CMS Releases Draft Guidance for Third Cycle of Medicare Drug Price Negotiation Program

The Centers for Medicare & Medicaid Services (CMS) is issuing draft guidance for public comment on the third cycle of negotiations under the Medicare Drug Price Negotiation Program (Negotiation Program). The draft guidance includes new policies to incorporate drugs payable under Part B into the Negotiation Program for the first time and solicits comments on how to facilitate access to any negotiated maximum fair price (MFP) for drugs payable under Part B. Additionally, the draft guidance outlines how CMS would choose, for renegotiation, certain drugs that were negotiated for initial price applicability in years 2026 or 2027.

CMS will announce up to 15 drugs covered under Part D or payable under Part B for potential negotiation in the third cycle of negotiations by February 1, 2026. This third cycle of negotiations will occur during 2026, and negotiated MFPs will be effective starting January 1, 2028. Additionally, CMS will publish the selected drug list for negotiation for the initial price applicability year 2028 by February 1, 2026. At the same time, CMS will announce any drugs chosen for the first cycle of renegotiation, with renegotiated prices also taking effect on January 1, 2028. Public comment is requested by 11:59 p.m. PT, June 26, 2025. CMS is also publishing a related information collection request on the Small Biotech Exception request for a Biosimilar Delay, and voluntary submission of information for the Identification and Selection of Renegotiation-Eligible Drugs for a 60-day comment period through July 14, 2025.