September 5, 2007
Humanitarian use device and humanitarian device exemptions
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 4000 individuals in the United States per year. The costs of research and development for such devices could exceed the returns when treating such small populations. The HUD provision of the regulations is intended to provide an incentive for the development of devices, which might provide benefit to these small populations of individuals. To obtain approval for marketing of a HUD, the manufacturer submits a humanitarian device exemption (HDE) application to the Food and Drug Administration (FDA). Such applications are exempt from the “effectiveness” requirement outlined in the Food, Drug and Cosmetic Act (Ch. 5, Sub. Ch. A, Sec. 514-515). In short, the HDE need not demonstrate that the device is effective for its intended use, but instead must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit to health, outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. FDA decisions regarding a device’s classification as a HUD and its use under an HDE relate to marketing of the device. The Centers for Medicare & Medicaid Services (CMS) and/or its contractor determine coverage of such devices.
Currently, CMS does not have a national coverage determination (NCD) for HDEs. The Social Security Act [Title XVIII, Sec 1862(a)(1)(a)] precludes Medicare program payment for any and all services not reasonable and necessary for the treatment of an illness or injury or to improve the functioning of a malformed body member. Contractors have offered only limited coverage, if any, for HDEs, as a device whose effectiveness is questionable, may not meet the requirements of the provisions of section 1862(a)(1)(a).
First Coast Service Options Inc. (FCSO) will consider coverage for a humanitarian use device when:
1. The FDA has designated the device as a humanitarian use device (HUD).
2. The FDA has approved the device for marketing under an HDE.
3. The device has local IRB (institutional review board) approval in the setting in which it is proposed to be used.
4. Appropriate informed consent has been obtained from the patient.
5. There exists a benefit category and the device is not statutorily excluded from coverage.
6. There is no national or local coverage determination (NCD/LCD), which prohibits coverage.
7. If there is a national or local coverage determination applicable to the device and/or its proposed use, the criteria noted in the NCD/LCD are met.
8. The device is used in an episode of care that is reasonable and necessary for the diagnosis and treatment of an illness or injury or to improve the function of a malformed body member.
FCSO requires providers seeking to use a HUD in the diagnosis and treatment of Medicare beneficiaries to submit the following information:
1. Details about the specific device, including documentation that the device is classified by the FDA as a HUD and has been approved by the FDA under an HDE.
2. A description of the clinical scenario(s) in which the device will be used.
3. A list of expected CPT/HCPCS codes expected to be billed in conjunction with the use of the device. In the event that an unlisted code will be used, the service to which it will apply must be described.
4. A copy of the local IRB approval. The FDA requires that a HUD be used only in facilities that have established an IRB approval process responsible for supervising the use of the device and related services.
Upon receipt of the required documentation, FCSO will review your submission and respond as soon as possible. Though there is no prior approval process in traditional Medicare, this process will help ensure Medicare beneficiaries are receiving covered services and have adequate access to care. 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 CMS beneficiary notice initiative may be found at http://www.cms.hhs.gov/bni/ 
. All coverage/payment decisions are made at the time of claims submission. Do not submit clinical records unless specifically asked to do so. Medical records, when submitted, should document why the benefits of use of the device outweigh the risks, considering both other available devices and other available therapies.
. All coverage/payment decisions are made at the time of claims submission. Do not submit clinical records unless specifically asked to do so. Medical records, when submitted, should document why the benefits of use of the device outweigh the risks, considering both other available devices and other available therapies.