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Rhode Island-based drug chain CVS has agreed to pay $315 million to resolve allegations of unlawful and fraudulent activities involving the illegal filling of prescriptions of controlled substances and then seeking payment for filling those prescriptions from the government through Medicare and other federal healthcare programs.
According to an announcement Tuesday by the U.S. Department of Justice (DOJ), the settlement follows allegations that, between October 2013 and December 2025, CVS was in violation of the Controlled Substances Act (CSA) and the False Claims Act (FCA).
According to the settlement agreement:
The United States contends that it has certain civil claims pursuant to the CSA against CVS related to its dispensing of controlled substance prescriptions that were not valid, were not for a medically accepted indication, were not medically necessary, were not issued for a legitimate medical purpose and/or in the usual course of professional practice, presented red flags that were not resolved or documented, and/or were in violation of the restrictions on refills.
While the settlement agreement constitutes “neither an admission of liability by CVS nor a concession by the United States that its claims are not well founded,” Associate Attorney General Stanley E. Woodward Jr. said it serves two purposes.
“Not only does this settlement hold bad actors accountable for their fraudulent activities, but Americans are safer because of it,” he observed. “Today’s settlement is a significant milestone in the Justice Department’s efforts to combat the opioid epidemic by cracking down on pharmacies who unlawfully fulfill prescriptions for controlled substances.”
According to the DOJ’s announcement, the federal government alleged that 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 United States alleged that CVS dispensed prescriptions for dangerous and excessive quantities of opioids, opioid prescriptions filled too early, and ‘trinity’ prescriptions, a dangerous and abused combination of an opioid, a benzodiazepine, and a muscle relaxant,” the DOJ continued, arguing as well that the pharmacy chain “filled prescriptions for controlled substances from ‘pill mill’ prescribers who issued large numbers of controlled substance prescriptions without any medical purpose.”
“Further, the United States alleged that CVS pharmacists filled these prescriptions despite clear red flags indicating that there was a high likelihood that the prescriptions lacked a legitimate medical purpose, were not valid, or were not issued in the course of professional practice,” the department said, noting that “[m]any of these prescriptions were ultimately billed to and reimbursed by federal healthcare programs.”
The DOJ also asserted that CVS’s staffing policies “prioritized corporate profits over patient safety.”
In a press statement titled “CVS Health statement regarding the U.S. Department of Justice’s lawsuit against CVS Pharmacy – December 18, 2024,” the drug chain described the situation of “community pharmacists” as that of a “dilemma,” arguing that pharmacists “face threats of liability no matter their actions.”
“When it comes to filling opioid prescriptions, pharmacists are held to vague, undefined, and ever-changing standards of practice,” the statement read, continuing that opioids are “approved and regulated by the U.S. Food and Drug Administration (FDA)” and must be prescribed by a “licensed physician authorized by the U.S. Drug Enforcement Administration (DEA).”
“Whichever decision they make, community pharmacists know they can—and will—be second-guessed later,” CVS said. “Too often, we have seen government agencies and trial lawyers question the good-faith decisions made by pharmacists while a patient waits at the pharmacy counter, often in pain.”
But First Assistant U.S. Attorney Charles C. Calenda for the District of Rhode Island asserted that “[p]harmacies that dispense controlled substances must maintain effective compliance systems to identify and respond to warning signs that prescriptions may be unlawful or medically unnecessary.”
“This settlement demonstrates the importance of those obligations and the consequences of failing to implement safeguards designed to prevent the improper dispensing of controlled substances,” Calenda added.
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