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Clinical Research Compliance: A Year in Review


Product Code - LGA150
Speaker(s): F. Lisa Murtha, Dentons US LLP
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Any healthcare organization engaged in clinical research has seen numerous amendments and updates to the laws and regulations that govern such research. This program will outline the new laws, regulations, settlements, investigations, and other items of note from year 2012 and year 2013 to date. Any organization, consultant, or attorney practicing or clinical research or representing those who do must fully understand these issues.

Specifically, this program will address the OIG’s 2013 work plan, delays in updating the “Common Rule” which was originally adopted in 1991, the protection of human subjects during research testing, the omnibus rule, how sequestration may affect funding for research, and more.

Educational Objectives:

• Learn about pending and finalized laws, regulations, investigations, and enforcement initiatives in clinical research.
• Understand how to protect research portfolios and support research services.

Who would benefit most from attending the program?

Research professionals and compliance professionals and the attorneys and consultants who represent them; administrative staff; physicians.

Program Level: Intermediate-Advanced

Credit Available: CLE. For more information, please click on the “CLE Credit” tab.

F. Lisa Murtha, Dentons US LLP

F. Lisa Murtha, Dentons US LLP
Lisa Murtha is a member of Dentons’ healthcare practice. She has more than 22 years of experience working on complex clinical research and healthcare compliance issues. Ms. Murtha focuses her practice on clinical research compliance, which includes human subject protections, effort reporting, scientific misconduct, conflicts of interest, and clinical trial billing and process improvement. She also provides guidance regarding revenue cycle work, billing and coding issues, internal investigations, compliance program effectiveness, corporate governance/ethics, and HIPAA-related matters. She leads project teams responsible for redesigning and implementing new clinical research billing processes at several large academic medical centers around the United States, serves as the engagement lead on numerous compliance program assessments at large healthcare organizations, and serves as an expert witness on several research and healthcare compliance cases.

Ms. Murtha is the author of numerous articles and books on research, healthcare compliance, and fraud and abuse topics, including several articles published in Bloomberg BNA’s Medical Research Law and Policy Report.

Ms. Murtha earned a J.D. from Dickinson School of Law and a B.A. from The Pennsylvania State University. She is certified in healthcare compliance in Pennsylvania and the District of Columbia.

This program’s CLE-credit eligibility varies by state. Bloomberg BNA is an accredited provider in the states of New York, California, Pennsylvania, Texas and Virginia, and most other jurisdictions grant CLE credit on a per-program basis. At this time, Bloomberg BNA does not apply directly to the states of Florida, Rhode Island, Montana and Hawaii although credit is usually available for attorneys who wish to apply individually. Additionally, the following states currently do not grant credit for Bloomberg BNA OnDemand programming: Arkansas, Ohio, Nebraska, and Delaware. All requests are subject to approval once the live webinar has taken place or the customer has viewed the OnDemand version. Please contact the Bloomberg BNA accreditations desk if you have specific questions that have not been addressed.

If you have further questions regarding a specific state or how to file for CLE credit, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditation Coordinator.

Hardship Policy
Bloomberg BNA offers a hardship policy for attorneys earning less than $50,000 per year. If an attorney wishes to take advantage of this option, he or she must contact Bloomberg BNA directly. For attorneys who are unemployed or earning less than $35,000 per year, a full discount off the price of the program will be awarded upon written proof of hardship. Attorneys earning between $35,000 and $50,000 per year will receive a 50% discount off the price of the program. Any attorney working in the public service sector also qualifies for a special price. If you have further questions regarding the hardship policy or seek additional information, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditations Coordinator, or email us at accreditations@bna.com.

Questions
For more information about Mandatory or Minimum Continuing Legal Education (MCLE) requirements, visit the American Bar Association website at http://www.abanet.org/cle/mandatory.html.