CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Balloon Dilation of the Eustachian Tube (BDET) Coverage Criteria

Defines medical necessity, coding, and prior authorization expectations for balloon dilation of the eustachian tube for chronic obstructive eustachian tube dysfunction for BlueCHP/BlueCHiP Medicare and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBalloon Dilation of the Eustachian Tube (BDET) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization for BlueCHP (required) and document comprehensive diagnostic assessment, failed conservative management, and abnormal tympanogram (Type B or C).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

22+minimum patient age for FDA-cleared use / policy

12 mominimum symptom duration required

Type B/Crequired tympanogram types

69705/69706specified CPT procedure codes

Medical Necessity and Coverage Criteria

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Medical necessity criteria

Covered when ALL of the following are met

Age and symptom duration: Adult patients 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.age >=22; duration >=12 months

See diagnostic criteria and exclusions in policy.

Diagnostic assessment and findings: Comprehensive diagnostic assessment including patient-reported questionnaires, history and physical exam, tympanometry (if tympanic membrane intact), nasal endoscopy, and comprehensive audiometry with abnormal tympanic membrane (eg, retraction, effusion, perforation) AND abnormal tympanogram (Type B or C).tympanogram = Type B or C

Dysfunction must be documented by exam and tympanometry.

Failure of medical management: Failure to respond to appropriate medical management of potential co-occurring conditions (eg, allergic rhinitis, rhinosinusitis, laryngopharyngeal reflux), including 4-6 weeks of nasal steroid spray if indicated.

Conservative therapies should be attempted and documented prior to BDET.

Exclusion of other causes: Other causes of aural fullness (eg, temporomandibular joint disorders, extrinsic obstruction including neoplasms, superior semicircular canal dehiscence, and endolymphatic hydrops) have been ruled out.

Evaluate and exclude alternative diagnoses prior to proceeding.

Prior tympanostomy tube response if applicable: If patient had prior tympanostomy tube placement, symptoms should have improved while tubes were patent.

Reversible ETD demonstrated: Eustachian tube dysfunction demonstrated to be reversible: patient can relieve pressure by performing Valsalva with provider-visualized lateral tympanic membrane movement or transient normalization of tympanogram to Type A with Valsalva.

Symptom pattern: Symptoms are continuous rather than episodic (eg, not only occurring with barochallenge such as flying).

No prior BDET: Patient has not had a previous balloon dilation of the eustachian tube procedure.

No contraindications: No diagnosis of patulous eustachian tube dysfunction (suggested by autophony, audible respirations, pulsatile tinnitus, and/or aural fullness) or other contraindications such as neoplasm causing extrinsic obstruction, craniofacial syndromes (including cleft palate spectrum), history of nasopharyngeal radiation, enlarged adenoids, neuromuscular disorders causing ineffective ET opening, nasopharyngeal mass, ongoing active systemic mucosal autoimmune disease, or chronic severe atelectatic ears.

Patients with patulous eustachian tube dysfunction are excluded from coverage. Patulous ETD is suggested by symptoms such as autophony of voice, audible respirations, pulsatile tinnitus, and/or aural fullness. If a diagnosis of patulous ETD is present, BDET is not an appropriate treatment option.

BDET is excluded when eustachian tube dysfunction is caused by identifiable extrinsic reversible or irreversible conditions. Examples include neoplasms causing extrinsic obstruction of the eustachian tube, craniofacial syndromes (including cleft palate spectrum), prior nasopharyngeal radiation, enlarged adenoid pads, nasopharyngeal mass, neuromuscular disorders that produce hypotonia or ineffective ET opening, ongoing active systemic mucosal or autoimmune inflammatory disease, and chronic severe atelectatic ears.

Balloon dilation of the eustachian tube (BDET) is not medically necessary when the policy’s listed medical necessity criteria are not met. Common situations that would make BDET not medically necessary include absence of an abnormal tympanogram (Type B or C), lack of documented failure of appropriate conservative medical management (for example, 4–6 weeks of nasal steroid spray when indicated), symptoms that are episodic or occur only with barochallenge, a history of prior BDET, or the presence of any contraindicating conditions (for example, patulous ETD or the extrinsic causes listed in the exclusions).

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for BlueCHP (Medicare) and is recommended for Commercial products. Providers should obtain prior authorization before scheduling BDET or related procedures to avoid claim denials or delays.

Prior authorization required for BlueCHP (Medicare)
Prior authorization recommended for Commercial products

Note

Conservative Management Prerequisite

Document a trial of targeted conservative medical management before surgical intervention. Conservative measures should include, when appropriate: systemic decongestants, oral antihistamines, intranasal steroid sprays (at least 4–6 weeks if indicated), reflux management (behavioral modifications and/or proton pump inhibitors), and treatment of underlying allergic rhinitis or rhinosinusitis. Record duration, medications/therapies used, patient response, and rationale for proceeding to procedural therapy.

Minimum 4–6 weeks of nasal steroid spray when indicated
Treatments may include decongestants, antihistamines, nasal steroids, reflux therapy, and management of sinus/allergic disease
Document failure to respond to appropriate medical management prior to procedure

Documentation Required

Required Diagnostic Documentation

Include comprehensive diagnostic documentation in the medical record to support the diagnosis and medical necessity: patient-reported symptom questionnaires, complete history and physical exam, tympanometry if the tympanic membrane is intact, nasal endoscopy findings, and comprehensive audiometry. Note tympanic membrane exam findings (retraction, effusion, perforation, etc.) and tympanogram type (Type B or C) when present.

Patient-reported questionnaires (symptom severity/impact)
History and physical exam with tympanic membrane description
Tympanometry (if tympanic membrane intact) showing abnormal results (Type B or C)
Nasal endoscopy findings
Comprehensive audiometry results

Denial Risk

Denial Triggers

Claims may be denied if prior authorization is not obtained for BlueCHP or if medical criteria are not met. Common denial triggers include insufficient symptom duration (less than 12 months when required), lack of documented abnormal tympanogram or abnormal tympanic membrane findings, absence of documented conservative management trial, failure to document exclusion of other causes (e.g., TMJ disorders, nasopharyngeal mass, patulous ETD), or presence of contraindications (e.g., active nasopharyngeal mass, patulous ETD, certain craniofacial syndromes).

No prior authorization for BlueCHP (Medicare)
Symptom duration shorter than required (e.g., < 12 months when specified)
No abnormal tympanogram (Type B or C) or lack of documented abnormal TM exam
No documentation of trial and failure of conservative medical management
Failure to document exclusion of alternative causes (TMJ, nasopharyngeal mass, patulous ETD, etc.)
Documented contraindications such as active nasopharyngeal mass or patulous ETD

Definitions and Device Indications

Balloon dilation of the eustachian tube (BDET) — procedure definition

Procedure nameBalloon dilation of the eustachian tube (BDET)

Procedure descriptionMinimally invasive transnasal endoscopic tuboplasty in which a saline-filled balloon catheter is introduced into the eustachian tube via the nose and pressurized (pressure maintained up to 2 minutes or less) to dilate the cartilaginous portion, then emptied and removed.

Anesthesia and settingUsually performed under general anesthesia; may be standalone or performed with concurrent intranasal/adenoid/myringotomy procedures.

Typical balloon inflation durationPressure is maintained for 2 minutes or less before balloon deflation and removal.

Intended effectImprove patency of the cartilaginous eustachian tube to relieve obstructive ETD symptoms.

FDA-cleared use age

FDA-cleared minimum ageDevices referenced are cleared for use in patients ages 22 years and older for persistent eustachian tube dysfunction.

Example cleared devicesAERAD (Acclarent) de novo 510(k) classification (Sept 2016) cleared for patients 22+; XprESS ENT Dilation System cleared via 510(k) (Dec 2016).

Regulatory classificationAERAD granted de novo 510(k) (class II, FDA product code: PNZ); other devices cleared as substantially equivalent via 510(k).

OpenPayer

Balloon Dilation of the Eustachian Tube (BDET) Coverage Criteria

Medical Necessity and Coverage Criteria

Procedure and Billing Codes

Prior Authorization, Documentation, and Denial Risks

Definitions and Device Indications

Clinical Background

69705	Nasopharyngoscopy, surgical with dilation of eustachian tube (eg: balloon dilation); unilateral
69706	Nasopharyngoscopy, surgical with dilation of eustachian tube (eg: balloon dilation); bilateral