Life Science Compliance Update

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.

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.

December

2016

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Omnicare’s Unwanted Spotlight Produces Mixed Results

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

Omnicare has been in the news for two separate cases recently, one involving a whistleblower suit, and another involving Abbott Laboratories. The case outcomes were mixed. This article gives an overview of both cases, as well as potential implications for compliance officers to pay attention to.

October

2016

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Tracking Towards a Banner Year for FCPA and FCA Enforcement

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

There are some strong indicators to suggest that 2016 is on track to be a real banner year regarding Foreign Corrupt Practices Act (“FCPA”) enforcement and qui tam actions. One of the most notable indicators is that FCPA enforcement for 2016 is on track to exceed actions for 2015, with to data, actions involving a total of 13 corporate and three individuals, including most significant the VimpelCom case. Additionally, newly unsealed qui tam cases show the FCPA focus on health care and hi-tech companies and the enforcement actions involving other countries, in particular, China is growing. This year is also an introduction to the DOJ’s pilot program.

October

2016

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GSK & China – The Latest FCPA Settlement Isn’t the End

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

GlaxoSmithKline(“GSK”) reached a settlement with the Chinese government in 2014 related to bribes and improper actions taken by company officials. Recently, GSK reached an agreement with the United States Securities and Exchange Commission for allegations that GSK violated the FCPA. While the SEC settlement is nowhere near the value of the 2014 Chinese settlement, they are both worth taking a look at.

October

2016

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Examining the FY2015 Report on Medicaid Fraud Control Units

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

Medicaid Fraud Control Units play an important, if often overlooked, role in the Government’s continuing effort to control program fraud and abuse. The recently released FY 2015 sheds light on the work of the Units as well as confirms trends seen by other enforcement agencies.

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