Policy and Medicine Compliance Update – June 2022 Issue: Explores Role of FDA, New FCA Cases, Blown Whistle on Whistle Blower and Revised AdvaMed Code
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In our June 2022 issue we begin by focusing on the FDA and the challenges it faces in the disruptive world of health care. Specifically, we focus on drug compounding and laboratory-developed tests (“LDTs”).
Next, we look at recent False Claim Act (“FCA”) cases in the context of case mechanics. So far, the year has been an active one. We also examine a recent case filed against a former whistleblower, who aided the Justice Department in previous FCA cases.
Shifting focus, we also examine the new developments surrounding McKinsey’s role in advising both sides in the opioid crisis.
Finally, we round out this month’s issue with a look at the most recent updates to the AdvaMed Code of Ethics.
FDA in the New Disruptive World of Health Care
A Shrinking Role While Balancing Medical Innovation and Patient Risk
By Gwendolyn A. Ball, Staff Writer
Summary: The FDA has been entrusted with regulatory authority over drugs and devices, but there are limits to its authority. In particular, FDA’s authority has frequently been limited regarding small, localized activities that were viewed as state-level issues or part of the “practice of medicine.” This month we will review two traditional medical technologies where commercial and technical developments have challenged that division—compounded drugs and laboratory diagnostic tests (LDTs).
Litigation & Enforcement
2022 Already is a Busy Year for False Claims Case Mechanics
By Dr. Seth B. Whitelaw, Editor
Summary: The first few months of 2022 have generated several important cases involving the mechanics of bringing FCA cases. This article provides a brief recap of significant developments.
Biting Hand That Feeds You or Karma
DOJ Charges a Serial Whistleblower with FCA Violations
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: Recently, the Justice Department filed an FCA lawsuit against Dr. Thomas Prose, a Michigan-based physician providing care to nursing home and assisted living facility residents. The case is unusual because Dr. Prose has been a whistleblower in several previous FCA cases. However, it is yet another sign that the Justice Department continues to regard whistleblowers as a mixed blessing.
McKinsey’s Reputation Takes Another Hit
By Kirt Kraeuter, Staff Writer
Summary: After making headlines for a $600 million settlement featuring internal firm documents that confirmed discussions on destroying emails and other electronic records related to work for its client Purdue Pharma, McKinsey is once again thrust into an unflattering spotlight by a House Oversight investigation. The Committee’s Interim Report detailed “significant, years-long conflicts of interest” at the firm based on its work for the FDA and the opioid manufacturers.
AdvaMed Code Update Addresses New Federal Guidance & Safe Harbors
By Christopher L. White, General Counsel, Chief Operating Officer AdvaMed
In March 2022, AdvaMed announced updates to its Code of Ethics concerning value-based care considerations and best practices for meetings with health care professionals. The new update will take effect on June 1, 2022.
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy during these challenging times. We encourage you to subscribe and for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.