Life Science Compliance Update



August 2015: Life Science Compliance Update

Written by , Posted in August 2015 LSC Update, This Month in Compliance

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May 2015 LSCU Cover

The August issue of Life Science Compliance Update provides the life sciences industry with important news and analysis, covering:

* Open Payments data analysis, and potential trends in spending
* Compliance risks and important tips for engaging in Open Payments Disputes
* Insight into how manufacturers are using Open Payments context boxes
* Outlining the compliance landscape for Medical Science Liaisons
* Best Practices for leveraging Open Payments data for commercial and compliance insights

Issue Summary

The August issue of Life Science Compliance Update provides an interesting look at the recently released 2014 Open Payments data. One article outlines the drastic decline in research payments from 2013. Another looks into what manufacturers are writing in Open Payments comment spaces—free-text boxes that allow manufacturers to offer context to their various transfers of value.

Also in this month’s edition, Paul Silver, the Managing Director and Practice Leader at Huron Life Sciences, as well as other members of his team at Huron, contributed an article entitled “Open Payments Driving Adjustments in HCP Engagement Practices.” The article provides insight into how organizations may use Open Payments for compliance and commercial insights. The article includes specific examples from the Open Payments database, and offers best practices for how to analyze the information.

The issue also features an article on the Open Payments “Review and Dispute” process by Abraham Gitterman, JD, an FDA/Healthcare Associate at the law firm Arnold and Porter. In it, Gitterman offers recommendations for manufacturers to consider when addressing physician disputes, not only to resolve inaccuracies to ensure compliance with the Sunshine Act, but also to identify and potentially mitigate additional compliance risks that may arise from or be attributed to disputes.

This publication also includes an article titled “Ensuring Compliant MSL Interactions with Healthcare Providers.” As manufacturers continue to move away from a traditional sales rep model, the government has adjusted its spotlight onto how Medical Science Liaisons (MSLs) interact with healthcare providers. This article provides a look at risk areas and government guidance for compliance within the MSL role.

Table of Contents


Sunshine Data Reveals Major Decrease in Research Payments


Open Payments Driving Adjustments in HCP Engagement Practices

Jeffrey Fisher, Manager, Huron Life Sciences
Mark Linver, Managing Director, Huron Life Sciences
Paul J. Silver, Managing Director & Practice Leader, Huron Life Sciences
Juan Tessi, Associate, Huron Life Sciences


Context Please: What Are Companies Writing in Open Payments Comment Boxes?


Ensuring Compliant MSL Interactions With Healthcare Providers


I Never Ate That Bagel! Navigating Compliance Risks Associated with Disputes Under the Physician Payments Sunshine Act

Abraham Gitterman, JD, FDA/Healthcare Associate, Arnold & Porter

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