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Balloon Ostial Dilation for Treatment of Sinusitis

Policy Number: MP-225

Latest Review Date: March 2024

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);
  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 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.

Effective for dates of service prior to October 1, 2021:

Use of a catheter-based inflatable device (balloon ostial dilation) in the treatment of sinusitis is considered not medically necessary and investigational.

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.

Chronic and Recurrent Acute Rhinosinusitis

Chronic rhinosinusitis (CRS) is characterized by purulent nasal discharge, usually without fever, that persists for weeks to months. Symptoms of congestion often accompany the nasal discharge. There also may be mild pain and/or headache. Thickening of mucosa may restrict or close natural openings between sinus cavities and the nasal fossae, although symptoms are variable because considerable variation exists in the location and shape of these sinus ostia.

Recurrent acute rhinosinusitis (RARS) is defined as 4 or more episodes per year of acute bacterial rhinosinusitis without signs or symptoms of rhinosinusitis between episodes.

Medical Treatment

Most cases of CRS and RARS are treated with medical therapy (e.g., antihistamines, steroids, nasal lavage, and antibiotics). Additionally, an anti-interleukin-5 (IL-5) monoclonal antibody (mAb), mepolizumab, received FDA-approval in July 2021 as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps. Previously in 2019, the FDA approved the interleukin-4 receptor alpha antagonist dupilumab as an add-on maintenance treatment in adults with inadequately controlled chronic rhinosinusitis with nasal polyps.

Functional Endoscopic Sinus Surgery

FESS involves the insertion of an endoscope into the nose for a direct visual examination of the openings into the sinuses. Using the endoscope and a combination of surgical tools (e.g., curettes, forceps, powered micro-debriders, powered shavers, and/or sinus balloon catheters), surgeons enlarge the patient’s sinus openings to clear passageways in order to restore normal sinus ventilation and drainage. The goal of surgery is to improve sinus ventilation and drainage by enlarging the openings of the sinuses, removing any polyps and correcting significant structural problems that may be hindering drainage.

The maxillary sinus creates a unique challenge. The maxillary ostia, located within the ethmoid infundibulum, often cannot be accessed transnasally without excising a portion of the uncinate process. An alternative approach to the maxillary ostia is through the sinus, via the canine fossa. A guidewire can be advanced from within the maxillary sinus to the nasal fossa. The dilating balloon can enlarge the ostia while deflecting the uncinate process.

Approximately 350,000 FESS procedures are done each year in the United States for CRS.

Balloon Ostial Dilation

Balloon ostial dilatation, can be used as an alternative to FESS 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 patient 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.

Outcomes

To quantify the severity of chronic sinusitis and to assess treatment response, various outcomes measures can be used, including patient-reported quality of life (QOL) measures, radiologic scores, and endoscopic grading.

The Lund-McKay scoring system uses radiologist-rated information derived from computed tomography (CT) scans regarding opacification of the sinus cavities, generating a score from 0-12.

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 patients complete 20 symptom questions on a categorical scale (0 [no bother] to 5 [worst symptoms can be]). Average rankings can be reported over all 20 symptoms, as well as by 4 subclassified symptom domains. The SNOT-22 is a variation of the SNOT-20 which includes 2 additional questions (“nasal obstruction” and “loss of smell and taste”). The minimal clinically-important difference (MCID) for the SNOT-22 has been estimated to be 8.9 points.

Additionally, QOL may be reported based on overall health-related QOL scores, such as the Short Form Health Survey-36 (SF-36). The SF-36 consists of 8 scaled scores on various health domains, which are transformed into a 0-100 scale (100 corresponding to best health).

KEY POINTS:

The most recent literature search was performed through January 22, 2024. 

Summary of Evidence

For individuals with CRS who receive BOD as a stand-alone procedure, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. In the REMODEL RCT, balloon ostial dilation was non-inferior to FESS for individuals with chronic rhinosinusitis. Durability of effect was demonstrated in uncontrolled studies that followed individuals who received balloon dilation for up to 24 months. Evidence from RCTs is supported by multiple observational studies and a systematic review showing improved quality of life following BOD. In a retrospective cohort study that used data from a large commercial insurance database to examine adverse events reported in individuals who underwent balloon dilation (n=2851), FESS (n=11,955), or a hybrid procedure (n=1234), the overall complication rate was 7.35% with FESS and 5.26% with balloon dilation. 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 RCTs. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. In the REMODEL study of BOD compared to FESS, 32% of individuals were diagnosed with recurrent acute rhinosinusitis (N=29). Balloon ostial dilation was non-inferior to FESS on measures of quality of life at 6 months and 12 months post-procedure. One RCT comparing balloon ostial dilation plus medical care to medical care alone in individuals with RARS found significantly improved quality of life and lower mean number of sinus infections after 24 months in the balloon dilation group. A third RCT included a mix of individuals with chronic and RARS and found improved quality of life compared to FESS, but results were not reported separately by diagnosis. The body of evidence is limited by the small number of individuals studied, unblinded outcome assessment, lack of appropriate comparators, and heterogeneity in outcome measures used. 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. he 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 American Academy of Otolaryngology—Head and Neck Surgery (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. “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).
    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 (Acclarent, Menlo Park, CA) 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. They include the Relieva Spin Sinus Dilation System® (cleared in 2011) and the Relieva Seeker Balloon Sinuplasty System® (cleared in 2012).

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 (ENTrigue Surgical, acquired by more recently by Smith & Nephew), 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 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)

PREVIOUS CODING:

CPT Codes:

31299

Unlisted procedure, accessory sinuses 

REFERENCES:

  1. Achar P, Duvvi S, Kumar BN. Endoscopic dilatation sinus surgery (FEDS) versus functional endoscopic sinus surgery (FESS) for treatment of chronic rhinosinusitis: a pilot study. Acta Otorhinolaryngol Ital. Oct 2012; 32(5): 314-9.
  2. American Academy of Otolaryngology - Head and Neck Surgery. Position Statement: Dilation of sinuses, any method (e.g., balloon, etc.). 2017; entnet.org/resource/position-statement-dilation-of-sinuses-any-method-e-g-balloon-etc.
  3. American Rhinologic Society (ARS). ARS Position Statement : Criteria for Sinus-ostial Dilitation.2019.www.american-rhinologic.org/index.php?option=com_content&view=artcle&id=49:ostial-balloon-dilittion-position-statement&catid=26:position-sttements&Itemid=197.
  4. Bikhazi N, Light J, Truitt T, Schwartz M, Cutler J; 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. 2014 Jul-Aug;28(4):323-9. doi: 10.2500/ajra.2014.28.4064. Epub 2014 May 12.
  5. Bizaki AJ, Numminen J, Taulu R, Rautiainen M. A Controlled, Randomized Clinical Study on the Impact of Treatment on Antral Mucociliary Clearance: Uncinectomy Versus Balloon Sinuplasty. Ann Otol Rhinol Laryngol. 2016 May;125(5):408-14. doi: 10.1177/0003489415618676. Epub 2015 Nov 26.
  6. Bizaki AJ, Taulu R, Numminen J, Rautiainen M. Quality of life after endoscopic sinus surgery or balloon sinuplasty: a randomized clinical study. Rhinology. 2014 Dec;52(4):300-5. doi: 10.4193/Rhino12.198.
  7. Chaaban MR, Rana N, Baillargeon J, Baillargeon G, Resto V, Kuo YF. Outcomes and Complications of Balloon and Conventional Functional Endoscopic Sinus Surgery. Am J Rhinol Allergy. 2018 Sep;32(5):388-396. doi: 10.1177/1945892418782248. Epub 2018 Jun 27.
  8. Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016 Jan;126(1):44-50. doi: 10.1002/lary.25507. Epub 2015 Jul 30.
  9. Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.
  10. Food and Drug Administration. Nucala Prescribing Information. July 29, 2021. www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf.
  11. Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope. 2015 Oct;125(10):2238-41. doi: 10.1002/lary.25276.
  12. 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. 2017 May;274(5):2165-2173. doi: 10.1007/s00405-016-4446-y. Epub 2017 Feb 2.
  13. 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. 2015 Feb;5(2):167-73. doi: 10.1002/alr.21432. Epub 2014 Oct 31.
  14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  15. 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. doi: 10.1007/s40258-017-0337-7.
  16. 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. doi: 10.1177/0194599815613087. Epub 2015 Oct 30.
  17. 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. doi: 10.26355/eurrev_201801_14170.
  18. Piccirillo JF, Payne SC, Rosenfeld RM, Baroody FM, Batra PS, DelGaudio JM, Edelstein DR, Lane AP, Luong AU, Manes RP, McCoul ED, Platt MP, Reh DD, Corrigan MD. Clinical Consensus Statement: Balloon Dilation of the Sinuses. Otolaryngol Head Neck Surg. 2018 Feb;158(2):203-214. doi: 10.1177/0194599817750086.
  19. 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. 2011 Aug;120(8):511-8. doi: 10.1177/000348941112000804.
  20. 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. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.
  21. 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. 2019 Feb;9(2):140-148. doi: 10.1002/alr.22248. Epub 2018 Nov 19.
  22. Taghi AS, Khalil SS, Mace AD, Saleh HA. Balloon Sinuplasty: balloon-catheter dilation of paranasal sinus ostia for chronic rhinosinusitis. Expert Rev Med Devices. 2009 Jul;6(4):377-82. doi: 10.1586/erd.09.24.
  23. American Rhinologic Society (ARS). Ostial Balloon Dilation Position Statement. 2023; www.american-rhinologic.org/index.php?option=com_content&view=article&id=494:ostial-balloon-dilation-position-statement&catid=26:position-statements&Itemid=197.

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.

 

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.