Intracanalicular and Intravitreal Corticosteroid Implants
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Defines medical benefit drug coverage criteria for intracanalicular (Dextenza) and intravitreal corticosteroid implant products (Iluvien, Ozurdex, Retisert) for UnitedHealthcare Community Plan members, excluding specific states listed in the document.
Revised list of applicable intracanalicular and intravitreal corticosteroid implant products and removed Yutiq (fluocinolone acetonide intravitreal implant) from the policy.
Removed language indicating Yutiq is proven and medically necessary when all listed criteria are met.
Removed HCPCS code J7314 from Applicable Codes.
Updated Background, Clinical Evidence, FDA, and References sections to reflect current information.
Coverage Criteria for Intracanalicular and Intravitreal Corticosteroid Implants
Dextenza (dexamethasone ophthalmic insert)
Dextenza is proven and medically necessary when ALL of the following are met:
Iluvien (fluocinolone acetonide intravitreal implant)
Iluvien is proven and medically necessary when ALL of the following are met:
Prior corticosteroid trial and absence of clinically significant IOP rise required when used for DME.
Ozurdex (dexamethasone intravitreal implant)
Ozurdex is proven and medically necessary when ALL of the following are met:
Clinical trials demonstrated visual benefit (e.g., ≥15-letter improvement endpoints) and noted IOP peaks that returned to baseline by ~180 days.
Retisert (fluocinolone acetonide intravitreal implant)
Retisert is proven and medically necessary when ALL of the following are met:
Covered Indications (FDA-labeled and trial-supported)
Covered indications discussed in the document include the following when consistent with clinical appropriateness and payer requirements:
Iluvien indication includes requirement of prior corticosteroid treatment without clinically significant IOP rise.
IOP peaked post-implant (e.g., ~16% at day 60) but returned to baseline by day 180 in trials.
Significant rates of IOP-lowering surgery and cataract extraction were reported in some fluocinolone acetonide implant trials.
Evidence from three randomized controlled trials.
Evaluated in three randomized trials using repeat conjunctival allergen challenge model.
Intracanalicular and intravitreal corticosteroid implant products are considered unproven and not medically necessary for the treatment of indications other than those specifically listed in this policy due to insufficient evidence of efficacy. Examples explicitly noted include cystoid macular edema after cataract surgery and radiation retinopathy.
Information about U.S. Food and Drug Administration (FDA) approvals is provided for context only; FDA approval alone is informational and is not a sole basis for coverage decisions under this policy.
The policy has been revised to remove Yutiq (fluocinolone acetonide intravitreal implant) from the list of applicable intracanalicular and intravitreal corticosteroid implant products and to delete related coverage language.
Use of intracanalicular and intravitreal corticosteroid implant products for any indication not specifically listed in the policy is considered not medically necessary and may be denied. Examples cited in the policy include cystoid macular edema after cataract surgery and radiation retinopathy.
Clinical trials and evidence summarized in the policy identify important safety concerns for some intravitreal fluocinolone acetonide implants and other corticosteroid implants, including elevated intraocular pressure (IOP) sometimes requiring IOP‑lowering surgery and high rates of cataract formation requiring extraction, which necessitate close monitoring when these products are used.
Policy History notes that language previously stating that Yutiq was proven and medically necessary when all listed criteria were met has been removed; Yutiq is no longer included as a covered product under those criteria.
Applicable Codes and Diagnosis Codes
| E08.311 | Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema |
| E08.3211 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, right eye |
| E08.3212 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, left eye |
| E08.3213 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, bilateral |
| E08.3219 | Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E11.3413 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye |
| E11.3419 | Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral |
| E11.3511 | Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E11.3512 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye |
| E11.3513 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye |
| E11.3519 | Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral |
| E11.37X1 | Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye |
| E11.37X2 | Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye |
| E11.37X3 | Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral |
| E11.37X9 | Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye |
| E13.311 | Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema |
| E13.3211 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye |
| E13.3212 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye |
| E13.3213 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral |
| E13.3219 | Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye |
| E13.3311 | Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye |
| H34.8110 | Central retinal vein occlusion, right eye, with macular edema |
| H34.8120 | Central retinal vein occlusion, left eye, with macular edema |
| H34.8130 | Central retinal vein occlusion, bilateral, with macular edema |
| H34.8190 | Central retinal vein occlusion, unspecified eye, with macular edema |
| H34.8310 | Tributary (branch) retinal vein occlusion, right eye, with macular edema |
| H34.8320 | Tributary (branch) retinal vein occlusion, left eye, with macular edema |
| H20.041 | Secondary noninfectious iridocyclitis, right eye |
| H20.042 | Secondary noninfectious iridocyclitis, left eye |
| H20.043 | Secondary noninfectious iridocyclitis, bilateral |
| H30.011 | Focal chorioretinal inflammation, juxtapapillary, right eye |
| H30.021 | Focal chorioretinal inflammation of posterior pole, right eye |
| H30.131 | Disseminated chorioretinal inflammation, generalized, right eye |
| H30.811 | Harada's disease, right eye |
| H30.90 | Unspecified chorioretinal inflammation, unspecified eye |
| H57.10 | Ocular pain, unspecified eye |
| J7314 | HCPCS code J7314 (removed from Applicable Codes) |
Prior Authorization, Documentation, and Billing Guidance
Prior authorization required; 60‑day authorization and one per‑eye limit
Prior authorization is required and authorizations are limited to no more than 60 days; dose must not exceed one insert/implant per eye as specified by product criteria.
- Prior authorization required with documentation that product‑specific coverage criteria are met.
- Authorization period limited to no more than 60 days.
- Dose limited to one insert/implant per eye.
Iluvien requires prior corticosteroid exposure without significant IOP rise
For Iluvien, prior clinical history must document a course of corticosteroid treatment and that the member did not have a clinically significant rise in intraocular pressure.
- Member previously treated with a course of corticosteroids.
- No clinically significant rise in intraocular pressure during that corticosteroid course.
Updated applicable codes — J7314 removed; verify current codes and benefits
The policy removes HCPCS code J7314 from the Applicable Codes list; providers must follow current applicable code sets and verify benefit plan requirements for prior authorization and billing.
- HCPCS code J7314 was removed from Applicable Codes.
- Use current HCPCS/J code sets when submitting claims and checking prior authorization needs.
- Verify benefit plan contractual, state or federal requirements that may affect coding and authorization.
Document prior corticosteroid trial and IOP response for Iluvien
When requesting coverage for Iluvien, include documentation of the prior corticosteroid course and clinical response (specifically no clinically significant increase in IOP) to satisfy the product‑specific prior steroid trial requirement.
- Document the corticosteroid regimen used (agent, route, dates).
- Document clinical monitoring showing no clinically significant intraocular pressure increase during/after the steroid course.
Step‑wise prior therapy for DME — document prior macula‑directed treatments
For diabetic macular edema, implants (Iluvien, Ozurdex) are considered in patients with persistent DME despite prior macula‑directed therapy; prior macular laser or other prior therapy should be documented as part of step‑therapy context.
- Document prior macular laser or other prior therapy and persistent DME despite those treatments.
- Recognize implants are positioned for persistent disease after prior macula‑directed interventions.
Provider instructions and governing benefit guidance (administrative)
See Instructions for Use section for governing benefit plan statements and other administrative instructions provided in the policy.
- The policy instructs providers to reference federal, state, or contractual benefit plan requirements that govern coverage.
- UnitedHealthcare may use third‑party tools (e.g., InterQual) to assist in administering benefits.
Document diagnosis that matches product‑specific criteria
Document the diagnosis consistent with the product‑specific criteria (e.g., postoperative ocular inflammation/pain or allergic conjunctivitis for Dextenza; chronic non‑infectious posterior uveitis or specified DME criteria for Iluvien; BRVO/CRVO macular edema, posterior non‑infectious uveitis, or DME for Ozurdex; chronic non‑infectious posterior uveitis for Retisert).
- Ensure the submitted diagnosis matches the specific product indication listed in the policy.
- Include laterality and relevant diagnostic details (e.g., DME, BRVO/CRVO, posterior non‑infectious uveitis).
Support implant choice, prior treatments, outcomes, and monitoring in clinical records
Include clinical documentation supporting the chosen implant and indication, prior treatments and responses, and monitoring for adverse events (e.g., intraocular pressure elevations, cataract formation). For Iluvien specifically, include documentation of prior corticosteroid treatment and IOP monitoring results.
- Support implant choice with indication‑specific clinical notes and prior treatment history.
- Document monitoring and outcomes, including IOP measurements and any interventions for elevated IOP or cataract.
Reference governing federal, state, or contractual benefit documents
Reference federal, state, or contractual benefit plan requirements when submitting authorization or claims, as those requirements govern in the event of a conflict with this policy.
- If federal, state, or contractual terms differ from this policy, those terms take precedence.
- Verify applicable plan documents before relying solely on this policy for coverage decisions.
Non‑listed indications are not medically necessary — risk of denial
Use of intracanalicular and intravitreal corticosteroid implant products for any indication not listed (for example, cystoid macular edema after cataract surgery or radiation retinopathy) is considered not medically necessary and may be denied.
- Do not submit authorization requests for indications outside the policy’s listed indications; such requests may be denied as not medically necessary.
- Examples of non‑covered indications include cystoid macular edema after cataract surgery and radiation retinopathy.
Iluvien approval requires documented prior steroid course without clinically significant IOP rise
Iluvien may be approved only for patients who have been previously treated with a course of corticosteroids and who did not experience a clinically significant rise in intraocular pressure; lack of documentation of prior steroid exposure and IOP response could result in denial.
- Document the prior corticosteroid course and contemporaneous IOP assessments showing no clinically significant rise.
- Authorization for Iluvien for DME requires this documented prior steroid history.
Coding or contractual conflicts (e.g., removed J7314) can trigger denials
Failure to follow updated Applicable Codes (HCPCS code J7314 removed) or to reference applicable federal, state, or contractual benefit requirements when they conflict with this policy may trigger denial or claim coverage issues.
- Do not bill or authorize using HCPCS code J7314; use the current codes listed in the policy and submit claims consistent with plan requirements.
- If plan contracts or state/federal rules differ, those governing rules apply and may affect coverage decisions.
Background and Scope
Background: This policy addresses UnitedHealthcare medical benefit coverage for specified intracanalicular and intravitreal corticosteroid implants used to treat certain ophthalmic inflammatory conditions and causes of macular edema. Products discussed in this policy include intracanalicular Dextenza and intravitreal implants such as Iluvien, Ozurdex, and Retisert. The document defines product‑specific, evidence‑based coverage criteria, documents applicable HCPCS and diagnosis codes, and sets prior authorization and documentation expectations for members covered under the plan.
Product Definitions and Characteristics
Policy Revision History
Revised list of applicable intracanalicular and intravitreal corticosteroid implant products and removed Yutiq (fluocinolone acetonide intravitreal implant) and its coverage language
Removed HCPCS code J7314 from the Applicable Codes list
Archived previous policy version CS2026D00107J
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