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Date Printed: August 18, 2017: 08:00 PM

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09-E0000-46

Original Effective Date: 12/15/03

Reviewed: 01/27/11

Revised: 10/01/16

Subject: Transtympanic Micropressure Applications as a Treatment of Meniere’s Disease

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Meniere’s disease is an idiopathic disorder of the inner ear that is usually characterized by four symptoms:

The underlying pathophysiology of the disease is unknown, however, it is thought to be related to a disturbance in the pressure/volume relationship of the endolymph within the inner ear.

Conservative therapy includes low sodium diet and diuretics to reduce the fluid accumulation (hydrops), and pharmacologic therapy to reduce vestibular symptoms. Individuals not responding to these measures may receive gentamicin drops in the ear as a technique of chemical labyrinthectomy, to ablate vestibular function on the affected side. There is no available therapy to restore hearing loss.

Research has shown that the symptoms of Meniere’s disease improve with fluctuations in ambient pressure, and patients with acute vertigo have been treated successfully 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 middle ear, thus relieving vertigo. In 1999, the Meniett device (Medronic Xomed) received clearance to market through a U.S. Food and Drug Administration (FDA) 510(k) process specifically as a symptomatic treatment of Meniere’s disease. The device consists of a hand-held air pressure generator that delivers intermittent complex pressure pulses.

Use of the Meniett device consists of 2 phases:

  1. A conventional ventilation tube is surgically placed in the eardrum of the ear to be treated; AND
  2. Patients are instructed to place an ear-cuff in the external ear canal to minimize leakage to the external environment.

Patients are instructed to treat themselves three times daily for three minutes each time. The treatment is continued for as long as the individual has attacks of vertigo. During periods of remission, no treatment is needed.

POSITION STATEMENT:

Transtympanic micropressure applications as a treatment of Meniere’s disease meet the definition of medical necessity for individuals experiencing intractable vertigo, resistant to relief or control, with or without any of the following symptoms/conditions:

NOTE: Other conservative therapy includes dietary changes, lifestyle changes, and medications.

BILLING/CODING INFORMATION:

CPT Coding:

There is no specific CPT code describing this device.

HCPCS Coding:

A4638

Replacement battery for patient-owned ear pulse generator, each

E2120

Pulse generator system for tympanic treatment of inner ear endolymphatic fluid

LOINC Codes:

The following information may be required documentation to support medical necessity: Physician history and physical notes, laboratory tests reports.

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note or treatment notes

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Clinical notes and chart section

28650-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date.

DEFINITIONS:

Ambient pressure: surrounding pressure within the inner ear.

Endolymphatic fluid: the fluid contained within the membranous labyrinth of the inner ear.

Hydrops: an excessive accumulation of clear, watery fluid in any of the tissues or cavities of the body (i.e., inner ear); synonymous with edema, ascites.

RELATED GUIDELINES:

None applicable.

OTHER:

Indexing terms:

Meniere’s disease
Meniett device

REFERENCES:

  1. American Academy of Otolaryngology – Head and Neck Surgery, AAO-HNS position statement on Micropressure Therapy, (approved 03/08).
  2. American Hearing Research Foundation. Meniere’s Disease, (website accessed 10/08/10).
  3. Blue Cross of Blue Shield Association Medical Policy 1.01.23 – Transtympanic Micropressure Applications as a Treatment Meniere’s Disease, (10/06/09).
  4. ECRI HTA News – Technology Updates. “Short-term RCT Results on Meniett Device Do Not Alter ECRI’s Previous Conclusions”, (Sept 2004).
  5. ECRI Institute, Transtympanic Micropressure Treatment for Meniere’s Disease, 12/06.
  6. ECRI Target Report. “Portable low-pressure air pulse generator to treat Ménière’s disease” #845, (April 2004).
  7. Gates, G.A., Green, J. D., Tucci, D. L., & Telian, S. A. (2004). The effects of transtympanic micropressure treatment in people with unilateral Ménière’s Disease. Archives of Otolaryngology Head and Neck Surgery, 130, 718-725.
  8. Hayes Alert Technology Assessment Brief – “Meniett Device for Treatment of Mé́niè̀̀re’s Disease,” vol VI, #4, (April 2003).
  9. Hayes, Inc., Meniett™ Low-Pressure Pulse Generator (Medtronic Xomend Inc.) for Treatment of Meniere’s Disease, 11/21/06.
  10. Thomason J, Sass K, Odkvist L, Arlinger S. Local overpressure treatment reduced vestibular symptoms in patients with Meniere’s disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Oto Neurotol. 2005 Jan; 26(1): 68-73.
  11. U.S. Food and Drug Administration (FDA) approval letter for Meniett 20 (K991562), (12/28/99).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/27/11.

GUIDELINE UPDATE INFORMATION:

12/15/03

New Medical Coverage Guideline Developed

12/15/04

Scheduled review; code added; maintain investigational.

01/01/06

Scheduled review; investigational status removed; coverage criteria added.

03/15/06

Revisions consisting of adding criteria defining duration for conservative medical treatment.

08/15/07

Reviewed; coverage statement maintained, guideline reformatted, references updated.

02/15/09

Reviewed, position statement maintained, but reformatted; references updated.

12/15/10

Revision; related ICD-10 codes added, formatting changes.

02/15/11

Reviewed; Position Statement unchanged; references updated.

09/15/11

Revision; formatting changes.

05/15/14

Revision; Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

10/01/16

Revision; coding section updated; formatting changes.

Date Printed: August 18, 2017: 08:00 PM