| Scheduling Clinical Study Protocol Visits |
Do I have to schedule “standard of care” as linked to the study when it is part of a Qualified Clinical Trial protocol?Even “standard of care” services/items provided to a patient/subject as part of a Qualified Clinical Trial protocol must be scheduled and billed as study-related though it would otherwise be provided to the patient absent participation in the clinical trial. These items/services must be reported to Medicare and other government payors, and usually must also be reported to commercial insurers, as related to the clinical trial by using the required special codes and modifiers on the claim. (See FAQ below.) As of January 1, 2013, the clinicaltrials.gov NCT# must also appear on the claim. For example, even a physical exam or CBC, performed as standard of care for the patient but which will also be used under the qualified clinical trial protocol for recording protocol activity, must be reported as study-related.