Life Science Compliance Update
Life Science Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry.

April

2017

April 2017: Life Science Compliance Update

Written by , Posted in April 2017 LSC Update, Home page, This Month in Compliance

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April 2017 LSCU Cover

Issue Summary

As we await the Easter bunny, this month we feature Chris Cobourn’s article on what pharmaceutical manufacturers need to know about 340B programs. Next, we travel around the globe to explore the recent regulatory changes that are impacting the Chinese life sciences market. Finally, we look at several trend setting enforcement actions, including Baxter’s recent cGMP False Claims Act, Teva’s FCPA settlement and the OIG’s new exclusion criteria.


Feature

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340B and You – Thoughts on Program Oversight for Pharmaceutical Manufacturers
Chris Cobourn, Managing Director, Huron Life Sciences
Abstract

The 340B Drug Discount Program plays an important role in the United States healthcare system by providing healthcare services primarily to entities that serve low-income populations. The program also is complex and evolving, so compliance challenges will abound for years to come. This article examines those complexities and compliance challenges.

Global Issues

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Healthcare Reform – Chinese Style
Amy Greenstein, Senior Consultant and Dana Liu, Consultant, Polaris
Abstract

The PRC continues to focus on three principle life science industry concerns: (1) drug quality, development, and approval, (2) healthcare affordability; and (3) preventing bribery and corruption in the healthcare industry. The recently published “Several Opinions Concerning Further Reforms of the Policies Governing Drug Production, Circulation and Usage” (“The Opinions”) continue and expand on those efforts.

Enforcement

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Project Exclusion: The OIG’s Latest Attempt to Make Its Exclusion Authority Real
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

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.

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Going Back to the Roots of the False Claims Act – Baxter Settles cGMP Allegations
Seth Whitelaw, JD, LL.M., S.J.D., Editor and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

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.

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TEVA – Using Legitimate Distributor Payments to Conceal Bribes
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

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.

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The Murky Future of Physician Owned Distributorships (“PODs”)?
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

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.

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