Clinical Research Billing

Clinical Research Billing

This is a very important part of medical research but it is a little bit complex because there are usually more than one person involved or responsible for the bill or cost of a research.

There are three ways the billing of a clinical research can play out:

  • When the procedures and services of a clinical research is solely for study purpose, the bill is generally cleared by the research sponsor.

  • When the procedures and services of the research is considered to be a standard of health care or routine treatment and would have been administered to the subject even if there was no research. In this case, the bill is generally on the subject or the subject's insurer but the sponsor can be involved in the payment depending on contractual agreement.

  • There are those that are a mixture of both. Procedures that are standard treatment billed on the subject and their insurer and procedures that are solely for research purposes billed on the research sponsor.

Depending on contractual agreement between the research sponsor and the subject of the research, treatment of adverse effects of the study might be paid for by either the sponsor or the subject (and their insurer).

It is important to note that the clinical research centres have financial regulations to comply with, which is the clinical research billing compliance. This will make them more careful to guard against financial issues that may occur like double billing.

Due to the number of parties involved in the billing process, there could be some miscommunication and it could lead to billing errors. For instance, if a research has already been paid for by the sponsor, it must be communicated to the clinical research institute, so that they don't bill the subject (patient) or their insurer anymore. If the subject is billed for a research paid for by the sponsor, that is called double billing and this is an obvious transgression against the clinical research billing compliance. The exception will be in cases where there's a legal contractual agreement for both parties to be responsible for the payment. This is possible in a situation like the third scenario above where some procedures are standard treatment and other procedures are for research purposes. The sponsors can clear the bill for the procedures that are solely for research purposes while the subject and their insurer is billed for the procedures that are standard treatment. Communication between concerned parties is key in clinical research billing.

Another compliance risk would be to charge a subject for a procedure that was promised as free in the research informed consent form. Every promise made to the subject in the form must be kept.

To learn more, you can take a course in clinical research billing compliance. This will help develop your knowledge and skill in maintaining compliance and other practices involved with clinical research billing.