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The U.S. Justice Division (DOJ) filed a civil grievance in federal courtroom alleging CVS Pharmacy crammed illegal prescriptions in violation of the Managed Substance Act (CSA) and False Claims Act (FCA).
The federal government’s grievance targets the nation’s largest pharmaceutical firm with over 9,000 shops nationwide, alleging it “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.”
The DOJ alleges the pharmacy large continued its illegal observe from Oct. 17, 2013, to the current.
The Division of Justice alleged CVS crammed extreme and harmful portions of opioids, early fills of opioids and “trinity prescriptions” illegally.
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A lawsuit alleges CVS Well being crammed illegal prescriptions. (Joe Raedle/Getty Pictures / Getty Pictures)
“Trinity prescriptions” are a mixture of prescribed drugs that features an opioid, a benzodiazepine and a muscle relaxant.
The grievance additionally claims CVS crammed prescriptions written by prescribers it knew to have interaction in “pill mill practices,” which was when prescribers subject giant portions of medication with none medical objective.
“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 DOJ mentioned.
Tablets of the opioid hydrocodone at a pharmacy in Portsmouth, Ohio, June 21, 2017. (Reuters/Bryan Woolston/File Picture / Reuters)
The Justice Division accuses CVS of violating the acts as a consequence of efficiency metrics, compensation incentives and staffing insurance policies.
“CVS set staffing levels far too low for pharmacists to both meet their performance metrics and comply with their legal obligations,” the grievance mentioned.
It moreover withheld essential data from pharmacists that might have prevented the quantity of illegal prescriptions crammed, the DOJ alleged.
The DOJ additionally alleged that CVS, by its malpractice, helped gas the persevering with opioid disaster within the U.S.
“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,” U.S. Lawyer Zachary Cunha mentioned.
“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,” he mentioned.
The DOJ mentioned CVS may face civil penalties for each single illegal prescription crammed in violation of the CSA, penalties for every prescription reimbursed by federal well being care applications and injunctive aid to stop CVS from committing additional violations.
A CVS Pharmacy (Jeffrey Greenberg/Schooling Pictures/Common Pictures Group by way of Getty Pictures / Getty Pictures)
Ticker Safety Final Change Change % CVS CVS HEALTH CORP. 59.08 -0.77
-1.29%
“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,” the corporate mentioned. “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.
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“The federal government’s lawsuit seeks to impose a shifting customary for pharmacy observe. Most of the litigation theories specified by the grievance aren’t present in any statute or regulation and relate to matters on which the federal government has declined to supply steering,” CVS added. “Every of the prescriptions in query was for an FDA-approved opioid remedy prescribed by a practitioner who the federal government itself licensed, licensed and empowered to put in writing controlled-substance prescriptions.”
A sign for the Food And Drug Administration outside its headquarters July 20, 2020, in White Oak, Md. (Sarah Silbiger/Getty Images / Getty Images)
The CVS Pharmacy spokesperson pointed to its history of being an industry leader in developing ways to fight the opioid crisis.
“As one instance, 12 years in the past, CVS Pharmacy pioneered a first-of-its-kind program to dam controlled-substance prescriptions written by medical doctors of potential concern. Thus far, we have now blocked greater than 1,250 practitioners, together with practically 600 prescribers who the federal government continues to license,” CVS said.
“This program isn’t required by any statute or regulation, and CVS Well being repeatedly has defended lawsuits from these alleging we go too far in blocking opioid prescribers.
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“The government’s lawsuit intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids and too few.”