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Humanitarian Device Exemption Approval Process

Though there is no prior approval process in traditional Medicare, CGS will consider case-by-case 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.

CGS requires providers seeking to use a HUD in the diagnosis and treatment of Medicare beneficiaries to submit the following information:

  • CGS IDE Submission Form PDFPDF
  • HUD Information is to be submitted to the CGS with an introductory letter.
  • 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.
  • A description of the clinical scenario(s) in which the device will be used.
  • 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.
  • 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, CGS will review the submission and respond as soon as possible. Again, while there is no prior approval process in traditional Medicare, the process outlined above 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 Advance Beneficiary Notice of Noncoverage (ABN).

Additional information on the CMS beneficiary notice initiative is located on the CMS website. 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.

OF NOTE: Revenue Code 0624 should be used, along with applicable clinical trial coding, when the HDE has been reviewed and approved as a clinical trial meeting medical necessity.

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