Investigational Devices in Research

This message is for investigators and study teams who do trials of investigational devices.

Drs. Eric Larson and Jim LoGerfo have asked that investigators and study teams who do investigational device trials be reminded that it is very important for these trials to be reviewed by the Implant and Investigational Device Committee (IIDC) for investigators located at UWMC and by the Surgical Council (SC) for investigators located at Harborview. These committees review trials for devices that are either (1) implantable or (2) non-implantable with an FDA Investigational Device Exemption Number. The purpose for review is to assure compliance with medicare billing regulations. Improper billing can lead to organizational as well as individual liability. Both the IIDC and the SC have application forms, available by calling Bill Anton (548-6538) at UWMC or Don Millbauer (731-8094) at Harborview.

Under medicare billing regulations, most medical devices fall into either "Category A" or "Category B." Category A and Category B are FDA designations. The FDA will have informed the investigational device manufacturer of the device's designation, and the device manufacturer (who is ordinarily the study sponsor) will provide this information to investigators, usually in the study protocol. If this information is not in the study protocol or in other correspondence from the investigator, investigators will need to obtain it from the sponsor.

Current Medicare rules specify that bills may not be submitted to Medicare for any services related to the use of a Category A device. This means that costs associated with studies of Category A devices (e.g., the device, all physician fees, inpatient and outpatient services) will not be covered by Medicare. IIDC and SC review forms for Category A devices will be routed to the UWMC and HMC Executive and Medical Directors for an authorization decision.

Medicare guidelines specify that a bill may be submitted for services related to use of a Category B device, but only if specific information has been previously submitted to Medicare and if Medicare has provided a billing authorization code. UWMC or Harborview will forward to Medicare the information necessary for assignment of the billing authorization code. The IIDC and SC applications gather the information required for this process.

Insurers other than Medicare are expected to follow suit.

Gigi Streidl Clinical Trials Administrative
Manager Industry Relations Office 616-8289