PHILADELPHIA, PA — United States Attorney Jacqueline C. Romero this week announced a $16.4 million civil settlement with Essilor International, Essilor of America, Inc., Essilor Laboratories of America, Inc., and Essilor Instruments USA (collectively, “Essilor”), headquartered in Dallas, Texas, 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 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.
The United States alleges that between January 1, 2011 and December 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. Specifically, the United States contends that Essilor, through its Strategic Alliance, Practice Builder Loyalty, Practice Builder Elite, and Growth Financing programs (collectively, “Threshold Programs”) knowingly and willfully offered or paid unlawful remuneration to providers to induce providers to order and purchase Essilor products and knowingly caused providers to submit false claims to Medicare and Medicaid for Essilor products that were tainted by kickbacks that Essilor offered or paid to providers enrolled in Threshold Programs.
“Our healthcare system is predicated on providers making decisions solely in the best interest of the patient,” said United States Attorney Romero. “Kickbacks threaten to corrupt that decision-making. The United States Attorney’s Office stands ready to pursue anyone who fails to abide by the rules that ensure our system functions as it should.”
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.).
“We sincerely thank Ms. Thompson, Ms. Brez, and Ms. Rudolph. Without the willingness of relators to shed light on allegations of fraud, preserving government program funds would be far more challenging.” said U.S. Attorney Romero.
In connection with the settlement, Essilor entered into a five-year Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General. 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 put in place new written review and approval process to ensure all existing and new discount arrangements comply with the Anti-Kickback Statute.
“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. “Essilor’s Corporate Integrity Agreement is intended to establish policies and practices so it complies with the Anti-Kickback Statute moving forward.”
This case was investigated by the U.S. Department of Health and Human Services Office of the Inspector General. For the U.S. Attorney’s Office, the investigation and settlement were handled by Assistant U.S. Attorney Paul W. Kaufman and auditor Dawn Wiggins.
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 claims resolved by the settlement are allegations only and there has been no determination of liability.
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