Medicare Advantage

Medical Policy

Title:

Cochlear Implantation

Policy #:

MA11.039e

Policy

This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.

MEDICALLY NECESSARY

Cochlear implantation is considered medically necessary and, therefore, covered for individuals with a documented diagnosis of bilateral pre- or postlinguistic moderate-to-profound sensorineural hearing impairment when all of the following criteria are met:

The individual demonstrates limited benefit from hearing (or vibrotactile) aids.
- Limited benefit from amplification is defined by test scores of less than or equal to 60% correct on recorded tests of open-set sentence cognition in the best-aided listening condition.
The individual has the cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation.
The cochlear lumen is accessible, structurally suited to implantation, free of middle ear infection, and free of lesions in the auditory nerve and acoustic areas of the central nervous system.
A cochlear implant must be used in accordance with the labeling approved by the US Food and Drug Administration (FDA).
The individual has no contraindications to surgery

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

Cochlear implantation may be covered for individuals who meet all the requirements of Original Medicare’s Coverage with Evidence Development (CED) provisions and who are enrolled in a Medicare-approved clinical study.

INVESTIGATIONAL DEVICE EXEMPTION (IDE)

Cochlear implantation may be covered for individuals not meeting the above medically necessary criteria when the professional provider is participating in, and the individual is enrolled in, an FDA-approved category B IDE clinical trial.

A list of IDE studies meeting the Centers for Medicare & Medicaid (CMS) standards for coverage are listed and maintained on the CMS Coverage website at: https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html.

EXPERIMENTAL/INVESTIGATIONAL

Cochlear implantation for all other indications including as a treatment for unilateral hearing loss with or without tinnitus is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

NOT COVERED

An assistive listening device for use with a cochlear implant (e.g., telephone microphone) is not covered by the Company because it is an item not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

BILLING REQUIREMENTS

Claims submitted for cochlear implantation must be reported with the appropriate medical codes representing the most specific condition and laterality.

Claims for cochlear implantation for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.

Professional providers are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial and the Category B IDE device. If Original Medicare determines that the device does, in fact, meet the requirements of coverage, and the clinical trial is approved, coverage for the routine costs associated with a qualifying clinical trial and the category B IDE device are submitted to the Medicare Advantage plan.

Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, cochlear implantation (unilateral and bilateral) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as noncovered are not eligible for coverage or reimbursement by the Company.

Subject to the applicable Evidence of Coverage, an assistive listening device for use with a cochlear implant is not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered not covered.

Services that are experimental/investigational are excluded from the Company's Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

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 multichannel 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.

References

Centers for Medicare & Medicaid Services (CMS). Approved IDE Studies [CMS Web site]. 12/01/2021. Available at: https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.
Accessed January 23, 2025.

Centers for Medicare & Medicaid Services (CMS). Coverage with Evidence Development – Cochlear Implantation. [CMS Web site]. 09/06/2023. Available at: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Cochlear-Implantation-. Accessed January 23, 2025.

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Cochlear Implantation (CAG-00107N). [CMS Web site]. 04/04/2005. Available at:
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=134. Accessed January 23, 2025.

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Cochlear Implantation (CAG-00107R). [CMS Web site}. 09/26/2022. Available at: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=306. Accessed January 23, 2025.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 50.3: Cochlear implantation. [CMS Web site]. Original: 04/04/05. Update: 03/24/2023. Available
at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=245&ncdver=3&bc=BAABAAAAAAAA&=. Accessed January 23, 2025.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 310.1 Routine Costs of Clinical Trials. 07/09/2007. Updated 05/27/2024. [CMS Web site]. Available at:
https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=1&ncdver=3&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=routine&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAA&=. Accessed January 23, 2025.

ClinicalTrials.gov. Evaluation of revised indications (ERID) for cochlear implant candidacy for the adult CMS population [Clinical Trials.gov Web site]. 07/27/2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02075229. Accessed January 23, 2025.

Roland JT, Jr., Gantz BJ, Waltzman SB, et al. United States multicenter clinical trial of the cochlear nucleus hybrid implant system. Laryngoscope. 2016;126(1):175-81.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Cochlear Implants. Premarket approval database. [FDA Web site]. 06/18/2018. Available at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed January 23, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Devices@FDA. Cochlear Implant [FDA Web site]. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/CochlearImplants/ucm062882.htm. Accessed January 23, 2025.

Coding

CPT Procedure Code Number(s)

69930, 92601, 92602, 92603, 92604, 92626, 92627, 92630, 92633

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

H90.3 Sensorineural hearing loss, bilateral

H90.6 Mixed conductive and sensorineural hearing loss, bilateral

EXPERIMENTAL/INVESTIGATIONAL

H90.A11 Conductive hearing loss, unilateral, right ear with restricted hearing on the contralateral side

H90.A12 Conductive hearing loss, unilateral, left ear with restricted hearing on the contralateral side

H90.11 Conductive hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side

H90.12 Conductive hearing loss, unilateral, left ear, with unrestricted hearing on the contralateral side

H90.41 Sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side

H90.42 Sensorineural hearing loss, unilateral, left ear, with unrestricted hearing on the contralateral side

H90.71 Mixed conductive and sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side

H90.72 Mixed conductive and sensorineural hearing loss, unilateral, left ear, with unrestricted hearing on the contralateral side

HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

L8614 Cochlear device, includes all internal and external components

L8615 Headset/headpiece for use with cochlear implant device, replacement

L8616 Microphone for use with cochlear implant device, replacement

L8617 Transmitting coil for use with cochlear implant device, replacement

L8618 Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement

L8619 Cochlear implant, external speech processor and controller, integrated system, replacement

L8621 Zinc air battery for use with cochlear implant device, replacement, each

L8622 Alkaline battery for use with cochlear implant device, any size, replacement

L8623 Lithium ion battery for use with cochlear implant device speech processor, other than ear level, replacement, each

L8624 Lithium ion battery for use with cochlear implant or auditory osseointegrated device speech processor, ear level, replacement, each

L8625 External recharging system for battery for use with cochlear implant or auditory osseointegrated device, replacement only, each

L8627 Cochlear implant, external speech processor, component, replacement

L8628 Cochlear implant, external controller component, replacement

L8629 Transmitting coil and cable, integrated, for use with cochlear implant device, replacement

THE FOLLOWING DEVICE IS NOT COVERED BY MEDICARE; THEREFORE, IT IS NOT ELIGIBLE FOR REIMBURSEMENT CONSIDERATION:

V5273 Assistive listening device, for use with cochlear implant

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA11.039e:

05/27/2026	This policy has been reissued in accordance with the Company's annual review process.
04/02/2025	This policy has been reviewed and reissued to communicate the Company’s continuing position on Cochlear Implantation.
04/03/2024	This policy has been reviewed and reissued to communicate the Company’s continuing position on Cochlear Implantation.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
07/12/2023	This policy has been reissued in accordance with the Company's annual review process.
02/06/2023	This version of the policy will become effective 02/06/2023. The intent of this policy remains unchanged; however, the Medically Necessary and Experimental/Investigational criteria has been revised in consideration of the National Coverage Analysis Decision Memo. Billing Requirements have been updated including those for individuals enrolled in a CED clinical trial and for routine care items and services related to a Category B IDE study. The following ICD-10 CM codes have been removed from this policy: H90.A21, H90.A22, H90.A31, H90.A232, T85.618A, T85.618D, T85.618S T85.628A, T85.628D, T85.628S, T85.638A, T85.638D, T85.638S, T85.698A, T85.698D, T85.698S, Z45.321, Z45.328, Z45.49, Z46.2, Z51.89

Revisions From MA11.039d:

03/24/2021	The policy has been reviewed and reissued to communicate the Company’s continuing position on Cochlear Implants.
01/01/2020	This policy has been identified for the CPT code update, effective 01/01/2020. The following narratives have been revised in this policy: 92626, 92627.

Revisions From MA11.039c:

09/25/2019	This policy has been reissued in accordance with the Company's annual review process.
08/29/2018	The policy has been reviewed and reissued to communicate the Company’s continuing position on Cochlear Implantation.
01/01/2018	This policy has undergone a code update. The following changes were made: The following HCPCS code has been added to this policy: L8625 The following narratives have been revised in this policy: L8618; L8624

Revisions From MA11.039b:

02/15/2017	The policy has been reviewed and reissued to communicate the Company’s continuing position on Cochlear Implants.
10/01/2016	The Company’s coverage position has changed from Experimental/Investigational to Medically Necessary for cochlear implantation with a hybrid cochlear implant/hearing aid device.

Revisions From MA11.039a:

06/22/2016

The policy has been reviewed and reissued to communicate the Company’s continuing position on Cochlear Implants.

03/27/2015

This policy was expanded to communicate the Company's position of experimental/investigational for cochlear implantation for unilateral hearing loss and with a hybrid cochlear implant/hearing aid device.

The following ICD-9 CM code has been removed from this policy: 389.10 Sensorineural hearing loss, unspecified
The following ICD-9 CM codes have been added to this policy: 389.05, 389.13, 389.15, 389.17, 389.21, 996.59
The following ICD-10 CM codes have been added to this policy: T85.618A, T85.618D, T85.618S, T85.628A, T85.628D, T85.628S, T85.638A, T85.638D, T85.638S, T85.698A, T85.698D, T85.698S, Z45.328, Z45.49, Z46.2, H90.11, H90.12, H90.41, H90.42, H90.71, H90.72
The following ICD-10 CM codes have been removed from this policy: H90.5 Unspecified sensorineural hearing loss, Z45.320 Encounter for adjustment and management of bone conduction device
The following HCPCS codes have been added to this policy: L8615, L8616, L8617, L8618, L8619, L8621, L8622, L8623, L8624, L8627, L8628, L8629
The following CPT code has been added to this policy to represent the NUCLEUS® HYBRID™ L24 COCHLEAR IMPLANT SYSTEM: 69930
The following HCPCS code has been added to this policy to represent the NUCLEUS® HYBRID™ L24 COCHLEAR IMPLANT SYSTEM: L8614

Revisions From MA11.039:

01/01/2015

This is a new policy.

Version Effective Date:

1/1/2024

Version Issued Date: