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    OpenPayerPolicy UpdatesObstetrics/GynecologyHealth Choice AZ Maternal Biomarker Update | OpenP…
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    CurrentHealth Choice ArizonaPolicy O1121

    Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes

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    This policy governs coverage determinations for maternal serum biomarker tests, with or without algorithmic analysis, used to predict preeclampsia or spontaneous preterm birth. Testing is considered experimental or investigational when specified regulatory, evidentiary, comparative-effectiveness, or non-investigational-setting criteria are met.

    Policy Summary
    PayerHealth Choice Arizona
    PolicyMaternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes
    Policy CodePolicy O1121
    Change TypeNo material change
    Effective DateJan 3, 2023
    Last ReviewJan 3, 2023
    Next Review DateJan 1, 2024
    Key ActionProviders requesting an exception should submit complete medical rationale to BCBSAZ.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2Obstetric outcomes addressed
    5Experimental or investigational criteria

    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.

    2
    CPT codes listed
    11-13 weeksScreening gestational timing
    1st Qtr 2024Next annual review period

    Experimental or Investigational Criteria

    Experimental or Investigational Maternal Serum Biomarker Testing

    The use of maternal serum biomarker tests, with or without additional algorithmic analysis, for the prediction of preeclampsia or spontaneous preterm birth is considered experimental or investigational when ANY ONE or more of the following criteria are met:

    ANY ONE or more of the following

    • Lack of final approval from the appropriate governmental regulatory bodies (e.g., Food and Drug Administration).
    • Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes.
    • Insufficient evidence to support improvement of the net health outcome.
    • Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives.
    • Insufficient evidence to support improvement outside the investigational setting.

    CPT Coding

    CPTCPT
    0243U
    0247U

    Exception Requests and Coverage Impact

    Documentation Required

    Exception Requests and Benefit Eligibility

    Coverage is dependent on the member’s specific benefit plan and eligibility, and the Evidence-Based Criteria must be read in its entirety to determine coverage eligibility. Providers requesting an exception should submit complete medical rationale to BCBSAZ; the provider and member remain responsible for decisions regarding the appropriateness of care.

    • Verify member-specific benefit eligibility: Coverage for the service, procedure, device, or drug is subject to the member’s applicable benefit plan.
    • Exception requests: Submit complete medical rationale supporting the requested exception to these guidelines.
    • Regulatory consideration: State or federal mandates, including the FEP program, may affect whether an FDA-approved product is classified as experimental or investigational.
    Denial Risk

    Experimental or Investigational Testing

    Policy Background

    This policy addresses maternal serum biomarker testing, with or without additional algorithmic analysis, proposed as an adjunct to standard screening for identifying women at risk of preeclampsia or spontaneous preterm birth. Improved identification of these risks may help reduce maternal and perinatal morbidity and mortality; traditional assessment relies on historical risk and other clinical factors.

    Clinical Terms and Test Definition

    Preeclampsia
    Clinical definitionNew-onset maternal hypertension and proteinuria, or new-onset hypertension and significant end-organ dysfunction, with or without proteinuria, after the 20th week of gestation.
    OnsetAfter the 20th week of gestation.
    Diagnostic featuresHypertension with proteinuria or significant end-organ dysfunction.
    Preterm birth
    DefinitionBirth occurring between the 20th and 37th week of pregnancy.
    Spontaneous birthMay follow preterm labor and rupture of membranes.
    Iatrogenic birth
    Policy Summary
    PayerHealth Choice Arizona
    PolicyMaternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes
    Policy CodePolicy O1121
    Change TypeNo material change
    Effective DateJan 3, 2023
    Last ReviewJan 3, 2023
    Next Review DateJan 1, 2024
    Key ActionProviders requesting an exception should submit complete medical rationale to BCBSAZ.
    SourceLink
    On This Page
    Experimental or Investigational CriteriaCPT CodingException Requests and Coverage ImpactPolicy BackgroundClinical Terms and Test Definition

    Maternal serum biomarker testing, with or without additional algorithmic analysis, is considered experimental or investigational for predicting preeclampsia or spontaneous preterm birth when any one or more of the criteria below apply. Providers should expect coverage denial when the testing meets one or more of these conditions, subject to applicable mandates and the member’s benefit plan.

    • Lack of final approval from the appropriate governmental regulatory bodies, such as the Food and Drug Administration.
    • Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes.
    • Insufficient evidence to support improvement of the net health outcome.
    • Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives.
    • Insufficient evidence to support improvement outside the investigational setting.
    May result from clinical interventions for maternal or fetal medical indications.
    PreTRM test
    TestThe PreTRM™ test is a maternal serum biomarker test from Sera Prognostics.
    BiomarkersUses insulin-like growth factor binding protein-4 (IBP4) and sex hormone binding globulin (SHBG).
    Additional measuresCombines the biomarkers with biometric measures.
    PurposeAssesses the risk of spontaneous preterm birth.