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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

-- [ Page 53 ] --

Member benefit coverage and limitations may vary based on the member’s benefit plan.

ADOPTED FROM UNITEDHEALTHCARE FOR PACIFICARE USE

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supersede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

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Cochlear Implants - Commercial Medical Management Guideline Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale Unilateral Cochlear Implantation Unilateral cochlear implantation is proven for severe to profound prelingual or perilingual bilateral sensorineural hearing loss in children when used according to US Food and Drug Administration (FDA) labeled indications.

UnitedHealthcare covers* unilateral cochlear implantation for severe to profound postlingual bilateral sensorineural hearing loss in children when used according to US Food and Drug Administration (FDA) labeled indications.

*At this time, there is insufficient clinical evidence that unilateral cochlear implants used for postlingual hearing loss in children increases speech perception and improves language. UnitedHealthcare will continue to review the clinical evidence and will base future conclusions on the review of that evidence.

Unilateral cochlear implantation is proven for severe to profound postlingual bilateral sensorineural hearing loss in adults when used according to US Food and Drug Administration (FDA) labeled indications.

Unilateral cochlear implantation is unproven for prelingual sensorineural hearing loss in adults. Well-designed studies demonstrating the efficacy of cochlear implants in prelingually deafened adults are limited. Additional studies are required to demonstrate the benefits of cochlear implants in this patient population.

Bilateral Cochlear Implantation UnitedHealthcare covers* bilateral cochlear implantation for severe to profound prelingual or perilingual bilateral sensorineural hearing loss in children when used according to US Food and Drug Administration (FDA) labeled indications.

*At this time, there is insufficient clinical evidence that bilateral cochlear implants used for prelingual or perilingual hearing loss in children increases speech perception and improves language. UnitedHealthcare will continue to review the clinical evidence and will base future conclusions on the review of that evidence.

Bilateral cochlear implantation is unproven for postlingual sensorineural hearing loss in children. There is minimal data regarding the use of bilateral cochlear implants in the peer-reviewed medical literature for postlingual bilateral sensorineural hearing loss in children. Well-designed studies are needed to evaluate the potential advantages of bilateral cochlear implants and to identify which patients would benefit from this procedure.

Bilateral cochlear implantation is unproven for prelingual and postlingual sensorineural hearing loss in adults.

There is minimal data in peer-reviewed medical literature regarding the use of bilateral cochlear implants for prelingual bilateral sensorineural hearing loss in adults. Well-designed studies are needed to evaluate the potential advantages of bilateral cochlear implants and to identify which patients would benefit from this procedure.

Several small studies evaluated bilateral cochlear implantation (CI) in adults with postlingual deafness. Patient response in these studies was variable and one study (Summerfield et al., 2006) reported a negative or neutral impact on quality of life (QOL) measures. Additionally, it was difficult to determine if the improvements reported under the test conditions translated into functional improvements in daily activities involving conversations in a variety of setting. Small sample sizes and short duration of follow-up in most of these studies preclude definitive statements about bilateral CI in adults with postlingual sensorineural hearing loss.

Cochlear hybrid implants are investigational because these implants have not been approved by the FDA.

Cochlear Implants - Commercial Medical Management Guideline Additional Information

The greatest advantages from cochlear implants occur when the following conditions are present:

- Diagnosis of severe to profound bilateral sensorineural hearing loss and severely deficient speech discrimination (defined by the US Food and Drug Administration (FDA) criteria in postlingually hearing impaired adults as aided word recognition in sentences of 50% or less in the ear to be implanted or 60% or less with bilateral amplification)

- Patient has responsive auditory nerves but obtains limited benefit from appropriately fitted hearing aids





- Patient has the cognitive ability to use auditory clues and patient and/or support system is willing to undergo an extended program of rehabilitation

- Accessible cochlear lumen that is structurally suited to implantation, and freedom from lesions in the auditory nerve and acoustic area of the central nervous system. The middle ear should be free of infection

- Each case should be evaluated by a an experienced cochlear implant team that may include an otolaryngologist, audiologist, rehabilitation and educational professionals, and psychologists

- Audiological evaluation is performed unaided and aided, with a comparative analysis

- Patients with ossification in the cochlea should be counseled regarding the potential for incomplete insertion of the active electrode or failure for stimulation of the auditory nerve. Success may be influenced by the degree of intracochlear fibrosis and/or ossification.

- Because the primary purpose of cochlear implantation is to improve communication, a prolonged period of aural rehabilitation is necessary The use of cochlear implant devices should conform to FDA indications. For a list of indications for each device, refer to

the FDA web site for medical devices (Product code MCM [implant, cochlear]):

http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Accessed February 2009.

Benefit Considerations If benefits exist for a cochlear implant, the external components (i.e., speech processor, microphone, and transmitter coil) are considered durable medical equipment (DME), and the implantable components are considered under the medical-surgical benefit(s). The enrolleespecific benefit document must be referenced to determine the DME benefits for upgrade or replacement of external components. These benefits indicate that the purchase, repair, or replacement of an item is limited to once every specified number of years and to a limited dollar amount per year.

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Regulatory Requirements US Food and Drug Administration (FDA): At the present time, there are 3 manufacturers of FDA-approved cochlear implant devices, including Cochlear Americas (previously Cochlear Corp.), Advanced Bionics Corp., and MED-EL Corp. Since the first cochlear implant device was approved in the 1980s, these devices have undergone progressive technological refinement, and approved indications for their use gradually have expanded and have become more specific. Currently, the available cochlear implant devices are indicated for adults (age18 years or older) with severe-toprofound or moderate-to-profound, bilateral, sensorineural hearing loss or children age 12 months or older or age 18 months or older (depending on the device) with profound, bilateral, sensorineural hearing loss who obtain limited benefit

Cochlear Implants - Commercial Medical Management Guideline

from appropriately fitted hearing aids. Specific criteria vary with the device. See the following website for more information (use product code MCM): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm. Accessed Februray 2009. FDA approval language does not address unilateral or bilateral use.

Cochlear Americas currently manufactures the Nucleus® series of cochlear implant devices, including the Nucleus 22 Channel Cochlear Implant System and the Nucleus 24 and Nucleus 24 Contour Systems. The original premarket approval (PMA) for the Nucleus 22 system occurred in 1985. Indications for the Nucleus 22 system include adults with severe-toprofound, bilateral, sensorineural hearing loss who obtain 30% or less speech recognition on tests of recorded sentence materials in the best-aided condition and children aged 18 months or older with profound, bilateral, sensorineural hearing loss who obtain little or no benefit from conventional amplification in the best-aided condition. See the following website for more information (use product code MCM): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm.

Accessed July 2008. Subsequent technological refinements led to the Nucleus 24 Cochlear Implant System and, later, the Nucleus 24 Contour Cochlear Implant System. In 2000, the Nucleus 24 Contour System was approved for adults with moderate-to-profound, bilateral, sensorineural, hearing loss who obtain test scores of 50% or less in the ear to be implanted, or 60% or less in the best-listening condition on tape recorded tests of open-set sentence recognition and approved for children aged 12 months or older with profound, bilateral, sensorineural hearing loss who obtain little or no benefit from appropriate binaural hearing aids. See the following Web site for more information (use product code MCM): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm. Accessed February 2009. Cochlear Americas received approval from the FDA to market Nucleus® Freedom™ (Nucleus 24) in 2005. The Nucleus Freedom

features both an internal component and an external speech processor. See the following Web site for more information:

http://www.cochlearamericas.com/Products/2012.asp. Accessed February 2009.

MED-EL Corp. produces the MED-EL COMBI 40+ Cochlear Implant System®includes a series of devices, including the PULSARci100 Cochlear Implant System. In 2001, the COMBI 40+ device was approved for adults (age 18 years or older) with severe-to-profound, bilateral, sensorineural hearing impairment (based on a pure tone average of 70 decibels [dB] or more at 500 Hertz [Hz], 100 Hz, and 2000 Hz) and children aged 18 months to 17 years 11 months with profound, bilateral, sensorineural hearing loss (with thresholds of 90 dB or more at 1000 Hz) who obtain limited benefit from appropriately fitted binaural hearing aids. Limited benefit for adults was defined as scores of 40% or less in the best-aided listening condition on CD recorded tests of open-set sentence recognition, or the Hearing in Noise Test (HINT). Limited benefit in younger children (maximum age not specified) was defined as lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a 3- to 6-month period. Limited benefit in older children was defined as less than 20% correct on the Multi-syllabic Lexical Neighborhood Test (MLNT) or the Lexical Neighborhood Test (LNT), depending on cognitive ability and linguistic skills. In children without prior hearing aid experience, a 3- to 6-month hearing aid trial is required, although this trial may be shortened in patients with radiological evidence of cochlear ossification. See the following

website for more information (use product code MCM):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm. Accessed February 2009. In 2003, approval was

broadened to include children age 12 months or older. See the following Web site for more information:

http://www.fda.gov/cdrh/cochlear. Accessed February 2009.

Advanced Bionics Corp. manufactures CLARION® and Hi Resolution™ cochlear implant devices. The initial device, the CLARION Multi-Strategy Cochlear Implant, was approved in March 1996 for adults (age 18 years or older) with severe to profound, bilateral, sensorineural hearing loss. In December 1996, approval expanded to include children aged 2 years to 17 years, or 18 months if there was radiological evidence of ossification, with profound, bilateral, sensorineural deafness who do not benefit from appropriately fitted hearing aids. Lack of benefit in younger children (age maximum not specified) was defined as failure to attain basic auditory milestones (e.g., inconsistent response to own name or environmental sounds) and in older children was defined as a score of 0% on open-set word recognition (phonetically balanced kindergarten test - word list) administered with monitored live-voice (70 dB sound pressure level). Approval specified that all children must demonstrate only minimal ability on age-appropriate open-set sentence Cochlear Implants - Commercial Medical Management Guideline measures and a plateau in auditory development. See the following website for more information (use product code MCM): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/PMA.cfm. Accessed February 2009.



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