Pharmaceutical company to pay $47M for false federal health claims A pharmaceutical company has been instructed to pay $47 million to resolve false federal health care claims allegations. QOL Medical LLC (QOL), alongside co-owner and CEO Frederick E. Cooper, has...
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A pharmaceutical company has been instructed to pay $47 million to resolve false federal health care claims allegations.
QOL Medical LLC (QOL), alongside co-owner and CEO Frederick E. Cooper, has stumped up the money, bringing the submission of false claims to federal healthcare programs allegations to a close.
The allegations were brought about after concerns were raised by Elizabeth Allen, Lauren Canlas, Donald Johnson, and Stacey Adams, former QOL Medical employees.
"QOL provided free goods to doctors and patients in order to induce prescriptions for the very expensive drug QOL manufactured," said Acting U.S. Attorney Joshua S. Levy for the District of Massachusetts. "Not all kickbacks come in the form of cash going into a doctor's or a patient's pocket. Here, the defendants relied on free breath tests and misleading sales tactics to drive patients to their product. This conduct unnecessarily drained money from the federal health care programs and improperly influenced treatment decisions by physicians and their patients."
QOL and CEO pay to resolve whistleblower case
The former employees stated that the company and Cooper's activities directly violated the False Claims Act, as both were reportedly offering free Carbon-13 breath testing services, which would result in increased claims for a QOL-produced drug named Sucraid.
Sucraid is an FDA-approved therapy for the rare genetic condition Congenital Sucrase-Isomaltase Deficiency (CSID), but it comes with a hefty price tag. QOL and Cooper have admitted that they inflated the drug's importance with false statements and testimonies aimed at increasing claims and, in turn, drug sales profits.
It was reported that QOL distributed these free kits in 2018 and stated that it could locate and diagnose gastrointestinal issues like CSID. However, the verity of the results was questioned, as the court heard that "approximately 30% of the Carbon-13 breath tests from QOL were positive for low sucrase activity."
The court report further stated that "QOL suggested that sales representatives tell health care providers, "If you have a positive breath test, the patient will not improve unless you treat with Sucraid."
False and misleading statements like these resulted in misinformation and led to illegal claims on federal healthcare plans. QOL were also found to have used the data collated from test results to give to their sales team.
The report stated that the results specifically showed "the name of the health care 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 health care providers whose patients had positive Carbon-13 breath test results."
Regarding the $47 million recovered from QOL and Cooper, $43.6 million will be awarded to the federal government, and $3.4 million constitutes a recovery for State Medicaid programs. Elizabeth Allen, Lauren Canlas, Donald Johnson, and Stacey Adam will be awarded $8 million from the federal portion of the recovery.
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