Drug prices & Part D
CMS Proposes Making Medicare Drug Price Negotiations a Permanent Federal Regulation
A proposed rule published June 16, 2026, would replace the program's expiring guidance authority with binding regulation covering negotiations starting with the 2029 price year.
By the Goodsurance editorial teamJuly 8, 2026
The Centers for Medicare and Medicaid Services published proposed rule CMS-4215-P in the Federal Register on June 16, 2026, to establish a durable regulatory framework for Medicare's drug price negotiation program. The proposal covers initial price applicability year 2029 and every cycle thereafter.
The Inflation Reduction Act of 2022 created the negotiation program and authorized CMS to operate the first three cycles, with prices taking effect in 2026, 2027, and 2028, through administrative guidance rather than formal rulemaking. That authority expires after the 2028 cycle.
CMS wants to lock drug price negotiations into permanent federal rules. The public has until August 17, 2026, to weigh in.
CMS-4215-P would codify each phase of the program: drug selection and ranking, manufacturer agreement requirements, the offer-and-counteroffer process, renegotiation criteria, and publication of maximum fair prices.
The third negotiation cycle, covering 15 drugs with prices effective January 1, 2028, is currently under way. All 15 manufacturers chose to participate. The first cycle set prices on 10 drugs starting in 2026, and the second on 15 drugs starting in 2027. The third cycle is the first to include Part B drugs, which are given in a doctor's office or clinic.
The comment period closes August 17, 2026. Comments may be submitted at regulations.gov. CMS expects to finalize the rule in fall 2026 in time to govern the 2029 cycle.
In plain words
Medicare can negotiate prices on some expensive drugs because of a 2022 law. Until now the rules for how this works came from CMS instructions, not formal regulations. That was what the law allowed for the first three rounds of talks, which cover prices through 2028. Now CMS wants to make those rules permanent. It published a proposed regulation in June 2026. The new rule would explain how CMS picks drugs, how talks with drug companies work, and how final prices are set. It would apply starting in 2029. Anyone can send comments to the government until August 17, 2026.
Understand the basics first
Source: Federal Register
Read at the source →