The company alleged to have paid kickbacks to a Derby nurse in exchange for her prescribing of a potent pain medication has agreed to pay $1.1 million to settle a case brought by the state of Oregon, which accused the firm of deceptive marketing and kickback payments involving the same drug.
In a notice of unlawful trade practices filed against the Arizona-based drug maker Insys, the Oregon attorney general’s office charged that the company used an “unconscionable tactic by making payments to doctors that you intended to be a kickback to incentivize the doctor to prescribe Subsys.” The attorney general also charged Insys with using “unconscionable, false and deceptive sales tactics” designed to increase the “off-label” use of Subsys, which is approved only to treat breakthrough cancer pain.
The case in Oregon comes as Connecticut nurse practitioner Heather Alfonso, formerly with the Comprehensive Pain and Headache Treatment Center in Derby, awaits sentencing on charges she received $83,000 in kickbacks from Insys from 2013 to 2015. In pleading guilty, Alfonso, 42, admitted that the money she was paid for attending “dinner programs” as a speaker — many of them sham dinners, with just an Insys sales representative or her friends or co-workers — influenced her prescribing of the drug, according to the U.S. Attorney’s Office for Connecticut.
The charge of receipt of kickbacks in relation to a federal healthcare program carries a maximum term of imprisonment of five years and a fine of up to $250,000. Connecticut, to date, has taken no action against Insys.
In the Oregon case, the attorney general’s office charged Insys with encouraging “off-label” or unapproved uses of Subsys, such as to treat neck or back pain. Because of the drug’s highly addictive nature and potential for fatal side effects, it is approved only for cancer patients with severe pain. The company promoted Subsys among physicians in Oregon who were “already predisposed to prescribe (Schedule II narcotics) off-label,” the attorney general’s complaint says. And Insys pressured its sales representatives to get doctors to write prescriptions at higher-than-needed dosages, which were more expensive, the complaint says.
One Oregon doctor mentioned in the complaint was paid up to $2,400 by Insys to give promotional talks about Subsys. Some of those talks “were shams that were essentially an excuse to make a payment to (the physician) to encourage increased prescribing of Subsys,” the complaint says. On at least one occasion, the doctor was paid $2,400 to speak to his own physician assistant over a meal at an expensive restaurant. When the doctor’s “prescribing numbers” were deemed to be too low, Insys told him he would not be used as a speaker again, he said.
Other claims in the Oregon case include that an Insys sales representative sent flirtatious texts to a physician; and that the company hired the son of a doctor as a sales representative in order to pressure the father to prescribe Subsys.
Insys has not commented on the Oregon allegations or responded to requests for comment on the case involving Alfonso. The company previously has denied any wrongdoing in its marketing of Subsys.
The settlement requires Insys to pay $533,000 to the state of Oregon and $567,000 to another organization, to be selected by the attorney general, to help prevent opioid abuse and misuse in the state.
In Connecticut, Alfonso was the highest prescriber of Subsys in the Medicare program in 2013, writing 69 out of 89 total Subsys prescriptions. She was the 10th highest prescriber nationally of the drug in the Medicare program.
Last month, the state notified the staff of the Derby pain clinic that they could no longer participate in the Medicaid program because of improprieties in treatment and oversight. Documents from the Department of Social Services show the physician heading the clinic, Dr. Mark Thimineur, and four nurses and assistants were notified in July that their participation in the Connecticut Medical Assistance Program, which includes Medicaid, was being terminated on Aug. 30. Alfonso was removed from the Medicaid program in May.
A number of Thimineur’s patients have launched a petition drive protesting the state’s decision to terminate the clinic from Medicaid.