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West Virginia University Health System settles $4.17M for Controlled Substance Act violations; mandates 3-year compliance plan.

The United States Attorney’s Offices for the Northern and Southern Districts of West Virginia have announced a significant civil settlement with West Virginia University Health System, Inc., operating as WVU Health System (WVUHS). The agreement, which includes a payment of over $4.17 million, aims to resolve allegations of violations of the Controlled Substances Act across various WVUHS facilities spanning a seven-year period from 2017 to 2024. The settlement also mandates a three-year compliance agreement with the Drug Enforcement Administration (DEA) to address identified deficiencies.

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The investigation, conducted by the DEA, reportedly uncovered numerous recordkeeping and reporting failures within WVUHS facilities. These alleged violations include instances where the system failed to report thefts or significant losses of controlled substances to the DEA. Additionally, the United States identified issues such as inaccuracies in ordering controlled substances, deficiencies in maintaining current and accurate inventory records, and a lack of proper authorization for the use of DEA order forms. The healthcare system’s policies and procedures were also found to be not entirely consistent with the requirements of the Controlled Substance Act, along with other administrative violations.

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In conjunction with the financial settlement, WVUHS has entered into a comprehensive three-year Memorandum of Agreement. This agreement outlines specific, system-wide compliance requirements designed to enhance the safeguarding of controlled substances and prevent their diversion. Key provisions include enhanced diversion oversight, a mandate for rapid reporting of any thefts or losses, and the installation of hundreds of security cameras at locations where controlled substances are stored. Furthermore, the agreement calls for improved training protocols, more rigorous auditing procedures, and other policy enhancements aimed at detecting, investigating, and preventing the diversion of controlled medications. The settlement and subsequent agreement are intended to hold the healthcare system accountable and drive meaningful reform in its handling of controlled substances, ultimately contributing to public safety in West Virginia.

Article by Mel Anara, based upon information from the U.S. Attorney’s Office, Northern District of West Virginia

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