Policy & Medicine Compliance Update
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JUNE 2020 Issue
Policy & Medicine Compliance Update
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ISSUE SUMMARY:
For June, we decided to take a partial step back and look at some other issues not pandemic-related. Therefore, this month our feature article is the first of two-parts from the RDCC, a rare disease compliance officer think tank, established in 2019. Part 1 of their series on compliance in the rare disease space examines the patient’s journey.
Next, we turn our attention back to the other major U.S. public health crisis – the opioid epidemic. Our first article provides a consolidated recap of the Insys saga and its lessons. In the second, we look at the recent attempts by Allergan and Teva to use lack of jurisdiction to avoid a suit by the City of San Francisco.
Since we cannot ignore the impacts of COVID-19, we have three articles of interest. In the first, Kirt Kraeuter and his fellow authors explore monitoring in the tele-compliance ecosystem, which they introduced in our May issue. The second provides a recap of the first two webinars hosted by Global Health Care and the Pharmaceutical Compliance Forum on the compliance impacts of the pandemic. Finally, we round out this issue and our pandemic coverage with a look at the Stark Law waivers issued by CMS in response to the crisis.
Articles
FEATURE
Considerations in View of the Patient Journey
Compliance in the Rare Disease Space (Part 1)
By Lori Alarimo, Paul Curtin, Jill Dailey, Patrik Florencio, Indrani Franchini, Al Garrido, Kristin Rand, Gary Giampetruzzi, and Sandra González
Summary: This is the first in a series of articles by members of the Rare Disease Compliance Consortium (“RDCC”). In Part 1, the authors discuss the difficult patient journey and identified some of the factors that contribute to it
TAGS: Rare disease compliance consortium, rdcc, rare diseases, patients, Patient journey
Opioids
Burning Down the House
Lessons from the Insys Therapeutics Saga
By Robert N. Wilkey, Esq., Senior Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: The conviction of the founder and other former executives of lnsys Therapeutics Inc. in May 2019 was characterized in the media as the “stiffest conviction yet for an opioid executive.” The case of Insys and its executives provides many substantive lessons for life sciences companies, compliance professionals, and attorneys.
TAGS: Opioids, Insys, Kapoor, Indictments, Bankruptcy
Stepping Out
Teva and Allergan Play the Jurisdiction Card Trying to Escape Opioid Liability
By Robert N. Wilkey, Esq., Senior Staff Writer for Life Science Compliance Update
Summary: The opioid litigation has taken yet another turn. In December 2018, the San Francisco City Attorney Dennis Herrera filed suit against the opioid manufacturers and distributors for their roles in contributing to the crisis. Now Teva and Allergan are attempting to dismiss the lawsuit against them by claiming a lack of personal jurisdiction. Establishing jurisdiction is both a fundamental and trick business, especially when it involves international parent companies. This article explores their motions and the underlying precedent.
TAGS: Opioids, Teva, Allergan, Jurisdiction, San Francisco
COVID-19 Impacts
The Tele-Compliance Ecosystem (Part 1)
Transforming the Monitoring Function
By: Kirt Kraeuter, Michael Jelen, John Auerbach, and Jenny McVey, Ph.D.[i]
Summary: This article continues the discussion about how the COVID-19 pandemic has highlighted the urgency of incorporating remote capabilities into current compliance programs (tele-compliance). Tele-compliance involves more than virtual communication tools or videoconferencing, but rather is a comprehensive re-thinking of how data, process, people and tools work together improve compliance effectiveness. In this article we shift our focus to the tele-compliance transformation for the Monitoring & Oversight function.
TAGS: Tele-Compliance, Ecosystem, COVID-19, Pandemic, Cornavirsus, Monitoring, Oversight, AIM, Data
COVID-19 and Compliance
Practical Advice on Addressing the Impact of the Pandemic
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: Global Health Care and the Pharmaceutical Compliance Forum recently held a series of webinars discussing how the pandemic impacts compliance practice. This article presents the highlights from the first two webinars.
TAGS: COVID-19, pandemic, COMPLIANCE, Cornavirsus, Global Healthcare, pcf, business continuity, medical information
Delivering Health Care in a Pandemic
CMS Responds with “Blanket Waivers” of the Stark Law
By Gwendolyn A. Ball, Staff Writer
Summary: To help address the COVID-19 pandemic, CMS recently enacted a series of “blanket waivers” for arrangements that generally would trigger enforcement under the Stark Law. This article reviews those waivers and their limitations. It also highlights essential compliance steps that healthcare providers and institutions should take to avoid future problems when the environment returns to normal. TAGS: COVID-19, PANDEMIC, STARK, CMS, WAIVERS, REIMBURSEMENT
[i] Mr. Kraeuter is a Principal at Kirt Kraeuter, LLC, Mr. Jelen is a Director and Mr. Auerbach is a Managing Director with the Berkeley Research Group. Dr. McVey works in Risk Strategy Management for Novo Nordisk, Inc. She also is an Editorial Board Member with the Policy & Medicine Compliance Update.
