Manufacturer Effectuation of MFP Draft Guidance for 2028 Medicare Drug Price Negotiation

Administration Share Medicare Drug Price Negotiation Program: Draft Guidance for Manufacturer Effectuation of the Maximum Fair Price in 2028 On July 16, 2026, the Centers for Medicare & Medicaid Services (CMS) issued program guidance that provides interested parties with detailed processes and requirements for manufacturer effectuation of the maximum fair price (MFP) in 2028. Sections 11001 and 11002 of the Inflation Reduction Act of 2022 (IRA) (P.L. 117-169) establish the Medicare Drug Price Negotiation Program (hereinafter the “Negotiation Program”) to negotiate MFPs for certain high expenditure, single source drugs and biological products. The program’s requirements are described in sections 1191 through 1198 of the Social Security Act (hereinafter “the Act”), as added by sections 11001 and 11002 of the IRA and subsequently amended. This draft guidance sets forth policies regarding manufacturer effectuation of the MFP in 2028 for selected drugs payable under Part B and/or covered under Part D. The Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028 (“final guidance for initial price applicability year 2028”) established the MFP effectuation policies for 2026, 2027, and 2028 for selected drugs covered under Part D and such policies currently remain in effect. When issued later this year, the final guidance will supersede for 2028 only the sections of the final guidance for initial price applicability year 2028 with respect to MFP effectuation for selected drugs covered under Part D that are included and updated herein. Additionally, this draft guidance describes procedures that may apply to drug manufacturers, Medicare Part D plan sponsors (both Prescription Drug Plans [PDPs] and Medicare Advantage Prescription Drug [MA-PD] Plans), Medicare Advantage (MA) organizations, pharmacies, mail order services, and other entities that dispense drugs covered under Medicare Part D (hereinafter “dispensing entities”), in addition to hospitals, physicians, and other providers of services and suppliers that furnish or administer drugs payable under Medicare Part B (hereinafter “Part B providers”). There will be a 60-day public comment period on the draft guidance. CMS encourages all interested parties to submit comments so that CMS can consider them as we develop the final guidance for release this fall. Comments can be submitted via email to IRARebateandNegotiation@cms.hhs.gov with the subject line, “Medicare Drug Price Negotiation Program Draft Guidance.” Comments received by 11:59 PM Pacific Time (PT) on September 18, 2026 will be considered. Topics that are not relevant to MFP effectuation in 2028 are not addressed in this draft guidance. CMS refers readers to its Negotiation Program website for information on MFP effectuation policies in 2026 and 2027, Negotiation Program implementation for initial price applicability year 2028, and the proposed rule for Negotiation Program policies for initial price applicability year 2029 and subsequent years. Overview of MFP Effectuation for Selected Drugs Payable under Part B Consistent with section 1193(a) of the Act, this draft guidance describes for the first time how Primary Manufacturers of drugs selected for negotiation or renegotiation for initial price applicability year 2028, that reached an agreement on an MFP through negotiation or renegotiation, as applicable, must provide access to the agreed-upon MFP in 2028 to Part B providers for MFP-eligible individuals who are administered or furnished that selected drug during a price applicability period pursuant to the Medicare Drug Price Negotiation Program Agreement (hereinafter also referred to as an “Agreement”). A Primary Manufacturer must provide access to the MFP in one of two ways: (1) prospectively ensuring that the price paid by the dispensing entity and/or Part B provider when acquiring the drug is no greater than the MFP; or (2) retrospectively providing reimbursement for the difference between the dispensing entity and/or Part B provider’s acquisition cost and the MFP. CMS has engaged a Medicare Transaction Facilitator (MTF) contractor for the Negotiation Program to facilitate the exchange of information between Primary Manufacturers and dispensing entities and/or Part B providers (as applicable). The MTF Data Module (MTF DM) supports the verification that the selected drug was dispensed, administered, or furnished to an MFP-eligible individual. CMS has also engaged a separate MTF contractor to support the MTF Payment Module (MTF PM). The MTF PM facilitates payments from Primary Manufacturers and complements MTF DM data-related activities. This draft guidance describes adjustments to MTF operations to address structural differences (e.g., Medicare billing methodologies) between selected drugs covered under Part D and/or