Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Balloon Catheter Dilation of Sinus Ostia for Treatment of Chronic Rhinosinusitis

Policy #:11.16.06h

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract…

Balloon catheter dilation of sinus ostia as a stand-alone procedure is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

When performed on the same sinus in conjunction with another surgical procedure, such as functional endoscopic sinus surgery (FESS), balloon catheter dilation of sinus ostia is considered inclusive to the surgical procedure and is not eligible for separate reimbursement by the Company.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, balloon catheter dilation of sinus ostia as a stand-alone procedure is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are multiple devices approved by the FDA for balloon dilation of the sinuses (balloon sinuplasty).

Description

Paranasal sinuses are cavities within the skull that lead into the nose and are lined with the same type of membranes that line the inside of the nose. When one or more of the sinus cavities are inflamed and the sinuses cannot drain properly, a condition known as rhinosinusitis develops. Sinusitis often results in an infection that can be bacterial, fungal, or viral, and that can be caused by inflammation and allergies.

Chronic rhinosinusitis may persist for three months or longer. Symptoms may include nasal congestion, facial pain, headache, fever, general malaise, purulent nasal discharge, increased sensation of facial fullness on bending over, or aching teeth. Medical management remains the primary treatment option for chronic rhinosinusitis. This typically includes various oral and topical agents such as antibiotics, steroids, antihistamines, leukotriene receptor antagonists, saline irrigations, and mucolytics.

To quantify the severity of chronic sinusitis and to assess treatment response, various outcomes measures can be used, including radiologic scores, patient-reported quality of life (QOL) measures, and endoscopic grading. The Lind-McKay scoring system uses radiologist-rated information derived from computed tomography (CT) scans regrading opacification of the sinus cavities, generating a score from 0-12. Several disease-specific patient-reported QOL scores have been used. Commonly used is the Sino-Nasal Outcome Test-20 (SNOT-20) which is a validated questionnaire in which individuals complete 20 symptom questions on a categorical scale (0 [no bother] to 5 [worst symptoms can be]). Average ranking can be reported over all 20 symptoms, as well as by four subclassified symptom domains. The SNOT-22 is a variation of the SNOT-20 which includes two additional questions of nasal obstruction and loss of smell and taste. The minimal clinically important difference for the SNOT-22 has been estimated to be 8.9 points. In addition, QOL may be reported based on overall health-related QOL score, such as the Short Form Health Survey-36. The health survey consists of eight scales scores on various health domains, which are transformed into a 0-100 scale.

The natural history of the disorder includes resolution with medical therapy or no therapy in a large proportion of individuals. However, if aggressive medical management does not improve symptoms, surgical drainage of the sinuses may be necessary. Functional endoscopic sinus surgery (FESS) has become important in the surgical management of chronic rhinosinusitis. A nasal endoscope is used to visualize the sinuses. Inflamed tissue and bone is removed and any obstruction found in the sinus ostia is corrected. This restores patency allowing mucous transport through the natural ostium, removes diseased tissue and also improves access for topical therapy.

Balloon catheter dilation of sinus ostia has been used as an adjunct to FESS. Compared with FESS, where the tissue and bone is removed, the balloon compresses the mucosa and causes microfracture of the underlying bone (Ahmed et al. 2011). Additionally, it has been investigated as a stand-alone procedure as an alternative to FESS. Unlike most endoscopic sinus surgery, which requires tissue reduction (such as inferior turbinate reduction), in the balloon catheter dilation of sinus ostia procedure, a device such as the Relieva® Sinus Balloon Inflation Device (Acclarent®, Inc.; Menlo Park, CA) or the Relieva® Sinus Balloon Dilation Catheter (ExploraMed® NCI, Inc.; Mountain View, CA) is used to stretch and open the sinus ostia to improve sinus drainage.

There is a growing body of published literature and/or clinical studies regarding balloon catheter dilatation of sinus ostia as a stand-alone procedure. However, the published literature consists of non-comparative results on only a small number of individuals, somewhat limited follow up, and no controls. The long-term safety and efficacy of balloon catheter dilation of sinus ostia is unknown: randomized studies and longer-term outcome data are needed. In particular, prospective comparative studies of balloon catheter dilation of sinus ostia with larger populations compared with standard surgical or medical treatments are needed to determine symptom improvement, durability of balloon catheter dilation of sinus ostia, and the need for subsequent revision. More information is also needed to determine which individuals and sinuses might be treated with the balloon technique, and which individuals and sinuses require standard approaches.

PEER-REVIEWED LITERATURE
Bikhazi et al (2014) published results from a prospective, multicenter, randomized trial performed to evaluate and compare one year outcomes from the Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up (REMODEL) study. The study compared office based balloon dilation and FESS, and expanded on the six month study findings previously reported by Cutler et al (2013). Ninety-two adults with maxillary chronic rhinosinusitis (CRS), including those with anterior ethmoid disease, who failed medical management and were surgical candidates for FESS, underwent either stand-alone balloon dilation or FESS (50 balloon dilation; 42 FESS) in a 1-to-1 randomization scheme. They were followed for a minimum of one year. Sinonasal symptom improvement was assessed using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey, which is a valid outcome measure for individuals with rhinosinusitis consisting of a questionnaire in which individuals complete 20 symptom questions on a categorical scale (0=least severe to 5=most severe). Standardized effect sizes were computed to further assess clinical significance. Also compared between the two groups were 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. Eighty-nine participants (96.7 percent) completed one year follow-up. Both groups showed improvement in mean overall SNOT-20 scores and in all four SNOT-20 subscales. The one year mean change in SNOT-20 after balloon dilation (-1.64) was noninferior to FESS (-1.65; p < 0.001). The standardized effect size was large, showing improvement for both interventions. Ostial patency was 96.7 percent and 98.7 percent after balloon dilation and FESS, respectively, and each group reported reductions (p < 0.0001) 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 improved (p < 0.001) in both groups. There were no complications. Revision surgery rate was two percent in each arm through one year. Limitations of this trial include an unblinded design, lack of blinded outcome assessment across the range of outcome measures, and differential dropout between groups, such that 13 individuals withdrew consent prior to treatment, 11 in the FESS group (21 percent) and two in the balloon ostial dilation group (4 percent). The study population also included more than 25 percent of individuals with seasonal allergies and 60 percent of individuals with septal deviation, such that the effect of including concomitant conditions in the study population is unknown. In addition, more information is needed to determine which individuals and which sinuses benefit from the balloon dilation as an adjunct to traditional FESS, and which individuals should get standard approaches. Further high-quality trials are needed to determine the comparative efficacy of balloon dilation and FESS.

As a follow up publication, Bizaki et al (2015) reported on nasal airway resistance and sinus symptoms between FESS and balloon ostial dilation treated groups for this analysis, 62 individuals were included (32 from the FESS group and 30 from the balloon ostial dilation group). Individuals in the balloon ostial dilation group had significant improvements in nasal volume from pre to postoperative measurements, but there was no significant differences between groups pre- or postoperatively in nasal volume.

An additional publication by Bizaki reported on an RCT that compared balloon ostial dilation with FESS with a focus on mucociliary clearance. It was conducted at the same institution as the previously enrolled 36 individuals who were randomized to balloon ostial dilation or FESS; however, it is not specified that it was the same set of individuals. In addition, seven individuals dropped out and were not included in the analysis. SNOT-22 scores improved in both groups for pre to postoperative analyses. However, change in total SNOT-22 score did not differ significantly between groups. There was no significant change in mucociliary clearance before and after either treatment, and no significant between-group difference in mucociliary clearance.

In 2015, Chandra et al reported the final results of up to two years post-procedure 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 individuals and 74 balloon sinus dilation individuals. Follow-up data were available for 130, 66, and 25 subjects at 12, 18, and 24 months, respectively. Details about group-specific treatment received and loss to follow up are not reported for the additional 30 subjects not described by 2013 Cutler et al. The balloon sinus dilation group required 0.2 debridements per individual, compared with 1.0 per individual in the FESS group (P<0.0001). The mean change in SNOT-20 score from baseline to 12 month follow-up was -1.59 (P<0.0001) and -1.60 (P<0.0001) 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 percent and 6.9 percent in the balloon sinus dilation and FESS groups, respectively. In addition to the longer-term results of the REMODEL trial, this article includes a meta-analysis of stand-alone balloon sinus dilation studies including the REMODEL balloon dilation treated individuals and data from six manufacturer sponsored trials, three of which had previously been reported in peer-reviewed form. The meta-analysis included 846 individuals who were treated with balloon sinus dilation, including 121 who were 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. This evidence shows some support for balloon ostial dilation as an alternative to FESS in individuals with chronic rhinosinusitis, but it is not definitive because of the small quantity of evidence and limitations that are consistent with earlier REMODEL reports.

In a prospective multicenter study, Gould et al (2014) reported the one year outcomes from 81 individuals treated with an office based balloon dilation under local anesthesia for multisinus disease. Intraoperative procedure technical success and subject procedure tolerance were recorded. Efficacy was assessed using the patient reported SNOT-20 and Rhinosinusitis Symptom Inventory (RSI). Complications and revision surgeries were also recorded. Analysis of data showed that among the study participants, mean procedure tolerance was 2.8 ± 2.2 (0 = no pain; 10 = severe pain). The participants also showed symptom improvement in mean overall SNOT-20 scores (p < 0.0001) observed at one and six months and sustained through one year.

The RSI showed a treatment effect for all major rhinosinusitis symptoms, and improvement (p < 0.0001) in each was noted. Compared with the previous one year period, individuals reported an average of 2.3 fewer acute sinus infections (p < 0.0001), 2.4 fewer antibiotic courses taken (p < 0.0001), and 3.0 fewer sinus related physician visits (p < 0.0001) after balloon dilation. No serious device- or procedure related adverse events occurred. One individual (1.3 percent) underwent revision surgery. The study authors concluded that office based multisinus balloon dilation is safe, effective, and well tolerated. Although evidence may show some support for office based multisinus balloon dilation, this study, however has several limitations. For example, it lacks a comparison group to compare balloon dilation to standard care in order to determine efficacy. Additionally, although all individuals were required to have documented CRS or recurrent acute rhinosinusitis and failure of maximal medical therapy, the specific medical therapy was not controlled, and adherence to medical treatment is unknown such that individual compliance reports could be inaccurate. The study population also included 65.8 percent of individuals with asthma and 59.8 percent of individuals with septal deviation, such that the effect of including concomitant conditions in the study population is unknown. Furthermore, the results of pre-enrollment CT scan are not provided to give a quantitative measure of disease severity. Concomitant turbinate reduction procedure was allowed and performed in 57 percent of the study participants, so it is unclear how this concomitant procedure affects the study outcomes. It is also unclear if SNOT-20 is validated for the different types of rhinosinusitis and is subject to the reliability of recall of individually reported outcomes. Other limitations include small size, need for long-term follow-up time, and a lack of a control group, which prevented assessment of possible placebo effects.

A single-arm study reported by Tomazic et al (2013), evaluated the feasibility of balloon catheter dilation of sinus ostia in routine treatment of individuals with chronic rhinosinusitis refractory to medical therapy. Forty-five consecutive individuals were included in this study, in whom 112 sinuses were approached by balloon catheter dilation of sinus ostia. Of the 112 sinuses, 68 (60 percent) were planned as a balloon-only procedure and 44 (40 percent) were planned as a hybrid procedure. Of the 68 sinuses in the balloon-only group, 44 sinuses failed, equating to a failure rate of 65 percent. Forty-four sinuses were planned for hybrid procedures. In 29 of these sinuses, balloon catheter dilation of sinus ostia failed, giving a failure rate of 66 percent. The authors concluded that according to literature, balloon catheter dilation of sinus ostia can be a useful adjunct technique to standard FESS. In their experience with this study, however, a failure rate of 65 percent for balloon-only and of 66 percent for hybrid procedures occurred, which was regarded as unacceptable. Therefore, the study initially scheduled for a cohort of 200 individuals, was abandoned.

A retrospective comparative study was published in 2012 by Koskinen et al that included 53 participants with refractory chronic rhinosinusitis without previous sinonasal operations. The study was composed of 29 participants in the FESS group and 24 participants in the balloon catheter dilation of the sinus ostia group. The intent of this study was to compare the symptom outcomes after maxillary sinus surgery with either the FESS or the balloon sinuplasty technique. No previous or additional sinonasal operations were accepted. The individuals who met with the inclusion criteria replied to a questionnaire, which was mailed and contained questions on symptoms, exacerbations of chronic rhinosinusitis, medication use, work exposure, and the Lund-Mackay score. The Lund-Mackay score was assigned to each sinus based on the degree of mucosal inflammation or hypertrophy within the sinus. The mean symptom score was worse in the balloon sinus ostial dilation group compared to the FESS group (4.37 vs. 3.22, p=0.04). Individuals in the balloon sinus ostial dilation group reported a greater number of exacerbations compared to the FESS group. The majority of other outcome measures were similar between groups, and there were no measures on which the balloon sinus ostial dilation group showed superior outcomes compared to the FESS group. The authors recommended that prospective randomized controlled trials with an increased number of participants are warranted.

Plaza et al (2011) performed a randomized clinical trial comparing balloon sinus ostial dilation/hybrid with FESS to FESS alone, for 32 individuals who had frontal sinus disease refractory to medical management. Primary outcome measurements at 12 months of follow-up included symptoms, the rhinosinusitis disability index, computed tomography (CT) results of sinus patency, and the patency of the frontal recesses as assessed by endoscopy performed in an office setting. 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 results of sinus patency in both groups but no differences between groups. There are several limitations to this study: it was inadequately powered and did not evaluate differences in outcomes between the two treatments, nor did it demonstrate that balloon sinus dilation is as safe and effective when compared to existing techniques.

An industry-sponsored prospective multicenter case series study named the Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR) compared the individual's baseline status to outcomes up to 2 years after surgery. The CLEAR study included consecutive individuals with chronic rhinosinusitis unresponsive to medical management who had either balloon sinus ostial dilation alone for disease in the maxillary, frontal, or sphenoid sinuses, or had hybrid FESS if the disease was also located in the ethmoid sinus. Three articles were published from the CLEAR study (Bolger 2007, Kuhn 2008, Weiss 2008): the longest follow-up was 24 months, and outcomes from as many as 43 percent of individuals were lost to follow-up. Methodological flaws include potential biases created by lack of controls, no blinding, patient selection, a mixed population of primary and revisional surgeries, the proportion of individuals lost to follow-up, and manufacturer sponsorship of the study, all of which may impact the results of the reported data, so that efficacy cannot be determined.

A retrospective chart review compared 35 individuals who received balloon sinus ostial dilation (without ethmoidectomy) and 35 individuals who received FESS (with ethmoidectomy) (Friedman 2008). The purpose of this study was to determine how functional endoscopic dilatation of the sinuses (FEDS) compares with FESS in a select group of individuals with respect to elimination of symptoms, individual satisfaction, postoperative narcotic use, and cost. The FESS group had more sinuses treated than the balloon sinus ostial dilation group, indicating potentially more severe disease. Among the various outcome measures, individuals in the study completed the SNOT-20. Both groups showed a clinical and statistical improvement, or a decrease in SNOT-20 scores at 3 months. The decrease in the SNOT-20 score was greater in the balloon sinus ostial dilation group than the FESS group (1.99 versus 1.41, p=0.005). An overall rating of individual satisfaction assessed at a 3-month follow-up favored balloon sinus ostial dilation (3.71 versus 2.94 on a -5 to +5 scale, p=0.016). Postoperative narcotic use was lower in the balloon sinus ostial dilation group (0.80 days versus 1.34 days, p=0.011). Turbinate lateralization or scarring was the only adverse event mentioned, and this occurred in 8 balloon sinus ostial dilation individuals and in 3 FESS individuals. Methodological limitations have been noted with this study. The individuals in this study did not undergo matching or randomization since they decided on their surgical intervention. Because ethmoid sinuses cannot be dilated with the balloon sinus ostial dilation device used in this study, this selection criterion potentially creates imbalance between the two arms of the study. The fact that this study only provides a 3-month follow-up of a chronic disease process is a limitation: long-term sinus patency and efficacy of the methods examined in this study remain unknown (Batra 2012).

Levine (2008) discusses a multicenter retrospective uncontrolled review of 1036 individuals who underwent FESS that included the use of balloon catheters. Although in such combined procedures, it is difficult to assess which procedure contributed to clinical success or failure, these case series uniformly report symptom improvement, which appears to be durable in the subset of individuals followed for up to 2 years. Revision rates ranged between 3 and 9 percent, but the follow-up time varied across studies. Acute adverse event rates appeared low. The authors report that there were differences between the groups with regard to blood loss, operation time, debridements, and endoscopies, with outcomes favoring the balloon sinus ostial dilation. However, no statistical data was provided to support this finding. Although none of the studies specify a protocol or procedure for identifying and recording adverse events, it might be presumed that the known adverse events of FESS, such as cerebral spinal fluid leakage or excessive bleeding, would be reasonably reported. In addition, the authors of this study cautioned that they did not provide a comparative outcome analysis of this retrospective review.

SUMMARY

Balloon catheter dilation of sinus ostia is being studied as a minimally invasive alternative to FESS, or as an adjunct to endoscopic sinus surgery. While there are some studies that suggest that the technique may provide some symptom resolution, there is still insufficient evidence on the impact of balloon sinus ostial dilation on health outcomes. Conclusions about the efficacy of balloon sinus ostial dilation compared to FESS are difficult to make based on a lack of high-quality evidence, mostly consisting of evaluation of case series data, small randomized and nonrandomized comparative studies. Success rates, adverse event rates, and revision rates may be due to influences of disease severity. An additional complicating factor in the evaluation of this technology is that, depending on the individual and the judgment of the treating professional provider, FESS and balloon sinus ostial dilation may be combined during one operation as a hybrid procedure, making it difficult to determine the specific role of balloon sinus ostial dilation. Non-comparative single-arm series report high success rates, but are not sufficient to determine comparative efficacy with alternative treatments. Additional prospective comparative studies with larger patient populations are needed to determine the clinical outcomes for this treatment compared with standard surgical or medical approaches. This information is important to determine symptom improvement, as well as the durability of the procedure and the need for subsequent revision. In addition, the individual selection criteria for this procedure have not been well defined, more information is needed to determine which individuals and which sinuses benefit from the balloon technique as an adjunct to traditional endoscopic sinus surgery, and which individuals should receive standard approaches.
References


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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;76:1355-1360.

Tomazic PV, Stammberger H, Braun H, et al. Feasibility of balloon sinuplasty in patients with chronic rhinosinusitis: the Graz experience. Rhinology. 2013;51(2):120-127.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODES ARE USED TO REPORT BALLOON SINUS OSTIAL DILATION WHEN NO OTHER SURGICAL INTERVENTION HAS BEEN PERFORMED ON THE SAME SINUS SITE


31295, 31296, 31297, 31298



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

11.16.06h
05/23/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on balloon catheter dilation of sinus ostia for treatment of chronic rhinosinusitis.
01/01/2018This policy has been identified for the CPT code update, effective 01/01/2018.

The following CPT code has been added to this policy: (experimental/investigational)
31298


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2018
Version Issued Date: 12/29/2017
Version Reissued Date: 05/23/2018

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