Clinical Trial Billing - Building a Compliant Process that Works!

Why Should You Attend:

Beginning in 2000, with the National Coverage Decision (now “Clinical Trials Policy” or CTP), Medicare covers routine costs for Medicare participants in clinical trials. Though designed to protect taxpayer’s funds from fraud and abuse, the rules and regulations related to the CTP can become a minefield to institutions that conduct clinical trials. Many high profile academic and community health care systems have paid a high price in fines and penalties for inadequate processes to identify, capture and appropriately bills for clinical trial items and services.

This 90-minute session will provide a thorough overview of the CTP, its associated rules and regulations and practical help in designing a process to manage clinical trial billing that will assure optimal compliance.

Learning Objectives:

At the end of this session, attendees will be able to:

• Recite the relevant terms of the CTP.
• List the essential elements of a qualifying clinical trial.
• Create a Medicare Coverage Analysis from scratch.
• Devise a system to manage the billing of clinical trial charges in compliance with Federal rules and regulations.
• Create a plan to measure and assure compliance of the clinical trial billing process.

Areas Covered in the Webinar:

• The Clinical Trial Policy and clinical trial billing.
• “Qualifying” clinical trials;  what does that mean?
• What a robust Medicare Coverage Analysis (MCA) looks like.
• Contract terms to be wary of.
• Managing the clinical trial charge from its inception to its final payment without risk.
• Monitoring the process.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel involved in the clinical research enterprise, including:

• Sponsors
• Research Institutional Leaders
• Research Compliance professionals
• Clinical Research Professionals
• Billing/coding professionals

Instructor Profile:

Bob Romanchuk, is a clinical research professional with over a decade of experience in a broad range of clinical research infrastructure building, operation and management of both IRBs and research programs. This includes assembling and managing an IRB, building a cardiovascular research center for a large community hospital and creation and operation of a central research office for a 13 hospital system across North Carolina, South Carolina and Virginia. His certifications include CIP (Certified IRB Professional), CHRC (Certification in Health Research Compliance), CCRC (Certified Clinical Research Coordinator) and CCRCP (Certified Clinical Research Contract Professional). He has presented numerous times nationally on the subjects of clinical trial billing, human subjects protections and the creation and operation of centralized research offices.

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