Medicare drug price negotiation rules become federal regulation Dec. 5

The Centers for Medicare & Medicaid Services' drug price negotiation program, run until now under agency guidance, takes effect as federal regulation Dec. 5 under a final rule published Nov. 9. The rule's Part D coverage provisions take effect Jan. 1, 2029.

The Inflation Reduction Act of 2022 created the program, which lets Medicare negotiate prices for certain high-cost drugs that have no generic competition. Medicare picked 10 Part D drugs for the first round, with negotiated prices taking effect in 2026, then 15 drugs for 2027 and 15 for 2028.

Starting with 2029, CMS can select up to 20 drugs a year. Existing guidance will keep governing the drugs chosen for 2026 through 2028. Part D plans must cover whichever drugs are chosen at the negotiated price.

More than 121,000 Alaskans were on Medicare as of September 2025, according to the Alaska Commission on Aging's Senior Snapshot.

CMS called the rule "a permanent framework for negotiating prices of high-cost drugs" in a Nov. 5 release. It also sets a temporary price floor for small biotech drugs in 2029 and 2030.

The agency received about 11,330 comment letters on the proposal. Many supported the program, some opposed it outright and many raised concerns it could stifle drug innovation. CMS said the program will make drugs more affordable without restricting innovation.

The next list of negotiated drugs is due Feb. 1, 2027. CMS waived the usual 60-day waiting period before a new rule takes effect, saying it needs about seven weeks before that deadline to review biosimilar makers' requests to delay a drug's selection.