Associate Medical Director of Baltimore County Pain Management Practice Pleads Guilty to Accepting Kick-Backs
Baltimore, Maryland – Howard Hoffberg, M.D., age 65, of Reisterstown, Maryland, 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 the company marketed for breakthrough pain in cancer patients for off-label purposes.
The guilty plea was announced by Acting United States Attorney for the District of Maryland Jonathan F. Lenzner; Acting Special Agent in Charge Rachel Byrd of the Federal Bureau of Investigation, Baltimore Field Office; Assistant Special Agent in Charge Orville O. Greene of the Drug Enforcement Administration, Baltimore District Office; Special Agent in Charge Maureen Dixon, Office of Investigations, Office of Inspector General of the Department of Health and Human Services; and Chief Melissa R. Hyatt of the Baltimore County Police Department.
According to his guilty plea, Howard Hoffberg, is a doctor and was licensed to practice medicine in the State of Maryland. He served as the Associate Medical Director and part-owner of Rosen-Hoffberg Rehabilitation and Pain Management (the “Practice”). The Practice’s Medical Director was Norman Rosen, who worked primarily at the Practice’s Towson, Maryland locations. Hoffberg principally worked at the Practice’s location in Owings Mills, Maryland, but at times also was at the Practice’s locations in Towson, Maryland.
Hoffberg was a Medicare provider and submitted claims to Medicare, which is federal healthcare program. In September 2011, Hoffberg certified to Medicare that he would comply with Medicare rules and regulations, including that he would refrain from violating the federal anti-kickback statute. Further, in August 2013, Hoffberg certified to the U.S. Food and Drug Administration (“FDA”), as part of his ability to prescribe drugs known as Transmucosal Immediate Release Fentanyl (“TIRF”) drugs, that: (a) he understood TIRF drugs are indicated only for the management of breakthrough pain in cancer patients; (b) he understood that TIRF drugs can be abused by patients; and (c) he understood that one TIRF drug is not interchangeable with another TIRF drug.
As detailed in his plea agreement, starting in June 2012, Hoffberg solicited and received kickbacks and bribes for himself in the form of payments from Insys Therapeutics, Inc. (“Insys”) (a pharmaceutical company) and related entities. In January 2012, the FDA approved Insys’s application to sell and market a TIRF drug named Subsys to treat cancer patients experiencing break-through pain, which is a sudden onset of pain in cancer patients that cannot be controlled with their usual treatment regimen. Subsys is a potent opioid designed to rapidly enter a patient’s bloodstream upon being sprayed under the tongue. Subsys contains fentanyl, which is a synthetic opioid pain reliever that has a high potential for abuse and addiction.
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 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, through January 2018 Hoffberg prescribed Subsys 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.
Hoffberg faces a maximum sentence of five years in federal prison. U.S. District Judge George L. Russell, III has scheduled sentencing for September 29, 2021 at 11:00 a.m.
Acting United States Attorney Jonathan F. Lenzner commended the FBI, the DEA, HHS-OIG, and the Baltimore County Police Department for their work in the investigation. Mr. Lenzner thanked Assistant U.S. Attorney Jason D. Medinger, who is prosecuting the case.
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