Life Science Compliance Update

March

2018

March 2018: Life Science Compliance Update

Written by , Posted in March 2018 LSC Update, This Month in Compliance

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A Bright Future or Unfulfilled Promise – An Update on Biosimilars and Their Prospects for Contributing to Meaningful Cost Reduction
By George Schroeder, M.D. M.S., FACEP.; Seth Whitelaw, J.D., LL.M., S.J.D.; John Murphy, Esq.
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Biosimilars have a bright future and promise potentially significant health care cost savings, provided the regulatory, legal and commercial hurdles are removed. Recent activity by CVS and United Healthcare are promising signs that indeed the commercial barriers are starting to come down. However, it remains unclear whether the FDA will help on the regulatory front.

March 2018 Issue Summary

March 2018 LSCU Cover

We start out the March issue focusing on false claims. Our feature article discusses the recent Third Circuit case which outlines the minimum need to transform a kickback violation into a false claim. Next, we turn to the FY 2017 settlement figures for insights into the future. Finally, we examine how failing to make timely repayment can increase False Claims Act liability.

Switching gears, we turn to the issue of biosimilars and whether or not they will bring about a meaningful reduction in health care costs both here and abroad. We also examine the FDA’s continued regulatory efforts surrounding stem cells. On a global note, we have an excellent article outlining the new medical representative requirements that are coming online in China. Finally, this issue could also be billed as the Editorial Board member issue as we have articles from three of our members: Nicodemo Fiorentino, Dr. George Schroeder and John Murphy.


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Establishing the Link – The False Claims Act and Temporal Proximity
Nicodemo Fiorentino, Esq., Member, Life Science Compliance Update Editorial Board
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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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Soldiering On – The False Claims Act Cases Continue to Significantly Impact Life Science Companies in FY 2017
Gwen Ball, Staff Writer, Life Science Compliance Update
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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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Uncle Sam Wants His Money – First Coast Cardiovascular Institute as a Case Study in Repaying Overpayments Can Generate in FCA Liability
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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In October 2017, First Coast Cardiovascular Institute, entered into an almost $450,000 settlement with the DOJ to resolve allegations that it violated the False Claims Act by knowingly delaying repayment of more than $175,000 in overpayments. This settlement involving First Coast is a substantive example of how failing to make timely repayment can bring substantial, additional liability under the FCA. Therefore, it is crucial to ensure timely repayment to and reconcile any overbalances with the U.S. Government.

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The FDA Continues Its Effort to Reign in Rogue Stem Cell Therapy Companies
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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On August 28, 2017, the U.S. Food and Drug Administration (“FDA”) issued a scathing Warning Letter to a U.S. Stem Cell Clinic for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. Although the FDA Warning Letter was directed to a specific stem cell company, many observers note the FDA’s more extensive and broader efforts to regulate, enforce, and otherwise ensure compliance with good stem cell practices and procedures.

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Transforming Health Care in the Middle Kingdom – China’s New Medical Representative Regulation
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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China is the world’s largest and perhaps most complex economy. As the PRC emerges the world stage, it continues to transform its health care system. This article examines the nature of some of the regulatory reforms impacting the pharmaceutical industry with particular focus on the new medical representative requirements.

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ARTICLE UPDATE: Has the Shine Worn Off False Claims QUI TAM Actions
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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