CurrentUnitedHealthcarePolicy ENT 021.18

Sinus Surgeries and Interventions (Balloon sinus ostial dilation and FESS)

Defines medical necessity criteria, indications, exclusions, relevant procedure codes, documentation expectations, and evidence summary for balloon sinus ostial dilation (BSD/balloon sinuplasty), functional endoscopic sinus surgery (FESS), and related sinus interventions. Applies to members covered under UnitedHealthcare policy ENT 021.18 effective July 1, 2025.

Policy Summary

PayerUnitedHealthcare

PolicySinus Surgeries and Interventions (Balloon sinus ostial dilation and FESS)

Policy CodePolicy ENT 021.18

Change TypeSupporting information updated

Effective DateJul 1, 2025

Next Review Date

Key ActionDocument completion of full courses of required recent medical management (antibiotics if bacterial suspected, intranasal corticosteroids ± oral corticosteroids when appropriate, nasal lavage/irrigation) prior to imaging and surgery.

POLICY UPDATE CHANGES

07/01/2025: Supporting Information Updated Clinical Evidence and References sections to reflect the most current information; previous policy versions archived (ENT 021.17).

>=4Episodes/year threshold for RARS

12CRS duration threshold (weeks)

31240-31299Referenced CPT codes

multipleFESS evidence volume

self-expandingDevices unsupported

Coverage Summary

This policy (Policy Number: ENT 021.18) defines coverage for balloon sinus ostial dilation (BSD/balloon sinuplasty), functional endoscopic sinus surgery (FESS), and related sinus interventions. It summarizes medical necessity criteria, indications, exclusions, relevant procedure codes, documentation expectations, and evidence for these interventions. The policy is effective July 1, 2025 and applies to members covered under UnitedHealthcare policy ENT 021.18. The overall coverage stance is mixed, with BSD and FESS accepted in specific, documented scenarios and some devices/interventions considered investigational or unproven.

Quick-reference thresholds and codes

CRS duration threshold> 12 weeks

RARS frequency threshold>= 4 episodes per 12 months with distinct symptom-free intervals

Recent CT timeframeCT within 12 months of planned procedure

CPT code range (referenced)31240-31288; 31295-31299

BSD anatomic limitationDilation limited to frontal, maxillary, or sphenoid sinuses (BSD only)

Medical-Necessity Criteria

Medically Necessary — Balloon sinus ostial dilation and/or FESS

Balloon sinus ostial dilation and/or Functional Endoscopic Sinus Surgery (FESS) are proven and medically necessary when ALL of the following are met:

ANY of the following

Medically Necessary — Balloon sinus ostial dilation and/or FESS
- Symptoms lasting longer than 12 weeks
- Chronic Rhinosinusitis (CRS) with persistent symptoms despite recent medical management with full courses of all of the following treatments:
- ALL of the following
  - Antibiotic therapy if bacterial infection is suspected

Not Medically Necessary / Experimental

Coding

Referenced Procedure CPT codesCPT

31240	Nasal/sinus endoscopy, surgical; with concha bullosa resection
31253	Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including frontal sinus exploration, with removal of tissue from frontal sinus, when performed
31254	Nasal/sinus endoscopy, surgical with ethmoidectomy; partial (anterior)
31255	Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior)
31256	Nasal/sinus endoscopy, surgical, with maxillary antrostomy
31257	Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including sphenoidotomy
31259	Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including sphenoidotomy, with removal of tissue from the sphenoid sinus
31267	Nasal/sinus endoscopy, surgical, with maxillary antrostomy; with removal of tissue from maxillary sinus
31276	Nasal/sinus endoscopy, surgical, with frontal sinus exploration, including removal of tissue from frontal sinus, when performed
31287	Nasal/sinus endoscopy, surgical, with sphenoidotomy

1–10 of 16

1/2

Regulatory/device classificationmixed

FDA product code LRC

Instrument; ENT, manual surgical - includes devices used for balloon catheter dilation for treating CRS; 510(k)-exempt

No explicit procedure or diagnosis codes listed in this partmixed

No codes listed

Provider Actions / Documentation Requirements

Prior Authorization

Prior authorization implication

Prior authorization may be required for balloon sinus ostial dilation (BSD) and Functional Endoscopic Sinus Surgery (FESS) per the member's benefit plan. Submit prior authorization requests as indicated by the member-specific plan. Medical records may be requested to demonstrate that the member meets the clinical criteria in this policy. CT imaging used to document disease should generally be obtained within 12 months of the planned procedure; older imaging may be acceptable only with clear justification and reviewer agreement.

Medical records may be required to substantiate clinical criteria and prior authorization requests
Recent CT scan generally defined as within 12 months of planned procedure
Refer to member-specific benefit plan for coverage and prior authorization requirements

Documentation Required

CT imaging and CT-based documentation

Background and Evidence Summary

Functional Endoscopic Sinus Surgery (FESS) is described as an established, minimally invasive, mucosal‑sparing surgical technique used to treat medically refractory chronic rhinosinusitis (CRS) with or without polyps and recurrent acute rhinosinusitis (RARS). FESS may also be used for complications of sinusitis (e.g., abscess), mucocele, concha bullosa, polyposis with obstructive symptoms, or sinonasal tumors.

Balloon sinus ostial dilation (BSD, also called balloon sinuplasty or sinus ostial dilation SOD) is presented as an alternative or adjunct to FESS. BSD uses an inflatable balloon catheter to dilate the frontal, maxillary, or sphenoid ostia and may be performed as a standalone or hybrid procedure. Potential advantages cited include minimal mucosal damage, less intraoperative bleeding, faster recovery, and suitability for selected patients with limited disease.

The policy states that self‑expanding absorptive sinus ostial dilation devices are investigational: current evidence is insufficient to support their use due to small sample sizes and lack of comparison groups. Available pilot data show short‑term technical success and patency in small cohorts but do not establish effectiveness versus established alternatives.

Source	Key finding
Hayes HTA (Adults)	Moderate-quality evidence: BSD leads to significant improvements and similar efficacy to FESS; no clear superiority (Hayes HTA Sept 2019, updated Sept 2022).
REMODEL / Meta-analysis	REMODEL and pooled meta-analyses: technical success ~97.5%; SNOT improvements comparable to FESS up to 24 months; faster recovery and less postoperative pain reported.
Pediatric evidence	Limited/low-quality pediatric data (Hayes pediatric HTA, Soler et al.): symptom relief and QOL improvement after BSD but few comparative trials.
NICE guidance (XprESS)	NICE (2016): XprESS supported for uncomplicated CRS without severe nasal polyposis; similar outcomes to FESS with faster recovery and more local anesthesia use.
FESS systematic reviews	Multiple systematic reviews/meta-analyses show FESS improves SNOT-22 and objective outcomes vs medical therapy; greater extent of ESS often linked to greater symptom improvement.
FESS vs BSD randomized trials (selected)	RCTs (e.g., Minni 2018, Sikand 2018) and comparative studies report no significant difference in SNOT outcomes between BSD and FESS in selected patients; heterogeneity limits definitive conclusions.
Self-expanding device studies	Small single-arm pilot studies report successful insertion and short-term ostial dilation but lack control groups; evidence insufficient.
Pilot study outcomes (self-dilation device)	Pilot: 12 patients, 19 MSOs attempted; 17 devices remained 60 minutes; mean dilation 4.8 ± 0.5 mm; 14 of 15 MSOs patent at 3 months; no insertion/removal AEs reported.
Hayes HTA (Pediatrics)	Hayes pediatric HTA: small, low-quality body of evidence suggests symptom relief and improved QOL after BCS; safety conclusions limited by limited data.
Overall evidence statement	For BSD: evidence shows comparable short- to mid-term outcomes to FESS in selected patients; for self-expanding absorptive devices: evidence insufficient due to small sample sizes and lack of comparison groups.
searchable":false

Important study metrics and sample sizes

Pediatric BSD study size (Soler et al. 2016)n=50 children; 157 dilations attempted; all successful; no complications; 92% achieved MCID >=1.0 on SN-5 at 6 months

REMODEL/meta-analysis technical success

Definitions

Chronic Rhinosinusitis (CRS): An inflammatory process of the paranasal sinuses persisting >12 weeks with ≥2 symptoms (nasal obstruction, mucopurulent drainage, facial pain/pressure/fullness, or decreased sense of smell) plus documented inflammation (polyps, edema, purulent mucus, or radiographic inflammation).

Recurrent Acute Rhinosinusitis (RARS): Defined as ≥ 4 episodes per year of acute bacterial rhinosinusitis with distinct symptom‑free intervals; each episode should meet ARS diagnostic criteria (failure to improve within 10 days, double worsening, or presumed bacterial infection).

Recent CT Scan: A computed tomography scan performed within 12 months of the planned procedure is considered recent for policy purposes.

Functional Endoscopic Sinus Surgery (FESS): A minimally invasive, mucosal‑sparing surgical technique used to treat medically refractory CRS (with or without polyps) or RARS; FESS is a surgical procedure (not regulated by FDA as a device).

Balloon sinus ostial dilation (BSD) / Sinus ostial dilation (SOD): A procedure using an inflatable balloon catheter to dilate sinus ostia (frontal, maxillary, or sphenoid), performed as standalone or adjunct (hybrid) to FESS.

SNOT‑22: Sinonasal Outcome Test‑22, a patient‑reported outcome measure to assess sinonasal quality of life; some guidelines use a preoperative threshold of ≥ 20 to consider ESS.

Lund‑Mackay score (modified Zinreich): A CT‑based scoring system to quantify sinus opacification per sinus (0 = 0%, 1 = 1–25%, 2 = 26–50%, 3 = 51–75%, 4 = 76–99%, 5 = 100%) and ostiomeatal complex scoring; used to quantify disease burden.

Maxillary Sinus Ostium (MSO): The natural drainage opening of the maxillary sinus; referenced in procedural descriptions and device studies.

FDA and Device Information (Informational)

FDA product code LRC: Devices used for balloon catheter dilation for treating CRS are classified under product code LRC (instrument; ENT, manual surgical) and this product code is 510(k)-exempt; manufacturers must register establishments and submit Device Listing forms though 510(k) submissions are voluntary for this category.

The SinuSys Vent‑OS Sinus Dilation System received FDA 510(k) clearance in 2013 for dilation of the maxillary sinus ostia and associated spaces in adults (informational only).

FESS is a procedure and therefore is not regulated by the FDA as a device; however, devices and instruments used during FESS may be subject to FDA regulation.

This FDA and device information is provided for informational purposes only and is not itself a basis for coverage decisions.

Revision History

2025-07-01revisedLatest

Supporting Information Updated Clinical Evidence and References sections to reflect the most current information; previous policy versions archived (ENT 021.17).

Policy Summary

PayerUnitedHealthcare

PolicySinus Surgeries and Interventions (Balloon sinus ostial dilation and FESS)

Policy CodePolicy ENT 021.18

Change TypeSupporting information updated

Effective DateJul 1, 2025

Next Review Date

On This Page

Intranasal corticosteroids (and/or oral corticosteroids when appropriate)

Nasal lavage/irrigation if appropriate

CT images obtained after completion of the medical management described above

Confirmation of Chronic Rhinosinusitis on a recent Computed Tomography (CT) scan for each sinus to be treated meeting all of the following criteria:

ALL of the following

Documentation of which sinus has disease and extent of disease, including percent of opacification
CT findings include one or more of: bony thickening, bony remodeling, or opacified sinus
Sinonasal symptoms (pain, pressure, or drainage) are present on the same side as CT findings of rhinosinusitis
Ostial obstruction (outflow tract obstruction) and mucosal thickening

For balloon sinus ostial dilation only, dilation is limited to the frontal, maxillary, or sphenoid sinuses

Recurrent Acute Rhinosinusitis (RARS): four or more episodes per year with distinct symptom-free intervals between episodes

ALL of the following

For RARS: sinonasal symptoms such as pain, pressure, or drainage are present on the same side as CT scan findings of rhinosinusitis
For balloon sinus ostial dilation, ostial obstruction and mucosal thickening in the sinus to be dilated

Recent CT scan evidence of ostial obstruction (outflow tract obstruction) in the sinus to be treated for FESS

For the maxillary, frontal, or sphenoid sinuses, mucosal thickening in the sinus to be treated; for the ethmoid sinus, mucosal thickening is present

FESS is also medically necessary when CT confirms complications or other conditions such as abscess, symptomatic mucocele, symptomatic concha bullosa, polyposis with obstructive symptoms, or sinonasal tumor

Appropriate use of balloon sinus ostial dilation (BSD/SOD)

Appropriate use of balloon sinus ostial dilation (BSD/SOD). Use for guidance on consensus appropriate indications and inappropriate uses.

ANY of the following

Appropriate use of balloon sinus ostial dilation (BSD/SOD)
- Balloon sinus ostial dilation is appropriate for dilation limited to the frontal, maxillary, or sphenoid sinuses when the criteria for chronic rhinosinusitis or recurrent acute rhinosinusitis are met (see Medically Necessary group)
- Appropriate when ostial obstruction and mucosal thickening are present in the sinus to be dilated and CT and clinical findings correlate
- Appropriate as an alternative or adjunct to FESS in selected patients with disease limited to ostial obstruction without extensive sinonasal polyposis or diffuse sinonasal mucosal disease
Inappropriate or not medically necessary uses of balloon sinus ostial dilation
- Cases of CRS or RARS that do not meet the above criteria
- Sinonasal polyps or tumors
- Self-expanding absorptive sinus ostial dilation devices for evaluating or treating sinusitis and all other conditions due to insufficient evidence of efficacy

Appropriate use of Functional Endoscopic Sinus Surgery (FESS)

Appropriate use of Functional Endoscopic Sinus Surgery (FESS). Use for guidance when FESS is indicated and evidence-based modifiers.

ANY of the following

Appropriate use of Functional Endoscopic Sinus Surgery (FESS)
- FESS is appropriate for medically refractory CRS (symptoms >12 weeks) after completion of appropriate medical therapy as outlined in the Medically Necessary group
- Appropriate when CT confirms ostial obstruction or mucosal disease in the sinus to be treated and clinical symptoms correlate
- Appropriate when CT confirms complications of sinusitis such as abscess, symptomatic mucocele, or sinonasal tumor
- Appropriate for symptomatic concha bullosa or polyposis with obstructive symptoms (for CRS with polyps, refer to the Medically Necessary group)
Evidence-based modifiers and limits for FESS
- FESS may include endoscopic frontal sinus procedures (Draf classifications) as indicated by disease extent
- FESS is favored over balloon dilation when diffuse mucosal disease, extensive polyposis, or need for tissue removal exists
- FESS is not medically necessary for CRS or RARS that do not meet the specified criteria due to insufficient evidence of benefit

Medical-Necessity Criteria

General FDA and Device Information (Informational). The following device and regulatory information is provided for context and does not by itself determine coverage.

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id":"medical-necessity-criteria","label":"COVERAGE","title":"Medical-Necessity Criteria"}}

Obtain and document a Recent Computed Tomography (CT) scan for each sinus planned for treatment. CT-based documentation should include which sinus is affected, extent of disease, and percentage of opacification (use Modified Lund–Mackay or equivalent). CT findings that support surgical intervention include bony thickening or remodeling, opacified sinus, ostial/outflow tract obstruction, and mucosal thickening. For BSD, document ostial obstruction and mucosal thickening in the targeted sinus; BSD is limited to frontal, maxillary, or sphenoid sinuses per policy.

Document which sinus(es) have disease and percent opacification (e.g., Modified Lund–Mackay scores)
CT findings supportive of surgery: bony thickening/remodeling, opacified sinus, ostial obstruction, mucosal thickening
For BSD, document ostial obstruction and mucosal thickening in the sinus to be dilated

Documentation Required

Require objective confirmation prior to BSD or ESS

Objective confirmation of chronic or recurrent disease is required prior to performing BSD or FESS. This includes documentation of persistent symptoms > 12 weeks for CRS or meeting RARS episode criteria, plus CT evidence correlating to symptoms in the same anatomic location. For RARS, ensure episodes meet diagnostic criteria for acute bacterial rhinosinusitis.

CRS: symptoms > 12 weeks with inflammation documented clinically and on CT
RARS: ≥4 episodes/year of acute bacterial rhinosinusitis with distinct symptom-free intervals and episode-specific confirmation when possible
Symptoms must correspond to CT findings on the same side

Documentation Required

Confirm failure of appropriate medical therapy (AMT)

Confirm and document failure of appropriate medical therapy (AMT) before considering surgery. AMT should include a full course of antibiotics if bacterial infection is suspected, intranasal corticosteroids (and oral corticosteroids when appropriate), and nasal saline lavage when appropriate. Ensure medical management was recent and completed prior to CT imaging when possible.

Antibiotic therapy if bacterial infection suspected
Intranasal corticosteroids ± oral corticosteroids when appropriate
Nasal lavage/irrigation when appropriate
Medical management should be completed prior to obtaining CT imaging used for surgical decision-making

Documentation Required

Patient selection restrictions

Patient selection exclusions and restrictions should be documented. BSD is not covered for sinonasal polyps, tumors, or when CRS/RARS criteria are not met. FESS is indicated for complications (e.g., abscess), symptomatic mucocele, symptomatic concha bullosa, polyposis with obstructive symptoms, sinonasal tumor, or other CT-confirmed indications. Ensure the procedure selection aligns with policy-specified indications.

BSD not indicated for sinonasal polyps or tumors or CRS/RARS that do not meet policy criteria
FESS indicated for complications of sinusitis (abscess), symptomatic mucocele, symptomatic concha bullosa, polyposis with obstructive symptoms, sinonasal tumor
Document why chosen procedure (BSD vs FESS) is appropriate for the member

Documentation Required

Reference member-specific benefit plan

Always verify coverage against the member-specific benefit plan. Presence of clinical indications in this policy does not guarantee coverage; coverage is determined by the member's plan document and applicable laws. Coordinate with the member's benefits team when coverage language or medical necessity rules are unclear.

Benefit coverage determined by member-specific plan document and applicable laws
Clinical criteria in this policy do not guarantee coverage or payment
Check plan exclusions, prior authorization rules, and member cost-share

Documentation Required

Use clinical judgment and third-party tools as appropriate

Use clinical judgment and, when appropriate, third-party decision tools to assess candidacy for BSD or FESS. Consider comorbidities, prior surgeries, anatomic variations, and severity scoring systems (e.g., Lund–Mackay). Document the rationale for proceeding with surgery when the clinical picture is nuanced or when exceptions to standard criteria are considered.

Apply clinical judgment for individual patient factors (comorbidities, prior procedures, anatomy)
Use validated scoring tools (e.g., Modified Lund–Mackay) as appropriate
Document rationale when deviation from standard criteria is justified

Technical success ~97.5% for standalone balloon dilation (meta-analysis)

Self-expanding absorptive pilot study (osmotic device)Pilot: 12 patients; 19 MSOs attempted; 17 devices remained 60 minutes; mean dilation 4.8 ± 0.5 mm; 14 of 15 MSOs patent at 3 months; no insertion/removal AEs recorded

REMODEL larger cohort follow-upREMODEL cohort: up to 24 months follow-up; comparable SNOT improvements and faster recovery vs FESS reported