ADA applauds the decision by the Centers for Medicare & Medicaid Services (CMS) to reconsider the national coverage determination established at section 50.3 of the Medicare National Coverage Determinations manual. CMS is expanding coverage by broadening the patient criteria and removing the requirement that for individuals with hearing test scores of > 40 % and ≤ 60 %, cochlear implantation may be covered only when the provider is participating in and patients are enrolled in either an FDA-approved category B IDE clinical trial, a trial under the CMS Clinical Trial Policy, or a prospective, controlled comparative trial approved by CMS.
According to CMS, it concluded that the evidence is sufficient to determine that cochlear implantation may be covered for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification. Limited benefit from amplification is defined by test scores of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence cognition. Patients must meet all of the following criteria.
- Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids;
- Cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation;
- Freedom from middle ear infection, an accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the auditory nerve and acoustic areas of the central nervous system;
- No contraindications to surgery; and
- The device must be used in accordance with Food and Drug Administration (FDA)-approved labeling.
- CMS may also provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed above when performed in the context of FDA-approved category B investigational device exemption clinical trials as defined at 42 CFR 405.201 or as a routine cost in clinical trials under section 310.1 of the National Coverage Determinations Manual titled Routine Costs in Clinical Trials.
ADA submitted comments in support of the CMS proposal in March 2022, and is pleased that CMS is moving forward with this initiative.