Clinical Trial Billing

Clinical Trial Billing

The process of billing for research-related procedures and services is complex because more than one entity is usually responsible for the costs incurred in a study.  Some procedures and services are provided solely for purposes of the study, and are generally paid for by the sponsor of the research. Some procedures and services may be considered routine treatment or standard of care and may be appropriately billed to the subject or his/her insurer.  Bottom line – in general, these costs may be billed to the subject or his/her insurer as long as they are not also being paid for or provided by the study sponsor.

Treatment of adverse events that result from participation in the study may be the responsibility of the subject, the subject’s insurer, or the sponsor, depending on the agreement between the sponsor and the institution (refer to the informed consent and the clinical trial agreement for the study).

To add to the complexity of clinical trial billing, the Centers for Medicare and Medicaid Services has in place a Clinical Trial Policy, along with separate regulations, related specifically to device trials.

Billing Medicare (and any other third party payer) for items and services that are part of a research study must be undertaken very carefully. Decisions on who will be responsible for the various costs of study procedures and services should take place early, before any subjects are enrolled, and before any charges are incurred.

The Clinical Trials Office can assist you with subject registration issues, reconciling of patient account statements, and will perform study billing reviews.

Contact Budget & Billing Coordinators.

Budget & Billing Process.