A humanitarian use device is defined by the Food and Drug Administration (FDA) as “a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4000 individuals in the United States per year.”
• Medical suppliers
• Indian Health Services
• Federally Qualified Health Center
• Rural Health Clinic
Providers must meet any provider criteria, including accreditation, for third party insurance or for Medicare in order to assist recipients for whom MHCP is not the primary payer.
MHCP quantity limits and thresholds apply to all recipients unless only Medicare co-insurance or deductible is requested.
Humanitarian Use Devices are covered for all eligible MHCP recipients who meet coverage criteria.
Humanitarian use devices are covered when all of the following are met:
• The device has received a Humanitarian Device Exemption from the FDA
• The device is requested for the specific indication for which it received a Humanitarian Device Exemption
• All treatment options within the community standard of care have failed or are medically contraindicated for the recipient
Humanitarian use devices are not covered for any indication which has not been specifically approved by the FDA under a Humanitarian Device Exemption.
• Authorization is always required for the humanitarian use device
• Authorization may be required for associated medical procedures, i.e. surgeries. Refer to the relevant MHCP policy for information about authorization requirements for medical procedures
Submit authorization request and required documentation to the authorization medical review agent.
• If the recipient has Medicare, MHCP will pay only the deductible / co-insurance on any item for which Medicare made payment, regardless of any MHCP prior authorization.
• If the recipient has Medicare, any items for which Medicare denies payment must meet MHCP coverage and authorization requirements.
• Use the Professional 837P or the Inpatient or Outpatient 837I claim as appropriate via MN–ITS Interactive or batch.
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