Frequently Asked Questions

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:

1. Items or services that are typically provided absent a clinical trial (e.g., “conventional care”, “standard of care”, “ordinary care”); and
2. Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
3. Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications.

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.)