BALLOON SINUS OSTIAL DILATION

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1 BALLOON SINUS OSTIAL DILATION MEDICAL POLICY Policy Number: 2016T0571B Effective Date: January 1, 2016 Table of Contents BENEFIT CONSIDERATIONS... COVERAGE RATIONALE APPLICABLE CODES.. DESCRIPTION OF SERVICES... CLINICAL EVIDENCE.. U.S. FOOD AND DRUG ADMINISTRATION CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS). REFERENCES.. POLICY HISTORY/REVISION INFORMATION.. Page Related Policies: None INSTRUCTIONS FOR USE This Medical Policy provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Summary Plan Description (SPD) and Medicaid State Contracts) may differ greatly from the standard benefit plans upon which this Medical Policy is based. In the event of a conflict, the enrollee's specific benefit document supersedes this Medical Policy. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the enrollee specific plan benefit coverage prior to use of this Medical Policy. Other Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational purposes. It does not constitute medical advice. UnitedHealthcare may also use tools developed by third parties, such as the MCG Care Guidelines, to assist us in administering health benefits. The MCG Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. BENEFIT CONSIDERATIONS Essential Health Benefits for Individual and Small Group: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits ( EHBs ). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this guideline, it is important to refer to the enrollee specific benefit document to determine benefit coverage. 1

2 COVERAGE RATIONALE Balloon sinus ostial dilation is medically necessary for treating chronic rhinosinusitis (defined as rhinosinusitis lasting longer than 12 weeks) when all of the following are met: Chronic rhinosinusitis of the sinus to be dilated is confirmed on computed tomography (CT) scan. CT scan findings of chronic rhinosinusitis include one or more of the following: o mucosal thickening, o bony remodeling, o bony thickening or o obstruction of the ostiomeatal complex Balloon sinus ostial dilation is limited to the frontal, maxillary or sphenoid sinuses Balloon sinus ostial dilation is performed either as a stand-alone procedure or as part of functional endoscopic sinus surgery (FESS) Balloon sinus ostial dilation is performed in persons older than 12 years of age whose symptoms persist despite medical therapy with one or more of the following: o Nasal lavage o Antibiotic therapy, if bacterial infection is suspected o Intranasal corticosteroids Balloon sinus ostial dilation is not medically necessary for the treatment of nasal polyps or tumors. There is insufficient published clinical evidence to conclude that balloon sinus ostial dilation is safe and effective for treating nasal polyps or tumors. Balloon sinus ostial dilation is not medically necessary in children 12 years of age or younger. There is insufficient evidence to support the use of balloon sinus ostial dilation in the management of rhinosinusitis in children. Long-term, well-designed studies using appropriate controls are needed to determine the effectiveness of balloon sinus ostial dilation in this population. APPLICABLE CODES The Current Procedural Terminology (CPT ) codes and Healthcare Common Procedure Coding System (HCPCS) codes listed in this policy are for reference purposes only. Listing of a service code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the enrollee specific benefit document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other policies and coverage determination guidelines may apply. This list of codes may not be all inclusive. CPT Code Description Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (e.g., balloon dilation), transnasal or via canine fossa Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (e.g., balloon dilation) Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (e.g., balloon dilation) CPT is a registered trademark of the American Medical Association. DESCRIPTION OF SERVICES Patients who have persistent or chronic rhinosinusitis that has failed pharmacologic treatment may require surgery. Functional endoscopic sinus surgery (FESS) is an accepted procedure for chronic rhinosinusitis refractory to medical therapy. FESS is a minimally invasive technique in 2

3 which the sinus air cells and ostia are opened and drained under direct visualization. Polyps and infected tissue can be removed at the same time (Stewart and Vaughn, 2010; Hayes, 2012). Chronic rhinosinusitis is defined as rhinosinusitis lasting longer than 12 weeks (Rosenfeld et al., 2015; Peters et al., 2014). Balloon sinus ostial dilation, also known as balloon dilation sinuplasty or balloon catheter sinusotomy, has been proposed as an alternative or an addition to traditional endoscopic sinus surgery. Several procedural approaches have been proposed for balloon sinus ostial dilation. The first type of approach is done through the nostrils by inserting a small balloon through a tube placed in the nasal cavity where the blocked sinus is located. Using fluoroscopic guidance, the balloon is gradually inflated to compress tissue and bone and widen the sinus. The balloon is then removed and an endoscope may be used to assess the width of the nasal passage. The second type of approach is the transantral approach which is done by creating a small entry point under the lip. The balloon catheter is then directly inserted into the target sinus. Potential advantages of sinus balloon catheterization include minimal mucosal damage, minimal intraoperative bleeding, and minimal discomfort (Brown, 2006). Balloon sinus ostial dilation can be performed as a stand-alone procedure or with FESS. When performed with FESS, it may be referred to as a hybrid procedure. CLINICAL EVIDENCE In a prospective, multicenter, randomized trial, Bikhazi et al. (2014) evaluated and compared 1- year outcomes from the REMODEL study between office balloon dilation and functional endoscopic sinus surgery (FESS). Adults with maxillary chronic rhinosinusitis (CRS), including those with anterior ethmoid disease, who failed medical management and were surgical candidates for FESS, underwent either standalone balloon dilation or FESS in a 1:1 randomization scheme and were followed through a minimum of 1 year. Sinonasal symptom improvement was assessed using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey. Standardized effect sizes were computed to further assess clinical significance. Ostial patency rate, rhinosinusitis episode frequency, impact of sinus disease on activity and work productivity using the validated Work Productivity and Activity Impairment survey, complications, and revision rate were also compared between the two groups. Ninety-two patients (50 balloon dilation; 42 FESS) were treated and 89 (96.7%) completed 1-year follow-up. Both groups showed clinically meaningful and statistically significant (p less than ) improvement in mean overall SNOT-20 scores and in all four SNOT-20 subscales. The 1-year mean change in SNOT-20 after balloon dilation (-1.64) was non-inferior to FESS (-1.65; p less than 0.001). The standardized effect size was large, showing clinically significant improvement for both interventions. Ostial patency was 96.7 and 98.7% after balloon dilation and FESS, respectively, and each group reported significant reductions in rhinosinusitis episodes (mean decrease, 4.2 for balloon dilation and 3.5 for FESS). Overall work productivity and daily activity impairment due to chronic sinusitis were significantly improved in both groups. There were no complications and revision surgery rate was 2% in each arm through 1 year. The authors concluded that with 1-year follow-up, standalone balloon dilation is as effective as FESS in the treatment of CRS in patients with maxillary sinus disease with or without anterior ethmoid disease who failed medical therapy and met the criteria for medically necessary FESS. Chandra et al. (2015) reported the final results from the REMODEL full-study cohorts and performed meta-analyses of standalone balloon sinus dilation studies to explore long-term outcomes in a large patient sample. Final outcomes from the REMODEL randomized trial, including a larger cohort of 135 patients treated with functional endoscopic sinus surgery (FESS) or in-office balloon dilation, were evaluated. One hundred thirty patients had 12-month data, 66 had 18-month data, and 25 had 24-month data. In addition, a meta-analysis evaluated outcomes from six studies including 358 standalone balloon dilation patients with up to 24 months follow-up. Outcomes out to 2 years from the REMODEL full-study cohort are consistent with 6-month and 12-month outcomes. In the meta-analysis of standalone balloon dilation studies, technical success is 97.5%, and mean 20-item Sino-Nasal Outcomes Test scores are significantly and 3

4 clinically improved at all time points. There are significant reductions in work/school days missed, homebound days, physician/nurse visits, acute infections, and antibiotic prescriptions. Mean recovery time is 1.4 days. Comparison of 12-month symptom improvements and revision rates between the REMODEL FESS arm (n = 59), REMODEL balloon dilation arm (n = 71), and pooled single-arm standalone balloon dilation studies (n = 243) demonstrated no statistical difference. The authors concluded that all outcomes are comparable between FESS and balloon dilation at all time points from 6 months to 24 months. Balloon dilation produces faster recovery, less postoperative pain, and fewer debridements than FESS. There is significant, durable benefit in a large series of 358 patients undergoing standalone balloon dilation. Cutler et al. (2013) conducted a prospective randomized controlled study on patients with chronic rhinosinusitis (CRS) to test the hypotheses that symptom improvement after balloon dilation was non-inferior to functional endoscopic sinus surgery (FESS) and balloon dilation was superior to FESS for postoperative debridement. Adults with uncomplicated CRS of the maxillary sinuses with or without anterior ethmoid disease who met criteria for medically necessary FESS were randomized 1:1 to office balloon dilation or FESS and followed for 6 months. A minimum of 36 patients per arm were required to test the hypotheses with 90% power. Symptom improvement using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey, debridements, recovery outcomes, complications, and revision surgeries were compared between groups. Ninety-two patients (50 balloon dilation; 42 FESS) were treated. Mean SNOT-20 improvement was 1.67 ± 1.10 and 1.60 ± 0.96 in the balloon and FESS arms, respectively. Both groups showed clinically meaningful and statistically significant improvement and the balloon arm was non-inferior to FESS. The mean number of postprocedure debridement per patient was 0.1 ± 0.6 in the balloon arm versus 1.2 ± 1.0 in the FESS arm, with the balloon group showing superiority. Occurrence of postoperative nasal bleeding, duration of prescription pain medication use, recovery time, and short-term symptom improvement were all significantly better for balloon dilation versus FESS. No complications occurred in either group and one revision surgery was reported in each arm. The authors concluded that balloon dilation is non-inferior to FESS for symptom improvement and superior to FESS for postoperative debridement in patients with maxillary and anterior ethmoid disease. The authors stated that balloon dilation is an effective treatment in patients with uncomplicated CRS who meet the criteria for medically necessary FESS. In a double-blind randomized controlled trial (Plaza et al., 2011), the efficacy and safety of balloon sinuplasty with the Relieva was compared with standard FESS with the Draf I procedure in 40 patients (median age 41.3 years) with chronic sinusitis of the frontal sinus in whom medical therapy had failed. All of the patients had nasal polyposis treated during surgery. The patients were randomly allocated in a 1:1 manner to balloon dilation of the affected frontal recess or to conventional frontal sinus drainage with a Draf I procedure. Both procedures were performed during FESS directed to the affected frontal sinus. The patients and the evaluating physician were blinded to the treatment arm. Before initiation of treatment, 6 patients dropped out or were excluded leaving 17 patients in each group. The patients were followed for 12 months. In both groups, a statistically significant reduction in the Lund-Mackay stage was obtained. Resolution of frontal sinus disease confirmed by computed tomographic scan seemed to be more common after balloon dilation, although this finding was not statistically significant. Permeability of the frontal recess was seen on endoscopy statistically more frequently after balloon treatment (73% versus 62.5%). Four patients needed revision surgery. No major complications were observed. The authors concluded that balloon dilation of the frontal recess is a relatively safe and effective tool in the management of chronic frontal rhinosinusitis after intensive medical treatment has failed. In a prospective, non-blinded randomized controlled pilot study, Achar et al. (2012) compared the efficacy of functional endoscopic dilatation sinus surgery (FEDS) with functional endoscopic sinus surgery (FESS) in treatment of chronic rhinosinusitis in patients who failed medical therapy. Twenty four patients were included in the study; 12 in the FESS group and 12 in the FEDS group. The FEDS group of patients underwent mainly frontal dilatation in 17 sinuses and maxillary dilatation in 18 sinuses. All patients completed sino-nasal outcome test (SNOT)-20 4

5 questionnaires and underwent saccharine test preoperatively and 24 weeks post operatively. Only trained surgeons performed surgery. The SNOT-20 questionnaire and saccharine clearance time (SCT) were used to measure outcomes. The SNOT-20 scores for both patient groups showed similar, consistent symptomatic improvement compared with baseline measures. SCT was reduced in both groups. No significant post-operative complications were recorded in either group. No patient in the FEDS group had any bleeding, and all were ready for discharge within hours of the procedure. According to the authors, FEDS is as effective as FESS in treatment of chronic rhinosinusitis. It is can be considered an additional tool in endoscopic surgery and has the potential to be undertaken as a day procedure. Marzetti et al. (2014) compared the effect of conventional functional endoscopic sinus surgery and the balloon sinuplasty to treat headaches attributed to rhinosinusitis. The study included 83 consecutive patients who were diagnosed with sinus headache according the diagnostic criteria of AAO-HNS and of HIS. Forty patients were randomized to Conventional Endoscopy Sinus Surgery for frontal sinus (ESS Group) and 35 to balloon sinuplasty of frontal sinus (BS Group). The preoperative mean of SNOT-22 scores improved from 28.6 ± 1.2 in ESS group and 27.3 ± 0.8 in BS group to a 1-month postoperative scores of 14.5 ± 0.6 in ESS group and 10.3 ± 0.5 in BS group and to a 6-month postoperative scores of 7.8 ± 0.6 and 5.3 ± 0.3, respectively. The headache scores base on analog visual scale improved from a preoperative mean of 6.5 ± 0.3 in ESS group and 7.1 ± 0.4 in Bs group to a 1-month postoperative scores of 5.4 ± 0.4 in ESS group and 5.5 ± 0.4 in BS group and to a 6-month postoperative scores of 2.7 ± 0.5 and 1.2 ± 0.1, respectively, representing a statistically significant reduction in headache score in both group. According to the authors, improvement in headache can be expected in patients treated with balloon catheter. In a retrospective controlled study, Koskinen et al. (2012) compared the symptom outcomes after maxillary sinus surgery with either the endoscopic sinus surgery (ESS) or the balloon sinuplasty technique. Two hundred eight patients with chronic rhinosinusitis (CRS) without nasal polyps underwent either balloon sinuplasty or ESS. The patients who met the inclusion criteria (n = 45 in ESS group and n = 40 in balloon group) replied to a questionnaire of history factors, exacerbations, and a visual analog scale (VAS) scoring of the change in symptoms, on average 28 ± 6 (mean ± SD) months postoperatively. The groups were identical in the response rate (64%), patient characteristics, and the improvement in all of the asked symptoms. Patients with CRS-related comorbidity and/or present occupational exposure had a statistically significantly better symptom reduction after ESS than after balloon sinusotomy. Moreover, the balloon sinusotomy group reported a statistically significant higher number of maxillary sinus punctures and antibiotic courses during the last 12 months. The authors concluded that ESS might be superior to balloon sinuplasty, especially in patients with risk factors. In a prospective, nonrandomized controlled study, Ramadan and Terrell (2010) compared the efficacy and safety of Relieva balloon sinuplasty combined with adenoidectomy (n=30) with that of adenoidectomy alone (n=19) in 49 children (mean age 6.6 years, range 2-11) with chronic sinusitis that was refractory to medical therapy for 6 months. The patients were followed at regular intervals for up to 1 year. Twenty-four of the 30 (80%) patients in the Relieva + Adenoidectomy group showed symptom improvement at 1 year compared with 10 of 19 (52.6%) children in the Adenoidectomy Alone group. Two (6%) patients with hypoplastic sinuses failed balloon sinuplasty and required revision FESS. One patient was lost to follow-up, and another had no improvement in SN-5 scores. Three (15%) children who did not improve after adenoidectomy had balloon sinuplasty. Overall, the mean SN-5 score for all of the children decreased from a baseline value of 4.1 to 2.9 after surgery. In the Relieva + Adenoidectomy group, the mean SN-5 score decreased from 4.2 to 3.0 while in the Adenoidectomy Alone group, the score decreased from 3.8 to 2.9. A multivariate analysis that adjusted for age, sex, asthma, and CT score showed that the hybrid procedure was more efficacious than adenoidectomy alone. No major complications occurred in either treatment group. 5

6 In a retrospective comparative study, Thottam et al. (2012) evaluated the incremental value of Relieva balloon catheter sinuplasty when combined with FESS in 31 children (mean age 9.3 years) who had persistent chronic sinusitis despite standard maximal medical therapy. The authors performed a blinded chart review of 15 children who underwent balloon catheter sinuplasty with ethmoidectomy and 16 children who underwent FESS. Thirteen children had prior adenoidectomy. A total symptom score was constructed for the number of complaints presurgery, postsurgery, and at the final postsurgical examination (> 4 months) including facial pain, sinus congestion, postnasal drip, rhinorrhea, headache, and low-grade fever. Success and improvement were defined as a decrease in the total complaint score of 1 point at the last visit, while total improvement was defined as total resolution of all complaints (i.e., symptom score of 0). Compared with baseline values, significant posttreatment reductions in overall sinusitis symptoms and needed interventions were observed in both treatment groups. In the Relieva balloon catheter sinuplasty group, 80% of the patients reported improvements in their overall sinus symptoms at an average of 37 weeks, versus 62.5% of the FESS patients. This difference between groups was not significant. No serious complications occurred. In a prospective, multicenter study, Gould et al. (2014) assessed 1-year changes in sinonasal symptoms and health care use after office-based multisinus balloon dilation. Adults diagnosed with chronic or recurrent acute rhinosinusitis per the 2007 adult sinusitis guidelines were enrolled in this Institutional Review Board-approved study. Balloon dilation of the maxillary sinuses/ethmoid infundibula with or without frontal or sphenoid ostial dilation was performed in the physician's office under local anesthesia. A total of 313 ostial dilations were attempted and 307 were successfully completed (98.1%) in 81 subjects. Mean procedure tolerance was 2.8 ± 2.2 (0 = no pain; 10 = severe pain). Clinically meaningful and statistically significant mean Sino- Nasal Outcome Test (SNOT-20) symptom improvement was observed at 1 and 6 months and sustained through 1 year. The Rhinosinusitis Symptom Inventory (RSI) treatment effect for all major rhinosinusitis symptoms was "large" and improvement in each was significant. Compared with the previous 1-year period, patients reported an average of 2.3 fewer acute sinus infections, 2.4 fewer antibiotic courses taken, and 3.0 fewer sinus-related physician visits after balloon dilation. No serious device or procedure-related adverse events occurred. One subject (1.3%) underwent revision surgery. The authors concluded that in-office, multi-sinus balloon dilation is safe, effective, and well tolerated. Patients reported significant reductions in both sinonasal symptoms and health care use after balloon dilation. Efficacy observed at 1 and 6 month followup was sustained through 1 year with a very low rate of revision surgery. Karanfilov et al. (2013) conducted an Institutional Review Board (IRB)-approved, prospective, 14- center trial that included 203 patients requiring endoscopic sinus surgery (ESS) for medically refractory chronic sinusitis who underwent transnasal balloon sinus dilation (BSD) treatment in an office setting under local anesthesia. Safety, tolerability, technical success, clinical efficacy (20- item Sino-Nasal Outcome Test [SNOT-20]), and radiographic outcome (Lund-Mackay [LMK] score) of ESS with BSD in the office setting were assessed. Patients were followed at 2, 8, and 24 weeks. A total of 552 sinuses were dilated in 203 patients: 47.6% maxillaries, 45.5% frontals, and 6.9% sphenoids. Seventy-seven patients were revisions of prior ESS. The mean number of sinuses dilated per patient was 2.7. Technical dilation success was 93.3%, 90.5%, and 93.7% for maxillary, sphenoid, and frontal sinuses, respectively. SNOT-20 and LMK computed tomography (CT) scoring showed statistically significant improvement at 24 weeks and clinically significant improvement in quality of life. The procedure was reported as tolerable or highly tolerable by 82.3% of patients. There were 0.15 postoperative debridements per patient and the majority returned to normal activity within 48 hours. The authors concluded that performance of ESS with BSD in the office under local anesthesia is feasible, well-tolerated, safe, and effective. Twentyfour week follow-up demonstrates clinical and statistical improvement in patient quality of life and radiographic outcomes. Additional followup data were obtained by Sikand et al. (2015) who reported outcomes 1 year after office-based BSD. According to the authors, significant improvements in quality of life observed at 24 weeks were maintained 1 year postsurgery. 6

7 In a manufacturer sponsored, multi-center review, Levine et al. (2008) (with declared affiliation) conducted a standardized retrospective chart review of 1,036 patients (3,276 sinuses) having functional endoscopic sinus surgery that included the use of balloon catheter instruments. All of the patients had a diagnosis of chronic sinusitis unresponsive to medical management and had undergone endoscopic sinus surgery. Sinus guide catheters, sinus guide wires, and sinus balloon catheters (from a single manufacturer, Acclarent) were used in the study. Patients were followed for an average of 40.2 weeks. Balloon catheters were used widely across the maxillary, frontal, and sphenoid sinuses. The revision rate was 1.3% of sinuses treated with balloon catheters. Of the patients treated with balloon catheters, 95.5% reported improvement of their sinus symptoms. In addition, 73.8% of patients were free of sinus infections in the follow-up period after treatment with balloon catheters. No major adverse events attributed to the balloon catheter were reported. The authors conclude that the use of balloon catheters to treat patients with chronic sinusitis appears to be relatively safe and effective. In a nonrandomized controlled study, Friedman et al. (2008) compared balloon catheter sinusotomy with FESS in 70 patients who had chronic sinusitis (mean age 43 years, range 18-74). All patients had Lund-McKay scores 12 and 35 patients were assigned to each treatment group. Clinically meaningful improvement was defined as a change in SNOT-20 score of > 0.8. Patients in both groups underwent treatment of a mean of 3 sinuses. A total of 13 Balloon group patients (37%) and 12 FESS group patients (34%) were undergoing revision sinus surgery. At baseline, there were no significant differences between the treatment groups in SNOT-20 scores; however, at 3 months follow-up, the mean decrease in SNOT-20 score was 2.0 for the Balloon group versus 1.4 for the FESS group, a statistically significant improvement compared with baseline for both groups and a statistically significant difference between groups in favor of the Balloon group. After surgery, mean duration of narcotic use was 0.8 days for the Balloon group versus 1.3 days for the FESS group. Balloon catheter sinusotomy was also associated with an increase in patient satisfaction based on Global Patient Assessment scores (+3.7 for the Balloon group versus +2.9 for the FESS group). There were no significant differences between the Balloon group and the FESS group in turbinate lateralization or scarring during surgery or in sinus infections or revision surgery during the 3-month follow-up. The multicenter U.S. Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR) study conducted by Bolger et al. (2007) evaluated the efficacy and safety of balloon sinuplasty and FESS in 115 chronic sinusitis patients (mean age 47.8 years, range 21-76) who were unresponsive to medical management. Six patients dropped out leaving evaluable data for 109 patients. All patients underwent balloon catheter sinusotomy and 59 (51%) underwent sinusotomy combined with FESS (358 sinuses; mean 3.1 sinuses per patient). Patients were followed for 6 months after treatment. Sinusotomy using balloon catheters was successfully performed in 143 maxillary ostia, 75 sphenoid ostia, and 124 frontal recesses. Sinusotomy using balloon catheter devices was attempted in 358 sinuses, and cannulation was successful in 347 (96.9%) sinus ostia. Among 95 patients who completed 6 months of follow-up, endoscopy revealed that the sinusotomy was patent in 80.5% (247 of 307) of sinuses, nonpatent in 1.6% (5), and ostial patency status could not be determined in 17.9% (55). Of the 255 ostia visualized on endoscopy, 247 (98%) were patent while 5 (2%) were considered nonpatent. Revision surgery was required in 3 of 307 sinuses (0.98%) in 3 patients (3 of the original 109 patients, 2.75%). In patients treated with balloon sinuplasty alone, the mean SNOT-20 score improved significantly from 2.14 at baseline to 1.27 at 6 months. The SNOT-20 score also improved in patients who had the hybrid procedure (from 2.42 to 1.02). The degree of symptom improvement was slightly higher in the latter group. Patients who had the hybrid procedure showed an improvement in symptoms in 88% (45 of 51) at 6 months versus 80% (35 of 44) of patients treated with balloon sinuplasty alone. No significant adverse events. Nine patients had bacterial sinusitis postdilation that resolved with oral antibiotic treatment. This study was extended by Kuhn et al. (2008), who performed 1-year follow-up examinations on 66 patients and 202 sinuses. At this point, 172 (85%) sinuses were patent, 2 (1%) were nonpatent, and 28 (14%) could not be evaluated. Additional followup data were obtained by Weiss et al. (2008) who reported that, for 61 available patients assessed 2 years after treatment, mean SNOT-20 7

8 symptoms scores had decreased from 2.2 at baseline to 0.9 and mean Lund-MacKay CT sinusitis scores decreased from 10.2 at baseline to 2.7. There are numerous other case series evaluating the use of balloon sinus ostial dilation (Abreu et al. 2014; Ramadan, 2009; Ramadan and Terrell, 2010; Ramadan et al., 2010; Kutluhan et al., 2009; Hopkins et al., 2011; Stankiewicz et al., 2012; Stankiewicz et al., 2011; Stankiewicz et al., 2009; Raghunandhan et al., 2013; Levine et al. 2013; Brodner et al., 2013; Cutler et al., 2011; Albritton et al., 2012; Catalano and Payne, 2009, Luong et al, 2008). In 2008, the National Institute for Health and Care Excellence (NICE) published guidance on balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. Evidence on the short-term efficacy of balloon catheter dilation was considered adequate without raising major safety concerns. NICE recommended that this procedure be performed by surgeons experienced in complex sinus surgery, and who have specific training in the procedure and the use of fluoroscopy. NICE advocated the publication of long-term outcomes to guide the future use of the technique. NICE noted that both patient selection and the selection of specific sinus(es) for treatment can be difficult (NICE, 2008). Professional Societies American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS): The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) position statement, Dilation of Sinuses, Any Method (e.g., balloon) (2014)states the following (AAO-HNS, 2014): Sinus ostial dilation (e.g., balloon ostial dilation) is an appropriate therapeutic option for selected patients with sinusitis. This approach may be used alone to dilate a sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other instruments (e.g., microdebrider, forceps). The final decision regarding use of techniques or instrumentation for sinus surgery is the responsibility of the attending surgeon. In an AAO-HNS Statement on Reimbursement of Balloon Sinus Ostial Dilation (September 2014), the AAO-HNS states that they support the use of a balloon as a tool in a standard approach to sinus ostial dilation along with other indicated endoscopic surgery. According to the AAO-HNS, surgical management for patients that have failed medical management has progressed from open surgical procedures to functional endoscopic sinus surgery (FESS) to balloon sinus ostial dilation (BSOD). The AAO-HNS states that sinus ostial dilation may be used alone to dilate a sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other instruments (e.g., microdebrider, forceps) (AAO-HNS, 2014). The AAO-HNS clinical pediatric chronic rhinosinusitis consensus statement concluded that the effectiveness of balloon sinuplasty compared to traditional endoscopic sinus surgery for pediatric CRS cannot be determined based on current evidence (Brietzke et al. 2014). In a 2015 Clinical Practice Guideline (Update) for Adult Sinusitis, the AAO-HNS indicates that clinicians should recommend saline nasal irrigation, topical intranasal corticosteroids, or both for symptom relief of chronic rhinosinusitis. Surgical management of CRS is not discussed because of insufficient evidence (e.g., randomized controlled trials) for evidence-based recommendations (Rosenfeld et al. 2015). American Rhinological Society (ARS): In a position statement released in 2015, the ARS states that sinus ostial dilation (e.g. balloon ostial dilation) is an appropriate therapeutic option for selected patients with sinusitis. This approach may be used alone to dilate a sinus ostium (frontal, maxillary, or sphenoid) or in conjunction with other instruments (e.g., microdebrider, forceps). The final decision regarding use of techniques or instrumentation for sinus surgery is the responsibility of the attending surgeon (ARS, 2015). 8

9 American Academy of Allergy Asthma and Immunology (AAAA), the American College of Allergy Asthma and Immunology (ACAAI), and the Joint Council of Allergy Asthma and Immunology (JCAAI): In a practice parameter for the diagnosis and management of rhinosinusitis, the AAAA, ACAAI, and JCAAI recommends that ostial dilatation with a balloon should be considered in a small sub-segment of patients with medically unresponsive acute rhinosinusitis (ARS), primarily those with early or localized disease (strength of evidence D - directly based on category IV evidence or extrapolated recommendation from category I, II, or III evidence). According to the authors, there are different opinions regarding the extent of surgery that should be performed for chronic rhinosinusitis (CRS), ranging from a very minimal procedure or balloon dilatation of the affected ostia, to very complete opening of all the sinuses. The authors state that the standard teaching for the functional endoscopic approach is that the surgical procedure should extend beyond the margins of the ostiomeatal disease and the inflamed boney partitions should be removed. Although symptomatic improvement from balloon dilation has been well documented, in general, patients selected for this approach have only minor disease, a significant proportion of which might be amenable to medical therapy alone. According to the authors, conclusions regarding long-term resolution of disease with minimal interventional approaches remain unproved. The authors state that it remains debatable whether balloon sinus ostial dilation is efficacious as an alternative to traditional functional endoscopic sinus surgery (FESS). In summary, balloon catheter technology has been shown as a safe method to dilate sinus ostia but no studies to date can conclude an advantage over FESS (Peters et al. 2014). Regarding medical management for chronic rhinosinusitis, the AAAA, ACAAI, and JCAAI indicate that the role of antibiotics in chronic rhinosinusitis CRS is controversial. For CRS associated with suspected bacterial infection, a longer duration of therapy beyond the usual 10 to 14 days is suggested; the choice of appropriate antibiotic therapy may need to consider the possible presence of anaerobic pathogens. Because CRS is an inflammatory disease, intranasal corticosteroids (INSs) are indicated for treatment. Other adjunctive therapy, such as intranasal antihistamines, decongestants, saline irrigation, mucolytics, and expectorants, might provide symptomatic benefit in select cases (Peters et al. 2014). The American College of Radiology (ACR): The ACR Appropriateness Criteria for Sinonasal Disease states that computed tomography (CT) of the sinuses without contrast is the imaging method of choice in patients with recurrent acute sinusitis or chronic sinusitis, or to define sinus anatomy prior to surgery (ACR, 2012). U.S. FOOD AND DRUG ADMINISTRATION (FDA) The FDA classifies devices used for balloon catheter dilation for treating chronic sinusitis under product code LRC (instrument, ENT, manual surgical). This is a broad product code category that includes a variety of devices used in ear, nose, and throat surgeries (e.g., knives, hooks, injection systems, dilation devices). Additionally, this product code is 510(k)-exempt. Although manufacturers may voluntarily submit product information via the 510(k) process, it is not a requirement. All manufacturers are, however, required to register their establishment and submit a Device Listing form; these records can be viewed in the Registration and Device Listing Database (search by product code, device, or manufacturer name). See the following web site for more information: (Accessed August 2015) The Relieva Sinus Balloon Catheter (Acclarent Inc.) is classified by the Center for Devices and Radiological Health (CDRH) as an ENT (ear-nose-throat) manual surgical instrument and regulated as a Class I device. Acclarent, Inc. received FDA approval for the Relieva Sinus Catheter and the Relieva Sinus Guidewire on August 18, This device is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. Subsequent devices developed by Acclarent have also been granted 510(k) marketing clearance. These include the Relieva Spin Sinus Dilation System approved in August 2011, and the Relieva Seeker Balloon 9

10 Sinuplasty System approved in November Balloon Sinuplasty is a trademarked term that describes the use of the Acclarent Relieva Sinus Balloon Catheter. See the following web site for more information: (Accessed August 2015) Entellus Medical, Inc. received FDA approval for the Entellus Medical RS-Series System on April 8, This device is intended to access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures. A modification was approved on June 27, 2008 to change the trade name to FinESS Sinus Treatment. See the following web site for more information: (Accessed August 2015) Until August 2012, Acclarent Inc. and Entellus Medical were the only U.S. manufacturers of balloon sinuplasty devices. On August 29, 2012, ENTrigue Surgical Inc. joined the field with FDA clearance of its Sinus Dilation System. See the following web site for more information: (Accessed August 2015) To view all 510(k) substantial equivalence summaries for ENT manual surgical instruments, search [Product Code: LRC] at: (Accessed August 2015) Additional Products Balloon Sinuplasty System; Functional INfundibular Endoscopic Sinus System (FinESS ) Sinus Treatment; Entellus Medical RS Series System; OptiLINK Extension; ReliENT Adaptor and Calibration Device; Relieva Acella Sinus Balloon Catheter; Relieva Sinus Balloon Catheter; Relieva Sinus Balloon Inflation Device; Relieva Sinus Exchange and Sinus Lavage Catheters; Relieva Sinus Guide Catheter; Relieva Sinus Guidewire; XprESS Multi- Sinus Dilation Tool Vent-Os Sinus Dilation System; Ventera Sinus Dilation System CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS) Medicare does not have a National Coverage Determination (NCD) for balloon sinus ostial dilation used in the treatment of chronic rhinosinusitis. Local Coverage Determinations (LCDs) do not exist at this time. (Accessed September 11, 2015) REFERENCES Abreu CB, Balsalobre L, Pascoto GR, et al. Effectiveness of balloon sinuplasty in patients with chronic rhinosinusitis without polyposis. Braz J Otorhinolaryngol Nov-Dec;80(6): 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;32(5): Albritton FD 4th, Casiano RR, Sillers MJ. Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation. Am J Rhinol Allergy May-Jun;26(3): Academy of Otolaryngology Head and Neck Surgery (AAO-HNS). Dilation of sinuses, any method (e.g., balloon, etc.) Available at: Accessed August American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Statement on Reimbursement of Balloon Sinus Ostial Dilation. September Available at: 10

11 results?anatomy=&condition=&resource_type=&specialty_area=&content_type=&keys=balloon+s inus+ostial+dilation Accessed August American College of Radiology (ACR). [Web site] ACR Appropriateness Criteria. Sinonasal Disease Available at: Accessed August American Rhinologic Society (ARS). Ostial balloon dilation position statement. January Available at: Accessed August Bikhazi N, Light J, Truitt T, et al.; REMODEL Study Investigators. 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;28(4): Bolger WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg. 2007;137(1): Brietzke SE, Shin JJ, Choi S, et al. Clinical consensus statement: pediatric chronic rhinosinusitis. Otolaryngol Head Neck Surg Oct;151(4): 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;3(8): Brown C, Bolger W. Safety and Feasibility of Balloon Catheter Dilation of Paranasal Sinus Ostia: A Preliminary Investigation. Annals of Otology, Rhinology & Laryngology. 2006:115(4): Catalano PJ, Payne SC. Balloon dilation of the frontal recess in patients with chronic frontal sinusitis and advanced sinus disease: an initial report. Ann Otol Rhinol Laryngol Feb;118(2): 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 30. 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. 2013;27(5): 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;1(6): ECRI Institute. Emerging Technology Evidence Report. Standalone Balloon Sinus Dilation for Treating Chronic Rhinosinusitis In Adults. August ECRI Institute. Hotline Response. Balloon Catheter Dilation for Treating Chronic Sinusitis. January ECRI Institute. Hotline Response. Balloon Catheter Dilation for Treating Frontal Sinusitis. September Friedman M, Schalch P, Lin HC, et al. Functional endoscopic dilatation of the sinuses: patient satisfaction, postoperative pain, and cost. Am J Rhinol. 2008;22(2): 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;28(2):

12 Gwaltney JM Jr, Phillips CD, Miller RD, et al. Computed tomographic study of the common cold. N Engl J Med Jan 6;330(1): Hayes, Inc. Hayes Health Technology Brief. Relieva Balloon Sinuplasty (Acclarent Inc.) for Chronic Sinusitis in Adults. Lansdale, Pa: Hayes, Inc.; October Updated August Hayes, Inc. Hayes Health Technology Brief. Relieva Balloon Sinuplasty (Acclarent Inc.) for Chronic Sinusitis in Children. Lansdale, Pa: Hayes, Inc.; October Updated August Hopkins C, Noon E, Bray D, Roberts D. Balloon sinuplasty: our first year. J Laryngol Otol. 2011;125(1): Karanfilov B, Silvers S, Pasha R, et al.; ORIOS2 Study Investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol May;3(5): 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. 2008;139(3 Suppl 3):S27-S37. Kutluhan A, Bozdemir K, Cetin H, et al. Endoscopic balloon dilation sinuplasty including ethmoidal air cells in chronic rhinosinusitis. Ann Otol Rhinol Laryngol. 2009;118(12): Levine HL, Sertich AP 2nd, Hoisington DR, et al.; PatiENT Registry Study Group. Multicenter registry of balloon catheter sinusotomy outcomes for 1,036 patients. Ann Otol Rhinol Laryngol Apr;117(4): Levine SB, Truitt T, Schwartz M, Atkins J. In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with-1-year follow-up. Ann Otol Rhinol Laryngol Nov;122(11): Luong, A, Batra, PS, Fakhri, S, et al. Balloon catheter dilatation for frontal sinus ostium stenosis in the office setting. Am J Rhinol. 2008;22(6): Marzetti A, Tedaldi M, Passali FM. The role of balloon sinuplasty in the treatment of sinus headache. Otolaryngol Pol Jan-Feb;68(1):15-9. National Institute for Health and Care Excellence (NICE). Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis. London, UK: National Institute for Health and Care Excellence; Interventional Procedure Guidance No Available at: Accessed August Peters AT, Spector S, Hsu J, et al. Diagnosis and management of rhinosinusitis: a practice parameter update. Ann Allergy Asthma Immunol Oct;113(4): Plaza, G, Eisenberg, G, Montojo, J, et al. Balloon dilation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. 2011;120(8): Ramadan HH. Safety and feasibility of balloon sinuplasty for treatment of chronic rhinosinusitis in children. Ann Otol Rhinol Laryngol. 2009;118(3): Ramadan HH, Bueller H, Hester ST et al. Sinus balloon catheter dilation after adenoidectomy failure for children with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2012;138(7):

13 Ramadan HH, McLaughlin K, Josephson G, Rimell F, Bent J, Parikh SR. Balloon catheter sinuplasty in young children. Am J Rhinol Allergy Jan-Feb;24(1):e54-6. Ramadan HH, Terrell AM. Balloon catheter sinuplasty and adenoidectomy in children with chronic rhinosinusitis. Ann Otol Rhinol Laryngol. 2010;119(9): 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;65(Suppl 2): Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(2 Suppl):S1-S39. Sikand A, Silvers SL, Pasha R, et al.; ORIOS 2 Study Investigators. Office-Based Balloon Sinus Dilation: 1-Year Follow-up of a Prospective, Multicenter Study. Ann Otol Rhinol Laryngol Aug;124(8): Stankiewicz J, Tami T, Truitt T, et al. Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol Jan-Feb;1(1): Stankiewicz J, Tami T, Truitt T, et al. Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. Am J Rhinol Allergy May-Jun;23(3): Stankiewicz J, Truitt T, Atkins J, et al. Two-year results: transantral balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol May-Jun;2(3): Stewart AE, Vaughan WC. Balloon sinuplasty versus surgical management of chronic rhinosinusitis. Curr Allergy Asthma Rep. 2010;10(3): Thottam PJ, Haupert M, Saraiya S, et al. Functional endoscopic sinus surgery (FESS) alone versus balloon catheter sinuplasty (BCS) and ethmoidectomy: A comparative outcome analysis in pediatric chronic rhinosinusitis. Int J Pediatr Otorhinolaryngol. 2012;76(9): Weiss RL, Church CA, Kuhn FA, Levine HL, Sillers MJ, Vaughan WC. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg. 2008;139(3 Suppl 3):S38-S46. POLICY HISTORY/REVISION INFORMATION Date 01/01/2016 Action/Description Updated coverage rationale; removed language indicating if service is proven or unproven from applicable medically necessary/not medically necessary statement Updated supporting information to reflect the most current clinical evidence and references Archived previous policy version 2015T0571A 13