Click Fraud Protection Whistleblower Rewarded Over $1 Million for Unveiling Genetic Testing Kickback Scheme - TZ Legal - Fraud Fighters
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Whistleblower Rewarded Over $1 Million for Unveiling Genetic Testing Kickback Scheme

December 28, 2023. The Executive Assistant Director of the FBI’s Criminal, Cyber, Response and Services Branch said, “Those who engage in activity that violates the False Claims Act must face the consequences of their actions,” to the tune of a $6 million settlement with the United States Department of Justice in this recent genetic testing kickback case. A whistleblower earned a $1.07 million reward for reporting pharmaceutical company Ultragenyx Pharmaceutical Inc. (Ultragenyx)’s genetic testing kickback scheme via a qui tam lawsuit—almost 18% of the government’s recovery.

According to the allegations, Ultragenyx cooked up a scheme to pay for genetic testing for X-linked hypophosphatemia (XLH), pay for the results of the tests, then market its XLH pharmaceutical, Crysvita, to healthcare providers who referred patients that ultimately had positive tests. People with the hereditary disease XLH tend to have low levels of phosphate in their blood, resulting in weak and bowed bones. Definitive diagnosis of XLH usually requires a genetic test, and the pharmaceutical company knew that Medicare and Medicaid would pay for their drug to treat XLH once a patient received a diagnosis through genetic testing.

The Anti-Kickback Statute (AKS) prohibits healthcare providers from knowingly and willfully accepting remunerations as inducements to refer Medicare or Medicaid-insured patients. The AKS also prohibits pharmaceutical companies from paying healthcare providers to prescribe their drugs to Medicare and Medicaid patients. However, Ultragenyx violated the statute’s provisions by paying a lab to perform genetic testing for XLH, at no cost to patients or providers. The pharmaceutical company then paid the lab for the test results, and then marketed Crysvita to healthcare providers who referred patients with positive test results. This scheme ultimately generated more claims for Crysvita that were covered by Medicare and Medicaid. As stated in the settlement agreement, Ultragenyx admitted to certain facts about the fraud scheme, which ran from February 2019 – May 2022.

The nature of this scheme violates the Anti-Kickback Statute, which enshrines ethical business practices in the healthcare industry while also ensuring Medicaid and Medicare patients receive affordable, reliable care. The statute’s provisions ensure healthcare providers prioritize patients’ health over financial gain. However, Ultragenyx’s disregard for these provisions led to the submission of false claims to Medicare and Medicaid, which were ultimately reported by a whistleblower.

The total recovery amount of $6 million includes $5.8 million for Medicare, $200,000 for state Medicaid, programs, with the whistleblower receiving $1.07 million from the federal portion.

If you would like to report Medicare or Medicaid fraud, pharmaceutical fraud, genetic testing fraud, or you suspect a company is violating the Anti-Kickback Statute, you can contact attorneys at Tycko & Zavareei LLP. Eva Gunasekera and Renée Brooker are former officials of the United States Department of Justice and prosecuted whistleblower cases under the False Claims Act. Eva was the Senior Counsel for Health Care Fraud. Renée served as Assistant Director at the United States Department of Justice, the office that supervises False Claims Act cases in all 94 United States District Courts. Eva and Renée now represent whistleblowers. For a free consultation, you can contact Eva Gunasekera at [email protected] or contact Renée at [email protected] (tel.: 202-417-3664). Visit Tycko & Zavareei LLP’s website for whistleblowers to learn more at

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