CMS finalized the Medicare Drug Price Negotiation Program rule (CMS-4215-F), including policy updates relevant to smaller biopharma. The final rule clarifies how CMS treats certain fixed-dose combinations and new formulations when products share an active ingredient, moiety, or antigen, aggregating them for negotiation eligibility and applying a single Maximum Fair Price (MFP). CMS also implements the statutory Temporary Floor for Small Biotech Drugs, restricting counteroffers for MFP below a defined floor for eligible drugs during initial price applicability years 2029 and 2030. The rule’s direction indicates CMS prioritized program integrity and “anti-product hopping” considerations over industry requests to defer to the FDA’s application-based framework for distinguishing distinct products by route or formulation.