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Frequently Asked Questions

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Frequently Asked Questions

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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)


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