Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Ears/Nose/Throat. 
Treatment:  Surgical Services - Eustachian Tube Dilation 
The insurer denied the Eustachian Tube Dilation. 
The denial is upheld in whole.

The patient is a male with eustachian tube dysfunction.  Hearing test shows a moderate, bilateral sensorineural hearing loss. Tympanograms were normal bilaterally.  Flonase has been used without success.  Computed tomography (CT) scan of temporal bone is normal.  At least one set of ear tubes has been placed in the past.  Ear exam is normal.  Balloon eustachian dilation has been proposed.

The health plan's determination is upheld in whole.

The proposed eustachian tube dilation is not likely to be more beneficial than any standard treatment for the patient's condition.

Although balloon dilatation of the Eustachian tube (BDET) provides exciting research for chronic eustachian tube dysfunction, the literature does not support long term effectiveness.  The current literature is based on non-controlled case series with poor standardization.  Recent 12 month studies showed a 50-60% improvement rate in symptoms and tympanogram data (see Poe and Anand), yet these studies are prone to bias as there were few patients left in the control arm.  Although the procedure is safe, there is no strong, high quality evidence that this procedure is effective.  A recent systemic review concluded, "Due to the limited and poor quality evidence it is inappropriate to make conclusions on the effectiveness of any intervention; the evidence base is insufficient to guide recommendations for a trial of any particular intervention.  Consensus on diagnostic criteria for Eustachian tube dysfunction is required to inform inclusion criteria of future trials."  [3]

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) recently released a clinical consensus statement.  It should be noted that this document stated "Consequently, the panel ultimately could not reach consensus regarding the overall short-term or long-term effectiveness of BDET."  A summary of the literature included in the clinical consensus statement is below:

Multiple studies have investigated the short- and long-term efficacy of BDET.  In a recent systematic review, Huisman et al evaluated the impact of BDET on reducing symptoms of obstructive eustachian tube dysfunction (OETD) in adult patients.  Fifteen studies were identified, all of which were case series, encompassing 1155 patients and 1881 procedures.  Of the 8 studies that used patient-reported symptoms as an outcome measure, all showed significant short-term improvement after a mean follow-up of 6.9 months (range, 0-50 months).  Meta-analysis of pooled data from 3 studies (670 procedures) also demonstrated significant improvement in multidimensional eustachian tube scores.  However, no conclusions could be drawn regarding the long-term effectiveness of BDET.  In addition, as none of the studies had a control group or were blinded, risk of selection bias was high.

In summary, the literature does not support that the requested procedure is likely to be more beneficial for this patient than standard treatment.