Medical Policy: 01.03.02 

Original Effective Date: October 2015 

Reviewed: September 2017 

Revised:  

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy 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 will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Cochlear Implants

While hearing loss may relate to abnormalities in the sound conduction system of the outer and middle ear, most severe hearing deficits in newborns and the elderly result from sensorineural abnormalities, particularly cochlear hair cell loss which limits the ability of the cochlea to convert sound vibrations into nerve impulses. This type of hearing loss is usually irreversible and has been treated with rehabilitation strategies involving hearing aids, sign language, and speech and language therapy. Amplification does not replace the function of lost cochlear hair cells and often cannot provide adequate hearing in the case of severe cochlear hair loss. If appropriate neural elements in the ear are intact and functional, it is possible to stimulate auditory nerve impulses with a cochlear implantation device to improve sound recognition.

 

Several cochlear implants are commercially available in the United States, and are manufactured by Cochlear Corporation, Advanced Bionics, and the Med El Corporation. Over the years, subsequent generations of the various components of the devices have been approved by the U.S. Food and Drug Administration (FDA), focusing on improved electrode design and speech-processing capabilities.

 

The cochlear implant is composed of three parts, which include external components and two internal surgically implanted components. Externally, a microphone, speech processor, and transmitter coil with cables are worn. The speech processor converts sound into electrical stimuli. Internal components include an antenna and electrodes. The antenna electromagnetically captures the stimuli transmitted by the speech processor and directs this information to internal electrodes. The electrodes provide direct electrical stimulation to the auditory nerve, bypassing the transducer cells which are absent or nonfunctional. Because the cochlear implant does not magnify sound, none of its components are considered a hearing aid.

 

Prior Approval:

 

Prior approval is required.

 

Policy:

For the replacement cochlear implant to be considered medically necessary ALL of the following criteria must be met:

  • Currently used component is no longer functional and cannot be repaired. (If an existing implant is functioning, an upgrade or replacement of electrodes to another processor will not be approved.) AND
  • There is no evidence to suggest that the device has been lost, abused or neglected. AND
  • The replacement must not be solely for better technology or improved aesthetics. AND
  • It has been a minimum of five years from original placement.  The processor must be non-functional.  Age alone does not meet necessity for processor replacement. AND
  • The original processor was being used on a daily basis until malfunction

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-CM diagnostic codes.

  • L8619 Cochlear implant external speech processor and controller, integrated system, replacement
  • L8627 Cochlear implant, external speech processor, component, replacement
  • L8628 Cochlear implant, external controller component, replacement

 

Selected References:

  • Sterkers F, Merklen F, Piron JP, et al. Outcomes after cochlear reimplantation in children. Int J Pediatr Otorhinolaryngol. Mar 23 2015. PMID 25843784
  • Fernandes NF, Morettin M, Yamaguti EH, et al. Performance of hearing skills in children with auditory neuropathy spectrum disorder using cochlear implant: a systematic review. Braz J Otorhinolaryngol. Jan-Feb 2015;81(1):85-96. PMID 25458263
  • Centers for Medicare and Medicaid (CMS). National Coverage Determination (NCD) Pub. 100.3, section 50.3 Cochlear Implantation
  • American Academy of Otolarygology-Head and Neck Surgery Foudation. Position Statement on Bilateral Cochlear Implants 2014 revision.
  • Gaylor JM, Raman G, Chung M, et al. Cochlear implantation in adults: a systematic review and meta-analysis. JAMA Otolaryngol Head Neck Surg. Mar 2013;139(3):265-272. PMID 23429927
  • Institute for Health and Clinical Excellence (NICE). Technology Appraisal Guidance 166. Cochlear implants for children and adults with severe to profound deafness 2009 January 28.
  • NIH Consensus Statement Online 1995   May 15-17; 13(2):1-30.
  • Jurawitz MC, Büchner A, Harpel T, et al. Hearing preservation outcomes with different cochlear implant electrodes: Nucleus® Hybrid™-L24 and Nucleus Freedom™ CI422. Audiol Neurootol. 2014;19(5):293-309.
  • National Institutes of Health. National Institute on Deafness and Other Communication Disorders. Auditory Neuropathy 2011.
  • Roland JT Jr, Gantz BJ, Waltzman SB, et al.; Multicenter Clinical Trial Group. United States multicenter clinical trial of the cochlear nucleus hybrid implant system. Laryngoscope. 2016 Jan;126(1):175-81.

  • Gantz BJ, Dunn C, Oleson J, et al. Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes. Laryngoscope. 2016 Apr;126(4):962-73.

  • Abbas, P., Brown, C. Clinicaltrials.org (NCT02203305) Cochlear Implantation in Cases of Single-Sided Deafness; planned enrollment 30; completion date December 2018.

  • Woodson, E. A., Reiss, L. A. J., Turner, C. W., Gfeller, K., & Gantz, B. J. (2010). The Hybrid cochlear implant: A review. Advances in Oto-Rhino-Laryngology, 67, 125–134.

 

Policy History:

  • September 2017 - Annual Review, Policy Renewed
  • September 2016 - Annual Review, Policy Renewed
  • October 2015 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.