Summary & Overview
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.
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
Clinical & Coding Specifications
Clinical Context
A 64-year-old patient with newly diagnosed non–small cell lung cancer (NSCLC) presents after initial imaging and histopathologic confirmation. The treating oncologist orders comprehensive tumor genomic profiling to identify actionable genomic alterations and to determine eligibility for targeted therapies and companion diagnostic indications. A tissue or plasma specimen is submitted to Foundation Medicine, Inc. for the FoundationOne CDx™ test billed under 0037U. The laboratory performs next-generation sequencing (NGS) on the submitted specimen, reports companion diagnostic results for specified tumor types, and returns a molecular pathology report to the oncology team. The clinical workflow includes specimen collection during biopsy or surgical resection, pathology confirmation, test requisition and specimen shipment, laboratory processing and sequencing, result interpretation, and integration of the report into the oncology treatment planning visit.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Standard reporting indicator | Used when no specific modifier applies and the service is reported in the usual manner |
26 |