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    v1.0.28
    OpenPayerPolicy UpdatesInfectious DiseaseAmbetter Nevada CMV testing Coverage Update | Open…
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    ModifiedAmbetter NevadaPolicy N/A

    CONCERT INFECTIOUS DISEASE: MULTISYSTEM TESTING

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    Defines medical necessity criteria for cytomegalovirus (CMV) antibody and nucleic acid/PCR or antigen detection tests, and states the coverage stance on untargeted metagenomic sequencing for pathogen detection in the outpatient setting.

    Policy Summary
    PayerAmbetter Nevada
    PolicyCONCERT INFECTIOUS DISEASE: MULTISYSTEM TESTING
    Policy CodePolicy N/A
    Change TypeWording clarifiedcoding reorganizedassay added
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument indication and supporting clinical details when ordering CMV antibody or nucleic acid/PCR testing.
    SourceLink
    POLICY UPDATE CHANGES

    Changed wording in CMV-related policy statements to note that tests 'are considered medically necessary' instead of the prior 'may be considered medically necessary'.

    Added CPT code table and moved the 'coding implications' section; removed CPT and ICD-10 codes from the policy reference table.

    Added specific metagenomic sequencing assay (Mayo Clinic MSCSF) to the Policy Reference Table and updated related background references.

    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.

    2CMV test categories with explicit medical necessity criteria
    1Metagenomic sequencing investigational
    8CPT codes listed
    OutpatientIntended setting

    Coverage Criteria

    Cytomegalovirus (CMV) Antibody Tests — Medically Necessary

    Covered when ANY of the following are met:

    CMV antibody test covered indications: A. The member/enrollee is a prospective organ transplant donor or recipient undergoing pre-transplant evaluation; OR B. The member/enrollee has suspected mononucleosis AND had negative testing for Epstein-Barr Virus (EBV); OR C. The member/enrollee is pregnant AND (1) has symptoms of active CMV infection OR (2) has ultrasound findings consistent with in utero CMV infection.

    Cytomegalovirus (CMV) antibody tests are considered investigational for all other indications.

    Cytomegalovirus (CMV) Nucleic Acid/PCR or Antigen Detection Tests — Medically Necessary

    Covered when ANY of the following are met:

    CMV nucleic acid/PCR or antigen test covered indications: A. The member/enrollee is immunocompromised; OR B. The member/enrollee is 12 months of age or younger AND is a prospective organ transplant donor or recipient undergoing pretransplant evaluation; OR C. The member/enrollee is undergoing post-transplant monitoring; OR D. The member/enrollee is a newborn with very low birth weight (less than 1500 grams); OR E. The member/enrollee is a premature newborn (born before 37 weeks 0 days gestation); OR F. The member/enrollee is an infant with suspected congenital CMV infection (signs/symptoms, documented maternal CMV infection, or ultrasound findings consistent with in utero CMV infection); OR G. The member/enrollee is pregnant AND has ultrasound findings consistent with in utero CMV infection; OR H. The member/enrollee has suspected mononucleosis AND had negative testing for Epstein-Barr Virus (EBV).

    Cytomegalovirus (CMV) nucleic acid/PCR or antigen detection tests are considered investigational for all other indications.

    Untargeted Metagenomic Sequencing Tests for Pathogen Detection — Investigational

    mNGS investigational stance: Untargeted metagenomic sequencing tests for pathogen detection are considered investigational for all indications.

    No supported indications in this policy.

    CMV-specific laboratory testing is addressed in two categories. CMV antibody tests are considered medically necessary only for the indications listed in the policy (prospective organ transplant donor/recipient evaluation; suspected mononucleosis with prior negative EBV testing; or pregnancy with symptoms of active CMV infection or ultrasound findings consistent with in utero infection). CMV nucleic acid/PCR or antigen detection tests are considered medically necessary only for the listed indications (including immunocompromised patients; transplant pre- and post‑transplant settings; newborns who are very low birth weight or preterm; infants with suspected congenital CMV; pregnant patients with ultrasound findings consistent with in utero infection; and suspected mononucleosis with prior negative EBV testing). All other indications for these CMV tests are considered investigational. Untargeted metagenomic sequencing (mNGS) assays for pathogen detection are explicitly stated as investigational for all indications and have no supported indications in this policy.

    For Medicaid members/enrollees, state Medicaid coverage provisions take precedence over the coverage provisions in this clinical policy when there is a conflict. Providers should refer to the applicable state Medicaid manual for coverage provisions that apply to Medicaid enrollees.

    For Medicare members/enrollees, providers should review and follow any applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles prior to applying the criteria in this clinical policy to ensure consistency with Medicare coverage requirements.

    Untargeted metagenomic sequencing tests for pathogen detection are considered investigational for all indications and are not supported by this policy. Claims for these tests may be denied on the basis that they are investigational.

    Coding

    Referenced CPT codesCPT
    86644Antibody; cytomegalovirus (CMV).
    86645Antibody; cytomegalovirus (CMV), IgM.
    87495Infectious agent detection by nucleic acid (DNA or RNA); cytomegalovirus, direct probe technique.
    87496Infectious agent detection by nucleic acid (DNA or RNA); cytomegalovirus, amplified probe technique.
    87497Infectious agent detection by nucleic acid (DNA or RNA); cytomegalovirus, quantification.
    0152UInfectious disease (bacteria, fungi, parasites, and DNA viruses), microbial cell-free DNA, plasma, untargeted next-generation sequencing, report for significant positive pathogens.
    inv-09: Very low birth weight
    Very low birth weight< 1500 grams
    Equivalentless than 1.5 kg (1500 grams)
    Approximate ounces~52.9 oz (3 lbs 4.9 oz)
    inv-10: Preterm infant
    Preterm infantborn before 37 weeks 0 days gestation
    WHO definition referenceborn before 37 0/7 weeks of gestation
    Contextual use in policyApplied to newborns for CMV nucleic acid/PCR or antigen testing coverage

    Provider Actions and Administrative Notes

    Billing Rule

    Coding and potential prior authorization

    This policy references CPT coding and other code descriptors for informational purposes only. Inclusion or exclusion of codes does not guarantee coverage. Providers must reference current professional coding guidance and submit claims using appropriate, up-to-date codes.

    • CPT: 86644, 86645, 87495, 87496, 87497; Proprietary/other: 0152U (untargeted NGS)
    Prior Authorization

    Prior authorization: refer to plan documents

    Prior authorization requirements, if any, are determined by the member's specific plan and administrative policies. Providers should verify prior authorization and medical necessity requirements with the member's plan before ordering tests.

    Background

    Cytomegalovirus (CMV) infection is common and often asymptomatic in healthy individuals, but it can cause significant morbidity in certain populations. In immunocompromised patients (for example, transplant recipients), CMV can lead to systemic viral disease requiring targeted testing and management. Congenital CMV infection in newborns may present with findings such as rash, jaundice, microcephaly, low birth weight, hepatosplenomegaly, seizures, and retinitis; very low birth weight is defined as below 1.5 kg (1500 grams), and prematurity is defined as birth before 37 weeks 0 days gestation. Clinical contexts cited in this policy (immunocompromise, transplant evaluation and monitoring, newborns with low birth weight or prematurity, suspected congenital infection, and pregnancy with ultrasound findings) reflect the populations at higher risk for clinically significant CMV disease and where diagnostic testing has recognized clinical utility. By contrast, untargeted metagenomic sequencing can detect many organisms from a single specimen but currently has limitations in distinguishing colonization from true infection and lacks demonstrated, policy-supported indications in this outpatient clinical policy.

    Definitions

    inv-20: Very low birth weight defined as below 1.5 kg (1500 grams)
    Very low birth weight (numeric)Below 1.5 kg (1500 grams)
    Policy phrasingUsed as a criterion for CMV nucleic acid/PCR or antigen testing in newborns
    WHO sourceWHO defines very low birth weight as below 1.5 kg or 1500 grams
    inv-21: Signs of congenital CMV
    RashCongenital CMV may present with a rash
    JaundiceYellowing of the skin or whites of the eyes
    MicrocephalySmall head size associated with congenital CMV
    Policy Summary
    PayerAmbetter Nevada
    PolicyCONCERT INFECTIOUS DISEASE: MULTISYSTEM TESTING
    Policy CodePolicy N/A
    Change TypeWording clarifiedcoding reorganizedassay added
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument indication and supporting clinical details when ordering CMV antibody or nucleic acid/PCR testing.
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider Actions and Administrative NotesBackgroundDefinitions
    • Check member benefit documents (Evidence of Coverage, certificate of coverage, contract) for PA requirements
    • Follow Health Plan administrative policies and procedures for prior authorization
    Documentation Required

    Indication documentation for CMV testing

    Providers must document the clinical indication for CMV testing in the medical record to support medical necessity and claims submission. Acceptable indications include pre-transplant donor/recipient evaluation, suspected mononucleosis with negative EBV testing, pregnancy with compatible symptoms or ultrasound findings, immunocompromised status, neonatal risk factors (age ≤12 months, very low birth weight, prematurity), post-transplant monitoring, or suspected congenital infection with compatible clinical signs.

    • Document specific indication (e.g., transplant donor/recipient status, negative EBV result, pregnancy with ultrasound findings, neonatal weight/gestational age, signs of congenital CMV)
    • Include relevant supporting data: lab results, imaging, maternal infection status, transplant status, and clinical signs/symptoms
    Denial Risk

    Investigational — untargeted metagenomic sequencing

    Untargeted metagenomic (mNGS) pathogen detection tests are considered investigational for all indications. Claims for untargeted mNGS tests should be processed per plan rules for investigational services (typically denied or coded as not covered).

    • Untargeted mNGS (e.g., plasma or CSF) classified as investigational — do not authorize absent a plan exception
    • If billed, ensure coding and claims handling reflect investigational status per contract
    Note

    Coverage subject to member contract terms / Provider responsibility

    Coverage decisions are subject to all terms, conditions, exclusions and limitations of the member's contract. This policy is a guide to medical necessity and is not a guarantee of payment. Providers are expected to exercise professional medical judgment; this policy does not dictate care.

    • Verify member eligibility and benefits prior to testing
    • Policy is not a substitute for clinical judgment; document rationale for testing in the medical record
    Step Therapy

    Step therapy

    No step therapy requirements are specified in this policy.

    Low birth weightObserved in congenital CMV infection
    HepatosplenomegalyEnlarged liver and spleen
    SeizuresNeurologic manifestation in some newborns
    RetinitisRetinal damage associated with congenital CMV
    inv-22: Definition of 'Health Plan'
    'Health Plan' definitionA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates, as applicable.
    ScopeApplies to health plans that implement this clinical policy
    Administrative implicationCoverage decisions remain subject to plan terms, conditions, exclusions and limitations