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`	Technical component	Use when billing only the technical component (laboratory processing, sequencing) if split billing is allowed.
`QX`	Ordering physician obtains specimen	Use when the ordering practitioner or their staff obtained the maternal blood specimen for the test.
`QK`	CLIA-waived lab testing performed by technician (not typically used)	Rarely applied; use per payer policy when distinguishing specific laboratory processing responsibilities if required.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist service when performed in part	Use when a qualified advanced practice clinician is involved in specimen collection or test-related counseling per payer rules.
`52`	Reduced services	Use if the laboratory performed a reduced or partial version of the assay.
`53`	Discontinued procedure	Use if specimen collection or processing was started but discontinued for clinical reasons.
`78`	Unscheduled return to the operating/procedure room by the same physician following initial procedure for a complication	Rarely applicable; use only if a direct complication required an immediate return for a procedure related to specimen collection.
`22`	Unusual procedural services (increased procedural services)	Use when work or resources substantially exceed typical processing and documentation supports a higher resource use.
`80`	Assistant surgeon	Not typically applicable for this lab test; include only if an assistant surgeon performed an associated invasive diagnostic procedure billed with this test.

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).

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Summary & Overview

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

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

Billing Code Overview

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

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`	Technical component	Use when billing only the technical component (laboratory processing, sequencing) if split billing is allowed.
`QX`	Ordering physician obtains specimen	Use when the ordering practitioner or their staff obtained the maternal blood specimen for the test.
`QK`	CLIA-waived lab testing performed by technician (not typically used)	Rarely applied; use per payer policy when distinguishing specific laboratory processing responsibilities if required.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist service when performed in part	Use when a qualified advanced practice clinician is involved in specimen collection or test-related counseling per payer rules.
`52`	Reduced services	Use if the laboratory performed a reduced or partial version of the assay.
`53`	Discontinued procedure	Use if specimen collection or processing was started but discontinued for clinical reasons.
`78`	Unscheduled return to the operating/procedure room by the same physician following initial procedure for a complication	Rarely applicable; use only if a direct complication required an immediate return for a procedure related to specimen collection.
`22`	Unusual procedural services (increased procedural services)	Use when work or resources substantially exceed typical processing and documentation supports a higher resource use.
`80`	Assistant surgeon	Not typically applicable for this lab test; include only if an assistant surgeon performed an associated invasive diagnostic procedure billed with this test.

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).