August 2020
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ISSUE SUMMARY:
This month we are focusing on the twin themes of patients and data. To being with, our feature article is the second of two-parts from the RDCC, a rare disease compliance officer think tank, established in 2019. Part 2 of their series on compliance in the rare disease space examines the challenges facing companies coping with the rare disease patient’s unique journey. Continuing with the patient theme, we next examine the new compliance guide issued by the CME Coalition to address compliance questions with continuing medical education programs.
Shifting to the theme of data, we begin with the second installment in our tele-compliance series which looks at data-driven risk management and how using data can improve efficiencies and capabilities. Our second article on data, examines both the promise and pitfalls of data analytics, especially in the context of data mining by third parties to develop whistleblower cases.
As always seems the case, we also have more litigation to cover. Here we examine the recent developments in the ongoing and every widening probe of generic drug price fixing. Finally, we cover the shareholder settlement with McKesson over its non-compliance with DEA requirements and what it may signal for the industry overall and not just opioids.
Considerations in View of the Patient Journey
Compliance in the Rare Disease Space (Part 2)
By Lori Alarimo, Paul Curtin, Jill Dailey, Patrik Florencio, Indrani Franchini, Al Garrido, Kristin Rand, Gary Giampetruzzi, and Sandra González
Summary: This is the second in a series of articles by members of the Rare Disease Compliance Consortium (“RDCC”). In Part 2, we address the challenges that may be experienced by some companies dedicated to helping patients living with a rare disease, and how those companies’ activities are judged via a legal and regulatory framework developed for a different patient journey.
Governance & Operations
Back-to-Basics: Navigating the Thicket of Continuing Medical Education
The CME Coalition Releases A New Compliance Guide
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: In March 2020, the Continuing Medical Education (CME) Coalition released a 47-page document of Frequently Asked Questions about the Accreditation Council for Continuing Medical Education Standards for Commercial Support. This article outlines the FAQs as published by the CME Coalition.
The Tele-Compliance Ecosystem (Part 2)
Data-Driven Risk Management
By: Jenny M. McVey, Ph.D., Michael Jelen, and John Auerbach
Summary: This article continues the discussion about digitally transforming data to allow for increased efficiency and remote capabilities into current compliance programs. On the heels of the DOJ’s update to evaluating a compliance program, in this article, we shift our focus to compliance risk management principles, government expectations, and how weaving data into compliance activities results in both increased compliance accuracy and cost savings.
Governance & Operations
The Promise and Pitfalls of Data Analytics
Impact of Whistleblower Analytics Firms Remains Unclear
By Kirt Kraeuter, Staff Writer
Summary: With the expansion of the available data sets from HHS, and Open Payments some commentators have anticipated the rise of data analytics will generate increased healthcare fraud cases. So far, that has not happened, and third-party data analytics firms have yet to capitalize on the publicly available data in the qui tam context. The most recent Fifth Circuit Court of Appeals’ decision shows that these firms face a high bar when bringing qui tam cases, but it is too soon to count them out.
Litigation
Widening the Net
New Price Fixing Complaint Includes Both Companies and Individuals
By Kirt Kraeuter, Staff Writer
Summary: The U.S. Department of Justice and States Attorneys General investigation into price-fixing by generic pharmaceutical companies and their executives continues to sweep in more corporate and individual defendants. The most recent civil complaint, with Sandoz as primary defendant, provides substantial evidence to support widening the investigative net.
The DEA, Plaintiffs’ Counsel & Now Shareholders
McKesson’s Opioid Woes Continue
By Robert N. Wilkey, Senior Staff Writer
Summary: On April 10, 2020, United States District Judge Claudia Wilken, for the Northern District of California, entered an order, approving the settlement of a derivative lawsuit against the McKesson Corporation. The lawsuit alleged that McKesson’s Board of Directors and senior executives failed to monitor and oversee the company’s operations concerning its distribution of controlled substances. The significance of this settlement is how shareholder derivative litigation supports internal compliance efforts, and it serves as a template for future similar actions.