US Congressional Delegation Expresses Concern Over Biosimilar Reimbursement Policy

May 19, 2017

Nine US Senators and 52 House members

Nine US Senators and 52 House members recently wrote to HHS Secretary Tom Price and CMS administrator Seema Verma, MPH, expressing their concerns with the biosimilar reimbursement policy in CMS’ 2016 Medicare Physician Fee Schedule proposed rule, which states that each follow-on biologic, or biosimilar, associated with the same reference product will be reimbursed at a single payment rate based on their average sales price under Medicare Part B, which was established on October 30, 2015.

Biosimilars Forum president Stacie Phan said the action was needed more than ever now that the FDA has approved 2 biosimilars for the same reference product, infliximab—following CT-P13 (Inflectra), infliximab-abda (Renflexis) was just recently approved. “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. 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 biologic medicines.

The letters that the members of Congress wrote to Dr Price and Ms Verma urge the officials to correct the current policy to reflect the biosimilar payment and coding requirements of the Biologics Price Competition and Innovation Act of 2009. The letters urged the reversal of current reimbursement policy, and requested that the policy instead employ a separate billing code and reimbursement rate so each biosimilar gets its own unique Healthcare Common Procedure Coding System code, commonly called the HCPCS code.

The letters stress that biologics are complex molecules and any reimbursement structure must appropriately reflect the complexity of these products and the differences between individual biosimilars. These differences are acknowledged by the statutory provisions establishing the biosimilar approval pathway, the letter to Secretary Price notes.

The members of Congress said that patients and physicians, pharmacy groups, biosimilar makers, and stakeholders that appropriate reimbursement for biosimilars have all expressed concerns about the rule, which does not appropriately reflect the complexity of the biosimilar products or the differences between individual biosimilars. “Biosimilar drugs hold enormous promise for improving health care outcomes for patients and reducing costs for both patients and health care payers such as Medicare and Medicaid,” the letter to Ms Verma states. “The emergence of biosimilar drugs has the potential to revolutionize the treatment landscape for many patients by offering them more treatment options at lower cost.” A more market-based policy will better support innovation, access, and affordability of these medications, the letter notes.


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