ModifiedBlue Cross Blue Shield - LouisianaPolicy 00549

Intravitreal and Suprachoroidal Corticosteroid Products

This policy governs coverage and medical necessity criteria for intravitreal and suprachoroidal corticosteroid implants and injections (e.g., Retisert, Iluvien, Yutiq, Ozurdex, Xipere) for ocular conditions such as non-infectious uveitis, macular edema after retinal vein occlusion, and diabetic macular edema for members of Blue Cross and Blue Shield of Louisiana and HMO Louisiana, Inc.

Policy Summary

PayerBlue Cross Blue Shield - Louisiana

PolicyIntravitreal and Suprachoroidal Corticosteroid Products

Policy CodePolicy 00549

Change TypeNot medically necessary updateproduct additions and title change (material update)

Effective Date08/01/2026

Next Review Date05/2027

Key ActionObtain and document prior authorization with evidence of prior therapies (including required trial of triamcinolone for Xipere) and baseline lens/IOP status.

SourceLink

POLICY UPDATE CHANGES

Updated criteria for Yutiq and Iluvien, stating that the use of both drugs for the treatment of chronic non-infectious intermediate uveitis, posterior uveitis, or panuveitis is considered not medically necessary.

Added a new product, Xipere, to the policy and added information about suprachoroidal injections.

Changed policy title from 'Intravitreal Corticosteroid Implants' to 'Intravitreal and Suprachoroidal Corticeroid Products'.

08/01/2026Current effective date

05/2027Next review

00549Policy number

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

0.59,0.19,0.18,0.7,4 mgDrug doses referenced

Higher IOP & cataractAdverse events noted

1RCT for Xipere (uveitic ME)

Coverage Criteria and Policy Determinations

Fluocinolone 0.59 mg (Retisert) and 0.19 mg (Iluvien) coverage statements

Covered when ALL of the following are met

Retisert (fluocinolone 0.59 mg): Company may consider Retisert (0.59 mg) eligible for coverage for treatment of chronic non-infectious intermediate uveitis, posterior uveitis, or panuveitis.

Based on review of available data; benefits and medical necessity criteria must be met.

Iluvien (fluocinolone 0.19 mg): Company may consider Iluvien (0.19 mg) eligible for coverage for treatment of diabetic macular edema in patients previously treated with a course of corticosteroids who did not have a clinically significant rise in intraocular pressure.

Requires prior corticosteroid exposure without clinically significant IOP rise.

Iluvien 0.19 mg for DME

Covered when ALL of the following are met

Iluvien for diabetic macular edema: Iluvien (0.19 mg) is eligible for coverage for diabetic macular edema when the patient has received a prior course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

Prior corticosteroid exposure and absence of clinically significant IOP rise must be documented.

Ozurdex (dexamethasone 0.7 mg) patient selection

Covered when ONE of the following is met

Indications for Ozurdex (dexamethasone 0.7 mg): Patient has non-infectious ocular inflammation/uveitis affecting the intermediate or posterior segment, OR macular edema following branch or central retinal vein occlusion, OR diabetic macular edema.

Coverage eligibility considered when one listed indication is present; trial retreatment intervals and lens status may affect expected benefit.

Xipere (triamcinolone suprachoroidal 4 mg) patient selection

Covered when ALL of the following are met

Xipere (triamcinolone suprachoroidal 4 mg) coverage criteria: Patient has non-infectious anterior-, intermediate-, posterior-, or pan-uveitis; AND macular edema associated with non-infectious uveitis; AND has tried and failed (intolerance or inadequate response) triamcinolone intravitreal injections 4 mg (Triesence) unless clinical evidence/history suggests Triesence would be ineffective or cause an adverse reaction; AND dosing does not exceed 4 mg every 12 weeks per impacted eye.<= 4 mg every 12 weeks

Failure to meet the Triesence trial requirement will be denied as not medically necessary; RCT evidence showed superiority to sham for uveitic macular edema (≥15-letter BCVA improvement at 24 weeks).

Covered indications described in evidence summary

Covered for FDA-approved indications when consistent with supporting trial populations and labeling (per text in this section):

Fluocinolone acetonide implants (0.18/0.19/0.59 mg): Used for chronic (≥1 year) noninfectious uveitis affecting the posterior segment; trials enrolled chronic recurrent uveitis patients and demonstrated reduced recurrence rates.chronic >=1 year

Evidence includes randomized trials with up to 36-month follow-up; applicability should match trial populations and labeling.

Dexamethasone intravitreal implant (0.7 mg): Used for non-infectious intermediate or posterior uveitis, macular edema following branch or central retinal vein occlusion, and diabetic macular edema per FDA labeling and pivotal trials.

Indications reflect pivotal RCTs (HURON, GENEVA) and FDA-approved uses.

Suprachoroidal triamcinolone (Xipere): FDA-approved for macular edema associated with uveitis; use should align with the RCT population demonstrating benefit.

Evidence-based coverage considerations

Summary of evidence findings and outcomes reported in RCTs and meta-analyses:

Fluocinolone for chronic noninfectious posterior uveitis: Pivotal RCTs found statistically significantly lower uveitis recurrence rates at 6 and 12 months and at 36 months in one trial; trial results were inconsistent in magnitude and subject to imputed recurrence concerns.

Consider inconsistency between trials when extrapolating benefit magnitude.

Dexamethasone (0.7 mg) for RVO-related macular edema: GENEVA trials showed faster time to ≥15-letter BCVA improvement and higher proportions achieving ≥15 letters in the first 3 months versus sham with effects diminishing by 6 months; implant effect lasts ~6 months.

Retreatment intervals in trials were typically ≥6 months.

Comparative effectiveness vs anti-VEGF: Meta-analyses and trials generally favor anti-VEGF therapy for letters gained in RVO-related macular edema; steroids may reduce injection burden but increase risk of IOP elevation and cataract.

Balance efficacy and higher ocular adverse events when considering implants versus anti-VEGF.

Dexamethasone (0.7 mg) — Evidence summary

Coverage stance summaries from clinical evidence in this section:

Dexamethasone implant (0.7 mg) evidence summary: RCTs and observational studies show faster, clinically meaningful improvements in vision versus sham for macular edema from RVO and DME with peak gains at 1–3 months and decline thereafter, and increased IOP and cataract events; retreatment typically allowed at ≥6 months.

Subgroup effects favor pseudophakic patients; monitor for IOP and cataract.

Fluocinolone implants — Evidence summary

Fluocinolone implant evidence and coverage implications:

Retisert (fluocinolone 0.59 mg) evidence: One RCT in refractory DME showed early visual benefit but substantially higher rates of elevated IOP (≈61% ≥30 mm Hg), glaucoma surgery (≈34%), and cataract extraction (~91% in phakic eyes); implant active ~30 months and is not indicated for DME due to adverse events and availability of safer agents.

High adverse event rates limit use for DME.

Iluvien (fluocinolone 0.19 mg) evidence: Two double-blind RCTs showed superiority over sham for proportion gaining ≥15 letters at 2 years with greater benefit in pseudophakic and chronic DME, but nearly 80% of phakic patients develop cataracts and IOP elevation occurred in ~34% leading to a restricted indication requiring prior steroid exposure without clinically significant IOP rise.

Prior corticosteroid exposure without significant IOP rise should be documented.

Coverage considerations by indication

Coverage considerations derived from RCT and observational evidence summaries for discrete indications

DME — dexamethasone implant: Covered when RCT evidence shows clinically meaningful improvements in visual acuity; consider greater benefit in pseudophakic patients and monitor for cataract and IOP elevation.RCT evidence supports use

Two identical RCTs established efficacy; subgroup effects favor pseudophakic patients.

Dexamethasone plus anti-VEGF: Not routinely covered as additive therapy solely to reduce retinal thickness because trials show no consistent visual acuity benefit and increased IOP risk; may be considered only with documented anti-VEGF resistance or contraindication.documented inadequate response to anti-VEGF or contraindication

Small RCTs showed CFT reduction without VA benefit and higher IOP events.

Implant plus laser for DME:

Coverage by Indication

Coverage stance varies by indication based on available evidence

Macular edema associated with uveitis: Covered when supported by clinical documentation: one RCT demonstrated Xipere (suprachoroidal triamcinolone 4 mg) superior to sham with 47% vs 16% achieving ≥15-letter BCVA improvement at 24 weeks.≥15-letter BCVA improvement endpoint demonstrated in RCT

Document diagnosis of uveitic macular edema and baseline BCVA to support expected benefit.

Postoperative chronic macular edema (Irvine-Gass): Coverage may be considered but additional RCTs are needed; documentation of prior therapies and chronicity recommended given limited RCT evidence and mixed observational data.

One small RCT (N=29) found no significant difference versus triamcinolone injection; larger trials needed.

Idiopathic Macular Telangiectasia Type 1: Not well supported — no RCTs identified; evidence limited to case reports with mixed results; insufficient to conclude efficacy and typically considered investigational.

Not Medically Necessary (updated)

Policy determinations include specific not medically necessary statements:

Yutiq and Iluvien - Not medically necessary for uveitis indications: Use of Yutiq and Iluvien for treatment of chronic non-infectious intermediate uveitis, posterior uveitis, or panuveitis is considered not medically necessary.

Updated 05/13/2026 per Medical Policy Implementation Committee.

Xipere prior trial requirement not met: Xipere will be considered not medically necessary if the patient has not tried and failed triamcinolone intravitreal injections 4 mg (Triesence) unless there is documented clinical rationale why Triesence would be ineffective or cause an adverse reaction.

Failure to document prior Triesence trial will result in denial as not medically necessary.

Medical Necessity Criteria

Covered when meeting medical necessity as defined

Medical Necessity Requirements: Service must meet ALL of the following: A) in accordance with nationally accepted standards of medical practice; B) clinically appropriate in type, frequency, extent, level of care, site and duration; C) not primarily for personal comfort or convenience and not more costly than an alternative service likely to produce equivalent therapeutic or diagnostic results.

Documentation must also demonstrate benefits are available in the member's contract and indication-specific criteria (e.g., prior corticosteroid exposure for Iluvien, prior Triesence trial for Xipere) are met.

Use of intravitreal and suprachoroidal corticosteroid products (Retisert, Iluvien, Yutiq, Ozurdex, Xipere) is governed by indication-specific criteria in this policy. Retisert (fluocinolone 0.59 mg) and Iluvien (fluocinolone 0.19 mg) may be considered for chronic noninfectious uveitis of the posterior segment when coverage criteria and medical necessity are met; Iluvien has an FDA-labeled restriction for diabetic macular edema in patients previously treated with corticosteroids without a clinically significant rise in intraocular pressure. Ozurdex (dexamethasone 0.7 mg) is considered for non-infectious intermediate or posterior uveitis, macular edema following branch or central retinal vein occlusion, and diabetic macular edema where trial evidence supports use. Xipere (triamcinolone suprachoroidal 4 mg) is FDA-approved for macular edema associated with uveitis and eligibility requires meeting the product-specific selection criteria in this policy.

Intravitreal triamcinolone acetonide (eg, Triesence) is described in the policy as an off-label intravitreal corticosteroid sometimes used adjunctively for diabetic macular edema; such off-label use is acknowledged but is not explicitly endorsed by the policy and may require documentation or prior authorization consistent with medical necessity requirements.

No randomized controlled trials were identified for the use of the fluocinolone acetonide 0.59 mg implant (Retisert) to treat macular edema following retinal vein occlusion; therefore the evidence base for this indication is lacking.

Retisert (fluocinolone 0.59 mg) is associated with substantial ocular adverse events in trials for diabetic macular edema, including high rates of cataract surgery and intraocular pressure elevation; because of these safety concerns and the availability of alternatives with safer tolerability profiles, Retisert is not indicated for DME.

For rare or uncommon disorders such as birdshot retinochoroidopathy and idiopathic macular telangiectasia type 1, the policy found no randomized controlled trials supporting intravitreal corticosteroid implants; available evidence is limited to case series and reports with short-term follow-up, so long-term efficacy and safety remain uncertain.

The policy designates use of intravitreal corticosteroid implants for many non-uveitic indications (for example, idiopathic macular telangiectasia type 1, circumscribed choroidal hemangioma, proliferative vitreoretinopathy, radiation retinopathy, postoperative macular edema) as investigational when RCT-level evidence is absent; requests for these indications generally lack high-quality trial support and are considered unsupported by the available evidence.

The policy states that the use of fluocinolone intravitreal implants Yutiq (0.18 mg) and Iluvien (0.19 mg) for the treatment of chronic non-infectious intermediate uveitis, posterior uveitis, or panuveitis is considered not medically necessary as updated 05/13/2026; this exclusion applies notwithstanding other coverage statements in the document.

Federal and State law, and any specific contract provisions or exclusions in the member's health insurance contract, take precedence over this medical policy. Coverage determinations must first follow applicable contract language and legal requirements before applying the policy's coverage statements.

For Xipere, the policy requires a prior trial and documented failure (intolerance or inadequate response) of triamcinolone intravitreal injections 4 mg (Triesence) unless there is clinical evidence or history that Triesence would be ineffective or cause an adverse reaction. If the Triesence trial criterion is not met, Xipere is considered not medically necessary.

Evidence summaries for some fluocinolone 0.18/0.19 mg trials note limitations such as reliance on imputed recurrence events and inconsistent findings between pivotal trials; these evidence limitations reduce confidence in some outcome estimates and are considered when defining coverage scope.

Comparative evidence summarized in the policy indicates that corticosteroid implants may be less favorable than anti-VEGF therapy for retinal vein occlusion–related macular edema with respect to letters gained and with higher rates of ocular adverse events (eg, intraocular pressure elevation and cataract), supporting preference for anti-VEGF as first-line therapy in many cases.

The fluocinolone acetonide 0.59 mg implant (Retisert) is not indicated for diabetic macular edema and is considered not medically necessary for DME because trials demonstrated high rates of adverse events (notably cataract surgery and elevated intraocular pressure) relative to available alternatives.

Randomized trials adding dexamethasone implants to anti-VEGF therapy for diabetic macular edema or neovascular AMD showed reductions in retinal thickness but did not demonstrate consistent visual acuity benefit and were associated with increased intraocular pressure events; therefore routine addition of dexamethasone implants to anti-VEGF therapy is not supported by the RCT evidence.

Many therapies for non-uveitic indications are supported only by case reports, small case series, or retrospective cohorts with mixed results; absent randomized data, these uses are considered investigational or not medically necessary when submitted without stronger evidence.

The policy explicitly states that the concurrent use of both Yutiq and Iluvien for the treatment of chronic non-infectious intermediate uveitis, posterior uveitis, or panuveitis is considered not medically necessary per the updated committee decision.

Services that are primarily for personal comfort or convenience, or that are more costly than an alternative service likely to produce equivalent results, do not meet the policy definition of medically necessary and are not covered under this policy.

Coding and Billing References

Products mentionedmixed

Retisert 0.59 mg	fluocinolone acetonide intravitreal implant 0.59 mg
Iluvien 0.19 mg	fluocinolone acetonide intravitreal implant 0.19 mg
Yutiq 0.18 mg	fluocinolone acetonide intravitreal implant 0.18 mg
Ozurdex 0.7 mg	dexamethasone intravitreal implant 0.7 mg
Xipere 4 mg	triamcinolone suprachoroidal injection 4 mg
Triesence 4 mg	triamcinolone intravitreal injection 4 mg (alternative intravitreal product)

No explicit CPT/HCPCS/ICD-10/NDC codes listed in this excerptmixed

No codes listed

Coding notedmixed

Not listed

No CPT/HCPCS/ICD codes provided in this document excerpt

Policy identifiers included in documentmixed

Policy #00549

Intravitreal and Suprachoroidal Corticosteroid Products

Covered CPT Codes (examples listed)CPT

67027	Intravitreal injection procedure (CPT) listed in policy
67028	Intravitreal injection procedure (CPT) listed in policy
67516	Vitrectomy or related retinal surgery code (CPT) listed in policy

HCPCS codes referencedHCPCS

J7311	Injection, dexamethasone intravitreal implant, 0.35 mg (HCPCS) - listed
J7312	Injection, dexamethasone intravitreal implant, 0.7 mg (HCPCS) - listed
J7313	Fluocinolone acetonide intravitreal implant HCPCS - listed
J7314	Fluocinolone acetonide intravitreal implant HCPCS - listed
J3299	Unclassified drug or biological (HCPCS) - listed

ICD-10 DiagnosisICD-10

All Related Diagnoses

Policy states 'All Related Diagnoses' for ICD-10 diagnosis listing

CPTCPT

67027
67028
67516

HCPCSHCPCS

J7311
J7312
J7313
J7314
J3299

ICD-10 DiagnosisICD-10

All Related Diagnoses

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization — general note

Prior authorization requirements vary by product and are not always explicitly listed in the excerpt. When prior authorization is required it is implied by coverage criteria and medical necessity rules; if no PA list is present, verify benefits and PA rules with the payer before scheduling treatment.

Prior authorization not specified in excerpt — confirm with payer and member benefits prior to service.
Prior authorization is implied where coverage criteria/medical necessity language apply.

Prior Authorization

Fluocinolone (0.19 mg) — prior authorization recommended

Iluvien (fluocinolone acetonide 0.19 mg) carries a restricted indication: coverage is considered for DME only in patients previously treated with corticosteroids who did not have a clinically significant rise in intraocular pressure. Prior authorization is recommended to document prior steroid exposure and IOP response.

Document prior corticosteroid course and absence of clinically significant IOP rise.

Background and Clinical Rationale

Intravitreal implants and suprachoroidal injections provide sustained local corticosteroid delivery to treat posterior segment inflammation and macular edema while limiting systemic exposure. Ozurdex, Iluvien, Retisert, Yutiq and Xipere are examples of devices and formulations that deliver corticosteroid to the vitreous or suprachoroidal space; all routes carry risks including cataract formation and intraocular pressure elevation and selection should consider indication-specific evidence and safety profiles.

Definitions and Key Terms

Intravitreal implant — definition and examples

DefinitionA device placed into the vitreous cavity that releases corticosteroid continuously over months to years to provide sustained intraocular drug delivery.

Examples (nonbiodegradable & biodegradable)Retisert (fluocinolone acetonide 0.59 mg), Iluvien (fluocinolone acetonide 0.19 mg), Ozurdex (dexamethasone 0.7 mg), Yutiq (fluocinolone 0.18 mg).

PurposeIntended to reduce posterior-segment inflammation and macular edema while decreasing frequency of intravitreal injections or systemic therapy.

Suprachoroidal injection — definition and example

DefinitionInjection of drug into the suprachoroidal space (between sclera and choroid) to deliver medication directly to the choroid and retina.

Example product and dose

Policy Revision History

2026-05-13Material policy changeLatest

Medical Policy Implementation Committee approved updated criteria clarifying that use of Yutiq and Iluvien for chronic non-infectious intermediate, posterior, or panuveitis is not medically necessary; literature updated.

2022-05-11Non-material change

Medical Policy Implementation Committee approved addition of Xipere and changed the policy title to include suprachoroidal injections (title changed from 'Intravitreal Corticosteroid Implants' to 'Intravitreal and Suprachoroidal Corticeroid Products').

Policy Summary

PayerBlue Cross Blue Shield - Louisiana

PolicyIntravitreal and Suprachoroidal Corticosteroid Products

Policy CodePolicy 00549

Change TypeNot medically necessary updateproduct additions and title change (material update)

Effective Date08/01/2026

Next Review Date05/2027

Key ActionObtain and document prior authorization with evidence of prior therapies (including required trial of triamcinolone for Xipere) and baseline lens/IOP status.

SourceLink

On This Page

Coverage aligned to trial populations showing BCVA improvement at 24 weeks.

Adverse events: Intravitreal corticosteroids are associated with increased risks of elevated intraocular pressure and cataract progression/surgery compared with sham or anti-VEGF, with rates varying across products and trials.

Document baseline lens status and IOP history when selecting therapy.

Combination implant plus laser showed transient benefit at 9 months but not at 12 months; use should weigh increased cataract and IOP risks and be limited to select patients.

consider for select patients; evidence limited

One multicenter RCT found benefit at 9 months but not 12 months and higher adverse events.

Other indications (birdshot retinochoroidopathy, cystoid macular edema related to retinitis pigmentosa, idiopathic macular telangiectasia type 1): Typically investigational or limited coverage due to lack of RCT evidence or only small trials/case series with mixed results; long-term efficacy and safety not established.lack of RCT evidence or only small studies

No large RCTs identified for many of these indications.

Long-term efficacy and safety data limited.

Circumscribed Choroidal Hemangioma and Proliferative Vitreoretinopathy: Insufficient RCT evidence; available evidence is limited to case reports/series and does not support routine coverage.

Consider investigational status absent stronger evidence.

Radiation Retinopathy: No RCTs identified; observational studies report anatomic improvements with mixed visual outcomes; RCTs are needed before routine coverage.

Consider case-by-case with supportive documentation.

Indicate indication: diabetic macular edema (DME) and prior steroid tolerance.

Prior Authorization

Dexamethasone implant (Ozurdex) — prior authorization recommended

For intravitreal dexamethasone implant (Ozurdex 0.7 mg) prior authorization is recommended to document the indication, prior therapies tried, and baseline lens status and IOP monitoring plan.

Document diagnosis (uveitis, RVO-related macular edema, or DME) and prior anti-VEGF or laser if applicable.
Provide baseline lens status (phakic vs pseudophakic) and plan for IOP and cataract monitoring.
If combined with anti-VEGF, document rationale given limited VA benefit and higher IOP risk.

Prior Authorization

Prior authorization may be required — coding triggers

Certain codes and services associated with intravitreal or suprachoroidal steroid products may trigger prior authorization depending on payer rules. Providers should expect that CPT/HCPCS/J‑codes listed in the policy could require PA.

Potentially affected codes include CPT 67027, 67028, 67516; HCPCS J7311–J7314, J3299.
Confirm PA requirements for injected drug or implant codes with the payer prior to billing.

Prior Authorization

Prior plan authorizations — 90‑day transition

When a member switches health plans, prior plan authorizations for an ongoing course of treatment may be honored for a 90-day transition period if documentation of the prior authorization is provided and the service is covered under the new plan.

Provide documentation of the prior plan's authorization to Louisiana Blue within the 90‑day transition window.
This transition provision does not apply to medications covered under the pharmacy benefit.

Step Therapy

Xipere (suprachoroidal triamcinolone) — step therapy / prior trial required

For Xipere (suprachoroidal triamcinolone 4 mg) the policy requires a prior trial and failure (intolerance or inadequate response) of intravitreal triamcinolone injections (Triesence) unless contraindicated; document the trial and outcome when seeking coverage.

Document prior intravitreal triamcinolone (Triesence) trial: dose, dates, and reason for failure/intolerance.
Note dosing limit for Xipere: not to exceed 4 mg every 12 weeks per impacted eye.

Documentation Required

Off‑label use (triamcinolone for DME) — document justification

Intravitreal triamcinolone (off‑label) is noted as an alternative adjunctive therapy for DME; when used off‑label document the rationale and prior standard therapies tried (eg, tight glycemic/BP control, laser, anti‑VEGF).

Explicitly state when intravitreal triamcinolone is being used off‑label for DME and why other standard therapies were insufficient.
Include prior anti‑VEGF, laser, and systemic control measures in documentation.

Note

PA lists and billing triggers — not fully specified in excerpt

The excerpt does not provide an exhaustive list of PA triggers or denial codes; providers should not assume absence of PA requirements and must verify payer-specific PA and billing rules.

No explicit PA code lists provided in the excerpt — verify with payer policy/PA portal.
Do not rely solely on the policy text when scheduling services that may require authorization.

Documentation Required

Safety and monitoring — required documentation

Corticosteroid implants and injections have notable safety risks (eg, elevated intraocular pressure, glaucoma surgery, cataract requiring extraction, vitreous hemorrhage). Prior authorization should include documentation of baseline IOP, prior steroid response, and a monitoring plan.

Document baseline intraocular pressure and history of steroid‑induced IOP elevation.
Include plan for IOP monitoring and cataract management (especially for phakic eyes).
Highlight prior adverse ocular events that would influence treatment selection.

Denial Risk

Denial risk for combined therapy without demonstrated benefit

Combination therapy of dexamethasone implant plus anti‑VEGF may reduce retinal thickness but has not demonstrated additional visual acuity benefit and increases IOP risk; include supporting clinical rationale if submitting for combined therapy.

If requesting combination therapy, document prior anti‑VEGF response and why added steroid is needed.
Be aware of higher intraocular pressure risk when combining steroid implant with anti‑VEGF.

Denial Risk

Insufficient evidence for non‑uveitic indications — expect denial without robust support

Evidence is limited or insufficient for many non‑uveitic or less‑studied indications (eg, idiopathic macular telangiectasia type 1). For such indications, prior authorization should include high‑quality supporting evidence; otherwise coverage may be denied as not medically necessary.

Provide RCT data or peer‑reviewed literature when requesting coverage for non‑uveitic indications.
If evidence is scant, expect requests for additional documentation or potential denial.

Denial Risk

Denial for lack of medical necessity — follow policy criteria

Services or uses that do not meet the policy's definition of medical necessity or Company requirements (eg, failure to meet Xipere's prior‑trial criterion) will be denied as not medically necessary. Ensure all Company‑specified patient selection criteria are met and documented.

Verify and document that the requested service meets the policy's medical necessity criteria.
For Xipere, omission of the prior‑trial requirement will result in denial as not medically necessary.

Documentation Required

General documentation expectations

General documentation expectations: demonstrate member benefits, medical necessity, and adherence to Company patient selection criteria. Include diagnosis, prior therapies, treatment chronology, and objective outcome measures.

Provide member contract/benefit verification when submitting requests.
Include clear chronology of prior treatments and responses (dates, agents, doses).
Supply objective measures (BCVA, OCT central subfield thickness, IOP readings) and duration/chronicity where relevant.

Documentation Required

Clinical evidence to document

Clinical evidence to include with prior authorization requests: pivotal trial outcomes, recurrence‑rate data for uveitis, duration/chronicity of disease (eg, ≥1 year for chronic uveitis), and subgroup data when relevant (eg, pseudophakic vs phakic outcomes).

For uveitis, include recurrence rates from pivotal trials and duration of disease (>=1 year when applicable).
For fluocinolone implants, include relevant trial results and subgroup analyses (IOP and cataract risk).

Documentation Required

Required clinical outcome documentation

Required clinical outcome documentation: provide primary and secondary efficacy endpoints from pivotal trials when available (eg, BCVA change, recurrence rates) and any observed safety outcomes relevant to the member (eg, IOP elevation, cataract surgery).

Include BCVA change (letters), recurrence rates, and time to first recurrence for uveitis when applicable.
Document any prior or expected adverse ocular events and management plans.

Documentation Required

Required clinical documentation elements

Required clinical documentation elements include: diagnosis with laterality, disease chronicity, prior treatment details (agents, dates, responses), baseline ocular status (phakic/pseudophakic), and baseline objective measures (BCVA, OCT thickness, IOP).

Specify laterality (right, left, bilateral) and exact diagnosis (eg, macular edema due to uveitis, DME, RVO).
Include prior anti‑VEGF/laser history where applicable and response to prior steroids.

Documentation Required

Uveitic macular edema — required documentation for Xipere

For macular edema associated with uveitis (Xipere), include clear documentation of the diagnosis, prior therapies tried for uveitis and macular edema, and the clinical rationale for choosing suprachoroidal delivery.

Document diagnosis: macular edema associated with anterior/intermediate/posterior/panuveitis.
List prior therapies (topical, periocular, intravitreal steroids, systemic therapy) and responses/limitations.

Billing Rule

Coding and documentation — billing guidance

Coding and documentation: use the CPT and HCPCS codes referenced in the policy when submitting claims and include supporting clinical documentation with PA requests. Verify NDC or J‑code requirements for drug administration versus pharmacy coverage.

Common procedure codes: CPT 67027, 67028, 67516.
Common HCPCS/J‑codes: J7311–J7314, J3299. Confirm specific J‑code applicability and payer billing pathway (medical vs pharmacy).

Prior Authorization

Transition authorization documentation — actions

Transition authorization documentation: if relying on a prior plan authorization during the 90‑day transition period, provide the previous plan's authorization documentation with the request and confirm the service is covered under Louisiana Blue's in‑network benefits.

Submit prior plan authorization documentation with the PA request to Louisiana Blue within 90 days.
Ensure the ongoing course of treatment aligns with Louisiana Blue coverage rules; pharmacy benefits excluded from this provision.

Step Therapy

Stepwise therapy context — treatment sequencing

Stepwise therapy context: first‑line management includes systemic control (glycemic and blood pressure), laser photocoagulation for appropriate patients, and anti‑VEGF agents as preferred first‑line therapy for many causes of macular edema. Steroid implants/injections are often second‑line when anti‑VEGF or laser are inadequate or contraindicated.

Document attempts at systemic optimization and prior laser or anti‑VEGF therapy when applicable.
For RVO and DME, expect anti‑VEGF to be considered first‑line; document rationale for steroid selection if used earlier.

Step Therapy

Consider prior anti‑VEGF/laser — document trial and response

Consider prior anti‑VEGF or laser therapy when selecting steroid implants: prior use and response should be included in the PA request, as steroid implants are typically considered when those therapies are inadequate or contraindicated.

Provide dates, agents, and clinical response to prior anti‑VEGF or laser photocoagulation.
If anti‑VEGF was not tried, provide clinical justification (contraindication, intolerance, refractory disease).

Step Therapy

Step therapy preference for DME — anti‑VEGF first‑line

For diabetic macular edema (DME), anti‑VEGF therapy is the preferred first-line treatment; intravitreal dexamethasone implants may be appropriate for certain scenarios (eg, pseudophakic patients, anti‑VEGF nonresponders) and should be justified in the PA documentation.

If requesting steroid implant for DME, document prior anti‑VEGF therapy and response unless a clear contraindication exists.
Note phakic status: phakic patients have higher cataract risk and may have different expected outcomes.

Xipere — triamcinolone suprachoroidal injection, 4 mg (effects last ~12 weeks).

Alternative/related productTriesence (triamcinolone 4 mg) is an intravitreal triamcinolone product sometimes used as an alternative; not studied head-to-head with Xipere.

Macular edema / Diabetic macular edema (DME) — definition summary

DefinitionFluid accumulation in the central macula causing vision loss due to breakdown of the blood–retinal barrier; when caused by diabetes it is termed diabetic macular edema (DME).

Clinical significanceDME is a leading cause of moderate vision loss in people with diabetes; management includes glycemic/blood pressure control, laser, anti-VEGF, and adjunctive corticosteroids.

Trial populationsRandomized trials include treatment‑naive, chronic, and refractory DME populations; dexamethasone and fluocinolone implants have RCT evidence in DME.

Age-related macular degeneration (AMD) — definition summary

DefinitionDegenerative retinal disease causing central vision loss; exists as dry (atrophic) and wet (exudative/neovascular) forms, with wet AMD characterized by choroidal neovascularization.

Standard therapyWet AMD is primarily treated with intravitreal anti‑VEGF injections; corticosteroid implants are not primary therapy for AMD.

Clinical featuresWet AMD may present with serous or hemorrhagic detachment of the retinal pigment epithelium and carries high risk of severe irreversible vision loss.

BCVA — best-corrected visual acuity definition

DefinitionBest‑corrected visual acuity (BCVA) — the best visual acuity achieved with refractive correction, commonly measured using ETDRS letter scores in trials.

Use in trialsBCVA is a primary efficacy endpoint in pivotal RCTs (e.g., proportion gaining ≥15 ETDRS letters).

AbbreviationAlso referenced as VA or ETDRS in the policy tables and outcomes.

PSV-FAI-005 — trial identifier definition

DefinitionPSV‑FAI‑005 — a multicenter, controlled safety and efficacy study of a fluocinolone acetonide intravitreal insert in subjects with chronic non‑infectious posterior uveitis.

ContextReferenced in evidence summaries assessing fluocinolone implants and recurrence outcomes.

PurposeUsed to evaluate long‑term recurrence rates and safety of intravitreal fluocinolone implants.

DME (Diabetic Macular Edema) — definition and trial populations

DefinitionDiabetic macular edema (DME) — macular edema secondary to diabetes mellitus; trial populations include treatment‑naive, chronic (≥3 years in some subgroups), and refractory DME.

Trial evidenceFluocinolone 0.19 mg (ILUVIEN) demonstrated superiority over sham in two RCTs with durable benefit at 2–3 years; dexamethasone 0.7 mg also has RCT evidence for DME.

Subgroup findingsILUVIEN showed greater benefit in pseudophakic and chronic DME subgroups.

Pseudophakic vs Phakic — lens status influences efficacy and safety

DefinitionPseudophakic — eye with an intraocular lens implant after cataract extraction; Phakic — eye with native crystalline lens.

Clinical influencePseudophakic patients tend to experience greater visual‑acuity benefit from steroid implants; phakic patients have much higher rates of cataract development after implants (≈80% reported).

Safety considerationsPhakic status is associated with higher cataract risk and may influence choice of implant and counseling.

BCVA / VA / ETDRS — visual acuity measurement definitions

BCVA/VA/ETDRSBCVA (best‑corrected visual acuity) measured using ETDRS letter scores is the standard visual‑acuity metric in trials; VA improvements often reported as ≥15‑letter gains.

UsageETDRS scores used as primary efficacy endpoints in DME and uveitis trials (e.g., 15‑letter improvement at 2 years for ILUVIEN).

AbbreviationsVA = visual acuity; ETDRS = Early Treatment Diabetic Retinopathy Study letter score.

CMT / CFT — OCT measurements for retinal edema

DefinitionsCMT (central macular thickness) / CFT (central foveal thickness) — OCT‑measured retinal thickness metrics used to quantify macular edema.

Clinical roleCMT/CFT reductions are commonly reported as anatomic outcomes in trials; they do not always correlate with sustained visual‑acuity benefit.

Measurement modalityMeasured by optical coherence tomography (OCT) in clinical trials and practice.

Postoperative chronic macular edema (Irvine-Gass) — definition

DefinitionPostoperative chronic macular edema (pseudophakic cystoid macular edema, Irvine‑Gass syndrome) — persistent macular edema following cataract surgery thought to arise from postoperative inflammatory mediators.

Clinical impactA common cause of visual loss after cataract surgery; may be refractory and require intravitreal therapies.

EvidenceSmall RCTs and case series assess dexamethasone implants versus triamcinolone for refractory postoperative CME.

Radiation retinopathy — definition

DefinitionRadiation retinopathy — delayed, slowly progressive retinal damage occurring months after exposure to ionizing radiation (e.g., plaque brachytherapy).

Evidence statusNo RCTs identified for corticosteroid implants; evidence limited to retrospective studies and case series reporting anatomic improvements and mixed VA results.

Clinical courseOften slowly progressive; management reported in small retrospective series using dexamethasone implants.

Intravitreal implant — repeated entry for definition/examples

DefinitionA device placed into the vitreous cavity that releases corticosteroid continuously over months to years to provide sustained intraocular drug delivery.

ExamplesRetisert (0.59 mg), Iluvien (0.19 mg), Yutiq (0.18 mg), Ozurdex (0.7 mg).

PurposeUsed to treat posterior‑segment inflammation and macular edema while aiming to reduce systemic exposure and injection frequency.

Suprachoroidal injection — repeated definition (Xipere)

DefinitionInjection into the suprachoroidal space to deliver drug to the choroid and retina.

ExampleXipere (triamcinolone suprachoroidal injection 4 mg) — effects last approximately 12 weeks.

AlternativeTriesence (4 mg intravitreal triamcinolone) is an intravitreal alternative; not studied head‑to‑head with Xipere.

Medically Necessary — policy definition

DefinitionMedically Necessary — health care services that a provider, exercising prudent clinical judgment, would provide to prevent, evaluate, diagnose or treat an illness, injury, disease or its symptoms and that meet criteria A–C detailed in the policy (in accordance with nationally accepted standards; clinically appropriate in type, frequency, extent, level of care, site and duration; not primarily for comfort/convenience and not more costly than an alternative likely to produce equivalent results).

Criteria basisDetermination relies on peer‑reviewed literature, specialty society recommendations, expert opinion, and federal regulations where applicable.

Policy applicationServices not meeting this definition (or not consistent with contract provisions) may be denied as not medically necessary.