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Advisory Opinions Risk Management Office of the Inspector General

ArentFox Schiff

Navigating OIG’s Advisory Opinion on Medical Device Billing Arrangements and Anti-Kickback Statute Risks

ArentFox Schiff on

On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device...more

Gardner Law

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

Gardner Law on

Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

Mintz - Health Care Viewpoints

OIG Issues Advisory Opinion Nixing Purchased Services Arrangement Between Certain Anatomic Pathology Laboratories

Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more

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