Hello i work in the Clinical Trials Office of a large Hospital.
if the patient come to hospital for standard of care not related to study protocol there is not need to code ICD V70.7 and modifier Q1.
Activity that needs to be coded is the ones that benefit the study even if pay by insurance/CMS - Remember many clinical studies benefits from SOC, therefore these procedures, labs, etc. need to be coded with V70.7 and Q1. (Q1 use for outpatient only)
The services sponsor agree to pay can not be billed to insurance/CMS and need to be transfered from bill send to insurance carrier; these charges are not coded with V70.7 nor modifiers: Q1/Q0.
Modifier Q0 is used for investigational item itself (we used it mainly for device studies).
Well I hope this helps. let me know if you need more information.
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