OptumRx Inc., a prescription drug benefit provider, has agreed to pay $20 million to resolve allegations that it improperly filled certain opioid prescriptions in violation of the Controlled Substances Act.
The settlement resolves an investigation initiated by the Drug Enforcement Administration (DEA) into whether, between April 2013 and April 2015, OptumRx improperly filled certain opioid prescriptions in combination with other drugs such as benzodiazepines and muscle relaxants, commonly referred to as “trinity” prescriptions. The United States alleged that these combination prescriptions, which OptumRx filled primarily from a mail order pharmacy location in Carlsbad, California, 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 also contended that these trinity prescriptions carry significant risk of harm and that these red flags must be resolved prior to filling a controlled substance prescription. During the course of its investigation, the government alleged that OptumRx received numerous trinity prescriptions that raised red flags but filled those prescriptions without always resolving the red flags.
OptumRx reports that the company has instituted enhanced protocols in handing opioid prescriptions since 2017 to reduce the number, dose and duration of opioid prescriptions it dispenses. OptumRx also reports that it instituted more robust concurrent drug utilization review procedures to assist in identifying and not filling prescriptions for dangerous opioid combinations and excess dosing. During the course of the government’s investigation, OptumRx also closed its mail order pharmacy operations in Carlsbad, California.
“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.”
“Pharmacies are the last line of defense protecting the public from potentially dangerous and addictive medications,” said U.S. Attorney Tara McGrath for Southern District of California. “Combating the opioid crisis on all fronts includes holding pharmacies accountable if they shirk any part of the responsibilities required in filling prescriptions for potentially harmful drugs.”
“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.”
DEA’s Office of Diversion Control, San Diego Division Office conducted the investigation.
Assistant U.S. Attorneys Joseph Price, Dylan Aste, Betsy Boutelle and Colin McDonald for the Southern District of California and Trial Attorneys Scott B. Dahlquist and Brandon Robers and Assistant Directors Rachael Doud and Gabriel H. Scannapieco of the Civil Division's Consumer Protection Branch represented the United States.
This is the second substantial resolution of an opioid related investigation announced by the Justice Department in recent months. Late last year, the department announced a $12 million resolution and consent decree involving Droguería Betances LLC, one of Puerto Rico’s largest drug distributors. In that case, the United States alleged that Betances failed to report to the DEA hundreds of “suspicious orders” for opioids and other controlled substances distributed to Betances’ pharmacy customers.
The claims resolved by the settlement agreement announced today are allegations only. And there has been no determination of liability.
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