3-hr Virtual Seminar: Building a Process for Clinical Trial Billing That Works

This 3-hour training will explain how to devise a clinical trial billing system or process to manage the billing of clinical trial charges in compliance with Federal rules and regulations.

Why Should You Attend:

Though designed to protect taxpayer’s funds from fraud and abuse, the rules and regulations related to the Clinical Trials Policy or 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 bill for clinical trial items and services. This session will approach the clinical trial billing process in three steps:

Part I : Discussion of the regulations that govern clinical trial billing including the Stark rule, Anti-Kickback Statute, the False Claims Act and Medicare Secondary Payor Rule. The lay of the land; a review of current survey findings on institutional practices in clinical trial billing.

Part II : The components of a clinical trial billing process and the institutional roles that are accountable. The creation of a Medicare Billing Analysis (MCA) will be described in detail with a case exercise.

Part III : Operationalizing the billing process. The section will include how all the components are assembled and work in tandem for a successful process. Consideration of EHRs and Clinical Trial Management Systems will be included. Challenges to implementation and a compliance program will follow.

Areas Covered in the Seminar:

• The Clinical Trial Policy and clinical trial billing
• How the Stark Rule, Medicare Secondary Payor Rule, Anti-Kickback Statute and False Claims Act impact the clinical trial billing process.
• Creation of a robust Medicare Coverage Analysis (MCA)
• Negotiating Clinical Trial Contracts and Budgets that meet regulatory restraints
• Managing clinical trial charges from their inception to final payment with an effective and comprehensive process.
• High risk areas
• Monitoring the process

Learning objectives:

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

• Recite the relevant terms of the CTP
• Understand the impact of Stark, AKS, FCA and MSP on clinical trial billing
• Create and implement an effective Medicare Coverage Analysis
• Devise a system to manage the billing of clinical trial charges in compliance with Federal rules and regulations.
• Identify and manage high risk areas in clinical trial billing
• Create a plan to measure and assure compliance of the clinical trial billing process