Health and Human Services Department, Centers for Medicare & Medicaid Services
This rule finalizes and codifies the Medicare Drug Price Negotiation Program ("Negotiation Program") and establishes certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program ("Part D Program") as required by the Inflation Reduction Act of 2022. This final rule also finalizes a proposed policy for specific fixed combination drugs that are new formulations.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Parts 423 and 429 [CMS-4215-F] RIN 0938-AV90 ( printed page 72176) AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS). ACTION: Final rule. SUMMARY: This rule finalizes and codifies the Medicare Drug Price Negotiation Program (“Negotiation Program”) and establishes certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program (“Part D Program”) as required by the Inflation Reduction Act of 2022. This final rule also finalizes a proposed policy for specific fixed combination drugs that are new formulations. DATES: Effective date: These regulations are effective on December 5, 2026. Applicability date: These regulations are applicable to the Negotiation Program beginning with respect to initial price applicability year 2029 and to Part D Program coverage beginning January 1, 2029. FOR FURTHER INFORMATION CONTACT: Elisabeth Daniel, IRARebateandNegotiation@cms.hhs.gov , or (667) 290-8793, for issues related to the Medicare Drug Price Negotiation Program. SUPPLEMENTARY INFORMATION: I. Executive Summary and Background A. Executive Summary 1. Purpose This final rule finalizes and codifies policies related to the implementation of certain provisions of the Inflation Reduction Act of 2022 (IRA) ( Pub. L. 117-169 , August 16, 2022) and amendments made by the “Working Families Tax Cut&rdquo…
Citation: 91 FR 72176
