Life Science Compliance Update

March

2018

Soldiering On – The False Claims Act Cases Continue to Significantly Impact Life Science Companies in FY 2017

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Gwen Ball, Staff Writer, Life Science Compliance Update

For FY 2017, the Federal False Claim Act continued to be a potent weapon for combating health care fraud by life sciences companies. However, while overall the settlements appeared to hold steady, there were more defendants and smaller settlements. This article explores the FY 2017 data for what it may reveal about the future of FCA cases against life sciences companies.


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March

2018

Establishing the Link – The False Claims Act and Temporal Proximity

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Nicodemo Fiorentino, Esq., Member, Life Science Compliance Update Editorial Board

Under the Patient Protection and Affordable Care Act of 2010, a provision was added to significantly strengthen the Federal Anti-Kickback Statute by making a violation of the AKS also a violation of the Federal False Claims Act. Thus, if a relator or government can prove that Anti-Kickback Statute was violated, then it would constitute a false or fraudulent claim under the False Claims Act. But, what type of evidence is needed to connect a kickback to a false or fraudulent claim? A recent United States Court of Appeals for the Third Circuit case, United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89 (3d Cir. 2018), answered this question. This article discusses that case and its implications.


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  • February

    2018

    Has the Shine Worn Off False Claims QUI TAM Actions

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    Gwendolyn Ball, Staff Writer, Life Science Compliance Update

    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.


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    February

    2018

    Revisiting the Past – Warner Chilcott vs. Insys

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    Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

    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.


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    February

    2018

    One Purpose to Rule Them All – A Resounding “Yes” According to the District Court in U.S. EX Rel. Cairns

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    Robert N. Wilkey, Esq., Staff Writer and Seth B. Whitelaw, J.D., LL.M., S.J.D., Editor for Life Science Compliance Update

    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


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    February

    2018

    Staring Down Another First Amendment Challenge – The OIG vs. Patient Services

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    Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

    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.


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    February

    2018

    When Good Intentions Go Astray – United Therapeutics Settles AKS Suit

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    Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

    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.


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    October

    2017

    Getting Serious About Fraud – The DOJ Charges 412

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    Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

    With the new administration, there appears to be a renewed commitment to enforcing anti-kickback rules against healthcare providers committing fraud against the government insurance programs. In July 2017, the Department of Justice and Department of Health and Human Services announced the largest-ever fraud takedown in the health care arena. This article outlines the announcement, and what it may mean for the future of health care.


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