CurrentBlue Cross Blue Shield - IowaPolicy 07.01.31

Balloon Ostial Dilation for Treatment of Chronic and Recurrent Acute Rhinosinusitis

This policy governs coverage criteria and documentation requirements for use of catheter-based inflatable devices (balloon ostial dilation) to treat chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis (RARS) for Wellmark/Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyBalloon Ostial Dilation for Treatment of Chronic and Recurrent Acute Rhinosinusitis

Policy CodePolicy 07.01.31

Change TypeNo material clinical or coverage changes

Effective DateMay 1, 2006

Next Review DateApril 2025

Key ActionDocument prior medical therapy failure, baseline SNOT scores, and CT or endoscopy findings when requesting coverage; prior approval not required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age

>=12 weeksCRS symptom duration

4RCTs reported

0.8SNOT-20 threshold

insufficientRARS evidence status

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Coverage Criteria for Balloon Ostial Dilation (BOD)

Medical Necessity Criteria for BOD (CRS)

Covered when ALL of the following are met for the sinus being considered for dilation:

Age: Individual is 18 years of age or older>=18 years

See Policy Guidelines for younger ages

Diagnosis: CRS without nasal polyps: Chronic rhinosinusitis (CRS) without nasal polyps that negatively impacts quality of life, characterized by at least 2 symptoms with one being (a) or (b) present for >=12 continuous weeks>=12 weeks

Symptoms: a. Mucopurulent nasal drainage; b. Nasal obstruction (congestion); c. Facial pain/pressure/fullness; d. Decreased sense of smell

Medical management failure or intolerance: Has tried and failed medical management as indicated by ALL the following or has documented intolerance/contraindication: allergy evaluation and treatment when indicated; decongestant when indicated; topical and/or systemic corticosteroids >=8 weeks; saline nasal irrigation >=8 weeks; two 10-day antibiotic courses or one prolonged >=21-day course; treatment of rhinitis medicamentosa when presentsee detailed list

Documented intolerance/contraindication to intranasal corticosteroids, antihistamine nasal spray/decongestants and antibiotics is acceptable in lieu of trials

Objective evidence after medical therapy: Nasal endoscopy showing purulent mucus or edema in the middle meatus, anterior ethmoid, or sphenoid ethmoid region AND abnormal CT scan of the paranasal sinusesendoscopy positive AND abnormal CT

CT findings per AAO-HNS may include mucosal thickening, opacification, or air-fluid levels

Stand‑alone BOD — coverage criteria

Covered when ALL of the following are met

General coverage criteria: Adult (≥18 years) with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) for whom medical therapy has failed; BOD used as a standalone procedure (not adjunct to FESS) to improve sinus drainage; adequate documentation of baseline symptoms/QOL (e.g., SNOT) and plan for 6–12 month follow-up.

REMODEL included patients with failure of medical therapy and excluded gross sinonasal polyposis.

Initial therapy coverage criteria

Covered when ALL of the following are met

Patient selection: Age >=18 years with a diagnosis of chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) per AAO‑HNS criteria

REMODEL and CABERNET enrolled adults meeting AAO‑HNS definitions

Prior therapy: Failure of appropriate medical therapy when treating CRS or RARS unless documented intolerance/contraindication

REMODEL included patients meeting criteria for medically necessary FESS; CABERNET compared BOD plus medical therapy to medical therapy alone

Diagnostic documentation: For RARS, documentation of 4 or more episodes per year consistent with AAO‑HNS definitions; when following CABERNET enrollment criteria, CT evidence of sinus or osteomeatal complex disease during an acute episode is required4+ episodes/year for RARS; CT evidence when applicable

Document baseline symptom/QOL measures and plan for 6–12 month follow-up to demonstrate efficacy

Covered with criteria

Evidence and guideline-based considerations for BOD in RARS/CRS

Evidence for effectiveness: Randomized trials (REMODEL, CABERNET) demonstrated improved quality of life and reductions in acute exacerbations for selected patients; REMODEL showed non-inferiority to FESS and CABERNET showed benefit versus medical therapy at 6 monthsRCT results

Small sample sizes, unblinded assessment, and heterogeneity in outcomes limit strength of evidence

Patient selection criteria: Patients should have sinonasal symptoms plus positive CT findings; RARS defined as ≥4 acute episodes per 12 months per AAO‑HNS or trial definitions; BOD is an option after failure of appropriate medical therapyCT required

Not appropriate for patients without CT evidence or sinonasal symptoms; gross sinonasal polyposis was excluded from major RCTs

Procedure setting and anesthesia: BOD can be performed in office or operating room and under local anesthesia with or without sedation per society guidance

When balloon ostial dilation (BOD) is performed during the same operation as functional endoscopic sinus surgery (FESS), its use in the same sinus cavity is considered integral to the FESS procedure. If BOD is used as an adjunct (for example, FESS on one sinus and BOD on another sinus during the same operation), then the coverage criteria for BOD apply specifically to the sinus being treated with BOD.

Patients with gross sinonasal polyposis were excluded from the REMODEL trial; because REMODEL was a principal randomized study of standalone BOD, trial evidence for standalone BOD is limited for this population and providers should not assume trial-based indications apply to patients with gross polyposis.

Clinical trial enrollment did not include patients with gross sinonasal polyposis; REMODEL explicitly excluded patients with nasal polyps, and therefore the randomized trial evidence does not represent individuals with gross polyposis.

Balloon dilation is not appropriate for management of isolated headache or sleep apnea in patients who do not otherwise meet diagnostic criteria for chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS). These indications require symptoms plus objective findings before considering BOD.

Use of BOD for CRS is considered investigational when the policy coverage criteria are not met because available evidence is insufficient to establish net health benefit. Use of BOD for RARS is also considered investigational due to insufficient evidence that it improves net health outcomes.

A pooled analysis reported a mean difference in SNOT-20 change favoring BOD over FESS of 0.435 (95% CI, 0.054 to 0.817) in the primary meta-analysis (n=186), which is statistically significant but below the predefined clinically meaningful threshold of 0.8. Sensitivity analyses incorporating additional studies produced smaller pooled estimates that similarly did not consistently reach the 0.8 threshold.

A meta-analysis and section summaries found statistically significant differences in quality-of-life measures favoring BOD versus FESS, but the magnitude of pooled SNOT-20 differences did not reach the clinically meaningful threshold of 0.8, indicating statistical significance without clear clinically meaningful superiority of BOD over FESS.

Balloon dilation should not be performed when a sinus CT does not demonstrate evidence of sinonasal disease; BOD is not appropriate for patients who have sinonasal symptoms but a CT scan that is negative for disease (no ostial occlusion, mucosal thickening, or other objective findings).

Coding, Measures, and Thresholds

See Codes tablemixed

No codes listed

Clinical trial identifiers and study referencesmixed

NCT01525849	REMODEL trial identifier (clinical trial)
NCT01714687	CABERNET trial identifier (clinical trial)

Covered CPT CodesCPTCovered

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).
31299	Unlisted procedure, accessory sinuses (may be utilized for balloon ostial dilation [BOD]).

HCPCS device codesHCPCS

C1726

Catheter, balloon dilatation, non-vascular (may be utilized for balloon ostial dilation [BOD]).

inv-17: Clinically meaningful SNOT-20 change

ThresholdSNOT-20 mean change ≥ 0.8 is considered clinically meaningful

Measure descriptionSNOT-20 is a 20-item patient-reported questionnaire (0–5 per item; higher = worse) with average scores reported across items

Use in trialsSNOT-20 change used as primary QOL outcome in randomized trials comparing BOD and FESS

inv-18: SNOT-22 minimally important difference

ThresholdSNOT-22 minimally important difference = 8.9 points

Relation to SNOT-20

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Approval

Not applicable.

Denial Risk

Investigational if criteria not met

Balloon ostial dilation (BOD) is considered investigational when the coverage criteria are not met. Procedures that do not meet the policy’s medical necessity criteria (including failure to document required medical therapy, diagnostic criteria, or imaging) may be denied as investigational.

BOD investigational when policy criteria not met
BOD investigational for recurrent acute rhinosinusitis (RARS) when criteria not met

Background and Context

Balloon ostial dilation (BOD) is a minimally invasive procedure that dilates sinus ostia by advancing a guidewire and balloon into the ostium and inflating the balloon to widen the opening, improving sinus drainage. It is used as an alternative to or adjunct with functional endoscopic sinus surgery (FESS) for adults with CRS or RARS after failure of medical management and can be performed in the office or operating room setting.

Definitions and Measurement Thresholds

inv-37: Recurrent acute rhinosinusitis (RARS) definition

Core definitionRecurrent acute rhinosinusitis (RARS) = 4 or more episodes of acute rhinosinusitis per year, each lasting ≥10 days, without persistent symptoms between episodes

Episode diagnostic criteriaAn acute bacterial episode meets ABRS criteria when symptoms fail to improve within 10 days or worsen within 10 days after initial improvement ('double worsening')

ConfirmationMicrobiologic confirmation of bacterial infection is desirable but not essential to diagnose RARS

inv-38: Chronic rhinosinusitis (CRS) definition

Core definitionChronic rhinosinusitis (CRS) = rhinosinusitis symptoms (e.g., mucopurulent drainage, nasal congestion, facial pain/pressure, decreased smell) persisting for >12 weeks

Subtypes

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyBalloon Ostial Dilation for Treatment of Chronic and Recurrent Acute Rhinosinusitis

Policy CodePolicy 07.01.31

Change TypeNo material clinical or coverage changes

Effective DateMay 1, 2006

Next Review DateApril 2025

Key ActionDocument prior medical therapy failure, baseline SNOT scores, and CT or endoscopy findings when requesting coverage; prior approval not required.

SourceLink

On This Page

Surgeon experience and device reprocessing regulations apply

SNOT-22 is SNOT-20 plus two items ('nasal obstruction' and 'loss of smell and taste')

Use in outcomesReported as a minimally important difference for patient-reported QOL in CRS/RARS studies

inv-19: Duration of follow-up to demonstrate efficacy

Recommended follow-up6 to 12 months of follow-up is considered necessary to demonstrate efficacy

Outcome timingKey patient-reported outcomes (SNOT-20/22) and reduction in acute infections assessed at 6–12 months

Longer-term dataSome trials report 12- and 24-month data, but primary efficacy demonstration commonly uses 6–12 months

Documentation Required

Document AAO‑HNS diagnostic criteria for

Prior authorization reviewers should document that patients met AAO‑HNS diagnostic criteria for CRS or RARS and that they fulfilled indications similar to those in trials (e.g., REMODEL). Document that patients met diagnostic thresholds (CRS: ≥12 weeks of symptoms with at least two signs/symptoms, one being mucopurulent drainage or nasal obstruction; RARS: ≥4 episodes/year) and that patients would meet criteria for medically necessary FESS when applicable.

Document AAO‑HNS diagnostic criteria were met (CRS or RARS)
If claiming equivalence to trial populations, note that REMODEL excluded patients with gross sinonasal polyposis

Documentation Required

Imaging requirement / appropriateness

CT imaging of the sinuses is required prior to considering BOD. Balloon dilation is not appropriate without both sinonasal symptoms and CT findings demonstrating sinonasal disease (opacification, ostial occlusion, or mucosal thickening). Include CT reports with imaging findings and Lund‑Mackay scoring when available.

CT scan required and must show evidence of disease to support BOD
BOD not appropriate for patients with sinonasal symptoms but negative CT findings
Include CT report (and Lund‑Mackay score if available) in prior authorization package

Prior Authorization

Evidence base evaluated BOD after failure of medical therapy

Prior authorization should include documentation that appropriate medical management was attempted and failed before BOD. Evidence from trials and society statements supports BOD after failure of comprehensive medical therapy for selected patients.

Document specific prior medical management attempts (saline irrigation, topical intranasal corticosteroids ≥8 weeks, systemic corticosteroids when indicated)
Document courses of antibiotics (two 10‑day courses or one ≥21‑day course) or documented intolerance/contraindication to medical therapies
Document allergy evaluation and treatment when indicated, decongestant use when indicated, and treatment of rhinitis medicamentosa if present
Document baseline symptom/QOL measure (e.g., SNOT‑20 or SNOT‑22) and planned follow‑up (6–12 months) to demonstrate clinical benefit

CRS with nasal polyposis vs CRS without nasal polyposis (policy focuses on CRS without nasal polyps for BOD coverage)

ImpactCRS is associated with impaired quality of life and can rarely cause serious complications (orbital, intracranial)

inv-39: Balloon ostial dilation (BOD) / Balloon sinuplasty definition

Procedure descriptionBalloon ostial dilation (BOD) involves placing a guidewire into the sinus ostium, advancing a balloon over the guidewire, and inflating the balloon to dilate the ostial opening to improve sinus drainage

Use settingsCan be performed as a standalone procedure or adjunct to FESS, in office or operating room settings

Anesthesia and approachPerformed under local anesthesia with or without sedation or under general anesthesia; transnasal or via canine fossa approaches may be used

inv-40: SNOT-20 / SNOT-22 instruments and thresholds

InstrumentsSNOT-20 and SNOT-22 are validated disease-specific patient-reported QOL instruments for CRS/RARS

Scoring SNOT-20SNOT-20: 20 items scored 0–5; mean change of ≥0.8 (per-item) is considered clinically meaningful

Scoring SNOT-22SNOT-22 includes 2 additional items; minimally important difference = 8.9 points

inv-41: RARS definition (alternate reference)

Trial RARS definition (CABERNET)CABERNET enrolled adults with RARS defined as ≥4 episodes of acute bacterial rhinosinusitis in the prior 12 months with symptom duration ≥10 days or double worsening

Trial enrollment noteTrials (REMODEL, CABERNET) required documentation consistent with AAO‑HNS definitions for RARS when enrolling participants

Trial identifiersCABERNET trial registered as NCT01714687 (Sikand et al. 2019)

inv-42: SNOT-20 details and clinically meaningful change

SNOT-20 specificsSNOT-20 is a 20-item questionnaire with item scores 0–5; higher scores indicate greater burden

Clinically meaningful changeA mean per-item change of 0.8 or greater on SNOT-20 is considered clinically meaningful and used to interpret trial results

Meta-analysis contextSystematic review pooled SNOT-20 differences showed statistical but not clinically meaningful advantage for BOD vs FESS relative to the 0.8 threshold

inv-43: Chronic Sinusitis Survey (CSS)

Instrument descriptionChronic Sinusitis Survey (CSS) measures symptoms and medication usage over an 8-week recall; total score 0–100 (lower = worse)

SubscoresCSS includes symptom and medication subscales (3 questions each) and yields total and subscale scores

Clinical interpretationMinimally clinically significant difference for CSS has not been established

inv-44: RARS definition as used in CABERNET

CABERNET RARS criteriaCABERNET defined RARS as ≥4 episodes of acute bacterial rhinosinusitis in prior 12 months with episodes meeting ABRS timing criteria (≥10 days or double worsening)

Enrollment specificsCABERNET randomized BOD plus medical management (N=29) vs sham plus medical management (N=30)

Documentation implicationWhen following CABERNET-like criteria, CT evidence during an acute episode was used to justify procedure enrollment

inv-45: BOD procedural definitions and settings

Procedure scopeBOD refers to dilation of sinus ostia using balloon catheter systems; may be performed in office or operating room settings

Adjunct vs standaloneBOD can be performed as an adjunct to FESS (considered integral to FESS if used in same sinus cavity) or as a standalone procedure for selected patients

Setting and anesthesiaCan be performed under local anesthesia with or without sedation or under general anesthesia; device reprocessing regulations should be followed if reusing devices