Colorado Rocky Mountain Health Plans corticosteroid implants Coverage

Coverage Criteria for Intracanalicular and Intravitreal Corticosteroid Implants

Dextenza (dexamethasone ophthalmic insert)

Dextenza is proven when ALL of the following are met:

Dextenza criteria: Diagnosis of one of the following: ocular inflammation and pain following ophthalmic surgery OR ocular itching associated with allergic conjunctivitis; prescribed by or in consultation with an ophthalmologist; dose does not exceed one insert per eye; authorization is for no more than 60 days.

Iluvien (fluocinolone acetonide intravitreal implant)

Iluvien is proven when ALL of the following are met:

Iluvien criteria: Diagnosis of chronic non-infectious uveitis affecting the posterior segment of the eye OR (diagnosis of diabetic macular edema AND member has been previously treated with a course of corticosteroids AND member did not have a clinically significant rise in intraocular pressure); authorization is for no more than 60 days.

Ozurdex (dexamethasone intravitreal implant)

Ozurdex is proven when ALL of the following are met:

Ozurdex criteria: Diagnosis of one of the following: macular edema following branch retinal vein occlusion (BRVO) OR macular edema following central retinal vein occlusion (CRVO) OR non-infectious uveitis affecting the posterior segment of the eye OR diabetic macular edema (DME); dose does not exceed one implant per eye; authorization is for no more than 60 days.

Retisert (fluocinolone acetonide intravitreal implant)

Retisert is proven when ALL of the following are met:

Retisert criteria: Diagnosis of chronic non-infectious uveitis affecting the posterior segment of the eye; dose does not exceed one implant per eye; authorization is for no more than 60 days.

Yutiq (fluocinolone acetonide intravitreal implant)

Yutiq is proven when ALL of the following are met:

Yutiq criteria: Diagnosis of chronic non-infectious uveitis affecting the posterior segment of the eye; dose does not exceed one implant per eye; authorization is for no more than 60 days.

DME (FDA indications and trial evidence)

Devices/indications described with supporting trial evidence:

Diabetic Macular Edema (DME): Iluvien and Ozurdex are indicated for treatment of diabetic macular edema (DME); randomized trials demonstrated improved proportions achieving >=15 ETDRS-letter BCVA gains and reductions in central retinal thickness versus sham/control, including benefits in populations with persistent DME after prior macular laser in some studies.clinical response endpoints: >=15 ETDRS letters improvement at 24 months (Iluvien trials) or study end (Ozurdex trials)

Risks include elevated intraocular pressure and cataract; Iluvien low-dose had a superior risk–benefit profile compared with high-dose in cited trials.

Macular edema following retinal vein occlusion

Ozurdex is indicated for macular edema following BRVO or CRVO.

RVO-related macular edema: Ozurdex 0.7 mg demonstrated faster and greater incidence of >=15-letter BCVA improvement versus sham in BRVO/CRVO trials; intraocular pressure increases (IOP >=25 mmHg) peaked around day 60 and returned toward baseline by day 180.>=15-letter improvement endpoint; IOP >=25 mmHg reported

Single administration trials showed benefit lasting up to ~6 months.

Non-infectious uveitis affecting posterior segment

Iluvien, Ozurdex, Retisert, and Yutiq are indicated for non-infectious posterior uveitis; trials demonstrated reduced recurrence and improved inflammation control.

Non-infectious posterior uveitis: Randomized trials of dexamethasone and fluocinolone intravitreal implants showed increased proportions achieving vitreous haze score of 0, delayed time to recurrence, and reduced recurrence rates versus control; benefits persisted months to years depending on implant, while adverse events included elevated IOP (sometimes requiring surgery) and high rates of cataract extraction.reduced recurrence rates and time-to-first-recurrence endpoints over 6 to 36 months

Close IOP and lens monitoring required.

Postoperative inflammation/pain and allergic conjunctivitis (Dextenza)

Dextenza is indicated for postoperative ocular inflammation and pain and for ocular itching from allergic conjunctivitis; trials and comparative studies reported reduced pain and inflammation and mixed comparative results versus topical drops.

Postoperative inflammation/pain: Dextenza applied immediately after cataract surgery increased the proportion of patients pain-free at Day 8 and absence of anterior chamber cells at Day 14 versus placebo in randomized trials.trial endpoints: pain-free at Day 8; absence of anterior chamber cells at Day 14

Monitor for breakthrough inflammation and IOP changes; retrospective comparisons to topical prednisolone show variable breakthrough inflammation rates.

Allergic conjunctivitis (ocular itching): Dextenza reduced mean ocular itching scores versus vehicle in repeat conjunctival allergen challenge trials over one month, with statistically significant reductions at several post-challenge time points.reduction in patient-reported itching scores at multiple time points

Indicated for patients aged 2 years and older for allergic conjunctival itching.

General coverage framing for listed corticosteroid products

Coverage stance and criteria were revised; products are described as 'proven when all of the [listed] criteria are met' with specific indication-based requirements.

General: Dextenza, Iluvien, Ozurdex, Retisert, and Yutiq are characterized as proven for their listed FDA indications when all specified criteria in this policy are met.

Policy language changed to use 'proven' rather than 'proven and medically necessary' and the prescriber consultation requirement for intravitreal implants was removed.

Iluvien (fluocinolone) criteria

Iluvien-specific clinical requirement

Iluvien prior corticosteroid exposure: For DME, Iluvien is indicated in patients previously treated with a course of corticosteroids who did not experience a clinically significant rise in intraocular pressure.

Prior corticosteroid exposure and absence of clinically significant IOP rise are part of the clinical pathway for Iluvien use.

Dextenza (dexamethasone intracanalicular insert) criteria

Dextenza indication summary

Dextenza indications: Dextenza is indicated for ocular inflammation and pain following ophthalmic surgery and for ocular itching associated with allergic conjunctivitis in adults and pediatric patients (aged >=2 years for allergic conjunctivitis).

Dose limit: one insert per eye; authorization up to 60 days.

Ozurdex / Retisert / Yutiq criteria

Intravitreal implant indications

Ozurdex indications: Ozurdex is indicated for macular edema following BRVO or CRVO, non-infectious uveitis affecting the posterior segment, and diabetic macular edema.

Dose limit: no more than one implant per eye; authorization up to 60 days.

Retisert/Yutiq indications: Retisert and Yutiq are indicated for chronic non-infectious uveitis affecting the posterior segment of the eye.

Dose limit: no more than one implant per eye; authorization up to 60 days.

Use of intracanalicular and intravitreal corticosteroid implant products for any indication not listed in this policy is considered unproven and not medically necessary and may be denied. Examples of non‑covered uses include, but are not limited to, cystoid macular edema after cataract surgery and radiation retinopathy.

FDA marketing approval is provided here for informational context only. FDA approval alone is not a basis for coverage; coverage determinations depend on the member’s specific benefit plan and any applicable state mandates, which may supersede policy language.

The policy was revised to remove the prior requirement that Iluvien, Ozurdex, Retisert, and Yutiq be prescribed by or in consultation with an ophthalmologist; that prescriber consultation criterion is no longer part of the coverage criteria.

Intracanalicular and intravitreal corticosteroid implant products are regarded by this policy as unproven and not medically necessary for any indication not specifically listed. Coverage is limited to the indications enumerated in the policy where sufficient evidence supports their use; other uses lack adequate evidence of efficacy.

FDA approval is described in this document for informational purposes only and should not be interpreted as a standalone basis for coverage. Prior to treatment, verify the member’s benefit plan and any state-mandated coverage requirements for off‑label or investigational uses.

Coding: HCPCS and ICD-10 Codes

HCPCS / J-codesHCPCS

J1096	Dexamethasone, lacrimal ophthalmic insert, 0.1 mg
J7311	Injection, fluocinolone acetonide, intravitreal implant (Retisert), 0.01 mg
J7312	Injection, dexamethasone, intravitreal implant, 0.1 mg
J7313	Injection, fluocinolone acetonide, intravitreal implant (Iluvien), 0.01 mg
J7314	Injection, fluocinolone acetonide, intravitreal implant (Yutiq), 0.01 mg

Diabetic Macular Edema (DME) — extended ICD-10 codes (examples)ICD-10Covered

E08.3312	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E08.3313	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E08.3319	Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
E08.3411	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye
E08.3412	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, left eye

Macular Edema Following Retinal Vein Occlusion — ICD-10ICD-10Covered

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

Non-Infectious Uveitis — ICD-10 (selected)ICD-10Covered

H20.041	Secondary noninfectious iridocyclitis, right eye
H20.042	Secondary noninfectious iridocyclitis, left eye
H20.043	Secondary noninfectious iridocyclitis, bilateral
H20.049	Secondary noninfectious iridocyclitis, unspecified eye
H30.001	Unspecified focal chorioretinal inflammation, right eye

Non-Infectious Posterior Segment Uveitis — peripheral focal codesICD-10Covered

H30.031	Focal chorioretinal inflammation, peripheral, right eye
H30.032	Focal chorioretinal inflammation, peripheral, left eye
H30.033	Focal chorioretinal inflammation, peripheral, bilateral
H30.039	Focal chorioretinal inflammation, peripheral, unspecified eye

Non-Infectious Posterior Segment Uveitis — additional ICD-10 codesICD-10Covered

H30.101	Unspecified disseminated chorioretinal inflammation, right eye
H30.102	Unspecified disseminated chorioretinal inflammation, left eye
H30.103	Unspecified disseminated chorioretinal inflammation, bilateral
H30.109	Unspecified disseminated chorioretinal inflammation, unspecified eye
H30.111	Disseminated chorioretinal inflammation of posterior pole, right eye

Ocular inflammation / postoperative pain; Allergic conjunctivitis — ICD-10ICD-10Covered

H57.10	Ocular pain, unspecified eye
H57.11	Ocular pain, right eye
H57.12	Ocular pain, left eye
H57.13	Ocular pain, bilateral
H10.45	Other chronic allergic conjunctivitis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Verify benefits / prior authorization

Verify member-specific benefits and prior authorization requirements before treatment. Member benefit plan documents and any applicable federal or state mandates may supersede this policy; confirm coverage, prior authorization (PA) requirements, and any limits on quantity or place of service prior to scheduling.

Check the member's Certificate of Coverage for plan-specific terms and any state mandates that may require coverage for off‑label uses.
Confirm whether the service requires prior authorization and the payer's submission process (portal, fax, phone).
Verify limits: one implant per eye and authorization duration (authorization may be limited to no more than 60 days).

Prior Authorization

Prior authorization requirement — documentation that criteria are met

Prior authorization is required when the coverage criteria for Iluvien, Ozurdex, Retisert, or Yutiq apply. Authorization decisions should follow the revised coverage criteria and the current allowed diagnosis code lists; always verify plan terms against the member's benefit document.

Background and Clinical Context

Intracanalicular and intravitreal corticosteroid implants and inserts are drug delivery systems placed in or near the eye to provide sustained local corticosteroid release for intraocular inflammation and macular edema. Examples include the intracanalicular dexamethasone insert Dextenza (designed to release medication over about 30 days), intravitreal dexamethasone implant Ozurdex (biodegradable, up to ~6 months release), and longer‑acting intravitreal fluocinolone acetonide implants such as Iluvien, Retisert, and Yutiq (non‑bioerodible implants with prolonged release over many months to years). These devices are used for FDA‑labeled indications including postoperative ocular inflammation and pain, ocular itching from allergic conjunctivitis, diabetic macular edema, macular edema from retinal vein occlusion, and chronic non‑infectious posterior uveitis, with risks such as elevated intraocular pressure and cataract formation noted in clinical studies.

Products and Definitions

Products referenced

DextenzaDexamethasone ophthalmic intracanalicular insert (0.4 mg release up to ~30 days).

IluvienFluocinolone acetonide intravitreal implant (0.19 mg; sustained release ~36 months).

OzurdexDexamethasone intravitreal biodegradable implant (0.7 mg; release up to ~6 months).

RetisertFluocinolone acetonide non-biodegradable intravitreal implant (0.59 mg; sustained release ~30 months).

YutiqFluocinolone acetonide intravitreal implant (0.18 mg; sustained release ~36 months).

Corticosteroid implants/inserts

Definition

Revision History and Policy Changes

2025-11-01policy_revisionLatest

Revised coverage rationale wording to replace 'proven and medically necessary' phrasing with 'proven when all of the [listed] criteria are met' for Dextenza, Iluvien, Ozurdex, Retisert, and Yutiq; removed the requirement that Iluvien/Ozurdex/Retisert/Yutiq be prescribed by or in consultation with an ophthalmologist; added multiple ICD-10 codes (H30.141, H30.142, H30.143, H30.149, H30.21, H30.22, H30.23, H30.811, H30.812, H30.813, H30.819) for non-infectious posterior uveitis; and removed ICD-10 codes G89.18 and H05.00 from the postoperative ocular inflammation/pain indication.