The United States Department of Justice (DOJ) recently filed a lawsuit against CVS Pharmacy Inc. and various subsidies, alleging that they filled “unlawful” prescriptions in violation of the federal Controlled Substances Act. The complaint further alleged that CVS sought reimbursement from federal health care programs for the unlawful prescriptions, a violation of the False Claims Act.
The government alleged that from October 2013 to the present, CVS knowingly filled prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice. The Complaint alleges “illegitimate prescriptions for extremely high doses and excessive quantities of potent opioids that fed dependence and addiction, as well as illegitimate prescriptions for dangerous combinations of opioids and other drugs.” The Complaint further noted that among the prescriptions at issue were early fills of opioids as well as “trinity” prescriptions, which are a combination of an opioid, a benzodiazepine, and a muscle relaxant.
According to the DOJ, CVS also allegedly filled large quantities of controlled substances prescriptions written by prescribers known to be engaged in “pill mill practices,” ignoring evidence from multiple sources – including its own pharmacists – indicating that its stores were dispensing unlawful prescriptions.
The violations allegedly were the result of corporate performance metrics, incentive compensation, and staffing policies that put a heavy priority and emphasis on corporate profits. CVS also allegedly prevented its pharmacists from accessing important information that could have reduced the number of unlawful prescriptions filled, such as preventing pharmacists from warning one another about certain prescribers.
The Complaint goes so far as to allege that CVS “failed to instruct pharmacies not to fill any prescriptions from [“pill mill”] prescribers, and others, whom it knew to be practicing outside the usual course of professional practice. CVS even prohibited individual pharmacies from refusing to fill all prescriptions from these prescribers.”
The DOJ notes that these actions “contributed to the opioid crisis” as CVS and individual pharmacists “knew that they were required by law not to dispense drugs pursuant to prescriptions that bore unresolved red flags of invalidity, medical inappropriateness, and/or dangerousness” but filled prescriptions anyway. DOJ puts the onus on CVS – as opposed to the pharmacists who filled the prescriptions – due to the work conditions driven by CVS management.
If CVS is found liable in the lawsuit, it could face civil penalties for each unlawful prescription filled in violation of the Controlled Substances Act as well as treble damages and applicable penalties for each prescription reimbursed by federal health care programs in violation of the False Claims Act. The Court is also able to award injunctive relief to prevent CVS from engaging in further violations of the Controlled Substances Act, including ordering changes to their corporate compliance programs and policies.
“CVS is alleged to have dispensed large amounts of highly addictive opioid medications to persons they knew had no medical need for them,” said Administrator Anne Milgram of the Drug Enforcement Administration (DEA). “Simply put, they put profits over their obligation to keep their customers safe. A pharmacy is the final step in the pharmaceutical distribution process that is in place to keep customers safe. In the fight against the opioid epidemic, DEA will continue to be relentless in holding those accountable who violate our drug laws and place our communities in danger whether they are a criminal cartel or large pharmacy chain.”
A copy of the Complaint can be found here. Attachment 1 to the Complaint (a list of false claims fo prescriptions written by pill mill prescribers) is here and Attachment 2 (additional sample false claims is here.