Balloon Ostial Dilation for Treatment of Chronic and Recurrent Acute Rhinosinusitis

POLICY NUMBER

A.7.01.105

DESCRIPTION

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 policy 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 policy 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 patients, 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 patients with and without CRS found a quantitative increase in bacterial and fungal RNA expression in patients 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 patients responding well to treatments such as topical nasal sprays and oral antibiotics. It is rare for patients 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 patients 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. Patients 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 (eg, Caldwell-Luc procedure), although open procedures may have a role in complicated sinus pathologies (eg, 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 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.

This policy 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 1 sinus and FESS on another sinus in the same patient during the same operation.

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.The FDA determined that this device was substantially equivalent to existing devices for use in dilating the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children. Subsequent devices developed by Acclarent have also been cleared by the FDA through the 510(k) process (see table below).

In 2008, the FinESS™ Sinus Treatment (Entellus Medical, Maple Grove, MN) was cleared for marketing by the 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 (Smith & Nephew, formerly ENTrigue Surgical), and the XprESS™ Multi-Sinus Dilation Tool (Stryker, formerly Entellus Medical), 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 the 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™ Sinus Dilation System 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.

The table below summarizes the currently FDA cleared balloon sinus dilation devices.

Balloon Ostial Dilation Devices Cleared by the U.S. Food and Drug Administration

POLICY

Use of a catheter-based inflatabledevice (balloonostial dilation)for the treatment of chronic rhinosinusitis in the sinus being considered for dilation may be medically necessary when the following criteria are present:

• Individual is 18 years of age or older (see Policy Guidelines for younger ages).

AND

• Chronic rhinosinusitis without nasal polyps that negatively impacts quality of life, characterized by at least 2 of the following, at least 1 of which is (a) or (b), present for at least 12 continuous weeks:

  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 1 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 (see Policy Guidelines).

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 for the treatment of recurrent acute rhinosinusitis is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Inflammation may be documented by all of the following:

• Nasal endoscopy showing purulent (not clear) mucus or edema in the middle meatus, anterior ethmoid, or sphenoethmoid region.

AND

• Abnormal CT scan of the paranasal sinuses.

According to the 2015 American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) guideline on adult sinusitis, abnormal findings on CT imaging may include moderate-to-severe mucosal thickening, opacification, or air-fluid levels. A subsequent consensus statement on balloon dilation of the sinuses published by the AAO-HNS in 2018 states: "The requirement of objective evidence of inflammation in addition to sinonasal symptoms suggestive of rhinosinusitis is consistent with AAO-HNSF [AAO-HNS Foundation] diagnostic criteria for rhinosinusitis. However, evidence of inflammation or other findings on a CT scan was not deemed sufficient alone to make a patient a candidate for balloon dilation. The consensus that both symptoms and objective evidence of sinonasal disease are needed to deem a patient appropriate for a SOD [sinus ostial dilation] procedure is also reflected in many of the randomized clinical trials involving balloon dilation. The inclusion criteria for many of these trials require that the patient be deemed appropriate for conventional sinus surgery, which includes a trial of medical therapy and the presence of sinonasal symptoms in addition to objective evidence of sinus mucosal inflammation. On the surface, this statement may seem incompatible with the guidelines that mandate the presence of objective findings but do not specify which objective findings those are (ie, polyps, purulence, or CT findings) for the diagnosis of CRS. However, the panel felt that the transition from diagnosis to management requires additional information. In that vein, a CT scan is necessary before proceeding with surgical management, and the findings of that CT scan would direct which sinuses were to be addressed. It was also agreed that an improved taxonomy for the classification of sinusitis would be helpful to improve the quality of clinical research."

Balloon Ostial Dilation (BOD) used in combination with Functional Endoscopic Sinus Surgery (FESS)

• BOD when used as a tool during functional endoscopic sinus surgery (FESS) in the same sinus cavity is considered to be an integral part of the FESS procedure.

• When BOD is used as an adjunct to FESS (defined as FESS on 1 sinus and BOD on another sinus in the same individual during the same operation) medical necessity criteria for BOD apply to the sinus being considered for BOD.

Considerations for the use of BOD in children under age 18 years include the following:

• U.S. Food and Drug Administration labeling for several 510(k) cleared devices includes use in children 17 years of age and under and is indicated to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

• A 2014 AAO-HNS Clinical Consensus Statement on Pediatric Chronic Rhinosinusitis had near consensus on the safety of BOD in children but did not reach a consensus on efficacy.

• American Academy of Pediatrics Clinical Practice Guidelines only address the diagnosis and treatment of acute bacterial rhinosinusitis.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

9/28/2006: Policy updated.

12/27/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions.

8/3/2007: Policy reviewed, no changes.

9/11/2008: Policy description amended, policy statement unchanged.

6/2/2009: Coding section updated. CPT codes 31256, 31276, 31287 deleted from the non-covered table. These codes should not be used to report  the balloon sinuplasty procedure. Note added to code 31299: It is inappropriate to use any of the nasal/sinus endoscopy codes (31231-31294) to report the balloon sinuplasty procedure. The most appropriate code to use to report the balloon sinuplasty procedure is HCPC Level II code S2344. However, we will accept unlisted code 31299 if your system does not support the use of code S2344.

04/21/2010: Policy description updated regarding FDA status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. 

03/07/2011: Added new CPT codes 31295, 31296, and 31297 to the Code Reference section.

08/11/2011: Policy reviewed; no changes.

07/12/2012: Policy reviewed; no changes.

05/06/2013: Removed ICD-9 diagnosis codes 473.0-473.9 from the Code Reference section.

03/19/2014: Policy reviewed; no changes.

12/05/2014: Policy title changed from "Balloon Sinuplasty for Treatment of Chronic Sinusitis" to "Balloon Ostial Dilation for Treatment of Chronic Sinusitis." Policy description updated regarding balloon ostial dilation, maxillary sinus, and devices. Policy statement updated to add "device" and change "balloon sinuplasty" to "balloon ostial dilation." Intent unchanged.

07/08/2015: Code Reference section updated for ICD-10.

12/18/2015: Policy description updated regarding devices. Policy statement unchanged. Policy guidelines updated to add investigative definition and to remove coding information.

05/31/2016: Policy number A.7.01.105 added.

09/19/2016: Policy description updated regarding outcomes in the evaluation of chronic rhinosinusitis. Policy statement unchanged.

06/21/2017: Policy title, policy description, and policy statement updated to change "sinusitis" to "chronic rhinosinusitis."

12/20/2017: Code Reference section updated to add new 2018 CPT code 31298.

03/07/2018: Policy reviewed; no changes.

03/20/2019: Policy description updated regarding devices. Policy statement unchanged.

12/20/2019: Code Reference section updated to revise descriptions for CPT codes 31295, 31296, 31297, and 31298 effective 01/01/2020.

07/01/2025: Policy title changed from "Balloon Ostial Dilation for Treatment of Chronic Rhinosinusitis" to "Balloon Ostial Dilation for Treatment of Chronic and Recurrent Acute Rhinosinusitis." Policy description extensively revised regarding rhinosinusitis, medical therapy, functional endoscopic sinus surgery, balloon ostial dilation, and devices. Policy changed from investigational to medically necessary. The policy states that the use of a catheter-based inflatable device (balloon ostial dilation) for the treatment of chronic rhinosinusitis in the sinus being considered for dilation may be medically necessary when the listed criteria are present. The use of balloon ostial dilation for the treatment of recurrent acute rhinosinusitis is considered investigational. Policy Guidelines updated regarding inflammation, balloon ostial dilation used in combination with functional endoscopic sinus surgery, and considerations for the use of balloon ostial dilation in children under age 18 years. Added medically necessary definition. Code Reference section updated to change the coding table from investigational to medically necessary. Removed CPT code 31299 and deleted HCPCS code S2344. Added HCPCS code C1726 and ICD-10 diagnosis codes J32.0 - J32.9.

SOURCE(S)

Blue Cross Blue Shield Association policy #7.01.105

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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