CMS finalized the Medicare Drug Price Negotiation Program rule (CMS-4215-F), preserving a temporary price floor for eligible Small Biotech Drugs in initial price applicability (IPAY) years 2029 and 2030. CMS also codified how fixed-dose combinations and new formulations that share active ingredients, moieties, or antigens with existing products are treated under QSSD eligibility and negotiation timing. For smaller biopharma, the most consequential change is CMS’s decision to aggregate certain route-of-administration “conversions” (for example, intravenous-to-subcutaneous biologic shifts) into a single negotiated maximum fair price tied to the originating qualifying single source drug. Industry groups had urged CMS to treat such changes as distinct products, aligned with FDA application boundaries. Overall, the final rule prioritizes negotiation program integrity over innovation-and-access arguments raised during the comment period, while maintaining the small-biotech floor intended to reduce downside pricing risk during early implementation years.