Life Science Compliance Update

April

2017

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Going Back to the Roots of the False Claims Act – Baxter Settles cGMP Allegations

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Seth Whitelaw, JD, LL.M., S.J.D., Editor and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

While False Claims Act cases are relatively common in the life science industry, FCA cases for cGMP violations are not. This article explores the most recent case involving Baxter Healthcare Corporation and some of its troubling implications.

April

2017

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The Murky Future of Physician Owned Distributorships (“PODs”)?

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

On January 9, 2017, a physician was recently sentenced for his role in a criminal health care fraud scheme totaling approximately $2.8 million and focused on False Claims Act (FCA) related allegations concerning this physicians’ participation in very complex and elaborate physician-owned distributorships (PODs). PODS are described by the government as physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their patients at hospitals or ambulatory surgical centers. In recent years, PODs have been subjected to heightened regulatory scrutiny and oversight because of the potential for abuse, fraud, and conflicts of interest; as a result, the future of PODs remains highly uncertain.

April

2017

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TEVA – Using Legitimate Distributor Payments to Conceal Bribes

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

On December 22, 2016, the Securities and Exchange Commission (SEC) announced that Teva Pharmaceutical Industries Limited had agreed to pay more than $519 million to settle parallel civil and criminal charges that it violated the Foreign Corrupt Practices Act (FCPA) by paying bribes to foreign government officials in Russia, Ukraine, and Mexico. The interesting aspect of this settlement is as the government alleges, the bribes were concealed in the form of legitimate payments to distributors.

April

2017

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Project Exclusion: The OIG’s Latest Attempt to Make Its Exclusion Authority Real

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

On January 11, 2017, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS), issued a new robust set of policy and rule-making guidelines, significantly clarifying and reaffirming regulatory efforts to place both individuals and corporations that engage in fraudulent Medicare and Medicaid programs on the Agency’s exclusionary list. Although such regulatory enhancements strengthen the Agency’s overall approach to combating fraudulent activity, it also seeks to impart a level of “objective fairness” in such process.

March

2017

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March

2017

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Do DPA’s Work? – The BioMet Case Study

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Robert N. Wilkey, Esq., LSCU Staff Writer

On January 12, 2017, the U.S. Department of Justice (DOJ) announced publicly that Zimmer Biomet Holdings, Inc. (Zimmer BioMet) had agreed to pay a $17.4 million criminal penalty “in connection with a scheme to pay bribes to government officials in Mexico and for violations of the internal controls provisions of the Foreign Corrupt Practices Act (FCPA) involving the company’s operations in Mexico and Brazil.” This is not the first time BioMet faced allegations involving its business practices in foreign countries, and in 2012 entered a deferred prosecution agreement (DPA). The BioMet settlement highlights the significant liability life health science companies face when failing to adhere to DPAs and how large-scale settlements are used by the government to ensure industry compliance.

March

2017

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Medical Devices & False Claims – Shire’s Settlement Is One for the History Books

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

We have seen many large False Claims and Anti-kickback settlements with pharmaceutical companies and the prescriptions they manufacture. Now, a medical device company has gotten into difficulty for many of the same types of violative activities. This article provides an overview of the allegations and the settlement.

February

2017

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Valeant and Philidor Controversy Comes to a Head

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

Valeant Pharmaceuticals, Inc. has had quite the year – they have been under scrutiny since October 2015. However, in November 2016, one former Valeant executive and one former Philidor executive, were arrested and charged with criminal complaints. This article outlines those complaints, and the actions the individuals allegedly took to be criminally charged.

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.

February

2017

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2017 Trending Towards a Banner Year for Industry Compliance

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

There are strong indications that 2017 is already trending towards a banner year for industry compliance, including most notably the continued and active efforts by the U.S. Department of Justice (“DOJ”), U.S. Securities and Exchange Commission (“SEC”) and other government agencies, to investigate, prosecute, and settle with life science companies for issues related to noncompliance, lack of transparency, and the falsification of science based data. There are also a few pending investigations by the DOJ involving various generic drug companies, including allegations of illegal pricing agreements and collusion, which will similarly impact compliance in 2017.

February

2017

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Anti-corruption: all roads lead to enforcement

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Caroline Franco, Amy Greenstein, Darren Jones & Veronique Monjardet

When it comes to corruption, Life Sciences companies are a frequent target of investigation and enforcement. The French enactment of Sapin II is the latest in a long line of laws to combat corruption. This article explores Sapin II and why the authors feel that Life Sciences companies are among the best positioned to comply with Sapin II’s requirements.

January

2017

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Not All Discounts Are Equal: Evaluating When Discounts May Be Construed as Unlawful

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Robert N. Wilkey, Esq., Staff Writer and Dr. Seth B. Whitelaw, Editor for Life Science Compliance Update

Discounts within the health care industry are historically viewed as not being subject to the U.S. Federal Anti-Kick Back Statutes (“AKS”). Recently, the U.S. Department of Justice (“DOJ”) and U.S. Courts have sought to clarify, refine, and otherwise limit the scope of the discount “safe harbor” provision, putting the life sciences and health industry on notice that not all discounts are necessarily immune from AKS violations. As a result, companies are no longer blindly able to rely on “safe harbor” protections and need to re-evaluate their discount programs.

January

2017

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Nursing Facilities & Kickbacks – Is the DOJ Shifting Away from Pharma?

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

DOJ may have a new focus for Anti-Kickback Statute violations: care facilities and their owners. This year alone, at least two high-profile cases have emerged where a care facility wound up in high-profile enforcement actions involving anti-kickback violations. This article examines the cases and explores why life science compliance professionals should pay attention to them.

January

2017

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Co-Payment & Deductible Waivers as Illegal Inducements

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

Health insurance providers and out-of-network providers, have found themselves in murky water by providing waivers of co-payments, coinsurance, and deductibles to patients treated by out-of-network laboratories and other providers, where commercial insurers continue to seek legal reimbursement actively, recovery and collection claims against such providers, alleging in pertinent part False Claims Act (“FCA”), Anti-Kickback Statute Violations (“AKS”), and other legal claims. Such efforts are requiring Courts to identify, determine, evaluate, and when waivers of co-payments, coinsurance, and deductibles, constitute such FCA and AKS violations.

January

2017

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Planning for the Future – HHS OIG’s 2017 Work Plan

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

Health and Human Services Office of Inspector General has released their 2017 Work Plan. The updated work plan includes some new and revised audits and evaluations, as well as some older audits and evaluations that OIG continues to focus on. This article goes through many of the items focused on the drug and device world and discusses what compliance officers should do with this Work Plan.

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