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BioCommunique Article

Courts Block Implementation of Most Favored Nation Rule

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

Over the holidays, Biocom and our industry partners were successful in helping prevent the most-favored nation model interim final rule (IFR) from taking effect on January 1, 2021. The rule would test aligning Medicare Part B payments for certain drugs and biologics to the lowest price among 22 countries. Biocom has consistently opposed this policy and similar proposals. Click here for our statement on the rule. We also joined the Biotechnology Innovation Organization (BIO) in a lawsuit against the rule. Click here for our statement on the lawsuit.

On December 28, 2020, the Northern District of California issued a preliminary injunction enjoining the Department of Health and Human Services (HHS) from implementing the rule pending completion of the notice and comment procedures required by the Administrative Procedures Act (APA) (BIO lawsuit). It built upon a previous order from the District of Maryland, which issued a 14-day nationwide temporary restraining order on December 23, 2020 (PhRMA lawsuit). On January 6, 2021, the Court extended the temporary restraining order through January 20, 2021. On December 30, 2020, the Southern District of New York issued a preliminary injunction also ruling that the APA process had been circumvented (Regeneron lawsuit).

These three consecutive court orders effectively render the IFR unenforceable until the new Administration decides whether it wants to proceed with a formal rulemaking process on this policy. Biocom will continue to advocate against this policy with both the Administration and the new Congress to ensure that innovation isn’t hindered and patients continue to have access to the most innovative therapies and treatments.