Cochlear Implantation

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.

B. Nationally Covered Indications

Effective for services performed on or after September 26, 2022, 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 recognition. 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.

C. Nationally Non-Covered Indications

Medicare beneficiaries not meeting all of the coverage criteria for cochlear implantation listed in Section B are deemed not eligible for Medicare coverage except as described in Section D below.

D. Other

CMS may provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed in Section B 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.

(This NCD last reviewed September 2022)

CED page

08/2023 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. (TN 12184) (CR13278)

03/2023 - Transmittal 11875 issued February 23, 2023, is being rescinded and replaced by Transmittal 11929, dated, March 27, 2023, to correct the Pub.100-04 Claims Processing Manual Chapter 32, Section 105 diagnostic code reference. This correction does not make any revisions to the companion Pubs. 100-03; all revisions are associated with Pub. 100-04. All other information remains the same. (TN 11929) (CR13073)

02/2023 - The purpose of this Change Request (CR) is to update the manuals with revised eligibility criteria for the cochlear implantation NCD policy that is expanding beneficiary coverage for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-to-profound hearing loss in individuals who demonstrate limited benefit from amplification. (TN 11875) (CR13073)

07/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 10261) (CR11905)

06/2016 - Transmittal 1665, dated May 13, 2016, is being rescinded and replaced by Transmittal 1672 to: (1) 9631.1: Remove FISS responsibility and 1st sentence; (2) 9631.2: Remove additional procedure codes, including 0075T, 0076T; (3) 9631.4: Revise descriptor of dx L59.8; (4) 9631.6: Add deletion of dx C49.10, C65.9, remove deletion of dx C54.9, remove deletion of invalid dx C47.90; (5) 9631.8: Remove deletion of invalid dx C51.29, replace with deletion of dx C50.029; (6) 9631.9: Add deletion of 0V504ZZ, 0V500ZZ, override capability, and contractor discretion verbiage. All other information remains the same. (TN 1672) (CR9631)

05/2016 - This change request (CR) is the 7th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, and CR9540. Some are the result of revisions required to other NCD-related CRs released separately. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1665) (CR9631)

05/2014 - 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: 10/06/2014 Effective date: 10/1/2015. (TN 1388) (TN 1388) (CR 8691)

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: 10/1/2015. (TN 1199) (TN 1199) (CR 8197)

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)

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)