Omnicare, Inc., a subsidiary of CVS Health and a leading provider of pharmacy services to long-term care facilities, has agreed to pay the United States a $15.3 million civil penalty to resolve allegations that it violated federal law by allowing opioids and other controlled substances to be dispensed without a valid prescription, DEA Acting Administrator Uttam Dhillon announced Wednesday.
Omnicare operates “closed-door” pharmacies, which are pharmacies that are not open to the public, that deliver controlled substances to nursing homes and other long-term care facilities. Omnicare makes daily deliveries of prescription medications to residents of long-term care facilities; but it also pre-positions limited stockpiles of controlled substances at long-term care facilities in “emergency kits,” which are to be dispensed to patients on an emergency basis. These emergency kits, which often include opioids and other controlled substances that are commonly abused and diverted, remain part of Omnicare’s inventory and must be tightly controlled and tracked. The controlled substances may be dispensed only pursuant to a valid prescription.
“Omnicare failed in its responsibility to ensure proper controls of medications used to treat some of the most vulnerable among us,” said Acting Administrator Dhillon. “DEA is committed to keeping our communities safe by holding companies like Omnicare accountable for such failures while ensuring continuity of care and necessary access to emergency prescription drug supplies.”
The United States alleged that Omnicare violated the federal Controlled Substances Act in its handling of emergency prescriptions, its controls over the emergency kits, and its processing of written prescriptions that had missing elements. The federal investigation found that Omnicare failed to control emergency kits by improperly permitting long-term care facilities to remove opioids and other controlled substances from emergency kits days before doctors provided a valid prescription. The investigation also revealed that Omnicare had repeated failures in its documentation and reporting of oral emergency prescriptions of Schedule II controlled substances.
As part of the settlement agreement announced Wednesday, Omnicare agreed to pay the $15.3 million civil penalties and entered into a Memorandum of Agreement with the Drug Enforcement Administration that will require Omnicare to increase its auditing and monitoring of emergency kits placed at long-term care facilities.
The settlement agreement, which was finalized on May 6, resolves Omnicare’s civil liability for the alleged Controlled Substances Act violations in those five districts.
The claims settled by this civil agreement are allegations and in entering into this settlement agreement, Omnicare did not admit to any liability.