Drug Company Falsely Claimed Patients Had Cancer, Feds Allege

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 A former executive of Insys Therapeutics has been criminally charged for leading a special “reimbursement unit” at the company that defrauded insurers into paying for a potent opioid pain medication by falsely claiming patients had cancer and other conditions needed for pre-approval.

Elizabeth Gurrieri, a former manager of reimbursement services for Arizona-based Insys, was charged with wire fraud conspiracy in a criminal complaint filed in federal court in Boston. The complaint sheds light on a Connecticut case involving a Derby nurse who has been charged with taking kickbacks from Insys in exchange for prescribing the company’s fentanyl spray, Subsys. The nurse, Heather Alfonso, has been cooperating with investigators in Boston and Connecticut in an ongoing probe of Insys’ sales tactics.

The complaint against Gurrieri notes that patients needed prior authorizations from insurance companies to cover the costs of Subsys, an expensive drug approved by the Food and Drug Administration in 2012 for the management of breakthrough pain in patients with cancer who already were receiving opioid pain treatment. Many patients were required to have a “specific medical diagnosis of cancer” before authorization was granted, the complaint says.

Gurrieri directed the reimbursement unit staff to call insurance companies and represent themselves as employees of the prescribing doctors, using a script referred to as “the spiel,” the complaint by the FBI says. The employees would claim that patients had “breakthrough pain,” add a diagnosis of dysphagia (difficulty swallowing), regardless of whether the patients actually had it, and mention any prior cancer diagnoses that patients might have had, even if they had recovered years earlier, according to the complaint.

The Insys unit employees were further directed to “assert fraudulently a cancer diagnosis, regardless of the patient’s history,” and to “falsely confirm” a list of “tried and failed medications” that would qualify the patient to try Subsys.

Insys’ reimbursement unit was in operation from January 2013 through October 2016, according to the complaint. The costs of Subsys prescriptions were covered by both commercial and government insurance, including Medicare.

Representatives of Insys could not be reached Tuesday. The company previously has denied wrongdoing in its sales and marketing of Subsys.

Alfonso, formerly a nurse at the Comprehensive Pain and Headache Treatment Center of Derby, awaits sentencing on charges that she accepted kickbacks from Insys for writing large numbers of prescriptions for Subsys. C-HIT reported in June that she was cooperating in the ongoing probe of Insys.

Alfonso pleaded guilty in June 2015 to receiving $83,000 in kickbacks from the company from January 2013 to March 2015, while she was employed at the pain clinic. She admitted in court that Insys paid her through a sham “speakers program,” supposedly to give presentations to other prescribers about Subsys. Instead, court documents say, Insys paid her about $1,000 per event for going out to dinner with friends and co-workers, or with just an Insys sales rep. At the same time, she wrote out Subsys prescriptions at what prosecutors called “an alarming rate.”

Court documents in her case say that some of the patients who were given Subsys did not have cancer, but that “prior authorizations” submitted on their behalf falsely represented that they did.

Last month, a former district sales manager for Insys was arrested on federal charges that he helped to orchestrate the kickback scheme. Jeffrey Pearlman, who was district sales manager for the New York region through 2015, was charged with defrauding federal healthcare programs of millions of dollars by inducing clinicians to prescribe Subsys by paying them to participate in hundreds of sham “speaker programs,” according to the U.S Attorney’s Office for Connecticut.

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