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 June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more
6/30/2025
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In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more
8/15/2023
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Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently published a favorable determination, Advisory Opinion 22-06, on behalf of a biopharmaceutical company (the Requestor) regarding the...more