Comment on CMS-2026-2080-0001

I. STATEMENT OF OPPOSITION The undersigned strongly opposes CMS’s proposed rule codifying the Medicare Drug Price Negotiation Program. The proposed framework exceeds statutory mandates under the Social Security Act, suppresses biopharmaceutical research and development, and risks restricting beneficiary access to novel therapies. II. SUBSTANTIVE LEGAL & CONSTITUTIONAL DEFICIENCIES 1. Statutory Overreach Post-Loper Bright: Under Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), courts independently judge statutory limits without deference to CMS. CMS’s attempt to broadly alter fixed-combination drug definitions and restrict manufacturer administrative remedies under Part 429 exceeds explicit statutory text in Sections 1191–1198. 2. Major Questions Doctrine: Under West Virginia v. EPA, 597 U.S. 697 (2022), agency actions of vast economic significance require explicit congressional authorization. Unilaterally restructuring drug pricing and market dynamics across Part D without clear statutory command violates this doctrine. 3. Arbitrary & Capricious Action (5 U.S.C. § 706): CMS failed to evaluate the cumulative impact on early-stage biotech capital and rare disease R&D pipeline reductions, rendering the proposed rule arbitrary and capricious under the APA. III. PUBLIC HEALTH & INNOVATION HARMS Chilled Innovation: Capping returns on complex therapies will stifle investment in small-molecule drug discovery and clinical trials. Access Barriers: Strict price mandates threaten to induce formulary narrowing, limiting treatment choices for Medicare enrollees. IV. CONCLUSION CMS must withdraw the proposed regulatory expansions and align Part 429 strictly with narrow statutory mandates.