Clinical Trials Update (Audio Conference)

AUDIOCONFERENCE ON CD OR AUDIO ON-DEMAND

Sponsored by The Healthcare Professional's Guide to Clinical Trials

presented on July 16, 2008

Go beyond the basics of CMS' Clinical Trial Research Policy

In October 2007, CMS issued its final decision memo for a new Clinical Trial Research Policy (CTP) National Coverage Determination (NCD).Compliance officers need to know the intricacies of clinical trial programs to prevent fraudulent billing practices. Proper billing can include up to three or more different payers—from trial sponsors, to Medicare and Medicaid, to third-party-private payers, even patients themselves. This makes tracking the who to charge for what aspect of clinical trial-related medical care challenging at best.

Being familiar with the policy isn't enough. You need to go beyond the requirements with specific, real-world case studies to help ensure compliance. Listen to HCPro for the 90-minute audioconference Clinical Trials Update: Case Studies to Handle FDA Oversight, OIG Investigations, and New CMS Regulations. Expert speakers F. Lisa Murtha, J.D., CHC, of the Huron Consulting Group, and James A. Moran J.D., CPA, Executive Director of the Center for Clinical Studies, Washington University, offer real-world scenarios to help compliance officers understand Medicare reimbursement rules and implement effective strategies to protect their facilities from False Claims Act violations.

Learn how to navigate protocols for proper research reimbursement. Our speakers also provide tips to minimize reimbursement delays and strategies to bring incongruous internal departments together for clinical trials compliance.

At the end of this audioconference, you will be able to:

• Compare the new regulatory enforcement environment for clinical research billing to historical compliance risks
• Incorporate examples of how organizations have tackled this issue into your facility program
• Identify tests to determine if clinical trial costs can be reimbursed, and by whom
• Identify stake holders and decision makers in the process

AGENDA

• Enforcement initiatives on clinical research billing
  • Recent OIG investigations/settlements
  • CMS focus areas
  • Business imperative to realign clinical research models to investigator needs
• Four Clinical research billing models
• Protocol case study
• The optimal process of starting a research study
• Question & Answer session

MEET THE SPEAKERS

F. Lisa Murtha, J.D., CHC, managing director, Huron Consulting Group, New York City. Ms. Murtha focuses her practice in clinical research compliance (human subject protections, effort reporting, scientific misconduct, conflicts of interest, and clinical trial billing and process improvement), revenue cycle work, billing and coding issues, internal investigations, corporate governance/ethics, and HIPAA work.

James A. Moran J.D., CPA, Assistant Dean for Clinical Trials and Executive Director of the Center for Clinical Studies (CCS), Washington University. CCS supports the effective, efficient, and reliable evaluation of new pharmaceuticals and medical devices in collaboration with sponsoring organizations. CCS supports investigators with industry contract negotiation and clinical trial referrals, a full spectrum of services for planning and conducting clinical trials. CCS also provides sponsoring organizations with access to top-quality investigators, study coordinators, participants and outpatient research facilities for the conduct of clinical trials.

WHO SHOULD LISTEN?

Professionals from large hospitals as well as academic medical centers, who work in the following departments or have the following titles:

• Compliance officer
• Auditor
• Integrity coordinator
• CFO/ COO
• Billing
• Registration
• Medical Records
• Laboratory
• Pharmacy
• Radiology
• Budgeting Specialist
• Contracting Specialist
• Physician
• Principle Investigator
• Research Coordinator

PROGRAM MATERIALS:

Program materials are provided with PDF links.

AUDIO ON-DEMAND

In addition to the regular purchase option for HCPro audioconferences, we are pleased to offer another option, an audio on-demand. Audio on-demand allows you to download the program and play it back at your convenience through your computer or MP3 player. Purchase a CD or audio on-demand of the program and listen when you can. It's also a perfect training tool for new staff or as a refresher for veteran staff.

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