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Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2014, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2014 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-69000-03

Original Effective Date: 08/15/03

Reviewed: 10/23/14

Revised: 11/15/14

Subject: Cochlear Implants

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates  

DESCRIPTION:

A cochlear implant is a device for people with severe-to-profound hearing loss who only receive limited benefit from amplification with hearing aids. A cochlear implant provides direct electrical stimulation to the auditory nerve, bypassing the usual transducer cells that are absent or nonfunctional in deaf cochlea.

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

Sounds that are picked up by the microphone are carried to the external sound processor, which transforms sound into coded signals that are then transmitted transcutaneously to the implanted internal receiver. The receiver converts the incoming signals to electrical impulses that are then conveyed to the electrode array, ultimately resulting in stimulation of the auditory nerve.

Several FDA-approved cochlear implant systems are commercially available in the United States.

POSITION STATEMENT:

Unilateral or bilateral implantation of an FDA approved single or multi-channel cochlear implant in adults and children meets the definition of medical necessity when ALL of the following criteria are met:

Diagnostic analysis and programming of cochlear implants meets the definition of medical necessity when criteria for the implant device are met.

Upgrades of an existing, functioning external system to achieve a cosmetic improvement, such as smaller profile components, or a switch from a body-worn, external sound processor to a behind the ear (BTE) model, are considered cosmetic in nature do not meet the definition of medical necessity.

A hybrid cochlear implant is considered experimental or investigational for all indications. The available scientific evidence remains insufficient to permit conclusions concerning the effect of this procedure on net health outcomes.

BILLING/CODING INFORMATION:

The following codes may be used to describe services related to cochlear implantation and diagnostic analysis of cochlear implant.

CPT Coding:

69930

Cochlear device implantation, with or without mastoidectomy

92601

Diagnostic analysis of cochlear implant, patient under 7 years of age; with programming

92602

Diagnostic analysis of cochlear implant, patient under 7 years of age; subsequent reprogramming

92603

Diagnostic analysis of cochlear implant, age 7 years or older; with programming

92604

Diagnostic analysis of cochlear implant, age 7 years or older; subsequent reprogramming

HCPCS Coding:

L7510

Repair prosthetic device, repair or replace minor parts (excludes repair of oral or laryngeal prosthesis or artificial larynx)

L8614

Cochlear device/system 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, 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, each

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 device speech processor, ear level, replacement 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

V5273

Assistive listening device, for use with cochlear implant

ICD-9 Diagnoses Codes That Support Medical Necessity:

389.10 – 389.18

Sensorineural hearing loss

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

H90.3 – H90.5

Sensorineural hearing loss

REIMBURSEMENT INFORMATION:

Reimbursement for replacement of a cochlear implant AND its external components may be covered for any one of the following:

Reimbursement for batteries and replacement batteries for cochlear implant devices are covered when criteria for the cochlear implant device are met.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline revised date: Cochlear Implantation (50.3) located at cms.gov.

DEFINITIONS:

Auditory nerve: either of the 8th pair of cranial nerves connecting the inner ear with the brain; transmits impulses relating to hearing and balance; composed of the cochlear nerve and the vestibular nerve.

Cochlea: a division of the labyrinth of the ear coiled into the form of a snail shell consisting of a spiral canal.

Conductive hearing loss: the result of disorders of the external or middle ear.

Hybrid cochlear implant: a unilateral implant with a shorter cochlear electrode in combination with a hearing aid-like amplification device; intended to provide electric stimulation to the mid-to-high frequency region of the cochlea and acoustic amplification to the low frequency regions.

Labyrinth: the internal ear or its bony or membranous part.

Neural hearing loss: results from disease or the auditory (eighth) nerve or central auditory channel connections.

Perlingual deafness: around or during the time speech begins.

Postlingual deafness: after speech has started.

Prelingual deafness: before speech begins.

Profound sensorineural hearing impairment: a bilateral hearing threshold of 90 decibels and above.

Sensorineural hearing loss: the result of damage to the inner ear (cochlea), or to the nerve pathways from the inner ear to the brain.

Severe sensorineural hearing impairment: a bilateral hearing threshold of 70-90 decibels (dB).

RELATED GUIDELINES:

Aural Rehabilitation (Audiologic Rehabilitation) After Cochlear Implantation, 02-69000-04
Implantable Bone-Conduction and Bone-Anchored Hearing Aids, 02-69000-06

Prosthetics, 09-L0000-05

Semi-Implantable Middle Ear Hearing Aids, 02-69000-05

Treatment of Tinnitus, 01-92502-11

OTHER:

None applicable.

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ) Technology Assessment Program, Effectiveness of Cochlear Implants in Adults with Sensorineural Hearing Loss, 04/11/11.
  2. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse NGC:008637: Quality of life in children with sequential bilateral cochlear implants. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2011 Jun 9.
  3. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse NGC:007126: Cochlear implants for children and adults with severe to profound deafness. London (UK): National Institute for Health and Clinical Excellence (NICE); 2009 Jan.
  4. American Academy of Audiology-Cochlear Implants in Children, accessed 06/25/07.
  5. American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Position Statement: Cochlear Implants (12/27/07). Accessed at http://www.entnet.org/Practice/Position-Statements.cfm on 09/30/14.
  6. American Academy of Otolaryngology — Head and Neck Surgery: Response to Washington State Health Technology Assessment for Unilateral/Bilateral Cochlear Implants. June 2012. Accessed at http://www.entnet.org on 01/16/13.
  7. American Speech Language Hearing Association-New Coding Options for Diagnostic Analysis of Cochlear Implants.
  8. American Speech-Language-Hearing Association (ASLHA). Cochlear implants. Accessed at http://www.asha.org/public/hearing/treatment/cochlear_implant.htm on 09/30/14.
  9. Audiology Online-First Pediatric Bilateral Cochlear Implant Recipients at Dallas Otolaryngology Associates, 02/19/03.
  10. Bittencourt A G et al . Post-lingual deafness: benefits of cochlear implants vs. conventional hearing aids. Braz. J. Otorhinolaryngol., São Paulo, v. 78, n. 2, Apr. 2012.
  11. Blue Cross Blue Shield Association. Medical Policy Reference Manual. 7.01.05 Cochlear Implant, May 2014.
  12. Centers for Disease Control and Prevention (CDC). Vaccines and preventable diseases: cochlear implants & meningitis vaccination. June 1, 2012. Accessed at http://www.cdc.gov/Vaccines/vpd-vac/mening/cochlear/dis-cochlear-faq-hcp.htm on 09/30/14.
  13. Centers for Medicaid & Medicare Services (CMS), MEDCAC Meeting – Cochlear Implants for Sensorineural Hearing Loss, 05/11/11.
  14. Centers for Medicaid & Medicare Services (CMS), NCD for Cochlear Implantation (50.3), 07/25/05. (Accessed on 09/30/14)
  15. Centers for Medicaid and Medicare Services Coverage Issues-Durable Medical Equipment-Cochlear Implantation (65-14), accessed 06/27/06.
  16. Centers for Medicaid and Medicare Services Coverage Medlearn Matters (#MM3796)-Cochlear Implantation, 04/04/05.
  17. ClinicalTrials.gov. NCT00960102: Children's Bilateral Cochlear Implantation in Finland (FinBiCI). Kuopio University Hospital. Last updated: August 8, 2012.
  18. ClinicalTrials.gov. NCT01256229: Outcomes In Children With Developmental Delay And Deafness. Stanford University. Last updated: July 28, 2011.
  19. Deeks JM, Carlyon RP. Simulations of cochlear implant hearing using filtered harmonic complexes: implications for concurrent sound segregation. J Acoust Soc Am. Apr; 115(4): 1736-46.
  20. ECRI Institute, Bilateral Cochlear Implantation, updated 04/28/06.
  21. First Coast Service Options, Inc. Local Coverage Determination (LCD) L29289: Therapy and Rehabilitation Services (02/02/09). Revised 01/07/14.
  22. Hayes Medical Technology Directory-Cochlear Implantation, 09/12/05, update 09/30/06.
  23. InterQual® 2012.2. CP:Procedures Adult: Cochlear Implantation.
  24. InterQual® 2014. CP: Procedures. Cochlear Implantation.
  25. InterQual® 2014. CP: Procedures. Cochlear Implantation (Pediatric).
  26. Kuhn-Inacker H, Shehata-Dieler W, Muller J et al. Bilateral Cochlear Implants: A Way to Optimize Auditory Perception Abilities in Deaf Children? International Journal of Pediatric Otorhinolaryyngology 2004; 68(10): 1257-1266.
  27. Laszig R, Aschendorff A, Stecker M et al. Benefits of Bilateral Electrical Stimulation with the Nucleus Cochlear Implant in Adults: 6-Month Postoperative Results. Otology & Neurotology 2004; 25(6): 658-968.
  28. Litovsky RY, Parkinson A, Arcaroli J et al. Bilateral Cochlear Implants in Adults and Children. Archives of Otolaryngology-Head & Neck Surgery 2004; 130: 648-655.
  29. Loundon N, Blanchard M, Roger G, Denoyelle F, Garabedian EN. Medical and Surgical Complications in Pediatric Cochlear Implantation. Arch Otolaryngol Head Neck Surg. 2010;136(1):12-15.
  30. Moody-Antonio S, Takayanagi S, Masuda A et al. Improved Speech Perception in Adult Congenitally Deafened Cochlear Implant Recipients. Otology & Neurotology 2005; 26(4): 649-654.
  31. National Institute on Deafness and Other Communication Disorders (NIDCD)-Cochlear Implants, 05/06.
  32. National Institute on Deafness and Other Communication Disorders (NIDCD). Cochlear Implants (2013). Accessed at http://www.nidcd.nih.gov/health/hearing/Pages/Default.aspx on 09/30/14.
  33. National Institute for Health and Clinical Excellence (NICE). Technology Appraisal 166: Cochlear implants for children and adults with severe to profound deafness. January 2009.
  34. Nelson HD, Bougatsos C, Nygren P. Universal Newborn Hearing Screening: Systematic Review to Update the 2001 U.S. Preventive Services Task Force Recommendation. Evidence Synthesis No. 62. AHRQ Publication No. 08-05117-EF-1. Rockville, Maryland: Agency for Healthcare Research and Quality, July 2008.
  35. Offeciers E, Morera C, Muller J et al. International Consensus on Bilateral Cochlear Implants and Bimodal Stimulation. Acta Oto-Laryngologica 2005; 125(9): 918-919.
  36. Osberger M et al. Cochlear Implant Candidacy and Performance Trends in Children. Ann Otol Rhinol Laryngol Suppl 2002; 189:62-65.
  37. Rubin LG, Papsin B. American Academy of Pediatrics Committee on Infectious Diseases and Section on Otolaryngology-Head and Neck Surgery. Cochlear implants in children: surgical site infections and prevention and treatment of acute otitis media and meningitis. Pediatrics. 2010; 126(2):381-391.
  38. Sargent EW. Cochlear Implants, Indications. eMedicine. 2005.
  39. Tanamati Liege F, Bevilacqua MC, Costa OA. Cochlear implant in postlingual children: functional results 10 years after the surgery. Braz. J. Otorhinolaryngol., São Paulo, v. 78, n. 2, Apr. 2012.
  40. Tyler RS, Dunn CC, Witt S et al. Update on Bilateral Cochlear Implantation. Current Opinion Otolaryngology & Head and Neck Surgery 2003; 11(5): 388-393.
  41. U.S. Food and Drug Administration website for cochlear implants, (10/26/04).
  42. U.S. Food and Drug Administration. FDA Public Health Notification: Continued Risk of Bacterial Meningitis in Children with Cochlear Implants with a Positioner Beyond Twenty-Four Months Post-Implantation. February 6, 2006. Accessed at http://www.fda.gov on 01/16/13.
  43. U.S. Food and Drug Administration (FDA). Premarket Approval Database. Approval Order P130016. Rockville, MD: FDA. Nucleus Hybrid L24 Cochlear Implant System. Accessed at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P130016 on 09/30/14.
  44. U.S. Food and Drug Administration (FDA). Premarket Approval Database. Summary of Safety and Effectiveness. Rockville, MD: FDA. Nucleus Hybrid L24 Cochlear Implant System. Accessed at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P130016 on 09/30/14.
  45. U.S. Preventive Services Task Force (USPSTF), Universal Screening for Hearing Loss in Newborns: Clinical Summary of U.S. Preventive Services Task Force Recommendation. AHRQ Publication No. 08-05117-EF-3, July 2008, accessed at: uspreventiveservicestaskforce.org 05/23/11.
  46. University of Miami School of Medicine-Active Research Studies Recruiting Subjects-Clinical Study of Bilateral Implantation in children, 2005.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/23/14.

GUIDELINE UPDATE INFORMATION:

08/15/03

Annual review/new Medical Coverage Guideline. Implanted Devices for Hearing Loss and Aural Rehabilitation guideline 02-69000-02 archived.

09/15/04

Added investigational statement for bilateral cochlear implantation. Updated references.

01/15/05

HCPCS update; added codes: L8615, L8616, L8617, L8618, L8620, L8621, and L8622.

07/01/05

HCPCS update. Added codes K0731 and K0732.

08/15/05

Scheduled review; no change in coverage statement; added reimbursement information regarding batteries.

01/01/06

HCPCS update; Deleted codes L8620, K0731 and K0732. Added codes L8623 and L8624. Updated references.

08/15/06

Revised DESCRIPTION section. Revised WHEN SERVICES ARE COVERED section; add coverage statement for post-cochlear rehabilitation program (aural rehabilitation). Revised BILLING/ CODING INFORMATION section, delete 2003 CPT statement regarding codes: 92601, 92602, 92603, 92604, and 92606. Added program exception for Medicare Advantage products. Updated references.

11/15/06

Added coverage statement for bilateral cochlear implant. Added coverage statement for upgrades of an exiting functioning system. Revised definition for postlingual deafness and prelingual deafness. Updated references.

01/01/07

HCPCS update. Revise code L8614 descriptor.

08/15/07

Annual review, coverage statements maintained, Description section updated, guideline reformatted, references updated.

08/15/09

Scheduled review; no change in position statement. Update references.

01/01/10

Annual HCPCS coding update: add HCPCS codes L8627, L8628, and L8629; update descriptor for code L8619.

10/15/10

Revision; related ICD-10 codes added.

07/15/11

Scheduled review; position statements maintained and references updated.

03/15/13

Unscheduled review. Revised description, position statement, reimbursement section, Medicare Advantage program exception, definitions and related guidelines. Updated references.

05/11/14

Revision: Program Exceptions section updated.

11/15/14

Unscheduled review. Revised description, position statement and definitions. Updated references.

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is copyright 2013, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2013 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association.The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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Date Printed: March 3, 2015: 11:17 PM