Life Science Compliance Update

July

2017

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The California Hurdle – SB 790 and Pharma

Written by , Posted in Transparency

Jenny McVey, Life Sciences Manager, FRA

Seven states and the District of Columbia currently have regulations that limit or ban industry gifts to physicians, and it seems as though others are following suit. The California state Senate passed SB 790 in May 2017, a bill restricting pharmaceutical companies from giving gifts and incentives to medical professionals. This article reviews the changes SB 790 calls for, and what compliance professionals should keep an eye on.

June

2017

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Chicago’s Attempt to Regulate Drug Reps – A Real Public Health Initiative or Simple Revenue Generator?

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

Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has joined D.C. in the attempt to regulate pharmaceutical representatives. Billed by Chicago Mayor Rahm Emanuel as a measure to curb opioid addiction, the actual purpose seems less clear. What is clear is that the ordinance will induce additional costs and complexities for pharmaceutical compliance officers charged with overseeing sales activities.

September

2016

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On a Collision Course – FDA Clinical Investigator Disclosure and Open Payments

Written by , Posted in Abstract, Transparency

Dr. Seth B. Whitelaw, Editor, Life Science Compliance Update

FDA’s requirements for clinical investigator disclosure and the Open Payments requirements are at odds in many ways. This article explores those differences and what might be done to remedy the situation.

September

2016

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State of the European Union – Transparency in Europe 2016 and Beyond

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Geert van Gansewinkel, Partner and Managing Director, Polaris Europe

Three years ago, EFPIA adopted the EFPIA transparency code. Now three years later, this article takes the opportunity to look at what has happened so far with transparency reporting in Europe and what the future may hold.

September

2016

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Pharma & Medtech – Like Chalk & Cheese?

Written by , Posted in Abstract, Transparency

Nick Merryfield and Andrew Wiles of WorldDataOnline LLC.

The pharmaceutical and medical technology industries appear to show marked transfer of value variations in this year’s Open Payments data. This study investigates further and asks, is it a case of two sectors using unique commercial models, or a simple case of different reporting methodologies?

August

2016

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Transparency Across the Pond – A Look at Efforts in Germany and the UK

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

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.

August

2016

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Caveat User, Caveat Emptor – Issues from the Soft Under Belly of The CMS Data Sets

Written by , Posted in Abstract, Transparency

Mark Labovitz, Ph.D., MS, MBA, Principal, Attest Open-Payments™ and President, Data Analysis Consulting (DAC), LLC.

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.

June

2016

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Detecting the “Sham” in Speaker Programs

Written by , Posted in Abstract, Transparency

Mark Labovitz, Ph.D., MBA and Jeffrey DiFrancesco, M.Sci., M.Eng., Principals, Attest Open-PaymentsTM

This paper explores whether the publically available Open Payments data can be employed, using the same factual basis as the Government in its March 2016 allegations against Novartis to detect potential “sham” speaker programs.

April

2016

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Sun Glare- The Confusing World of the Physician Payment Sunshine Act and Biomedical Research

Written by , Posted in Abstract, Transparency

Thomas Sullivan, BS, President Rockpointe Corporation

As part of the Affordable Care Act, the Physician Payment Sunshine Act tracks payments and transfers of value from manufacturers of drugs, devices, biologics, and medical supplies (applicable manufacturers) to physicians and teaching hospitals. This article explores which data are tracked and what this tracking means for research, including what researchers should do to ensure that their data are accurately reported and how to handle questions that may arise from the publication of the data. Results for the first two reporting cycles (5 months 2013, and 12 months in 2014) are highlighted.

February

2016

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Parting the Clouds – Some Thoughts on Why CMS Has Not Imposed Civil Monetary Penalties for Sunshine Act Violations

Written by , Posted in Abstract, Transparency

By: Timothy M. Moore, Esq., Attorney with Shook, Hardy & Bacon L.L.P

Although the Sunshine Act allows for the imposition of Civil Monetary Penalties, CMS has yet to bring a single action. This article reviews the rocky implementation of the Sunshine Act and explores possible reasons for the lack of enforcement actions.

January

2016

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Global Transparency Trend: Lessons Learned from Sunshine shining on EFPIA

Written by , Posted in Abstract, Transparency

By: Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM

Presently, both the U.S. and France have enacted legislation requiring various degrees of disclosure about payments made by life sciences companies to Healthcare Professionals. Beginning in 2016, EFPIA will be added to the mix. This article explores some of the similarities and differences between the U.S., France and EFPIA requirements. In addition, this article discusses some ways to prepare for and potentially improve global transparency.

January

2016

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De-Polarizing Transparency

Written by , Posted in Abstract, Transparency

By: Ian J. Clark, Editorial Board Member, Life Science Compliance Update, Former Director of Transparency, Medical Affairs and Professional Education at Abbott Vascular

As part of the Affordable Care Act, the Physician Payment Sunshine Act requires manufacturers of drugs, devices, biologics, and medical supplies (applicable manufacturers to track all transfers of value to physicians and teaching hospitals. This article explores some of the ways in which the data can be used beyond the more traditional risk and compliance areas. It looks at the various ways the data could be used to support and supplement the everyday business questions of the medical industry and suggests ways to broaden and deepen working relationships across organization.

January

2016

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The Purcell Uncertainty Principle – Ambiguity and Indirect Payments Under the Sunshine Act

Written by , Posted in Abstract, Transparency

By: Nicodemo (Nico) Fiorentino, Esq., Senior Advisor, Research & Compliance, for G&M Health LLC. and Editorial Board Member, Life Science Compliance Update

Open Payments, commonly known as the Sunshine Act, requires applicable manufacturers to report payments or other transfers of value provided to covered recipients and teaching hospitals. Beginning January 1, 2016, new rules take effect regarding Open Payments and CE/CME sponsored activities and programs, whereby CME exemption provisions are eliminated and replaced with the indirect payments or other transfers of value exclusion. Due to the vagueness of the term, “indirect payments or other transfers of value,” compliance officers and counsel must navigate through the ambiguity created by CMS. In the absence of guidance, a recently decided False Claims Act case provides some protection, though it remains to be seen how robust it will be.

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