DEA Announces National Opioid Takedown Initiative, Netting Nearly 350 Responsible for $6 Billion in Fraud

Last week, the Department of Justice led a multiagency, nationwide initiative that brought charges against nearly 350 individuals thought to be responsible for more than $6 billion in healthcare fraud. Of the $6 billion targeted as part of the takedown, more than $1.6 billion is directly attributed opioid-related treatment and recovery initiatives with particular focus on inappropriate prescribing and patient brokering and treatment fraud. Nearly 250 healthcare providers were targeted in the takedown for false and fraudulent prescribing and billing related to prescription opioids and other pain management regimens totaling more than $800 million. A dozen defendants were arrested as part of a $845 million body brokering and fraudulent treatment scheme that included kickbacks, bribes and referrals for treatment and recovery services, testing, and unnecessary prescribing.

DEA Assistant Administrator Tim McDermott, who helms the Diversion Control Division, noted  that “the opioid epidemic our country is battling is exacerbated when unscrupulous individuals seek to profit from people, in particular those confronting addiction…When doctors, pharmacists, and individuals exploit the weakness of a fellow human being in order to line their own pockets, DEA will use every tool at its disposal to stop and bring them to justice.”

Articles & Resources

Department of Justice –  National Health Care Fraud and Opioid Takedown Results in Charges Against 345 Defendants Responsible for More than $6 Billion in Alleged Fraud Losses

LINK to Case Descriptions

LINK to Court Documents

FDA Releases Industry Guidance on MAT Endpoints

Following on last week’s reporting on the completed OMB review of FDA’s MAT product endpoint guidance, the Food and Drug Administration released the updated document last week. The guidance, which updates an earlier 2018 version, provides the industry with additional clarification around the types of studies and data collection that can be used to help bring new medication-assisted products to market. The guidance notes the traditional endpoints focused on reduction of drug-using behavior with new areas of interest focused on additional primary and secondary endpoints that are of greatest interest to patients, caregivers and their families.

The agency is interested in patient-reported outcomes and efforts to better understand how the administration of MAT affects the mood and behavior of a patient (including urges around illicit use). Outlined in the document is also a series of other outcome measures such as reduction in hospitalization or ability to return to school/work as key metrics to identify successful outcomes.

Articles & Resources

FDA Guidance – Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment; Guidance for Industry

Bloomberg – Work Productivity Among New Ways to Assess Opioid Use Drugs

HHS OIG Questions Effectiveness of REMS in Combatting the Opioid Crisis

The Department of Health and Human Services Office of Inspector General issued a report last week evaluating the efficacy of the Risk Evaluation and Mitigation Strategies (REMS) program used to identify and address the potential harms associated with prescription opioids and other drugs. Since publication of a similar report by OIG in 2013, this current report indicates that while the nation saw a precipitous rise in opioid-related morbidity and mortality, the REMS for transmucosal immediate-release fentanyl (TIRF) and extended-release/long-acting (ER/LA) opioids were unsuccessfully leveraged to maximize effectiveness. A lack of comprehensive reporting impacted the FDA’s ability to determine whether the REMS program was helping to reduce serious adverse events related to prescription opioid misuse, abuse or diversion. Of particular concern was the lack of prescriber education and outreach related to these particular products and downstream impacts on inappropriate prescribing practices. Overall, the report noted that “REMS are not well-suited to quickly address the opioid crisis” and suggested more robust agency engagement and oversight with sponsors.

Articles & Resources

HHS OIG – FDA’s Risk Evaluation and Mitigation Strategies: Uncertain Effectiveness in Addressing the Opioid Crisis

LINK to Complete Report

STAT News – An FDA Safety Program is Failing to Stem the Opioid Crisis, Report Finds

Hopkins Study Identifies Issues With Recent FDA Opioid Drug Approvals

Researchers from the Johns Hopkins University published findings in the Annals of Internal Medicine last week chronicling the approval of prescription opioids by the Food and Drug Administration over the last two decades. The School of Public Health surveyed the 48 prescription opioid drug applications filed and accepted between 1997 and 2018 (9 for acute pain; 38 for chronic pain). The findings identified that the clinical data provided as part of these approvals was narrow in scope and often lacked appropriate inclusion of outcomes focused on patient safety. Of particular worry was the short studies, often no more than three months, used to validate key markers for use of prescription opioids for chronic pain.

G. Caleb Alexander, a national leader in addressing the opioid epidemic and co-author on this paper noted, “While the FDA on the whole gets much more right than they get wrong in the approval process for prescription opioids, our findings suggest that over time the agency missed important opportunities to strengthen the regulation of opioid products.”

Articles & Resources

Johns Hopkins School of Public Health – Study Identifies Shortcomings in FDA Evaluations for New Opioid Drug Approvals Over Two Decades

Annals of Internal Medicine – Key Evidence Supporting Prescription Opioids Approved by the U.S. Food and Drug Administration, 1997 to 2018

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Articles & Resources

New York Times – ‘The Drug Became His Friend’: Pandemic Drives Hike in Opioid Deaths

Wall Street Journal – Judge Extends Shield Protecting Purdue’s Sacklers from Opioid Lawsuits

NPR Shots – Health on Wheels: Tricked-Out RVs Deliver Addiction Treatment to Rural Colorado

ICER Draft Evidence Report – Digital Therapeutics as an Adjunct to Medication Assisted Therapy for Opioid Use Disorder

Bipartisan Policy Center – Tracking FY2019 Federal Funding to Combat the Opioid Crisis

US News & World Report – The Real Reason for 2018 Drop in Fatal U.S. Drug Overdoses

POLITICO – More Drivers in Serious Fatal Crashes Tested Positive for Drugs, Including Marijuana

Bloomberg – San Francisco Bellwether Opioid Lawsuit Trimmed But Advancing

Reuters – U.S. Senators Aim to Stop Sale of Drugs Online by Going After Tech’s Legal Immunity

Forbes – Senators Target Big Tech’s Legal Immunity In Online Drug-Dealing Crackdown

Bloomberg Government – Bipartisan Bill Targets Drugs, Terrorist Content Online

U.S. Attorney for the Northern District of Texas – Operation Wasted Daze: 49 charged in $18 Million Pill Mill Scheme

U.S. Attorney for the Eastern District of Tennessee – Addiction Recovery Physician Pays $530,000 To Resolve False Claims Act Allegations Of Billing For Psychotherapy Rendered By Unlicensed Or Unsupervised Providers And Other Improper Billings

U.S. Attorney for the District of Massachusetts – Registered Nurse Pleads Guilty to Drug Diversion

This Week’s Calendar

The House and Senate have no opioid-related hearings or events scheduled at this time as they continue to address several pressing topics including a Supreme Court nomination, coronavirus pandemic relief and the forthcoming presidential election. In the instance that there are any changes to the schedule for this week, we will make additional information available.

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