Biosimilars Forum Issues Comments for CMS Proposed Rule on Biosimilar Payment and Coding

Washington, D.C. (September 8, 2015) –The Biosimilars Forum issued comments in response to proposed rules released by the Center for Medicare and Medicaid Services (CMS) regarding biosimilar payment issued in July. As currently written, the Part B rule proposes that multiple biosimilars to the same reference product be grouped and issued the same J-code for Medicare reimbursement purposes.

The following is a summary of the Biosimilars Forum’s general comments to the proposed Part B rule. To read the Forum’s complete comments, click here: (Part B Submission and HOPPS NPRM Submission).

Biosimilars Forum’s General Comments to the Proposed Rule

We strongly disagree with CMS’s intent to group all biosimilar products of a single reference product under the same HCPCS code. We urge 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. CMS’s proposed approach contradicts the statutory language of the Section 1847A of the Social Security Act. In addition, CMS’s interpretation inappropriately treats biosimilar products as if they were multisource or generic drugs. This treatment is inconsistent with not only how the Food and Drug Administration (“FDA”) classifies biosimilars, but also how CMS itself defines biosimilar products under Medicaid and Medicare Part D. Finally, CMS’s proposed payment methodology is likely to dramatically reduce investment in, and the subsequent availability of, biosimilar products, which is clearly against the intent of Congress in providing for a vibrant U.S. biosimilars market.

In July, the Biosimilars Forum expressed similar concern for the proposed rule, which can be read here: (July Statement) The public comment period to respond to the proposed rule ends today. The Biosimilars Forum looks forward to working closely with CMS and policy makers to correct the proposed regulation to reflect the BPCIA’s biosimilar payment and coding requirements.

About the Biosimilars Forum:

The Biosimilars Forum will advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The Biosimilars Forum will provide evidence-based information to inform and support public policies that encourage access, awareness and adoption of biosimilars. 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