Changes to National Coverage Determination Improve Access to Cochlear Implants

October 27, 2022


The updated coverage guidelines are effective for services provided on or after September 26, 2022. However, CMS provides it contractors additional time to update claims processing and other systems to reflect the changes. This is known as the implementation date. The implementation date has not been announced and CMS recommends that clinicians hold claims until the implementation date for those services based on the updated guidelines and provided on or after September 26. If a claim is submitted prior to the implementation date and is subsequently denied, the provider can appeal and the claim should be paid because coverage is contingent on the effective date, not the implementation date.

September 30, 2022

Access to cochlear implants for Medicare beneficiaries was slightly improved based on changes to the National Coverage Determination (NCD) issued this week.

Under the revisions to the NCD, candidacy for a cochlear implant was expanded to patients with bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss who demonstrate limited benefit from amplification. Limited benefit from amplification is now defined as test scores of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence cognition. Previously coverage was restricted to patients with hearing test scores of > 40 % and ≤ 60 %.

Earlier this year, ASHA commented in support of these changes during the revision process, both in March and July. ASHA also developed a template letter that ASHA members could submit independently in support of this change.

To qualify for Medicare coverage of cochlear implants, 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 the FDA approved category B investigational device exemption clinical trials or as a routine cost in clinical trials.

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