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Drug makers face permanent Medicare negotiation rules in 2029
CMS would lock the current framework into regulation as it carries out the Inflation Reduction Act. That matters for how selected drugs are negotiated, reviewed and kept in compliance.
Federal Medicare officials want to move the drug-price negotiation program onto firmer legal ground. In Washington, CMS is proposing to turn the program from guidance into binding regulation, giving drug makers, plans and the agency a more durable set of rules to follow as the system heads toward 2029.
The proposal is tied to the Inflation Reduction Act of 2022 and would establish new policies for both the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Benefit Program.
Where the rules would go
CMS says it would add a new Part 429 to title 42, Chapter IV of the Code of Federal Regulations. It would also revise Part 423, which covers the Medicare Prescription Drug Benefit Program.
The agency says it wants to codify, with limited modification, policies that are now set out in guidance. That would put the negotiation program, renegotiation, publication and compliance rules into the federal rulebook instead of leaving them scattered across agency documents.
What the change means for Medicare
For people on Medicare, the biggest effect is not a new benefit card or a new enrollment step. It is the machinery behind drug pricing. A regulation carries more weight than guidance and is harder to change without going through the formal rulemaking process.
That matters for the companies that make selected drugs, for Part D plans that help cover them, and for CMS itself. A single set of written rules could make it clearer how negotiations are supposed to work and what obligations follow once a drug is selected.
When it would take effect
CMS says it expects to publish a final version in fall 2026 after reviewing public comments. The final requirements would then apply starting with initial price applicability year, or IPAY, 2029, and for the years that follow.
The agency also says the provisions would apply in 2029 to drugs selected for the earlier initial price applicability years of 2026, 2027 and 2028. That means the rules are being written now with the next stage of the program in mind.