On May 16, 2018, the U.S. Attorney’s Office for the Southern District of Georgia announced that it had entered into the “largest hospital drug diversion civil penalty settlement in U.S. History” in the amount of $4.1 million dollars. The settlement with a Georgia hospital resolves allegations that the hospital “failed to provide effective controls and procedures to guard against theft and loss of controlled substances” that resulted in tens of thousands of 30mg oxycodone tablets being unaccounted for and believed to have been diverted for illegal uses over a four year period.
The settlement resolves an investigation commenced by the Drug Enforcement Administration (DEA) in 2017 after it received reports of diversion at the hospital. In addition to alleging that the hospital failed to meet its obligations under the Controlled Substances Act (CSA) to securely maintain its controlled substances, DEA alleged that the hospital failed to notify DEA of the suspected diversion within the requisite time period. In connection with this settlement, the hospital agreed to enter into to a performance improvement plan with DEA to improve its handling of controlled substances, which will include quarterly internal accountability audits and requirements for tracking controlled substances within the hospital.
The announcement of this settlement references the recent creation by the Attorney General of the Department of Justice Prescription Interdiction & Litigation Task Force for combatting the prescription opioid crisis. The announcement also notes that the Department of Justice will use all available remedies under the CSA against providers, pharmacies, and others that violate federal drug laws. It therefore may be the case that this settlement portends heightened federal scrutiny of providers involved in the prescribing and dispensing of opioid drugs.