Howard Hoffberg, Accepting Kick-Backs, Maryland 2021

Howard Hoffberg, a 65-year-old doctor from Reisterstown, Maryland, pleaded guilty to conspiracy to violate the anti-kickback statutes on June 9, 2021.

Baltimore, Maryland – Howard Hoffberg, M.D., age 65, of Reisterstown, Maryland, pleaded guilty 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.

Hoffberg was a Medicare provider and submitted claims to Medicare, which is a 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.

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.

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 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.

Defendant: Howard Hoffberg, M.D., 65, of Reisterstown, Maryland.

Criminal Charges: Conspiracy to violate the anti-kickback statutes.

City and State: Baltimore, Maryland.

Date: June 9, 2021.

Sentence/Outcome: Currently awaiting sentencing.

Dollar Amounts: Not specified.

Source: https://www.justice.gov/usao-md/pr/associate-medical-director-baltimore-county-pain-management-practice-pleads-guilty