A Humanitarian Use Device (HUD), is a device intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals per year in the United States.
FDA Humanitarian Use Device Exemption (HDE)
- The HDE FDA regulation was developed to provide an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting limited populations.
- When a Humanitarian Use Device Exemption (HDE) application is submitted to the FDA, it must include sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury to the patient and that the probable benefits to health outweigh the risk of injury or illness from its use.
- HDE applications do NOT have to provide the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose prior to marketing (see FDA regulations [21 CFR 814.124]); HUDs are rareley used in research studies.
- More information on HDEs can be found on the FDA website.
IRB Review of Humanitarian Use Devices
- HUDs are typically NOT provided in the context of a research study, but FDA requires that HUDs only be used in institutions where an institutional review board (IRB) has approved the use of the device to treat or diagnose the specific rare disease.
- The requirement for IRB review and informed consents often confuses study teams and research support offices into thinking the HUD use is research; it usually is NOT.
Medicare Coverage Criteria for HUD Devices
- A device classified by the FDA as an HUD under an HDE application is NOT addressed by the any Medicare Pre-approval process.
- An HDE-designated device may only be considered for coverage at the claim level (after the devices has been used).
- The medical record must support that the device meets the Medicare “reasonable and necessary” threshold for coverage assuming all other applicable requirements of the program are met.
- The device is specifically not covered if noted as such by national or local coverage determination or used off-label per the FDA indications.
- For more information on Medicare coverage of HUDs, see our local Medicare contractor’s website, First Coast Service Options.
Advanced Beneficiary Notice (ABN) for HUDs
- Given the complexities of determining whether a HUD is reasonable and necessary when it has not been proven effective for its intended use, providers may wish to discuss this issue with their patients and consider the use of an advanced beneficiary notice (ABN).
- Additional information on the beneficiary notice initiative may be found at the Centers for Medicaid and Medicare (CMS) webpage http://www.cms.gov/bni/.