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

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.

The commenter, writing as a patient, supports the Medicare Drug Price Negotiation Program but emphasizes that CMS must balance lower costs with ensuring medication availability, supply-chain transparency, and patient safety. They urge the agency to consider factors like shortages and treatment delays when evaluating the effects of negotiated prices.

Treshia Ann McDonald supports CMS's goal of increasing transparency and fiscal integrity in Medicaid payments to states. However, she urges CMS to ensure that these changes do not create access barriers for beneficiaries and requests that implementation be gradual and monitored closely.