Medical Policy: 10.01.14
Original Effective Date: April 2009
Reviewed: June 2016
Revised: August 2014
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
A humanitarian use device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. A device manufacturer's research and development costs could exceed its market returns for diseases or conditions affecting small patient populations.
In 1996, the Food and Drug Administration (FDA) issued a regulation to carry out provisions of the Safe Medical Devices Act of 1990 regarding HUDs. The regulation requires the submission of a humanitarian device exemption (HDE) application which is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application must contain sufficient information for the FDA to determine that the devise 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. An approved HDE authorizes the marketing of a HUD; however, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device for the FDA-approved indication. The healthcare provider is responsible for obtaining IRB approval before using the HUD to treat or diagnose patients.
Devices that have been designated by the FDA as Humanitarian use device (HUD) may be subject to individual review unless stated otherwise in a Wellmark medical policy. HUDs may be subject to an individual review because they are exempt from effectiveness data and scientifically-validated clinical evidence required by the FDA to gain approval.
Humanitarian use device (HUD) may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-labeled indication(s). In addition documentation of IRB approval may be requested to ensure compliance with the FDA-labeled indication(s) under the Humanitarian Device Exemption (HDE).
Humanitarian use devices (HUD) requested for off-label uses (i.e., outside of their FDA-labeled Humanitarian Device Exemption indications) are considered investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer reviewed literature.
A comprehensive list of devices and their respective FDA-labeled HDE indication(s) is available at the FDA website. External Site.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.