Optum Rx recently reached a $20 million settlement with the United States Department of Justice (DOJ) over allegations that it improperly filled opioid prescriptions in violation of the Controlled Substances Act (CSA).
The settlement stems from a Drug Enforcement Administration (DEA) investigation into whether OptumRx improperly filled certain opioid prescriptions in combination with other drugs such as benzodiazepines and muscle relaxants, commonly known as “trinity” prescriptions, between April 2013 and April 2015. The United States alleged that these combination prescriptions raised “red flags,” indicating that the prescriptions may not have been intended for legitimate medical use and could lead to abuse or diversion of highly addictive and powerful opioids. The United States further alleged that trinity prescriptions carry a significant risk of harm and that the red flags must be resolved before filling a controlled substance prescription.
Most of the prescriptions were dispensed from OptumRx’ mail order pharmacy operations located in Carlsbad, California. OptumRx closed that pharmacy during the DEA’s investigation.
OptumRx has reported that it has implemented protocols since the timeframe to reduce the number, dose, and duration of opioid prescriptions dispensed by the company. OptumRx also noted it implemented more robust concurrent drug utilization review procedures to help identify and not fill prescriptions for dangerous opioid combinations and excess dosing.
As we often see, the claims resolved under the settlement agreement are only allegations and no determination of liability has been made. Reuters noted that this settlement “appeared to be the first reached by the government with a pharmacy benefit manager (PBM) over allegedly illicit opioid prescriptions.”
“DEA registrants have an obligation to protect the public, not help fuel the opioid epidemic,” said Assistant Administrator Thomas W. Prevoznik of the DEA Diversion Control Division. “The trinity style prescription combination helped fuel the start of the opioid addiction crisis and raises a red flag, which this registrant should have recognized and reacted to rather than putting profits before patients’ safety.”
“Pharmacies providing opioids and other controlled substances have a duty under the Controlled Substances Act to ensure that they fill prescriptions only for legitimate medical purposes,” said Principal Deputy Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work with its law enforcement partners to ensure that pharmacies do not contribute to the opioid addiction crisis.”