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Medical Policy: 08.01.19
Original Effective Date: September 2008
Reviewed: September 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Ménière'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 activities of daily living. Therapy is symptomatic in nature and does not address the underlying pathophysiology. Although the pathophysiology of Ménière’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. 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 a more physiologic approach to treatment by applying local pressure treatment to restore the underlying fluid homeostasis. Transtympanic micropressure is a treatment option that has been proposed as an alternative to surgery. A tympanostomy tube is implanted between the external ear canal and the middle ear. At the time of treatment, an ear cuff is inserted into the external ear canal, and a hand-held air pressure generator, connected to a table-top pressure unit, automatically delivers low-frequency, low-amplitude pressure pulses to the middle ear through the tympanostomy tube. Patients are instructed to treat themselves 3 times daily for 3 minutes each time. The treatment is continued for as long as patients find themselves in a period of attacks of vertigo. During periods of remission, no treatment is needed. It is hypothesized that the application of low-frequency, low-amplitude pressure pulse to the middle ear functions to evacuate endolymphatic fluids from the middle ear, thus relieving vertigo. In 1999, the Meniett device (Medronic Xomed) received clearance to market through the U.S. Food and Drug Administration (FDA) 510(k) process specifically as a symptomatic treatment of Ménière’s disease.
Data submitted to the FDA as part of the approval process consisted of a case series of 20 patients. Other case series have also been published in the peer-reviewed literature. However, a randomized, placebo-controlled trial is necessary to distinguish any treatment effect from the intermittent natural history of Ménière’s disease. In 2004, Gates and colleagues published the 4-month results of a randomized multi-institutional study that enrolled 67 patients with active unilateral Ménière’s disease refractory to a 3-month trial of medical management. All patients underwent tympanostomy, and patients were additionally randomized to either a sham device or a Meniett device. Outcomes were assessed using symptom report cards that focused on the severity and frequency of vertigo. Vertigo was assessed on a scale of 1 to 4, and vertigo scored as 2 or higher was considered definitive vertigo. The total number of days of definitive vertigo for all the participants was reported at each month. While an ANOVA analysis showed that over the entire 4-month trial there was a significant difference in the total number of episodes of vertigo in the treatment group compared to the control group, the difference between the groups is most apparent at 1 month, while at 4 months the treatment effect has disappeared almost entirely.
Similarly, overall, there was a significant decrease in the frequency of vertigo in the treatment group, but again this difference was most apparent at the 1-month interval and almost disappeared at 4 months. No statistical analysis is provided for the 1-month interval. It is difficult to interpret these results, and longer term follow-up is required. For example, the results could suggest that the device is only associated with a short-term improvement in vertigo, or a delayed placebo effect in the control group, or perhaps reflect the cyclical nature of the natural history of Ménière’s disease. In the control group, the total number of days with definitive vertigo initially declines slowly, then increases again, and then sharply declines at 4 months. If these changes in vertigo are due to the cyclical nature of Ménière’s disease, one might expect to see the number of vertigo days again rise in the control group in subsequent months.
A multicenter, double-blind, placebo-controlled trial with 63 patients reported an improvement in functionality (American Academy of Otolaryngology–Head and Neck Surgery [AAO-HNS] criteria) and a trend (p=0.09) toward a reduction in episodes of vertigo compared with a group treated with ventilation tubes and sham pressure devices. The frequency of attacks decreased from 10.5 to 4.0 in the placebo group and from 9.6 to 1.9 in the active group. There were no changes in secondary outcome measures (patient’s perception of tinnitus, aural pressure, and hearing). In addition to a marginal improvement in efficacy over placebo, this study is limited by the high dropout rate (37%), lack of intent-to-treat analysis, and short (2-month) monitoring period.
In 2006, Gates and colleagues reported 2-year follow-up of patients from their randomized trial. At the end of the randomized phase of the study, 61 of 67 patients from both the control and active treatment arms were treated openly with the Meniett device; 3 were subsequently lost to follow-up or excluded due to concurrent health problems. Vertigo episodes were reported on a daily symptom diary (44 patients) or by a structured telephone interview (17 patients). Of the 58 patients followed up for 2 years, 14 (24%) dropped out to seek alternative surgical treatment, 5 (9%) showed little or no improvement, and 39 (67%) reported being in remission or substantially improved. For patients who went into remission, there was an 80% probability of remaining in remission for the 2 years. This assessment is limited, however, by the lack of a control group with ventilation tubes followed up over the same period.
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Prior Approval:
Not applicable
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Policy:
Transtympanic micropressure as a treatment of Meniere’s disease is considered investigational.
Overall, the scientific evidence does not permit conclusions concerning the effect of this technology on health outcomes. As illustrated in trials conducted to date, frequency of vertigo attacks has been reported to decrease with placement of ventilation tubes alone. It is therefore not clear if the improvement is due to the Meniett device, the insertion of the ventilation tubes, or to variability in disease course. Assessment of the long-term efficacy and adverse effects of this device requires study with appropriately treated controls over an adequate length of time.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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E2120 Pulse generator system for tympanic treatment of inner ear endolymphatic fluid
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A4638 Replacement battery for patient-owned ear generator, each
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Selected References:
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Gates GA, Green JD. Intermittent pressure therapy of intractable Ménière’s disease using the Meniett device: a preliminary report. Laryngoscope 2002; 112(8 pt 1):1489-93.
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Densert B, Sass K. Control of symptoms in patients with Ménière’s disease using middle ear pressure applications: two years follow-up. Acta Otolaryngol 2001; 121(5):616-21.
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Barbara M, Consagra C, Monini S et al. Local pressure protocol, including Meniett, in the treatment of Ménière’s disease: short-term results during the active stage. Acta Otolaryngol 2001; 121(8):939-44.
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Gates GA, Green JD, Tucci DL et al. The effects of transtympanic micropressure treatment in people with unilateral Ménière’s disease. Arch Otolaryngol Head Neck Surg 2004; 130(6):718-25.
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Thomsen J, Sass K, Odkvist L et al. Local overpressure treatment reduces vestibular symptoms in patients with Ménière’s disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Otol Neurotol 2005; 26(1):68-73.
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Gates GA, Verrall A, Green JD Jr et al. Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg 2006; 132(12):1311-6.
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Barbara M, Monini S, Chiappini I, Filipo R. Meniett therapy may avoid vestibular neurectomy in disabling Ménière's disease. Acta Otolaryngol. 2007 Nov;127(11):1136-41.
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Peterson WM, Isaccson JE. Current management of Ménière's disease in an only hearing ear. Otol Neurotol. 2007 Aug;28(5):696-9.
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Mattox DE, Reichert M. Meniett device for Ménière's disease: use and compliance at 3 to 5 years. Otol Neurotol. 2008 Jan;29(1):29-32.
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Park JJ, Chen YS, Westhofen M. Ménière’s disease and middle ear pressure- vestibular function after transtympanic tube placement. Acta Otolaryngol 2009 Mar 4:1-6. [Epub ahead of print].
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Policy History:
Date Reason Action
September 2011 Annual review Policy renewed
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drugs, etc. They are developed to
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*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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