Summary & Overview

CPT 0288U: DetermaRx™ NSCLC Gene Expression Recurrence Risk

CPT code 0288U designates DetermaRx™, a Proprietary Laboratory Analyses (PLA) molecular diagnostic that produces an algorithmic recurrence risk score for non–small cell lung cancer (NSCLC) using mRNA expression of 11 genes from FFPE tumor tissue. As a PLA code, 0288U represents a single manufacturer-specific test and is used for claims and coverage reviews tied to Oncocyte Corporation’s assay. The code matters nationally because molecular prognostic assays influence post-surgical management, surveillance strategies, and discussions about adjuvant therapy in early-stage NSCLC.

Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise review of what the code represents, typical clinical and laboratory settings where the service is performed, and the payer landscape covered in the analysis. The publication outlines benchmarks for coverage and utilization patterns, summarizes relevant policy considerations affecting access and reimbursement for PLA molecular tests, and provides clinical context on how an mRNA-based recurrence score is used in NSCLC prognostication. Data not available in the input are noted where applicable.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0288UCPTProprietary Laboratory AnalysesMolecular diagnosticsNon-small cell lung cancerGene expressionRecurrence riskFFPEPCR

Billing Code Overview

CPT code 0288U is a Proprietary Laboratory Analyses (PLA) code that describes a single, manufacturer-specific molecular diagnostic test: DetermaRx™ from Oncocyte Corporation. The assay uses a formalin–fixed paraffin–embedded (FFPE) tissue specimen from non–small cell lung cancer (NSCLC) to measure messenger RNA (mRNA) expression of 11 genes by polymerase chain reaction (PCR). An algorithmic analysis of the gene expression data produces a recurrence risk score for NSCLC.

Service type: Molecular diagnostic laboratory test (proprietary gene expression assay)
Typical site of service: Clinical laboratory or hospital laboratory performing specialized molecular testing

Clinical & Coding Specifications

Clinical Context

A 62-year-old patient with a history of stage I–III non–small cell lung cancer (NSCLC) undergoes surgical resection of a lung tumor. Formalin-fixed, paraffin-embedded (FFPE) tumor tissue is submitted to a specialty molecular laboratory for prognostic testing using the DetermaRx™ assay (0288U). The pathology team selects representative tumor blocks, documents percent tumor content, and prepares an FFPE specimen and requisition with clinical history and pathology report. The laboratory extracts mRNA from the FFPE specimen, performs polymerase chain reaction (PCR)–based expression analysis of the 11-gene panel, and applies the proprietary algorithm to generate a recurrence risk score. The final report is returned to the ordering thoracic surgeon or medical oncologist and becomes part of the multidisciplinary treatment planning discussion regarding adjuvant therapy decisions and surveillance intensity.

Coding Specifications

Modifier	Description	When to Use
`00`	Procedure performed with no modifier	Rarely used; default when no specific modifier applies to the laboratory PLA service.
`22`	Increased procedural services	Use when documentation supports increased lab work or extensive pathology review beyond routine for test processing or reporting.
`26`	Professional component	Use when billing only the professional component (interpretation/analysis) of the test separate from technical processing, if payer allows split billing.
`52`	Reduced services	Use when the test was partially performed or limited in scope (eg, inadequate specimen processing resulting in partial data).
`53`	Discontinued procedure	Use if processing was started but discontinued due to specimen unsuitability or preanalytical failure.
`62`	Two surgeons or providers	Use when two qualified providers share responsibility for test interpretation under specific payer policy (rare for PLA tests).
`78`	Unplanned return to the operating/procedure room by the same physician following initial procedure	Uncommon; included only if a repeat tissue acquisition during the same operative encounter occurs leading to a new specimen for testing.
`80`	Assistant surgeon	Use when an assistant surgeon performs tissue acquisition as part of the operative specimen collection that leads to the test.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery	Use when an advanced practice provider assists in specimen procurement related to the tested tissue.
`TC`	Technical component	Use when billing only the technical component (laboratory processing, reagents, instrumentation) of the `0288U` PLA test.

Taxonomy Code	Specialty	Notes
207U00000X	Thoracic Surgery	Ordering surgeon who obtains surgical specimen and coordinates pathology submission.
207R00000X	Pathology	Pathologist responsible for specimen selection, pathology reporting, and ordering of molecular tests.
207Q00000X	Medical Oncology	Oncologist who uses recurrence risk score to guide adjuvant therapy decisions.
363L00000X	Clinical Laboratory Director	Laboratory director overseeing molecular diagnostic testing and test result sign-out.
208D00000X	Pulmonology	Pulmonologist involved in initial diagnosis or biopsy procurement that leads to testing.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C34.10`	Malignant neoplasm of upper lobe, bronchus or lung, unspecified	Primary tumor site commonly submitted as FFPE tissue for DetermaRx testing.
`C34.11`	Malignant neoplasm of upper lobe, right bronchus or lung	Specific laterality code used on the pathology report and claim when applicable.
`C34.12`	Malignant neoplasm of upper lobe, left bronchus or lung	Specific laterality code used on the pathology report and claim when applicable.
`C34.90`	Malignant neoplasm of unspecified part of bronchus or lung	Used when documentation does not specify tumor subsite but NSCLC diagnosis is present.
`Z85.118`	Personal history of malignant neoplasm of bronchus and lung	Relevant for surveillance and risk assessment context when ordering prognostic testing.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Pathology evaluation of the resected specimen and selection of FFPE blocks for molecular testing prior to `0288U`.
`88172`	Cytopathology, cell block, or molecular preparation of specimen	Preparation of cytology cell block or nucleic acid extraction steps that may precede molecular assays when applicable.
`88342`	Immunohistochemistry, per specimen; initial single antibody stain	Ancillary testing to characterize tumor (eg, TTF-1) that informs diagnosis before ordering prognostic molecular testing.
`G0452`	Pharmacogenomic/other molecular pathology procedure (Note: example molecular code often used for lab services)	Administrative/molecular panel coding used by some payers for reporting genomic services alongside PLA codes in coverage discussions.
`G0447`	Patient-facing genetic counseling (individual) (example)	Genetic counseling or consultation that may be provided when molecular prognostic results impact treatment planning.

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Summary & Overview

CPT 0288U: DetermaRx™ NSCLC Gene Expression Recurrence Risk

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0288UCPTProprietary Laboratory AnalysesMolecular diagnosticsNon-small cell lung cancerGene expressionRecurrence riskFFPEPCR

Billing Code Overview

Service type: Molecular diagnostic laboratory test (proprietary gene expression assay)
Typical site of service: Clinical laboratory or hospital laboratory performing specialized molecular testing

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Modifier	Description	When to Use
`00`	Procedure performed with no modifier	Rarely used; default when no specific modifier applies to the laboratory PLA service.
`22`	Increased procedural services	Use when documentation supports increased lab work or extensive pathology review beyond routine for test processing or reporting.
`26`	Professional component	Use when billing only the professional component (interpretation/analysis) of the test separate from technical processing, if payer allows split billing.
`52`	Reduced services	Use when the test was partially performed or limited in scope (eg, inadequate specimen processing resulting in partial data).
`53`	Discontinued procedure	Use if processing was started but discontinued due to specimen unsuitability or preanalytical failure.
`62`	Two surgeons or providers	Use when two qualified providers share responsibility for test interpretation under specific payer policy (rare for PLA tests).
`78`	Unplanned return to the operating/procedure room by the same physician following initial procedure	Uncommon; included only if a repeat tissue acquisition during the same operative encounter occurs leading to a new specimen for testing.
`80`	Assistant surgeon	Use when an assistant surgeon performs tissue acquisition as part of the operative specimen collection that leads to the test.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery	Use when an advanced practice provider assists in specimen procurement related to the tested tissue.
`TC`	Technical component	Use when billing only the technical component (laboratory processing, reagents, instrumentation) of the `0288U` PLA test.

Taxonomy Code	Specialty	Notes
207U00000X	Thoracic Surgery	Ordering surgeon who obtains surgical specimen and coordinates pathology submission.
207R00000X	Pathology	Pathologist responsible for specimen selection, pathology reporting, and ordering of molecular tests.
207Q00000X	Medical Oncology	Oncologist who uses recurrence risk score to guide adjuvant therapy decisions.
363L00000X	Clinical Laboratory Director	Laboratory director overseeing molecular diagnostic testing and test result sign-out.
208D00000X	Pulmonology	Pulmonologist involved in initial diagnosis or biopsy procurement that leads to testing.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C34.10`	Malignant neoplasm of upper lobe, bronchus or lung, unspecified	Primary tumor site commonly submitted as FFPE tissue for DetermaRx testing.
`C34.11`	Malignant neoplasm of upper lobe, right bronchus or lung	Specific laterality code used on the pathology report and claim when applicable.
`C34.12`	Malignant neoplasm of upper lobe, left bronchus or lung	Specific laterality code used on the pathology report and claim when applicable.
`C34.90`	Malignant neoplasm of unspecified part of bronchus or lung	Used when documentation does not specify tumor subsite but NSCLC diagnosis is present.
`Z85.118`	Personal history of malignant neoplasm of bronchus and lung	Relevant for surveillance and risk assessment context when ordering prognostic testing.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Pathology evaluation of the resected specimen and selection of FFPE blocks for molecular testing prior to `0288U`.
`88172`	Cytopathology, cell block, or molecular preparation of specimen	Preparation of cytology cell block or nucleic acid extraction steps that may precede molecular assays when applicable.
`88342`	Immunohistochemistry, per specimen; initial single antibody stain	Ancillary testing to characterize tumor (eg, TTF-1) that informs diagnosis before ordering prognostic molecular testing.
`G0452`	Pharmacogenomic/other molecular pathology procedure (Note: example molecular code often used for lab services)	Administrative/molecular panel coding used by some payers for reporting genomic services alongside PLA codes in coverage discussions.
`G0447`	Patient-facing genetic counseling (individual) (example)	Genetic counseling or consultation that may be provided when molecular prognostic results impact treatment planning.