Life Science Compliance Update

July

2018

When “Free” Really Isn’t Free – A Look at the Abiomed Case

Written by , Posted in Uncategorized

Robert N. Wilkey, Esq.

In March, the United State Department of Justice (DOJ) and U.S. Attorney’s Office for the District of Massachusetts announced a $3.1 million-dollar settlement with Abiomed to resolve allegations that the company was actively using illicit marketing tactics with physicians to increase sales in a manner that violated the AKS and FCA.  Such settlement highlights that there is no such as a free lunch.


   or   

  • Return to July 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints
  • Topic tags:

    July

    2018

    You Say Marketing Incentive; I Say Kickback – Former Valeant and Philidor Execs Convicted of Fraud in Kickback Scheme

    Written by , Posted in Uncategorized

    Carolyn Greene, Esq.

    Former executives of Valeant Pharmaceuticals and Philidor Rx Services, a specialty pharmacy, recently went on trial in Manhattan charged with fraud and conspiracy for allegedly engaging in a kickback scheme in which the Valeant executive encouraged Valeant to purchase an option agreement to acquire Philidor. The Philidor executive allegedly personally obtained $40 million from the deal and paid an almost $10 million kickback to the Valeant executive. Both were convicted, and each faces a potentially lengthy prison term at sentencing. In recent years, the DOJ has stepped up enforcement in holding company executives personally liable for corporate malfeasance. However, before this case, the DOJ had little success in obtaining convictions in these cases.


       or   

  • Return to July 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints

  • March

    2018

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

    Written by , Posted in Uncategorized

    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.


       or   


    March

    2018

    Establishing the Link – The False Claims Act and Temporal Proximity

    Written by , Posted in Uncategorized

    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.


       or   

  • Return to March 2018 LSC Update Table of Contents
  • Copy abstract URL
  • Order Reprints

  • February

    2018

    Has the Shine Worn Off False Claims QUI TAM Actions

    Written by , Posted in Uncategorized

    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.


       or   

    Topic tags:

    February

    2018

    Revisiting the Past – Warner Chilcott vs. Insys

    Written by , Posted in Uncategorized

    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.


       or   

    Topic tags:

    February

    2018

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

    Written by , Posted in Uncategorized

    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


       or   


    February

    2018

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

    Written by , Posted in Uncategorized

    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.


       or   


    February

    2018

    When Good Intentions Go Astray – United Therapeutics Settles AKS Suit

    Written by , Posted in Uncategorized

    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.


       or   


    October

    2017

    Getting Serious About Fraud – The DOJ Charges 412

    Written by , Posted in Uncategorized

    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.


    or

    Topic tags:

    Menu Title