CMS begins formal rulemaking for Medicare drug price negotiations under the Inflation Reduction Act

Starting in 2026, CMS shifts from guidance-based administration to formal notice-and-comment rulemaking for the Medicare drug price negotiation program, as required by the IRA after the first three years of implementation. The fourth cycle of drug selection and price negotiations will be governed by the new rulemaking process. The Commonwealth Fund reported in May 2025 that CMS had issued its last round of IRA-required guidance documents, closing the informal implementation period.