Lexology May 4, 2022
On April 20, 2022, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion (no. 22-07) regarding physician ownership of a medical device company that manufactures products ordered by the physician owners and other affiliated physicians.
The advisory opinion is significant because, though narrow, it provides a path forward for physician ownership of device companies, an area where OIG is typically concerned. That said, despite this favorable advisory opinion, OIG’s comments suggest it will retain its inherent skepticism and care needs to be taken to structure such an arrangement.
The OIG concluded that while the proposed arrangement would implicate the federal Anti-Kickback Statute (AKS), the OIG would not impose administrative sanctions even...
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