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August, 2022
This month our focus again is on litigation and enforcement across a wide spectrum of topics. We begin with two cases involving the 340B drug discount program. First, we examine how a hospital system focused on the rebate potential of the program and allegedly engaged in kickbacks and false claims involving the acquisition of an oncology clinic.
Next, we review the recent Supreme Court decision in the American Hospital Association (AHA) case challenging HHS 340B reimbursement reductions. Not unexpectedly, the Court handed a win to the AHA.
Leaving the U.S., we focus on the Italian Sunshine Act. Italy has joined other EU countries requiring disclosure of transfers of value to HCPs and HCOs, but with a uniquely Italian spin on implementation.
Sticking with the international arena, we examine the OECD’s latest foreign bribery recommendations. The recommendations not only focus on the recipients of bribes, but they also contain important considerations for compliance programs.
Rounding out this issue, we look at the myths surrounding using of integrated risk management software and the latest case involving FCA whistleblowers before the Supreme Court.
Articles
FEATURE
More 340B Woes
DOJ Intervenes in Methodist Whistleblower Case
By Gwendolyn A. Ball, Staff Writer
Summary: The 340B drug discount program has been the source of many controversies, but this case is a rare example in which the program was the basis of a qui tam—and now DOJ—case alleging violations of the Anti-Kickback Statute. Hospital administrators allegedly “kicked back” 340B rebate revenues to referring doctors though compensation exceeding market rates and payments for work never performed. The case illustrates how legal (though controversial) hospital acquisitions of oncology clinics to expand 340B revenues can cross the line into illegal behavior.
340B LITGATION & Enforcement
Clipped Wings
The Supreme Court Limits HHS’s Authority in Recent 340B Case
By Dr. Seth B. Whitelaw, Editor
Summary: HHS’s interpretation of the 340B statute and its desire to limit hospital reimbursement have been the center of controversy since 2017. With the latest Supreme Court ruling, the issue is now resolved, and the Court has handed a win to the American Hospital Association.
INTERNATIONAL Litigation & Enforcement
Italian Sunshine
New Transparency Act is Now in Force
By Elan Schefflein
Summary: The Italian government has passed and published new laws mandating disclosure of benefits granted by manufacturers to covered recipients in the healthcare system. The new law requires manufacturers to publicly disclose these transfers of value annually on a new central platform to be created by the Ministry of Health. The new system will be implemented in phases over the next several years
Hidden Impacts for Compliance
OECD 2021 Recommendation on Foreign Bribery
By Kirt Kraeuter, Staff Writer
Summary: While most coverage of OECD’s recently released 2021 Recommendation on Foreign Bribery has addressed the critical topic of the demand side of bribery, a welcome change for anti-bribery professionals, the document’s true impact on compliance programs lies elsewhere. Prosecuting foreign officials for soliciting or accepting bribes will provide some welcome relief. Still, three fundamental changes will have much more substantive and short-term impacts, particularly in those countries where the OECD has been encouraging the more rapid implementation of the Anti-Bribery Convention.
Governance & Operations
Technology for Compliance Risk Management
Top Four Myths About Enabling Your Program
By Eric M. Baim and Amanda Holst
Summary: Integrated risk management software is often touted as an intuitive, easy way to enable your risk management program and ensure success. This article highlights common myths about these software-focused solutions. It suggests better, more effective, and efficient ways to leverage your compliance expertise and existing tools to enable your risk management program.
FCA LITIGATION & ENFORCEMENT
Whistleblowers Versus the Justice Department
Latest Wrinkle in DOJ’s Authority to Dismiss Qui Tam Lawsuits
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: The Supreme Court recently agreed to hear a case involving the government’s authority to dismiss a case where it previously declined to intervene. The case provides the Supreme Court to determine the overall breadth of the government’s dismissal authority and resolve a significant split among the Circuit Courts of Appeals.
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