Life Science Compliance Update
Life Science Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry.

February

2018

February 2018: Life Science Compliance Update

Written by , Posted in February 2018 LSC Update, Home page, This Month in Compliance

The full text of the entire issue is now available to our subscribers. If you are a subscriber please log in now. You may also buy this issue by clicking on the button below.


   or   

February 2018 Issue Free Article

Click here to view this article for free.

Arrow

One Purpose to Rule Them All – A Resounding “Yes” According to the District Court in U.S. Ex Rel. Cairns
By Robert N. Wilkey, Esq., Staff Writer and Seth B. Whitelaw, J.D., LL.M., S.J.D., Editor for Life Science Compliance Update
Tags: , , ,
The breadth of liability under the False Claims Act and Anti-Kickback Statute is a closely watched area. Recently, the U.S District Court for the Eastern District of Missouri concluded that liability might extend to a health care provider even where the plaintiff fails to demonstrate that the “primary purpose” of providing the benefits was to create an inducement. Although the impact of such Court case remains somewhat uncertain, it is expected that the Court’s ruling will continue to expand FCA and AKS liability.

February 2018 Issue Summary

February 2018 LSCU Cover

This month’s issue is focused on three main areas: drug pricing, patient assistance programs and the False Claims Act. As our feature article, Nicodemo Florentino explores the often-overlooked antitrust areas of “shadow pricing” and “conscious parallelism.” Next, we look at the recent settlement by United Therapeutics and its potential impact on patient assistance program charities and how the OIG’s efforts to regulate this area may lead to the next big 1st Amendment battleground.

We then turn our attention recent False Claims Act developments including the one purpose test and the DOJ’s apparent shifting view of qui tam actions.


Arrow

Casting Some Light on Shadow Pricing
Nicodemo Fiorentino, Esq.
Tags: , , ,
Prescription drug prices continue to rise and focus attention on the pharmaceutical industry. Currently the industry faces hearings at the federal level, new legislation at the state level and almost daily media coverage due to this issue. The Sherman Antitrust Act, passed in 1890, is also being used against the industry. Often overlooked, “shadow pricing” and “conscious parallelism” are two ways in which manufacturers allegedly can restrain trade and competition. This article is aimed at helping compliance and legal professionals become familiar with antitrust and how it presents a present and future compliance risk. The article further represents a call for compliance and legal professionals to be involved with how their company sets pricing.

Arrow

When Good Intentions Go Astray – United Therapeutics Settles AKS Suit
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Tags: , , ,
With the United Therapeutics settlement, it is clear that the DOJ remains focused on patient assistance programs and other similar charities. As a result, additional settlements involving these programs are likely to continue in 2018, once more pitting established legal constructs against current fiscal realities.

Arrow

Staring Down Another First Amendment Challenge – The OIG vs. Patient Services
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Tags: , , , ,
Patient Assistance Programs (“PAPs”) are starting to feel the heat from various United States agencies, as we have noted in several issues over the past year. Recently, Patient Services, Inc., filed suit in response to a Modified Advisory Opinion issued by the HHS OIG. This article outlines the changes and the suit.

Arrow

One Purpose to Rule Them All – A Resounding “Yes” According to the District Court in U.S. EX Rel. Cairns
Robert N. Wilkey, Esq., Staff Writer and Seth B. Whitelaw, J.D., LL.M., S.J.D., Editor for Life Science Compliance Update
Tags: , , ,
The breadth of liability under the False Claims Act and Anti-Kickback Statute is a closely watched area. Recently, the U.S District Court for the Eastern District of Missouri concluded that liability might extend to a health care provider even where the plaintiff fails to demonstrate that the “primary purpose” of providing the benefits was to create an inducement. Although the impact of such Court case remains somewhat uncertain, it is expected that the Court’s ruling will continue to expand FCA and AKS liability.

Arrow

Revisiting the Past – Warner Chilcott vs. Insys
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Tags: , , , , ,
Those who remember the Warner Chilcott and W. Carl Reichel case from just two years ago may have had déjà vu when they heard about the recent legal controversy surrounding John N. Kapoor and Insys. This article reviews the current Insys and Kapoor developments and compares the two cases to analyze whether the trend of involving high-ranking executives is the future of enforcement.

Arrow

Has the Shine Worn Off False Claims QUI TAM Actions
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
Tags: , ,
At the recent HCCA Annual Conference, the Deputy Director of DOJ’s Civil Fraud Section may have signaled a change in policy relative to handling qui tam cases. This article explores the issue and what it might mean for life science companies going forward.

Gravityscan Badge
Menu Title