Summary & Overview

CPT 0409U: LiquidHALLMARK Plasma NGS cfDNA and cfRNA Profiling

CPT code 0409U designates LiquidHALLMARK®, a proprietary plasma-based next-generation sequencing (NGS) assay from Lucence Health Inc. that evaluates circulating cell-free DNA (80 genes) and RNA (36 genes) to identify genomic alterations and provide guidance on potentially actionable treatment options. As a PLA code, 0409U maps to one unique commercial test and is used when reporting this specific laboratory's service. Nationally, PLA codes like 0409U matter because they enable distinct tracking and reimbursement of single-source genomic tests that can impact oncology diagnostics and targeted therapy selection.

Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will learn how 0409U is defined clinically and operationally, typical sites of service, and what to expect in payer coverage discussions. The publication provides benchmarks for PLA code adoption, summarizes relevant policy considerations for laboratory NGS testing, and offers clinical context on when a plasma-based cfDNA/cfRNA panel is deployed in oncology care pathways. Data not available in the input includes specific payer coverage policies, reimbursement rates, and associated ICD-10 diagnoses.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0409UCPTProprietary Laboratory AnalysesLiquidHALLMARKnext-generation sequencingcell-free DNAplasma-based testingoncology diagnostics

Billing Code Overview

CPT code 0409U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the LiquidHALLMARK® test from Lucence Health Inc. The test uses next-generation sequencing (NGS) to analyze circulating cell-free DNA and RNA from a plasma specimen, evaluating alterations across 80 DNA genes and 36 RNA genes and reporting identified mutations alongside a guide to possible clinically actionable treatment options.

Service type: Comprehensive plasma-based NGS tumor profiling (cell-free DNA and RNA analysis)
Typical site of service: Commercial clinical laboratory (testing performed by the manufacturer or its contracted laboratory) with specimen collection occurring in outpatient phlebotomy settings or other noninpatient collection sites

Clinical & Coding Specifications

Clinical Context

A 62-year-old patient with newly diagnosed metastatic non-small cell lung cancer (NSCLC) is referred for comprehensive genomic profiling of circulating tumor DNA and RNA to identify actionable somatic alterations and guide systemic therapy selection. The oncology clinic collects a peripheral blood plasma specimen during an outpatient visit; the specimen is sent to Lucence Health Inc. for the proprietary LiquidHALLMARK® test reported under 0409U. Results include detected alterations across an 80-gene DNA panel and a 36-gene RNA panel with an interpretation that maps identified variants to potential targeted therapies and clinical trials. The typical workflow includes order entry by the oncologist, preauthorization if required by the insurer, phlebotomy in an ambulatory infusion or outpatient lab setting, shipment to the performing lab, analytic processing using next-generation sequencing, and generation of a molecular report sent back to the treating team for therapy selection or trial enrollment decisions.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier — default reporting	Use when no special circumstances apply to the service.
`22`

Taxonomy Code	Specialty	Notes
`207RG0100X`	Hematology & Oncology	Medical oncologists order and interpret tumor genomic profiling.
`208D00000X`	Pathology	Molecular pathologists oversee test validation and interpretation.
`363L00000X`	Clinical Laboratory	Clinical laboratory directors manage technical testing and reporting.
`208000000X`	Anatomic & Clinical Pathology	Specialists who may review molecular oncology reports and integrate with pathology findings.

ICD-10 Code	Description	Clinical Relevance
`C34.90`	Malignant neoplasm of unspecified part of unspecified bronchus or lung	Common indication for circulating tumor DNA testing to identify actionable mutations in lung cancer.
`C78.01`	Secondary malignant neoplasm of right lung	Used when metastatic disease involves the lung and tumor profiling may guide therapy.
`C80.1`	Malignant (primary) neoplasm, unspecified	Employed when cancer type is not yet specified and broad genomic profiling is clinically useful.
`Z85.118`	Personal history of other malignant neoplasm of bronchus and lung	For surveillance or recurrence assessment using liquid biopsy in patients with prior lung cancer.
`D47.Z9`	Neoplasm of uncertain behavior of other lymphoid, hematopoietic and related tissue	Included when molecular profiling is considered for hematologic differential diagnosis or overlapping presentations.

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Venipuncture is performed during the outpatient visit to obtain the plasma specimen for `0409U`.
`36416`	Collection of capillary blood specimen	Alternate collection method when venipuncture is not feasible for specimen acquisition.
`N/A`	Data not available in the input.	Data not available in the input.

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