Billing & Documentation for Professional Charges for Clinical Trials

Goals for today The UMA Compliance office is providing education to providers and staff who are involved in clinical trials Billing correctly for clinical trials services is a complex and highly manual process This presentation will provide an overview on what physicians, research coordinators and support staff need to know in order for services to be billed correctly.

Documentation All insurance carriers require documentation for all billable services Medicare specifically states documentation must exist at the time the service is billed If a service in your clinical trial is standard of care and being billed to insurance, you must have documentation in the electronic medical record The documentation needs to state that the patient is participating in a clinical trial

Correct registration is the key to correct billing Most often it is the research coordinators who schedule the patients for the clinical trial services It is the responsibility of the principal investigator or research coordinator to ensure that all professional services are registered correctly

Standard of Care A service that would have been provided to the patient anyway as part of their standard of care. You are using the documentation as part of your study and it is listed in your protocol. The service will be billed to the insurance carrier (ie: the grant is not paying for this). You must report the diagnosis code V70.7 as the secondary diagnosis and the Q1 modifier on the claim form. These codes must be marked on the charge ticket.

Services Paid by the Grant The grant financial class needs to be indicated on the charge ticket. This code will start with a G and is listed in the insurance field. If there is something other than a G listed in the insurance field, you will need to have registration generate a new charge ticket with the grant financial class If this is not done correctly it may result in duplicate billing

Example Patient comes in for a clinical trials visit. The patient is seen by the doctor and also has a procedure done. The visit is standard of care and the procedure is being paid for by the grant. How would you handle this?

Answer One charge ticket is completed for the office visit with the V70.7 diagnosis and Q1 modifier checked. This claim will be billed to insurance A second ticket will be completed for the procedure with the Grant financial class indicated in the insurance field with a code that starts with G Remember, facility charges will be completed separately.

Thank You! If you need assistance with the professional billing process for your clinical trial please contact the UMA Compliance Department at