Thanks for Joining! CEPOP’s 2020 Strategy Session…
Thank you to all who were able to join CEPOP for its annual All-Participants Strategy Session last week. Over the 90-minute meeting, CEPOP participants were able to discuss the organization’s successes over the past year and look forward towards areas of opportunity and growth with the ultimate goal of combatting the evolving opioid epidemic. The CEPOP Steering Committee will distill down the core areas of consensus gleaned from the meeting and begin to draft a 2020 workplan for review and feedback during the February meeting.
The next CEPOP All-Participants Teleconference will be held on Monday, February 24th (3:00pm). A calendar appointment and call logistics is forthcoming.
Articles & Resources
Agenda for CEPOP’s 2020 All-Participants Strategy Session
Amid Slight Increase in Life Expectancy, OD Rate Drops 4%
The CDC announced this week that U.S. life expectancy ticked up 0.1 years in 2018 up to 78.7 having dropped or remained stagnant the prior three years. This data release was coupled with additional information made available as part of the DEA’s release of the National Drug Threat Assessment for 2019. According to that report, drug-related overdose deaths dropped 4.1% in 2018 and was coupled by a concurrent reduction in prescribing. Preliminary estimates show indicate that there were 67,637 drug overdose deaths in 2018, down from more than 72,000 the year prior. A caveat to this data, however, is that the 2018 statistics still remain the second highest rate tracked in the nation’s history. While prescription opioid-related overdose deaths continue to drop, the statistics still remain alarming for other categories of drugs. Synthetic opioid overdoses increased by 10% between 2017 and 2018 and cocaine-related deaths by more than 25%. Polysubstance use is becoming more common and also leading to greater issues around treatment and general overdose trends.
Articles & Resources
White House Newsroom – Press Briefing by Senior Counselor Kellyanne Conway, ONDCP Director Jim Carroll, and Assistant Secretary of Public Health ADM Brett Giroir
CDC National Center for Health Statistics – Data Brief No. 355: Mortality in the United States, 2018
DEA Newsroom – DEA Releases 2019 National Drug Threat Assessment
NPR – Life Expectancy Rose Slightly in 2018, As Drug Overdose Deaths Fell
CDC Morbidity and Mortality Weekly Report – Opioid Prescribing Behaviors – Prescription Behavior Surveillance System, 11 States, 2010-2016
Express Scripts Subsidiary Settles Opioid-Related Kickback Scheme for $145 Million
Led by U.S. Attorney for the District of Vermont Christina Nolan, electronic health records vendor Practice Fusion announced this week a settlement totaling $145 million in response to allegations around receipt of kickbacks from an undisclosed pharmaceutical manufacturer for implementation of software that incentivized the prescribing of opioids. According to the Department of Justice, it was alleged that Practice Fusion developed and integrated clinical decision support software within its EHR that would encourage sales of a given company’s products. The unnamed pharmaceutical company was permitted, according to U.S. Attorney Nolan, to have oversight of the guideline development for the CDS alerts, often times falling far from accepted medical standards. The agreement between Practice Fusion, a subsidiary of Express Scripts, and the Department of Justice involves both civil and criminal settlements. As part of the criminal component, Practice Fusion entered into a deferred prosecution agreement and will forfeit over $26 million. The civil settlement will amount to more than $118 million paid back to states and the federal governments for submission of false claims.
Later in the week, Reuters broke the news that the alleged “Pharma Co. X” cited in the case documents was OxyContin manufacturer Purdue Pharma. It is alleged that Purdue paid Practice Fusion approximate $1 million under the guise of a sponsorship to help develop the aforementioned alerts. At this time, Purdue Pharma is not a named defendant in the criminal case nor are they accused of any wrongdoing.
Articles & Resources
Department of Justice – Electronic Health Records Vendor to Pay $145 Million to Resolve Civil and Criminal Investigations
Law360 – DOJ Details Allscripts Unit’s ‘Abhorrent’ Opioid Kickback Plot
Reuters – Exclusive: OxyContin Maker Purdue is ‘Pharma Co. X’ in U.S. Opioid Kickback Probe
White House Releases Comprehensive Rural Toolkit
On Friday, the White House and Department of Agriculture announced the release of a new toolkit aimed at promoting a comprehensive response to the opioid epidemic in rural communities. The 97-page toolkit serves as a direct follow-on to the 2019 National Drug Control Strategy and provides specific proposals around how best to address drug misuse and abuse in rural communities and the development and implementation of “flexible and creative solutions at the local level.” With rural communities hit hard by the opioid epidemic and overdose rates spiking more than 325% between 1999 and 2015, the toolkit will serve as a useful tool to help provide support to rural leaders dealing with the epidemic.
Upon release of the report, Director of the Office of National Drug Control Policy Jim Carroll noted, “Families and communities in rural America have been hard hit by the crisis of addiction, and face unique challenges in developing effective responses to this disease. The Rural Community Action Guide empowers local leaders to meet these challenges head on with recommended action steps and best practices for local solutions that will create real change.”
Articles & Resources
White House Newsroom – New Tool Empowers Local Leaders to Take Action Against Rural Drug Addiction
LINK – Rural Community Action Guide: Building Stronger, Health, Drug-Free Rural Communities
GAO Report Highlights Further Need for Suspicious Order Oversight
Pursuant to Section 3292 of the SUPPORT for Patients and Communities Act, the Government Accountability Office released this week a study highlighting further needs to better support investigations of controlled substance diversion and suspicious orders. In their report, the GAO found that there was currently:
- Limited proactive and robust analysis of industry-reported data; and
- No data governance structure to manage all drug transaction data.
Recognizing the need for further action to be taken to help combat the improper shipment and distribution of controlled substances, GAO puts forth four core recommendations, including:
- Develop an algorithm that would proactively monitor ARCOS data for potentially problematic transactions;
- Development of a department-wide data strategy that targets a robust and centralized data governance structure to better capture and analyze industry-reported transactions;
- Establish outcome-oriented goals related to diversion based upon the available data; and
- Identification of any limitations that exist in the ARCOS Enhanced Lookup Buyer Statistic Tool to better assist registrants and coordinate on appropriate order reporting.
Articles & Resources
Government Accountability Office – Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders
House Passes Extension of Fentanyl Scheduling Bill
In a 320-88 vote this week, the House passed S. 3201, extending DEA’s temporary ban on all fentanyl analogues and similar entities for fifteen months. Over the last several weeks, the bill had riled up some progressive lawmakers and other allied parties around potential over-criminalization due to mandatory minimum sentences included as part of the existing authority. During the last several weeks, members of the Department of Justice and U.S. Attorney’s offices urged the House to pass this bill and more permanently classify fentanyl analogues as a Schedule I drug. The bill had been passed out of the Senate by unanimous consent on January 16th and will now go to the President’s desk before it is set to expire on February 6th.
Articles & Resources
S.3201 – Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues
New York Times – U.S. House Passes Bill to Extend Temporary Ban on Fentanyl Look-Alikes for 15 Months
Bloomberg – House Splits Over Extending Federal Fentanyl-Banning Powers
What We Read Last Week
Inside Health Policy – Providers Want CMS to Unbundle Non-Opioid Drugs in Outpatient Care
British Medical Journal – Opioid Prescribing Patterns Among Medical Providers in the United States, 2003-17; Retrospective, Observational Study
New York Times – Bitcoin Has Lost Steam. But Criminals Still Love It.
Law360 – Opioid MDL’s Pharmacy Bellwether Trial Nudged To November
Law360 – Opioid MDL Special Master Sets Data Production Guidelines
Law360 – Pharmacies Cant Escape Public Nuisance in Opioid MDL
POLITICO – Federal Opioid Prescribing Guidelines Under Scrutiny Again
U.S. Attorney for the Southern District of New York – Manhattan Doctor Sentenced To Nearly Five Years In Prison For Accepting Bribes And Kickbacks In Exchange For Prescribing Fentanyl Drug
U.S. Attorney for the Northern District of West Virginia – Morgantown Pharmacist Sentenced to 10 Years for Drug Charges
U.S. Attorney for the Western District of Virginia – Blacksburg Doctor Convicted of 60 Federal Offenses Including Health Care Fraud, Distribution of a Controlled Substance, Obstruction of Justice
U.S. Attorney for the Northern District of Alabama – Alabama Physician Pleads Guilty to Drug Distribution Charges for Prescription of Opioids
U.S. Attorney for the Eastern District of Virginia – Man Pleads Guilty to Selling Drugs on Dark Web
This Week’s Calendar
The House and Senate are both in session this week and the following as the Senate looks to wrap up relevant impeachment proceedings. The President is set to deliver his State of the Union speech on Tuesday evening. At this time there are no opioid-related events noticed at this time. Should there be any additions to House or Senate schedules or updates with respect to additional events, this information will be made available.
Questions about the above content can be directed to Matthew.Rubin@FaegreDrinker.com.