Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Sinusitis. 
Treatment: CPT 31298 (50) Nasal/Endoscopy, Surgical w/ Dilation Frontal & 
Sphenoid Sinus, CPT 31254 (50) Nasal/Sinus Endoscopy w/ Ethmoidectomy, 
CPT 31295 (50) Nasal/Sinus Endoscopy Maxillary Sinus. 

The insurer denied the CPT 31298 (50) Nasal/Endoscopy, Surgical w/ Dilation
Frontal & Sphenoid Sinus, CPT 31254 (50) Nasal/Sinus Endoscopy w/ Ethmoidectomy,
CPT 31295 (50) Nasal/Sinus Endoscopy Maxillary Sinus. 

The denial is overturned.

The patient is a female with chronic rhino sinusitis with multiple courses of antibiotics, nasal steroid, decongestant, and antihistamine therapies. The provider describes mucosal thickening in the relevant sinus spaces, including obstruction of the nasofrontal ducts with hypo plastic frontal sinuses. Nasal septal deviation and turbinate hypertrophy is also described. Surgery describes balloon dilation of the maxillary, frontal and sphenoid sinuses with bilateral ethmoidectomy. 

Yes, the requested therapy is likely to be more beneficial. 

Balloon sinuplasty is a standard of care. Balloon Sinuplasty is really just a tool that follows this continuum of progressively conservative surgery. This was articulated in Welch and Stankiewicz in their review of endoscopic sinus surgery, where they noted that balloon dilation is not really a new procedure, but rather a new tool. Similar assessment was made by Kim and Cutler in the Otolaryngology Clinics in their review. In this light, the initial FDA (United States Food and Drug Administration) 510(k) application yielded a substantially equivalent decision. 

Though the procedure is innovative in its application, the technical characteristics are essentially the same as the goals of more traditional endoscopic sinus surgery, but accomplished through a more conservative approach. The work value of this procedure was deemed to be different than the existing endoscopic sinus procedures and this yielded new coding, when balloon procedures are done in isolation from associated "open" elements of endoscopic sinus surgery. These codes are reimbursed by Medicare and a variety of other carriers for many years. 

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 10 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 (computed tomography)/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 patient 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 7 of 195 sinuses (3.6%). CT (computed tomography) 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 2 years. There were no major adverse events reported (conventional FESS [functional endoscopic sinus surgery] has about a 1% serious complication rate in the literature). 

As noted above, 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 nonguided system.

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

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. 

Some carriers have suggested that randomized placebo controlled clinical trials should be the standard to assess this new technology. As a past chair of the AMA's (American Medical Association) Council on Ethical and Judicial Affairs (which edits the Code of Medical Ethics), this reviewer can share with assurance that there are significant obstacles to surgical placebo controls in contrast to most medication trials. Sham surgery especially with attendant general anesthesia risks is not often acceptable to an institutional review board unless the surgery itself is a new high-risk procedure for an otherwise untreatable condition. In balloon sinuplasty, with a progressive innovation on existing surgical technologies, it is unlikely that any IRB (institutional review board) would approve sham surgery to achieve a placebo controlled surgical trial. 

In summary, all data to date support the safety and efficacy of balloon sinuplasty as a tool in conservative endoscopic sinus surgery. The technology has been widely implemented across the Otolaryngology and Rhinology communities with support from the principal academic organizations of the specialty and subspecialty. This tool presents the opportunity to preserve normal structures, facilitate the preservation of the mucociliary clearance anatomy of the sinuses, does not preclude other surgery in the future if needed and protect the sinus cavity from open colonization from the nasal cavity. It is beneficial both to conservatively manage patients with milder disease and particularly for the frontal sinus represents the most conservative efficacious technique to address this challenging region of anatomy. 

By no means does this widely utilized tool represent an investigational technology, but like all areas of innovation will continue to benefit from ongoing evaluation through large-scale longitudinal studies.