CPT 0341U Single Cell Prenatal Diagnosis Reimbursement | OpenPayer

Summary & Overview

CPT 0341U: Single Cell Prenatal Diagnosis (SCPD) Test

CPT code 0341U designates a proprietary laboratory test — the Single Cell Prenatal Diagnosis (SCPD) Test from Luna Genetics Inc. — that isolates fetal cells from maternal blood early in pregnancy for DNA sequencing to detect aneuploidies, duplication/deletion variants, and mosaicism. As a PLA code, 0341U identifies a single manufacturer-specific assay and is used in claims when reporting this unique test. Nationally, proprietary prenatal genomic assays are increasingly relevant to prenatal care pathways and payer coverage discussions due to their potential to offer earlier, noninvasive genomic diagnosis.

Key payers addressed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of coverage considerations and common billing practices for PLA codes, a summary of payer patterns and benchmarks where available, and clinical context about the SCPD Test’s intended use and service setting. The publication also highlights coding specifics for claim submission and lists commonly used modifiers. This analysis is presented for a national audience and focuses on payer coverage frameworks, clinical implications of single-cell prenatal sequencing, and operational considerations for laboratories and providers submitting CPT code 0341U.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0341UCPTProprietary Laboratory AnalysesPrenatal TestingGenomic SequencingSingle CellLaboratoryNoninvasive Prenatal Diagnosis

Billing Code Overview

CPT code 0341U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Single Cell Prenatal Diagnosis (SCPD) Test from Luna Genetics Inc. The assay uses a maternal blood sample collected early in pregnancy to isolate fetal cells for DNA sequencing. The test evaluates fetal cells for aneuploidies, duplication/deletion variants, and mosaicism.

Service Type: Laboratory — cell-free fetal cell isolation and genomic sequencing

Typical Site of Service: Clinical laboratory or reference laboratory; maternal blood draw performed in outpatient clinic or phlebotomy setting

Clinical & Coding Specifications

Clinical Context

A 34-year-old pregnant person at 9 weeks' gestation presents for early noninvasive prenatal testing because of advanced maternal age and an earlier pregnancy with a chromosomal abnormality. The obstetrics provider orders the Single Cell Prenatal Diagnosis (SCPD) Test (0341U) from Luna Genetics Inc. A maternal blood draw is obtained in an outpatient antepartum clinic or a specialty prenatal diagnostic laboratory collection site. The sample is shipped to the performing laboratory where fetal cells are isolated from maternal blood, DNA is sequenced, and results are analyzed for common aneuploidies, subchromosomal duplications/deletions, and fetal mosaicism. Results are reported back to the ordering obstetrician or maternal–fetal medicine specialist to inform counseling and decisions about potential diagnostic testing (for example, chorionic villus sampling or amniocentesis), pregnancy management, and genetic counseling referrals.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when billing only the professional/interpretive portion of the test by a qualified laboratory director or molecular pathologist.
`TC`

Related Codes

CPT-0169U-NUDT15-TPMT-GENOTYPING-PANEL

CPT 0169U: NUDT15 and TPMT Genotyping Panel

CPT-0089U-PIGMENTED-LESION-ASSAY-PCR-GENE-EXPRESSION

CPT 0089U: Pigmented Lesion Assay (RTqPCR) for PRAME and LINC00518

CPT-0597U-AIDABREAST-MOLECULAR-BREAST-RECURRENCE-RISK

CPT 0597U: AidaBreast™ Molecular Test for Breast Tumor Recurrence Risk

CPT-0276U-INHERITED-THROMBOCYTOPENIA-NGS-PANEL

CPT 0276U: Versiti Inherited Thrombocytopenia NGS Panel

CPT-0178U-VERIMAP-PEANUT-SENSITIVITY-EPITOPE-ASSAY

CPT 0178U: VeriMAP Peanut Sensitivity Bead-Based Epitope Assay

CPT-0234U-GENOMIC-UNITY-MECP2-ANALYSIS-WGS

CPT 0234U: Genomic Unity MECP2 Analysis via PCR-free WGS

CPT-0356U-NAVDX-OROPHARYNGEAL-ANAL-HPV-CELL-FREE-DNA-RECURRENCE-TEST

CPT 0356U: NavDx® HPV Cell‑free DNA Test for Cancer Recurrence

CPT-0281U-VERSITI-VWF-PROPEPTIDE-ANTIGEN-ELISA

CPT 0281U: Versiti VWF Propeptide Antigen ELISA, Plasma

CPT-0216U-ATAXIA-REPEAT-EXPANSION-SEQUENCE-ANALYSIS

CPT 0216U: Ataxia Repeat Expansion and Sequence Analysis

CPT-0377U-NMR-LIPOPROTEIN-PROFILE-LIPOSCALE

CPT 0377U: NMR Lipoprotein Profile (Liposcale®)

Showing 1–10 of 536

Taxonomy Code	Specialty	Notes
207Q00000X	Obstetrics & Gynecology	Ordering and follow-up counseling; routine prenatal care providers.
207RP1010X	Maternal-Fetal Medicine	High-risk pregnancy evaluation and interpretation of advanced prenatal genetic results.
208D00000X	Clinical Laboratory	Laboratory directors and staff who perform testing and result interpretation.
2080P0207X	Molecular Pathology	Specialists who oversee sequencing assays and analytic validation.
362M00000X	Genetic Counseling	Providers who interpret results, perform risk assessment, and provide patient counseling.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`O09.511`	Supervision of pregnancy with history of preterm labor, first trimester	Relevant when high-risk pregnancy status prompts early genetic evaluation with SCPD testing.
`Z36.89`	Encounter for antenatal screening of other specified conditions	Used for encounter-based prenatal screening tests such as advanced noninvasive fetal genetic assays.
`O09.519`	Supervision of pregnancy with history of poor reproductive or obstetric outcome, first trimester	Indicates prior adverse outcome that may prompt early fetal genetic analysis.
`Z31.69`	Encounter for other genetic testing of mother	Used when maternal genetic testing or prenatal cell-based testing is ordered.
`O09.522`	Supervision of pregnancy with history of preterm labor, second trimester	May apply when follow-up or repeat testing occurs in later first/early second trimester.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Typically performed to obtain the maternal blood sample used for the SCPD test.
`81025`	Urine pregnancy test, by visual color comparison methods	May be used in clinic to confirm pregnancy prior to the blood draw when indicated.
`76801`	Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, first trimester (transabdominal)	May be performed as part of early pregnancy dating and assessment when ordering or interpreting prenatal genetic test results.
`99406`	Smoking and tobacco use cessation counseling visit (example preventive counseling)	Not specific to the test but may appear as part of prenatal counseling visits when sample collection occurs.
`81225`	Chromosome analysis, fetal (for example, from CVS or amniocyte culture)	Represents confirmatory diagnostic testing that may follow abnormal SCPD results (e.g., CVS or amniocentesis karyotype).