For Immediate Release
Media Contact: Kriss Bivens Cloyd
(208) 334-4119

Date: October 15, 2015

NuVasive, Inc. Pays $13.5 Million Dollars to Resolve Off-Label Marketing and Kickback Allegations

(Boise) - Attorney General Lawrence Wasden announced today that Idaho 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. Nuvasive marketed the company’s CoRoent System for surgical uses that were not approved by the U.S. Food and Drug Administration (FDA) and caused false claims by paying kickbacks to induce physicians to use the CoRoent System.

NuVasive, a California-based medical device manufacturer, paid to the states and the federal government $13.5 million dollars, including $2,182,348 to the Medicaid program. 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. As part of the settlement, the State of Idaho received $3,163 in restitution and other recovery.

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.

A National Association of Medicaid Fraud Control Units (NAMFCU) Team participated in the investigation and conducted the settlement negotiations with NuVasive on behalf of the states.

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