Download Auditory Brainstem Implant - Blue Cross and Blue Shield of Louisiana

Auditory Brainstem Implant
Policy # 00475
Original Effective Date:
Current Effective Date:
07/15/2015
07/20/2016
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana,
Inc.(collectively referred to as the “Company”), unless otherwise provided in the applicable contract. Medical technology is constantly
evolving, and we reserve the right to review and update Medical Policy periodically.
When Services Are Eligible for Coverage
Coverage for eligible medical treatments or procedures, drugs, devices or biological products may be
provided only if:
 Benefits are available in the member’s contract/certificate, and
 Medical necessity criteria and guidelines are met.
Based on review of available data, the Company may consider unilateral use of an auditory brainstem
implant [(ABI) using surface electrodes on the cochlear nuclei] in patients with neurofibromatosis type 2
when patient selection criteria are met to be eligible for coverage.
Patient Selection Criteria
 ≥12 years of age
 Rendered deaf due to bilateral resection of neurofibromas of the auditory nerve.
When Services Are Considered Investigational
Coverage is not available for investigational medical treatments or procedures, drugs, devices or biological
products.
The unilateral use of an auditory brainstem implant (ABI, using surface electrodes on the cochlear nuclei) in
patients with neurofibromatosis type 2 when patient selection criteria are not met is considered to be
investigational.*
Based on review of available data, the Company considers an auditory brainstem implant (ABI) in all other
conditions to be investigational.*
Based on review of available data, the Company considers bilateral use of an auditory brainstem implant
(ABI) to be investigational.*
Based on review of available data, the Company considers penetrating electrode auditory brainstem implant
(PABI) to be investigational.*
Background/Overview
The ABI is intended to restore some hearing in people with neurofibromatosis type 2 (NF2) who are
rendered deaf by bilateral removal of the characteristic neurofibromas involving the auditory nerve. The ABI
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 st imulates multiple sites on the
©2016 Blue Cross and Blue Shield of Louisiana
An independent licensee of the Blue Cross and Blue Shield Association
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.
Page 1 of 8
Auditory Brainstem Implant
Policy #
00475
Original Effective Date:
Current Effective Date:
07/15/2015
07/20/2016
cochlear nucleus, which is then processed normally by the brain. ABIs are also being studied to restore
hearing for other nonneurofibromatosis indications.
FDA or Other Governmental Regulatory Approval
U.S. Food and Drug Administration (FDA)
One device has received approval by FDA for ABI: the Nucleus ®‡ 24 Auditory Brainstem Implant System
(Cochlear Corp.). 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 NF2. FDA product code: MCM.
Centers for Medicare and Medicaid Services (CMS)
There is no national coverage determination. The Medicare Benefit Policy Manual references hearing aids
and auditory implants, stating that hearing aids are excluded from coverage, including air-conduction and
bone-conduction devices. However, devices which produce the perception of sound by replacing the
function of the middle ear, cochlea, or auditory nerve are payable by Medicare as prosthetic devices. These
devices are indicated only when hearing aids are medically inappropriate or cannot be utilized. Along with
cochlear and auditory brainstem implants, the benefit manual specifically refers to osseointegrated implants
as prosthetic devices.
Rationale/Source
The most recent literature review of the MEDLINE database for this policy was performed through February
2, 2015. Following is a summary of the key literature to date.
Assessment of efficacy for therapeutic intervention involves a determination of whether the intervention
improves health outcomes compared with available alternatives. The optimal study design for this purpose
is a randomized controlled trial (RCT) that compares the therapeutic intervention with existing alternative
treatments and includes clinically relevant measures of health outcomes. Intermediate outcome measures,
also known as surrogate outcome measures, may also be adequate if there is an established link between
the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled
studies can sometimes provide useful information on health outcomes but are prone to biases such as
noncomparability of treatment groups, placebo effect, and variable natural history of the condition.
Unilateral Auditory Brainstem Implant in Patients With Neurofibromatosis Type 2
U.S. FDA approval of the Nucleus 24 Auditory Brainstem Implant System was based on results in a case
series of 90 patients with NF2, ages 12 years and older. Of the 90 subjects evaluated, 28 complications
occurred in 26 patients; 26 of these complications resolved without surgical or extensive medical
intervention. Two patients had infections of the postoperative flap requiring explantation of the device. A
total of 60 patients had a minimum experience of 3 to 6 months with the device, and thus effectiveness
outcomes were also evaluated. Overall device benefit was defined as a significant enhancement of lipreading or an above-chance improvement on sound-alone tests. Based on this definition, a total of 95%
patients (57/60) derived benefit from the device. While the use of an ABI is associated with a very modest
improvement in hearing, this level of improvement is considered significant in this group of patients who
have no other treatment options. Among the 90 patients receiving the implant, 16 did not receive auditory
©2016 Blue Cross and Blue Shield of Louisiana
An independent licensee of the Blue Cross and Blue Shield Association
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.
Page 2 of 8
Auditory Brainstem Implant
Policy #
00475
Original Effective Date:
Current Effective Date:
07/15/2015
07/20/2016
stimulation from the device postoperatively, either due to migration of the implanted electrodes or surgical
misplacement. To place the electrode array on the surface of the cochlear nucleus, the surgeon must be
able to visualize specific anatomic landmarks. Because large neurofibromas compress the brainstem and
distort the underlying anatomy, it may be difficult or impossible for the surgeon to correctly place the
electrode array. For this reason, patients with large, long-standing tumors may not benefit from the device.
In 2013 Mathies et al reported on 32 patients with ABIs placed for NF2. Activation of the ABI occurred in 27
patients. Three patients experienced no auditory perception and 2 patients were unable to complete testing
due to illness. At 12-month follow-up, significant improvements were seen in the Sound Effects Recognition
Test and Monosyllable-Trochee-Polysyllable test. Open-set sentence recognition was 5% at first fitting and
improved to 37% at 12 months. Performance was not significantly related to number of active electrodes
implanted.
In 2012 Sanna et al reported on 25 ABIs placed in 24 patients with NF2. In this retrospective case study,
patients were followed up for a range of 2 to 53 months. One patient died due to NF2 progression. Sound
recognition was present in 19 patients, of whom 11 had some word recognition and 8 had good speech
recognition (50% speech discrimination in 4 patients, 75%-100% speech discrimination and telephone use
in 4 patients). A multivariate analysis did not identify any factors that were statistically significant in
predicting ABI performance outcomes. The authors also conducted a review of the literature on ABIs and
found it difficult to compare outcomes as reporting methods and outcomes measured were inconsistent and
imprecise. A retrospective review by Goffi-Gomez et al report mixed results in audiologic outcomes in 5
adults (4 with NF2) and 4 children (all with nontumor diseases) who received ABIs between 2005 and 2009
at a university center in Brazil.
Unilateral ABI in Nontumor Patients
Merkus et al reported on a systematic review of ABIs for non-NF2 indications in 2014. Included in the
review were 144 non-NF2 ABI cases from 31 articles. Non-NF2 indications for which ABIs have been
evaluated included cochlear otosclerosis, temporal bone fractures, bilateral traumatic c ochlear nerve
disruption, autoimmune inner ear disease, auditory neuropathy, cochlear nerve aplasia and when vestibular
schwannoma is in the only hearing ear. Cochlear implants generally resulted in better hearing than ABIs
when the cochlea and cochlear nerve were intact. Complete bilateral disruption of the cochlear nerve from
trauma did not exist in the literature and cochlear malformation did not preclude cochlear implant. While the
evidence is limited, it appears cochlear implants demonstrate greater hearing benefits than ABI in patients
with non-NF2 indications. ABI may only have potential for improved outcomes in bilateral complete cochlear
and inner ear aplasia, when imaging and electrophysiologic testing demonstrated that the cochlear nerve is
absent. However, the available evidence is too limited to draw conclusions on the benefits of ABI for these
patients.
In a 2014 systematic review by Medina et al of ABI for traumatic deafness, cochlear implant was found to
perform better than ABI. However, there is limited evidence available to draw conclusions, because only 3
articles totaling 7 patients were identified in the review on ABI for traumatic deafness.
©2016 Blue Cross and Blue Shield of Louisiana
An independent licensee of the Blue Cross and Blue Shield Association
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.
Page 3 of 8
Auditory Brainstem Implant
Policy #
00475
Original Effective Date:
Current Effective Date:
07/15/2015
07/20/2016
In a 2004 study in Italy, V. Colletti et al reported on the use of ABIs in patients with deafness unrelated to
neurofibromatosis and who had a poor response to cochlear implants. In 2013, L. Colletti reported on ABIs
in 21 children, ranging in age from 1.7 to 5 years, with deafness unrelated to neurofibromatosis, who had a
poor response to cochlear implants. In this study, at surgery, the cochlear nerve was found to be absent in
each of the patients. Significant improvement in Category of Auditory Performance scale was seen after ABI
(p<0.001). However, there are inadequate data to permit scientific conclusions regarding this additional
indication.
V. Colletti et al, in 2005, presented data from ABIs in 16 children and adults who had nontumor diseases of
the cochlear nerve or cochlea and 13 patients with NF2. Ages ranged from 14 months to 70 years; the
nontumor group included patients with head trauma, complete cochlear ossification, 1 child with auditory
neuropathy, and 5 children with bilateral cochlear nerve aplasia. Following implantation, the adult nontumor
group scored substantially higher than the patients with NF2 in open set speech perception tests. Some of
the children showed dramatic improvements in word and sentence recognition over a 1-year follow-up.
Short-term adverse effects included dizziness or tingling sensations in the leg, arm, and throat (20/29
patients).
Additional studies report improvement in hearing with ABIs in “nontumor” patients; V. Colletti has reported
results on 54 nontumor patients, and L. Colletti has reported results on 22 nonneurofibromatosis patients.
In a 2010 retrospective review, the authors previously cited, V. Colletti et al, reported on the complications
from ABI surgery in 83 adults and 31 children, 78 of whom had nontumor cochlear or cochlear nerve
disorders. The authors found complication rates were similar to cochlear implant surgery. Additionally,
major and minor complications were significantly fewer in nontumor patients than in NF2 patients. These
authors concluded ABIs can be used in a wider population of patients than only those with NF2. However,
this review did not evaluate hearing outcomes.
Sennaroglu et al, in 2009, reported on the use of ABIs in 11 prelingually deaf children ages 30 to 56
months. Results showed mean performance on the Meaningful Auditory Integration Scale improved in all
patients. However, the results of this small study are described as only preliminary.
Bilateral ABIs
Nucleus 24 Auditory Brainstem Implant System (Cochlear Corp.) labeling states: “The efficacy of bilateral
implantation with the ABI has not been studied.” No evidence was identified to support bilateral auditory
brainstem stimulation. The studies included to date only included patients with unilateral ABI.
Penetrating Electrode ABI
In 2008, Otto et al conducted a prospective clinical trial (N=10) with patients with NF2 who received a
penetrating electrode auditory brainstem implant (PABI) after vestibular schwannoma removal. The PABI is
an extension of the ABI technology that uses surface electrodes on cochlear nuclei. The PABI uses 8 or 10
penetrating microelectrodes in conjunction with a separate array of 10 to 13 surface electrodes. The PABI
met the goals of lower threshold, increased pitch range, and high selectivity, but these properties did not
©2016 Blue Cross and Blue Shield of Louisiana
An independent licensee of the Blue Cross and Blue Shield Association
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.
Page 4 of 8
Auditory Brainstem Implant
Policy #
00475
Original Effective Date:
Current Effective Date:
07/15/2015
07/20/2016
result in improved speech recognition. These data are inadequate to draw conclusions regarding the
effectiveness of PABI compared with conventional ABI.
Three general reviews were identified on ABI. Sennaroglu and Ziyal review the history and development of
ABI, indications, side selection criteria, surgical options and audiologic outcomes after ABI. Colletti et al
discuss new developments on ABI specifically for NF2. Schwartz et al discuss in a 2008 review article the
future directions in central implants for hearing, including PABI, the use of ABI in nontumor patients, and the
auditory midbrain implant.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in February 2015 identified the following trials on the auditory brainstem
implant (see Table 1).
Table 1. Summary of Key Active Trials
NCT No.
NCT01904448
Trial Nam e
An Early Feasibility Study of the Safety and Efficacy of the
Nucleus 24 Auditory Brainstem Implant in Children With
Cochlear or Cochlear Nerve Disorders Not Resulting From
Neurofibromatosis Type II
NCT01864291
Study of the Nucleus 24 Auditory Brainstem Implant in Pediatric
Non-Neurofibromatosis Type 2
NCT01736267
Study of Nucleus 24 Auditory Brainstem Implant (ABI) in Adult
Non-Neurofibromatosis Type 2 Subjects
NCT02102256
A Feasibility Study of the Placement, Use, and Safety of the
Nucleus 24 Auditory Brainstem Implant in NonNeurofibromatosis Type 2 (NF2) Pediatric Patients
NCT02310399
Auditory Brainstem Implant (ABI) in Children With No Cochleae
or Auditory Nerves
NCT: national clinical trial.
Planned
Enrollm ent
10
Com pletion
Date
Apr 2023
15
Nov 2022
10
Nov 2022
10
Feb 2019
20
Apr 2016
Summary of Evidence
The ABI is a device designed to restore some hearing in people with NF2 who are rendered deaf by
bilateral removal of the characteristic neurofibromas involving the auditory nerve. ABIs have also been
studied to restore hearing for other nonneurofibromatosis indications.
The Nucleus 24 Auditory Brainstem Implant received FDA approval only for patients age 12 years or older
with NF2 following tumor removal. The available evidence for unilateral use of ABI devices in patients with
NF2 is sufficient to demonstrate improvements in net health outcomes. Therefore, the policy statement
indicates an ABI may be considered medically necessary in this condition.
ABIs hold promise for select patients with bilateral complete cochlear aplasia and demonstrated absence of
a cochlear nerve on imaging and electrophysiologic testing. In patients with other non-NF2 conditions, ABIs
have not demonstrated hearing benefits over cochlear implants. However, studies on ABIs for non-NF2
conditions are limited, with small numbers of patients and insufficient data to make scientific conclusions.
©2016 Blue Cross and Blue Shield of Louisiana
An independent licensee of the Blue Cross and Blue Shield Association
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.
Page 5 of 8
Auditory Brainstem Implant
Policy #
00475
Original Effective Date:
Current Effective Date:
07/15/2015
07/20/2016
Given the lack of both high-quality evidence and FDA approval, ABI for non-NF2 conditions and bilateral
ABI are considered investigational. Penetrating electrode ABI is also considered investigational, because
the very limited evidence available is insufficient to draw conclusions on health outcomes.
References
1.
2.
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5.
6.
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9.
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15.
16.
17.
18.
19.
20.
21.
Blue Cross and Blue Shield Association, Medica l Policy Reference Manual, “Auditory Brainstem Implant”, Policy #7.01.83,
3:2015.
Nucleus
24
Auditory
Brainstem
Implant
System.
FDA
Summary
of
Safety
and
Effectiveness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p000015. Acc essed January 21, 2015.
Ebinger K, Otto S, Arcaroli J, et al. Multichannel auditory brainstem implant: US clinical trial results. J Laryngol Otol Sup pl.
2000(27):50-53. PMID 11211440
Matthies C, Brill S, Kaga K, et al. Auditory brainstem implantation impro ves speech recognition in neurofibromatosis type II
patients. ORL J Otorhinolaryngol Relat Spec. 2013;75(5):282 -295. PMID 24042846
Sanna M, Di Lella F, Guida M, et al. Auditory brainstem implants in NF2 patients: results and review of the literature. Otol
Neurotol. Feb 2012;33(2):154-164. PMID 22246383
Goffi-Gomez MV, Magalhaes AT, Brito Neto R, et al. Auditory brainstem implant outcomes and MAP parameters: report of
experiences in adults and children. Int J Pediatr Otorhinolaryngol. Feb 2012;76(2):257 -264. PMID 22226602
Merkus P, Di Lella F, Di Trapani G, et al. Indications and contraindications of auditory brainstem implants: systematic revie w and
illustrative cases. Eur Arch Otorhinolaryngol. Jan 2014;271(1):3 -13. PMID 23404468
Medina M, Di Lella F, Di Trapani G, et al. Cochlear implantation versus auditory brainstem implantation in bilateral total deafness
after head trauma: personal experience and review of the literature. Otol Neurotol. Feb 2014;35(2):260 -270. PMID 24448286
Colletti V, Fiorino FG, Carner M, et al. Auditory brainstem implant as a salvage treatment after unsuccessful cochlear
implantation. Otol Neurotol. Jul 2004;25(4):485 -496; discussion 496. PMID 15241227
Colletti L, Wilkinson EP, Colletti V. Auditory brainstem implantation after unsucce ssful cochlear implantation of children with
clinical diagnosis of cochlear nerve deficiency. Ann Otol Rhinol Laryngol. Oct 2013;122(10):605 -612. PMID 24294682
Colletti V, Carner M, Miorelli V, et al. Auditory brainstem implant (ABI): new frontiers in adul ts and children. Otolaryngol Head
Neck Surg. Jul 2005;133(1):126-138. PMID 16025066
Colletti V. Auditory outcomes in tumor vs. nontumor patients fitted with auditory brainstem implants. Adv Otorhinolaryngol.
2006;64:167-185. PMID 16891842
Colletti L. Beneficial auditory and cognitive effects of auditory brainstem implantation in children. Acta Otolaryngol. Sep
2007;127(9):943-946. PMID 17712673
Colletti V, Shannon RV, Carner M, et al. Complications in auditory brainstem implant surgery in adults and childre n. Otol
Neurotol. Jun 2010;31(4):558-564. PMID 20393378
Sennaroglu L, Ziyal I, Atas A, et al. Preliminary results of auditory brainstem implantation in prelingually deaf children wi th inner
ear malformations including severe stenosis of the cochlear apertu re and aplasia of the cochlear nerve. Otol Neurotol. Sep
2009;30(6):708-715. PMID 19704357
Otto SR, Shannon RV, Wilkinson EP, et al. Audiologic outcomes with the penetrating electrode auditory brainstem implant. Otol
Neurotol. Dec 2008;29(8):1147-1154. PMID 18931643
Sennaroglu L, Ziyal I. Auditory brainstem implantation. Auris Nasus Larynx. Oct 2012;39(5):439 -450. PMID 22196501
Colletti L, Shannon R, Colletti V. Auditory brainstem implants for neurofibromatosis type 2. Curr Opin Otolaryngol Head Neck
Surg. Oct 2012;20(5):353-357. PMID 22886036
Schwartz MS, Otto SR, Shannon RV, et al. Auditory brainstem implants. Neurotherapeutics. Jan 2008;5(1):128 -136. PMID
18164492
National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 108. Au ditory brain stem implants. 2005;
http://guidance.nice.org.uk/IPG108. Accessed January 21, 2015.
Centers for Medicare and Medicaid Services. Medicare Policy Benefit Manual. Chapter 16 - General Exclusions from Coverage.
http://www.cms.gov/manuals/Downloads/bp102c16.pdf. Accessed January 21 , 2015
Policy History
Original Effective Date:
07/15/2015
Current Effective Date:
07/20/2016
06/25/2015
Medical Policy Committee review
©2016 Blue Cross and Blue Shield of Louisiana
An independent licensee of the Blue Cross and Blue Shield Association
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.
Page 6 of 8
Auditory Brainstem Implant
Policy #
00475
Original Effective Date:
Current Effective Date:
07/15/2015
07/20/2016
07/15/2015
Medical Policy Implementation Committee approval. New Policy
06/30/2016
Medical Policy Committee review
07/20/2016
Medical Policy Implementation Committee approval. Coverage eligibility unchanged.
01/01/2017
Coding update: Removing ICD-9 Diagnosis codes
Next Scheduled Review Date:
07/2017
Coding
The five character codes included in the Blue Cross Blue Shield of Louisiana Medical Policy Coverage Guidelines are
® ‡
obtained from Current Procedural Terminology (CPT ) , copyright 2015 by the American Medical Association (AMA).
CPT is developed by the AMA as a listing of descriptive terms and five character identifying codes and modifiers for
reporting medical services and procedures performed by physician.
The responsibility for the content of Blue Cross Blue Shield of Louisiana Medical Policy Coverage Guidelines is with
Blue Cross and Blue Shield of Louisiana and no endorsement by the AMA is intended or should be implied. The AMA
disclaims responsibility for any consequences or liability attributable or related to any use, nonuse or interpretation of
information contained in Blue Cross Blue Shield of Louisiana Medical Policy Coverage Guidelines. Fee schedules,
relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT,
and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense
medical services. The AMA assumes no liability for data contained or not contained herein. Any use of CPT outside of
Blue Cross Blue Shield of Louisiana Medical Policy Coverage Guidelines should refer to the most current Current
Procedural Terminology which contains the complete and most current listing of CPT codes and descriptive terms .
Applicable FARS/DFARS apply.
CPT is a registered trademark of the American Medical Association.
Codes used to identify services associated w ith this policy may include (but may not be limited to) the follow ing:
Code Type
Code
CPT
61863, 61864, 61867, 61868, 64568, 64569, 64570, 92640
HCPCS
S2235
ICD-10 Diagnosis
Q85.02
*Investigational – A medical treatment, procedure, drug, device, or biological product is Investigational if the effectiveness has not
been clearly tested and it has not been incorporated into standard medical pract ice. Any determination we make that a medical
treatment, procedure, drug, device, or biological product is Investigational will be based on a consideration of the followin g:
A. Whether the medical treatment, procedure, drug, device, or biological product can be lawfully marketed without approval of
the U.S. FDA and whether such approval has been granted at the time the medical treatment, procedure, drug, device, or
biological product is sought to be furnished; or
B. Whether the medical treatment, procedure, drug, device, or biological product requires further studies or clinical trials to
determine its maximum tolerated dose, toxicity, safety, effectiveness, or effectiveness as compared with the standard means
of treatment or diagnosis, must improve health o utcomes, according to the consensus of opinion among experts as shown
by reliable evidence, including:
1. Consultation with the Blue Cross and Blue Shield Association technology assessment program (TEC) or other
nonaffiliated technology evaluation center(s);
2. Credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant
medical community; or
3. Reference to federal regulations.
©2016 Blue Cross and Blue Shield of Louisiana
An independent licensee of the Blue Cross and Blue Shield Association
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.
Page 7 of 8
Auditory Brainstem Implant
Policy #
00475
Original Effective Date:
Current Effective Date:
07/15/2015
07/20/2016
**Medically Necessary (or “Medical Necessity”) - Health care services, treatment, procedures, equipment, drugs, devices, items or
supplies that a Provider, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, eva luating,
diagnosing or treating an illness, injury, disease or its symptoms, an d that are:
A. In accordance with nationally accepted standards of medical practice;
B. Clinically appropriate, in terms of type, frequency, extent, level of care, site and duration, and considered effective for th e
patient's illness, injury or disease; and
C. Not primarily for the personal comfort or convenience of the patient, physician or other health care provider, and not more
costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic
results as to the diagnosis or treatment of that patient's illness, injury or disease.
For these purposes, “nationally 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, Physician Specialty
Society recommendations and the views of Physicians practicing in relevant clinical areas and any other relevant factors.
‡ Indicated trademarks are the registered trad emarks of their respective owners.
NOTICE: Medical Policies are scientific based opinions, provided solely for coverage and informational purposes. Medical Policies
should not be construed to suggest that the Company recommends, advocates, requires, enco urages, or discourages any particular
treatment, procedure, or service, or any particular course of treatment, procedure, or service.
©2016 Blue Cross and Blue Shield of Louisiana
An independent licensee of the Blue Cross and Blue Shield Association
No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means,
electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana.
Page 8 of 8