Biosimilars Forum Opposes Current CMS Rule That Would Adversely Affect Biosimilars Development in the U.S.; Submits Comments on Appropriate Biosimilar Reimbursement Policy

WASHINGTON, D.C. September 14, 2017 – Recently, the Biosimilars Forum submitted comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed Medicare Physician Fee Schedule (MPFS) regarding biosimilar reimbursement policy that was finalized in 2016.

As stated in the submission, The Biosimilar Forum is requesting that CMS include a revised biosimilar reimbursement policy in the CY 2018 MPFS Final Rule. Rather than continue the current policy adopted beginning in 2016 that groups all biosimilars with a single reference product into a single HCPCS [Healthcare Common Procedure Coding System] billing and payment code, effective January 1, 2018, the Biosimilar Forum requests that each biosimilar have its own HCPCS code for billing and payment.

Sixty-one members of Congress and more than 200 organizations representing patients, providers, and other stakeholders also weighed in urging CMS to foster a competitive biosimilar market by assigning separate payment codes for each biosimilar including the American Cancer Society Cancer Action Network, American College of Rheumatology, Association of Community Cancer Centers, Crohn’s and Colitis Foundation of America, Arthritis Foundation, American Medical Association, Global Healthy Living Foundation, and the U.S. Pain Foundation.

The full comments and an updated version of the Forum’s published Xcenda Study “Estimating the Budgetary Impact of Biosimilar Coding Policies Under Medicare Part B,” relating to CMS reimbursement of biosimilars are on the Biosimilars Forum website. The study has been updated to reflect new data and demonstrates the need for changes in CMS reimbursement for Biosimilars under Medicare part B. The existing CMS policy will save $49.9 billion over 10 years. If CMS were to follow the Xcenda Study Alternative Model, cost savings over 10 years would increase by 30% or $15.1B.

The Biosimilars Forum is grateful that CMS decided to revisit biosimilar coding policy by allowing the Forum and others the opportunity to submit comments on CMS’ biosimilar reimbursement policy that was finalized in 2016. That said, the Biosimilars Forum continues to press upon CMS the importance of employing a policy included in the final rule that assigns each biosimilar a unique HCPCS code for billing and payment effective January 1, 2018 in order to prevent lasting damage to the viability of this nascent biosimilars market.

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 Facebook/USBiosimilars to follow related conversations and join the dialogue.

Aimee Steel Lubin