BOSTON — This is an official press release from the U.S. Department of Justice (USAO - Massachusetts), published as received.
BOSTON – 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 health care programs. Inform voluntarily self-disclosed the conduct to the U.S. Attorney’s Office earlier this year.
Inform is a clinical laboratory with headquarters in Irving, Texas that provides anatomic pathology services to physician practices throughout the United States.
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 health care programs. The United States contends that Inform’s PTAs resulted in the submission of false claims for payment to federal health care programs because those claims were tainted by violations of the AKS.
The settlement credits Inform for its self-disclosure. Inform self-reported the conduct, which was unknown to the United States at the time of the disclosure in March 2024, including the results of an internal investigation, the nature of the potentially problematic relationships, and the potential financial impact to the government. Inform has terminated all of its PTAs.
“By self-disclosing this conduct to the federal government, Inform saved itself hundreds of thousands of dollars. That benefit is available to any company that takes the responsible step of reporting false claims to the government. This office is committed to making sure that companies that come forward with information regarding potential violations of the law before the government learns of them get real benefits from such a decision,” said United States Attorney Joshua S. Levy. “While we do not condone unlawful conduct, we commend companies that save time and resources on both sides by disclosing what they know and allowing the government to determine whether to proceed. That is what Inform did here, and today’s resolution both recognizes Inform’s laudable decision to self-disclose and should serve as an incentive for other companies to do the same. Self-disclosures will be resolved fairly and expeditiously.”
United States Attorney Levy; Roberto Coviello, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG); and Patrick Hegarty, Special Agent in Charge, Defense Criminal Investigation Service, Northeast Field Office made the announcement. Assistant U.S. Attorneys Abraham R. George, Chief of the Civil Division and Alexandra Brazier of the Affirmative Civil Enforcement Unit handled the matter.
