Preliminary Injunction Follows ACCC Lawsuit Challenging Legality of HHS Most Favored Nation

Washington, D.C. (December 30, 2020)—On December 28, 2020, a second federal court blocked implementation of the Most Favored Nation (MFN) Model.  This order, issued in response to a suit filed by the California Life Sciences Association (CLSA), the Biotechnology Innovation Organization (BIO), and other organizations, prevents the Centers for Medicare & Medicaid Services (CMS) from implementing the MFN Model until CMS completes the rulemaking process, which requires the agency to solicit comments on a proposal and respond to those comments before implementing a new payment model.

This ruling builds off the recent decision on December 23, 2020 in which a federal court in Maryland issued a temporary restraining order (TRO) blocking CMS from implementing the rule as part of a lawsuit filed on December 4, 2020 by the Association of Community Cancer Centers (ACCC), Pharmaceutical Research and Manufacturers of America (PhRMA), Global Colon Cancer Association (GCCA) and National Infusion Center Association (NICA). This lawsuit was filed asserting that the MFN Interim Final Rule exceeds the statutory authority provided to CMS, raises serious constitutional questions, and improperly fails to follow required rulemaking procedures.

Originally scheduled to go into effect January 1, 2021, these two rulings have put CMS implementation of the new model linking tying drug payments to foreign rates on hold. Several factors may impact the final outcomes of the MFN model, its implementation date or whether it will move forward at all. The decision of CMS to appeal these recent legal decisions and a change in administration coming on January 20, 2021 will impact if CMS will proceed with the MFN Model at all or to continue to defend it against litigation.

The case by ACCC and several other suits challenging the model continue to move forward. We will provide updates on our case and the other challenges over the coming weeks.

For more information from ACCC on this ongoing litigation, please review the Most Favored Nation Drug Pricing Model on our website: https://www.accc-cancer.org/home/advocate/most-favored-nation-drug-pricing-model

The Association of Community Cancer Centers (ACCC) is the leading education and advocacy organization for the cancer care community. Founded in 1974, ACCC is a powerful network of 28,000 multidisciplinary practitioners from 2,100 hospitals and practices nationwide. As advances in cancer screening and diagnosis, treatment options, and care delivery models continue to evolve—so has ACCC—adapting its resources to meet the changing needs of the entire oncology care team. For more information, visit accc-cancer.org or call 301.984.9496. Follow us on Facebook, Twitter, and LinkedIn; read our blog, ACCCBuzz; and tune in to our podcast, CANCER BUZZ.