Biosimilars Forum Applauds Senator Roberts, Reps. Barton, Eshoo for Leadership on Medicare Policy on Biosimilar Coding

52 House Members, Nine Senators Send Letters to CMS, HHS Sharing Concerns Over Rule That May Result in Fewer Treatment Options

WASHINGTON, D.C., May 12, 2017 – The Biosimilars Forum today expressed support for Senator Pat Roberts (R-KS), and Representatives Joe Barton (R-TX) and Anna Eshoo (D-CA) as well as a delegation of 52 House Members and nine Senators for their leadership in sending letters to Dr. Tom Price, Health & Human Services Secretary and Seema Verma, Administrator for the Centers for Medicare & Medicaid Services (CMS) regarding biosimilar reimbursement policy in the CMS’s 2016 Medicare Physician Fee Schedule proposed rule. Click to read the House and Senate letters.

The 2016 Medicare Physician Fee Schedule final rule issued by CMS on October 30, 2015, states that each follow-on biologic, or biosimilar, that is tied to a common reference product will be reimbursed at a single payment rate based on their average sales price under Medicare Part B.

“With the approval of two biosimilars that share the same reference product, it is now more pressing than ever to address this reimbursement issue,” said Stacie Phan, Biosimilars Forum President. “Unless action is taken now, this will be a critically missed opportunity to help so many who are facing serious diseases and disorders and who could benefit from biosimilars,” Phan said.

Issuing unique Healthcare Common Procedure Coding System (HCPCS) codes to each individual biosimilar is essential to facilitate accurate attribution of adverse events as well as ensure a robust, competitive biosimilar market. 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 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 or biosimilar 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 rule 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 continues to attract the interest of Congress and applaud the 52 House members and nine Senators who are working to correct the current policy to reflect the BPCIA’s biosimilar payment and coding requirements. We urge CMS to reverse its 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,” Phan concluded.

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

Lynn Blenkhorn