CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Auditory Brainstem Implant (ABI) Coverage Criteria

Coverage determination for auditory brainstem implants (ABIs) for Blue Cross Blue Shield - Rhode Island members, specifying indications, age limits, and devices covered for Medicare and commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyAuditory Brainstem Implant (ABI) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 3, 2010

Next Review Date

Key ActionConfirm documentation supports diagnosis of neurofibromatosis type 2 (ICD-10 Q85.02) and age ≥12 years before billing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=12minimum patient age for covered ABI

Q85.02required diagnosis (NF2)

unilateralcoverage limited to

excludedPABI status

92640 / S2235procedure codes listed

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Medically necessary - unilateral ABI for NF2

Unilateral auditory brainstem implant is covered/medically necessary when ALL of the following are met:

Indication and eligibility: Diagnosis of neurofibromatosis type 2 (ICD-10 Q85.02)

Age: Patient is 12 years of age or older>=12 years

Clinical status: Patient is rendered deaf due to bilateral resection of neurofibromas of the auditory nerve

An auditory brainstem implant (ABI) is not covered and is considered not medically necessary for indications other than neurofibromatosis type 2 (NF2). The evidence for use of ABIs in non‑NF2, nontumor etiologies (for example, cochlear aplasia or cochlear nerve aplasia and other congenital or acquired non‑tumor causes of deafness) is limited to case series and systematic reviews of case series and is insufficient to determine the effects of the technology on health outcomes. Ongoing studies may better define subgroups (particularly in children) who could benefit, but at present these non‑NF2 indications remain excluded from coverage.

Bilateral implantation of auditory brainstem implants is not covered and is considered not medically necessary. Available evidence does not adequately demonstrate the effects of bilateral ABIs on health outcomes, and therefore bilateral use is excluded from coverage.

Penetrating electrode auditory brainstem implants (PABI) are explicitly not covered and are considered not medically necessary. The literature does not provide sufficient evidence to support the safety and effectiveness of PABI compared with surface‑electrode ABIs, and PABI is therefore excluded from coverage.

Auditory brainstem implants for any condition other than neurofibromatosis type 2 (NF2) are considered not medically necessary due to insufficient evidence. This exclusion includes nontumor etiologies and other non‑NF2 indications where studies are limited to case series and systematic reviews without clear demonstration of improved functional outcomes or durability; until higher‑quality evidence demonstrates benefit, these uses remain non‑covered.

Provider Requirements and Billing Notes

Prior Authorization

Prior authorization applicability

Prior authorization is not applicable for this policy. Providers should still submit complete clinical documentation with the claim to support medical necessity and correct billing.

Not applicable

Note

Benefit variability — verify member benefits

Benefits and coverage may vary between groups and contracts. Always verify the member’s specific benefit booklet, Evidence of Coverage, or Subscriber Agreement for applicable coverage determinations, limits, and whether the service is considered not medically necessary or not covered under the member’s plan.

Check member-specific benefit booklet or Evidence of Coverage for contract-specific limits and coverage status.

Denial Risk

Denial triggers — common reasons for claim denial

Claims are likely to be denied when documentation or clinical indications do not meet the policy criteria. Common denial triggers include:

Bilateral auditory brainstem implant — policy does not cover bilateral use.
Penetrating electrode auditory brainstem implant (PABI) — not covered / not medically necessary.
Implantation for indications other than Neurofibromatosis type 2 (ICD-10 Q85.02) — not covered / not medically necessary.
Claims submitted without documentation that the patient was rendered deaf due to bilateral resection of neurofibromas of the auditory nerve, or without documentation of NF2 diagnosis and age criteria.

Documentation Required

Required documentation and coding

Required documentation must be supplied to support medical necessity and correct coding. Submit the following:

Clinical documentation confirming diagnosis of Neurofibromatosis type 2 (ICD-10 Q85.02).
Evidence the patient is 12 years of age or older at time of procedure.
Operative and clinical notes documenting the patient was rendered deaf due to bilateral resection of neurofibromas of the auditory nerve.
Procedure documentation and device information (implant type — surface electrode ABI; PABI is not covered).
Include appropriate diagnosis and procedure codes on the claim: CPT 92640 (diagnosis analysis with programming of auditory brainstem implant, per hour); HCPCS S2235 (implantation of auditory brainstem implant); ICD-10 Q85.02.

Background

An auditory brainstem implant (ABI) is a neuroprosthetic device that bypasses the inner ear and auditory nerve by placing an electrode array on the surface of the cochlear nucleus to stimulate the brainstem and provide auditory information. ABIs consist of an implanted receiver/stimulator connected to the electrode array and an external speech processor. They were developed primarily for patients with neurofibromatosis type 2 (NF2) who become deaf after bilateral resection of vestibular schwannomas (neurofibromas of the auditory nerve). Outcomes with ABIs are generally modest but can be meaningful for patients without alternative options; research into non‑NF2 uses (including in children with cochlear or cochlear nerve aplasia) is ongoing but currently insufficient to support coverage for those indications.

Definitions

Auditory brainstem implant (ABI) — definition and components

Device definitionAn auditory brainstem implant consists of an externally worn speech processor that sends electrical signals to an implanted receiver/stimulator attached to an electrode array placed on the surface of the cochlear nucleus to bypass the inner ear and auditory nerve.

Components — externalExternally worn speech processor that provides auditory information.

Components — internalImplanted receiver/stimulator in the temporal bone connected to an electrode array on the cochlear nucleus.

Electrode array functionStimulates multiple sites on the cochlear nucleus to provide auditory signals to the brain.

Penetrating electrode ABI (PABI) — definition and coverage status

DefinitionA penetrating electrode auditory brainstem implant (PABI) is a type of ABI that uses penetrating electrodes rather than surface electrodes on the cochlear nucleus.

Coverage statusPenetrating electrode auditory brainstem implant (PABI) is not covered / considered not medically necessary due to insufficient evidence.

Policy notePolicy specifies coverage is limited to unilateral ABIs using surface electrodes; PABI is explicitly excluded.

OpenPayer

Auditory Brainstem Implant (ABI) Coverage Criteria

Coverage and Medical Necessity Criteria

Billing and Diagnosis Codes

Provider Requirements and Billing Notes

Background

Definitions