Pharmaceutical company QOL Medical LLC (QOL) and its co-owner and CEO, Frederick E. Cooper, have agreed to pay $47 million to resolve allegations that they caused the submission of false claims to federal healthcare programs, in violation of the False Claims Act and similar state statutes, by offering kickbacks in the form of free Carbon-13 breath testing services to induce claims for QOL’s drug Sucraid. Sucraid is an FDA-approved therapy for the rare genetic condition Congenital Sucrase-Isomaltase Deficiency (CSID). CSID patients have difficulty digesting sucrose (table sugar) and suffer from gastrointestinal symptoms such as diarrhea, abdominal pain, bloating and gas. Beginning in 2018, QOL, with Cooper’s approval, distributed free Carbon-13 breath test kits to healthcare providers and asked providers to give the kits to patients with common gastrointestinal symptoms. QOL claimed that the test could “rule in or rule out” CSID. In fact, the test does not specifically diagnose CSID. Conditions other than CSID can cause a patient to test “positive” for low sucrase activity on a Carbon-13 breath test. Approximately 30% of the Carbon-13 breath tests from QOL were positive for low sucrase activity.
QOL paid a laboratory to analyze the breath tests, report the results to healthcare providers and also provide the results to QOL. The results provided to QOL did not contain patient names, but did contain the name of the healthcare provider who ordered the test, along with the patient’s age, gender, symptoms and test result. Between 2018 and 2022, QOL disseminated this information to its sales force with instructions to make sales calls for Sucraid to healthcare providers whose patients had positive Carbon-13 breath test results. QOL tracked whether sales representatives converted “positive” Carbon-13 breath tests into Sucraid prescriptions. As QOL’s CEO, Cooper was aware of and approved the implementation and continuation of this marketing program. Some QOL sales representatives also made claims to healthcare providers regarding the Carbon-13 test’s ability to definitively diagnose CSID that were not supported by published scientific literature.
