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.

August

2016

August 2016: Life Science Compliance Update

Written by , Posted in August 2016 LSC Update, Home page

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August 2016 LSCU Cover

Issue Summary

August is transparency season, and appropriately this month we focus our attention not only the recent Open Payments data release, thanks to an excellent article from Huron Life Sciences, but also some global numbers out of Germany and the UK. The team at Attest Open-Payments has taken a look at the 2015 Open Payments data set and noted some challenges with the data quality. Chris Cobourn, also from Huron, continues his series on AMP, and of course, no Update issue would be complete without the usual enforcement case roundup.


Feature

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Tis The Season – 2015 Open Payments Highlights and Risk Management Considerations
Mark Linver, Jeff Fisher, Juan Tessi of Huron Life Sciences
Abstract

On June 30th, 2016 CMS published the third year of Open Payments data. With more than two full years of transaction level spend data publicly available, an opportunity exists for Life Sciences companies to utilize Open Payments data as an additional tool in their technology-enabled risk management strategies.

Transparency

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Caveat User, Caveat Emptor – Issues from the Soft Under Belly of The CMS Data Sets
Mark Labovitz, Ph.D., MS, MBA, Principal, Attest Open-Payments™ and President, Data Analysis Consulting (DAC), LLC.
Abstract

While the goal of Open Payments and transparency are arguably good public policy, the usefulness of Open Payments depends entirely on the quality of the underlying data. This paper explores some of challenges found in the 2015 data set that negatively impact that usefulness.

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Transparency Across the Pond – A Look at Efforts in Germany and the UK
Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update
Abstract

On June 30, 2016, transparency efforts around the world released numbers on financial interactions between industry and physicians. This article goes through recent releases in Germany and the United Kingdom, including analysis on where the money is coming from, and who it is going to.

Pricing

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What You Don’t Know About AMP Can Hurt You – Part 2 This is Not Your Father’s AMP
Chris Cobourn, Managing Director, Huron Life Sciences
Abstract

As part of a series on the Average Manufacturer Price (AMP), this month’s article explores the of AMP from the beginning of the Medicaid Drug Rebate Program (MDRP) to where it is today and why there is so much public scrutiny on this once obscure statutory price calculation.

Enforcement

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Weighing in on the Recent Acquittals – Former HHS Inspector General Offers Practical Suggestions for Compliance Officers
Matthew Hay, Guest Contributor, Life Science Compliance Update
Abstract

Richard Kusserow served as Health and Human Services Inspector General from 1981 to 1992. In this article, he discusses the implications for compliance officers of the recent Warner Chilcott acquittals.

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A Mixed Bag – Implied Certification in False Claim Act Cases after the Escobar Decision
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

The United States Supreme Court, in its Court recent decision in Universal Health Services, Inc. v. United States ex rel. Escobar (“Escobar”) reaffirmed that the government and realtors via qui tam suits can pursue False Claim Act (“Act”) liability against life science and healthcare companies. In doing so, the Court recognized such claims can proceed on an implied false certification theory. The Court also added a requirement that such parties must also demonstrate any misrepresentations were “material” on statutory, regulatory, or contractual requirements that make such representations misleading on those goods and services. Given that this heightened materiality standard is new, and the Court has remanded some cases for application of such new standard, the impact of Escobar on FCA liability will require a wait and see approach.

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Railroad Retirement Board (RRB) First to Double-Down on DOJ’s Civil Penalties for FCA Violations
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

The United States Supreme Court, in its Court recent decision in Universal Health Services, Inc. v. United States ex rel. Escobar (“Escobar”) reaffirmed that the government and realtors via qui tam suits can pursue False Claim Act (“Act”) liability against life science and healthcare companies. In doing so, the Court recognized such claims can proceed on an implied false certification theory. The Court also added a requirement that such parties must also demonstrate any misrepresentations were “material” on statutory, regulatory, or contractual requirements that make such representations misleading on those goods and services. Given that this heightened materiality standard is new, and the Court has remanded some cases for application of such new standard, the impact of Escobar on FCA liability will require a wait and see approach.

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Misleading Survival Data Leads to FCA Liability in Recent Genentech Case
Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update
Abstract

The DOJ and FDA are starting to back off prosecuting cases involving just off-label claims, after making several unsuccessful attempts. However, the recent Genentech settlement may illuminate a path to success for the DOJ utilizing the False Claims Act. This article outlines the Genentech case, why it is different from other off-label cases, and what compliance officers can do to prevent their company from experiencing the same fate.

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