Medical Policies - DME


Transtympanic Micropressure Applications as a Treatment of Meniere Disease

Number:DME101.043

Effective Date:07-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

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

Description:

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 and incapacitating and may impede 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.

Treatment

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 treatment approach 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 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.

Regulatory Status

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

Rationale:

This medical policy was created in 2003 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through January 16, 2018.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Meniere disease has a variable natural history, with waxing and waning symptomatology and spontaneous recovery. Also, some outcome measures are subjective and, thus, may be particularly susceptible to placebo effects. For of these reasons, controlled trials are essential to demonstrate the clinical effectiveness of treatment of transtympanic micropressure therapy compared with alternatives (e.g., continued medical management).

Transtympanic Micropressure Therapy for Meniere Disease

The data submitted to the U.S. Food and Drug Administration (FDA) as part of the FDA approval process of the Meniett device consisted of a case series of 20 patients. (1) Other case series have also been published in the peer- reviewed literature, some reporting 2- to 4-year outcomes in patients who had failed medical therapy. (2-8) These case series do not provide significant information about the comparative effectiveness of the Meniett device due to the lack of control groups, and they will not be discussed further in this review. The remaining literature review focuses on systematic reviews and RCTs.

Systematic Reviews

A 2015 Cochrane review on positive pressure therapy for Meniere disease included 5 double-blind, placebo-controlled randomized trials (total N=265 patients). (9) Three trials were considered to be at low risk of bias, 1 was at unclear risk, and 1 was at high risk of bias. Results on the primary outcome measure (control of vertigo) could not be pooled due to heterogeneity in measurement, but most trials showed no significant difference in vertigo between Meniett therapy and placebo. Reviewers concluded that evidence did not support the effectiveness of positive pressure therapy for the treatment of Meniere disease and that there is some evidence that hearing is impaired with this treatment. Another systematic review (2015), which included 4 of the same RCTs that specifically used the Meniett device, also found no significant difference between low pressure therapy and placebo for the frequency of vertigo. (10)

Randomized Controlled Trials

The 3 trials, considered to be of low risk of bias in the Cochrane review, are described next.

Gates et al. (2014) reported on 4-month results of a randomized, multi-institutional study that enrolled 67 patients with active unilateral Meniere disease refractory to a 3-month trial of medical management. (11) All patients underwent tympanostomy, and patients were additionally randomly assigned to a sham device or a Meniett device. Over the entire 4-month trial, there was a significant difference in the total number of episodes of vertigo in the treatment group compared with the control group. However, the difference between the groups was most apparent at 1 month, while at 4 months the treatment effect had 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. This study was limited by a number of methodologic issues related to the data analysis, and results did not permit drawing conclusions about the impact of this device on patient outcomes.

Gates et al. (2016) reported on the 2-year, open-label, follow-up to the 2004 randomized trial. (12) At the end of the randomized phase of the trial, 61 of 67 patients from both the control and active treatment arms were treated with the Meniett device. Vertigo episodes were reported on a daily symptom diary or by a structured telephone interview. Of the 58 patients followed 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. Patients who went into remission had an 80% probability of remaining in remission for the 2 years. This assessment is limited, however, by the lack of a control group followed over the same period.

A multicenter, double-blind, placebo-controlled trial of 63 patients by Thomsen et al. (2005) compared micropressure devices with ventilation tubes and sham pressure devices. (13) This trial reported an improvement in functionality (American Academy of Otolaryngology-Head and Neck Surgery criteria) and a trend (p=0.09) toward a reduction in episodes of vertigo for the active treatment group compared with controls. 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 significant differences in secondary outcome measures (patient’s perception of tinnitus, aural pressure, hearing). In addition to a marginal improvement in efficacy over ventilation tubes with sham pressure, this trial was limited by a high dropout rate (37%), lack of intention-to-treat analysis, and short (2-month) monitoring period.

Gurkov et al. (2012) reported on a randomized, double-blind, sham-controlled trial with the Meniett device. (14) After a 4-week baseline period, 74 patients underwent ventilation tube placement and were monitored for another 4 weeks. Patients were then randomized to 16 weeks of active or sham treatment (5 minutes, 3 times daily). The primary outcomes were subjective vertigo score, number of definitive vertigo days, and number of sick days as recorded on a daily log over the last 4 weeks of treatment. Sixty-eight (92%) patients completed the study. The cumulative vertigo score decreased by 6.5 in the active group and by 1.19 in the sham group (p=0.048). The number of vertigo days decreased by 2.42 in the active treatment group and by 0.42 in the sham group (p=0.102), and the number of sick days decreased by 2.32 in the active treatment group and increased by 0.58 days in the sham group (p=0.041). There was no significant difference between groups in the vertigo-free days, activity score, hearing level, or slow phase velocity. This trial showed a modest improvement in 2 of 5 subjective measures, but not in objective outcome measures, with the Meniett device.

Subsequent to the 2015 Cochrane review, Russo et al. (2017) reported on an industry-sponsored, multicenter, double-blind RCT of the Meniett device. (15) A total of 129 patients with Meniere disease not controlled by medical treatment were withdrawn from any vertigo treatment and received placement of a transtympanic tube. Patients (n=97 [75%]) who continued to have symptoms (≥2 vertigo episodes during a 6-week period) after placement of a transtympanic tube were randomized to an active or sham device for 6 weeks and then were followed for an additional 6 weeks. The number of vertigo episodes during the baseline period did not differ significantly between groups (p=0.07). The trial was powered to detect a 30% difference in vertigo episodes compared with the sham group. Per protocol analysis showed a significant decrease in vertigo episodes in both groups (see Table 1), but no between-group difference (p=0.11), suggesting a possible effect of the transtympanic tube. Vertigo-related quality of life also did not differ between groups.

Table 1. Number of Vertigo Episodes

Treatment Arms

Before Treatment (SEM)

During Treatment (SEM)

After Treatment (SEM)

Active

3.2 (0.4)

2.5 (NR)a

1.5 (0.02)b

Sham

4.3 (0.6)

2.6 (0.05)a

1.8 (0.8)b

NR: not reported; SEM: standard error of the mean.

a p<0.05 vs baseline

b p<0.005 vs during treatment.

Summary of Evidence

For individuals who have Meniere disease who receive transtympanic micropressure therapy (Meniett), the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Six RCTs 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 improvement 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.

Practice Guidelines and Position Statements

American Academy of Otolaryngology-Head and Neck Surgery

In 2016, the American Academy of Otolaryngology-Head and Neck Surgery updated its position statement on the use of transtympanic micropressure: “We find that there is some medical evidence to support the use of micropressure therapy (such as the Meniett device) in certain cases of Meniere disease. Micropressure therapy is best used as a second level therapy when medical treatment has failed. The device represents a largely non-surgical therapy that should be available as one of the many treatments for Meniere’s disease.” (16) No supporting evidence was provided.

National Institute for Clinical Excellence

In 2012, guidance from the United Kingdom’s National Institute for Clinical Excellence concluded that “[c]urrent evidence on the safety of micropressure therapy for refractory Ménière’s disease is inadequate in quantity. There is some evidence of efficacy, but it is based on limited numbers of patients. Therefore, this procedure should only be used with special arrangements….” (17)

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in January 2018 did not identify any ongoing or unpublished trials that would likely influence this review.

Contract:

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 exclusions 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.

Coding:

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.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

None

HCPCS Codes

A4638, E2120

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. U.S. Food and Drug Administration (FDA). FDA 510(k) marketing clearance information for the Meniett® device. Available at < http://www.accessdata.fda.gov> (accessed January 16, 2018).

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):939-944. PMID 11813899

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):616-621. PMID 11583396

4. 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):1489-1493. PMID 12172267

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):1136-1141. PMID 17851896

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):868-874. PMID 18617868

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. PMID 18199955

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):1408-1413. PMID 19922090

9. van Sonsbeek S, Pullens B, van Benthem PP. Positive pressure therapy for Ménière's disease or syndrome. Cochrane Database Syst Rev. 2015; 3:CD008419. PMID 25756795

10. Syed MI, Rutka JA, Hendry J, et al. Positive pressure therapy for Meniere’s syndrome/disease with a Meniett device: a systematic review of randomized controlled trials. Clin Otolaryngol. Jun 2015; 40(3):197-207. PMID 25346252

11. 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):718-725. PMID 15210552

12. Gates GA, Verrall A, Green JD, Jr., et al. Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg. 2006; 132(12):1311-1316. PMID 17178941

13. 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. 2005; 26(1):68-73. PMID 15699722

14. Gurkov R, Filipe Mingas LB, Rader T, et al. Effect of transtympanic low-pressure therapy in patients with unilateral Menierè's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial. J Laryngol Otol. Apr 2012; 126(4):356-362. PMID 22365373

15. 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

16. American Academy of Otolaryngology - Head and Neck Surgery. Position statement: micropressure therapy. (2016). Available at <http://www.entnet.org> (accessed January 16, 2018).

17. National Institute for Clinical Excellence (NICE). Micropressure therapy for refractory Ménière's disease. NICE interventional procedure guidance 426. (2012). Available at < http://www.nice.org.uk> (accessed January 16, 2018).

18. Transtympanic Micropressure Applications as a Treatment of Meniere Disease. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 February) Durable Medical Equipment 1.01.23.

Policy History:

Date Reason
7/1/2018 Document updated with literature review. Coverage unchanged. References 15-16 added.
6/1/2017 Reviewed. No changes.
10/1/2016 Document updated with literature review. The following change was made to Coverage: position changed from “experimental, investigational and/or unproven” to “not medically necessary”.
3/15/2015 Reviewed. No changes.
7/1/2014 Document updated with literature review. The following change was made to Coverage: Transtympanic micropressure applications as a treatment of Meniere's disease are considered experimental, investigational and/or unproven. CPT/HCPCS code(s) updated. Title changed from “Meniett Low Pressure Pulse generator for Menieres Disease”.
4/15/2008 Policy reviewed without literature review; new review date only.
5/15/2006 Revised/updated entire document
12/1/2003 New medical document

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