Humana Implantable and Non-Implantable Hearing Devices - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.

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Implantable and Non-Implantable Hearing Devices

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• Internet- Only Manuals (IOMs) | Chapter 32 Billing | Requirements for Special Services; Section 100 Billing Requirements for Expanded Coverage of Cochlear Implantation
• NCD | Cochlear Implantation | 50.3

Description

Hearing aids are the most commonly known devices for assisting an individual with hearing loss. These are external devices worn either just inside the ear or looped over the ear and can be removed by the wearer. Other types of devices (implantable and semi-implantable) have been developed to treat varying types of hearing loss. Hearing loss is classified by the severity or degree of hearing loss and can be unilateral or bilateral.

There are three main types of hearing loss including:

• Conductive – Caused by disruptions in sound transmission from getting through the outer ear or middle ear to the cochlea, the hollow tube coiled in the shape of a snail's shell, that changes sound into nerve messages and sends them to the brain.
• Sensorineural hearing loss – Caused by disruptions in sound transmission from the cochlea to the brain. This type of hearing loss occurs when there is an issue with the way the inner ear or hearing nerve works.
• Mixed hearing loss – Caused by a mix of both conductive and sensorineural hearing loss.

Auditory Brainstem Implant

An auditory brainstem implant is a specialized implantable hearing device used in an individual who have had surgical removal of auditory nerve tumors and are totally deaf as a result. Similar to a cochlear implant, it consists of several components: a microphone, which picks up sound and transmits an electrical signal to the speech processor; the speech processor converts the signal to digital impulses, which are sent to a transmitter coil worn behind the ear and directly over the implant that is embedded in the skull.

The implant relays the signals to an electrode placed on the brainstem near the severed auditory nerve; the signals stimulate the brainstem and can be interpreted by the brain in a manner similar to the interpretation of signals normally received from the ear. After surgical placement, the implant must be programmed and tested. The individual must undergo a period of training to recognize sounds and communicate with the device. Currently, the only US Food & Drug Administration (FDA) approved auditory brainstem implant is the Nucleus Profile Plus Auditory Brainstem Implant.

Bone Anchored/Bone Conduction Hearing Aids

A percutaneous bone anchored hearing aid (pBAHA), also known as an osseointegrated mastoid implant, is a type of implantable hearing device based on bone conduction of sound. Certain individuals, typically those with conductive or mixed hearing loss, who are unable to utilize a conventional hearing aid may benefit from this device since it transmits sound directly through the skull. A titanium post is surgically embedded into the skull with a small section, called an abutment, exposed outside of the skin. A sound processor sits on the abutment and transmits sound vibrations via the titanium post. The vibrations to the skull and inner ear stimulate the nerve fibers of the inner ear, which enables hearing.

Examples of bone anchored hearing aids include, but may not be limited to, Baha Connect System and Ponto Bone Anchored Hearing System, both of which have several different sound processor models.

A transcutaneous bone anchored hearing aid (tBAHA), also known as a partially implantable hearing aid, utilizes a magnetic abutment under the skin which is surgically implanted in an outpatient setting. These systems use the magnetic connection to join the sound processor and implant. This device creates an electromagnetic field that vibrates and stimulates the ossicles, sending signals to the cochlea to improve hearing acuity. Examples of transcutaneous bone anchored hearing aids include, but may not be limited to, Alpha 2 MPO ePlus, Baha Attract System, BONEBRIDGE and Osia System.

Cochlear Implant

A cochlear implant is an electronic device that can provide improved speech and hearing communication abilities for an individual who has severe-to-profound, sensorineural hearing loss (SNHL) in both ears and who still has difficulty hearing despite appropriately fitting conventional hearing aids. The implant is surgically placed under the skin, behind the ear. It generally consists of four parts: a microphone, which picks up sound from the environment; a speech processor, which is worn externally or carried and arranges the sound transmitted by the microphone; a receiver/stimulator that receives signals from the speech processor and converts them into electrical impulses; and an electrode, which collects the impulses from the stimulator and sends them to the brain.

Although it cannot restore normal hearing, the cochlear implant enables an individual with profound or total deafness to hear sound, including speech, by stimulating the auditory nerve in the inner ear. Following implantation, the device must be programmed, calibrated and the individual trained to use it. The effectiveness of the implant depends heavily on postoperative rehabilitation that is necessary for the individual to learn to communicate using the device. Examples of cochlear implants include, but may not be limited to, HiRes Ultra/HiRes Ultra 3D Cochlear Implant, Neuro Cochlear Implant System, Nucleus Profile Plus Cochlear Implant System, and Synchrony 2 Cochlear Implant.

Assistive listening devices purportedly enhance the function of a cochlear implant or hearing aid by helping to separate desired sounds from background noise. These devices generally consist of a microphone to collect sound, a transmitter to send the signal across a distance, a receiver to intercept the signal and any one of several different listening attachments to send the sound from the receiver to the individual’s ear, hearing aid or cochlear implant.

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Hybrid cochlear implants purportedly provide both electric (cochlear implant portion) and acoustic (hearing aid portion) stimulation to individuals with severe-to-profound hearing loss that may still hear low frequency sounds. The hybrid implant electrodes are shorter and thinner than cochlear implant electrodes and are implanted only halfway in an effort to preserve the area responsible for low frequency sounds. An example of a hybrid cochlear implant includes, but may not be limited to, the Nucleus Hybrid Implant System.

Fully Implantable Middle Ear Hearing System

Fully implantable middle ear hearing systems, in which all components are surgically positioned in the middle ear, are purported to be an alternative to the traditional over the ear hearing aid. The device uses the eardrum like a microphone and there is a sensor placed on the incus. The mechanical motion produced at the incus is then converted into an electrical signal and is sent to the processor which amplifies and filters that signal. Once converted to a vibratory signal it is then transmitted into the inner ear where it is perceived as sound.

An example of a fully implantable hearing system includes, but may not be limited to, the Esteem Implant.

Non-Implantable Hearing Devices

Nonimplanted bone conduction devices are intended for children and some adults to use prior to bone anchored hearing aid placement. These include bands or adhesive patches that can be worn over the mastoid bone which purportedly send sound waves through the bone and into the inner ear. Examples of these devices include, but may not be limited to, Baha Softband, Baha SoundArc, ADHEAR and Ponto Softband 5.

An intraoral bone conduction hearing system consists of two pieces; a processor worn behind the ear and a custom fitted, removable, oral retainer-like device that works as a receiver. The intraoral system purportedly functions similar to a bone conduction hearing aid and is indicated for adults with single sided deafness.

Semi-Implantable Middle Ear Hearing Aid

A semi-implantable middle ear hearing aid involves a procedure where a magnetic implant coil is wrapped around the ossicles behind the eardrum via a small incision. Electromagnetic energy then vibrates the implant which directly stimulates the inner ear or cochlea. Examples of semi-implantable middle ear hearing aids include, but may not be limited to, Maxum Hearing Implant System or the Vibrant SOUNDBRIDGE System.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

Please refer to the above CMS guidance for cochlear implantation.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

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Implantable and Non-Implantable Hearing Devices

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage