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What are the conditions that must be met to bill the patient or a third party payor for study-related services?

The study-related item or service may be billed to the patient or third party payor if it is not paid by the study sponsor or promised free to the patient in the informed consent, and it either:

    1. qualifies for coverage under applicable Medicare rules if it is a government payor, or
    2. qualifies for coverage under applicable State law and private payor contracts if it is a private payor


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