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    v1.0.28
    OpenPayerPolicy UpdatesLaboratory/PathologyWest Virginia At-Home COVID Tests Coverage | OpenP…
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    CurrentWest Virginia Offices of the Insurance CommissionerPolicy 20-14

    At-Home COVID-19 Testing Kits

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    This bulletin governs coverage by group health plans and individual health insurance issuers for at-home COVID-19 diagnostic testing kits, including tests using self-collected specimens. It explains when coverage must be provided without cost sharing, prior authorization, or other medical management requirements, including when a provider evaluates the request remotely or indirectly.

    Policy Summary
    PayerWest Virginia Offices of the Insurance Commissioner
    PolicyAt-Home COVID-19 Testing Kits
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJuly 9, 2020
    Next Review DateN/A
    Key ActionDocument the screening or eligibility assessment, licensed provider review, scope of practice, and provider authorization or order for the at-home COVID-19 test.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    0Cost-sharing requirements permitted for qualifying covered tests
    0Prior authorization or medical management requirements permitted
    4Required elements for indirect or remote authorization
    EUA

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    FDA authorization pathway generally required

    Coverage Criteria

    At-home COVID-19 diagnostic testing coverage

    At-home COVID-19 diagnostic testing is covered when all applicable statutory and clinical criteria are met.

    Core coverage requirements

    • FDA EUA status: The test has received an Emergency Use Authorization under the Federal Food, Drug, and Cosmetic Act from the FDA.FDA EUA
    • Pending EUA pathway: The developer has requested or intends to request an EUA from the FDA; the EUA request has not been denied; and the request was submitted within a reasonable timeframe.Reasonable timeframe

      The plan or insurer may take reasonable or necessary steps to verify that the test meets statutory EUA criteria.

    Provider involvement pathway

    • Direct provider pathway: An attending healthcare provider orders the test after determining it is medically appropriate.
    • Indirect or remote pathway: The individual undergoes a valid screening or eligibility assessment; a licensed healthcare provider reviews and evaluates the assessment; the provider acts within the scope of the license; and the provider authorizes or orders the test.4 required elements
    Cost-sharing and utilization-management treatment: For a qualifying covered at-home COVID-19 diagnostic test, the insurer must provide coverage without imposing cost sharing, prior authorization, or other medical management requirements on the covered individual.No deductible, copayment, coinsurance, prior authorization, or other medical management requirement

    This treatment is subject to the applicable statutory and state requirements described in the bulletin.

    This bulletin’s coverage guidance does not override or supersede West Virginia’s existing COVID-19 testing coverage mandates, including Emergency Order 20-EO-07 and Emergency Order 20-EO-08. Qualifying at-home COVID-19 diagnostic testing must therefore be evaluated under this guidance together with all applicable state requirements.

    Covered Indications

    Diagnostic detection of COVID-19 using an at-home test

    Covered for diagnostic detection of COVID-19 when all applicable clinical and statutory requirements are met.

    Medical necessity and statutory criteria

    • Qualifying FDA authorization pathway: The test has received an Emergency Use Authorization under the Federal Food, Drug, and Cosmetic Act from the FDA.FDA EUA
    • Qualifying pending authorization pathway: The developer has requested or intends to request an EUA from the FDA; the EUA request has not been denied; and the developer submitted the EUA request within a reasonable timeframe.Reasonable timeframe

      The plan or insurer may take reasonable or necessary steps to verify that the test meets the statutory EUA criteria.

    Provider Actions

    Documentation Required

    Screening and Provider Authorization Documentation

    Before the at-home COVID-19 test is covered without cost-sharing, the individual must undergo a valid screening or eligibility assessment. A licensed healthcare provider must review and evaluate that assessment, act within the scope of the provider’s license, and authorize or order the test.

    • Document the individual’s valid screening or eligibility assessment.
    • Document licensed healthcare provider review and evaluation of the assessment.
    • Confirm the provider acted within the scope of the provider’s license.
    • Confirm the provider authorized or ordered the at-home COVID-19 test.
    Documentation Required

    FDA EUA Eligibility Documentation

    Retain or verify evidence that the at-home test satisfies the FDA Emergency Use Authorization pathway required by section 6001(a) of the FFCRA. A plan or insurer may take reasonable or necessary steps to verify qualifying pending authorization information.

    • The test has received an Emergency Use Authorization (EUA) from the FDA under the Federal Food, Drug, and Cosmetic Act; or

    Ordering Requirements

    Note

    Obtain an attending provider order

    An attending healthcare provider must determine that the at-home COVID-19 test is medically appropriate based on accepted standards of medical practice and authorize or order it. The provider may act remotely, virtually, or indirectly and need not directly interact with the individual, but must be licensed or authorized, act within the scope of the license or authorization, and review or perform a valid screening or eligibility assessment when using the indirect pathway.

    Definitions

    Attending healthcare provider
    DefinitionAn individual who is licensed or authorized and responsible for providing care to the patient.
    Authorization and scopeThe provider must act within the scope of the applicable license or authorization.
    Clinical responsibilityThe provider must make an individualized clinical assessment to determine whether testing is medically appropriate in accordance with accepted standards of medical practice.
    Direct patient contactThe provider need not be directly responsible for providing care or directly interact with the individual when making the individualized clinical assessment.
    Diagnostic testing
    DefinitionTesting for detection of COVID-19 that meets the applicable statutory criteria.

    Background

    The bulletin addresses at-home COVID-19 diagnostic testing, including testing performed with specimens collected by the individual. Coverage without cost sharing, prior authorization, or other medical-management requirements depends on medical appropriateness determined with healthcare-provider involvement. That involvement may occur remotely, virtually, or indirectly through review of a screening or eligibility assessment, but a licensed healthcare provider must review the assessment, act within the scope of the license, and authorize or order the test.

    Policy Summary
    PayerWest Virginia Offices of the Insurance Commissioner
    PolicyAt-Home COVID-19 Testing Kits
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJuly 9, 2020
    Next Review DateN/A
    Key ActionDocument the screening or eligibility assessment, licensed provider review, scope of practice, and provider authorization or order for the at-home COVID-19 test.
    SourceLink
    On This Page
    Coverage CriteriaCovered IndicationsProvider ActionsOrdering RequirementsDefinitionsBackground
  1. The developer has requested, or intends to request, an FDA EUA, the request has not been denied, and it was or will be submitted within a reasonable timeframe.
  2. Reasonable or necessary verification requests do not violate the FFCRA prohibition on medical management requirements.
    3. Denial Risk

    Required Screening, Provider Review, and Authorization

    Coverage without cost-sharing, prior authorization, or other medical management requirements depends on the required screening, provider review, and authorization conditions being met. A healthcare provider must be involved—even remotely, virtually, or indirectly through review or assessment—in determining that the test is medically appropriate.

    • Coverage may be disqualified when the individual has not undergone a valid screening or eligibility assessment.
    • Coverage may be disqualified when a licensed healthcare provider has not reviewed and evaluated the assessment.
    • Coverage may be disqualified when the provider is not acting within the scope of the provider’s license.
    • Coverage may be disqualified when the provider has not authorized or ordered the test.
    • Insurers should give deference to the provider’s clinical judgment regarding medical appropriateness, but provider involvement remains required.
    Billing Rule

    Test Must Satisfy EUA Criteria

    The at-home diagnostic test must satisfy the statutory diagnostic-testing criteria under section 6001(a)(1) of the FFCRA. Generally, this means the test has received an FDA Emergency Use Authorization or qualifies under a pending EUA pathway.

    • The test must have received an FDA EUA; or
    • The developer must have requested, or intend to request, an FDA EUA, provided the request has not been denied and was or will be submitted within a reasonable timeframe.
    • The test must otherwise satisfy the applicable statutory criteria for diagnostic testing.
    At-home testingIncludes COVID-19 tests intended for at-home use, including at-home COVID-19 testing kits.
    Self-collected specimensIncludes tests in which an individual self-collects a specimen at home.
    Medical appropriatenessThe test must be medically appropriate for the individual based on an attending healthcare provider's assessment and accepted standards of medical practice.