19 November 2024. Four whistleblowers put an end to an alleged healthcare fraud scheme involving billing federal healthcare programs for testing and medication for a rare genetic disorder. The United States Department of Justice and QOL Medical LLC and its co-owner and CEO have reached a $47 million settlement to resolve allegations of unlawful kickbacks in violation of the Anti-Kickback Statute and the False Claims Act. The four whistleblowers, former employees of QOL, will receive approximately 18.5% of the federal portion of the settlement.

Allegations Against QOL Medical

The allegations center around QOL Medical’s marketing practices for their FDA-approved drug, Sucraid, used to treat Congenital Sucrase-Isomaltase Deficiency (CSID). People affected by CSID tend to have difficulty digesting sugar. To promote Sucraid, QOL distributed free Carbon-13 breath test kits to healthcare providers, suggesting that these tests could “rule in or rule out” CSID—an assertion not supported by scientific evidence.

The company allegedly paid a laboratory to analyze these tests and shared the results, which included test outcomes and providers but not specific patient identities, with its sales force. The sales team was then instructed to target healthcare providers who received positive test results, aggressively linking these outcomes to the need for Sucraid prescriptions. The Sucraid prescriptions were “tainted” by QOL offering free Carbon-13 tests to providers and paying the lab for...

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