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    v1.0.28
    OpenPayerPolicy UpdatesLaboratory/PathologyNorth Dakota Insurance COVID-19 Coverage | OpenPay…
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    CurrentNorth Dakota Insurance DepartmentPolicy 2020-10

    Antibody Testing - COVID-19

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    This bulletin governs coverage expectations for FDA-authorized COVID-19 antibody testing when medically necessary to diagnose or treat COVID-19 or another covered health condition.

    Policy Summary
    PayerNorth Dakota Insurance Department
    PolicyAntibody Testing - COVID-19
    Policy CodePolicy 2020-10
    Change TypeNo material change
    Effective DateMay 18, 2020
    Next Review DateN/A
    Key ActionOrder the antibody test through an appropriate treating professional who tracks the patient's symptoms, diagnosis, and prognosis.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    CoveredFDA-authorized antibody tests
    Not coveredNon-diagnostic or non-treatment testing
    3Testing types discussed
    In/outNetwork access addressed

    Antibody Testing Coverage 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.

    Medically Necessary Antibody Testing

    FDA-authorized COVID-19 antibody tests are covered when medically necessary and ordered by an appropriate treating medical professional.

    ALL of the following

    • The antibody test is FDA-authorized, including authorization through premarket approval or an emergency use pathway.
    • The test is medically necessary for the particular patient.
    • The test is ordered by an appropriate treating medical professional who is tracking the patient's symptoms, diagnosis, and prognosis.

    • The test is used to support

      • Diagnosis or treatment of COVID-19.
      • Treatment of another disease in the particular patient.

    COVID-19 antibody testing is not medically necessary when it is not associated with diagnosing or treating disease in a particular patient. Testing used for non-diagnostic or non-treatment purposes falls outside medically necessary coverage.

    COVID-19 antibody testing is not considered medically necessary when used as part of return-to-work programs, public health surveillance testing, or any other effort not associated with disease diagnosis or treatment.

    Provider Documentation and Coverage Risks

    Documentation Required

    Medical Necessity and Ordering Documentation

    Coverage requires documentation that the COVID-19 antibody test is medically necessary and ordered by an appropriate treating medical professional who is tracking the patient’s symptoms, diagnosis, and prognosis. The documentation must support diagnosis or treatment of COVID-19 or treatment of another disease or condition in that particular patient.

    • Order from an appropriate treating medical professional.
    • Document symptom, diagnosis, and prognosis tracking.
    • Support the test’s use for diagnosis or treatment of COVID-19 or another disease or condition in the individual patient.
    Denial Risk

    Non-Diagnostic Uses May Be Denied

    A COVID-19 antibody test is not considered medically necessary when used for purposes unrelated to disease diagnosis or treatment. Such uses create a coverage denial risk.

    • Return-to-work programs
    • Public health surveillance testing
    • Other efforts not associated with disease diagnosis or treatment
    Prior Authorization

    FDA Authorization Required

    Carriers are expected to cover COVID-19 antibody tests only when the test is authorized by the FDA and the applicable medical-necessity and ordering requirements are met. FDA authorization includes approval for patient use through a premarket approval pathway or an emergency-use pathway.

    • Confirm FDA authorization before ordering or billing.
    • FDA authorization may be through premarket approval.
    • FDA authorization may be through an emergency-use pathway.

    COVID-19 Testing Context

    COVID-19 PCR and antigen tests detect the virus or components of the virus. Antigen tests identify a unique part of COVID-19, such as a specific protein on a viral spike. Antibody tests, also called serology tests, detect antibodies in the patient's immune system that may fight COVID-19.

    Testing Definitions

    Antibody tests (serology tests)
    DefinitionTests that look for the presence of antibodies in a patient's immune system that may fight off COVID-19.
    Also known asSerology tests
    What it detectsAntibodies in the immune system
    Antigen tests
    DefinitionTests that look for a unique part of COVID-19, such as a specific protein on one of the unique COVID-19 spikes.
    What it detectsA unique part of COVID-19
    Example targetA specific protein on one of the COVID-19 spikes

    Covered Clinical Indications

    Diagnosis or Treatment of COVID-19

    Covered when all of the following conditions are met:

    COVID-19 diagnosis or treatment

    • The COVID-19 antibody test is medically necessary.
    • The test is FDA-authorized.

    • FDA authorization pathway

      • The test is approved through a premarket approval pathway.
      • The test is authorized through an emergency use pathway.
    • The test supports the diagnosis or treatment of COVID-19.

    Treatment of Another Disease or Condition in a Particular Patient

    Covered when all of the following conditions are met:

    Treatment of another disease or condition in a particular patient

    • The COVID-19 antibody test is medically necessary.
    • The test is ordered by an appropriate treating medical professional.
    • The ordering treating professional is tracking the patient's symptoms, diagnosis, and prognosis.
    • The test supports treatment of another disease or condition in that particular patient.

    Ordering Professional Requirements

    Documentation Required

    Order through the treating professional

    The test must be ordered by an appropriate treating medical professional who is tracking the patient’s symptoms, diagnosis, and prognosis.

    Non-Covered Testing Uses

    The following antibody testing uses are not covered as medically necessary: return-to-work programs; public health surveillance; and antibody testing or other efforts not associated with disease diagnosis or treatment.

    Policy Summary
    PayerNorth Dakota Insurance Department
    PolicyAntibody Testing - COVID-19
    Policy CodePolicy 2020-10
    Change TypeNo material change
    Effective DateMay 18, 2020
    Next Review DateN/A
    Key ActionOrder the antibody test through an appropriate treating professional who tracks the patient's symptoms, diagnosis, and prognosis.
    SourceLink
    On This Page
    Antibody Testing Coverage CriteriaProvider Documentation and Coverage RisksCOVID-19 Testing ContextTesting DefinitionsCovered Clinical IndicationsOrdering Professional RequirementsNon-Covered Testing Uses