The U.S. Department of Justice alleges in a civil suit unsealed Wednesday, Dec. 18, 2024, that CVS ignored clear patterns of prescription fraud for opioids and other tightly regulated depressants. (Courtesy of CVS Health)
The U.S. Department of Justice has targeted CVS in a nationwide lawsuit, alleging the retail pharmacy giant worsened the opioid crisis by filling — and using government money to pay for — phony prescriptions for powerful drugs.
The civil complaint filed on Friday and unsealed Wednesday names CVS and its numerous subsidiaries in all 50 states as defendants. The 97-page suit accuses the pharmacy chain, which numbers more than 9,000 branches, of ignoring clear patterns of prescription fraud for opioids and other tightly regulated depressants.
The national pharmacy giant’s filling of questionable prescriptions ultimately contributed to “the epidemic of opioid death” over the 10-year period investigated in the lawsuit, U.S. Attorney for the District of Rhode Island Zachary A. Cunha told reporters in a press event Wednesday.
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“It is our allegation that CVS as a corporation ignored repeated red flags that large numbers of opioid prescriptions were not legitimate and should not have been filled,” Cunha said.
CVS Pharmacy Inc. is headquartered in Woonsocket and is the largest pharmacy chain in the country. It operates directly in six states, including Rhode Island, and owns subsidiaries in other states which are responsible for local compliance with Drug Enforcement Administration rules for controlled substances.
The pharmacy chain’s parent company, CVS Health, has expanded into most areas of the health care industry but has experienced tough times in recent months. In September, it announced it would lay off 2,900 people, and a year ago, its stock price was $74.88 per share. Shares rose 2.82% to $45.28 Wednesday.
The suit argues that CVS ignored internal suspicions about certain problematic doctors and prescriptions, and essentially defrauded federal programs like TRICARE, a military health care program, by filling these prescriptions. The suit places the blame squarely on corporate policies, and notes that pharmacists themselves often raised alarms about prescriptions, including those from known fraudulent physicians, to no avail.
“CVS pharmacists described working at CVS as ‘soul crushing’ because it was impossible to meet the company’s expectations while performing their jobs properly and safely,” the lawsuit reads.
The misery of employees derived from CVS’ attempts to lighten its labor costs, the Department of Justice alleges, because the company “set staffing levels so low that it was impossible for pharmacists to comply with their legal obligations and meet CVS’s demanding metrics,” according to the lawsuit. “CVS repeatedly ignored the increasingly impassioned complaints from pharmacists that their pharmacies were dangerously understaffed.”
‘These are not subtle red flags, they are overt’
One doctor mentioned in the suit doled out an estimated 16,000 controlled substance prescriptions over roughly 21 months — about 25 prescriptions for controlled substances per day.
“The fact that a prescription is for a legitimately licensed drug doesn’t make the individual prescription legitimate,” Cunha told reporters. “If I go to my physician and I pay that physician $100 in the absence of a medical condition to issue me a prescription for an opioid, that’s not a legitimate prescription.”
A case study of a Virginia resident identified as “Patient #2” shows that CVS, over the course of about three months, filled four prescriptions at CVS for 2mg alprazolam tablets — the highest commercial dose of the drug also known as Xanax. The prescriptions were all written by the same doctor and amounted to 201 tablets in all, “and together generated an excess supply of 166 tablets in three months,” according to the lawsuit.
Patient #2 was also filling opioid and tranquilizer prescriptions from the same doctor at other pharmacies. Patient #2 died from a mixed overdose 10 days after picking up their last bottle of alprazolam at CVS.
Other patients mentioned in the lawsuit were able to successfully fill “trinity cocktails” at CVS, which are simultaneous prescriptions for an opioid, a benzodiazepine like alprazolam or diazepam (Valium), and muscle relaxant carisoprodol. The drugs can exert a fatal depressant effect when ingested together, and the lawsuit shows very high amounts of these drugs being dispensed in tandem at CVS locations.
One trinity cocktail dispensed in a single day by an unidentified CVS location in 2020 had 270 opioid-containing tablets, 90 diazepam, and 90 carisoprodol.
Those numbers are far above recommended limits for opioid prescriptions. In one 2019 study published in the Journal of the American College of Surgeons, a review panel discussed the ideal number of opioids to prescribe for an assortment of common surgeries. According to the study, “For all 20 surgical procedures reviewed, the minimum number of opioid tablets recommended by the panel was zero.”
The lawsuit is founded on the violation of two statutes: the Controlled Substances Act, because the prescriptions were unlawfully and knowingly filled, and the False Claims Act, because federal funds were used to subsidize these unlawful prescriptions. The suit’s possible civil penalties include fines between $5,500 and $23,607 for each false payment claim fulfilled by federal programs, with false claims after November 2015 carrying a higher price tag.
“I don’t think it could be more clear that a pharmacy has an obligation under the Controlled Substances Act that the prescriptions that it lets go out the door are legitimate, particularly when there are repeated red flags that we allege,” Cunha said. “These are not subtle red flags, they are overt…The notion that there is some sort of regulatory ambiguity here; I reject that.”
‘A shifting standard’
Kara Page, a spokesperson for the pharmacies’ parent company CVS Health, wrote in an email Wednesday that the firm complied with the Justice Department’s investigation for “more than four years.”
“We strongly disagree with the allegations and false narrative within this complaint,” Page wrote. “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.”
That settlement arrived in 2022 and saw CVS agree to pay possibly up to $5 billion for opioid prescribing claims, without any admission of wrongdoing or liability.
“The government’s lawsuit seeks to impose a shifting standard for pharmacy practice,” Page continued. “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.”
Page also claimed the company created a program 12 years ago to block doctors with suspicious prescribing practices, and that the effort has blocked 1,250 practitioners since, “including nearly 600 prescribers who the government continues to license,” Page wrote.
“The government’s lawsuit intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids, and too few,” Page added.
Cunha had a different take at the press conference.
“We’re not requesting that CVS be rendered unable to fill prescriptions,” he said. “We’re demanding that CVS be held accountable for its conduct in the past, and we hope to encourage them to make sure that their practices are compliant with the law in the future.”
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