Spinal device manufacturer Innovasis Inc. and senior executives Brent Felix and Garth Felix agreed to pay a total of $12 million to resolve allegations that they violated the False Claims Act by paying kickbacks to spine surgeons to induce their use of Innovasis’s spinal devices. Brent Felix is the founder, President and Chairman of the Board of Innovasis, which is headquartered in Utah. Garth Felix served in various leadership roles for Innovasis, including as the company’s Chief Financial Officer.
“Payments from medical device manufacturers intended to influence a physician’s judgment about which medical devices or supplies to select are illegal,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “When medical devices are used in surgical procedures, patients deserve to know that their device was selected based on quality of care considerations and not on improper payments from manufacturers.”
“The integrity of our healthcare system is dependent upon physicians’ recommendations being motivated by patient health,” said U.S. Attorney Leigha Simonton for the Northern District of Texas. “Any time we learn that physician recommendations are being corrupted by improper financial inducements, we will seek to hold those involved accountable.”
“Improper financial arrangements can compromise medical judgment and adversely influence the medical decision-making process,” said Special Agent in Charge Jason E. Meadows of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “These arrangements have no place in our healthcare system, and we will continue working with our federal partners to pursue such allegations.”
The Federal Anti-Kickback Statute prohibits offering or paying anything of value to induce referrals of items or services covered by Medicare and other federally funded programs. The statute is intended to ensure that medical providers’ judgments are not compromised by improper financial incentives.
The settlement announced resolves allegations that from Jan. 1, 2014, through Dec. 31, 2022, Innovasis provided improper remuneration to seventeen orthopedic surgeons and neurosurgeons to induce them to use Innovasis spinal implants, devices and other equipment in medical procedures the physicians performed on Medicare beneficiaries, in violation of the Anti-Kickback Statute. The improper remuneration was allegedly provided in the form of consulting fees, intellectual property acquisition and licensing fees, registry payments and performance shares in Innovasis, as well as travel to a luxury ski resort, lavish dinners and holiday parties for surgeons, their office staff and family members. For example, Innovasis allegedly paid physicians for consulting services at rates far in excess of fair market value or, in some cases, for work that was never actually performed. Similarly, the company allegedly paid physicians far in excess of fair market value to acquire or license purported intellectual property for which Innovasis never obtained any valuation prior to purchase and thereafter never used for meaningful product development. Innovasis also paid physicians to attend a company-sponsored conference held at a luxury resort in Deer Valley, Utah, which included the cost of travel, lodging and high-end meals, among other things. During the relevant period, Brent Felix, along with his brother Garth Felix, allegedly controlled or otherwise directed Innovasis’s operations, strategic decisions, and the agreements with surgeons who allegedly received improper remuneration from Innovasis.
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Robert Richardson, a former Regional Sales Director for Innovasis. Under those provisions, a private party can file an action for false claims on behalf of the United States and receive a portion of any recovery. Richardson will receive approximately $2.2 million as his share of the recovery in this case. The qui tam case is captioned United States ex rel. Richardson v. Innovasis Inc., et al., No. 3:19-CV-02440-X (N.D. Tex.).
The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section and the U.S. Attorney’s Office for the Northern District of Texas, with assistance from HHS-OIG.
Trial Attorneys Jessica E. Krieg, Olga Yevtukhova and Adam J. DiClemente of the Justice Department’s Civil Division and Assistant U.S. Attorneys Andrew S. Robbins and George M. Padis for the Northern District of Texas handled the matter.
The investigation and resolution of this matter illustrates the government’s emphasis on combating health care fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to the HHS at 800-HHS-TIPS (800-447-8477).
The claims resolved by the settlement are only allegations. There has been no determination of liability.
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