Comment on CMS-2026-2080-0001

Summary: The Plasma Protein Therapeutics Association (PPTA) supports CMS's proposal to distinguish between products where a plasma-derived protein is the active pharmaceutical ingredient and those where it serves only as an adjuvant or excipient. They argue that this distinction aligns with statutory intent and FDA regulations, ensuring that only genuine plasma-derived therapies are excluded from the Medicare Drug Price Negotiation Program.