CMS Considers New Billing Code Policy for Biosimilars

U.S. FDA News

Last week, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule regarding payment policies.  Among other things, the proposed rule included a request for comment on the policy for biosimilar reimbursement.  A fact sheet prepared by CMS explains that the existing policy, finalized in 2016, provided that “average sales price (ASP) for all national drug codes (biosimilar products) assigned to the same reference biological product would be included in the same billing and payment code. This means that biosimilar products that rely on a common reference product’s biologics license application are grouped into the same payment calculation for determining a single average sales price payment limit, and that a single Healthcare Common Procedure Coding System (HCPCS) code is used for such biosimilar products.”  CMS is now seeking comments based on market experience thus far for approved biosimilar products, including “market analyses or research articles that provide evidence which supports positions expressed in comments,” indicating that CMS may be revisiting the payment policy in the coming years.

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