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.
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.
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Service type: Laboratory diagnostic test using AI-driven image analysis and bioinformatics to generate a recurrence risk score from FFPE breast tumor slides.
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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 |