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    v1.0.28
    OpenPayerPolicy UpdatesOphthalmology/OptometryCareFirst DecisionDx-UM Coverage Update | OpenPaye…
    Ask Trek AI about this page
    RetiredCareFirstPolicy N/A

    DecisionDx-UM gene expression profile for uveal melanoma — Coverage Criteria

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    Governs coverage of the DecisionDx-UM 15-gene expression profile for patients with uveal (uveal tract) melanoma; affects ordering providers, laboratories, and CareFirst members.

    Policy Summary
    PayerCareFirst
    PolicyDecisionDx-UM gene expression profile for uveal melanoma — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeRetiredclarified coverage stance
    Effective DateOct 6, 2016
    Last ReviewFeb 1, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization to confirm the indication is primary, localized uveal melanoma before ordering DecisionDx-UM.
    SourceLink
    POLICY UPDATE CHANGES

    This policy has been retired as of 02/01/2025 and is no longer scheduled for review.

    DecisionDx-UM is considered medically necessary for primary, localized uveal melanoma but experimental/investigational for all other indications.

    15genes measured by DecisionDx-UM
    3reported risk classifications
    4–5/millionannual incidence
    Class 2

    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.

    high-risk class
    02/01/2025retirement date

    Coverage Criteria

    Medically necessary indication

    Covered when ALL of the following are met

    Primary localized uveal melanoma: DecisionDx-UM GEP is considered medically necessary for patients with primary, localized uveal melanoma (choroidal or ciliary body).

    Supported by evidence of prognostic validity (GEP classification predicts metastatic risk) and clinical utility data indicating surveillance intensity may be guided by risk class.

    Experimental / investigational indications

    Considered experimental/investigational when ANY of the following apply

    Other indications: Use of DecisionDx-UM for indications other than primary, localized uveal melanoma is considered experimental/investigational (does not meet TEC criteria #2-5).

    Examples are not exhaustively listed in the policy; uses outside the covered indication require case-by-case review and are subject to denial.

    Use of DecisionDx-UM for any indication other than primary, localized uveal melanoma is excluded from coverage. The policy specifies that the gene expression profile is considered medically necessary only for patients with primary, localized uveal melanoma; uses outside that indication do not meet coverage criteria and are not covered.

    DecisionDx-UM for any indication other than primary, localized uveal melanoma is considered not medically necessary and is classified as experimental/investigational. The policy states that the assay does not meet the Technology Evaluation Committee criteria for other uses and that the 2018 update affirmed investigational status for all non–primary, localized uveal melanoma indications.

    Coding and Test Identification

    Test identification / LDTmixed
    laboratory-developed test (LDT)DecisionDx-UM (Castle Biosciences) — 15-gene expression profile; CLIA-certified laboratory test
    5-year metastasis risk reporting
    Reported metricPercentage risk for metastatic disease within five years
    Timeframe5-year risk
    Use in reportProvided alongside one of three risk classifications (DecisionDx-UM)
    Specimen types usedFine needle aspiration (FNA/FNAB) biopsy or formalin-fixed paraffin-embedded (FFPE) slide

    Provider Actions and Billing

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required when requesting coverage for DecisionDx-UM to confirm the indication is primary, localized uveal melanoma.

    • Applicable when DecisionDx-UM is ordered
    • Verify diagnosis supports primary, localized uveal melanoma prior to authorization
    Step Therapy

    Step Therapy

    No step therapy requirements specified for coverage of DecisionDx-UM.

    Documentation Required

    Specimen and Diagnosis Documentation

    Background

    Uveal melanoma is the most common intraocular malignancy in adults with an incidence of approximately 4–5 new cases per million annually. Tumors arising in the uveal tract include those of the choroid, ciliary body, and iris; metastatic risk is higher for posterior uveal melanomas (choroid and ciliary body) compared with iris lesions, and when metastasis occurs it most commonly involves the liver. The DecisionDx-UM 15‑gene expression profile classifies tumors into risk categories to estimate 5‑year metastatic risk and is intended to guide surveillance intensity.

    Definitions

    DecisionDx-UM (definition)
    Test nameDecisionDx-UM (15-gene expression profile)
    Specimen typesFine needle aspiration biopsy (FNAB/FNA) or FFPE tumor material
    OutputOne of three risk classifications with a percentage estimate for 5-year metastatic risk
    Developer / typeCastle Biosciences; laboratory-developed test (LDT)
    Clinical intentPrognostic stratification to guide surveillance intensity for uveal melanoma
    GEP class 2
    DefinitionGEP class 2 = high-risk gene expression profile associated with increased metastasis and worse melanoma-specific survival
    Policy Summary
    PayerCareFirst
    PolicyDecisionDx-UM gene expression profile for uveal melanoma — Coverage Criteria
    Policy CodePolicy N/A
    Change TypeRetiredclarified coverage stance
    Effective DateOct 6, 2016
    Last ReviewFeb 1, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization to confirm the indication is primary, localized uveal melanoma before ordering DecisionDx-UM.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Test IdentificationProvider Actions and BillingBackgroundDefinitions

    Specimen and diagnosis documentation must be provided. The DecisionDx-UM assay is performed on either fine needle aspiration biopsy (FNAB/FNA) material or formalin-fixed paraffin-embedded (FFPE) tumor tissue. Clinical documentation must support the specimen source and confirm the diagnosis of primary, localized uveal melanoma.

    • Acceptable specimens: FNAB/FNA or FFPE tumor tissue
    • Documented diagnosis: evidence the tumor is primary, localized uveal melanoma
    • Include pathology or clinical notes confirming tumor location and staging as needed for prior authorization
    Denial Risk

    Denial Risk for Non-Covered Indications

    Claims for DecisionDx-UM submitted for indications other than primary, localized uveal melanoma are at risk for denial as experimental/investigational.

    • Denial basis: experimental / investigational for non-covered indications
    • Covered indication: primary, localized uveal melanoma only
    Associated outcomesLower metastasis-free survival (example: 3-year MFS ~63% for class 2 in a registry study)
    Impact on managementClass 2 patients were more often managed with high-intensity surveillance (imaging and liver function testing every 3–6 months)
    Role in PrognosisPredictor of metastatic disease and survival used to stratify surveillance intensity