ModifiedMolina HealthcarePolicy C11728-A

Iluvien (fluocinolone acetonide intravitreal implant) Coverage Criteria

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This policy governs Molina Healthcare coverage and prior authorization requirements for Iluvien administered for diabetic macular edema or non-infectious posterior uveitis. Coverage depends on benefit eligibility, documented medical necessity, applicable clinical criteria, and required provider documentation.

Policy Summary

PayerMolina Healthcare

PolicyIluvien (fluocinolone acetonide intravitreal implant)

Policy CodePolicy C11728-A

Change TypeModified

Effective DateDec 1, 2025

Next Review DateOct 1, 2025

Key ActionSubmit complete medical rationale and supporting clinical documentation with every prior authorization request.

SourceLink

POLICY UPDATE CHANGES

A prior revision broadened criterion 3a from requiring intravitreal triamcinolone acetonide injection to requiring a previous course of corticosteroid.

The annual review states that no coverage-criteria changes were made.

The policy history records updates to the required medical information and coding/billing information templates.

The policy was converted to the MCP format and references were updated during prior policy reviews.

2Covered diagnosis categories

36 monthsContinuation interval

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ModifiedMolina HealthcarePolicy C11728-A

Iluvien (fluocinolone acetonide intravitreal implant) Coverage Criteria

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Policy Summary

PayerMolina Healthcare

PolicyIluvien (fluocinolone acetonide intravitreal implant)

Policy CodePolicy C11728-A

Change TypeModified

Effective DateDec 1, 2025

Next Review DateOct 1, 2025

Key ActionSubmit complete medical rationale and supporting clinical documentation with every prior authorization request.

SourceLink

POLICY UPDATE CHANGES

A prior revision broadened criterion 3a from requiring intravitreal triamcinolone acetonide injection to requiring a previous course of corticosteroid.

The annual review states that no coverage-criteria changes were made.

The policy history records updates to the required medical information and coding/billing information templates.

The policy was converted to the MCP format and references were updated during prior policy reviews.

2Covered diagnosis categories

36 monthsContinuation interval

1 per eyeUveitis quantity limit

18+Minimum uveitis age

2FDA-approved indications

Coverage Criteria

Initial Therapy — Diabetic Macular Edema

Covered for initial therapy when ALL of the following criteria are met:

ALL of the following

Documented diagnosis of diabetic macular edema (DME).
Documentation of baseline visual status with notation of the eye being treated.
Documentation required.
ONE of the following
- Documentation of an inadequate response, defined as 1-2 injections with minimal to no improvement, clinically significant adverse effects, or contraindication to bevacizumab.
- Bevacizumab is indicated by the provider as unavailable, with documentation of an inadequate response, serious side effects, or contraindication to ranibizumab.
Documentation of an inadequate response to an appropriate trial of intravitreal glucocorticoids, such as triamcinolone.
Member was previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
Prescriber attests, or clinical reviewer has found, that Iluvien will not be administered simultaneously by bilateral implantation.
Simultaneous bilateral implantation should not be performed because corticosteroid-related reduction in resistance to infection may increase the potential for bilateral postoperative infection.
Prescriber attests, or clinical reviewer has found, that the member does not have any FDA-labeled contraindications that have not been addressed in the submitted documentation.
Contraindications include ocular or periocular infections, glaucoma, and hypersensitivity to any component of Iluvien.

Initial Therapy — Non-Infectious Posterior Uveitis

Covered for initial therapy when ALL of the following criteria are met:

ALL of the following

Documented diagnosis of non-infectious posterior segment uveitis.
Documentation of the member's baseline best-corrected visual acuity (BCVA) to measure efficacy, with notation of the eye or eyes being treated.
Documentation of an inadequate response, including an appropriate trial period, serious side effects, or contraindication to formulary topical glucocorticoids, an intravitreal steroid (e.g., triamcinolone or dexamethasone), or a systemic corticosteroid.
Documented trial and failure, serious side effects, or contraindication to an antimetabolite (e.g., methotrexate, azathioprine, or mycophenolate) or a calcineurin inhibitor (e.g., cyclosporine or tacrolimus).
Member was previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

Continuation Therapy — Diabetic Macular Edema

Covered for continuation therapy when ALL of the following criteria are met:

ALL of the following

Reauthorization is requested for the same eye as the initial authorization, and at least 36 months have passed since the last Iluvien administration.
Continuation criteria apply only to the same previously treated eye. If the condition develops in an untreated eye, submit a new request meeting all initial coverage criteria.
Documentation of improvement or stabilization of the disease state, such as macular edema, and visual status.
Documentation required.
Prescriber attests that the member is likely to benefit from retreatment without being exposed to significant risk, according to the prescriber's clinical judgment.
Prescriber attests, or clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity, such as cataracts, increased intraocular pressure, hypotony, or endophthalmitis.

Continuation Therapy — Non-Infectious Posterior Uveitis

Covered for continuation therapy when ALL of the following criteria are met:

ALL of the following

Reauthorization is requested for the same eye as the initial authorization, and at least 36 months have passed since the last Iluvien administration.
Continuation criteria apply only to the same previously treated eye. If the condition develops in an untreated eye, submit a new request meeting all initial coverage criteria.
At least ONE positive treatment response is documented
- Lack of recurrence.
- An increase of greater than 15 letters, or 3 lines, in BCVA from baseline.
- The member achieved driving visual acuity.

Uveitis Authorization Parameters

For non-infectious posterior uveitis, ALL of the following authorization parameters apply:

ALL of the following

Authorization duration: initial authorization is 36 months; continuation authorization is 36 months.
Prescribed by, or in consultation with, a board-certified ophthalmologist, ophthalmic surgeon, retinal specialist experienced in administering intravitreal implants, or other specialist in uveal eye disease.
If prescribed in consultation, consultation notes must be submitted with the initial request and reauthorization requests.
Member is 18 years of age or older.>= 18 years
Quantity is limited to one implant per eye per 36 months.1 implant per eye per 36 months

FDA-Approved Indications

Iluvien is covered for either of the following FDA-approved indications:

ONE of the following FDA-approved indications

Treatment of diabetic macular edema (DME) in patients previously treated with a course of corticosteroids who did not have a clinically significant rise in intraocular pressure.
Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Coverage requires documentation of the applicable treatment history and clinical findings described in the initial and continuation criteria. Iluvien is not covered when ocular or periocular infection, glaucoma, or hypersensitivity to any component is present, unless the applicable contraindication has been addressed by the prescriber in the submitted documentation. The member must have been previously treated with corticosteroids without a clinically significant rise in intraocular pressure, as required for the applicable indication.

For diabetic macular edema, Iluvien must not be administered simultaneously by bilateral implantation.

All other uses of Iluvien are considered experimental or investigational and are subject to Molina's Off-Label policy.

Contraindications to Iluvien include ocular or periocular infections, glaucoma, and hypersensitivity to any component of the product.

Iluvien must not be administered with other intravitreal implants, including Ozurdex (dexamethasone intravitreal implant) and Retisert (fluocinolone acetonide intravitreal implant).

Molina Healthcare reserves the right to require additional documentation for coverage determination, quality improvement, and fraud, waste, and abuse prevention. Required documentation may include patient records, test results, and credentials of the provider ordering or performing the drug or service. Molina may deny reimbursement or take other appropriate action if the documentation does not support medical necessity, non-investigational status, and coverage within the member's benefits, or demonstrates inappropriate or excessive billing or other practice.

Coding and Billing

HCPCSHCPCS

J7313

Injection, fluocinolone acetonide intravitreal implant (Iluvien), 0.01 mg

Provider Requirements and Request Outcomes

Prior Authorization

Medical Rationale and Label-Based Review

When requesting an exception or coverage review, the provider must submit complete medical rationale. Medical necessity will be reviewed against the current FDA label, applicable state and federal requirements, the member's benefit, and formulary preferencing. If the FDA label was updated within the prior 180 days, Molina may use the updated labeling and determine coverage case by case until policy criteria are revised.

Additional information may be requested, including member-specific dosing data when applicable.

Prior Authorization

Qualified Prescriber Required

For non-infectious uveitis, Iluvien must be prescribed by or in consultation with a board-certified ophthalmologist, ophthalmic surgeon, retinal specialist experienced in intravitreal implants, or another specialist in uveal eye disease.

Prior Authorization

Policy Background

Iluvien is a long-acting ophthalmic steroid implant administered by intravitreal injection. This policy addresses its use for diabetic macular edema and non-infectious posterior segment uveitis, subject to requirements for prior treatment response, visual-status monitoring, intraocular-pressure risk assessment, and contraindication review.

Key Terms

Definition

Covered indicationDiabetic Macular Edema (DME) is a covered indication for Iluvien.

Definition

Covered indicationNon-infectious posterior uveitis is uveitis involving the posterior segment of the eye and is a covered indication for Iluvien.

Definition

Drug classIluvien is classified as an ophthalmic steroid.

Definition

Policy Summary

PayerMolina Healthcare

PolicyIluvien (fluocinolone acetonide intravitreal implant)

Policy CodePolicy C11728-A

Change TypeModified

Effective DateDec 1, 2025

Next Review DateOct 1, 2025

Key ActionSubmit complete medical rationale and supporting clinical documentation with every prior authorization request.

SourceLink

On This Page

Prescriber attests, or clinical reviewer has found, that the member does not have any FDA-labeled contraindications that have not been addressed in the submitted documentation.

Contraindications include ocular or periocular infections, glaucoma, and hypersensitivity to any component of Iluvien.

Visual acuity was maintained at least 50% of the best recorded visual acuity following diagnosis of uveitis.

Prescriber attests that the member is likely to benefit from retreatment without being exposed to significant risk, according to the prescriber's clinical judgment.

Prescriber attests, or clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity, such as cataracts, increased intraocular pressure, hypotony, or endophthalmitis.

The implant is administered in a place of service that is a non-hospital facility-based location.

Intravitreal injection medications in this policy are recommended for pharmacy or medical benefit coverage.

Adult Age Requirement

Coverage for Iluvien for non-infectious uveitis is limited to members who are 18 years of age or older.

Billing Rule

Quantity Limit

The quantity limit is one Iluvien implant per eye per 36 months for non-infectious uveitis.

Billing Rule

Administration and Benefit Setting

The implant is administered by ophthalmic intravitreal injection. It may be covered under the pharmacy or medical benefit, as applicable, and should be administered in a non-hospital facility-based place of service.

Step Therapy

DME Prior Therapy

For DME, documentation must show an inadequate response, clinically significant adverse effects, or a contraindication to bevacizumab. If bevacizumab is unavailable as documented by the provider, the record must instead show an inadequate response, serious side effects, or a contraindication to ranibizumab.

An inadequate response to bevacizumab is defined as 1–2 injections with minimal to no improvement.
Documentation must also support an inadequate response to an appropriate trial of intravitreal glucocorticoids, such as triamcinolone, and prior corticosteroid treatment without a clinically significant rise in intraocular pressure.

Documentation Required

DME Clinical Documentation

For DME, submit the documented diagnosis, baseline visual status, the eye being treated, and evidence supporting all required prior therapies and their outcomes, adverse effects, or contraindications.

The record must also address the requirement that Iluvien will not be administered simultaneously by bilateral implantation.

Step Therapy

Uveitis Prior Therapy

For non-infectious uveitis, coverage requires documentation of an inadequate response after an appropriate trial, serious side effects, or a contraindication to formulary topical glucocorticoids, an intravitreal steroid, or a systemic corticosteroid.

Documentation must also support a trial and failure, serious side effects, or contraindication to an antimetabolite or calcineurin inhibitor.
Prior corticosteroid treatment must not have caused a clinically significant rise in intraocular pressure.

Documentation Required

Medical Records and Provider Credentials

Molina may request patient records, test results, and credentials of the provider ordering or performing the drug or service. Submit records sufficient to support medical necessity, non-investigational status, and coverage under the member's benefit.

Documentation Required

Uveitis Clinical Documentation

For non-infectious uveitis, submit the documented diagnosis, baseline best-corrected visual acuity (BCVA), the treated eye or eyes, and documentation of required corticosteroid and immunomodulatory prior therapy.

The record must support the clinical response, serious side effects, or contraindication for each required prior treatment.

Documentation Required

Continuation Documentation

For reauthorization, document that the request is for the same previously treated eye and that at least 36 months have passed since the last Iluvien administration. A request for a newly affected untreated eye must meet all initial criteria.

For DME, document stabilization or improvement of the disease and visual status, likely benefit from retreatment, and no intolerable adverse effects or drug toxicity.
For uveitis, document positive response, such as lack of recurrence, more than 15 letters gained in BCVA, achievement of driving visual acuity, or maintenance of at least 50% of the best visual acuity recorded after diagnosis; also document likely benefit and no intolerable toxicity.

Documentation Required

Specialist Consultation Notes

When the prescription is issued in consultation, consultation notes must accompany the initial request and each reauthorization request.

Denial Risk

Unaddressed FDA Contraindication

Coverage may be denied when submitted documentation does not address an FDA-labeled contraindication. The prescriber must attest, or the clinical reviewer must find, that no contraindication remains unaddressed.

Contraindications include ocular or periocular infection, glaucoma, and hypersensitivity to any component of Iluvien.

Denial Risk

DME Criteria Not Met

A DME request may be denied when the diagnosis, baseline visual status, treated eye, or required prior therapy documentation is missing or does not support the policy criteria.

This includes failure to document required bevacizumab or, when applicable, ranibizumab therapy and the required intravitreal glucocorticoid trial.

Denial Risk

Uveitis Criteria Not Met

A non-infectious uveitis request may be denied when the disease diagnosis, baseline BCVA, treated eye or eyes, or required prior treatment documentation is missing or does not support the policy criteria.

Required prior treatment includes corticosteroid therapy and the specified antimetabolite or calcineurin inhibitor trial, failure, serious side effect, or contraindication.

Denial Risk

Continuation Criteria Not Met

Reauthorization may be denied when the request is not for the same treated eye, less than 36 months have passed since the last administration, required response or stabilization is not documented, or the prescriber does not support likely benefit without significant risk.

Requests must also address intolerable adverse effects or drug toxicity and include the required supporting clinical documentation.

Denial Risk

Insufficient or Inappropriate Documentation

Molina may deny reimbursement or take other appropriate action when submitted records are insufficient or inappropriate to support medical necessity, non-investigational status, or coverage under the member's benefit, including when records show inappropriate or excessive billing practices.

Denial Risk

Non-Approved Use

All other uses of Iluvien are considered experimental or investigational and are subject to Molina's Off-Label policy.

Denial Risk

Contraindications

Do not administer Iluvien in the presence of an ocular or periocular infection, glaucoma, or hypersensitivity to any component of the product.

Denial Risk

Concurrent Intravitreal Implant

Do not administer Iluvien with another intravitreal implant, including Ozurdex (dexamethasone intravitreal implant) or Retisert (fluocinolone acetonide intravitreal implant).

Billing Rule

Improper Billing or Non-Covered Benefit

Claims may be denied or payments recovered when Iluvien is billed inappropriately or for a non-covered benefit. Providers and facilities must use industry-standard coding practices; listed codes do not guarantee coverage, and code applicability may vary by state or line of business.

Reference HCPCS J7313: injection, fluocinolone acetonide intravitreal implant (Iluvien), 0.01 mg.

Diabetic Macular Edema (DME) is leakage of fluid from retinal blood vessels that causes the macula to swell.

Definition

DefinitionDiabetic Retinopathy (DR) is the progressive damage to the blood vessels in the back of the eye.

Definition

DefinitionIntravitreal refers to injection into the eye's vitreous humor between the lens and the retina; intravitreal implants deliver a continuous concentration of drug over a prolonged period.

Definition

DefinitionPhakic describes an eye containing the natural lens.

Definition

DefinitionPseudophakic describes an eye in which the natural lens has been replaced with an artificial lens implant.

Definition

DefinitionRetinopathy is damage to the retina.

Definition

DefinitionVascular Endothelial Growth Factor (VEGF) is a chemical signal produced by the body's cells that stimulates growth of new blood vessels.

Definition

DefinitionUveitis is inflammation of part or all of the uvea, the middle (vascular) tunic of the eye, commonly involving the sclera, cornea, and retina as well.