FLORIDA – A Tampa pain management physician has agreed to pay $1.5 million to settle False Claims Act liability for allegedly receiving bribes and writing unnecessary fentanyl prescriptions, the U.S. Attorney’s Office for the Middle District of Florida (USAO) has announced.
On Friday, United States Attorney Roger B. Handberg announced that pain management physician Edward Lubin has agreed to pay the United States $1.5 million to resolve allegations that he violated the False Claims Act (FCA) by causing the submission of claims for fentanyl prescriptions that were written in exchange for kickback payments and that were medically unnecessary.
The agreement resolves the United States’ claims against Lubin under the FCA, said the USAO. The claims resolved by the settlement are allegations only, and there has been no admission or determination of liability.
According to the USAO, the claims in the complaint and the actions covered by the settlement agreement have to do with submitting claims for Subsys, a fentanyl spray drug made by Insys Therapeutics, Inc. According to the complaint, the United States alleges that Lubin knowingly and willfully accepted approximately $159,580 in kickback payments from Insys in return for prescribing Subsys.
The settlement figure is almost 10 times the amount that Lubin received in kickbacks.
The United States alleges that once Lubin became involved with Insys, he immediately began prescribing Subsys in exchange for kickbacks and regardless of medical necessity. The United States contends that the kickbacks paid to Lubin were disguised as payment for speaking at sham “events” that lasted a few minutes, never occurred, or had repeat attendees despite the lack of any reason to present the same information multiple times to the same individuals.
According to court documents filed by the United States, Lubin allegedly caused more than 400 false claims for Subsys to be submitted to the Medicare and TRICARE programs, in violation of the federal Anti-Kickback Statute (AKS) and the FCA, which paid in excess of $4 million for these claims.
“The United States will not be thwarted in its efforts to hold doctors like Dr. Lubin accountable for issuing medically unnecessary prescriptions tainted by kickbacks,” said Handberg.
In 2019, Insys was prosecuted under a criminal information filed in the District of Massachusetts. Pursuant to the terms of a deferred prosecution agreement, Insys’s wholly owned subsidiary, Insys Pharma, Inc., pleaded guilty to five counts of mail fraud in connection with a scheme to defraud patients and insurers, including Medicare.
In its deferred prosecution agreement, Insys admitted that bribes paid to medical practitioners through its speaker program were used to induce practitioners to write increasing amounts of medically unnecessary Subsys prescriptions in exchange for the payment of speaker fees.
To date, in addition to the company, at least 15 doctors, seven former Insys executives, and seven former Insys sales representatives have been criminally convicted for their roles in Insys’s sham speaker program, according to the USAO.
The resolution obtained in this case was the result of a coordinated effort by the U.S. Attorney’s Office for the Middle District of Florida, the U.S. Department of Health and Human Services’ Office of Inspector General, and the Defense Criminal Investigative Service, the criminal investigative arm of the U.S. Department of Defense’s Office of Inspector General.
Assistant United States Attorneys Jeremy R. Bloor, Kelley Howard-Allen, and Soma Nwokolo litigated the FCA case. Assistant United States Attorney Christopher Emden litigated Dr. Lubin’s bankruptcy case for the United States.
A bankruptcy court will determine final approval of the settlement agreement, said the USAO.