Frequently Asked Questions

What items/services are not considered “Routine Costs” of a Qualified Clinical Trial and are therefore not billable under Medicare rules?

Even if it is determined that the study is a Qualified Clinical Trial, the following will NOT be covered:

1. The investigational item/service itself (unless it is otherwise covered outside the study)
2. Items/services provided solely to satisfy data collection and analysis needs and not used in direct clinical management
3. Items/services customarily provided by the sponsor free of charge for any enrollee