Balloon Dilation of the Eustachian Tube

POLICY NUMBER

A.7.01.158

DESCRIPTION

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 eustachian tube dysfunction can lead to hearing loss, otitis media, tympanic membrane perforation, and cholesteatomas. Balloon dilation of the eustachian tube is a procedure intended to improve 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 eustachian tube dysfunction can include aural fullness, aural pressure, hearing loss, and otalgia. In milder cases, eustachian tube dysfunction 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 eustachian tube dysfunction are nonspecific, clinical practice guidelines emphasize the importance of ruling out other causes of eustachian tube dysfunction 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 eustachian tube dysfunction 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 eustachian tube dysfunction.

Patients 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 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 Dilatation of the Eustachian Tube

Balloon dilation 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 stand alone 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 or without tympanostomy tube placement. This policy addresses balloon dilation of the eustachian tube as a stand alone procedure.

Devices Cleared by the U.S. Food and Drug Administration

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).

POLICY

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

• Adults (age 22 years and older) with symptoms of obstructive eustachian tube dysfunction (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 to 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 eustachian tube dysfunction should have improved while tubes were patent.

  AND

• The individual does not have patulous eustachian tube dysfunction or another contraindication to the procedure (see Policy Guidelines)

  AND

• The individual's eustachian tube dysfunction 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 balloon dilation of the eustachian tube procedure.

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

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Symptoms of obstructive eustachian tube dysfunction 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., patients 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 eustachian tube dysfunction

    • A diagnosis of patulous eustachian tube dysfunction is suggested by symptoms of autophony of voice, audible respirations, pulsatile tinnitus, and/or aural fullness.

  • Individuals with extrinsic reversible or irreversible causes of eustachian tube dysfunction 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 Eustachian Tube dysfunction 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 balloon dilation of the eustachian tube (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.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

1. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

2. appropriate with regard to standards of good medical practice; and

3. not solely for the convenience of the Member, his or her Provider; and

4. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

08/01/2019: New policy added. Approved by Medical Policy Advisory Committee.

12/16/2020: Code Reference section updated to add new CPT codes 69705 and 69706, effective 01/01/2021.

09/01/2021: Policy description updated regarding eustachian tube dysfunction (ETD), medical and surgical management of ETD, and balloon dilation of the eustachian tube. Policy statement revised to state that balloon dilation of the eustachian tube for treatment of chronic obstructive eustachian tube dysfunction may be considered medically necessary when the specified conditions are met. Policy Guidelines updated regarding contraindications to balloon dilation of the eustachian tube, reversibility of eustachian tube dysfunction, balloon dilation of the eustachian tube used in combination with other procedures, and to define medically necessary. Code Reference section updated to add ICD-10 diagnosis codes H65.00 - H65.93, H66.001 - H66.93, H67.1 - H67.9, H68.001 - H68.029, H69.80 - H69.93, H71.00 - H71.93, H72.00 - H72.93, H81.311 - H81.49, H90.0 - H90.A32, H91.01 - H91.93, J30.0 - J30.9, and J31.0 - J32.9.

01/11/2022: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted HCPCS code C9745.

12/05/2022: Policy description updated. Policy statements and Policy Guidelines updated to change "patients" to "individuals."

10/13/2023: Policy reviewed; no changes.

03/15/2025: Policy description updated regarding devices. Policy statements unchanged. Code Reference section updated to remove CPT code 69799.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.158

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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