Essilor International, Essilor of America Inc., Essilor Laboratories of America Inc. and Essilor Instruments USA (collectively, “Essilor”), headquartered in Dallas, have agreed to pay $16.4 million to resolve allegations that the company violated the False Claims Act by causing claims to be submitted to Medicare and Medicaid that resulted from violations of the Anti-Kickback Statute.
Essilor manufactures, markets and distributes optical lenses and equipment used to produce optical lenses. The United States alleged that between Jan. 1, 2011, and Dec. 31, 2016, Essilor knowingly and willfully offered or paid remuneration to eye care providers, such as optometrists and ophthalmologists, to induce those providers to order and purchase Essilor products for their patients, including Medicare and Medicaid beneficiaries, in violation of the Anti-Kickback Statute. The Anti‑Kickback Statute prohibits offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid and other federally-funded programs. The statute is intended to ensure that medical providers’ judgments are not compromised by improper financial incentives.
“When medical equipment manufacturers provide kickbacks to referring providers, it can compromise the integrity of medical decision-making,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to pursue violations of the Anti-Kickback Statute to ensure that patient care is not influenced by improper financial incentives.”
“The Anti-Kickback Statute was designed to ensure doctors make medical decisions with only their patients’ best interests in mind,” said U.S. Attorney Chad Meacham of the Northern District of Texas. “We are pleased to see Essilor taking financial responsibility for their conduct.”
“Our healthcare system is predicated on providers making decisions solely in the best interest of the patient,” said U.S. Attorney Jacquelin Romero of the Eastern District of Pennsylvania. “Kickbacks threaten to corrupt that decision-making. The U.S. Attorney’s Office stands ready to pursue anyone who fails to abide by the rules that ensure our system functions as it should.”
“Kickback schemes can impact medical judgment, eroding the trust of both patients and taxpayers,” said Lisa M. Re, Acting Chief Counsel at the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “Essilor’s Corporate Integrity Agreement is intended to establish policies and practices so it complies with the Anti-Kickback Statute moving forward.”
In connection with the settlement, Essilor entered into a five-year Corporate Integrity Agreement (CIA) with HHS-OIG. The CIA requires, among other things, that Essilor hire an independent review organization to review its systems, policies, processes and procedures for ensuring that any discounts, rebates, or other reductions in price offered to providers comply with the Anti-Kickback Statute. The CIA also requires Essilor to implement a new written review and approval process to ensure all existing and new discount arrangements comply with the Anti-Kickback Statute.
The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by relators Laura Thompson, Lisa Brez, and Christie Rudolph, former Essilor district sales managers. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The qui tam cases are captioned United States ex rel. Laura Thompson & Lisa Brez v. Essilor Int’l, No. 3:15-CV-2853-C (N.D. Tex.) and United States ex rel. Christie Rudolph v. Essilor Labs. of Am., Inc., No. 16-CV-0537 (WB) (E.D. Pa.).
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. Attorneys’ Offices for the Northern District of Texas and the Eastern District of Pennsylvania.
The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare 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 Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
The matter was handled by Senior Trial Counsel Diana Cieslak and Assistant U.S. Attorneys Braden Civins of the Northern District of Texas and Paul Kaufman of the Eastern District of Pennsylvania.
The claims resolved by the settlement are allegations only and there has been no determination of liability.