger, or anhedonia are more costly than patients who
                do not present these conditions. Therefore, we are proposing to add a
                new comorbidity category recognizing the costs associated with
                Intensive Management for High-Risk Behavior.
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                 Lastly, we are proposing to maintain the adjustment factors for the
                Developmental Disabilities and Uncontrolled Diabetes comorbidity
                categories. Based on the regression analysis, the Developmental
                Disabilities comorbidity category adjustment factor was not
                statistically significant; however, the current adjustment factor is
                within the confidence interval. As discussed in section III.C.3.a of
                this proposed rule, a non-statistically significant adjustment factor
                within the confidence interval indicates that the current adjustment
                factor would be a reasonable approximation of the increased costs. The
                Uncontrolled Diabetes comorbidity category adjustment factor did not
                change from the current adjustment factor based on the 2019 through
                2021 regression.
                 We are also proposing to decrease the adjustment factors for the
                following comorbidity categories: Renal Failure--Acute, Artificial
                Openings--Digestive & Urinary, Cardiac conditions, Renal Failure--
                Chronic, Chronic Obstructive Pulmonary Disease, Infectious Diseases,
                and Severe Musculoskeletal & Connective Tissue Diseases.
                 The regression analysis found the Renal Failure--Acute, Artificial
                Openings--Digestive & Urinary, Cardiac conditions, Renal Failure--
                Chronic, Chronic Obstructive Pulmonary Disease, Infectious Diseases,
                and Severe Musculoskeletal & Connective Tissue Diseases comorbidity
                categories resulted in a statistically significant adjustment factor.
                While payment would still be increased when the claim includes one of
                these comorbidity categories, the proposed adjustment factors for FY
                2025 would be less than the current adjustment factors for these
                categories. The proposed FY 2025 comorbidity adjustment factors are
                displayed in Table 8, and can be found in Addendum A, available on the
                CMS website at https://www.cms.gov/medicare/payment/prospective-payment-systems/inpatient-psychiatric-facility/tools-and-worksheets.
                [[Page 23170]]
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                 As discussed in section III.F of this proposed rule, we are
                proposing to implement revisions to the comorbidity category
                adjustments budget-neutrally. A detailed discussion of the
                distributional impacts of these proposed changes is found in section
                VIII.C of this proposed rule.
                 We solicit comments on these proposed revisions to the comorbidity
                category adjustment factors. Lastly, we are proposing that if more
                recent data become available, we would use such data, if appropriate,
                to determine the final FY 2025 comorbidity category adjustment factors.
                (2) Proposed Coding Updates for FY 2025
                 For FY 2025, we are proposing to add 2 ICD-10-CM/PCS codes to the
                Oncology Treatment comorbidity category. The proposed FY 2025
                comorbidity codes are shown in Addenda B, available on the CMS website
                at https://www.cms.gov/medicare/payment/prospective-payment-systems/inpatient-psychiatric-facility/tools-and-worksheets.
                 In accordance with the policy established in the FY 2015 IPF PPS
                final rule (79 FR 45949 through 45952), we reviewed all new FY 2025
                ICD-10-CM codes to remove codes that were site ``unspecified'' in terms
                of laterality from the FY 2023 ICD-10-CM/PCS codes in instances where
                more specific codes are available. As we stated in the FY 2015 IPF PPS
                final rule, we believe that specific diagnosis codes that narrowly
                identify anatomical sites where disease, injury, or a condition exists
                should be used when coding patients' diagnoses whenever these codes are
                available. We finalized in the FY 2015 IPF PPS rule, that we would
                remove site ``unspecified'' codes from the IPF PPS ICD-10-CM/PCS codes
                in instances when laterality codes (site specified codes) are
                available, as the clinician should be able to identify a more specific
                diagnosis based on clinical assessment at the medical encounter. There
                were no proposed changes to the FY 2025 ICD-10-CM/PCS codes, therefore,
                we are not proposing to remove any of the new codes.
                c. Proposed Patient Age Adjustments
                 As explained in the RY 2005 IPF PPS final rule (69 FR 66922), we
                analyzed the impact of age on per diem cost by examining the age
                variable (range of ages) for payment adjustments. In general, we found
                that the cost per day increases with age. The older age groups are
                costlier than the under 45 age group, the differences in per diem cost
                increase for each successive age group, and the differences are
                statistically significant. While our regression analysis of CY 2019
                through CY 2021 data supports maintaining a payment adjustment factor
                based on age as was established in the RY 2005 IPF PPS final rule, the
                results suggest that revisions to the adjustment factor for age are
                warranted.
                 For FY 2025, we are proposing to revise the patient age adjustments
                as shown in Addendum A of this proposed rule, which is available on the
                CMS website at (see https://www.cms.gov/medicare/payment/prospective-payment-systems/inpatient-psychiatric-facility/tools-and-worksheets).
                We are proposing to adopt the patient age adjustments derived from the
                regression
                [[Page 23171]]
                model using a blended set of 2019 through 2021 data, as discussed in
                section III.C.3 of this proposed rule. Table 9 summarizes the current
                and proposed patient age adjustment factors for FY 2025. As discussed
                in section III.F of this proposed rule, we are proposing to implement
                this revision to the patient age adjustments budget-neutrally. A
                detailed discussion of the distributional impacts of this proposed
                change is found in section VIII.C of this proposed rule.
                 We solicit comment on these proposed revisions to the patient age
                adjustment factors. Lastly, we are proposing that if more recent data
                become available, we would use such data, if appropriate, to determine
                the final FY 2025 patient age adjustment factors.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.012
                d. Proposed Variable Per Diem Adjustments
                 We explained in the RY 2005 IPF PPS final rule (69 FR 66946) that
                the regression analysis indicated that per diem cost declines as the
                LOS increases. The variable per diem adjustments to the Federal per
                diem base rate account for ancillary and administrative costs that
                occur disproportionately in the first days after admission to an IPF.
                As discussed in the RY 2005 IPF PPS final rule, where a complete
                discussion of the variable per diem adjustments can be found, we used a
                regression analysis to estimate the average differences in per diem
                cost among stays of different lengths (69 FR 66947 through 66950). As a
                result of this analysis, we established variable per diem adjustments
                that begin on day 1 and decline gradually until day 21 of a patient's
                stay. For day 22 and thereafter, the variable per diem adjustment
                remains the same each day for the remainder of the stay. However, the
                adjustment applied to day 1 depends upon whether the IPF has a
                qualifying ED. If an IPF has a qualifying ED, it receives a 1.31
                adjustment factor for day 1 of each stay. If an IPF does not have a
                qualifying ED, it receives a 1.19 adjustment factor for day 1 of the
                stay. The ED adjustment is explained in more detail in section III.D.4
                of this proposed rule.
                 For FY 2025, we are proposing to revise the variable per diem
                adjustment factors as indicated in the table below, and shown in
                Addendum A to this rule, which is available on the CMS website at
                https://www.cms.gov/medicare/payment/prospective-payment-systems/inpatient-psychiatric-facility/tools-and-worksheets. We are proposing
                to increase the adjustment factors for days 1 through 9. As shown in
                Table 10, the results of the latest regression analysis indicate that
                there is not a statistically significant decrease in cost per day after
                day 10; therefore, we are proposing that days 10 and above would
                receive a 1.00 adjustment. Table 10 summarizes the current and proposed
                variable per diem adjustment factors for FY 2025. As discussed in
                section III.F of this proposed rule, we are proposing to implement this
                revision to the variable per diem adjustments budget-neutrally. A
                detailed discussion of the distributional impacts of this proposed
                change is found in section VIII.C of this proposed rule.
                 We solicit comments on these proposed revisions to the variable per
                diem adjustment factors. Lastly, we are proposing that if more recent
                data become available, we would use such data, if appropriate, to
                determine the
                [[Page 23172]]
                final FY 2025 variable per diem adjustment factors.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.013
                D. Proposed Updates to the IPF PPS Facility-Level Adjustments
                 The IPF PPS includes facility-level adjustments for the wage index,
                IPFs located in rural areas, teaching IPFs, cost of living adjustments
                for IPFs located in Alaska and Hawaii, and IPFs with a qualifying ED.
                We are proposing to use the existing regression-derived facility-level
                adjustment factors established in the RY 2005 IPF final rule for FY
                2025.
                 As previously discussed, in section I.A of this proposed rule, we
                are proposing to revise the methodology for determining payments under
                the IPF PPS as required by the CAA, 2023. We are not proposing changes
                to the facility-level adjustment factors for rural location and
                teaching status for FY 2025; however, section IV.A of this proposed
                rule includes a request for information regarding potential future
                updates to these facility-level adjustments. We are particularly
                interested in comments on the results of our updated regression
                analysis as they apply to facility-level adjustors.
                1. Wage Index Adjustment
                a. Background
                 As discussed in the RY 2007 IPF PPS final rule (71 FR 27061), and
                the RY 2009 IPF PPS (73 FR 25719) and RY 2010 IPF PPS notices (74 FR
                20373), to provide an adjustment for geographic wage levels, the labor-
                related portion of an IPF's payment is adjusted using an appropriate
                wage index. Currently, an IPF's geographic wage index value is
                determined based on the actual location of the IPF in an urban or rural
                area, as defined in Sec. 412.64(b)(1)(ii)(A) and (C).
                 Due to the variation in costs and because of the differences in
                geographic wage levels, in the RY 2005 IPF PPS final rule, we required
                that payment rates under the IPF PPS be adjusted by a geographic wage
                index. We proposed and finalized a policy to use the unadjusted, pre-
                floor, pre-reclassified IPPS hospital wage index to account for
                geographic differences in IPF labor costs. We implemented use of the
                pre-floor, pre-reclassified IPPS hospital wage data to compute the IPF
                wage index since there was not an IPF-specific wage index available. We
                believe that IPFs generally compete in the same labor market as IPPS
                hospitals therefore, the pre-floor, pre-reclassified IPPS hospital wage
                data should be reflective of labor costs of IPFs. We believe this pre-
                floor, pre-reclassified IPPS hospital wage index to be the best
                available data to use as proxy for an IPF-specific wage index. As
                discussed in the RY 2007 IPF PPS final rule (71FR 27061 through 27067),
                under the IPF PPS, the wage index is calculated using the IPPS wage
                index for the labor market area in which the IPF is located, without
                considering geographic reclassifications, floors, and other adjustments
                made to the wage index under the IPPS. For a complete description of
                these IPPS wage index adjustments, we refer readers to the FY 2019
                IPPS/LTCH PPS final rule (83 FR 41362 through 41390). Our wage index
                policy at Sec. 412.424(a)(2) provides that we use the best Medicare
                data available to estimate costs per day, including an appropriate wage
                index to adjust for wage differences.
                 When the IPF PPS was implemented in the RY 2005 IPF PPS final rule,
                with
                [[Page 23173]]
                an effective date of January 1, 2005, the pre-floor, pre-reclassified
                IPPS hospital wage index that was available at the time was the FY 2005
                pre-floor, pre-reclassified IPPS hospital wage index. Historically, the
                IPF wage index for a given RY has used the pre-floor, pre-reclassified
                IPPS hospital wage index from the prior FY as its basis. This has been
                due in part to the pre-floor, pre-reclassified IPPS hospital wage index
                data that were available during the IPF rulemaking cycle, where an
                annual IPF notice or IPF final rule was usually published in early May.
                This publication timeframe was relatively early compared to other
                Medicare payment rules because the IPF PPS follows a RY, which was
                defined in the implementation of the IPF PPS as the 12-month period
                from July 1 to June 30 (69 FR 66927). Therefore, the best available
                data at the time the IPF PPS was implemented was the pre-floor, pre-
                reclassified IPPS hospital wage index from the prior FY (for example,
                the RY 2006 IPF wage index was based on the FY 2005 pre-floor, pre-
                reclassified IPPS hospital wage index).
                 In the RY 2012 IPF PPS final rule, we changed the reporting year
                timeframe for IPFs from a RY to FY, which begins October 1 and ends
                September 30 (76 FR 26434 through 26435). In that FY 2012 IPF PPS final
                rule, we continued our established policy of using the pre-floor, pre-
                reclassified IPPS hospital wage index from the prior year (that is,
                from FY 2011) as the basis for the FY 2012 IPF wage index. This policy
                of basing a wage index on the prior year's pre-floor, pre-reclassified
                IPPS hospital wage index has been followed by other Medicare payment
                systems, such as hospice and inpatient rehabilitation facilities. By
                continuing with our established policy, we remained consistent with
                other Medicare payment systems.
                 In FY 2020, we finalized the IPF wage index methodology to align
                the IPF PPS wage index with the same wage data timeframe used by the
                IPPS for FY 2020 and subsequent years. Specifically, we finalized the
                use of the pre-floor, pre-reclassified IPPS hospital wage index from
                the FY concurrent with the IPF FY as the basis for the IPF wage index.
                For example, the FY 2020 IPF wage index was based on the FY 2020 pre-
                floor, pre-reclassified IPPS hospital wage index rather than on the FY
                2019 pre-floor, pre-reclassified IPPS hospital wage index.
                 We explained in the FY 2020 proposed rule (84 FR 16973), that using
                the concurrent pre-floor, pre-reclassified IPPS hospital wage index
                will result in the most up-to-date wage data being the basis for the
                IPF wage index. We noted that it would also result in more consistency
                and parity in the wage index methodology used by other Medicare payment
                systems. We indicated that the Medicare skilled nursing facility (SNF)
                PPS already used the concurrent IPPS hospital wage index data as the
                basis for the SNF PPS wage index. We proposed and finalized similar
                policies to use the concurrent pre-floor, pre-reclassified IPPS
                hospital wage index data in other Medicare payment systems, such as
                hospice and inpatient rehabilitation facilities. Thus, the wage
                adjusted Medicare payments of various provider types are based upon
                wage index data from the same timeframe. For FY 2025, we are proposing
                to continue to use the concurrent pre-floor, pre-reclassified IPPS
                hospital wage index as the basis for the IPF wage index.
                 In the FY 2023 IPF PPS final rule (87 FR 46856 through 46859), we
                finalized a permanent 5-percent cap on any decrease to a provider's
                wage index from its wage index in the prior year, and we stated that we
                would apply this cap in a budget neutral manner. In addition, we
                finalized a policy that a new IPF 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 IPF would not have a wage
                index in the prior FY. We amended the IPF PPS regulations at Sec.
                412.424(d)(1)(i) to reflect this permanent cap on wage index decreases.
                We refer readers to the FY 2023 IPF PPS final rule for a more detailed
                discussion about this policy.
                 We are proposing to apply the IPF wage index adjustment to the
                labor-related share of the national IPF PPS base rate and ECT payment
                per treatment. The proposed labor-related share of the IPF PPS national
                base rate and ECT payment per treatment is 78.8 percent in FY 2025.
                This percentage reflects the labor-related share of the 2021-based IPF
                market basket for FY 2025 and is 0.1 percentage point higher than the
                FY 2024 labor-related share (see section III.A.3 of this proposed
                rule).
                b. Office of Management and Budget (OMB) Bulletins
                (1) Background
                 The wage index used for the IPF PPS is calculated using the
                unadjusted, pre-reclassified and pre-floor IPPS wage index data and is
                assigned to the IPF based on the labor market area in which the IPF is
                geographically located. IPF labor market areas are delineated based on
                the Core-Based Statistical Area (CBSAs) established by the OMB.
                 Generally, OMB issues major revisions to statistical areas every 10
                years, based on the results of the decennial census. However, OMB
                occasionally issues minor updates and revisions to statistical areas in
                the years between the decennial censuses through OMB Bulletins. These
                bulletins contain information regarding CBSA changes, including changes
                to CBSA numbers and titles. OMB bulletins may be accessed online at
                https://www.whitehouse.gov/omb/information-for-agencies/bulletins/. In
                accordance with our established methodology, the IPF PPS has
                historically adopted any CBSA changes that are published in the OMB
                bulletin that corresponds with the IPPS hospital wage index used to
                determine the IPF wage index and, when necessary and appropriate, has
                proposed and finalized transition policies for these changes.
                 In the RY 2007 IPF PPS final rule (71 FR 27061 through 27067), we
                adopted the changes discussed in the OMB Bulletin No. 03-04 (June 6,
                2003), which announced revised definitions for Metropolitan Statistical
                Areas (MSAs), and the creation of Micropolitan Statistical Areas and
                Combined Statistical Areas. In adopting the OMB CBSA geographic
                designations in RY 2007, we did not provide a separate transition for
                the CBSA-based wage index since the IPF PPS was already in a transition
                period from TEFRA payments to PPS payments.
                 In the RY 2009 IPF PPS notice, we incorporated the CBSA
                nomenclature changes published in the most recent OMB bulletin that
                applied to the IPPS hospital wage index used to determine the current
                IPF wage index and stated that we expected to continue to do the same
                for all the OMB CBSA nomenclature changes in future IPF PPS rules and
                notices, as necessary (73 FR 25721).
                 Subsequently, CMS adopted the changes that were published in past
                OMB bulletins in the FY 2016 IPF PPS final rule (80 FR 46682 through
                46689), the FY 2018 IPF PPS rate update (82 FR 36778 through 36779),
                the FY 2020 IPF PPS final rule (84 FR 38453 through 38454), and the FY
                2021 IPF PPS final rule (85 FR 47051 through 47059). We direct readers
                to each of these rules for more information about the changes that were
                adopted and any associated transition policies.
                 As discussed in the FY 2023 IPF PPS final rule, we did not adopt
                OMB Bulletin 20-01, which was issued March 6, 2020, because we
                determined this bulletin had no material impact on
                [[Page 23174]]
                the IPF PPS wage index. This bulletin creates only one Micropolitan
                statistical area, and Micropolitan areas are considered rural for the
                IPF PPS wage index. That is, the constituent county of the new
                Micropolitan area was considered rural effective as of FY 2021 and
                would continue to be considered rural if we adopted OMB Bulletin 20-01.
                 Finally, on July 21, 2023, OMB issued Bulletin 23-01, which revises
                the CBSA delineations based on the latest available data from the 2020
                census. This bulletin contains information regarding updates of
                statistical area changes to CBSA titles, numbers, and county or county
                equivalents.
                (2) Proposed Implementation of New Labor Market Area Delineations
                 We believe it is important for the IPF PPS to use, as soon as is
                reasonably possible, the latest available labor market area
                delineations to maintain a more accurate and up-to-date payment system
                that reflects the reality of population shifts and labor market
                conditions. We believe that using the most current delineations would
                increase the integrity of the IPF PPS wage index system by creating a
                more accurate representation of geographic variations in wage levels.
                We have carefully analyzed the impacts of adopting the new OMB
                delineations and find no compelling reason to delay implementation.
                Therefore, we are proposing to implement the new OMB delineations as
                described in the July 21, 2023, OMB Bulletin No. 23-01, effective
                beginning with the FY 2025 IPF PPS wage index. We are proposing to
                adopt the updates to the OMB delineations announced in OMB Bulletin No.
                23-01 effective for FY 2025 under the IPF PPS.
                 As previously discussed, we finalized a 5-percent permanent cap on
                any decrease to a provider's wage index from its wage index in the
                prior year. For more information on the permanent 5-percent cap policy,
                we refer readers to the FY 2023 IPF PPS final rule (87 FR 46856 through
                46859). In addition, we are proposing to phase out the rural adjustment
                for IPFs that are transitioning from rural to urban based on these CBSA
                revisions, as discussed in section III.D.1.c. of this proposed rule.
                (a) Micropolitan Statistical Areas
                 OMB defines a ``Micropolitan Statistical Area'' as a CBSA
                associated with at least one urban cluster that has a population of at
                least 10,000, but less than 50,000 (75 FR 37252). We refer to these as
                Micropolitan Areas. After extensive impact analysis, consistent with
                the treatment of these areas under the IPPS as discussed in the FY 2005
                IPPS final rule (69 FR 49029 through 49032), we determined the best
                course of action would be to treat Micropolitan Areas as ``rural'' and
                include them in the calculation of each state's IPF PPS rural wage
                index. We refer readers to the FY 2007 IPF PPS final rule (71 FR 27064
                through 27065) for a complete discussion regarding treating
                Micropolitan Areas as rural. We are not proposing any changes to this
                policy for FY 2025.
                (b) Change to County-Equivalents in the State of Connecticut
                 The June 6, 2022 Census Bureau Notice (87 FR 34235 through 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 have evaluated the changes and
                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 to maintain
                consistency with OMB updates. We are providing the following crosswalk
                for each county in Connecticut with the current and proposed FIPS
                county and county-equivalent codes and CBSA assignments.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.014
                [[Page 23175]]
                (c) Urban Counties That Would Become Rural Under the Revised OMB
                Delineations
                 As previously discussed, we are proposing to implement the new OMB
                labor market area delineations (based upon OMB Bulletin No. 23-01)
                beginning in FY 2025. Our analysis shows that a total of 53 counties
                (and county equivalents) and 15 providers are located in areas that
                were previously considered part of an urban CBSA but would be
                considered rural beginning in FY 2025 under these revised OMB
                delineations. Table 12 lists the 53 urban counties that would be rural
                if we finalize our proposal to implement the revised OMB delineations.
                BILLING CODE 4120-01-P
                [[Page 23176]]
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                [[Page 23177]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.016
                 We are proposing that the wage data for all providers located in
                the counties listed above would now be considered rural, beginning in
                FY 2025, when calculating their respective state's rural wage index.
                This rural wage index value would also be used under the IPF PPS. We
                recognize that rural areas typically have lower area wage index values
                than urban areas, and providers located in these counties may
                experience a negative impact in their IPF payment due to the proposed
                adoption of the revised OMB delineations. However, as discussed in
                section III.D.1.c of this proposed rule, providers located in these
                counties would receive a rural adjustment beginning in FY 2025, which
                would mitigate the impact of decreases to the wage index for these
                providers. In addition, the permanent 5-percent cap on wage index
                decreases under the IPF PPS would further mitigate large wage index
                decreases for providers in these areas.
                (d) Rural Counties That Would Become Urban Under the Revised OMB
                Delineations
                 As previously discussed, we are proposing to implement the new OMB
                labor market area delineations (based upon OMB Bulletin No. 23-01)
                beginning in FY 2025. Analysis of these OMB labor market area
                delineations shows that a total of 54 counties (and county equivalents)
                and 10 providers are located in areas that were previously considered
                rural but would now be considered urban under the revised OMB
                delineations. Table 13 lists the 54 rural counties that would be urban
                if we finalize our proposal to implement the revised OMB delineations.
                [[Page 23178]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.017
                [[Page 23179]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.018
                 We are proposing that when calculating the area wage index,
                beginning with FY 2025, the wage data for providers located in these
                counties would be included in their new respective urban CBSAs.
                Typically, providers located in an urban area receive a wage index
                value higher than or equal to providers located in their state's rural
                area. We also note that providers located in these areas would no
                longer be considered rural beginning in FY 2025. We refer readers to
                section III.D.1.c of this proposed rule for a discussion of the
                proposed policy to phase out the payment of the rural adjustment for
                providers in these areas.
                (e) Urban Counties That Would Move to a Different Urban CBSA Under the
                New OMB Delineations
                 In certain cases, adopting the new 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 10540
                (Albany-Lebanon, OR) would experience a change to its name, and become
                CBSA 10540 (Albany, OR), while its one constituent county would remain
                the same. Table 14 shows the current CBSA code and our proposed CBSA
                code where we are proposing to change either the name or CBSA number
                only. We are not discussing further in this section these proposed
                changes because they are inconsequential changes with respect to the
                IPF PPS wage index.
                [[Page 23180]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.019
                 In some cases, if we adopt the new OMB delineations, counties would
                shift between existing and new CBSAs, changing the constituent makeup
                of the CBSAs. We consider this type of change, where CBSAs are split
                into multiple new CBSAs, or a CBSA loses one or more counties to
                another urban CBSA to be significant modifications.
                [[Page 23181]]
                 Table 15 lists the urban counties that would move from one urban
                CBSA to another newly proposed or modified CBSA if we adopted the new
                OMB delineations.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.020
                [[Page 23182]]
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                [[Page 23183]]
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                [[Page 23184]]
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                [[Page 23185]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.024
                [[Page 23186]]
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                [[Page 23187]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.026
                BILLING CODE 4120-01-C
                 We have identified 68 IPF providers located in the affected
                counties listed in Table 15. If providers located in these counties
                move from one CBSA to another under the revised OMB delineations, there
                may be impacts, either negative or positive, upon their specific wage
                index values.
                c. Proposed Adjustment for Rural Location
                 In the RY 2005 IPF PPS final rule, (69 FR 66954), we provided a 17-
                percent payment adjustment for IPFs located in a rural area. This
                adjustment was based on the regression analysis, which indicated that
                the per diem cost of rural facilities was 17-percent higher than that
                of urban facilities after accounting for the influence of the other
                variables included in the regression. This 17-percent adjustment has
                been part of the IPF PPS each year since the inception of the IPF PPS.
                As discussed earlier in this rule, we are proposing a number of
                revisions to the patient-level adjustment factors as well as changes to
                the CBSA
                [[Page 23188]]
                delineations. In order to minimize the scope of changes that would
                impact providers in any single year, we are proposing to use the
                existing regression-derived adjustment factor, which was established in
                RY 2005, for FY 2025 for IPFs located in a rural area as defined at
                Sec. 412.64(b)(1)(ii)(C). See 69 FR 66954 for a complete discussion of
                the adjustment for rural locations. However, as discussed in the
                section IV.A of this FY 2025 IPF PPS proposed rule, we have completed
                analysis of more recent cost and claims information and are soliciting
                comments on those results.
                 As proposed earlier in this proposed rule, the adoption of OMB
                Bulletin No. 23-01 in accordance with our established methodology would
                determine whether a facility is classified as urban or rural for
                purposes of the rural payment adjustment in the IPF PPS. Overall, we
                believe implementing updated OMB delineations would result in the rural
                payment adjustment being applied where it is appropriate to adjust for
                higher costs incurred by IPFs in rural locations. However, we recognize
                that implementing these changes would have distributional effects among
                IPF providers, and that some providers would experience a loss of the
                rural payment adjustment because of our proposals. Therefore, we
                believe it would be appropriate to consider, as we have in the past,
                whether a transition period should be used to implement these proposed
                changes.
                 Prior changes to the CBSA delineations have included a phase-out
                policy for the rural adjustment for IPFs transitioning from rural to
                urban status. On February 28, 2013, OMB issued OMB Bulletin No. 13-01,
                which 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. We
                adopted these new OMB CBSA delineations in the FY 2016 IPF final rule
                (80 FR 46682 through 46689), and identified 105 counties and 37 IPFs
                that would move from rural to urban status due to the new CBSA
                delineations. To reduce the impact of the loss of the 17-percent rural
                adjustment, we adopted a budget-neutral 3-year phase-out of the rural
                adjustment for existing FY 2015 rural IPFs that became urban in FY 2016
                and that experienced a loss in payments due to changes from the new
                CBSA delineations. These IPFs received two-thirds of the rural
                adjustment for FY 2016 and one-third of the rural adjustment in FY
                2017. For FY 2018, these IPFs did not receive a rural adjustment.
                 For subsequent adoptions of OMB Bulletin No. 15-01 for FY 2018 (82
                FR 36779 through 36780), OMB Bulletin 17-01 for FY 2020 (84 FR 38453
                through 38454), and OMB Bulletin 18-04 for FY 2021 (85 FR 47053 through
                47059), we identified that fewer providers were affected by these
                changes than by the changes relating to the adoption of OMB Bulletin
                13-01. We did not phase out the rural adjustment when adopting these
                delineation changes.
                 For facilities located in a county that transitioned from rural to
                urban in Bulletin 23-01, we considered whether it would be appropriate
                to phase out the rural adjustment for affected providers consistent
                with our past practice of using transition policies to help mitigate
                negative impacts on hospitals of OMB Bulletin proposals that have a
                material effect on a number of IPFs. Adoption of the updated CBSAs in
                Bulletin 23-01 will change the status of 10 IPF providers currently
                designated as ``rural'' to ``urban'' for FY 2025 and subsequent fiscal
                years. As such, these 10 newly urban providers will no longer receive
                the 17-percent rural adjustment. Consistent with the transition policy
                adopted for IPFs in FY 2016 (80 FR 46682 through 4668980 FR 46682
                through 46689), we are proposing a 3-year budget neutral phase-out of
                the rural adjustment for IPFs located in the 54 rural counties that
                will become urban under the new OMB delineations, given the potentially
                significant payment impacts for these IPFs. We believe that a phase-out
                of the rural adjustment transition period for these 10 IPFs
                specifically is appropriate because we expect these IPFs will
                experience a steeper and more abrupt reduction in their payments
                compared to other IPFs. Therefore, we are proposing to phase out the
                rural adjustment for these providers to reduce the impact of the loss
                of the FY 2024 rural adjustment of 17-percent over FYs 2025, 2026, and
                2027. This policy would allow IPFs that are classified as rural in FY
                2024 and would be classified as urban in FY 2025 to receive two-thirds
                of the rural adjustment for FY 2025. For FY 2026, these IPFs would
                receive one-third of the rural adjustment. For FY 2027, these IPFs
                would not receive a rural adjustment. We believe a 3-year budget-
                neutral phase-out of the rural adjustment for IPFs 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 IPFs. The purpose of the gradual phase-out of
                the rural adjustment for these providers is to mitigate potential
                payment reductions and promote stability and predictability in payments
                for existing rural IPFs 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 re-designation. This policy would be
                specifically for rural IPFs that become urban in FY 2025. We are not
                proposing a transition policy for urban IPFs that become rural in FY
                2025 because these IPFs will receive the full rural adjustment of 17-
                percent beginning October 1, 2024. We solicit comments on this proposed
                policy.
                d. Proposed Wage Index Budget Neutrality Adjustment
                 Changes to the wage index are made in a budget neutral manner so
                that updates do not increase expenditures. Therefore, for FY 2025, we
                are proposing to continue to apply a budget neutrality adjustment in
                accordance with our existing budget neutrality policy. This policy
                requires us to update the wage index in such a way that total estimated
                payments to IPFs 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 IPF PPS rates. We are proposing to use the following
                steps to ensure that the rates reflect the FY 2025 update to the wage
                indexes (based on the FY 2021 hospital cost report data) and the labor-
                related share in a budget neutral manner:
                 Step 1: Simulate estimated IPF PPS payments, using the FY 2024 IPF
                wage index values (available on the CMS website) and labor-related
                share (as published in the FY 2024 IPF PPS final rule (88 FR 51054).
                 Step 2: Simulate estimated IPF PPS payments using the proposed FY
                2025 IPF wage index values (available on the CMS website), and the
                proposed FY 2025 labor-related share (based on the latest available
                data as discussed previously).
                 Step 3: Divide the amount calculated in step 1 by the amount
                calculated in step 2. The resulting quotient is the proposed FY 2025
                budget neutral wage adjustment factor of 0.9995.
                 Step 4: Apply the FY 2025 budget neutral wage adjustment factor
                from step 3 to the FY 2024 IPF PPS Federal per diem base rate after the
                application of the IPF market basket increase reduced by the
                productivity adjustment described in section III.A of this proposed
                rule to determine the FY 2025 IPF PPS Federal per diem base rate. As
                discussed in section III.F of this proposed rule, we are also proposing
                to apply a refinement standardization
                [[Page 23189]]
                factor to determine the FY 2025 IPF PPS Federal per diem base rate.
                2. Proposed Teaching Adjustment
                Background
                 In the RY 2005 IPF PPS final rule, we implemented regulations at
                Sec. 412.424(d)(1)(iii) to establish a facility-level adjustment for
                IPFs that are, or are part of, teaching hospitals. The teaching
                adjustment accounts for the higher indirect operating costs experienced
                by hospitals that participate in graduate medical education (GME)
                programs. The payment adjustments are made based on the ratio of the
                number of fulltime equivalent (FTE) interns and residents training in
                the IPF and the IPF's average daily census.
                 Medicare makes direct GME payments (for direct costs such as
                resident and teaching physician salaries, and other direct teaching
                costs) to all teaching hospitals including those paid under a PPS and
                those paid under the TEFRA rate-of-increase limits. These direct GME
                payments are made separately from payments for hospital operating costs
                and are not part of the IPF PPS. The direct GME payments do not address
                the estimated higher indirect operating costs teaching hospitals may
                face.
                 The results of the regression analysis of FY 2002 IPF data
                established the basis for the payment adjustments included in the RY
                2005 IPF PPS final rule. The results showed that the indirect teaching
                cost variable is significant in explaining the higher costs of IPFs
                that have teaching programs. We calculated the teaching adjustment
                based on the IPF's ``teaching variable,'' which is (1 + [the number of
                FTE residents training in the IPF's average daily census]). The
                teaching variable is then raised to the 0.5150 power to result in the
                teaching adjustment. This formula is subject to the limitations on the
                number of FTE residents, which are described in this section of this
                proposed rule.
                 We established the teaching adjustment in a manner that limited the
                incentives for IPFs to add FTE residents for the purpose of increasing
                their teaching adjustment. We imposed a cap on the number of FTE
                residents that may be counted for purposes of calculating the teaching
                adjustment. The cap limits the number of FTE residents that teaching
                IPFs may count for the purpose of calculating the IPF PPS teaching
                adjustment, not the number of residents teaching institutions can hire
                or train. We calculated the number of FTE residents that trained in the
                IPF during a ``base year'' and used that FTE resident number as the
                cap. An IPF's FTE resident cap is ultimately determined based on the
                final settlement of the IPF's most recent cost report filed before
                November 15, 2004 (69 FR 66955). A complete discussion of the temporary
                adjustment to the FTE cap to reflect residents due to hospital closure
                or residency program closure appears in the RY 2012 IPF PPS proposed
                rule (76 FR 5018 through 5020) and the RY 2012 IPF PPS final rule (76
                FR 26453 through 26456).
                 In the regression analysis that informed the FY 2004 IPF PPS final
                rule, the logarithm of the teaching variable had a coefficient value of
                0.5150. We converted this cost effect to a teaching payment adjustment
                by treating the regression coefficient as an exponent and raising the
                teaching variable to a power equal to the coefficient value. We note
                that the coefficient value of 0.5150 was based on the regression
                analysis holding all other components of the payment system constant. A
                complete discussion of how the teaching adjustment was calculated
                appears in the RY 2005 IPF PPS final rule (69 FR 66954 through 66957)
                and the RY 2009 IPF PPS notice (73 FR 25721).
                 We are proposing to retain the coefficient value of 0.5150 for the
                teaching adjustment to the Federal per diem base rate as we are not
                proposing refinements to the facility-level payment adjustments for
                rural location or teaching status for FY 2025. As noted earlier, given
                the scope of changes to the wage index and patient-level adjustment
                factors, we believe this will minimize the total impacts to providers
                in any given year.
                3. Proposed Cost of Living Adjustment for IPFs Located in Alaska and
                Hawaii
                 The IPF PPS includes a payment adjustment for IPFs located in
                Alaska and Hawaii based upon the area in which the IPF is located. As
                we explained in the RY 2005 IPF PPS final rule, the FY 2002 data
                demonstrated that IPFs in Alaska and Hawaii had per diem costs that
                were disproportionately higher than other IPFs. As a result of this
                analysis, we provided a COLA in the RY 2005 IPF PPS final rule. We
                refer readers to the FY 2024 IPF PPS final rule for a complete
                discussion of the currently applicable COLA factors (88 FR 51088
                through 51089).
                 We adopted a new methodology to update the COLA factors for Alaska
                and Hawaii for the IPF PPS in the FY 2015 IPF PPS final rule (79 FR
                45958 through 45960). For a complete discussion, we refer readers to
                the FY 2015 IPF PPS final rule.
                 We also specified that the COLA updates would be determined every 4
                years, in alignment with the IPPS market basket labor-related share
                update (79 FR 45958 through 45960). Because the labor-related share of
                the IPPS market basket was updated for FY 2022, the COLA factors were
                updated in FY 2022 IPPS/LTCH rulemaking (86 FR 45547). As such, we also
                finalized an update to the IPF PPS COLA factors to reflect the updated
                COLA factors finalized in the FY 2022 IPPS/LTCH rulemaking effective
                for FY 2022 through FY 2025 (86 FR 42621 through 42622). This is
                reflected in Table 16 below. We are proposing to maintain the COLA
                factors in Table 16 for FY 2025 in alignment with the policy described
                in this paragraph.
                [[Page 23190]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.027
                 The proposed IPF PPS COLA factors for FY 2025 are also shown in
                Addendum A to this proposed rule, which is available on the CMS website
                at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientPsychFacilPPS/tools.html.
                4. Proposed Adjustment for IPFs With a Qualifying ED
                 The IPF PPS includes a facility-level adjustment for IPFs with
                qualifying EDs. As defined in Sec. 412.402, qualifying emergency
                department means an emergency department that is staffed and equipped
                to furnish a comprehensive array of emergency services and meets the
                requirements of 42 CFR 489.24(b) and Sec. 413.65.
                 We provide an adjustment to the Federal per diem base rate to
                account for the costs associated with maintaining a full-service ED.
                The adjustment is intended to account for ED costs incurred by a
                psychiatric hospital with a qualifying ED, or an excluded psychiatric
                unit of an IPPS hospital or a critical access hospital (CAH), and the
                overhead cost of maintaining the ED. This payment applies to all IPF
                admissions (with one exception which we describe in this section),
                regardless of whether the patient was admitted through the ED. The ED
                adjustment is made on every qualifying claim except as described in
                this section of this proposed rule. As specified at Sec.
                412.424(d)(1)(v)(B), the ED adjustment is not made when a patient is
                discharged from an IPPS hospital or CAH, and admitted to the same IPPS
                hospital's or CAH's excluded psychiatric unit. We clarified in the RY
                2005 IPF PPS final rule (69 FR 66960) that an ED adjustment is not made
                in this case because the costs associated with ED services are
                reflected in the DRG payment to the IPPS hospital or through the
                reasonable cost payment made to the CAH.
                a. Proposed Update for FY 2025
                 For FY 2025, we are proposing to update the adjustment factor from
                1.31 to 1.53 for IPFs with qualifying EDs using the same methodology
                used to determine ED adjustments in prior years. Thus, we are proposing
                to use the following steps, as used in prior years, to calculate the
                updated ED adjustment factor. (A complete discussion of the steps
                involved in the calculation of the ED adjustment factors can be found
                in the RY 2005 IPF PPS final rule (69 FR 66959 through 66960) and the
                RY 2007 IPF PPS final rule (71 FR 27070 through 27072).)
                 Step 1: Estimate the proportion by which the ED costs of a stay
                would increase the cost of the first day of the stay. Using the IPFs
                with ED admissions in years 2019 through 2021, we divided the average
                ED cost per stay when admitted through the ED ($519.97) by the average
                cost per day ($1,338.93), which equals 0.39.
                 Step 2: Adjust the factor estimated in step 1 to account for the
                fact that we would pay the higher first day adjustment for all cases in
                the qualifying IPFs, not just the cases admitted through the ED. Since
                on average, 66 percent of the cases in IPFs with ED admissions are
                admitted through the ED, we multiplied 0.39 by 0.66, which equals 0.26.
                 Step 3: Add the adjusted factor calculated in the previous 2 steps
                to the variable per diem adjustment derived from the regression
                equation that we used to derive our other payment adjustment factors.
                As discussed in section III.C.4.d. of this proposed rule, the proposed
                first day payment factor for FY 2025 is 1.27. Adding 0.26, we obtained
                a first day variable per adjustment for IPFs with a qualifying ED equal
                to 1.53.
                 The ED adjustment is incorporated into the variable per diem
                adjustment for the first day of each stay for IPFs with a qualifying
                ED. We are proposing that those IPFs with a qualifying ED would receive
                an adjustment factor of 1.53 as the variable per diem adjustment for
                day 1 of each patient stay. If an IPF does not have a qualifying ED, we
                are proposing that it would receive an adjustment factor of 1.27 as the
                variable per diem adjustment for day 1 of each patient stay, as
                discussed in section III.C.4.d. of this proposed rule. As discussed in
                section III.F of this proposed rule, we are proposing to implement this
                revision to the ED adjustment budget--neutrally by applying a
                refinement standardization factor. A detailed discussion of the
                distributional impacts of this proposed change is found in section
                VIII.C of this proposed rule.
                 We solicit comment on this proposal. Lastly, we are proposing that
                if more recent data become available, we would use such data, if
                appropriate, to determine the FY 2025 ED adjustment factor.
                b. Alternatives Considered
                 In response to the FY 2023 IPF PPS proposed rule (87 FR 19428
                through 19429) comment solicitation on our technical report describing
                the analysis of IPF PPS adjustments, two
                [[Page 23191]]
                commenters requested that we conduct further analysis related to the
                exception for the ED adjustment. These commenters indicated that
                patients transferred to an IPF from an acute care unit or hospital
                often have higher costs per stay than patients with similar
                comorbidities admitted from the community. Commenters requested that
                CMS analyze data related to source of admission and consider a payment
                adjustment to account for the resources used by these patients. In
                response to these comments, we conducted a regression analysis to
                investigate whether the source of admission is a statistically
                significant variable in the cost of a patient's care in an IPF. We
                analyzed the following sources of admission: clinic referral, transfer
                from hospital (different facility), transfer from a SNF or Intermediate
                Care Facility (ICF), transfer from another health care facility, court/
                law enforcement, information not available, transfer from hospital
                inpatient in the same facility, transfer from ambulatory surgical
                center, and transfer from hospice. In this context, it is important to
                note that the source of admission indicator ``court/law enforcement''
                is not the equivalent of an involuntary admission; we do not currently
                collect data on involuntary admissions.
                 The regression analysis found that the source of admission was not
                a statistically significant factor in the cost of care. The results for
                the two source of admission variables that indicate higher costs
                (transfer from hospital inpatient in the same facility and transfer
                from ambulatory surgical center) are accounted for by the known
                difference in cost structures between hospital psychiatric units and
                freestanding psychiatric hospitals. We considered the results of our
                analysis, as well as the potential that adjusting payment based on
                source of admission could inadvertently create incentives for IPFs to
                prioritize certain admissions over others. Based on these
                considerations, we are not proposing to add additional payment
                adjustments based on source of admission (other than the existing
                adjustment for a qualifying ED) to the IPF PPS in FY 2025.
                E. Other Proposed Payment Adjustments and Policies
                1. Outlier Payment Overview
                 The IPF PPS includes an outlier adjustment to promote access to IPF
                care for those patients who require expensive care and to limit the
                financial risk of IPFs treating unusually costly patients. In the RY
                2005 IPF PPS final rule, we implemented regulations at Sec.
                412.424(d)(3)(i) to provide a per case payment for IPF stays that are
                extraordinarily costly. Providing additional payments to IPFs for
                extremely costly cases strongly improves the accuracy of the IPF PPS in
                determining resource costs at the patient and facility level. These
                additional payments reduce the financial losses that would otherwise be
                incurred in treating patients who require costlier care; therefore,
                reduce the incentives for IPFs to under-serve these patients. We make
                outlier payments for discharges in which an IPF's estimated total cost
                for a case exceeds a fixed dollar loss threshold amount (multiplied by
                the IPF's facility-level adjustments) plus the federal per diem payment
                amount for the case.
                 In instances when the case qualifies for an outlier payment, we pay
                80 percent of the difference between the estimated cost for the case
                and the adjusted threshold amount for days 1 through 9 of the stay
                (consistent with the median LOS for IPFs in FY 2002), and 60 percent of
                the difference for day 10 and thereafter. The adjusted threshold amount
                is equal to the outlier threshold amount adjusted for wage area,
                teaching status, rural area, and the COLA adjustment (if applicable),
                plus the amount of the Medicare IPF payment for the case. We
                established the 80 percent and 60 percent loss sharing ratios because
                we were concerned that a single ratio established at 80 percent (like
                other Medicare PPSs) might provide an incentive under the IPF per diem
                payment system to increase LOS to receive additional payments.
                 After establishing the loss sharing ratios, we determined the
                current fixed dollar loss threshold amount through payment simulations
                designed to compute a dollar loss beyond which payments are estimated
                to meet the 2 percent outlier spending target. Each year when we update
                the IPF PPS, we simulate payments using the latest available data to
                compute the fixed dollar loss threshold so that outlier payments
                represent 2 percent of total estimated IPF PPS payments.
                2. Proposed Update to the Outlier Fixed Dollar Loss Threshold Amount
                 In accordance with the update methodology described in Sec.
                412.428(d), we are proposing to update the fixed dollar loss threshold
                amount used under the IPF PPS outlier policy. Based on the regression
                analysis and payment simulations used to develop the IPF PPS, we
                established a 2 percent outlier policy, which strikes an appropriate
                balance between protecting IPFs from extraordinarily costly cases while
                ensuring the adequacy of the federal per diem base rate for all other
                cases that are not outlier cases. We are proposing to maintain the
                established 2 percent outlier policy for FY 2025.
                 Our longstanding methodology for updating the outlier fixed dollar
                loss threshold involves using the best available data, which is
                typically the most recent available data. We note that for FY 2022 and
                FY 2023 only, we made certain methodological changes to our modeling of
                outlier payments, and we discussed the specific circumstances that led
                to those changes for those years (86 FR 42623 through 42624; 87 FR
                46862 through 46864). We direct readers to the FY 2022 and FY 2023 IPF
                PPS proposed and final rules for a more complete discussion.
                 We are proposing to update the IPF outlier threshold amount for FY
                2025 using FY 2023 claims data and the same methodology that we have
                used to set the initial outlier threshold amount each year beginning
                with the RY 2007 IPF PPS final rule (71 FR 27072 and 27073). For this
                FY 2025 IPF PPS rulemaking, consistent with our longstanding practice,
                based on an analysis of the latest available data (the December 2023
                update of FY 2023 IPF claims) and rate increases, we believe it is
                necessary to update the fixed dollar loss threshold amount to maintain
                an outlier percentage that equals 2 percent of total estimated IPF PPS
                payments. Based on an analysis of these updated data, we estimate that
                IPF outlier payments as a percentage of total estimated payments are
                approximately 2.1 percent in FY 2024. Therefore, we are proposing to
                update the outlier threshold amount to $35,590 to maintain estimated
                outlier payments at 2 percent of total estimated aggregate IPF payments
                for FY 2025. This proposed rule update is an increase from the FY 2024
                threshold of $33,470.
                 Lastly, we are proposing that if more recent data become available
                for the FY 2025 IPF PPS final rule, we would use such data as
                appropriate to determine the final outlier fixed dollar loss threshold
                amount for FY 2025.
                3. Proposed Update to IPF Cost-to-Charge Ratio Ceilings
                 Under the IPF PPS, an outlier payment is made if an IPF's cost for
                a stay exceeds a fixed dollar loss threshold amount plus the IPF PPS
                amount. To establish an IPF's cost for a particular case, we multiply
                the IPF's reported charges on the discharge bill by its overall cost-
                to-charge ratio (CCR). This approach to determining an IPF's cost is
                consistent with the approach
                [[Page 23192]]
                used under the IPPS and other PPSs. In the FY 2004 IPPS final rule (68
                FR 34494), we implemented changes to the IPPS policy used to determine
                CCRs for IPPS hospitals, because we became aware that payment
                vulnerabilities resulted in inappropriate outlier payments. Under the
                IPPS, we established a statistical measure of accuracy for CCRs to
                ensure that aberrant CCR data did not result in inappropriate outlier
                payments.
                 As indicated in the RY 2005 IPF PPS final rule (69 FR 66961), we
                believe that the IPF outlier policy is susceptible to the same payment
                vulnerabilities as the IPPS; therefore, we adopted a method to ensure
                the statistical accuracy of CCRs under the IPF PPS. Specifically, we
                adopted the following procedure in the RY 2005 IPF PPS final rule:
                 Calculated two national ceilings, one for IPFs located in
                rural areas and one for IPFs located in urban areas.
                 Computed the ceilings by first calculating the national
                average and the standard deviation of the CCR for both urban and rural
                IPFs using the most recent CCRs entered in the most recent Provider
                Specific File (PSF) available.
                 For FY 2025, we are proposing to continue following this
                methodology. To determine the rural and urban ceilings, we multiplied
                each of the standard deviations by 3 and added the result to the
                appropriate national CCR average (either rural or urban). The proposed
                upper threshold CCR for IPFs in FY 2025 is 2.3362 for rural IPFs, and
                1.8600 for urban IPFs, based on current CBSA-based geographic
                designations. If an IPF's CCR is above the applicable ceiling, the
                ratio is considered statistically inaccurate, and we assign the
                appropriate national (either rural or urban) median CCR to the IPF.
                 We apply the national median CCRs to the following situations:
                 New IPFs that have not yet submitted their first Medicare
                cost report. We continue to use these national median CCRs until the
                facility's actual CCR can be computed using the first tentatively or
                final settled cost report.
                 IPFs whose overall CCR is in excess of three standard
                deviations above the corresponding national geometric mean (that is,
                above the ceiling).
                 Other IPFs for which the Medicare Administrative
                Contractor (MAC) obtains inaccurate or incomplete data with which to
                calculate a CCR.
                 We are proposing to update the FY 2025 national median and ceiling
                CCRs for urban and rural IPFs based on the CCRs entered in the latest
                available IPF PPS PSF.
                 Specifically, for FY 2025, to be used in each of the three
                situations listed previously, using the most recent CCRs entered in the
                CY 2023 PSF, we provide an estimated national median CCR of 0.5720 for
                rural IPFs and a national median CCR of 0.4200 for urban IPFs. These
                calculations are based on the IPF's location (either urban or rural)
                using the current CBSA-based geographic designations. A complete
                discussion regarding the national median CCRs appears in the RY 2005
                IPF PPS final rule (69 FR 66961 through 66964).
                 Lastly, we are proposing that if more recent data become available,
                we would use such data to calculate the rural and urban national median
                and ceiling CCRs for FY 2025.
                4. Requirements for Reporting Ancillary Charges and All-Inclusive
                Status Eligibility Under the IPF PPS
                a. Background
                 As discussed in section III.E.4.b of this proposed rule, to analyze
                variation in cost between patients with different characteristics, it
                is crucial for us to have complete cost information about each patient,
                including data on ancillary services provided. Currently, IPFs and
                psychiatric units are required to report ancillary charges on cost
                reports. As specified at 42 CFR 413.20, hospitals are required to file
                cost reports on an annual basis and maintain sufficient financial
                records and statistical data for proper determination of costs payable
                under the Medicare program.
                 However, our ongoing analysis has found a notable increase in the
                number of IPFs, specifically for-profit freestanding IPFs, that appear
                to be erroneously identifying on form CMS-2552-10, Worksheet S-2, Part
                I, line 115, as eligible for filing all-inclusive cost reports. These
                hospitals identifying as eligible for filing all-inclusive cost reports
                (indicating that they have one charge covering all services) are
                consistently reporting no ancillary charges or very minimal ancillary
                charges and are not using charge information to apportion costs in
                their cost report. Generally, based on the nature of IPF services and
                the conditions of participation applicable to IPFs, we expect to see
                ancillary services and correlating charges, such as labs and drugs, on
                most IPF claims.\3\
                ---------------------------------------------------------------------------
                 \3\ IPFs are subject to all hospital conditions of
                participation, including 42 CFR 482.25, which specifies that ``The
                hospital must have pharmaceutical services that meet the needs of
                the patients,'' and 482.27, which specifies that ``The hospital must
                maintain, or have available, adequate laboratory services to meet
                the needs of its patients.''
                ---------------------------------------------------------------------------
                 In the FY 2016 IPF PPS final rule (80 FR 46693 through 46694), we
                discussed analysis conducted to better understand IPF industry
                practices for future IPF PPS refinements. This analysis revealed that
                in 2012 to 2013, over 20 percent of IPF stays show no reported
                ancillary charges, such as laboratory and drug charges, on claims. In
                the FY 2016 IPF PPS final rule (80 FR 46694), FY 2017 IPF PPS final
                rule (81 FR 50513), FY 2018 IPF PPS final rule (82 FR 36784), FY 2019
                IPF PPS final rule (83 FR 38588), and FY 2020 IPF PPS final rule (84 FR
                38458), we reminded providers that we only pay the IPF for services
                furnished to a Medicare beneficiary who is an inpatient of that IPF,
                except for certain professional services, and payments are considered
                to be payments in full for all inpatient hospital services provided
                directly or under arrangement (see 42 CFR 412.404(d)), as specified in
                42 CFR 409.10.
                 On November 17, 2017, we issued Transmittal 12, which made changes
                to the hospital cost report form CMS-2552-10 (OMB No. 0938-0050) and
                included cost report level 1 edit 10710S, effective for cost reporting
                periods ending on or after August 31, 2017. Edit 10710S required that
                cost reports from psychiatric hospitals include certain ancillary costs
                or the cost report will be rejected. On January 30, 2018, we issued
                Transmittal 13, which changed the implementation date for Transmittal
                12 to be for cost reporting periods ending on or after September 30,
                2017. CMS suspended edit 10710S effective April 27, 2018, pending
                evaluation of the application of the edit to all-inclusive rate
                providers. We issued Transmittal 15 on October 19, 2018, reinstating
                the requirement that cost reports from psychiatric hospitals, except
                all-inclusive rate providers, include certain ancillary costs. This
                requirement is still currently in place. For details, we refer readers
                to see these Transmittals, which are available on the CMS website at
                https://www.cms.gov/medicare/regulations-guidance/transmittals.
                 Under IPF PPS regulations at 42 CFR 412.404(e), all inpatient
                psychiatric facilities paid under the IPF PPS must meet the
                recordkeeping and cost reporting requirements as specified at Sec.
                413.24. Historically, in accordance with Sec. 413.24(a)(1), most
                hospitals that were approved to file all-inclusive cost reports were
                Indian Health Services (IHS) hospitals, government-owned psychiatric
                and acute care hospitals, and nominal charge hospitals. Although IPFs
                are no longer reimbursed on the basis of reasonable costs, we continue
                to expect that most IPFs, other than government-owned or tribally owned
                [[Page 23193]]
                IPFs, should report cost data that is based on an approved method of
                cost finding and on the accrual basis of accounting. The option to
                elect to file an all-inclusive rate cost report is limited to providers
                that do not have a charge structure and that, therefore, must use an
                alternative statistic to apportion costs associated with services
                rendered to Medicare beneficiaries.
                 Current cost reporting rules allow hospitals that do not have a
                charge structure to file an all-inclusive cost report using an
                alternative cost allocation method. We refer readers to the Provider
                Reimbursement Manual (PRM) 15-1; chapter 22, Sec. 2208 for detailed
                information on the requirements to file an alternative method.
                b. Challenges Related to Missing IPF Ancillary Cost Data
                 In general, most providers allocate their Medicare costs using
                costs and charges as described at Sec. 413.53(a)(1)(i) and referred to
                as the Departmental Method, which is the ratio of beneficiary charges
                to total patient charges for the services of each ancillary department.
                For cost reporting periods beginning on or after October 1, 1982, the
                cost report uses the Departmental Method to apportion the cost of the
                department to the Medicare program. Added to this amount is the cost of
                routine services for Medicare beneficiaries, determined based on a
                separate average cost per diem for all patients for general routine
                patient care areas as required at Sec. 413.53(a)(1)(i) and (e); and
                15-1, chapter 22, Sec. 2200.1.\4\
                ---------------------------------------------------------------------------
                 \4\ IPFs are subject to all hospital conditions of
                participation, including 42 CFR 482.25, which specifies that ``The
                hospital must have pharmaceutical services that meet the needs of
                the patients,'' and 482.27, which specifies that ``The hospital must
                maintain, or have available, adequate laboratory services to meet
                the needs of its patients.''
                ---------------------------------------------------------------------------
                 We use cost-to-charge ratios (CCRs) from Medicare cost reports as
                the method of establishing reasonable costs for hospital services and
                as the basis for ratesetting for several hospital prospective payment
                systems. In general, detailed ancillary cost and charge information is
                necessary for accurate Medicare ratesetting. When hospitals identify as
                all-inclusive, they are excluded from ratesetting because they do not
                have CCRs but use an alternative basis for apportioning costs. When
                hospitals erroneously identify as all-inclusive but have a charge
                structure, data that is necessary for accurate Medicare ratesetting is
                improperly excluded.
                 Since the issuance of Transmittal 15, we have continued to identify
                an increase in the number of IPFs, specifically for-profit freestanding
                IPFs, that appear to be erroneously identifying on form CMS- 2552-10,
                Worksheet S-2, Part I, line 115, as filing all-inclusive cost reports.
                In conjunction with the FY 2023 IPF PPS proposed rule (87 FR 19428
                through 19429), we posted a report on the CMS website that summarizes
                the results of the latest analysis of more recent IPF cost and claim
                information for potential IPF PPS adjustments and requested comments
                about the results summarized in the report. The report showed that
                approximately 23 percent of IPF stays were trimmed from the data set
                used in that analysis because they were stays at facilities where fewer
                than 5 percent of their stays had ancillary charges. The report is
                available on the CMS website at https://www.cms.gov/medicare/payment/prospective-payment-systems/inpatient-psychiatric-facility/ipf-reports-and-educational-resources.
                 Section 4125 of the CAA, 2023 authorizes the Secretary to collect
                data and information, specifically including charges related to
                ancillary services, as appropriate to inform revisions to the IPF PPS.
                 In the FY 2024 IPF PPS proposed rule (88 FR 21270 through 21272),
                we included a request for information (RFI) related to the reporting of
                charges for ancillary services, such as labs and drugs, on IPF claims.
                We were interested in better understanding IPF industry practices
                pertaining to the billing and provision of ancillary services to inform
                statutorily mandated IPF PPS refinements. We stated that we were
                considering whether to require charges for ancillary services to be
                reported on claims and potentially reject claims if no ancillary
                services are reported, and whether to consider payment for such claims
                to be inappropriate or erroneous and subject to recoupment.
                 In response to the comment solicitation, we received a comment from
                MedPAC regarding facilities that do not report ancillary charges on
                most or any of their claims. MedPAC stated that it is not known:
                whether IPFs fail to report ancillary charges separately because they
                were appropriately bundled with all other charges into an all-inclusive
                per diem rate; if no ancillary charges were incurred because the IPF
                cares for a patient mix with lower care needs or inappropriately fails
                to furnish the kinds of care reflected in ancillary charges when
                medically necessary; or if ancillary charges for services furnished
                during the IPF stay are inappropriately billed outside of the IPF base
                rate (unbundling). MedPAC recommended CMS conduct further investigation
                into the lack of certain ancillary charges and whether IPFs are
                providing necessary care and appropriately billing for inpatient
                psychiatric services under the IPF PPS.
                 MedPAC also encouraged CMS to require the reporting of ancillary
                charges and clarify the requirements related to IPFs' ``all-inclusive-
                rate'' hospital status. MedPAC noted that it observed in cost report
                data that IPFs that previously were not all-inclusive-rate hospitals
                have recently changed to an all-inclusive-rate status. MedPAC noted
                that the timing of many of these changes appears to correspond to CMS's
                transmittals requiring ancillary services to be reported on cost
                reports for IPFs that do not have an all-inclusive rate.
                 Other commenters, including IPFs and hospital associations,
                responded to the RFI stating that the lack of ancillary charges on
                claims does not indicate a lack of services being provided. The
                commenters strongly opposed any claim-level editing and stated that
                reporting ancillary charges at the claim level would be inefficient and
                burdensome, particularly for government and IHS all-inclusive
                hospitals.
                c. Clarification of Eligibility Criteria for the Option To Elect To
                File an All-Inclusive Cost Report
                 After taking into consideration the feedback we received from both
                MedPAC and IPF providers, for FY 2025 we are clarifying the eligibility
                criteria to be approved to file all-inclusive cost reports. Only
                government-owned or tribally owned facilities are able to satisfy these
                criteria, and thus only these facilities will be permitted to file an
                all-inclusive cost report for cost reporting periods beginning on or
                after October 1, 2024.
                 We remind readers that in order to be approved to file an all-
                inclusive cost report, hospitals must either have an all-inclusive rate
                (one charge covering all services) or a no-charge structure.\5\ We are
                clarifying that this does not mean any hospital can elect to have an
                all-inclusive rate or no-charge structure. Our longstanding policy as
                discussed in the PRM 15-1, chapter 22, Sec. 2208.1, only allows a
                hospital to use an all-inclusive rate or no charge structure if it has
                never had a charge structure in place. In addition, we are clarifying
                that our expectation is that any new IPF would have the ability to have
                a charge structure under which it could allocate
                [[Page 23194]]
                costs and charges. As previously stated, only a government-owned or
                tribally owned facility will be able to satisfy these criteria and will
                be eligible to file its cost report using an all-inclusive rate or no
                charge structure.
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                 \5\ PRM 15-1, chapter 22, Sec. 2208.1.
                ---------------------------------------------------------------------------
                 For cost reporting periods beginning on or after October 1, 2024,
                we will issue instructions to the MACs and put in place edits to
                operationalize our longstanding policy that only government-owned or
                tribally owned IPF hospitals are permitted to file an all-inclusive
                cost report. All other IPF hospitals must have a charge structure and
                must report ancillary costs and charges on their cost reports. IPFs
                that have previously filed an all-inclusive cost report erroneously
                will no longer be able to do so. We further note that to the extent
                government-owned or tribally owned hospitals can report ancillary
                charges on their cost reports, we strongly encourage them to do so to
                allow CMS to review and analyze complete and accurate data.
                 We believe clarifying the current eligibility criteria to be
                approved to file all-inclusive cost reports and implementing these
                operational changes will appropriately require freestanding IPFs with
                the ability to have a charge structure, that is, all IPFs other than
                those which are government-owned or tribally owned, to track and report
                ancillary charge information. In addition, we expect that more IPFs
                reporting ancillary charge information will result in an increase of
                IPFs having a CCR, which will in turn result in an increased number of
                IPFs being included in ratesetting. Therefore, we believe these
                operational changes will improve the quality of data reported, which
                will result in increased accuracy of future payment refinements to the
                IPF PPS.
                 Furthermore, we believe collecting charges of ancillary services
                from freestanding IPFs supports the directive for competition under the
                Executive Order on Promoting Competition in the American Economy as it
                facilitates accurate payment, cost efficiency, and transparency.\6\
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                 \6\ https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/.
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                F. Refinement Standardization Factor
                 Section 1886(s)(5)(D)(iii) of the Act, as added by section 4125(a)
                of the CAA, 2023, states that revisions in payment implemented pursuant
                to section 1886(s)(5)(D)(i) for a rate year shall result in the same
                estimated amount of aggregate expenditures under this title for
                psychiatric hospitals and psychiatric units furnished in the rate year
                as would have been made under this title for such care in such rate
                year if such revisions had not been implemented. We interpret this to
                mean that revisions in payment adjustments implemented for FY 2025 (and
                for any subsequent fiscal year) must be budget neutral.
                 Historically, we have maintained budget neutrality in the IPF PPS
                using the application of a standardization factor, which is codified in
                our regulations at Sec. 412.424(c)(5) to account for the overall
                positive effects resulting from the facility-level and patient-level
                adjustments. As discussed in section III.B.1 of this proposed rule,
                section 124(a)(1) of the BBRA required that we implement the IPF PPS in
                a budget neutral manner. In other words, the amount of total payments
                under the IPF PPS, including any payment adjustments, must be projected
                to be equal to the amount of total payments that would have been made
                if the IPF PPS were not implemented. Therefore, we calculated the
                standardization factor by setting the total estimated IPF PPS payments,
                taking into account all of the adjustment factors under the IPF PPS, to
                be equal to the total estimated payments that would have been made
                under the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA)
                (Pub. L. 97-248) methodology had the IPF PPS not been implemented. A
                step-by-step description of the methodology used to estimate payments
                under the TEFRA payment system appears in the RY 2005 IPF PPS final
                rule (69 FR 66926).
                 We believe the budget neutrality requirement of section 4125(a) of
                the CAA, 2023 is consistent with our longstanding methodology for
                maintaining budget neutrality under the IPF PPS. Therefore, for FY
                2025, we are proposing to apply a refinement standardization factor in
                accordance with our existing policy at Sec. 412.424(c)(5). This policy
                requires us to update IPF PPS patient-level adjustment factors, ED
                adjustment, and ECT per treatment amount as proposed in this FY 2025
                IPF PPS proposed rule, in such a way that total estimated payments to
                IPFs for FY 2025 are the same with or without the changes (that is, in
                a budget neutral manner) by applying a refinement standardization
                factor to the IPF PPS rates. We are proposing to use the following
                steps to ensure that the rates reflect the FY 2025 update to the
                patient-level adjustment factors (as previously discussed in section
                III.C and III.D of this proposed rule, and summarized in Addendum A) in
                a budget neutral manner:
                 Step 1: Simulate estimated IPF PPS payments using the FY 2024 IPF
                patient-level and facility-level adjustment factor values and FY 2024
                ECT payment per treatment (available on the CMS website).
                 Step 2: Simulate estimated IPF PPS payments using the proposed FY
                2025 IPF patient-level and facility-level adjustment factor values (see
                Addendum A of this proposed rule, which is available on the CMS
                website) and ECT per treatment amount based on the CY 2022 geometric
                mean cost for ECT under the OPPS.
                 Step 3: Divide the amount calculated in step 1 by the amount
                calculated in step 2. The resulting quotient is the proposed FY 2025
                refinement standardization factor of 0.9514.
                 Step 4: Apply the FY 2025 refinement standardization factor from
                step 3 to the FY 2024 IPF PPS Federal per diem base rate and ECT per
                treatment amount (based on the CY 2022 geometric mean cost for ECT
                under the OPPS), after the application of the wage index budget
                neutrality factor and the IPF market basket increase reduced by the
                productivity adjustment described in section III.A of this proposed
                rule to determine the FY 2025 IPF PPS Federal per diem base rate and FY
                2025 ECT payment amount per treatment.
                IV. Requests for Information (RFI) To Inform Future Revisions to the
                IPF PPS in Accordance With the CAA, 2023
                 As discussed in the following sections, we are requesting
                information on two main topics to inform future revisions to the IPF
                PPS, in accordance with the CAA, 2023. First, we are requesting
                information regarding potential revisions to the IPF PPS facility-level
                adjustments. Second, we are requesting information regarding the
                development of a patient assessment instrument under the IPFQR program.
                 Please note, each of these sections is a request for information
                (RFI) only. In accordance with the implementing regulations of the
                Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4),
                this general solicitation is exempt from the PRA. Facts or opinions
                submitted in response to general solicitations of comments from the
                public, published in the Federal Register or other publications,
                regardless of the form or format thereof, provided that no person is
                required to supply specific information pertaining to the commenter,
                other than that necessary for self-identification, as a condition of
                the agency's full consideration, are not generally considered
                information collections and therefore not subject to the PRA.
                [[Page 23195]]
                Respondents are encouraged to provide complete but concise responses.
                This RFI is issued solely for information and planning purposes; it
                does not constitute a Request for Proposal (RFP), applications,
                proposal abstracts, or quotations. This RFI does not commit the U.S.
                Government to contract for any supplies or services or make a grant
                award. Further, CMS is not seeking proposals through this RFI and will
                not accept unsolicited proposals. Responders are advised that the U.S.
                Government will not pay for any information or administrative costs
                incurred in response to this RFI; all costs associated with responding
                to this RFI will be solely at the interested party's expense. Not
                responding to this RFI does not preclude participation in any future
                procurement, if conducted. It is the responsibility of the potential
                responders to monitor this RFI announcement for additional information
                pertaining to this request. Please note that CMS will not respond to
                questions about the policy issues raised in this RFI. CMS may or may
                not choose to contact individual responders. Such communications would
                only serve to further clarify written responses. Contractor support
                personnel may be used to review RFI responses. Responses to this notice
                are not offers and cannot be accepted by the U.S. Government to form a
                binding contract or issue a grant. Information obtained as a result of
                this RFI may be used by the U.S. Government for program planning on a
                non-attribution basis. Respondents should not include any information
                that might be considered proprietary or confidential. This RFI should
                not be construed as a commitment or authorization to incur cost for
                which reimbursement would be required or sought. All submissions become
                U.S. Government property and will not be returned. CMS may publicly
                post the comments received, or a summary thereof.
                A. Request for Information Regarding Revisions to IPF PPS Facility-
                Level Adjustments
                 The CAA, 2023 added section 1886(s)(5)(D) to require CMS to revise
                the IPF PPS methodology for determining payment rates for FY 2025, and
                for any subsequent FY as determined appropriate by the Secretary. As
                detailed in sections III.C and III.D of this proposed rule, we are
                proposing to revise the patient-level payment adjustments in FY 2025
                and retain the current facility-level payment adjustments for rural
                location and teaching status. We have also conducted analysis of the
                IPF PPS facility-level adjustments using an updated regression analysis
                of cost and claims data for CY 2019 through 2021, as discussed in
                section III.C.3. of this proposed rule. The updated analysis identified
                potential changes in the regression factors for rural location and
                teaching status and suggests there may be value in including a new
                facility-level variable for safety net patient population, based on the
                Medicare Safety Net Index (MSNI) methodology developed by MedPAC for
                the IPPS. We note that the analysis of MSNI builds on prior analysis
                that CMS conducted regarding the applicability of an adjustment for
                disproportionate share intensity. Our review is ongoing and may be used
                to inform future rulemaking.
                 In the following sections, we describe the results of our latest
                analysis and request public comment on them. We are interested in
                comments regarding whether it would be appropriate to consider
                proposing revisions to the IPF PPS facility-level adjustments in the
                future based on the results of our latest regression analysis in future
                years.
                1. Adjustment for Rural Location
                 In our MedPAR data set, which included data from CY 2019 through CY
                2021, 101,483 stays, or 12.6 percent of all stays, were at rural IPFs.
                Our analysis shows that the regression coefficient for rural stays is
                1.19. This means that holding all other variables constant and
                controlling for area wage differences, stays at rural IPFs have
                approximately 19-percent higher cost per day than stays at urban IPFs.
                As previously discussed, we did not include control variables in our
                regression model to account for occupancy rate. However, we note that
                if we included these control variables, we estimate the rural
                adjustment in the regression would decrease to approximately 1.13.
                 In addition, as discussed later in section IV.A.3 of this proposed
                rule, we evaluated the potential inclusion of a new variable for
                facilities' safety net patient population, as measured by the MSNI
                ratio. We observe that the inclusion of the MSNI ratio in the
                regression model would have an impact on the rural adjustment factor.
                In the regression model that includes the MSNI ratio, the rural
                adjustment factor is 1.16. In other words, if we were to adopt an MSNI
                payment adjustment, our FY 2025 regression model indicates that the
                rural adjustment factor would decrease relative to the rural adjustment
                factor calculated without the MSNI variable. However, for rural
                facilities with a high level of safety net patients, the combined
                effect of the rural adjustment and a safety net adjustment would
                increase payments. These results are presented in Table 17, and we are
                seeking public comments on these results.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.028
                 We have modeled informational impacts reflecting the potential
                change in payments, as discussed in section IV.A.4 of this proposed
                rule, though we note future additional data and analysis may produce
                results that differ from those presented in this proposed rule.
                2. Teaching Adjustment
                 In the IPF PPS payment methodology, the teaching status for each
                facility is calculated as one plus the facility's ratio of intern and
                resident FTEs to the average daily census (69 FR 66954 through 66955).
                The teaching variable used in the regression is the natural log of each
                facility's teaching status, resulting in a continuous variable with a
                distribution ranging from 0.0000 to 1.6079. The payment adjustment for
                teaching status, as explained in section III.D.2 of this proposed rule,
                is calculated by raising a facility's teaching ratio to the power of
                the teaching status coefficient derived from the regression analysis.
                 In our updated regression analysis of data for CY 2019 through CY
                2021, there
                [[Page 23196]]
                were 155,458 stays in teaching facilities, comprising 19.3 percent of
                IPF stays for the time period. As previously discussed in this proposed
                rule, we found that the occupancy variables used in the original IPF
                PPS regression model were correlated with rural status, and have been
                removed in this updated model. We note that if we were to include
                occupancy control variables in the regression model, the adjustment for
                teaching status would increase to 1.0087.
                 The teaching status variable continues to be statistically
                significant at the 0.001 level in all of our updated models; in other
                words, we found that a facility's teaching status explains differences
                in costs between IPF stays. As shown in Table 18, the teaching status
                coefficient would increase in either updated regression model compared
                to its current value.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.029
                 As discussed in section IV.A.4. of this proposed rule, we have
                modeled informational impacts reflecting the potential change in
                payments from these adjustment factors. We are seeking public comment
                on these results. We note that future additional data and analysis may
                produce results that differ from those presented in this proposed rule.
                3. Adjustment for Safety Net Patient Population
                a. Prior Analysis of Disproportionate Share Hospital Status
                 In contrast to other Medicare hospital payment systems, the IPF PPS
                does not have an adjustment that recognizes disproportionate share
                intensity. Section 1886(s) of the Act does not require any specific
                adjustment of this type, nor does it require the use of any particular
                methodology. In the past, we have explored the application of the
                disproportionate share hospital (DSH) variable used in other Medicare
                prospective payment systems (that is, the sum of the proportion of
                Medicare days of care provided to recipients of Supplemental Security
                Income and the proportion of the total days of care provided to
                Medicaid beneficiaries) for the IPF PPS. We refer readers to the RY
                2005 IPF PPS final rule (69 FR 66958 through 66959) and the FY 2023 IPF
                PPS final rule (87 FR 46865). For psychiatric units, both proportions
                are specific to the unit and not the entire hospital.
                 In the RY 2005 IPF PPS final rule, we explained that the DSH
                variable was highly significant in our cost regressions; however, we
                found that facilities with higher DSH had lower per diem costs. We note
                that the previously cited study for the American Psychiatric
                Association also found the same results. The relationship of high DSH
                with lower costs cannot be attributed to downward bias in the Medicaid
                proportion due to the IMD exclusion. This is because public psychiatric
                hospitals already have lower costs on average than other types of IPFs.
                Therefore, if we had proposed a DSH adjustment based on the regression
                analysis, IPFs with high DSH shares would have been paid lower per diem
                rates (69 FR 66958).
                 In the FY 2023 IPF PPS proposed rule, we summarized and discussed
                the results of more recent analysis using data from 2018 (87 FR 19428
                through 19429). In response to that proposed rule, commenters
                encouraged CMS to continue evaluating ways to increase IPF PPS payments
                for disproportionate share intensity. MedPAC recommended that we
                consider the applicability of the MSNI, which has previously been
                discussed in the context of the IPPS, to the IPF PPS. As discussed in
                the following paragraphs, we have conducted analysis of the MSNI and
                are soliciting comments on our findings.
                b. Analysis of the Medicare Safety Net Index in the IPF PPS
                (1) Background
                 MSNI is an index that MedPAC developed as its recommended
                alternative to the current statutorily required methodology for
                disproportionate share payments to IPPS hospitals. In their March 2023
                Report to Congress, MedPAC recommend that MSNI would better target
                scarce Medicare resources to support hospitals that are key sources of
                care for low-income Medicare beneficiaries and may be at risk of
                closure.\7\ For further discussion of this safety net index in the
                context of the Medicare program, we refer readers to the FY 2024 IPPS
                final rule (88 FR 58640), which includes a discussion of how MSNI could
                be calculated for acute care hospitals and an RFI on the potential use
                of MSNI or other safety net indicators in the IPPS, such as the area
                deprivation index (ADI) or Social Deprivation Index (SDI).
                ---------------------------------------------------------------------------
                 \7\ Medicare Payment Advisory Commission. (2023). Report to the
                Congress: Medicare Payment Policy. Available at: https://www.medpac.gov/wp-content/uploads/2023/03/Ch3_Mar23_MedPAC_Report_To_Congress_SEC_v2.pdf. Accessed on January
                22, 2024.
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                 For our analysis, we constructed an MSNI for each IPF in our data
                set, which we calculated as the sum of three ratios:
                 The low-income subsidy (LIS) volume ratio, which is the
                ratio of total stays for low-income beneficiaries to a facility's total
                stays for Medicare beneficiaries. For our analysis, low-income
                beneficiaries are identified based on dual-enrollment or enrollment in
                Part D low-income subsidies, and stays are identified from MedPAR
                claims. This ratio was defined the same way in the FY 2024 IPPS final
                rule's discussion of MSNI (88 FR 59306).
                 The proportion of revenue spent on uncompensated care
                (UCC), defined the same way as it was in the FY 2024 IPPS final rule's
                discussion of MSNI (88 FR 59306). UCC and total revenue are available
                data elements from the hospital cost report, but only for the acute
                care hospital. These elements are not currently detailed at the level
                of the IPF unit.
                 The Medicare dependency ratio, which is a hospital's total
                covered days for Medicare patients divided by its total patient days.
                This information comes from the hospital cost report. We have also
                defined this ratio in the same way as it was defined in the FY 2024
                IPPS final rule's discussion of MSNI (88 FR 59306).
                 The final MSNI score is calculated as: LIS Volume Ratio +
                Proportion of Revenue Spent on UCC ratio + 0.5 * Medicare Dependency
                Ratio. This formula follows MedPAC's methodology based on its analysis
                of data for the IPPS hospital setting. As discussed in its
                [[Page 23197]]
                March 2023 Report to Congress, the Medicare Dependency Ratio is
                multiplied by 0.5 because MedPAC's prior analysis of costs in the IPPS
                setting found that the Medicare Dependency Ratio had approximately half
                the effect on cost as the other two components of MSNI.
                (2) Regression Analysis Results
                 The adjusted r-square, a measure of how much of the variation in
                costs between stays our model can explain, increases by approximately
                2.8 percent when we add the variable for MSNI to the updated model
                analyzing cost and claims data for CY 2019 through CY 2021. The
                adjusted r-square for the model without the MSNI variable is 0.32340,
                while the adjusted r-square for the model with the MSNI variable is
                0.33250. Our regression analysis indicates an MSNI coefficient of
                0.5184, which is statistically significant at the .001 level.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.030
                 Section 1886(s)(5)(D)(iii) of the Act, as added by section 4125(a)
                of the CAA, 2023, states that revisions in payment implemented pursuant
                to section 1886(s)(5)(D)(i) for a rate year shall result in the same
                estimated amount of aggregate expenditures under this title for
                psychiatric hospitals and psychiatric units furnished in the rate year
                as would have been made under this title for such care in such rate
                year if such revisions had not been implemented. Therefore, our
                estimates of payments associated with a potential MSNI payment
                adjustment include the application of a standardization factor, which
                we note would reduce the IPF PPS Federal per diem base rate by
                approximately $245. Total payments to IPFs would remain the same, but
                there would be significant distributional impacts, which would reduce
                payments to IPFs with a lower MSNI and increase payments to IPFs with a
                higher MSNI. We refer readers to section IV.A.4 of this proposed rule
                for informational analysis and discussion of the potential
                distributional impacts estimated for the MSNI payment adjustment.
                 We note that for certain elements of the MSNI calculation, some
                data was not available for IPFs at the same level of detail available
                for IPPS hospitals. We also identified that for some elements, data
                reported by IPFs may be incomplete. First, as mentioned above, both UCC
                amounts and total revenue amounts are reported at the hospital level
                only. As a result, we were able to calculate a UCC ratio for IPF units
                based on the overall ratio of the hospital's UCC to its revenues. This
                assumes that a hospital's overall UCC ratio would be comparable to that
                of its IPF unit. However, because we lack unit-level data, we are not
                able to validate this assumption. Table 20 shows that most freestanding
                IPF hospitals are not reporting any UCC, which leads to lower MSNI
                values for these IPFs. We recognize that the absence of UCC for
                nonprofit IPFs, which we believe in fact provide a significant amount
                of UCC, may reflect differences in reporting, rather than provision of
                UCC.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.031
                 There are also a number of key differences between our analysis and
                the way that MedPAC has recommended that MSNI be applied to payments in
                the IPPS setting. For the IPPS, MedPAC recommends to the Congress in
                their March 2023 report that they create an MSNI pool of funds for MSNI
                add-on payments of about $2 billion, which could be increased each year
                by the market basket update. MedPAC contemplates hospitals choosing
                between an MSNI payment and other special payment rates designed to
                protect access, for example, in rural areas, or the adoption of a
                percentage-based cap on all special payment rates.\8\ In contrast, our
                modeling of an MSNI payment adjustment in the IPF PPS, assumes that
                IPFs could be eligible for both an MSNI payment and the payment
                adjustment for rural location, for example, without a cap imposed. Our
                modeling also assumes that an MSNI payment adjustment would be budget
                neutral; in other words, the payment would not be an add-on. In
                contrast to the recommended approach for the IPPS, which would come
                from a new funding pool, we estimate that the application of an MSNI
                adjustment would affect the Federal IPF PPS per diem base rate. As a
                result, the MSNI payment in our model would represent a redistribution
                of funds within the IPF PPS, as is
                [[Page 23198]]
                statutorily required under section 4125(a) of the CAA, 2023.
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                 \8\ Medicare Payment Advisory Commission. (2023). Report to the
                Congress: Medicare Payment Policy. Available at: https://www.medpac.gov/wp-content/uploads/2023/03/Ch3_Mar23_MedPAC_Report_To_Congress_SEC_v2.pdf. Accessed on January
                22, 2024.
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                 We constructed the MSNI variable in our regression model similarly
                to the construction of the teaching adjustment (that is, as the natural
                log of a facility's MSNI ratio plus 1). Consequently, a payment
                adjustment derived from our regression results would work like the
                teaching status adjustment: the MSNI adjustment factor is expressed in
                an un-exponentiated form. A provider's MSNI factor plus one would be
                raised to the power of the MSNI adjustment factor to calculate the
                facility's MSNI payment adjustment.
                 We are considering the potential operational changes that would be
                necessary to implement an adjustment for MSNI in the future. For
                example, we anticipate the need to periodically recalculate facilities'
                MSNI ratios, which could potentially correspond to a facility's cost
                report settlement process. We also anticipate the need to develop a
                reconciliation process, should such an adjustment for MSNI be
                implemented in the future. Further, we expect that because a facility's
                LIS ratio would not be an available data element on the hospital cost
                report, we may need to develop and publish a facility-level file with
                this information or consider collecting additional data on the hospital
                cost report. As discussed in the following section, we are seeking
                public comment on our regression results, as well as our methodology
                used to construct the MSNI variable for IPFs, and on the operational
                considerations we have noted. We note that future additional data and
                analysis produce results that differ from those presented in this
                proposed rule.
                (3) Request for Information
                 We are particularly seeking comment on the following questions:
                 Should we consider adjusting payment using MedPAC's MSNI
                formula with adaptations, as described above? What, if any, changes to
                the methodology should we consider for the IPF setting? For example,
                should we develop a separate payment adjustment for each component
                (that is, the low-income ratio, uncompensated care ratio, and Medicare
                dependency ratio)?
                 We note that our construction of the MSNI did not scale or
                index facility-level variables to a national standard or median value.
                We anticipate that doing so would result in less of a change to the IPF
                Federal per diem base rate but would still result in comparable
                distributional impacts (that is, IPFs with lower MSNIs would receive
                lower payments, and IPFs with higher MSNIs would receive higher
                payments). Should we consider scaling or indexing the MSNI to a
                national average MSNI for all IPFs?
                 Is MedPAC's MSNI formula, as adapted, an accurate and
                appropriate measure of the extent to which an IPF acts as a safety-net
                hospital for Medicare beneficiaries?
                 Should additional data be collected through the cost
                report to improve the calculation of MSNI, such as collecting UCC and
                revenue at the IPF unit level?
                 Is the current cost report data submitted by IPFs
                sufficiently valid and complete to support the implementation of an
                MSNI payment? We note our concerns about the low or non-existent
                amounts reported for uncompensated care for freestanding IPFs and the
                use of hospital-level UCC and revenue amounts to calculate the UCC
                ratio for IPF units.
                 What administrative burden or challenges might providers
                face in reporting their UCC and low-income patient stays?
                 Would IPFs have the information necessary to report their
                low-income patient stays to CMS for the purpose of the MSNI
                calculation? What challenges might IPFs face in gathering and reporting
                this information?
                 In the FY 2023 IPPS proposed rule, CMS noted that, when
                calculating the MSNI, the following circumstances may be encountered:
                new hospitals (for example, hospitals that begin participation in the
                Medicare program after the available audited cost report data),
                hospital mergers, hospitals with multiple cost reports and/or cost
                reporting periods that are shorter or longer than 365 days, cost
                reporting periods that span fiscal years, and potentially aberrant
                data. How should CMS consider addressing these circumstances when
                calculating the MSNI for IPFs?
                4. Informational Impacts of Potential Facility-Level Revisions on IPF
                PPS Payments
                 We estimate that an MSNI payment adjustment in concert with the
                potential rural payment adjustment and teaching adjustments detailed in
                this section would have a refinement standardization factor of 0.7202.
                In other words, adoption of these facility-level payment adjustments as
                described in this section of this proposed rule would decrease the
                Federal per diem base rate by $244.81. In contrast, we estimate that
                updating only the rural and teaching adjustments without MSNI would
                have a refinement standardization factor of 0.9926, which would
                decrease the Federal per diem base rate by $6.48.
                 Estimates of distributional impacts by facility type, location,
                ownership, teaching status, and region are detailed in Table 21. We are
                seeking public comment on these informational impacts to potentially
                inform future rulemaking.
                 To illustrate the impacts of these potential changes to the IPF PPS
                facility-level adjustments, our analysis begins with the same FY 2023
                IPF PPS claims (based on the 2023 MedPAR claims, December 2023 update)
                as discussed in section VIII.C of this proposed rule. We begin with
                estimated FY 2025 IPF PPS payments using these 2023 claims, the
                proposed FY 2025 IPF PPS Federal per diem base rate and ECT per
                treatment amount, the proposed refinements to the FY 2025 IPF PPS
                patient and facility level adjustment factors, and the proposed FY 2025
                IPF PPS wage index. At each stage, total outlier payments are
                maintained at 2 percent of total estimated FY 2025 IPF PPS payments.
                 Each of the following changes is added incrementally to this
                baseline model in order for us to isolate the effects of each change:
                 The potential updates to the IPF teaching adjustment and
                rural adjustment, without the addition of an adjustment for MSNI.
                 Adding an adjustment for MSNI and reducing the IPF rural
                adjustment and teaching adjustment as shown in the third column of
                Tables 17 and 18 of this proposed rule.
                BILLING CODE 4120-01-P
                [[Page 23199]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.032
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                [GRAPHIC] [TIFF OMITTED] TP03AP24.033
                BILLING CODE 4120-01-C
                B. Request for Information (RFI)--Patient Assessment Instrument Under
                IPFQR Program (IPF PAI) To Improve the Accuracy of the PPS
                 Section 4125(b)(1) of CAA, 2023 amended section 1886(s)(4) of the
                Act, by inserting a new paragraph (E), to require IPFs participating in
                the IPFQR Program to collect and submit to the Secretary certain
                standardized patient assessment data, using a standardized patient
                assessment instrument (PAI) developed by the Secretary, for RY 2028 (FY
                2028) and each subsequent rate year. IPFs must submit such data with
                respect to at least the admission to and discharge of an individual
                from the IPF, or more frequently as the Secretary determines
                appropriate. For IPFs to meet this new data collection and reporting
                requirement for RY 2028 and each subsequent rate year, the Secretary
                must implement a standardized PAI that collects data with respect to
                the following categories: functional status; cognitive function and
                mental status; special services, treatments, and interventions for
                psychiatric conditions; medical conditions and comorbidities;
                impairments; and other categories as determined appropriate by the
                Secretary. This IPF-PAI must enable comparison of the patient
                assessment data across all IPFs which submit these data. In other
                words, the data must be standardized such that data from IPFs
                participating in the IPFQR Program can be compared; the IPF-PAI each
                IPF administers must be made up of identical questions and identical
                sets of response options to which identical standards and definitions
                apply.
                 As we develop the IPF-PAI, in accordance with these new statutory
                requirements, we seek to collect information that will help us achieve
                the following goals: (1) improve the quality of care in IPFs, (2)
                improve the accuracy of the IPF PPS in accordance with section
                4125(b)(2) of CAA, 2023, and (3) improve health equity.\9\ In this
                Request for Information (RFI), we are soliciting comments for
                development of this IPF-PAI, in accordance with these new statutory
                requirements, and to achieve these goals.
                ---------------------------------------------------------------------------
                 \9\ For more information on our strategic goals to improve
                health equity by expanding the collection, reporting, and analysis
                of standardized data, we refer readers to Priority 1 of our
                Framework for Health Equity at https://www.cms.gov/priorities/health-equity/minority-health/equity-programs/framework.
                ---------------------------------------------------------------------------
                 This RFI consists of four sections. The first section discusses a
                general framework or set of principles for development of the IPF-PAI.
                The second section outlines potential approaches that could be used to
                develop the items or data elements that
                [[Page 23201]]
                make up the PAI. This section also discusses patient assessment data
                elements in use in PAIs for skilled nursing facilities and other
                healthcare settings that could potentially be adapted for use in the
                IPF-PAI. The third section outlines potential approaches that could be
                used to collect patient assessment data. Finally, the fourth section
                solicits public comment on the principles and approaches listed in the
                first three sections and seeks other input regarding the IPF-PAI.
                1. Framework for Development of the IPF-PAI
                 We considered similar legislatively derived PAIs previously
                implemented for certain post-acute care (PAC) providers to inform the
                goals and guiding principles for the IPF-PAI because of similarities of
                section 4125(b) of CAA, 2023 to the Improving Medicare Post-Acute Care
                Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185, October 6,
                2014), codified at section 1899B of the Act. Similar to section 4125(b)
                of CAA, 2023, section 1899B of the Act requires certain PAC providers,
                specifically home health agencies (HHAs), skilled nursing facilities
                (SNFs), inpatient rehabilitation facilities (IRFs), and long-term care
                hospitals (LTCHs), to submit certain standardized patient assessment
                data (as set forth at section 1899B(b)(1)(B)) using a standardized PAI
                under the PAC providers' respective quality reporting programs. While
                IPFs are acute care providers and not PAC providers, given the
                similarities between the CAA, 2023 and section 1899B of the Act, we
                considered the goals and guiding principles that we followed to
                implement section 1899B of the Act for certain PAC providers and
                examined their applicability and appropriateness for IPFs.
                 We previously identified four key considerations when assessing
                Standardized Patient Assessment Data Elements for the PAC PAIs to
                collect: (1) Overall clinical relevance; (2) Interoperable exchange to
                facilitate care coordination during transitions in care; (3) Ability to
                capture medical complexity and risk factors that can inform both
                payment and quality; and (4) Scientific reliability and validity,
                general consensus agreement for its usability.\10\ For the reasons
                discussed in the following subsections, we believe that these
                considerations are also appropriate for the development of the IPF-PAI.
                In addition, we seek to balance the need to collect meaningful patient
                data to improve care with the need to minimize administrative burden.
                The remainder of this section describes each of these considerations in
                the context of the IPF-PAI. As we discuss in section IV.B.4.a of this
                proposed rule, we are soliciting comment on these considerations.
                ---------------------------------------------------------------------------
                 \10\ We refer readers to the Prospective Payment System and
                Consolidated Billing for Skilled Nursing Facilities; Updates to the
                Quality Reporting Program and Value-Based Purchasing Program for
                Federal fiscal year 2020 final rule (84 FR 38767); the Medicare
                Program; Inpatient Rehabilitation Facility (IRF) Prospective Payment
                System for Federal fiscal year 2020 and Updates to the IRF Quality
                Reporting Program final rule (84 FR 39110), the Medicare and
                Medicaid Programs; CY 2020 Home Health Prospective Payment System
                Rate Update; Home Health Value-Based Purchasing Model; Home Health
                Quality Reporting Requirements; and Home Infusion Therapy
                Requirements CY 2020 final rule (84 FR 60567), and the Medicare
                Program; Hospital Inpatient Prospective Payment Systems for Acute
                Care Hospitals and the Long-Term Care Hospital Prospective Payment
                System and Policy Changes and fiscal year 2020 Rates; Quality
                Reporting Requirements for Specific Providers; Medicare and Medicaid
                Promoting Interoperability Programs Requirements for Eligible
                Hospitals and Critical Access Hospitals final rule (84 FR 42537).
                ---------------------------------------------------------------------------
                a. Overall Clinical Relevance
                 In each category of assessment required by section
                1886(s)(4)(E)(ii), as added by section 4125(b) of CAA, 2023,
                (functional status; cognitive function and mental status; special
                services, treatments, and interventions for psychiatric conditions;
                medical conditions and comorbidities; impairments, and other categories
                as determined appropriate by the Secretary), we seek to establish
                Standardized Patient Assessment Data Elements that providers can use to
                support high quality care and outcomes in the IPF setting. As we
                evaluate Standardized Patient Assessment Data Elements in PAIs designed
                for other care settings, we intend to work with CMS Medical Officers,
                including psychiatrists, to consider the clinical relevance for IPF
                patients as a determining factor in whether an item merits inclusion in
                the IPF-PAI. For an example of a PAI in use in another setting, we
                refer readers to the IRF-PAI instrument available at https://www.cms.gov/files/document/irf-pai-version-40-eff-10012022-final.pdf.
                We are particularly interested in learning about specific instruments
                and tools in each area of assessment that have high clinical relevance
                in the IPF setting and welcome comments regarding Standardized Patient
                Assessment Data Elements that may not be clinically relevant to the IPF
                setting.
                 To ensure the clinical relevance of the instrument across a diverse
                group of IPF patients, we are considering structuring the assessment
                with conditional questions, so that certain sets of questions are only
                indicated if the questions are relevant to the patient. Furthermore, we
                note that some data elements may only be appropriate for collection at
                certain times during the patient's stay (for example, only at admission
                or only at discharge). We solicit comments regarding the most effective
                structure to employ in the development of the IPF-PAI.
                b. Interoperability
                 Interoperability is a key priority and initiative at CMS. Across
                the organization, we aim to promote the secure exchange, access, and
                use of electronic health information to support better informed
                decision making and a more efficient healthcare system. As a part of
                this effort, we make interoperability a priority for standardized data
                collection. We intend to ensure that the IPF-PAI meets Health Level
                7[supreg] (HL7[supreg]) Fast Healthcare Interoperability
                Resources[supreg] (FHIR[supreg]) standards.
                 As part of our interoperability considerations, we are interested
                in whether Standardized Patient Assessment Data Elements already in use
                in the CMS Data Element Library (DEL) are appropriate and clinically
                relevant for the IPF setting. In CY 2021, approximately 8,000
                admissions to IPFs were individuals transferred from SNFs or IRFs. We
                are interested in whether Standardized Patient Assessment Data Elements
                already used in the DEL can be used to better support interoperability
                between providers, given the high number of transfers.
                c. Ability To Capture Medical Complexity and Risk Factors
                 We intend to expand our efforts to refine the IPF PPS to increase
                the accuracy of the payment system by better identifying patient
                characteristics that best predict resource use during an IPF stay. To
                identify Standardized Patient Assessment Data Elements that would help
                predict resource use, we intend to evaluate Standardized Patient
                Assessment Data Elements for their ability to explain medical
                complexity, the need for special services and treatments, and to
                measure case-mix differences that impact costs. It is our expectation
                that an IPF-PAI that effectively differentiates treatment needs between
                patients will also help IPFs plan and distribute their resources. Our
                hope is that the IPF-PAI can therefore integrate with IPFs' business
                practices. In addition, Standardized Patient Assessment Data Elements
                that capture patient risk factors can
                [[Page 23202]]
                contribute to quality of care and patient safety.
                d. Scientific Reliability and Validity
                 Standardized Patient Assessment Data Elements considered for
                inclusion in the IPF-PAI must be scientifically reliable and valid in
                IPF settings. We intend to draw on our significant experience in
                development of quality measures in the IPFQR Program and development of
                Standardized Patient Assessment Data Elements for other PAIs, such as
                the IRF-PAI and the Minimum Data Set (MDS) (the PAI for SNFs), in our
                development of Standardized Patient Assessment Data Elements for the
                IPF-PAI.\11\ It is important to note that the statutorily required
                timeframe for implementation of the IPF-PAI for RY 2028 limits our
                ability to develop and test a full battery of new Standardized Patient
                Assessment Data Elements for the launch of the IPF-PAI. We anticipate
                the need and opportunity for incremental revisions to the IPF-PAI in
                the future.
                ---------------------------------------------------------------------------
                 \11\ For more information on other PAIs, we refer readers to
                https://www.cms.gov/medicare/payment/prospective-payment-systems/inpatient-rehabilitation/pai (for the IRF-PAI), to https://www.cms.gov/medicare/quality/home-health/oasis-data-sets (for the
                OASIS data set for HHAs), to https://www.cms.gov/medicare/quality/long-term-care-hospital/ltch-care-data-set-ltch-qrp-manual (for the
                CARE data set for LTCHs), and to https://www.cms.gov/medicare/quality/nursing-home-improvement/resident-assessment-instrument-manual (for the Minimum Data Set (MDS) Resident Assessment
                Instrument (RAI)).
                ---------------------------------------------------------------------------
                 We anticipate that our development process for new Standardized
                Patient Assessment Data Elements will include working with teams of
                researchers for each category including a group of advisors made up of
                clinicians and academic researchers for each team with expertise in
                IPFs. We expect to convene a Technical Expert Panel (TEP) to provide
                expert input on new and existing Standardized Patient Assessment Data
                Elements that merit consideration for inclusion and testing, including
                environmental scans and reviews of scientific literature. In an ideal
                scenario, Standardized Patient Assessment Data Elements would be tested
                in a representative sample of IPFs for appropriateness in different IPF
                settings and across a range of patients. Standardized Patient
                Assessment Data Elements would be tested for inter-rater (that is,
                consistency in results regardless of who is administering the
                assessment) and inter-organizational reliability, for validity in all
                IPF settings, for internal consistency, and for breadth of application
                among a range of IPF patients. We anticipate that Standardized Patient
                Assessment Data Elements would also need to be tested for their ability
                to detect differences among patients and costs of treatment. Due to the
                constraints of the statutorily required implementation timeframe, it
                may not be possible to complete all testing before launching the IPF-
                PAI.
                 The process for scientifically testing each question and set of
                responses is lengthy and resource-intensive. This process is based on
                the steps for quality measure development described in the Blueprint
                Measure Lifecycle,\12\ developed by the CMS Measures Management System.
                These steps include literature review and environmental scanning;
                various levels of field testing to understand the ``real world''
                performance of the data elements; and iterative expert and interested
                parties engagement to include broader perspectives on topics, candidate
                data elements, and interpretation of testing results. If appropriate,
                using data currently collected by IPFs or Standardized Patient
                Assessment Data Elements that have been tested and validated for use in
                other clinical settings can reduce these timeframes because test data
                are already available.
                ---------------------------------------------------------------------------
                 \12\ https://mmshub.cms.gov/blueprint-measure-lifecycle-overview.
                ---------------------------------------------------------------------------
                e. Administrative Burden
                 In evaluating Standardized Patient Assessment Data Elements for
                inclusion in the IPF-PAI, we are considering the burden of data
                collection through the PAI and aiming to minimize additional burden by
                considering whether any data that is currently collected through IPFQR
                Program measures or on IPF claims could be collected as Standardized
                Patient Assessment Data Elements to avoid duplication of data that IPFs
                are already reporting. We are also considering how collecting some data
                for some IPFQR Program measures through the IPF-PAI and collecting
                other data through the Hospital Quality Reporting (HQR) system would
                affect the reporting burden for participating IPFs. Licensing,
                permissions costs, or copyright restrictions that would add to
                administrative costs and burdens are also a consideration as we
                evaluate existing PAIs and mechanisms or tools for submitting IPF-PAI
                data.
                 As we develop the IPF-PAI, we are interested in receiving
                information about how to find a balance between collecting the most
                relevant and useful information and the administrative burden of
                administering the assessment and submitting the assessment data.
                2. Elements of the IPF-PAI
                 Section 1886(s)(4)(E)(ii) of the Act, added by section
                4125(b)(1)(C) of the CAA, 2023, requires that the standardized patient
                assessment data to be collected in the IPF-PAI must be with respect to
                six enumerated categories.
                a. Functional Status
                 The first enumerated category of data for the IPF-PAI is functional
                status. Section 1886(s)(4)(E)(ii)(I) of the Act provides that
                functional status may include mobility and self-care at admission to a
                psychiatric hospital or unit and before discharge from a psychiatric
                hospital or unit. We note that information in this category is
                generally found in a patient's discharge summary and are interested in
                learning about standardized elements that correspond to functional
                status as relevant to IPFs. We are interested in what assessments may
                be currently in use in the IPF setting and meet criteria for inclusion
                in the IPF-PAI.
                b. Cognitive Function and Mental Status
                 The second enumerated category of data for the IPF-PAI is cognitive
                function and mental status. Section 1886(s)(4)(E)(ii)(II) of the Act
                provides that cognitive function may include the ability to express
                ideas and to understand, and mental status may include depression and
                dementia. We note that in the IPF setting, a patient's diagnoses, which
                can be abstracted from their medical chart, provide some information
                related to this category. We are aware that IPFs may be currently
                assessing cognitive function using existing instruments. We are
                interested in hearing from IPFs about which instruments are currently
                in use to measure cognitive function in IPFs and which have high
                clinical relevance for the IPF setting.
                c. Special Services, Treatments, and Interventions
                 The third enumerated category of data for the IPF-PAI is special
                services, treatments, and interventions for psychiatric conditions.
                Section 1886(s)(4)(E)(ii)(III) of the Act neither addresses what these
                terms mean nor provides any illustrative examples. As discussed in
                section V.C. of this rule, the IPFQR Program already collects
                information about the use of restraint and seclusion through quality
                measures (Hospital Based Inpatient Psychiatric Services (HBIPS)-2,
                Hours of Physical Restraint, and HBIPS-3, Hours of Seclusion Use),
                while claims include information about ECT treatments provided. Other
                areas of interest in this
                [[Page 23203]]
                category may include high-cost medications, use of chemical restraints,
                one-to-one observation, and high-cost technologies. We are interested
                in whether these or any other special services, treatments, or
                interventions should be considered for inclusion in the IPF-PAI.
                d. Medical Conditions and Comorbidities
                 The fourth enumerated category of data for the IPF-PAI is medical
                conditions and comorbidities. Section 1886(s)(4)(E)(ii)(IV) of the Act
                provides that medical conditions and comorbidities may include
                diabetes, congestive heart failure, and pressure ulcers. We note that
                IPF claims record a significant number of medical conditions and
                comorbidities to receive the payment adjustment for comorbidities in
                the IPF PPS and conditions that are relevant to the IPF stay. In
                reviewing Standardized Patient Assessment Data Elements listed in this
                category in PAIs in use in PAC settings, we observed that these PAIs
                include Standardized Patient Assessment Data Elements regarding pain
                interference in this category, such as the effect of pain on sleep,
                pain interference with therapy activities, and pain interference with
                day-to-day activities. We are interested in learning from commenters
                whether these existing data elements from the PAC settings would be
                clinically relevant for inclusion in this category for the IPF-PAI.
                e. Impairments
                 The fifth enumerated category of data for the IPF-PAI is
                impairments. Section 1886(s)(4)(E)(ii)(V) of the Act provides that
                impairments may include incontinence and an impaired ability to hear,
                see, or swallow. PAIs in use in other settings include Standardized
                Patient Assessment Data Elements regarding hearing and vision (for
                example, Section B, ``Hearing, Speech, and Vision'' of the IRF-PAI
                Version 4.2 (Effective October 1, 2024)).\13\ We are interested both in
                whether Standardized Patient Assessment Data Elements regarding
                additional impairments merit consideration for the IPF-PAI, and whether
                the Standardized Patient Assessment Data Elements regarding hearing and
                vision included in the IRF-PAI are appropriate for the IPF setting. We
                note that the Standardized Patient Assessment Data Element categories
                are not intended to be duplicative, so we would seek to avoid any
                overlap in measuring cognitive deficits in the Cognitive Function
                category with the Impairments category.
                ---------------------------------------------------------------------------
                 \13\ https://www.cms.gov/files/document/irf-pai-version-42-effective-10-01-24.pdf.
                ---------------------------------------------------------------------------
                f. Other Categories Deemed Appropriate
                 The sixth enumerated category of data for the IPF-PAI is other
                categories as determined appropriate by the Secretary. We believe this
                provision allows for flexibility to include additional areas in the
                IPF-PAI.
                 One of our strategic priorities, as laid out in the CMS Strategic
                Plan,\14\ reflects our deep commitment to improvements in health equity
                by addressing the health disparities that underlie our health system.
                In line with that strategic priority, we are interested in Standardized
                Patient Assessment Data Elements that would provide insight about any
                demographic factors (for example, race, national origin, primary
                language, ethnicity, sexual orientation, and gender identity) as well
                as SDOH (for example, housing status and food security) associated with
                underlying inequities. We are also interested in whether there are
                Standardized Patient Assessment Data Elements that would provide
                insight into special interventions that IPFs are providing to support
                patients after discharge which could serve to potentially reduce the
                incidence of readmissions.
                ---------------------------------------------------------------------------
                 \14\ The CMS Strategic Plan. Available at https://www.cms.gov/about-cms/what-we-do/cms-strategic-plan. Accessed February 20, 2024.
                ---------------------------------------------------------------------------
                 We note that, beginning with mandatory reporting of CY 2025 data
                for FY 2027 payment determination, the IPFQR Program includes the
                Screening for SDOH measure, which assesses the percentage of patients,
                aged 18 years and over at the time of admission, who are screened for
                five specific health-related social needs (HRSNs)--food insecurity,
                housing instability, transportation needs, utility difficulties, and
                interpersonal safety, but which does not require reporting of that
                information at the patient-level (88 FR 51117). Furthermore, we note
                that PAIs adopted for the PAC settings discussed previously include
                collection of SDOH data under section 1899B(b)(1)(B)(vi) of the Act,
                which contains a similar provision for other categories deemed
                appropriate by the Secretary.\15\
                ---------------------------------------------------------------------------
                 \15\ For further information detailing the rationale for
                adopting SDOH Standardized Patient Assessment Data Elements in these
                settings, we refer readers to the Prospective Payment System and
                Consolidated Billing for Skilled Nursing Facilities; Updates to the
                Quality Reporting Program and Value-Based Purchasing Program for
                Federal fiscal year 2020 final rule (84 FR 38805 through 38817); the
                Medicare Program; Inpatient Rehabilitation Facility (IRF)
                Prospective Payment System for Federal fiscal year 2020 and Updates
                to the IRF Quality Reporting Program final rule (84 FR 39149 through
                38161), the Medicare and Medicaid Programs; CY 2020 Home Health
                Prospective Payment System Rate Update; Home Health Value-Based
                Purchasing Model; Home Health Quality Reporting Requirements; and
                Home Infusion Therapy Requirements CY 2020 final rule (84 FR 60597
                through 60608), and the Medicare Program; Hospital Inpatient
                Prospective Payment Systems for Acute Care Hospitals and the Long-
                Term Care Hospital Prospective Payment System and Policy Changes and
                fiscal year 2020 Rates; Quality Reporting Requirements for Specific
                Providers; Medicare and Medicaid Promoting Interoperability Programs
                Requirements for Eligible Hospitals and Critical Access Hospitals
                final rule (84 FR 42577 through 42588).
                ---------------------------------------------------------------------------
                 We note that, if we deem it appropriate to add a SDOH category for
                the IPF-PAI and these SDOH data are included as Standardized Patient
                Assessment Data Elements in the PAI, they could potentially be used to
                risk adjust or stratify measures collected for the IPFQR Program. We
                are interested in learning whether using some of these SDOH data
                adopted in other PAIs to risk adjust or stratify these measures would
                make the measures in the IPFQR Program more meaningful.
                3. Implementation of the PAI--Data Submission
                 We plan to develop flexible methods for providers to submit IPF-PAI
                data to CMS, including batch uploads in specified formats and a portal
                for submission of files. We welcome public comment on tools and methods
                for submission of data that balance administrative burden and ease of
                use.
                4. Request for Information on IPF-PAI
                 In this proposed rule, we are requesting information from the
                public to inform the selection of Standardized Patient Assessment Data
                Elements to be collected on the IPF-PAI and the implementation process.
                We are seeking information about PAIs IPFs currently use upon admission
                and discharge, as well as information about how IPFs estimate resource
                needs to determine capacity before a patient is admitted. We are also
                seeking information about methods for IPFs to submit patient assessment
                data and the potential administrative burden on IPFs, MACs, and CMS.
                Finally, we are seeking input on the relationship between the IPF-PAI
                and the measures within the IPFQR Program.
                 We solicit comment on the following topics:
                a. Principles for Selecting Standardized Patient Assessment Data
                Elements
                 To what extent do you agree with the principles for
                selecting and developing Standardized Patient Assessment Data Elements
                for the IPF-PAI?
                 What, if any, principles should CMS eliminate from the
                Standardized
                [[Page 23204]]
                Patient Assessment Data Element selection criteria?
                 What, if any, principles should CMS add to the
                Standardized Patient Assessment Data Element selection criteria?
                b. Patient Assessments Recommended for Use in the IPF-PAI
                 Are there PAIs currently available for use, or that could
                be adapted or developed for use in the IPF-PAI, to assess patients':
                (1) functional status; (2) cognitive function and mental status; (3)
                special services, treatments, and interventions for psychiatric
                conditions; (4) medical conditions and comorbidities; (5) impairments;
                (6) health disparities; or (7) other areas not mentioned in this RFI?
                c. Functional Status Standardized Patient Assessment Data Elements
                 What aspects of function are most predictive of medical
                complexity or increased resource needs to treat a patient in the IPF
                setting?
                 Which of the Standardized Patient Assessment Data Elements
                related to mobility (that is, the ability to toilet transfer, walk 10
                feet, car transfer, walk 10 feet on an uneven surface, 1 step up (that
                is, a curb), 4 steps up, 12 steps up, and pick up an object) currently
                collected by PAC settings in their respective PAIs are clinically
                relevant in the IPF setting? Do they otherwise meet the principles for
                inclusion in the IPF-PAI?
                d. Cognitive Function and Mental Status Standardized Patient Assessment
                Data Elements
                 What aspects of cognitive function and mental status are
                most predictive of medical complexity or increased resource needs to
                treat a patient in the IPF setting?
                 What components or instruments are used to assess
                cognitive function, mental status, or a combination thereof upon
                admission? What, if any, differences are there between assessments
                administered at admission and at discharge? What are the components of
                the mental status assessments administered at admission and discharge?
                e. Special Services, Treatments, and Interventions for Psychiatric
                Conditions Standardized Patient Assessment Data Elements
                 What special services, treatments, and interventions are
                most predictive of increased resource intensity during an IPF stay?
                 Do data currently collected as part of the IPFQR Program
                related to special services and treatments (such as HBIPS-2 Hours of
                Physical Restraint Use and HBIPS-3 Hours of Seclusion Use) meet the
                criteria for inclusion in the IPF-PAI?
                f. Medical Conditions and Comorbidities Standardized Patient Assessment
                Data Elements
                 Is the Standardized Patient Assessment Data Element
                regarding pain interference (effect on sleep, interference with therapy
                activities, interference with day-to-day activities) currently
                collected by PAC settings in their respective PAIs clinically relevant
                in the IPF setting? Does it otherwise meet the criteria for inclusion
                in the IPF-PAI?
                 Do the medical conditions and comorbidities coded on IPF
                claims meet the criteria for inclusion in the IPF-PAI?
                g. Impairments Standardized Patient Assessment Data Elements
                 Are Standardized Patient Assessment Data Elements related
                to impairments (that is, the ability to hear and see in adequate light)
                currently collected PAC settings in their respective PAIs clinically
                relevant in the IPF setting? Do they otherwise meet the principles for
                inclusion in the IPF-PAI?
                 What impairments are most predictive of increased resource
                intensity during an IPF stay?
                h. Other Categories of Standardized Patient Assessment Data Elements
                 What other assessment elements would contribute to the
                clinical utility of the IPF-PAI?
                 What other assessment elements would best capture medical
                complexity in the interest of refining and improving the accuracy of
                the IPF PPS?
                 What other assessment elements would inform CMS's
                understanding of health equity for IPF patients?
                 Are there special interventions that IPFs provide which
                support patients after discharge, and which could serve to reduce the
                incidence of hospital readmissions for psychiatric conditions? What, if
                any, assessment elements would inform CMS's understanding of such
                interventions?
                i. Implementation
                 We anticipate that IPFs will need to make changes to
                systems and processes and train staff in order to administer the
                assessment and submit assessment data by the implementation date. What
                operational or practical limitations would IPFs face in making those
                necessary changes? Are there particular categories of Standardized
                Patient Assessment Data Elements that would be more or less feasible
                for IPFs to operationalize? We are particularly interested in impacts
                to facilities of varying sizes and ownership characteristics.
                 What forms of training and guidance would be most useful
                for CMS to provide to support IPFs in the implementation of the IPF-
                PAI?
                j. Relationship to the IPFQR Program
                 Would having some measures which require data submission
                through the HQR system and having other measures, which require data
                collection and submission through the IPF-PAI increase operational
                complexity or administrative burden? If so, how would you recommend
                mitigating this complexity or burden?
                 Would any of the current chart-abstracted measures be
                easier to report through the IPF-PAI? If so, which measures?
                 Would any of the current measures in the program be more
                meaningful if they were stratified or risk-adjusted using data from the
                required patient assessment categories or other categories not
                specified by the CAA, 2023 that should be added to the IPF-PAI?
                 What new measure concepts, which would use data collected
                through Standardized Patient Assessment Data Elements in the IPF-PAI,
                should we consider?
                V. Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program
                A. Background and Statutory Authority
                 The Inpatient Psychiatric Facility Quality Reporting (IPFQR)
                Program is authorized by section 1886(s)(4) of the Act, and it applies
                to psychiatric hospitals and psychiatric units paid by Medicare under
                the IPF PPS (see section II.A. of this proposed rule for a detailed
                discussion of entities covered under the IPF PPS). Section
                1886(s)(4)(A)(i) requires the Secretary to reduce by 2 percentage
                points the annual update to the standard Federal rate for discharges
                occurring during such rate year \16\ for
                [[Page 23205]]
                any IPF that does not comply with quality data submission requirements
                under IPFQR program, set forth in section 1886(s)(4)(C) of the Act,
                with respect to an applicable rate year.
                ---------------------------------------------------------------------------
                 \16\ We note that the statute uses the term ``rate year'' (RY).
                However, beginning with the annual update of the inpatient
                psychiatric facility prospective payment system (IPF PPS) that took
                effect on July 1, 2011 (RY 2012), we aligned the IPF PPS update with
                the annual update of the ICD codes, effective on October 1 of each
                year. This change allowed for annual payment updates and the ICD
                coding update to occur on the same schedule and appear in the same
                Federal Register document, promoting administrative efficiency. To
                reflect the change to the annual payment rate update cycle, we
                revised the regulations at 42 CFR 412.402 to specify that, beginning
                October 1, 2012, the IPF PPS RY means the 12-month period from
                October 1 through September 30, which we refer to as a ``fiscal
                year'' (FY) (76 FR 26435). Therefore, with respect to the IPFQR
                Program, the terms ``rate year,'' as used in the statute, and
                ``fiscal year'' as used in the regulation, both refer to the period
                from October 1 through September 30. For more information regarding
                this terminology change, we refer readers to section III of the RY
                2012 IPF PPS final rule (76 FR 26434 through 26435).
                ---------------------------------------------------------------------------
                 Section 1886(s)(4)(C) of the Act requires IPFs to submit to the
                Secretary data on quality measures specified by the Secretary under
                section 1886(s)(4)(D) of the Act. Except as provided in section
                1886(s)(4)(D)(ii) of the Act, section 1886(s)(4)(D)(i) of the Act
                requires that any measure specified by the Secretary must have been
                endorsed by the consensus-based entity (CBE) with a contract under
                section 1890(a) of the Act. Section 1886(s)(4)(D)(ii) of the Act
                provides that, in the case of a specified area or medical topic
                determined appropriate by the Secretary for which a feasible and
                practical measure has not been endorsed by the CBE with a contract
                under section 1890(a) of the Act, the Secretary may specify a measure
                that is not endorsed as long as due consideration is given to measures
                that have been endorsed or adopted by a consensus organization
                identified by the Secretary.
                 Section 4125(b)(1) of CAA, 2023 amended section 1886(s)(4) of the
                Act, by inserting a new paragraph (E), to require IPFs participating in
                the IPFQR Program to collect and submit to the Secretary certain
                standardized patient assessment data, using a standardized patient
                assessment instrument (PAI) developed by the Secretary, for RY 2028 (FY
                2028) and each subsequent rate year. We refer readers to section IV.B
                of this proposed rule in which we solicit public comment on the
                development of this PAI.
                 We refer readers to the FY 2019 IPF PPS final rule (83 FR 38589)
                for a discussion of the background and statutory authority of the IPFQR
                Program. We have codified procedural requirements and reconsideration
                and appeals procedures for IPFQR Program decisions in our regulations
                at 42 CFR 412.433 and 412.434. Consistent with previous IPFQR Program
                regulations, we refer to both inpatient psychiatric hospitals and
                psychiatric units as ``facilities'' or ``IPFs.'' This usage follows the
                terminology in our IPF PPS regulations at Sec. 412.402.
                 For additional information on procedural requirements related to
                statutory authority, participation and withdrawal, data submission,
                quality measure retention and removal, extraordinary circumstances
                exceptions, and public reporting we refer readers to 42 CFR 412.433
                Procedural requirements under the IPFQR Program.
                 For the IPFQR Program, we refer to the year in which an IPF would
                receive the 2-percentage point reduction to the annual update to the
                standard Federal rate as the payment determination year. An IPF
                generally meets IPFQR Program requirements by submitting data on
                specified quality measures in a specified time and manner during a data
                submission period that occurs prior to the payment determination year.
                These data reflect a period prior to the data submission period during
                which the IPF furnished care to patients; this period is known as the
                performance period. For example, for a measure for which CY 2025 is the
                performance period which is required to be submitted in CY 2026 and
                affects FY 2027 payment determination, if an IPF did not submit the
                data for this measure as specified during CY 2026 (and meets all other
                IPFQR Program requirements for the FY 2027 payment determination) we
                would reduce by 2-percentage points that IPF's update for the FY 2027
                payment determination year.
                B. Measure Adoption
                 We strive to put patients and caregivers first, ensuring they are
                empowered to partner with their clinicians in their healthcare decision
                making using information from data driven insights that are
                increasingly aligned with meaningful quality measures. We support
                technology that reduces burden and allows clinicians to focus on
                providing high-quality healthcare for their patients. We also support
                innovative approaches to improve quality, accessibility, and
                affordability of care while paying particular attention to improving
                clinicians' and beneficiaries' experiences when interacting with our
                programs. In combination with other efforts across HHS, we believe the
                IPFQR Program helps to incentivize IPFs to improve healthcare quality
                and value while giving patients and providers the tools and information
                needed to make the best individualized decisions. Consistent with these
                goals, our objective in selecting quality measures for the IPFQR
                Program is to balance the need for information on the full spectrum of
                care delivery and the need to minimize the burden of data collection
                and reporting. We have primarily focused on measures that evaluate
                critical processes of care that have significant impact on patient
                outcomes and support CMS and HHS priorities for improved quality and
                efficiency of care provided by IPFs. When possible, we also propose to
                incorporate measures that directly evaluate patient outcomes and
                experience. We refer readers to the CMS National Quality Strategy,\17\
                the Behavioral Health Strategy,\18\ the Framework for Health
                Equity,\19\ and the Meaningful Measures Framework \20\ for information
                related to our priorities in selecting quality measures.
                ---------------------------------------------------------------------------
                 \17\ Schreiber, M, Richards, A, et al. (2022). The CMS National
                Quality Strategy: A Person-Centered Approach to Improving Quality.
                Available at: https://www.cms.gov/blog/cms-national-quality-strategy-person-centered-approach-improving-quality.
                 \18\ CMS. (2022). CMS Behavioral Health Strategy. Available at
                https://www.cms.gov/cms-behavioral-health-strategy.
                 \19\ CMS. (2022). CMS Framework for Health Equity 2022-2032.
                Available at https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
                 \20\ CMS. (2023). Meaningful Measures 2.0: Moving from Measure
                Reduction to Modernization. Available at https://www.cms.gov/medicare/quality/meaningful-measures-initiative/meaningful-measures-20. Accessed on March 20, 2024.
                ---------------------------------------------------------------------------
                1. Measure Selection Process
                 Section 1890A(a) of the Act requires that the Secretary establish
                and follow a pre-rulemaking process, in coordination with the CBE
                contracted under 1890(a) of the Act, to solicit input from multi-
                stakeholder groups on the selection of quality and efficiency measures
                for the IPFQR Program. Before being proposed for inclusion in the IPFQR
                Program, measures are placed on a list of Measures Under Consideration
                (MUC list), which is published annually. Following publication on the
                MUC list, a multi-stakeholder group convened by the CBE reviews the
                measures under consideration for the IPFQR Program, among other federal
                programs, and provides input on those measures to the Secretary. Under
                the Partnership for Quality Measurement (PQM), which is convened by the
                entity which currently holds the contract under 1890(a) of the Act,
                this process is known as the Pre-Rulemaking Measure Review (PRMR). We
                consider the input and recommendations provided by this multi-
                stakeholder group in selecting all measures for the IPFQR Program,
                including the 30-Day Risk-Standardized All-Cause Emergency Department
                (ED) Visit Following an IPF Discharge measure discussed in this
                proposed rule.
                [[Page 23206]]
                2. Proposal To Adopt the 30-Day Risk-Standardized All-Cause ED Visit
                Following an IPF Discharge Measure Beginning With the CY 2025
                Performance Period/FY 2027 Payment Determination
                a. Background
                 We have consistently stated our commitment to identifying measures
                that examine the care continuum for patients with mental health
                conditions and substance use disorders and to quantify outcomes
                following IPF-discharge (see for example, the adoption of the
                Medication Continuation Following Hospitalization in an IPF measure in
                the FY 2020 IPF PPS Final Rule, 84 FR 38460 through 38462). Post-
                discharge outcomes are an important part of our measurement strategy
                because patient-centered discharge planning and coordination of care
                for patients with any combination of mental health conditions and
                substance use disorders improves long-term outcomes, including reducing
                readmissions and other post-discharge acute care
                services.21 22
                ---------------------------------------------------------------------------
                 \21\ Nelson, E.A. Maruish, M.E., Axler, J.L. Effects of
                Discharge Planning with Outpatient Appointments on Readmission
                Rates. https://ps.psychiatryonline.org/doi/10.1176/appi.ps.51.7.885.
                 \22\ Steffen S, K[ouml]sters M, Becker T, Puschner B. Discharge
                planning in mental health care: a systematic review of the recent
                literature. Acta Psychiatr Scand. 2009 Jul;120(1):1-9. doi: 10.1111/
                j.1600-0447.2009.01373.x. Epub 2009 Apr 8. PMID: 19486329.
                ---------------------------------------------------------------------------
                 Although not all post-discharge acute care visits are preventable,
                there are actions that the IPF can take to maximize the chance for
                patients' successful community reintegration.\23\ For example, care
                transition models to reduce the need for additional acute care
                following an inpatient stay have been adapted to the inpatient
                psychiatric setting. To implement these models, IPFs may need to
                consider how to include the patient and their caregivers, including
                family, in discharge planning, how to communicate with post-discharge
                providers, and how to ensure whole-person care for patients during and
                following their discharge.\24\ Specifically, IPFs may need to assist
                patients in connecting with outpatient providers, such as coordinating
                with the patient and their caregiver to schedule the patient's first
                post-discharge follow-up appointment, arranging for the patient's
                intensive outpatient (IOP) care, or connecting to peer support
                services. Additionally, IPFs may need to identify and address barriers
                patients may face in accessing medications and adhering to scheduled
                post-discharge follow-up appointments. Barriers may include financial
                factors, transportation, and childcare, which may necessitate support
                from social services, beginning during hospitalization and continuing
                after discharge.25 26 Barriers may also include the
                patient's concerns regarding the stigmatization associated with seeking
                care post-discharge. This can be addressed through treatment provided
                during the IPF stay.27 28 Improvements in patient experience
                of care and patient-centeredness of care have been associated with
                improved follow-up post-discharge and a reduction in patients requiring
                post-discharge acute care.29 30 In summary, by proactively
                addressing potential barriers to post-charge care, improving patient
                experience of care and patient-centeredness of care, and implementing
                care transition models, IPFs can reduce the need for post-discharge
                acute care.
                ---------------------------------------------------------------------------
                 \23\ Haselden, M., Corbeil, T., Tang, F., Olfson, M., Dixon,
                L.B., Essock, S.M., Wall, M.M., Radigan, M., Frimpong, E., Wang, R.,
                Lamberti, S., Schneider, M., & Smith, T.E. (2019). Family
                Involvement in Psychiatric Hospitalizations: Associations With
                Discharge Planning and Prompt Follow-Up Care. Psychiatric Services,
                70(10), 860-866. https://doi.org/10.1176/appi.ps.201900028.
                 \24\ Pincus, Harold, Care Transition Interventions to Reduce
                Psychiatric Re-Hospitalizations. National Association of State
                Mental Health Program Directors. 2015. Available at https://nasmhpd.org/sites/default/files/Assessment%20%233_Care%20Transitions%20Interventions%20toReduce%20Psychiatric%20Rehospitalization.pdf. Accessed on January 23, 2024.
                 \25\ Allen, E.M., Call, K.T., Beebe, T.J., McAlpine, D.D., &
                Johnson, P.J. (2017). Barriers to Care and Healthcare Utilization
                among the Publicly Insured. Medical Care, 55(3), 207-214.
                doi:10.1097/MLR.0000000000000644.
                 \26\ Mutschler, C., Lichtenstein, S., Kidd, S.A., & Davidson, L.
                (2019). Transition experiences following psychiatric
                hospitalization: A systematic review of the literature. Community
                Mental Health Journal, 55(8), 1255-1274. doi:10.1007/s10597-019-
                00413-9.
                 \27\ Allen, E.M., Call, K.T., Beebe, T.J., McAlpine, D.D., &
                Johnson, P.J. (2017). Barriers to Care and Healthcare Utilization
                among the Publicly Insured. Medical Care, 55(3), 207-214.
                doi:10.1097/MLR.0000000000000644.
                 \28\ Mutschler, C., Lichtenstein, S., Kidd, S.A., & Davidson, L.
                (2019). Transition experiences following psychiatric
                hospitalization: A systematic review of the literature. Community
                Mental Health Journal, 55(8), 1255-1274. doi:10.1007/s10597-019-
                00413-9.
                 \29\ Donisi V, Tedeschi F, Wahlbeck K, Haaramo P, Amaddeo F.
                Pre-discharge factors predicting readmissions of psychiatric
                patients: a systematic review of the literature. BMC Psychiatry.
                2016 Dec 16;16(1):449. doi: 10.1186/s12888-016-1114-0. PMID:
                27986079; PMCID: PMC5162092.
                 \30\ Morgan C Shields, Mara A G Hollander, Alisa B Busch, Zohra
                Kantawala, Meredith B Rosenthal, Patient-centered inpatient
                psychiatry is associated with outcomes, ownership, and national
                quality measures, Health Affairs Scholar, Volume 1, Issue 1, July
                2023, qxad017, https://doi.org/10.1093/haschl/qxad017.
                ---------------------------------------------------------------------------
                 The IPFQR Program currently has three measures that assess post-
                discharge outcomes: (1) Follow-up After Psychiatric Hospitalization
                (FAPH); (2) Medication Continuation Following Inpatient Psychiatric
                Discharge; and (3) Thirty Day All-Cause Unplanned Readmission Following
                Psychiatric Hospitalization (CBE #2860, the IPF Unplanned Readmission
                measure). Each of these measures serves a unique role in assessing care
                coordination and post-discharge outcomes.
                 The FAPH measure, which we adopted in the FY 2022 IPF PPS Final
                Rule (86 FR 42640 through 42645), uses Medicare FFS claims to determine
                the percentage of inpatient discharges from an IPF stay for which the
                patient received a follow-up visit for treatment of mental illness. The
                FAPH measure represents an important component of post-discharge care
                coordination, specifically the transition of care to an outpatient
                provider. However, this measure does not quantify patient outcomes.
                 The Medication Continuation Following Inpatient Psychiatric
                Discharge measure, which we adopted in FY 2020 IPF PPS Final Rule (84
                FR 38460 through 38465), assesses whether patients admitted to IPFs
                with diagnoses of Major Depressive Disorder (MDD), schizophrenia, or
                bipolar disorder filled at least one evidence-based medication prior to
                discharge or during the post-discharge period. Medication continuation
                is important for patients discharged from the IPF setting with these
                disorders because of significant negative outcomes associated with non-
                adherence to medication regimes. However, this measure does not
                quantify patient outcomes with respect to the use of acute care
                services post-discharge.
                 The IPF Unplanned Readmission measure, which we adopted in the FY
                2017 IPPS/LTCH PPS final rule (81 FR 57241 through 57246), assesses
                outcomes associated with worsening condition, potentially due to
                insufficient discharge planning and post-discharge care coordination,
                by assessing post-discharge use of acute care. The IPF Unplanned
                Readmission measure estimates the incidence of unplanned, all-cause
                readmissions to IPFs or short-stay acute care hospitals following
                discharge from an eligible IPF index admission. A readmission is
                defined as any admission that occurs within 3 to 30 days after the
                discharge date from an eligible index admission to an IPF, except those
                considered planned.\31\ However, this measure does not quantify the
                proportion of patients 18 and older with an ED visit, without
                [[Page 23207]]
                subsequent admission, within 30 days of discharge from an IPF. Without
                collecting this information in a measure, we believe there is a gap in
                our understanding regarding patients' successful reintegration into
                their communities following their IPF discharge.
                ---------------------------------------------------------------------------
                 \31\ https://p4qm.org/measures/2860.
                ---------------------------------------------------------------------------
                 To further understand this gap, we analyzed post-discharge outcomes
                using claims data. In this analysis, we determined that, for patients
                discharged from IPFs, the risk-adjusted rate of ED visits after an IPF
                discharge between June 1, 2019 and July 31, 2021 (excluding the first
                two quarters of 2020 due to the COVID-19 public health emergency) was
                20.7 percent. The rate of readmissions captured under the IPF Unplanned
                Readmission measure for this same period was 20.1 percent.\32\ This
                means that approximately 40 percent of patients discharged from an IPF
                had either an ED visit or an unplanned readmission within 30-days of
                IPF discharge, but only about half of those visits are being captured
                in the publicly reported IPF Unplanned Readmission measure. Visits to
                an ED within 30 days of discharge from an IPF (regardless of whether
                that visit results in a hospital readmission, observation stay,
                discharge, or patient leaving without being seen) often indicate
                deteriorating or heightened mental or physical health needs. That is,
                these visits often represent a patient seeking care for symptoms that
                were present during the patient's stay in the IPF, regardless of
                whether the symptom was the reason for the admission, that have become
                worse for the patient in the time since discharge. Therefore, we
                believe that IPFs and the public would benefit from having these data
                made publicly available to inform care decisions and quality
                improvement efforts. Specifically, members of the public could use
                these data to inform care decisions and IPFs could use these data to
                compare their performance to that of similar IPFs. For example, by
                having these data publicly reported IPFs could compare their
                performance with that of other IPFs with similar patient populations, a
                comparison which is not possible without this measure. If IPFs
                identified that other IPFs with similar patient populations had better
                rates of post-discharge ED visits (that is, other IPFs had fewer
                patients seek care in an ED within 30 days of discharge from the IPF),
                the IPF could identify a need to evaluate discharge planning and post-
                discharge care coordination to identify process changes which could
                improve outcomes.
                ---------------------------------------------------------------------------
                 \32\ As depicted in the April 2023 file available at https://data.cms.gov/provider-data/archived-data/hospitals.
                ---------------------------------------------------------------------------
                 To address this gap, we developed and are proposing the inclusion
                of the new, claims-based 30-Day Risk-Standardized All-Cause ED Visit
                Following an IPF Discharge measure (the IPF ED Visit measure) in the
                IPFQR program beginning with the CY 2025 performance period/FY 2027
                payment determination. This proposed IPF ED Visit measure aims to
                provide information to patients, caregivers, other members of the
                public, and IPFs about the proportion of patients who seek care in ED
                in the 30 days following discharge from an IPF, but are not admitted as
                an inpatient to an acute care hospital or IPF. This proposed measure
                would assess the proportion of patients 18 and older with an ED visit,
                including observation stays, for any cause, within 30 days of discharge
                from an IPF, without subsequent admission.
                 We recognize that not all post-discharge ED visits are preventable,
                nor are all post-discharge ED visits associated with the initial IPF
                admission. However, we developed an all-cause ED visit rate, as opposed
                to a more narrowly focused measure of ED admissions for mental health
                or substance use concerns, for three primary reasons. First, such a
                measure aligns most closely with the IPF Unplanned Readmission measure
                as this measure is also an all-cause measure. Second, an all-cause
                measure emphasizes the importance of whole-person care for patients.
                Whole-person care, during the inpatient stay and through referral at
                discharge, includes addressing the conditions that may jeopardize a
                patient's health, but are not the reason for admission to the IPF, if
                the IPF has reason to identify these conditions during the course of
                treatment. For example, if an IPF were to identify through metabolic
                screening that a patient has diabetes, it would be appropriate for that
                IPF to recommend appropriate follow-up for that patient, such as with a
                primary care provider, endocrinologist, or dietician. Such post-
                discharge coordination of care could prevent the patient from seeking
                acute care after discharge from the IPF for complications of diabetes,
                such as diabetic ketoacidosis. Third, this measure includes ED visits
                for all conditions because patients visiting the ED may do so for
                physical symptoms associated with a mental health condition or
                substance use disorder. An example is a patient with anxiety that
                presents to the ED with chest pain and shortness of breath. If the
                clinician documents the primary diagnosis as chest pain (R07.9) or
                shortness of breath (R06.02), the patient would not be included in a
                mental health and substance use-specific IPF ED Visit measure, despite
                their history of anxiety (F41.9), a potential contributor to their
                presenting symptoms at the ED. We recognize that it is possible that
                such a visit may not be related to the patient's anxiety. However,
                while not all acute care visits after discharge from an IPF are
                preventable or necessarily related to the quality of care provided by
                the IPF, there is evidence that improvements in the quality of care for
                patients in the IPF setting can reduce rates of patients seeking acute
                care after discharge from an IPF, representing an improved outcome for
                patients.\33\
                ---------------------------------------------------------------------------
                 \33\ See for instance Chung, D.T., Ryan, C.J., Hadzi-Pavlovic,
                D., Singh, S.P., Stanton, C., & Large, M.M. (2017). Suicide rates
                after discharge from psychiatric facilities: A systematic review and
                meta-analysis. JAMA Psychiatry, 74(7), 694-702. https://doi.org/10.1001/jamapsychiatry.2017.1044 or Durbin, J., Lin, E., Layne, C.,
                et al. (2007). Is readmission a valid indicator of the quality of
                inpatient psychiatric care? Journal of Behavioral Health Services
                Research, 34, 137-150. doi:10.1007/s11414- 007-9055-5.
                ---------------------------------------------------------------------------
                 Additionally, we considered whether 30 days was an appropriate
                timeframe for this measure. That is, we sought to identify whether a
                measure that assessed post-discharge ED visits over a period shorter or
                longer than 30 days would be more appropriate. Because IPFs are already
                familiar with interpreting data for the 30-day period in the IPF
                Unplanned Readmission measure, we determined that it would be
                appropriate to maintain the 30-day period for the IPF ED Visit measure.
                Additionally, by maintaining the same timeframe as the IPF Unplanned
                Readmission measure, we can provide IPFs and patients with a more
                complete picture of acute care among IPF patients after discharge from
                the IPF.
                 Pursuant to the Meaningful Measures 2.0 Framework (a CMS initiative
                that identifies priority domains for measures within CMS Programs
                \34\), this measure addresses the ``Seamless Care Coordination'' and
                the ``Person-Centered Care'' quality domains by encouraging facilities
                to provide patient-centric discharge planning and support post-
                discharge care transitions. The IPF ED Visit measure also aligns with
                the CMS National Quality Strategy Goals \35\ of ``Engagement'' and
                ``Outcomes and Alignment.'' It supports outcomes and
                [[Page 23208]]
                alignment because this measure provides a quantified estimate of one
                post-discharge outcome that patients may experience, that is a post-
                discharge acute care visit that does not result in an admission. It
                also supports the Behavioral Health Strategy \36\ domains of ``Quality
                of Care'' and ``Equity and Engagement'' because engaging patients to
                improve post-discharge outcomes is an element of providing quality
                care. Furthermore, similar to the Meaningful Measures domain of
                ``Person-Centered Care,'' this measure supports the Universal
                Foundation domain of ``Person-Centered Care.''
                ---------------------------------------------------------------------------
                 \34\ https://www.cms.gov/medicare/quality/meaningful-measures-initiative/meaningful-measures-20.
                 \35\ Schreiber, M, Richards, A, et al. (2022). The CMS National
                Quality Strategy: A Person-Centered Approach to Improving Quality.
                Available at: https://www.cms.gov/blog/cms-national-quality-strategy-person-centered-approach-improving-quality.
                 \36\ CMS. (2022). CMS Behavioral Health Strategy. Available at
                https://www.cms.gov/cms-behavioral-health-strategy.
                ---------------------------------------------------------------------------
                b. Overview of Measure
                 The IPF ED Visit measure was developed with input from clinicians,
                patients, and policy experts; the measure was subject to the pre-
                rulemaking process required by section 1890A of the Act, as discussed
                further in section V.B.1 of this rule. Consistent with the CMS key
                elements of the CMS Measure Development Lifecycle,\37\ we began with
                measure conceptualization during which we performed a targeted
                literature review and solicited input from a behavioral health
                technical expert panel (TEP). This allowed us to ensure that this topic
                addresses a gap that is important to interested parties. After
                confirming this, we developed the measure specifications for the IPF ED
                Visit measure. With these specifications, we issued a 30-day call for
                public comment in the Federal Register and performed empirical testing
                using claims data, including modeling for risk-adjustment. After
                refining the measure specifications based on testing and public
                comment, we performed an equity analysis in which we tested the risk-
                adjustment methodology to ensure that the measure does not reflect
                access issues related to patient demographics instead of quality of
                care. By following steps in accordance with the Measure Development
                Lifecycle, we sought to ensure that this is a vetted, valid, reliable,
                and ready-to-implement claims-based measure which would assess the
                proportion of patients 18 and older with an ED visit, including
                observation stays, for any cause, within 30 days of discharge from an
                IPF, without subsequent admission. By using the same definitions of
                index admission and patient populations as those used in the IPF
                Unplanned Readmission measure, we have designed the IPF ED Visit
                measure to complement the IPF Unplanned Readmission measure to the
                extent possible. We have also sought to minimize administrative burden
                by developing this as a claims-based measure so that it adds no
                information collection burden to clinicians and staff working in the
                IPF setting.
                ---------------------------------------------------------------------------
                 \37\ https://mmshub.cms.gov/blueprint-measure-lifecycle-overview.
                ---------------------------------------------------------------------------
                (1) Measure Calculation
                 The focus population for this measure is adult Medicare FFS
                patients with a discharge from an IPF. The measure is based on all
                eligible index admissions from the focus population. An eligible index
                admission is defined as any IPF admission for which the patient meets
                the following criteria: (1) age 18 or older at admission; (2)
                discharged alive from an IPF; (3) enrolled in Medicare FFS Parts A and
                B during the 12 months before the admission date, the month of
                admission, and at least one month after the month of discharge from the
                index admission (that is, the original stay in an IPF); and (4)
                discharged with a principal diagnosis that indicates a psychiatric
                disorder. Excluded from the measure are patients discharged against
                medical advice (AMA) from the IPF index admission (because the IPF may
                not have had the opportunity to conduct full discharge planning for
                these patients); patients with unreliable data regarding death
                demographics or a combination thereof in their claims record (because
                these data are unreliable, they may lead to inaccuracies in the measure
                calculation); patients who expired during the IPF stay (because post-
                discharge care is not applicable to these patients); patients with a
                discharge resulting in a transfer to another care facility (because the
                receiving care facility would be responsible for discharge planning for
                these patients); and patients discharged but readmitted within 3 days
                of discharge, also known as an interrupted stay (because interrupted
                stays are often reflective of patient needs outside of the IPF, such as
                treatment for another condition).
                 To calculate the measure, we would use the following data sources
                which are all available from Medicare administrative records and data
                submitted by providers through the claims process: (1) Medicare
                beneficiary and coverage files, which provide information on patient
                demographic, enrollment, and vital status information to identify the
                measure population and certain risk factors; (2) Medicare FFS Part A
                records, which contain final action claims submitted by acute care and
                critical access hospitals, IPFs, home health agencies, and skilled
                nursing facilities to identify the measure population, readmissions,
                and certain risk factors; and (3) Medicare FFS Part B records, which
                contain final action claims submitted by physicians, physician
                assistants, clinical social workers, nurse practitioners, and other
                outpatient providers to identify certain risk factors. To ensure that
                diagnoses result from encounters with providers trained to establish
                diagnoses, this measure would not use claims for services such as
                laboratory tests, medical supplies, or other ambulatory services. Index
                admissions and ED visits would be identified in the Medicare FFS Part A
                records. Comorbid conditions for risk-adjustment would be identified in
                the Medicare Part A and Part B records in the 12 months prior to
                admission, including the index admission. Demographic and FFS
                enrollment data would be identified in the Medicare beneficiary and
                coverage files.
                 To calculate the IPF ED Visit measure, CMS would: (1) identify all
                IPF admissions in the one-year performance period; (2) apply inclusion
                and exclusion criteria to identify index admissions; (3) identify ED
                visits and observation stays within 30 days of discharge from each
                index admission; (4) identify risk factors in the 12 months prior to
                index admission and during the index admission; and (5) run
                hierarchical logistic regression to compute the risk-standardized ED
                visit rate for each IPF.\38\ This hierarchical logistic regression
                would allow us to apply the risk-adjustment factors developed in
                measure testing to ensure that measure results are comparable across
                IPFs regardless of the clinical complexity of each IPF's patient
                population.
                ---------------------------------------------------------------------------
                 \38\ For an example of the hierarchal logistic risk-adjustment
                algorithm, we refer readers to the algorithm for the IPF Unplanned
                Readmission measure at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/hospitalqualityinits/downloads/inpatient-psychiatric-facility-readmission-measure.zip.
                ---------------------------------------------------------------------------
                (2) Pre-Rulemaking Measure Review and Measure Endorsement
                 As required under section 1890A of the Act, the CBE established the
                Partnership for Quality Measurement (PQM) to convene clinicians,
                patients, measure experts, and health information technology
                specialists to participate in the pre-rulemaking process and the
                measure endorsement process. The pre-rulemaking process, also called
                the Pre-Rulemaking Measure Review (PRMR), includes a review of measures
                published on the publicly available list of Measures Under
                Consideration (MUC List) by one of several committees convened by the
                PQM for the purpose
                [[Page 23209]]
                of providing multi-stakeholder input to the Secretary on the selection
                of quality and efficiency measures under consideration for use in
                certain Medicare quality programs, including the IPFQR Program. The
                PRMR process includes opportunities for public comment through a 21-day
                public comment period, as well as public listening sessions. The PQM
                posts the compiled comments and listening session inputs received
                during the public comment period and the listening sessions within five
                days of the close of the public comment period.\39\ More details
                regarding the PRMR process may be found in the CBE's Guidebook of
                Policies and Procedures for Pre-Rulemaking Measure Review and Measure
                Set Review, including details of the measure review process in Chapter
                3.\40\
                ---------------------------------------------------------------------------
                 \39\ These materials are available at the PRMR section of the
                PQM website: https://p4qm.org/PRMR.
                 \40\ https://p4qm.org/sites/default/files/2023-09/Guidebook-of-Policies-and-Procedures-for-Pre-Rulemaking-Measure-Review-%28PRMR%29-and-Measure-Set-Review-%28MSR%29-Final_0.pdf.
                ---------------------------------------------------------------------------
                 The CBE-established PQM also conducts the measure endorsement and
                maintenance (E&M) process to ensure measures submitted for endorsement
                are evidence-based, reliable, valid, verifiable, relevant to enhanced
                health outcomes, actionable at the caregiver-level, feasible to collect
                and report, and responsive to variations in patient characteristics,
                such as health status, language capabilities, race or ethnicity, and
                income level, and are consistent across types of health care providers,
                including hospitals and physicians (see section 1890(b)(2) of the Act).
                The PQM convenes several E&M project groups twice yearly, formally
                called E&M Committees, each comprised of an E&M Advisory Group and an
                E&M Recommendations Group, to vote on whether a measure meets certain
                quality measure criteria. More details regarding the E&M process may be
                found in the E&M Guidebook, including details of the measure
                endorsement process in the section titled, ``Endorsement and Review
                Process.'' \41\
                ---------------------------------------------------------------------------
                 \41\ The Partnership for Quality Measurement. (October 2023).
                Endorsement and Maintenance (E&M) Guidebook. Available at: https://p4qm.org/sites/default/files/2023-12/Del-3-6-Endorsement-and-Maintenance-Guidebook-Final__0.pdf.
                ---------------------------------------------------------------------------
                 As part of the PRMR process, the IPF ED Visit measure was reviewed
                during the PRMR Hospital Recommendation Group meeting on January 18,
                2024. For the voting procedures of the PRMR and E&M process, the PQM
                utilized the Novel Hybrid Delphi and Nominal Group (NHDNG) multi-step
                process, which is an iterative consensus-building approach aimed at a
                minimum of 75 percent agreement among voting members, rather than a
                simple majority vote, and supports maximizing the time spent to build
                consensus by focusing discussion on measures where there is
                disagreement. For example, the PRMR Hospital Recommendation Group can
                reach consensus and have the following voting results: (A) Recommend,
                (B) Recommend with conditions (with 75 percent of the votes cast as
                recommend with conditions or 75 percent between recommend and recommend
                with conditions), and (C) Do not recommend. If no voting category
                reaches 75 percent or greater (including the combined [A] Recommend and
                [B] Recommend with conditions) the PRMR Hospital Recommendation Group
                did not come to consensus and the voting result is ``Consensus not
                reached.'' Consensus not reached signals continued disagreement amongst
                the committee despite being presented with perspectives from public
                comment, committee member feedback and discussion, and highlights the
                multi-faceted assessments of quality measures. More details regarding
                the PRMR voting procedures may be found in Chapter 4 of the PQM
                Guidebook of Policies and Procedures for Pre-Rulemaking Measure Review
                and Measure Set Review.\42\ More details regarding the E&M voting
                procedures may be found in the PQM Endorsement and Maintenance (E&M)
                Guidebook.\43\ The PRMR Hospital Recommendation Group \44\ reached
                consensus and recommended including this measure in the IPFQR Program
                with conditions.
                ---------------------------------------------------------------------------
                 \44\ We note that the PRMR Hospital Recommendation Group was
                previously the Measure Applications Partnership (MAP) Hospital
                Workgroup under the pre-rulemaking process followed by the previous
                CBE.
                ---------------------------------------------------------------------------
                 Seven members of the group recommended adopting the measure into
                the IPFQR program without conditions; eleven members recommended
                adoption with conditions; and one committee member voted not to
                recommend the measure for adoption. Taken together, 94.73 percent of
                the votes were between recommend & recommend with conditions.
                 The conditions specified by the PRMR Hospital Recommendation Group
                were: (1) that the measure be considered for endorsement by a
                consensus-based entity; and (2) further consideration of how the
                measure addresses 72-hour transfers to the ED. We have taken those
                considerations into account and are proposing this measure for adoption
                because we believe we have adequately addressed the concerns raised by
                those considerations.
                 To address the first condition, we have submitted the measure to
                the CBE for consideration. For more information on submission to and
                consideration by the CBE we refer readers to section V.B.2.b.(3) of
                this rule.
                 The second voting condition requested that we further consider how
                the measure addresses 72-hour transfers to the ED because of concerns
                that IPFs may appear to have worse performance if ``interrupted stays''
                are not excluded from the measure. An ``interrupted stay'' occurs when
                a patient is discharged from an IPF and readmitted to the same IPF
                within 72 hours. This frequently occurs when a patient needs medical
                treatment that is beyond the scope of the IPF, such as care in an ED
                for an emergent health issue. We believe that this concern is
                sufficiently addressed in the ED Visit measure's specifications because
                these ``interrupted stays'' are excluded from the measure, as described
                in section V.B.2.b.(1) of this rule. This exclusion is defined as an
                index admission with a readmission on Days 0, 1, or 2 post-discharge.
                In other words, patients transferred to the ED and subsequently
                readmitted to the IPF within 72 hours are excluded from the measure.
                Therefore ``interrupted stays'' are excluded from the measure as per
                the group's recommendation.
                (3) CBE Endorsement
                 Section 1886(s)(4)(D)(i) of the Act generally requires that
                measures specified by the Secretary shall be endorsed by the entity
                with a contract under section 1890(a) of the Act (that is, the CBE).
                After a measure has been submitted to the CBE, the committee
                responsible for reviewing the measure evaluates the measure on five
                domains: (1) Importance; (2) Feasibility; (3) Scientific Acceptability
                (that is, reliability and validity); (4) Equity; and (5) Use and
                Usability. Committee members evaluate whether the measure the domain is
                ``Met'', ``Not Met but Addressable'' or ``Not Met'' for each domain
                using a set of criteria provided by the CBE.\45\ When a measure is
                submitted it is assigned to one of the CBE's projects based on where in
                the patient's healthcare experience the measure has the most relevance.
                The five projects are (1) Primary Prevention; (2) Initial Recognition
                and Management; (3) Management of Acute Events, Chronic Disease,
                Surgery, Behavioral Health; (4) Advanced Illness and Post-Acute Care;
                and (5) Cost and Efficiency.
                ---------------------------------------------------------------------------
                 \45\ https://p4qm.org/EM.
                ---------------------------------------------------------------------------
                 The measure developer submitted the measure for CBE endorsement
                consideration in the Fall 2023 review
                [[Page 23210]]
                cycle. The measure was assigned to the Cost and Efficiency Project. The
                CBE Cost and Efficiency Endorsement committee met on January 31, 2024
                and did not reach consensus regarding the IPF ED Visit measure, with
                60.6 percent voting in favor of endorsement or endorsement with
                conditions and the remaining members voting to not endorse, which is
                below the 75 percent threshold necessary for the endorsement of the
                measure, as described in V.B.2.b. During the Cost and Efficiency
                Endorsement committee's meeting, members of the committee discussed
                whether an all-cause measure was appropriate and whether IPFs are able
                to implement interventions to reduce post-discharge acute care.\46\
                ---------------------------------------------------------------------------
                 \46\ For information about the Cost and Efficiency endorsement
                review we refer readers to the meeting summary, available at https://p4qm.org/sites/default/files/Cost%20and%20Efficiency/material/EM-Cost-and-Efficiency-Fall2023-Endorsement-Meeting-Summary.pdf.
                ---------------------------------------------------------------------------
                 As discussed in section V.B.2.a of this proposed rule, an all-cause
                measure would complement the IPF Unplanned Readmission measure, would
                emphasize whole-person care, and would capture visits to the ED for
                patients with physical symptoms associated with mental health
                conditions. Additionally, evidence shows that there are interventions
                that reduce post-discharge acute care. These include adopted care
                transition models, proactively connecting patients with post-discharge
                providers, identifying and addressing patients' barriers to post-
                discharge care, and focusing on providing patient-centered care and
                improving patient experience of care.
                 Although section 1886(s)(4)(D)(i) of the Act generally requires
                that measures specified by the Secretary shall be endorsed by the
                entity with a contract under section 1890(a) of the Act, section
                1886(s)(4)(D)(ii) of the Act states that, in the case of a specified
                area or medical topic determined appropriate by the Secretary for which
                a feasible and practical measure has not been endorsed by the entity
                with a contract under section 1890(a) of the Act, the Secretary may
                specify a measure that is not so endorsed as long as due consideration
                is given to a measure that has been endorsed or adopted by a consensus
                organization identified by the Secretary.
                 We have determined that this is an appropriate topic for the
                adoption of a measure absent CBE endorsement because where possible we
                focus on measures that assess patient outcomes. Unplanned use of acute
                care after discharge from an IPF is often associated with worsening
                condition, potentially due to insufficient discharge planning and post-
                discharge care coordination. While the IPFQR Program currently has a
                measure that assesses unplanned readmissions after discharge from an
                IPF, there is a gap in the measure set with respect to unplanned ED
                visits without a subsequent admission to an acute care hospital or IPF.
                The IPF ED Visit measure fills that gap. We also reviewed CBE-endorsed
                measures and were unable to identify any other CBE-endorsed measures
                that assess outcomes that solely result in a patient's ED visit after
                the patient's discharge from an IPF. The only endorsed measure that we
                identified that addresses an IPF patient seeking acute care after
                discharge is the IPF Unplanned Readmission measure. As we discussed
                previously, the IPF Unplanned Readmission measure does not assess ED
                visits that do not result in an admission. Therefore, we believe that
                the IPF ED Visit measure is an important complement to the IPF
                Unplanned Readmission measure. We did not find any other measures that
                assess post-discharge ED visits without a subsequent admission, and
                therefore the exception in section 1886(s)(4)(D)(ii) of the Act
                applies.
                c. Data Collection, Submission, and Reporting
                 Because all files used to calculate the IPF ED Visit measure are
                available on Medicare claims, this measure requires no additional data
                collection or submission by IPFs. We are proposing a reporting period
                beginning with data from CY 2025 performance period/FY 2027 payment
                determination year.
                C. Summary of IPFQR Program Measures for the FY IPFQR Program
                 We are proposing one new measure for the FY 2027 IPFQR Program. If
                we finalize adoption of this measure, the FY 2027 IPFQR Program measure
                set would include 16 mandatory and one voluntary measure. Table 22 sets
                forth the measures in the FY 2027 IPFQR Program.
                BILLING CODE 4120-01-P
                [[Page 23211]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.034
                BILLING CODE 4120-01-C
                D. Proposal To Modify Data Submission Requirements for the FY 2027
                Payment Determination and Subsequent Years
                 Section 1886(s)(4)(C) of the Act requires the submission of quality
                data in a form and manner, and at a time, specified by the Secretary.
                In the Medicare Program; Hospital Inpatient Prospective Payment Systems
                for Acute Care Hospitals and the Long-Term Care Hospital Prospective
                Payment System and fiscal year 2013 Rates; Hospitals' Resident Caps for
                Graduate Medical Education Payment Purposes; Quality Reporting
                Requirements for Specific Providers and for Ambulatory Surgical Centers
                (FY 2013 IPPS/LTCH PPS) final rule (77 FR 53655), we specified that
                data must be submitted between July 1 and August 15 of the calendar
                year preceding a given payment determination year (for example, data
                were required to be submitted between July 1, 2015 and August 15, 2015
                for the FY 2016 payment determination). In the Medicare Program;
                Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals
                and the Long-Term Care Hospital Prospective Payment System and fiscal
                year 2014 Rates; Quality Reporting Requirements for Specific Providers;
                Hospital Conditions of Participation; Payment Policies Related to
                Patient Status (FY 2014 IPPS/LTCH PPS) final rule (78 FR 50899), we
                clarified that this policy applied to all future years of data
                submission for the IPFQR Program unless we changed the policy through
                future rulemaking.
                 In the FY 2018 IPF PPS final rule (82 FR 38472 through 38473) we
                updated this policy by stating that the data submission period will be
                a 45-day period beginning at least 30 days
                [[Page 23212]]
                following the end of the data collection period and that we will
                provide notification of the exact dates through subregulatory means.
                 In the FY 2022 IPF PPS Final Rule (86 FR 42658 through 42661), we
                finalized voluntary patient-level data reporting for the FY 2023
                payment determination and mandatory patient-level data reporting for
                chart-abstracted measures within the IPFQR Program beginning with FY
                2024 payment determination and subsequent years. The measures currently
                in the IPFQR Program affected by this requirement are set forth in
                Table 23.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.035
                 As we have gained experience with patient-level data submission for
                the IPFQR program, during the voluntary data submission period for FY
                2023 (which occurred in CY 2022) and the first mandatory data
                submission period for FY 2024 (which occurred in CY 2023), we have
                observed that annual data submission periods require IPFs to store
                large volumes of patient data to prepare for transmission to CMS.
                Furthermore, the volume of data associated with all IPFs reporting a
                full year of patient-level data during one data submission period
                creates the risk that systems will be unable to handle the volume of
                data.
                 We have reviewed how other quality reporting programs that require
                patient-level data submission address these concerns and determined
                that the Hospital Inpatient Quality Reporting (IQR) Program (78 FR
                50811) and the Hospital Outpatient Quality Reporting (OQR) Program (72
                FR 66872) both require quarterly submission of patient-level data. As
                we considered requiring quarterly reporting for the IPFQR Program, we
                also determined that increasing the frequency of data submission would
                allow additional analysis of measure trends over time. We believe that
                having additional data points (from additional quarters of data) could
                allow for more nuanced analyses of the IPFQR Program's measures.
                Specifically, we would be able to better identify quarterly highs or
                lows that may be less apparent when data are combined over a full year.
                We recognize that, if we update data reporting requirements to require
                reporting four times per year instead of once per year, then IPFs would
                need to meet four incremental deadlines instead of one deadline, and
                that this increases the risk that an individual IPF may fail to submit
                data specified for the measures and not receive its full market basket
                update. However, we believe that this risk is low because IPFs already
                have experience submitting some data required by the IPFQR Program on a
                more frequent basis. Specifically, the COVID-19 Healthcare Personnel
                (HCP) Vaccination Measure is currently reported into the CDC's National
                Healthcare Safety Network (NHSN) for one week per month resulting in a
                quarterly measure result (as originally adopted in the FY 2022 IPF PPS
                final rule (86 FR 42636) and restated in the FY 2024 IPF PPS final rule
                (88 FR 51131 through 51132). In addition, if this proposal for
                quarterly data submission is finalized, data submission for each
                calendar quarter would be required during a period of at least 45 days
                beginning three months after the end of the calendar quarter. Table 24
                summarizes these proposed deadlines for the CY 2025 and CY 2026
                performance periods:
                [[Page 23213]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.036
                 Furthermore, we are proposing that all data which continue to be
                reported on an annual basis (that is, non-measure data, aggregate
                measures, and attestations) would be required to be reported
                concurrently with the data from the fourth quarter of the applicable
                year. For example, data reflecting the entirety of CY 2025 (that is,
                non-measure data, aggregate measures, and attestations) would be
                required by the Q4 2025 submission deadline (that is, May 15, 2026).
                 We welcome comments on this proposal.
                VI. Collection of Information Requirements
                 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et
                seq.), 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. For the purposes of the PRA and this section
                of the preamble, collection of information is defined under 5 CFR
                1320.3(c) of the PRA's implementing regulations.
                 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.
                 We are soliciting public comment (see section VI.C of this proposed
                rule) on each of these issues for the following sections of this
                document that contain information collection requirements. Comments, if
                received, will be responded to within the subsequent final rule.
                 The following changes will be submitted to OMB for review under
                control number 0938-1171 (CMS-10432). We are not proposing any changes
                that would change any of the data collection instruments that are
                currently approved under that control number.
                 In section VI.2 of this proposed rule, we restate our currently
                approved burden estimates. In section VI.3 of this proposed rule, we
                estimate the changes in burden associated with update more recent wage
                rates. Then in section VI.4 of this proposed rule, we estimate the
                changes in burden associated with the policies proposed in this
                proposed rule.
                A. Wage Estimates
                 In the FY 2024 IPF PPS final rule, we utilized the median hourly
                wage rate for Medical Records Specialists, in accordance with the
                Bureau of Labor Statistics (BLS), to calculate our burden estimates for
                the IPFQR Program (88 FR 51145). While the most recent data from the
                BLS reflects a mean hourly wage of $24.56 per hour for all medical
                records specialists, $26.06 is the mean hourly wage for ``general
                medical and surgical hospitals,'' which is an industry within medical
                records specialists.\47\ We believe the industry of ``general medical
                and surgical hospitals'' is more specific to the IPF setting for use in
                our calculations than other industries that fall under medical records
                specialists, such as ``office of physicians'' or ``nursing care
                facilities (skilled nursing facilities).'' We calculated the cost of
                indirect costs, including fringe benefits, at 100 percent of the median
                hourly wage, consistent with previous years. This is necessarily a
                rough adjustment, both because fringe benefits and other indirect costs
                vary significantly by employer and methods of estimating these costs
                vary widely in the literature. Nonetheless, we believe that doubling
                the hourly wage rate ($26.06 x 2 = $52.12) to estimate total cost is a
                reasonably accurate estimation method. Accordingly, unless otherwise
                specified, we will calculate cost burden to IPFs using a wage plus
                benefits estimate of $52.12 per hour throughout the discussion in this
                section of this rule for the IPFQR Program.
                ---------------------------------------------------------------------------
                 \47\ Medical Records Specialists (bls.gov).
                ---------------------------------------------------------------------------
                 Some of the activities previously finalized for the IPFQR Program
                require beneficiaries to undertake tasks such as responding to survey
                questions on their own time. In the FY 2024 IPF PPS final rule, we
                estimated the hourly wage rate for these activities to be $20.71/hr (88
                FR 51145). We are updating that estimate to a post-tax wage of $24.04/
                hr.
                [[Page 23214]]
                The Valuing Time in U.S. Department of Health and Human Services
                Regulatory Impact Analyses: Conceptual Framework and Best Practices
                identifies the approach for valuing time when individuals undertake
                activities on their own time.\48\ To derive the costs for
                beneficiaries, we used a measurement of the usual weekly earnings of
                wage and salary workers of $1,118, divided by 40 hours to calculate an
                hourly pre-tax wage rate of $27.95/hr.\49\ This rate is adjusted
                downwards by an estimate of the effective tax rate for median income
                households of about 14 percent calculated by comparing pre- and post-
                tax income,\50\ resulting in the post-tax hourly wage rate of $24.04/
                hr. Unlike our State and private sector wage adjustments, we are not
                adjusting beneficiary wages for fringe benefits and other indirect
                costs since the individuals' activities, if any, would occur outside
                the scope of their employment.
                ---------------------------------------------------------------------------
                 \48\ https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework.
                 \49\ https://www.bls.gov/news.release/pdf/wkyeng.pdf. Accessed
                January 1, 2024.
                 \50\ https://www.census.gov/library/stories/2023/09/median-household-income.html. Accessed January 2, 2024.
                ---------------------------------------------------------------------------
                B. Previously Finalized IPFQR Estimates
                 We are finalizing provisions that impact policies beginning with
                the FY 2027 payment determination. For the purposes of calculating
                burden, we attribute the costs to the year in which the costs begin.
                Under our previously finalized policies, data submission for the
                measures that affect the FY 2027 payment determination occurs during CY
                2026 and generally reflects care provided during CY 2025. If we
                finalize our proposal to switch to quarterly reporting in section XX.X
                of this proposed rule, data submission for the FY 2027 payment
                determination would begin during CY 2025. Our currently approved burden
                for CY 2025 is set forth in Table 25.
                BILLING CODE 4120-01-P
                [[Page 23215]]
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                [[Page 23216]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.038
                BILLING CODE 4120-01-C
                C. Updates Due to More Recent Information
                 In section VI.A of this proposed rule, we described our updated
                wage rates which increase from $44.86/hr to $52.12/hr (an increase of
                $7.26/hr) for activities performed by Medical Records Specialists and
                from $20.71/hr to $24.04/hr (an increase of $3.33/hr) for activities
                performed by individuals. The effects of these updates are set forth in
                Table 26.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.039
                D. Updates Due to Proposals in This Proposed Rule
                 In section V.B.2 of this proposed rule, we are proposing to adopt
                the 30-Day Risk-Standardized All-Cause ED Visit Following an IPF
                Discharge measure beginning with the CY 2025 performance period/FY 2027
                payment determination. As described in section V.B.2.c. of this
                preamble, we will calculate the 30-Day Risk-Standardized All-Cause ED
                Visit Following an Inpatient Psychiatric Facility Discharge measure
                using Medicare claims that IPFs and other providers submit for payment.
                Since this is a claims-based measure there is no additional burden
                outside of submitting a claim. The claim submission is approved by OMB
                under control number 0938-0050 (CMS-2552-10). This rule does not
                warrant any changes under that control number.
                 In Section V.D. of this proposed rule, we are proposing to require
                IPFs to submit data on chart-abstracted measures quarterly. In CY 2025,
                this would equate to one additional data submission period (that is,
                the reporting period which would close on November 15, 2025 as set
                forth in Table 27). In CY 2026, there would be an additional two data
                submission periods (for a total of four annually). We estimate that the
                [[Page 23217]]
                increase in burden associated with the increase in data submission
                periods is approximately equal to the burden of reporting one
                attestation measure because both of these activities require logging
                into and interacting with user interfaces within the CMS data reporting
                system (that is, the Hospital Quality System--HQS). The effects of this
                increase on the IPFQR Program for CY 2025 are set forth in Table 27.
                The effects of this increase on the IPFQR Program for CY 2026 are set
                forth in Table 28.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.040
                E. Consideration of Burden Related to Clarification of Eligibility
                Criteria for the Option To Elect To File an All-Inclusive Cost Report
                 As discussed in section III.E.4 of this proposed rule, we are
                clarifying the eligibility criteria to be approved to file all-
                inclusive cost reports. Only government-owned and tribally owned
                facilities are able to satisfy these criteria, and thus only these
                facilities will be permitted to file an all-inclusive cost report for
                cost reporting periods beginning on or after October 1, 2024.
                 We do not estimate any change in the burden associated with the
                hospital cost report (CMS-2552-10) OMB control number 0938-0050. We
                anticipate that IPFs which are currently filing all-inclusive cost
                reports, but are not government-owned or tribally owned, would not
                incur additional burden related to the submission of the cost report.
                The approved burden estimate associated with the submission of the
                hospital cost report includes the same amount of burden for the
                submission of an all-inclusive cost report as for the submission of a
                cost report with a charge structure.
                 We recognize that these IPFs would be required to track ancillary
                costs and charges using a charge structure; however, we expect that any
                burden associated with this tracking would be part of the normal course
                of a hospital's activities.
                F. Submission of PRA-Related Comments
                 We have submitted a copy of this proposed rule's information
                collection requirements to OMB for their review. The requirements are
                not effective until they have been approved by OMB.
                 To obtain copies of the supporting statement and any related forms
                for the proposed collections discussed above, please visit the CMS
                website at https://www.cms.gov/regulationsand-guidance/legislation/paperworkreductionactof1995/pra-listing, or call the Reports Clearance
                Office at 410-786-1326.
                 We invite public comments on these potential information collection
                requirements. If you wish to comment, please submit your comments
                electronically as specified in the DATES and ADDRESSES sections of this
                proposed rule and identify the rule (CMS-1806-P), the ICR's CFR
                citation, and OMB control number.
                VII. Response to Comments
                 Because of the large number of public comments we normally receive
                on Federal Register documents, we are not able to acknowledge or
                respond to them individually. We will consider all comments we receive
                by the date and time specified in the DATES section of this preamble,
                and, when we proceed with a subsequent document, we will respond to the
                comments in the preamble to that document.
                VIII. Regulatory Impact Analysis
                A. Statement of Need
                 This rule proposes updates to the prospective payment rates for
                Medicare inpatient hospital services provided by IPFs for discharges
                occurring during FY 2025 (October 1, 2024 through September 30, 2025).
                We are proposing to apply the 2021-based IPF market basket increase of
                3.1 percent, reduced by the productivity adjustment of 0.4 percentage
                point as required by 1886(s)(2)(A)(i) of the Act for a proposed total
                FY 2025 payment rate update of 2.7 percent. In this proposed rule, we
                [[Page 23218]]
                are proposing to update the outlier fixed dollar loss threshold amount,
                update the IPF labor-related share, adopt new CBSA delineations based
                on OMB Bulletin 23-01, and update the IPF wage index to reflect the FY
                2025 hospital inpatient wage index. Section 1886(s)(4) of the Act
                requires IPFs to report data in accordance with the requirements of the
                IPFQR Program for purposes of measuring and making publicly available
                information on health care quality; and links the quality data
                submission to the annual applicable percentage increase.
                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). Section
                3(f) of Executive Order 12866, as amended by Executive Order 14094,
                defines a ``significant regulatory action'' as an action that is likely
                to result in a rule that may: (1) have an annual effect on the economy
                of $200 million or more (adjusted every 3 years by the Administrator of
                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) create a
                serious inconsistency or otherwise interfere with an action taken or
                planned by another agency; (3) materially alter the budgetary impacts
                of entitlements, 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 Executive Order 12866. In
                accordance with the provisions of Executive Order 12866, this
                regulation was reviewed by the Office of Management and Budget.
                 A regulatory impact analysis (RIA) must be prepared for regulatory
                actions that are significant under section 3(f)(1) of Executive Order
                12866. We estimate that the total impact of these changes for FY 2025
                payments compared to FY 2024 payments will be a net increase of
                approximately $70 million. This reflects a $75 million increase from
                the update to the payment rates (+$85 million from the 4th quarter 2023
                IGI forecast of the 2021-based IPF market basket of 3.1 percent, and -
                $10 million for the productivity adjustment of 0.4 percentage point),
                as well as a $5 million decrease as a result of the update to the
                outlier threshold amount. Outlier payments are estimated to change from
                2.1 percent in FY 2024 to 2.0 percent of total estimated IPF payments
                in FY 2025.
                 Based on our estimates, OMB's Office of Information and Regulatory
                Affairs has determined that this rulemaking is ``significant,'' though
                not significant under section 3(f)(1) of Executive Order 12866.
                Nevertheless, because of the potentially substantial impact to IPF
                providers, we have prepared a Regulatory Impact Analysis that to the
                best of our ability presents the costs and benefits of the rulemaking.
                OMB has reviewed these proposed regulations, and the Departments have
                provided the following assessment of their impact.
                 Nevertheless, because of the potentially substantial impact to IPF
                providers, we have prepared a Regulatory Impact Analysis that to the
                best of our ability presents the costs and benefits of the rulemaking.
                Based on our estimates, OMB's Office of Information and Regulatory
                Affairs has determined that this rulemaking is ``significant.''
                Therefore, OMB has reviewed these proposed regulations, and the
                Departments have provided the following assessment of their impact.
                C. Detailed Economic Analysis
                 In this section, we discuss the historical background of the IPF
                PPS and the impact of this proposed rule on the Federal Medicare budget
                and on IPFs.
                1. Budgetary Impact
                 As discussed in the RY 2005 and RY 2007 IPF PPS final rules, we
                applied a budget neutrality factor to the Federal per diem base rate
                and ECT payment per treatment to ensure that total estimated payments
                under the IPF PPS in the implementation period would equal the amount
                that would have been paid if the IPF PPS had not been implemented. This
                budget neutrality factor included the following components: outlier
                adjustment, stop-loss adjustment, and the behavioral offset. As
                discussed in the RY 2009 IPF PPS notice (73 FR 25711), the stop-loss
                adjustment is no longer applicable under the IPF PPS.
                 As discussed in section III.D.1.d of this proposed rule, we are
                proposing to update the wage index and labor-related share, as well as
                update the CBSA delineations based on OMB Bulletin 23-01, in a budget
                neutral manner by applying a wage index budget neutrality factor to the
                Federal per diem base rate and ECT payment per treatment. In addition,
                as discussed in section III.F of this proposed rule, we are proposing
                to apply a refinement standardization factor to the Federal per diem
                base rate and ECT payment per treatment to account for the proposed
                revisions to the ECT per treatment amount, ED adjustment, and patient-
                level adjustment factors (as previously discussed in sections III.B,
                III.C, and III.D of this proposed rule, and summarized in Addendum A),
                which must be made budget-neutrally. Therefore, the budgetary impact to
                the Medicare program of this proposed rule would be due to the proposed
                market basket update for FY 2025 of 3.1 percent (see section III.A.2 of
                this proposed rule) reduced by the productivity adjustment of 0.4
                percentage point required by section 1886(s)(2)(A)(i) of the Act and
                the update to the outlier fixed dollar loss threshold amount.
                 We estimate that the FY 2025 impact would be a net increase of $70
                million in payments to IPF providers. This reflects an estimated $75
                million increase from the update to the payment rates and a $5 million
                decrease due to the update to the outlier threshold amount to set total
                estimated outlier payments at 2.0 percent of total estimated payments
                in FY 2025. This estimate does not include the implementation of the
                required 2.0 percentage point reduction of the productivity-adjusted
                market basket update factor for any IPF that fails to meet the IPF
                quality reporting requirements (as discussed in section III.B.2. of
                this proposed rule).
                2. Impact on Providers
                 To show the impact on providers of the changes to the IPF PPS
                discussed in this proposed rule, we compare estimated payments under
                the proposed IPF PPS rates and factors for FY 2025 versus those under
                FY 2024. We determined the percent change in the estimated FY 2025 IPF
                PPS payments compared to the estimated FY 2024 IPF PPS payments for
                each category of IPFs.
                [[Page 23219]]
                In addition, for each category of IPFs, we have included the estimated
                percent change in payments resulting from the proposed update to the
                outlier fixed dollar loss threshold amount; the proposed revisions to
                the patient-level adjustment factors, ED adjustment, and ECT per
                treatment amount; the updated wage index data including the proposed
                labor-related share and the proposed changes to the CBSA delineations;
                and the proposed market basket increase for FY 2025, as reduced by the
                proposed productivity adjustment according to section 1886(s)(2)(A)(i)
                of the Act.
                 To illustrate the impacts of the proposed FY 2025 changes in this
                proposed rule, our analysis begins with FY 2023 IPF PPS claims (based
                on the 2023 MedPAR claims, December 2023 update). We estimate FY 2024
                IPF PPS payments using these 2023 claims, the finalized FY 2024 IPF PPS
                Federal per diem base rate and ECT per treatment amount, and the
                finalized FY 2024 IPF PPS patient and facility level adjustment factors
                (as published in the FY 2024 IPF PPS final rule (88 FR 51054)). We then
                estimate the FY 2024 outlier payments based on these simulated FY 2024
                IPF PPS payments using the same methodology as finalized in the FY 2024
                IPF PPS final rule (88 FR 51090 through 51092) where total outlier
                payments are maintained at 2 percent of total estimated FY 2024 IPF PPS
                payments.
                 Each of the following changes is added incrementally to this
                baseline model in order for us to isolate the effects of each change:
                 The proposed update to the outlier fixed dollar loss
                threshold amount.
                 The proposed revisions to patient-level adjustment
                factors, ED adjustment, and the ECT per treatment amount.
                 The proposed FY 2025 IPF wage index, the proposed changes
                to the CBSA delineations, and the proposed FY 2025 labor-related share
                (LRS).
                 The proposed market basket increase for FY 2025 of 3.1
                percent reduced by the proposed productivity adjustment of 0.4
                percentage point in accordance with section 1886(s)(2)(A)(i) of the Act
                for a payment rate update of 2.7 percent.
                 Our proposed column comparison in Table 29 illustrates the percent
                change in payments from FY 2024 (that is, October 1, 2023, to September
                30, 2024) to FY 2025 (that is, October 1, 2024, to September 30, 2025)
                including all the proposed payment policy changes.
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                [[Page 23221]]
                [GRAPHIC] [TIFF OMITTED] TP03AP24.042
                3. Impact Results
                 Table 30 displays the results of our analysis. The table groups
                IPFs into the categories listed here based on characteristics provided
                in the Provider of Services file, the IPF PSF, and cost report data
                from the Healthcare Cost Report Information System:
                 Facility Type.
                 Location.
                 Teaching Status Adjustment.
                 Census Region.
                 Size.
                 The top row of the table shows the overall impact on the 1,430 IPFs
                included in the analysis. In column 2, we present the number of
                facilities of each type that had information available in the PSF, had
                claims in the MedPAR dataset for FY 2023. We note that providers are
                assigned urban or rural status in Table 30 based on the current CBSA
                delineations for FY 2024.
                 In column 3, we present the effects of the update to the outlier
                fixed dollar loss threshold amount. We estimate that IPF outlier
                payments as a percentage of total IPF payments are 2.1 percent in FY
                2024. Therefore, we are proposing to adjust the outlier threshold
                amount to set total estimated outlier payments equal to 2.0 percent of
                total payments in FY 2025. The estimated change in total IPF payments
                for FY 2025, therefore, includes an approximate 0.1 percent decrease in
                payments because we would expect the outlier portion of total payments
                to decrease from approximately 2.1 percent to 2.0 percent.
                [[Page 23222]]
                 The overall impact of the estimated decrease to payments due to
                updating the outlier fixed dollar loss threshold (as shown in column 3
                of Table 30), across all hospital groups, is a 0.1 percent decrease.
                The largest decrease in payments due to this change is estimated to be
                0.2 percent for urban government IPF units, IPFs with more than 30
                percent interns and residents to beds, and IPF units with 76+ beds.
                 In column 4, we present the effects of the proposed revisions to
                the patient-level adjustment factors, ED adjustment, and ECT per
                treatment amount and the application of the refinement standardization
                factor that is discussed in section III.F of this proposed rule. We
                estimate the largest payment increases would be for rural freestanding
                government-owned IPFs. Conversely, we estimate that for-profit IPF
                hospitals in rural areas would experience the largest payment decrease.
                Payments to IPF units in urban areas would increase by 0.4 percent, and
                payments to IPF units in rural areas would increase by 0.3 percent.
                 In column 5, we present the effects of the proposed budget-neutral
                update to the IPF wage index, the proposed LRS, and the proposed
                changes to the CBSA delineations for FY 2025. In addition, this column
                includes the application of the 5-percent cap on any decrease to a
                provider's wage index from its wage index in the prior year as
                finalized in the FY 2023 IPF PPS final rule (87 FR 46856 through
                46859). The change in this column represents the effect of using the
                concurrent hospital wage data as discussed in section III.D.1.a of this
                proposed rule. That is, the impact represented in this column reflects
                the proposed update from the FY 2024 IPF wage index to the proposed FY
                2025 IPF wage index, which includes basing the FY 2025 IPF wage index
                on the FY 2025 pre-floor, pre-reclassified IPPS hospital wage index
                data, applying a 5-percent cap on any decrease to a provider's wage
                index from its wage index in the prior year, and updating the LRS from
                78.7 percent in FY 2024 to 78.8 percent in FY 2025. We note that there
                is no projected change in aggregate payments to IPFs, as indicated in
                the first row of column 5; however, there would be distributional
                effects among different categories of IPFs. For example, we estimate
                the largest increase in payments to be 2.9 percent for freestanding
                rural for-profit IPFs, and the largest decrease in payments to be 1.6
                percent for IPFs located in the Pacific region.
                 Overall, IPFs are estimated to experience a net increase in
                payments of 2.6 percent as a result of the updates in this proposed
                rule. IPF payments are therefore estimated to increase by 2.4 percent
                in urban areas and 4.0 percent in rural areas. The largest payment
                increase is estimated at 5.0 percent for IPFs located in the East South
                Central region.
                4. Effect on Beneficiaries
                 Under the FY 2025 IPF PPS, IPFs will continue to receive payment
                based on the average resources consumed by patients for each day. Our
                longstanding payment methodology reflects the differences in patient
                resource use and costs among IPFs, as required under section 124 of the
                BBRA. We expect that updating IPF PPS rates in this rule will improve
                or maintain beneficiary access to high quality care by ensuring that
                payment rates reflect the best available data on the resources involved
                in inpatient psychiatric care and the costs of these resources. We
                continue to expect that paying prospectively for IPF services under the
                FY 2025 IPF PPS will enhance the efficiency of the Medicare program.
                 As discussed in sections V.B.2 of this proposed rule, we expect
                that the proposed additional IPFQR Program measure will support
                improving discharge planning and care coordination to decrease the
                likelihood that a patient will need to seek emergency care within 30
                days of discharge from an IPF.
                5. Effects of the Updates to the IPFQR Program
                 In section V.B.2. of this rule, we are proposing the 30-Day Risk-
                Standardized All-Cause ED Visit Following an Inpatient Psychiatric
                Facility Discharge measure beginning with data from the CY 2025
                performance period for the FY 2027 payment determination. We do not
                believe this update would impact providers' workflows or information
                systems to collect or report the data because this measure is
                calculated by CMS using information that IPFs already submit as part of
                the claims process. There may be some effects of this measure on IPF
                workflows and clinical processes to improve care coordination and
                discharge planning to improve performance on the measure.
                 We are also proposing to adopt a quarterly data submission
                requirement for measures for which we require patient-level data. We
                believe there may be some non-recurrent costs associated with training
                staff and updating processes to submit these data more frequently. We
                believe that the recurring costs of these updates will be an increase
                of 800 hours across all IPFs, equating to change of $41,696.
                 In accordance with section 1886(s)(4)(A) of the Act, we will apply
                a 2-percentage point reduction to the FY 2025 market basket update for
                IPFs that have failed to comply with the IPFQR Program requirements for
                FY 2025, including reporting on the mandatory measures. For the FY 2024
                payment determination, of the 1,568 IPFs eligible for the IPFQR
                Program, 194 IPFs did not receive the full market basket update because
                of the IPFQR Program; 42 of these IPFs chose not to participate and 152
                did not meet the requirements of the program.
                 We intend to closely monitor the effects of the IPFQR Program on
                IPFs and help facilitate successful reporting outcomes through ongoing
                education, national trainings, and a technical help desk.
                6. 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 be directly impacted and will review this proposed rule, we
                assume that the total number of unique commenters on the most recent
                IPF proposed rule will be the number of reviewers of this proposed
                rule. For this FY 2025 IPF PPS proposed rule, the most recent IPF
                proposed rule was the FY 2024 IPF PPS proposed rule, and we received
                2,506 unique comments on this proposed rule. We acknowledge that this
                assumption may understate or overstate the costs of reviewing this
                proposed rule. It is possible that not all commenters reviewed the FY
                2024 IPF proposed rule in detail, and it is also possible that some
                reviewers chose not to comment on that proposed rule. For these
                reasons, we thought that the number of commenters would be a fair
                estimate of the number of reviewers who are directly impacted by this
                proposed rule. We are soliciting comments on this assumption.
                 We also recognize that different types of entities are in many
                cases affected by mutually exclusive sections of this proposed rule;
                therefore, for the purposes of our estimate, we assume that each
                reviewer reads approximately 50 percent of this proposed rule.
                 Using the May, 2022 mean (average) wage information from the BLS
                for medical and health service managers (Code 11-9111), we estimate
                that the cost of reviewing this proposed rule is $123.06 per hour,
                including other indirect costs https://www.bls.gov/oes/current/oes119111.htm. Assuming an
                [[Page 23223]]
                average reading speed of 250 words per minute, we estimate that it
                would take approximately 112 minutes (1.87 hours) for the staff to
                review half of this proposed rule, which contains a total of
                approximately 56,000 words. For each IPF that reviews the proposed
                rule, the estimated cost is (1.87 x $123.06) or $230.12. Therefore, we
                estimate that the total cost of reviewing this proposed rule is
                $576,680.72 ($230.12 x 2,506 reviewers).
                D. Alternatives Considered
                 The statute gives the Secretary discretion in establishing an
                update methodology to the IPF PPS. We continue to believe it is
                appropriate to routinely update the IPF PPS so that it reflects the
                best available data about differences in patient resource use and costs
                among IPFs, as required by the statute. Therefore, we are proposing to:
                update the IPF PPS using the methodology published in the RY 2005 IPF
                PPS final rule (our ``standard methodology'') pre-floor, pre-
                reclassified IPPS hospital wage index as its basis, along with the
                proposed changes to the CBSA delineations. Additionally, we apply a 5-
                percent cap on any decrease to a provider's wage index from its wage
                index in the prior year. Lastly, we are proposing to revise the
                patient-level adjustment factors, ED adjustment, and to increase the
                ECT per treatment amount for FY 2025 (reflecting the pre-scaled and
                pre-adjusted CY 2024 OPPS geometric mean cost).
                E. Accounting Statement
                 As required by OMB Circular A-4 (available at www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf ), in Table 30, we
                have prepared an accounting statement showing the classification of the
                expenditures associated with the updates to the IPF wage index and
                payment rates in this proposed rule. Table 30 provides our best
                estimate of the increase in Medicare payments under the IPF PPS as a
                result of the changes presented in this proposed rule and based on the
                data for 1,430 IPFs with data available in the PSF, with claims in our
                FY 2023 MedPAR claims dataset. Lastly, Table 30 also includes our best
                estimate of the costs of reviewing and understanding this proposed
                rule.
                [GRAPHIC] [TIFF OMITTED] TP03AP24.043
                F. Regulatory Flexibility Act
                 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. The great majority of hospitals and most
                other health care providers and suppliers are small entities, either by
                being nonprofit organizations or by meeting the Small Business
                Administration (SBA) definition of a small business (having revenues of
                less than $47 million in any 1 year).
                 According to the SBA's website at http://www.sba.gov/content/small-business-size-standards, IPFs falls into the North American Industrial
                Classification System (NAICS) code 622210, Psychiatric and Substance
                Abuse hospitals. The SBA defines small Psychiatric and Substance Abuse
                hospitals as businesses having less than $47 million.
                 Because we lack data on individual hospital receipts, we cannot
                determine the number of small proprietary IPFs or the proportion of
                IPFs' revenue derived from Medicare payments. Therefore, we assume that
                all IPFs are considered small entities.
                 The Department of Health and Human Services generally uses a
                revenue impact of 3 to 5 percent as a significance threshold under the
                RFA. As shown in Table 30, we estimate that the overall revenue impact
                of this proposed rule on all IPFs is to increase estimated Medicare
                payments by approximately 2.6 percent. As a result, since the estimated
                impact of this proposed rule is a net increase in revenue across almost
                all categories of IPFs, the Secretary has determined that this proposed
                rule will have a positive revenue impact on a substantial number of
                small entities.
                 In addition, section 1102(b) of the Act requires us to prepare a
                regulatory impact analysis 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 discussed in section
                VIII.C.2 of this proposed rule, the rates and policies set forth in
                this proposed rule will not have an adverse impact on the rural
                hospitals based on the data of the 199 rural excluded psychiatric units
                and 60 rural psychiatric hospitals in our database of 1,430 IPFs for
                which data were available. Therefore, the Secretary has determined that
                this proposed rule will not have a significant impact on the operations
                of a substantial number of small rural hospitals.
                [[Page 23224]]
                G. Unfunded Mandate Reform Act (UMRA)
                 Section 202 of the Unfunded Mandates Reform Act of 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 2023, 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. This proposed rule would not impose a mandate
                that will result in the expenditure by state, local, and tribal
                governments, in the aggregate, or by the private sector, of more than
                $183 million in any 1 year.
                H. Federalism
                 Executive Order 13132 establishes certain requirements that an
                agency must meet when it promulgates a proposed rule that imposes
                substantial direct requirement costs on state and local governments,
                preempts state law, or otherwise has Federalism implications. This
                proposed rule does not impose substantial direct costs on state or
                local governments or preempt state law.
                 In accordance with the provisions of Executive Order 12866, this
                proposed regulation was reviewed by the Office of Management and
                Budget.
                 Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
                Medicaid Services, approved this document on March 22, 2024.
                Xavier Becerra,
                Secretary, Department of Health and Human Services.
                [FR Doc. 2024-06764 Filed 3-28-24; 4:15 pm]
                BILLING CODE 4120-01-P
                

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