Summary & Overview
CPT 0571U: LiquidHALLMARK® ctDNA and ctRNA NGS Assay
CPT code 0571U designates a Proprietary Laboratory Analyses (PLA) test for LiquidHALLMARK® by Lucence Health Inc., a blood‑based next‑generation sequencing assay that interrogates 80 ctDNA genes and 10 ctRNA genes. The code matters nationally because it identifies a single‑manufacturer, clinically focused genomic test used to detect actionable somatic variants across multiple alteration types that can inform oncology treatment decisions. Its PLA status signals single‑source reporting and has implications for coverage and coding clarity.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical purpose and scope of the assay, payer coverage considerations, benchmark and reimbursement context where available, and operational details such as typical site of service and service type. The publication will also summarize common billing modifiers and note where input data are unavailable.
This briefing is intended for national audiences including payers, laboratory billing staff, and policy analysts who need a concise reference on CPT code 0571U, its clinical role in liquid biopsy testing, and the payer landscape relevant to laboratory reimbursement and coding practices.
Billing Code Overview
CPT code 0571U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to LiquidHALLMARK® ctDNA and ctRNA developed by Lucence Health Inc. The test is a blood‑based next‑generation sequencing (NGS) assay that evaluates 80 genes from circulating tumor DNA (ctDNA) and 10 genes from circulating tumor RNA (ctRNA) to identify clinically actionable genetic variants and multiple types of genomic alterations relevant to treatment decisions.
Service type: Laboratory diagnostic testing — blood‑based NGS for circulating tumor nucleic acids (ctDNA/ctRNA)
Typical site of service: Clinical laboratory or outpatient phlebotomy collection site, with testing performed by the reporting laboratory.
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult with known or suspected advanced solid tumor disease who requires comprehensive tumor genomic profiling to guide targeted therapy selection or enrollment in clinical trials. A medical oncologist orders the LiquidHALLMARK® circulating tumor DNA (ctDNA) and circulating tumor RNA (ctRNA) panel when tissue biopsy is unavailable, insufficient, or when real-time assessment of tumor genomics is needed to detect actionable alterations, resistance mutations, or gene fusions. The clinical workflow: the patient presents at an oncology clinic or outpatient infusion center; a phlebotomy draw is performed for a liquid biopsy (blood specimen) and sent to Lucence Health Inc. for Proprietary Laboratory Analysis reported under 0571U. The laboratory performs next-generation sequencing (NGS) of ctDNA (80 genes) and ctRNA (10 genes), analyzes single-nucleotide variants, insertions/deletions, copy-number alterations, and fusions, and returns a report of clinically actionable variants to the ordering oncologist. Results inform treatment selection (targeted therapy, immunotherapy considerations), detection of acquired resistance, or eligibility for clinical trials. Typical sites of service include outpatient hospital clinics, physician offices, and commercial laboratory specimen collection centers.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier reported (placeholder in input) | Use when no specific modifier applies and the claim is submitted without a special circumstance |
22 | Increased procedural services | Use when documentation supports substantially greater complexity or physician work than typical for the service (rarely applied to lab PLA codes; applies when an associated professional service meets criteria) |
52 | Reduced services | Use when the service provided is partially reduced or eliminated at patient request or due to clinical reason |
53 | Discontinued procedure | Use when the laboratory or specimen collection was started but discontinued for documented medical reasons prior to completion |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207RC0000X | Oncology | Medical oncologists commonly order comprehensive tumor genomic testing |
| 208D00000X | Hematology/Oncology | Hematology–oncology specialists frequently manage systemic cancer care and order ctDNA panels |
| 363L00000X | Pathology | Molecular pathology or clinical laboratory directors oversee test validation and interpretation |
| 207LP2900X | Surgical Oncology | Surgical oncologists may order testing when planning systemic therapy after resection |
| 261QM0800X | Nurse Practitioner — Oncology | Oncology advanced practice providers commonly order and coordinate specimen collection |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C80.1 | Malignant neoplasm, unspecified, with metastasis | Liquid biopsy often used in patients with metastatic disease to identify actionable genomic alterations |
C34.90 | Malignant neoplasm of unspecified part of bronchus or lung, unspecified | Non–small cell lung cancer commonly evaluated with ctDNA panels to detect EGFR, ALK, ROS1, and resistance mutations |
C50.919 | Malignant neoplasm of unspecified site of breast, female | Advanced breast cancer may be assessed with ctDNA for PIK3CA, ESR1, and other actionable alterations |
C18.9 | Malignant neoplasm of colon, unspecified | Colorectal cancers use ctDNA for RAS, BRAF, and other mutation detection to guide therapy and trial eligibility |
C79.51 | Secondary malignant neoplasm of bone | Detection of tumor-derived alterations in patients with metastatic spread can guide systemic therapy choices |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Preceding specimen collection required to obtain blood for the LiquidHALLMARK® NGS test |
88172 | Immunohistochemistry (IHC) interpretation (single or first stain) | May be performed in parallel when tissue IHC is used alongside liquid biopsy for biomarker correlation |
81479 | Unlisted molecular pathology procedure | Used when a specific molecular test lacks an established CPT code and for reporting supplemental or novel molecular analyses not covered by the PLA code |
0001U | Proprietary laboratory test (example PLA) | Other PLA codes may be billed for different manufacturers/tests in the molecular oncology workflow; listed here as a category comparator |
G0452 | Specimen collection in a mobile unit | Relevant when blood collection for the test occurs via mobile phlebotomy services in some programs |