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:
Obtain HDE approval from the FDA to use the HUD in the desired population.
Obtain IRB approval for use of the HUD under the FDA-approved HDE protocol.
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.
Provide HDE documentation to Jodee Collins - Hospital Charge Master, for set-up in the CDM.
Document required HDE and FDA approval criteria in the study subject’s medical record to support billing.
Follow IDE requirements and clinical study workflows if HUD is used under a clinical study protocol.
