Regulatory News

Congress Calls on HHS to Reverse Biosimilar Reimbursement Policy

Sen. Pat Roberts (R-KS), and Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA) as well as 52 other representatives and nine senators sent letters to Tom Price, Health & Human Services secretary, and Seema Verma, administrator for the Centers for Medicare & Medicaid Services (CMS) with concerns about the biosimilar reimbursement policy from a recently issued final rule.

The final rule, issued by CMS on 30 October 2015, stipulates that each biosimilar of the same reference product will be reimbursed at a single payment rate based on their average sales price under Medicare Part B.

The letter sent 5 May says that each biosimilar should have its own Healthcare Common Procedure Coding System (HCPCS) code for reimbursement.

The second letter sent 8 May notes concerns from patient and physician groups, biosimilar manufacturers and others, particularly as the US Food and Drug Administration (FDA) is beginning to approve multiple biosimilars for the same reference product.

Stacie Phan, president of the Biosimilars Forum, added in a statement: "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."

Letter from 5 May

Letter from 8 May