Policy & Medicine Compliance Update
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Issue Summary:
We begin the March issue with our first article of our “Back to Basics” series focusing on the relationship between the compliance and legal functions. Next we examine the landmark case of Practice Fusion case, which is the first kickback case involving electronic health records. Also on the enforcement front, we explore the recent Patient Services settlement. We also examine the recent sentencing of Insys executives and managers, and the implications of those sentences. Finally, we round out this issue with a review of FDA’s foreign inspection program which is timely given the impact being caused to global supply chains by the coronavirus.
FEATURE
The Compliance-Legal Relationship – A Never-Ending Debate
By Kristin Rand, David Davidovic, and Dr. Seth B. Whitelaw
Summary: In the first article of our “Back to Basics” series, we are starting with an examination of the history and ongoing debate surrounding the relationship between the compliance and legal functions.
TAGS: Back-to-basics, compliance, legal, DOJ, OIG
Enforcement
Records & Kickbacks are a Bad Combination for Practice Fusion
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: In January 2020, the Justice Department announced an agreement with electronic health records vendor Practice Fusion, Inc., for its involvement in a kickback scheme aimed at increasing opioid prescriptions. Before the agreement, an EHR vendor implicated in a kickback scheme was uncharted waters. This article outlines the agreement and how the different facets of the agreement will impact both electronic health records providers and the life science industry.
Tags: Electronic Health Records, kickbacks, false claims, practice fusion, integrity agreement, OIG
Starting the Year with a Bang – Patient Services, Inc. Settles FCA Suit and Drops First Amendment Challenge
By Carolyn Greene, Staff Writer
Summary: As Congress looks for solutions to spiraling drug prices, the DOJ has heightened its scrutiny of AKS issues relating to drug manufacturers and third-party conduits, such as patient advocacy organizations. The DOJ just announced a settlement with the non-profit Patient Services for alleged FCA violations
TAGS: Kickbacks, False claims, Third-Party Conduits, Patient Services, First amendment
Opioids
Judge’s Sentencing of Insys Executives Sends the Wrong Messages
By Dr. Seth B. Whitelaw, Editor, and Nicodemo Fiorentino, Associate Editor, of Policy & Medicine Compliance Update
Summary: Commentators, pharmaceutical executives, and compliance professionals have closely followed the Insys saga. Some, including this publication, believe it was a cautionary tale that others should heed. However, now that the Court has sentenced John Kapoor and the other individual defendants, we believe that the outcome sends the wrong messages about individual accountability and cooperation.
TAGS: Opioids, Insys, Kapoor, RICO, Kickbacks, False claims
International
Living Dangerously in a Global World – FDA’s International Inspection Program Makes Progress, but Problems Linger
By Gwendolyn A. Ball, Staff Writer
Summary: Over the past forty years conducting foreign establishment inspections, the FDA has scored several notable successes. However, substantial challenges remain, and since the global pharmaceutical supply chain remains a reality, the FDA’s job in assuring the safety of the U.S. drug supply will continue to be a difficult one
TAGS: inspections, api, global, supply chain, fda
Here are some of the topics we are working on for future issues of the Update:
- Washington State’s latest opioid suit against J&J
- Taro price fixing case
- ResMed final settlement
- New Developments in the effort to protect the global supply chain
