PROVIDENCE, R.I. (WLNE) — The U.S. Justice Department filed a civil complaint in federal court alleging CVS Pharmacy and various subsidiaries filled unlawful prescriptions in violation of the Controlled Substance Act and False Claims Act. The complaint claimed that 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,.” The Department of Justice  alleged that CVS filled excessive and dangerous quantities of opioids, early fills of opioids, and “trinity prescriptions” illegally. “Trinity prescriptions” are a combination of an opioid, benzodiazepine, and muscle relaxant. The complaint also said that CVS allegedly filled prescriptions written by prescribers it knew to engage in “pill mill practices,” which was when prescribers issued large amounts of controlled substances without any medical purpose. CVS also allegedly ignored evidence from sources, including its pharmacist and internal data, that showed its pharmacies were giving out unlawful prescriptions. The Justice Department accuses CVS of violating the acts due to performance metrics, compensation incentives, and staffing policies. “CVS set staffing levels far too low for pharmacists to both meet their performance metrics and comply with their legal obligations,” the complaint said.  They additionally withheld crucial information from pharmacists that could have prevent the amount of unlawful prescriptions filled. “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. Attorney Zachary Cunha said. “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.” The DOJ said CVS could face civil penalties for every single unlawful prescription filled in violation of the CSA, as well as penalties for each prescription reimbursed by federal healthcare programs in violation of the FCA. On Oct. 17, 2019, whisteblower Hillary Estright, a former CVS employee filed an action for the FCA. CVS responded to the lawsuit by saying that it “strongly disagreed” with the accusations and the “false narrative” from the Department of Justice. A spokesperson said the company had cooperated with a four-year-long investigation and that the lawsuit imposes 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,” the statement said. “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.” The full statement can be read 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. For more details about this dilemma, visit “Our Opioid Response.” 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). For more information, view the civil complaint here. Categories: News, Rhode Island, US & World News