The U.S. Department of Justice announced on January 30, 2019 that pathology laboratory company Inform Diagnostics has agreed to pay $63.5 million to settle allegations that it violated the False Claims Act by engaging in improper financial relationships with referring physicians. Inform Diagnostics, formerly known as Miraca Life Sciences Inc., is headquartered in Irving, Texas, and was a subsidiary of Miraca Holdings Inc., a Japanese company, during the relevant period. In 2017, majority ownership of the company changed and the company was renamed.

The settlement resolves allegations that Inform Diagnostics violated the Anti-Kickback Statute and the Stark Law by providing to referring physicians subsidies for electronic Health records (EHR) systems and free or discounted technology consulting services. The Anti-Kickback Statute and the Stark Law restrict the financial relationships that health care providers, including laboratories, may have with doctors who refer patients to them. Although regulations adopted by the Department of Health and Human Services (HHS) in 2006 included provisions that allowed laboratories to provide EHR donations to physicians under certain conditions, the United States alleged that Inform Diagnostics violated those conditions. HHS withdrew those exemptions for laboratories in 2013.

The allegations stem from three lawsuits that were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private citizens to bring suit on behalf of the United States for false claims and share in any recovery. The whistleblowers’ share of the settlement has not yet been determined.

In announcing the settlement, an Assistant Attorney General of the U.S. Department of Justice’s Civil Division stated, “The Department of Justice has longstanding concerns about improper financial relationships between health care providers and their referral sources because those relationships can alter a physician’s judgment about the patient’s true health care needs and drive up health care costs for everybody. In addition to yielding a substantial recovery for taxpayers, this settlement should deter similar conduct in the future and help make health care more affordable.”

The case was investigated by the Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s Office for the Middle District of Tennessee, the U.S. Attorney’s Office for the Middle District of Florida, the Department of Health and Human Services Office of Inspector General, and the Federal Bureau of Investigation. The cases are captioned United States ex rel. Dorsa v. Miraca Life Sciences, Inc., Case No. 13-cv-1025 (M.D. Tenn.); United States ex rel. LPF, LLC v. Miraca Life Sciences, Inc., et al., 3:16-cv-1355 (M.D. Tenn.); and United States ex rel. Heaphy, et al. v. Miraca Life Sciences, Inc., 3:18-cv-1027 (M.D. Tenn.).

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If you have information regarding false claims having been submitted to Medicare, Medicaid, TRICARE, other federal health care programs, or to other federal agencies/programs, and the information is not publically known and no actions have been taken by the government with regard to recovering the false claims, you should promptly consult with a False Claims Act attorney (also known as qui tam attorneys) in your U.S. state who may investigate the basis of your False Claims Act allegations and who may also assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.

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