Summary & Overview
CPT 0376U: ArteraAI Prostate Test, AI Pathology Risk Assessment
CPT code 0376U designates a Proprietary Laboratory Analyses (PLA) test — the ArteraAI Prostate Test from Artera Inc. — that uses artificial intelligence to analyze a digitized prostate pathology slide together with clinical inputs to estimate risks of distant metastasis and prostate cancer mortality and to suggest potential response to androgen deprivation therapy. As a PLA code, 0376U is reportable only for this single manufacturer’s assay, signaling its proprietary clinical utility and unique billing identity. Nationally, PLA codes are important because they provide a standardized mechanism to identify and track utilization of single-source laboratory tests that often involve complex analytic methods.
Key payers considered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The content addresses payer coverage landscapes, coding and billing considerations for proprietary laboratory tests, and the clinical context for use in prostate cancer prognostication and treatment planning.
Readers will learn the clinical purpose and service setting for CPT code 0376U, common billing implications for laboratory and pathology providers, and the types of benchmarks and policy issues to monitor for PLA-designated assays. Data not available in the input will be noted where relevant, and the document focuses on nationally applicable information rather than jurisdiction-specific rules.
Billing Code Overview
CPT code 0376U is a Proprietary Laboratory Analyses (PLA) code specific to a single laboratory test: the ArteraAI Prostate Test from Artera Inc. The test applies an artificial intelligence algorithm to a digitized prostate pathology slide and integrates selected clinical variables to generate algorithmic risk estimates for distant metastasis and prostate cancer–specific mortality, and it may provide information about likely response to androgen deprivation therapy.
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Service type: Laboratory-based, algorithmic diagnostic/prognostic test using digital pathology and clinical data
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Typical site of service: Clinical laboratory or pathology service associated with a diagnostic laboratory; specimen originates from surgical pathology or biopsy processing prior to digital slide analysis
Clinical & Coding Specifications
Clinical Context
A 67-year-old man with a history of intermediate-risk prostate adenocarcinoma (Gleason score 7, clinical stage T2) undergoes radical prostatectomy. Pathology yields a digitized whole-slide image of the tumor. The treating urologist and multidisciplinary tumor board order the 0376U ArteraAI Prostate Test to augment risk stratification. The laboratory performs AI-driven image analysis of the submitted digital pathology slide, integrates select clinical variables (such as Gleason score, pathologic stage, margin status, and preoperative PSA), and generates an algorithmic report estimating the patient’s risk of distant metastases and prostate cancer–specific mortality and potential response to androgen deprivation therapy.
Typical clinical workflow:
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The surgical pathology team prepares and digitizes the prostatectomy slide and submits the de-identified digital slide and required clinical data to Artera Inc. under the laboratory’s ordering protocol.
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The laboratory performs analytic processing and runs the proprietary AI algorithm unique to Artera Inc. to produce a quantitative risk report.
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The pathology report and ArteraAI result are returned to the ordering provider (urologist or oncologist) as an adjunctive prognostic tool to inform postoperative surveillance intensity and consideration of adjuvant therapies.
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Results are archived in the medical record and may be discussed at tumor board to guide shared decision-making about adjuvant radiation or systemic therapy.
Coding Specifications
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