CVS Pharmacy Inc., a Rhode Island-based pharmacy chain. 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.
Key details of the case
Americans are safer because of it,” said Associate Attorney General Stanley E. “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.
Meanwhile, 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. Calenda for the District of Rhode Island.
Enforcement actions and official statements
In addition, “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.
As a result, 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. “trinity” prescriptions, a dangerous and abused combination of an opioid, a benzodiazepine, and a muscle relaxant. For complete details, refer to the official DOJ press release.
Consequently, 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. Were not issued in the course of professional practice.
Notably, 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. Staffing policies that prioritized corporate profits over patient safety. For related coverage, see Florida laboratory vice president and marketer convicted of medicare fraud for COVID-19 testing scheme — DOJ.
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.
Subsequently, 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. 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. For related coverage, see Department of justice announces phase three of compensation process for western union fraud victims — DOJ.
“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. 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. We will continue to pursue those who betray the trust placed in them.”.
Investigation and prosecution details
The civil settlement resolves a civil lawsuit filed by Hillary Estright, a former CVS employee, under the whistleblower provision of the FCA. 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.