Policy & Medicine Compliance Update
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June, 2022
This month 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.
Articles
FEATURE
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).
Tags: FDA, Laboratory-Developed Tests, LDTs, Compounding, Practice of Medicine, VALID Act, In Vitro Diagnostics, CLIA, Homebrew Tests, DQSA, HHS
Litigation & Enforcement
Probing Under the FCA Hood
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.
Tags: False Claims, Whistleblower, Dismissal, Pleadings, Particularity, First-to-File, Scienter, State of Mind, Materiality, Case Mechanics.
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.
Tags: Whistleblower, False Claims, Thomas Prose, Nursing Home, Assisted Living Facility, General Medicine, Medically Unnecessary, Intervention, DOJ
When It Rains, It Pours
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.
Tags: McKinsey, Conflicts of Interest, House Oversight & Investigations, Purdue Pharma, OxyContin, Federal Acquisition Regulation, FAR, Opioids, Reputational Harm
Rising to New Challenges
AdvaMed Code Update Addresses New Federal Guidance & Safe Harbors
By Christopher L. White
Summary: 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.
Tags: AdvaMed Code, Value-Based Arrangements, Speaker Programs, Special Fraud Alert, OIG, HIMA, VBAs
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy. And as always, thank you for subscribing and for your continuing support in making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor