Wiki Clinical Trial Coding - I know CMS has a guidance for government payers

[cynthiel]

I am looking for guidance for coding of routine care associated with a clinical trial. I know CMS has a guidance for government payers, but my question is more specifically to the commercial payers. Per the coding book, DX V70.7 is for the "examiniation of a participant in clinical trial". There is also guidance in the book that states, "The codes are not to be used if the examiniation is for diagnosis of a suspected condition or for treatment purposes...". As an example, an oncology patient comes in for a clinic visit and also for labs, xray, chemo treatment. Does the clinic visit get coded or because there was additional treatment that day does it not get coded? Should all activities be coded with V70.7 if they are required activities for the study (but billable to insurance)?

Is anyone familiar with this? Any help is GREATLY appreciated.

 

[ecastillo]

ecastillo from Miami

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.