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FCPA Compliance and Ethics Report-Episode 121-FCPA Year in Review, Part II
On August 7, the US Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-09, providing significant guidance for physician-owned medical device companies (PODs)....more
On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-08 (Opinion) on July 7, 2025, highlighting the limitations of the often-leveraged Personal Services and...more
The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more
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
Regulation - OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor - On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more
In Advisory Opinion 18-10, issued September 10, 2018, the OIG permitted a manufacturer of surgical devices and wound care products to implement a warranty program under which the manufacturer's hospital customers could...more
The Department of Health and Human Services Office of the Inspector General (OIG) has issued Advisory Opinion No. 18-10 (Opinion) in response to a proposal by a surgical device and wound care product manufacturer...more