Inform Diagnostics Agrees to Pay $16 Million to Resolve Medically Unnecessary Testing Claims Under False Claims Act | USAO-MA

BOSTON – Inform Diagnostics, Inc., (Inform) formerly known as Miraca Life Sciences, Inc. (Inform), has agreed to pay $16 million to resolve allegations that it submitted false payment claims to Medicare and other federal health care programs.

Inform is a clinical laboratory headquartered in Irving, Texas that provides pathology services to medical practices across the United States. On April 27, 2022, Fulgent Genetics purchased Inform, and the company is now a wholly owned subsidiary of Fulgent Genetics.

According to the settlement, Inform admits that between 2013 and 2018, he routinely and automatically performed additional testing on biopsy specimens prior to a pathologist’s review and without an individualized determination as to whether further testing was medically necessary. The United States contends that Inform’s policy of routine additional testing has caused Inform to perform many medically unnecessary tests. Inform submitted these medically unnecessary tests for payment, forcing federal health care programs to pay for misrepresentations.

“Labs that charge for medically unnecessary tests drain funds from Medicare and other federally funded health care programs,” said U.S. Attorney Rachael S. Rollins. “Favoring profit over respect for the law is wasting taxpayers’ hard-earned money. Companies that engage in this fraudulent conduct will be held accountable. »

“Clinical labs are expected to follow Medicare rules closely and bill correctly — nothing more, nothing less,” said Special Agent in Charge Phillip M. Coyne of the U.S. Department of Health and Human Services, Office of the Inspector General. “When this obligation is violated, government health care programs — and American taxpayers — pay the price. We are committed to pursuing these types of allegations with our law enforcement partners as we work to protect the integrity of our federal healthcare system.

“Companies providing services to VA will be held to the highest standards of integrity, professionalism and accountability,” said Christopher Algieri, Special Agent in Charge of the VA Veterans Affairs Northeast Field Office. ‘Inspector General. “The submission of claims for medically unnecessary services will not be tolerated, and the VA OIG will continue to work with the U.S. Attorney’s Office and our law enforcement partners to hold wrongdoers accountable.”

“Submitting claims for medically unnecessary testing threatens the integrity of federal health care programs and wastes taxpayers’ money,” said Amy K. Parker, Special Agent in Charge of the Office of Inspector General of the Office of personnel management. “Today’s settlement reminds all providers that the OPM OIG will not tolerate fraud against the Federal Employee Health Benefits Program.”

“Charging federal health care programs for medically unnecessary tests contributes to skyrocketing health care costs for all of us,” said Joseph R. Bonavolonta, special agent in charge of the FBI’s Boston Division. “Today’s settlement with Inform Diagnostics demonstrates the FBI’s commitment to ensuring that health care providers base their treatment decisions on patient needs rather than their own financial interests.”

The False Claims Act allegations being resolved were originally brought in a whistleblower lawsuit under the qui tam provisions of the law on misrepresentation. Under these provisions, a private party can sue on behalf of the government and participate in any recovery. Under today’s settlement, the whistleblower will receive 17% of the clawback.

US Attorney Rollins, HHS-OIG SAC Coyne, FBI SAC Bonavolonta and OPM OIG SAC Parker made the announcement today. The Office of the Inspector General of the Department of Veterans Affairs also provided assistance. Assistant U.S. Attorneys Alexandra Brazier and Lindsey Ross of Rollins’ Affirmative Civil Enforcement Unit handled the case.

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