Mometasone Furoate (Sinuva) sinus implant
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Policy governing medical necessity and authorization criteria for Sinuva (mometasone furoate sinus implant) for treatment of chronic rhinosinusitis with nasal polyps in adults post-ethmoid sinus surgery; applies to Centene-affiliated health plans and lines of business specified.
No material clinical or coverage changes in this revision.
Coverage Criteria for Sinuva (mometasone furoate sinus implant)
Initial Therapy
Covered when ALL of the following are met:
For Illinois HIM requests, step therapy requirements may not apply as specified in state legislation.
Approval duration: 4 months (1 implant per sinus)
Maximum: 1 implant per sinus per product labeling.
Continuation Therapy
Continued coverage when ONE of the following is met and additional conditions apply:
Additionally, member must be responding positively to therapy (e.g., improvement in nasal congestion or obstruction, reduction of bilateral polyp grade). Approval duration: 4 months (1 implant per sinus).
Member must be responding positively to therapy. If request is for a dose increase, the new dose must not exceed 1,350 mcg (1 implant) per sinus per 90 days. Ethmoid sinus polyps grade ≥1 on the sinus(es) receiving the implant(s) required for reauthorization.
Placement and Indication Constraints
Coverage notes and constraints referenced in this section include:
Clarified in annual review; aligns with product labeling.
Document revised to reflect updated FDA language.
Codes in policy are informational; follow up-to-date professional coding guidance.
Stated maximum dose and implant limit per sinus; see approval duration notes.
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.
The inclusion or exclusion of any billing or procedure codes in this policy does not, by itself, guarantee coverage or payment. Providers must follow plan‑specific coding guidance and reference the most up‑to‑date professional coding resources when submitting claims.
Use of Sinuva (mometasone furoate sinus implant) for non‑FDA approved indications without adequate documentation demonstrating efficacy and safety, as required by the referenced off‑label use policies, is considered not authorized.
Coding and Dose Limits
| J7402 | HCPCS code referenced in policy (description abbreviated in source) |
| J7402 | 10 mcg (HCPCS code referenced for mometasone furoate implant) |
Provider Requirements and Prior Authorization
Prior Authorization Required
Prior authorization is required. Sinuva (intranasal implant) is covered only when the medical necessity criteria in this policy are met and prior authorization has been obtained before dispensing/placement.
- Affected code: HCPCS J7402 (implant). Follow plan-specific prior authorization processes for requests involving this code.
Non‑FDA Indications
Requests for indications that are not FDA‑approved and are not specifically addressed in this policy require submission of sufficient supportive documentation per the applicable off‑label use policies. Coverage for non‑FDA indications will be considered only when documentation demonstrates efficacy and safety consistent with the referenced off‑label use policies.
Provider billing/coding disclaimer
Inclusion or exclusion of any codes in this policy is informational and does not guarantee coverage or reimbursement. Providers must reference current professional coding guidance and payer billing requirements when submitting claims.
Supportive Documentation
Supportive documentation is required to substantiate that the member meets all approval criteria. Submit office chart notes, operative reports (e.g., documentation of ethmoid sinus surgery), imaging results, polyp grading, prior treatment history, and any clinical rationale for use (including reasons a formulary intranasal steroid was inadequate or contraindicated).
- Examples: office notes, ENT consultation notes, surgical reports, imaging, prior medication trials, adverse reaction documentation
Providers should reference the most up-todate coding guidance
Providers should reference the most up‑to‑date sources of professional coding guidance and payer-specific billing rules when preparing and submitting claims to ensure accurate coding and reimbursement.
- Codes referenced in this policy (e.g., HCPCS J7402) are for informational purposes only and may change; verify current code sets prior to claim submission.
Background
Sinuva is a bioabsorbable, corticosteroid‑eluting sinus implant that delivers mometasone furoate directly into the ethmoid sinus over approximately 90 days. It is FDA‑approved for adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have undergone ethmoid sinus surgery and is intended to reduce polyp burden and nasal congestion. Per product labeling and policy limits, placement is limited to one implant per sinus and dosing must not exceed 1,350 mcg per sinus per 90 days.
Definitions
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