Clinical Trials Administrative Start-Up Handbook

SECTION 9

General Information

Both the University of Washington Medical Center (UWMC) and Harborview Medical Center (HMC) require review for clinical trials of all investigational 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.

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 sponsor, you 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. Other insurers have followed Medicare's example and are unlikely to cover Category A devices. NIIDR forms for Category A devices will be routed to the Executive Director and the Medical Director at the UWMC or at HMC for an authorization decision. If funding for a Category A device is not authorized, you may need to request funding from the trial sponsor.

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 HMC will forward to Medicare the information necessary for assignment of the billing authorization code. The NIIDR form gathers the required information. Note that issuance of an authorization code by Medicare does not guarantee coverage; Medicare's final determination is made after receipt of a claim. Category B coverage decisions by other insurers are made on a case-by-case basis.

Improper billing can lead to organizational as well as individual liability.

Review at UWMC and HMC

To obtain review at UWMC, investigators need to complete the UWMC New Implant and Investigational Device Request (NIIDR) Form and submit the form to the UWMC Implant and Investigational Device Committee.

To obtain review at HMC investigators need to complete the HMC New Implant and Investigational Device Request Form and submit the form to the HMC Surgical Council.

Best Practices for Expediting the Review

• Determine early in your discussions with the sponsor whether the investigational device to be tested has been designated by the FDA to fall into Category A or Category B. Medicare (and other insurers soon to follow suit) will not pay costs associated with studies of Category A devices. The costs may be substantial.
• Write your study consent form so that it explains clearly who will be responsible for associated costs.
• Submit the NIIDR form to the UWMC or HMC review committee at approximately the same time you submit the Human Subjects Review Committee (HSRC) application to the Human Subjects Division. In the section of the NIIDR form that requires the HSRC approval date and number, indicate that the HSRC application has been submitted and is "pending review." Attach the consent form that you submitted along with the HSRC application.
• Send the HSRC approval number, approval date, approved consent form, and approved protocol to the IIDC immediately after your HSRC application has been approved. The IIDC will not make its final decision until it has these documents.

Administrative Start-Up Checklist
UWMC Implant and Investigational Device Committee
and HMC Surgical Council

Click to Download Checklist in Word

Key Contacts

UWMC
Bill Anton
Business Manager, Surgical Services
Box: 356118
Phone: 206-598-6538
Fax: 206-598-3751

HMC
Don Millbauer
- Operating Room Business Manager
Box: 359890
Phone: 206-731-8094
Fax: 206-731-6577

Timeline

Requests are reviewed as received. The Committee meets quarterly, but decisions are normally made by physician-members, outside of meetings. Requests are normally handled within two or three weeks of receipt.