In order to ensure that all clinical services are billed properly according to federal laws and OHSU policies, a Clinical Research Billing Schedule must be completed any time there are clinical services associated with a clinical trial. For billing purposes, "clinical services is defined as any billable, or potentially billable, service performed at an OHSU clinical facilty including, but not limited to, blood draws, imaging procedures, clinical lab tests, non invasive examinations, and dental work, regardless of whether the service is performed at no charge or considered standard of care.
The Clinical Research Billing Compliance Office (CRBO) uses this form to ensure that all study related services have a billing determination and that the cost language in the consent matches. Billers and coders use this to ensure services and encounters are coded and billed appropriately.All clinical services required by the protocol must be listed including: standard of care services, services that will be paid by the sponsor, and any services supplied/performed at no charge. Typically, these services are listed on a Schedule of Events within the protocol and/or spelled out in detail within the protocol procedures.
The template Clinical Research Billing Schedule (Word ) (Excel ) is also available in the IRQ in eIRB.
If the study is within eCRIS, the Billing Schedule does not need to be completed or uploaded to eIRB. The Visit Schedule will replace the Billing schedule and CRBO will perform the coverage analysis within eCRIS.
Which code should be used on the billing schedule for each item?
Research-only services: RES (research study) or NC (no charge)
- Study related clinical services that would NOT be provided except for the study (e.g. scans or labs performed more frequently than usual for the condition)
- Research-only services must be billed to the research study and cannot be billed to the patient or patient's third party payer(s)
Research-only services in the billing schedule must be coded with RES or NC.
Standard of care INS (insurance or patient), RES or NC
- Study related clinical services that would typically be provided absent a clinical study
- Can be billed to either the patient, patient's third party payer(s) or, with IRB approval and research sponsor agreement, to the research study
Standard of care items can be coded with INS, RES or NC depending on whether or not they are included in the study budget.
Return to the main CRBO page.