Transtympanic Micropressure Applications as a Treatment of Meniere’s Disease Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 02|16|2010 POLICY LAST REVIEWED: 04|03|2024 OVERVIEW Transtympanic micropressure applications as a 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.
MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable POLICY STATEMENT Medicare Advantage Plans Transtympanic micropressure applications as a treatment for Meniere’s disease is considered not covered as the evidence is insufficient to determine the effects of the technology on health outcomes. Commercial Products Transtympanic micropressure applications as a treatment for Meniere’s disease is considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes. COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable not medically necessary/not covered benefits/coverage. BACKGROUND 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 impede activities of daily living. Therapy addresses symptoms, not 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 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 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.
Medical Coverage Policy | Transtympanic Micropressure Applications as a Treatment of Meniere’s Disease

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

Transtympanic micropressure treatment for Meniere disease involves use of a handheld 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.

For individuals who have Meniere disease who receive transtympanic micropressure therapy (Meniett), the evidence includes randomized controlled trials and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Six randomized controlled trials of positive pressure therapy have been reported, with five specifically investigating the Meniett device. Systematic reviews of these 5 trials found that micropressure therapy does not result in a greater reduction in vertigo than placebo. The sixth trial also found no significant benefit of the transtympanic micropressure therapy for Meniere disease. The evidence is sufficient to determine that the technology is unlikely to improve the net health outcome.

CODING Medicare Advantage Plans and Commercial Products The following code(s) is considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products:
E2120 Pulse generator system for tympanic treatment of inner ear endolymphatic fluid

RELATED POLICIES None

PUBLISHED Provider Update, June 2024 Provider Update, August 2023 Provider Update, November 2022 Provider Update, June 2021 Provider Update, April 2020

REFERENCES:

1. US Food and Drug Administration. FDA 510(k) marketing clearance information for the Meniett device. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf/K991562.pdf.
2. Barbara M, Consagra C, Monini S et al. Local pressure protocol, including Meniett, in the treatment of Meniere's disease: short-term results during the active stage. Acta Otolaryngol 2001; 121(8):939-44.
3. Densert B, Sass K. Control of symptoms in patients with Meniere's disease using middle ear pressure applications: two years follow-up. Acta Otolaryngol 2001; 121(5):616-21.
4. Gates GA, Green JD. Intermittent pressure therapy of intractable Meniere's disease using the Meniett device: a preliminary report. Laryngoscope 2002; 112(8 pt 1):1489-93.
5. Barbara M, Monini S, Chiappini I et al. Meniett therapy may avoid vestibular neurectomy in disabling Meniere's disease. Acta Otolaryngol 2007; 127(11):1136-41.
6. Dornhoffer JL, King D. The effect of the Meniett device in patients with Ménière's disease: long-term results. Otol Neurotol 2008; 29(6):868-74.
7. Mattox DE, Reichert M. Meniett device for Ménière's disease: use and compliance at 3 to 5 years. Otol Neurotol 2008; 29 (1):29-32.
8. Park JJ, Chen YS, Westhofen M. Meniere's disease and middle ear pressure - vestibular function after transtympanic tube placement. Acta Otolaryngol 2009; 129(12):1408-13.
9. Gates GA, Green JD, Tucci DL et al. The effects of transtympanic micropressure treatment in people with unilateral Meniere’s disease. Arch Otolaryngol Head Neck Surg 2004; 130(6):718-25.
10. 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.
11. Gurkov R, Filipe Mingas LB, et al. Effect of transtympanic low-pressure therapy in patients with unilateral Meniere's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial. J Laryngol Otol. Apr 2012;126(4):356-362. PMID 22365373

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

12. American Academy of Otolaryngology - Head and Neck Surgery. AAO-HNS position on micropressure
    therapy. 2012; http://www.entnet.org/Practice/micropressure.cfm. Accessed July, 2014.
13. National Institute for Clinical Excellence (NICE). Micropressure therapy for refractory Ménière's disease. NICE interventional procedure guidance 426. 2012; http://guidance.nice.org.uk/IPG426/Guidance/pdf/English.
14. van Sonsbeek S, Pullens B, van Benthem PP. Positive pressure therapy for Meniere's disease or syndrome. Cochrane Database Syst Rev. 2015;3:CD008419. PMID 25756795
15. Syed MI, Rutka JA, Hendry J, et al. Positive pressure therapy for Meniere's syndrome/disease with a Meniett device: a systematic review of randomised controlled trials. Clin Otolaryngol. Jun 2015;40(3):197-
16. PMID 25346252
17. Russo FY, Nguyen Y, De Seta D, et al. Meniett device in Meniere disease: Randomized, double-blind, placebo-controlled multicenter trial. Laryngoscope. Feb 2017;127(2):470-475. PMID 27515294

18. Thomsen J, Sass K, Odkvist L, et al. Local overpressure treatment reduces vestibular symptoms in patients with Meniere's disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Otol Neurotol. Jan 2005;26(1):68-73. PMID 15699722

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    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association. CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS