CMS announced the Most Favored Nation (MFN) Model on November 20, 2020. Information about this Model is available on the MFN Model web page on the CMS Innovation Center.
This model was set to begin January 1, 2021 and end December 31, 2027. Similar to the Comprehensive Care for Joint Replacement (CJR) Model, this is a “mandatory nationwide model that requires participation from Medicare-participating providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs, with certain exceptions.” Specifically MFN participants includes:
- Medicare-participating physicians,
- non-physician practitioners, supplier groups (such as group practices),
- hospital outpatient departments (HOPDs) including 340B covered entities,
- ambulatory surgical centers (ASCs), and
- other providers and suppliers that receive separate Medicare Part B fee-for-service payment for the model’s included drugs, with certain exceptions
This Model focuses on approximately 50 Medicare Part B drugs that accounts for a high percentage of Medicare Part B drug spending. The January 2021 MFN Model Drug HCPCS Codes List and January 2021 MFN Model Drug Pricing File have both been posted on the MFN Model webpage.
Also available on the MFN webpage is an MLN Fact Sheet (ICN MLN2761019 December 2020) titled Billing Information for Most Favored Nation (MFN) Model Drugs.
You will note that earlier I mentioned that this model “was set to begin January 1, 2021.” However, a December 28, 2020 Update available on the MFN webpage indicates that “on December 28, 2020, the U.S. District Court for the Northern District of California issued a preliminary injunction in Biotechnology Innovation Organization v. Azar, No. 3:20-cv-08603, which preliminarily enjoins HHS from implementing the Most Favored Nations Rule.”
On December 31, 2020, the U.S. District Court for the Southern District of New York issued a preliminary injunction in Regeneron Pharmaceuticals v. United States Department of Health and Human Services, No. 7:20-cv-10488, which preliminarily enjoins HHS from applying the Most Favored Nation Rule to Regeneron's drug EYLEA.
Additionally, the public comment period for the MFN Model Interim Final Rule with Comment Period (IFC) does not end until January 26, 2021. If you have concerns I encourage you to submit comments to CMS.