Category: Surgery

POLICY:

 

Balloon dilation of the eustachian tube (BDET) for treatment of chronic obstructive eustachian tube dysfunction (ETD) may be considered medically necessary under the following conditions:

Adults (age 18 years and older) with symptoms of obstructive ETD (aural fullness, aural pressure, otalgia, and/or hearing loss) for 12 months or longer in one or both ears that significantly affects quality of life or functional health status;

• Aural fullness and pressure must be present (see Policy Guidelines).

AND

• The individual has undergone a comprehensive diagnostic assessment; including patient-reported questionnaires, history and physical exam, tympanometry if the tympanic membrane is intact, nasal endoscopy, and comprehensive audiometry, with the following findings: 
• Abnormal tympanogram (Type B or C);
• Abnormal tympanic membrane (retracted membrane, effusion, perforation, or any other abnormality identified on exam).

AND

• Failure to respond to appropriate medical management of potential co-occurring conditions, if any, such as allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, including 4-6 weeks of a nasal steroid spray, if indicated.

AND

• Other causes of aural fullness such as temporomandibular joint disorders, extrinsic obstruction of the eustachian tube, superior semicircular canal dehiscence, and endolymphatic hydrops have been ruled out.

AND

• If the individual had a history of tympanostomy tube placement, symptoms of obstructive ETD should have improved while tubes were patent.

AND

• The individual does not have patulous ETD or another contraindication to the procedure (see Policy Guidelines).

AND

• The individual’s ETD has been shown to be reversible (see Policy Guidelines).

AND

• Symptoms are continuous rather than episodic (e.g., symptoms occur only in response to barochallenge such as pressure changes while flying).

AND

• The individual has not had a previous BDET procedure.

Balloon dilation of the eustachian tube is considered investigational if the above criteria are not met.

POLICY GUIDELINES:

Symptoms of obstructive ETD may include aural fullness, aural pressure, otalgia, and hearing loss. Nearly all individuals will have aural fullness and aural pressure. Many individuals will have otalgia, but hearing loss may not be present in all individuals (e.g., individuals with Type C tympanograms).

Contraindications to Balloon Dilation of the Eustachian Tube

The following individuals should not be considered for balloon dilation of the eustachian tube:

• Individuals with patulous ETD.
  • A diagnosis of patulous ETD is suggested by symptoms of autophony of voice, audible respirations, pulsatile tinnitus, and/or aural fullness.
• Individuals with extrinsic reversible or irreversible causes of ETD including but not limited to:
  • craniofacial syndromes, including cleft palate spectrum;
  • neoplasms causing extrinsic obstruction of the eustachian tube;
  • history of radiation therapy to the nasopharynx;
  • enlarged adenoid pads;
  • nasopharyngeal mass;
  • neuromuscular disorders that lead to hypotonia/ineffective eustachian tube dynamic opening;
  • systemic mucosal or autoimmune inflammatory disease affecting the mucosa of the nasopharynx and eustachian tube (e.g., Samter’s triad, Wegener’s disease, mucosal pemphigus) that is ongoing/active (i.e., not in remission).
• Individuals with aural fullness but normal exam and tympanogram.
• Individuals with chronic and severe atelectatic ears.

Reversibility of Eustachian Tube Dysfunction

Reversibility of ETD can be demonstrated by several means, including any of the following:

• The individual states that they are able to relieve the pressure by performing a Valsalva maneuver to “pop” their ears;
• Performing a Valsalva maneuver produces temporary improvement of the individual’s tympanogram to Type A tympanogram;
• Performing a Valsalva maneuver causes the member’s middle ear to aerate, which is indicated by the provider visualizing lateral movement of the tympanic membrane on otoscopy.

Balloon Dilation of the Eustachian Tube Used in Combination with Other Procedures

• Individuals undergoing BDET concurrent with sinus ostial dilation should meet the same diagnostic criteria for BDET as those undergoing BDET alone.
• Individuals with a middle ear effusion at the time of BDET may benefit from concurrent myringotomy with or without tympanostomy tube placement.

DESCRIPTION OF PROCEDURE OR SERVICE:

Eustachian tube dysfunction occurs when the functional valve of the eustachian tube fails to open and/or close properly. This failure is frequently due to inflammation and can cause symptoms such as muffled hearing, ear fullness, tinnitus, and vertigo. Chronic obstructive ETD can lead to hearing loss, otitis media, tympanic membrane perforation, and cholesteatomas. Balloon dilation of the eustachian tube is a procedure intended to improve the patency by inflating a balloon in the cartilaginous part of the eustachian tube to cause local dilation.

Eustachian Tube Function and Dysfunction

The eustachian tube connects the middle ear space to the nasopharynx. It 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. Normally, the tube is closed or collapsed and opens during swallowing, sneezing or yawning. Eustachian tube dysfunction occurs when the functional valve of the eustachian tube fails to open and/or close properly. This failure may be due to inflammation or anatomic abnormalities. Symptoms of chronic obstructive ETD can include aural fullness, aural pressure, hearing loss, and otalgia. In milder cases, ETD may only be apparent in situations of barochallenge (inability to equalize with rapid barometric pressure changes), with otherwise normal function in stable ambient conditions.

Diagnosis

Because the symptoms of ETD are nonspecific, clinical practice guidelines emphasize the importance of ruling out other causes of ETD with a comprehensive diagnostic assessment that includes patient-report questionnaires, history and physical exam, tympanometry, nasal endoscopy, and audiometry to establish a diagnosis.

Medical and Surgical Management of Eustachian Tube Dysfunction

Medical management of ETD is directed by the underlying etiology. Treatment of identified underlying conditions, such as systemic decongestants, antihistamines, or nasal steroid sprays for allergic rhinitis; behavioral modifications and/or proton pump inhibitors for laryngopharyngeal reflux; or treatment of mass lesions, may be useful in resolving ETD.

Individuals who continue to have symptoms following medical management may be treated with surgery such as myringotomy with the placement of tympanostomy tubes or eustachian tuboplasty. These procedures create an alternative route for ventilation of the middle ear space but do not address the functional problem at the eustachian tube. There is limited evidence and no randomized controlled trials (RCTs) supporting use of these surgical techniques for this indication. Additionally, surgery may be associated with adverse events such as infection, perforation, and otorrhea. Tympanostomy tube placement may be a repeat procedure for the life of the patient, and the risk of complications from tympanostomy tubes increases with increasing numbers of tube placements and duration of tube placement.

Balloon Dilation of the Eustachian Tube

Balloon dilation of the eustachian tube is a tuboplasty procedure intended to improve the patency of the cartilaginous eustachian tube to cause local dilation. During the procedure, a saline-filled balloon catheter is introduced into the eustachian tube through the nose using a minimally invasive transnasal endoscopic method. Pressure is maintained for 2 minutes or less, after which the balloon is emptied and removed. The procedure is usually performed under general anesthesia.

Balloon dilation of the eustachian tube can be done as a standalone procedure or in conjunction with other procedures such as adenoidectomy, intranasal surgery (e.g., septoplasty, turbinate procedures or sinus surgery), surgery for obstructive sleep apnea or sleep disturbed breathing, and myringotomy with our without tympanostomy tube placement. This evidence review addresses BDET as a standalone procedure.

KEY POINTS:

The most recent literature search was conducted through August 1, 2024.

Summary of Evidence

For individuals who have chronic obstructive ETD despite medical management who receive BDET, the evidence includes randomized controlled trials (RCTs), prospective observational studies, case series, and systematic reviews of these studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Two 6-week RCTs found more improvement with balloon dilation plus medical management than medical management alone on individual-reported symptoms, ability to perform a Valsalva maneuver, proportion of individuals with normalized tympanograms, and otoscopy findings. Durability of these effects was demonstrated at 52 weeks in the uncontrolled extension phase of both RCTs. No serious device or procedure-related adverse events were reported through 52 weeks of follow-up. Multiple observational studies and case series have reported that individuals experienced improvement when comparing symptoms before and after balloon dilation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Otolaryngology-Head and Neck Surgery Foundation

In 2019, the American Academy of Otolaryngology published a clinical consensus statement on BDET. The target population was defined as adults ≥ 18 years who are candidates for BDET because of obstructive ETD in one or both ears for three months or longer that significantly affects quality of life or functional health status. The expert panel concluded:

• BDET is an option for treatment of patients with obstructive ETD.
• The diagnosis of obstructive ETD should not be made without a comprehensive and multifaceted assessment, including otoscopy, audiometry, and nasal endoscopy.
• BDET is contraindicated for patients diagnosed as having a patulous ETD
• Further study will be needed to refine patient selection and outcome assessment.

The authors emphasized the importance of identifying other potentially treatable causes of ETD, including allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, and noted that medical management of these disorders is indicated prior to offering BDET. They also noted that potential risks of BDET that are relevant to patient counseling include bleeding, scarring, infection, development of patulous ETD, and/or the need for additional procedures.

National Institute for Health and Care Excellence

In 2019, the National Institute for Health and Care Excellence (NICE) published updated guidance on BDET. The guidance was based on a rapid review of the evidence, and stated, "Evidence on the safety and efficacy of BDET is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit." NICE standard arrangements recommendations mean that there is enough evidence for doctors to consider the procedure as an option.

The guidance also noted:

• The procedure was not effective in all patients, and there was little evidence on the benefit of repeat procedures.
• The procedure is only indicated for chronic ETD refractory to medical treatment.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Balloon dilation, eustachian tube, Acclarent AERA®, Acclarent AERA® Eustachian Tube Balloon Dilatation System, XprESS® ENT dilation system, Nuvent® Eustachian Tube Dilation Balloon, Audion ®Et Dilation System, Vensure® Balloon Dilation System

APPROVED BY GOVERNING BODIES:

Table 1. Devices Cleared by the US Food and Drug Administration

Device	Manufacturer	Date Cleared	510(k) No.	Indication
Acclarent Aera® Eustachian Tube Balloon Dilatation System	Acclarent, Inc.	01/16/2018	K171761, K230742	Eustachian tube dilation
XprESS® ENT dilation system	Entellus Medical Inc.	04/05/2017	K163509	Eustachian tube dilation
Nuvent® Eustachian Tube Dilation Balloon	Medtronic Xomed, Inc.	08/16/2021	K210841	Eustachian tube dilation
Audion ®Et Dilation System	Entellus Medical, Inc.	04/12/2022	K220027	Eustachian tube dilation
Vensure® Balloon Dilation System	Fiagon GmbH	05/26/2023	K230065	Eustachian tube dilation

Multiple devices have been given a de novo 510(k) classification by the U.S. Food and Drug Administration (FDA) (class II, FDA product code: PNZ) (Table 1). 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

69705	Nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e., balloon dilation); unilateral
69706	Nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e., balloon dilation); bilateral

REFERENCES:

1. Aboueisha MA, Attia AS, McCoul ED, et al. Efficacy and safety of balloon dilation of eustachian tube in children:  Systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol. Mar 2022; 154: 111048.
2. 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. Apr 2019; 160(4): 687-694.
3. Cutler JL, Meyer TA, Nguyen SA, et al. Long-term Outcomes of Balloon Dilation for Persistent Eustachian Tube Dysfunction. Otol Neurotol. Dec 2019; 40(10): 1322-1325.
4. Froehlich MH, Le PT, Nguyen SA, et al. Eustachian Tube Balloon Dilation: A Systematic Review and Meta-analysis of Treatment Outcomes. Otolaryngol Head Neck Surg. Nov 2020; 163(5): 870-882. 
5. 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.
6. Hwang SY, Kok S, Walton J. Balloon dilation for eustachian tube dysfunction: systematic review. J Laryngol Otol. Jul 2016; 130 Suppl 4: S2-6.
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Llewellyn A, Norman G, Harden M, et al. Interventions for adult Eustachian tube dysfunction: a systematic review. Health Technol Assess. Jul 2014; 18(46):1-180, v-vi.
9. 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.
10. National Institute for Health and Care Excellence. Balloon dilation for chronic eustachian tube dysfunction. Interventional procedures guidance [IPG665]. December 2019. www.nice.org.uk/guidance/ipg665. 
11. National Institute for Health and Care Excellence. Interventional procedure overview of balloon dilation for chronic eustachian tube dysfunction. www.nice.org.uk/guidance/ipg665/documents/overview-2 December 2019.
12. 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.
13. Poe D, Anand V, Dean M, et al. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. May 2018; 128(5): 1200-1206.
14. Poe DS, Hanna BM. Balloon dilation of the cartilaginous portion of the eustachian tube: initial safety and feasibility analysis in a cadaver model. Am J Otolaryngol. Mar-Apr 2011; 32(2): 115-23.
15. 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..
16. 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.
17. Schroder S, Lehmann M, Ebmeyer J, et al. Balloon Eustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. Dec 2015; 40(6):629-638.
18. Tucci DL, McCoul ED, Rosenfeld RM, et al. Clinical Consensus Statement: Balloon Dilation of the Eustachian Tube. Otolaryngol Head Neck Surg. Jul 2019; 161(1): 6-17. 

POLICY HISTORY:

Medical Policy Panel, February 2018, New Association Policy

Medical Policy Group, February 2018 (6): New policy adopted from Association.

Medical Policy Administration Committee, February 2018

Available for comment February 17 through April 2, 2018

Medical Policy Panel, February 2019

Medical Policy Group, February 2019 (6): Updates to Key Points, Governing Bodies and References.

Medical Policy Panel, September 2020

Medical Policy Group, October 2020 (3): 2020 Updates to Key Points, Practice Guidelines and Position Statements, and References. Policy was reformatted. Policy statement updated to remove “not medically necessary,” no change to policy statement or intent.

Medical Policy Group, November 2020 (3): Annual Coding Update.  Added CPT codes 69705-69706 to the Current coding section.

Medical Group, August 2021 (3): Off cycle update to open up coverage for balloon dilation of the eustachian tube. Policy statement changed to: Balloon dilation of the eustachian tube for treatment of patients with chronic obstructive eustachian tube dysfunction may be considered medically necessary under specified conditions. Updates to Description, Key Points, Practice Guidelines and Position Statements, and References.

Medical Policy Administration Committee, August 2021

Available for comment August 16, 2021- September 30, 2021

Medical Policy Group, September 2021 (3): Updated policy statement to expand coverage for balloon dilation of the eustachian tube from adults 22 years of age and older to adults 18 years and older.

Available for comment August 16, 2021- September 30, 2021

Medical Policy Panel, September 2022

Medical Policy Group, September 2022 (6): Updates to Key Points and References.

Medical Policy Panel, September 2023

Medical Policy Group, September 2023 (9): Updates to Description, Key Points, Key Words, Approved by governing Bodies, Benefit Application and References. No change to Policy Statement.

Medical Policy Panel, September 2024

Medical Policy Group, September 2024 (9): Updates to Key Points, Key Words, Approved by Governing Bodies, and References. No change to Policy Statement. Previous coding section removed.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.