OIG Doesn’t Fault a Device Doctor-Distributor

A 4/10 HHS Office of Inspector General (OIG) advisory opinion says a specific physician-owned distributor of a medical device is structured in such a way that it will not face anti-kickback sanctions. Writing in a Washington Legal Foundation Legal Pulse, three Goodwin Procter attorneys say the OIG listed six reasons why the safeguards put in place are sufficient to avoid anti-kickback problems.

“The safeguards would limit any potential streams of inappropriate income and minimize conflicts of interest that might interfere with hospital purchasing and patient care decisions,” the attorneys write. “Only the requestor of Advisory Opinion 22-07 can rely on its conclusions, but the opinion does provide at least some signal from the government as to the types of appropriate controls around physician-owned entities in the MedTech supply chain that may mitigate anti-kickback statute risks.”