Omnicare Inc., a subsidiary of CVS Health and a provider of pharmacy services to long-term care facilities, agreed to pay a $15.3 million penalty to resolve allegations that it allowed opioids to be dispensed without prescriptions, federal prosecutors in Los Angeles announced Wednesday.
The Cincinnati-based Omnicare operates non-public "closed door" pharmacies that deliver controlled substances to nursing homes and other facilities, according to the U.S. Attorney's Office.
Prosecutors allege that Omnicare violated the federal Controlled Substances Act in its handling of emergency prescriptions, its controls over emergency supply kits at nursing homes, and its processing of written prescriptions that lacked required elements such as the prescriber's signature or Drug Enforcement Administration number.
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A CVS Health representative stated that in entering into the agreement, the company did not admit to any liability. The company also said that the allegations date back to 2012, three years before CVS Health acquired Omnicare.
"The company is committed to the highest standards of business practices and meeting the needs of its long-term care patients," according to CVS Health. "The matter was settled to avoid the expense and uncertainty of potential litigation and there was no admission of wrongdoing. This matter did not involve any of CVS Health's other businesses, including CVS Pharmacy, CVS Caremark or Aetna."
Omnicare makes daily deliveries of prescription medications to residents of the facilities, and it also pre-positions limited stockpiles of controlled substances at nursing homes in emergency kits, which are to be dispensed to patients on an emergency basis.
These 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.
The federal investigation allegedly found that Omnicare failed to control emergency kits by improperly permitting nursing homes and other facilities to remove opioids and other restricted substances from the 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, prosecutors allege.
"Omnicare dispensed powerful opioids without valid prescriptions and failed to inform federal authorities of significant losses of opioids and other drugs," U.S. Attorney Nick Hanna said. "With the opioid crisis still a very real concern, every entity that handles dangerous drugs will be held accountable to ensure powerful narcotics are properly dispensed and not diverted to the black market."
As part of the settlement agreement, Omnicare agreed to pay the $15.3 million civil penalty and entered into a memorandum of agreement with the DEA that requires Omnicare to increase its auditing and monitoring of emergency kits placed at long-term care facilities.
"Omnicare failed in its responsibility to ensure proper controls of medications used to treat some of the most vulnerable among us," DEA Acting Administrator Uttam Dhillon said. "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 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 in California, Colorado, Oregon, and Utah. The settlement agreement, which was finalized on May 6, resolves Omnicare's civil liability for alleged violations in those five districts.