Congressional Mandate: Noncovered Versions of Part B Drugs in 2025

OBJECTIVE

Under the Consolidated Appropriations Act, 2021, Congress directed CMS to remove noncovered self-administered versions of Cimzia and Orencia from Medicare Part B payment amount calculations beginning in July 2021 if doing so would lower payment amounts.  Through the same legislation, Congress required OIG to conduct periodic studies to identify additional drugs for which noncovered self-administered versions are included in Part B payment amounts and which OIG determines should be excluded from Part B payment amount calculations.  Accordingly, OIG will conduct periodic studies to identify drugs for which noncovered self-administered versions should be excluded from Part B payment amount calculations.  In general, for the drugs that OIG identifies, CMS is required to remove noncovered self-administered versions from payment amount calculations in subsequent quarters if the exclusions would result in lower payment amounts; however, the statute provides CMS with some discretion in addressing the requirement.

TIMELINE

• March 16, 2026
  Announced
• Today
  Office of Evaluation and Inspections In-Progress
• Est FY2028
  Estimated Fiscal Year for Project Completion

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