Biosimilars Forum Applauds CMS Decision to Revisit Biosimilars Coding Policy

Forum Sees CMS Decision as an Opportunity to Revisit and Amend a Rule That Would Adversely Affect Biosimilars Development in the U.S

WASHINGTON, DC, July 14, 2017 – The Biosimilars Forum is pleased that the Centers for Medicare and Medicaid Services (CMS) included in their just released CY 2018 proposed Medicare Physician Fee Schedule (MPFS) regulation a solicitation for comment on their biosimilar reimbursement policy that was finalized in 2016. CMS’ decision comes after numerous stakeholders expressed concern that the long-term stability of the biosimilar market will be jeopardized unless CMS reconsiders its policy, including through letters sent from 52 House members and nine Senators.

Under CMS’ current reimbursement policy, biosimilars tied to the same reference product are reimbursed at a single payment rate. However, biosimilars tied to the same reference product may, for example, not share all indications with one another or the reference product. Further, a blended payment model may cause significant confusion in a multi-tiered biosimilars market that may include both interchangeable and non-interchangeable products. This CMS rule may lead to decreased physician confidence in how they are reimbursed and also dramatically reduce the investment in the development of biosimilars and thereby limit treatment options available to patients.

Issuing unique Healthcare Common Procedure Coding System (HCPCS) codes to each individual biosimilar is essential to ensuring a robust, competitive biosimilar market by increasing the potential for innovation while lowering the risks associated with developing and marketing these complex products. To ensure that the prescribed physician-administered biologics are given to patients, Medicare should allow a fair and predictable reimbursement to purchasers of biosimilars. 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.

The Biosimilars Forum is pleased that CMS values additional thought and analysis of this important issue, and the Forum will continue to work with other stakeholders and CMS to provide additional comment and guidance regarding this reimbursement issue during the open rulemaking process.

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 Lubin