Progress or Regress...Does CMS’ Maximum Fair Price Negotiation Align With Patient-Centered Evidence Assessment in Healthcare Decision-Making?

In August 2022, Congress passed the Inflation Reduction Act (IRA), which gives the Centers for Medicare & Medicaid Services (CMS) the authority to set prices for select medicines in the Medicare Part B and D program. CMS is required by statute to consider factors relative to the selected drug’s effectiveness compared to therapeutic alternatives and the cost of producing the medicine to the biopharmaceutical manufacturer. As a result of including and, seemingly prioritizing, costs factors that drive towards contradictory approaches to price setting, as well as a statutory ceiling on how high prices may be set, both the statute and CMS’ guidance document leave open the question of whether the Maximum Fair Price (MFP) process will actually represent true health technology assessment (HTA), and whether it will help or hinder the goals of patient-centered HTA in the U.S.

In this panel session, we will discuss how the CMS drug price setting process contrasts with a patient-centered HTA process. The panelists will discuss how the IRA includes (or lacks) patient-centeredness in their (currently only outlined) deliberative process by focusing on key elements, including: evidence review process, meaningful engagement with diverse patients, selected factors considered in the negotiation, data collection, transparency, and accountability. They will consider and aim to answer three key questions: 1) When looking at “best practices” for patient-centered evidence assessment, and experience inside and outside the U.S., how do the standards and processes established for MFP decision-making by CMS for the IRA compare? 2) What does ex-U.S. experience tell us about the inherent challenges and limitations in use of HTA in public policy? And 3) Is there a way to be truly patient-centric in a centralized price setting framework?