Medical Devices: Evidence and Research (Apr 2014)
The impact of balloon catheter dilation on frequency of sinus surgery in the United States
Abstract
Chantal E Holy,1 John M Ellison,1 Charles Schneider,1 Howard L Levine2,3 1Health Economics and Reimbursement, 2Medical Affairs, Acclarent Inc., a Johnson & Johnson Company, Menlo Park, CA, USA; 3Cleveland Nasal-Sinus and Sleep Center, Cleveland, OH, USA Purpose: Endoscopic sinus surgery for patients with chronic rhinosinusitis (CRS) unresponsive to medical therapy has traditionally been performed under general anesthesia and in the operating room. Balloons for catheter dilation of paranasal sinuses were introduced in 2005, allowing sinus surgery to be safely performed either in the operating room or the office care setting, under local anesthesia. This change in care setting has raised concerns of overuse or expanded indications for sinus surgery. This study was thus designed to evaluate changes in surgical volumes in the United States, for the period 2006–2011, and to evaluate the impact of the sinus balloons on surgical practice. Methods: The MarketScan® Commercial Claims and Encounter Database was queried for the period 2006 to 2011 using CRS International Classification of Diseases, Ninth Revision codes (473.X) and sinus surgery US-based Common Procedural Terminology (CPT) codes (endoscopic sinus surgery: CPT codes 31254–31294 and 31299; balloon catheter dilation: CPT codes 31295–31297). MarketScan's projection methodology was applied to estimate the nationwide prevalence of CRS and the incidence of sinus surgery. Procedural case mix and total average payment per surgery were analyzed. Results: From 2006 to 2011, the yearly prevalence of CRS and sinus surgery volume remained flat with ~430 patients with CRS per 100,000 in the employer-sponsored insured population, of which ~117/100,000 underwent surgery. In 2006, 2.69 paranasal sinuses (95% confidence interval [95% CI]: 2.65–2.71) were treated during each individual sinus surgery, with an additional 1.11 nasal procedures (95% CI: 1.08–1.13) performed concurrently. By 2011, the procedural case mix had expanded to 2.90 sinus (95% CI: 2.87–2.93) and 1.16 nasal procedures (95% CI: 1.14–1.85) per surgery. Payments increased from $7,011.06 (α=$6,378.30; β=3.1490) in 2006 to $9,090.11 (α=$8,350.20; β=2.9535) in 2011, in line with US medical inflation. Conclusion: In the study population, approximately 1 in 3.7 patients diagnosed with CRS underwent sinus surgery. This ratio remained constant from 2006 to 2011. There was no evidence that the number of distinct sinus surgeries per 100,000 people increased despite the introduction and utilization of balloon catheter dilation tools that enabled migration of sinus surgery to the office. Keywords: needs and demand, surgical incidence, sinus surgery, lower-cost setting, balloon sinuplasty, ESS, office-based surgery