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LVHN to pay $2.75M for drug noncompliance

Lehigh Valley Hospital Network agreed to pay $2.75 million to resolve allegations that it failed to comply with provisions of the Controlled Substances Act intended to prevent the illegal diversion of controlled substances, according to an announcement Tuesday by U.S. Attorney David Metcalf.

The settlement stems from LVHN’s disclosure to federal authorities that on approximately 40 occasions, a pharmacy technician at its Cedar Crest pharmacy used another employee’s password to access, remove, and divert controlled substances. The technician also created fictitious reports to conceal the discrepancies in the inventory of those substances.

In addition, the U.S. Attorney’s Office said the settlement resolves other allegations involving failures at certain LVHN facilities, where controls and procedures were not sufficient to prevent theft and diversion. According to the allegations, these deficiencies allowed controlled substances to be transferred between inpatient pharmacies, outpatient pharmacies, and hospice facilities without proper documentation. LVHN was also accused of failing to maintain complete and accurate records of its stock of controlled substances.

Since discovering the thefts at the Cedar Crest facility, LVHN has worked cooperatively with the U.S. Attorney’s Office for the Eastern District of Pennsylvania and the Drug Enforcement Administration to identify potential CSA violations and improve compliance measures, a press release stated.

According to the U.S. Attorney’s Office, LVHN has invested in physical security upgrades, staff training, diversion-detection software, and the hiring of both employees and consultants with expertise in CSA compliance.

“The U.S. Attorney’s Office is committed to aggressively combating the opioid crisis on all fronts, including by holding hospitals and pharmacies responsible when they fail to take adequate steps to prevent controlled substances from being diverted for unlawful purposes,” Metcalf said. “In fashioning appropriate resolutions, we also give credit to DEA registrants like LVHN who act in good faith to report potential CSA violations, prevent further deficiencies, and improve compliance efforts. While the penalties here are substantial, they may have been far greater but for LVHN’s disclosures and cooperation.”

“The Drug Enforcement Administration ensures that medical providers and facilities follow established laws and procedures while dispensing controlled substances,” Thomas Hodnett, special agent in charge of the DEA’s Philadelphia Field Division, said. “DEA holds medical professionals to a high standard to protect public safety and ensure accountability, and this settlement demonstrates DEA’s resolve to maintain these standards.”

The case was handled by Assistant U.S. Attorneys Peter Carr and Charlene Keller Fullmer, along with former auditor Dawn Wiggins.