NuVasive, Inc. has escaped potential litigation and an intrusive Corporate Integrity Agreement (CIA) with the government for $13.5 million.
On July 28, 2015, the company announced it had reached a tentative agreement with the U.S. Department of Justice (DOJ) stemming from the subpoena issued by the Office of Inspector General (OIG) of the Department of Health and Human Services in 2013.
Interbody Inquiry
The OIG issued a federal administrative subpoena to the company in the second quarter 2013 in connection with an investigation into possible false or otherwise improper claims submitted to Medicare and Medicaid. The subpoena sought discovery of documents for the period January 2007 through April 2013. The exact details of the investigation were never disclosed by the government or the company. However, former CEO Alex Lukianov previously stated that the subpoena was a very broad document request, “focused on interbody with regard to Quadrant and biologics, both Osteocel and FormaGraft, but it’s very broad.”
The announcement of the agreement follows an April 29, 2015 statement from the company that it had reached an agreement in principle with the government.
The company did not have to admit to doing anything wrong and said it “cooperated fully” with the investigation.
No Corporate Integrity Agreement
The company will pay the $13.5 million, plus fees and accrued interest. Most interestingly, the company escaped a Corporate Integrity Agreement with the OIG. CIAs are a notorious tool of the DOJ to keep their fingers inside the books and workings of companies to monitor activities which may run afoul of false claims or Stark Law violations.
