Reported Impact of Discarded-Drug Refunds on Biosimilar Drugs
Section 90004 of the Infrastructure Investment and Jobs Act (the Act) requires manufacturers of certain single-dose containers or single-use package drugs, including biosimilar biologic products, payable under Medicare Part B to provide a refund for the discarded amounts of such drugs. In addition, section 90004 of the Act requires OIG, after consultation with CMS and the Food and Drug Administration, to submit a report to Congress on any reported impact that section 90004 may have on the licensure, market entry, market retention, or marketing of biosimilar biologic products. As such, we will determine the reported impact of discarded-drug refunds on licensure, market entry, market retention, or marketing of biosimilar drugs and submit a report to Congress.
|Announced or Revised||Agency||Title||Component||Report Number(s)||Expected Issue Date (FY)|
|November 2022||Centers for Medicare and Medicaid Services||Reported Impact of Discarded-Drug Refunds on Biosimilar Drugs||Office of Audit Services||WA-23-0005 (W-00-23-35894)||2024|