Public Comment Period on Proposed Permanent Medicare Drug Negotiation Rule Closes Today

The Centers for Medicare and Medicaid Services opened a 60-day public comment period on June 16, 2026, for proposed rule CMS-4215-P, which would permanently codify how Medicare conducts drug price negotiations. That comment window closes today, August 17, 2026, at 5 p.m. Eastern.

The proposal would move the program from its current guidance-based framework into formal federal regulation, covering every phase of the process: how CMS selects and ranks drugs for negotiation, the structure of the offer-and-counteroffer exchange with manufacturers, how maximum fair prices are set and published, criteria for renegotiation, and manufacturer compliance obligations. The codified rules would govern negotiations beginning with the 2029 initial price applicability year and all subsequent cycles.

Comments came from patient advocacy organizations, pharmaceutical manufacturers, pharmacy benefit managers, insurers, and members of the public. CMS will review those submissions and plans to publish a final rule in Fall 2026.

The Medicare drug price negotiation program has already completed two cycles. The first cycle covered 10 Part D drugs whose negotiated prices took effect January 1, 2026. The second cycle covered 15 additional Part D drugs at prices taking effect January 1, 2027. The third cycle, which for the first time includes drugs administered in physician offices and clinics and covered under Part B, is in active negotiation with final prices expected by November 2026.

By anchoring the program in regulation rather than guidance, CMS aims to give manufacturers and plan sponsors greater predictability about the rules in future years. Medicare beneficiaries are not required to take any action related to this deadline. The outcome will shape which drugs enter future negotiation cycles and how prices are determined, with direct implications for out-of-pocket drug costs beginning in 2029.