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Global Life Sciences Update

Centers for Medicare & Medicaid Services Issues “Most Favored Nation” Interim Final Rule for Select Medicare Part B Drugs

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On November 20, the Centers for Medicare & Medicaid Services (CMS) issued an advance copy of an Interim Final Rule with comment period (IFC) establishing a “Most Favored Nation (MFN) Model.” CMS describes the MFN Model as “a new Medicare payment model under section 1115A of the Social Security Act.” Under the IFC, the MFN Model will take into account certain international prices and discounts in setting Medicare Part B reimbursement rates for a select set of separately payable drugs and biologicals. 

The IFC is scheduled for publication in the Federal Register on November 27, and the IFC advance copy states that the MFN Model regulations will be effective on that date. Under the regulations, the MFN Model will mandate participation by identified Part B providers and will apply in all U.S. states and territories for a seven-year period beginning January 1, 2021, and ending December 31, 2027. The IFC has a 60-day comment period that, according to the advance copy of the IFC, will begin on the Federal Register publication date.

We have published related articles here, here and here

The remainder of this Update summarizes the MFN Model discussed in the IFC. In summarizing the IFC, we are not endorsing any positions or interpretations that CMS has taken.

 

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