Inform Diagnostics, Inc. has agreed to a $2.9 million settlement to address potential False Claims Act liability linked to alleged Anti-Kickback Statute violations. The clinical laboratory, headquartered in Irving, Texas, self-reported the conduct to the U.S. Attorney’s Office earlier this year.
From 2018 through 2023, Inform had entered into pathology test arrangements (PTAs) with some physician practice customers. These arrangements involved two components of anatomic pathology services: a technical component for specimen preparation and a professional component for slide analysis by pathologists. Inform billed commercial insurers for both components while reimbursing the customer at a set price and received referrals for other services billable to Medicare and federal health care programs.
The U.S. government claims that these PTAs led to false claims being submitted due to Anti-Kickback Statute violations. However, Inform's self-disclosure included details from an internal investigation about the potentially problematic relationships and their financial impact on the government.
“By self-disclosing this conduct to the federal government, Inform saved itself hundreds of thousands of dollars," said United States Attorney Joshua S. Levy. "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."
The announcement was made by United States Attorney Levy; Roberto Coviello from HHS-OIG; and Patrick Hegarty from Defense Criminal Investigation Service, Northeast Field Office. Assistant U.S. Attorneys Abraham R. George and Alexandra Brazier handled the matter.