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Advisory Opinions Physician-Owned Distributors

Sheppard Mullin Richter & Hampton LLP

OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company

On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving...more

Stevens & Lee

OIG Anti-Kickback Opinion Examines Physician Ownership of Medical Device Manufacturer and Referrals

Stevens & Lee on

The Office of Inspector General (“OIG”) in the Department of Health and Human Services has longstanding concerns regarding physician-owned entities that derive revenue from selling items ordered by their physician owners for...more

Holland & Knight LLP

OIG OKs Physician Ownership of Medical Device Company

Holland & Knight LLP on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion on April 20, 2022, regarding physician ownership in a medical device company. The Advisory Opinion is significant...more

King & Spalding

OIG Issues Advisory Opinion Regarding Physician-Owned Device Company

King & Spalding on

On April 20, 2022, OIG issued an advisory opinion regarding an arrangement involving a family of physicians having an ownership interest in a medical device company that manufactures products that the physicians also order. ...more

Bass, Berry & Sims PLC

OIG Approves Arrangement Involving Physician-Owned Device Manufacturer— Distinguishes Prior Special Fraud Alert on Physician-Owned...

Bass, Berry & Sims PLC on

On April 25, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-07, approving an arrangement whereby physicians hold ownership interests in a medical...more

Mintz - Health Care Viewpoints

OIG Approves Physician-Owned Medical Device Company

On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more

Manatt, Phelps & Phillips, LLP

OIG Advisory Opinion Recognizes Legitimacy of Certain Physician-Owned Device Companies

After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion by the Office of Inspector General for the U.S. Department of Health &...more

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