Medical Policy: 01.03.02
Original Effective Date: October 2015
Reviewed: September 2017
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.
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 is required.
For the replacement cochlear implant to be considered medically necessary ALL of the following criteria must be met:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-CM diagnostic codes.
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.
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.