Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

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-P] RIN 0938-AV90 ( printed page 36236) AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS). ACTION: Proposed rule. SUMMARY: This proposed rule would codify the Medicare Drug Price Negotiation Program (“Negotiation Program”) and would establish certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program as required by the Inflation Reduction Act of 2022. This proposed rule would also propose a modification to the fixed combination drug policy. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 17, 2026. ADDRESSES: In commenting, please refer to file code CMS-4215-P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov/​docket/​CMS-2026-CMS-2026-2080 . Follow the “Submit a comment” instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4215-P, P.O. Box 8013, Baltimore, MD 21244-8013. Please allow sufficient time for mailed comments to …