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    v1.0.28
    OpenPayerPolicy UpdatesOphthalmology/OptometryViva Health Plan Vabysmo Prior Auth | OpenPayer
    Ask Trek AI about this page
    CurrentViva Health PlanPolicy IC-0659

    Vabysmo (faricimab-svoa) intravitreal therapy

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    This policy governs prior authorization, dosing, renewal, coverage criteria, and billing for intravitreal Vabysmo in adult members with neovascular age-related macular degeneration, diabetic macular edema, or macular edema following retinal vein occlusion. It applies to providers treating Viva Health Plan Medicare FFS members.

    Policy Summary
    PayerViva Health Plan
    PolicyVabysmo (faricimab-svoa) intravitreal therapy
    Policy CodePolicy IC-0659
    Change TypeNo material change
    Effective DateN/A
    Last ReviewSep 1, 2026
    Next Review DateN/A
    Key ActionBefore Vabysmo is considered, document a contraindication, intolerance, or failure to a bevacizumab product.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsPrior authorization validity
    120 unitsMaximum maintenance dose per 28 days
    3Covered disease indications
    6 mgDose per affected eye
    8

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Retinal vein occlusion codes
    18Exudative AMD codes

    Coverage Criteria

    Initial Therapy

    Covered when all universal and applicable indication-specific criteria are met.

    Initial approval

    • Universal requirements: The patient has a contraindication, intolerance, or failure to a bevacizumab product before consideration of another ophthalmic VEGF inhibitor; the member is at least 18 years of age; the member has no FDA-labeled contraindication to Vabysmo, including ocular or periocular infection, active intraocular inflammation, or hypersensitivity to faricimab or any Vabysmo excipient; therapy will not be used concomitantly with other ophthalmic VEGF inhibitors; and best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment.Age >= 18 years

      Use as part of an alternating treatment regimen with another ophthalmic VEGF inhibitor is generally not permitted and is reviewed case by case.

    • Covered indication: The member has a definitive diagnosis of neovascular (wet) age-related macular degeneration, diabetic macular edema, or macular edema following retinal vein occlusion.One covered diagnosis

    Continuation and Renewal Therapy

    Renewal is covered when all renewal requirements are met.

    Renewal requirements: The member continues to meet the relevant universal and indication-specific criteria; has no unacceptable toxicity from the drug; has had a beneficial response to therapy, such as improvement from baseline BCVA; and continued administration is necessary to maintain treatment of the condition.Renewal every 12 months

    Examples of unacceptable toxicity include endophthalmitis, retinal detachment, increased intraocular pressure, arterial thromboembolic events, retinal vasculitis, and retinal vascular occlusion.

    Coverage requires that the member have no FDA-labeled contraindication to Vabysmo, including ocular or periocular infection, active intraocular inflammation, or hypersensitivity to faricimab or any Vabysmo excipient.

    Vabysmo must not generally be used concomitantly with another ophthalmic VEGF inhibitor. Alternating treatment regimens with other ophthalmic VEGF inhibitors are generally not permitted and require case-by-case review.

    Billing and Covered Codes

    HCPCS CodeHCPCSCovered
    J2777Injection, faricimab-svoa, 0.1 mg; 1 billable unit = 0.1 mg
    NDC(s)NDCCovered
    50242-0096-xxVabysmo 6 mg/0.05 mL (concentration 120 mg/mL) single-dose vial
    50242-0096xxVabysmo 6 mg/0.05 mL (concentration 120 mg/mL) single-dose prefilled syringe
    Covered Diagnosis CodesICD-10Covered
    E08.311Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
    E08.3211Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, right eye
    E08.3312Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye
    E08.3313Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
    E08.3319Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
    E08.3411Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye
    E08.3412Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, left eye
    E08.3413Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, bilateral
    E08.3419Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
    E08.3511Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye
    1–10 of 23
    1/3
    Covered Diagnosis Codes — diabetes mellitus due to underlying conditionICD-10Covered
    E08.3419Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
    E08.3511Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye
    Covered Diagnosis Codes — drug or chemical induced diabetes mellitus and type 1 diabetes mellitusICD-10Covered
    E09.3311Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
    E09.3411Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye
    E09.3412Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
    E09.3413Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
    E09.3419Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
    E09.3511Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
    E09.3512Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
    E09.3513Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral
    E09.3519Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye
    E10.311Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema
    Covered Diagnosis Codes — type 1 diabetes mellitusICD-10Covered
    E10.3211Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
    E10.3212Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
    E10.3213Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
    E10.3219Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye
    E10.3311Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
    E10.3412Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
    E10.3413Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
    E10.3419Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye
    E10.3511Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
    E10.3512Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
    1–10 of 12
    1/2
    Covered Diagnosis Codes — type 2 diabetes mellitusICD-10Covered
    E11.311Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
    E11.3211Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
    E11.3212Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
    E11.3213Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
    E11.3311Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
    E11.3511Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
    E11.3512Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
    E11.3513Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral
    E11.3519Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye
    Covered Diagnosis Codes — other specified diabetes mellitusICD-10Covered
    E13.311Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema
    E13.3211Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
    E13.3212Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
    E13.3213Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
    E13.3219Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye
    E13.3313Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
    E13.3319Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye
    E13.3411Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye
    E13.3412Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
    E13.3413Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
    1–10 of 14
    1/2
    Covered Diagnosis Codes — retinal vein occlusion with macular edemaICD-10Covered
    H34.8110Central retinal vein occlusion, right eye, with macular edema
    H34.8120Central retinal vein occlusion, left eye, with macular edema
    H34.8130Central retinal vein occlusion, bilateral, with macular edema
    H34.8190Central retinal vein occlusion, unspecified eye, with macular edema
    H34.8310Tributary (branch) retinal vein occlusion, right eye, with macular edema
    H34.8320Tributary (branch) retinal vein occlusion, left eye, with macular edema
    H34.8330Tributary (branch) retinal vein occlusion, bilateral, with macular edema
    H34.8390Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema
    Covered Diagnosis Codes — exudative age-related macular degenerationICD-10Covered
    H35.3210Exudative age-related macular degeneration, right eye, stage unspecified
    H35.3211Exudative age-related macular degeneration, right eye, with active choroidal neovascularization
    H35.3212Exudative age-related macular degeneration, right eye, with inactive choroidal neovascularization
    H35.3213Exudative age-related macular degeneration, right eye, with inactive scar
    H35.3220Exudative age-related macular degeneration, left eye, stage unspecified
    H35.3221Exudative age-related macular degeneration, left eye, with active choroidal neovascularization
    H35.3222Exudative age-related macular degeneration, left eye, with inactive choroidal neovascularization
    H35.3223Exudative age-related macular degeneration, left eye, with inactive scar
    H35.3230Exudative age-related macular degeneration, bilateral, stage unspecified
    H35.3231Exudative age-related macular degeneration, bilateral, with active choroidal neovascularization
    1–10 of 16
    1/2
    Neovascular AMD Initial Dosing
    IndicationNeovascular age-related macular degeneration (AMD)
    Maximum quantity120 billable units every 28 days
    Initial course4 doses
    Neovascular AMD Maintenance Dosing
    IndicationNeovascular age-related macular degeneration (AMD)

    Authorization and Provider Requirements

    Prior Authorization

    Authorization Duration

    Initial prior authorization is valid for 12 months (365 days). Renewal authorization may be issued every 12 months (365 days) thereafter.

    • Initial authorization: 12 months (365 days).
    • Renewal authorization: every 12 months (365 days).
    Documentation Required

    Initial Approval Documentation

    Before Vabysmo is considered, document that the member meets the applicable initial approval requirements, including the bevacizumab prerequisite, age eligibility, absence of FDA-labeled contraindications, no prohibited concomitant ophthalmic VEGF-inhibitor therapy, baseline BCVA measurement, and a definitive covered diagnosis.

    • Member must be at least 18 years of age.
    • Document absence of ocular or periocular infection, active intraocular inflammation, and hypersensitivity to faricimab or Vabysmo excipients.

    Therapy and Policy Background

    Vabysmo (faricimab-svoa) is an intravitreal ophthalmic VEGF-inhibitor therapy used for retinal vascular and macular diseases. This policy addresses treatment of neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion in adult members. Dosing may transition from monthly loading therapy to less frequent maintenance intervals based on optical coherence tomography and visual acuity findings.

    Abbreviations and Definitions

    MU
    AbbreviationMU
    MeaningMaintenance dosing
    Dosing-table designationDiagnosis 1 identifies initial dosing; diagnosis 2 identifies maintenance dosing
    BCVA
    AbbreviationBCVA
    MeaningBest corrected visual acuity
    Documentation useMeasure at baseline and periodically during treatment
    Policy Summary
    PayerViva Health Plan
    PolicyVabysmo (faricimab-svoa) intravitreal therapy
    Policy CodePolicy IC-0659
    Change TypeNo material change
    Effective DateN/A
    Last ReviewSep 1, 2026
    Next Review DateN/A
    Key ActionBefore Vabysmo is considered, document a contraindication, intolerance, or failure to a bevacizumab product.
    SourceLink
    On This Page
    Coverage CriteriaBilling and Covered CodesAuthorization and Provider RequirementsTherapy and Policy BackgroundAbbreviations and Definitions
    Maintenance quantity120 billable units every 28 days
    Treatment phaseAfter the initial 4 doses
    DME Initial Dosing
    IndicationDiabetic macular edema (DME)
    Maximum quantity120 billable units every 28 days
    Initial course6 doses
    DME Maintenance Dosing
    IndicationDiabetic macular edema (DME)
    Maintenance quantity120 billable units every 28 days
    Treatment phaseAfter initial dosing
    RVO Maintenance Dosing
    IndicationMacular edema following retinal vein occlusion (RVO)
    Initial dosingN/A
    Maintenance quantity120 billable units every 28 days
  1. Document a definitive diagnosis of an applicable indication.
    2. Step Therapy

    Bevacizumab Prerequisite

    Before Vabysmo or another ophthalmic VEGF-inhibitor product is considered, the member must have a contraindication, intolerance, or failure to a bevacizumab product.

    • Document the specific bevacizumab contraindication, intolerance, or treatment failure.
    • This prerequisite applies before consideration of Vabysmo or another ophthalmic VEGF inhibitor.
    Documentation Required

    BCVA Monitoring Required

    Document the member’s best corrected visual acuity (BCVA) at baseline and periodically during treatment.

    • Include baseline BCVA before treatment.
    • Repeat and retain periodic BCVA measurements during therapy.
    Documentation Required

    Renewal Response and Safety Documentation

    Renewal requires continued satisfaction of the applicable universal and indication-specific criteria, a beneficial response to therapy, and continued treatment need for maintenance. Document the absence of unacceptable toxicity, including relevant ocular and systemic adverse events.

    • Document continued eligibility under the initial and indication-specific criteria.
    • Document beneficial response, such as improvement from baseline BCVA, and the need for continued maintenance treatment.
    • Document absence of unacceptable toxicity, including endophthalmitis, retinal detachment, increased intraocular pressure, arterial thromboembolic events, retinal vasculitis, or retinal vascular occlusion.
    Documentation Required

    OCT, CST, and Visual Acuity Assessments

    For neovascular (wet) age-related macular degeneration maintenance decisions, obtain optical coherence tomography and visual acuity evaluations after the initial four doses, including assessments 8 and 12 weeks later. Use the results to determine the maintenance dosing interval.

    • Assess OCT and visual acuity after the first four doses, at 8 and 12 weeks later.
    • For applicable DME dosing decisions, document macular central subfield thickness (CST) by OCT together with visual acuity evaluations.

    Unsupported block type: billing_rule

    Billing Rule

    Verify CMS Jurisdiction Requirements

    Verify the CMS requirements applicable to the member’s jurisdiction before billing or requesting coverage. Identify and follow any applicable National Coverage Determination (NCD), Local Coverage Determination (LCD), Local Coverage Article (LCA), and Medicare Administrative Contractor (MAC) requirements.

    • Use the CMS Medicare Coverage Database to search for applicable NCD, LCD, or LCA documents.
    • Confirm the applicable MAC jurisdiction and contractor requirements for the member’s state or territory.
    Denial Risk

    Initial Approval Denial Risk

    Failure to meet any initial approval requirement may result in denial of Vabysmo. This includes failure to document the bevacizumab contraindication, intolerance, or failure prerequisite or failure to satisfy other eligibility, safety, diagnosis, BCVA, or therapy-use criteria.

    • Denial risk applies when the bevacizumab prerequisite is not met or adequately documented.
    • Denial risk also applies when age, contraindication, diagnosis, baseline BCVA, or prohibited-concomitant-therapy requirements are not satisfied.
    Denial Risk

    Concomitant or Alternating VEGF-Inhibitor Therapy

    Vabysmo generally must not be used concomitantly with other ophthalmic vascular endothelial growth factor (VEGF) inhibitors. Use as part of an alternating regimen is generally not permitted and requires case-by-case review.

    • Do not use Vabysmo concomitantly with another ophthalmic VEGF inhibitor.
    • Alternating treatment regimens may be reviewed case by case.
    Denial Risk

    Renewal Denial Risk

    Renewal may be denied if the member no longer meets the applicable eligibility criteria, has unacceptable toxicity, or has not demonstrated a beneficial response with continued treatment need.

    • Document continued universal and indication-specific eligibility.
    • Document response and absence of unacceptable toxicity for each renewal.
    Denial Risk

    Medicare Part B Compliance Denial Risk

    Medicare Part B claims may be denied when documentation or billing does not comply with applicable CMS guidance, coverage determinations, local coverage articles, or MAC jurisdiction requirements.

    • Follow the Medicare Benefit Policy Manual and applicable NCD, LCD, and LCA requirements.
    • Verify the correct MAC jurisdiction and contractor-specific requirements before submitting the claim.
    CST
    AbbreviationCST
    MeaningCentral subfield thickness of the macula
    Measurement methodMeasured by optical coherence tomography