Ciprofloxacin/Fluocinolone (Otovel) otic solution
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Defines medical necessity and prior authorization criteria for ciprofloxacin/fluocinolone (Otovel) otic suspension for treatment of acute otitis media with tympanostomy tubes and related uses across Centene-affiliated lines of business.
Clarified member must use otic formulation of generic ciprofloxacin/fluocinolone for brand Otovel requests unless contraindicated.
Revised systemic antibiotic requirement to an otic antibiotic for otitis media with tympanostomy tubes and added a step therapy bypass for Illinois HIM per IL HB 5395.
Clarified approval duration of 2 cartons allows for one carton per affected ear and maximum per-ear dosing.
Coverage Criteria
Initial Approval — Otitis Media
Covered when ALL of the following are met:
Other Diagnoses/Indications
For other diagnoses/indications:
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient clinical documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy for the member’s line of business (see CP.CPA.09, HIM.PA.154, CP.PMN.53) or provides other evidence of coverage.
Uses for indications that are not FDA‑approved and that do not have supporting evidence per the referenced off‑label policies or evidence of coverage are considered not authorized and will be denied.
Coding and Packaging
| NDC (single-use vial) | Single-use vials (14 of 0.25 mL vials in a carton): ciprofloxacin 0.3% (3 mg/mL) with fluocinolone acetonide 0.025% (0.25 mg/mL) |
Provider Actions and Prior Authorization
Initial approval requirements (prior auth)
Prior authorization will only be approved when the initial approval criteria for otitis media are met: diagnosis of otitis media; age ≥ 6 months; presence of tympanostomy tubes; failure of an otic antibiotic indicated for otitis media (see Appendix B) unless contraindicated or clinically significant adverse effects occur; for brand Otovel requests, member must use generic ciprofloxacin/fluocinolone otic suspension unless contraindicated or clinically significant adverse effects are experienced; and dose does not exceed 1 carton (14 single‑dose vials) per affected ear. Approval duration: 7 days (2 cartons total — one per affected ear).
- Diagnosis of otitis media required
- Age ≥ 6 months
- Presence of tympanostomy tubes
- Trial and failure of an otic antibiotic indicated for otitis media (Appendix B) unless contraindicated
- Brand Otovel requests require prior trial of generic ciprofloxacin/fluocinolone otic suspension unless contraindicated
- Dose limit: do not exceed 1 carton (14 single‑dose vials) per affected ear
- Approval duration: 7 days (2 cartons total — one per affected ear)
Step therapy requirement and Illinois HIM bypass
Step therapy requires trial and failure of an otic antibiotic indicated for otitis media (see Appendix B for examples such as ofloxacin and ciprofloxacin otic solutions) prior to approving brand Otovel, unless contraindicated or clinically significant adverse effects occur. For Illinois Health Insurance Marketplace (HIM) requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395.
- Step therapy: failure of an otic antibiotic (Appendix B) required before brand Otovel
- IL HIM bypass: step therapy requirements do not apply for Illinois HIM requests as of 1/1/2026 (per IL HB 5395)
Required supporting clinical documentation
Providers must submit supporting clinical documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria (diagnosis, age, tympanostomy tubes, prior otic antibiotic trial or documented contraindication, and dosing).
- Include office visit notes documenting diagnosis and presence of tympanostomy tubes
- Provide documentation of age (date of birth) to confirm ≥ 6 months
- Submit records showing trial and failure of an otic antibiotic or documentation of contraindication/adverse reaction
- Document planned dosing to confirm ≤ 1 carton (14 vials) per affected ear
Denial risk for missing documentation or unmet criteria
Requests that lack required supporting clinical documentation or that do not meet all initial approval criteria (diagnosis, age, presence of tympanostomy tubes, prior otic antibiotic trial or documented contraindication, generic-first requirement for Otovel, or dosing limits) will be denied.
- Missing items that may lead to denial: office chart notes, documentation of tympanostomy tubes, evidence of prior otic antibiotic use or documented contraindication, proof of age, or dosing details
- Non‑FDA approved indications without sufficient off‑label documentation will not be authorized (see off‑label policies)
Background
Otovel (ciprofloxacin/fluocinolone otic solution) is a combination fluoroquinolone antibacterial and corticosteroid indicated for treatment of acute otitis media in patients with tympanostomy tubes. The product is supplied as single‑use vials in a carton and should be used in accordance with the labeled indication; requests outside the FDA‑approved indication should follow off‑label use policies as noted above.
Definitions
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