CurrentWellCarePolicy N/A

Infectious Disease: Multisystem Testing — CMV and Metagenomic Sequencing Coverage Criteria

Governs outpatient medical necessity criteria for testing of pathogens that cause multisystem infections, focusing on cytomegalovirus (CMV) antibody and nucleic acid/PCR/antigen tests and untargeted metagenomic sequencing. Affects providers ordering these tests for WellCare members/enrollees.

Policy Summary

PayerWellCare

PolicyMultisystem infectious disease testing (CMV and metagenomic sequencing) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSupport claims with documented indications demonstrating the member meets listed medical necessity criteria before billing referenced CPT codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3CMV testing categories

OutpatientIntended care setting

6CPT codes referenced

NCApplicable state listed

Coverage Criteria

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inv-01: CMV Antibody Tests - Medically Necessary

Cytomegalovirus (CMV) Antibody Tests are considered medically necessary when ANY one of the following is 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 has symptoms of active CMV infection

CMV antibody tests are considered investigational for all other indications.

inv-02: CMV Nucleic Acid/PCR or Antigen Detection Tests - Medically Necessary

Cytomegalovirus (CMV) nucleic acid/PCR or antigen detection tests are considered medically necessary when ANY one of the following applies:

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 pre-transplant evaluation; OR C. Member is undergoing post-transplant monitoring; OR D. Newborn with very low birth weight (<1500 g); OR E. Premature newborn (born before 37 0/7 weeks gestation); OR F. Infant with suspected congenital CMV infection (signs or symptoms of congenital CMV, documented maternal CMV infection, or ultrasound findings consistent with in utero CMV infection); OR G. Member is 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. Definitions: very low birth weight <1500 g; preterm <37 0/7 weeks gestation.

Coding and Billing

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

Provider Actions and Requirements

Denial Risk

Investigational Indications May Be Denied

Tests performed for indications not listed in this policy are considered investigational and may be denied as not medically necessary.

Investigational indications are subject to denial and will not be covered under this policy.

Documentation Required

Provider Professional Judgment and Documentation

Providers are expected to exercise professional medical judgment in caring for members/enrollees and are responsible for documenting the clinical rationale for testing. The Health Plan does not dictate medical care; providers must ensure records support the medical necessity of requested tests.

Providers retain responsibility for medical decision-making and documentation.
Documentation must support the indication, test type, and clinical need.

Note

Recommended Testing Sequence for Transplant and Newborns

For transplant evaluations and neonatal care, nucleic acid testing (e.g., quantitative NAT/PCR) is the recommended testing modality for diagnosis and monitoring due to higher sensitivity and utility in these populations.

Use nucleic acid/PCR testing for pre‑ and post‑transplant donor and recipient evaluation and monitoring.
Use nucleic acid/PCR testing for newborns at risk for congenital CMV (including low birth weight, prematurity, or clinical signs of congenital infection).

Prior Authorization

Coverage and Prior Authorization

Coverage is governed by the member's benefit documents and the Health Plan's terms and conditions. Failure to meet plan terms, prior authorization requirements, or documentation standards may result in claim denial or nonpayment.

Verify member eligibility and benefits prior to testing.
Obtain any required prior authorization per the member's plan documents.

Documentation Required

Required Clinical Documentation

Clinical documentation should include relevant justification items such as donor/recipient transplant status, pregnancy details and ultrasound findings, neonatal criteria (birth weight, gestational age, signs of congenital infection), immunocompromised status, and prior EBV test results when applicable.

Document donor or recipient status when testing for transplant evaluation.
For pregnant members, document symptoms of active CMV or ultrasound findings consistent with in‑utero infection.
For newborns/infants, document birth weight, gestational age, and clinical signs of congenital CMV.
Document prior negative EBV testing when CMV testing is for suspected mononucleosis.

Background

Cytomegalovirus (CMV) is often asymptomatic in healthy persons but can cause significant disease in certain populations. CMV infection is important in immunocompromised patients (including transplant recipients) where active infection or reactivation can lead to morbidity and requires sensitive detection methods. In newborns and infants, particularly those who are very low birth weight (<1500 g) or preterm (born before 37 0/7 weeks gestation), congenital CMV infection can present with findings such as rash, jaundice, microcephaly, low birth weight, hepatosplenomegaly, seizures, and retinitis; timely nucleic acid testing is used for diagnosis and management. In pregnancy, CMV is clinically significant when maternal symptoms or fetal ultrasound findings suggest in utero infection. Metagenomic sequencing approaches are investigational and their clinical utility for pathogen detection has not been established in this outpatient policy.

Definitions

Very low birth weight / Preterm infant — definitions

Very low birth weight (VLBW)Birth weight below 1.5 kg (1500 grams)

Preterm (premature) infantBirth before 37 0/7 weeks of gestation

SourceWorld Health Organization definition as cited in policy notes

Congenital CMV infection features

Common clinical featuresRash, jaundice (yellowing of skin/eyes), microcephaly, low birth weight

Additional signsHepatosplenomegaly (enlarged liver and spleen), seizures

Ophthalmic involvementRetinitis (damaged retina)

Ultrasound findings consistent with congenital CMVMay include brain calcifications, echogenic bowel, ventriculomegaly, intraparenchymal cysts, corpus callosum abnormalities, cortical malformations, and intraventricular hemorrhages

Definition of 'Health Plan'

DefinitionA Health Plan is a 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 an affiliate.

Role of policyThe clinical policy provides guidance for medical necessity and assists in coverage decisions and benefit administration; it is not a contract or guarantee of payment.

Precedence and governanceCoverage decisions are subject to the member's coverage documents and applicable state/federal requirements; state Medicaid provisions supersede this policy when in conflict.