Long-term care pharmacy Omnicare has agreed to pay a $15.3 million civil penalty over allegations that it violated federal law by allowing opioids and other controlled substances to be dispensed without a valid prescription, the federal government announced Wednesday.

Omnicare denies the allegations but settled the lawsuit “to avoid the expense and uncertainty of potential litigation,” a spokesman for the company told McKnight’s Senior Living.

The subsidiary of Cincinnati-based CVS Health provides pharmacy services to assisted living and skilled nursing facilities, Programs of All-Inclusive Care for the Elderly and other long-term care entities. The settlement was reached after an investigation by the U.S. Drug Enforcement Administration field offices in Denver, Los Angeles, San Francisco and Seattle, and U.S. Attorney’s district offices of Central and Eastern California, Colorado, Oregon and Utah.

The charges focused on Omincare’s prescription drug deliveries to long-term care facilities, including “emergency kits” with limited stockpiles of controlled substances that can be dispensed to residents or patients on an emergency basis.

“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 in a statement. 

The DEA 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. A federal investigation found that Omnicare failed to control the emergency kits by improperly permitting long-term care facilities to “remove controlled substances from emergency kits without a valid prescription and obtain ‘after the fact’ prescriptions for physicians,” according to the DEA, which said that Omnicare also repeatedly failed to properly document and report emergency prescriptions of Schedule II controlled substances.

As part of the settlement agreement, Omnicare agreed to pay the civil penalty and entered into an agreement with the DEA that will require it to increase its auditing and monitoring of emergency kits placed at long-term care facilities, as well as properly train employees.

The settlement agreement, finalized May 6, resolves Omnicare’s civil liability for the alleged violations in those five districts.

Omnicare denies the allegations.

Mike DeAngelis, senior director of corporate communications for CVS, said the settlement agreement resolves allegations dating back to 2012 “concerning the handling and processing of controlled substance prescriptions at some of its long-term care pharmacy locations.” 

“CVS Health acquired Omnicare in 2015. The company is committed to the highest standards of business practices and meeting the needs of its long-term care patients,” DeAngelis said. “The matter was settled to avoid the expense and uncertainty of potential litigation and there was no admission of wrongdoing.”

He added the matter did not involve any of CVS Health’s other businesses, including CVS Pharmacy, CVS Caremark or Aetna.