CurrentBlue Cross Blue Shield - IowaPolicy N/A

Steroid Eluting Sinus Stents and Implants

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySteroid Eluting Sinus Stents and Implants

Policy CodePolicy N/A

Change TypeAnnual review / Renewal (no material change)

Effective DateN/A

Next Review Date2025-04

Key ActionVerify member benefits and prior authorization requirements with the plan and document prior ESS and indications, noting that investigational designation implies claims for these devices are not covered when the benefit does not exist.

POLICY UPDATE CHANGES

No material clinical or coverage changes — policy underwent routine annual review/renewal (April 2023–2025).

InvestigationalCoverage status

4 RCTs + 2 sham RCTsKey RCTs summarized

≥4.7NNT reported

3Professional society statements

CPT/HCPCS/J/S

Coverage Summary

This Wellmark (Blue Cross Blue Shield - Iowa) medical policy addresses the use of steroid-eluting sinus stents and implants for postoperative treatment following endoscopic sinus surgery (ESS), for recurrent sinonasal polyps after ESS, and for other indications, including regulatory status, evidence review, and coding guidance. The policy determination states that use of these devices (including but not limited to PROPEL, PROPEL Mini, PROPEL Contour, and SINUVA) is considered Investigational because the evidence is insufficient to determine effects on health outcomes; therefore the coverage stance is Not covered — Investigational.

Key Policy Facts

Policy scopeThis Wellmark (Blue Cross Blue Shield - Iowa) medical policy addresses the use of steroid-eluting sinus stents and implants for postoperative treatment following endoscopic sinus surgery (ESS), for recurrent sinonasal polyps after ESS, and for other indications, including regulatory status, evidence review, and coding guidance.

SubjectSteroid-eluting sinus stents and implants (PROPEL, PROPEL Mini, PROPEL Contour, SINUVA)

Coverage statusInvestigational

Last review2025-04

Next review2025-04

Medical-Necessity Criteria & Evidence Summary

Medically Necessary / Investigational Determination

Policy determination:

Use of steroid-eluting sinus stents and implants (including but not limited to PROPEL, PROPEL Mini, PROPEL Contour, SINUVA) for postoperative treatment following endoscopic sinus surgery (ESS) for chronic rhinosinusitis, recurrent sinonasal polyps, and all other indications is considered investigational.

Investigational = insufficient evidence to determine effects on health outcomes; therefore not covered per policy.

Evidence summary / applicability considerations

Findings and limitations from randomized controlled trials and recommendations from professional societies:

Two randomized controlled trials (RESOLVE and RESOLVE II) showed improvements in polyp grade and ethmoid obstruction for steroid-eluting implants after endoscopic sinus surgery.

Both trials had limitations including short follow-up (RESOLVE: 6 months; RESOLVE II: 90 days) insufficient to determine durability of treatment.

Provider Actions & Billing Guidance

Prior Authorization

Prior authorization

Policy states 'Prior Approval: Not applicable' but the policy considers these devices investigational and not covered; providers should verify member benefits and any authorization requirements with the plan before proceeding.

Documentation Required

Benefit verification and contract rules

Benefits vary by contract and individual member benefits must be verified; Wellmark determines medical necessity only if the benefit exists and no contract exclusions apply.

Coding

FDA product codemixed

OWO	FDA product code for PROPEL/SINUVA devices

Recommended CPT (Unlisted)CPT

30999	Unlisted procedure, nose
31299	Unlisted procedure, accessory sinuses

HCPCS / J-code / S-codeHCPCS

C1874	Stent, coated/covered, with delivery system
C2625	Stent noncoronary, temporary, with delivery system
J7402	Mometasone furoate sinus implant (Sinuva), 10 micrograms
S1091	Stent, noncoronary, temporary, with delivery system (Propel)

Type / Place of Servicemixed

Surgery	Type of Service: Surgery
Outpatient	Place of Service: Outpatient

Background

Steroid-eluting sinus stents are implantable, bioabsorbable devices placed under endoscopic guidance to maintain sinus patency and deliver local corticosteroid (mometasone furoate) over a defined elution period after ESS. PROPEL family devices are bioabsorbable and release mometasone over an approximate duration of 30 days and dissolve over several weeks (do not require removal). SINUVA is a mometasone furoate sinus implant that releases steroid over 90 days (dose: 1350 μg) and is designed to be removed at Day 90 or earlier. These devices are intended to stabilize sinus openings, reduce postoperative edema and adhesion formation, and provide local steroid therapy as an adjunct to ESS.

Definitions

Evidence at a glance

Revision History

April 2025revisedLatest

Annual Review; Policy Renewed.

April 2024revised

Annual Review; Policy Renewed.

April 2023revised

Annual Review; Policy Revised.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySteroid Eluting Sinus Stents and Implants

Policy CodePolicy N/A

Change TypeAnnual review / Renewal (no material change)

Effective DateN/A

Next Review Date2025-04

On This Page

High risk of bias due to outcomes assessed by treating (unblinded) physician in several trials.

Trials did not standardize decisions about repeat ESS or other treatments or have blinded adjudication of those outcomes.

Guideline / Position Statement Consensus

Professional society positions included as supplemental information:

AAO-HNS (2023): considers drug-eluting implants as a proven and effective therapeutic option for mucosal inflammation; notes enhanced wound healing and reduction of scarring and anatomic obstruction.

American Rhinologic Society (2023): states drug-eluting implants should not be considered investigational and should be available when selected by the physician; cites safety, efficacy, cost-effectiveness, and improved patient-centered outcomes.

International Consensus Statement on Allergy and Rhinology (2021): corticosteroid-eluting implants can be considered in a previously operated ethmoid cavity with recurrent nasal polyposis; notes evidence is high level but only short-term outcomes currently available.

Evidence includes systematic reviews/meta-analyses and randomized controlled trials. A 2024 meta-analysis (Zamaili et al.) reported reduced adhesions, mucosal inflammation, polyp reformation, need for oral steroids, and additional surgery at 30 days with moderate-quality evidence. A 2015 Cochrane review concluded there was insufficient high-quality RCT evidence to demonstrate benefit. Key randomized evidence includes the RESOLVE/RESOLVE II and multiple PROPEL RCTs: RESOLVE and RESOLVE II (SINUVA) showed improvements in polyp grade and ethmoid obstruction at 90 days (RESOLVE II also reported a lower proportion indicated for surgery at 3 months), while PROPEL trials demonstrated reductions in need for postoperative intervention with an NNT ≥ 4.7. Major limitations across trials are short follow-up (RESOLVE: 6 months; RESOLVE II: 90 days) and risk of bias from outcomes assessed by treating (unblinded) physicians; some PROPEL trials also had concerns about comparator treatment intensity and video-quality–related missing independent assessments.

Documentation Required

Document prior ESS and indication

Document prior endoscopic sinus surgery and the indication (recurrent nasal polyposis or chronic sinusitis) when submitting claims, as trials and guideline statements reference use in previously operated ethmoid cavities.

Billing Rule

Coding / Billing guidance

Report appropriate unlisted CPT (30999 or 31299) for the implant procedure when no specific CPT exists; report applicable HCPCS/J-code (e.g., J7402, C1874, C2625, S1091) for the device/drug as appropriate.

30999
31299
J7402
C1874
C2625
S1091