The Department of Justice is accusing CVS Pharmacy Inc. of unlawfully filling opioid prescriptions that directly led to overdose deaths, as well as fraudulently reimbursing some of those prescriptions through federal health care programs.
“CVS’s actions contributed to the opioid crisis,” the civil complaint states. “CVS’s unlawful dispensing of at least thousands of controlled substance prescriptions caused massive public harm.”
The DOJ announced the complaint as unsealed December 18, a week after filing it in federal District Court in Rhode Island. It represents a four-year investigation that spanned numerous federal agencies, but was led by the Drug Enforcement Administration, the Office of the Inspector General and the Defense Criminal Investigative Service.
The wide-ranging allegations include that CVS knowingly pressured pharmacists to fill high volumes of prescriptions written by prescribers who’d been repeatedly flagged. It alleges that in some cases, not only did people die of overdose shortly after CVS filled prescriptions marked by “egregious red flags,” but that CVS then kept filling their prescriptions knowing they were dead.
The DEA’s prosecution of “pill mill” prescribers over the past 15 years or so has succeeded making opioid analgesics less readily prescribed. In that period the opioid-involved overdose crisis has gotten exponentially worse as unregulated opioids become riskier. The crackdown has also caused a growing crisis of pain patients no longer able to access the medications they need.
Advocates have long argued that intense law-enforcement scrutiny of prescribing and dispensing practices, now illustrated by another high-profile case, does more harm than good. Whether opioids can improve someone’s quality of life isn’t determined by whether they have access to a legitimate prescription.
Pharmacists described a “soul-crushing” work environment.
CVS is the biggest pharmacy chain in the United States, with around 9,000 locations. It dispenses more than 1 billion prescriptions each year, including many opioid analgesics prescribed for pain. Leadership is vehemently denying the allegations, placing the blame squarely on the DEA for what the company characterizes as vague or shifting standards.
“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,” CVS stated. “The government’s lawsuit intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids, and too few.”
In the civil complaint, pharmacists who testified also described a serious dilemma, but one they attributed to CVS. The investigation itself began after a former CVS employee filed a suit under the False Claims Act in 2019, which allowed the DOJ to step in.
“To reduce its labor costs, CVS set staffing levels so low that it was impossible for pharmacists to comply with their legal obligations and meet CVS’s demanding metrics,” the complaint states. “CVS repeatedly ignored the increasingly impassioned complaints from pharmacists that their pharmacies were dangerously understaffed.”
CVS established “performance metrics” that pressured pharmacists to fill as many prescriptions as they could as quickly as they could, and “incentive compensation policies” that rewarded them for the same. Pharmacists described a “soul-crushing” work environment in which they were “being rushed to fulfill an order like mcdonalds.” One said that he and his colleagues were deciding the safety and legitimacy of each prescription in under one minute, and that he was “terrified for [his] patients.”
“Whatever decision pharmacists make, it will not be good enough for some interest group,” CVS stated.
The DEA is notoriously opaque and arbitrary in the requirements it places on pharmacies, and the “red flag” algorithms it uses to identify potentially unlawful prescribing are proprietary. But CVS is required by law to refuse prescriptions with “unresolved” red flags. Instead, the company allegedly prevented pharmacies from sharing information with each other, and in some cases required pharmacists to fill prescriptions written by providers who’d been flagged with notes like “PILL MILL” and “DO NOT FILL.”
The lawsuit materials included a data sheet of over 500 prescriptions written between 2013 and 2017, by the same six prescribers. Each prescription had been reimbursed by either Medicaid or Medicare, some for under $1 but others for up to $2,255.
If CVS is ultimately found liable, the company would be required to pay damages for each individual prescription that had been filled in violation of the CSA. But for each prescription reimbursed from federal health care dollars, CVS would be required to pay triple.
“Whatever decision pharmacists make, it will not be good enough for some interest group,” CVS stated. “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.”
Image via CVS
Show Comments