Lexology August 26, 2025
Barnes & Thornburg LLP

Highlights

  • The Department of Health and Human Services Office of Inspector General (OIG) has longstanding concerns about physician-owned entities that earn revenue from selling or arranging the sale of medical devices ordered by their physician owners.
  • In a new advisory opinion, the OIG confirmed that ownership in such entities may be permissible under the small entity investment safe harbor if properly structured.
  • The OIG emphasized that safe harbor protection applies only when all eight conditions are fully satisfied.

The Department of Health and Human Services OIG recently issued Advisory Opinion No. 25-09, providing additional guidance regarding physician ownership in medical device manufacturers and the applicability of the small entity investment safe harbor set forth in 42 C.F.R. ยง1001.952(a)(2).

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Topics: Govt Agencies, OIG, Physician, Provider
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