Last week, CMS released draft guidance that describes how the agency will implement the Medicare Drug Price Negotiation Program for initial price applicability year 2028 including the renegotiation process, for maximum fair price (MFP) - whether negotiated or renegotiated - to take effect Jan. 1, 2028.

This draft guidance also sets forth additional policies regarding effectuation of the MFP in 2026, 2027 and 2028, and specifies the requirements that will be applicable to manufacturers of drugs that are selected for negotiation and renegotiation.

Please send any comments to this draft guidance to IRARebateandNegotiation@cms.hhs.gov with the subject line “Medicare Drug Price Negotiation Program Draft Guidance.” Comments must be received by 11:59 PM Pacific Time (PT) on June 26, 2025 to be considered.

• Press Release:  https://www.cms.gov/newsroom/press-releases/cms-releases-draft-guidance-third-cycle-medicare-drug-price-negotiation-program-lower-drug-prices
  
• Fact Sheet:  https://www.cms.gov/files/document/ipay-2028-draft-guidance-fact-sheet.pdf
  
• IPAY 2028 Draft Guidance:  https://www.cms.gov/files/document/ipay-2028-draft-guidance.pdf

You may direct any questions about the program to the CMS Region 7 Office.