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An auditory brainstem implant (ABI) is a device designed to restore some hearing in people with neurofibromatosis type II who are rendered deaf by bilateral removal of neurofibromas involving the auditory nerve. ABIs have also been studied to restore hearing for other non-neurofibromatosis indications.
The ABI consists of an externally worn speech processor that provides auditory information by 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 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.
ABIs are also being studied to restore hearing for other non-neurofibromatosis causes of hearing impairment in adults and children, including absence of or trauma to the cochlea or auditory nerve. It is estimated that 1.7 per 100,000 children are affected by bilateral cochlea or cochlear nerve aplasia and 2.6 per 100,000 children are affected by bilateral cochlea or cochlear nerve hypoplasia.
In 2000, the Nucleus® 24 Auditory Brainstem Implant System (Cochlear Corp.) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process. 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. The Nucleus® 24 Auditory Brainstem Implant System (Cochlear Corp.) labeling states: “The efficacy of bilateral implantation with the ABI [auditory brainstem implant] has not been studied.” The Nucleus® 24 is currently obsolete.
In June 2016, the Nucleus ABI541 Auditory Brainstem Implant (Cochlear Corp.) was approved by the FDA through a supplement to the premarket approval for the Nucleus® 24. The new implant is indicated for individuals 12 years of age or older who have been diagnosed with neurofibromatosis type 2.
Unilateral use of an auditory brainstem 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 brainstem implant is considered investigational for all other conditions including non-neurofibromatosis type 2 indications.
Bilateral use of an auditory brainstem implant is considered investigational.
Penetrating electrode auditory brainstem implant (PABI) is considered investigational.
Federal 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
12/19/2006: 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.
04/29/2014: Policy reviewed; description updated. Revised second policy statement to state that an auditory brain stem implant is considered investigational for all other "conditions including nonneurofibromatosis type 2" indications.
04/06/2015: Policy description and statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
08/18/2015: Medical policy revised to add ICD-10 codes.
05/31/2016: Policy number A.7.01.83 added.
10/14/2016: Policy description updated regarding devices. Policy statements unchanged.
Blue Cross Blue Shield Association Policy # 7.01.83
This 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.