Corticosteroids for Ophthalmic Injection (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq)
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Defines prior authorization, medical necessity, and coverage criteria for ophthalmic corticosteroid products (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq) for Peach State Health Plan members across Commercial, HIM/ICHRA, and Medicaid lines of business.
Added Dextenza to policy.
Revised dosing frequency for Ozurdex several times (q4 months → q3 months → every 6 months → clarified every 6 months).
Updated HCPCS codes/descriptions for Xipere, Retisert, Iluvien, and Yutiq.
Removed required step through of intravitreal steroid injections for certain indications due to commercial availability/shortage of alternatives.
Coverage Criteria and Initial Approval
inv-01: Initial Approval Criteria — A. Ocular Inflammation and Pain Following Ophthalmic Surgery (must meet ALL)
Covered when ALL of the following are met:
A. Ocular inflammation and pain following ophthalmic surgery
- Diagnosis of ocular inflammation and pain following ophthalmic surgery
- Request is for Dextenza
- Prescribed by or in consultation with an ophthalmologist
- Member has received or is scheduled to receive ophthalmic surgery within 30 days of this request
- Failure of a topical corticosteroid unless contraindicated, clinically significant adverse effects are experienced, or member is unable to manage regular eye drop use (e.g., due to age or comorbidities including visual impairment)
- Dose does not exceed 0.4 mg (1 insert) per eye every 30 days
Approval duration: 1 month (one insert per eye)
inv-02: Initial Approval Criteria — B. Ocular Itching Associated with Allergic Conjunctivitis (must meet ALL)
Covered when ALL of the following are met:
B. Ocular itching associated with allergic conjunctivitis
- Diagnosis of ocular itching associated with allergic conjunctivitis
- Request is for Dextenza
- Prescribed by or in consultation with an ophthalmologist
- Age ≥ 2 years
- Failure of both of the following unless clinically significant adverse effects are experienced or both are contraindicated, or member is unable to manage regular eye drop use: (a) topical mast cell stabilizer and topical antihistamine (as a single dual-acting product or as two products used in combination); and (b) topical corticosteroid
- Dose does not exceed 0.4 mg (1 insert) per eye every 30 days
Approval duration: 1 month (one insert per eye)
inv-03: Initial Approval Criteria — C. Macular Edema following BRVO or CRVO (must meet ALL)
Covered when ALL of the following are met:
C. Macular edema following BRVO or CRVO
- Diagnosis of macular edema following BRVO or CRVO
- Request is for Ozurdex
- Prescribed by or in consultation with an ophthalmologist
- Age ≥ 18 years
- Failure of an intravitreal anti-vascular endothelial growth factor (VEGF) agent unless contraindicated or clinically significant adverse effects are experienced
- Dose does not exceed 1 implant per eye
Approval duration: 3 months (one implant per eye)
inv-03: Initial Approval Criteria — D. Non-Infectious Uveitis (must meet ALL)
Covered when ALL of the following are met:
D. Non-infectious uveitis affecting posterior segment
- Diagnosis of non-infectious uveitis affecting the posterior segment of the eye
- Request is for Iluvien, Ozurdex, Retisert, or Yutiq
- Prescribed by or in consultation with an ophthalmologist
- Member meets one of the following: (a) for Iluvien, Ozurdex, Yutiq: Age ≥ 18 years; or (b) for Retisert: Age ≥ 12 years
- Failure of one of the following unless clinically significant adverse effects are experienced or both are contraindicated: (a) systemic corticosteroid (e.g., prednisone); or (b) non-biologic systemic immunosuppressive therapy (e.g., azathioprine, cyclosporine, methotrexate, tacrolimus)
- Dose does not exceed 1 implant per eye
inv-05: Initial Approval Criteria — E. Diabetic Macular Edema (must meet ALL)
Covered when ALL of the following are met:
E. Diabetic macular edema
- Diagnosis of diabetic macular edema (DME)
- Request is for Ozurdex or Iluvien
- Prescribed by or in consultation with an ophthalmologist
- Age ≥ 18 years
- Failure of an intravitreal anti-vascular endothelial growth factor (VEGF) agent unless contraindicated or clinically significant adverse effects are experienced
- Dose does not exceed 1 implant per eye
Approval duration: 3 months (one implant per eye)
inv-06: Initial Approval Criteria — F. Macular Edema with Uveitis (must meet ALL)
Covered when ALL of the following are met:
F. Macular edema associated with non-infectious uveitis
- Diagnosis of macular edema associated with non-infectious uveitis
- Request is for Xipere
- Prescribed by or in consultation with an ophthalmologist
- Age ≥ 18 years
- Dose does not exceed 4 mg (1 vial) per eye every 12 weeks
Approval duration: 3 months (one implant per eye)
inv-07: General coverage requirement — FDA indications and off-label policy guidance
Coverage governed by FDA indications and applicable formulary/off-label policies; if not listed, follow off-label policy.
If drug label recently changed, follow relevant formulary/non‑formulary policy guidance.
inv-08: Product dosing and frequency — product-specific dosing/administration parameters and limits
Product-specific dosing/administration parameters (coverage limited to these or per labeling):
If a product has had a recent label change (within the last 6 months) that is not yet reflected in this policy, providers should follow the referenced formulary/non‑formulary or no‑coverage policies for the applicable line of business. For formulary/PDL drugs, see the no coverage criteria policies (e.g., CP.CPA.190 for commercial, HIM.PA.33 or HIM.PA.103 for marketplace/ICHRA, CP.PMN.255 for Medicaid). For non‑formulary/PDL drugs, see the non‑formulary policies (e.g., CP.CPA.190 for commercial, HIM.PA.103 for marketplace/ICHRA, CP.PMN.16 for Medicaid).
Requests for ophthalmic corticosteroid therapies are not authorized for members with active ocular infections. Specific product contraindications include, but are not limited to: Dextenza contraindicated in active corneal, conjunctival or canalicular infections (including epithelial herpes simplex keratitis, vaccinia, varicella), mycobacterial and fungal ocular infections, and dacryocystitis; Retisert contraindicated in active viral, bacterial, mycobacterial or fungal infections of the eye; and Iluvien, Ozurdex, Xipere and Yutiq contraindicated in active or suspected ocular or periocular infections (including most viral diseases of the cornea and conjunctiva). Non‑FDA indications not addressed in this policy are excluded unless supported per the off‑label use policies.
For Medicaid members, state Medicaid coverage provisions take precedence if they conflict with this clinical policy. Providers should refer to the state Medicaid manual for applicable coverage provisions and follow those requirements when differences exist.
This policy references additional conditions and cross‑references elsewhere in the document. Where a product has undergone a recent label change or the requested use is not specifically addressed here, follow the referenced formulary/non‑formulary and off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53 and related policies listed in the policy references). Explicit statements of not‑medically‑necessary (NMN) uses are provided in other sections of the policy and in referenced guidance.
Use of an ophthalmic corticosteroid for a non‑FDA approved indication that is not addressed in this policy will be considered not medically necessary unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy (e.g., CP.CPA.09 commercial, HIM.PA.154 marketplace/ICHRA, CP.PMN.53 Medicaid). Lack of supporting off‑label documentation may lead to denial of the request.
Products and Billing Codes
| Product list | Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq (products requiring prior authorization) |
| J1096 | Dexamethasone, lacrimal ophthalmic insert, 0.1 mg |
| J7311 | Injection, fluocinolone acetonide intravitreal implant, 0.01 mg (Retisert) |
| J7312 | Injection, dexamethasone intravitreal implant, 0.1 mg |
| J7313 | Injection, fluocinolone acetonide intravitreal implant, 0.01 mg (Iluvien) |
| J7314 | Injection, fluocinolone acetonide intravitreal implant, 0.01 mg (Yutiq) |
| J3299 | Injection, triamcinolone acetonide (Xipere), 1 mg |
Prior Authorization, Documentation, and Billing Guidance
Prior authorization required for listed ophthalmic corticosteroids
Prior authorization is required for the corticosteroid products listed in this policy: Dextenza, Iluvien, Ozurdex, Retisert, Xipere, and Yutiq. Requests for these products must follow the documented approval criteria and prior authorization process.
PA decisions reference therapeutic alternatives and dosing limits
Some products may require prior authorization per line of business and the policy provides therapeutic alternatives and dosing limits in Appendix B; prior authorization determinations are made in the context of those alternatives and labeled dosing.
PA and product HCPCS codes included
The policy lists HCPCS codes for the ophthalmic corticosteroid products; coverage decisions are governed by the clinical policy and may require prior authorization per Health Plan procedures.
Step therapy: document prior therapy failure unless contraindicated
Most labeled indications require documented failure of specified prior therapies before approval (examples: topical corticosteroid for post‑surgical inflammation; topical mast cell stabilizer + antihistamine and topical corticosteroid for allergic conjunctivitis; intravitreal anti‑VEGF for macular edema and DME; systemic corticosteroid or non‑biologic systemic immunosuppressive therapy for non‑infectious uveitis), unless contraindicated or adverse effects occur.
Preferred therapeutic alternatives (anti‑VEGF, systemic therapies)
Appendix B lists preferred therapeutic alternatives that should be considered before ophthalmic corticosteroid implants in relevant indications; examples include intravitreal anti‑VEGF agents for macular edema (bevacizumab, ranibizumab, aflibercept, Vabysmo) and systemic corticosteroids or non‑biologic systemic immunosuppressives for uveitis.
- Anti‑VEGF agents (bevacizumab, ranibizumab, aflibercept, Vabysmo) for macular edema/DME.
- Systemic corticosteroids (e.g., prednisone) and non‑biologic systemic immunosuppressive therapies for uveitis.
Step therapy bypassed for intravitreal steroid injections due to shortages
Required step-through (step therapy) for intravitreal steroid injections for DME, macular edema, and uveitis was removed due to limited commercial availability/shortage of intravitreal steroid injection products (Triesence shortage).
Submit clinical documentation supporting approval criteria
Providers must submit clinical documentation (e.g., office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria when requesting prior authorization.
Follow formulary/off‑label guidance for recent label changes
If a drug has undergone a recent label change not yet reflected in this policy, providers must follow the referenced formulary/non‑formulary or off‑label use policies for documentation and coverage determination (see policy references such as CP.CPA.09, HIM.PA.154, CP.PMN.53).
Coding references do not guarantee coverage — verify current coding guidance
Codes referenced in this clinical policy are for informational purposes only; inclusion or exclusion of codes in the policy does not guarantee coverage and providers should reference current professional coding guidance before claim submission.
Missing documentation may trigger denial
Failure to submit required supporting documentation (office chart notes, lab results, or other clinical information) demonstrating that the member meets all approval criteria may result in denial of the request.
Off‑label indications may be denied without sufficient documentation
Requests for non‑FDA approved (off‑label) indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the referenced off‑label use policies; submit supporting evidence per those policies.
Required supporting documentation and examples to include with PA request
Provide the specific supporting documentation listed in the policy when requesting coverage, including office chart notes and relevant clinical data, to demonstrate that all approval criteria and any step‑therapy or alternative therapy requirements have been met.
- Office chart notes documenting diagnosis and prior therapy trials/failures.
- Relevant lab or imaging results supporting the diagnosis and treatment response.
- Documentation of contraindications or adverse effects when prior therapies were not used or failed.
Products, Conditions, and Background
This policy covers multiple sustained‑release inserts and injectable ocular corticosteroid products used across a range of ophthalmic conditions. Covered products include intracanalicular inserts, intravitreal implants, and suprachoroidal injections with differing indications and dosing intervals. Examples include the dexamethasone intracanalicular insert (Dextenza) for post‑operative ocular inflammation and ocular itching from allergic conjunctivitis, the dexamethasone intravitreal implant (Ozurdex) for macular edema from BRVO/CRVO, non‑infectious posterior uveitis and diabetic macular edema, fluocinolone intravitreal implants (Iluvien, Retisert, Yutiq) for chronic non‑infectious posterior uveitis (and Iluvien for certain DME patients), and a suprachoroidal triamcinolone injection (Xipere) for macular edema associated with uveitis. Dosing, age limits, and maximum frequencies vary by product and must follow the product labeling or the specific limits in this policy (for example, Dextenza: 0.4 mg, one insert per eye every 30 days; Ozurdex: 0.7 mg, one implant per eye).
Policy Revision Notes
Added Dextenza to the policy and revised Ozurdex dosing frequency from q4 months to q3 months; updated HCPCS code for Xipere.
Added Dextenza to the policy and revised Ozurdex dosing frequency from q4 months to q3 months per literature review and specialist feedback; updated HCPCS code for Xipere.
3Q 2023 annual review — references reviewed and updated (no significant clinical policy changes recorded).
3Q 2024 annual review — updated commercially available branded therapeutic alternatives in Appendix B and revised Ozurdex maximum dosing interval from every 4 months to every 6 months per PI references.
Removed required step-through of intravitreal steroid injections for DME, macular edema, and uveitis due to limited commercial availability/shortage of alternatives (Triesence shortage).
Updated HCPCS code descriptions for Retisert, Iluvien, and Yutiq and added Iluvien indication for non-infectious uveitis affecting the posterior segment; updated contraindications to align with prescribing information.
3Q 2025 annual review — updated HCPCS code descriptions for Retisert, Iluvien, and Yutiq; added step therapy bypass for IL HIM per IL HB 5395 and clarifications for allergic conjunctivitis, macular edema following RVO/DME, and non-infectious uveitis.
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