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.

Jurisdiction

Type Title

ID Number

Medicare Administrative Contractors (MACs)

Applicable States/Territories

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NCD

Electrical Nerve Stimulators

160.7

. DME A - Noridian Healthcare Solutions, LLC DME MAC ( )

sue | ~~" AK, AZ, CA, HI, ID, IA, KS, MO, MT, SD, UT, WA, WY, American Samoa Guam, Northern Mariana Islands

LCD LCA

Outpatient Physical and Occupational Therapy Services Billing and Coding:

L34049 957067 J15 - CGS Administrators, LLC (Part A/B MAC) | KY, OH Outpatient Physical and Occupational Therapy Services

J6 - National Government Services, Inc. (Part A/B MAC) IL, MN, WI LCDLCA Billing and Coding: Outpatient Physical and Occupational Therapy Services

L33631 A56566 J6 - National Government Services, Inc. (Part A/B MAC) JK - National Government Services, Inc. (Part A/B MAC) CT, NY, ME, MA, NH, RI, VT

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Outpatient Occupational Therapy Billing and Coding:

L34427 JJ - Palmetto GBA (Part A/B MAC) AL, GA, TN Occupational Therapy JM - Palmetto GBA (Part A/B MAC) NC, SC, VA, WV

Outpatient Physical Therapy Billing and Coding:

L34428 JM - Palmetto GBA (Part A/B MAC) Outpatient Physical Therapy A53065

Description Tinnitus is the perception of sound in one ear, both ears or within the head when external sound is not present. It is often described as buzzing, hissing, ringing, roaring or whistling.

Although there is no cure for tinnitus, treatments are designed to provide relief of symptoms. Examples of types of treatments proposed for tinnitus include, but may not be limited to:

• Bimodal neuromodulation device – Noninvasive device that combines mild electrical stimulation to the tongue with sound stimulation provided via headphones to drive long-term changes or neuroplasticity in the brain to purportedly treat tinnitus. One example of this type of device is Lenire. This device consists of a handheld controller, tongue tip intra-oral device and electrodes, and wireless Bluetooth headphones. The handheld controller starts and stops treatment and adjusts sound volume and tongue stimulation intensity.

The tongue tip intra-oral device with electrodes delivers stimulation to the tongue surface and the wireless Bluetooth headphones are paired to the controller to deliver sounds designed to activate the auditory nerve.

Cognitive behavioral therapy (CBT) – Attempts to teach coping strategies or distraction skills and relaxation techniques so that the psychological response to the condition may be altered.

Competitive kinesthetic interaction therapy (KKIT) – Adapted physiotherapy using expressive movements of body language. Different groups of muscles in the hand, arm, leg, foot and body, from the feet up to the face, are activated, which purportedly guides the individual into a situation of peaceful resting, reduction of tension and finally into relaxation. This was adapted from a rehabilitation program for treating pain.

Electrical stimulation – Treatment may include placing electrodes directly on the bony cochlea or the round window niche (one of two openings that connect the inner ear to the middle ear), or anywhere in the vicinity of the ear. The exact mechanism by which electrical stimulation is proposed to reduce tinnitus is unclear. An example of electrical stimulation includes, but may not be limited to, transcutaneous electrical nerve stimulation.

Hearing aids – The goal is to bring in more sounds from the individual’s surroundings, thus naturally covering the tinnitus and making it less noticeable. Some hearing aids may exist as a combination hearing aid and a broadband noise generator or masking device for tinnitus relief. An example of a combination hearing aid includes, but may not be limited to, the Lyric hearing aid combined with Tinnitus Balance software.

Masking (sound therapy) devices – Produce constant low-level white noise intended to provide a distraction or purportedly habituate an individual from the tinnitus they experience, by using, matching or enhancing sounds. This technology used to be primarily utilized through tabletop sound machines, but today, many are now applications (apps) available on or incorporated into an individual’s personal electronic devices (eg, smartphone, tablet) or hearing aids. Examples of masking (sound therapy) devices include, but may not be limited to, Levo System and Oasis Pro.

Tinnitus retraining therapy (TRT) – Uses a combination of low-level broadband noise along with counseling to achieve the habituation of tinnitus. The goal is to become unaware of the tinnitus unless it is consciously focused on and to remain unbothered by it, even when aware of it.

Transmeatal laser irradiation – Low-level laser irradiation applied through the external acoustic meatus of the affected ear. The treatment takes place once a week for 6 minutes over a 4 week period or more.

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 tinnitus treatments.

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

Tinnitus Treatments

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

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