Transtympanic Micropressure Applications as a Treatment of Meniere Disease

POLICY NUMBER

L.1.01.413

DESCRIPTION

Meniere Disease

Meniere disease is an idiopathic disorder of the inner ear characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and ear pressure. The vertigo attacks are often unpredictable, incapacitating, and may prevent the activities of daily living. Therapy addresses symptoms, not the underlying pathophysiology. Although the pathophysiology of Meniere disease is not precisely known, it is thought to be related to a disturbance in the pressure-volume relationship of the endolymph within the inner ear.

TreatmentConservative therapy includes a low sodium diet and diuretics to reduce fluid accumulation (i.e., hydrops) and pharmacologic therapy to reduce vestibular symptoms. Persons who do not respond to these conservative measures may receive gentamicin drops in the ear, as a technique of chemical labyrinthectomy to ablate vestibular function on the affected side. No therapy is available to restore hearing loss.

There has been interest in developing a more physiologic approach to treatment by applying local transtympanic pressure treatment to restore the underlying fluid homeostasis. Researchers have noted that symptoms of Meniere disease improve with fluctuations in ambient pressure, and patients with acute vertigo have been successfully treated in hypobaric chambers. It is hypothesized that the application of low-frequency, low-amplitude pressure pulse to the middle ear functions to evacuate endolymphatic fluids from the inner ear, thus relieving vertigo.

Transtympanic micropressure treatment for Meniere disease involves use of a hand-held air pressure generator (Meniett) that delivers intermittent complex pressure pulses. For this device to be used, a conventional ventilation tube is surgically placed in the eardrum. Patients then place an ear-cuff in the external ear canal and treat themselves for 3 minutes, 3 times daily. Treatment continues for as long as patients have vertigo attacks.

In 1999, the Meniett® device (Medtronic Xomed, Jacksonville, FL) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process specifically as a symptomatic treatment of Meniere disease. 

POLICY

Transtympanic micropressure applications as a treatment of Meniere disease are considered not medically necessary.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity. 

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally 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, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

11/2003: Approved by Medical Policy Advisory Committee (MPAC).

2/16/2004: Code Reference section completed.

11/3/2004: Code Reference section updated, ICD-9 diagnosis code 386.00, 386.01, 386.02, 386.03, 386.04 deleted, HCPCS E1399 deleted, HCPCS A4638, E2120 added.

3/26/2007: Policy reviewed, no changes.

9/26/2008: Policy reviewed, no changes.

04/13/2010: Policy description updated. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. 

11/17/2010: Policy reviewed; no changes.

11/10/2011: Policy reviewed; no changes.

01/09/2013: Policy reviewed; no changes.

12/13/2013: Policy reviewed; no changes.

11/13/2014: Policy reviewed; description updated. Policy statement unchanged.

07/23/2015: Code Reference section updated for ICD-10.

04/25/2016: Policy description updated. Policy statement changed from investigational to not medically necessary. Investigative definition updated in Policy Guidelines section. Code Reference section updated to change "Investigational Codes" to "Not Medically Necessary Codes."

05/31/2016: Policy number A.1.01.23 added.

03/08/2017: Policy description updated. Policy statement unchanged.

02/26/2018: Policy description updated. Policy statement unchanged.

03/19/2019: Policy reviewed; no changes.

03/16/2020: Policy reviewed; no changes.

07/15/2023: Policy updated to change the medical policy number from "A.1.01.23" to "L.1.01.413." Policy reviewed. Policy statement unchanged.

06/25/2024: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 1.01.23

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

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