ModifiedAmbetter NevadaPolicy N/A

CONCERT INFECTIOUS DISEASE: MULTISYSTEM TESTING

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.

2CMV test categories with explicit medical necessity criteria

1Metagenomic sequencing investigational

8CPT codes listed

OutpatientIntended setting

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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

86644	Antibody; cytomegalovirus (CMV).
86645	Antibody; cytomegalovirus (CMV), IgM.
87495	Infectious agent detection by nucleic acid (DNA or RNA); cytomegalovirus, direct probe technique.
87496	Infectious agent detection by nucleic acid (DNA or RNA); cytomegalovirus, amplified probe technique.
87497	Infectious agent detection by nucleic acid (DNA or RNA); cytomegalovirus, quantification.
0152U	Infectious 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

Microcephaly