Frequently Asked Questions

What clinical research items/services may be billed to the patient and her/his Medicare/Medi-Cal third party payor?

Clinical research items/services may be billed to Medicare, Medi-Cal, or other government payors if the item/service is not paid by the study sponsor, promised to be paid for other subjects in the study, or promised free to the patient in the informed consent, and it is either:

1. a “routine cost” of a Qualified Clinical Trial (See FAQ below), OR
2. it would have nevertheless been provided and covered as reasonable and necessary care to the patient for prevention, diagnosis, or treatment absent the clinical trial, OR
3. it is for diagnosis and treatment of complications or injuries arising from participation in the research, and care of such complications or injuries is not promised to be paid or paid by the study sponsor for other subjects in the study.