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 a bill may be submitted for services related to use of both Category A and Category B devices, but only if specific information has been previously submitted to Medicare and if Medicare has provided a billing authorization code. (Generally speaking, Medicare may cover the actual device if it is a Category B device, but Medicare will never cover a Category A device.) UWMC or HMC will forward to the Medicare contractor the information necessary for assignment of the billing authorization code. The NIIDR form (see links below) 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. Investigational device coverage decisions by other insurers are made on a case-by-case basis.

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

Who can help you get it right?

• The Clinical Research Budget and Billing office (CRBB) will help with the billing plan for your study. CRBB will become involved with your device study when you include, as part of your initial CRBB submission package, the Clinical Trials Policy Coverage Analysis Checklist for Clinical Research Studies (the "CTP Analysis Checklist" from the CRBB Online Toolkit). CRBB staff are experts in this area, and you can depend on them for good, step-by-step advice.
• The Key Contact people for the IIDCs for Medicare submissions. These contacts will provide detailed advice about the Medicare process and where that process fits into your study's timeline.

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.

For device research done at both UWMC and HMC, please complete both request forms.

Best Practices for Expediting the IIDC 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. This information may have a substantial impact on the budget for your clinical study.
• Respond promptly to screening questions from the UWMC IIDC or HMC Surgical Council staff. If you don't, your study's review will be delayed.
• Respond promptly to review questions posed by the UWMC IIDS or HMC Surgical Council staff. If you don't, your study's approval will be delayed.
• 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.

Key Contacts

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

HMC
Don Millbauer
Director of Perioperative Services
Box: 359890
Phone: 206-744-8094
Fax: 206-744-6577

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.

The request to Medicare for coverage of the device and/or related costs cannot be submitted until the IRB has approved the study and until the research contract has been signed, both by the sponsor and the UW. The Medicare process can add several weeks to your study start-up timeline.