CMS moved to close a Medicare “fixed combination” drug loophole that the agency said can enable manufacturers to extend commercially protected product timelines under the Inflation Reduction Act’s drug price negotiation framework. The proposed rule would codify aspects of the Medicare Drug Price Negotiation Program, update negotiation and benefit policies, and adjust how fixed-combination drugs are handled—an area that could affect lifecycle management strategies for large biotech products. Separate reporting also indicates CMS is preparing future price-negotiation talks that could eventually sweep in newer subcutaneous formulations of blockbuster immunotherapies, including Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, depending on biosimilar entry and selection rules.