Summary & Overview

CPT 0418U: PreciseDx Breast Biopsy AI Recurrence Risk Score

CPT code 0418U denotes the PreciseDx Breast Biopsy Test, a Proprietary Laboratory Analyses (PLA) test that uses AI-driven analysis of glass or digitized slides from formalin–fixed paraffin–embedded (FFPE) breast tumor tissue to generate an eight-feature–based risk of recurrence score. As a PLA code, 0418U applies to a single manufacturer’s proprietary assay and signals a precision pathology service that may influence follow-up care planning and oncology risk stratification nationwide. Major payers reviewed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.

Readers will find a concise overview of the code’s clinical purpose, typical sites of service, and how the test is performed. The publication summarizes payer coverage patterns and benchmark considerations, explains the implications of PLA designation for billing and claims processing, and provides clinical context on the test’s role in recurrence risk assessment. It also highlights policy and coding updates relevant to proprietary laboratory tests and outlines the operational considerations for laboratories and pathology providers when submitting claims for CPT code 0418U.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicareCPT 0418Uproprietary laboratory analysesbreast biopsyFFPE pathologyAI in pathologyrecurrence risk scorelaboratory diagnosticspathology billingPLA code

Billing Code Overview

CPT code 0418U is a Proprietary Laboratory Analyses (PLA) code assigned exclusively to the PreciseDx Breast Biopsy Test by PreciseDx Inc. The test analyzes glass slides or digitized pathology slides from formalin–fixed paraffin–embedded (FFPE) breast tumor tissue. Using artificial intelligence (AI) algorithms and bioinformatics databases, the assay evaluates eight histologic and immunohistochemical features and reports a score estimating risk of recurrence.

Service type: Laboratory diagnostic test using AI-driven image analysis and bioinformatics to generate a recurrence risk score from FFPE breast tumor slides.
Typical site of service: Clinical diagnostic laboratory or pathology laboratory; sample acquisition occurs at outpatient or inpatient pathology/biopsy sites.

Clinical & Coding Specifications

Clinical Context

A 58-year-old female with newly diagnosed stage I–II estrogen receptor–positive invasive ductal carcinoma undergoes lumpectomy with sentinel lymph node biopsy. Formalin–fixed paraffin-embedded (FFPE) tumor blocks are submitted to pathology. After histologic review, the pathologist prepares diagnostic glass slides (or digitizes slides) and orders the PreciseDx Breast Biopsy Test to refine risk of recurrence and inform adjuvant therapy decisions. The test uses artificial intelligence algorithms to evaluate eight histologic and immunohistochemical features on the FFPE slides and returns a quantitative risk-of-recurrence score. Typical workflow steps: surgical specimen processing → pathology review and slide preparation → selection and submission of representative tumor slides to PreciseDx Inc. → laboratory receipt and AI-based analysis → report delivery to ordering oncologist and multidisciplinary tumor board. Typical site of service: hospital pathology laboratory, independent pathology reference lab, or specialized proprietary laboratory performing PLA testing. Service type: Proprietary Laboratory Analysis (PLA) — specialized diagnostic molecular/AI-based pathology assay.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier used / default	Use when no special modifier applies to the claim for the laboratory test
`26`

Taxonomy Code	Specialty	Notes
207P00000X	Pathology	Anatomic and clinical pathologists order and interpret PLA reports; oversee slide selection and reporting
208000000X	Hematology & Oncology	Medical oncologists request risk-of-recurrence testing to guide adjuvant systemic therapy decisions
207L00000X	Anatomic Pathology	Surgical pathologists perform slide preparation, selection, and initial staining for analysis
207K00000X	Clinical Pathology	Laboratory directors and clinical pathologists manage laboratory testing, quality control, and result sign-out
207H00000X	Surgical Pathology	Surgeons coordinate specimen submission; surgical pathologists provide correlation between operative findings and slide selection

ICD-10 Code	Description	Clinical Relevance
`C50.911`	Malignant neoplasm of unspecified site of right female breast	Primary breast cancer diagnosis; tumor tissue source for PLA recurrence-risk testing
`C50.912`	Malignant neoplasm of unspecified site of left female breast	Primary breast cancer diagnosis; tumor tissue source for PLA recurrence-risk testing
`C50.929`	Malignant neoplasm of unspecified site of breast, unspecified	General breast cancer code used when side not specified; indicates need for prognostic testing
`D05.90`	Unspecified ductal carcinoma in situ of unspecified breast	In select cases of high-risk DCIS, additional pathology-based risk assays may be considered for adjuvant planning
`Z85.3`	Personal history of malignant neoplasm of breast	Used when assessing recurrence risk in patients with prior breast cancer and new findings under evaluation

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Commonly performed by the pathology lab to render the primary histopathologic diagnosis and generate slides used by the PLA assay
`88331`	Consultation and review of slides by another pathologist, simple report	May be used when an external review or second opinion is requested prior to sending slides for PLA testing
`88342`	Immunohistochemistry (per specimen; per antibody)	IHC stains (e.g., ER, PR, HER2) are often performed on FFPE slides that are evaluated by the AI algorithm or provided as inputs to the PLA analysis
`88360`	Morphometric analysis; quantitative immunohistochemistry	Quantitative image analysis performed in-house or by reference labs may complement or precede AI-based PLA testing
`99000`	Handling of specimen for laboratory procedures (technical)	Reported in some billing systems for specimen handling or special preparation for referral testing when applicable

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