Patient and Public Involvement in the Medicare Drug Price Negotiation Program

Abstract: The Inflation Reduction Act gave the Centers for Medicare and Medicaid Services (CMS) the authority to negotiate prices for some prescription drugs for the first time in the program’s history. In 2023, CMS issued guidance on the prescription drug price negotiation program and began its first negotiations. The guidance leaves many steps in the process and program details unspecified. While CMS recognized the importance of patient and public involvement, the first implementation of patient input through listening sessions has been criticized and does not demonstrate serious engagement with patient perspectives.
This presentation will analyze regulations and statutory requirements that CMS must follow alongside the normative considerations that should inform the development of a more robust patient and public involvement process. We will present a stepped process of involvement that moves from broadly collecting information and perspectives to focused, public deliberation. For each involvement step, we will analyze two bioethical justifications for involvement. The first is an empirical, instrumental claim that involvement makes decisions better; the second is a normative claim that proper involvement makes decisions fair and legitimate, so necessary for a politically and ethically acceptable decision. The proposed process adheres to regulatory and statutory requirements, while realizing ethical norms of involvement. The drug price negotiation program is still in its infancy, with many gaps in its procedures to fill or revise, so there is an opportunity for bioethics to inform and support regulatory decision making.

Helen Mooney – Program on Regulation, Therapeutics, and Law (PORTAL) – Brigham and Women's Hospital; Aaron Kesselheim, MD, JD, MPH – 617-278-0930 – Brigham and Women's Hospital