In order to bill Medicare for items or services related to a clinical trial, a clinical trial must meet certain criteria.  For drug studies, Medicare outlines three requirements and seven desirable characteristics a trial must have in order to be a qualified clinical trial.  Some trials are presumed to have the seven desirable characteristics and are automatically qualified (if they also have the three requirements) to receive Medicare coverage if they are funded by certain federal agencies or have an IND or IND exemption. 

Additionally, there are regulations which allow certain items and services for device studies to be billed to Medicare.  For all Investigational device studies (Category A & B), embolic protective devices, and carotid stents, prior approval must be obtained from the Fiscal Intermediary before any Medicare billing can occur.  Please contact the Clinical Trials Office so we can assist with this process, 312-413-1632 or