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.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0037UCPTProprietary Laboratory AnalysesCompanion DiagnosticGenomic ProfilingOncologyMolecular DiagnosticsLaboratory Billing

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.

Service type: Laboratory-based genomic profiling / companion diagnostic
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`

Taxonomy Code	Specialty	Notes
208000000X	Pathology	Molecular pathology and laboratory directors overseeing NGS-based assays
207RP1001X	Hematology/Oncology	Medical oncologists ordering tumor genomic profiling for therapy selection
207R00000X	Medical Oncology	Oncologists managing systemic therapy and using CDx results for treatment decisions
363L00000X	Clinical Laboratory	Clinical laboratory directors and technical staff performing sequencing and reporting
207K00000X	Radiation Oncology	Radiation oncologists may use molecular results for multidisciplinary planning

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C34.90`	Malignant neoplasm of unspecified part of unspecified bronchus or lung	Common primary diagnosis for which FoundationOne CDx (`0037U`) is ordered to identify actionable mutations in non–small cell lung cancer
`C50.919`	Malignant neoplasm of unspecified site of unspecified female breast	Breast cancer may be tested with comprehensive genomic profiling when advanced disease or therapeutic biomarker guidance is needed
`C61`	Malignant neoplasm of prostate	Genomic profiling may be used in advanced or recurrent prostate cancer for targeted therapy considerations
`C18.9`	Malignant neoplasm of colon, unspecified	Colorectal cancer often undergoes molecular testing to identify mismatch repair status and targetable alterations
`C71.9`	Malignant neoplasm of brain, unspecified	Selected brain tumor cases may undergo comprehensive genomic profiling to identify actionable alterations
`C56.9`	Malignant neoplasm of ovary, unspecified	Ovarian cancers may be evaluated with broad genomic profiling for PARP inhibitor and other targeted therapy eligibility
`C80.1`	Malignant (primary) neoplasm, unspecified	Used when a primary site is not determined and broad genomic profiling is pursued to guide diagnosis and therapy

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Performed on biopsy or resection specimens prior to or alongside molecular testing to establish histologic diagnosis and ensure adequate tumor content for `0037U`
`88112`	Cytopathology, smears, interpretation	Used when cytology specimens are obtained and evaluated to confirm malignancy and adequacy for molecular testing
`81479`	Unlisted molecular pathology procedure	Occasionally used for reporting non-standard or additional molecular analyses that are not covered by the PLA when performed separately from `0037U`
`0004M`	Oncology biomarker test (example PLA)	Other PLA or molecular biomarker tests may be ordered alongside `0037U` for additional actionable targets
`88342`	Immunohistochemistry (IHC) for tumor markers	Performed to assess protein expression (eg, PD-L1) that complements genomic profiling from `0037U`