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    v1.0.31
    OpenPayerPolicy UpdatesGenetic & Molecular TestingRegence AMD Genetic Testing Coverage | OpenPayer
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    CurrentRegence BlueCross BlueShieldPolicy 75

    Genetic Testing for Macular Degeneration

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    This policy governs coverage of genetic testing intended to assess risk of developing or progressing age-related macular degeneration or to guide AMD treatment. Such testing is considered investigational.

    Policy Summary
    PayerRegence BlueCross BlueShield
    PolicyGenetic Testing for Macular Degeneration
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateNovember 1, 2026
    Last ReviewSep 1, 2026
    Next Review DateJuly 1, 2027
    Key ActionDo not request genetic testing for macular degeneration because it is considered investigational and at risk of denial.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    InvestigationalCoverage status of genetic testing for macular degeneration
    InvestigationalCoverage stance for genetic testing for AMD
    InsufficientEvidence for improved treatment decisions or health outcomes
    2025AAO guidance on routine genetic testing

    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.

    Coverage Criteria

    Genetic testing for macular degeneration

    Genetic testing for macular degeneration is considered investigational.

    Investigational service: Genetic testing for macular degeneration is considered investigational.

    The policy does not identify a covered clinical indication or exception.

    Genetic testing for AMD

    Genetic testing for AMD is considered investigational.

    Investigational status: Current evidence is insufficient to demonstrate that genetic testing for age-related macular degeneration improves treatment decisions or health outcomes.

    No covered indication is identified in this policy.

    Uses lacking demonstrated clinical utility

    Routine testing is not recommended or warranted when clinical utility has not been demonstrated.

    Unsupported clinical uses: Testing is used for routine assessment of patients with complex eye disease, unaffected individuals with a family history of AMD, prediction of progression to advanced AMD, guidance of anti-VEGF treatment, or nutritional supplement recommendations without evidence of improved outcomes.

    Routine genetic testing is not warranted because current evidence has not shown improved surveillance, visual outcomes, treatment decisions, or nutritional supplement recommendations.

    Genetic testing for macular degeneration is considered investigational under this policy.

    Routine genetic testing is not warranted for patients with complex eye diseases or for unaffected patients with a family history of these diseases. The AAO indicates that testing may become relevant when clinical trials demonstrate that specific genotypes benefit from specific therapy or surveillance.

    Genetic testing is not recommended for patients with neovascular AMD to guide anti-VEGF treatment because it has not provided clinically relevant information about treatment response.

    There is insufficient evidence to support the use of AMD genetic testing to determine nutritional supplement recommendations.

    Genetic testing for AMD is considered investigational because current evidence is insufficient to demonstrate that testing improves treatment decisions or health outcomes.

    Coding

    Investigational genetic testing codesmixedNot Covered
    0205UOphthalmology (age-related macular degeneration), analysis of 3 gene variants (2 CFH gene, 1 ARMS2 gene), using PCR and MALDI-TOF, buccal swab, reported as positive or negative for neovascular age-related macular-degeneration risk associated with zinc supplements
    81408Molecular pathology procedure, Level 9 (eg, analysis of >50 exons in a single gene by DNA sequence analysis)
    81479Unlisted molecular pathology procedure
    81599Unlisted multianalyte assay with algorithmic analysis

    Provider Actions

    Denial Risk

    Investigational testing may be denied

    Requests for genetic testing for macular degeneration are at risk of denial because the testing is considered investigational. Contract language governing investigational services takes precedence over the medical policy; inform members before rendering the service that they are likely to be financially responsible.

    • Confirm applicable contract terms before ordering the test.
    • Advise the member of likely financial responsibility before the service is rendered.
    Denial Risk

    AMD genetic testing lacks demonstrated benefit

    Genetic testing for AMD is considered investigational because current evidence is insufficient to demonstrate that testing improves treatment decisions or health outcomes. No covered indication is identified for this testing under the policy.

    Denial Risk

    Avoid unsupported AMD testing uses

    Routine genetic testing is not warranted for patients with complex eye diseases or unaffected patients with a family history of such diseases. Testing is also not recommended for patients with neovascular AMD to guide anti-VEGF treatment, or to determine nutritional supplement recommendations, because clinically meaningful benefit has not been demonstrated.

    • Do not order routine testing solely for complex eye disease or family history.
    • Do not use testing to guide anti-VEGF treatment in neovascular AMD.
    • Do not use testing to guide nutritional supplement recommendations.

    Background

    Age-related macular degeneration (AMD) is a complex condition influenced by genetic and environmental factors and is a major cause of severe vision loss in older adults. AMD includes dry and wet forms; wet AMD involves abnormal choroidal blood-vessel growth and may cause rapidly progressive, permanent central vision loss. Genetic testing has been proposed to predict progression to advanced AMD or guide treatment, but the testing remains investigational under this policy.

    Definitions

    Analytic validity
    DefinitionThe technical accuracy of a test in detecting a genetic variant that is present or excluding a variant that is absent.
    Clinical validity
    DefinitionThe diagnostic performance of a test, including sensitivity, specificity, and positive and negative predictive values, in detecting clinical disease.
    Clinical utility
    DefinitionThe extent to which test results change patient management and whether those changes produce clinically important improvements in health outcomes.
    Variant of uncertain significance
    DefinitionA genetic change whose effect on human health is unknown.
    Pathogenic variant
    DefinitionA variant associated with disease.
    Benign variant
    DefinitionA variant not associated with disease.
    AMD
    DefinitionAge-related macular degeneration, a complex eye disease for which genetic testing may be used to assess disease risk, progression, or treatment response.
    Policy relevanceGenetic testing for AMD is considered investigational because current evidence is insufficient to demonstrate improvement in treatment decisions or health outcomes.
    Neovascular AMD
    DefinitionA form of AMD involving abnormal blood-vessel growth.
    Treatment relevanceGenetic testing has not provided clinically relevant information regarding response to anti-vascular endothelial growth factor treatment.
    Policy positionGenetic testing is not recommended for patients with neovascular AMD to guide anti-VEGF treatment.

    Eligibility Requirements

    Testing of unaffected patients with a family history of complex eye disease or AMD is not warranted under current evidence. Routine testing is not recommended unless clinical trials demonstrate that specific genotypes provide benefit from specific therapy or surveillance.

    Not Covered

    The following uses are not covered because they lack demonstrated clinical utility: testing to identify individuals at risk of developing advanced AMD; testing to predict progression from early or intermediate AMD to advanced disease; single-gene or multigene testing associated with advanced AMD; routine AMD genetic testing; testing intended to alter management based on predicted progression; testing in neovascular AMD to predict response to anti-VEGF therapy; and testing to guide nutritional supplement recommendations.

    Policy Summary
    PayerRegence BlueCross BlueShield
    PolicyGenetic Testing for Macular Degeneration
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateNovember 1, 2026
    Last ReviewSep 1, 2026
    Next Review DateJuly 1, 2027
    Key ActionDo not request genetic testing for macular degeneration because it is considered investigational and at risk of denial.
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider ActionsBackgroundDefinitionsEligibility RequirementsNot Covered