Medical Policy: 08.01.25 

Original Effective Date: April 2017 

Reviewed: April 2020 

Revised: April 2020 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

The Eustachian tube is formed by an osseous part and a fibrocartilaginous part. Its function is to provide ventilation, drainage, and protection to the middle ear, as well as maintaining the same pressure present in the external environment (atmospheric pressure) in the tympanic cavity.

 

Eustachian tube dysfunction (ETD) is a common clinical condition of the middle ear that can affect patients of all ages. ETD occurs if the Eustachian tube becomes blocked, if the lining of the tube swells, or if the tube does not open fully to allow air to travel to the middle ear. The causes of ETD are both extrinsic and intrinsic to the Eustachian tube. The symptoms are hearing loss, dull hearing, and very rarely ear pain. These symptoms can occur when carrying out a variety of activities including air travel, mountain hiking, swimming, and diving activities. An important limitation with the available evidence is a lack of consensus on the definition and diagnosis of this disorder. Although in a strict sense Eustachian tube dysfunction is a failure to perform any of the Eustachian tube functions, in clinical practice, Eustachian tube dysfunction usually refers to a problem with the ventilatory function of the Eustachian tube. Otitis media with effusion (OME) is defined as a collection of fluid in the middle ear without signs or symptoms of ear infection and typically arises when the Eustachian tubes are not functioning normally. As such, Eustachian tube dysfunction is defined by symptoms and signs of pressure dysregulation in the middle ear. This can be both an acute or chronic (more than 3 months of signs and symptoms) condition. In many cases, the ETD is mild and does not last longer than a few days or a week.

 

In treating Eustachian tube dysfunction, obstructive dysfunction should be differentiated from patulous dysfunction during the clinical evaluation. Obstructive dysfunction is best differentiated by accompanying symptoms of hearing loss and abnormalities of the tympanic membrane such as retraction or middle ear effusion. Patulous dysfunction should be suspected when the primary complaint is autophony (hearing one's own voice and breathing sounds), yet there is no complaint of hearing loss and the tympanic membrane appears normal. Clinicians may be tempted to consider patients complaining of ear blockage as having obstructive dysfunction. However, ear blockage can occur in both obstructive and patulous dysfunction as well as other causes of aural fullness. Obstructive dysfunction treatments for patulous dysfunction will fail to help and may even exacerbate the symptoms.

 

Ear Popper® (autoinflation)

The EarPopper® is a non-invasive device for treating conditions such as otitis media with effusion, middle ear effusion, aerotitis/barotitis and eustachian tube dysfunction, without the need for surgery or antibiotics. The EarPopper® balances pressure in the middle ear by delivering a constant stream of air into the nasal cavity. During the moment of swallowing, the air opens the Eustachian Tube, clearing the middle ear, relieving negative ear pressure and allowing any fluids to drain.

 

Eustachian Tube Tuboplasty

Balloon Tuboplasty or Eustachian tube tuboplasty is a procedure approved by the FDA for adults with Eustachian tube dysfunction. This procedure uses a modified catheter that is introduced inside the Eustachian tube, using a special microendoscope to allow positioning. Once the catheter is introduced, the balloon located on its distal end is inflated by introducing a saline solution. This pressure is kept unvaried for two minutes. Then, the balloon is deflated and the catheter is removed under endoscopic vision.

 

The evidence for balloon dilation for Eustachian tube dysfunction (ETD) consists of case series, systematic reviews of these case series, cohort studies and a single RCT with additional follow-up. Evidence limitations includes failure to diminish a high risk of bias and lack of comparison between Eustachian tube dilation with other treatments or no treatments.

 

Practice Guidelines and Position Statements

NICE (National Institute for Health and Clinical Excellence)

Balloon dilatation of the Eustachian tube should only be used in the context of research, which should address the efficacy of the procedure in the short and longer term, and also document safety outcomes. Research studies should clearly describe which parts of the Eustachian tube are being treated and report subjective measurements of symptom improvement and objective measurements of Eustachian tube function. Current evidence on the efficacy and safety of balloon dilatation of the Eustachian tube is inadequate in quantity and quality.

 

Evidence update (2019) NICE completed an interventional procedure overview of available evidence.

 

Regulatory Status

Currently the ACCLARENT AERA™ Eustachian Tube Balloon Dilation System and the XprESS™ ENT Dilation System (Entellus Medical, Plymouth, MN) are approved by the U.S. Food and Drug Administration (FDA) for Eustachian Tube Dysfunction (ETD).

 

Prolaryn® Plus is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. It does not have approval for use in Eustachian tube dysfunction or patulous Eustachian tube.

 

Prior Approval:

Not applicable.

 

Policy:

The EarPopper device for the treatment of otitis media with effusion and Eustachian tube dysfunction or any other condition is considered investigational.

 

The use of the Eustachian tube balloon dilation systems for Eustachian tube dysfunction (either endoscopic or trans-tympanic) or any other condition is considered investigational.

 

Injection of synthetic implant or bulking agent (e.g. Prolaryn Plus) is considered investigational for the treatment of Eustachian tube dysfunction and patulous Eustachian tube. 

Rationale

Given the natural history of OME/ Eustachian tube dysfunction, particularly in relation to the high instance of spontaneous resolution, clinical decisions are complicated, and despite recent practice guidelines and systematic reviews, the comparative benefits and harms of treatments and treatment strategies for OME/Eustachian tube dysfunction are uncertain. There is no consensus or guidelines on indications for treatment, or on the optimal timing of the interventions. The longevity of symptom management is uncertain for both the auto inflation and Eustachian tube tuboplasty procedures. Currently there is a need to understand and develop the technique further. Prolaryn Plus does not have approval or evidence of efficacy for Eustachian tube dysfunction or patulous Eustachian tube.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 69705 Nasopharyngoscopy, surgical, with dialation of eustachian tube (ie, balloon dilation); unilateral
  • 69706 Nasopharyngoscopy, surgical, with dialation of eustachian tube (ie, balloon dilation); bilateral
  • 69799 Unlisted procedure, middle ear
  • C1726 Catheter, balloon dilatation, nonvascular
  • C1878 Material for vocal cord medialization, synthetic implantable (may be used for Prolaryn Plus) 
  • E1399 Durable medical equipment, miscellaneous (may be used for EarPopper®)

 

Selected References:

  • Banigo A, Hunt A, Rourke T, et al. Does the EarPopper(®) device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial. Clin Otolaryngol. 2016;41(1):59-65.
  • Yegin Y, Çelik M, Olgun B, et al. Is ventilation tube insertion necessary in children with otitis media with effusion? Otolaryngol Pol. 2015;69(6):39-44.
  • National Institute for Health and Clinical Excellence (NICE). Surgical management of otitis media with effusion in children. NICE Clinical Guideline 60. London, UK: NICE; February 2008.
  • Shekelle P, Takata G, Chan LS, et al. Diagnosis, History, and Late Effects of Otitis Media With Effusion. Evidence Report/Technology Assessment No. 55 (Prepared by Southern California Evidence-based Practice Center under Contract No 290-97-0001, Task Order No. 4). Rockville, MD: Agency for Healthcare Research and Quality; 2003. AHRQ Publication No. 03-E023.
  • National Institute for Health and Care Excellence. Balloon Dilation of the Eustachian tube [IPG 409]. 2011.
  • National Institute for Health and Care Excellence. Interventional procedure overview of balloon dilation for chronic eustachian tube dysfunction [IPG 665]. 2019
  • Agency for Healthcare Research and Quality. Otitis media with effusion: Comparative effectiveness of treatments. August 7, 2012. AHRQ: Rockville, MD.
  • BMJ Publishing Group Ltd. Eustachian Tube Dysfunction. 2012.
  • Schilder A, Bhutta M, Butler C, et al. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clinical Otolaryngology. 2015;40(5):407-411.
  • Adil E. Poe D. What is the full range of medical and surgical treatments available for patients with Eustachian tube dysfunction? Curr. Opin. Otolaryngol. Head Neck Surg. 2014;22:8–15.
  • Doyle WJ, Swarts JD, Banks J, et al. Sensitivity and specificity of eustachian tube function tests in adults. JAMA Otolaryngol. Head Neck Surg. 2013;139:719–727.
  • FDA Approval Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System. Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016.
  • Huisman JML, Verdam FJ, Stegeman I, et al. Treatment of Eustachian tube dysfunction with balloon dilation: A systematic review. Laryngoscope. Jan 2018;128(1):237-247. PMID 28799657
  • Poe D, Anand V, Dean M, et al. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. Sep 20 2017. PMID 28940574
  • Anand V, Poe D, Dean M et al. (2019) Balloon dilation of the eustachian tube: 12-month follow-up of the randomized controlled trial treatment group. Otolaryngology - Head & Neck Surgery 160: 687–94
  • Ward BK, Chao WC, Abiola G, Kawai K, Ashry Y, Rasooly T, Poe DS.Twelve-month outcomes of Eustachian tube procedures for management of patulous Eustachian tube dysfunction Laryngoscope. 2019 Jan;129(1):222-228. doi: 10.1002/lary.27443.
  • Food and Drug Administration. 510(k) Summary: XprESS ENT Dilation System. 2017.
  • Food and Drug Administration. De Novo Classification Request For Acclarent Aera™ Eustachian Tube Balloon Dilation System. 2015,
  • ECRI Institute, Custom Product Briefs. Acclarent Aera Eustachian tube balloon dilation system for treating persistent Eustachian tube dysfunction. 3/6/2018.
  • Satmis MC, van der Torn M. Balloon dilatation of the Eustachian tube in adult patients with chronic dilatory tube dysfunction: a retrospective cohort study. Eur Arch Otorhinolaryngol. Feb 2018;275(2):395-400. PMID 29285624
  • Meyer TA, O'Malley EM, Schlosser RJ, et al. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. Aug 2018;39(7):894-902. PMID 29912819
  • Cutler JL, Meyer TA, Nguyen SA et al. (2019) Long-term outcomes of balloon dilation for persistent eustachian tube dysfunction. Otology & Neurotology 40 doi: 10.1097/MAO.0000000000002396
  • Eustachian tube inflation; transnasal; with catheterization 69799 Investigational Evidence of benefit has not been established Poe D, Bassam H, Eustachian tube dysfunction In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated Jun 25, 2018.
  • PROLARYN GEL [instructions for use]. Greensboro, NC: Merz North America, Inc.; 2014.

 

Policy History:

  • April 2020 - Annual Review, Policy Revised
  • April 2019 - Annual Review, Policy Revised
  • April 2018 - Annual Review, Policy Revised
  • April 2017 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.