Agendia, Inc., a global molecular diagnostics company that offers genomic testing designed to profile certain types of breast cancer, including a lab test called MammaPrint, agreed to settle allegations under the False Claims Act (FCA) that the company submitted deceptive claims for reimbursement for MammaPrint genomic tests to government healthcare benefit programs. Under the terms of the settlement, Agendia will pay at least $3,250,000 and potentially additional sums if the privately held Company is sold. In separate settlements, Knoxville Comprehensive Breast Center (KCBC) and Knoxville Dermatopathology Laboratory (KDL) agreed to resolve related FCA allegations for $322,500 and $207,500, respectively.
According to filed documents, it was alleged that from August 1, 2019, through September 30, 2022, Agendia knowingly submitted false claims for MammaPrint testing to Medicare, Medicaid, and other government payors. The United States contended that the MammaPrint claims were false because Agendia caused physicians and providers (referring providers) to order MammaPrint testing that was not reasonable or medically necessary through standing or automatic orders. The government also maintained that certain claims submitted by Agendia were deceptive because they were tainted by the payment of illegal remuneration to referring providers who ordered the tests—including extravagant dinners, excessive or improper honoraria, gift cards, and payments per referral or monthly flat rate payment arrangements. The settlements also resolve allegations that KCBC and KDL, working together, knowingly participated in Agendia’s scheme to obtain referrals for MammaPrint that were not reasonable and necessary and/or were induced by illegal compensation provided by Agendia.