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 Dr. Lubin under the FCA. The claims resolved by the settlement are allegations only, and there has been no admission or determination of liability. The allegations in the complaint and the conduct covered by the settlement agreement relate to the submission of claims for a fentanyl-spray medication known as Subsys, which was manufactured by Insys Therapeutics, Inc. (Insys). According to the complaint, the United States alleges that Dr. 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 Dr. Lubin received in kickbacks.
The United States alleges that once Dr. 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 Dr. 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, Dr. 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.