Balloon Dilation Of The Eustachian Tube Form

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Balloon Dilation of the Eustachian Tube - Medical Policy
Updated Revision Effective: August 1, 2024 Policy Number:

UM713POL

Approval Date: 7/30/2024

Line(s) of Business:

Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

Eustachian Tube (ET) connects the middle ear space to the nasopharynx. The ET ventilates the middle ear space to equalize pressure across the tympanic membrane, clears mucociliary secretions, and protects the middle ear from infection and reflux of nasopharyngeal contents. The tube opens during swallowing or yawning. Eustachian tube dysfunction (ETD) occurs when the functional valve of the ET fails to open and/or close properly. This failure may be due to inflammation or anatomic abnormalities. Obstructive ET dysfunction is most commonly caused by inflammation including rhinosinusitis and allergic rhinitis. Obstructive ET dysfunction can cause symptoms such as muffled hearing, ear fullness, tinnitus, and vertigo. Chronic Obstructive ET dysfunction can lead to hearing loss, otitis media, tympanic membrane perforation, and cholesteatomas.

Medical management of Obstructive ET dysfunction is directed by the identified underlying etiology,such as treatment of chronic bacterial rhinosinusitis, antihistamines, or nasal steroid sprays for allergic rhinitis; behavioral modifications and/or proton pump inhibitors for laryngopharyngeal reflux; and treatment of mass lesions. Although topical nasal steroids are commonly used for obstructive ET dysfunction, triamcinolone acetonide failed to show benefit in patients ages 6 and older presenting with otitis media with effusion and/or negative middle ear pressure in a randomized, placebo-controlled, double-blind trial published (2011). Therefore, medical treatment in the absence of an identified underlying etiology is no longer recommended. Patients who continue to have symptoms following medical management may be treated with surgery. Available surgical management includes myringotomy with the placement of tympanostomy tubes or eustachian tuboplasty. Norman et al (2014) reported that eustachian tuboplasty (other than balloon dilation) has been evaluated in 7 case series and was associated with improvement in symptoms in 36% to 92% of patients with low rates (13%-36%) of conversion to type A tympanogram (which is normal). Myringotomy and tympanostomy have been evaluated in two case series and were associated with symptom alleviation in a subgroup of patients.

Balloon Dilation of Eustachian Tube (BDET) is a minimally invasive surgical treatment for chronic eustachian tube dysfunction (ETD) refractory to medical management. In this procedure, a balloon catheter is used to dilate the cartilaginous portion of the tube through a minimally invasive transnasal endoscopic approach. Balloon dilation reduces inflammation within the lumen; the mechanism of action may be through regeneration of healthy ciliated pseudocolumnar epithelium, reduction of submucosal inflammatory infiltrate and elimination of lymphoid follicles, replacing them with a thin layer of fibrosis. These histological changes are similar to those

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seen post-adenoidectomy, suggesting that long-term resolution of inflammation is possible as long as contributing medical conditions (eg, allergic rhinitis, chronic rhinosinusitis, LPR) are effectively controlled.

 Line of Business

Commercial:
Refer to criteria under Policy section in this medical policy.

Medicaid – BeHealthy:
This procedure is non-covered by MassHealth

Medicare:
Refer to criteria under Policy section in this medical policy. Medicare does not have a National Coverage Determination (NCD) or a Local Coverage Determination (LCD) for Balloon Dilation of the Eustachian Tube.

Policy

I. Balloon Dilation of the Eustachian Tube (BDET) for treatment of 18-years-and-older adults with chronic obstructive eustachian tube dysfunction may be considered MEDICALLY NECESSARY when ALL the criteria below are met:

A. Member has been diagnosed with medically refractive persistent obstructive eustachian tube dysfunction (OETD) in 1 or both ears for 3 months or longer that significantly affects quality of life or functional health status; AND

B. Member has chronic signs and symptoms of eustachian tube obstruction, including but not limited to:

 Difficulty equilibrating pressure in ears when challenged with ambient barometric changes (baro- challenge); OR
 Hearing loss or aural fullness that is temporarily relieved if the individual is capable of performing auto-insufflation; OR
 History of negative pressure in the middle ear; OR
 Recurrent middle ear effusion; AND

C. Failure of medical management consisting of minimum of 4 weeks of continuous daily usage of any intranasal steroid spray OR minimum of 1 completed course of oral steroids; AND

D. Objective findings including either of the following:

 Pathology on dynamic endoscopic examination of the eustachian tube; OR
 If no pathological findings visible, history and physical remain consistent with obstruction within the cartilaginous eustachian tube; AND

E. If the individual had a history of tympanostomy tube placement, symptoms of obstructive eustachian tube dysfunction should have improved while tubes were patent. Trial of tympanostomy tubes are not required prior to BDET.

II. Balloon dilation of the eustachian tube (BDET) for conditions that do not meet above criteria are considered EXPERIMENTAL and INVESTIGATIONAL.

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Policy Guidelines and Definitions

Policy Guidelines:

I. Contraindications:

A. Presence of an internal carotid artery dehiscence in the ET lumen.

Definitions:

Eustachian Tube (ET): The ET connects the middle ear space to the nasopharynx and ventilates the middle ear space which equalizes the pressure across the tympanic membrane. It also clears mucociliary secretions, protects infection to middle ear and prevents reflux of nasopharyngeal contents. The ET opens upon yawning or swallowing. Chronic ETD occurs when symptoms have been present for over 3 months.

Eustachian Tube Dysfunction (ETD): Inadequate ventilation of the middle ear resulting from the failure of the functional valve of the eustachian tube to either close properly or open. Symptoms include ear pain, fullness, crackling/popping sounds, muffled hearing and pain or discomfort with barometric changes.

Balloon Dilation of the Eustachian Tube (BDET): A medical procedure designed to dilate the cartilaginous portion of the eustachian tube (ET). Goal is to treat the persistent dysfunction. The procedure involves using a guide catheter into the nose which the medical provider then threads the balloon catheter through the guide catheter. The balloon is then inflated with saline or sterile water which opens a pathway that will enable mucus and air to flow through the ET. The balloon is deflated and removed after the dilation has occurred. Usually done under general anesthesia.

ETDQ-7 scores: A disease-specific instrument for assessment of member-reported severity of ETD. Scores are on a 7-point scale with a higher score symbolizing severe symptoms. Scoring is done pre-op and post-op yielding a change score to report outcomes. Scores are reported on a scale from 1-7. The higher score indicates more severe symptoms. The total score is divided by the number of items (7) to give an overall score ranging from
1-7.

Dynamic Slow Motion Video Endoscopic Analysis (DSVE) of Eustachian Tube (ET) (or dynamic endoscopic examination of eustachian tube): A potentially useful tool in the quest for further understanding the pathophysiology of tubal dysfunction. It can assess the severity of tubal pathology. DSVE is a vital tool in diagnosing ET dysfunction in patients with middle ear disease.

Coding Guidance

Code
Description
PA 69705 NASOPHARYNGOSCOPY, SURGICAL, WITH DILATION OF EUSTACHIAN TUBE (I.E., BALLOON DILATION); UNILATERAL Yes 69706 NASOPHARYNGOSCOPY, SURGICAL, WITH DILATION OF EUSTACHIAN TUBE (I.E., BALLOON DILATION); BILATERAL Yes *Non-payable by MassHealth

CPT® Copyright 2024 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

Poe D, Anand V, Dean M, et al. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope 2018; 128:1200. https://pubmed.ncbi.nlm.nih.gov/28940574/

Anand V, Poe D, Dean M, et al. Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group. Otolaryngol Head Neck Surg 2019; 160:687. https://pubmed.ncbi.nlm.nih.gov/30620688/

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 2018; 39:894. https://pubmed.ncbi.nlm.nih.gov/29912819/

Cutler JL, Meyer TA, Nguyen SA, et al. Long-term Outcomes of Balloon Dilation for Persistent Eustachian Tube Dysfunction. Otol Neurotol 2019; 40:1322. https://pubmed.ncbi.nlm.nih.gov/31385858/

Luukkainen V, Kivekäs I, Silvola J, et al. Balloon Eustachian Tuboplasty: Systematic Review of Long-term Outcomes and Proposed Indications. J Int Adv Otol 2018; 14:112. https://pubmed.ncbi.nlm.nih.gov/29764785/

Silvola J, Kivekäs I, Poe DS. Balloon Dilation of the Cartilaginous Portion of the Eustachian Tube. Otolaryngol Head Neck Surg 2014; 151:125. https://pubmed.ncbi.nlm.nih.gov/24705223/

Luukkainen V, Vnencak M, Aarnisalo AA, et al. Patient satisfaction in the long-term effects of Eustachian tube balloon dilation is encouraging. Acta Otolaryngol 2018; 138:122. https://pubmed.ncbi.nlm.nih.gov/29017385/

Leichtle A, Hollfelder D, Wollenberg B, Bruchhage KL. Balloon Eustachian Tuboplasty in children. Eur Arch Otorhinolaryngol 2017; 274:2411. https://pubmed.ncbi.nlm.nih.gov/28283791/

Tisch M, Maier H, Sudhoff H. Balloon dilation of the Eustachian tube: clinical experience in the management of 126 children. Acta Otorhinolaryngol Ital 2017; 37:509. https://pubmed.ncbi.nlm.nih.gov/29327736/

Toivonen J, Kawai K, Gurberg J, Poe D. Balloon Dilation for Obstructive Eustachian Tube Dysfunction in Children. Otol Neurotol 2021; 42:566. https://pubmed.ncbi.nlm.nih.gov/33351568/

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Schilder AG, Bhutta MF, Butler CC, et al. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol. Oct 2015;40(5):407-411.
https://pubmed.ncbi.nlm.nih.gov/26347263/

Seibert JW, Danner CJ. Eustachian tube function and the middle ear. Otolaryngol Clin North Am. Dec 2006;39(6):1221-1235.
https://pubmed.ncbi.nlm.nih.gov/17097443/

Norman G, Llewellyn A, Harden M, et al. Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: a health technology assessment. Clin Otolaryngol. Feb 2014;39(1):6-21.
https://pubmed.ncbi.nlm.nih.gov/24438176/

Xiong, H., Liang, M., Zhang, Z., Xu, Y., Ou, Y., Chen, S., … Zheng, Y. (2016, March). Efficacy of balloon dilation in the treatment of symptomatic Eustachian tube dysfunction: One year follow-up study.

https://www.ncbi.nlm.nih.gov/pubmed/26954860

Schmitt, D., Akkari, M., Mura, T., Mondain, M., Uziel, A., & Venail, F. (2018, April). Medium-term assessment of Eustachian tube function after balloon dilation.

https://www.ncbi.nlm.nih.gov/pubmed/29289487

Tisch, M., Maier, H., & Sudhoff, H. (2017, December). Balloon dilation of the Eustachian tube: clinical experience in the management of 126 children.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5782429/

Tucci, D. L., McCoul, E. D., Rosenfeld, R. M., Tunkel, D. E., Batra, P. S., Chandrasekhar, S. S., … Lambie, E. (2019, July). Clinical Consensus Statement: Balloon Dilation of the Eustachian Tube.

https://www.ncbi.nlm.nih.gov/pubmed/31161864

Gürtler, N., Husner, A., & Flurin, H. (2015, March). Balloon dilation of the Eustachian tube: early outcome analysis.

https://www.ncbi.nlm.nih.gov/pubmed/25356762

Miller, B J, Elhassan H A. Balloon dilatation of the Eustachian Tube: an evidence-based review of case series for those considering its use. 2013 Dec.

https://www.ncbi.nlm.nih.gov/pubmed/24188396

Poe, D, Silvola, J, Pyykko, I. Balloon dilation of the cartilaginous eustachian tube.

https://www.ncbi.nlm.nih.gov/pubmed/21493236

Abdel-Aziz, T, Schroder, S, Lehmann, M, Gehl, H, Ebmeyer, J, Sudhoff, Holger. Computed tomography before balloon Eustachian tuboplasty-a true necessity? (April 2014).

https://pubmed.ncbi.nlm.nih.gov/24622017/
Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 5/2020 Initial Policy Date

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Date Update 03/2022 Minor changes 04/2023 Criteria revised with minor changes. 1/2024 Line of Business section added 2/2024 Annual review with no changes to criteria Removed C9745 7/2024 Updated 69705-69706 are non-payable for MassHealth

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.