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CPT 0037U: FoundationOne CDx™ Companion Diagnostic Genomic Profiling
CPT code 0037U identifies the FoundationOne CDx™ (F1CDx®) proprietary companion diagnostic genomic profiling test from Foundation Medicine, Inc. As a PLA code, 0037U denotes a single manufacturer-specific assay used to detect genomic alterations across multiple tumor indications to guide targeted cancer therapies. Its use is clinically significant as precision oncology testing increasingly influences systemic therapy selection and eligibility for targeted agents and clinical trials.
Key national payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of code definition and clinical intent, payer coverage landscape, and typical sites of service. The publication summarizes benchmark topics relevant to billing and reimbursement for PLA companion diagnostics, notes common modifiers used with laboratory billing, and provides clinical context for the test’s role as a companion diagnostic across five tumor indications.
This summary is intended to inform revenue cycle, laboratory operations, and policy teams about the code’s purpose, how major payers are approached in analyses, and what to expect when managing billing and documentation for a manufacturer-specific CDx laboratory assay.
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Billing Code Overview
CPT code 0037U is a Proprietary Laboratory Analyses (PLA) code that describes the FoundationOne CDx™ (F1CDx®) test, a companion diagnostic (CDx) assay developed by Foundation Medicine, Inc. The code represents a single, manufacturer-specific genomic profiling test used to identify actionable genomic alterations across multiple tumor types to inform targeted therapy selection.
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Service type: Laboratory-based genomic profiling / companion diagnostic
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Typical site of service: Clinical laboratory or molecular diagnostics laboratory setting