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 accusations of False Claims Act liability.
The lawsuit against Rite Aid is a reminder that any healthcare provider dispensing controlled substances needs to consider potential False Claims Act exposure 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.
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 in filling these prescriptions, Rite Aid’s pharmacists failed to satisfy their corresponding responsibility to ensure the proper dispensing of controlled substances. The government alleges that as a result of these Controlled Substances Act violations, Rite Aid submitted false certifications to federal healthcare programs, including Medicare Part D, Medicaid, and TRICARE, about the validity of the prescriptions it was dispensing and its compliance with federal and state law.
The government and relators routinely base False Claims Act lawsuits on alleged violations of federal statutes—the Anti-Kickback Statute and Stark Law are prime examples. The government’s decision to intervene in the lawsuit against Rite Aid raises the question whether providers can expect to see more False Claims Act lawsuits based on alleged violations of the Controlled Substances Act. To that end, the government’s complaint against Rite Aid touts other similar enforcement efforts and lists other actions where the government has settled allegations that providers submitted claims for controlled substances that lacked a valid prescription, were not for a legitimate medical purpose, lacked a medically accepted indication, or did not comply with state law.
Rite Aid has moved to dismiss the lawsuit by arguing, in part, that it is insufficient for the government to allege merely that Rite Aid filled prescriptions that had alleged red flags. Rite Aid’s motion to dismiss is pending. The scope of a pharmacy’s corresponding responsibility and what constitutes a red flag are developing areas in the pharmacy enforcement arena, and we continue to monitor developments related to those issues, including in lawsuits like the one against Rite Aid.
For more information on Controlled Substances Act compliance and the interplay between the Controlled Substances Act and False Claims Act, contact the authors and subscribe to this blog.