Medical & Reimbursement Policies
Medical Policy
Policy Id
Topic
Section
Effective Date
Issued Date
Last Revision Date
Annual Review
Prepared By
DISCLAIMER
Highmark medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions.
POLICY STATEMENT
This policy provides information regarding the coverage of, as determined by applicable federal and/or state legislation.
This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records.
The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations.
Purpose
This medical policy outlines Highmark Health Options services for hearing loss and implants.
Definitions
Highmark Health Options (HHO) – Managed care organization serving vulnerable populations that have complex needs and qualify for Medicaid. Highmark Health Options members include individuals and families with low income, expecting mothers, children, and people with disabilities. Members pay nothing to very little for their health coverage. Highmark Health Options currently services Delaware Medicaid: Diamond State Health Plan (DSHP), Delaware Healthy Children Program (DHCP), and Diamond State Health Plan Plus (DSHP) LTSS members.
Hearing Impairment – A reduction in the ability to perceive sound. Hearing impairments can vary from slight to profound and are generally classified as conductive hearing loss, sensorineural hearing loss or mixed hearing loss.
Policy Position
Prior Authorization
Prior Authorization may be required. Please validate codes on the Prior Authorization Lookup Tool https://www.highmarkhealthoptions.com/providers/prior-auth-lookup.
Procedures
Hearing aids
Prescribed U.S. Food and Drug Administration (FDA)-approved hearing aids are eligible for payment (per the FDA, hearing aids marketed for use by the general public should have FDA approval). Any hearing aid that is not FDA approved will be denied as noncovered.
For adults aged 21 and older, one hearing aid per ear every two years, as needed, and batteries for one year, are covered.
For children aged 20 and younger, hearing exams, hearing aids, and batteries are covered.
Assistive Listening Devices
Assistive listening devices are used to improve speech intelligibility by reducing the degrading effects of distance and background noise. These devices are functionally similar to a personal sound amplifier system. These devices do not replace the function of the middle ear, cochlea or auditory nerve. Therefore, they are not considered as prosthetic devices and are non-covered.
Bone Conduction Implants
Bone anchored hearing devices (BAHA), unilateral or bilateral, full or partial, indicated for conductive, mixed hearing loss, or unilateral deafness hearing loss may be considered medically necessary as prosthetic devices when at least ONE of the following criteria are met:
- Congenital or surgically induced malformation (e.g., atresia) of the external ear, ear canal, or middle ear, or
- Infection of the ear canal resulting in chronic draining ears, or
- Fixation of the ossicles (middle ear bones), or
- Single sided deafness (SSD) (allow stimulation of the functioning cochlea) due to:
- Viral infections (CMV, HSV, measles, or others); or
- Meniere’s Disease; or
- Trauma; or
- Sudden deafness; or
- Acoustic neuroma; or
- Individual who is indicated for an air conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS; or
- Individuals who cannot wear conventional hearing aids for ONE or the following reasons:
- Tumors of the ear canal or tympanic cavity; or
- Dermatitis of the external ear canal; or
- Severe chronic otitis or otitis media; or
- Sensitivity to ear molds.
There MUST be a functioning cochlea or cranial nerve VIII for the BAHA to work and ALL the following audiological criteria must be met:
- Individual is age five (5) years or older;
- A pure tone average (PTA) bone-conduction threshold measured at 0.5, 1, 2, and 3 kHz of better than or equal to 45 dB (OBC and BP100 devices), 55 dB (Intenso device) or 65 dB (Cordele II device).
- As an alternative to an air-conduction CROS hearing aid in individuals five (5) years of age and older with single-sided sensorineural deafness and normal hearing in the other ear; and the pure tone average air conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2, and 3 kHz.
For bilateral implantation, individuals should meet the above audiologic criteria, and have a symmetrically conductive or mixed hearing loss as defined by a difference between left and right-side bone conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.
One (1) headband per year may be considered medically necessary. More than one (1) headband per year will be denied as not medically necessary.
Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as not medically necessary. BAHA for any other indication than listed above is considered not medically necessary.
BAHA not meeting the criteria as indicated in this policy is considered not medically necessary.
Auditory brainstem implant
Unilateral use of an auditory brainstem implant (using surface electrodes on the cochlear nuclei) may be considered medically necessary in individuals when ALL the following criteria have been met:
- Neurofibromatosis type II; and
- 12 years of age or older; and
- Are rendered deaf due to bilateral resection of neurofibromas of the auditory nerve.
An auditory brainstem implant not meeting the criteria as indicated in this policy, indlucing non-neurofibromatosis type 2 indications is considered experimental/investigational, and, therefore, non-covered because the safety and and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Bilateral use of an auditory brainstem implant is considered experimental/investigational, and, therefore, non-covered because the safety and and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
One (1) headband per year may be considered medically necessary. More than one (1) headband per year will be denied as not medically necessary.
Processor replacement may be considered medically necessary one (1) per five (5) years. Processor replacement greater than one (1) per five (5) years will be denied as not medically necessary.
Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as not medically necessary.
Audiological testing
Audiological testing is eligible as a diagnostic procedure, when not screening in nature.
Audiological testing performed without a physician evaluation and an order for the testing prior to testing are deemed to be screening in nature and is considered not medically necessary.
Aural Rehabilitation
An audiologist performs the primary evaluation of the status of an aural rehabilitation program under the direction of physicians or speech-language pathologists within their scope of practice.
The speech-language pathologist is typically responsible for evaluating the individual's receptive and expressive communication skills and providing the services to anchor improvement.
Aural rehabilitation not meeting the criteria as indicated in this policy is considered not medically necessary.
Post-payment audit statement
The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement.
Place of service: inpatient/outpatient
Experimental/investigational (E/I) services are not covered regardless of place of service.
External hearing aids, auditory brainstem implant, bone-anchored hearing devices, and audiological testing is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a comorbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
Reimbursement
Participating facilities will be reimbursed per their Highmark Health Options contract.
References
American Academy of Otolaryngology-Head and Neck Surgery. Position Statement: Bone Conduction Hearing Devices. September 17, 2016. Accessed January 16, 2019.
American Academy of Otolaryngology-Head and Neck Surgery. Position Statement: Active Middle Ear Implants. September 17, 2016. Accessed January 17, 2019.
Wong K., Kozin E, Kanumuri K et al., Auditory brainstem implants: Recent progress and future perspectives. Front. Neurosci. 2019:13:10.
Shokri T, Czarnecki B, Baker A, Isildak H. Hearing rehabilitation implementing a transcutaneous bone conduction device: Single- center experience. Ear Nose Throat J. 2019,(9).
den Besten CA, Monksfield P, Bosman A, et al. Audiological and clinical outcomes of a transcutaneous bone conduction hearing implant: Six-month results from a multicentre study. Clin Otolaryngol. 2019; 44(2): 144-157.
Schwab B, Wimmer W, Severens JL, et al. Adverse events associated with bone-conduction and middle-ear implants: A systematic review. Eur Arch Otorhinolaryngol. 2020; 277(2): 423-438.
Food and Drug Administration. Nucleus 24 Auditory Brainstem Implant System. FDA Summary of Safety and Effectiveness. 2000; https://www.accessdata.fda.gov/cdrh_docs/pdf/P000015B.pdf. Accessed December 17, 2021.
Ontario Health (Quality). Auditory brainstem implantation for adults with neurofibromatosis 2 or severe inner ear abnormalities: a health technology assessment. Ont Health Technol Assess Ser [Internet]. 2020 Mar;20(4): 185. https://www.hqontario.ca/evidence-to-improve-care/healthtechnology- assessment/reviews-and-recommendations/auditory-brainstem-implantation-foradults-with- neurofibromatosis-2-or-severe-inner-ear-abnormalities. Accessed December 17,2021.
Hayes, Inc. Hayes Medical Technology Directory Report. Percutaneous Bone-Anchored Hearing Aids. Lansdale, PA: Hayes, Inc. 12/07/2022. Accessed on 05/30/2023.
Kruyt IJ, Bakkum KHE, Caspers CJI, et. al. The efficacy of bone-anchored hearing implant surgery in children: A systematic review. Int J Pediatr Otorhinolaryngol. 2020;132:109906.
Behr, R., Schwager, K., & Hofmann, E. Auditory brainstem implants--hearing restoration in congenitally deaf children. Deutsches Aerzteblatt International, 2022:119(9).
Highmark Health Options. 2023. Quick Guide to Your Medicaid Benefits. Retrieved from https://www.highmarkhealthoptions.com/content/dam/digital-marketing/en/highmark/highmarkhealthoptions/members/2023-QuickGuide-DSHP-DHCP.pdf
