WVU Medicine To Pay Over $4M For Controlled Substance Act Violations

WVU Medicine has agreed to pay $4.17 million for multiple violations of the Controlled Substances Act, the United States Attorney’s Offices for the Northern and Southern Districts of West Virginia announced Monday.  

An investigation by the Drug Enforcement Administration (DEA) found WVU Medicine had committed numerous record keeping and reporting violations over a seven-year period beginning in 2017.  

First Assistant U.S. Attorney Christopher J. Prezioso, one of several government attorneys who litigated the case, said the work of DEA diversion investigations has 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,” Prezioso said in a statement. “This settlement, along with the corresponding Memorandum of Agreement, demands accountability and mandates meaningful reform across WVUHS.”  

The violations include failures to:  

• notify the DEA about thefts or significant loss of controlled substances  

• maintain accurate inventory records  

• ensure proper authority for use of DEA order forms 

• maintain policies consistent with requirements of the Controlled Substances Act 

WVU Medicine will pay $4.17 million to resolve the civil allegations and enter a Memorandum of Agreement. 

The memorandum imposes systemwide compliance requirements that include:  

• rapid reporting of thefts or losses 

• installation of 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 WVU Medicine spokesperson said throughout the government’s review, the system cooperated fully with federal authorities and has worked diligently to strengthen policies, procedures, oversight, and training to ensure continued compliance with the Controlled Substances Act.  
 
“Importantly, this matter concerned regulatory compliance, recordkeeping, and documentation requirements,” she added in a statement. “It did not involve findings that WVU Health System intentionally engaged in unlawful distribution of controlled substances or that patient care was compromised.”