Pharmaceutical company QOL Medical, LLC (QOL) and its CEO, Frederick E. Cooper, have agreed to pay $47 million to resolve allegations that they caused the submission of false claims to federal health care programs, in violation of the False Claims Act, 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 chronic gastrointestinal symptoms such as diarrhea, abdominal pain, bloating and gas.
As part of the settlement, QOL and Mr. Cooper admitted and accepted responsibility for certain facts providing the basis of the settlement. Beginning in 2018, QOL, with Mr. Cooper’s approval, distributed free Carbon-13 breath test kits to health care 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 health care providers, and provide the results to QOL. The results QOL received from the laboratory did not contain patient names, but did contain 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. QOL tracked whether sales representatives converted “positive” Carbon-13 breath tests into Sucraid prescriptions. As QOL’s CEO, Mr. Cooper was aware of and approved the implementation and continuation of this marketing program.
Some QOL sales representatives also made claims regarding the Carbon-13 test’s ability to definitively diagnose CSID that were not supported by published scientific literature. For example, in slides at a 2019 national sales training, which Mr. Cooper reviewed, 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.”
The allegations resolved by the settlement agreement were, in part, originally bought in a case filed under the qui tam or whistleblower provisions of the False Claims Act by former QOL Medical employees. The case is captioned United States ex rel. John Doe 1, et al. v. QOL Medical, LLC, et al., No. 1:20-cv-11243 (D. Mass.).
Of the total $47 million recovery, approximately $43.6 million constitutes the federal portion of the recovery and approximately $3.4 million constitutes a recovery for State Medicaid programs. The whistleblowers will receive approximately $8 million as their share of the recovery.
This matter was handled by Assistant U.S. Attorneys Brian LaMacchia and Lindsey Ross for the District of Massachusetts and Trial Attorneys Emily Bussigel and Paige Ammons of the Justice Department’s Civil Division. The case was investigated by HHS-OIG, FBI, DCIS and the Office of Inspector General for the Department of Veterans Affairs.