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, U.S. Attorney McGregor W. Scott announced today.
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 DEA Acting Administrator Uttam 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.”
“When controlled substances are diverted from their intended lawful purpose, whether from a large ‘closed door’ pharmacy chain like Omnicare or a pharmacy open to the public, there is a substantial danger to public health and safety,” U.S. Attorney Scott stated. “That is why the United States Attorney’s Office, together with our law enforcement partners, will continue to enforce the Controlled Substances Act against pharmacies of any size or type that violate the Act and will seek substantial civil penalties when warranted.”
“Failure to control access to prescription drugs can lead to the diversion of medication that could fall into the wrong hands with potentially devastating consequences,” stated DEA Special Agent in Charge Daniel C. Comeaux. “Today’s settlement demonstrates DEA’s commitment in protecting the health and safety of the public by ensuring all entities involved in the distribution of controlled substances follow the law.”
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 today, Omnicare agreed to pay the $15.3 million civil penalty 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.
This matter was investigated by the DEA’s Field Divisions in Denver, Los Angeles, San Francisco and Seattle, in conjunction with five U.S. Attorney’s Offices: the Central District of California, the Eastern District of California, the District of Colorado, the District of Oregon, and the District of Utah. 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. In entering into this settlement agreement, Omnicare did not admit to any liability.