Frequently Asked Questions

What steps should I follow when setting up a Humanitarian Use Device (“HUD”) protocol?

Critical steps to follow when setting up a HUD/HDE protocol:

1. Obtain HDE approval from the FDA to use the HUD in the desired population.
2. Obtain IRB approval for use of the HUD under the FDA-approved HDE protocol.
3. Provide required documents to UCLA Finance Department for submission to Noridian (local Medicare Administrative Contractor) to allow hospital/physicians to bill Medicare Part A&B for items/services associated with the use of the HUD under the HDE at UCLA.
4. Provide HDE documentation to Jodee Collins - Hospital Charge Master, for set-up in the CDM.
5. Document required HDE and FDA approval criteria in the study subject’s medical record to support billing.
6. Follow IDE requirements and clinical study workflows if HUD is used under a clinical study protocol.