Device Trials

This page provides guidelines for initiating sponsored device trials.

Device trials can be complicated; the Office of Clinical Trials has developed a guidance document and needs to be alerted when participation in such a trial is contemplated.

We ask that you consider the following issues, and contact us for any additional questions.

• Is the device experimental for the population or indication?
• If experimental, does it have an IDE and Category B designation?
• Is the Sponsor providing the device?
• If the device is experimental, does the company provide billing/reimbursement specialists to help map appropriate billing codes and provide information for submission to the Local Medicare Carrier?
• Is it being provided at no cost or at some other rate (standard market value, Medicare-accepted rate, etc.)
  If the device has to be purchased, is it done through standard hospital purchasing or does some special process need to be set up?
• Does the device have appropriate billing codes already established in the hospital system? If not, Patient Revenue must be contacted immediately to start this process.
• If these devices are indicated to be billed to insurance/Medicare, have they been covered before? If not, the hospital may not accept billing other than to the study account.