Last Modified: 8/12/2024
Location: FL, PR, USVI
Business: Part A, Part B
First Coast does not review HDE requests for approval
The humanitarian device exemption (HDE) is the application process. An HDE is similar in both form and content to a pre-market approval (PMA) application; however, the HDE is “exempt” from the effectiveness requirements of a PMA.
An HDE application does not require the explanation of scientific results of a valid clinical investigation which demonstrates the device is effective for its intended purpose.
An HDE must contain sufficient information for the Food and Drug Administration (FDA) to determine that the probable benefit to health outweighs the risk of injury or illnesses, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. (See section 520(m)(2)(C)). An FDA approved HDE authorizes marketing of a Humanitarian Use Device (HUD).
First Coast does not review HUD requests for approval
Medicare has no specific rules, regulations, or instructions with regard to HUDs. Medicare does not require nor is there any process for obtaining prior approval for HUDs. Furthermore, Medicare does not perform "prior authorizations" for insertion of these devices.
Additionally, coverage under general Medicare rules (see Social Security Act, Section 1862 (a)(1)(A) Medically Reasonable & Necessary) indicates most HUDs are not covered by Medicare.
A HUD, as defined by the FDA, 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. When the manufacturer submits a HDE application to the FDA, it must provide 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. The manufacturer is not required 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]). This 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. Such devices may 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.
Claims for HUDs may be reviewed pre or post payment. Documentation must support that the services were reasonable and necessary. No prior approval will be provided for these devices even if the patient is a participant in a clinical trial. Documentation, if requested, supporting the medical necessity of the procedure/device for the beneficiary must be made available upon request and includes:
• Details about the specific device, including the device number and documentation that the device is classified by the FDA as a HUD and has been approved by the FDA under a HDE.
• A description of the clinical indications for the patient and why the device is needed. Medical records should document why the benefits of use of the device outweigh the risks, considering both other available devices and other available therapies.
• A copy of the institution’s IRB approval letter for each individual patient.
Given the complexities of determining whether a device 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
Advance Beneficiary Notice 
(ABN). Additional information can be found on the Centers for Medicare & Medicaid Services (CMS)
beneficiary notice initiative page.
Each FDA-approved HUD is assigned an identification code by the FDA, which enables Medicare contractors to establish special claims processing procedures. The HDE code will be seven positions in length and may or may not include an alphabetic value in the first position.
Part A Claims
When submitting a claim to First Coast for HDE, follow these special claims processing procedures:
• Do not report the HDE number in the IDE field.
• Report the HDE number H###### in ‘remarks’.
• When reporting the charge for the humanitarian device
• For implants use revenue code 0278
• For other services use an appropriate revenue code
• Do not report revenue code 0624. This code is ONLY used for investigational device exemptions (IDE) clinical trials.
Part B Claims
When submitting a claim to First Coast for HDE, follow these special claims processing procedures:
• Physicians who bill electronically must place the HDE number on the 2300 IDE number REF segment, data element REF02 (REF01=LX) of the 837P.
• List the CPT code(s) that appropriately describes the service(s) performed; when a not otherwise classified code is used, then a description of the services and the device must be entered on line 19.
• ICD-9 diagnosis code V70.7 or ICD-10 diagnosis code Z00.6 (in either the primary or the secondary positions)
• CT12345678 (8-digit or generic NCT clinical trial number) in CMS-1500 paper form field 19 or on the electronic form, 837P-Loop 2300, REF02, REF01=P4 (do not use “CT” on the electronic form)
• HCPCS modifier “Q1” or “Q0” as appropriate (not reported on “inpatient)
First Coast Service Options (First Coast) strives to ensure that the information available on our provider website is accurate, detailed, and current. Therefore, this is a dynamic site and its content changes daily. It is best to access the site to ensure you have the most current information rather than printing articles or forms that may become obsolete without notice.
