Frequently Asked Questions

What is required medical record documentation to support billing study protocol items/services to insurance?

Documentation to support billing protocol items/services to insurance must be present in the patient’s medical record, just as for any clinical care.  Supporting documentation required by the payor would include a complete, accurate, and detailed record of the care, such as:

• trial name, sponsor name and sponsor-assigned Protocol number (required for Medicare)
• subject’s condition prior to enrollment in study
• reasons for study-related tests/procedures required
• treatment rendered during the clinical study
• study subject’s response to treatment and plan of future care
• written precertification/preauthorization (as required by private payor)