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    v1.0.28
    OpenPayerPolicy UpdatesAdministrative/Operational PolicyCareSource Georgia Cystic Fibrosis Testing Coverag…
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    CurrentCareSource GeorgiaPolicy Cystic Fibrosis Testing-MP-AD-1219

    Cystic Fibrosis Testing

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    Defines CareSource Marketplace coverage and medical necessity criteria for cystic fibrosis (CF) genetic and diagnostic testing, including carrier screening and diagnostic indications, and applies to Marketplace members in listed states.

    Policy Summary
    PayerCareSource Georgia
    PolicyCystic Fibrosis Testing
    Policy CodePolicy Cystic Fibrosis Testing-MP-AD-1219
    Change TypeNo material changes
    Effective DateJun 1, 2025
    Last ReviewNov 5, 2024
    Next Review Date
    Key ActionMedical necessity review is required only for CF genomic sequence analysis.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Diagnostic & carrierIndications included
    One-timeTesting frequency
    GA, IN, KY, OH, WVMarketplaces
    Repeat/fetalExclusions

    Coverage and Medical Necessity Criteria

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    Covered Indications for Testing

    Coding and Diagnostic Thresholds

    CF testing coverage codingmixed
    No codes listed
    Sweat chloride diagnostic threshold
    Sweat chloride — diagnostic>= 60 mmol/L indicates cystic fibrosis (diagnostic)
    Sweat chloride — intermediate30-59 mmol/L considered intermediate (indeterminate)
    Role in diagnosisElevated sweat chloride is evidence of CFTR dysfunction used with clinical features and/or genetic findings to establish diagnosis

    Provider Actions and Documentation Requirements

    Documentation Required

    Post-payment documentation and potential recoupment

    CareSource may request documentation for post-payment review of claims submitted for payment of CF testing; if documentation is not provided, CareSource may recoup previously paid claim(s).

    Prior Authorization

    Medical necessity review required only for CF genomic sequence analysis

    A medical necessity review is required only for CF genomic sequence analysis; other CF genetic testing using ACMG-recommended CFTR panels does not require prior medical necessity review.

    Note

    Carrier testing may inform reproductive decision-making; counseling policy referenced

    Carrier testing can provide reproductive information and the policy references the related Genetic Testing and Counseling policy; there is no explicit requirement for pre- or post-test genetic counseling in this document.

    • Carrier testing may inform reproductive decision-making and identify carriers.
    • Related policy: Genetic Testing and Counseling (referenced).
    Note

    No clinician-type ordering restriction specified

    The policy does not state any clinician-type restriction for who may order CF testing; no explicit ordering limitation by clinician specialty is specified.

    Definitions and Abbreviations

    ACMG
    ACMG full nameAmerican College of Medical Genetics and Genomics
    RoleProvides technical recommendations for genetic diseases, including recommended CFTR testing panels
    Use in policyPolicy requires use of currently recommended ACMG CFTR panels for genetic testing
    Autosomal Recessive
    DefinitionAutosomal Recessive: requires deleterious variants in both copies of a gene to express a phenotype
    Implication for CFCF is inherited in an autosomal recessive manner; two disease-causing CFTR variants typically required for classic CF
    Relevance to carrier screeningParents who each carry one pathogenic variant can have affected offspring
    Carrier
    DefinitionCarrier: an individual with a gene variant who can pass it to offspring but typically has no symptoms
    Reproductive relevanceCarrier status informs reproductive risk and is an indication for carrier screening when pregnancy is planned or ongoing
    Testing implicationCarrier detection uses ACMG-recommended CFTR panels per policy
    CFTR-Related Disorder
    DefinitionCFTR-Related Disorder: a single pathogenic CFTR variant causing disease limited to one organ system in an individual who does not meet diagnostic criteria for cystic fibrosis
    Distinction from CFDoes not meet full diagnostic criteria for CF (e.g., lacks multisystem disease or confirmatory CFTR dysfunction criteria)
    Clinical relevanceRecognizing CFTR-related disorders helps avoid misclassification and guides appropriate management/testing
    CRMS / CFSPID
    DefinitionCRMS / CFSPID: infants and children who are asymptomatic but have positive newborn CF screening results (CF screen positive, inconclusive diagnosis)
    Prevalence on screeningFound in approximately 3-4% of infants with a positive newborn CF screen
    Follow-up implicationCRMS/CFSPID designation indicates need for follow-up and monitoring rather than immediate CF diagnosis
    IRT
    DefinitionImmunoreactive Trypsinogen (IRT): a pancreatic enzyme precursor measured in newborn screening for cystic fibrosis
    Role in screeningElevated IRT on newborn screen prompts further testing (e.g., sweat chloride and/or genetic testing)
    Use in diagnostic pathwayPolicy cites newborn IRT as part of the multistage diagnostic process for CF

    Eligibility Requirements

    This policy includes an Eligibility Requirements section but contains no top-level eligibility nodes specified in the document. Applicable indications for testing (diagnostic and carrier) and any limits on testing are described elsewhere in the policy under Coverage Criteria and Covered Indications.

    There are no separate, explicit eligibility requirement entries listed as top-level nodes in this policy. Diagnostic evaluation and testing eligibility are defined by the clinical indications and diagnostic criteria in the document (for example, clinical symptoms consistent with CF plus evidence of CFTR dysfunction such as elevated sweat chloride, two disease-causing CFTR variants, or abnormal NPD, and newborn screening pathways involving IRT, sweat chloride, and genetic testing). Carrier screening eligibility is defined under covered indications (pregnant or reproductive-age members intending to procreate, partners of positive testers, family history, or when both parents are carriers).

    Not Medically Necessary / Exclusions

    The policy explicitly states that the following are not considered medically necessary and will not be covered: repeat testing for the same CFTR panel, fetal testing, and gene sequencing of anything other than the CFTR gene. These exclusions apply regardless of other testing circumstances and should be considered when submitting claims for CF-related genetic testing.

    Policy Summary
    PayerCareSource Georgia
    PolicyCystic Fibrosis Testing
    Policy CodePolicy Cystic Fibrosis Testing-MP-AD-1219
    Change TypeNo material changes
    Effective DateJun 1, 2025
    Last ReviewNov 5, 2024
    Next Review Date
    Key ActionMedical necessity review is required only for CF genomic sequence analysis.
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaCovered Indications for TestingCoding and Diagnostic ThresholdsProvider Actions and Documentation RequirementsDefinitions and AbbreviationsEligibility RequirementsNot Medically Necessary / Exclusions