United States Drug Enforcement Administration

CVS Pharmacy Inc., a Rhode Island-based pharmacy chain, and its related corporate entities (collectively, CVS) have agreed to pay $315 million to resolve allegations that, from October 17, 2013 through December 2, 2025, CVS illegally filled prescriptions for opioids and other controlled substances in violation of the Controlled Substances Act (CSA), and then sought payment for many of those invalid prescriptions from Medicare and other federal healthcare programs in violation of the False Claims Act (FCA). 

“Not only does this settlement hold bad actors accountable for their fraudulent activities, but Americans are safer because of it,” said Associate Attorney General Stanley E. Woodward Jr. “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.”

“Today’s settlement requires CVS to implement additional safeguards to ensure that prescriptions for opioids and other controlled substances are dispensed only when medically appropriate,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “The remedial measures in this agreement — including proactive monitoring of opioid prescribing patterns — will provide critical protections for patients and federal healthcare programs. The Department of Justice will continue to take steps to prevent the unlawful dispensing of opioids.”

“The opioid epidemic has affected families and communities across Rhode Island and throughout the nation,” said First Assistant U.S. Attorney Charles C. Calenda for the District of Rhode Island. “Pharmacies 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.”

The settlement resolves allegations in the government’s complaint, which the United States filed on Dec. 13, 2024, in the U.S. District Court for the District of Rhode Island, 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. CVS also allegedly 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. Many of these prescriptions were ultimately billed to and reimbursed by federal healthcare programs.

The complaint further alleged that CVS’s violations stemmed from corporate-imposed performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety. CVS failed to employ enough pharmacists to serve patients, comply with CVS’s legal obligations, and meet corporate performance metrics. In addition, CVS’s policies allegedly prevented pharmacists from warning one another about certain problematic prescribers.

In addition to the monetary payment announced today, CVS has entered into a memorandum of agreement with DEA to address its future obligations in dispensing controlled substances. This agreement requires CVS to establish a hotline for both employees and the public to report suspected illegal dispensing of controlled substances, proactively monitor the dispensing patterns of its pharmacies to identify and address potentially illegal dispensing, and establish a process to evaluate prescribers suspected of illegal prescribing.

“This settlement agreement highlights DEA’s commitment to protecting the health and safety of Americans while holding CVS accountable for dispensing unlawful prescriptions and endangering the public,” said DEA Assistant Administrator Cheri Oz. “DEA is unwavering in its commitment to protect public health and ensuring pharmacies adhere to the highest standards of responsible dispensing. We will continue to work closely with law enforcement, regulatory agencies, and the healthcare community to prevent the misuse of controlled substances, and we will hold those who jeopardize the safety of our citizens accountable.”

“Behind every unlawful prescription is a patient who could be put in harm’s way,” said Acting Deputy Inspector General for Investigations Scott J. Lampert of the U.S. Department of Health and Human Services Office of Inspector General (HHS‑OIG). “The allegations in this case point to warning signs that should never be overlooked. HHS‑OIG will not tolerate conduct that jeopardizes lives, and we will continue to pursue those who betray the trust placed in them.”

The civil settlement resolves a civil lawsuit filed by Hillary Estright, a former CVS employee, under the whistleblower provision of the FCA, which authorizes private parties to sue on behalf of the United States and receive a share of any recovery.  It also permits the United States to intervene and take over such lawsuits, as it did here. The amount to be recovered by the private whistleblower has not yet been determined.  The qui tam case is captioned United States ex rel. Hillary Estright v. CVS Health Corporation, et al., No. 22-cv-00222 (D.R.I.).

This year the Administration launched the Task Force to Eliminate Fraud and the National Fraud Enforcement Division to enhance the Administration’s war on fraud, waste, and abuse in federal programs. When unscrupulous actors exploit these programs for their own financial gain, they defraud the government, harm the people these programs are designed to aid and protect, and undermine American businesses that play by the rules. The Civil Division’s FCA enforcement plays a critical role in combatting such fraudulent schemes, recovering billions of dollars for the American taxpayers, and holding wrongdoers accountable. FCA matters will continue to be on the forefront of the battle against fraud, and the Civil Division’s FCA work will support and advance the mission of the Task Force to Eliminate Fraud and the National Fraud Enforcement Division.

The resolution obtained in this matter was the result of a coordinated effort between the Civil Division’s Commercial Litigation Branch, Fraud Section, and the Enforcement & Affirmative Litigation Branch, along with the U.S. Attorneys’ Offices for the District of Rhode Island, Eastern District of Virginia, Eastern District of Texas, and District of Hawaii. The DEA’s Office of Diversion Control, Los Angeles Field Division, Richmond District Office, and Office of Chief Counsel led this case with substantial assistance from Health and Human Services Office of Inspector General, Defense Criminal Investigative Service, Defense Health Agency (DHA), Office of Personnel Management (OPM), Department of Labor (DOL) Office of Inspector General, and the Department of Veterans Affairs (VA).

The investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

The United States is represented in this matter by attorneys from the Justice Department’s Civil Division Commercial Litigation Branch, Fraud Section (Assistant Director Natalie Waites and Trial Attorneys Claire Norsetter and Megan Engel) and Enforcement & Affirmative Litigation Branch (Deputy Director Lisa Hsiao and Trial Attorneys Kathleen Brunson and Katherine Ho), as well as from the U.S. Attorneys’ Offices for the District of Rhode Island (Assistant U.S. Attorney Rachna Vyas), Eastern District of Virginia (Assistant U.S. Attorney John Beerbower), Eastern District of Texas (Assistant U.S. Attorney James Gillingham), and District of Hawaii (Assistant U.S. Attorney Tracy J. Weinstein).

The claims resolved by the settlement are allegations only and there has been no determination of liability.

Note: Find the CSA agreement here and the FCA agreement here.

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