CAHC provided comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed rule entitled Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program (CMS-4215-P).
CAHC has commented extensively on CMS’s implementation of the Medicare Drug Price Negotiation Program since its inception. As CMS transitions from implementing the program through guidance to establishing permanent regulations for initial price applicability year 2029 and subsequent years, it is particularly important that CMS establish clear statutory guardrails, preserve incentives for continued pharmaceutical innovation, and provide sufficient transparency for beneficiaries and other stakeholders to understand how the government makes decisions that have significant consequences for patient access and the health care market.
CAHC’s principal concern with the proposed rule is that it would expand the definition of a qualifying single-source drug beyond its statutory footing while leaving significant agency determinations unexplained.
CAHC offered the following recommendations:
- Withdraw the proposed expansion of the qualifying single source drug definition for certain fixed combination products and new formulations.
- Revise the broader qualifying single-source drug policy to recognize meaningful distinctions among separately approved products.
- Implement the expanded orphan drug exclusion in a manner that protects continued investment in rare disease treatments.
- Strengthen transparency throughout drug selection, negotiation, and public stakeholder engagement.