Awareness : OBC Tips

Qualified Clinical Trial Cost Types Not Billable to Patients or Insurance

The following qualified clinical trial cost types cannot be billed to patients or insurance, and must be paid by the study sponsor or covered by another appropriate funding source:

  • Any item/service that is promised free in the informed consent or customarily provided by the research sponsor free of charge for any enrollee in the trial.
  • The investigational item/service that is the objective of the clinical trial unless it is otherwise covered outside the study or by other CMS coverage determination.
  • Protocol activity/items/services that are not for the direct clinical safety and management of the subject at the time of the order (e.g., consent, inclusion/exclusion labs/imaging/services, research-only protocol activity, monthly CT scans for a condition usually requiring only a single scan).