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National Coverage Determination (NCD) for Cochlear Implantation (50.3)

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Benefit Category
Prosthetic Devices

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

A cochlear implant device is an electronic instrument, part of which is implanted surgically to stimulate auditory nerve fibers, and part of which is worn or carried by the individual to capture, analyze, and code sound. Cochlear implant devices are available in single-channel and multi-channel models. The purpose of implanting the device is to provide awareness and identification of sounds and to facilitate communication for persons who are moderately to profoundly hearing impaired.


Indications and Limitations of Coverage

B. Nationally Covered Indications

1. Effective for services performed on or after April 4, 2005, 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 40% correct in the best-aided listening condition on tape-recorded tests of open-set sentence cognition. Medicare coverage is provided only for those patients who meet all of the following selection guidelines.

  • 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.

2. Effective for services performed on or after April 4, 2005, cochlear implantation may be covered for individuals meeting the selection guidelines above and with hearing test scores of greater than 40% and less than or equal to 60% only when the provider is participating in, and patients are enrolled in, either an FDA-approved category B investigational device exemption clinical trial as defined at 42 CFR 405.201, a trial under the Centers for Medicare & Medicaid (CMS) Clinical Trial Policy as defined at section 310.1 of the National Coverage Determinations Manual, or a prospective, controlled comparative trial approved by CMS as consistent with the evidentiary requirements for National Coverage Analyses and meeting specific quality standards.

C. Nationally Non-Covered Indications

Medicare beneficiaries not meeting all of the coverage criteria for cochlear implantation listed are deemed not eligible for Medicare coverage under section 1862(a)(1)(A) of the Social Security Act.

D. Other

All other indications for cochlear implantation not otherwise indicated as nationally covered or non-covered above remain at local Medicare Administrator Contractor discretion.


Claims Processing Instructions
Transmittal Number

42

Revision History

09/1986 - Provided coverage for post-lingual deaf adults. Effective date 10/01/1986. (TN 10)

12/1992 - Allowed coverage for children ages 2 through 17 with bilateral profound sensorineural hearing impairment and demonstrate little or no benefit from a hearing aid. Effective date 12/31/1992. (TN 64)

04/1998 - Updated coverage policy consistent with changes in technology and FDA labeling for product, and expanded coverage for children and adults. Effective date 05/01/1998. (TN 104) (CR 390)

07/2005 - Expanded coverage to cover moderate-to-profound hearing loss in individuals with specified hearing test scores. Effective date 04/04/2005. Implementation date 07/25/2005. (TN 42) (CR 3796)

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/07/2013 Effective date: 10/1/2014. (TN 1199) (TN 1199) (CR 8197)


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Other Versions
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