Summary & Overview

CPT 0405U: Early Detection of Pancreatic Cancer via Plasma cfDNA

CPT code 0405U is a Proprietary Laboratory Analyses (PLA) code representing the BTG Early Detection of Pancreatic Cancer test from Breakthrough Genomics. The assay evaluates circulating tumor cell–free DNA (cfDNA) in plasma for a panel of 59 biomarkers to help detect early pancreatic cancer in patients identified as high risk. As a PLA code, 0405U is tied to a single manufacturer’s proprietary test and is used to document and bill that specific molecular diagnostic service.

Nationally, PLA codes like 0405U are important because they standardize billing for novel, manufacturer-specific tests that can influence early diagnosis pathways and downstream care. Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The summary addresses how coverage and billing for this test intersect with clinical use, coding clarity, and payer policy considerations.

Readers will learn the clinical scope of the test, typical sites of service and specimen requirements, common modifiers used in billing, and where to find policy and coverage guidance. The publication also provides benchmarks and policy context relevant to adoption and reimbursement of proprietary molecular diagnostics, and it outlines the implications for laboratories and clinicians ordering the test. Data not available in the input is noted where applicable.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0405UCPTProprietary Laboratory Analysesmolecular diagnosticscirculating tumor DNApancreatic cancerlaboratory billingearly detection

Billing Code Overview

CPT code 0405U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the BTG Early Detection of Pancreatic Cancer test from Breakthrough Genomics. The test analyzes a plasma specimen to evaluate circulating tumor cell–free DNA (cfDNA) for 59 specified biomarkers to assist in the early detection of pancreatic cancer in patients at high risk for developing the disease.

Service Type: Laboratory — Proprietary molecular diagnostic test

Typical Site of Service: Clinical laboratory or outpatient specimen collection site (plasma specimen)

Clinical & Coding Specifications

Clinical Context

A 62-year-old patient with a strong family history of pancreatic cancer and newly discovered, unexplained weight loss and intermittent abdominal pain presents to a gastroenterology clinic for risk stratification. The clinician orders the Breakthrough Genomics BTG Early Detection of Pancreatic Cancer test reported with 0405U. A peripheral blood draw (plasma specimen) is obtained in the clinic or outpatient phlebotomy laboratory and sent to the manufacturer-specified laboratory for Proprietary Laboratory Analyses (PLA). The laboratory performs cfDNA analysis for the 59 specified biomarkers and returns a report indicating presence or absence of assay signals associated with early pancreatic neoplasia. Results are reviewed by the ordering provider during a follow-up visit or via secure electronic messaging to inform subsequent diagnostic imaging (for example, pancreatic MRI or endoscopic ultrasound) or enrollment in intensified surveillance programs for high-risk patients.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier (default)	Use when no special circumstances apply to the service.
`26`	Professional component	Use if reporting a professional interpretation component separate from the laboratory technical component (rare for PLA; usually laboratory provides complete service).
`52`	Reduced services	Use when the laboratory test is partially performed or specimen is inadequate but a limited report is issued.
`53`	Discontinued procedure	Use if specimen collection or testing was started but discontinued for reasons outside the control of the performing lab.
`62`	Two surgeons	Use when two qualified laboratories or providers share responsibility for a complex, joint laboratory analysis (rare).
`78`	Unplanned return to the operating/procedure room by the same physician following initial procedure	Typically not applicable; include only if an associated invasive procedure required immediate repeat intervention.
`80`	Assistant at surgery	Not commonly applicable; used only when an assistant surgeon participates in a related invasive procedure.
`82`	Assistant not available	Use when an assistant was not available for a related invasive procedure.
`QK`	Medical direction of two, three, or four clinical staff	Use if the ordering physician directed clinical staff performing specimen collection under this supervisory arrangement.
`QX`	CRNA service: medical direction by an anesthesiologist	Not typically applicable to this laboratory test; include only if part of a procedure requiring anesthesia.
`QY`	CRNA service: medical direction by a physician	Not typically applicable; see `QX`.
`SH`	Diagnostic radiology services—interpretation only on hospital/facility	Use when imaging ordered as a follow-up is interpreted separately and needs facility-specific modifier.
`TC`	Technical component	Use if reporting only the technical component of the test when the laboratory separates technical and professional components.
`TG`	Identifies services rendered under the Indian Health Service (IHS) or Tribal/Urban Indian Health Program (I/T/U)	Use when the service is provided within IHS or an authorized tribal facility.

Taxonomy Code	Specialty	Notes
208000000X	Gastroenterology	Ordering clinicians who manage pancreatic risk and surveillance.
207RC0000X	Radiology – Diagnostic	Interpreting follow-up imaging (MRI, CT, EUS) after a positive or indeterminate result.
207K00000X	Pathology	Laboratory directors or molecular pathologists overseeing cfDNA assay validation and interpretation.
208000000X-1	Internal Medicine	Primary care physicians who may order testing for high-risk screening and coordinate follow-up.
363L00000X	Clinical Laboratory	Clinical laboratory personnel and directors who perform or oversee the PLA testing.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
Data not available in the input.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0394U`	Oncology (cfDNA) assay — multianalyte molecular signature test (example PLA)	Another proprietary cfDNA assay code representing similar laboratory-based cancer risk detection; may be an alternative PLA in oncology testing workflows.
`0001U`	Molecular pathology procedure or PLA code (example)	Represents other Proprietary Laboratory Analyses that may be ordered in parallel for comprehensive molecular risk assessment.
`0002U`	Molecular pathology procedure or PLA code (example)	Additional PLA that could be part of a multi-test panel strategy for cancer surveillance.
`74181`	Computed tomography, abdomen and pelvis; with contrast, diagnostic	Common imaging ordered after a positive cfDNA result to localize or characterize pancreatic lesions.
`43238`	Endoscopic ultrasound, diagnostic, with or without FNA	Used to obtain tissue diagnosis or further evaluate pancreatic lesions after a positive screening test.
`74183`	CT abdomen and pelvis with and without contrast	Alternative cross-sectional imaging frequently used in the pancreatic cancer diagnostic pathway.