MEDICALLY NECESSARY
Cochlear implantation is considered medically necessary and, therefore, covered for individuals with a documented diagnosis of bilateral pre- or postlinguistic moderate-to-profound sensorineural hearing impairment when all of the following criteria are met:
- The individual demonstrates limited benefit from hearing (or vibrotactile) aids.
- Limited benefit from amplification is defined by test scores of less than or equal to 60% correct on recorded tests of open-set sentence cognition in the best-aided listening condition.
- The individual has the cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation.
- The cochlear lumen is accessible, structurally suited to implantation, free of middle ear infection, and free of lesions in the auditory nerve and acoustic areas of the central nervous system.
- A cochlear implant must be used in accordance with the labeling approved by the US Food and Drug Administration (FDA).
- The individual has no contraindications to surgery
COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
Cochlear implantation may be covered for individuals who meet all the requirements of Original Medicare’s Coverage with Evidence Development (CED) provisions and who are enrolled in a Medicare-approved clinical study.
INVESTIGATIONAL DEVICE EXEMPTION (IDE)
Cochlear implantation may be covered for individuals not meeting the above medically necessary criteria when the professional provider is participating in, and the individual is enrolled in, an FDA-approved category B IDE clinical trial.
EXPERIMENTAL/INVESTIGATIONAL
Cochlear implantation for all other indications including as a treatment for unilateral hearing loss with or without tinnitus is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.
BILLING REQUIREMENTS
Claims submitted for cochlear implantation must be reported with the appropriate medical codes representing the most specific condition and laterality.
Claims for cochlear implantation for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.
Professional providers are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial and the Category B IDE device. If Original Medicare determines that the device does, in fact, meet the requirements of coverage, and the clinical trial is approved, coverage for the routine costs associated with a qualifying clinical trial and the category B IDE device are submitted to the Medicare Advantage plan.
