Physician-Owned Medical Device Arrangement Approved by HHS-OIG

Lexology August 20, 2025
Sidley Austin LLP

Last week, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued a favorable advisory opinion, Advisory Opinion 25-09, approving the investment structure of a medical device company (Requestor) that is partially owned by physicians (Physician Owners), including the physician-creator of the company’s medical devices, who are in a position to make or influence referrals to, or otherwise generate business for Requestor. Although OIG ultimately concluded that the arrangement satisfied all elements of the federal Anti-Kickback Statute (AKS) small entity investment safe harbor,¹ the opinion underscores the agency’s continued suspicion of such arrangements and its intent to closely scrutinize physician joint venture arrangements.

The Proposed Arrangement

Requestor, a manufacturer of medical devices used in emergency stroke...

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