July 10, 2015

Alston & Bird LLP — Earlier this year, the U.S. Food and Drug Administration (FDA) approved the first biosimilar in the United States. The Centers for Medicare & Medicaid Services (CMS) recently issued three guidances regarding reimbursement for biosimilars under Medicare Parts B and D, as well as under Medicaid. These guidances address questions that have arisen regarding reimbursement policies that CMS will implement for biosimilars. When these guidances were released, a number of issues were left outstanding, including the applicability of pass-through payment eligibility to biosimilars and Healthcare Common Procedure Coding System (HCPCS) coding policies.