Inform Diagnostics, Inc. (Inform) has agreed to pay $2.9 million to resolve potential False Claims Act liability arising out of conduct that potentially violated the Anti-Kickback Statute (AKS), resulting in the submission of false claims for payment to Medicare and other federal healthcare programs. Inform voluntarily self-disclosed the conduct to the US Attorney’s Office earlier this year. According to the settlement, Inform admitted that, from 2018 through 2023, Inform had purchased test arrangements (PTAs) with a small number of its physician practice customers. Reimbursement for anatomic pathology laboratory services involves two components: a “technical” component, involving the physical preparation of the specimen for pathologist review, and a “professional” component, involving analysis of the slide by the pathologist. Under Inform’s PTAs, the customer performed one component while referring the other component to Inform to perform and Inform billed commercial insurers for both components, reimbursing the customer at a set price. Customers with PTAs also referred other services to Inform, including services that Inform billed to Medicare and federal healthcare programs. The United States contends that Inform’s PTAs resulted in the submission of false claims for payment to federal healthcare programs because those claims were tainted by violations of the AKS. The settlement credits Inform for its self-disclosure. Inform has terminated all of its PTAs.
