Summary & Overview
CPT 0388U: InVisionFirst–Lung Liquid Biopsy for NSCLC ctDNA Profiling
CPT code 0388U designates the InVisionFirst®–Lung Liquid Biopsy from Inivata Inc., a proprietary plasma-based molecular diagnostic that detects circulating tumor DNA (ctDNA) in patients with non–small cell lung cancer (NSCLC). As a PLA code, 0388U is uniquely tied to a single manufacturer’s test and signals detection of tumor genomic alterations that can affect targeted therapy and monitoring decisions. The code matters nationally as liquid biopsy use expands for molecular profiling when tissue is unavailable or to monitor emerging resistance.
Key payers in most national analyses include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication summarizes payer coverage patterns, reimbursement benchmarks, and clinical context for ctDNA testing in NSCLC. Readers will find an overview of how PLA coding affects billing and payer recognition, typical sites of service for specimen collection and testing, and the clinical scenarios in which InVisionFirst–Lung is applied. The report also outlines common modifiers and administrative considerations used when billing this laboratory service. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0388U is a Proprietary Laboratory Analyses (PLA) code for the InVisionFirst®–Lung Liquid Biopsy produced by Inivata Inc. The test evaluates a plasma specimen from a patient with non–small cell lung cancer (NSCLC) to detect circulating tumor DNA (ctDNA) and generate a tumor genetic profile that can inform treatment decisions.
Service type: Clinical laboratory molecular diagnostic test (proprietary liquid biopsy)
Typical site of service: Clinical laboratory or specialty diagnostic laboratory; specimen collected in an outpatient clinic or hospital phlebotomy setting and sent to a reference laboratory for analysis.
Clinical & Coding Specifications
Clinical Context
A 66-year-old patient with a history of smoking and recently diagnosed non–small cell lung cancer (NSCLC) presents for molecular profiling to guide targeted therapy selection. The treating oncologist orders the InVisionFirst®–Lung liquid biopsy test (0388U) to analyze a plasma specimen for circulating tumor DNA (ctDNA). A phlebotomy is performed at an outpatient oncology clinic or an independent drawing center; the specimen is sent to the performing laboratory (Inivata Inc.) or a designated reference lab. Results provide a tumor genetic profile including actionable mutations (EGFR, ALK, ROS1, BRAF, MET, KRAS, etc.) and may inform use of targeted agents, enrollment in clinical trials, or decisions when tissue biopsy is infeasible or insufficient. The clinical workflow includes: ordering the PLA test in the electronic medical record, obtaining informed consent per facility policy, drawing peripheral blood, verifying specimen labeling and shipping per manufacturer instructions, laboratory processing and ctDNA analysis, result reporting to the ordering clinician, and integration of findings into treatment planning and documentation in the oncology chart.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier appended | When no modifier applies and service is billed as usual |
22 | Increased procedural services | When reporting unusually extensive laboratory interpretation or ancillary services documented beyond standard test complexity |
26 | Professional component | When billing professional interpretation separate from technical laboratory components (if allowed by payer) |
52 | Reduced services | When the test is partially performed or truncated for documented reasons |
53 | Discontinued procedure | When specimen collection was attempted but the procedure was discontinued prior to completion |
62 | Two surgeons | Not typically used for this test but available when two providers share responsibility for services related to specimen collection |
78 | Unplanned return to the operating/procedure room | Rarely applicable; use only if the patient returns for an unplanned procedure related to the testing process |
80 | Assistant surgeon | Not typically applicable; use if an assistant surgeon is documented for an associated invasive procedure |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist billing as a service provider | When an authorized nonphysician practitioner collects the specimen or performs billable services in accordance with payer rules |
QK | Medical direction of two, three, or four technicians/technologists | When the ordering provider documents supervision/ direction consistent with laboratory staffing rules and the payer recognizes the modifier |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208000000X | Medical Oncology | Medical oncologists order and interpret tumor genotyping to guide systemic therapy selection |
| 201Q00000X | Hematology & Oncology | Combined specialty commonly involved in ordering and applying ctDNA results |
| 207RC0000X | Pathology | Pathologists oversee laboratory testing, molecular diagnostics, and result validation |
| 363L00000X | Laboratory Director | Laboratory medicine specialists or molecular diagnostics directors manage test performance and compliance |
| 2086S0105X | Thoracic Oncology | Thoracic oncologists/care teams frequently use lung-specific molecular profiling in NSCLC management |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung | Common primary diagnosis for NSCLC patients undergoing plasma-based genomic profiling |
C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung | Anatomic site-specific NSCLC diagnosis often requiring molecular testing to guide therapy |
C34.12 | Malignant neoplasm of middle lobe, right bronchus or lung | Site-specific NSCLC diagnosis relevant to staging and molecular profiling |
C34.31 | Malignant neoplasm of upper lobe, left bronchus or lung | Left-sided NSCLC where ctDNA testing supports systemic treatment selection |
Z85.118 | Personal history of other malignant neoplasm of bronchus and lung | Used when monitoring for recurrence or residual disease with plasma ctDNA assays |
R91.8 | Other nonspecific abnormal findings of lung field | When imaging finds indeterminate lung lesions and molecular profiling assists in diagnostic strategy |
C78.01 | Secondary malignant neoplasm of right lung | Used when lung is site of metastasis and molecular profiling of primary or metastatic disease guides therapy |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Performed immediately prior to 0388U to obtain the plasma specimen for ctDNA analysis |
36416 | Collection of capillary blood specimen | Alternative specimen collection method when venous access is not feasible; rarely used for this test per manufacturer guidance |
88360 | Immunohistochemistry interpretation, first slide | Performed on tissue specimens when tissue-based molecular testing or IHC is used alongside liquid biopsy for comprehensive profiling |
81210 | EGFR (epidermal growth factor receptor) gene analysis | Tissue- or plasma-based single-gene test that may be ordered in parallel or as confirmatory testing to findings reported by 0388U |
81599 | Unlisted molecular pathology procedure | Used for reporting other proprietary or novel molecular tests when no specific CPT exists; related in the context of alternative molecular assays |
99000 | Handling and/or conveyance of specimen for transfer to another facility | Billed when additional specimen handling or shipping is required to send the plasma sample to the performing laboratory |