Biosimilars Forum Applauds Reps. Barton, Eshoo for Leadership on Proposed Medicare Rule on Biosimilar Coding

Proposed CMS Ruling May Result in Fewer Treatment Options

WASHINGTON, DC, August 5, 2015 – The Biosimilars Forum today expressed support for House Energy and Commerce Committee members Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA), as well as a delegation of 33 House members for their leadership in sending a letter to Andrew Slavitt, acting administrator for the Centers for Medicare & Medicaid Services (CMS) regarding the provisions relating to biosimilar reimbursement in the CMS’s 2016 Medicare Physician Fee Schedule proposed rule. As currently proposed in the 2016 Medicare Physician Fee Schedule rule, multiple biosimilars for the same reference product would be grouped and issued the same J-code for Medicare reimbursement purposes. If implemented, this proposal could result in fewer biosimilars being introduced in the United States and ultimately in fewer treatment options for health care professionals and patients. [View the letter from the House leaders.]

“The Biosimilars Forum is deeply concerned that the provisions for biosimilars in the proposed rule may limit the future treatment options health care professionals would be able to offer their patients,” said Michael Werner, Biosimilars Forum policy advisor. “If this proposed rule is adopted as currently written, we fear that thousands of patients facing serious diseases and disorders who are expected to benefit from biosimilars may have limited access to these therapies.”

Issuing unique Healthcare Common Procedure Coding System (HCPCS) codes to each individual biosimilar is essential to facilitate accurate attribution of adverse events. To ensure that the prescribed physician-administered biologics are given to patients, CMS 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 lawmakers who passed the Biologics Price Competition and Innovation Act of 2009 (BPCIA) understood that biosimilars are not the same as generic drugs and should not be treated that way in policymaking. This is also evident in the multi-tiered system of biologics and biosimilars, with interchangeable and non-interchangeable biosimilars, and the potential for multiple different reference biologics within a therapy as well as the possibility that multiple biosimilars to a single reference product may not share all indications. Furthermore, consistent with the statute, an interchangeability determination only applies to a specific biosimilar and the reference product, and does not apply between or among multiple biosimilars approved to a single reference product. This CMS proposal may lead to confusion in each of these areas, and dramatically reduce the investment in the development of biosimilars and thereby reduce treatment options available to patients.

“We are pleased that this issue has quickly attracted the interest of Congress and applaud the House members who are working to correct the proposed regulation to reflect the BPCIA’s biosimilar payment and coding requirements,” said Werner. “We urge CMS to revise its proposed rule for Part B to better reflect the law and to support this new industry by giving each biosimilar of the same reference product its own, unique Medicare claims code and payment amount.”

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