| Coverage Analysis and Routine Costs of Qualified C |
Which items/services are covered as “Routine Costs” of a Qualified Clinical Trial?
Once it is determined that the study is a Qualified Clinical Trial, the following will be covered under the Medicare Clinical Trial Policy as a “routine cost” of the study so long as it is not agreed to be paid or paid by the sponsor and it is not promised free to the subject in the informed consent:
ALL OTHER MEDICARE RULES APPLY - (e.g. MEDICAL NECESSITY must exist at the time the item or service is provided, and must be documented to support the claim.)