Clinical Research Billing Compliance

FDA Investigational Device Exemption (IDE) Trials

Prior to beginning a clinical trial involving an investigational device, approval for reimbursement must be obtained from External link Medicare for costs related to the device. It is the responsibility of the provider participating in the clinical trial to furnish all necessary information concerning the device and the clinical trial that the Medicare contractor deems necessary for a coverage determination and claims processing. Per the Investigational Device Exemptions, 21CFR 812, the following device categories require Medicare contractor approval:

Category A Devices – Experimental - Innovative devices believed to be in class III for which absolute risk of the device type has not been established (i.e., initial questions of safety and effectiveness have not been resolved and the FDA is unsure whether the device type is safe and effective). Medicare does not cover Category A devices under Medicare because they do not satisfy the statutory requirement that Medicare pay for devices determined to be reasonable and necessary.

Category B Devices – Nonexperimental and/or investigational devices believed to be in classes I or II or devices believed to be in Class III where the incremental risk is the primary risk in question (i.e., underlying questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA approval for that device type.

Medicare may cover Category B devices if they are considered reasonable and necessary and if all other applicable Medicare coverage requirements are met.

The Medicare contractor must review the use of the device to make a final determination regarding reimbursement before the clinical trial begins. A copy of the Medicare contractor determination and supporting documentation must be maintained with the study budget files for research billing purposes.

Wisconsin Physicians Service Ins. Co
111 East Wacker Drive
Chicago, IL 60611

WPS Submissions: Investigational Device Exemption (IDE) Submissions