Medical Policy Bulletin Title: Auditory Brainstem Implant

Policy #: 11.01.04c The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service. This Medical Policy Bulletin 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 Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent

The intent of this policy is to communicate the coverage positions for auditory brainstem implants. Cochlear implants are not the same as auditory brainstem implants. Cochlear implants are distinct devices that are indicated for specific conditions and are not the focus of this policy. For information on policies related to cochlear implants, refer to the Cross References Table in this policy.

Description

Auditory brainstem implants are considered distinct from cochlear implants. The auditory brainstem implant is a device that is intended to impart useful hearing to people with neurofibromatosis type 2 who are bilaterally deaf because of the removal of auditory nerve tumors. Neurofibromatosis is a rare condition (it occurs in approximately 1 in 40,000 births) that causes the growth of benign tumors on the auditory nerves, often bilaterally; these tumors are known as acoustic neuromas or vestibular schwannomas. Although the tumors are benign, their growth causes life-threatening pressure in the brain. Thus, they require removal, usually with part or all of the auditory nerve. When the auditory nerve is dissected, hearing aids and cochlear implants are ineffective. The auditory brainstem implant restores the individual's ability to detect certain environmental and speech sounds, but it does not re-establish normal hearing. The implant is composed of battery-operated external components (a microphone, speech processor, and transmitter) and surgically implanted internal components (a receiver/stimulator and electrode array). Sounds picked up by the microphone are carried to the external speech processor, which then transforms the sounds into coded signals that are transmitted transcutaneously to the receiver/stimulator that is implanted in the temporal bone. The speech processor sends impulses to the receiver/stimulator, which then transmits to the electrode array placed directly on the surface of the cochlear nerve in the brainstem, circumventing the inner ear and auditory nerve. The electrodes stimulate multiple sites on the cochlear nucleus, and the brain processes the stimulation as sound. One device that has received approval by the US Food and Drug Administration for auditory brainstem implantation is the Nucleus® 24 Auditory Brainstem Implant System (Cochlear Corporation, Englewood, CO). The device includes a speech processor and receiver/stimulator that are identical to the ones used in cochlear implants, but it differs from a cochlear implant in the placement of the electrode array. In the Nucleus® 24, the array is placed on the brainstem rather than in the inner ear as with a cochlear implant. Aural rehabilitation (also known as auditory rehabilitation) is a post-implant program that focuses on improving the individual's ability to interpret the auditory information that is received through the implant. The program emphasizes the recognition of specific speech sounds, word discrimination and identification, and conversational skills. While an auditory brainstem implant does not restore normal hearing, it provides the only treatment option for individuals who are bilaterally deaf secondary to auditory nerve disruption.

Policy

Auditory brainstem implants are considered medically necessary and, therefore, covered for individuals 12 years of age or older who have bilateral deafness from acoustic neuromas due to neurofibromatosis type 2. ACCESSORIES FOR AUDITORY BRAINSTEM IMPLANT Aural rehabilitation associated with and required for the proper functioning of an auditory brainstem implant is considered medically necessary and, therefore, covered if an individual meets the medical necessity criteria listed above for the implantation of the device. Aural rehabilitation services reported using Current Procedural Terminology (CPT) codes 92626, 92627, 92630, and 92633 are not considered speech therapy and, therefore, are not applied to an individual's speech therapy benefit. The replacement of the internally implanted components of an auditory brainstem implant is considered medically necessary and, therefore, covered for individuals who have an inadequate response to existing internal components. Accessories for covered devices required for the proper functioning of an auditory brainstem implant (including replacement items) are considered medically necessary and, therefore, covered and eligible for reimbursement consideration. Upgrades to an existing external system for aesthetic improvement, such as a smaller profile component, are deluxe features that serve no medical purpose. They are considered not medically necessary and, therefore, not covered. Assistive listening devices for use with an auditory brainstem implant are a benefit contract exclusion, as they do not meet the definition of durable medical equipment (DME). Therefore, these items are not covered and not eligible for reimbursement consideration. Replacement batteries that are required for these devices can be purchased over the counter and are a benefit contract exclusion, as they do not meet the definition of DME. Therefore, these items are not covered and not eligible for reimbursement consideration. REQUIRED DOCUMENTATION The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports. The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

Use of auditory brainstem implantation in individuals who have had stereotactic radiosurgery should be considered with extreme caution due to the possibility of injury to the cochlear nucleus. BENEFIT APPLICATION Subject to the terms and conditions of the applicable benefit contract, auditory brainstem implantation is covered under the medical benefits of the Company's products when the medical necessity criteria listed in the medical policy are met. MEDICARE This policy is consistent with Medicare's coverage determination.The Company's payment methodology may differ from Medicare. US FOOD AND DRUG ADMINISTRATION (FDA) STATUS The Nucleus® 24 Auditory Brainstem Implant System was approved by the FDA on July 21, 2000 for individuals 12 years of age or older who have been diagnosed with bilateral deafness related to neurofibromatosis type 2.

References

American Speech-Language-Hearing Association (ASHA). Adult aural/audiologic rehabilitation. [ASHA Web site]. Available at: http://www.asha.org/public/hearing/treatment/adult_aur_rehab.htm. Accessed March 24, 2009. Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Pub 100-02: Medicare Benefit Policy. Transmittal 39. Auditory osseointegrated and auditory brainstem devices. [CMS Web site]. 11/10/05. Available at: http://cms.hhs.gov/Transmittals/downloads/R39BP.pdf. Accessed March 24, 2009. Colletti L. Beneficial auditory and cognitive effects of auditory brainstem implantation in children. Acta Otolaryngol. 2007;127(9):943-946. Colletti V. Auditory outcomes in tumor vs. non-tumor patients fitted with auditory brainstem implants. Adv Otorhinolaryngol. 2006;64:167-185. Colletti V, Carner M, Miorelli V, et al. Auditory brainstem implant (ABI): new frontiers in adults and children. Otolaryngol Head Neck Surg. 2005;133(1):126-138. Colletti V, Fiorino FG, Carner M, et al. Auditory brainstem implant as a salvage treatment after unsuccessful cochlear implantation. Otol Neurotol. 2004;25(4):485-496. Ebinger K, Otto S, Arcaroli J, Staller S, Arndt P. Multichannel auditory brainstem implant: US clinical trial results. J Laryngol Otol Suppl. 2000;(27):50-53. Miller VS, Roach ES. Neurocutaneous syndromes. In: Bradley WG, Daroff RB, Fenichel GM, Marsden CD, eds. Neurology in Clinical Practice: The Neurological Disorders. 3rd ed. Boston, MA: Butterworth-Heinemann; 2000: 1674. US Food and Drug Administration (FDA). Nucleus® 24 Auditory Brainstem Implant System. Proposed package insert. [FDA Web site]. 10/20/2000. Available at: http://www.fda.gov/cdrh/pdf/p000015c.pdf. Accessed March 24, 2009. US Food and Drug Administration (FDA). Nucleus® 24 Auditory Brainstem Implant System. Summary of safety and effectiveness. [FDA Web site]. 10/20/2000. Available at: http://www.fda.gov/cdrh/pdf/p000015b.pdf. Accessed March 24, 2009.

Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply. The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates. In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code System Code Number(s) and Narrative(s) CPT POSTOPERATIVE EVALUATIVE AND THERAPEUTIC SERVICES 92640 REHABILITATION AND TRAINING 92626, 92627, 92630, 92633 ICD Procedure N/A ICD Diagnosis 237.72: Neurofibromatosis, Type 2 (acoustic neurofibromatosis) HCPCS Level II L8614: Cochlear device, 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. 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, replacement DEVICE IMPLANTATION S2235: Implantation of auditory brainstem implant THE FOLLOWING CODE IS CONSIDERED NONCOVERED: V5273: Assistive listening device, for use with cochlear implant Revenue Codes N/A

Cross References

Cross Reference Policies

05.00.44f:Repair and Replacement of Durable Medical Equipment (DME) 05.00.45f:Repair or Replacement of an External Prosthetic Device 11.01.02i:Cochlear Implant

Version Effective Date: 01/01/2010

The Policy Bulletins on this web site were developed to assist AmeriHealth and its subsidiaries ("AmeriHealth") in administering the provisions of the respective benefit programs, and do not constitute a contract. If you are an AmeriHealth member, please refer to your specific benefit program for the terms, conditions, limitations and exclusions of your coverage. AmeriHealth does not provide health care services, medical advice or treatment, or guarantee the outcome or results of any medical services/treatments. The facility and professional providers are responsible for providing medical advice and treatment. Facility and professional providers are independent contractors and are not employees or agents of AmeriHealth. If you have a specific medical condition, please consult with your doctor. AmeriHealth reserves the right at any time to change or update its Policy Bulletins. ©2012 AmeriHealth, Inc. All Rights Reserved.  Current Procedural Terminology ©2012 American Medical Association. All Rights Reserved.