CMS Clarifies Medicare Payments for Biosimilars

The 2016 proposed physician fee schedule rule released July 8 includes provisions clarifying that the Medicare Part B payment amount for biosimilars is based on the average sales price (ASP) of all biosimilar products that reference the same original biologic’s license application.

The Affordable Care Act, through its Biologics Price Competition and Innovation Act, created a pathway for the Food and Drug Administration to approve follow-on biologic drugs, or biosimilars. In 2010, the Centers for Medicare & Medicaid Services issued regulations on the payment approach for biosimilars that was specified by the ACA. The proposed rule would update the regulations ...