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Public Policy Newsletter Article

Biocom California Submits Comments on Most Favored Nation Rule

  • 2021-01-28T16:00:00.000+0000
  • Author: Laure Fabrega

On January 26, 2021, Biocom California submitted comments in response to the Centers for Medicare & Medicaid Services’ (CMS) interim final rule Most Favored Nation (MFN) Model, which would test aligning Medicare Part B payments for certain drugs and biologics to the lowest price among 22 countries. The model was released on November 20 as an interim final rule with an implementation date of January 1 and a comment period deadline of January 26. Click here to view our comments.

Biocom California strongly opposes this rule (like we have similar models) and joined the Biotechnology Innovation Organization (BIO) in a lawsuit against the rule in December. Click here for our statement on the rule, and here for our statement on the lawsuit. The lawsuit resulted in a preliminary injunction enjoining CMS from implementing the rule. Click here to learn more.

Our comments describe four main reasons why we believe the rule is flawed and should be permanently withdrawn: it misuses the authority granted by the Centers for Medicare and Medicaid Innovation (CMMI), violates the Administrative Procedure Act (APA), would harm the research and development of innovative treatments and therapies, and would ultimately limit patient access to such medicines.

Biocom California will continue to advocate against future price control proposals, whether they are similar to this rule, past international pricing index (IPI) proposals or H.R. 3, the Lower Drug Costs Now Act, legislation that passed in the House of Representatives in December 2019. We will continue to keep you informed of all actions and initiatives that Biocom undertakes on this important matter.