Manufacturer and distributor of optical lenses and equipment Essilor will pay $22 million to resolve claims that it broke the False Claims Act (FCA) by using payments to increase sales .
Dallas-based The Department of Justice (DOJ) announced in a press release on Tuesday that Essilor International and its affiliates Essilor of America, Essilor Laboratories of America, and Essilor Instruments USA ran an incentive program from 2011 to 2016 that paid eye doctors and optometrists to persuade patients to choose Essilor products.
According to the settlement agreement, this led clinicians to submit erroneous claims to Medicare and Medicaid on behalf of those patients who were "tainted by kickbacks."
The FCA's anti-kickback law forbids "offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, and other Federally Funded Programs," according to the DOJ, and Essilor's alleged scheme allegedly violates this law.
In the announcement, Principal Deputy Assistant Attorney General Brian Boynton, chief of the DOJ's Civil Division, warned that the integrity of medical decision-making could be jeopardized when medical equipment makers give referral bonuses to healthcare professionals. To guarantee that illegal financial incentives do not affect patient care, the agency will keep looking into anti-kickback legislation infractions.
According to the settlement agreement, Essilor will pay $16.4 million to the federal government and $5.6 million to the states whose Medicaid programs were impacted by the alleged misbehavior. According to the DOJ, Essilor will reach separate agreements with the states. The states that are covered by the settlement are not identified in the agreement.
The DOJ agreement resolves two qui tam complaints brought by former Essilor district sales managers Laura Thompson, Lisa Brez, and Christie Rudolph in U.S. District Court for the Northern District of Texas and the Eastern District of Pennsylvania. The FCA stipulates that a percentage of the settlement funds paid by Essilor to the federal government will go to the whistleblowers, according to the agreement.
Essilor settled into a settlement without acknowledging fault and refuted several of the government's allegations.
As part of the settlement, Essilor signed a corporate integrity agreement (CIA) with the Office of Inspector General at the Department of Health and Human Services that will last for five years.
In order to ensure that any discounts, rebates, or other price reductions granted to providers comply with the anti-kickback statute, Essilor will "hire an independent review organization to review its systems, policies, processes, and procedures," the DOJ said. In order to verify that all current and future discount arrangements conform with the anti-kickback statute, the CIA additionally mandates that Essilor develop a new written review and approval process.
Other producers of medical equipment and pharmaceutical firms that have lately come into conflict with the FCA's anti-kickback clause include Biogen, which in July came to a $900 million agreement in principle to resolve claims made by a whistleblower that it paid bribes to doctors. Arriva Medical, a mail-order provider of diabetic testing supplies, agreed to a $160 million settlement in August 2021 to resolve allegations relating to a kickback system.
Requests for comment from Essilor were not answered.
By fLEXI tEAM