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Most Favored Nation Drug Pricing Model

WASHINGTON, D.C. (December 4, 2020) – Today, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Association of Community Cancer Centers (ACCC), the Global Colon Cancer Association (GCCA) and National Infusion Center Association (NICA) filed a lawsuit in the U.S. District Court for the District of Maryland asserting that the Most Favored Nation (MFN) Interim Final Rule exceeds the statutory authority provided to the Centers for Medicare and Medicaid Services, raises serious constitutional questions and improperly fails to follow required rulemaking procedures.

UPDATE: On January 13, 2021, a federal court agreed to a stay in the lawsuit filed by the Association of Community Cancer Centers (ACCC) and other organizations. 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 public comment period on the MFN Model interim final rule ends on Tuesday, January 26, 2021.

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Christian Downs Headshotbegin-quote"This Interim Final Rule is impractical, unworkable and does not address the reforms necessary to protect Medicare beneficiaries and strengthen the cancer delivery infrastructure. It will have a disproportionate impact on smaller hospitals and practices which are already struggling due to the COVID-19 pandemic and force them to curtail services and access to ensure their viability."

Christian G. Downs, JD, MHA,
Executive Director
Association of Community Cancer Centers 
 
 

On Friday, November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released the Most Favored Nation (MFN) Model Interim Final Rule with Comment Period (IFC). The Model is mandatory for all Medicare physicians, non-physician practitioners, supplier groups (such as group practices), hospital outpatient departments (including 340B covered entities), ambulatory surgical centers, and other providers and suppliers that receive separate Medicare Part B fee-for-service payment for the Model’s included drugs, with certain exceptions.

A policy that ties Medicare payment for outpatient drugs to international prices, if implemented without broader payment reform and over an extended period, could have a devastating impact on cancer programs across the country. This proposal will reduce or eliminate these Medicare beneficiaries’ access to appropriate care and exasperate health inequities.

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