Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsViva Health Visudyne (verteporfin) Prior Auth | Op…
    Ask Trek AI about this page
    CurrentViva HealthPolicy IC-0181

    Visudyne (verteporfin) (Intravenous) Coverage Criteria

    Customize your policy alerts

    Sign up for Viva Health Policy IC-0181 alerts

    Get alerted when Policy IC-0181 changes without checking for updates manually.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Covers prior authorization, dosing, eligible indications, and billing for intravenous Visudyne (verteporfin) therapy for Viva Health members; applies to providers requesting coverage for Visudyne infusions.

    Policy Summary
    PayerViva Health
    PolicyVisudyne (verteporfin) (Intravenous) Coverage Criteria
    Policy CodePolicy IC-0181
    Change TypeNo material changes
    Effective DateJun 2, 2026
    Last ReviewJun 2, 2026
    Next Review DateJun 2, 2026
    Key ActionObtain prior authorization; initial approval covers 1 infusion per eye for 90 days and may be renewed for 1 infusion per eye every 3 months with required documentation of response and safety.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1/eyeinitial authorization quantity
    q3 monthsrenewal frequency
    300max units /3 months
    J3396HCPCS

    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.

    >=18
    min age

    Coverage Criteria

    inv-01: Initial Therapy — Covered when ALL of the following are met

    Covered when ALL of the following are met:

    Age requirement: Member is at least 18 years of age
    Universal criteria: Use with activation via nonthermal diode laser; not used in combination with anti-angiogenic agents; no FDA-labeled contraindications (e.g., porphyria)
    Indication-specific: Member has classic subfoveal choroidal neovascularization associated with neovascular age-related macular degeneration OR presumed ocular histoplasmosis OR pathologic myopia

    FDA-approved indication

    inv-02: Renewal — Renewal allowed when ALL of the following are met

    Renewal allowed when ALL of the following are met:

    Continued eligibility: Member continues to meet the universal and indication-specific criteria in the initial approval section
    Clinical response: Disease response demonstrated by improvement in lines of visual acuity from baseline and/or reduction in episodes of severe visual acuity loss
    Safety: Absence of unacceptable toxicity from the drug (examples include extravasation, severe decrease in visual acuity, anaphylactic/serious allergic reactions)

    Use of Visudyne (verteporfin) in combination with anti-angiogenic agents is excluded. The policy requires that Visudyne be administered only when the universal treatment conditions are met, including activation via a nonthermal diode laser and not being used concomitantly with any anti-angiogenic therapy.

    Requests that propose combining Visudyne with anti-angiogenic agents or that are for patients with FDA-labeled contraindications (for example, porphyria) are not appropriate for coverage under these criteria. Such requests should be denied unless documentation demonstrates adherence to the universal criteria, including use with nonthermal diode laser activation and absence of FDA contraindications.

    Coding

    Covered HCPCS CodesHCPCSCovered
    J3396Injection, verteporfin, 0.1 mg
    NDCNDCCovered
    24208-5600-xxVisudyne 15 mg single-dose vial
    Covered ICD-10 Diagnosis CodesICD-10Covered
    B39.4Histoplasmosis capsulata, unspecified
    B39.5Histoplasmosis duboisii
    B39.9Histoplasmosis, unspecified
    H32Chorioretinal disorders in diseases classified elsewhere
    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
    1–10 of 28
    1/3
    Max HCPCS units
    Maximum HCPCS units300 billable units per 3 months (based on administration to both eyes)
    Unit definitionHCPCS billable unit corresponds to verteporfin 0.1 mg per unit (see coding section: J3396)
    Measurement intervalLimit applies to a rolling 3-month (90 day) period

    Provider Actions & Documentation

    Prior Authorization

    Obtain prior authorization and note duration

    Prior authorization is required. Initial authorization is valid for 1 infusion per eye for 3 months (90 days). Authorization may be renewed for 1 infusion per eye every 3 months (90 days) thereafter.

    • Initial: 1 infusion per eye for 3 months (90 days).
    • Renewal: may be renewed for 1 infusion per eye every 3 months (90 days).
    Step Therapy

    Prohibited combination therapy with anti-angiogenics

    Do not administer Visudyne together with any anti-angiogenic (anti‑VEGF) agents; combination use is explicitly prohibited.

    Background

    Visudyne (verteporfin) is a photosensitizing agent administered intravenously and activated by light from a nonthermal diode laser to treat classic subfoveal choroidal neovascularization (CNV).

    Definitions

    Classic Subfoveal CNV — definition
    TermClassic Subfoveal CNV
    DefinitionChoroidal neovascularization that is classic in appearance and subfoveal, associated with neovascular AMD, presumed ocular histoplasmosis, or pathologic myopia
    Regulatory noteListed as an FDA‑approved indication for Visudyne (verteporfin)

    Initial Therapy Criteria

    inv-15: Initial Therapy — Initial coverage criteria (detailed nested logic)

    Initial coverage criteria

    Age: Member >= 18 years
    Universal treatment conditions: Use with nonthermal diode laser activation and not combined with anti-angiogenic agents; member has no FDA-labeled contraindications (e.g., porphyria)
    Indications: Diagnosis of classic subfoveal choroidal neovascularization due to neovascular AMD OR presumed ocular histoplasmosis OR pathologic myopia

    FDA approved indication

    Continuation / Renewal Criteria

    inv-16: Continuation Therapy — Renewal requirements

    Renewal requirements

    Continued response and safety: Member continues to meet universal and indication-specific criteria, demonstrates improvement in visual acuity and absence of unacceptable toxicity

    Step Therapy

    StepRequirement / Restriction
    1Not to be used concomitantly with anti-angiogenic agents (restriction — not a prior-step requirement)
    NotesThis is a combination-therapy exclusion: Visudyne must not be administered in combination with any anti-angiogenic agents.

    Quantity Limits

    Visudyne (verteporfin) — maximum units listed (300)
    ProductVisudyne (verteporfin)
    Maximum units300 billable units per 3 months
    Basis for limitMax units assume administration to both eyes

    Site of Care

    Note

    Infusion center administration and timing

    Administer Visudyne via IV infusion per dosing instructions and follow the infusion timing and laser activation protocol when treating one or both eyes.

    • Administer 6 mg/m2 IV infusion over 10 minutes (rate ~3 mL/min).
    • If treating the second eye after one week, ensure no significant toxicity; if treating both eyes concurrently after a prior acceptable safety profile, treat the more aggressive lesion first at 15 minutes after infusion start and begin the second eye no later than 20 minutes from infusion start.
    • Follow the nonthermal diode laser activation procedure immediately after infusion as specified.

    Revision History

    2013-11-07policy_origin

    Policy originated (Date of Origin).

    2014-08review

    Policy reviewed (Dates Reviewed: 08/2014).

    2015-07review

    Policy reviewed (Dates Reviewed: 07/2015).

    Policy Summary
    PayerViva Health
    PolicyVisudyne (verteporfin) (Intravenous) Coverage Criteria
    Policy CodePolicy IC-0181
    Change TypeNo material changes
    Effective DateJun 2, 2026
    Last ReviewJun 2, 2026
    Next Review DateJun 2, 2026
    Key ActionObtain prior authorization; initial approval covers 1 infusion per eye for 90 days and may be renewed for 1 infusion per eye every 3 months with required documentation of response and safety.
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider Actions & DocumentationBackgroundDefinitionsInitial Therapy CriteriaContinuation / Renewal CriteriaStep TherapyQuantity LimitsSite of CareRevision History
    Documentation Required

    Supply dosing/administration and response documentation

    Include documentation of dosing and administration and objective evidence of disease response to support renewal requests.

    • Dosing/administration: IV infusion details per dosing protocol (e.g., 6 mg/m2 over 10 minutes).
    • Evidence of response: improvement in lines of visual acuity from baseline and/or reduction in lesion activity or episodes of severe visual acuity loss.
    Denial Risk

    Missing required criteria or response may lead to denial

    Requests may be denied if the submission lacks proof that the member meets universal criteria or shows clinical response and safety; common denial triggers include failure to document use with nonthermal diode laser activation, use in combination with an anti‑VEGF agent, or presence of FDA‑labeled contraindications.

    • No documentation of activation via nonthermal diode laser.
    • Request indicates concomitant use with anti‑angiogenic agents.
    • Missing evidence that member meets criteria or has acceptable safety/response.
    2016-07review

    Policy reviewed (Dates Reviewed: 07/2016).

    2016-10review

    Policy reviewed (Dates Reviewed: 10/2016).

    2017-08review

    Policy reviewed (Dates Reviewed: 08/2017).

    2018-07review

    Policy reviewed (Dates Reviewed: 07/2018).

    2019-07review

    Policy reviewed (Dates Reviewed: 07/2019).

    2020-07review

    Policy reviewed (Dates Reviewed: 07/2020).

    2021-09review

    Policy reviewed (Dates Reviewed: 09/2021).

    2022-09review

    Policy reviewed (Dates Reviewed: 09/2022).

    2023-09review

    Policy reviewed (Dates Reviewed: 09/2023).

    2024-06review

    Policy reviewed (Dates Reviewed: 06/2024).

    2025-06review

    Policy reviewed (Dates Reviewed: 06/2025).

    2026-06-02last_reviewLatest

    Last review date; policy status marked current and effective as of this date.