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DESCRIPTIONThe auditory brain stem implant is a device designed to restore some hearing in people with neurofibromatosis type II who are rendered deaf by bilateral removal of the characteristic neurofibromas involving the auditory nerve. The device consists of an externally worn speech processor that provides auditory information to an electrical signal that is transferred to a receiver/stimulator that is implanted in the temporal bone. The receiver stimulator is, in turn, attached to an electrode array that is implanted on the surface of the cochlear nerve in the brainstem, thus bypassing the inner ear and auditory nerve. The electrode stimulates multiple sites on the cochlear nucleus, which is then processed normally by the brain. One device has received approval by the U.S. Food and Drug Administration (FDA) for auditory brainstem implantation, the Nucleus 24 Auditory Brainstem Implant System (Cochlear Corporation). The speech processor and receiver are similar to the devices used in cochlear implants; the electrode array placed on the brainstem is the novel component of the device. The device is indicated for individuals 12 years of age or older, who have been diagnosed with neurofibromatosis type 2 (NF2).
POLICYUnilateral use of an auditory brain stem implant (using surface electrodes on the cochlear nuclei)may be considered medically necessary in patients with neurofibromatosis type II, who are 12 years of age or older, who are rendered deaf due to bilateral resection of neurofibromas of the auditory nerve.
An auditory brain stem implant is considered investigational for all other indications.
Bilateral use of an auditory brainstem implant is considered investigational.
Penetrating electrode auditory brainstem implant (PABI) is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY12/19/2006: Policy added
3/22/2007: Reviewed and approved by Medical Policy Advisory Committee (MPAC)
4/29/2008: Policy reviewed, no changes
12/09/2009: Policy Exceptions revised with FEP verbiage. Policy Coding Section revised as follows: CPT4 code 61860 removed from Covered Codes Table. ICD9 procedure code 95.49 added to Covered Codes Table.
06/22/2011: Policy statement reworded for clarity; intent unchanged.
05/09/2012: Added the following policy statements: Bilateral use of an auditory brainstem implant is considered investigational. Penetrating electrode auditory brainstem implant (PABI) is considered investigational.
04/29/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.83
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.