CurrentAvMedPolicy Pub. 100-2

Ophthalmic Corticosteroid Injections Prior Authorization

Prior authorization and step-edit requirements for ophthalmic corticosteroid injections (Ozurdex, Iluvien, Xipere) for AvMed members, including documentation, clinical criteria, quantity limits, and reauthorization conditions. Applies to providers requesting coverage for these drugs under AvMed plans.

Policy Summary

PayerAvMed

PolicyOphthalmic Corticosteroid Injections Prior Authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with complete documentation including prescriber signature, diagnosis, dosing, laterality, and supporting labs/notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3drugs/formulations listed

1/4moOzurdex limit

1/36moIluvien limit

1/12wkXipere limit

12 moauthorization length

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Product-specific initial authorization criteria

Covered when ALL of the following are met for the selected product (product-specific differences noted):

Indication: Member diagnosed with one of the allowed indications: macular edema following BRVO or CRVO, non-infectious posterior uveitis, diabetic retinopathy, or other specified indication.

Age: Member is at least 18 years of age (product-specific).

Infection status: Member does NOT have any ocular or periocular infections (including active ocular herpes simplex for Xipere).

Glaucoma/IOP: Member does NOT have glaucoma or use medications to treat glaucoma (Iluvien: no glaucoma with cup-to-disc ratio > 0.8; Xipere: no untreated intraocular pressure or uncontrolled glaucoma).

Diabetes control: Member does NOT have uncontrolled diabetes (A1c > 10%).

Prior corticosteroid exposure: Medication will NOT be used in combination with other sustained-release intravitreal corticosteroids; product-specific lookback periods apply (e.g., Xipere: no dexamethasone within prior 4 months; no fluocinolone within prior 30–36 months).

Baselines/monitoring: Baseline best corrected visual acuity (BCVA) and intraocular pressure must be measured and documented; periodic BCVA and IOP monitoring will occur during treatment.

Contraindication to anti-VEGF: For Ozurdex and Iluvien approvals, member has a contraindication to bevacizumab intravitreal injection.

Reauthorization criteria

Reauthorization covered when ALL of the following are met:

Response: Member has experienced disease response indicated by improvement of best corrected visual acuity (BCVA) compared to baseline.

Safety: Member has NOT experienced serious side effects related to toxicity (e.g., increased intraocular pressure, endophthalmitis, conjunctival hemorrhage) and has not had loss of visual acuity from baseline.

Timing since prior dose: Minimum interval since last administration met (Iluvien: at least 12 months since last Iluvien; Xipere: at least 4 months since last Xipere; Ozurdex: quantity limit of 1 implant per eye every 4 months).

Use of two or more sustained‑release ophthalmic corticosteroid products in combination (for example Dextenza, Ozurdex, Iluvien, Retisert, Xipere, or Yutiq) is considered experimental/investigational and will not be permitted. If a member already has an active authorization on file for any of these agents, requests for an additional ophthalmic corticosteroid injection will not be approved. Incomplete or illegible request information may delay authorization decisions, so submit complete documentation with the prescribing physician’s signature as required on the prior authorization form.

Requests that do not meet the specified indication, documented baseline measurements, or safety exclusions will be considered not medically necessary. Specifically, approval requires documentation of the applicable indication (e.g., macular edema related to non‑infectious uveitis or retinal vein occlusion), a recorded baseline best corrected visual acuity (BCVA), and evidence of required baseline safety assessments (for example absence of ocular or periocular infections and no untreated or uncontrolled glaucoma).

Additional denials or delays may occur when supporting documentation is missing; to avoid this, include lab results, diagnostic reports, chart notes, and the completed prior authorization form showing product, dose, laterality, and prescriber signature. Requests that violate product‑specific prior therapy lookback periods (for example dexamethasone within the prior 4 months or fluocinolone within the prior 30–36 months) or exceed quantity limits will not meet medical necessity criteria.

Coding and Billing

Covered HCPCS codesHCPCSCovered

J7312	Ozurdex (dexamethasone intravitreal implant)
J7313	Iluvien (fluocinolone acetonide intravitreal implant)
J3299	Xipere (triamcinolone acetonide injectable suspension) - miscellaneous injectable

Covered NDC codesNDCCovered

NDC 00023-3348-xx	Ozurdex NDC
NDC 68611-0190-xx	Iluvien NDC
NDC 71565-0040-xx	Xipere NDC

inv-06: A1c threshold — Member does NOT have uncontrolled diabetes (A1c > 10%)

A1c thresholdMember must NOT have uncontrolled diabetes defined as A1c > 10%.

Where appliedRequired for initial authorization across listed products (documented on initial authorization checklists).

Reauthorization considerationReauthorization requires continued absence of uncontrolled diabetes as part of safety monitoring.

inv-07: Intraocular pressure history threshold — No history of steroid-induced increased IOP > 23 mmHg in treatment eye(s)

IOP history thresholdNo history of steroid-induced increased intraocular pressure (IOP > 23 mmHg) in the treatment eye(s).

Where appliedRequired on product-specific initial authorization checklists (e.g., Ozurdex, Iluvien, Xipere).

Related safety exclusionMember must not have untreated intraocular pressure or uncontrolled glaucoma per Iluvien/Xipere criteria.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the ophthalmic corticosteroid injections listed below. Requests will be reviewed only when the prescribing physician has signed and clearly printed their name on the request form (preprinted stamps are not valid). Authorization may be delayed or denied if the form is incomplete, illegible, or missing required supporting documentation (including pertinent chart notes, diagnostics, and baseline measurements).

Affected agents: Ozurdex (J7312), Iluvien (J7313), Xipere (J3299)
Fax required: 1-877-535-1391
Medicare members: CMS NCDs/LCDs and Pub. 100-2 Chapter 15 §50 apply where relevant

Step Therapy

Step/Sequence and Prior Therapy Requirements

For Ozurdex and Iluvien, prior authorization approvals require demonstration of step/sequence and prior therapy considerations. Specifically, Iluvien approvals require that the member has a contraindication to bevacizumab intravitreal injection. Members must not have received specified sustained‑release intravitreal corticosteroids within the listed washout periods before approval.

Iluvien: member must have a contraindication to bevacizumab intravitreal injection
Do not approve if member received dexamethasone (Ozurdex) within prior 4 months
Do not approve if member received fluocinolone (Retisert) within prior 30 months or Iluvien/Yutiq within prior 36 months

Documentation Required

Provider Signature and Required Fields

Prescribing physician signature and printed name are required on the prior authorization request (preprinted stamps are not acceptable). All required request fields should be completed; office staff may complete other fields but missing or incorrect contact information (phone/fax) can delay processing.

Prescribing physician must sign and clearly print name on form (preprinted stamps not valid)
Ensure phone and fax numbers are correct on the request form to avoid processing delays
Provide baseline BCVA and intraocular pressure measurements when requested

Denial Risk

Active Authorization / Concomitant Therapy Exclusion

Requests for an additional ophthalmic corticosteroid injection will NOT be approved when there is an active authorization on file for Dextenza, Ozurdex, Iluvien, Retisert, Xipere, or Yutiq. The use of concomitant therapy with these sustained‑release intravitreal corticosteroids is considered experimental/investigational and will not be permitted.

Do not submit additional ophthalmic corticosteroid request if member has an active authorization for Dextenza, Ozurdex, Iluvien, Retisert, Xipere, or Yutiq
Concomitant use of two sustained‑release intravitreal corticosteroids is not allowed

Definitions and Operational Thresholds

inv-14: Best corrected visual acuity (BCVA) — Baseline and periodic measurements required for initiation and reauthorization decisions

BCVA measurement requirementBaseline best corrected visual acuity (BCVA) must be measured and documented prior to initiation.

Periodic monitoringBCVA must be measured periodically during treatment and documented for reauthorization evaluations.

Role in decisionsImprovement in BCVA compared to baseline is used to demonstrate response for reauthorization (specified for some products).

inv-15: Quantity limit / billable units — Each product has specified billable unit conversion and quantity limit per eye

Ozurdex billable conversion & limit1 implant = 7 billable units; quantity limit: 1 implant per eye every 4 months.

Iluvien billable conversion & limitProduct-specific conversion with quantity limit: 1 implant per eye every 30–36 months (policy lists 36 months for Iluvien).

Xipere billable conversion &limit1 single dose vial (SDV) = 36 billable units; quantity limit: 1 vial per eye every 12 weeks.

OpenPayer

Ophthalmic Corticosteroid Injections Prior Authorization

Coverage Criteria

Coding and Billing

Provider Actions and Requirements

Definitions and Operational Thresholds

Background