Effects of Including Noncovered Versions of Stelara Biosimilars in Part B Payment Amount Calculations

Under the Consolidated Appropriations Act, 2021, Congress required OIG to periodically conduct studies to identify drugs for which noncovered self-administered versions are included in Medicare Part B payment amount calculations, and to determine whether they should be excluded from Part B payment amount calculations. The FDA has recently approved seven biosimilar drugs for Stelara (ustekinumab), a high-cost prescription biologic drug approved to treat certain autoimmune diseases. The intravenous versions of these drugs are administered by a health care provider and are covered by Medicare Part B. Conversely, the subcutaneous versions are typically self-administered and not covered under Medicare Part B. The provider-administered intravenous versions for five of these biosimilars were each approved under the same application number as their self-administered subcutaneous versions. Under CMS policy, both versions will therefore be included when calculating each drug's Part B payment amount. OIG will determine the effect of including noncovered self-administered versions of Stelara biosimilar drugs in Part B payment amount calculations.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
June 2025	CMS	Effects of Including Noncovered Versions of Stelara Biosimilars in Part B Payment Amount Calculations	Office of Evaluation and Inspections	OEI-BL-25-00240	2025