Last Modified: 7/8/2019
Location: FL, PR, USVI
Business: Part A, Part B
A Humanitarian use device (HUD), as defined by the Food and Drug Administration (FDA), is a device intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in not more than 8,000 individuals per year in the United States. When the manufacturer submits a Humanitarian device exemption (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.
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.
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 to the Medicare administrative contractor, First Coast Service Options Inc. upon request and includes:
1. Details about the specific device, including the device number and documentation that the device is classified by the FDA as a humanitarian use device (HUD) and has been approved by the FDA under a humanitarian device exemption (HDE).
2. 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.
3. 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 advanced beneficiary notice (ABN). Additional information on the Centers for Medicare & Medicaid Services (CMS) beneficiary notice initiative may be found at https://www.cms.gov/Medicare/Medicare-General-Information/BNI/index.html
Billing & coding guidelines
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.
• Physicians who bill electronically must place the HDE number on the 2300 Investigational Device Exemption Number REF Segment, data element REF02 (REF01=LX) of the 837p.
• List the Current Procedural Terminology® (CPT®) code(s) that appropriately describe the service(s) performed; when a not otherwise classified (NOC) code is used, a description of the services and the device must be entered on line 19.
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