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Medical Policy: 07.01.40
Original Effective Date: July 2007
Reviewed:
Revised: January 2008
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
Description:
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 cochlear implants are commercially available in the United States, the Nucleus family of devices, manufactured by Cochlear Corporation; the Clarion family of devices, manufactured by Advanced Bionics; and the Med El Combi 40+ device, manufactured by 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. Furthermore, smaller devices and the accumulating experience in children have resulted in broadening of the selection criteria to include children as young as 12 months.
While cochlear implants have typically been used monolaterally, in recent years, interest in bilateral cochlear implantation has arisen. The proposed benefits of bilateral cochlear implants are to improve understanding of speech in noise and localization of sounds. Improvements in speech intelligibility may occur with bilateral cochlear implants through binaural summation; i.e., signal processing of sound input from two sides may provide a better representation of sound and allow one to separate out noise from speech. Speech intelligibility and localization of sound or spatial hearing may also be improved with head shadow and squelch effects, i.e., the ear that is closest to the noise will be received at a different frequency and with different intensity, allowing one to sort out noise and identify the direction of sound.
Bilateral cochlear implantation may be performed independently with separate implants and speech processors in each ear or with a single processor. However, no single processor for bilateral cochlear implantation has been approved by the FDA for use in the United States. In addition, single processors do not provide binaural benefit and may impair sound localization and increase the signal to noise ratio received by the cochlear implant.
Policy:
An FDA-approved cochlear implant and associated aural rehabilitation program may be considered medically necessary in patients 1 year and older with severe to profound pre- or postlingual hearing loss, defined as a hearing threshold of 70 decibels or above, who have shown limited benefit from hearing aids.
Bilateral cochlear implantation may be considered medically necessary when the criteria above are met.
Next generation devices have typically offered a marginal improvement over previous devices, such that replacement of the internally implanted components is not routinely performed and thus may be considered medically necessary only in the small subset of patients who have an inadequate response to existing components.
Upgrades of an existing, functioning external system to achieve aesthetic improvement, such as smaller profile components or a switch from a body-worn, external sound processor to a behind-the-ear model, are considered not medically necessary.
Prior approval is recommended for external speech processor replacement (HCPCS L8619): Submit a prior approval now
See also related topics:
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Procedure Codes and Billing
Guidelines:
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To report provider services, use appropriate CPT** codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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CPT 69930; Cochlear device implantation, with or without mastoidectomy
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CPT 92601; Diagnostic analysis of cochlear implant, patient under 7 years of age; with programming
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CPT 92602; Diagnostic analysis of cochlear implant, patient under 7 years of age; subsequent programming
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CPT 92603; Diagnostic analysis of cochlear implant, age 7 years or older; with programming
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CPT 92604; Diagnostic analysis of cochlear implant, age 7 years or older; subsequent reprogramming
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HCPCS L8614; Cochlear device; includes all internal and external components
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HCPCS L8615; Headset/headpiece for use with cochlear implant device, replacement
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HCPCS L8616; Microphone for use with cochlear implant device, replacement
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HCPCS L8617; Transmitting coil for use with cochlear implant device, replacement
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HCPCS L8618; Transmitter cable for use with cochlear implant device, replacement
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HCPCS L8619; Cochlear implant external speech processor, replacement
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HCPCS L8621-L8624; Code range for replacement batteries used with cochlear implant device/system
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Selected References:
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The Medical Policy Reference Manual (MPRM) developed by the Blue Cross and Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
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Hehar SS, Nikolopoulos TP, Gibbin KP, O'Donoghue GM. Surgery and functional outcomes in deaf children receiving cochlear implants before age 2 years. Arch Otolaryngol Head Neck Surg. 2002 Jan;128(1):11-4.
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Waltzman SB, Cohen NL, Green J, Roland JT. Long-term effects of cochlear implants in children. Otolaryngol Head Neck Surg. 2002 May;126(5):505-11.
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Bichey BG, Hoversland JM, et al. Changes in quality of life and the cost-utility associated with cochlear implantation in patients with large vestibular aqueduct syndrome. Otol Neurotol. 2002 May;23(3):323-7.
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Peterson A, Shallop J, et al. Outcomes of cochlear implantation in children with auditory neuropathy. J Am Acad Audiol. 2003 May-Jun;14(4):188-201.
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Pulsifer MB, Salorio CF, Niparko JK. Developmental, audiological, and speech perception functioning in children after cochlear implant surgery. Arch Pediatr Adolesc Med. 2003 Jun;157(6):552-8.
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Tyler RS, Dunn CC, Witt SA, Preece JP. Update on bilateral cochlear implantation. Curr Opin Otolaryngol Head Neck Surg. 2003 Oct;11(5):388-93.
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Schoen F, Mueller J, et al. Sound localization and sensitivity to interaural cues in bilateral users of the Med-El Combi 40/40+cochlear implant system. Otol Neurotol. 2005 May;26(3):429-37.
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Ricketts TA, Grantham DW, et al. Speech recognition for unilateral and bilateral cochlear implant modes in the presence of uncorrelated noise sources. Ear Hear. 2006 Dec;27(6):763-73.
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Litovsky R, Parkinson A, et al. Simultaneous bilateral cochlear implantation in adults: a multicenter clinical study. Ear Hear. 2006 Dec;27(6):714-31.
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309
*Prior Approval is recommended for this policy.
**Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
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.
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