Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization s have the option to manually enter data directly into the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) web-based application or by uploading a CSV file. CDC estimates that each hospital requires between 40 minutes (0.67 hours) to upload a CSV file and 45 minutes (0.75 hours) monthly to enter the data manually. CDC assumes that manual data entry is completed by a Microbiologist with a wage rate of $58.60/hour and uploading of a CSV file is completed by an Information Technologist with a wage rate of $56.50/hour. Therefore, we estimate that this policy will result in a decrease in burden of between 24,400 hours (0.67 hours × 12 months × 3,050 IPPS hospitals) at a cost of $1,378,600 (24,400 hours × $56.50) and 27,450 hours (0.75 hours × 12 months × 3,050 IPPS hospitals) at a cost of $1,608,570 (27,450 hours × $58.60) annually across all 3,050 IPPS hospitals under OMB control number 0920–1317. f. Information Collection Burden Estimate for the Removal of the Screening for Social Drivers of Health Measure Beginning with the CY 2024 Reporting Period/FY 2026 Payment Determination In section X.C.4.c. of the preamble of this final rule, we are r Removal of the Screening for Social Drivers of Health Measure Beginning with the CY 2024 Reporting Period/FY 2026 Payment Determination In section X.C.4.c. of the preamble of this final rule, we are removing the Screening for Social Drivers of Health measure beginning with the CY 2024 reporting period/FY 2026 payment determination. There are two components to this measure: patient screening for five health related social needs domains and hospital submission of aggregated hospital-level measure data. We estimate each patient requires 2 minutes (0.033 hours) to complete the screening and each hospital requires 10 minutes (0.167 hours) annually to report this measure. With regard to patient screening, the currently approved burden estimate under OMB control number 0938–1022 is 625,500 hours annually for 18,765,000 patients (0.033 hours × 18,765,000 patients). With regard to measure reporting, the currently approved burden estimate is 509 hours 501 Available at https://www.reginfo.gov/public/ do/PRAViewICR?ref_nbr=202501-0920-003. Accessed February 26, 2025. annually across all 3,050 IPPS hospitals (0.167 hours × 3,050 IPPS hospitals). We determine the cost for patients (or their repr lic/ do/PRAViewICR?ref_nbr=202501-0920-003. Accessed February 26, 2025. annually across all 3,050 IPPS hospitals (0.167 hours × 3,050 IPPS hospitals). We determine the cost for patients (or their representative) undertaking administrative and other tasks, such as filling out a survey or intake form, using a post-tax wage of $25.63/hour based on the report ‘‘Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices,’’ which identifies the approach for valuing time when individuals undertake activities on their own time.502 To derive the costs for patients (or their representatives), a measurement of the usual weekly earnings of wage and salary workers of $1,192 is divided by 40 hours to calculate an hourly pre-tax wage rate of $29.80/hour.503 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,504 resulting in the post-tax hourly wage rate of $25.63/hour. Unlike our state and private sector wage adjustments, we are not adjusting beneficiary wages for fringe benefits and other indirect costs beca esulting in the post-tax hourly wage rate of $25.63/hour. Unlike our state and private sector wage adjustments, we are not adjusting beneficiary wages for fringe benefits and other indirect costs because the individuals’ activities, if any, will occur outside the scope of their employment. Therefore, we estimate the removal of this measure will decrease the burden for all 3,050 IPPS hospitals by 626,009 hours (625,500 + 509) annually at a savings of $16,059,753 (625,500 hours × $25.63 + 509 hours × $55.38). g. Information Collection Burden Estimate for the Removal of the Screen Positive Rate for Social Drivers of Health Measure Beginning With the CY 2024 Reporting Period/FY 2026 Payment Determination In section X.C.4.c. of the preamble of this final rule, we are removing the 502 Office of the Assistant Secretary for Planning and Evaluation, Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices, September 17, 2017. Available at https:// aspe.hhs.gov/reports/valuing-time-us-department- health-human-services-regulatory-impact-analyses- conceptual-framework. 503 Bureau of Labor and Statistics, Usual Weekly Earni 7. Available at https:// aspe.hhs.gov/reports/valuing-time-us-department- health-human-services-regulatory-impact-analyses- conceptual-framework. 503 Bureau of Labor and Statistics, Usual Weekly Earnings of Wage and Salary Workers, First Quarter 2024. Available at https://www.bls.gov/ news.release/pdf/wkyeng.pdf. Accessed March 3, 2025. 504 U.S. Census Bureau, Income in the United States: 2023, p. 43, September 2024. Available at https://www2.census.gov/library/publications/2024/ demo/p60-282.pdf. Screen Positive Rate for Social Drivers of Health measure beginning with the CY 2024 reporting period/FY 2026 payment determination. For this measure, hospitals are required to report on an annual basis the number of patients who screen positive for one or more of the five Social Drivers of Health domains divided by the total number of patients screened (reported as five separate rates). We estimate each hospital requires 10 minutes (0.167 hours) annually to report this measure. The current burden estimate approved under OMB control number 0938–1022 is 509 hours annually across all 3,050 IPPS hospitals (0.167 hours × 3,050 IPPS hospitals). Therefore, we estimated the removal of this measu urden estimate approved under OMB control number 0938–1022 is 509 hours annually across all 3,050 IPPS hospitals (0.167 hours × 3,050 IPPS hospitals). Therefore, we estimated the removal of this measure will decrease the burden for all 3,050 IPPS hospitals by 509 hours annually at a savings of $28,188 (509 hours × $55.38/hour). We invited public comments on the proposed information collection requirements and whether our estimated burden reduction of 0.033 hours per patient and an annual decrease of 509 hours in burden per hospitals at admission is an accurate estimate. We received no comments regarding these information collection requirements or the associated burden estimates and therefore, are finalizing without modification. h. Summary of Information Collection Burden Estimates for the Hospital IQR Program In summary, under OMB control number 0938–1022 (expiration date January 31, 2026), we estimate that the policies finalized in this final rule will result in a decrease in information collection burden of 627,027 hours at a savings of $16,116,129. We also estimate that the policies finalized in this final rule will result in a decrease in information collection burden of betw ation collection burden of 627,027 hours at a savings of $16,116,129. We also estimate that the policies finalized in this final rule will result in a decrease in information collection burden of between 24,400 hours at a savings of $1,378,600 and 27,450 hours at a savings of $1,608,570 under OMB control number 0920–1317. We will submit the revised information collection estimates to OMB for approval under OMB control number 0938–1022. With respect to any costs/ burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis (section I.K. of Appendix A of this final rule). BILLING CODE 4120–01–P VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00659 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37194 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations BILLING CODE 4120–01–C 5. ICRs for the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program OMB has currently approved 109 hours of burden at a cost of $2,844 under OMB control number 0938–1175 (expiration date November 30, 2027), accounting for the annual information collection requirements MB has currently approved 109 hours of burden at a cost of $2,844 under OMB control number 0938–1175 (expiration date November 30, 2027), accounting for the annual information collection requirements for 11 PCHs for the PCHQR Program. In this final rule, we describe the burden changes regarding collection of information under OMB control number 0938–1175 for PCHs. For more detailed information on our finalized policies for the PCHQR Program, we refer readers to section X.D. of the preamble of this final rule. We are removing three measures beginning with the FY 2026 program year: (1) the Hospital Commitment to Health Equity measure; (2) the Screening for Social Drivers of Health measure; and (3) the Screen Positive Rate for Social Drivers of Health Measure. We discuss the impacts on information collection burden associated with these policies later in this section. We are also modifying the public reporting requirements to allow for public reporting of the PCHQR Program on the Care Compare tool on Medicare.gov or a successor website in addition to current publication in the Provider Data Catalog. This policy will not affect information collection burden as neither the amount of dat pare tool on Medicare.gov or a successor website in addition to current publication in the Provider Data Catalog. This policy will not affect information collection burden as neither the amount of data collected nor frequency of data submission are impacted. Using the most recent data from the BLS for medical records specialists (SOC 29–2072), entitled, the May 2023 National Occupational Employment and Wage Estimates (OEWS), we are finalizing to use the mean hourly wage for medical records specialists for the industry, ‘‘general medical and surgical hospitals,’’ which is $27.69. We believe the industry of ‘‘general medical and surgical hospitals’’ is more specific to this program compared to other industries under medical records specialists, such as ‘‘office of physicians’’ or ‘‘nursing care facilities.’’ We calculated the cost of overhead, including fringe benefits, at 100 percent of the mean hourly wage, consistent with previous years. This is necessarily a rough adjustment, both because fringe benefits and overhead 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 cause fringe benefits and overhead 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 ($27.69 × 2 = $55.38) to estimate total cost is a reasonably accurate estimation method. Unless otherwise specified, we will calculate cost burden to hospitals using a wage plus benefits estimate of $55.38 per hour throughout the discussion in this section of this final rule for the PCHQR Program. b. Information Collection Burden Estimate for the Removal of the Hospital Commitment to Health Equity Measure Beginning With the FY 2026 Program Year In section X.D.2.a. of the preamble of this final rule, we are removing the Hospital Commitment to Health Equity (HCHE) measure beginning with the FY 2026 program year. Reporting on the HCHE measure involves each PCH being VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00660 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00661 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 37196 Federal Register / Vol. 90 i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00661 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 37196 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations BILLING CODE 4120–01–C 6. ICRs for the Long-Term Care Hospital Quality Reporting Program (LTCH QRP) As required by section 1886(m)(5)(A)(i) of the Act, an LTCH that does not meet the requirements of the LTCH QRP for a fiscal year will receive a 2-percentage point reduction to its otherwise applicable annual update for that fiscal year. We estimated that the burden associated with the LTCH QRP is the time and effort associated with complying with the requirements of the LTCH QRP. In section X.E.5. of this final rule, we are finalizing our proposal to amend the LTCH QRP reconsideration request policy and process. As we noted in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49755), we believe the reconsideration requirements, and the associated burden would be incurred subsequent to an administrative action. In accordance with the implementing regulations for the PRA (5 CFR 1320.4(a)(2) and (c)), the burden associated with any infor sociated burden would be incurred subsequent to an administrative action. In accordance with the implementing regulations for the PRA (5 CFR 1320.4(a)(2) and (c)), the burden associated with any information collected subsequent to the administrative action is exempt from the requirements of the PRA. However, we have provided detailed cost burden estimates in section I.M. of Appendix A of this final rule. We did not receive any public comments on the accuracy of the cost estimate assigned to this administrative burden. a. Information Collection Burden Estimate for the Modification of Reporting Requirements for the COVID– 19 Vaccine: Percent of Patients/ Residents Who Are Up to Date Measure Beginning With the FY 2028 LTCH QRP In section X.E.3. of this final rule, we are finalizing our proposal to modify reporting requirements for the COVID– 19 Vaccine: Percent of Patients/ Residents Who Are Up to Date (Patient/ Resident COVID–19 Vaccine) measure to exclude patients who have expired in the LTCH beginning with the FY 2028 LTCH QRP. Version 5.1 of the LCDS, which includes the Patient/Resident COVID–19 Vaccine item (O0350) for purposes of reporting the Patient/ Resident COVID–19 Vaccine e LTCH beginning with the FY 2028 LTCH QRP. Version 5.1 of the LCDS, which includes the Patient/Resident COVID–19 Vaccine item (O0350) for purposes of reporting the Patient/ Resident COVID–19 Vaccine measure, has been approved under OMB control number 0938–1163 (Expiration date: 12/ 31/2027). To implement these modifications to this measure, we also are finalizing our proposal to remove the related Patient/Resident COVID–19 Vaccine Status item (O0350) from the LTCH Continuity Assessment Record and Evaluation (CARE) Data Set (LCDS) form used for patients who have expired. The remaining LCDS forms used for Planned Discharge and Unplanned Discharge would continue to include the Patient/Resident COVID–19 Vaccine Status item (O0350) for purposes of collecting and reporting data on the COVID–19 Vaccine: Percent of Patients/Residents Who Are Up to Date measure. The following is a VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00662 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00663 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 / > H P G 2014 00: S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00663 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00664 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00665 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37200 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations currently approved under OMB control number 0938–1278. relations, Medicare, Penalties, Reporting and recordkeeping requirements. f. Summary of Estimates Used To Calculate the Collection of Information Burden In summary, under OMB control number 0938–1278 (expiration date April 30, 2027), we estimate that the policies in this final rule will not result in a change in information collection burden. With respect to any costs/ burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis (section I.N. of Appendix A of this final rule). in information collection burden. With respect to any costs/ burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis (section I.N. of Appendix A of this final rule). 8. ICRs for the Transforming Episode Accountability Model In section XI.A. of the preamble of this final rule, we discuss testing the Transforming Episode Accountability Model (TEAM), finalized in the FY 2025 IPPS/LTCH PPS final rule (89 FR 68986), and finalized updates to the model under the authority of the CMS Innovation Center. Section 1115A of the Act authorizes the CMS Innovation Center to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and Children’s Health Insurance Program beneficiaries. As stated in section 1115A(d)(3) of the Act, chapter 35 of title 44, United States Code, shall not apply to the testing and evaluation of models under section 1115A of the Act. As a result, the information collection requirements contained in this final rule for TEAM need not be reviewed by the Office of Management and Budget. Dr Mehmet Oz, Administrator of the Centers for Medi a result, the information collection requirements contained in this final rule for TEAM need not be reviewed by the Office of Management and Budget. Dr Mehmet Oz, Administrator of the Centers for Medicare & Medicaid Services, approved this document on July 30, 2025. List of Subjects 42 CFR Part 412 Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements. 42 CFR Part 495 Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Health professions, Health records, Medicaid, Medicare, Penalties, Privacy, and Reporting and recordkeeping requirements. 42 CFR Part 512 Administrative practice and procedure, Health care, Health facilities, Health insurance, Intergovernmental 45 CFR Part 170 Computer technology, Electronic health record, Electronic information system, Electronic transactions, Health, Healthcare, Health information technology, Health insurance, Health records, Hospitals, Incorporation by reference, Laboratories, Medicaid, Medicare, Privacy, Reporting and record keeping requirements, Public health, Security. For the reasons set out in the preamble, 42 CFR parts 412, 495, orporation by reference, Laboratories, Medicaid, Medicare, Privacy, Reporting and record keeping requirements, Public health, Security. For the reasons set out in the preamble, 42 CFR parts 412, 495, and 512 and 45 CFR part 170 are amended as follows: Title 42—Public Health PART 412—PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES ■ 1. The authority citation for part 412 continues to read as follows: Authority : 42 U.S.C. 1302 and 1395hh. ■ 2. Section 412.24 is amended by revising paragraphs (e) and (f) to read as follows: * * * § 412.24 Requirements under the PPS- Exempt Cancer Hospital Quality Reporting (PCHQR) Program. * * (e) Extraordinary circumstances exceptions (ECEs)—(1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the PCH. For purposes of this paragraph (e), an extraordinary circumstance is an event beyond the control of a PCH (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the PCH to comply with one or more applicable reporting requirements with res or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the PCH to comply with one or more applicable reporting requirements with respect to a fiscal year. (2) Process for requesting an ECE. (i) A PCH may request an ECE within 60 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. (ii) CMS notifies the PCH of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the PCH, the written decision specifies whether the PCH is exempted from one or more reporting requirements or whether CMS has granted the PCH an extension of time to comply with one or more reporting requirements. (3) Authority to grant an ECE. (i) CMS may grant an ECE to one or more PCHs that have not requested an ECE if CMS determines that— (A) A systemic problem with a CMS data collection system directly impacted the ability of the PCH to comply with a quality data reporting requirement; or (B) An extraordinary circumstance has affected an entire region or locale. (ii) Any ECE granted under this paragraph (e)(3) spe ility of the PCH to comply with a quality data reporting requirement; or (B) An extraordinary circumstance has affected an entire region or locale. (ii) Any ECE granted under this paragraph (e)(3) specifies whether the affected PCHs are exempted from one or more reporting requirements or whether CMS has granted the PCHs an extension of time to comply with one or more reporting requirements. (f) Public reporting of PCHQR Program data. CMS makes data submitted by PCHs under the PCHQR Program available to the public on CMS websites. Prior to making any such data submitted by a PCH available to the public, CMS gives the PCH an opportunity to review the data via the Hospital Quality Reporting (HQR) system and announces the timeline for review on the QualityNet website and applicable listservs. ■ 4. Section 412.85 is amended by revising the section heading and paragraphs (b) and (c) to read as follows: § 412.85 Payment adjustment for certain immunotherapy cases. * * * * * (b) Discharges subject to payment adjustment. Payment is adjusted in accordance with paragraph (c) of this section for discharges assigned to MS– DRG 018 involving expanded access use of immunotherapy or that are part o ect to payment adjustment. Payment is adjusted in accordance with paragraph (c) of this section for discharges assigned to MS– DRG 018 involving expanded access use of immunotherapy or that are part of an applicable clinical trial as determined by CMS based on the reporting of a diagnosis code indicating the encounter is part of a clinical research program on the claim for the discharge or, for discharges occurring on or after October 1, 2025, other cases where the immunotherapy product is not purchased in the usual manner, such as provided at no cost. (c) Adjustment. The DRG weighting factor determined under § 412.60(b) is adjusted by a factor that reflects the average cost for cases assigned to MS– DRG 018 that involve expanded access use of immunotherapy, are part of an applicable clinical trial, or where the immunotherapy product is not purchased in the usual manner, such as provided at no cost, to the average cost for all other cases assigned to MS–DRG 018. § 412.90 [Amended] ■ 5. Section 412.90(j) is amended in by removing the date ‘‘January 1, 2025’’ VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00666 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h Section 412.90(j) is amended in by removing the date ‘‘January 1, 2025’’ VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00666 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37201 and adding in its place the date ‘‘October 1, 2025’’. § 412.101 [Amended] ■ 6. Section 412.101 is amended by— ■ a. In paragraph (b)(2)(i), removing the phrase ‘‘FY 2010, the portion of FY 2025 beginning on January 1, 2025 and subsequent fiscal years,’’ and adding in its place the phrase ‘‘FY 2010 and FY 2026 and subsequent years,’’; ■ b. In paragraph (b)(2)(iii), removing the phrase ‘‘FY 2024 and the portion of FY 2025 beginning on October 1, 2024, and ending on December 31, 2024,’’ and adding in its place the phrase ‘‘FY 2025,’’; ■ c. In paragraph (c)(1), removing the phrase ‘‘FY 2010, the portion of FY 2025 beginning on January 1, 2025, and subsequent fiscal years,’’ and adding in its place the phrase ’’ FY 2010 and FY 2026 and subsequent years,’’; and ■ d. In paragraph (c)(3) introductory text, removing the phrase ‘‘FY 2024 and the portion equent fiscal years,’’ and adding in its place the phrase ’’ FY 2010 and FY 2026 and subsequent years,’’; and ■ d. In paragraph (c)(3) introductory text, removing the phrase ‘‘FY 2024 and the portion of FY 2025 beginning on October 1, 2024, and ending on December 31, 2024,’’ and adding in its place ‘‘FY 2025,’’. § 412.108 [Amended] ■ 7. Section 412.108 is amended by— ■ a. In paragraph (a)(1) introductory text, removing the date ‘‘January 1, 2025’’ and adding in its place the date ‘‘October 1, 2025’’; and ■ b. In paragraph (c)(2)(iii) introductory text, removing the date ‘‘January 1, 2025’’ and adding in its place the date ‘‘October 1, 2025’’. ■ 8. Section 412.140 is amended by revising paragraph (c)(2) to read as follows: § 412.140 Participation, data submission, and validation requirements under the Hospital Inpatient Quality Reporting (IQR) Program. * * * (c) * * * (2) Extraordinary circumstance * * exception (ECE)—(i) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (c)(2), an extraordinary circumstance is an event beyond requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (c)(2), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man- made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a fiscal year. extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. (B) CMS notifies the hospital of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the hospital, the written decision specifies whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements. (iii) Authority to grant an ECE. CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that— (A) A systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply an ECE to one or more hospitals that have not requested an ECE if CMS determines that— (A) A systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement; or (B) An extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (c)(2)(iii) specifies whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. * ■ 9. Section 412.152 is amended by— ■ a. Revising and republishing the definition of ‘‘Applicable period’’; and ■ b. In the definition of ‘‘Applicable period for dual eligibility,’’ removing the phrase ‘‘3-year data period’’ and adding in its place the phrase ‘‘2-year or 3-year data period’’. * * * * The revision reads as follows: § 412.152 Definitions for the Hospital Readmissions Reduction Program. * * * * * Applicable period is, with respect to a fiscal year, the 2-year or 3-year period (specified by the Secretary) from which data are collected in order to calculate excess readmission ratios and adjustments und ble period is, with respect to a fiscal year, the 2-year or 3-year period (specified by the Secretary) from which data are collected in order to calculate excess readmission ratios and adjustments under the Hospital Readmissions Reduction Program. (1) The applicable period for FY 2022 is the 3-year period from July 1, 2017 through June 30, 2020; (2) Beginning with the FY 2023 program year, the applicable period is the 3-year period advanced by 1-year from the prior year’s period from which data are collected in order to calculate excess readmission rations and adjustments under the Hospital Readmissions Reduction Program, unless otherwise specified by the Secretary; and (ii) Process for requesting an ECE. (A) (3) Beginning with the FY 2027 A hospital may request an ECE within 60 calendar days of the date that the program year, the applicable period is the 2-year period advanced by 1-year from the prior year’s period from which data are collected in order to calculate excess readmission ratios and adjustments under the Hospital Readmissions Reduction Program, unless otherwise specified by the Secretary. * * * * * ■ 10. Section 412.154 is amended by adding paragraph (d) to read as fo ratios and adjustments under the Hospital Readmissions Reduction Program, unless otherwise specified by the Secretary. * * * * * ■ 10. Section 412.154 is amended by adding paragraph (d) to read as follows: § 412.154 Payment adjustments under the Hospital Readmissions Reduction Program. * * (d) Extraordinary circumstance * * * exception (ECE)—(1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (d), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a fiscal year. (2) Process for requesting an ECE. (i) A hospital may request an ECE within 60 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. (ii) CMS notifies the hospital of its decision on the request, in writing, vi e extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. (ii) CMS notifies the hospital of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the hospital, the written decision specifies whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements. (3) Authority to grant an ECE. CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that a systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement, or that an extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (d)(3) specifies whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. * * * * * VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00667 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR nted the hospitals an extension of time to comply with one or more reporting requirements. * * * * * VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00667 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37202 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations § 412.160 [Amended] ■ 11. Section 412.160 is amended by removing the definition of ‘‘Health equity adjustment bonus points.’’ ■ 12. Section 412.165 is amended by— ■ a. Removing paragraph (b)(5); ■ b. Redesignating paragraph (b)(6) as paragraph (b)(5); ■ c. Revising newly redesignated paragraph (b)(5) and paragraph (c). The revisions read as follows: § 412.165 Performance scoring under the Hospital Value-Based Purchasing (VBP) Program. * * * (b) * * * (5) The hospital’s Total Performance Score for the fiscal year is the sum of the weighted domain scores up to a maximum score of 100. * * (c) Extraordinary circumstance exception (ECE)—(1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For pur ption (ECE)—(1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (c), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a fiscal year. (2) Process for requesting an ECE. (i) A hospital may request an ECE within 60 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. (ii) CMS notifies the hospital of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the hospital, the written decision will specify whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements. (3) Authority to grant an ECE. CMS may grant an ECE one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements. (3) Authority to grant an ECE. CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that a systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement or that an extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (c)(3) specifies whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. ■ 13. Section 412.172 is amended by adding paragraph (c) to read as follows: § 412.172 Payment adjustments under the Hospital-Acquired Condition Reduction Program. * * (c) Extraordinary circumstance * * * exception (ECE)—(1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (c), an MS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (c), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a fiscal year. (2) Process for requesting an ECE. (i) A hospital may request an ECE within 60 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website. (ii) CMS notifies the hospital of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the hospital, the written decision specifies whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements. (3) Authority to grant an ECE. CMS may grant an ECE to one or more hospitals that have s or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements. (3) Authority to grant an ECE. CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that a systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement, or that an extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (c)(3) will specify whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. * * * ■ 14. Section 412.273 is amended by— ■ a. Revising the section heading, the definitions of ‘‘Termination’’ and ‘‘Withdrawal’’ in paragraph (a), and paragraphs (c)(1), (d), and (e)(2); and ■ b. Adding paragraph (e)(3). * * The revisions and addition read as follows: § 412.273 Withdrawing an application, terminating an approved 3-year reclassification, or reinstating a previous termination. (a) * * * Termination refers to the termination of an approved 3-year MG : § 412.273 Withdrawing an application, terminating an approved 3-year reclassification, or reinstating a previous termination. (a) * * * Termination refers to the termination of an approved 3-year MGCRB reclassification. A termination is effective only for the full fiscal year(s) remaining in the 3-year period at the time the request is received. Requests for terminations for part of a fiscal year are not considered. Withdrawal refers to the withdrawal of a 3-year MGCRB reclassification where the MGCRB has not yet issued a decision on the application. * * * (c) * * * (1) A request for withdrawal must be * * received by the MGCRB at any time before the MGCRB issues a decision on the application. * * * * * (d) Reapplication within the approved 3-year period, reinstatement of terminations, and prohibition on overlapping reclassification approvals— (1) Reinstatement of terminations. Subject to the provisions of this section, a hospital (or group of hospitals) may cancel a termination, effective for the subsequent year, and request the MGCRB to reinstate the wage index reclassification for the remaining fiscal year(s) of the 3-year period. (2) Timing and process of reinstatement reques ective for the subsequent year, and request the MGCRB to reinstate the wage index reclassification for the remaining fiscal year(s) of the 3-year period. (2) Timing and process of reinstatement request. Reinstatement requests must be submitted in writing to the MGCRB according to the method prescribed by the MGCRB no later than the deadline for submitting reclassification applications for the following fiscal year, as specified in § 412.256(a)(2). (3) Reapplications. A hospital may apply for reclassification to a different area (that is, an area different from the one to which it was originally reclassified for the 3-year period). If the application is approved, the reclassification will be effective for 3 years. Once a 3-year reclassification becomes effective, a hospital may no longer reinstate a termination of another 3-year reclassification, regardless of whether the termination request is made within 3 years from the date of the withdrawal or termination. (4) Termination of existing 3-year reclassification. In a case in which a hospital with an existing 3-year wage index reclassification applies to be reclassified to another area, its existing 3-year reclassification will be t ng 3-year reclassification. In a case in which a hospital with an existing 3-year wage index reclassification applies to be reclassified to another area, its existing 3-year reclassification will be terminated when a second 3-year wage index reclassification goes into effect for payments for discharges on or after the VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00668 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37203 following October 1. The terminated reclassification in such a case is not eligible for reinstatement. (e) * * * (2) A request to terminate or reinstate an approved individual reclassification must be submitted in writing to the MGCRB according to the method prescribed by the MGCRB. (3) A request to terminate or reinstate an approved group reclassification must be submitted in writing to the MGCRB according to the method prescribed by the MGCRB. (i) A request to terminate or reinstate an approved group reclassification that has not yet gone into effect must include all hospitals party to the reclassifi g to the method prescribed by the MGCRB. (i) A request to terminate or reinstate an approved group reclassification that has not yet gone into effect must include all hospitals party to the reclassification. (ii) Termination requests for group reclassification for the second or third year of the 3-year wage index reclassification and reinstatement requests for a group reclassification effective for the third year of the 3-year wage index reclassification may be submitted by an individual hospital that is party to the reclassification. * * ■ 14. Section 412.312 is amended by revising paragraph (f) to read as follows: * * * § 412.312 Payment based on the Federal rate. * * * * * (f) Payment adjustment for certain immunotherapy cases. For discharges occurring on or after October 1, 2020, in determining the payment amount under this section for certain clinical trial or expanded access use immunotherapy cases, or, for discharges occurring on or after October 1, 2025, other cases where the immunotherapy product is not purchased in the usual manner, such as provided at no cost, as described in § 412.85(b), the DRG weighting factor described in paragraph (b)(1) of this section is adjusted mmunotherapy product is not purchased in the usual manner, such as provided at no cost, as described in § 412.85(b), the DRG weighting factor described in paragraph (b)(1) of this section is adjusted as described in § 412.85(c). ■ 15. Section 412.560 is amended by— ■ a. Revising paragraph (d)(3); and ■ b. Adding paragraphs (d)(4) and (5). The revision and additions read as follows: * § 412.560 Requirements under the Long- Term Care Hospital Quality Reporting Program (LTCH QRP). * * * (d) * * * (3) CMS decision on reconsideration request. (i) CMS notifies the LTCH, in writing, of its final decision regarding any reconsideration request through at least one of the following methods: * (A) CMS designated data submission system. (B) The United States Postal Service. (C) Via email from the CMS Medicare Administrative Contractor (MAC). (ii) CMS grants a timely request for reconsideration, and reverses an initial finding of non-compliance, only if CMS determines that the long-term care hospital was in full compliance with the LTCH QRP requirements for the applicable program year. (4) Request for an extension to file a reconsideration of noncompliance request. A long-term care hospital may al was in full compliance with the LTCH QRP requirements for the applicable program year. (4) Request for an extension to file a reconsideration of noncompliance request. A long-term care hospital may request, and CMS may grant, an extension to file a reconsideration request if, during the period to request a reconsideration as set forth in paragraph (d)(2) of this section, the long-term care hospital was affected by an extraordinary circumstance beyond the control of the LTCH (for example, a natural or man-made disaster). (i) The long-term care hospital must submit its request for an extension to file a reconsideration request no later than 30 calendar days from the date of the written notification of noncompliance. (ii) The long-term care hospital must submit its request for an extension to CMS via email to LTCHQRPReconsiderations@ cms.hhs.gov, and it must contain the following information: (A) The CCN for the long-term care hospital. (B) The business name of the long- term care hospital. (C) The business address of the long- term care hospital. (D) Contact information for the long- term care hospital’s chief executive officer or designated personnel, including the name, telephon ital. (C) The business address of the long- term care hospital. (D) Contact information for the long- term care hospital’s chief executive officer or designated personnel, including the name, telephone number, title, email address, and physical mailing address, which may not be a post office box. (E) A statement of the reason for the request for the extension. (F) Evidence of the impact of the extraordinary circumstances, including, for example, photographs, newspaper articles, and other media. (5) CMS decision on extension to file a reconsideration of noncompliance request. CMS notifies the long-term care hospital in writing of its final decision regarding its request for an extension to file a reconsideration of noncompliance request via an email from CMS. * * * * * PART 495—STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM ■ 16. The authority citation for part 495 continues to read as follows: Authority: 42 U.S.C. 1302 and 1395hh. ■ 17. Section 495.4 is amended in the definition of ‘‘EHR reporting period for a payment adjustment year’’ by adding paragraphs (2)(x) and (3)(x) to read as follows: § 495.4 Definitions. * * * * * EHR reporting period for a paymen in the definition of ‘‘EHR reporting period for a payment adjustment year’’ by adding paragraphs (2)(x) and (3)(x) to read as follows: § 495.4 Definitions. * * * * * EHR reporting period for a payment adjustment year. * * * (2) * * * (x) For an eligible hospital in CY 2026 and subsequent years, the EHR reporting period is any continuous 180-day period within that calendar year and applies for the fiscal year payment adjustment year that is 2 years after the calendar year of the EHR reporting period. (3) * * * (x) For a CAH in CY 2026 and subsequent years, the EHR reporting period is any continuous 180-day period within that calendar year and applies for the fiscal year payment adjustment year for the calendar year of the EHR reporting period. * * * * * PART 512—STANDARD PROVISIONS FOR MANDATORY INNOVATION CENTER MODELS AND SPECIFIC PROVISIONS FOR CERTAIN MODELS ■ 18. The authority citation for part 512 continues to read as follows: Authority: 42 U.S.C. 1302, 1315a, and 1395hh. ■ 19. The heading for part 512 is revised to read as set forth above. § 512.500 [Amended] ■ 20. Section 512.500 is amended by removing and reserving paragraph (b)(18). ■ 21. Section 512.505 is amended by— ■ he heading for part 512 is revised to read as set forth above. § 512.500 [Amended] ■ 20. Section 512.500 is amended by removing and reserving paragraph (b)(18). ■ 21. Section 512.505 is amended by— ■ a. Removing the definition for ‘‘ADI’’; ■ b. Adding definitions for ‘‘APC’’ and ‘‘CDI’’ in alphabetical order; ■ c. Removing the definition for ‘‘Decarbonization and Resilience Initiative’’; ■ d. Revising the definition for ‘‘Final normalization factor’’; ■ e. Removing the definitions for ‘‘Health equity goal’’, ‘‘Health equity plan’’, ‘‘Health equity plan intervention strategy’’, and ‘‘Health equity plan performance measure’’; f. Revising the definition for ‘‘High- cost outlier cap’’; ■ g. Adding definitions for ‘‘Medicare ID’’ and ‘‘PECOS’’ in alphabetical order; ■ h. Revising the definitions for ‘‘Prospective normalization factor’’ and ‘‘Region’’; i. Adding a definition for ‘‘Scaling factor’’ in alphabetical order; j. Revising the definition for ‘‘TEAM participant’’; ■ k. Adding a definition for ‘‘Trend year’’ in alphabetical order; and VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00669 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S ition for ‘‘Trend year’’ in alphabetical order; and VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00669 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k ■ ■ ■ 37204 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations l. Removing the definition for ‘‘Underserved community’’. The additions and revisions read as follows: § 512.505 Definitions. * * * * * APC stands for Ambulatory Payment Classification. * * * CDI stands for the Community * * Deprivation Index. * * * * * Final normalization factor refers to the mean of the benchmark price for each MS–DRG/HCPCS episode type and region divided by the mean of the risk- adjusted benchmark price for the same MS–DRG/HCPCS episode type and region. * * * * * High-cost outlier cap refers to the 99th percentile of regional spending for a given MS–DRG/HCPCS episode type, region, and baseline year, which is the amount at which episode spending would be capped for purposes of determining baseline and performance year episode spending. * * * * * Medicare ID means the hospital CCN in the PECOS. * * * * * PECOS stands for the Provider Enrollm g would be capped for purposes of determining baseline and performance year episode spending. * * * * * Medicare ID means the hospital CCN in the PECOS. * * * * * PECOS stands for the Provider Enrollment, Chain, and Ownership System. * * * * * Prospective normalization factor refers to the multiplier incorporated into the preliminary target price to ensure that the average of the total risk-adjusted benchmark price does not exceed the average of the total non-risk adjusted benchmark price, calculated as set forth in § 512.540(b)(6). * * * * * Region means one of the nine U.S. census divisions, as defined by the U.S. Census Bureau, with the U.S. territories included in Census Division 9. * * * * * Scaling factor means the ratio of the remapped MS–DRG or HCPCS/APC relative weight in the performance year, as applicable, to the original MS–DRG or HCPCS/APC relative weight in the baseline period. * * * * * TEAM participant means an acute care hospital that either— (1) Initiates episodes and is paid under the IPPS and OPPS with a CCN primary address located in one of the mandatory CBSAs selected for participation in TEAM in accordance with § 512.515; or (2) Makes a voluntary opt-in TEAM is paid under the IPPS and OPPS with a CCN primary address located in one of the mandatory CBSAs selected for participation in TEAM in accordance with § 512.515; or (2) Makes a voluntary opt-in TEAM in accordance with § 512.510 and is accepted to participate in TEAM by CMS. * * * * * Trend year means either of the 2 years immediately prior to the 3-year baseline period used in combination with the baseline period to calculate the prospective trend factor. * * ■ 22. Section 512.508 is added, under undesignated center heading ‘‘TEAM Participation,’’ to read as follows: * * * § 512.508 Mandatory participation. (a) General. TEAM participants, as defined in § 512.505, must participate in TEAM for the full duration of the model performance period, unless CMS terminates TEAM or the TEAM participant receives notice of termination from TEAM in accordance with § 512.596. (b) New hospital exception. New hospitals with a Medicare ID with an initial effective date after December 31, 2024, within the PECOS that initiate episodes and are paid under the IPPS and OPPS with a CCN primary address located in one of the mandatory CBSAs selected for participation in TEAM in accordance with § 512.515, m he PECOS that initiate episodes and are paid under the IPPS and OPPS with a CCN primary address located in one of the mandatory CBSAs selected for participation in TEAM in accordance with § 512.515, must participate in TEAM at the beginning of the performance year that follows one full performance year since their Medicare ID initial effective date. (1) As described in § 512.550(b)(2)(ii), CMS performs reconciliation calculations for any new or surviving TEAM participant that results from a TEAM participant’s reorganization event, as defined in § 512.505, for episodes where the anchor hospitalization admission or anchor procedure occurred on or after the effective date of the reorganization event. Therefore, new hospitals that result from a TEAM participant’s reorganization event begin participation in TEAM on the effective date of the reorganization event. (2) [Reserved] (c) Newly qualifying hospital exception. (1) Hospitals that begin to satisfy the definition of TEAM participant, as described in § 512.505, must participate in TEAM at the beginning of the performance year that follows one full performance year since the date on which they began to satisfy the definition of TEAM p described in § 512.505, must participate in TEAM at the beginning of the performance year that follows one full performance year since the date on which they began to satisfy the definition of TEAM participant. (2) Hospitals that no longer satisfy the definition of TEAM participant, as described in § 512.505, end TEAM participation on the date they no longer satisfy the definition. (i) CMS notifies hospitals identified in participation election to participate in this paragraph (c)(2) within 30 days of the hospital no longer satisfying the TEAM participant definition or as soon as is reasonably practicable. (ii) [Reserved] (d) Monitoring. CMS may monitor specifically for the potential shifting of patients with ■ high anticipated treatment costs from TEAM participants to new non- participant hospitals, including hospitals in the participation deferment period in accordance with § 512.505(b) and (c). 23. Section 512.520 is amended by revising paragraph (b)(4)(i) to read as follows: * * § 512.520 Participation tracks. * * * (b) * * * (4) * * * (i) Medicare-dependent hospital (as defined in § 512.505) and the Medicare Dependent Hospital program, as authorized by statute, is not expired 512.520 Participation tracks. * * * (b) * * * (4) * * * (i) Medicare-dependent hospital (as defined in § 512.505) and the Medicare Dependent Hospital program, as authorized by statute, is not expired at the time Track 2 selections are due, as described in paragraph (b)(2) of this section. * * * ■ 24. Section 512.540 is amended by revising paragraphs (a)(2) and (3), (b)(1) introductory text, and (b)(2) through (8) to read as follows: * * § 512.540 Determination of preliminary target prices. (a) * * * (2) Applicable time period for preliminary target prices. CMS calculates preliminary target prices for each MS–DRG/HCPCS episode type and region for each performance year and applies the preliminary target price to each episode based on the episode’s date of discharge from the anchor hospitalization or the date of the anchor procedure, as applicable. CMS also does all of the following: (i) Accounts for MS–DRG and HCPCS/ APC code changes between the baseline period and performance year by identifying diagnosis or procedure codes that are being moved from one MS–DRG or HCPCS/APC to another for the relevant performance year and mapping the new or revised MS–DRG or HCPCS/APC codes to the o dentifying diagnosis or procedure codes that are being moved from one MS–DRG or HCPCS/APC to another for the relevant performance year and mapping the new or revised MS–DRG or HCPCS/APC codes to the original codes that were used in the baseline period. (ii) Constructs preliminary target prices using the remapped MS–DRG or HCPCS/APC codes in the same manner described in paragraph (b) of this section, with target prices for each MS– DRG/HCPCS episode type, inclusive of episodes initiated by anchor hospitalizations and anchor procedures that would be related to the remapped MS–DRG or HCPCS/APC codes. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00670 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k ■ Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37205 (iii) Adjusts the preliminary target price by calculating and applying the scaling factor to the standardized episode spending of the MS–DRG portion for the anchor hospitalization or standardized episode spending of the HCPCS/APC portion of the anchor procedure. (3) Episodes that begin in one performance year and end in ding of the MS–DRG portion for the anchor hospitalization or standardized episode spending of the HCPCS/APC portion of the anchor procedure. (3) Episodes that begin in one performance year and end in the subsequent performance year. CMS applies the preliminary target price to the episode based on the date of discharge from the anchor hospitalization or the date of the anchor procedure, as applicable, and reconciles the episode based on the date of discharge from the anchor hospitalization or the date of the anchor procedure. (b) * * * (1) Calculation of the preliminary target price. CMS calculates preliminary target prices based on average baseline episode spending for the region where the TEAM participant is located. * * * * * (2) Baseline periods and associated performance years. CMS uses the following baseline periods to determine baseline episode spending: (i) Performance Year 1: Episodes with anchor hospitalization start dates or anchor procedure dates beginning on or after January 1, 2022, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2022, and December 31, 2024. (ii) Performance Year 2: Episodes with anchor hospitalization or anchor y 1, 2022, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2022, and December 31, 2024. (ii) Performance Year 2: Episodes with anchor hospitalization or anchor procedure start dates beginning on or after January 1, 2023, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2023, and December 31, 2025. (iii) Performance Year 3: Episodes with anchor hospitalization or anchor procedure start dates beginning on or after January 1, 2024, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2024, and December 31, 2026. (iv) Performance Year 4: Episodes with anchor hospitalization or anchor procedure start dates beginning on or after January 1, 2025, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2025, and December 31, 2027. (v) Performance Year 5: Episodes with anchor hospitalization or anchor procedure start dates beginning on or after January 1, 2026, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2026, and December 31, 2028. (3) Baseline episode spending weights. CMS calculates the benchmark pric y 1, 2026, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2026, and December 31, 2028. (3) Baseline episode spending weights. CMS calculates the benchmark price as the weighted average of baseline episode spending, applying the following weights: (i) Baseline episode spending from baseline year 1 is weighted at 17 percent. (ii) Baseline episode spending from baseline year 2 is weighted at 33 percent. (iii) Baseline episode spending from baseline year 3 is weighted at 50 percent. (4) Exclusion for high episode spending. CMS applies a high-cost outlier cap to baseline episode spending at the 99th percentile of regional spending for each of the MS–DRG/ HCPCS episode types specified in paragraph (a)(1)(ii) of this section for each baseline year individually. (5) Exclusion of incentive programs and add-on payments under existing Medicare payment systems. Certain Medicare incentive programs and add- on payments are excluded from baseline episode spending by using, with certain modifications, the CMS Price (Payment) Standardization Detailed Methodology used for the Medicare spending per beneficiary measure in the Hospital Value-Based Purchasing Pro ing by using, with certain modifications, the CMS Price (Payment) Standardization Detailed Methodology used for the Medicare spending per beneficiary measure in the Hospital Value-Based Purchasing Program. (6) Prospective normalization factor. Based on the episodes in the most recent calendar year of the baseline period, CMS calculates a prospective normalization factor at the MS–DRG/ HCPCS region level, which is a multiplier that ensures that the average of the total risk-adjusted benchmark price does not exceed the average of the total non-risk adjusted benchmark price, by doing the following: (i) CMS applies risk adjustment multipliers, as specified in § 512.545(a)(1) through (3), to the most recent baseline year episodes to calculate the estimated risk-adjusted target price for all performance year episodes. (ii) CMS divides the mean of the preliminary target price for each episode across all hospitals and regions by the mean of the estimated risk-adjusted target price calculated in § 512.540(b)(6)(i) for the same episode types across all hospitals and regions. (7) Prospective trend factor. CMS calculates a multiplier for each MS– DRG/HCPCS episode type and region which is appl n § 512.540(b)(6)(i) for the same episode types across all hospitals and regions. (7) Prospective trend factor. CMS calculates a multiplier for each MS– DRG/HCPCS episode type and region which is applied to the most recent calendar year of the applicable baseline period. The multiplier is calculated using linear regression on the logarithmically transformed average regional spending for each MS–DRG/ HCPCS episode type in the baseline years and trend years at both the regional and national level. CMS exponentiates the coefficient from this regression to calculate the estimated annual change (where an exponentiated coefficient of 1 signifies no change) in average regional spending for each MS– DRG/HCPCS episode type from year to year. CMS then squares this value to calculate the 2-year prospective trend factor. The prospective trend factor for each MS–DRG/HCPCS episode type and region is the average (arithmetic mean) of the multiplier for that MS–DRG/ HCPCS episode type and region and the national average for that MS–DRG/ HCPCS episode type. (8) Communication of preliminary target prices. CMS communicates the preliminary target prices for each MS– DRG/HCPCS episode type for each regi e national average for that MS–DRG/ HCPCS episode type. (8) Communication of preliminary target prices. CMS communicates the preliminary target prices for each MS– DRG/HCPCS episode type for each region, and the preliminary target prices for each MS–DRG/HCPCS episode type specific to the TEAM participant before the performance year in which they apply. * * * ■ 25. Section 512.545 is amended by revising paragraphs (a), (e)(1)(i), and (f) introductory text to read as follows: * * § 512.545 Determination of reconciliation target prices. * * * * * (a) CMS risk adjusts the preliminary episode target prices computed under § 512.540 at the beneficiary level using a TEAM Hierarchical Condition Category (HCC) count risk adjustment factor, an age bracket risk adjustment factor, a beneficiary economic risk adjustment factor, and at the hospital level using a hospital bed size risk adjustment factor and a safety net hospital risk adjustment factor, and at the episode category-specific beneficiary level using factors specified in paragraphs (a)(6)(i) through (v) of this section. (1) The TEAM HCC count risk adjustment factor uses five variables, representing beneficiaries with zero, one, two, th level using factors specified in paragraphs (a)(6)(i) through (v) of this section. (1) The TEAM HCC count risk adjustment factor uses five variables, representing beneficiaries with zero, one, two, three, or four or more CMS– HCC conditions based on a 180-day lookback period that ends on the day prior to the anchor hospitalization or anchor procedure. (2) The age bracket risk adjustment factor uses four variables, representing beneficiaries in the following age groups as of the first day of the episode: (i) Less than 65 years. (ii) 65 to less than 75 years. (iii) 75 years to less than 85 years. (iv) 85 years or more. (3) The beneficiary economic risk adjustment factor uses two variables, representing beneficiaries that, as of the first day of the episode— (i) Meet one or more of the following economic measures: (A) [Reserved] VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00671 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37206 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations (B) National CDI above the 80th (T) HCC 326: Chronic Kidney Disease, percentile. Stage 5. A o d n o m m a h k 37206 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations (B) National CDI above the 80th (T) HCC 326: Chronic Kidney Disease, percentile. Stage 5. Acute Myeloid Leukemia Except Promyelocytic. (C) Eligibility for the low-income (U) HCC 327: Chronic Kidney Disease, (C) HCC 22: Bladder, Colorectal, and subsidy. Severe (Stage 4). Other Cancers. (D) Eligibility for full Medicaid (V) HCC 383: Chronic Ulcer of Skin, (D) HCC 37: Diabetes with Chronic benefits. (ii) Do not meet any of the three economic measures in paragraph (a)(3)(i) of this section. (4) The hospital bed size risk adjustment factor uses four variables based on the TEAM participant’s characteristics: (i) 250 beds or fewer. (ii) 251–500 beds. (iii) 501–850 beds. (iv) 850 beds or more. (5) The safety net hospital risk adjustment factor is based on the TEAM participant meeting the definition of safety net hospital, as defined in § 512.505. (6) Episode category-specific beneficiary level risk adjustment factors represent the presence or absence in beneficiaries, based on a 180-day lookback period that ends on the day prior to the anchor hospitalization or anchor procedure, of y level risk adjustment factors represent the presence or absence in beneficiaries, based on a 180-day lookback period that ends on the day prior to the anchor hospitalization or anchor procedure, of each of the following conditions: (i) CABG episode category. (A) Prior post-acute care use. (B) HCC 37: Diabetes with Chronic Complications. (C) HCC 48: Morbid Obesity. (D) HCC 125: Dementia, Severe. (E) HCC 126: Dementia, Moderate. (F) HCC 127: Dementia, Mild or Unspecified. Except Pressure, Not Specified as Through to Bone or Muscle. (W) [Reserved] (X) HCC 409: Amputation Status, Lower Limb/Amputation Complications. (ii) LEJR episode category. (A) Ankle procedure or reattachment, partial hip procedure, partial knee arthroplasty, total hip arthroplasty or hip resurfacing procedure, and total knee arthroplasty. (B) Disability as the original reason for Medicare enrollment. (C) Prior post-acute care use. (D) HCC 17: Cancer Metastatic to Lung, Liver, Brain, and Other Organs; Acute Myeloid Leukemia Except Promyelocytic. (E) HCC 36: Diabetes with Severe Acute Complications. (F) HCC 37: Diabetes with Chronic Complications. (G) HCC 48: Morbid Obesity. (H) HCC 125: Dementia, Severe. (I) HCC 1 ukemia Except Promyelocytic. (E) HCC 36: Diabetes with Severe Acute Complications. (F) HCC 37: Diabetes with Chronic Complications. (G) HCC 48: Morbid Obesity. (H) HCC 125: Dementia, Severe. (I) HCC 126: Dementia, Moderate. (J) HCC 127: Dementia, Mild or Unspecified. (K) HCC 151: Schizophrenia. (L) HCC 155: Major Depression, Moderate or Severe, without Psychosis. (M) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia. (N) HCC 224: Acute on Chronic Heart (G) HCC 155: Major Depression, Failure. Moderate or Severe, without Psychosis. (H) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia. (I) HCC 213: Cardio-Respiratory Failure and Shock. (O) HCC 225: Acute Heart Failure (Excludes Acute on Chronic). (P) HCC 226: Heart Failure, Except End-Stage and Acute. (Q) HCC 238: Specified Heart (J) HCC 224: Acute on Chronic Heart Arrhythmias. Failure. (R) HCC 253: Hemiplegia/ (K) HCC 226: Heart Failure, Except Hemiparesis. End-Stage and Acute. (S) HCC 267: Deep Vein Thrombosis (L) HCC 228: Acute Myocardial and Pulmonary Embolism. Infarction. (M) HCC 229: Unstable Angina and Other Acute Ischemic Heart Disease. (N) HCC 238: Specified Heart Arrhythmias. (O) HCC 249: I rombosis (L) HCC 228: Acute Myocardial and Pulmonary Embolism. Infarction. (M) HCC 229: Unstable Angina and Other Acute Ischemic Heart Disease. (N) HCC 238: Specified Heart Arrhythmias. (O) HCC 249: Ischemic or Unspecified (T) HCC 280: Chronic Obstructive Pulmonary Disease, Interstitial Lung Disorders, and Other Chronic Lung Disorders. (U) [Reserved] (V) HCC 326: Chronic Kidney Disease, Complications. (E) HCC 48: Morbid Obesity. (F) HCC 78: Intestinal Obstruction/ Perforation. (G) HCC 125: Dementia, Severe. (H) HCC 126: Dementia, Moderate. (I) HCC 127: Dementia, Mild or Unspecified. (J) HCC 151: Schizophrenia. (K) HCC 155: Major Depression, Moderate or Severe, without Psychosis. (L) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia. (M) HCC 201: Seizure Disorders and Convulsions. (N) HCC 211: Respirator Dependence/ Tracheostomy Status/Complications. (O) HCC 213: Cardio-Respiratory Failure and Shock. (P) HCC 224: Acute on Chronic Heart Failure. (Q) HCC 226: Heart Failure, Except End-Stage and Acute. (R) HCC 238: Specified Heart Arrhythmias. (S) HCC 253: Hemiplegia/ Hemiparesis. (T) HCC 267: Deep Vein Thrombosis and Pulmonary Embolism. (U) HCC 280: Chronic Obstructiv e, Except End-Stage and Acute. (R) HCC 238: Specified Heart Arrhythmias. (S) HCC 253: Hemiplegia/ Hemiparesis. (T) HCC 267: Deep Vein Thrombosis and Pulmonary Embolism. (U) HCC 280: Chronic Obstructive Pulmonary Disease, Interstitial Lung Disorders, and Other Chronic Lung Disorders. (V) HCC 326: Chronic Kidney Disease, Stage 5. (W) HCC 327: Chronic Kidney Disease, Severe (Stage 4). (X) HCC 383: Chronic Ulcer of Skin, Except Pressure, Not Specified as Through to Bone or Muscle. (Y) HCC 463: Artificial Openings for Feeding or Elimination. (iv) SHFFT episode category. (A) HCC 36: Diabetes with Severe Acute Complications. (B) HCC 37: Diabetes with Chronic Complications. (C) HCC 38: Diabetes with Glycemic, Unspecified, or No Complications. (D) HCC 48: Morbid Obesity. (E) HCC 63: Chronic Liver Failure/ End-Stage Liver Disorders. (F) HCC 93: Rheumatoid Arthritis and Other Specified Inflammatory Rheumatic Disorders. (G) HCC 109: Acquired Hemolytic, Aplastic, and Sideroblastic Anemias. (H) HCC 125: Dementia, Severe. (I) HCC 126: Dementia, Moderate. (J) HCC 127: Dementia, Mild or Stroke. (P) HCC 253: Hemiplegia/ Hemiparesis. (Q) HCC 263: Atherosclerosis of Arteries of the Extremities with Ul 125: Dementia, Severe. (I) HCC 126: Dementia, Moderate. (J) HCC 127: Dementia, Mild or Stroke. (P) HCC 253: Hemiplegia/ Hemiparesis. (Q) HCC 263: Atherosclerosis of Arteries of the Extremities with Ulceration or Gangrene. (R) HCC 280: Chronic Obstructive Pulmonary Disease, Interstitial Lung Disorders, and Other Chronic Lung Disorders. (S) HCC 298: Severe Diabetic Eye Disease, Retinal Vein Occlusion, and Vitreous Hemorrhage. 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Stage 5. (W) HCC 327: Chronic Kidney Disease, Severe (Stage 4). (X) HCC 383: Chronic Ulcer of Skin, Except Pressure, Not Specified as Through to Bone or Muscle. (Y) HCC402: Hip Fracture/ Dislocation. (iii) Major Bowel Procedure episode Unspecified. category. (A) Long-term institutional care use. (B) HCC 17: Cancer Metastatic to Lung, Liver, Brain, and Other Organs; (K) HCC 180: Quadriplegia. (L) HCC 181: Paraplegia. (M) HCC 191: Quadriplegic Cerebral Palsy. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00672 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37207 (V) HCC 254: Monoplegia, Other (iii) Fo 5001 PO 00000 Frm 00672 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37207 (V) HCC 254: Monoplegia, Other (iii) For all episode categories: (N) HCC 198: Multiple Sclerosis. (O) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia. Paralytic Syndromes. (W) HCC 267: Deep Vein Thrombosis (P) HCC 211: Respirator Dependence/ and Pulmonary Embolism. Tracheostomy Status/Complications. (Q) HCC 213: Cardio-Respiratory Failure and Shock. (R) HCC 226: Heart Failure, Except End-Stage and Acute. (S) HCC 238: Specified Heart Arrhythmias. (T) HCC 249: Ischemic or Unspecified Stroke. (U) HCC 253: Hemiplegia/ Hemiparesis. (V) HCC 280: Chronic Obstructive Pulmonary Disease, Interstitial Lung Disorders, and Other Chronic Lung Disorders. (W) HCC 326: Chronic Kidney Disease, Stage 5. (X) HCC 383: Chronic Ulcer of Skin, Except Pressure, Not Specified as Through to Bone or Muscle. (Y) HCC 402: Hip Fracture/ Dislocation. (v) Spinal Fusion episode category. (A) Prior post-acute care use. (B) HCC 17: Cancer Metastatic to Lung, Liver, Brain, and Other Organs; Acute Myeloid Leukemia Except Promyelocytic. (C) HC slocation. (v) Spinal Fusion episode category. (A) Prior post-acute care use. (B) HCC 17: Cancer Metastatic to Lung, Liver, Brain, and Other Organs; Acute Myeloid Leukemia Except Promyelocytic. (C) HCC 18: Cancer Metastatic to Bone, Other and Unspecified Metastatic Cancer; Acute Leukemia Except Myeloid. (D) HCC 37: Diabetes with Chronic Complications. (E) HCC 48: Morbid Obesity. (F) HCC 93: Rheumatoid Arthritis and Other Specified Inflammatory Rheumatic Disorders. (G) HCC 125: Dementia, Severe. (H) HCC 126: Dementia, Moderate. (I) HCC 127: Dementia, Mild or Unspecified. (J) HCC 155: Major Depression, Moderate or Severe, without Psychosis. (K) HCC 180: Quadriplegia. (L) HCC 181: Paraplegia. (M) HCC 182: Spinal Cord Disorders/ Injuries. (N) HCC 192: Cerebral Palsy, Except Quadriplegic. (O) HCC 193: Chronic Inflammatory Demyelinating Polyneuritis and Multifocal Motor Neuropathy. (P) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia. (Q) HCC 224: Acute on Chronic Heart Failure. (R) HCC 226: Heart Failure, Except End-Stage and Acute. (S) HCC 238: Specified Heart Arrhythmias. (T) HCC 249: Ischemic or Unspecified Stroke. (U) HCC 253: Hemiplegia/ Hemiparesis. (X) HCC 326: lure. (R) HCC 226: Heart Failure, Except End-Stage and Acute. (S) HCC 238: Specified Heart Arrhythmias. (T) HCC 249: Ischemic or Unspecified Stroke. (U) HCC 253: Hemiplegia/ Hemiparesis. (X) HCC 326: Chronic Kidney Disease, Stage 5. (Y) HCC 383: Chronic Ulcer of Skin, Except Pressure, Not Specified as Through to Bone or Muscle. (Z) HCC 401: Vertebral Fractures * * without Spinal Cord Injury. * * * (e) * * * (1) * * * (i) Is the mean benchmark price for each MS–DRG/HCPCS episode type and region divided by the mean risk- adjusted benchmark price for the same MS–DRG/HCPCS episode type and region. * * * * * * * * (f) CMS calculates a multiplier for each MS–DRG/HCPCS episode type and region which is applied during reconciliation to the most recent calendar year of the applicable baseline period. The multiplier is calculated as the average regional capped performance year episode spending for each MS–DRG/HCPCS episode type divided by the average regional capped baseline period episode spending for each MS–DRG/HCPCS episode type. * * ■ 26. Section 512.547 is amended by— ■ a. In paragraph (a) introductory text, removing the phrase ‘‘Hospital Inpatient Quality Reporting Program and the Hosp ng for each MS–DRG/HCPCS episode type. * * ■ 26. Section 512.547 is amended by— ■ a. In paragraph (a) introductory text, removing the phrase ‘‘Hospital Inpatient Quality Reporting Program and the Hospital-Acquired Condition Reduction Program’’ and adding in its place ‘‘Hospital Inpatient Quality Reporting Program, the Hospital-Acquired Condition Reduction Program, and the Hospital Outpatient Quality Reporting Program’’; ■ b. In paragraph (a)(2) introductory text, removing the phrase ‘‘years 2 through 5’’ and adding in its place ‘‘year 2’’; ■ c. Adding paragraph (a)(3); and ■ d. Revising paragraphs (b)(1)(i)(B) introductory text and (b)(1)(i)(D). The addition and revisions read as follows: § 512.547 Quality measures, composite quality score, and display of quality measures. (a) * * * (3) For performance years 3 through 5: (i) For all episode categories: Hybrid Hospital-Wide All-Cause Readmission Measure with Claims and Electronic Health Record Data (CMIT ID #356) with a CY 2025 CQS baseline period. (ii) For all episode categories: Hospital Harm—Falls with Injury (CMIT ID #1518) with a CY 2026 CQS baseline period. Hospital Harm—Postoperative Respiratory Failure (CMIT ID #1788) with a line period. (ii) For all episode categories: Hospital Harm—Falls with Injury (CMIT ID #1518) with a CY 2026 CQS baseline period. Hospital Harm—Postoperative Respiratory Failure (CMIT ID #1788) with a CY 2026 CQS baseline period. (iv) For all episode categories: Thirty- day Risk-Standardized Death Rate among Surgical Inpatients with Complications (Failure-to-Rescue) (CMIT ID #134) with a CY 2026 CQS baseline period. (v) For LEJR episodes: Hospital-Level Total Hip and/or Total Knee Arthroplasty (THA/TKA) Patient- Reported Outcome-Based Performance Measure (PRO–PM) (CMIT ID #1618) with a CY 2025 CQS baseline period. (vi) For LEJR and Spinal Fusion * * episodes: Information Transfer PRO–PM (CMIT ID #1797) with a CY 2027 CQS baseline period. * * * (b) * * * (1) * * * (i) * * * (B) For the Hospital-Level Total Hip and/or Total Knee Arthroplasty (THA/ TKA) Patient-Reported Outcome-Based Performance Measure (PRO–PM) (CMIT ID #1618) and the Information Transfer PRO–PM (CMIT ID # 1797): * * * * * (D) CMS assigns a scaled quality measure of 50 if the TEAM participant has no or an incomplete raw quality measure score for a given quality measure. * * ■ 27. Section 512.550 is amended by revisin * (D) CMS assigns a scaled quality measure of 50 if the TEAM participant has no or an incomplete raw quality measure score for a given quality measure. * * ■ 27. Section 512.550 is amended by revising paragraph (c) to read as follows: * * * § 512.550 Reconciliation process and determination of the reconciliation payment or repayment amount. * * * * * (c) Calculation of the reconciliation amount. CMS compares the reconciliation target prices described in § 512.545 and the TEAM participant’s performance year spending to establish a reconciliation amount for the TEAM participant for each performance year as follows: (1) CMS determines the performance year spending for each episode included in the performance year (other than episodes that have been canceled in accordance with § 512.537(b)) for each MS–DRG/HCPCS episode type using claims data that is available 6 months after the end of the performance year. (2) CMS calculates and applies the high-cost outlier cap for performance year episode spending by applying the calculation described in § 512.540(b)(4) to performance year episode spending for each MS–DRG/HCPCS episode type. (3) CMS applies the adjustments specified in § 512.545 to ode spending by applying the calculation described in § 512.540(b)(4) to performance year episode spending for each MS–DRG/HCPCS episode type. (3) CMS applies the adjustments specified in § 512.545 to the preliminary VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00673 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37208 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations target prices computed in accordance with § 512.540 to calculate the reconciliation target prices for each MS– DRG/HCPCS episode type. (4) CMS aggregates the reconciliation target prices computed in accordance with paragraph (c)(3) of this section for all episodes included in the performance year (other than episodes that have been canceled in accordance with § 512.537(b)) for each MS–DRG/ HCPCS episode type. (5) CMS subtracts the performance year spending amount determined under paragraphs (c)(1) and (2) of this section from the reconciliation target price amount determined under paragraph (c)(4) of this section for each MS–DRG/HCPCS episode type. (6) CMS sums the values calculated under paragraph (c)( f this section from the reconciliation target price amount determined under paragraph (c)(4) of this section for each MS–DRG/HCPCS episode type. (6) CMS sums the values calculated under paragraph (c)(5) of this section across all MS–DRG/HCPCS episode types to determine the reconciliation amount. (7) Exception for low volume hospitals: CMS caps the performance year spending amount for each MS– DRG/HCPCS episode type determined under paragraphs (c)(1) and (2) of this section to equal the reconciliation target price computed in accordance with paragraph (c)(3) of this section for episode categories where the TEAM participant did not meet the low volume threshold of at least 31 episodes during the 3-year baseline period. Low volume hospital episodes, including episode categories where CMS caps performance year spending, are included in the CQS, as calculated in § 512.547(b), and stop- loss/stop-gain thresholds, as applied at paragraph (e) of this section, * * ■ 28. Section 512.562 is amended by revising paragraph (c)(3) to read as follows: * * * § 512.562 Data sharing with TEAM participants. * * * (c) * * * (3) Sex. * * * * * * * ■ 29. Section 512.563 is amended by: ■ a. Revising the s ed by revising paragraph (c)(3) to read as follows: * * * § 512.562 Data sharing with TEAM participants. * * * (c) * * * (3) Sex. * * * * * * * ■ 29. Section 512.563 is amended by: ■ a. Revising the section heading; and ■ b. Removing and reserving paragraphs (a) and (b). The revision read as follows: * § 512.563 Health data reporting. * * ■ 30. Section 512.564 is amended by revising paragraph (a) to read as follows: * * § 512.564 Referral to primary care services. to an established supplier of primary care services, as recorded on admission to the hospital or hospital outpatient department, for a TEAM beneficiary, on or prior to discharge from an anchor hospitalization or anchor procedure. In the event an established supplier of primary care services is not recorded on admission to the hospital or hospital outpatient department, the TEAM participant must include in hospital discharge planning a referral to a supplier of primary care services for a TEAM beneficiary, on or prior to discharge from an anchor hospitalization or anchor procedure. * * * * * ■ 31. Section 512.580 is amended by revising the section heading and paragraph (b)(3) to read as follows: * * § 512.580 TEAM Medicare arge from an anchor hospitalization or anchor procedure. * * * * * ■ 31. Section 512.580 is amended by revising the section heading and paragraph (b)(3) to read as follows: * * § 512.580 TEAM Medicare Program Waivers. * * * (b) * * * (3) Determination of qualified SNFs. CMS determines the qualified SNFs for each calendar quarter based on a review of the most recent rolling 12 months of overall star ratings on the Five-Star Quality Rating System for SNFs on the Nursing Home Compare website. (i) Qualified SNFs are rated an overall of 3 stars or better for at least 7 of the 12 months. (ii) Qualified SNFs include providers furnishing SNF services under swing bed agreements, which will not be subject to the star ratings requirement. * * * * * § 512.598 [Removed] ■ 32. Section 512.598 is removed. Title 45—Public Welfare PART 170—HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY ■ 33. The authority citation for part 170 continues to read as follows: Authority: 42 U.S.C. 300jj–11; 42 U.S.C 300jj–14; 5 U.S.C. 552. ■ 34. Section 170.102 is amended by— revising and republishing the de The authority citation for part 170 continues to read as follows: Authority: 42 U.S.C. 300jj–11; 42 U.S.C 300jj–14; 5 U.S.C. 552. ■ 34. Section 170.102 is amended by— revising and republishing the definition of ‘‘Base EHR’’ to read as follows: § 170.102 Definitions. * * * * * Base EHR means an electronic record (a) A TEAM participant must include in hospital discharge planning a referral of health-related information on an individual that— (1) Includes patient demographic and clinical health information, such as medical history and problem lists; (2) Has the capacity— (i) To provide clinical decision support; (ii) To support physician order entry; (iii) To capture and query information relevant to healthcare quality; (iv) To exchange electronic health information with, and integrate such information from other sources; and (3) Has been certified to the certification criteria adopted by the Secretary in all of the following: (i) Section 170.315(a)(1), (2), or (3); (a)(5) and (14), (b)(1), (c)(1), and (g)(7), (9), (10); and (h)(1) or (2). (ii) Section 170.315(a)(9) or (b)(11) for the period up to and including December 31, 2024. (iii) Section 170.315(b)(11) on and after January 1, 2 1), (c)(1), and (g)(7), (9), (10); and (h)(1) or (2). (ii) Section 170.315(a)(9) or (b)(11) for the period up to and including December 31, 2024. (iii) Section 170.315(b)(11) on and after January 1, 2025. (iv) Section 170.315(b)(4) on and after * * January 1, 2028. * * ■ 35. Section 170.207 is amended by revising paragraph (d) to read as follows: * § 170.207 Vocabulary standards for representing electronic health information. * * * * * (d) Medications—(1) Clinical drugs— (i) Standard. RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, December 4, 2023, Full Update Release (incorporated by reference in § 170.299). (ii) Standard. RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, Full Update Release, July 5, 2022 (incorporated by reference, see § 170.299). (iii) Standard. RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, September 8, 2015, Full Release Update (incorporated by reference in § 170.299). (2) Standard. National Drug Codes. The code set specified at 45 CFR 162.1002(b)(2) as reference al Library of Medicine, September 8, 2015, Full Release Update (incorporated by reference in § 170.299). (2) Standard. National Drug Codes. The code set specified at 45 CFR 162.1002(b)(2) as referenced in 45 CFR 162.1002(c)(1) for the time period on or after October 1, 2015. (3)–(4) [Reserved] * * * ■ 36. Section 170.215 is revised and republished to read as follows: * * § 170.215 Application Programming Interface Standards. The Secretary adopts the following standards and associated implementation specifications as the available standards for application programming interfaces (API): VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00674 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37209 (a) API base standard. The following are applicable for purposes of standards- based APIs. (1) Standard. HL7® Fast Healthcare Interoperability Resources (FHIR® ) Release 4.0.1 (incorporated by reference, see § 170.299). (2) [Reserved] (b) API constraints and profiles. The following are applicable for purposes of constraining and profil ility Resources (FHIR® ) Release 4.0.1 (incorporated by reference, see § 170.299). (2) [Reserved] (b) API constraints and profiles. The following are applicable for purposes of constraining and profiling data standards. (1) United States Core Data Implementation Guides—(i) Implementation specification. HL7® FHIR® US Core Implementation Guide STU 3.1.1 (incorporated by reference in § 170.299). The adoption of this standard expires on January 1, 2026. (ii) Implementation Specification. HL7® FHIR® US Core Implementation Guide STU 6.1.0 (incorporated by reference, see § 170.299). (2) [Reserved] (c) Application access and launch. The following are applicable for purposes of enabling client applications to access and integrate with data systems. (1) Implementation specification. HL7® SMART Application Launch Framework Implementation Guide Release 1.0.0, including mandatory support for the ‘‘SMART Core Capabilities’’ (incorporated by reference, see § 170.299). The adoption of this standard expires on January 1, 2026. (2) Implementation specification. HL7® SMART App Launch Implementation Guide Release 2.0.0, including mandatory support for the ‘‘Capability Sets’’ of ‘‘Patient Access for St pires on January 1, 2026. (2) Implementation specification. HL7® SMART App Launch Implementation Guide Release 2.0.0, including mandatory support for the ‘‘Capability Sets’’ of ‘‘Patient Access for Standalone Apps’’ and ‘‘Clinician Access for EHR Launch’’; all ‘‘Capabilities’’ as defined in ‘‘8.1.2 Capabilities,’’ excepting the ‘‘permission-online’’ capability; ‘‘Token Introspection’’ as defined in ‘‘7 Token Introspection’’ (incorporated by reference, see § 170.299). (d) Bulk export and data transfer standards. The following are applicable for purposes of enabling access to large volumes of information on a group of individuals. (1) Implementation specification. FHIR® Bulk Data Access (Flat FHIR® ) (v1.0.0: STU 1), including mandatory support for the ‘‘group-export’’ ‘‘OperationDefinition’’ (incorporated by reference, see § 170.299). (2) [Reserved] (e) API authentication, security, and privacy. The following are applicable for purposes of authorizing and authenticating client applications. (1) Standard. OpenID Connect Core 1.0, incorporating errata set 1 (incorporated by reference, see § 170.299). (2) [Reserved] (f) API-based workflow triggers. The following are applicable for purp ons. (1) Standard. OpenID Connect Core 1.0, incorporating errata set 1 (incorporated by reference, see § 170.299). (2) [Reserved] (f) API-based workflow triggers. The following are applicable for purposes of initiating calls to decision support services or initiating interactions that can be presented to users synchronously in their workflows. (1) Implementation specification. HL7 FHIR® CDS Hooks Implementation Guide, Version 2.0.1—STU 2 Release 2 (incorporated by reference in § 170.299). (2) [Reserved] (g) [Reserved] (h) API-based event notifications. The following are applicable for the purposes of supporting proactive notifications from a server to a client when new information has been added or existing information has been updated. (1) FHIR Subscriptions: Implementation specification. HL7® FHIR® Subscriptions R5 Backport Implementation Guide, Version 1.1.0— Standard for Trial Use (incorporated by reference in § 170.299). (2) [Reserved] (i) [Reserved] (j) Prior authorization—(1) Coverage requirements discovery—(i) Implementation specification. HL7 FHIR® Da Vinci—Coverage Requirements Discovery (CRD) Implementation Guide, Version 2.0.1— STU 2 (incorporated by reference in § 170. verage requirements discovery—(i) Implementation specification. HL7 FHIR® Da Vinci—Coverage Requirements Discovery (CRD) Implementation Guide, Version 2.0.1— STU 2 (incorporated by reference in § 170.299). (ii) [Reserved] (2) Prior authorization documentation—(i) Implementation specification. HL7 FHIR® Da Vinci— Documentation Templates and Rules (DTR) Implementation Guide, Version 2.0.1—STU 2 (incorporated by reference in § 170.299). (ii) [Reserved] (3) Prior authorization submission— (i) Implementation specification. HL7 FHIR Da Vinci Prior Authorization Support (PAS) FHIR Implementation Guide, Version 2.0.1—STU 2 (incorporated by reference in § 170.299). (ii) [Reserved] (k) Payer data exchange—(1) Blue button—(i) Implementation specification. HL7 FHIR® CARIN Consumer Directed Payer Data Exchange (CARIN IG for Blue Button® ) Implementation Guide, Version 2.0.0— STU 2 US (incorporated by reference in § 170.299). (ii) [Reserved] (2) Payer data exchange—(i) Implementation specification. HL7 FHIR® Da Vinci Payer Data Exchange (PDex) Implementation Guide, Version 2.1.0—STU 2.1 (incorporated by reference in § 170.299). (ii) [Reserved] (l) [Reserved] (m) Drug formulary—(1) Implementation HL7 FHIR® Da Vinci Payer Data Exchange (PDex) Implementation Guide, Version 2.1.0—STU 2.1 (incorporated by reference in § 170.299). (ii) [Reserved] (l) [Reserved] (m) Drug formulary—(1) Implementation specification. HL7 FHIR® Da Vinci Payer Data Exchange (PDex) US Drug Formulary Implementation Guide, Version 2.0.1— STU 2 (incorporated by reference in § 170.299). (2) [Reserved] (n) Directory information—(1) Implementation specification. HL7 FHIR® Da Vinci Payer Data Exchange (PDex) Plan Net Implementation Guide, Version 1.1.0—STU 1.1 US (incorporated by reference in § 170.299). (2) [Reserved] ■ 37. Section 170.299 is amended by adding paragraphs (g)(41) through (49) and (r)(10) to read as follows: § 170.299 Incorporation by reference. * * * * (g) * * * (41) HL7 FHIR® Da Vinci—Coverage * Requirements Discovery (CRD) Implementation Guide, Version 2.0.1— STU 2, January 8, 2024, IBR approved for § 170.215(j). (42) HL7 FHIR® Da Vinci— Documentation Templates and Rules (DTR) Implementation Guide, Version 2.0.1—STU 2, January 11, 2024, IBR approved for § 170.215(j). (43) HL7 FHIR® Da Vinci Prior Authorization Support (PAS) FHIR Implementation Guide, Version 2.0.1— STU 2, December 1, 2023, ide, Version 2.0.1—STU 2, January 11, 2024, IBR approved for § 170.215(j). (43) HL7 FHIR® Da Vinci Prior Authorization Support (PAS) FHIR Implementation Guide, Version 2.0.1— STU 2, December 1, 2023, IBR approved for § 170.215(j). (44) HL7 FHIR® CARIN Consumer Directed Payer Data Exchange (CARIN IG for Blue Button® ) Implementation Guide, Version 2.0.0—STU 2 US, November 28, 2022, IBR approved for § 170.215(k). (45) HL7 FHIR® Da Vinci Payer Data Exchange (PDex) Implementation Guide, Version 2.1.0—STU 2.1, June 18, 2025, IBR approved for § 170.215(k). (46) HL7 FHIR® Da Vinci Payer Data Exchange (PDex) US Drug Formulary Implementation Guide, Version 2.0.1— STU 2, December 1, 2023, IBR approved for § 170.215(m). (47) HL7 FHIR® Da Vinci Payer Data Exchange (PDex) Plan Net Implementation Guide, Version 1.1.0— STU 1.1 US, April 4, 2022, IBR approved for § 170.215(n). (48) HL7 FHIR® Subscriptions R5 Backport Implementation Guide, Version 1.1.0—Standard for Trial Use, draft as of January 11, 2023, IBR approved for § 170.215(h). (49) HL7 FHIR® CDS Hooks Implementation Guide, Version 2.0.1— STU 2 Release 2, March 12, 2025, IBR approved for § 170.215(f). * * * * * VerDate Sep 2014 00:36 Aug 0 023, IBR approved for § 170.215(h). (49) HL7 FHIR® CDS Hooks Implementation Guide, Version 2.0.1— STU 2 Release 2, March 12, 2025, IBR approved for § 170.215(f). * * * * * VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00675 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37210 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations (r) * * * (10) RxNorm, December 4, 2023, Full * * Update Release, IBR approved for § 170.207(d). * * * ■ 38. Section 170.315 is amended by— ■ a. Revising and republishing paragraph (b)(3); ■ b. Revising paragraph (b)(4); ■ c. Adding paragraph (g)(2); ■ d. Removing and reserving paragraph (g)(8); ■ e. Adding and reserving paragraphs (g)(11) through (30); f. Adding paragraphs (g)(31) through (33); ■ g. Adding and reserving paragraph (i); and ■ h. Adding paragraph (j). The revisions and additions read as follows: § 170.315 ONC Certification Criteria for Health IT. * * * (b) * * * (3) Electronic prescribing. (i) * * [Reserved] (ii) For technology certified subsequent to June 30, 2020: (A)(1) For the time period up to and including December 31, 2027, e Health IT. * * * (b) * * * (3) Electronic prescribing. (i) * * [Reserved] (ii) For technology certified subsequent to June 30, 2020: (A)(1) For the time period up to and including December 31, 2027, enable a user to perform the prescription-related electronic transactions specified in paragraph (b)(3)(ii)(A)(3) of this section in accordance with the standards specified in § 170.205(b)(1) or (2). (i) At a minimum, at least one of the versions of the standard adopted in § 170.207(d)(1). (ii) The standard in § 170.207(d)(2) if using the standard in § 170.205(b)(2). (2) On and after January 1, 2028, enable a user to perform the prescription-related electronic transactions specified in paragraph (b)(3)(ii)(A)(3) of this section in accordance with the standard specified in § 170.205(b)(2). (i) At a minimum, at least one of the versions of the standard adopted in § 170.207(d)(1). (ii) The standard in § 170.207(d)(2). (3) The prescription-related electronic transactions are as follows: (i) New prescriptions (NewRx). (ii) Request and respond to change prescriptions (RxChangeRequest, RxChangeResponse). (iii) Request and respond to cancel prescriptions (CancelRx, CancelRxResponse). (iv) Reque prescriptions (NewRx). (ii) Request and respond to change prescriptions (RxChangeRequest, RxChangeResponse). (iii) Request and respond to cancel prescriptions (CancelRx, CancelRxResponse). (iv) Request and respond to renew prescriptions (RxRenewalRequest, RxRenewalResponse). (v) Receive fill status notifications (RxFill). (vi) Request and receive medication history (RxHistoryRequest, RxHistoryResponse). (vii) Relay acceptance of a transaction back to the sender (Status). (viii) Respond that there was a problem with the transaction (Error). (ix) Respond that a transaction requesting a return receipt has been received (Verify). (x) Electronic prior authorization transactions (PAInitiationRequest, PAInitiationResponse, PARequest, PAResponse, PAAppealRequest, PAAppealResponse, PACancelRequest, PACancelResponse, and PANotification). These transactions are required if using the standard in § 170.205(b)(2). (B) Enable a user to exchange race and ethnicity information when performing the following prescription-related electronic transactions, if using the standard in § 170.205(b)(2): (1) Receive fill status notifications (RxFill). (2) Request and respond to change prescriptions (RxChangeR owing prescription-related electronic transactions, if using the standard in § 170.205(b)(2): (1) Receive fill status notifications (RxFill). (2) Request and respond to change prescriptions (RxChangeRequest, RxChangeResponse). (3) Request to cancel prescriptions (CancelRx). (4) Request and respond to renew prescriptions (RxRenewalRequest, RxRenewalResponse). (C) For the following prescription- related transactions, the technology must be able to receive and transmit the diagnosis or diagnoses that are the reason for prescription: (1) Required transactions: (i) New prescriptions (NewRx). (ii) Request and respond to change prescriptions (RxChangeRequest, RxChangeResponse). (iii) Cancel prescriptions (CancelRx). (iv) Request and respond to renew prescriptions (RxRenewalRequest, RxRenewalResponse). (v) Receive fill status notifications (RxFill). (vi) [Reserved] (vii) Electronic prior authorization transactions (PAInitiationRequest, PAInitiationResponse, PARequest, PAResponse, PAAppealRequest, PAAppealResponse and PACancelRequest, PACancelResponse, PANotification). These transactions are required if using the standard in § 170.205(b)(2). (2) [Reserved] (D) [Reserved] (E) Limit a user’s st, PAAppealResponse and PACancelRequest, PACancelResponse, PANotification). These transactions are required if using the standard in § 170.205(b)(2). (2) [Reserved] (D) [Reserved] (E) Limit a user’s ability to prescribe all oral liquid medications in only metric standard units of mL (that is, not cc). (F) Always insert leading zeroes before the decimal point for amounts less than one and must not allow trailing zeroes after a decimal point when a user prescribes medications. user to perform the following transactions using the XML format in accordance with at least one of the versions of the standards adopted in § 170.205(c); at a minimum, a standard adopted in § 170.207(d)(1); and the standard in § 170.207(d)(2), as follows: (A) Request patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with the RTPBRequest transaction. (B) Receive patient-specific prescription benefit information, estimated cost information, and alternative products in response to a request, in accordance with the RTPBResponse transaction. (ii) Display. Display to a user in human readable format patient-specific prescription benefit information, ernative products in response to a request, in accordance with the RTPBResponse transaction. (ii) Display. Display to a user in human readable format patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with at least one of the versions of the standard adopted in § 170.205(c). * * * * (g) * * * (2) Automated measure calculation. * For each Promoting Interoperability Programs percentage-based measure that is supported by a capability included in a technology, record the numerator and denominator and create a report including the numerator, denominator, and resulting percentage associated with each applicable measure. * * * * * (8) [Reserved] * * * * * (11)–(30) [Reserved] (31) Provider prior authorization API—coverage requirements discovery. Support the following capabilities to enable users to request and receive coverage requirements. (i) Coverage discovery. Support the capability to initiate and exchange information as a ‘‘CRD Client’’ to enable the identification of coverage requirements according to at least one of the versions of the implementation specification adopted in § 170.215(j)(1), including the followin a ‘‘CRD Client’’ to enable the identification of coverage requirements according to at least one of the versions of the implementation specification adopted in § 170.215(j)(1), including the following: (A) Registration. Support registration capabilities applicable to ‘‘CRD Clients’’. (B) CDS Hooks support. Support the capabilities in paragraph (j)(20) of this section to enable workflow triggers to call decision support services including support for the ‘‘order-sign’’ CDS Hook. (C) CRD Client capabilities. Support all requirements and required capabilities applicable to a ‘‘CRD Client.’’ (ii) Documentation. Supported API (4) Real-time prescription benefit—(i) Send and receive information. Enable a server capabilities of ‘‘CRD Clients’’ from an implementation specification VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00676 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k ■ Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37211 adopted in § 170.215(j)(1) must include complete accompanying technical documentation. (32) Provider prior authorization API—documentation temp 7 / Monday, August 4, 2025 / Rules and Regulations 37211 adopted in § 170.215(j)(1) must include complete accompanying technical documentation. (32) Provider prior authorization API—documentation templates and rules. Support the capability for users to request and populate prior authorization documentation using templates and rules as a ‘‘Full DTR EHR’’ according to at least one of the versions of the implementation specification adopted in § 170.215(j)(2), including: (i) Registration. Support registration capabilities applicable to a ‘‘Full DTR EHR.’’ (ii) Authentication and authorization. Support system authentication and authorization as a client in accordance with the ‘‘Backend Services’’ section of at least one of the versions of the implementation specification adopted in § 170.215(c). (iii) Full DTR EHR capabilities. Support all requirements and required capabilities applicable to a ‘‘Full DTR EHR.’’ (33) Provider prior authorization API—prior authorization support. Support the following capabilities to enable users to submit prior authorization requests. (i) Prior authorization submission. Support submitting a prior authorization request as a client in accordance with at le following capabilities to enable users to submit prior authorization requests. (i) Prior authorization submission. Support submitting a prior authorization request as a client in accordance with at least one of the versions of the implementation specification adopted in § 170.215(j)(3) including the following: (A) Registration. Support registration capabilities applicable to a client system. (B) Authentication and authorization. Support system authentication and authorization as a client in accordance with the ‘‘Backend Services’’ section of at least one of the versions of the implementation specification adopted in § 170.215(c). (C) Prior authorization transactions. Support the ability to submit a prior authorization request as a client system including the following: (1) Support the capabilities in the ‘‘EHR PAS Capabilities’’ Capability Statement. (2) Support the ability to consume and process a ‘‘ClaimResponse.’’ (3) Support subscriptions as a client according to the requirements in paragraph (j)(21) of this section in order to support ‘‘pended authorization responses.’’ (ii) Documentation. Supported subscriptions client endpoint capabilities for the ‘‘REST-Hook’’ channel from n paragraph (j)(21) of this section in order to support ‘‘pended authorization responses.’’ (ii) Documentation. Supported subscriptions client endpoint capabilities for the ‘‘REST-Hook’’ channel from implementation specifications adopted in § 170.215(j)(3) must include complete accompanying technical documentation. * * * * * (i) [Reserved] (j) Modular API capabilities. The following technical outcomes and conditions must be met through the demonstration of application programming interface technology. (1)–(19) [Reserved] (20) Workflow triggers for decision support interventions—clients. Support the requirements applicable to a ‘‘CDS Client’’ according to at least one of the implementation specifications in § 170.215(f) including the following: (i) Registration. Support registration capabilities applicable to ‘‘CDS Clients’’. (ii) Authentication and authorization. Support authentication and authorization, including the following: (A) Support for client authentication using JSON web tokens (JWT). (B) Support for data access authorization of a ‘‘CDS Service’’ using access tokens. (iii) Workflow triggers. Support the execution of decision support workflow triggers. (iv) Information exc ns (JWT). (B) Support for data access authorization of a ‘‘CDS Service’’ using access tokens. (iii) Workflow triggers. Support the execution of decision support workflow triggers. (iv) Information exchange. Send a decision support request to a ‘‘CDS Service,’’ including support for the following: (A) Resource access via API. Support access to HL7 FHIR Resources via a RESTful API to support decision support intervention workflows according to the ‘‘FHIR Resource Access’’ section. (B) Receive and display response. Support the receipt of a decision support response, including support for the display of the contents of a decision support response to an end-user. (21) Subscriptions—client. Support subscriptions as a client according to at least one of the implementation specifications in § 170.215(h), including the following: (i) Support the requirements in section ‘‘Topic-Based Subscriptions— FHIR R4.’’ (ii) Support the ‘‘R4/B Topic-Based Subscription’’ profile. (iii) Support the accompanying client capabilities for the minimum requirements included in the ‘‘R4 Topic-Based Subscription Server Capability Statement,’’ including support for ‘‘create,’’ ‘‘update,’’ and ‘‘delete’’ interacti ing client capabilities for the minimum requirements included in the ‘‘R4 Topic-Based Subscription Server Capability Statement,’’ including support for ‘‘create,’’ ‘‘update,’’ and ‘‘delete’’ interactions for Subscription Resources. (iv) Receive subscription notifications according to section ‘‘Topic-Based Subscriptions—FHIR R4,’’ including support for consuming notifications via the ‘‘REST-Hook’’ channel as specified in the ‘‘Channels’’ section. ■ 39. Section 170.404 is amended by— ■ a. Revising the introductory text; ■ b. Revising paragraph (b)(1); and ■ c. Revising definitions for ‘‘Certified API Developer’’ and ‘‘Certified API technology’’ in paragraph (c). The revisions read as follows: § 170.404 Application programming interfaces. The following Condition and Maintenance of Certification requirements apply to developers of Health IT Modules certified to any of the certification criteria adopted in § 170.315(g)(7) through (10), and (31) through (g)(33) unless otherwise specified in this section. * * * (b) * * * (1) Authenticity verification and registration for production use. The following apply to a Certified API Developer with a Health IT Module certified to one or more of § this section. * * * (b) * * * (1) Authenticity verification and registration for production use. The following apply to a Certified API Developer with a Health IT Module certified to one or more of § 170.315(g)(10), (31), and (33): * * (i) Authenticity verification. A Certified API Developer is permitted to institute a process to verify the authenticity of API Users so long as such process is objective and the same for all API Users and completed within ten business days of receipt of an API User’s request to register their software application for use with the Certified API Developer’s Health IT Module certified to § 170.315(g)(10), (g)(31), and (g)(33). (ii) Registration for production use. A Certified API Developer must register and enable all applications for production use within five business days of completing its verification of an API User’s authenticity, pursuant to paragraph (b)(1)(i) of this section. * * * * (c) * * * Certified API Developer means a * health IT developer that creates ‘‘certified API technology.’’ Certified API technology means the capabilities of Health IT Modules that are certified to any of the API-focused certification criteria adopted in § 170.315(g at creates ‘‘certified API technology.’’ Certified API technology means the capabilities of Health IT Modules that are certified to any of the API-focused certification criteria adopted in § 170.315(g)(7) through (10), and (31) through (33). § 170.405 [Amended] ■ 40. Section 170.405 is amended in paragraph (a), by removing the phrase ‘‘(g)(7) through (10), and (h) must’’ and adding in its place the phrase ‘‘(g)(7) through (10), (g)(31) through (33), (h), and (j)(20) and (21) must’’. ■ 41. Section 170.550 is amended by— ■ a. Adding paragraph (g)(6); and ■ b. Removing paragraph (m). The addition reads as follows: VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00677 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37212 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations * * § 170.550 Health IT Module certification. * * * (g) * * * (6) Section 170.315(b)(4) if the Health IT Module is presented for certification to the certification criteria in § 170.315(b)(3). * * * * * Robert J. Kennedy, Jr. Secretary, Department of Health and Human Services. Note: The following addendum and e is presented for certification to the certification criteria in § 170.315(b)(3). * * * * * Robert J. Kennedy, Jr. Secretary, Department of Health and Human Services. Note: The following addendum and appendices will not appear in the Code of Federal Regulations. Addendum—Schedule of Standardized Amounts, Update Factors, Rate-of- Increase Percentages Effective With Cost Reporting Periods Beginning On or After October 1, 2025, and Payment Rates for LTCHs Effective for Discharges Occurring On or After October 1, 2025 I. Summary and Background In this Addendum, we are setting forth a description of the methods and data we used to determine the prospective payment rates for Medicare hospital inpatient operating costs and Medicare hospital inpatient capital- related costs for FY 2026 for acute care hospitals. We also are setting forth the rate- of-increase percentage for updating the target amounts for certain hospitals excluded from the IPPS for FY 2026. We note that, because certain hospitals excluded from the IPPS are paid on a reasonable cost basis subject to a rate-of-increase ceiling (and not by the IPPS), these hospitals are not affected by the figures for the standardized amount tals excluded from the IPPS are paid on a reasonable cost basis subject to a rate-of-increase ceiling (and not by the IPPS), these hospitals are not affected by the figures for the standardized amounts, offsets, and budget neutrality factors. Therefore, in this final rule, we are setting forth the rate-of- increase percentage for updating the target amounts for certain hospitals excluded from the IPPS that would be effective for cost reporting periods beginning on or after October 1, 2025. In addition, we are setting forth a description of the methods and data we used to determine the LTCH PPS standard Federal payment rate that would be applicable to Medicare LTCHs for FY 2026. In general, except for SCHs and MDHs, for FY 2026, each hospital’s payment per discharge under the IPPS is based on 100 percent of the Federal national rate, also known as the national adjusted standardized amount. This amount reflects the national average hospital cost per case from a base year, updated for inflation. SCHs are paid based on whichever of the following rates yields the greatest aggregate payment: • The Federal national rate (including, as discussed in section IV.E. of the preamble of this fin lation. SCHs are paid based on whichever of the following rates yields the greatest aggregate payment: • The Federal national rate (including, as discussed in section IV.E. of the preamble of this final rule, uncompensated care payments under section 1886(r)(2) of the Act). • The updated hospital-specific rate based on FY 1982 costs per discharge. • The updated hospital-specific rate based on FY 1987 costs per discharge. • The updated hospital-specific rate based on FY 1996 costs per discharge. • The updated hospital-specific rate based on FY 2006 costs per discharge. Under section 1886(d)(5)(G) of the Act, MDHs historically were paid based on the Federal national rate or, if higher, the Federal national rate plus 50 percent of the difference between the Federal national rate and the updated hospital-specific rate based on FY 1982 or FY 1987 costs per discharge, whichever was higher. However, section 5003(a)(1) of Public Law 109–171 extended and modified the MDH special payment provision that was previously set to expire on October 1, 2006, to include discharges occurring on or after October 1, 2006, but before October 1, 2011. Under section 5003(b) of Public Law 109–171, if the ch on that was previously set to expire on October 1, 2006, to include discharges occurring on or after October 1, 2006, but before October 1, 2011. Under section 5003(b) of Public Law 109–171, if the change results in an increase to an MDH’s target amount, we must rebase an MDH’s hospital specific rates based on its FY 2002 cost report. Section 5003(c) of Public Law 109– 171 further required that MDHs be paid based on the Federal national rate or, if higher, the Federal national rate plus 75 percent of the difference between the Federal national rate and the updated hospital specific rate. Further, based on the provisions of section 5003(d) of Public Law 109–171, MDHs are no longer subject to the 12-percent cap on their DSH payment adjustment factor. Section 2202 of the Full-Year Continuing Appropriations and Extensions Act, 2025 extended the MDH program through FY 2025. Therefore, under current law, the MDH program will expire for discharges on or after October 1, 2025. We note that if the MDH program were to be extended by law beyond September 30, 2025, into FY 2026, the updates to the hospital-specific rates for SCHs as described in this section would also apply to the hospital-sp the MDH program were to be extended by law beyond September 30, 2025, into FY 2026, the updates to the hospital-specific rates for SCHs as described in this section would also apply to the hospital-specific rates for MDHs for FY 2026. We refer readers to section V.F. of the preamble of this final rule for further discussion of the MDH program. As discussed in section V.B.2. of the preamble of this final rule, section 1886(n)(6)(B) of the Act was amended to specify that the adjustments to the applicable percentage increase under section 1886(b)(3)(B)(ix) of the Act apply to subsection (d) Puerto Rico hospitals that are not meaningful EHR users, effective beginning FY 2022. In general, Puerto Rico hospitals are paid 100 percent of the national standardized amount and are subject to the same national standardized amount as subsection (d) hospitals that receive the full update. Accordingly, our discussion later in this section does not include references to the Puerto Rico standardized amount or the Puerto Rico-specific wage index. As discussed in section II. of this Addendum, we are making changes in the determination of the prospective payment rates for Medicare inpatient operating c unt or the Puerto Rico-specific wage index. As discussed in section II. of this Addendum, we are making changes in the determination of the prospective payment rates for Medicare inpatient operating costs for acute care hospitals for FY 2026. In section III. of this Addendum, we discuss our policy changes for determining the prospective payment rates for Medicare inpatient capital-related costs for FY 2026. In section IV. of this Addendum, we are setting forth the rate-of-increase percentage for determining the rate-of-increase limits for certain hospitals excluded from the IPPS for FY 2026. In section V. of this Addendum, we discuss policy changes for determining the LTCH PPS standard Federal rate for LTCHs paid under the LTCH PPS for FY 2026. The tables to which we refer in the preamble of this final rule are listed in section VI. of this Addendum and are available via the internet on the CMS website. II. Changes to Prospective Payment Rates for Hospital Inpatient Operating Costs for Acute Care Hospitals for FY 2026 The basic methodology for determining prospective payment rates for hospital inpatient operating costs for acute care hospitals for FY 2005 and subsequent fiscal year Acute Care Hospitals for FY 2026 The basic methodology for determining prospective payment rates for hospital inpatient operating costs for acute care hospitals for FY 2005 and subsequent fiscal years is set forth under § 412.64. The basic methodology for determining the prospective payment rates for hospital inpatient operating costs for hospitals located in Puerto Rico for FY 2005 and subsequent fiscal years is set forth under §§ 412.211 and 412.212. In this section, we discuss the factors we are using for determining the prospective payment rates for FY 2026. In summary, the standardized amounts set forth in Tables 1A, 1B, and 1C that are listed and published in section VI. of this Addendum (and available via the internet on the CMS website) reflect— • Equalization of the standardized amounts for urban and other areas at the level computed for large urban hospitals during FY 2004 and onward, as provided for under section 1886(d)(3)(A)(iv)(II) of the Act. • The labor-related share that is applied to the standardized amounts to give the hospital the highest payment, as provided for under sections 1886(d)(3)(E) and 1886(d)(9)(C)(iv) of the Act. For FY 2026, depending on whether a hat is applied to the standardized amounts to give the hospital the highest payment, as provided for under sections 1886(d)(3)(E) and 1886(d)(9)(C)(iv) of the Act. For FY 2026, depending on whether a hospital submits quality data under the rules established in accordance with section 1886(b)(3)(B)(viii) of the Act (hereafter referred to as a hospital that submits quality data) and is a meaningful EHR user under section 1886(b)(3)(B)(ix) of the Act (hereafter referred to as a hospital that is a meaningful EHR user), there are four possible applicable percentage increases that can be applied to the national standardized amount. We refer readers to section VI.B. of the preamble of this final rule for a complete discussion on the FY 2026 inpatient hospital update. The table that follows shows these four scenarios: VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00678 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37213 FY 2026 APPLICABLE PERCENTAGE INCREASE FOR THE IPPS FY 2026 Hospital submitted quality data and is a meanin k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37213 FY 2026 APPLICABLE PERCENTAGE INCREASE FOR THE IPPS FY 2026 Hospital submitted quality data and is a meaningful EHR user Hospital submitted quality data and is NOT a meaningful EHR user Hospital did NOT submit quality data and is a meaningful EHR user Hospital did NOT submit quality data and is NOT a meaningful EHR user Market Basket Rate-of-Increase ...................................................................... Adjustment for Failure to Submit Quality Data under Section 1886(b)(3)(B)(viii) of the Act ......................................................................... Adjustment for Failure to be a Meaningful EHR User under Section 1886(b)(3)(B)(ix) of the Act .......................................................................... Productivity Adjustment under Section 1886(b)(3)(B)(xi) of the Act ............... Applicable Percentage Increase Applied to Standardized Amount ................. 3.3 0 0 ¥0.7 2.6 3.3 0 ¥2.475 ¥0.7 0.125 3.3 ¥0.825 0 ¥0.7 1.775 3.3 ¥0.825 ¥2.475 ¥0.7 ¥0.7 We note that section 1886(b)(3)(B)(viii) of the Act, which specifies the adjustment to the ap ............. 3.3 0 0 ¥0.7 2.6 3.3 0 ¥2.475 ¥0.7 0.125 3.3 ¥0.825 0 ¥0.7 1.775 3.3 ¥0.825 ¥2.475 ¥0.7 ¥0.7 We note that section 1886(b)(3)(B)(viii) of the Act, which specifies the adjustment to the applicable percentage increase for ‘‘subsection (d)’’ hospitals that do not submit quality data under the rules established by the Secretary, is not applicable to hospitals located in Puerto Rico. In addition, section 602 of Public Law 114–113 amended section 1886(n)(6)(B) of the Act to specify that Puerto Rico hospitals are eligible for incentive payments for the meaningful use of certified EHR technology, effective beginning FY 2016, and also to apply the adjustments to the applicable percentage increase under section 1886(b)(3)(B)(ix) of the Act to subsection (d) Puerto Rico hospitals that are not meaningful EHR users, effective beginning FY 2022. Accordingly, the applicable percentage increase for subsection (d) Puerto Rico hospitals that are not meaningful EHR users for FY 2026 and subsequent fiscal years is adjusted by the adjustment for failure to be a meaningful EHR user under section 1886(b)(3)(B)(ix) of the Act. The regulations at 42 CFR 412.64(d)(3)(ii) reflect the current law equent fiscal years is adjusted by the adjustment for failure to be a meaningful EHR user under section 1886(b)(3)(B)(ix) of the Act. The regulations at 42 CFR 412.64(d)(3)(ii) reflect the current law for the update for subsection (d) Puerto Rico hospitals for FY 2022 and subsequent fiscal years. • An adjustment to the standardized amount to ensure budget neutrality for DRG recalibration and reclassification, as provided for under section 1886(d)(4)(C)(iii) of the Act. • An adjustment to the standardized amount to ensure budget neutrality for the permanent 10-percent cap on the reduction in a MS–DRG’s relative weight in a given fiscal year, as discussed in section II.D.2.c. of the preamble of this final rule, consistent with our current methodology for implementing DRG recalibration and reclassification budget neutrality under section 1886(d)(4)(C)(iii) of the Act. • An adjustment to ensure the wage index and labor-related share changes (depending on the fiscal year) are budget neutral, as provided for under section 1886(d)(3)(E)(i) of the Act (as discussed in the FY 2006 IPPS final rule (70 FR 47395) and the FY 2010 IPPS final rule (74 FR 44005)). We note that section 1886(d)(3)(E , as provided for under section 1886(d)(3)(E)(i) of the Act (as discussed in the FY 2006 IPPS final rule (70 FR 47395) and the FY 2010 IPPS final rule (74 FR 44005)). We note that section 1886(d)(3)(E)(i) of the Act requires that when we compute such budget neutrality, we assume that the provisions of section 1886(d)(3)(E)(ii) of the Act (requiring a 62-percent labor-related share in certain circumstances) had not been enacted. • An adjustment to ensure the effects of geographic reclassification are budget neutral, as provided for under section 1886(d)(8)(D) of the Act, by removing the FY 2025 budget neutrality factor and applying a revised factor. • An adjustment to the standardized amount to implement in a budget neutral manner the wage index cap policy (as described in section III.G.6. of the preamble of this final rule). • Using our authority under section 1886(d)(5)(I)(i) of the Act, an adjustment to the standardized amount to implement in a budget neutral manner the transition for the discontinuation of the low wage index hospital policy (as described in section III.F.7. of the preamble of this final rule). • An adjustment to ensure the effects of the Rural Community Hospital r the discontinuation of the low wage index hospital policy (as described in section III.F.7. of the preamble of this final rule). • An adjustment to ensure the effects of the Rural Community Hospital Demonstration program required under section 410A of Public Law 108–173 (as amended by sections 3123 and 10313 of Public Law 111–148, which extended the demonstration program for an additional 5 years and section 15003 of Public Law 114– 255), are budget neutral as required under section 410A(c)(2) of Public Law 108–173. • An adjustment to remove the FY 2025 outlier offset and apply an offset for FY 2026, as provided for in section 1886(d)(3)(B) of the Act. For FY 2026, consistent with current law, we are applying the rural floor budget neutrality adjustment to hospital wage indexes. Also, consistent with section 3141 of the Affordable Care Act, instead of applying a State-level rural floor budget neutrality adjustment to the wage index, we are applying a uniform, national budget neutrality adjustment to the FY 2026 wage index for the rural floor. For FY 2026, we are continuing to not remove the Stem Cell Acquisition Budget Neutrality Factor from the prior year’s standardized amount a ty adjustment to the FY 2026 wage index for the rural floor. For FY 2026, we are continuing to not remove the Stem Cell Acquisition Budget Neutrality Factor from the prior year’s standardized amount and to not apply a new factor. If we removed the prior year’s adjustment, we would not satisfy budget neutrality. We believe this approach ensures the effects of the reasonable cost-based payment for allogeneic hematopoietic stem cell acquisition costs under section 108 of the Further Consolidated Appropriations Act, 2020 (Pub. L. 116–94) are budget neutral as required under section 108 of Public Law 116–94. For a discussion of Stem Cell Acquisition Budget Neutrality Factor, we refer the reader to the FY 2021 IPPS/LTCH PPS final rule (85 FR 59032 and 59033). We finally note, as discussed in section III.G.5. of the preamble to this final rule, in the FY 2025 IFC we recalculated the FY 2025 IPPS hospital wage index to remove the low wage index hospital policy for FY 2025. We also removed the low wage index budget neutrality factor from the FY 2025 standardized amounts. For FY 2026 and subsequent fiscal years, after considering the D.C. Circuit’s decision in Bridgeport Hosp. v. Becerra, we low wage index budget neutrality factor from the FY 2025 standardized amounts. For FY 2026 and subsequent fiscal years, after considering the D.C. Circuit’s decision in Bridgeport Hosp. v. Becerra, we are discontinuing the low wage index hospital policy. Because we are discontinuing the low wage index hospital policy for FY 2026 and subsequent fiscal years we are no longer applying the low wage index budget neutrality factor to the standardized amounts. A. Calculation of the Adjusted Standardized Amount 1. Standardization of Base-Year Costs or Target Amounts In general, the national standardized amount is based on per discharge averages of adjusted hospital costs from a base period (section 1886(d)(2)(A) of the Act), updated and otherwise adjusted in accordance with the provisions of section 1886(d) of the Act. The September 1, 1983, interim final rule (48 FR 39763) contained a detailed explanation of how base-year cost data (from cost reporting periods ending during FY 1981) were established for urban and rural hospitals in the initial development of standardized amounts for the IPPS. Sections 1886(d)(2)(B) and 1886(d)(2)(C) of the Act require us to update base-year per discharge blished for urban and rural hospitals in the initial development of standardized amounts for the IPPS. Sections 1886(d)(2)(B) and 1886(d)(2)(C) of the Act require us to update base-year per discharge costs for FY 1984 and then standardize the cost data in order to remove the effects of certain sources of cost variations among hospitals. These effects include case-mix, differences in area wage levels, cost-of-living adjustments for Alaska and Hawaii, IME costs, and costs to hospitals serving a disproportionate share of low- income patients. For FY 2026, we are finalizing to rebase and revise the national labor-related and nonlabor-related shares (based on the 2023- based hospital IPPS market basket discussed in section IV.B.3. of the preamble of this final rule). Specifically, under section 1886(d)(3)(E) of the Act, the Secretary estimates, from time to time, the proportion of payments that are labor-related and adjusts the proportion (as estimated by the Secretary from time to time) of hospitals’ costs which are attributable to wages and wage-related VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00679 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D hospitals’ costs which are attributable to wages and wage-related VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00679 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37214 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations costs of the DRG prospective payment rates. We refer to the proportion of hospitals’ costs that are attributable to wages and wage- related costs as the ‘‘labor-related share.’’ For FY 2026, as discussed in section III.H. of the preamble of this final rule, as proposed, we are finalizing to use a labor-related share of 66.0 percent for the national standardized amounts for all IPPS hospitals (including hospitals in Puerto Rico) that have a wage index value that is greater than 1.0000. Consistent with section 1886(d)(3)(E) of the Act, as proposed, we are applying the wage index to a labor-related share of 62 percent of the national standardized amount for all IPPS hospitals (including hospitals in Puerto Rico) whose wage index values are less than or equal to 1.0000. The standardized amounts for operating costs appear in Tables 1A, 1B, and 1C that are all IPPS hospitals (including hospitals in Puerto Rico) whose wage index values are less than or equal to 1.0000. The standardized amounts for operating costs appear in Tables 1A, 1B, and 1C that are listed and published in section VI. of the Addendum to this final rule and are available via the internet on the CMS website. 2. Computing the National Average Standardized Amount Section 1886(d)(3)(A)(iv)(II) of the Act requires that, beginning with FY 2004 and thereafter, an equal standardized amount be computed for all hospitals at the level computed for large urban hospitals during FY 2003, updated by the applicable percentage increase. Accordingly, we are calculating the FY 2026 national average standardized amount irrespective of whether a hospital is located in an urban or rural location. 3. Updating the National Average Standardized Amount Section 1886(b)(3)(B) of the Act specifies the applicable percentage increase used to update the standardized amount for payment for inpatient hospital operating costs. We note that, in compliance with section 404 of the MMA, we are using the 2023-based IPPS operating and capital market baskets for FY 2026. As discussed in section VI.B. of t hospital operating costs. We note that, in compliance with section 404 of the MMA, we are using the 2023-based IPPS operating and capital market baskets for FY 2026. As discussed in section VI.B. of the preamble of this final rule, in accordance with section 1886(b)(3)(B) of the Act, as amended by section 3401(a) of the Affordable Care Act, we are reducing the FY 2026 applicable percentage increase (which for this final rule is based on IGI’s second quarter 2025 forecast of the 2023-based IPPS market basket) by the productivity adjustment, as discussed elsewhere in this final rule. Based on IGI’s second quarter 2025 forecast of the IPPS hospital market basket percentage increase (as discussed in appendix B of this final rule), the forecast of the hospital market basket percentage increase for FY 2026 for this final rule is 3.3 percent and the forecast of the productivity adjustment for FY 2026 for this final rule is 0.7 percentage point. As discussed earlier, for FY 2026, depending on whether a hospital submits quality data under the rules established in accordance with section 1886(b)(3)(B)(viii) of the Act and is a meaningful EHR user under section 1886(b)(3)(B)(ix) of the Act, t whether a hospital submits quality data under the rules established in accordance with section 1886(b)(3)(B)(viii) of the Act and is a meaningful EHR user under section 1886(b)(3)(B)(ix) of the Act, there are four possible applicable percentage increases that can be applied to the standardized amount. We refer readers to section VI.B. of the preamble of this final rule for a complete discussion on the FY 2026 inpatient hospital update to the standardized amount. We also refer readers to the previous table for the four possible applicable percentage increases that would be applied to update the national standardized amounts. The standardized amounts shown in Tables 1A through 1C that are published in section VI. of this Addendum and that are available via the internet on the CMS website reflect these differential amounts. Although the update factors for FY 2026 are set by law, we are required by section 1886(e)(4) of the Act to recommend, taking into account MedPAC’s recommendations, appropriate update factors for FY 2026 for both IPPS hospitals and hospitals and hospital units excluded from the IPPS. Section 1886(e)(5)(A) of the Act requires that we publish our recommendations in t propriate update factors for FY 2026 for both IPPS hospitals and hospitals and hospital units excluded from the IPPS. Section 1886(e)(5)(A) of the Act requires that we publish our recommendations in the Federal Register for public comment. Our recommendation on the FY 2026 update factors is set forth in appendix B of this final rule. 4. Methodology for Calculation of the Average Standardized Amount The methodology we used to calculate the proposed FY 2026 standardized amount is as follows: • To ensure we are only including hospitals paid under the IPPS in the calculation of the standardized amount, we applied the following inclusion and exclusion criteria: include hospitals whose last four digits fall between 0001 and 0879 (section 2779A1 of Chapter 2 of the State Operations Manual on the CMS website at: https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/Downloads/ som107c02.pdf); exclude CAHs and Rural Emergency Hospitals (REHs) at the time of this final rule (we finalized to remove REHs in the calculation of the standardized amount in the FY 2025 IPPS/LTCH final rule (89 FR 69941–69942); exclude hospitals in Maryland (because these hospitals are paid under an all paye to remove REHs in the calculation of the standardized amount in the FY 2025 IPPS/LTCH final rule (89 FR 69941–69942); exclude hospitals in Maryland (because these hospitals are paid under an all payer model under section 1115A of the Act); and remove PPS excluded- cancer hospitals that have a ‘‘V’’ in the fifth position of their provider number or a ‘‘E’’ or ‘‘F’’ in the sixth position. • As in the past, we are adjusting the FY 2026 standardized amount to remove the effects of the FY 2026 geographic reclassifications and outlier payments before applying the FY 2026 updates. We then applied budget neutrality offsets for outliers and geographic reclassifications to the standardized amount based on FY 2026 payment policies. • We do not remove the prior year’s budget neutrality adjustments for reclassification and recalibration of the DRG relative weights and for updated wage data because, in accordance with sections 1886(d)(4)(C)(iii) and 1886(d)(3)(E) of the Act, estimated aggregate payments after updates in the DRG relative weights and wage index should equal estimated aggregate payments prior to the changes. If we removed the prior year’s adjustment, we would not satisfy these con ments after updates in the DRG relative weights and wage index should equal estimated aggregate payments prior to the changes. If we removed the prior year’s adjustment, we would not satisfy these conditions. Budget neutrality is determined by comparing aggregate IPPS payments before and after making changes that are required to be budget neutral (for example, changes to MS–DRG classifications, recalibration of the MS–DRG relative weights, updates to the wage index, and different geographic reclassifications). We include outlier payments in the simulations because they may be affected by changes in these parameters. • Consistent with our methodology established in the FY 2011 IPPS/LTCH PPS final rule (75 FR 50422 through 50433), because IME Medicare Advantage payments are made to IPPS hospitals under section 1886(d) of the Act, we believe these payments must be part of these budget neutrality calculations. However, we note that it is not necessary to include Medicare Advantage IME payments in the outlier threshold calculation or the outlier offset to the standardized amount because the statute requires that outlier payments be not less than 5 percent nor more than 6 percent of tota ents in the outlier threshold calculation or the outlier offset to the standardized amount because the statute requires that outlier payments be not less than 5 percent nor more than 6 percent of total ‘‘operating DRG payments,’’ which does not include IME and DSH payments. We refer readers to the FY 2011 IPPS/LTCH PPS final rule for a complete discussion on our methodology of identifying and adding the total Medicare Advantage IME payment amount to the budget neutrality adjustments. • Consistent with the methodology in the FY 2012 IPPS/LTCH PPS final rule, in order to ensure that we capture only fee-for-service claims, we are only including claims with a ‘‘Claim Type’’ of 60 (which is a field on the MedPAR file that indicates a claim is an FFS claim). • Consistent with our methodology established in the FY 2017 IPPS/LTCH PPS final rule (81 FR 57277), in order to further ensure that we capture only FFS claims, we are excluding claims with a ‘‘GHOPAID’’ indicator of 1 (which is a field on the MedPAR file that indicates a claim is not an FFS claim and is paid by a Group Health Organization). • Consistent with our methodology established in the FY 2011 IPPS/LTCH PPS final rule (75 FR on the MedPAR file that indicates a claim is not an FFS claim and is paid by a Group Health Organization). • Consistent with our methodology established in the FY 2011 IPPS/LTCH PPS final rule (75 FR 50422 through 50423), we examine the MedPAR file and remove pharmacy charges for anti-hemophilic blood factor (which are paid separately under the IPPS) with an indicator of ‘‘3’’ for blood clotting with a revenue code of ‘‘0636’’ from the covered charge field for the budget neutrality adjustments. We are removing organ acquisition charges, except for cases that group to MS–DRG 018, from the covered charge field for the budget neutrality adjustments because organ acquisition is a pass-through payment not paid under the IPPS. Revenue centers 081X–089X are typically excluded from ratesetting, however, we are not removing revenue center 891 charges from MS–DRG 018 claims during ratesetting because those revenue 891 charges were included in the relative weight calculation for MS–DRG 018, which is consistent with the policy finalized in the FY 2021 final rule (85 FR 58600). We note that a new MedPAR variable for revenue code 891 charges was introduced in April 2020. • For FY 2026, we are co is consistent with the policy finalized in the FY 2021 final rule (85 FR 58600). We note that a new MedPAR variable for revenue code 891 charges was introduced in April 2020. • For FY 2026, we are continuing to remove allogeneic hematopoietic stem cell acquisition charges from the covered charge field for budget neutrality adjustments. As discussed in the FY 2021 IPPS/LTCH PPS final rule, payment for allogeneic hematopoietic stem cell acquisition costs is made on a reasonable cost basis for cost VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00680 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37215 reporting periods beginning on or after October 1, 2020 (85 FR 58835 through 58842). • The participation of hospitals under the BPCI (Bundled Payments for Care Improvement) Advanced model started on October 1, 2018. The BPCI Advanced model, tested under the authority of section 3021 of the Affordable Care Act (codified at section 1115A of the Act), is comprised of a single payment and risk track, which bundles payments for vanced model, tested under the authority of section 3021 of the Affordable Care Act (codified at section 1115A of the Act), is comprised of a single payment and risk track, which bundles payments for multiple services beneficiaries receive during a Clinical Episode. Acute care hospitals may participate in the BPCI Advanced model in one of two capacities: as a model Participant or as a downstream Episode Initiator. Regardless of the capacity in which they participate in the BPCI Advanced model, participating acute care hospitals would continue to receive IPPS payments under section 1886(d) of the Act. Acute care hospitals that are participants also assume financial and quality performance accountability for Clinical Episodes in the form of a reconciliation payment. For additional information on the BPCI Advanced model, we refer readers to the BPCI Advanced web page on the CMS Center for Medicare and Medicaid Innovation’s website at: https://innovation.cms.gov/ initiatives/bpci-advanced/. For FY 2026, consistent with how we treated hospitals that participated in the BPCI Advanced Model in the FY 2021 IPPS/LTCH PPS final rule (85 FR 59029 and 59030), as we proposed, we are including a . For FY 2026, consistent with how we treated hospitals that participated in the BPCI Advanced Model in the FY 2021 IPPS/LTCH PPS final rule (85 FR 59029 and 59030), as we proposed, we are including all applicable data from subsection (d) hospitals participating in the BPCI Advanced model in our IPPS payment modeling and ratesetting calculations. We believe it is appropriate to include all applicable data from the subsection (d) hospitals participating in the BPCI Advanced model in our IPPS payment modeling and ratesetting calculations because these hospitals are still receiving IPPS payments under section 1886(d) of the Act. For the same reasons, as we proposed, we included all applicable data from subsection (d) hospitals participating in the Comprehensive Care for Joint Replacement (CJR) Model in our IPPS payment modeling and ratesetting calculations. • Consistent with our methodology established in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53687 through 53688), we believe that it is appropriate to include adjustments for the Hospital Readmissions Reduction Program and the Hospital VBP Program (established under the Affordable Care Act) within our budget neutrality calculation is appropriate to include adjustments for the Hospital Readmissions Reduction Program and the Hospital VBP Program (established under the Affordable Care Act) within our budget neutrality calculations. Both the hospital readmissions payment adjustment (reduction) and the hospital VBP payment adjustment (redistribution) are applied on a claim-by-claim basis by adjusting, as applicable, the base-operating DRG payment amount for individual subsection (d) hospitals, which affects the overall sum of aggregate payments on each side of the comparison within the budget neutrality calculations. In order to properly determine aggregate payments on each side of the comparison, consistent with the approach we have taken in prior years, for FY 2026, we are applying a proxy based on the prior fiscal year hospital readmissions payment adjustment and a proxy based on the prior fiscal year hospital VBP payment adjustment on each side of the comparison, consistent with the methodology that we adopted in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53687 through 53688). Under this policy for FY 2026, we used the final FY 2025 readmissions adjustment factors from Table 15 of the FY 2025 IPPS/ LTCH PPS n the FY 2013 IPPS/LTCH PPS final rule (77 FR 53687 through 53688). Under this policy for FY 2026, we used the final FY 2025 readmissions adjustment factors from Table 15 of the FY 2025 IPPS/ LTCH PPS final rule and the final FY 2025 hospital VBP adjustment factors from Table 16B of the FY 2025 IPPS/LTCH PPS final rule. These proxy factors are applied on both sides of our comparison of aggregate payments when determining all budget neutrality factors described in section II.A.4. of this Addendum. We refer the reader to section V.K. of the preamble of this final rule for a complete discussion on the Hospital Readmissions Reduction Program and section V.L. of the preamble of this final rule for a complete discussion on the Hospital VBP Program. • The Affordable Care Act also established section 1886(r) of the Act, which modifies the methodology for computing the Medicare DSH payment adjustment beginning in FY 2014. Beginning in FY 2014, IPPS hospitals receiving Medicare DSH payment adjustments receive an empirically justified Medicare DSH payment equal to 25 percent of the amount that would previously have been received under the statutory formula set forth under section 1886(d)(5)(F tments receive an empirically justified Medicare DSH payment equal to 25 percent of the amount that would previously have been received under the statutory formula set forth under section 1886(d)(5)(F) of the Act governing the Medicare DSH payment adjustment. In accordance with section 1886(r)(2) of the Act, the remaining amount, equal to an estimate of 75 percent of what otherwise would have been paid as Medicare DSH payments, reduced to reflect changes in the percentage of individuals who are uninsured and any additional statutory adjustment, is available to make additional payments to Medicare DSH hospitals based on their share of the total amount of uncompensated care reported by Medicare DSH hospitals for a given time period. In order to properly determine aggregate payments on each side of the comparison for budget neutrality, prior to FY 2014, we included estimated Medicare DSH payments on both sides of our comparison of aggregate payments when determining all budget neutrality factors described in section II.A.4. of this Addendum. To do this for FY 2026 (as we did in the last 12 fiscal years), as we proposed, we are including the estimated empirically justified Medicare DSH factors described in section II.A.4. of this Addendum. To do this for FY 2026 (as we did in the last 12 fiscal years), as we proposed, we are including the estimated empirically justified Medicare DSH payments that would be paid in accordance with section 1886(r)(1) of the Act and estimates of the additional uncompensated care payments made to hospitals receiving Medicare DSH payment adjustments as described by section 1886(r)(2) of the Act. That is, we considered estimated empirically justified Medicare DSH payments at 25 percent of what would otherwise have been paid, and also the estimated additional uncompensated care payments for hospitals receiving Medicare DSH payment adjustments on both sides of our comparison of aggregate payments when determining all budget neutrality factors described in section II.A.4. of this Addendum. We also are including the estimated supplemental payments for eligible IHS/ Tribal hospitals and Puerto Rico hospitals on both sides of our comparison of aggregate payments when determining all budget neutrality factors described in section II.A.4. of this Addendum. • When calculating total payments for budget neutrality, to determine total payments for gregate payments when determining all budget neutrality factors described in section II.A.4. of this Addendum. • When calculating total payments for budget neutrality, to determine total payments for SCHs, we model total hospital- specific rate payments and total Federal rate payments and then include whichever one of the total payments is greater. As discussed in section IV.G. of the preamble to this final rule and later in this section, we are continuing to use the FY 2014 finalized methodology under which we take into consideration uncompensated care payments in the comparison of payments under the Federal rate and the hospital-specific rate for SCHs. Therefore, we are including estimated uncompensated care payments in this comparison. As discussed elsewhere in this final rule, section 2202 of the Full-Year Continuing Appropriations and Extensions Act, 2025 extended the MDH program through FY 2025. Therefore, under current law, the MDH program will expire for discharges on or after October 1, 2025. In the proposed rule we stated that if the MDH program were to be extended by law into FY 2026, we would, depending on the timing of such legislation in relation to the final rule, in October 1, 2025. In the proposed rule we stated that if the MDH program were to be extended by law into FY 2026, we would, depending on the timing of such legislation in relation to the final rule, include the total payments for MDHs in the budget neutrality discussed in this section. We also stated that for the final rule, if the MDH program were extended by law into FY 2026, consistent with historical practice for MDHs, when computing payments under the Federal national rate plus 75 percent of the difference between the payments under the Federal national rate and the payments under the updated hospital-specific rate, we would continue to take into consideration uncompensated care payments in the computation of payments under the Federal rate and the hospital-specific rate for MDHs under any such extension. As of the time of the development of this final rule, the MDH program has not been extended by law into FY 2026. Therefore, for purposes of this final rule’s calculations, we computed payments under the Federal national rate (not including 75 percent of the difference between the payments under the Federal national rate and the payments under the updated hospital-specific rate uted payments under the Federal national rate (not including 75 percent of the difference between the payments under the Federal national rate and the payments under the updated hospital-specific rate as applicable) for the total payments for these hospitals in the budget neutrality discussed in this section. and we accounted for uncompensated care payments in the computation of total payments under the Federal rate. • As proposed, we included an adjustment to the standardized amount for those hospitals that are not meaningful EHR users in our modeling of aggregate payments for budget neutrality for FY 2026. Similar to FY 2025, we are including this adjustment based on data on the prior year’s performance. Payments for hospitals would be estimated based on the applicable standardized amount in Tables 1A and 1B for discharges occurring in FY 2026. • In our determination of all budget neutrality factors described in section II.A.4. of this Addendum, we used transfer-adjusted discharges. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00681 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37216 Federal Regist VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00681 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37216 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations We note, in the FY 2023 IPPS/LTCH PPS final rule (87 FR 49414 through 49415), we finalized a change to the ordering of the budget neutrality factors in the calculation so that the RCH Demonstration budget neutrality factor is applied after all wage index and other budget neutrality factors. We refer the reader to the FY 2023 IPPS/LTCH PPS final rule for further discussion. a. Reclassification and Recalibration of MS– DRG Relative Weights Before Cap Section 1886(d)(4)(C)(iii) of the Act specifies that, beginning in FY 1991, the annual DRG reclassification and recalibration of the relative weights must be made in a manner that ensures that aggregate payments to hospitals are not affected. As discussed in section II.D. of the preamble of this final rule, we normalized the recalibrated MS–DRG relative weights by an adjustment factor so that the average case relative weight after recalibration is equal to the average cas the preamble of this final rule, we normalized the recalibrated MS–DRG relative weights by an adjustment factor so that the average case relative weight after recalibration is equal to the average case relative weight prior to recalibration. However, equating the average case relative weight after recalibration to the average case relative weight before recalibration does not necessarily achieve budget neutrality with respect to aggregate payments to hospitals because payments to hospitals are affected by factors other than average case relative weight. Therefore, as we have done in past years, we are making a budget neutrality adjustment to ensure that the requirement of section 1886(d)(4)(C)(iii) of the Act is met. For this FY 2026 final rule, as we proposed, to comply with the requirement that MS–DRG reclassification and recalibration of the relative weights be budget neutral for the standardized amount and the hospital-specific rates, we used FY 2024 discharge data to simulate payments and compared the following: • Aggregate payments using the FY 2025 labor-related share percentages, the FY 2025 relative weights, and the FY 2025 pre- reclassified wage data, and applied the prox ents and compared the following: • Aggregate payments using the FY 2025 labor-related share percentages, the FY 2025 relative weights, and the FY 2025 pre- reclassified wage data, and applied the proxy hospital readmissions payment adjustments and proxy hospital VBP payment adjustments (as described previously); and • Aggregate payments using the FY 2025 labor-related share percentages, the FY 2026 relative weights before applying the 10- percent cap, and the FY 2025 pre-reclassified wage data, and applied the same proxy hospital readmissions payment adjustments and proxy hospital VBP payment adjustments applied previously. Because this payment simulation uses the FY 2026 relative weights (before applying the 10-percent cap), consistent with our policy in section V.I. of the preamble to this final rule, we are applying the adjustor for certain cases that group to MS–DRG 018 in our simulation of these payments. We note that because the simulations of payments for all of the budget neutrality factors discussed in this section also use the FY 2026 relative weights, we are applying the adjustor for certain MS–DRG 018 (Chimeric Antigen Receptor (CAR) T-cell and other immunotherapies) ca ality factors discussed in this section also use the FY 2026 relative weights, we are applying the adjustor for certain MS–DRG 018 (Chimeric Antigen Receptor (CAR) T-cell and other immunotherapies) cases in all simulations of payments for the budget neutrality factors discussed later in this section. We refer the reader to section V.I. of the preamble of this final rule for a complete discussion on the adjustor for certain cases that group to MS–DRG 018 and to section II.D.2.b. of the preamble of this final rule, for a complete discussion of the adjustment to the FY 2026 relative weights to account for certain cases that group to MS–DRG 018. Based on this comparison, we computed a budget neutrality adjustment factor and applied this factor to the standardized amount. As discussed in section IV. of this Addendum, we are applying the MS–DRG reclassification and recalibration budget neutrality factor to the hospital-specific rates that are effective for cost reporting periods beginning on or after October 1, 2025. Please see the table later in this section setting forth each of the FY 2026 budget neutrality factors. b. Budget Neutrality Adjustment for Reclassification and Recalibratio or after October 1, 2025. Please see the table later in this section setting forth each of the FY 2026 budget neutrality factors. b. Budget Neutrality Adjustment for Reclassification and Recalibration of MS– DRG Relative Weights With Cap As discussed in section II.D.2.c. of the preamble of this final rule, in the FY 2023 IPPS/LTCH PPS final rule (87 FR 48897 through 48900), we finalized a permanent 10- percent cap on the reduction in an MS– DRG’s relative weight in a given fiscal year, beginning in FY 2023. As also discussed in section II.D.2.c. of the preamble of this final rule, and consistent with our current methodology for implementing budget neutrality for MS–DRG reclassification and recalibration of the relative weights under section 1886(d)(4)(C)(iii) of the Act, we apply a budget neutrality adjustment to the standardized amount for all hospitals so that this 10-percent cap on relative weight reductions does not increase estimated aggregate Medicare payments beyond the payments that would be made had we never applied this cap. We refer the reader to the FY 2023 IPPS/LTCH PPS final rule for further discussion. To calculate this budget neutrality adjustment factor for FY 202 s that would be made had we never applied this cap. We refer the reader to the FY 2023 IPPS/LTCH PPS final rule for further discussion. To calculate this budget neutrality adjustment factor for FY 2026, we used FY 2024 discharge data to simulate payments and compared the following: • Aggregate payments using the FY 2025 labor-related share percentages, the FY 2026 relative weights before applying the 10- percent cap, and the FY 2025 pre-reclassified wage data, and applied the proxy hospital readmissions payment adjustments and the proxy hospital VBP payment adjustments (as described previously); and • Aggregate payments using the FY 2025 labor-related share percentages, the FY 2026 relative weights after applying the 10-percent cap, and the FY 2025 pre-reclassified wage data, and applied the same proxy FY 2026 hospital readmissions payment adjustments and proxy FY 2026 hospital VBP payment adjustments applied previously. Because this payment simulation uses the FY 2026 relative weights, consistent with our proposal in section V.I. of the preamble to this final rule and our historical policy, and as discussed in the preceding section, we applied the adjustor for certain cases that g , consistent with our proposal in section V.I. of the preamble to this final rule and our historical policy, and as discussed in the preceding section, we applied the adjustor for certain cases that group to MS–DRG 018 in our simulation of these payments. In addition, we applied the MS–DRG reclassification and recalibration budget neutrality adjustment factor before the cap (derived in the first step) to the payment rates that were used to simulate payments for this comparison of aggregate payments from FY 2025 to FY 2026. Based on this comparison, we computed a budget neutrality adjustment factor and applied this factor to the standardized amount. As discussed in section IV. of this Addendum, as we are applying this budget neutrality factor to the hospital-specific rates that are effective for cost reporting periods beginning on or after October 1, 2024. Please see the table later in this section setting forth each of the FY 2026 budget neutrality factors. c. Updated Wage Index—Budget Neutrality Adjustment Section 1886(d)(3)(E)(i) of the Act requires us to update the hospital wage index on an annual basis beginning October 1, 1993. This provision also requires us to make any updat Neutrality Adjustment Section 1886(d)(3)(E)(i) of the Act requires us to update the hospital wage index on an annual basis beginning October 1, 1993. This provision also requires us to make any updates or adjustments to the wage index in a manner that ensures that aggregate payments to hospitals are not affected by the change in the wage index. Section 1886(d)(3)(E)(i) of the Act requires that we implement the wage index adjustment in a budget neutral manner. However, section 1886(d)(3)(E)(ii) of the Act sets the labor- related share at 62 percent for hospitals with a wage index less than or equal to 1.0000, and section 1886(d)(3)(E)(i) of the Act provides that the Secretary shall calculate the budget neutrality adjustment for the adjustments or updates made under that provision as if section 1886(d)(3)(E)(ii) of the Act had not been enacted. In other words, this section of the statute requires that we implement the updates to the wage index in a budget neutral manner, but that our budget neutrality adjustment should not take into account the requirement that we set the labor-related share for hospitals with wage indexes less than or equal to 1.0000 at the more advantageous level dget neutrality adjustment should not take into account the requirement that we set the labor-related share for hospitals with wage indexes less than or equal to 1.0000 at the more advantageous level of 62 percent. Therefore, for purposes of this budget neutrality adjustment, section 1886(d)(3)(E)(i) of the Act prohibits us from taking into account the fact that hospitals with a wage index less than or equal to 1.0000 are paid using a labor-related share of 62 percent. Consistent with current policy, for FY 2026, we are adjusting 100 percent of the wage index factor for occupational mix. We describe the occupational mix adjustment in section III.D. of the preamble of this final rule. To compute a budget neutrality adjustment factor for wage index and labor-related share percentage changes, we used FY 2024 discharge data to simulate payments and compared the following: • Aggregate payments using the FY 2026 relative weights and the FY 2025 pre- reclassified wage indexes, applied the FY 2025 labor-related share of 67.6 percent to all hospitals (regardless of whether the hospital’s wage index was above or below 1.0000), and applied the proxy hospital readmissions payment adjustment an 2025 labor-related share of 67.6 percent to all hospitals (regardless of whether the hospital’s wage index was above or below 1.0000), and applied the proxy hospital readmissions payment adjustment and the proxy hospital VBP payment adjustment (as described previously). • Aggregate payments using the FY 2026 relative weights and the FY 2026 pre- reclassified wage indexes, applied the labor- related share for FY 2026 of 66.0 percent to all hospitals (regardless of whether the hospital’s wage index was above or below 1.0000), and applied the same proxy FY 2026 hospital readmissions payment adjustments and proxy FY 2026 hospital VBP payment adjustments applied previously. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00682 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37217 In addition, we applied the MS–DRG reclassification and recalibration budget neutrality adjustment factor before the cap (derived in the first step) and the 10-percent cap on relative weight reductions adjustment factor (derived from the second step) and recalibration budget neutrality adjustment factor before the cap (derived in the first step) and the 10-percent cap on relative weight reductions adjustment factor (derived from the second step) to the payment rates that were used to simulate payments for this comparison of aggregate payments from FY 2025 to FY 2026. Based on this comparison, we computed a budget neutrality adjustment factor and applied this factor to the standardized amount for changes to the wage index. Please see the table later in this section for a summary of the FY 2026 budget neutrality factors. Comment: A commenter requested that CMS explain how it applies budget neutrality for a reduction to the labor-related share and show the related adjustment to the standardized amount as it does for all budget neutral provisions. The commenter questioned whether CMS first applies budget neutrality as a change to the national labor- related share including hospitals with a wage index less than 1.0 and then applies the 62 percent labor-related share without budget neutrality. The commenter stated that if so, they requested that CMS apply an alternative methodology that ensures that the decrease in payments for high 62 percent labor-related share without budget neutrality. The commenter stated that if so, they requested that CMS apply an alternative methodology that ensures that the decrease in payments for high-wage hospitals requires a positive budget neutrality adjustment to the standardized amount. Response: The calculation of the FY 2026 wage index budget neutrality factor is the same as every fiscal year except for FY 2026 we also include the change of the labor share on each side of the comparison. Specifically, as explained in the previous comparison, we applied the FY 2025 labor-related share of 67.6 percent to all hospitals (regardless of whether the hospital’s wage index was above or below 1.0000) and applied the labor- related share for FY 2026 of 66.0 percent to all hospitals (regardless of whether the hospital’s wage index was above or below 1.0000). We do not assign hospitals a labor share of 62 percent in the calculation of the wage index budget neutrality factor. d. Reclassified Hospitals—Budget Neutrality Adjustment Section 1886(d)(8)(B) of the Act provides that certain rural hospitals are deemed urban. In addition, section 1886(d)(10) of the Act provides for the reclassific Hospitals—Budget Neutrality Adjustment Section 1886(d)(8)(B) of the Act provides that certain rural hospitals are deemed urban. In addition, section 1886(d)(10) of the Act provides for the reclassification of hospitals based on determinations by the MGCRB. Under section 1886(d)(10) of the Act, a hospital may be reclassified for purposes of the wage index. Under section 1886(d)(8)(D) of the Act, the Secretary is required to adjust the standardized amount to ensure that aggregate payments under the IPPS after implementation of the provisions of sections 1886(d)(8)(B) and (C) and 1886(d)(10) of the Act are equal to the aggregate prospective payments that would have been made absent these provisions. We note, in the FY 2024 IPPS/LTCH final rule (88 FR 58971 through 58977), we finalized a policy beginning with FY 2025 to include hospitals with § 412.103 reclassification along with geographically rural hospitals in all rural wage index calculations, and only exclude ‘‘dual reclass’’ hospitals (hospitals with simultaneous § 412.103 and MGCRB reclassifications) in accordance with the hold harmless provision at section 1886(d)(8)(C)(ii) of the Act. Consistent with the previous policy, begin s (hospitals with simultaneous § 412.103 and MGCRB reclassifications) in accordance with the hold harmless provision at section 1886(d)(8)(C)(ii) of the Act. Consistent with the previous policy, beginning with FY 2024, we include the data of all § 412.103 hospitals (including those that have an MGCRB reclassification) in the calculation of ‘‘the wage index for rural areas in the State in which the county is located’’ as referred to in section 1886(d)(8)(C)(iii) of the Act. We refer the reader to the FY 2015 IPPS final rule (79 FR 50371 and 50372) for a complete discussion regarding the requirement of section 1886(d)(8)(C)(iii) of the Act. We further note that the wage index adjustments provided for under section 1886(d)(13) of the Act are not budget neutral. Section 1886(d)(13)(H) of the Act provides that any increase in a wage index under section 1886(d)(13) of the Act shall not be taken into account in applying any budget neutrality adjustment with respect to such index under section 1886(d)(8)(D) of the Act. To calculate the budget neutrality adjustment factor for FY 2026, we used FY 2024 discharge data to simulate payments and compared the following: • Aggregate payments using 1886(d)(8)(D) of the Act. To calculate the budget neutrality adjustment factor for FY 2026, we used FY 2024 discharge data to simulate payments and compared the following: • Aggregate payments using the FY 2026 labor-related share percentage, the FY 2026 relative weights, and the FY 2026 wage data prior to any reclassifications under sections 1886(d)(8)(B) and (C) and 1886(d)(10) of the Act, and applied the proxy hospital readmissions payment adjustments and the proxy hospital VBP payment adjustments (as described previously). • Aggregate payments using the FY 2026 labor-related share percentage, the FY 2026 relative weights, and the FY 2026 wage data after such reclassifications, and applied the same proxy hospital readmissions payment adjustments and the proxy hospital VBP payment adjustments applied previously. We note that the reclassifications applied under the second simulation and comparison are those listed in Table 2 associated with this final rule, which is available via the internet on the CMS website. This table reflects reclassification crosswalks for FY 2026 and applies the policies explained in section III. of the preamble of this final rule. Based on this compariso internet on the CMS website. This table reflects reclassification crosswalks for FY 2026 and applies the policies explained in section III. of the preamble of this final rule. Based on this comparison, we computed a budget neutrality adjustment factor and applied this factor to the standardized amount to ensure that the effects of these provisions are budget neutral, consistent with the statute. Please see the table later in this section for a summary of the FY 2026 budget neutrality factors. The FY 2026 budget neutrality adjustment factor was applied to the standardized amount after removing the effects of the FY 2025 budget neutrality adjustment factor. We note that the FY 2026 budget neutrality adjustment reflects FY 2026 wage index reclassifications approved by the MGCRB or the Administrator at the time of development of this final rule. e. Rural Floor Budget Neutrality Adjustment Under § 412.64(e)(4), we make an adjustment to the wage index to ensure that aggregate payments after implementation of the rural floor under section 4410 of the BBA (Pub. L. 105–33) are equal to the aggregate prospective payments that would have been made in the absence of this provision. Consistent implementation of the rural floor under section 4410 of the BBA (Pub. L. 105–33) are equal to the aggregate prospective payments that would have been made in the absence of this provision. Consistent with section 3141 of the Affordable Care Act and as discussed in section III.G. of the preamble of this final rule and codified at § 412.64(e)(4)(ii), the budget neutrality adjustment for the rural floor is a national adjustment to the wage index. Similar to our calculation in the FY 2015 IPPS/LTCH PPS final rule (79 FR 50369 through 50370), for FY 2026, we calculated a national rural Puerto Rico wage index. Because there are no rural Puerto Rico hospitals with established wage data, our calculation of the FY 2026 rural Puerto Rico wage index is based on the policy adopted in the FY 2008 IPPS final rule with comment period (72 FR 47323). That is, we use the unweighted average of the wage indexes from all CBSAs (urban areas) that are contiguous to (share a border with) the rural counties to compute the rural floor (72 FR 47323; 76 FR 51594). Under the OMB labor market area delineations, all urban Puerto Rico urban areas are contiguous to a rural area. Therefore, based on our existing p o compute the rural floor (72 FR 47323; 76 FR 51594). Under the OMB labor market area delineations, all urban Puerto Rico urban areas are contiguous to a rural area. Therefore, based on our existing policy, the FY 2026 rural Puerto Rico wage index is calculated based on the average of the FY 2026 wage indexes for the following urban areas: Aguadilla, PR (CBSA 10380); Arecibo, PR (CBSA 11640), Guayama, PR (CBSA 25020); Mayaguez, PR (CBSA 32420); Ponce, PR (CBSA 38660); and San Juan-Bayamon- Caguas, PR (CBSA 41980). We note, in the FY 2024 IPPS/LTCH final rule (88 FR 58971–77), we finalized a policy beginning with FY 2025 to include hospitals with § 412.103 reclassification along with geographically rural hospitals in all rural wage index calculations and are only excluding ‘‘dual reclass’’ hospitals (hospitals with simultaneous § 412.103 and MGCRB reclassifications) in accordance with the hold harmless provision at section 1886(d)(8)(C)(ii) of the Act. Consistent with the previous policy, beginning with FY 2024, we include the data of all § 412.103 hospitals (including those that have an MGCRB reclassification) in the calculation of the rural floor. To calculate the national rural f y, beginning with FY 2024, we include the data of all § 412.103 hospitals (including those that have an MGCRB reclassification) in the calculation of the rural floor. To calculate the national rural floor budget neutrality adjustment factor, we used FY 2024 discharge data to simulate payments, and the post-reclassified national wage indexes and compared the following: • National simulated payments without the rural floor. • National simulated payments with the rural floor. Based on this comparison, we determined a national rural floor budget neutrality adjustment factor. The national adjustment was applied to the national wage indexes to produce rural floor budget neutral wage indexes. Please see the table later in this section for a summary of the FY 2026 budget neutrality factors. As further discussed in section III.G.2. of this final rule, we note that section 9831 of the American Rescue Plan Act of 2021 (Pub. L. 117–2), enacted on March 11, 2021 amended section 1886(d)(3)(E)(i) of the Act (42 U.S.C. 1395ww(d)(3)(E)(i)) and added section 1886(d)(3)(E)(iv) of the Act to establish a minimum area wage index (or imputed floor) for hospitals in all-urban States for discharges occurri the Act (42 U.S.C. 1395ww(d)(3)(E)(i)) and added section 1886(d)(3)(E)(iv) of the Act to establish a minimum area wage index (or imputed floor) for hospitals in all-urban States for discharges occurring on or after October 1, 2022. Unlike the imputed floor that was in effect from FY 2005 through FY VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00683 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37218 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 2018, section 1886(d)(3)(E)(iv)(III) of the Act provides that the imputed floor wage index shall not be applied in a budget neutral manner. Specifically, section 9831(b) of Public Law 117–2 amends section 1886(d)(3)(E)(i) of the Act to exclude the imputed floor from the budget neutrality requirement under section 1886(d)(3)(E)(i) of the Act. In the past, we budget neutralized the estimated increase in payments each year resulting from the imputed floor that was in effect from FY 2005 through FY 2018. For FY 2022 and subsequent years, in applying the imputed floor required under section 1886(d)(3)(E)(iv) of the Act, we are ting from the imputed floor that was in effect from FY 2005 through FY 2018. For FY 2022 and subsequent years, in applying the imputed floor required under section 1886(d)(3)(E)(iv) of the Act, we are applying the imputed floor after the application of the rural floor and would apply no reductions to the standardized amount or to the wage index to fund the increase in payments to hospitals in all-urban States resulting from the application of the imputed floor. We refer the reader to section III.G.2. of the preamble of this final rule for a complete discussion regarding the imputed floor. f. Permanent Cap Policy for Wage Index— Budget Neutrality Adjustment As noted previously, in section III.G.6. of the preamble to this final rule, in the FY 2023 IPPS/LTCH PPS final rule (87 FR 49018 through 49021) we finalized a policy to apply a 5-percent cap on any decrease to a hospital’s wage index from its wage index in the prior FY, regardless of the circumstances causing the decline. That is, a hospital’s wage index would not be less than 95 percent of its final wage index for the prior FY. We also finalized the application of this permanent cap policy in a budget neutral manner through an hospital’s wage index would not be less than 95 percent of its final wage index for the prior FY. We also finalized the application of this permanent cap policy in a budget neutral manner through an adjustment to the standardized amount to ensure that estimated aggregate payments under our wage index cap policy for hospitals that will have a decrease in their wage indexes for the upcoming fiscal year of more than 5 percent will equal what estimated aggregate payments would have been without the permanent cap policy. To calculate a wage index cap budget neutrality adjustment factor for FY 2026, we used FY 2024 discharge data to simulate payments and compared the following: • Aggregate payments without the 5- percent cap using the FY 2026 labor-related share percentages, the FY 2026 relative weights, and applied the proxy hospital readmissions payment adjustments and the proxy hospital VBP payment adjustments (as described previously). • Aggregate payments with the 5-percent cap using the FY 2026 labor-related share percentages, the FY 2026 relative weights, and applied the same proxy hospital readmissions payment adjustments and the proxy hospital VBP payment adjustments applied pr he FY 2026 labor-related share percentages, the FY 2026 relative weights, and applied the same proxy hospital readmissions payment adjustments and the proxy hospital VBP payment adjustments applied previously. h. Rural Community Hospital Demonstration Program Adjustment g. Transition for the Discontinuation of the Low Wage Index Hospital Policy Budget Neutrality Factor As discussed in section III.G.5. of the preamble to this final rule, in the FY 2025 IFC we recalculated the FY 2025 IPPS hospital wage index to remove the low wage index hospital policy for FY 2025. We also removed the low wage index budget neutrality factor from the FY 2025 standardized amounts. For FY 2026 and subsequent fiscal years, after considering the D.C. Circuit’s decision in Bridgeport Hosp. v. Becerra, we are finalizing to discontinue the low wage index hospital policy. Because we are discontinuing the low wage index hospital policy for FY 2026 and subsequent fiscal years we would no longer apply the low wage index budget neutrality factor to the standardized amounts. As noted previously, in section III.G.7. of the preamble to this final rule, we are finalizing as proposed to use our authority under sectio index budget neutrality factor to the standardized amounts. As noted previously, in section III.G.7. of the preamble to this final rule, we are finalizing as proposed to use our authority under section 1886(d)(5)(I)(i) of the Act twice. First, to adopt a narrow transitional exception to the calculation of FY 2026 IPPS payments for low wage index hospitals significantly impacted by the discontinuation of the low wage index hospital policy, and then again to do so in a budget neutral manner. To calculate the transition wage index budget neutrality adjustment factor for FY 2026, we used FY 2024 discharge data to simulate payments and compared the following: • Aggregate payments without the transition for the discontinuation of the low wage index hospital policy, the 5-percent cap using the FY 2026 labor-related share percentages, the FY 2026 relative weights, and applied the proxy hospital readmissions payment adjustments and the proxy hospital VBP payment adjustments (as described previously). • Aggregate payments with the transition for the discontinuation of the low wage index hospital policy, the 5-percent cap using the FY 2026 labor-related share percentages, the FY 2026 relative usly). • Aggregate payments with the transition for the discontinuation of the low wage index hospital policy, the 5-percent cap using the FY 2026 labor-related share percentages, the FY 2026 relative weights, and applied the same proxy hospital readmissions payment adjustments and the proxy hospital VBP payment adjustments applied previously. This FY 2026 budget neutrality adjustment factor was applied to the standardized amount. We note, Table 2 associated with this final rule contains the wage index by provider before and after applying 5 percent cap and the transition for the discontinuation of the low wage index hospital policy. In section VI.N. of the preamble of this final rule, we discuss the Rural Community Hospital (RCH) Demonstration program, which was originally authorized for a 5-year period by section 410A of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108–173), and extended for another 5-year period by sections 3123 and 10313 of the Affordable Care Act (Pub. L. 111–148). Subsequently, section 15003 of the 21st Century Cures Act (Pub. L. 114–255), enacted December 13, 2016, amended section 410A of Public Law 108–173 to req of the Affordable Care Act (Pub. L. 111–148). Subsequently, section 15003 of the 21st Century Cures Act (Pub. L. 114–255), enacted December 13, 2016, amended section 410A of Public Law 108–173 to require a 10-year extension period (in place of the 5-year extension required by the Affordable Care Act, as further discussed later in this section). Finally, Division CC, section 128(a) of the Consolidated Appropriations Act of 2021 (Pub. L. 116–260) again amended section 410A to require a 15-year extension period in place of the 10-year period. We make an adjustment to the standardized amount to ensure the effects of the RCH Demonstration program are budget neutral as required under section 410A(c)(2) of Public Law 108–173. We refer readers to section VI.N. of the preamble of this final rule for complete details regarding the Rural Community Hospital Demonstration. With regard to budget neutrality, as mentioned earlier, we make an adjustment to the standardized amount to ensure the effects of the Rural Community Hospital Demonstration are budget neutral, as required under section 410A(c)(2) of Pub. L. 108–173. For FY 2026, based on the latest data for this final rule, the total amount of the Rural Community Hospital Demonstration are budget neutral, as required under section 410A(c)(2) of Pub. L. 108–173. For FY 2026, based on the latest data for this final rule, the total amount that we are applying to make an adjustment to the standardized amounts to ensure the effects of the Rural Community Hospital Demonstration program are budget neutral is $47,586,847. Accordingly, using the most recent data available to account for the estimated costs of the demonstration program, FY 2026, we computed a factor for the Rural Community Hospital Demonstration budget neutrality adjustment that would be applied to the standardized amount. Please see the table later in this section for a summary of the Final FY 2026 budget neutrality factors. We refer readers to section VI.N. of the preamble of this final rule on complete details regarding the calculation of the amount we are applying to make an adjustment to the standardized amounts. The following table is a summary of the FY 2026 budget neutrality factors, as discussed in the previous sections. SUMMARY OF FY 2026 BUDGET NEUTRALITY FACTORS MS-DRG Reclassification and Recalibration Budget Neutrality Factor .................... 6 budget neutrality factors, as discussed in the previous sections. SUMMARY OF FY 2026 BUDGET NEUTRALITY FACTORS MS-DRG Reclassification and Recalibration Budget Neutrality Factor .............................................................................................. Cap Policy MS–DRG Weights Budget Neutrality Factor .................................................................................................................... Wage Index Budget Neutrality Factor ................................................................................................................................................. Reclassification Budget Neutrality Factor ............................................................................................................................................ * Rural Floor Budget Neutrality Factor ................................................................................................................................................. Cap Policy Wage Index Budget Neutrality Factor ............................................................................................................................... Transition for the Discontinuati icy Wage Index Budget Neutrality Factor ............................................................................................................................... Transition for the Discontinuation of the Low Wage Index Hospital Policy Budget Neutrality Factor ................................................ 0.998580 0.999897 1.001531 0.956835 0.973976 0.999397 0.999726 VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00684 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37219 SUMMARY OF FY 2026 BUDGET NEUTRALITY FACTORS—Continued Rural Demonstration Budget Neutrality Factor ................................................................................................................................... 0.999552 * The rural floor budget neutrality factor is applied to the national wage indexes while the rest of the budget neutrality adjustments are applied to the standardized amounts. i. Outlier Payments Section 1886(d)(5)(A) of the Act provides for payments in addition to the basic prospective payments for ‘‘outlier t neutrality adjustments are applied to the standardized amounts. i. Outlier Payments Section 1886(d)(5)(A) of the Act provides for payments in addition to the basic prospective payments for ‘‘outlier’’ cases involving extraordinarily high costs. To qualify for outlier payments, a case must have costs greater than the sum of the prospective payment rate for the MS–DRG, any IME and DSH payments, uncompensated care payments, supplemental payment for eligible IHS/Tribal hospitals and Puerto Rico hospitals, any new technology add-on payments, and the ‘‘outlier threshold’’ or ‘‘fixed-loss’’ amount (a dollar amount by which the costs of a case must exceed payments in order to qualify for an outlier payment). We refer to the sum of the prospective payment rate for the MS–DRG, any IME and DSH payments, uncompensated care payments, supplemental payment for eligible IHS/Tribal hospitals and Puerto Rico hospitals, any new technology add-on payments, and the outlier threshold as the outlier ‘‘fixed-loss cost threshold.’’ To determine whether the costs of a case exceed the fixed-loss cost threshold, a hospital’s CCR is applied to the total covered charges for the case to convert the charges to d-loss cost threshold.’’ To determine whether the costs of a case exceed the fixed-loss cost threshold, a hospital’s CCR is applied to the total covered charges for the case to convert the charges to estimated costs. Payments for eligible cases are then made based on a marginal cost factor, which is a percentage of the estimated costs above the fixed-loss cost threshold. The marginal cost factor for FY 2026 is 80 percent, or 90 percent for burn MS–DRGs 927, 928, 929, 933, 934 and 935. We have used a marginal cost factor of 90 percent since FY 1989 (54 FR 36479 through 36480) for designated burn DRGs as well as a marginal cost factor of 80 percent for all other DRGs since FY 1995 (59 FR 45367). In accordance with section 1886(d)(5)(A)(iv) of the Act, outlier payments for any year are projected to be not less than 5 percent nor more than 6 percent of total operating DRG payments (which does not include IME and DSH payments) plus outlier payments. When setting the outlier threshold, we compute the percent target by dividing the total projected operating outlier payments by the total projected operating DRG payments plus projected operating outlier payments. As discussed in the next se mpute the percent target by dividing the total projected operating outlier payments by the total projected operating DRG payments plus projected operating outlier payments. As discussed in the next section, for FY 2026, we are incorporating an estimate of the impact of outlier reconciliation when setting the outlier threshold. We do not include any other payments such as IME and DSH within the outlier target amount. Therefore, it is not necessary to include Medicare Advantage IME payments in the outlier threshold calculation. Section 1886(d)(3)(B) of the Act requires the Secretary to reduce the average standardized amount by a factor to account for the estimated total of outlier payments as a proportion of total DRG payments. More information on outlier payments may be found on the CMS website at: https:// www.cms.gov/Medicare/Medicare-Fee-for- Service-Payment/AcuteInpatientPPS/ outlier.html. (1) Methodology To Incorporate an Estimate of the Impact of Outlier Reconciliation in the FY 2026 Outlier Fixed-Loss Cost Threshold The regulations in 42 CFR 412.84(i)(4) state that any outlier reconciliation at cost report settlement will be based on operating and capital cost-to-charge ratio 026 Outlier Fixed-Loss Cost Threshold The regulations in 42 CFR 412.84(i)(4) state that any outlier reconciliation at cost report settlement will be based on operating and capital cost-to-charge ratios (CCRs) calculated based on a ratio of costs to charges computed from the relevant cost report and charge data determined at the time the cost report coinciding with the discharge is settled. Instructions for outlier reconciliation are in section 20.1.2.5 of chapter 3 of the Claims Processing Manual (available at https:// www.cms.gov/Regulations-and-Guidance/ Guidance/Manuals/Downloads/ clm104c03.pdf). The original instructions issued in July 2003 1 instruct MACs to identify for CMS any instances where: (1) a hospital’s actual operating CCR for the cost reporting period fluctuates plus or minus 10 percentage points or more compared to the interim operating CCR used to calculate outlier payments when a bill is processed; and (2) the total operating and capital outlier payments for the hospital exceeded $500,000 for that cost reporting period. Cost reports that meet these criteria will have the hospital’s outlier payments reconciled at the time of cost report final settlement if approve ital exceeded $500,000 for that cost reporting period. Cost reports that meet these criteria will have the hospital’s outlier payments reconciled at the time of cost report final settlement if approved by the CMS Central Office. For the remainder of this discussion, we refer to these criteria as the original criteria for outlier reconciliation (or the original criteria). On March 28, 2024, we issued Change Request (CR) 13566, which is available at https://www.cms.gov/medicare/regulations- guidance/transmittals/2024-transmittals/ r12558cp. CR 13566 provides additional instructions to MACs that expand the criteria for identifying cost reports MACs are to refer to CMS for approval of outlier reconciliation. As discussed in the FY 2025 IPPS/LTCH final rule, we anticipate that MACs will identify more cost reports to refer to CMS for outlier reconciliation approval. Specifically, CR 13566 states that for cost reports beginning on or after October 1, 2024, MACs shall identify for CMS any instances where: (1) the actual operating CCR is found to be plus or minus 20 percent or more from the operating CCR used during that time period to make outlier payments, and (2) the total operating and ances where: (1) the actual operating CCR is found to be plus or minus 20 percent or more from the operating CCR used during that time period to make outlier payments, and (2) the total operating and capital outlier payments for the hospital exceeded $500,000 for that cost reporting period. For the remainder of this discussion, we refer to these criteria as the new criteria for outlier reconciliation (or the new criteria). These new criteria for identifying hospital cost reports that MACs identify for outlier reconciliation approval are in addition to the 1 Change Request 2785 (Transmittal A–03–058; July 3, 2003) found at https://www.cms.gov/ regulations-and-guidance/guidance/transmittals/ downloads/a03058.pdf. original criteria for reconciliation described previously. That is, under the new criteria, MACs identify hospitals for outlier reconciliation approval that would not have met the original criteria. In addition, CR 13566 instructs that for cost reporting periods that begin on or after October 1, 2024, a hospital in its first cost reporting period will be referred for approval of reconciliation of outlier payments at the time of cost report final settlement. As such, new hosp after October 1, 2024, a hospital in its first cost reporting period will be referred for approval of reconciliation of outlier payments at the time of cost report final settlement. As such, new hospitals will be referred for outlier reconciliation approval regardless of the change to the operating CCR and no matter the amount of outlier payments during the cost reporting period. If we determine that a hospital’s outlier payments should be reconciled, we reconcile both operating and capital outlier payments. We refer readers to section 20.1.2.5 of Chapter 3 of the Medicare Claims Processing Manual for complete instructions regarding outlier reconciliation, including the update to the outlier reconciliation criteria provided in CR 13566. (Refer to the FY 2025 IPPS/ LTCH PS final rule for additional information (89 FR 69950).) Comment: One commenter objected to the new criteria adopted in CR 13566 without first going through notice and comment rulemaking. Response: We responded to a similar comment in the FY 2025 IPPS/LTCH final rule (89 FR 69949). Similar to our response in that final rule, CMS established the outlier reconciliation regulation under § 412.84(i)(4) effective for dis ilar comment in the FY 2025 IPPS/LTCH final rule (89 FR 69949). Similar to our response in that final rule, CMS established the outlier reconciliation regulation under § 412.84(i)(4) effective for discharges on or after August 8, 2003 which makes all hospital outlier payments subject to reconciliation. CMS has not modified the outlier regulation. The instructions CMS has issued via CR 13566 have set forth an enforcement policy that determines when MACs will identify additional hospitals for reconciliation referral. They do not change the legal standards that govern the hospitals. We explained that we believe the new criteria balance current administrative feasibility with the goal of expanding the scope of cost reports identified for outlier reconciliation approval to increase the accuracy of outlier payments. These new criteria for identifying hospital cost reports that MACs should be referred for outlier reconciliation approval are in addition to the original criteria for reconciliation described previously. We refer the reader to the FY 2025 IPPS/LTCH final rule for a complete discussion regarding the new criteria adopted in CR 13566. In the FY 2020 IPPS/LTCH PPS final rule (84