Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Cochlear Implant

Policy #:11.01.02n

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

A unilateral or bilateral implantation of a US Food and Drug Administration (FDA)--approved single- or multi-channel cochlear implant is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has a documented diagnosis of bilateral pre- or post-linguistic moderate-to-profound sensorineural hearing impairment with limited benefit from hearing (or vibrotactile) aids.
    • In adults (18 years of age and older), limited benefit from amplification is defined by test scores of less than or equal to 40 percent correct on tape-recorded tests of open-set sentence cognition in the best-aided listening condition.
    • In children (12 months to 17 years of age), limited benefit is defined as a failure to develop basic auditory skills, or less than or equal to 30 percent correct on open-set tests 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 FDA.

Bilateral cochlear implants may be performed at the same time or subsequently.

Cochlear implantation with a hybrid cochlear implant/hearing aid device that includes the hearing aid integrated into the external sound processor of the cochlear implant (e.g., the Nucleus® Hybrid™ L24 Cochlear Implant System) is considered medically necessary and, therefore, covered when all of the following criteria are) met:
  • Individual is 18 years and older
  • Individual has bilateral severe-to-profound high-frequency sensorineural hearing loss with residual low-frequency hearing sensitivity;
  • Individual received limited benefit from appropriately fit bilateral hearing aids;
  • Individual has the following hearing thresholds:
    • Low-frequency hearing thresholds no poorer than 60 dB hearing level up to and including 500 Hz (averaged over 125, 250, and 500 Hz) in the ear selected for implantation; AND
    • Severe to profound mid- to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥75 dB hearing level) in the ear to be implanted; AND
    • Moderately severe to profound mid- to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥60 dB hearing level) in the contralateral ear; AND
    • Aided consonant-nucleus-consonant word recognition score from 10% to 60% in the ear to be implanted in the preoperative aided condition and in the contralateral ear will be equal to or better than that of the ear to be implanted but not more than 80% correct.

Accessories for covered devices required for the proper functioning of a cochlear implant (e.g., specialized batteries), including replacement items, are considered medically necessary and, therefore, covered.

Replacement of internal and/or external components is considered medically necessary and, therefore, covered only in a small subset of individuals who have inadequate response to existing component(s) to the point of interfering with the individual’s activities of daily living, or the component(s) is/are no longer functional and cannot be repaired.

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.

When a member has a benefit for hearing aids and assistive listening devices, an assistive listening device for use with a cochlear implant approved by the FDA is covered for individuals who have a cochlear implant.

EXPERIMENTAL/INVESTIGATIONAL

Cochlear implantation 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 MEDICALLY NECESSARY

Upgrades to an existing external system for aesthetic improvement, such as a smaller profile component or a switch from a body-worn model to a behind-the-ear (BTE) model, are deluxe features that are considered not medically necessary because they serve no medical purpose. Therefore, these upgrades are not eligible for reimbursement consideration.

Replacement of internal and/or external components solely for the purpose of upgrading to a system with advanced technology or to a next-generation device is not eligible for payment under the medical benefits of the Company’s products because the service is considered not medically necessary and, therefore, not covered.

AURAL REHABILITATION

Aural rehabilitation and training (also known as auditory rehabilitation) associated with a cochlear implant is covered and eligible for reimbursement if the individual meets the medical necessity criteria listed above for the implantation of the device. Aural rehabilitation services reported using Current Procedural Terminology (CPT) codes 92626, 92627, 92630, and 92633 are not considered speech therapy and, therefore, are not applied to the member's speech therapy benefit.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must reflect the medical necessity of the care and services 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.

An order for each item billed must be signed and dated by the professional provider who is treating the member and kept on file by the supplier. Medical record documentation must include a shipment confirmation or member's receipt of supplies and equipment. 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.
Guidelines

BENEFIT APPLICATION

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

Subject to the terms and conditions of the applicable benefit contract, upgrades to an existing external cochlear implant system for aesthetic improvement or replacement of internal and/or external components solely for the purpose of upgrading to a system with advanced technology or to a next-generation device is not eligible for payment under the medical benefits of the Company’s products because the service is considered not medically necessary and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

DURATION OF AURAL REHABILITATION

Aural rehabilitation and training (post-cochlear implant) is necessary to attain benefits from a cochlear implant. It generally consists of six to ten sessions that last approximately two hours each.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous cochlear implant devices approved by the FDA.

Description

A cochlear implant allows direct electrical stimulation to the auditory nerve, bypassing the usual transducer cells that are absent or improperly functioning in the cochlea of an individual who has moderate, severe, or profound sensorineural hearing impairment. A cochlear implant device is indicated for individuals with moderate, severe, or profound bilateral sensorineural hearing impairment who only received limited benefit from amplification with hearing aids.

The following criteria are used to measure the severity of hearing loss:
  • Moderate hearing loss is defined as a bilateral hearing threshold of 40-60 dB.
  • Severe hearing loss is defined as a bilateral hearing threshold of 70-90 dB.
  • Profound hearing loss is defined as a bilateral hearing threshold of 90 dB and above.

There is a distinction between cochlear implants and cochlear hearing aids. Cochlear implants have external components, as well as certain internal components that are surgically implanted in the ear. Cochlear implants are not classified as hearing aids because they produce an electrical signal that directly stimulates the auditory nerve, unlike a hearing aid which just makes sound louder or clearer.

COMPONENTS

The implant consists of external and internal components. The external components include a microphone, a sound processor, and a transmitter. The internal components are implanted surgically and include a receiver placed in the temporal bone and an electrode array that extends from the receiver into the cochlea through an opening in the round window of the middle ear.

Sounds picked up by the microphone are carried to the external sound processor, which then transforms sounds into coded signals that are transmitted transcutaneously to the implanted receiver. The receiver converts the incoming signals to electrical impulses that are then conveyed to the electrode array, ultimately resulting in the stimulation of the auditory nerve. The device provides for both the awareness and the identification of sounds in order to facilitate communication in individuals who have been diagnosed as hearing impaired.

INDICATIONS FOR USE

BILATERAL HEARING LOSS
Cochlear implants typically have been used unilaterally. However, in recent years, interest in bilateral cochlear implantation has increased. The proposed auditory benefits of bilateral cochlear implants are to improve the understanding of speech in noise and the localization of sounds (or spatial hearing). Improvements in speech intelligibility may occur with bilateral cochlear implants through binaural summation (i.e., signal processing of sound input from two sides). Binaural summation is thought to provide a better representation of sound and allows individuals to separate noise from speech. Speech intelligibility and localization of sound may also be improved with head shadow and squelch effects (i.e., when the ear that is closer to the noise receives sound at a different frequency and intensity). Head shadow and squelch effects allow individuals to sort noise and identify the direction of sound.

Bilateral cochlear implantation may be performed independently with separate implants and speech processors in each ear. Bilateral cochlear implantation may also be performed with a single processor. However, no single processor for bilateral cochlear implantation has been approved by the US Food and Drug Administration (FDA) for use in the United States. In addition, single processors do not provide binaural benefit and may impair localization and increase the signal-to-noise ratio received by the cochlear implant.

UNILATERAL HEARING LOSS
A number of small observational studies from outside the United States have reported results on cochlear implantation in adults with unilateral deafness, which would be an off-label indication. For example, Arndt and colleagues published a German pilot study in 2010 of 11 adults with unilateral hearing loss of various causes looking at the use of unilateral electrical stimulation with normal hearing on the contralateral side after a period of six months compared with conventional contralateral routing of signal or bone-anchored hearing aids. Ten of the 11 study participants also suffered from tinnitus. The authors reported that cochlear implantation improved hearing abilities in these study participants and was superior to conventional contralateral routing of signal or bone-anchored hearing aids. The use of the cochlear implant did not interfere with speech understanding in the normal-hearing ear.

The application of cochlear implants for tinnitus relief in people with unilateral deafness has also been described in earlier studies. van de Heyning and colleagues, for example, published a study in 2008 of 21 people with unilateral hearing loss accompanied by severe tinnitus for at least two years who underwent cochlear implants at a University Center in Belgium. Three of the 21 study participants showed complete tinnitus relief, whereas the majority demonstrated a significant reduction in tinnitus loudness based on a visual analogue scale (two years after implantation). The evidence-base to date on unilateral hearing loss is based on a few observational studies with a small number of study participants. Future controlled studies with appropriate participant selection comparing cochlear implants to alternative treatment options are needed to yield stronger evidence.

AURAL REHABILITATION

Aural rehabilitation (also known as auditory rehabilitation) is a post-cochlear implant program that focuses on improving the individual's ability to interpret auditory information that is received through the implant. The program emphasizes the recognition of specific speech sounds, word discrimination and identification, and conversational skills.

HYBRID COCHLEAR IMPLANTATION

In March 2014, FDA approved the Nucleus® Hybrid™ L24 Cochlear Implant System (Cochlear Corporation, Centennial, CO), an electro-acoustic stimulation system, through the premarket approval process. This system is a hybrid cochlear implant and hearing aid, with the hearing aid integrated into the external sound processor of the cochlear implant. It is indicated for unilateral use in individuals aged 18 years and older who have severe to profound mid- and high- frequency sensorineural hearing loss and normal to moderate low- frequency hearing loss, and who obtain limited benefit from appropriately fit bilateral hearing aid.
References


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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed June 18, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Nucleus Hybrid L24 Cochlear Implant System -- P130016. Premarket approval letter. [FDA Web site]. 03/20/2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130016a.pdf. June 18, 2018.

Van de Heyning P, Vermeire K, Diebl M, et al. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008; 117(9):645-52.

van Hoesel RJ, Tyler RS. Speech perception, localization, and lateralization with bilateral cochlear implants. J Acoust Soc Am. 2003;113(3):1617-1630.

van Hoesel R, Ramsden R, Odriscoll M. Sound-direction identification, interaural time delay discrimination, and speech intelligibility advantages in noise for a bilateral cochlear implant user. Ear Hear. 2002;23(2):137-149.

van Schoonhoven J, Sparreboom M, van Zanten BG, et al. The effectiveness of bilateral cochlear implants for severe-to-profound deafness in adults: a systematic review. Otol Neurotol. 2013; 34(2):190-8.

van Zon A, Peters JP, Stegeman I, et al. Cochlear implantation for patients with single-sided deafness or asymmetrical hearing loss: a systematic review of the evidence. Otol Neurotol. 2015;36(2):209-219.

van Zon A, Smulders YE, Ramakers GG, et al. Effect of unilateral and simultaneous bilateral cochlear implantation on tinnitus: A Prospective Study. Laryngoscope. 2016;126(4):956-961.

Vermeire K, Brokx JP, Van de Heyning PH, et al. Bilateral cochlear implantation in children. Int J Pediatr Otorhinolaryngol. 2003;67(1):67-70.

Vlastarakos PV, Nazos K, Tavoulari EF, et al. Cochlear implantation for single-sided deafness: the outcomes. An evidence-based approach. Eur Arch Otorhinolaryngol. 2014;271(8):2119-26.

Vlastarakos PV, Proikas K, Papacharalampous G, et al. Cochlear implantation under the first year of age--the outcomes. A critical systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol. 2010; 74(2):119-126.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

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


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

H90.A21 Sensorineural hearing loss, unilateral, right ear, with restricted hearing on the contralateral side

H90.A22 Sensorineural hearing loss, unilateral, left ear, with restricted hearing on the contralateral side

H90.A31 Mixed conductive and sensorineural hearing loss, unilateral, right ear with restricted hearing on the contralateral side

H90.A32 Mixed conductive and sensorineural hearing loss, unilateral, left ear with restricted hearing on the contralateral side

H90.3 Sensorineural hearing loss, bilateral

H90.6 Mixed conductive and sensorineural hearing loss, bilateral

T85.618A Breakdown (mechanical) of other specified internal prosthetic devices, implants and grafts, initial encounter

T85.618D Breakdown (mechanical) of other specified internal prosthetic devices, implants and grafts, subsequent encounter

T85.618S Breakdown (mechanical) of other specified internal prosthetic devices, implants and grafts, sequela

T85.628A Displacement of other specified internal prosthetic devices, implants and grafts, initial encounter

T85.628D Displacement of other specified internal prosthetic devices, implants and grafts, subsequent encounter

T85.628S Displacement of other specified internal prosthetic devices, implants and grafts, sequela

T85.638A Leakage of other specified internal prosthetic devices, implants and grafts, initial encounter

T85.638D Leakage of other specified internal prosthetic devices, implants and grafts, subsequent encounter

T85.638S Leakage of other specified internal prosthetic devices, implants and grafts, sequela

T85.698A Other mechanical complication of other specified internal prosthetic devices, implants and grafts, initial encounter

T85.698D Other mechanical complication of other specified internal prosthetic devices, implants and grafts, subsequent encounter

T85.698S Other mechanical complication of other specified internal prosthetic devices, implants and grafts, sequela

Z45.321 Encounter for adjustment and management of cochlear device

Z45.328 Encounter for adjustment and management of other implanted hearing device

Z45.49 Encounter for adjustment and management of other implanted nervous system device

Z46.2 Encounter for fitting and adjustment of other devices related to nervous system and special senses

Z51.89 Encounter for other specified aftercare

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 COVERED ONLY WHEN THE MEMBER HAS A BENEFIT FOR HEARING AIDS:

V5273 Assistive listening device, for use with cochlear implant




Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

11.01.02n:
09/10/2018This version of the policy will become effective 09/10/2018.

This policy was updated to communicate that replacement of internal and/or external components is considered medically necessary for specified criteria and services that do not meet the medical necessity criteria, such that replacement of internal and/or external components solely for the purpose of upgrading to a system with advanced technology or to a next-generation device is considered not medically necessary.

11.01.02m:
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2018.

The following HCPCS code has been added to this policy: L8625
The following narratives have been revised in this policy: L8618, L8624
Version Effective Date: 09/10/2018
Version Issued Date: 09/10/2018
Version Reissued Date: N/A

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