Research Compliance is responsible for the Clinical Research Billing Compliance (CRBC) program in order to mitigate risk related to the billing for items and services related to subject participation in a clinical trial.

Purpose:

The purpose of the Clinical Research Billing Compliance program is to promote:

• Compliance with federal guidelines for healthcare billings associated with clinical research

• Consistency in payment terms as related to the research study contract, budget protocol, informed consent, Medicare Coverage Analysis (MCA) and Separation of Allowable Costs

• Understanding of the billing process required to ensure research billing compliance

• Reduce billing risks between research and routine (conventional) care charges

• Ensure appropriate recovery of clinical research study costs

• Reduce the risks of inappropriately billing patients and/or third party payors

Synchronization of the understanding of Medicare rules, compensation arrangements with the sponsors and financial discussion in the patient's informed consent are key components to reducing the risk of incorrect application of research study related costs.