Life Science Compliance Update

April

2017

COMMENTS

0

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

Arrow

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

Arrow

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

Arrow

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.

Arrow

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.

Arrow

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.

Arrow

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.

April

2017

COMMENTS

0

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

Written by , Posted in Enforcement

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

COMMENTS

0

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

Written by , Posted in Enforcement

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

COMMENTS

0

TEVA – Using Legitimate Distributor Payments to Conceal Bribes

Written by , Posted in Enforcement

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

COMMENTS

0

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

Written by , Posted in Enforcement

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.

April

2017

COMMENTS

0

Healthcare Reform – Chinese Style

Written by , Posted in Global Issues

Amy Greenstein, Senior Consultant and Dana Liu, Consultant, Polaris

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.

April

2017

COMMENTS

0

340B and You – Thoughts on Program Oversight for Pharmaceutical Manufacturers

Written by , Posted in Feature Article

Chris Cobourn, Managing Director, Huron Life Sciences

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.

March

2017

COMMENTS

0

March 2017: Life Science Compliance Update

Written by , Posted in March 2017 LSC Update, This Month in Compliance

The full text of this issue is available to our subscribers. If you are a subscriber please log in now. If you are not a subscriber, and would like to become one, please click on the subscribe link or read about all of the benefits a subscription brings by clicking on the Subscribe menu item above.

March 2017 LSCU Cover

Issue Summary

It’s March madness for Life Science Compliance. Medical devices are our focus this month. First, we highlight at all the new FDA device guidances issued when Obama departed the White House. We also look at how the FCA can impact devices with the Shire settlement. Also on the enforcement front, we explore whether DPA’s work as intended, as well as dive into the FY 2016 FCA recovery numbers. We finish up with two articles from Mitchell Hamline law students, Matthew Gunzehauser and Corey Hoze and one from Darren Jones of Polaris Management Partners on the future of life science compliance.


Feature

Arrow

Privacy Regulation: The Final Frontier of Life Science Compliance
Matthew Gunzenhauser
Abstract

Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the first in a two-part series.

Compliance Operations

Arrow

Accountability: The shifting landscape of compliance responsibilities
Darren Jones, Managing Partner, Polaris Management Partners
Abstract

The meaning of effectiveness of healthcare compliance programs has shifted in recent years. This article examines that shift and what it means for the role of the Compliance Officer including the need to evaluate and oversee a portfolio of risks.

Arrow

Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?
Corey Hoze, J.D. Candidate, Mitchell Hamline School of Law (2018)
Abstract

Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the second in the two-part series.

FDA

Arrow

A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the outgoing Obama Administration issued a litany of final and draft guidances in a roughly six-week period. This article briefly reviews these new guidance documents.

Enforcement

Arrow

Medical Devices & False Claims – Shire’s Settlement Is One for the History Books
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

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.

Arrow

Do DPA’s Work? – The BioMet Case Study
Robert N. Wilkey, Esq., LSCU Staff Writer
Abstract

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.

Arrow

DOJ Has Third Highest Annual Recovery in FCA History
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

The United States Department of Justice has announced the fiscal year 2016 recoveries from civil False Claims Act. This article delves into the numbers, extracting those recoveries.

March

2017

COMMENTS

0

March

2017

COMMENTS

0

Do DPA’s Work? – The BioMet Case Study

Written by , Posted in Enforcement

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

COMMENTS

0

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

Written by , Posted in Enforcement

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.

March

2017

COMMENTS

0

A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure

Written by , Posted in FDA

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

In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the outgoing Obama Administration issued a litany of final and draft guidances in a roughly six-week period. This article briefly reviews these new guidance documents.

March

2017

COMMENTS

0

Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?

Written by , Posted in Compliance Operations

Corey Hoze, J.D. Candidate, Mitchell Hamline School of Law (2018)

Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the second in the two-part series.

March

2017

COMMENTS

0

Accountability: The shifting landscape of compliance responsibilities

Written by , Posted in Compliance Operations

Darren Jones, Managing Partner, Polaris Management Partners

The meaning of effectiveness of healthcare compliance programs has shifted in recent years. This article examines that shift and what it means for the role of the Compliance Officer including the need to evaluate and oversee a portfolio of risks.

March

2017

COMMENTS

0

Privacy Regulation: The Final Frontier of Life Science Compliance

Written by , Posted in Feature Article

Matthew Gunzenhauser

Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the first in a two-part series.

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