MORGANTOWN -- The U.S. Attorney's Offices for the Northern and Southern Districts of West Virginia announced Monday that West Virginia United Health System, doing business as West Virginia University Health System, has agreed to pay $4,177,139 and enter a memorandum of agreement to resolve civil allegations that it violated provisions of the Controlled Substances Act across various registered facilities over a seven-year span.
According to a Drug Enforcement Agency investigation, WVUHS committed numerous record-keeping and reporting violations from 2017-2024.
WVUHS facilities failed to notify the DEA regarding thefts or significant losses of controlled substances. In addition to these failures to report, other violations included errors in orders regarding controlled substances; failures to maintain accurate and current inventory records; failures to ensure proper authority for use of DEA order forms; maintaining policies and procedures not fully consistent with the requirements of the Controlled Substance Act; and other administrative violations.
In addition to the civil monetary settlement, WVUHS has signed a comprehensive, three-year memorandum of agreement with the DEA. The MOA imposes detailed systemwide compliance requirements, including additional diversion oversight; rapid reporting of thefts or losses; installing hundreds of security cameras at controlled substance storage sites; enhancing training and auditing procedures; and other policy improvements to detect, investigate, and prevent diversion.
A WVUHS spokesperson provided a statement about the case. The spokesperson said this was a regulatory matter primarily involving controlled substance record keeping, documentation and related compliance requirements at several WVU Health System hospitals.
"The agreement resolves this matter without any admission of liability by WVU Health System of the covered conduct," the spokesperson said. "Throughout the government’s review, we cooperated fully with federal authorities and have worked diligently to strengthen our policies, procedures, oversight and training to ensure continued compliance with the Controlled Substances Act and its implementing regulations."
The spokesperson continued, "Even before the DEA’s investigation commenced, WVU Health System had proactively invested millions of dollars in additional personnel, advanced diversion detection technology, and expanded security infrastructure, and continues to strengthen those safeguards across its hospitals.
"Importantly, this matter concerned regulatory compliance, recordkeeping and documentation requirements," the spokesperson said. "It did not involve findings that WVU Health System intentionally engaged in unlawful distribution of controlled substances or that patient care was compromised. We are pleased to have resolved this matter and remain focused on providing the highest quality care to the patients and communities we serve."
First Assistant U.S. Attorney Christopher J. Prezioso commented on the case: "The DEA diversion investigators who worked this matter should be commended for uncovering failures that put controlled substances at risk of diversion, and their work has undoubtedly made West Virginia a safer place. When a healthcare system controls large quantities of addictive medications, strict compliance with the Controlled Substances Act is necessary to protect the public. This settlement, along with the corresponding Memorandum of Agreement, demands accountability and mandates meaningful reform across WVUHS."
Special Agent in Charge Jim Scott, head of DEA's Louisville Field Division, said, "Hospital systems stockpile controlled medications with a high potential for abuse, so it's imperative that they safeguard those drugs and maintain accurate records to prevent diversion. The multi-million dollar fine levied against the WVUHS in this case reflects the serious nature of their failure to meet their obligations in accordance with the Controlled Substances Act."
The settlement agreement is posted here: https://www.justice.gov/usao-ndwv/media/1452226/dl?inline.