Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments; and Appeal Rights for Certain Changes in Patient Status; Corrections and Correcting Amendment

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Medicare & Medicaid Services</SUBAGY> <CFR>42 CFR Parts 401, 405, 410, 411, 414, 423, 424, 425, 427, 428, and 491</CFR> <DEPDOC>[CMS-1807-F2 and CMS-4204-F3]</DEPDOC> <RIN>RINs 0938-AV33 and 0938-AV16</RIN> <SUBJECT>Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments; and Appeal Rights for Certain Changes in Patient Status; Corrections and Correcting Amendment</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rules; corrections and correcting amendment. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This document corrects technical and typographical errors in the final rule that appeared in the December 9, 2024 <E T="04">Federal Register</E> titled “Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments” (hereinafter referred to as the “CY 2025 PFS final rule”). The effective date was January 1, 2025. It also corrects a technical error in the final rule correcting amendment that appeared in the December 30, 2024, <E T="04">Federal Register</E> titled “Medicare Program: Appeal Rights for Certain Changes in Patient Status and Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures; Correcting Amendment”. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> <E T="03">Effective date:</E> The corrections and correcting amendment are effective May 16, 2025. <E T="03">Applicability date:</E> The CY 2025 PFS final rule corrections indicated in this document are applicable beginning January 1, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for any issues not identified below. Please indicate the specific issue in the subject line of the email. <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E> for the following issues: digital mental health treatment (DMHT), certification of therapy plans of care with a physician or NPP order, telehealth, continuous glucose monitoring, and estimated impacts by specialty. Michele Franklin, (410) 786-9226, or <E T="03">RHC@cms.hhs.gov</E> for issues related to RHC payments. Sabrina Ahmed, (410) 786-7499, or <E T="03">SharedSavingsProgram@cms.hhs.gov,</E> for issues related to the Medicare Shared Savings Program (Shared Savings Program) Quality performance standard and quality reporting requirements. Janae James, (410) 786-0801, or <E T="03">SharedSavingsProgram@cms.hhs.gov,</E> for issues related to Shared Savings Program benchmarking methodology. Rachel Radzyner, (410) 786-8215 for issues related to Part B for preventive services, including payment for COVID-19 vaccination. Elisabeth Daniel, (667) 290-8793, for issues related to the Medicare Prescription Drug Inflation Rebate Program. Amy Gruber, (410) 786-1542, for issues related to low titer O+ whole blood transfusion therapy during ground ambulance transport. Trevey Davis, (667) 290-8527, for issues related to Alternative Payment Models (APMs). Aucha Prachanronarong, (410) 786-1879, for inquiries related to the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program. Kristy Nishimoto, (206) 615-2367, for issues related to the Appeal Rights for Certain Changes in Patient Status. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> In FR Doc. 2024-25382 of December 9, 2024, the CY 2025 PFS final rule (89 FR 97710), there were technical and typographical errors that are identified and corrected in this correcting amendment. These corrections are applicable as if they had been included in the CY 2025 PFS final rule, which was effective January 1, 2025. In FR Doc. 2024-31146 of December 30, 2024 (89 FR 106362), in the final rule correcting amendment titled “Medicare Program: Appeal Rights for Certain Changes in Patient Status and Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures; Correcting Amendment” (hereinafter referred to as the Medicare Appeals Correcting Amendment) there is a technical error associated with the amendatory instructions for regulation text that is identified and corrected in this correcting amendment. The Medicare Appeals Correcting Amendment corrected errors in the October 15, 2024 final rule (89 FR 83240). <HD SOURCE="HD1">II. Summary of Errors</HD> <HD SOURCE="HD2">A. Summary of Errors in the CY 2025 Physician Fee Schedule Final Rule</HD> <HD SOURCE="HD3">1. Summary of Errors in the Preamble</HD> On page 97767, we inadvertently made a typographical error in the 2025 Facility Fee for Q3014. On page 97804, we inadvertently mischaracterized a public comment submitted in response to the CY 2025 PFS proposed rule (89 FR 61596). On page 97913, we made a typographical error in the preamble in referring to a section of Pub. 100-02, chapter 15. On page 97917, we inadvertently made a typographical error in response to a public comment. On page 97925, we inadvertently included a reference to the “FD&C Act”. On page 97927, we inadvertently mischaracterized State authority as State “prescriptive authority”. On page 98078, we inadvertently provided an incomplete and incorrect description of the monthly dosing intervals for Sublocade® and Brixadi®. On page 98103, we inadvertently included an incorrect description of the number of measures for performance year 2025 under our proposal to adopt the APP Plus quality measure set and after the CMS Web Interface sunsets, compared to the number of measures reported in performance year 2024. On page 98113, we inadvertently made an error in the description of the heading in the final regulation text at 42 CFR 425.512(a)(7). On page 98118, we inadvertently included an incorrect Quality # for the Controlling High Blood Pressure measure. On pages, 98119, 98121, 98128, 98129, 98130, and 98131 we inadvertently included a former measure title for Quality #: 001. On pages 98128 and 98164, we made typographical errors in table numbers. On page 98217, we inadvertently made typographical errors. On page 98229, we inadvertently made a typographical error in the discussion of the proposed policies for the Medicare Part B Drug Inflation Rebate Program. On page 98244, we inadvertently stated the term for “Billing and payment code FDA approval or licensure date” is defined in the regulations text at § 427.302(c). On page 98248, 98253, 98258, 98263, 98264, 98265, 98266, 98268, 98271, 98296, 98306, 98307, and 98308, we made technical errors in section references. On page 98251, we inadvertently included language indicating we proposed to codify a policy at § 427.303(b)(4) and inadvertently made a typographical error. On pages 98257, 98261, 98262, 98298, and 98301, we inadvertently made technical errors in table references. On page 98262, we inadvertently omitted language from an explanation about “Example 1” in Table 59 due to a drafting error. On page 98266, we inadvertently made technical errors in the discussion of the statutory preclusion of administrative or judicial review on the determination of units. On page 98269, we inadvertently omitted a section reference and made a technical error in the discussion of the reconciliation process. On page 98278, we inadvertently made a typographical error in our comment response regarding the definitions of “line extension” and “new formulation”. On page 98278, we inadvertently made technical errors in terminology in our discussion of the calculation of the total Part D drug rebate amount. On page 98279, we inadvertently made a technical error in terminology to the section heading and text in our discussion of the calculation of the per unit Part D drug rebate amount. On page 98284, we inadvertently made a typographical error in our comment response regarding how CMS will determine whether an NDC-9 represents a new NDC-9 of a Part D rebatable drug. On page 98287, we inadvertently made a technical error in terminology in our discussion of the calculation of the inflation adjusted payment amount and situations in which manufacturers do not report units to the Medicaid Drug Rebate Program. On page 98306, we inadvertently made a typographical error in our discussion of the Preliminary Rebate Report. On page 98308, we inadvertently made a typographical error in our discussion of the multi-step process to provide each manufacturer of a Part D rebatable drug with a reconciled rebate amount on a regular basis. On page 98310, we inadvertently made errors in several section references and a technical error in terminology used in our discussion of data elements included in Rebate Reports. On page 98311, we inadvertently made a typographical error in our discussion of Rebate Reports for the applicable periods beginning October 1, 2022, and October 1, 2023. On page 98312, we inadvertently made a typographical error in our discussion of severability. On page 98332, we inadvertently made a typographical error. On pages 98358, 98366, 98367, 98368, 98369, and 98370, we inadvertently included a former measure title for Quality #001. On pages 98369, 98370, and 98371, we inadvertently omitted previously finalized and available measure collection types. On page 98408, in Table 75, we inadvertently made a typographical error ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 55k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━