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National Coverage Determination (NCD)

Cochlear Implantation

50.3

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Tracking Information

Publication Number
100-3
Manual Section Number
50.3
Manual Section Title
Cochlear Implantation
Version Number
1
Effective Date of this Version
05/01/1998
Ending Effective Date of this Version
04/04/2005
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Prosthetic Devices


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

Item/Service Description

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 an awareness and identification of sounds and to facilitate communication for persons who are profoundly hearing impaired.
Indications and Limitations of Coverage

Medicare coverage is provided only for those patients who meet all of the following selection guidelines.

A - General

  • Diagnosis of bilateral severe-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 withe the FDA-approved labeling.

B - Adults

Cochlear implants may be covered for adults (over age 18) for prelinguistically, perilinguistically, and postlinguistically deafened adults. Postlinguistically deafened adults must demonstrate test scores of 30 percent or less on sentence recognition scores from tape recorded tests in the patient's best listening condition.

C - Children

Cochlear implants may be covered for prelinguistically and postlinguistically deafened children aged 2 through 17. Bilateral profound sensorineural deafness must be demonstrated by the inability to improve on age appropriate closed-set word identification tasks with amplification.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
104
Revision History

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)

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)

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

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.

Coding Analyses for Labs (CALs)

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

Additional Information

Other Versions
Title Version Effective Between
Cochlear Implantation 3 09/26/2022 - N/A View
Cochlear Implantation 2 04/04/2005 - 09/26/2022 View
Cochlear Implantation 1 05/01/1998 - 04/04/2005 You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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