CMS, HHS Propose Rule to Codify Medicare Drug Price Negotiation Program
HHS and CMS issued a proposed rule to codify the Medicare Drug Price Negotiation Program, largely formalizing existing guidance. The rule includes new provisions, such as clarifications for new drug formulations. The proposal is now open for public comment.
The Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) released a proposed rule on June 12 to codify the Medicare Drug Price Negotiation Program into formal regulation. The proposal aims to formalize existing guidance for the program, which was established to negotiate lower prices for certain high-cost Medicare drugs.
The rule would largely codify the current framework but also introduces some new provisions and modifications. A key clarification in the proposed rule addresses the handling of new formulations of drugs. The initiative is a significant step in implementing the drug pricing negotiation authority granted by recent federal legislation.
The agencies are now seeking public comment on the proposal as part of the formal rulemaking process. If finalized, the regulation would provide a more stable legal foundation for the ongoing drug price negotiations between Medicare and pharmaceutical manufacturers.