Lab Genomics LLC, a clinical laboratory based in Fountain Valley, California, and its owner, Leena Dalal, have agreed to pay the United States $1.25 million to resolve allegations involving payments to marketers, the Justice Department announced November 6.
The department says the claims resolved by the settlement are allegations only and there has been no determination of liability.
The allegations
The department alleges that, from January 2020 through September 2022, the laboratory and Dalal knowingly and willfully paid commissions based on the value and volume of referrals to three independent contractor marketers. According to the announcement, the payments were intended to induce the marketers to arrange or recommend that health care providers order and refer laboratory tests to Lab Genomics.
The settlement also resolves allegations that the laboratory and Dalal knew the payments did not comply with the Anti-Kickback Statute and structured invoices to make commissions appear to be flat fees, the department says.
The law and the case
The Anti-Kickback Statute prohibits offering, paying, soliciting or receiving remuneration to induce referrals for items or services covered by Medicare, Medicaid and other federally funded health care programs. The department says knowingly submitted claims that violate that statute are ineligible for payment and can violate the False Claims Act.
The settlement resolves certain allegations in a lawsuit brought by two whistleblowers under the False Claims Act, according to the department. They will receive $225,000 of the settlement proceeds. The department says it previously resolved similar allegations involving two other companies named in the case.
The announcement does not itself establish that the allegations against Lab Genomics and Dalal were proven. The settlement agreement and underlying complaint were not reviewed for this report.