Life Science Compliance Update

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

February

2018

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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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January

2018

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August

2017

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This Isn’t Walmart: The Supreme Court Narrows Forum-Shopping Options

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

In a decision of great import to pharmaceutical and device companies, the Supreme Court ruled in favor of Bristol-Myers Squibb in a jurisdictional argument at the nation’s Highest Court. This article outlines the background, the case decision, and the decision’s ramifications to companies.


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February

2017

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Are the Safe Harbors Still Safe? – OIG Issues Final Rule

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

The Department of Health and Human Services Office of Inspector General published a final rule, after considering various comments from stakeholders, about safe harbor provisions of the Anti-Kickback statute. This article goes into detail of what the changes were, and how they affect various health care providers.


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August

2016

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A Mixed Bag – Implied Certification in False Claim Act Cases after the Escobar Decision

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

The United States Supreme Court, in its Court recent decision in Universal Health Services, Inc. v. United States ex rel. Escobar (“Escobar”) reaffirmed that the government and realtors via qui tam suits can pursue False Claim Act (“Act”) liability against life science and healthcare companies. In doing so, the Court recognized such claims can proceed on an implied false certification theory. The Court also added a requirement that such parties must also demonstrate any misrepresentations were “material” on statutory, regulatory, or contractual requirements that make such representations misleading on those goods and services. Given that this heightened materiality standard is new, and the Court has remanded some cases for application of such new standard, the impact of Escobar on FCA liability will require a wait and see approach.


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December

2016

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Old Weapons with A New Purpose – Using Antitrust Laws to Control Drug Pricing

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Robert N. Wilkey, Esq., Staff Writer

U.S. Antitrust laws traditionally have been used to address, manage, and deter companies from engaging in anti-competitive conduct at the expense of consumers. Recently, the Government has turned to the antitrust laws to combat increasing drug prices. However, significant questions remain as to whether U.S. antitrust laws are an effective means to curb perceived excessive drug prices.


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March

2016

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Be Careful What You Sign Up For – Implied Certification and the False Claims Act (FCA)

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By: Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

The U.S. Supreme Court recently granted certiorari in the Escobar case from the 1st Circuit Court of Appeals that will significantly impact the way in which the False Claim Act (FCA) may impose civil liability. Given the overall purpose, scope, and intent of the FCA, we believe that the Court will seek to uphold rather than diminish the role of implied certification.


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July

2016

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Dentsply v. Bates: Taking a “Bite” Out of False Claim Act (FCA) Violations for Lack of Evidence

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

Recently the U.S. District Court for the Eastern District of Pennsylvania dismissed Plaintiffs’ qui tam False Claim Act (FCA) claims, finding that the plaintiffs had failed to produce any evidence that Defendants “influenced” any health care provider to submit a false claim for reimbursement to the federal government.


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February

2015

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January

2017

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Feeling Needy – The Why, What and How of Needs Assessments

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Tynan P. Olechny, MBA/MPH, CVA, Consulting Principal, PYA, and Christina L. Hummel, MBA, Senior Consultant, PYA

Given trade association guidance and recent government involvement in life sciences transactions, this article emphasizes the importance of developing and implementing needs assessments related to engaging healthcare professionals to provide services to pharmaceutical or medical device companies. It describes a four-step process for identifying and documenting the business purpose of such arrangements, including 1) developing and implementing a written needs assessment policy, 2) identifying the business purpose, 3) completing a provider analysis, and 4) addressing additional considerations and documenting the need.


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February

2015

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October

2015

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October 2015: Life Science Compliance Update Volume 1.8

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The October issue of Life Science Compliance Update features articles on growing enforcement targets for the government, including misleading marketing and improper “cheerleading” of scientific studies. This topic is especially relevant in the wake of Pacira’s recent challenge to the FDA’s enforcement of “truthful and non-misleading” promotion, a lawsuit this month’s issue also reviews.

Also in October, David Vulcano, the Responsible Executive for Clinical Research at HCA, contributed an article entitled “Highlights of the Notice of Proposed Rulemaking (NPRM) Changes to the Common Rule.” In it, Vulcano outlines the proposed changes to the Federal Policy for Protection of Human Subjects (the “Common Rule”), and highlights some of the implications of the proposal.

This publication also explores a recent state settlement coming out of New York where a manufacturer of opioid medication agreed to broad oversight requirements over the physicians who prescribe its products. Lastly, the October issue includes an analysis of a recent OIG Advisory Opinion that examines the Anti-Kickback Statute implications of providing co-payment subsidies for participation in a clinical study.

To view the table of contents for this issue, click here.

May

2017

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Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances

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

As we noted in last month’s issue, the FDA issued a slew of last-minute Obama Administration guidances. Overlooked among all the guidances was a Final Rule regarding tobacco products and their regulation. Several Industry groups banded together and submitted a Citizen’s Petition to the FDA, requesting a stay of the rule. This article outlines the regulation, the petition, and the FDA’s response.


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August

2017

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A New Application of Escobar: Gilead or When Half-Truths Can Become Actionable Under the FCA

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

On July 7, 2017, the Ninth Circuit in a very closely watched opinion determined that the whistleblowers in this case had demonstrated viable claims under the False Claims Act (“FCA”), alleging that their employer, Gilead Sciences, Inc. (“Gilead”) had made false statements to the U.S. Food and Drug Administration (“FDA”) regarding its HIV drug, resulting in billions of dollars of illicit payments from the government to Gilead. Such judicial decision is highly significant in that it is the first substantive Circuit Court decision since the U.S. Supreme Court decision in Universal Health Care v. Escobar, which effectively raised the legal burden by whistleblowers to demonstrate claims under the FCA.


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October

2017

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Will Your Whistle Be Heard at Home?

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Sally Foroughi, Staff Writer, Life Science Compliance Update

The distinct split between the Second and Fifth Circuit Courts’ interpretation as to when whistleblower protections are allowed has now summoned the attention of the U.S. Supreme Court. Despite clarifications issued in 2015 by the SEC to shed more clarity on Dodd Frank’s anti-retaliation protection to whistleblowers who reported alleged misconduct either internally to company officials or externally to government regulatory bodies, the U.S. Supreme Court will take the case of Digital Realty Trust v. Somer in the Fall of 2017, and finally render a final verdict for when whistleblower protection becomes enforceable. During the interim, it becomes vital for Compliance Officers to have appropriate policies and procedures in place to guide employees in reporting potential misconduct and/or fraud, and to establish a tone of non-retaliation for such reporting, in order to safeguard the best interests of the public and shareholders of the company.


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