The Justice Department has filed a lawsuit against CVS Pharmacy Inc., the country’s largest pharmacy chain, for filling unlawful prescriptions in violation of the False Claims Act and seeking reimbursement from federal health care programs.
In a civil complaint unsealed in Providence, R.I., the government claims that since October 17, 2013, CVS has knowingly filled prescriptions for controlled substances that did not have a legitimate medical reason, were not valid, and weren’t issued in the usual course of professional practice. The government alleges that the unlawful prescriptions include 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.
The complaint also claims CVS filled large quantities of prescriptions for controlled substances written by prescribers it knew to be engaged in “pill mill practices” or 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.
In response to the lawsuit, CVS issued a lengthy statement and said that when it comes to filling opioid prescriptions, pharmacists are held to vague, undefined, and ever-changing standards of practice. The pharmacy chain said opioids are approved and regulated by the U.S. Food and Drug Administration, and opioid prescriptions can only be written by a licensed physician authorized by the U.S. Drug Enforcement Administration to do so. With the knowledge that opioids are often vital to patients enduring relentless pain, CVS said 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,” CVS said.
But the Justice Department blames the illegal practices on corporate-mandated performance metrics, incentive compensation, and staffing policies that prioritized corporate profits over patient safety, according to the complaint. The Justice Department alleges CVS set staffing levels far too low for pharmacists to both meet their performance metrics and comply with their legal obligations. In addition, the government said 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’ actions helped to fuel the 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 U.S. Attorney Zachary A. Cunha for the District of Rhode Island, in the announcement. “This lawsuit alleges that CVS failed to exercise its critical role as gatekeeper of dangerous prescription opioids and, instead, facilitated the illegal proliferation 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.”
If CVS is found liable, it could face civil penalties for each unlawful prescription filled in violation of the Controlled Substances Act and treble damages and applicable penalties for each prescription reimbursed by federal health care programs in violation of the False Claims Act. The court also may award injunctive relief to prevent CVS from committing further Controlled Substances Act violations, including ordering appropriate changes to corporate compliance programs and policies.
“When lives are destroyed or lost to opioid abuse, it doesn’t matter if the supplier is a street-level dealer, a pill mill, or a nationwide corporation,” said U.S. Attorney Jessica D. Aber for the Eastern District of Virginia, in the announcement. “Our laws regarding the dispensing of opioids and other controlled substances are clear and apply to everyone. We will pursue whatever legal action is necessary to stop any enterprise, regardless of size, that places profit over the safety of our citizens.”
CVS said it’s implemented best practices to help pharmacists make the best decisions on behalf of patients and in compliance with the law. Those actions include:
- Voluntarily blocking dispensing of controlled substances written by certain doctors whose prescribing patterns have raised concerns.
- Developed cutting-edge algorithms to help pharmacists identify forged prescriptions, a task which CVS said can be extraordinarily difficult because of the sophistication of the forgeries.
- Check within the system that the prescriber has an active Drug Enforcement Administration registration that permits them to prescribe opioids.
- Provide pharmacists with system safety alerts for certain opioid prescriptions, such as those written for particularly high dosages.
- Give pharmacists access to state prescription drug monitoring databases and encourage pharmacists to use them.
- Train pharmacists about appropriate opioid dispensing multiple times each year.
- Support the judgements of pharmacists when they refuse to fill a prescription.
In addition, CVS said that it has developed an opioid response that includes a safe medication disposal program; pharmacist-patient consultation for first opioid prescription; community investments to support addiction recovery and prevention; opioid misuse prevention education for teens and parents; access to both prescription and over-the-counter opioid-overdose reversal medication and fentanyl-testing strips where allowed by law; and a CVS Health Ethics hotline where patients and colleagues can report suspected in appropriate or illegitimate dispensing, prescribing or diversion of controlled substances.