Virginia Hospital System to Pay $4.36 Million to Settle Claims of Controlled Substance Act Violations

Sovah Health has agreed to pay the United States $4.36 million to settle claims that the hospital system violated the Controlled Substances Act (CSA) on numerous occasions between 2017 and 2020. As part of the resolution, Sovah Health further agreed to be subject 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 that could result in additional monetary sanctions and injunctive relief. The settlement is the third-largest civil penalty ever obtained from a hospital system under the Controlled Substances Act and the largest ever in the Fourth Circuit. The claims center around Sovah Health’s failure to have effective controls in place to prevent the diversion of powerful painkilling prescription opioids. Sovah Health is a regional healthcare delivery system comprised of a hospital with two campuses.

From 2017 to 2019, a Sovah Health employee diverted more than 11,000 Schedule II controlled substances from Sovah Health. From January to May 2020 a second Sovah Health employee tampered with Fentanyl vials and hydromorphone injectables by replacing the controlled substance with saline and diverting the controlled substance. 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.

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