Policy & Medicine Compliance Update
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JANUARY 2020 Issue
Issue Summary:
January 2020 Issue
Since 2019 was a landmark year for compliance, we felt it appropriate as we begin our sixth publication year to feature a retrospective look at 2019’s Top 10 Compliance Milestones, and what they mean for 2020. In this issue, Katherine Norris and Jennifer Vondee provided a detailed analysis of the Top 5 developments. In the February issue, they will review the remainder of the Top 10.
For the remainder of this month’s Update, we expand on some of the developments highlighted in the feature. Thus, Gwedolyn Ball provides a year-end update on White House and Congressional efforts to address drug prices. Next, Robert Wilkey analyzes the partial reversal of the latest developments in the Insys case.
FEATURE
Looking Back on a Landmark Year: 2019’s Top Ten Compliance Milestones (and what they mean for 2020)
By Katherine Norris and Jennifer Vondee
Summary: 2019 was a watershed year for ethics and compliance. This article identifies the ten most significant events of 2019 and assesses the first five topics relative to their implications for 2020 and beyond.
Drug Pricing
Drug Pricing Year-End Wrap Up – Lots of Activity, But Little Real Reform
By Gwendolyn A. Ball, Staff Writer
Summary: Since January 2019, there have been numerous proposed drug price policies. The White House has released several proposals, only to see most of them derailed. Meanwhile, despite general agreement on the provisions in the “Creates Act” and inflation-linked price caps for Medicare, Congress has been unable to create a legislative package acceptable to both House Democrats and Senate Republicans. Thus, the prospects for progress on this important voter issue remain slim.
Governance & Operations
Redressing Corporate Misdeeds – Is Holding Individuals Accountable the Answer?
By Nicodemo Fiorentino, Esq. and Dr. Seth B. Whitelaw
Summary: Since 2015, the U.S. Department of Justice, through then DOJ Deputy Attorney General Sally Yates, has made it a priority to target individuals, such as executives, and hold them criminally and civilly accountable. While it appears that the DOJ’s individual accountability policies are not applied effectively, it is clear the DOJ will continue trying to hold individuals, including executives, accountable for corporate misdeeds.
Opioids
It’s Still Not Over – Judge Partially Reverses Convictions of Insys Executives
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: In May 2019, the founder and four former executives of lnsys Therapeutics Inc. (“Insys”) were convicted by a federal jury in Boston in connection with bribing medical practitioners to prescribe Subsys. However, in November, U.S. District Judge Allison Burroughs overturned some of the executives’ convictions. This article examines the ruling and its potential implications going forward.
New for 2020
Here is a brief snapshot of what we currently are working on and what you can expect to see in future issues.
You also will see some changes to our format. For starters, we will be adding a “look ahead” to give our readers an idea of the topics we are working on for upcoming issues. It also is an opportunity for you, our loyal readers, to suggest important topics you feel we should cover. All you need to do is drop me an email at editorial@policymed.com.
Also, beginning with this issue, we are rebranding the “Operations” heading as “Governance & Operations” because the items we cover under this heading don’t always fall neatly under operations, but instead often focus on governance.
This year we also are launching a new series that we are calling “Back to Basics.” As our profession continues to grow, we believe there is a need to revisit compliance issues and topics covered in the past, but which still emerge today. For example, the advisability of having the Compliance Officer report into or even be the Company General Counsel.
