July 26, 2020

The U.S. Attorney’s Office for the Western District of North Carolina announced on April 27, 2020 that Genova Diagnostics Inc. (“Genova”), a clinical laboratory services company based in Asheville, North Carolina, has agreed to pay up to approximately $43 million to resolve allegations that it violated the False Claims Act, including claims that it billed for medically unnecessary lab tests.

Under the settlement, Genova has agreed to pay approximately $17 million, through the surrender of claim funds held in suspension by Medicare and TRICARE, plus up to an additional $26 million if certain financial contingencies occur within the next five years, for a total potential payment of up to $43 million.

Genova also entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General. The CIA requires, among other things, that Genova establish and maintain a compliance program with specific requirements and that it engage an independent review organization.

The settlement resolves allegations that Genova improperly submitted claims to Medicare, TRICARE, and the federal employee health program for its IgG allergen, NutrEval and GI Effects lab test profiles because the tests were not medically necessary; engaged in improper billing techniques; and, paid compensation to three phlebotomy vendors that violated the physician self-referral prohibition commonly known as the Stark Law. The Stark Law is intended to ensure that physician referrals are determined by the medical needs of patients and not the financial interests of physicians.

The settlement agreement resolves allegations brought by Darryl Landis under the qui tam, or whistleblower, provisions of the False Claims Act. The False Claims Act permits private citizens to bring a lawsuit on behalf of the United States for fraud and to share in any recovery. The settlement provides for a payment of up to approximately $6 million to Dr. Landis.

The lawsuit is captioned United States ex rel. Darryl Landis, M.D. v. Genova Diagnostics, Inc., et al., No. 1:17-cv-341 (W.D.N.C.).

In announcing the settlement, the Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services stated, “Labs are expected to bill taxpayer-supported federal health programs for medically necessary services, not pad their bottom lines as alleged by the government in this case. We will continue working with our law enforcement partners to safeguard these vital programs.”


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.

Click here to visit our website or call us toll-free in the United States at 800-295-3959 to be connected with qui tam lawyers (False Claims Act lawyers) in your U.S. state who may assist you with a False Claims Act lawsuit.

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