The U.S. Attorney for the District of Maryland announced on June 10, 2021 that 65-year-old Howard Hoffberg, M.D. (“Hoffman”) pleaded guilty on June 9, 2021 to the federal charge of conspiracy to violate the anti-kickback statutes in connection with a scheme to accept payments from a pharmaceutical company in exchange for prescribing a drug for off-label purposes that the company marketed for breakthrough pain in cancer patients.

According to his guilty plea, Hoffberg served as the Associate Medical Director and part-owner of Rosen-Hoffberg Rehabilitation and Pain Management (the “Practice”). Hoffman admitted in his plea agreement that starting in June 2012, he solicited and received kickbacks and bribes for himself in the form of payments from Insys Therapeutics, Inc. (“Insys”), and related entities, to prescribe Subsys off-label for conditions other than breakthrough pain in cancer patients. Subsys is a Transmucosal Immediate Release Fentanyl (TIRF) drug FDA-approved to treat cancer patients experiencing break-through pain.

According to the plea agreement, because of the limited number of cancer patients experiencing breakthrough pain who fit the FDA-approved criteria, Insys devised an illegal kickback and bribery scheme to induce Hoffberg and others to prescribe Subsys off-label for conditions other than breakthrough pain in cancer patients. In order to conceal and disguise that kickbacks and bribes were being paid to Hoffberg to prescribe Subsys, Insys falsely designated the payments to Hoffberg as “honoraria” for purportedly providing educational programs about Subsys (the “Speakers Bureau Program”). Hoffberg admitted that his participation in the Speakers Bureau Program was a sham. Hoffberg often made these presentations at high-end restaurants and to staff at the Practice and/or to persons who could not even prescribe controlled substances. Hoffberg knew that these presentations were not designed to promote any bona fide educational initiative about Subsys but rather were required to receive the honoraria.

Hoffberg was paid $66,600 by Insys and he knew that these payments were kickbacks and bribes that were paid, at least in part, to induce Hoffberg to prescribe, or in exchange for Hoffberg prescribing, Subsys. As part of the scheme, Hoffberg prescribed Subsys through January 2018 to patients of the Practice who were not suffering from cancer, some of whose insurance coverage was paid for, in whole or in part, by a federal healthcare program. Further, Hoffberg admitted that he switched several other patients to Subsys from another fentanyl-based drug because of the kickbacks he received from Insys, even though he previously certified that TIRF drugs were not interchangeable and he knew that TIRF drugs are indicated only for the management of breakthrough pain in cancer patients.

Hoffberg faces a maximum sentence of five years in federal prison. He is scheduled for sentencing on September 29, 2021.

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