Biosimilars Forum Disappointed with CMS Final Rule on Biosimilar Payment and Coding

Washington, D.C. (October 30, 2015) – The Biosimilars Forum expressed serious concern about the final rule issued today by the Center for Medicare and Medicaid Services (CMS) regarding biosimilar payment. The final rule states: we are finalizing our proposal to amend the regulation text at §414.904(j) to make clear that the payment amount for a biosimilar biological product is based on the ASP of all NDCs assigned to the biosimilar biological products included within the same billing and payment code. We are also finalizing the proposal’s effective date: January 1, 2016.

“The Biosimilars Forum feels strongly that this rule will lead to confusion with respect to proper product use, safety monitoring and will reduce investment in development of biosimilars thereby reducing treatment options available to patients,” said Michael Werner, Biosimilars Forum policy advisor. “We have spoken to many prescribers and other stakeholders who have shared this concern and how it will impact their practice and ability to treat patients.”

In September, the Biosimilars Forum joined more than 80 groups in submitting comments to the proposed rule expressing our concern to group all biosimilar products of a single reference product under the same HCPCS code, and urged CMS to enact a final payment rule that assigns each biosimilar product of a reference biologic its own payment amount and a unique HCPCS code.

Additionally, both the U.S. Senate and House of Representatives sent letters to CMS each signed by dozens of Members of Congress expressing their collective concern as well. You can read the Forum’s comments here (Part B Submission and HOPPS NPRM Submission) and the Congressional letters here.

“The law, legislative history, and biosimilar science support the requirement that CMS assign each biosimilar biological product a unique HCPCS code and not consider biologics and biosimilars in the same fashion as generic drugs,” Werner concluded. “Patients in need of life-saving drugs are ultimately the ones who will suffer from this final rule. We truly hope the decision CMS has made does not have the detrimental effect that we fear it might.”

About the Biosimilars Forum

The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.

To learn more about biosimilars, the Forum, and how to get involved, visit or go to @USBiosimilars to follow related conversations and join the dialogue.

Aimee Steel

Lynn Blenkhorn