ABINGDON, Virginia – Sovah Health agreed to pay the United States $ 4.36 million to resolve complaints that the hospital system violated the Controlled Substances Act (CSA) on numerous occasions between 2017 and 2020. As part of the resolution, Sovah Health has also agreed to be subject to a four-year period of enhanced compliance and scrutiny during which any failure to comply with its obligations may result in contempt of court conclusions which could result in additional fines and injunctive relief. The agreement is the third largest civil penalty ever obtained by a hospital system under the Controlled Substances Act and the largest ever in the fourth circuit.
The claims center around Sovah Health’s inability to have effective controls to prevent the diversion of potent prescription opioid pain relievers. Sovah Health is a regional health care system consisting of a hospital with two campuses: Danville and Martinsville. In 2017, Danville (formerly Danville Regional Medical Center) and Martinsville (formerly Memorial Hospital of Martinsville and Henry County) joined together to form Sovah Health.
From 2017 to 2019, a Sovah Health employee hijacked more than 11,000 Schedule II controlled substances from Sovah Health. From January to May 2020, a second Sovah Health employee tampered with fentanyl ampoules and hydromorphone injectables by replacing the controlled substance with saline and diverting the controlled substance. The United States said Sovah Health did not provide effective controls and procedures to protect itself from diversion of controlled substances, fulfilled orders for controlled substances without a system in place to reveal suspicious orders for controlled substances, and did not maintain easily recoverable records of the substances. check.
“As opioid overdose deaths skyrocket, it is critical that healthcare companies are held accountable when they fail to effectively safeguard these powerful prescriptions within their facilities,” said US 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 US 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 the communities of Virginia. “
“Today’s agreement sends a clear message to all registrants that it is essential to maintain effective controls to prevent diversion of controlled substances,” said Jarod Forget, DEA Washington Special Agent in charge. “The DEA is committed to fighting the problem of prescription drug abuse in Virginia and across the country and to holding all DEA registrants accountable.”
“The FDA oversees drug delivery in the United States to ensure patients receive safe and effective drugs,” said Acting Special Agent George A. Scavdis of the FDA’s Office of Criminal Investigations Metro Washington Field Office. “We will continue to protect public health by holding healthcare companies accountable for failing to safeguard their prescription drug inventory and thereby compromising the health and comfort of their patients.”
“With opioid deaths and overdoses at record levels, especially throughout Southside Virginia, there must be zero tolerance for trusted health care professionals engaged in drug diversion,” said Colonel Gary T. Settle, Superintendent of Police. of the state of Virginia. “For the safety and security of Virginia’s communities, our Virginia State Police Special Drug Diversion Agents, in conjunction with our local and federal public safety partners, will continue to aggressively pursue investigations relating to the illegal distribution of fentanyl and other prescription drugs. “
The deal, which is available here, resolves Sovah Health’s potential civil and criminal liability based on the investigation. As part of the resolution, Sovah Health has undertaken to adopt further compliance measures including, by way of example but not limited to, having cameras in all automatic dispensing machines to capture the introduction / removal of controlled substances; timely reporting of leaks and diversion of controlled substances; adopt and report the disciplinary measures adopted against employees held responsible for the theft, diversion or loss of controlled substances; maintain a mandatory program of random drug testing for employees; and conduct a complete physical inventory of all federally scheduled II-V controlled substances more frequently than required by law.
US Assistant Attorneys Justin Lugar and Randy Ramseyer have 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.