ACCC Lawsuit Challenging Legality of HHS Most Favored Nation Placed on Hold

Washington, D.C. (January 15, 2021)—On January 13, 2021, a federal court agreed to a stay in the lawsuit that the Association of Cancer Care Centers (ACCC) filed in partnership with the Pharmaceutical Research and Manufacturers of America (PhRMA), the Global Colon Cancer Association (GCCA) and National Infusion Center Association (NICA) against the Centers for Medicare & Medicaid Services (CMS). The lawsuit, filed on December 4, 2020 asserted that the Most Favored Nation (MFN) Interim Final Rule exceeded the statutory authority provided to CMS and improperly failed to follow required rulemaking procedures.

ACCC’s challenge to the MFN Model has been placed on hold, by agreement with the government, because the government has decided to not appeal the preliminary injunction in the BIO/CLSA litigation that prevents CMS from implementing the model.

The agreement stated that CMS cannot implement the MFN Model until it considers public comments and issues a final rule, and if CMS issues a final rule, it must provide at least 60 days notice between publication of the rule and any change in payment rates. If CMS does issue a final rule, then ACCC and the other parties can resume their suits challenging the rule.

The public can now post comments on the Most Favored Nation Rule Document webpage. Click the ‘Comment Now” button in the upper right-hand side of the screen. If you have questions, please direct them to MFN@cms.hhs.gov. The public comment period on the MFN Model interim final rule ends on Tuesday, January 26, 2021.

ACCC will file comments opposing the Model before the deadline, and we encourage members to comment as well. After CMS reviews the public comments, it will need to decide if it wants to move forward with the Model. ACCC believes that the incoming Biden Administration will carefully review all regulations from the end of the Trump Administration, and it can decide to postpone or revise those regulations.

ACCC is hopeful that our comments, along with those from many other stakeholders, will persuade the incoming Biden Administration that it should not move forward with the rule.

For more information from ACCC on this litigation, please review the Most Favored Nation Drug Pricing Model on the ACCC website.

If you have any questions about our statement or would like to discuss in further detail, please contact Kristin M. Ferguson, ACCC Senior Director, Cancer Care Delivery & Health Policy, at 301.798.6463 ext. 213 or kferguson@accc-cancer.org