Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Sinusitis
Treatment: Balloon Sinuplasty, Pre-service
The insurer denied the Balloon Sinuplasty, Pre-service.
The denial is overturned.

The patient is a female with chronic sinusitis and nasal polyposis.  The patient had endoscopic sinus surgery with recurrent disease at present.  Exam shows deviated septum and nasal polyps.  The patient has been treated with antibiotics, singulair, topical steroid, and systemic steroid.  Computed tomography (CT) shows deviated septum, mucosal thickening in multiple sinus spaces, and opacification of frontal sinuses with obstruction of ostia.

Yes, the proposed Balloon Sinuplasty is medically necessary.

This patient has CT evidence of chronic sinusitis and has had prior maximal medical therapy.  There was prior endoscopic sinus surgery performed and revision surgery has been recommended.  New CT after the date of the prior surgery shows the persistent/recurrent disease.

Catheter-based balloon dilation of the sinuses was described by Bolger, et al with safe dilation of maxillary, sphenoid, and frontal ostea in cadaveric specimens without trauma to surrounding tissues.

A subsequent preliminary study with ten patients dilating 18 affected sinuses further confirmed the safety of this procedure in a trial conducted by Brown and Bolger.

The study by Bolger, et al at multiple centers, with 24 week follow-up in 115 patients, had both dramatic symptomatic improvement in patients as well as high persisting patency demonstrated when the sinuses could be endoscopically visualized.  The revision rate was less than 1%.

Initially, the procedures were done using fluoroscopy for guidewire visualization.  This raised the question of radiation dose (especially to the lens of the eye) in these procedures.  Fluoroscopy of 29 minutes duration would place the lens at risk for opacity.  This concern was obviated with the innovation of a fiberoptic guidewire, which allowed placement to be visualized without the use of radiation.

Kuhn, et al reported one year follow-up data in 66 patients (202 sinuses) with CT/endoscopic normalcy in 91% of patients and significant improvement in sinus symptom scoring from baseline.  This demonstrated with one year efficacy and persistence of the intervention.

A two-year outcome follow-up was published by Weiss, et al reporting 65 patients and 195 sinuses treated.  This included 31 hybrid cases.  Again, the subjective symptoms scores were significantly improved.  The number of patients requiring revision was 9.2% (six of 65 patients) and seven of 195 sinuses (3.6%).  CT evidence also confirmed statistically significant improvement versus baseline and stable improvement compared to one year data.

The multicenter study by Levine, et al reported on 1036 patients with 95% symptom improvement and 73% absence of sinus infection post-surgery at two years.  There were no major adverse events reported (conventional functional endoscopic sinus surgery [FESS] has about a 1% serious complication rate in the literature).

An ongoing challenge for sinus surgeons is management of frontal sinus obstruction.  In addition to frontal dilation in the operative setting in previous studies, Luong described frontal sinus dilations in office in six patients with a non-guided system.

A second system by entellus for use in the office or operating room (OR) without the added safety of illuminated guidewire is described by Stankiewicz under local anesthetic for the left (OS) maxillary.

Stewart and Vaughan reported in a review that more than 88,000 patients had undergone procedures utilizing balloon catheter dilation.

Wycherly, et al reported on 13 patients in regard to revision frontal sinus surgery and concluded that post treatment patency is comparable to conventional endoscopic techniques through a less invasive approach.

Plaza, et al reported on 40 patients randomized to balloon sinuplasty versus conventional endoscopic surgery of the frontal sinus and reported 73% patency for balloon versus 62% for conventional surgery at 12 months.  CT resolution of disease was also more common in the balloon group.

Much attention has been directed to the Ahmed review in Cochrane Database.  Unfortunately, the review had the wrong goals.  It was looking for randomized trials of conventional functional endoscopic sinus surgery (FESS) versus balloon dilation, rather than evaluating the efficacy of balloon dilation.  The patient selection for each procedure can be different, the mixture of hybrids in the hands of experienced surgeons is the norm and as a consequence, the question is not which is better but rather are each efficacious.  The use of hybrid surgery is represented by Bhandakar and Smith.

Present data have all suggested both radiographic and subjective improvement in the patients treated with balloon sinuplasty.  By way of comparison, we have simultaneous utilization of angioplasty and coronary artery bypass grafting in the Coronary Artery Disease population.  Not all patients are candidates for one or the other procedure but rather each has been established to be an efficacious modality for accomplishing the goal of coronary revascularization.  This case is even more compelling with balloon catheter dilatation, which is really just a refinement of the same operation being performed through the excision of soft tissue and bone to reestablish patent sinus ostea.  That having been said, Piaza since reported a double-blind randomized trial comparing balloon and conventional endoscopic sinus surgery of the frontal recess.  They found CT evidence of permeability with statistically higher frequency in balloon dilatation versus conventional surgery.

This is particularly critical data if the health plan's goal is to provide coverage for safe efficacious surgery.  For frontal sinus surgery, all preexisting procedures were subject to potential morbidities and limitations in successful outcome in all but the most invasive procedures.  Balloon sinuplasty has facilitated conservative successful improvement in frontal disease for both primary patients and patients who have failed prior traditional endoscopic techniques for this sinus site.

The patient has all elements justifying the proposed surgery with prior medical therapy and CT evidence of chronic sinus disease.

Recent literature have continued to support the efficacy of balloon assisted sinus surgery, with additional meta analysis studies and randomized studies showing faster recovery with balloon procedures and similar outcomes to conventional endoscopic sinus surgery.  A most recent example is the Chandra, et al REMODEL study.