In an email statement to USA TODAY, a CVS representative stated, “We have cooperated with the DOJ’s investigation for over four years, and we strongly refute the allegations and inaccurate portrayal in this complaint.” The statement further indicated that the company intends to vigorously defend itself against the federal lawsuit, following previous litigations at state and local levels that were largely settled through a global agreement with state Attorneys General.
CVS is accused of disregarding the presence of pill mills and evidence provided by its own pharmacists. The U.S. Attorney’s Office alleges that CVS filled numerous prescriptions for controlled substances from prescribers known to engage in “pill mill practices.” Pill mills are illicit pharmacies that excessively prescribe controlled substances to patients without medical need, as defined by the National Library of Medicine.
Despite having significant evidence from various sources, including its own pharmacists and internal data, CVS allegedly turned a blind eye to the illegal prescriptions being dispensed at its stores, as stated in the complaint.
The Justice Department asserts that CVS’s actions contributed to the opioid crisis by neglecting evidence and violating the Controlled Substances Act (CSA) and False Claims Act (FCA). The Department accuses CVS of prioritizing profit over patient safety through corporate performance metrics, incentive compensation, and staffing policies that compromised compliance with legal responsibilities.
The complaint also alleges that CVS’s actions exacerbated the opioid crisis, with tragic incidents where patients fatally overdosed on opioids shortly after obtaining unlawful prescriptions from CVS.
Former CVS employee Hillary Estright was identified as a whistleblower by the Justice Department. She filed a report on October 17, 2019, under the qui tam provisions of the FCA, allowing private individuals to sue on behalf of the U.S. for false claims and potentially share in any recovery.
CVS has maintained that the prescriptions in question were for an FDA-approved opioid medication.
According to a statement released by CVS, the pharmacy giant has responded to the government’s lawsuit by accusing it of attempting to enforce a “shifting standard for pharmacy practice.” The statement asserts that many of the legal arguments presented in the complaint lack a basis in existing statutes or regulations and pertain to issues on which the government has refrained from offering guidance.
CVS contends that the prescriptions flagged by the Justice Department as “unlawful” were actually for an FDA-approved opioid medication prescribed by a practitioner who had been duly licensed, authorized, and empowered by the government to issue controlled-substance prescriptions. The pharmacy points out that it initiated a pioneering program over a decade ago to intercept controlled-substance prescriptions from doctors deemed potentially problematic. According to CVS, this initiative has led to the blocking of over 1,250 practitioners, including 600 prescribers who are still licensed by the government.
The statement emphasizes that this intervention program is not mandated by any existing laws or regulations. CVS Health alleges that it has faced legal challenges from various quarters over concerns that its efforts to curb opioid prescribing go beyond what is necessary or appropriate. The pharmacy company asserts that the current lawsuit from the government only serves to compound the difficulties faced by pharmacists, who are caught in a bind of being criticized for both dispensing too many opioids and too few.
The ongoing legal dispute between CVS and the Department of Justice highlights the broader challenges and complexities surrounding prescription drug practices in the United States. At the heart of the matter is a fundamental disagreement over the appropriate scope and limits of pharmacy responsibilities and government oversight in combating the opioid crisis.
The government’s decision to pursue legal action against CVS underscores the heightened scrutiny faced by healthcare providers and entities in the wake of the opioid epidemic. As regulators and law enforcement agencies seek to hold accountable those deemed responsible for fueling the crisis, companies like CVS find themselves navigating a precarious landscape of legal challenges and public scrutiny.
CVS’s defense against the allegations leveled by the Department of Justice sheds light on the divergent perspectives within the healthcare industry regarding the best strategies to address the opioid epidemic. While the government asserts that certain prescriptions filled by CVS were unlawful, the pharmacy maintains that its actions were consistent with existing regulations and aimed at preventing the misuse of controlled substances.
As the legal proceedings unfold, the case against CVS serves as a focal point for the broader conversations taking place around the role of pharmacies, doctors, and regulators in combating the opioid crisis. The outcome of this legal battle is likely to have far-reaching implications for how pharmacies operate and collaborate with prescribers in the ongoing efforts to address the complex challenges posed by opioid misuse and addiction.
In the face of mounting legal pressure and public scrutiny, CVS’s response to the government’s lawsuit underscores the complexities and nuances inherent in navigating the evolving landscape of prescription drug practices and regulatory oversight. The outcome of this legal dispute will not only impact the future operations of CVS Health but also shape the broader policy discussions and initiatives aimed at addressing the multifaceted issues underlying.
