Medicare Drug Price Negotiation Program: Final Guidance for Applicability Year 2028

The Centers for Medicare & Medicaid Services (CMS) issued final guidance that details requirements and parameters for the third cycle of negotiations and the first cycle of renegotiations for the Medicare Drug Price Negotiation Program (“Negotiation Program”), which will occur during 2026 and may result in negotiated Maximum Fair Prices (MFPs) that would be effective beginning in 2028. In accordance with the Inflation Reduction Act of 2022 (IRA), CMS will select up to 15 additional negotiation-eligible drugs covered under Part D and/or payable under Part B for this third cycle of negotiations. CMS may also select drugs negotiated in the first or second cycles of negotiation to be renegotiated, if those selected drugs meet certain eligibility and selection criteria. This final guidance also includes additional clarifications and policies regarding how participating manufacturers will make any agreed upon negotiated MFPs available in 2026, 2027, and 2028.