Name
Study Billing Breakout: Billing Compliance and Reimbursement for Device Trials
Date & Time
Monday, October 17, 2022, 10:45 AM - 11:30 AM
Location Name
Melrose 3
Description

Explore the key aspects of protecting the patient experience in clinical trial research involving investigational devices. 

Presenters from both Sponsor and Site perspective identify key challenges within device trials, in terms of ensuring a compliant environment and preventing undue financial burden on any of the parties…including participants.

Speakers
Melissa Orbegoso - Manager , Sponsored Programs - University of Miami
Lisa Butler - Associate Director, Reimbursement Clinical Trials - MCRA, LLC
Geoffrey Schick - Director, Strategic Site Partnerships - WCG
Melissa Orbegoso Lisa Butler Geoffrey Schick
Learning Objectives
  1. Identify the key compliance factors of clinical trials research for investigative devices including IDE; differences between Category A, B, and 510k devices for research; claims coding specific to investigative devices.
  2. Describe the differences between investigative drug and device clinical trials regarding potential financial exposure to clinical trial research participants.
  3. Recognize special circumstances to be cognizant of for more efficient and compliant clinical trials with investigative devices.
This Module is Eligible for
ACRP CE Points, CCB Credits, CIP CE Units, CME Credits, CNE Credits
ACRP CE Points
0.75