CurrentUnitedHealthcarePolicy CSNCT0560.08

Cell-Free Fetal DNA Testing (for North Carolina Only)

Policy governing coverage and coding guidance for cell-free fetal DNA (cfDNA) testing for pregnant individuals covered under UnitedHealthcare Community Plan in North Carolina. Applies to providers ordering prenatal cfDNA tests and to claims processing for North Carolina enrollees.

Policy Summary

PayerUnitedHealthcare Community Plan

PolicyCell-Free Fetal DNA Testing (for North Carolina Only)

Policy CodePolicy CSNCT0560.08

Change TypeCode list updatesstate policy reference revised

Effective DateAugust 1, 2025

Next Review DateN/A

Key ActionFollow the North Carolina Medicaid Clinical Coverage Policy 1S-10 for medical necessity criteria when ordering prenatal cfDNA tests.

SourceLink

POLICY UPDATE CHANGES

Replaced reference to North Carolina Medicaid Clinical Coverage Policy Laboratory Services: 1S-4 with 1S-10 for medical necessity clinical coverage criteria.

Added CPT code 0536U to the Applicable Codes list.

Removed CPT codes 0327U, 81420, and 81507 from the Applicable Codes list.

Notated that CPT code 0536U is not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program.

Removed an extensive list of ICD-10 diagnosis codes previously included in the policy.

1state-specific (NC)

>=1new CPT codes

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Coverage Criteria — Clinical Necessity and Scope

Medical necessity — follow NCDHHS 1S-10

Medical necessity clinical coverage criteria are determined by the referenced state Medicaid clinical coverage policy.

State-referenced medical necessity: Coverage and medical necessity determinations for cell-free fetal DNA testing follow the North Carolina Medicaid (Division of Health Benefits) Clinical Coverage Policy, Laboratory Services: 1S-10 (Genetic Testing for Carrier and Prenatal).

Providers must refer to NCDHHS Clinical Coverage Policy 1S-10 for specific patient selection and clinical criteria.

Codes marked with an asterisk (*) in the Applicable Codes list are noted as not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program. Providers should verify state fee schedule coverage before billing or relying on reimbursement.

Listing of a procedure or diagnosis code in this policy does not imply that the service is covered or not covered. Benefit coverage is determined by federal, state, or contractual requirements and applicable laws, and inclusion of a code does not guarantee reimbursement or claim payment.

Covered Indications

Aneuploidy screening, fetal RBC antigen, twin zygosity, select single-gene NIPT — refer to NCDHHS 1S-10 for specifics

Covered indications and acceptable clinical scenarios are defined by the referenced NCDHHS Clinical Coverage Policy 1S-10; the list below summarizes the test-types addressed by this policy.

Covered test types: Aneuploidy screening for trisomy 21, trisomy 18, and trisomy 13; fetal red blood cell antigen determination (including RhD); twin zygosity analysis; and select single-gene noninvasive prenatal testing to detect paternally inherited or relative-dosage maternal variants.

Specific medical necessity criteria, indications, and any testing prerequisites are defined in NCDHHS Clinical Coverage Policy 1S-10.

Assay examples and targets: Examples of assays and gene targets include: twin zygosity analysis (CPT 0060U); fetal aneuploidy sequencing (CPT 0168U); fetal antigen noninvasive prenatal tests and red blood cell antigen/RhD analysis (CPTs 0488U, 0494U, 0536U); single-gene NIPT targets such as CFTR, SMN1, HBB, HBA1, and HBA2 (CPT 0489U); and fetal chromosomal microdeletion analysis (CPT 81422).

Gestational age requirement for CPT 0536U is 10+ weeks; providers should verify state fee schedule coverage for codes marked with an asterisk.

Operational note:

Eligibility Requirements

Operational eligibility and medical necessity determinations for cell-free fetal DNA testing are governed by the referenced state Medicaid clinical coverage policy. Providers must follow the North Carolina Medicaid (Division of Health Benefits) Clinical Coverage Policy, Laboratory Services: 1S-10, for specific patient selection and clinical criteria.

This policy does not define additional top-level eligibility nodes within the document. Any supplemental eligibility requirements (for example, gestational age limits, prior testing, or specific clinical findings) are specified in and should be confirmed against NCDHHS Clinical Coverage Policy 1S-10.

Coding — Applicable CPT/PLA and Fee Schedule Notes

Applicable CPT/PLA Codesmixed

0060U	Twin zygosity, genomic targeted sequence analysis of chromosome 2, using circulating cell-free fetal DNA in maternal blood.
0168U	Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma without fetal fraction cutoff, algorithm reported as a risk score for each trisomy.
0488U	Obstetrics (fetal antigen noninvasive prenatal test), cell-free DNA sequence analysis for detection of fetal presence or absence of 1 or more of the Rh, C, c, D, E, Duffy (Fya), or Kell (K) antigen in alloimmunized pregnancies, reported as selected antigen(s) detected or not detected.
0489U	Obstetrics (single-gene noninvasive prenatal test), cell-free DNA sequence analysis of 1 or more targets (e.g., CFTR, SMN1, HBB, HBA1, HBA2) to identify paternally inherited pathogenic variants, and relative mutation-dosage analysis based on molecular counts to determine fetal inheritance of maternal mutation, algorithm reported as a fetal risk score for the condition (e.g., cystic fibrosis, spinal muscular atrophy, beta hemoglobinopathies [including sickle cell disease], alpha thalassemia).
0494U	Red blood cell antigen (fetal RhD gene analysis), next-generation sequencing of circulating cell-free DNA (cfDNA) of blood in pregnant individuals known to be RhD negative, reported as positive or negative
0536U	Red blood cell antigen (fetal RhD), PCR analysis of exon 4 of RHD gene and housekeeping control gene GAPDH from whole blood in pregnant individuals at 10+ weeks gestation known to be RhD negative, reported as fetal RhD status.
81422	Fetal chromosomal microdeletion(s) genomic sequence analysis (e.g., DiGeorge syndrome, Cri-du- chat syndrome), circulating cell-free fetal DNA in maternal blood.
81479	Unlisted molecular pathology procedure

State fee schedule notationmixed

*0536U

Not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program

inv-06: Gestational age requirement for CPT 0536U (e.g., 10+ weeks)

Gestational age requirementCPT 0536U is performed at 10+ weeks gestation

Code description0536U: Red blood cell antigen (fetal RhD), PCR analysis of exon 4 of RHD gene and housekeeping control gene GAPDH from whole blood in pregnant individuals known to be RhD negative

State fee schedule note0536U is not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program

Provider Actions — Authorization, Documentation, and Ordering

Prior Authorization

Prior Authorization Required When Plan Requires It

Prior authorization — follow the member's plan rules and any applicable federal, state, or contractual requirements. This policy does not by itself establish prior authorization (PA) requirements; providers must check the member's specific UnitedHealthcare plan and applicable program rules (including state Medicaid/managed care contract terms) for any PA, notification, or precertification requirements before ordering services.

Check the member's benefit plan and the UnitedHealthcare provider portal or call center for current PA requirements.
If the member is covered under a state Medicaid program, follow the state's contractual PA rules (e.g., NCDHHS for North Carolina).
PA may be required even when a service meets this policy's clinical criteria; prior authorization decisions are governed by the member's plan terms.

Documentation Required

Documentation and Medical Necessity Support

Providers should follow all applicable documentation standards when submitting requests for coverage or claims. Include clinical rationale, relevant test results, and any documentation required by the member's plan or state contract. Failure to provide required documentation may result in denial or delayed processing.

Definitions and Test Types

inv-12: Definitions — cfDNA test types (aneuploidy, twin zygosity, fetal RBC antigen, select single-gene NIPT)

Aneuploidy (cfDNA)Cell-free fetal DNA sequencing for fetal aneuploidy (trisomy 21, 18, 13) using maternal plasma, reported as a risk score for each trisomy

Twin zygosityGenomic targeted sequence analysis of chromosome 2 using circulating cfDNA to determine twin zygosity

Fetal red blood cell antigen (RhD and others)Noninvasive prenatal fetal antigen testing (e.g., Rh, C, c, D, E, Fya, K) via cfDNA sequencing or targeted PCR (e.g., RhD exon 4) to report antigen detected/not detected or positive/negative

Select single-gene NIPTSingle-gene noninvasive prenatal tests by cfDNA for paternally inherited pathogenic variants or relative mutation-dosage (examples: CFTR, SMN1, HBB, HBA1, HBA2)

Not Covered — Limitations and Exclusions

This policy itself does not list specific tests as not covered. Coverage determinations depend on applicable federal, state, or contractual requirements and the referenced NCDHHS coverage rules. Inclusion or omission of a test or code in this policy is informational; providers should confirm coverage with the member’s plan and the State of North Carolina Medicaid rules before assuming a service is payable.

Background

This policy addresses prenatal cell-free fetal DNA (cfDNA) testing performed on maternal blood for purposes such as aneuploidy screening (trisomy 21, 18, 13), fetal red blood cell antigen determination (including RhD), twin zygosity analysis, and select single-gene noninvasive prenatal tests to detect paternally inherited or relative-dosage maternal variants. Medical necessity criteria and detailed testing indications are determined by the North Carolina Medicaid Clinical Coverage Policy, Laboratory Services: 1S-10.