Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Transtympanic Micropressure Device as a Treatment of Meniere Disease
Policy #:MA05.065

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

Although the US Food and Drug Administration (FDA) has approved devices for the treatment of Meniere disease, the Company has determined that the available published peer-reviewed literature does not support transtympanic micropressure devices as a useful aid in the treatment of illness or injury. Therefore, transtympanic micropressure devices are considered not medically necessary by the Company and not covered.
Policy Guidelines

Subject to the terms and conditions of the applicable Evidence of Coverage, transtympanic micropressure device as a treatment of Meniere disease is not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered not medically necessary and, therefore, not covered.


Description

In 1999, the Meniett® device (Medtronic Xomed, Inc., Jacksonville, Florida) received 510(k) approval by the US Food and Drug Administration (FDA). The Meniett® is a low-pressure pulse generator developed to provide treatment for the vertigo symptoms of Meniere disease. This portable handheld medical device sends painless micropressure pulses to your inner ear. Prior to using the Meniett®, a tiny tube is placed in the eardrum that allows the pressure pulses to reach the inner ear. The recommended therapy last for about 6 weeks.  

Meniere disease is characterized by a set of episodic symptoms including vertigo (attacks of a spinning sensation), hearing loss, tinnitus (a ringing sound in the ear), and a sensation of fullness or pressure in the affected ear. Episodes typically last from 20 minutes up to 4 hours. Hearing loss is often intermittent, occurring mainly at the time of the attacks of vertigo. Loud sounds may seem distorted and cause discomfort. Typically, the hearing loss involves mainly the lower pitches, but over time, often affects tones of all pitches. After months or years of the disease, hearing loss often becomes permanent. Tinnitus and fullness of the ear may come and go with changes in hearing, occur during or just before attacks, or be constant.

Meniere disease is also called idiopathic endolymphatic hydrops and is one of the most common causes of dizziness originating in the inner ear. In most cases only one ear is involved, but both ears may be affected in about 15 percent of individuals. Meniere disease typically starts between the ages of 20 and 50 years, affecting men and women equally.

Meniere disease is a chronic condition with no cure. However, there are a variety of treatments for Meniere disease that may help with the symptoms. These range from medication to surgery for the most severe cases. Treatment using medication usually alleviates the symptoms of Meniere disease, such as motion sickness, vertigo, nausea, and vomiting.

A 2015 Cochrane review on positive pressure therapy for Meniere disease included five double-blind, placebo-controlled RCTs (total N=265 patients). Three of the studies were considered to be at low risk of bias, one was at unclear risk, and one study 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® device therapy and placebo. This review supports the conclusion that there is no evidence that positive pressure therapy is effective for the treatment of Meniere disease, and that there is some evidence that hearing is impaired with this treatment.

In addition, another systematic review, which included four of the same RCTs that specifically used the Meniett® device, also found no significant difference between low pressure therapy and placebo for the treatment of vertigo.
Based on the available evidence, the Meniett® device is unlikely to improve the net health outcome in individuals with Meniere. There are no published studies that addressed the use of the Meniett® device for individuals with other conditions.
References

American Academy of Otolaryngology - Head and Neck Surgery. AAO-HNS position on micropressure therapy. 2012. Available at: http://www.entnet.org/Practice/micropressure.cfm. Accessed August 8, 2019.

American Academy of Otolaryngology - Head and Neck Surgery.Available at:
http://www.enthealth.org/conditions/menieres-disease. Accessed August 8, 2019.

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.

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.

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.

Dornhoffer JL, King D. The effect of the Meniett device in patients with Meniere's disease: long-term results. Otol Neurotol. 2008;29(6):868-874.

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):1489-1493.

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.

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.

Gurkov R, Filipe Mingas LB, Rader T, 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. 2012;126(4):356-362.

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.

National Institute for Clinical Excellence (NICE). Micropressure therapy for refractory Ménière's disease. NICE interventional procedure guidance 426. 2012: Available at; http://guidance.nice.org.uk/IPG426/Guidance/pdf/English. Accessed August 8, 2019.

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.

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

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

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. 2015;40(3):197-207.

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.

United States (US) Food and Drug Administration. FDA 510(k) marketing clearance information for the Meniett device. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf/K991562.pdf. Accessed August 8, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



A4638 Replacement battery for patient-owned ear pulse generator, each

E2120 Pulse generator system for tympanic treatment of inner ear endolymphatic fluid


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA05.065
09/25/2019The policy has been reviewed and reissued to communicate the Company's continuing position on a Transtympanic Micropressure Device as a Treatment of Meniere's Disease.


MA05.065
04/25/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on the transtympanic micropressure device as a treatment of Meniere disease.
03/29/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on the transtympanic micropressure device as a treatment of Meniere disease.
10/01/2016This version of the policy will become effective 10/01/2016.

The following new policy has been developed to to communicate the Company’s position for transtympanic micropressure applications as a treatment of Meniere disease.






Version Effective Date: 10/01/2016
Version Issued Date: 09/30/2016
Version Reissued Date: 09/25/2019