Next Steps in Clinical Research Billing

Great attention and detail has been given to institutions struggling with the ideas and processes behind clinical research billing. Compliance, legal, and institutional management have studied their own organizations, attempting to operationalize their billing process and implement new methods and systems to identify their research billing practices and evolve them to meet the regulations set forth by CMS. What all these organizations come to understand is that the issue of research billing is not a finite goal but one that is continually evolving to address both internal and external factors that continually change the billing landscape.

This session presents additional and more in-depth ideas and practices related to a compliant research billing practice. We go beyond the basics of the Clinical Trials Policy and the current regulations to discuss and analyze new challenges facing research teams and their current research billing operation. Focus is placed on the internal audit and self-disclosure process for potential billing irregularities, how to handle complex research billing issues that don’t align neatly with established regulations, building and maintaining a robust information process, and training and education challenges related to staff turnover and new research team members.

Session Objectives

Upon completion of this webinar, attendees should be able to:        

• Describe the steps to an internal audit of a research billing operation and next steps when potential irregularities are discovered.
• Identify how some institutions deal with non-qualifying research projects.
• Recognize the steps to building an information repository of Medicare related coverage information.
• Recognize the importance of an ongoing training program and steps necessary for maintaining and disseminating research billing information to stake-holders.

Target Audience

PI’s and research coordinators, institutional compliance officials and legal counsel, research administration management and leadership, Billing or Patient Financial Services staff dealing with research billing

Presenters

Beau S. Gostomsky

Beau S. Gostomsky is a manager at Huron Consulting Group in their Clinical Research Solutions and Healthcare Compliance practice.  He works with the assessment, design, implementation, and operations of research billing compliance systems, Medicare coverage analyses, research revenue cycle, and centralized research administration.  In addition, he supports the practice through clinical trial management system implementation and operations, and claim denial reviews and appeals.

Prior to joining Huron, Beau was the director in the Office of Clinical Trials at NYU Medical Center where he was responsible for the research billing operation which included compliance management, coverage analysis, revenue cycle integration, and front-end/back end process management.   Operationally, he was responsible for the management and negotiations for industry sponsored research, sponsored research financial and account management, clinical trials management system implementation and research process management.  He developed and taught several core research educational trainings including study budget development, GCP training, and research billing.  Prior to his director’s role, Beau was a systems specialist with the Office of Clinical Trials focusing on diverse therapeutic group research team administration and institutional integration with a centralized research system.  He is a registered nurse and a certified clinical research professional (CCRP).

Leah Guidry

Leah Guidry has 20 years of experience working with various healthcare entities including healthcare systems, hospitals, academic medical centers, physician groups, group purchasing organizations, and pharmaceutical and device manufacturers. She advises academic medical centers and other research sites on a variety of compliance related matters. Her particular expertise is working with clients on government disclosure determinations, development and implementation of the infrastructure necessary to appropriately bill Medicare for research related items and services, and staff training.

Prior to joining Huron, Leah practiced healthcare law in Washington, DC and New York, NY and focused on defending clients against government investigations.  She also has extensive clinical and administrative experience in healthcare settings in Louisiana, Arizona, and New York.

Please note: Webinar presentations are delivered online at the scheduled presentation time only and will not be distributed prior to or following the event. Speakers maintain all copyrights on presentation materials and duplication or preservation of webinar content is strictly prohibited.

Continuing Nursing Education The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing nursing education credit (Program Number CBRN-11147-2008-AUD-374). Continuing Pharmacy Education The Association of Clinical Research Professionals is accredited by the Accreditation Council on Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Program Number 234-08-016-C04-P has been assigned to this program. This program provides 1.5 contact hours of continuing education credit. A statement of credit will be e-mailed to participants within 2 weeks of the program. Each participant must submit a completed evaluation form at the end of the program to receive a Continuing Education Statement of credit. Partial credit will not be awarded. Release date: 6/13/08. Association of Clinical Research Professionals The Association of Clinical Research Professionals (ACRP) provides 1.5 continuing education credits for the completion of this educational activity with the completion of the online evaluation form.  These credits can be used to meet the certification maintenance requirement. (Program Number ACRP-2008-AUD-373).