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DESCRIPTIONTranstympanic micropressure treatment for Meniere’s disease involves use of a hand-held air pressure generator 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 is continued for as long as patients find themselves in a period of attacks of vertigo.
Meniere’s 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 and incapacitating, and may prevent the activities of daily living. Therapy is symptomatic in nature and does not address the underlying pathophysiology. Although the pathophysiology of Meniere's 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. Conservative therapy includes a low sodium diet and diuretics to reduce the fluid accumulation (i.e., hydrops), and pharmacologic therapy to reduce vestibular symptoms. Those that 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's 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.
In 1999, the Meniett® device (Medtronic) received clearance to market through a U.S. Food and Drug Administration (FDA) 510(k) process specifically as a symptomatic treatment of Meniere’s disease.
POLICYTranstympanic micropressure applications as a treatment of Meniere's disease are considered investigational.
POLICY EXCEPTIONSFederal 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 GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/2003: 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 1.01.23
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.