Medicare Program: Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

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.

Research!America, a nonprofit alliance advocating for science and innovation, opposes the proposal to treat fixed-dose combination products as single-source drugs. They argue that such a policy could discourage research into making treatments more convenient and accessible for patients, such as moving from intravenous to subcutaneous injections.

Robert Sepulveda, a public health student at San Diego State University, supports the proposed rule to implement the Medicare Drug Price Negotiation program. He argues that improving prescription drug affordability is essential for patients with chronic diseases to maintain access to necessary medications and improve their quality of life.

Valentina Hansen, a healthcare professional and former law enforcement officer, supports the proposed rule for the Medicare Drug Price Negotiation Program. She recommends specific improvements, including maintaining transparency for the top 50 ranked drugs, requiring clinical data for fixed combination drug exceptions, and establishing an audit framework for biosimilar delay requests.

A registered nurse and student nurse practitioner supports the rule to negotiate Medicare drug prices to improve affordability. The commenter also recommends that CMS study mechanisms to reinvest the resulting savings into public research for rare diseases.

The commenter opposes the proposed rule codifying the Medicare Drug Price Negotiation Program, arguing that it exceeds statutory authority and violates the Major Questions Doctrine. They claim the rule will stifle biopharmaceutical research and development while restricting patient access to novel therapies.