BlueCross and BlueShield of Montana Medical Policy/Codes
Meniett Low Pressure Pulse Generator for Menieres Disease
Chapter: Medicine: Treatments
Current Effective Date: December 27, 2013
Original Effective Date: March 16, 2011
Publish Date: December 27, 2013
Revised Dates: December 6, 2012; December 12, 2013
Description

Ménière's disease is a complex progressive disorder of the inner ear characterized by dizziness or a spinning sensation (rotary vertigo), hearing loss, fullness or pressure in the ear, and roaring or ringing (tinnitus) in the ear.  Nausea or vomiting frequently accompanies severe attacks of vertigo.  Some patients also experience headaches as part of their symptoms.  Attacks can last from 20 minutes to a day or more with a recovery period often lasting from one to three days.  The effect of these symptoms can be debilitating.  About 80% of patients with Mèniére's disease experience the problem in one ear (unilateral), while 20% of patients have the disease in both ears.

Research has shown that by applying pressure to the inner ear the excess endolymph fluid can be reduced and thus relieve the symptoms.  It is believed that the mechanism of the reduction is a combination of mechanical and chemical processes.

The Meniett Low Pressure Pulse Generator delivers a complex algorithm of low-pressure pulses (a maximum of 35 cm of H2O) that are transmitted to the middle ear space and act on the round window membrane.  It is believed that the energy of the pressure pulses causes a displacement of the perilymphatic fluid which stimulates endolymphatic fluid flow resulting in a reduction of endolymphatic fluid.  This treatment requires the prior insertion of a tympanostomy tube through the eardrum to enable the pressure pulses to be transmitted into the middle ear where they have a positive effect. 

The patient receives in-office training with the device.  The stimulator is used to administer treatment three times a day (five minutes per session).  The treatments continue until remission.  Thereafter, treatment depends on the duration and severity of symptoms.

There is no cure for Ménière’s disease. If conservative treatment is not effective, surgeries and other procedures are sometimes performed.  A list of these procedures includes: 

  • Endolymphatic sac decompression,
  • Labyrinthectomy,
  • Vestibular neurectomy,
  • Chemical labyrinthectomy (using gentamycin or streptomycin).
Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusion or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Meniett Low Pressure Generator may be considered medically necessary for patients with Meniere’s disease who are experiencing intractable vertigo (vertigo resistant to relief or control) with or without nausea and/or vomiting, hearing loss, tinnitus or a feeling of fullness in the ear, and for whom other conservative medical therapy has failed to control symptoms.

Conservative medical therapies may include symptomatic treatments such as:

  • Dietary changes such as restriction of salt;
  • Lifestyle changes such as the elimination of smoking and caffeine, and an increase in exercise; and
  • Medications such as diuretics, Valium (Diazepam) and Benzodiazepines.

NOTE:  There should be a six-week trial period before final purchase of the Meniett Low Pressure Pulse Generator to determine if it is effective for the individual patient.  There should be a decrease in the subjective symptoms, which may be evaluated using patient diaries or visual analog scales.  Return to work or return to activities of daily living are also signs that the Meniett Low Pressure Pulse Generator is helping to control the symptoms.

Rationale

When conservative treatment has been tried and failed, a patient with Ménière's disease has few other non-surgical options.  Even though the Meniett Low Pressure Pulse Generator requires an office based tympanostomy tube placement, it is less invasive than other surgical alternatives. There were no adverse effects noted in the studies reviewed.  In the studies, no patient became worse while using it.  There were relapses if treatment was not continued and symptoms were relieved when treatment was resumed.

Barbara, et al. reported on a clinical trial of patients with Mèniére’s disease using the Meniett device once a ventilation tube (VT) had been placed in the affected ear.  A comparison was made of the number of vertigo spells during the two months preceding treatment and during the forty-day treatment period.  In addition, within this latter period a comparison was made between use of VT and use of VT plus Meniett.  Use of VT only had a positive effect in 90% of patients, with either absence (n = 10: 50%) or marked reduction (n = 8:40%) in episodes of vertigo.  When Meniett was also applied, stabilization of the positive effect on vertigo was registered, with a concomitant improvement in hearing threshold in two patients (10%).  The authors concluded that this therapeutic approach has been proven to induce a dramatic improvement in the symptoms affecting patients with Mèniére’s disease.

The effects of middle ear pressure pulses were studied in 37 patients with a diagnosis of definite Mèniére's disease and active vestibular symptoms, 31 of whom had failed to respond to medical treatment including diuretics prior to pressure treatment.  The number of vertigo spells during the six months prior to treatment and for six, eighteen and twenty-four months after the start of treatment were evaluated.  The functionality level scores were three or worse according to the American Academy of Otolaryngology-- Head and Neck Surgery (AAO-HNS) criteria.  The results of the study were as follows: 19 patients experienced freedom from vertigo spells; 15 patients reported a significant decrease in the frequency of vertigo spells; and three patients did not respond to pressure treatment and were subjected to gentamicin injections, one of whom consequently became deaf in the affected ear.  No patient became worse in connection with pressure treatment.  With the exception of the three patients who did not respond to pressure treatment, all patients reported an improvement in functionality of at least two levels according to the AAO-HNS functionality scale.  No side effects or adverse events were observed during the two years of pressure treatment.  Overall, the results indicate that pressure treatment provides efficient control of symptoms in patients with intractable forms of Mènéire's disease without producing any adverse effects on the inner ear.

Rajan, et al. conducted an independent investigation of the long term efficacy and safety of transtympanic pressure treatment in the management of recalcitrant vertigo in Mèniére’s disease. The design was a cross-sectional study of eighteen patients with Mèniére’s disease, suffering from intractable symptoms.  Twelve out of eighteen patients showed significant improvement in the functional score and in the visual analogue scale (VAS).  Five patients displayed an audiometric improvement, out of which three patients showed a pertaining significant hearing gain of more than ten decibels; the remainder had stable hearing levels.  Of six patients without any improvement, four had previous invasive surgery for their Mèniére’s disease and two had previous vestibular ablation with gentamicin.  No changes in vestibular function were noted.  In conclusion, the Meniett device seems to be a minimally invasive, non-destructive treatment tool, which can reduce vertigo and associated functional handicap in Mèniére’s disease.  These effects are maintained for up to eighteen months after treatment.  Previous surgical or chemical vestibular ablation procedures may adversely influence the effect of the Meniett device.

Thomsen et al. conducted a clinical, randomized, multicenter, double-blind, placebo controlled study of 40 patients with Mèniére's disease.  Primary study endpoints were change in frequency of vertigo, change of functionality profile, and change in patient perception of vertigo VAS; secondary endpoints were perception of tinnitus, aural pressure, and hearing, as well as an audiologic evaluation of hearing before and after the treatment period.  The functionality level improved statistically significantly in the active group compared with the placebo group (p=0.0014), as did the VAS evaluation of vertigo (p=0.005).  There was a trend toward a reduction of the frequency of vertiginous attacks that was not significant (p=0.090).  With regard to the secondary endpoints, there was no statistical difference between active and placebo groups. The authors concluded that local overpressure treatment is a novel treatment that is noninvasive, nondestructive, and safe.  It significantly reduces vestibular symptoms in patients with Mèniére’s disease.

Gates, et al conducted a randomized, placebo-controlled, double-blind, multicenter clinical trial of four months duration.  These trials were set up in four study sites; three academic medical centers and one private practice.  The study included 67 people ages 33 to 71 years with established, active, unilateral cochleovestibular Mèniére’s disease randomly assigned to a treatment or control group.  The Meniett device was self-administered three times daily.  The placebo Meniett device was identical but exerted no pressure.  All participants had a tympanostomy tube inserted in the affected ear.  The treatment group experienced significantly less severe vertigo, fewer days with definitive vertigo, and fewer days lost from work during the follow-up period than did the control group.  Hearing and electrocochleographic results did not differ between the groups.  Outcomes did not differ by age, gender, laterality, or duration of symptoms.  Outcomes were affected by vestibular loss and baseline level of vertigo.  The tympanostomy tube had no short-term effect on vertigo symptoms.  The authors concluded that the Meniett device is a minimally invasive, safe, and efficacious intermediate treatment for people with substantial vertigo uncontrolled by medical therapy.

A search of the MEDLINE database for the period of May 2004 through February 2007 identified one randomized trial along with several case series.  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 (two-month) monitoring period.

Gates and colleagues reported two-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; three 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 two years, 14 (24%) dropped out to seek alternative surgical treatment, five (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 two years.  This assessment is limited, however, by the lack of a control group with ventilation tubes followed up over the same period.

2013 Update

A search of peer reviewed literature through June 2013 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

Rationale for Benefit Administration

ICD-9 Codes
386.00 – 386.04
ICD-10 Codes
H81.01-H81.09
Procedural Codes: A4638, E2120
References
  1. State of Texas Insurance Code.  Speech and Hearing.  Article 3.70-2(G).  Austin, Texas.  Update (2004 March 22).
  2. State of Oklahoma Insurance Code.  §36-6060.7.  Added by Laws 1999, c. 136, § 1, eff. Nov. 1, 1999.  Amended by Laws 2002, c. 30, § 1, effective. (2002 November 1).
  3. Odkvist, L.M., Arlinger, S., et al.  Effects of middle ear pressure changes on clinical symptoms in patients with Mèniére's disease – a clinical multicentre placebo-controlled study.  Acta Otolaryngologica Supplementum (2000) 543: 99-101.
  4. Densert, B., Sass K.  Control of symptoms in patients with Mèniére's disease using middle ear pressure applications: two year follow-up.  Acta Otolaryngoogica (2001 July) 121(5): 616-21.
  5. Barbara, M., Consagra, C. et al.  Local pressure protocol, including Meniett, in the treatment of Mèniére's disease: short term results during active stage.  Acta Otolaryngoogical (2001 December) 121(8): 939-44.
  6. Gates, G.A., Green, J.D.  Intermittent pressure therapy of intractable Mèniére’s disease using the Meniett device: a preliminary report Laryngoscope (2002 August) 112(8 Pt 1): 1489-93.
  7. Gates, G.A., Green, J.D., et al.  The effects of transtympanic micropressure treatment in people with unilateral Meniere’s disease.  Archives of Otolaryngology – Head and Neck Surgery (2004) 130(6):718-25.
  8. Thomsen, J., Sass, K., et al.  Local overpressure treatment reduces vestibular symptoms in patients with Mèniére’s disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study.  Otology and Neurotology:  official publication of the Otological society, American Neurological Society and European Academy of Otology and Neurotology.  (2005 January) 26(1): 68-73.
  9. Perez, R., Ducati, A., et al.  Retrosigmoid approach for vestibular neurectomy in Mèniére’s disease.  Acta Neurochirurgica.  (2005 April) 147(4): 401-4.
  10. Rajan, G.P., Din, S., et al.  Journal of Laryngology and Otology (2005 May) 119(5): 391-5.
  11. Kim, H.H., Wiet, R.J., et al.  Trends in the diagnosis and the management of Mèniére’s disease:  results of a survey.  Otolaryngology – Head and Neck Surgery (2005 May) 132(5): 722-6.
  12. eMedicine.com – Inner ear, Mèniére’s disease, medical treatment November 2, 2005.  eMedicine (accessed-- 2005 June 2) http://www.emedicine com .
  13. Gates, G.A., Verrall, A., et al.  Meniett clinical trial: long-term follow-up.  Archives of Otolaryngology Head and Neck Surgery (2006) 132(12):1311-6.
  14. Transtympanic Micropressure Applications as a Treatment of Meniere’s Disease. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2013 May) Durable Medical Equipment 1.01.23.
History
December 2012  Policy updated with literature search through August 2012; references 12 and 14 added; policy statement unchanged.
December 2013 Policy formatting and language revised.  Title changed from "Transtympanic Micropressure Applications as a Treatment of Meniere's Disease" to "Meniett Low Pressure Pulse Generator for Menieres Disease".  Policy statement changed from investigational to possibly medically necessary.
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Meniett Low Pressure Pulse Generator for Menieres Disease