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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/15/2011 Title: Bone Anchored Hearing Aids (BAHA)
Revision Date: 01/01/2018 Document: BI289:00
CPT Code(s): 69710, 69714, 69715, L8690, L8691
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Bone Anchored Hearing Aids (BAHA) require pre-authorization.

2)    BAHA are used to augment hearing when air conduction hearing aids cannot be used.

3)    The aids and their components are subject to the hearing aid limits and may not be available for all plans.

4)    The services related to the implantation are covered under the medical benefits.


Medical Statement

1)    Bone anchored hearing aids (BAHAs) require pre-authorization.

2)    Implantable bone-anchored hearing aids (BAHAs) or temporal bone stimulators are considered medically necessary hearing aids for persons age 5 years and older with a unilateral or bilateral conductive (H90.0 - H90.2) or mixed conductive and sensorineural hearing loss (H90.6 - H90.8) who have any of the following conditions, preventing restoration of hearing using a conventional air-conductive hearing aid and who also meet the audio logic criteria below:

A.   Uncorrectable stenosis of the external ear canal, either congenital or acquired (H61.301-H61.399, H95.811-H95.819)

B.   Congenital malformations of the ear causing impairment of hearing (Q16.1-Q16.9); or

C.   Dermatitis of the external ear, including hypersensitivity reactions to ear moulds used in air conduction hearing aids; or

D.   Hearing loss secondary to otosclerosis (H80.00-H80.13, H80.80-H80.93) in persons who cannot undergo stapedectomy; or

E.   Severe chronic external otitis (H60.20-H60.329, H60.391-H60.399, H60.60-H60.63) or otitis media (H65.20-H65.499, H66.10-H66.3X9); or

F.    Tumors of the external ear canal and/or tympanic cavity (C44.201 – C44.299, D04.20 – D04.22, D22.20 – D22.22, D23.20 – D23.22); or

G.   Other conditions in which an air-conduction hearing aid is contraindicated.

AND:

Audio logic criteria:

    1. Unilateral implant: Conductive or mixed (conductive and sensorineural) hearing loss with pure tone average bone conduction threshold (measured at 0.5, 1, 2, and 3 kHz) less than or equal to 45 dB HL (BAHA Divino, BAHA BP100), 55 dB HL (BAHA Intenso) or 65 dB HL (BAHA Cordelle II).
    2. Bilateral implant: Moderate to severe bilateral symmetric conductive or mixed (conductive and sensorineural) hearing loss, meeting above-listed bone conduction thresholds in both ears. Symmetric bone conduction threshold is defined as less than:
      1. 10 dB average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies (BAHA Divino, BAHA BP100); or 
      2. 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies (BAHA Cordelle II, BAHA Intenso).

Codes Used In This BI:

 

69710             Implant/replace hearing aid

69714             Implant temple bone w/stimul

69715             Temple bne implnt w/stimulat

L8690             Auditory osseointegrated device, internal and external components

L8691             Auditory osseointegrated device, external sound processor, excludes 

                      transducer/actuator, replacement only, each


Limits

Implantable BAHA are considered experimental and investigational for bilateral pure sensorineural hearing loss, and for all other indications.


Background

The bone-anchored hearing aid (BAHA) is a bone-conduction hearing aid that allows direct bone-conduction through a titanium implant and has become available as an acceptable alternative if an air-conduction hearing aid is contraindicated. The bone-anchored hearing aid transmits sound vibrations through the skull bone via a skin-penetrating titanium implant, and then sounds are further transmitted to the cochlea, bypassing the middle ear. Several clinical trials have shown its efficacy in patients with a conductive or mixed hearing loss. Indications for the BAHA include hearing loss from congenital ear problems, chronic suppurative otitis media, and in some cases otosclerosis as a third treatment option in those who cannot or will not undergo stapedectomy. A second group of potential candidates are patients who suffer from an almost instantaneous skin reaction to any kind of ear mold. In some patients, the benefits are not necessarily those in hearing ability but relate to cosmetic or comfort improvements. Preoperative assessment of the size of the air-bone gap is of some help to predict whether speech recognition may improve or deteriorate with the BAHA compared with the air-conduction hearing aid.

There is evidence in the peer-reviewed published medical literature to support the use of bone anchored hearing aids over air conduction hearing aids; however, most of the studies have focused on individuals who suffer from single sided deafness, with unilateral sensorineural deafness in one ear while the other ear has normal hearing. The FDA has cleared for marketing the bone anchored hearing aid for individuals aged 5 years and older who have conductive or mixed hearing loss and for patients with sensorineural deafness in one ear and normal hearing in the other based on a 510(k) application. Such clearance was granted based on a determination that the BAHA was substantially equivalent to a contralateral routing of sound (CROS) air conduction hearing aid.   A unilateral implant is used for individuals with unilateral conductive or mixed hearing loss and for unilateral sensorineural hearing loss.  According to the FDA-approved indications, a bilateral implant is intended for patients with bilaterally symmetric moderate to severe conductive or mixed hearing loss.

In a recently published met analysis of the evidence for BAHA for single sided deafness, Baguley and colleagues (2006) explained that acquired unilateral sensorineural hearing loss reduces the ability to localize sounds and to discriminate in background noise. Four controlled trials have been conducted to determine the benefit of contralateral BAHAs over CROS hearing aids and over the unaided condition. Speech discrimination in noise and subjective questionnaire measures of auditory abilities showed an advantage for BAHA over CROS and over unaided conditions. However, these studies did not find significant improvements in auditory localization with either aid. The investigators noted that these conclusions should be interpreted with caution because these studies have material shortfalls: (i) the BAHA was always trialed after the CROS aid; (ii) CROS aids were only trialed for 4 weeks; (iii) none used any measure of hearing handicap when selecting subjects; (iv) two studies have a bias in terms of patient selection; (v) all studies were under-powered; (vi) double reporting of patients occurred (Baugley, et al., 2006).


Reference
  1. UK National Health Service (NHS), National Library for Health. Knowledge update: Hearing aid provision and rehabilitation. Specialist Library for ENT and Audiology. London, UK: NHS; April 2006.
  2. Bergeron F.  Bone-anchored hearing aid. AETMIS 06-05. Summary.Montreal, QC: Agence D’Evaluation des Technologies et des Modes D’Intervention en Santé (AETMIS); May 2006.
  3. Parrella A, Mundy L. Bone anchored hearing aid (BAHA). Horizon Scanning Prioritising Summary - Volume 8. Adelaide, SA: Adelaide Health Technology Assessment (AHTA) on behalf of National Horizon Scanning Unit (Health PACT and MSAC); 2005.
  4. Baguley DM, Bird J, Humphriss RL, Prevost AT. The evidence base for the application of contralateral bone anchored hearing aids in acquired unilateral sensorineural hearing loss in adults. Clin Otolaryngol. 2006; 31(1):6-14.
  5. Davids T, Gordon KA, Clutton D, Papsin BC. Bone-anchored hearing aids in infants and children younger than 5 years. Arch Otolaryngol Head Neck Surg. 2007; 133(1):51-55. 
  6. Wisconsin Department of Health and Family Services. Replacement parts for cochlear implant and bone-anchored hearing devices. Attachment 3. Wisconsin Medicaid and Badger Care Update. No. 2005-20. Madison, WI: Wisconsin Department of Health and Family Services; March 2005. Available at: http://dhs.wisconsin.gov/medicaid/updates/2005/2005pdfs/2005-20.pdf. Accessed July 29, 2008.
  7. U.S. Food and Drug Administration (FDA) 510(k). Branemark Bone Anchored Hearing Aid (BAHA) System. Summary of Safety and Effectiveness. 510(k) No. K984162. Rockville, MD: FDA; June 28, 1999.
  8. U.S. Food and Drug Administration (FDA) 510(k). Bilateral fitting of BAHA. Summary of Safety and Effectiveness. 510(k) No. K011438. Rockville, MD: FDA; July 23, 2001.
  9. U.S. Food and Drug Administration (FDA). BAHA Divino. Summary of Safety and Effectiveness. 510(k) No. K042017. Rockville, MD: FDA; August 26, 2004.
  10. U.S. Food and Drug Administration (FDA). BAHA Cordelle II. Summary of Safety and Effectiveness. 510(k) No. K080363. Rockville, MD: FDA; April 10, 2008.
  11. U.S. Food and Drug Administration (FDA). BAHA Intenso. Summary of Safety and Effectiveness. 510(k) No. K081606. Rockville, MD: FDA; August 28, 2008.
  12. U.S. Food and Drug Administration (FDA). BAHA BP100. Summary of Safety and Effectiveness. 510(k) No. K090720. Rockville, MD: FDA; June 17, 2009.
  13. Priwin C, Jönsson R, Hultcrantz M, et al. BAHA in children and adolescents with unilateral or bilateral conductive hearing loss: A study of outcome. Int J Pediatr Otorhinolaryngol. 2007; 71(1):135-145.
  14. Verhaegen VJ, Mulder JJ, Mylanus EA, et al. Profound mixed hearing loss: Bone-anchored hearing aid system or cochlear implant? Ann Otol Rhinol Laryngol. 2009; 118(10):693-697.
  15. Christensen L, Richter GT, Dornhoffer JL. Update on bone-anchored hearing aids in pediatric patients with profound unilateral sensorineural hearing loss. Arch Otolaryngol Head Neck Surg. 2010; 136(2):175-177.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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