Office of the Attorney General
Attorney General Conway Joins Multistate Settlement with NuVasive
Attorney General Conway announced today that Kentucky has joined with other states and the federal government to settle allegations that NuVasive, Inc. caused health care providers to submit false claims to Medicaid and other federal health care programs for spine surgeries by marketing the company’s CoRoent System for surgical uses that were not approved by the U.S. Food and Drug Administration (FDA). It is also alleged that NuVasive caused false claims by paying kickbacks to induce physicians to use the CoRoent System.
NuVasive, a California-based medical device manufacturer, paid the states and the federal government $13.5 million dollars, including $2,182,348.00 to the Medicaid program. $30,373.59 of the settlement is attributed to Kentucky Medicaid claims related to the NuVasive practices. The investigation resulted from a qui tam action originally filed in the United States District Court for the District of Maryland under the federal False Claims Act and various state false claims statutes.
“Reckless promotion of medical devices resulting in false claims to state and national healthcare programs is unacceptable,” said Attorney General Jack Conway. “Companies that exploit Kentucky taxpayers through deceptive marketing practices and illegal kickbacks will face the consequences.”
The settlement resolves allegations that between 2008 and 2013, NuVasive promoted the use of CoRoent System for surgical uses that were not approved or cleared by the FDA; including for use in treating two complex spine deformities, severe scoliosis and severe spondylolisthesis. As a result, the settlement resolves allegations NuVasive caused physicians and hospitals to submit false claims to Medicaid and other federal health care programs for certain spine surgeries that were not eligible for reimbursement. Finally, the settlement resolves allegations that NuVasive knowingly offered and paid illegal remuneration to certain physicians to induce them to use the CoRoent System in spine fusion surgeries, in violation of the federal anti-kickback statute. The illegal remuneration consisted of promotional speaker fees, honoraria and expenses relating to physicians’ attendance at events sponsored by a group known as the Society of Lateral Access Surgery (SOLAS). SOLAS was allegedly created, funded and operated solely by NuVasive, despite its outward appearance of independence.
Since Attorney General Conway took office in January 2008, his Office of Medicaid Fraud and Abuse Control has recovered more than $300 million for the state and federal Medicaid and other health care programs. These cases range from lawsuits and settlements against pharmaceutical companies to cases against individual providers.
In 2012, General Conway’s Medicaid Fraud Unit was named one of the most aggressive in the country by the nonprofit watchdog group Public Citizen. The Attorney General’s tip line for reporting allegations of abuse is 1-877-228-7384.