CVS Pharmacy will pay $315 million to settle a federal lawsuit accusing the chain of knowingly filling prescriptions for opioids and other controlled substances that lacked a legitimate medical purpose or were otherwise not valid, and of billing Medicare and other government health programs for many of them, the Justice Department announced Tuesday.
The settlement covers conduct the government says stretched from October 2013 to early December 2025. It resolves a complaint the United States filed in December 2024 in federal court in Rhode Island, where CVS is based, according to the department. That suit was brought during the Biden administration.
Beyond the payment, CVS signed a memorandum of agreement with the Drug Enforcement Administration that sets out its future obligations for dispensing controlled substances. The company must set up a hotline that employees and members of the public can use to report suspected illegal dispensing. It also has to monitor dispensing patterns at its pharmacies proactively, so it can find and address potentially illegal dispensing, and create a process for evaluating prescribers suspected of illegal prescribing.
"Not only does this settlement hold bad actors accountable for their fraudulent activities, but Americans are safer because of it," Associate Attorney General Stanley E. Woodward Jr. said in the department's announcement. Brett A. Shumate, the assistant attorney general who leads the Civil Division, said the agreement requires CVS "to implement additional safeguards to ensure that prescriptions for opioids and other controlled substances are dispensed only when medically appropriate."
The government alleged that CVS dispensed dangerous and excessive quantities of opioids, filled opioid prescriptions too early and filled so-called trinity prescriptions, a mix of an opioid, a benzodiazepine and a muscle relaxant that the department called "a dangerous and abused combination." It also accused the chain of filling prescriptions from "pill mill" prescribers who issued large numbers of controlled-substance prescriptions without any medical purpose, and said CVS pharmacists filled such prescriptions despite clear red flags.
The complaint traced those alleged failures to the company's own policies. It said that corporate performance metrics, incentive pay and staffing policies put profits ahead of patient safety, that CVS did not employ enough pharmacists to serve patients and meet its legal obligations, and that company policies kept pharmacists from warning one another about certain problematic prescribers.
CVS disputes the government's account. In a statement reported by the Associated Press, the company said its pharmacists were trained "in the safe and appropriate use of all medications" and that it had implemented "best-in-class" programs to help them "make the best decisions on behalf of patients." It said it strongly disagreed with the lawsuit's claims and that the settlement admits no wrongdoing.
In 2024, CVS said pharmacists were being held to "vague, undefined, and ever-changing standards of practice" when filling opioid prescriptions, the AP reported. The department's announcement notes that the claims resolved by the deal are allegations only and that there has been no determination of liability.
The settlement also resolves a whistleblower suit that a former CVS employee filed under the False Claims Act, which allows private parties to sue on the government's behalf and collect a share of any recovery. The United States intervened and took over that case. The whistleblower's share has not yet been determined.
The Drug Enforcement Administration's Office of Diversion Control and other DEA offices led the case, with substantial help from the inspector general's office at the Department of Health and Human Services and several other federal agencies, the department said. The announcement presented the investigation and resolution as an illustration of the government's emphasis on combating health care fraud and pointed to the Task Force to Eliminate Fraud and the National Fraud Enforcement Division, which the administration launched this year.
Over the past decade, drugmakers, wholesalers, pharmacies and other companies have agreed to opioid settlements with governments in the United States totaling more than $50 billion, the AP reported, most of it with state and local governments. The bulk of that money is meant to address an addiction and overdose crisis that has been linked to more than 100,000 U.S. deaths in some years, although the numbers have fallen sharply recently. Federal authorities have reached several deals of their own, including settlements with Walgreens and Walmart in the last two years.