The United States recently filed a complaint in intervention in a False Claims Act (FCA) lawsuit against Rite Aid Corporation and various subsidies, alleging that the company knowingly filled unlawful prescriptions for controlled substances. In addition to the False Claims Act violation allegations, the United States further alleged that Rite Aid violated the Controlled Substances Act (CSA).
The complaint alleges that Rite Aid knowingly filled hundreds of thousands – and maybe more – of unlawful prescriptions for controlled substances without a legitimate medical purpose, that were not for a medically accepted indication, or were not issued in the usual course of professional practice from at least May 1, 2014, through June 10, 2019. The government alleges that the prescriptions included prescriptions for “extremely high doses and excessive quantities of opioids that fed opioid dependence and addiction,” prescriptions for “trinities” (a combination of an opioid, benzodiazepine, and muscle relaxer) and prescriptions that were written by prescribers “who Rite Aid’s own pharmacists had repeatedly identified as writing illegitimate prescriptions with no medically valid purpose.”
The government further alleges that the prescriptions were filled by Rite Aid pharmacists despite “obvious, and often multiple, red flags” that the prescription was connected to misuse, either through the prescription itself, the prescriber, the customer, or a combination of factors. Rite Aid pharmacists allegedly ignored those red flags, “making either no effort or a patently inadequate effort to resolve the red flags,” ultimately filling the “unlawful prescriptions despite knowing, based on their training and experience, that they had a legal obligation not to fill them.”
According to the complaint, Rite Aid also ignored evidence from multiple sources – including some of its own pharmacists, its distributor, and its own internal data – that its stores were dispensing unlawful prescriptions. Not only did the company ignore the evidence, but the Rite Aid Government Affairs Department “repeatedly directed employees in another Rite Aid department to delete in Rite Aid’s dispensing software Rite Aid pharmacists’ internal notes about suspicious prescribers such as, ‘cash only pill mill???’ ‘writing excessive dose[s] for oxycodone,’ and bluntly ‘DO NOT FILL CONTROLS.’” Taking it a step further, one pharmacist who added such a note was told by a Rite Aid Government Affairs analyst to “always be very cautious of what is put in writing.” The complaint also notes that in circumstances where Rite Aid “knew that a practitioner was not prescribing controlled substances for legitimate medical purposes,” Rite Aid “very rarely took action to stop the flow of opioids prescribed by that practitioner.”
Therefore, the DOJ argues, by knowingly filling unlawful prescriptions for controlled substances, Rite Aid violated the CSA and where Rite Aid sought reimbursement from federal health care programs, violated the FCA.
The qui tam complaint was initially filed in October 2019 by three former Rite Aid employees. The DOJ noted that their decision to intervene in this case emphasizes the ongoing battle against the opioid epidemic, and in the complaint, the DOJ stated “[b]ecause pharmacies are the last step in the supply chain before controlled substances are in the hands of individuals, the law vests pharmacies and pharmacists with important obligations to ensure that they fill only legitimate prescriptions.”
“The Justice Department is using every tool at our disposal to confront the opioid epidemic that is killing Americans and shattering communities across the country,” said Attorney General Merrick B. Garland. “That includes holding corporations, like Rite Aid, accountable for knowingly filling unlawful prescriptions for controlled substances.”
“Pharmacies are required to ensure prescription drugs are only dispensed based on valid prescriptions,” said Special Agent in Charge Maureen Dixon of the Department of Health and Human Services, Office of the Inspector General (HHS-OIG). “Prescriptions which are not medically necessary, and not for a medically accepted indication, will not be paid for by Medicare and Medicaid. HHS-OIG will continue to work with our law enforcement partners and the Department of Justice’s Civil Division to recover improperly paid funds through the FCA.”