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April, 2022
Summary:
Before we cover some of the latest litigation and enforcement actions, we begin with a recent review of a recent Medical Information benchmarking survey. The survey examines how Medical Information functions are coping with the current digital environment.
Turning to litigation and enforcement, we start by reviewing the most recent False Claims Act (“FCA”) statistics from the Justice Department. Discounting the Purdue Pharma global settlement, the data show modest results that are in line with previous fiscal years.
Next, we examine the FCA’s whistleblower anti-retaliation protections for former employees. The recent refusal by the U.S. Supreme Court to take up a Sixth Circuit case means that the current split among the circuits will continue and likely needs Congress to resolve.
Finally we review another FCA case involving alleged kickbacks by Medtronic, the U.S. District Court held that Fair Market Value payments do not provide complete protection against kickback and false claims allegations.
Feature
Medical Information in a Digital World
A Survey of Pharmaceutical Company Approaches
By Nadja Torres and Darshan Kulkarni, Pharm. D., M.S., Esq.
Summary: The emergence of digital technologies such as websites and bots provides Medical Information functions with opportunities to improve communications, but simultaneously can heighten regulatory risk. The recent phactMI™ survey provides a starting point to understand, discuss, and analyse the risks associated with medical information websites and digital technologies.
Litigation & Enforcement
The Trend Continues
Examining the DOJ’s FY 2021 False Claim Act Statistics
By Gwendolyn A. Ball, Staff Writer
Summary: The DOJ recently released its False Claims Act statistics for FY 2021. According to the DOJ, FY 2021 was a banner year for false claims recoveries, especially in the health care sector. However, the massive opioid settlement with Purdue Pharma skewed the results, and upon adjustment, the Justice Department’s results appear much more modest and in line with previous fiscal years.
Kicking the Can Down the Road
The Supreme Court Refuses to Address FCA Whistleblower Protections for Former Employees
By Robert N. Wilkey, Esq., Senior Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: With the Supreme Court’s refusal to address the split between the Sixth and Tenth Circuits on whether FCA whistleblower protections extend to former employees, achieving clarity is now in the hands of Congress. However, a timely resolution seems unlikely, requiring companies to act carefully when dealing with any former employee turned whistleblower.
Fair Market Value May Not Offer Complete Protection Against Kickback Violations
A Second Medtronic Motion to Dismiss Denied
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: On February 23, 2022, the United States District Court for the Central District of California denied Medtronic’s motion to dismiss a qui tam suit against the company that alleged Medtronic engaged in Anti-Kickback violations. The crux of the Court’s conclusion that “even some fair-market-value payments will qualify as illegal kickbacks.”
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 continued 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