CPT 0436U: PROphet NSCLC Plasma Protein Biomarker Test

Headline: New CPT PLA Code 0436U Designates PROphet® NSCLC Test for Plasma Protein Profiling

Lead: CPT code 0436U identifies a proprietary laboratory test — the PROphet® NSCLC Test from OncoHost Inc. — that measures 388 plasma proteins and uses an algorithm to predict likely benefit from immune checkpoint inhibitor therapy in patients with non–small cell lung cancer. The designation as a PLA code signals a single‑manufacturer, single‑test billing pathway.

Why it matters: As precision oncology and immunotherapy selection evolve, standardized billing for unique, algorithm‑driven assays affects clinical adoption, coverage decisions, and laboratory reimbursement nationally. PLA coding clarifies the test’s proprietary status for payers and providers and can influence prior authorization, claims adjudication, and medical necessity reviews.

Payers covered: Analysis considers major national payers including Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.

What readers will learn: This publication summarizes the clinical purpose of CPT code 0436U, typical site-of-service implications, the payer landscape relevant to single‑manufacturer biomarker tests, and the kinds of benchmarks and policy considerations that commonly accompany PLA‑coded assays. It highlights how algorithmic protein profiling is positioned in treatment decision pathways for NSCLC and outlines areas where payers often develop coverage policies or require additional clinical documentation.

Note: Data not available in the input for specific coverage decisions, coding modifiers usage beyond those listed, associated taxonomies, ICD‑10 diagnoses, related codes, and service line details.

Billing Code Overview

CPT code 0436U is a Proprietary Laboratory Analyses (PLA) code that applies only to the PROphet® NSCLC Test from OncoHost Inc. The test analyzes a plasma specimen from a patient with non–small cell lung cancer (NSCLC) to measure levels of 388 proteins and uses an algorithmic interpretation to report the probable clinical benefit from immune checkpoint inhibitor therapy such as anti–PD‑1/PD‑L1 treatments.

Service type: Laboratory — proprietary plasma protein biomarker assay with algorithmic interpretation

Typical site of service: Clinical laboratory or reference laboratory processing plasma specimens; specimen collection commonly occurs in outpatient clinics or phlebotomy sites.

Clinical Context

A 68-year-old patient with a history of smoking presents with newly diagnosed stage IV non–small cell lung cancer (NSCLC) confirmed by tissue biopsy. The oncology team is considering first-line systemic therapy and wants to assess likelihood of benefit from immune checkpoint inhibitor therapy. A plasma specimen is drawn during an outpatient oncology visit or at a hospital outpatient laboratory and sent to the manufacturer-specific laboratory for the PROphet® NSCLC Test. The laboratory performs a high-throughput proteomic assay measuring 388 proteins and applies a proprietary algorithm to stratify probable clinical benefit from anti–PD–1/PD–L1 therapy. Results are returned to the ordering oncologist and incorporated into multidisciplinary treatment planning.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier (default)	Applied when no special circumstances affect the service; report the PLA code as usual.
`22`	Increased procedural services	Use when work or resources for specimen handling, additional documentation, or complex interpretation are substantially greater than typical.

Taxonomy Code	Specialty	Notes
207RH0000X	Hematology & Oncology	Medical oncologists who order and interpret NSCLC molecular/proteomic testing.
2085P0206X	Molecular Pathology	Laboratories and pathologists specializing in molecular and proteomic diagnostics.
208000000X	Pathology	Anatomic and clinical pathologists overseeing laboratory testing.
363L00000X	Diagnostic Laboratory	Clinical laboratory organizations performing high-complexity testing.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C34.90`	Malignant neoplasm of unspecified part of unspecified bronchus or lung	Represents NSCLC diagnoses where proteomic testing may inform immunotherapy benefit.
`C34.91`	Malignant neoplasm of right bronchus or lung, unspecified	Specific lung primary site; test used to guide systemic therapy selection.
`C34.92`	Malignant neoplasm of left bronchus or lung, unspecified	Specific lung primary site relevant to staging and systemic treatment decisions.
`C34.1`	Malignant neoplasm of upper lobe, bronchus or lung	Common NSCLC location; test informs likelihood of benefit from checkpoint inhibitors.
`C79.31`	Secondary malignant neoplasm of brain	Metastatic disease where systemic immunotherapy decisions may be influenced by proteomic assay.
`Z85.118`	Personal history of other malignant neoplasm of bronchus and lung	Relevant when assessing recurrence and suitability for immune checkpoint therapy.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0436U`	PROphet® NSCLC Test — proteomic analysis of 388 proteins with algorithmic reporting of probable benefit from immune checkpoint inhibitors	Primary PLA code to report this manufacturer-specific plasma-based proteomic test.
`8023F`	Laboratory clinical test results report (example quality/reporting tracking code)	May be used in quality reporting contexts when documenting result reporting; payer-specific use.
`0001M`	Pharmacogenomic or specialized molecular test (example PLA companion diagnostics range)	Other PLA or molecular diagnostic codes may appear in the workflow for complementary biomarker testing.
`88172`	Flow cytometry; cell surface phenotype, each additional panel	Ancillary laboratory analyses that may be performed in comprehensive hematologic/oncologic workups (contextual).
`36415`	Collection of venous blood by venipuncture	Pre-analytic service for obtaining the plasma specimen sent for the PROphet® NSCLC Test.

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Summary & Overview