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.
The study sponsor has the responsibility to submit to the Centers for Medicare & Medicaid Services (“CMS”) for central coverage approval. If your UCLA device study is investigator-initiated and UCLA holds the Investigational Device Exemption (IDE), UCLA is the study sponsor. The study team will need to work with the Clinical Trial Administration Office during coverage analysis review to determine who the sponsor is and ensure required submission to CMS for coverage approval by the appropriate party.
For Investigator-initiated IDE and non-significant risk device studies, the Investigator will need to work with the Director of Reimbursement for UCLA Medical Financial Services to submit the device study information to local MAC for approval to bill Medicare. For industry-sponsored device studies initiated after January 1, 2015 the sponsor has the obligation to submit centrally to CMS for approval to bill Medicare. The Investigator should initiate this communication early as the approval or denial letter may be needed to complete contract negotiations and coverage analysis certification with the Clinical Trial Administration Office.
Effective January 1, 2015, the Center for Medicare and Medicaid Services (CMS) requires the study sponsor to submit a request to CMS for approval to bill Medicare for the items and services in Category A and B Investigational Device Exemption (“IDE”) studies.
Yes. The Medicare Administrative Contractors (“MAC”) are responsible for making coverage determinations on non-significant risk devices and are expected to apply the same coverage criteria, where appropriate, to the NSR devices as are applied to FDA-approved Category A and B IDE Devices.
You can visit the CMS website for Approved IDE Devices , and enter the name of the device in the search area. You will then be able to view the study that is CMS approved for the device in question. The study information will include the NCT#, IDE#, CMS approval date, and device category. The NCT # will enable you to search the clinicaltrials.gov website for additional information about the device study (e.g. study site locations and contacts, recruiting/not recruiting, study type, study phase, primary purpose, etc.)