Viva Health ranibizumab Coverage & Prior Auth

Coverage and Medical Necessity Criteria

Initial Approval Criteria

Initial approval is provided when ALL of the following criteria are met:

Patient must have a contraindication, intolerance, or failure to a bevacizumab product prior to consideration of another ophthalmic VEGF‑inhibitor product.

Patient is at least 18 years of age.

Patient is free of ocular and/or periocular infections.

Therapy will not be used concomitantly with other ophthalmic vascular endothelial growth factor (VEGF) inhibitors.

Patient's best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment.

Patient has a definitive diagnosis of one of the following FDA‑approved or compendia‑recommended indications: Neovascular (Wet) Age‑Related Macular Degeneration (nAMD); Diabetic Macular Edema (DME) (Lucentis and Cimerli only); Diabetic Retinopathy (DR) (Lucentis and Cimerli only); Macular Edema following Retinal Vein Occlusion (RVO); Myopic Choroidal Neovascularization (mCNV).

Renewal Criteria

Renewal of prior authorization is permitted when ALL of the following are met:

Patient continues to meet the universal and indication‑specific relevant criteria identified in the Initial Approval Criteria.

Absence of unacceptable toxicity from the drug (examples include endophthalmitis, retinal detachments, increased intraocular pressure, arterial thromboembolic events, retinal vasculitis with or without occlusion).

Patient has had a beneficial response to therapy (for example, improvement in BCVA from baseline) and continued administration is necessary for maintenance of the condition.

For myopic choroidal neovascularization ONLY: continued administration is necessary due to ongoing disease activity (e.g., drop in vision, visual symptoms such as metamorphopsia, or presence of intra‑/subretinal fluid or active leakage).

Diagnoses Meeting Medical Necessity

Diagnoses meeting medical necessity (treated eye diagnosis must match one of the following ICD‑10 codes):

Type 1, 2, other specified, and drug‑induced diabetes mellitus with diabetic retinopathy and/or diabetic macular edema (select E08–E13 series codes corresponding to the affected eye and macular edema status).

Exudative (neovascular) age‑related macular degeneration (H35.321x, H35.322x, H35.323x, H35.329x).

Central retinal vein occlusion and branch retinal vein occlusion with macular edema (H34.8110, H34.8120, H34.8130, H34.8190, H34.8310, H34.8320, H34.8330, H34.8390).

Degenerative myopia with choroidal neovascularization (H44.2A1, H44.2A2, H44.2A3, H44.2A9).

Medicare Part B coverage determinations may differ and supersede the non‑Medicare information herein; refer to CMS NCDs/LCDs and the Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals where applicable.

Concomitant use (simultaneous administration) with other ophthalmic VEGF inhibitors is prohibited; use as an alternating regimen is generally not permitted and will be reviewed case‑by‑case.

The excerpt does not list explicit 'not medically necessary' exclusions beyond the concomitant use prohibition and toxicity considerations; applicable exclusions should be confirmed elsewhere in the policy.

Codes, Units, and Billing Limits

HCPCS CodesHCPCSCovered

J2778	Injection, ranibizumab, 0.1 mg; 1 billable unit = 0.1 mg (Lucentis Only)
Q5124	Injection, ranibizumab-nuna, biosimilar, (byooviz), 0.1 mg; 1 billable unit = 0.1 mg (Byooviz Only)
Q5128	Injection, ranibizumab-eqrn (cimerli), biosimilar, 0.1 mg; 1 billable unit = 0.1 mg (Cimerli Only)

NDCsNDC

50242-0082-xx	Lucentis 0.3 mg/0.05 mL prefilled syringe for injection
50242-0080-xx	Lucentis 0.5 mg/0.05 mL prefilled syringe for injection
64406-0019-xx	Byooviz 0.5 mg/0.05 mL single-use vial for injection
70114-0440-xx	Cimerli 0.3 mg/0.05 mL single-use vial for injection
61314-0624-xx	Cimerli 0.3 mg/0.05 mL single-dose vial for injection
70114-0441-xx	Cimerli 0.5 mg/0.05 mL single-use vial for injection
61314-0625-xx	Cimerli 0.5mg/0.05 mL single-dose vial for injection

Listed ICD-10 Codes (examples across products/indications)ICD-10

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
H35.3210	Exudative age-related macular degeneration, right eye, stage unspecified
H44.2A1	Degenerative myopia with choroidal neovascularization, right eye
E08.311	Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

Referenced HCPCS codesHCPCS

J2778	Lucentis (ranibizumab) HCPCS
Q5128	Cimerli (ranibizumab-aqqg) HCPCS

Listed ICD-10 Codes (E08–E13 series) for diabetic retinopathy / macular edemaICD-10Covered

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
E08.3413	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, bilateral
E08.3419	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
E08.3491	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, right eye
E08.3492	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, left eye
E08.3493	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, bilateral
E08.3499	Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye
E08.3511	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye
E08.3512	Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, left eye

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Covered HCPCS CodesHCPCSCovered

J2778	Lucentis
Q5128	Cimerli

Covered ICD-10 Diagnosis CodesICD-10Covered

E11.3591	Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye
E11.3592	Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye
E11.3593	Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral
E11.3599	Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye
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
E13.3211	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

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Maximum units per 28 days

nAMD / RVO / mCNVMaximum 10 billable units per 28 days (based on administration to both eyes)

DME / DR (Lucentis & Cimerli only)Maximum 6 billable units per 28 days (based on administration to both eyes)

Measurement intervalLimits applied on a 28-day (approximately monthly) basis

Additional coding key/value

Inventory label(no additional inventory label provided in source)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required and Billing Codes

Prior authorization is required for the listed agents and will be provided initially for 12 months (3 months for mCNV). Applicable HCPCS codes include J2778 (ranibizumab injection) and Q5128 (biosimilar Cimerli). When submitting claims for J2778 or Q5128, include the definitive ICD-10 diagnosis code for the treated eye from the accepted lists in this policy.

Initial PA validity: 12 months (3 months for mCNV)
Renewal: may be renewed every 12 months (3 months for mCNV)
Affected HCPCS: J2778, Q5128
Submit claims with the ICD-10 code that corresponds to the treated eye

Note

Medicare Coverage / Prior Authorization Reference

Medicare Part B coverage rules may differ. This policy is intended for non‑Medicare coverage determinations. Verify applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs), and MAC guidance prior to billing; nonconforming Part B claims may be denied.

Background and Drug Information

Ranibizumab and its biosimilars are intravitreal anti‑VEGF agents used to treat retinal neovascular and edema conditions. The policy’s initial approval criteria state ranibizumab is indicated for neovascular (wet) age‑related macular degeneration (nAMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV); diabetic macular edema (DME) and diabetic retinopathy (DR) are covered for Lucentis and Cimerli only. Dosing varies by indication (for example, Lucentis/Cimerli use 0.3 mg for DME/DR and 0.5 mg for nAMD/RVO/mCNV per the clinical background and dosing guidance).

Dosing, Terms, and Definition Notes

Dosing by indication

DME / DR (Lucentis & Cimerli only)0.3 mg intravitreal per affected eye once a month (approximately every 28 days)

nAMD / RVO / mCNV0.5 mg intravitreal per affected eye once a month (approximately every 28 days)

mCNV initial courseFor mCNV: 0.5 mg monthly for up to 3 months; patients may be re‑treated if needed

Diabetic retinopathy / DME ICD-10 codes

ICD-10 code rangeIncludes E08–E13 series and multiple subcodes for diabetic retinopathy and diabetic macular edema (laterality and status specified)

Examples (sample codes)E08.3411, E09.3311, E10.3211, E11.3211, E13.3211 (see full code group in policy)

Document Revision History

2012-01-01Policy origin

Policy originated (date of origin) for ranibizumab intravitreal agents (Byooviz, Cimerli, Lucentis).

2012-03-01Periodic review

Initial series of early reviews began (listed review dates include 03/2012).

2019-10-01Periodic review

Document reviewed (listed in dates reviewed: 10/2019).

OpenPayer

Ranibizumab: Byooviz; Cimerli; Lucentis (Intravitreal) — Coverage Criteria