Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Eustachian tube dysfunction
Treatment: Outpatient nasopharyngoscopy with dilation of eustachian tube
The insurer denied outpatient nasopharyngoscopy with dilation of eustachian tube.
The determination is upheld.

The patient has eustachian tube dysfunction. Her previous medical therapy has included nasal steroids. The patient has had multiple sets of ear tubes. She also has a history of cholesteatoma with 4 ear surgeries.

Balloon dilatation of the eustachian tubes has been proposed. At issue is the medical necessity of outpatient nasopharyngoscopy with dilation of eustachian tube.

The requested procedure is not medically necessary. The patient has had multiple sets of ear tubes and she also has a history of cholesteatoma with 4 ear surgeries. Although balloon dilatation of the Eustachian tube 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% (percent) improvement rate in symptoms and tympanogram data (see Poe and Anand). However, 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" (see Norman).

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 balloon dilation of the eustachian tube (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.

Thus far, there have been only 2 prospective, multicenter randomized controlled trials (RCTs) examining the efficacy of BDET for persistent OETD. The first was conducted by Poe, et al, who randomized 323 patients with medically refractory OETD to either undergo BDET plus medical therapy (number [n] = 162) or medical therapy alone (n = 80). After 6 weeks, a significantly greater number of BDET patients demonstrated normalization of tympanograms and Eustachian Tube Dysfunction Patient Questionnaire [ETDQ-7] scores (less than or equal to 2.1) vs controls (51.8% versus [vs] 13.9%, probability (P) less than [<] .001; 56.2% vs 8.5%, P < .001). At 24 weeks, improvements in ETDQ-7 scores in the treatment arm were sustained but were no longer statistically significantly different from the control group (59.8% vs 22.2%, P greater than [>] .05). This finding was attributed to the fact that 82% of patients in the control arm (59/72) crossed over to the BDET group prior to their 12-week follow-up. Consequently, only 13 patients were left in the control arm, which may have biased statistical comparisons.

In the second RCT, Meyer, et al randomized 60 patients 18 years and older with medically refractory OETD greater than 12 months with 3 or more Eustachian tube (ET) obstructive symptoms to undergo BDET (n = 30) or continued medical therapy (n = 29). After 6 weeks, greater reductions in overall Eustachian Tube Dysfunction Patient Questionnaire [ETDQ-7] scores were observed in the BDET group relative to controls. In addition, symptom improvements in the treatment arm were sustained after a minimum follow-up of 1 year. However, it should be noted that similar to the Poe, et al study, most of the patients in the control arm (23/29) crossed over to the BDET arm after 6 weeks. Consequently, no statistical comparisons were performed between the treatment and control arms at the 12-month follow-up. At this time, additional RCTs with longer follow-up are still necessary to establish a higher level of evidence for BDET efficacy. Consequently, the panel ultimately could not reach consensus regarding the overall short-term or long-term effectiveness of BDET (Statements 52 and 50)."

A systemic review by Randrup stated: Objective: A systematic review and meta-analysis of the evidence on balloon Eustachian tuboplasty (BET) as a treatment modality for Eustachian tube dysfunction (ETD). We followed the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guideline and registered with prospective register of systematic reviews (PROSPERO) number CRD42014009461. Conclusion: The evidence of BET is poor and biased. No firm conclusions can be made to identify patients who will benefit from the procedure or to accurately predict surgical results. Randomized controlled trials or case-control trials are needed.

Additionally, for this patient who has a cholesteatoma, there are no long-term prospective studies showing that this treatment prevents cholesteatoma recurrence.