Clinical Research Billing Compliance

Guidelines for healthcare billing in clinical trials

Complying with federal guidelines for healthcare billing associated with a clinical trial is important but can be complicated. The Clinical Research Billing Compliance (CRBC) program at Indiana University helps researchers and research staff minimize risks when they are billing for services provided to human subjects participating in clinical trials. As a principal investigator, you are responsible for ensuring services associated with a clinical trial are billed accordingly. IU’s CRBC staff will provide support and guidance.

Coverage analysis

Coverage analysis (CA) is an independent review of a clinical study to determine which clinical procedures and services are billable to insurance.

Which studies need coverage analysis?

A documented coverage analysis is required for all clinical studies involving interventions in which any items or services are or may be invoiced to the patient insurer(s). Any clinical studies on human subjects submitted to the IU Institutional Review Board (IRB) must determine whether a CA will be required.

Why is it needed?

Coverage analyses are important to facilitate billing compliance, mitigate risks, and avoid billing errors. Additionally, a thorough CA can have the benefit of negotiating an accurate study budget.

Need to know more?

If you have questions about Clinical Research Billing Compliance, call 317-274-8289 or email

The Office of Clinical Research provides a team of coverage analysts who are skilled at Clinical Research Billing processes. For more information, or to access this team, please visit the Office of Clinical Research website.