Orthopedic Practice and Physician Pay $80K to Resolve Controlled Substances Act Allegations

Leonard C Boyle, Acting United States Attorney for the District of Connecticut, today announced that ORTHOPAEDIC SPECIALTY GROUP, P.C., and DR. LAWRENCE KIRSCHENBAUM entered into a civil settlement agreement with the federal government and have agreed to pay a total of $80,000 to resolve allegations that they violated civil provisions of the Controlled Substances Act.

Orthopaedic Specialty Group, P.C. (“OSG”) is an orthopedic practice with locations in Bridgeport, Fairfield, Milford and Shelton.  Kirschenbaum practices out of OSG’s Fairfield location, and specializes in interventional pain management.  The allegations against OSG and Kirschenbaum involve the claim that on 40 separate occasions between April 2017 and January 2019, Kirschenbaum’s patients received “early fills” of their prescriptions for controlled substances.  When a prescription is filled early, it is filled before the supply provided pursuant to an earlier prescription is or should be exhausted.  The government alleges that these 40 “early fills” violated the Controlled Substances Act and its implementing regulations.

Congress, with the passage of the Controlled Substances Act, took steps to create “a closed system” of distribution for controlled substances in which every facet of the handling of the substances – from their manufacture to their consumption by the ultimate user – was to be subject to intense governmental regulation.  This mission was taken against the backdrop of trying to prevent the diversion and abuse of legitimate controlled substances, while still ensuring that an adequate supply of those substances meet the medical and scientific needs of the United States.

As part of the settlement agreement, OSG and Kirschenbaum have agreed to stop dispensing Schedule II controlled substances from OSG’s offices.  Instead, OSG patients will fill their prescriptions for these opioids at pharmacies.  OSG has agreed to incorporate this change in protocol into a written policy, and will disseminate the written policy to all of OSG’s staff and physicians.

This investigation was conducted by the Drug Enforcement Administration’s Office of Diversion Control, and the Connecticut Department of Consumer Protection, Drug Control Division.  The case was prosecuted by Assistant U.S. Attorney Sara Kaczmarek.