CVS: Serious dilemma for pharmacists, second guessed for dispensing too many opioids; too few 

Statement by CVS in response to a USDOJ announcement of a civil complaint (noted below): “We have cooperated with the DOJ’s investigation for more than four years, and we strongly disagree with the allegations and false narrative within this complaint. We will defend ourselves vigorously against this misguided federal lawsuit, which follows on the heels of years of litigation over these issues by state and local governments — claims that already have been largely resolved by a global agreement with the participating state Attorneys General. 

The government’s lawsuit seeks to impose a shifting standard for pharmacy practice. Many of the litigation theories laid out in the complaint are not found in any statute or regulation, and relate to topics on which the government has declined to provide guidance.

Each of the prescriptions in question was for an FDA-approved opioid medication prescribed by a practitioner who the government itself licensed, authorized and empowered to write controlled-substance prescriptions.

CVS Health has been an industry leader in developing innovative programs to fight opioid misuse. As one example, 12 years ago CVS Pharmacy pioneered a first-of-its-kind program to block controlled-substance prescriptions written by doctors of potential concern. To date, we have blocked more than 1,250 practitioners, including nearly 600 prescribers who the government continues to license. This program is not required by any statute or regulation, and CVS Health repeatedly has defended lawsuits from those alleging we go too far in blocking opioid prescribers.

The government’s lawsuit intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids, and too few. 

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Prior to yesterday’s announcement, CVS has published other information about their opioid prescription situation:

Fill this opioid prescription. No, wait, actually you can’t do that. Or, maybe, you can: The dilemma for community pharmacists

Community pharmacy is the most accessible part of the U.S. health care system. Here at CVS Pharmacy®, more than 27,000 pharmacists do their part in helping to keep America healthy. They are highly trained in the safe and appropriate use of all medications, as well as in the state and federal laws governing the dispensing of medicines. 

Part of this role includes filling legitimate prescriptions for opioid medications for patients requiring pain relief. In doing so, our pharmacists help to care for and educate patients on the proper use and misuse of opioid medications.

When it comes to filling opioid prescriptions, pharmacists are held to vague, undefined, and ever-changing standards of practice.

Opioids are approved and regulated by the U.S. Food and Drug Administration (FDA), and opioid prescriptions can only be written by a licensed physician authorized by the U.S. Drug Enforcement Administration (DEA) to do so. With the knowledge that opioids are often vital to patients enduring relentless pain, community pharmacists are challenged to assess if a prescription written by a licensed physician should not be filled.   

Whichever decision they make, community pharmacists know they can—and will—be second-guessed later. 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. While simultaneously being accused of dispensing too few opioids* and too many, pharmacists and pharmacies face threats of liability no matter their actions.

Caught between these conflicting demands from government agencies and trial attorneys, we have implemented best-in-class and first-of-its-kind programs to help our pharmacists make the best decisions on behalf of patients and in compliance with the law.

DEA Declines to Give Guidance

Even the DEA has said repeatedly that there is no simple rule to apply. The DEA published in 2006 a policy statement in the Federal Register saying that “one cannot provide an exhaustive and foolproof list of ‘dos and don’ts’ when it comes to prescribing controlled substances for pain or any other medical purpose.”  When again asked in 2019 to help pharmacists caught in this difficult moment, the DEA said in a letter to the National Association of Chain Drug Stores:

Even after taking these actions, we’ve been met with state investigations and lawsuits for allegedly second-guessing doctors’ medical judgment and refusing to fill opioid prescriptions. Whatever decision pharmacists make, it will not be good enough for some interest group.

This after-the-fact scrutiny places our pharmacists in an unenviable position. Our past efforts to work with the DEA to improve this situation have been routinely and flatly rebuked by bureaucrats that have no interest in disrupting the status quo.

How we’re keeping communities safer

Our comprehensive approach includes designing programs and collaborating with community leaders, policymakers, law enforcement, health care professionals and others to increase community-based educational programs related to opioid misuse, create safe prescription drug disposal sites, expand access to life-saving antidotes and advocate for targeted and effective policies, locally and nationally. 

Our opioid response includes:

• Safe medication disposal program includes units in more than 3,900 CVS Pharmacy locations and donations of more than 1,000 units to local police departments which together have removed more than 8 million pounds of unwanted medications from communities
• Pharmacist counseling for patients filling their first opioid prescription
• Community investments to support addiction recovery and prevention
• Opioid misuse prevention education* for teens and parents impacting more than 2.6 million individuals
• Access to both prescription and over the counter (OTC) opioid-overdose reversal medication and OTC fentanyl-testing strips where allowed by law
• Patients and colleagues can report suspected inappropriate or illegitimate dispensing, prescribing or diversion of controlled substances, violations of CVS policies and/ or procedures, other applicable law, or the terms of any  agreement between CVS Health® and any state or federal entity by calling the CVS Health Ethics Line anonymously and toll-free at 1-877-CVS-2040 (1-877-287-2040; TTY:711) or visit the Ethics Line page

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Nationwide Lawsuit filed in Rhode Island alleging CVS knowingly dispensed controlled substances in violation of the Controlled Substances Act and the False Claims Act

In a civil complaint unsealed today in federal court in Providence, Rhode Island, the Justice Department alleges that CVS Pharmacy, Inc., and various subsidiaries (collectively, CVS) filled unlawful prescriptions in violation of the Controlled Substances Act (CSA) and sought reimbursement from federal healthcare programs for some of the unlawful prescriptions in violation of the False Claims Act (FCA). CVS is the country’s largest pharmacy chain, with more than 9,000 pharmacies across the United States.

The government’s complaint alleges that, from October 17, 2013, to the present, 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. Among the large quantities of unlawful prescriptions that CVS allegedly filled were prescriptions for dangerous and excessive quantities of opioids, early fills of opioids, and “trinity” prescriptions, an especially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine, and a muscle relaxant.

CVS also allegedly filled large quantities of prescriptions for controlled substances written by prescribers it knew to be engaged in “pill mill practices” – that is, prescribers who issue large numbers of controlled substance prescriptions without any medical purpose. According to the complaint, CVS ignored substantial evidence from multiple sources, including its own pharmacists and internal data, indicating that its stores were dispensing unlawful prescriptions. 

The complaint alleges that CVS’s violations resulted from corporate-mandated performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety. CVS set staffing levels far too low for pharmacists to both meet their performance metrics and comply with their legal obligations. CVS also allegedly deprived its pharmacists of crucial information (including by, for example, preventing pharmacists from warning one another about certain prescribers) that could have reduced the number of unlawful prescriptions filled. The complaint alleges that CVS’s actions helped to fuel the prescription opioid crisis and that, in some particularly tragic instances, patients died after overdosing on opioids shortly after filling unlawful prescriptions at CVS.

“Opioid deaths remain a scourge on communities across Rhode Island and the nation, robbing families of loved ones and leaving a path of devastation in their wake,” said Zachary A. Cunha, U.S. Attorney for the District of Rhode Island. “This lawsuit alleges that CVS failed to exercise its critical role as gatekeeper of dangerous prescription opioids and, instead, facilitated the illegal distribution of these highly addictive drugs, including by pill mill prescribers. When corporations such as CVS prize profits over patient safety and overburden their pharmacy staff so that they cannot carry out the basic responsibility of ensuring that prescriptions are legitimate, we will use every tool at our disposal to see that they answer for it.”

“Our complaint alleges that CVS repeatedly filled controlled substance prescriptions that were unlawful and pressured its pharmacists to fill such prescriptions without taking the time needed to confirm their validity,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The practices alleged contributed to the opioid crisis and opioid-related deaths, and today’s complaint seeks to hold CVS accountable for its misconduct.”

The government alleges that by knowingly filling unlawful prescriptions for controlled substances, CVS violated the CSA and, where CVS sought reimbursement from federal healthcare programs, also violated the FCA. The complaint alleges that CVS’s actions helped to fuel the prescription opioid crisis. If CVS is found liable, it could face civil penalties for each unlawful prescription filled in violation of the CSA and treble damages and applicable penalties for each prescription reimbursed by federal healthcare programs in violation of the FCA. The court also may award injunctive relief to prevent CVS from committing further CSA violations, including ordering appropriate changes to corporate compliance programs and policies.

Whistleblower Hillary Estright, who previously worked for CVS, filed an action on October 17, 2019, under the qui tam provisions of the FCA. Those provisions authorize private parties to sue on behalf of the United States for false claims and share in any recovery. The Act permits the United States to intervene and take over such lawsuits, as it has done here.

The case is captioned United States ex rel. Estright v. Health Corporation, et al., No. 1:22-cv-222 (D.R.I.).

The United States’ intervention in this matter underscores the government’s commitment to combating health care 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 HHS, at 800-HHS-TIPS (800-447-8477).

The United States’ enforcement action is being litigated by attorneys from the U.S. Attorneys’ Offices for the District of Rhode Island (First Assistant U.S. Attorney Sara M. Bloom and Assistant U.S. Attorneys Kevin Love Hubbard and Rachna Vyas), the Justice Department Civil Division’s Consumer Protection Branch (Assistant Directors Amy L. DeLine and C.B. Buente, Senior Litigation Counsel Donald Lorenzen, and Trial Attorneys Benjamin Cornfeld and Amanda K. Kelly) and Commercial Litigation Branch, Fraud Section (Trial Attorneys Claire L. Norsetter, Joshua Barron, and Megan F. Engel), as well as the Eastern District of Virginia (Assistant U.S. Attorneys Clare Wuerker and John Beerbower), the District of Hawaii (Assistant U.S. Attorneys Sydney Spector and Tracy Weinstein), and the Eastern District of Texas (Assistant U.S. Attorneys James Gillingham and Adrian Garcia).

The DEA’s Office of Diversion Control, Washington, D.C. Field Division, HHS-OIG, and DCIS conducted the investigation. Several other offices provided substantial assistance in the investigation, including the United States Attorneys’ Offices for the Southern District of California, the Northern District of Ohio, DEA’s Office of Chief Counsel, DEA’s Office of Diversion Control, Los Angeles Field Division, the Office of Personnel Management, the Department of Labor Office of Inspector General, United States Postal Service Office of Inspector General, and the FBI.

The claims asserted against the defendants are allegations only, and there has been no determination of liability.

CVS is a Rhode Island-based company.

This is a developing story.