SOVAH Health to pay millions to settle Controlled Substances Act violations claims

(WDBJ)
Published: Jun. 8, 2022 at 12:27 PM EDT
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ABINGDON, Va. (WDBJ) - A hospital system in the southside of Virginia has agreed to pay the United States $4.36 million to settle claims of Controlled Substances Act violations.

According to the United States Attorney’s Office for the Western District of Virginia, SOVAH Health has also agreed to be subjected to a period of four years of increased compliance and oversight during which any failure to comply with its obligations may result in contempt of court findings. Those findings could result in additional financial sanctions and injunctive relief.

SOVAH Health maintains a hospital with two campuses, one in Danville and another in Martinsville. SOVAH Health was formed in 2017 when the campuses of what were then known as the Danville Regional Medical Center and the Memorial Hospital of Martinsville and Henry County united.

Representatives with the US Attorney’s office say the claims SOVAH is paying to settle center around the regional health care system’s failure to prevent the diversion of painkilling prescription opioids. In a press release, the office said that from 2017 to 2019, a SOVAH pharmacy technician in Danville diverted more than 11,000 Schedule II controlled substances. From January to May of 2020, the office said a second employee, a Danville nurse, tampered with Fentanyl vials and hydromorphone injectables - replacing them with saline and diverting the controlled substance.

In a statement from the US Attorney’s Office, representatives said the United States alleged SOVAH Health failed to provide effective controls and procedures to guard against the diversion of controlled substances, filled orders for controlled substances without a system in place to disclose suspicious orders of controlled substances, and failed to maintain readily retrievable records of controlled substances.

“As opioid overdose deaths skyrocket, it is critical that health care companies are held accountable when they fail to effectively safeguard these powerful prescriptions within their facilities,” said U.S.  Attorney Christopher R. Kavanaugh for the Western District of Virginia. “The oversight provided by this resolution will ensure future compliance involving these important but potentially deadly substances, and the United States Attorney’s Office for the Western District of Virginia will continue to vigorously pursue these cases with our federal and local partners in order to protect Virginia’s communities.”

“Today’s settlement sends a clear message to all registrants that it is essential to maintain effective controls to prevent the diversion of controlled substances” said DEA Washington Division Special Agent in Charge Jarod Forget.  “DEA is dedicated to combat the prescription drug abuse problem in Virginia and throughout the country and to hold all DEA registrants accountable.”

“The FDA oversees the U.S. drug supply to ensure that patients receive medicines that are safe and effective,” said Special Agent in Charge George A. Scavdis of the FDA Office of Criminal Investigations Metro Washington Field Office. “We will continue to protect the public health by holding accountable health care companies that fail to safeguard their prescription drug inventory and thereby compromise their patients’ health and comfort.”

“With opioid deaths and overdoses at record-breaking highs, especially across Southside Virginia, there must be zero tolerance of trusted health professionals engaging in drug diversion,” said Colonel Gary T. Settle, Virginia State Police Superintendent. “For the safety and protection of Virginia’s communities, our Virginia State Police Drug Diversion special agents, in collaboration with our local and federal public safety partners, will continue to aggressively pursue investigations related to the illegal distribution of Fentanyl and other prescription drugs.”

According to the U.S. Attorney’s Office, this agreement resolves SOVAH’s potential civil and criminal liability based on the investigation. As part of the resolution, SOVAH is also committed to making changes to maintain compliance with the Controlled Substances Act. They include, but are not limited to, having cameras at all Automated Dispensing Machines to capture the activity of placing/removing controlled substances; promptly reporting losses and diversion of controlled substances; taking and reporting disciplinary action taken against employees found to have been responsible for theft, diversion or loss of controlled substances; maintaining a mandatory random drug testing program for employees; and conducting a full physical inventory of all federally scheduled II-V controlled substances more frequently than required by law.

Assistant U.S. Attorneys Justin Lugar and Randy Ramseyer represented the United States in this matter. The investigation was conducted by the Food and Drug Administration - Office of Criminal Investigations, the Drug Enforcement Administration – Roanoke Resident Office Diversion Group, and the Virginia State Police.

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