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    v1.0.28
    OpenPayerPolicy UpdatesLaboratory/PathologyWellCare Concert Genetics Lab Coverage Policy Upda…
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    CurrentWellCarePolicy N/A

    Application of the Concert Genetics Laboratory Testing Clinical Policies for Medicare Beneficiaries

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    Defines how Centene-affiliated Medicare Advantage plans apply Medicare NCDs/LCDs and, where those do not fully establish coverage for a laboratory test, how Concert Genetics clinical policies are used to determine medical necessity for laboratory testing. Affects providers ordering lab tests for Medicare Advantage members of Centene-affiliated plans.

    Policy Summary
    PayerWellCare
    PolicyApplication of the Concert Genetics Laboratory Testing Clinical Policies for Medicare Beneficiaries
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionWhen Medicare NCDs/LCDs do not fully establish coverage for a lab test, apply Concert Genetics clinical policy criteria or refer to medical director review if Concert does not address the test.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Centene-affiliatedapplicability
    Medicare Advantagelines of business governed
    biannualupdate frequency

    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 Determination & Criteria

    Coverage determination process

    Coverage decisions follow the hierarchy below when determining medical necessity for laboratory tests for Medicare Advantage members of Centene-affiliated plans:

    Tiered application of coverage rules: 1) Apply Traditional Medicare NCDs and LCDs where applicable; 2) If NCD/LCD do not fully establish coverage for a test, apply Concert Genetics clinical policy medical necessity criteria for that test; 3) If Concert Genetics policies do not address the test, refer case to medical director review for medical necessity determination.

    Order is mandatory and determinative

    Coverage decisions for laboratory tests for Medicare Advantage members follow a mandatory hierarchy. First, apply Traditional Medicare NCDs and LCDs where applicable. If an applicable NCD/LCD does not fully establish coverage for a test, apply the Concert Genetics clinical policy medical necessity criteria for that test. If Concert Genetics policies do not address the test, the case must be referred for individual medical director review to determine medical necessity.

    Laboratory tests that are supported by Traditional Medicare NCDs/LCDs or by Concert Genetics clinical policy medical necessity criteria.

    Laboratory tests are covered when supported by Traditional Medicare coverage determinations or by Concert Genetics clinical policy medical necessity criteria.

    ONE of the following must apply: Test is supported by an applicable Traditional Medicare national coverage determination (NCD) or local coverage determination (LCD).

    Medicare NCDs/LCDs take precedence

    ONE of the following must apply: If no applicable NCD/LCD fully establishes coverage, the test meets the medical necessity criteria specified in the Concert Genetics clinical policy for that test, which are derived from evidence-based professional guidelines or standards bodies and updated biannually.

    Apply Concert Genetics criteria when Medicare determinations are not definitive

    ONE of the following must apply: If neither an NCD/LCD nor Concert Genetics policy addresses the test, the case must be submitted for individual medical director review to determine medical necessity.

    Medical director review may functionally operate as prior authorization/review

    What Providers Must Do

    Note

    Apply Concert Genetics policies when NCD/LCD are insufficient

    For Medicare Advantage members, Traditional Medicare NCDs and LCDs take precedence. When an applicable NCD or LCD does not fully establish coverage for a laboratory test, the plan will apply the Concert Genetics Laboratory Testing Clinical Policies to determine medical necessity. If Concert Genetics policies do not address a specific test, the case will be reviewed by medical directors for medical necessity determinations.

    Prior Authorization

    (Operational note) Additional provider actions

    Providers should submit requests for coverage or prior authorization with clear clinical rationale and supporting documentation referencing the applicable Concert Genetics clinical policy criteria when an NCD/LCD does not fully address the test. For tests not covered by Concert Genetics policies, include comprehensive clinical details to support medical director review.

    • Include patient clinical history, indication for testing, and previous test results when available
    • Reference the specific Concert Genetics policy or guideline that supports testing when applicable
    • If no Concert Genetics policy exists, clearly state the clinical question and why testing is being requested

    Key Terms

    Concert Genetics clinical policies — definition and role
    DefinitionConcert Genetics clinical policies are evidence-based medical necessity criteria for laboratory tests adopted by Centene when Medicare NCDs/LCDs do not fully establish coverage.
    Source of criteriaCriteria are adopted from evidence-based professional guidelines and standards bodies (for example, IDSA, ATS, ACG, AUA; CDC; USPSTF).
    Role in coverage determinationsApplied by Centene when Traditional Medicare NCDs/LCDs do not fully establish coverage for a laboratory test; determinative unless an applicable NCD/LCD exists.
    When not applicableIf Concert Genetics policies do not address a test, the case is referred to medical director review for medical necessity determination.
    Update frequencyCriteria are updated biannually to reflect guideline updates and new evidence.
    NCD/LCD — Traditional Medicare national or local coverage determinations definition

    Ordering Rules for Medicare Advantage Members

    Step Therapy

    Ordering requirements: prioritize NCD/LCD; use Concert Genetics when unclear; medical director review if absent

    Order flow for Medicare Advantage members follows Medicare NCDs/LCDs first; when those determinations are unclear or incomplete, apply Concert Genetics policy criteria; if neither source establishes coverage, expect medical director review to determine medical necessity.

    • Prioritize Traditional Medicare NCDs and LCDs when applicable.
    • Use Concert Genetics clinical policy criteria when Medicare determinations do not fully establish coverage.
    • If unclear or absent, submit for medical director review.

    Indications Considered Covered

    Laboratory tests supported by NCDs/LCDs or Concert Genetics clinical policy medical necessity criteria (evidence-based guideline references)

    Evidence base and references used to support Concert Genetics medical necessity criteria:

    Guideline sources: Concert Genetics medical necessity criteria are adopted from evidence-based professional guidelines published by national medical societies (examples include the Infectious Disease Society of America, the American Thoracic Society, the American College of Gastroenterologists, and the American Urological Association).

    Examples listed in source document

    Standards bodies: Concert Genetics criteria also reference standards bodies such as the Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force when applicable.

    Standards bodies cited in source document

    Update frequency and transparency: Criteria and their supporting references (including evidence summaries) are updated biannually and published on Centene-affiliated plan websites and the Concert Genetics website for public access.

    Tests or Indications Not Covered

    This document does not list specific tests or indications that are categorically not covered. However, when a test is not addressed by an applicable Medicare NCD/LCD and is not covered by Concert Genetics clinical policies, the matter will be escalated for individual medical director review, which may result in non-coverage.

    Background and Evidence Basis

    The Concert Genetics clinical policies derive medical necessity criteria from evidence-based professional guidelines and recognized standards bodies (for example, Infectious Disease Society of America, American Thoracic Society, CDC, and USPSTF). These guidelines balance the benefits of testing against the harms of not testing or delaying testing. Policies and their supporting references are updated biannually and are publicly accessible through Centene-affiliated health plan sites and the Concert Genetics website.

    Policy Summary
    PayerWellCare
    PolicyApplication of the Concert Genetics Laboratory Testing Clinical Policies for Medicare Beneficiaries
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionWhen Medicare NCDs/LCDs do not fully establish coverage for a lab test, apply Concert Genetics clinical policy criteria or refer to medical director review if Concert does not address the test.
    SourceLink
    On This Page
    Coverage Determination & CriteriaWhat Providers Must DoKey TermsOrdering Rules for Medicare Advantage MembersIndications Considered CoveredTests or Indications Not CoveredBackground and Evidence Basis
    Documentation Required

    Documentation to support medical necessity

    Documentation must support medical necessity. Providers should be prepared to supply clinical records, guideline references, and any evidence that demonstrates the test meets Concert Genetics medical necessity criteria or applicable Medicare documentation standards.

    • Submit relevant clinical notes, labs, imaging, and prior treatments
    • Cite the specific Concert Genetics criteria or national guideline(s) that justify the test
    • Provide timeline of symptoms and prior diagnostic efforts when relevant
    Denial Risk

    Denial risk for tests lacking coverage criteria

    There is a high denial risk for tests that lack coverage criteria in an applicable NCD/LCD and are not supported by Concert Genetics clinical policies or sufficient clinical documentation. Tests without supporting Medicare determinations or Concert Genetics criteria are more likely to be denied on review.

    • Denials are more likely when no NCD/LCD applies and no Concert Genetics policy or guideline-based justification is provided
    • Consider prior authorization or pre-review with supporting evidence to reduce denial risk
    DefinitionNCD/LCD refers to Traditional Medicare national coverage determinations (NCDs) and local coverage determinations (LCDs).
    PrecedenceFor Medicare Advantage members, Centene-affiliated plans apply NCDs and LCDs first when determining coverage for laboratory tests.
    Action when incompleteWhen coverage criteria are not fully established in applicable Medicare statute, regulation, NCD or LCD, Concert Genetics clinical policies are applied.
    Interaction with Concert GeneticsNCDs/LCDs take precedence; Concert Genetics policies are secondary and used only when Medicare determinations are not fully definitive.

    Updates and public availability stated in source