Balloon Ostial Dilation for Treatment of Chronic Sinusitis

Transcription

1 Balloon Ostial Dilation for Treatment of Chronic Sinusitis Policy Number: Last Review: 3/2016 Origination: 3/2007 Next Review: 9/2016 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will not provide coverage for balloon sinuplasty. This is considered investigational. When Policy Topic is covered Not Applicable When Policy Topic is not covered Use of a catheter-based inflatable device (balloon sinuplasty) in the treatment of sinusitis is considered investigational. Considerations If balloon sinuplasty is performed in conjunction in conjunction with cutting tools such as curettes and forceps, the balloon dilation would be considered inclusive/incidental to the procedure. If balloon sinus ostial dilation is performed in conjunction with cutting tools such as curettes and forceps, the procedure might be coded using the CPT codes for nasal/sinus endoscopy with maxillary antrostomy (31256), nasal/sinus endoscopy with frontal sinus exploration (31276), or nasal/sinus endoscopy with sphenoidectomy (31287). Plans should be aware of this possibility. In this instance, the balloon dilation would be considered inclusive/incidental to the procedure. Description of Procedure or Service Populations Interventions Comparators Outcomes Individuals: With chronic or recurrent acute sinusitis Interventions of interest are: Balloon ostial dilation as a stand-alone procedure Comparators of interest are: Medical management Functional endoscopic sinus surgery Relevant outcomes include: Symptoms Change in disease status Quality of life Treatment-related morbidity

2 Individuals: With chronic or recurrent acute sinusitis Interventions of interest are: Balloon ostial dilation as an adjunct to functional endoscopic sinus surgery Comparators of interest are: Functional endoscopic sinus surgery alone Relevant outcomes include: Symptoms Change in disease status Quality of life Treatment-related morbidity Balloon ostial dilation (also known as balloon sinuplasty ) is proposed as an alternative to traditional endoscopic sinus surgery (ESS) for patients with chronic sinusitis who fail medical management. The procedure involves placing a balloon in the sinus ostium and inflating the balloon to stretch the opening. It can be performed as a stand-alone procedure or as an adjunctive procedure to functional endoscopic sinus surgery (FESS). The evidence for the use of balloon ostial dilation as a stand-alone procedure includes several systematic reviews, including a Cochrane review and a Blue Cross and Blue Shield Association TEC Assessment, several randomized controlled trials (RCTs), and a number of comparative and noncomparative single-arm studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The available systematic reviews have concluded that, although nonrandomized evidence suggests that balloon ostial dilation has similar outcomes to ESS, evidence from randomized trials is needed to demonstrate an improvement in outcomes for patients treated with balloon ostial dilation. Since the publication of the systematic reviews, an additional RCT has been published (the REMODEL study). It included 105 patients, reporting shortterm improvement in symptoms that are similar to those seen with FESS and potential advantages for balloon ostial dilation on postoperative recovery time and pain medication use. Limitations of the REMODEL study include the unblinded design, lack of blinded outcome assessment across the range of outcome measures, and differential dropout between groups. Other trials are either very small or nonrandomized comparisons. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for the use of balloon ostial dilation as an adjunct to FESS includes 2 small RCTs. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The 2 available RCTs did not report significant clinically meaningful benefits associated with the addition of FESS. The evidence is insufficient to determine the effects of the technology on health outcomes. Background Chronic rhinosinusitis (CRS) is characterized by purulent nasal discharge, usually without fever, that persists for weeks to months. Symptoms of congestion often accompany the nasal discharge. There also may be mild pain and/or headache. Thickening of mucosa may restrict or close natural openings between sinus cavities and the nasal fossae. Considerable variation exists in the location and shape of these sinus ostia.

3 Estimates are that approximately 30 million individuals in the U.S. suffer from chronic sinusitis. The majority of cases are treated with medical therapy, but surgical drainage is an option for patients who fail to respond to medical therapy. Functional endoscopic sinus surgery (FESS) has become an important aspect for surgical management of chronic sinusitis. For this procedure, a fiberoptic nasal endoscope is used to visualize the sinus ostia, and any obstruction found is corrected. This procedure restores patency and allows air and mucous transport through the natural ostium. Approximately 350,000 FESS procedures are done each year in the U.S. for chronic sinusitis. A newer procedure, balloon ostial dilatation, can be used as an alternative to FESS or as an adjunct to FESS for those with chronic sinusitis. The goal of this technique, when used as an alternative to FESS, is to achieve improved sinus drainage using a less invasive approach. When used as an adjunct to FESS, it is intended to facilitate and/or increase access to the sinuses. The procedure involves placing a guidewire in the sinus ostium, advancing a balloon over the guidewire, and then stretching the opening by inflating the balloon. The guidewire location is confirmed with fluoroscopy or with direct transillumination of the targeted sinus cavity. General anesthesia may be needed for this procedure to minimize patient movement. The maxillary sinus creates a unique challenge. The maxillary ostia, located within the ethmoid infundibulum, often cannot be accessed transnasally without excising a portion of the uncinate process. An alternate approach to the maxillary ostia is through the sinus, via the canine fossa. A guidewire can be advanced from within the maxillary sinus to the nasal fossa. The dilating balloon can enlarge the ostia while deflecting the uncinate process. To quantify the severity of chronic sinusitis and to assess treatment response, various outcomes measures can be used. The Lund-McKay scoring system utilizes radiologist-rated information derived from computed tomography (CT) scans regarding opacification of the sinus cavities. The Sino-Nasal Outcome Test (SNOT- 20) is a validated questionnaire in which patients complete 20 symptom questions on a categorical scale (0=no bother to 5=worst symptoms can be). Average rankings can be reported over all 20 symptoms, as well as by 4 subclassified symptom domains. Regulatory Status In March 2008, the device Relieva Sinus Balloon Catheter (Acclarent, Menlo Park, CA) was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for use in dilating the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children. Subsequent devices developed by Acclarent have also been granted 510(k) marketing clearance. These include the Relieva Spin Sinus Dilation System cleared in August 2011, and the Relieva Seeker Balloon Sinuplasty System cleared in November 2012.

4 In June 2008, the FinESS Sinus Treatment (Entellus Medical, Maple Grove, MN) was cleared for marketing by FDA through the 510(k) process. The indication noted is to access and treat the maxillary ostia/ethmoid infundibulum in adults using a transantral approach (FDA product code: EOB). The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. Two other balloon sinus ostial dilation devices by Entellus Medical, the ENTrigue Sinus Dilation System, and the XprESS Multi-Sinus Dilation Tool, also received 510(k) clearance in August, In 2013, a sinus dilation system (Medtronic Xomed, Jacksonville, FL), later named the NuVent EM Balloon Sinus Dilation System, was cleared for marketing by the FDA through the 510(k) process for use in conjunction with a Medtronic computerassisted surgery system when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone, or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, or sphenoid sinuses. Also in 2013, a sinus dilation system ( ArthroCare Corp., San Antonio, TX, a division of Smith and Nephew), later named the Ventera Sinus Dilation System, was cleared for marketing through the 510(k) process to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a transnasal approach. Rationale This evidence review was created in 2006 and has been updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period through September 3, The following is a summary of the key literature evidence to date. Balloon sinus ostial dilation can be performed as a stand-alone procedure or as an adjunct to functional endoscopic sinus surgery (FESS). When performed in combination with FESS, it is sometimes referred to as a hybrid procedure, because there are elements of both balloon sinus ostial dilation and FESS. Controlled trials are essential in determining the efficacy of this procedure in relation to alternatives. Medical therapy is effective in reducing symptoms for most patients, and surgical drainage is an invasive procedure with its own set of risks and benefits. Therefore, while single-arm series can give some information on success rates and adverse events, they are not sufficient to determine comparative efficacy of balloon sinus ostial dilation. The literature consists of a few small randomized controlled trials (RCTs), a small number of nonrandomized controlled trials, and a larger number of single-arm case series, most of which are retrospective. This evidence is reviewed next, with emphasis on the available controlled trials, in 2 categories: (1) balloon ostial dilation as a stand-alone procedure and (2) balloon ostial dilation as an adjunct to FESS.

5 Systematic Reviews of Balloon Ostial Dilation as a Stand-Alone or Adjunct Procedure A TEC Assessment was completed in 2012 titled Balloon Ostial Dilation for Treatment of Chronic Rhinosinusitis. 1 This Assessment reviewed evidence from 1 RCT, 3 nonrandomized comparative studies, and 9 case series. The following conclusions were made concerning the adequacy of this evidence for determining the effect of balloon sinus ostial dilation on outcomes. The Assessment concluded that the evidence was insufficient to determine the effect of the technology on health outcomes. One RCT comparing balloon sinus ostial dilation with FESS was inadequately powered and did not evaluate differences in outcomes between the 2 treatments. While most nonrandomized comparative studies of balloon sinus ostial dilation and FESS showed no difference in health outcomes between the 2 treatments, confounding factors may have biased the comparison of the 2 treatments. Several case series showed improvement in symptoms of rhinosinusitis over baseline measures, and such improvement appeared durable up to 2 years. Case series did not allow conclusions regarding the comparative efficacy of balloon sinus ostial dilation to FESS. A Cochrane systematic review on balloon sinus ostial dilation for chronic rhinosinusitis (CRS) was published in This review concentrated on RCTs, and included the Plaza et al RCT 3 as the sole controlled trial that met selection criteria. The authors rated this study as having a low risk for bias for most parameters, but a high risk for bias in reporting outcomes. They noted that symptom scores were not presented systematically and that details of statistical testing were not reported. The overall conclusion of this review was that there is no convincing evidence supporting the use of balloon sinus ostial dilation in CRS. In 2011, Batra et al performed a comprehensive review of the literature regarding balloon catheter technology (BCT) in rhinology. 4 This review concluded: The accrued data attests to its safety, whereas the largest published observational cohort studies have demonstrated the ability to achieve ostia patency for up to 2 years. However, because the selection criteria for these studies were not clearly defined, it is unclear if this data can be extrapolated to the general population with chronic rhinosinusitis (CRS). Is BCT superior or equivalent to the existing devices employed in FESS for the management of CRS? Will the use of BCT translate into improvements in patient outcomes, overall health, and/or quality of life? The many unsettled questions will be best answered by prospective randomized trials that directly compare FESS to BCT, or directly compare medical to surgical treatment. Controlled Trials of Balloon Ostial Dilation as a Stand-Alone Procedure Versus FESS

6 Randomized Controlled Trials REMODEL Trial The REMODEL study was an industry-sponsored study RCT (Cutler et al, 2013) that compared balloon ostial dilation as a stand-alone procedure with FESS. 5 A total of 105 patients with recurrent acute sinusitis or chronic sinusitis and failure of medical therapy were randomized to balloon ostial dilation or FESS. Balloon ostial dilation was performed with the Entellus device, which is labeled for a transantral approach. FESS consisted of maxillary antrostomy and uncinectomy with or without anterior ethmoidectomy. Thirteen patients withdrew consent before treatment, 11 in the FESS group (21%) and 2 in the balloon ostial dilation group (4%). The primary outcomes were the change in the Sino-Nasal Outcome Test (SNOT-20) score at 6-month follow-up, and the mean number of débridements performed postoperatively. Secondary outcomes included recovery time, complication rates, and rates of revision surgery. Both superiority and noninferiority analyses were performed on these outcomes. A total of 91 patients were available at 6-month follow-up. The improvement in the SNOT-20 score was 1.67±1.10 in the balloon dilation group and 1.60±0.96 in the FESS arm (p=0.001 for noninferiority). Postoperative débridements were more common in the FESS group than in the balloon dilation group (1.2±1.0 in the FESS arm vs 0.1±0.6 in the balloon ostial dilation arm, p<0.001 for superiority in the FESS arm). Patients in the balloon dilation arm returned to normal daily activities earlier (1.6 days vs 4.8 days, p=0.002 for superiority), and required fewer days of prescription pain medications (0.9 days vs 2.8 days, p=0.002 for superiority). There were no major complications in either group, and 1 patient in each group required revision surgery. Bikhazi et al reported 1-year follow-up from the REMODEL study in A total of 89 subjects (96.7%) were available for follow-up to 1 year. Improvement in the SNOT-20 score was 1.64 in the balloon dilation arm and 1.65 in the FESS arm (p<0.001 for noninferiority). During the year postprocedure, both the balloon dilation and FESS groups had fewer self-reported rhinosinusitis episodes (reduction of 4.2 episodes in the balloon arm, reduction of 3.5 episodes in the FESS; p=ns). In 2015, Chandra et al reported results up to 2 years postprocedure for subjects in the REMODEL study, along with an additional 30 subjects treated with either FESS or in-office balloon sinus dilation, for a total of 61 FESS patients and 74 balloon sinus dilation patients. 7 Follow-up data were available for 130, 66, and 25 patients at 12, 18, and 24 months, respectively. Details about group-specific treatment received and loss to follow-up were not reported for the additional 30 patients not described in the 2013 Cutler article. Balloon sinus dilation patients required 0.2 débridements per patient, compared with 1.0 per patient in the FESS group (p<0.001). Mean change in SNOT-20 score from baseline to 12-month follow-up was (p<0.001) and (p<0.001) for the balloon sinus dilation and FESS groups, respectively, which was considered clinically significant. These changes were maintained at 24 months. At 18 months, overall revision rates were 2.7% and 6.9% in the balloon sinus dilation and FESS groups, respectively. In addition

7 to the longer term results of the REMODEL trial, this article includes a metaanalysis including the REMODEL balloon dilation-treated patients and data from 5 manufacturer-sponsored trials, 3 of which had previously been reported in peerreviewed form (BREATHE, Stankiewicz et al [2010] 8 and Stankiewicz et al [2012] 9 ; RELIEF, Levine et al [2013] 10 ; XprESS Transnasal Maxillary Multi-Sinus, Gould et al [2014] 11 ). Across the 6 studies, 846 patients were treated with balloon sinus dilation, including 121 not described in prior publications. In a random-effects model, overall mean and subscale values for the SNOT-20 score improved compared with baseline at every follow-up time point. Additional RCTs Bizaki et al reported results from a small RCT that compared balloon ostial dilation with FESS among patients with symptomatic chronic or recurrent rhinosinusitis. 12 The study enrolled 46 subjects, 4 of whom withdrew; the analysis included 42 patients (n=21 in each group). Both groups demonstrated significant improvements in SNOT-20 scores from baseline to postprocedure. There were no differences in change in total SNOT-30 scores between the balloon sinus dilation and FESS groups at 3 months postprocedure. Marzetti et al reported results from a small RCT that compared balloon ostial dilation using an unspecified device (or devices) with FESS in the treatment of sinus headache. 13 The study included 83 patients with sinus headache, based on American Academy of Otolaryngology Head and Neck Surgery definitions, 44 randomized to conventional endoscopic sinus surgery (ESS) and 35 to balloon ostial dilation. In the balloon dilation group, 23 patients were only frontal sinus balloon patients, in which balloon catheters were the only tools used for frontal sinus sinusotomy, and 12 were hybrid, in which balloon catheters and traditional ESS were used concurrently. It was not specified how patients were selected for these groups. At 6-month follow-up, scores on the SNOT-22 improved from 28.6 at baseline to 7.8 in the ESS group and from 27.3 at baseline to 5.3 in the balloon ostial dilation group, with a statistically significant reduction in both groups (p<0.001). At 6-month follow-up, headache scores based on a visual analog scale (VAS) score improved from 6.5 at baseline to 5.4 in the ESS group and from 7.1 at baseline to 1.2 in the balloon ostial dilation group (p<0.001). A small RCT from Turkey was published in 2011 that reported on physiologic outcomes. 14 Twenty patients were randomly assigned to removal of the uncinate process via FESS or balloon sinus ostial dilation as a stand-alone procedure. The main outcome measures were co 2 concentration in the sinuses and maximum sinus pressure, both intended as surrogate measures for sinus ventilation. The co 2 concentration decreased in both study arms to a similar degree. The maximum sinus pressure decreased in the FESS group but did not change in the balloon sinus ostial dilation group. Another small RCT was published by Achar et al in This trial enrolled 24 patients with chronic sinusitis who had failed medical therapy and were scheduled for surgery. Patients were randomized to balloon dilation or FESS and followed for a total of 24 weeks. The primary outcome measures were changes in the SNOT-20

8 score and the clearance time by the saccharin test. Both groups improved significantly on both outcome measures. The degree of improvement was greater for the functional endoscopic dilatation sinus surgery group than the FESS group on both the SNOT-20 score (43.8±15.2 vs 29.7±12.3, p<0.03) and on the saccharin test score (7.5±5.1 vs 3.5±4.3, p=0.03). Adverse events were not reported. Bozdemir et al published a small study of 10 patients with nasal polyposis, in which 1 side was treated with FESS and the other with balloon sinus ostial dilation. 16 All procedures were performed by the same surgeon, and polypectomy was performed before FESS or balloon sinus ostial dilation in all patients. Outcome measures included sinus patency, as measured by computed tomography (CT) scan (Lund-McKay classification) or repeat endoscopy (McKay grading). At 10 days postprocedure, there were improvements in both groups on measures of patency, but there were no differences between groups. Nonrandomized Comparative Studies A nonrandomized comparison of balloon sinus ostial dilation with adenoidectomy in 49 children with CRS who had failed medical management was published in Thirty children had balloon sinus ostial dilation and 19 had adenoidectomy. Outcomes at 1 year included change in the Sinus and Nasal Quality of Life Survey (SN-5) scores and the need for revision surgery. Significantly more patients in the balloon sinus ostial dilation group had significant improvement in symptoms (24/30 [80%]) than in the adenoidectomy group (10/19 [53%]; p<0.05). There was no difference in the need for revision surgery between the 2 groups. In 2015, Wang et al reported on a prospective study comparing balloon sinus ostial dilation (with or without adenoidectomy) with conservative management for children with CRS refractory to medical therapy. 18 Although the study was described as a case-control, it appears to be a prospective nonrandomized comparative study; 96 patients were treated with either balloon sinus dilation (n=53) or conservative management (n=43) at the preference of guardians. Eleven balloon sinus dilation patients were excluded from analysis due to loss to follow up; in the conservative management group, 2 patients were excluded due to loss to follow-up and 4 for receiving the dilation procedure. Although the number of adenoidectomy procedures in the balloon ostial dilation group was not reported, 8 subjects were reported to have adenoid hypertrophy. Both groups demonstrated improvements in sinus symptoms on a VAS and on the SN-5 from baseline to follow-up. At 3, 6, and 12 months of follow-up, patients in the balloon ostial dilation group had lower VAS and SN-5 scores (eg, at 6 months, SN-5 was 2.7 and 3.3 in the balloon ostial dilation and conservative management groups, respectively; p=0.01). In 2008, Friedman et al reported a retrospective chart review that compared results in 35 consecutive patients who received balloon sinus ostial dilation and 35 consecutive patients who received FESS. 19 Patients with Lund-McKay scores below 13 (score range, 0-24) without polyps had been given a choice of procedures. Patients generally had a history of recurrent rhinosinusitis despite medical

9 management, but there were no consistent eligibility criteria. Individuals who received a combination of the 2 procedures or who were missing preoperative SNOT-20 scores were excluded from the analysis. The SNOT-20 score 3 months after surgery was significantly higher (more symptoms) in the endoscopic surgery group (see Table 1). Table 1. SNOT-20 Scores in Friedman et al (2008) Measurement Points Balloon Sinus Ostial Endoscopic p Dilation Surgery Baseline, mean (SD) 2.80 (0.52) 2.70 (0.85) NS Three months postoperatively, mean (SD) 0.78 (0.55) 1.29 (0.87) Postoperative pain, as measured by the number of days patients used a narcotic, was significantly lower in the group that underwent balloon sinus ostial dilation (0.8±0.7 days) compared with ESS (1.3±1.0 days; p=0.011). The patient satisfaction measure also favored the balloon sinus ostial dilation group. The primary complications reported were turbinate lateralization, or scarring, which occurred in 8 patients who underwent balloon sinus ostial dilation and in 3 patients who had endoscopic surgery. One or more sinus infections occurred in 6 balloon sinus ostial dilation patients and 9 endoscopic surgery patients during the 3-month follow-up; 1 patient in the balloon sinus ostial dilation group required revision surgery due to persistent infection. Another retrospective comparative study was published in 2012 by Koskinen et al. 20 This trial identified 208 patients who underwent balloon sinus ostial dilation or FESS. Of the 208 patients, 85 (41%) met inclusion criteria for the study and 53 (25%) responded to the mailed questionnaire. These 53 patients, 29 in the FESS group and 24 in the balloon sinus ostial dilation group, comprised the final study sample. The mailed questionnaires contained items on symptoms, exacerbations of chronic sinusitis, medication use, work exposure, and the Lund-Mackay score. Mean symptom score was worse in the balloon sinus ostial dilation group than in the FESS group (4.37 vs 3.22, p=0.04). Patients in the balloon sinus ostial dilation group reported a greater number of exacerbations than those in the FESS group. Most other outcome measures were similar between groups, and there were no measures on which the balloon sinus ostial dilation group showed superior outcomes to the FESS group. Section Summary: Balloon Ostial Dilation as a Stand-Alone Procedure Versus FESS There are a number of small randomized and nonrandomized comparative studies of balloon ostial dilation as a stand-alone procedure compared with FESS. These studies generally report that short-term outcomes of balloon ostial dilation are similar to those of FESS. However, there remains a lack of high-quality evidence on the comparative efficacy of the 2 procedures. Only 1 RCT, the REMODEL study (N=105 patients randomized), was likely to have adequate power to detect group differences. This study reported noninferiority for the change in the SNOT-20

10 scores and superiority for balloon ostial dilation on postoperative recovery and pain medication use. The trial had methodologic limitations. It was unblinded and did not have blinded outcome assessment for the symptom-based outcomes or the secondary clinical outcomes. There was evidence of differential dropout, with larger numbers of patients withdrawing from the FESS group following randomization (21% vs 4%). The other trials were either very small RCTs or nonrandomized comparative studies. This evidence shows some support for balloon ostial dilation as an alternative to FESS in patients with CRS, but it is not definitive because of the small quantity of evidence and limitations in the available trials. Further high-quality evidence is required to determine whether outcomes of balloon ostial dilation are equivalent to FESS. Controlled Trials of Balloon Ostial Dilation as an Adjunct to FESS Versus FESS Alone Hathorn et al reported results of a single-blinded, randomized trial of balloon dilation with the Ventera Sinus Dilation System as an adjunct to frontal sinusotomy (Draf 2a) in which each patient served as his or her own control. 21 The Draf 2a procedure involves a more extensive drainage procedure with resection of the floor of the frontal sinus. Thirty patients with CRS were included and randomized to right or left balloon sinus dilation in conjunction with frontal sinusotomy. Both groups had high (30/30) rates of sinus ostia patency at 3 months postprocedure. Several procedure-related factors differed between groups: the hybrid (balloon sinuplasty) procedures were significantly shorter (655 seconds vs 898 seconds; 95% CI for difference, 30.9 to seconds; p=0.03) and associated with less estimated blood loss (53 ml vs 91 ml; 95% CI for difference, 8.8 to 57.5 ml; p=0.008). A small double-blinded, RCT of balloon sinus ostial dilation as an adjunct to FESS versus FESS alone was published by Plaza et al in This study enrolled 34 patients with CRS who were refractory to intensive medical management. Patients were randomized to a hybrid approach that included balloon sinus ostial dilation of the affected frontal recess along with traditional FESS of other paranasal sinuses, or to traditional FESS with the Draf I procedure. In both groups, an anterior ethmoidectomy was performed. A posterior ethmoidectomy and/or sphenoidotomy was performed as required by intraoperative assessment in both groups. Outcome measures at 12-month follow-up included symptoms, the Rhinosinusitis Disability Index, CT results of sinus patency, and the permeability of the frontal recess, as assessed by office endoscopy. There was 1 dropout in each group, leaving a total of 16 patients per group for analysis. For both groups, there were improvements in symptoms and standardized rhinosinusitis scoring indices, but there were no differences between groups. There were also improvements in CT patency in both groups but no differences between groups. The outcome of endoscopic patency at 12 months was achieved by 73% of the balloon sinus ostial dilation patients versus 63% of the FESS patients. The published study contained contradictory statements on whether this difference was statistically significant. Personal communication with the first author 22 clarified that the difference

11 reported in the results for endoscopic patency was not statistically significant. There were no major complications reported. Section Summary: Balloon Ostial Dilation as an Adjunct to FESS Versus FESS Alone Two RCTs evaluating balloon ostial dilation as an adjunct to FESS were identified. Both studies suggested that the addition of balloon ostial dilation to traditional procedures can be done without adverse effects. One study reported improved procedure times and less blood loss with balloon ostial dilation, although it is not clear whether the procedure time and blood loss were evaluated by a blinded observer. Both studies reported no significant differences between the hybrid and standard approaches in terms of sinus ostia patency. Single-Arm Studies of Balloon Ostial Dilation as a Stand-Alone or Adjunct Procedure There are numerous single-arm series of balloon sinus ostial dilation. A representative sample, focusing on studies that are prospective, multicenter, large in number, or with extended follow-up, is presented next. A prospective multicenter series of 71 subjects with CRS was published by Cutler et al. 23 Successful dilatation was achieved in 129 of 132 (98%) of maxillary sinuses. Half the procedures were performed in an operating room and half in a clinic setting. Tolerance of the procedure was good, with patients discharged within 2 hours postprocedure. There were statistically significant improvements in symptoms at 3, 6, and 12 months postprocedure, with no difference in efficacy by site of procedure. Bolger and Vaughan reported on outcomes at 24 weeks from a prospective, multicenter study of balloon sinus ostial dilation. 24 In this study, 115 patients, for whom ESS was recommended, received treatment with the balloon catheter. Sinusotomy was attempted in 358 sinuses, and cannulation was successful in 347. Ostia patency rates were assessed at weeks 1, 12, and 24; at 24 weeks, 304 of the 347 sinuses were evaluated (88%). While only 5 were nonpatent, the status of 18% was reported as indeterminate. Patients symptoms as measured by the SNOT-20 also improved posttreatment. The device malfunctioned in 12 of 358 cases (3.4%), the balloon ruptured in 7 cases, and the catheter tip malfunctioned in 4 cases. The authors indicated that there were no serious adverse events. Additional follow-up up to 2 years, to this study has been published. 25,26 These articles report on the 1- and 2-year follow-up on a subset of the 115 patients studied. In the 1-year follow-up, a total of 70 of 115 patients (61%) remained in the study. 25 Of the 66 patients who had follow-up nasal endoscopy, 85% of sinus ostia were patent; however, by adding results of CT scans showing improvement, 92% were judged to have functional patency. The report on clinical symptoms with the 2-year follow-up involved a similar subset of patients (N=65). 26 In this longer term study, in which 34 patients had only balloon treatment, 85% of patients had improved symptoms. Revision treatment was required in 3.6% of sinuses involving 6 of 65 patients (9%).

12 A second prospective multicenter, single-arm study of balloon sinus ostial dilation in refractory rhinosinusitis was published by Stankiewicz et al in This study reported 1-year follow-up data of the Balloon Remodeling Antrostomy Therapy (BREATHE I) study. In this study, 30 patients received balloon dilation of the ethmoid infundibulum using the FinESS system, a transantral dilation approach via the canine fossa. 8 The primary outcome measure was patient-reported quality of life measured using the SNOT-20. Average overall symptom scores at baseline were 2.9±1.0. At 3, 6, and 12 months postintervention, average overall symptom scores were 0.7±0.8, 0.8±0.9, and 0.8±0.9, respectively. Two-year results of the BREATHE study were reported in At that time, 59 patients were treated with balloon sinus ostial dilation, with a mean follow-up of 27±3.6 months. Mean SNOT-20 scores improved from 2.65±0.97 at baseline to 0.79±0.71 at the longest follow-up. This report also included measures of functional impairment by the Work Limitation Questionnaire (WLQ) and the Work Productivity and Activity Impairment Questionnaire (WPAI). Mean scores on the WLQ for overall productivity loss decreased from 8% at baseline to 2.5% at longest follow-up (estimates from graphical representation), and this pre- and postchange was statistically significant (p<0.001). Similar improvements were reported on other parameters of the WLQ and WPAI. In 2014, Gould et al reported results of a prospective, single-arm study (XprESS Transnasal Maxillary Multi-Sinus) of balloon dilation of the maxillary sinuses and ethmoid infundibula with or without frontal or sphenoid ostial dilation with the XprESS device. 11 The study enrolled 82 adult patients with CRS (n=73 [89%]) or recurrent acute sinusitis (n=9 [11%]), who had, at minimum, maxillary sinus disease, but who could also have had frontal, sphenoid, and/or ethmoid disease. Three hundred thirteen ostial dilations were attempted in 82 subjects, and 307 were completed in 81 subjects. Follow-up to 1 year was available for 75 subjects (91.4%), at which point the SNOT-20 score improved to 0.75 from 2.27 at baseline (absolute reduction, -1.57; p<0.000) Patient-reported rates of sinusrelated physician visits and antibiotic courses also improved. Brodner et al reported a prospective, multicenter study to evaluate outcomes for the XprESS device for the treatment of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia in 175 adults who had previously been scheduled for conventional ESS. 27 The criteria for previously scheduled conventional ESS were not specified. There were a mean 2.7 sinuses per patient treated; of the targeted sinuses, 479 of 497 (96.4%) were successfully accessed and treated. One-year follow-up was planned in the first 50 subjects, who only underwent dilation of frontal recesses and sphenoid ostia; at 1 year, in the 41 subjects with 1-year follow-up available, 76 of 83 (91.6%) of the ostia dilated with the study device were patent. At 1 year, in 44 subjects who completed follow-up, the average overall SNOT-20 score was 0.8 (vs 1.9 at baseline; p<0.000 for change), which was considered a clinically meaningful improvement (change, 0.8).

13 Albritton et al reported results of a prospective, nonrandomized evaluation of the feasibility of in-office balloon sinus dilation with the Relieva device in patients who were enrolled in the ORIOS trial. 28 The study included 37 subjects (59 sinuses) who had a diagnosis of CRS (>12 weeks of symptoms including but not restricted to nasal obstruction, sinus/facial pressure, nasal discharge, and congestion) that was unresponsive to maximal medical management. Successful access and dilation of all targeted sinuses occurred in 33 of 37 subjects (89%). Follow-up was available for 32 (86.5%), 31 (83.8%), 26 (70.2%), and 21 (56.8%) subjects at 1, 4, 24, and 52 weeks postprocedure, respectively. Symptoms were assessed based on the change in SNOT-20 score from baseline to follow-up, with mean reductions of (95% confidence interval [CI], to -0.70), (95% CI, to ), (95% CI, to -0.85), and (95% CI, to -0.90) at 1, 4, 24, and 52 weeks postprocedure, respectively. For the 29 subjects who had CT scans available at baseline and at 24-week follow-up, Lund-Mackay score improved from 6.62 preprocedure to 2.79 postprocedure (p<0.000). In the ORIOS2 study, Karanfilov et al reported results of a prospective, nonrandomized, multicenter evaluation of office-based balloon sinus dilation with the Relieva device in 203 patients who required ESS for medically refractory chronic sinusitis. 29 Three cohorts were enrolled, a lead-in cohort, which consisted of each investigator s first cases where all targeted sinuses were successfully dilated (n=36), a standard enrollment cohort, which consisted of up to approximately 15 cases (n=84), and an extended enrollment cohort, which included subjects after the first 15 cases (n=83). Dilation was technically successful in 552 of 592 attempted sinuses (93.2%). Matched baseline and 24- week follow-up was available for 112 patients, who demonstrated a mean improvement in SNOT-20 scores of -1.1 (p<0.000). In the 110 patients with 24- week CT scans available, Lund-Mackay score improved by -4.3 compared with baseline (p<0.000 for change). Sikand et al reported longer term follow-up from the ORIOS2 study, including 122 patients who re-enrolled after 24 weeks of follow-up and were followed for an average of 1.4 years. 30 The SNOT-20 and Lund-Mackay score improvements were maintained over the follow-up period. Levine et al reported results of a prospective, nonrandomized, multicenter evaluation (the RELIEF study) of office-based balloon sinus dilation with the FinESS device in 74 patients with CRS (n=52) or recurrent acute sinusitis (n=17). 10 Balloon dilation was successful in 69 patients, and analyses were reported per protocol. The overall technical success rate in patients was 91.9% (124/135 ostia; not specified if this was in overall sample of 74 patients or in analysis sample of 69 patients). Mean SNOT-20 scores improved from a mean 2.3 at baseline to 1.1 at 6 and 12 months in the 66 patients with follow-up data available (mean change, -1.2; p<0.000). There were not significant differences in improvements reported between the CRS and recurrent acute sinusitis patients. A large retrospective, single-arm series published by Levine et al reported results from a registry study of 1036 patients who received a balloon sinus ostial dilation procedure at 27 sites from December 2005 to May This registry was developed through retrospective chart review of consecutive cases at these

14 institutions. All but 2 patients in this study had treatments while under general anesthesia. An average of 3.2 sinuses was treated per patient. Symptom improvement was reported at 95%. With average follow-up of 40 weeks, the revision rate was 1.3% There are numerous other published single-arm studies. They are mostly small, retrospective, and from a single center. 23,32-37 These studies generally report high rates of success, with continued patency at the longest follow-up and low rates of adverse events. The exception is a single-arm study reported by Tomazic et al, 36 in which the authors planned to evaluate a cohort of 200 patients with balloon ostial dilation or a hybrid procedure, but halted the study early after a high technical failure rate in 45 patients was noted, with 44 of 68 sinuses in a planned balloon ostial dilation group and 29 of 44 sinuses in a planned hybrid procedure group failing. Safety In 2010, Tomazic et al reported on a case of ethmoid roof cerebrospinal fluid leak following frontal balloon sinus ostial dilation that was not recognized until 3 weeks postprocedure. 38 This is a known risk factor of any ethmoid manipulation, including ESS. The bony defect matched the tip of a standard sinus balloon catheter device. The patient underwent subsequent repair and is reportedly symptom-free. The authors commented that, although relatively safe, complications can occur. Chandra discussed questions about potential radiation damage to the lens (lenticular opacity) from the fluoroscopic guidance used to position the guide wire. 39 By extrapolating information from other procedures, the author suggested that the threshold for lenticular opacity would be attained in the left eye after approximately 29 minutes of fluoroscopy. In a 2008 review, Vaughan commented that, in bilateral cases, less than 5 minutes of fluoroscopy is generally used. 40 Posttreatment swelling and inflammation can occur after balloon sinus ostial dilation and endoscopic surgery, which can lead to temporary sinus obstruction. The comparative complication rates with balloon sinus ostial dilation versus endoscopic surgery are not known. Also, the optimal treatment to reduce or prevent this adverse effect is uncertain. The most common treatment for postoperative swelling and obstruction are nasal packs and anti-inflammatory medications such as local or systemic steroids. Implantable spacers or stents are also available to maintain patency posttreatment. Repeat balloon sinus ostial dilation has also been used for this purpose, but no empiric evidence was identified in the literature on its use for this indication. Ongoing and Unpublished Clinical Trials Some currently unpublished trials that might influence this review are listed in Table 2.

15 Table 2. Summary of Key Trials NCT No. Trial Name Planned Ongoing NCT NCT a Unpublished NCT Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty Comparison of Balloon Sinuplasty In- Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET) Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis (MERLOT) NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial. Enrollment Completion Date 48 Mar Apr Aug 2015 Summary of Evidence The evidence for the use of balloon ostial dilation as a stand-alone procedure includes several systematic reviews, including a Cochrane review and a Blue Cross and Blue Shield Association TEC Assessment, several randomized controlled trials (RCTs), and a number of comparative and noncomparative single-arm studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The available systematic reviews have concluded that, although nonrandomized evidence suggests that balloon ostial dilation has similar outcomes to endoscopic sinus surgery (ESS), evidence from randomized trials is needed to demonstrate an improvement in outcomes for patients treated with balloon ostial dilation. Since the publication of the systematic reviews, an additional RCT has been published (the REMODEL study). It included 105 patients, reporting short-term improvement in symptoms that are similar to those seen with functional endoscopic sinus surgery (FESS) and potential advantages for balloon ostial dilation on postoperative recovery time and pain medication use. Limitations of the REMODEL study include the unblinded design, lack of blinded outcome assessment across the range of outcome measures, and differential dropout between groups. Other trials are either very small or nonrandomized comparisons. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for the use of balloon ostial dilation as an adjunct to FESS includes 2 small RCTs. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The 2 available RCTs did not report significant clinically meaningful benefits associated with the addition of FESS. The evidence is insufficient to determine the effects of the technology on health outcomes.

16 Supplemental Information Clinical Input Received From Physician Specialty Societies and Academic Medical Centers While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted Input In response to requests, input was received from 2 specialty societies and 6 academic medical centers while this policy was under review in The overall input was mixed on whether balloon ostial dilation should be medically necessary, either as a stand-alone procedure or as an adjunct to FESS. There was no consensus on subpopulations of patients with chronic rhinosinusitis that might benefit from balloon ostial dilation. There was consensus that RCTs should be performed comparing balloon ostial dilation with standard care in order to determine efficacy Input In response to requests, input was received from 2 physician specialty societies and 6 academic medical centers while this policy was under review in Input was mixed. A number of reviewers agreed that this technique was investigational. These reviewers commented about the need for additional trials to compare outcomes with standard approaches. There were also comments about the lack of selection criteria for use of the balloon catheter. Reviewers also noted that the current studies do not permit separating the results for use of the balloon from concurrent FESS, because most studies used both techniques Input In response to requests, input was received from 2 physician specialty societies and 2 academic medical centers while this policy was under review in Input from 1 specialty society did not specifically address the clinical aspects of this technique but made comments related to coding. Another specialty society noted concerns due to lack of controlled studies and also commented that the long-term objective follow-up (eg, computed tomography scans) was on a limited number of patients. Input from 2 academic centers felt this treatment was not investigational but should be viewed as just another surgical tool for the treatment of chronic sinusitis. Practice Guidelines and Position Statements National Institute for Health and Clinical Evidence A 2008 practice guideline on balloon catheter dilation of paranasal sinus ostia from the National Institute for Health and Clinical Evidence states: Current evidence on the short-term efficacy of balloon catheter dilation of paranasal sinus ostia for chronic sinusitis is adequate and raises no major safety concerns. Therefore, this

17 procedure can be used provided that normal arrangements are in place for clinical governance, consent and audit. 41 American Academy of Otolaryngology Head and Neck Surgery In 2012, the American Academy of Otolaryngology Head and Neck Surgery (AAO- HNS) Foundation offered a statement on balloon ostial dilation reaffirming its 2010 position statement: sinus ostial dilation is an appropriate therapeutic option for selected patient with sinusitis. This approach may be used alone or in conjunction with other instruments. 42 In 2014, the AAO-HNS Foundation issued updated clinical practice guidelines on adult sinusitis, which do not discuss surgical therapy or the use of balloon sinuplasty. 43 American Rhinologic Society In 2010, the American Rhinologic Society offered a statement that endoscopic balloon catheter sinus dilation technology is acceptable and safe in the management of sinus disease. 44 U.S. Preventive Services Task Force Recommendations Not applicable. Medicare National Coverage There is no national coverage determination (NCD) for balloon ostial dilation. In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. References 1. Blue Cross and Blue Shield Association Technology Evaluation Center Program. Balloon Ostial Dilation for Treatment of Chronic Rhinosinusitis. TEC Assessments 2012;27, Tab Ahmed J, Pal S, Hopkins C, et al. Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis. Cochrane Database Syst Rev. 2011(7):CD PMID Plaza G, Eisenberg G, Montojo J, et al. Balloon dilation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. Aug 2011;120(8): PMID Batra PS, Ryan MW, Sindwani R, et al. Balloon catheter technology in rhinology: Reviewing the Evidence. Laryngoscope. Sep ;121(1): PMID Cutler J, Bikhazi N, Light J, et al. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. Sep-Oct 2013;27(5): PMID Bikhazi N, Light J, Truitt T, et al. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. Jul 2014;28(4): PMID Chandra RK, Kern RC, Cutler JL, et al. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. Jul PMID Stankiewicz J, Truitt T, Atkins J, Jr. One-year results: Transantral balloon dilation of the ethmoid infundibulum. Ear Nose Throat J. Feb 2010;89(2): PMID Stankiewicz J, Truitt T, Atkins J, et al. Two-year results: transantral balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. May-Jun 2012;2(3): PMID Levine SB, Truitt T, Schwartz M, et al. In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a

18 prospective, multi-institutional study with-1-year follow-up. Ann Otol Rhinol Laryngol. Nov 2013;122(11): PMID Gould J, Alexander I, Tomkin E, et al. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. Mar-Apr 2014;28(2): PMID Bizaki AJ, Taulu R, Numminen J, et al. Quality of life after endoscopic sinus surgery or balloon sinuplasty: a randomized clinical study. Rhinology. Dec 2014;52(4): PMID Marzetti A, Tedaldi M, Passali FM. The role of balloon sinuplasty in the treatment of sinus headache. Otolaryngol Pol. Jan-Feb 2014;68(1): PMID Kutluhan A, Salviz M, Bozdemir K, et al. The effects of uncinectomy and natural ostial dilatation on maxillary sinus ventilation: a clinical experimental study. Eur Arch Otorhinolaryngol. Apr 2011;268(4): PMID Achar P, Duvvi S, Kumar BN. Endoscopic dilatation sinus surgery (FEDS) versus functional endoscopic sinus surgery (FESS) for treatment of chronic rhinosinusitis: a pilot study. Acta Otorhinolaryngol Ital. Oct 2012;32(5): PMID Bozdemir K, Kutluhan A, Cetin H, et al. Comparison of outcomes of simple polypectomy plus balloon catheter dilatation versus functional endoscopic sinus surgery in nasal polyposis: a preliminary study. Am J Rhinol Allergy. May-Jun 2011;25(3): PMID Ramadan HH, Terrell AM. Balloon catheter sinuplasty and adenoidectomy in children with chronic rhinosinusitis. Ann Otol Rhinol Laryngol. Sep 2010;119(9): PMID Wang F, Song Y, Zhang X, et al. Sinus balloon catheter dilation in pediatric chronic rhinosinusitis resistant to medical therapy. JAMA Otolaryngol Head Neck Surg. Jun 2015;141(6): PMID Friedman M, Schalch P, Lin HC, et al. Functional endoscopic dilatation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol. Mar-Apr 2008;22(2): PMID Koskinen A, Penttila M, Myller J, et al. Endoscopic sinus surgery might reduce exacerbations and symptoms more than balloon sinuplasty. Am J Rhinol Allergy. Nov-Dec 2012;26(6):e PMID Hathorn IF, Pace-Asciak P, Habib AR, et al. Randomized controlled trial: hybrid technique using balloon dilation of the frontal sinus drainage pathway. Int Forum Allergy Rhinol. Feb 2015;5(2): PMID Plaza G. Personal Communication with primary author (G Plaza). 4/12/12 April 12, Cutler J, Truitt T, Atkins J, et al. First clinic experience: patient selection and outcomes for ostial dilation for chronic rhinosinusitis. Int Forum Allergy Rhinol. Nov-Dec 2011;1(6): PMID Bolger WE, Vaughan WC. Catheter-based dilation of the sinus ostia: initial safety and feasibility analysis in a cadaver model. Am J Rhinol. May-Jun 2006;20(3): PMID Kuhn FA, Church CA, Goldberg AN, et al. Balloon catheter sinusotomy: one-year follow-up-- outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. Sep 2008;139(3 Suppl 3):S PMID Weiss RL, Church CA, Kuhn FA, et al. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg. Sep 2008;139(3 Suppl 3):S PMID Brodner D, Nachlas N, Mock P, et al. Safety and outcomes following hybrid balloon and balloononly procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. Aug 2013;3(8): PMID Albritton FDt, Casiano RR, Sillers MJ. Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation. Am J Rhinol Allergy. May-Jun 2012;26(3): PMID Karanfilov B, Silvers S, Pasha R, et al. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. May 2013;3(5): PMID Sikand A, Silvers SL, Pasha R, et al. Office-based balloon sinus dilation: 1-year follow-up of a prospective, multicenter study. Ann Otol Rhinol Laryngol. Aug 2015;124(8): PMID

19 Billing Coding/Physician Documentation Information Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (eg, balloon dilation), transnasal or via canine fossa Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (eg, balloon dilation) Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (eg, balloon dilation) Unlisted procedure, accessory sinuses C1726 Catheter, balloon dilatation, nonvascular 31. Levine HL, Sertich AP, 2nd, Hoisington DR, et al. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol. Apr 2008;117(4): PMID Brown CL, Bolger WE. Safety and feasibility of balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol. Apr 2006;115(4): ; discussion PMID Ramadan HH. Safety and feasibility of balloon sinuplasty for treatment of chronic rhinosinusitis in children. Ann Otol Rhinol Laryngol. Mar 2009;118(3): PMID Wittkopf ML, Becker SS, Duncavage JA, et al. Balloon sinuplasty for the surgical management of immunocompromised and critically ill patients with acute rhinosinusitis. Otolaryngol Head Neck Surg. Apr 2009;140(4): PMID Raghunandhan S, Bansal T, Natarajan K, et al. Efficacy & outcomes of balloon sinuplasty in chronic rhinosinusitis: a prospective study. Indian J Otolaryngol Head Neck Surg. Aug 2013;65(Suppl 2): PMID Tomazic PV, Stammberger H, Braun H, et al. Feasibility of balloon sinuplasty in patients with chronic rhinosinusitis: the Graz experience. Rhinology. Jun 2013;51(2): PMID ElBadawey MR, Alwaa A, ElTaher M, et al. Quality of life benefit after endoscopic frontal sinus surgery. Am J Rhinol Allergy. Sep-Oct 2014;28(5): PMID Tomazic PV, Stammberger H, Koele W, et al. Ethmoid roof CSF-leak following frontal sinus balloon sinuplasty. Rhinology. Jun 2010;48(2): PMID Chandra RK. Estimate of radiation dose to the lens in balloon sinuplasty. Otolaryngol Head Neck Surg. Dec 2007;137(6): PMID Vaughan WC. Review of balloon sinuplasty. Curr Opin Otolaryngol Head Neck Surg. Feb 2008;16(1):2-9. PMID NICE. National Institute of Health and Clinical Excellence (NICE). Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. Interventional Procedure Guidance ; AAOHNS. American Academy of Otolaryngology-Head and Neck Surgery. Statement on Balloon Dilation. Adopted June 28, (November 30, 2010.). PMID 43. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. Apr 2015;152(2 Suppl):S1-S39. PMID ARS. American Rhinologic Society (ARS) Revised Poisition Statement on Endoscopic Balloon Catheter Sinus Dilation Technology. 2010; J32.0- J32.9 ICD10 Codes Chronic sinusitis code range Beginning in 2011, there are specific category I CPT codes for these procedures ( ). These codes may be used to describe balloon sinuplasty when no other surgical intervention has been performed on the same sinus site.

20 Prior to 2011, and perhaps in the future, this procedure might be coded as an unlisted sinus procedure (31299). It could be submitted alone or along with other nasal/sinus endoscopy codes. If balloon sinuplasty is performed in conjunction with cutting tools such as curettes and forceps, the procedure might be coded using the CPT codes for nasal/sinus endoscopy with maxillary antrostomy (31256), nasal/sinus endoscopy with frontal sinus exploration (31276), or nasal/sinus endoscopy with sphenoidectomy (31287). Plans should be aware of this possibility. In this instance, the balloon dilation would be considered inclusive/incidental to the procedure. In the Medicare outpatient hospital setting, HCPCS code C1726 may be used for the device. Between 2007 and 2011, a specific HCPCS S code for the procedure was available S2344 Nasal/sinus endoscopy, surgical; with enlargement of sinus ostium opening using inflatable device (i.e., balloon sinuplasty) Additional Policy Key Words N/A Policy Implementation/Update Information 3/1/06 New policy; considered investigational. 3/1/07 No policy statement changes. 9/1/07 No policy statement changes. 3/1/08 No policy statement changes. 9/1/08 No policy statement changes. 3/1/09 No policy statement changes. 9/1/09 No policy statement changes. 3/1/10 No policy statement changes. 9/1/10 No policy statement changes. 1/1/11 Coding updated. 3/1/11 No policy statement changes. 9/1/11 No policy statement changes. 3/1/12 No policy statement changes. 9/1/12 No policy statement changes. 3/1/13 No policy statement changes. 9/1/13 No policy statement changes. 3/1/14 No policy statement changes. Changed title to Balloon Ostial Dilation for Treatment of Chronic Sinusitis 9/1/14 No policy statement changes. 3/1/15 No policy statement changes. 9/1/15 No policy statement changes. 3/1/16 No policy statement changes.