Standard of care items/services provided as part of a Non-Qualified Clinical Trial that would have otherwise been provided and covered as ordinary, reasonable and necessary care for the patient absent the trial may be billed as such without additional research identification or coding.
Even standard of care services/items provided to a patient as part of a Qualified Clinical Trial protocol must be scheduled and billed as research-related even though it would otherwise be “standard of care” for 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 research codes and modifiers on the claim. (See FAQ below.) 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 research data, must be reported as a research-related service.