ModifiedCentenePolicy N/A

CONCERT INFECTIOUS DISEASE: MULTISYSTEM TESTING

Defines medical necessity criteria for Cytomegalovirus (CMV) antibody and nucleic acid/antigen tests and states the stance on untargeted metagenomic sequencing tests for pathogen detection in the outpatient setting; applies to members/enrollees of Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyCONCERT INFECTIOUS DISEASE: MULTISYSTEM TESTING

Policy CodePolicy N/A

Change TypeRevised wordingcoding reorganization

Effective DateN/A

Next Review DateN/A

Key ActionDocument clinical indication in the chart/claims to support medical necessity (e.g., transplant status, pregnancy ultrasound findings, immunocompromised status, neonatal age/weight).

SourceLink

POLICY UPDATE CHANGES

In policy statements for CMV criteria sections, changed wording to note that tests 'are considered medically necessary' from the previous statement that they '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.

3distinct CMV criteria sections

6CPT codes listed

Outpatientintended setting

Centene

Policy Summary

PayerCentene

PolicyCONCERT INFECTIOUS DISEASE: MULTISYSTEM TESTING

Policy CodePolicy N/A

Change TypeRevised wordingcoding reorganization

Effective DateN/A

Next Review DateN/A

Key ActionDocument clinical indication in the chart/claims to support medical necessity (e.g., transplant status, pregnancy ultrasound findings, immunocompromised status, neonatal age/weight).

SourceLink

On This Page

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Coverage Criteria for Cytomegalovirus (CMV) and Metagenomic Testing

Cytomegalovirus (CMV) Antibody Tests - Medically Necessary

Cytomegalovirus (CMV) antibody tests are considered medically necessary when ANY of the following criteria are met:

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

CMV antibody tests are considered investigational for all other indications.

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

CMV nucleic acid/PCR or antigen detection tests are considered medically necessary when ANY of the following conditions are met (multiple pathways listed):

CMV Nucleic Acid/PCR Criteria: A. Member is immunocompromised; OR B. Member is 12 months of age or younger AND is a prospective organ transplant donor or recipient undergoing pretransplant evaluation; OR C. Member is undergoing post-transplant monitoring; OR D. Newborn with very low birth weight (< 1500 grams); OR E. Premature newborn (born before 37 weeks 0 days gestation); OR F. Infant with suspected congenital CMV infection (signs/symptoms of congenital CMV, documented maternal CMV infection, or ultrasound findings consistent with in utero infection); OR G. Pregnant AND has ultrasound findings consistent with in utero CMV infection; OR H. Suspected mononucleosis AND had negative testing for Epstein-Barr Virus (EBV).

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

Untargeted Metagenomic Sequencing Tests for Pathogen Detection

Coverage stance

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

No indications are covered per this policy; investigational uses may be denied and coverage is subject to member plan terms and exclusions.

Untargeted metagenomic sequencing tests for pathogen detection are considered investigational for all indications and are therefore excluded from coverage under this policy.

Coverage determinations in this clinical policy are a guide to medical necessity and do not guarantee payment. Coverage and administration of benefits remain subject to the terms, conditions, exclusions, and limitations of the member's applicable coverage documents (e.g., evidence of coverage, certificate of coverage, policy) and to applicable state and federal requirements.

CMV antibody tests and CMV nucleic acid/PCR or antigen detection tests that are used for indications not listed in the respective "medically necessary" sections of this policy are considered investigational (not medically necessary) and may be denied. Similarly, untargeted metagenomic sequencing is investigational for all indications per this policy and is excluded from coverage.

Coding and Definitions

Referenced CPT/Category III 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-08: Very low birth weight threshold — key value

Very low birth weight threshold< 1500 grams (less than 1.5 kg; also noted as 3 lbs 4.9 oz)

Source contextReferenced in CMV nucleic acid/PCR criteria for newborns (policy list) and WHO definition.

UsageApplies when determining medical necessity for CMV nucleic acid/PCR or antigen testing in newborns.

inv-09: Premature birth threshold — key value

Premature birth thresholdBorn before 37 weeks 0 days gestation

Source contextSpecified in CMV nucleic acid/PCR criteria for premature newborns and WHO definition.

Provider Actions, Documentation, and Billing

Billing Rule

Coding and Claims Guidance

Codes referenced in this clinical policy are provided for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers must reference current professional coding guidance and the most up-to-date code sets (CPT, HCPCS, ICD-10, NDC, etc.) prior to claim submission to ensure accurate billing.

Verify CPT/HCPCS/ICD-10 codes against the current AMA and payer guidance before billing
Code lists in this policy are not exhaustive — use applicable lab/test-specific codes as appropriate

Prior Authorization

Prior Authorization Determined by Health Plan

Prior authorization requirements are determined by the Health Plan and may vary by product, state, and member. This clinical policy provides medical necessity guidance but does not replace Health Plan prior authorization rules. Providers should check member-specific coverage and obtain any required prior authorization before performing tests.

Background and Clinical Context

Cytomegalovirus (CMV) is a common viral infection that is often asymptomatic in healthy individuals but can cause significant morbidity in specific populations. Clinically important presentations include congenital CMV infection in newborns—which may present with rash, jaundice, microcephaly, low birth weight, hepatosplenomegaly, seizures, or retinitis—and severe or disseminated disease in immunocompromised patients such as organ transplant recipients. Very low birth weight and preterm infants are also at increased risk. Diagnostic testing strategies described in this policy (antibody testing, nucleic acid/PCR or antigen detection) are targeted to these higher-risk scenarios and to specific clinical indications rather than broad, untargeted pathogen detection approaches.

Definitions

inv-19: Very low birth weight / preterm — definitions

Very low birth weight (VLBW)Defined as below 1500 grams (1.5 kg).

Preterm (premature)Defined as birth before 37 0/7 weeks of gestation.

RelevanceThese definitions are used to determine medical necessity for CMV nucleic acid/PCR testing in newborns per policy criteria.

inv-20: Congenital CMV infection — newborn signs and features used in definitions

Congenital CMV - characteristic signsRash; jaundice; microcephaly; low birth weight; hepatosplenomegaly; seizures; retinitis.

Ultrasound findings consistent with in utero CMVMay include microcephaly, brain and liver calcifications, echogenic bowel, hepatosplenomegaly, ventriculomegaly, intracranial cysts, corpus callosum abnormalities, cortical malformations, or intraventricular hemorrhages.