IBISResearch – IRB is a human subjects research protocol review system at the University of Miami. This system includes questions that ascertain the scope of work that the protocol entails, including the billing/costs related to a study. There have been questions from study teams asking how to answer the following question.
The question above is crucial to ensuring proper research billing practices, which can have significant implications for the University. Below you will find additional details to help ensure you answer this question correctly within the IRB system.
HOW DO I KNOW WHEN I’M SUPPOSED TO ANSWER “YES” TO THIS QUESTION?
If your study includes any procedures, items, or services performed at UM that could generate a charge in the billing systems (whether they are billing the research subject’s insurance or the industry sponsor/NIH funding entity is paying for it), you should answer yes. This question is important to answer correctly so that our billing systems know to look out for a coverage analysis (CA) which is discussed below.
HOW WILL THE BILLING SYSTEM KNOW WHERE TO BILL THE CHARGES?
At the beginning of your research submission in IBISResearch, the study documents are reviewed by the ORA pre-award team, and a coverage analysis (CA) is conducted. Coverage analysis is the review of study documentation to determine who will pay the costs of each item, service, and activity required by the protocol (Medicare, insurance, the patient, an industry sponsor, NIH funding entity, or a combination of payors). A CA is conducted pursuant to the Medicare Clinical Trial Policy (NCD310.1).
Once the CA is created, and the protocol is approved, the billing team at UM has access to the CA. When a patient undergoes services related to a protocol, the billing team reviews the CA to identify the service and designated payor for that service. For example, if a patient undergoes a CT scan that should be paid for by the study sponsor, the billing team will remove that charge from the patient’s account and move it to the study account to be invoiced to the sponsor.
The primary objective of the CA: To ensure all costs of a clinical trial are billed to the appropriate payor (sponsor, a third-party payer, institution, NIH funding entity, or subject).
HOW CAN I OBTAIN MORE TRAINING IN CLINICAL RESEARCH BILLING (CRB)?
We strongly encourage clinical research teams involved in scheduling, patient orders, and any part of medical record documentation to participate in the ORA-provided Medicare Coverage Analysis (MCA) in Clinical Research.
Recommended research team titles: Research coordinators, research nurses, investigators, regulatory teams, research financial analysts, personnel involved in research patient registration, etc.
If you have any questions regarding the information above, please contact our OVPRS Help Desk team at OVPRSHelpDesk@miami.edu.
