Earlier this week, the US Department of Justice (DOJ) launched a new front in its effort to combat the opioid crisis and explicitly stated that it will deploy the False Claims Act (FCA) as part of its offensive. In a press release and parallel speech delivered by Attorney General Jeff Sessions on February 28, 2018, DOJ announced the creation of the Prescription Interdiction & Litigation (PIL) Task Force.
According to DOJ, the PIL Task Force will combat the opioid crisis at every level of the distribution system, from manufacturers to distributors (including pharmacies, pain management clinics, drug testing facilities and individual physicians). DOJ will use all available civil and criminal remedies to hold manufacturers accountable, building on its existing coordination with the US Food and Drug Administration (FDA) to ensure proper labeling and marketing. Likewise, DOJ will use civil and criminal actions to ensure that distributors and pharmacies are following US Drug Enforcement Administration (DEA) rules implemented to prevent diversion and improper prescribing. Finally, DOJ will use the FCA and other enforcement tools to pursue pain-management clinics, drug testing facilities and physicians that make opioid prescriptions.
The task force will include senior officials from the Offices of the Attorney General, the Deputy Attorney General, and the Associate Attorney General, as well as senior officials from the Executive Office for US Attorneys, the Civil Division, the Criminal Division and the Drug Enforcement Administration. The attorney general has also directed the PIL Task Force to establish a working group to improve coordination across the federal government, evaluate possible regulatory changes and recommend changes to federal law. Sessions emphasized that the task force will work closely with the Department of Health and Human Services and all levels of law enforcement to address the diversion and over-prescription of opioid painkillers.
Sessions also ordered the task force to examine existing state and federal lawsuits to identify instances where the DOJ can provide assistance. He noted that the DOJ is already involved in several such lawsuits, and announced that it would soon file a statement of interest in multidistrict litigation currently pending in the Northern District of Ohio. In that case, US District Court Judge Dan Polster recently urged the parties to work towards a settlement that will not only resolve the monetary issues in the case, but that will also address the underlying crisis by reducing the quantity of pills in circulation and helping to ensure that the pills that are manufactured are used for legitimate purposes.
DOJ sees the FCA as a natural fit for fighting opioid abuse. As Attorney General Sessions outlined in his speech, the Medicare prescription drug program spent more than $4 billion on opioids in 2016 alone. Last year, the government settled FCA cases against a number of entities over opioid sales, including two pharmacies for combined total of nearly $14 million.
DOJ’s announcement follows the trend that we identified last month that the government is “expanding focus on prescribers and health care providers who submit claims to federal health care programs for opioid prescriptions, as well as drug treatment and drug testing services.” In addition to creating the Opioid Fraud and Abuse Detection Unit—a data analytics program to identify evidence of overprescribing and opioid-related health care fraud—DOJ has engaged in extensive enforcement activity over the past year, including prosecutions against several individuals (including physicians). The creation of the PIL Task Force further reinforces the importance of organizations ensuring that their compliance programs’ risk assessment, auditing and monitoring functions take into account the organizations’ opioid prescription issues and practices.