The United States recently intervened in a False Claims Act lawsuit accusing Rite Aid of defrauding federal healthcare programs by seeking reimbursement for opioids the pharmacy allegedly dispensed in violation of the Controlled Substances Act.

The government has shown an increased focus over the last few years on Controlled Substances Act enforcement for opioids and other controlled substances. But for many providers handling controlled substances, it might not be obvious that noncompliance with the Controlled Substances Act could also lead to False Claims Act liability.

The lawsuit against Rite Aid is a reminder that any healthcare provider dispensing controlled substances needs to consider False Claims Act liability when evaluating potential noncompliance with the Controlled Substances Act or diversion of controlled substances. A strong Controlled Substances Act compliance program can protect providers from myriad downstream consequences.

Background

In the lawsuit, U.S. ex rel. White v. Rite Aid Corp., pending in the U.S. District Court for the Northern District of Ohio, the government alleges that over a five-year period Rite Aid ignored red flags and filled controlled substance prescriptions involving:

• The Holy Trinity (combination of an opioid, benzodiazepine, and muscle relaxant).
• Early fills of fentanyl and oxycodone.
• Prescriptions from prescribers Rite Aid flagged internally for writing prescriptions with no medically valid purpose.

The government contends that...

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