Latest Review Date: March 2025

Category: Surgery    

POLICY:

Effective for dates of service on and after May 1, 2023:

Use of a catheter-based inflatable device (balloon ostial dilation) for the treatment of chronic rhinosinusitis in frontal, maxillary, or sphenoid sinuses may be medically necessary when the following criteria are present:

• Individual is 18 years of age or older.

AND

• Chronic rhinosinusitis without nasal polyps that negatively impacts quality of life and is present for at least 12 continuous weeks. This must be characterized by at least two of the following, at least one of which is (a) or (b):

1. Mucopurulent nasal drainage (anterior, posterior, or both);Nasal obstruction (congestion);
2. Facial pain-pressure-fullness;
3. Decreased sense of smell.

AND

• Optimal medical therapy has been attempted and failed, as indicated by at least two courses of treatment lasting a minimum of seven days including any of the following:
  • Intranasal corticosteroids; OR
  • Nasal lavage/irrigation; OR
  • Oral antibiotics; OR
  • Decongestants when indicated

AND

• Allergy evaluation, education, and optimal treatment when indicated; AND
• Treatment of rhinitis medicamentosa (rebound nasal congestion due to extended use of topical decongestants), when present; AND
• Education on environmental irritants including tobacco smoke.

AND

• Clinical and radiographic documentation of persistent inflammation following optimal medical therapy indicated by all of the following:
  • Nasal endoscopy showing purulent (not clear) mucus or edema in the middle meatus, anterior ethmoid, or sphenoethmoid region.
  • CT scan of the paranasal sinuses showing mucosal thickening of greater than 3mm, opacification, or air-fluid levels.

Immediate post-operative nasal endoscopy with debridement after balloon sinuplasty is considered not medically necessary.

The use of balloon ostial dilation for the treatment of chronic rhinosinusitis is considered investigational when the above criteria are not met.

The use of balloon ostial dilation in all other situations including the following situations is considered investigational:

• Recurrent acute sinusitis
• Repeat balloon procedure in any of the sinuses
• Nasal polyposis 
• Samter’s triad (aspirin sensitivity)
• Severe sinusitis secondary to autoimmune or connective tissue disorders (i.e. including, but not limited to, sarcoidosis, granulomatosis with polyangiitis (PGA))
• Severe sinusitis secondary to ciliary dysfunction, (i.e. including, but not limited to, cystic fibrosis, Kartagener's Syndrome)
• Bony dysplasia (i.e. including but not limited to Paget’s disease, fibrous dysplasia)
• Extensive fungal sinusitis
• Mucocele causing sinusitis
• Suppurative or non-suppurative complications of sinusitis including extension to adjacent structures such as the orbit or central nervous system
• Suspected or known sinonasal benign or malignant tumor (including but not limited to squamous cell, adenoid cystic or adenocarcinoma, inverted papilloma)
• History of failed balloon procedure in the sinus to be treated
• Isolated ethmoid sinus disease.

Effective for dates of service October 1, 2021 through April 30, 2023:

Use of a catheter-based inflatable device (balloon ostial dilation) for the treatment of chronic rhinosinusitis in frontal, maxillary, or sphenoid sinuses may be medically necessary when the following criteria are present:

• Individual is 18 years of age or older.

AND

• Chronic rhinosinusitis without nasal polyps that negatively impacts quality of life and is present for at least 12 continuous weeks. This must be characterized by at least two of the following, at least one of which is (a) or (b):

1. Mucopurulent nasal drainage (anterior, posterior, or both);
2. Nasal obstruction (congestion);
3. Facial pain-pressure-fullness;
4. Decreased sense of smell.

AND

• Optimal medical therapy has been attempted and failed, as indicated by all of the following:

• Allergy evaluation, education, and optimal treatment when indicated;
• Two 10-day courses of antibiotics, or one prolonged course of at least 21 days duration;
• Decongestants when indicated;
• Topical and/or systemic corticosteroids for at least 8 weeks;
• Saline nasal irrigation for at least 8 consecutive weeks;
• Treatment of rhinitis medicamentosa (rebound nasal congestion due to extended use of topical decongestants), when present;
• Education on environmental irritants including tobacco smoke.

AND

• Clinical and radiographic documentation of persistent inflammation following optimal medical therapy indicated by all of the following:
  • Nasal endoscopy showing purulent (not clear) mucus or edema in the middle meatus, anterior ethmoid, or sphenoethmoid region.
  • CT scan of the paranasal sinuses showing mucosal thickening of greater than 3mm, opacification, or air-fluid levels.

Immediate post-operative nasal endoscopy with debridement after balloon sinuplasty is considered not medically necessary.

The use of balloon ostial dilation for the treatment of chronic rhinosinusitis is considered investigational when the above criteria are not met.

The use of balloon ostial dilation in all other situations including the following situations is considered investigational:

• Recurrent acute sinusitis
• Repeat balloon procedure in any of the sinuses
• Nasal polyposis 
• Samter’s triad (aspirin sensitivity)
• Severe sinusitis secondary to autoimmune or connective tissue disorders (i.e. including, but not limited to, sarcoidosis, granulomatosis with polyangiitis (PGA))
• Severe sinusitis secondary to ciliary dysfunction, (i.e. including, but not limited to, cystic fibrosis, Kartagener's Syndrome)
• Bony dysplasia (i.e. including but not limited to Paget’s disease, fibrous dysplasia)
• Extensive fungal sinusitis
• Mucocele causing sinusitis
• Suppurative or non-suppurative complications of sinusitis including extension to adjacent structures such as the orbit or central nervous system
• Suspected or known sinonasal benign or malignant tumor (including but not limited to squamous cell, adenoid cystic or adenocarcinoma, inverted papilloma)
• History of failed balloon procedure in the sinus to be treated
• Isolated ethmoid sinus disease.

DESCRIPTION OF PROCEDURE OR SERVICE:

Balloon ostial dilation (BOD, also known as balloon sinuplasty) is proposed as an alternative to functional endoscopic sinus surgery (FESS) for individuals with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) 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 FESS. This evidence review addresses BOD as a standalone procedure.

Rhinosinusitis

Rhinosinusitis can be classified according to the duration of symptoms. Acute rhinosinusitis lasts fewer than 4 weeks, while subacute sinusitis lasts between 4 and 12 weeks. Chronic rhinosinusitis (CRS) lasts more than 12 weeks. Recurrent acute rhinosinusitis (RARS) is defined as experiencing 4 or more episodes of acute rhinosinusitis per year, with each episode lasting at least 10 days and without persistent symptoms in between individual episodes. Rhinosinusitis affects 1 in 8 adults and accounts for 20% of antibiotic prescriptions. A longitudinal analysis of a medical claims database from 2003-2008 showed that 1 in 3,000 individuals had RARS, with 72% being female and an average age of 43.5 years. Individuals had an average of 5.6 healthcare visits and 9.4 prescriptions annually.

Chronic Rhinosinusitis

CRS is a highly prevalent inflammatory disorder of the paranasal sinuses and the mucosa of the nasal passages that affects 3% to 7% of adults. In adults, CRS is characterized by symptoms related to nasal and sinus obstruction and inflammation, including mucopurulent nasal drainage, nasal congestion, facial pain or pressure, and anosmia or hyposmia, that persist for at least 12 weeks.

Three CRS subtypes exist and may have somewhat different treatment strategies: CRS without nasal polyposis; CRS with nasal polyposis; and allergic fungal sinusitis. The latter is a less common subtype thought to result from chronic allergic inflammation to colonizing nasal fungi. This evidence review focuses on the more common subtypes: CRS with and without nasal polyposis. Both subtypes present with similar symptoms. However, CRS with nasal polyposis is, by definition, associated with nasal polyps that are visible on rhinoscopy or nasal endoscopy. Further, CRS with nasal polyposis is more likely to be associated with asthma and aspirin intolerance; this triad is referred to as Samter syndrome or aspirin-exacerbated respiratory disease.

Chronic rhinosinusitis is associated with impaired quality of life for affected individuals, and with high direct and indirect costs for medical treatments and lost productivity. Most often, the negative health effects of CRS are related to the unpleasant symptoms associated with CRS, including nasal congestion, nasal drainage, and facial pain or pressure. In rare cases, CRS can be associated with serious complications, including orbital cellulitis, osteomyelitis, or intracranial extension of infection.

While acute sinusitis is considered a more traditional infectious process, CRS is a chronic inflammatory disease of the upper airways, with multiple underlying causes. Risk factors for CRS with or without nasal polyps include anatomic variations and gastroesophageal reflux. There are conflicting reports about the association between allergy and CRS without nasal polyps, although weak evidence has suggested that allergy may be associated with CRS with nasal polyps. In addition, aspirin sensitivity may be associated with CRS with nasal polyps. The role of bacterial, viral, and fungal microorganisms in CRS has been actively investigated. There is some evidence that CRS is associated with a predominance of anaerobic bacteria. On the other hand, a study that used bacterial ribosomal RNA sequencing to evaluate the sinus microbiome in individuals with and without CRS found a quantitative increase in bacterial and fungal RNA expression in individuals with CRS, but no major differences in the types of microorganisms detected. Bacterial biofilms have been identified in cases of CRS.

Recurrent Acute Rhinosinusitis

RARS is defined as having four or more episodes of acute bacterial rhinosinusitis per year, with no symptoms between episodes. Diagnosis is primarily based on medical history and physical examination, following the guidelines of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Because other diseases can present with similar symptoms, it is important to consider various differential diagnoses. Nasal endoscopy is recommended for severe, one-sided, or persistent cases without septal deviation. Routine radiological imaging is generally not necessary for uncomplicated RARS, but noncontrast CT scans are crucial for chronic cases, suspected anatomical problems, or when planning surgeries like balloon ostial dilation (BOD) or functional endoscopic sinus surgery (FESS). The outlook for RARS is usually positive, with most individuals responding well to treatments such as topical nasal sprays and oral antibiotics. It is rare for individuals to need hospitalization, surgery, or intravenous antibiotics for complications. BOD has been proposed as a viable treatment option to provide symptom relief and an improved quality of life.

Medical Therapy

Most cases of CRS and RARS are treated with medical therapy (e.g., antihistamines, steroids, nasal lavage, and antibiotics). Medical therapy for CRS, with or without polyps, is often multimodal, including nasal irrigation, topical and/or systemic corticosteroids, monoclonal antibodies, and/or antibiotic therapy. Guidelines from the AAO-HNS (2015; affirmed in 2020 by the American Academy of Family Physicians) have recommended the use of saline nasal irrigation, topical intranasal corticosteroids, or both, for symptom relief of CRS, on the basis of systematic reviews of randomized controlled trials (RCTs). There is a specific recommendation against the use of topical and systemic antifungal therapies. The guidelines do not include a statement specifically addressing the use of systemic antibiotics for CRS; however, in the list of future research needs, the authors included: “Perform additional RCTs to clarify the impact of antibiotic therapy on CRS outcomes.”

In 2019, the U.S. Food and Drug Administration (FDA) approved the first treatment for CRS with nasal polyps - dupilumab (Dupixent®). Results from clinical trials revealed that individuals who received dupilumab "had statistically significant reductions in their nasal polyp size and nasal congestion compared to the placebo group" and also "reported an increased ability to smell and required less nasal polyp surgery and oral steroids." This was followed by the approval of omalizumab (Xolair®) in 2020 as add-on maintenance treatment for adults with nasal polyps with an inadequate response to nasal corticosteroids. In 2021, mepolizumab (Nucala®) was also approved as an add-on maintenance treatment in adults with CRS with nasal polyps.

The mainstay of treatment for RARS is medical management, which often involves a multifaceted therapeutic approach. Individuals typically benefit from a range of treatments aimed at different aspects of RARS's complex pathophysiology. These may include topical intranasal therapies, antibiotics, decongestants, oral antihistamines, steroids, and leukotriene modifiers.

Functional Endoscopic Sinus Surgery

The goals of surgery for CRS include removing polyps and debris that may be sources of inflammatory mediators and preventing the effective delivery of local medical therapies. In addition, to varying degrees, surgical techniques involve the creation of open sinus cavities, usually via dilation of the sinus ostia, to permit better drainage from the sinus cavities and more effective delivery of local therapies.

Techniques for FESS, in which an endoscope is used to access the sinus cavities and varying degrees of tissue are removed and the sinus ostia are opened, have evolved since the development of the nasal endoscope in the 1960s. FESS has largely replaced various open techniques for CRS (e.g., Caldwell-Luc procedure), although open procedures may have a role in complicated sinus pathologies (egg, endonasal tumors). FESS encompasses a variety of degrees of sinus access and tissue removal and is described based on the sinuses accessed. This procedure can also be used to access the ethmoid sinuses, which may involve creation of drainage into the maxillary sinuses (maxillary antrostomy).

Balloon Ostial Dilation

BOD can be used as an alternative or as an adjunct to FESS for those with CRS or RARS. The goal of this technique, when used as an alternative to FESS, is to improve sinus drainage using a less invasive approach. 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 an individual's movement. According to the manufacturer, the RELIEVA SPINPLUS® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.https://www.jnjmedicaldevices.com/en-US/product/relieva-spinplus-balloon-sinuplasty-system.

This evidence review is limited to BOD when used as a standalone procedure. BOD may also be used in combination with FESS. When used as an adjunct to FESS, it is intended to facilitate and/or increase access to the sinuses. BOD may also be used on one sinus and FESS on another sinus in the same patient during the same operation.

KEY POINTS:

The most recent literature search was performed through December 9, 2024. 

Summary of Evidence

For individuals with CRS who receive BOD as a stand-alone procedure, the evidence includes a systematic review, randomized controlled trials (RCTs), and observational studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. A meta-analysis of three studies indicated a statistically significant yet not clinically significant preference for BOD over FESS in terms of individual-related quality of life. The REMODEL RCT confirmed that BOD was not inferior to FESS for treating chronic rhinosinusitis, with the effect's durability observed over 24 months. In a retrospective cohort study that used data from a large commercial insurance database to examine adverse events in individuals who underwent BOD (n=2851) or FESS (n=11,955), the overall complication rate was 5% with BOD and 7% with FESS. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with RARS who receive BOD as a stand-alone procedure, the evidence includes a systematic review and RCTs. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. A systematic review on RARS management identified two (of 10) studies focused on BOD as a treatment modality. Although an improvement in quality of life was observed across both studies, the small sample sizes, diverse outcome measures, and study heterogeneity prevented the authors from conducting a meta-analysis. In the REMODEL RCT, 32% of participants (N=29) with RARS were diagnosed. BOD was found to be non-inferior to FESS in terms of quality of life at both 6 and 12 months post-procedure. Another RCT, CABERNET, comparing BOD plus medical care to medical care alone in individuals with RARS (N=59), demonstrated significantly improved quality of life and fewer sinus infections after 6 months in the balloon dilation group. The current body of evidence is limited by small sample sizes, unblinded outcome assessment, lack of appropriate comparators, and heterogeneity in outcome measures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Otolaryngology – Head and Neck Surgery et al.

In 2018, the American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) published a clinical consensus statement on balloon dilation of the sinuses. Participating subgroups included the Triologic Society, the American Rhinologic Society, the American Academy of Otolaryngic Allergy, and the American Academy of Allergy, Asthma & Immunology. The expert panel used Delphi method surveys to assess consensus on proposed statements. Statements achieving a mean score of 7.00 or higher and having no more than 1 outlier (2 or more LIkert points from the mean in either direction) met criteria for consensus. Strong consensus was defined as a mean Likert score of 8.00 or higher with no outliers. The following statements met consensus; statements reaching strong consensus are emphasized. The updated information to guideline statement can be found on the AAO-HNS website dated April, 2021.

Patient Criteria:

• Balloon dilation is not appropriate for patients who are without both sinonasal symptoms and positive findings on CT. (Strong consensus)
• Balloon dilation is not appropriate for the management of headache in patients who do not otherwise meet the criteria for chronic sinusitis or recurrent acute sinusitis. (Strong consensus)
• Balloon dilation is not appropriate for the management of sleep apnea in patients who do not otherwise meet the criteria for chronic sinusitis or recurrent acute sinusitis. (Strong consensus)
• CT scanning of the sinuses is a requirement before balloon dilation can be performed. (Strong consensus)
• Balloon dilation is not appropriate for patients with sinonasal symptoms and a CT that does not show evidence of sinonasal disease.
• Balloon dilation can be appropriate as an adjunct procedure to FESS in patients with chronic sinusitis without nasal polyps.
• There can be a role for balloon dilation in patients with persistent sinus disease who have had previous sinus surgery.
• There is a role for balloon sinus dilation in managing patients with recurrent acute sinusitis as defined in the AAO-HNSF guideline based on symptoms and CT evidence of ostial occlusion and mucosal thickening.

Perioperative Considerations:

• Surgeons who consider reusing devices intended for dilation of the sinuses should understand the regulations set forth by the FDA for reprocessing such devices and ensure that they are followed. (Strong consensus)
• Balloon dilation can be performed under any setting as long as proper precautions are taken and appropriate monitoring is performed.
• Balloon dilation can be performed under local anesthesia with or without sedation.

Outcome:

• Balloon dilation can improve short-term quality-of-life outcomes in patients with limited CRS without polyposis.
• Balloon dilation can be effective in frontal sinusitis.

The AAO-HNS updated its statement on balloon ostial dilation, reaffirming its 2010 position statement: “Sinus ostial dilation … is a therapeutic option for selected patient with chronic rhinosinusitis…. This approach may be used alone... or in conjunction with other instruments….” (Most recent revision with references added, 4/13/2021).

In 2015, the Academy’s Foundation updated its 2007 clinical practice guidelines on adult sinusitis, which do not discuss surgical therapy or use of balloon sinuplasty.

National Institute for Health and Clinical Excellence

In 2008 (reaffirmed in 2012), a guidance on balloon catheter dilation of paranasal sinus ostia from the National Institute for Health and Care Excellence (NICE) stated:

• “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.”
• This procedure should only be carried out by surgeons with experience of complex sinus surgery, and specific training in both the procedure and the use of fluoroscopy.
• Publication of long-term outcomes will be helpful in guiding the future use of this technique. NICE may review the procedure upon publication of further evidence."

In 2016, NICE published a recommendation on the use of the XprESS Multi-Sinus Dilation System for the treatment of chronic rhinosinusitis:

1.1 “The case for adopting the XprESS multi-sinus dilation system for treating uncomplicated chronic sinusitis after medical treatment has failed is supported by the evidence. Treatment with XprESS leads to a rapid and sustained improvement in chronic symptoms, fewer acute episodes and improved quality of life which is comparable to functional endoscopic sinus surgery (FESS).

1.2 XprESS should be considered in patients with uncomplicated chronic sinusitis who do not have severe nasal polyposis. In these patients, XprESS works as well as FESS, is associated with faster recovery times, and can more often be done under local anesthesia.”

The recommendation was based on the results of the REMODEL study: the committee "considered that the evidence from REMODEL demonstrated that balloon dilation (with either XprESS or FinESS) is clinically non‑inferior to FESS in terms of alleviating symptoms in patients with uncomplicated chronic sinusitis." Single-arm observational studies were of lower quality but were consistent with the findings of the REMODEL study. This guidance was reaffirmed in July 2020.

American Rhinologic Society

A position statement, revised in 2023, from the American Rhinologic Society, stated that sinus ostial dilation is “a therapeutic option for selected patients with chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis (RARS) who have failed appropriate medical therapy.”

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Balloon sinuplasty, chronic sinusitis, Relieva™ Sinus Balloon Catheter, Acclarent, Entellus Medical RS Series System, Entellus Medical FinEss Sinus Treatment, endoscopic sinus surgery, balloon catheter sinus dilation, balloon sinus ostial dilation, Relieva Spin Sinus Dilation System®, Relieva Seeker Balloon Sinuplasty System®, ENTrigue® Sinus Dilation System, XprESS® Multi-Sinus Dilation Tool, Ventera™ Sinus Dilation System, NuVent™ EM Balloon Sinus Dilation System, RELIEVA SPINPLUS®, Ventera™, MESIRE, Relieva Ultirra Sinus Balloon Catheter, Sinusway Dilation System        

APPROVED BY GOVERNING BODIES:

In 2008, the Relieva™ Sinus Balloon Catheter (Integra LifeSciences, formerly Acclarent Inc.) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. 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 cleared by FDA through the 510(k) process (see Table 1 below). 

In 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, the ENTrigue® Sinus Dilation System, and the XprESS™ Multi-Sinus Dilation Tool also received 510(k) clearance in 2012.

In 2013, a sinus dilation system (Medtronic Xomed, Jacksonville, FL), later named the NuVent™ EM Balloon Sinus Dilation System, was cleared for marketing by FDA through the 510(k) process for use in conjunction with a Medtronic computer-assisted 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 (Smith & 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. Ventera SDS does not require a guide wire or an illumination system as it is intended for use as a tool in combination with endoscopic sinus surgery.

Table 1 summarizes a selection of FDA cleared balloon sinus dilation devices.

Table 1. Balloon Ostial Dilation Devices Cleared by the US Food and Drug Administration

Device	Manufacturer	510(k) No.	Date Cleared	Indication
Relieva Ultirra Sinus Balloon Catheter	Acclarent, Inc.	K190525	05/03/2019	Sinus Ostia Dilation
Sinusway Dilation System	3NT Medical Ltd.	K181838	12/20/2018	Sinus Ostia Dilation
MESIRE - Balloon Sinus Dilatation System	Meril Life Sciences	K172737	12/12/2017	Sinus Ostia Dilation
Relieva SpinPlus Nav Balloon Sinuplasty System	Acclarent, Inc.	K171687	10/13/2017	Sinus Ostia Dilation
Relieva UltirraNav Sinus Balloon Catheter	Acclarent Inc.	K161698	10/24/2016	Sinus Ostia Dilation
Vent-Os Sinus Dilation Family	Sinusys Corp.	K160770	6/29/2016	Sinus Ostia Dilation
Relieva Scout Multi-Sinus Dilation System	Acclarent Inc.	K153341	2/12/2016	Sinus Ostia Dilation
XprESS Multi-Sinus Dilation System	Entellus Medical Inc.	K152434	11/20/2015	Sinus Ostia Dilation
DSS Sinusplasty Balloon Catheter	Intuit Medical Products LLC	K143738	8/27/2015	Sinus Ostia Dilation
Relieva SpinPlus Balloon Sinuplasty System	Acclarent Inc.	K143541	4/22/2015	Sinus Ostia Dilation
XprESS Multi-Sinus Dilation Tool	Entellus Medical Inc.	K142252	10/17/2014	Sinus Ostia Dilation
Relieva Scout Multi-Sinus Dilation System	Acclarent Inc.	K140160	2/20/2014	Sinus Ostia Dilation

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

31295	Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (e.g., balloon dilation), transnasal or via canine fossa
31296	Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (e.g., balloon dilation)
31297	Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (e.g., balloon dilation)
31298	Nasal/sinus endoscopy, surgical; with dilation of frontal and sphenoid sinus ostia (e.g., balloon dilation)

REFERENCES:

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22. Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope. Oct 2015; 125(10): 2238-41.
23. Gregurić T, Trkulja V, Baudoin T, Grgić MV, Šmigovec I, Kalogjera L. Association between computed tomography findings and clinical symptoms in chronic rhinosinusitis with and without nasal polyps. Eur Arch Otorhinolaryngol. May 2017; 274(5): 2165-2173.
24. Hathorn IF, Pace-Asciak P, Habib AR, Sunkaraneni V, Javer AR. Randomized controlled trial: hybrid technique using balloon dilation of the frontal sinus drainage pathway. Int Forum Allergy Rhinol. Feb 2015; 5(2): 167-73.
25. Hopkins C, Browne JP, Slack R, et al. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict?. Otolaryngol Head Neck Surg. Oct 2007; 137(4): 555-61.
26. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
27. Jenks M, Willits I, Turner EE, Hewitt N, Arber M, Cole H, Craig J, Sims A. The XprESS Multi-Sinus Dilation System for the Treatment of Chronic Sinusitis: A NICE Medical Technology Guidance. Appl Health Econ Health Policy. 2017 Oct;15(5):567-582.
28. 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 prospective, multi-institutional study with-1-year follow-up. Ann Otol Rhinol Laryngol. Nov 2013; 122(11): 665-71. 
29. Levy JM, Marino MJ, McCoul ED. Paranasal Sinus Balloon Catheter Dilation for Treatment of Chronic Rhinosinusitis: A Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg. 2016 Jan;154(1):33-40.
30. Marzetti A, Tedaldi M, Passali FM. The role of balloon sinuplasty in the treatment of sinus headache. Otolaryngol Pol. 2014; 68(1): 15-9. 
31. Meltzer EO, Hamilos DL. Rhinosinusitis diagnosis and management for the clinician: a synopsis of recent consensus guidelines. Mayo Clin Proc. May 2011; 86(5): 427-43.
32. Meltzer EO, Hamilos DL, Hadley JA, et al. Rhinosinusitis: establishing definitions for clinical research and patient care. J Allergy Clin Immunol. Dec 2004; 114(6 Suppl): 155-212.
33. Minni A, Dragonetti A, Sciuto A, Cavaliere C, Rosati D, Azimonti D, Franzetti A. Use of balloon catheter dilation vs. traditional endoscopic sinus surgery in management of light and severe chronic rhinosinusitis of the frontal sinus: a multicenter prospective randomized study. Eur Rev Med Pharmacol Sci. 2018 Jan;22(2):285-293.
34. National Institute of Health and Care Excellence (NICE). Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis [IPG273]. 2008; www.nice.org.uk/guidance/ipg273.
35. National Institute of Health and Care Excellence (NICE). XprESS multi sinus dilation system for treating chronic sinusitis [MTG30]. 2016; www.nice.org.uk/guidance/mtg30.
36. Piccirillo JF, Payne SC, Rosenfeld RM, et al. Clinical Consensus Statement: Balloon Dilation of the Sinuses. Otolaryngol Head Neck Surg. Feb 2018; 158(2): 203-214.
37. Plaza G, Eisenberg G, Montojo J, Onrubia T, Urbasos M, O'Connor C. Balloon dilation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. Aug 2011; 120(8): 511-8.
38. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): Adult Sinusitis Executive Summary. Otolaryngol Head Neck Surg. Apr 2015; 152(4): 598-609. 
39. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. Apr 2015; 152(2 Suppl): S1-S39.
40. Rudmik L, Soler ZM. Medical Therapies for Adult Chronic Sinusitis: A Systematic Review. JAMA. Sep 01 2015; 314(9): 926-39. 
41. Saltagi MZ, Comer BT, Hughes S, et al. Management of Recurrent Acute Rhinosinusitis: A Systematic Review. Am J Rhinol Allergy. Nov 2021; 35(6): 902-909.
42. Senior BA, Glaze C, Benninger MS. Use of the Rhinosinusitis Disability Index (RSDI) in rhinologic disease. Am J Rhinol. 2001; 15(1): 15-20.
43. Sikand A, Ehmer DR Jr, Stolovitzky JP, McDuffie CM, Mehendale N, Albritton FD 4th. In-office balloon sinus dilation versus medical therapy for recurrent acute rhinosinusitis: a randomized, placebo-controlled study. Int Forum Allergy Rhinol. Feb 2019; 9(2): 140-148.
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47. Xolair prescribing information. South San Francisco, CA: Genentech, Inc.; 2023. www.gene.com/download/pdf/xolair_prescribing.pdf.

POLICY HISTORY:

Medical Policy Group, December 2006 (3)

Medical Review Committee, February 2007

Medical Policy Group, March 2007 (2)

Medical Review Committee May 2007

Medical Policy Administration Committee May 2007

Available for comment May 31-July 16, 2007

Medical Policy Group, July 2007 (2)

Medical Policy Administration Committee, July 2007

Medica Policy Group, March 2008 (2)

Medical Policy Group, September 2008 (2)

Medical Policy Group, October 2008 (2)

Medical Policy Group, January 2010 (2)

Medical Policy Group, November 2010: No policy changes

Medical Policy Group, November 2010: CPT Codes added

Medical Policy Group, March 2011 (2): Updated Code S2344

Medical Policy Panel, May 2011

Medical Policy Group, June 2011 (2): Key Points, Key Words, References updated

Medical Policy Group, October 2011 (2): Description, Key Points, References updated.

Medical Policy Panel, June 2012

Medical Policy Group, July 2012 (2): Policy updated for coverage for adults in the OR setting for patients with 12 weeks chronic sinusitis and refractive to 8 weeks medical treatment.

Medical Policy Administration Committee, August 2012

Available for comments, September 18 through October 31, 2012

TEC Assessment, November 2012

Medical Policy Panel, November 2013

Medical Policy Group, February 2014 (2): Policy statement changed from covered to non-covered and investigational.  Added statement to clarify if balloon sinus ostial dilation is performed in conjunction with cutting tools such as curettes and forceps, then the balloon dilation would be considered inclusive/incidental to the procedure and not separately payable.  Results of 2013 Blue Cross and Blue Shield Association clinical vetting added.  Key Points, Key Words, Approved by Governing Bodies, References updated to support policy change.

Medical Policy Administration Committee, February 2014

Available for comment March 7 through April 21, 2014

Medical Policy Panel October 2014

Medical Policy Group, October 2014 (1): Update to Description of Procedure, Key Points, and References. Policy statement edited to remove trademarked name, no change in coverage criteria

Medical Policy Panel, October 2015

Medical Policy Group, December 2015 (6):  Updates to Key Points, Key Words, Coding, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Panel, August 2016

Medical Policy Group, August 2016 (6): Updates to Description, Key Points, Approved by Governing Bodies, Summary and References. No change to policy intent.

Medical Policy Group, February 2017 (6): Removed “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). In this instance, the balloon dilation would be considered inclusive/incidental to the procedure and not separately payable.” from policy statement. No change to policy intent.

Medical Policy Panel, May 2017

Medical Policy Group, May 2017 (6): Updates to Key Points, Practice Guidelines and References. No change to policy intent; removed old policy statement from 2014.

Medical Policy Group, September 2017 (6): Removed “chronic” from policy title.

Medical Policy Group, December 2017 (6): Annual Coding Update. Added new coding for 2018: “31298 Nasal/sinus endoscopy, surgical; with dilation of frontal and sphenoid sinus ostia (e.g., balloon dilation) (Effective 01/01/2018)”

Medical Policy Panel, February 2018

Medical Policy Group, February 2018 (6): Updates to Key Points and Practice Guidelines.

Medical Policy Panel, February 2019

Medical Policy Group, March 2019 (6): Updates to Key Points, Governing Bodies and References.

Medical Policy Panel, May 2020

Medical Policy Group, May 2020 (6) Updates to Description, Key Points, Practice Guidelines, Governing Bodies, Key Words (RELIEVA SPINPLUS®, Ventera™) and References.

Medical Policy Panel, February 2021

Medical Policy Group, August, 2021 (5): Updates to Key Points, and References. Policy Statement updated to include coverage criteria for the use of a catheter-based inflatable device (balloon ostial dilation) for the treatment of chronic rhinosinusitis in the sinus. Available for Comment: August 16, 2021 through November 30, 2021.

Medical Policy Panel, February 2022

Medical Policy Group, February 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, minor update to Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, February 2023

Medical Policy Group, February 2023 (5): Updates to Description, Key Points, Benefit Application, and References. Policy statement updated to replace the word “patients” with the word “individuals.” No change to policy intent.

Medical Policy Group, April 2023 (5): Updates to Policy statement to include revised criteria around optimal medical therapy criteria.

Medical Policy Administration Committee, May 2023

Available for Comment: May 1, 2023 through June 15, 2023.

Medical Policy Panel, February 2024

Medical Policy Group, March 2024 (9): Updates to Description, Key Points; Practice Guidelines and Position Statements, Key Words, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, February 2025

Medical Policy Group, March 2025 (3): Updates to Description, Key Points, Practice Guidelines, Governing Bodies, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.