CPT 0110U: Oral OncolyticAssuranceRX LC–MS/MS Drug Detection

CPT code 0110U designates a Proprietary Laboratory Analyses (PLA) test — the Oral OncolyticAssuranceRX from Firstox Laboratories, LLC — that uses liquid chromatography–tandem mass spectrometry (LC–MS/MS) on serum or plasma from capillary or venous blood to detect and quantify oral oncology drugs and related substances. This code matters nationally as precision pharmacologic monitoring gains importance for oral cancer therapies, adherence assessment, toxicity prevention, and personalized dosing decisions.

Key payers included in the coverage analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication summarizes payer coverage approaches, coding and billing implications for laboratories and clinicians, and how this PLA code fits into existing laboratory testing pathways.

Readers will find a concise benchmark of payer coverage policies, an explanation of clinical context for using LC–MS/MS to measure oral oncolytic agents, and a clear summary of administrative considerations tied to a PLA-coded single-manufacturer test. The report highlights technical service details, typical sites of service, and the types of clinical situations where measurement of oral oncology drug levels is relevant. Data not available in the input: associated taxonomies, specific ICD-10 diagnoses, detailed payer policy language, and related or companion billing codes.

Billing Code Overview

CPT code 0110U is a Proprietary Laboratory Analyses (PLA) code for the Oral OncolyticAssuranceRX test produced by Firstox Laboratories, LLC. The test uses liquid chromatography and tandem mass spectrometry (LC–MS/MS) of serum or plasma from a capillary or venous blood specimen to determine the presence, absence, and quantity of one or more oral oncology drug(s) and substances in a patient’s body.

Service type: Laboratory diagnostic test using LC–MS/MS for therapeutic drug monitoring and detection of oral oncolytic agents.
Typical site of service: Clinical laboratory or outpatient blood draw collection site (capillary or venous).

Clinical Context

A 62-year-old patient with metastatic colorectal cancer is on oral capecitabine therapy and presents for routine therapeutic monitoring and adherence verification. The treating oncologist orders the Oral OncolyticAssuranceRX test (0110U) to detect and quantify capecitabine and its active metabolites in serum or plasma collected via capillary or venous blood. A phlebotomy or fingerstick specimen is collected at the outpatient oncology clinic or infusion center and sent to Firstox Laboratories, LLC. The laboratory performs liquid chromatography–tandem mass spectrometry (LC–MS/MS) to determine presence/absence and concentration of the oral oncology drug(s). Results are reported to the ordering provider and used to assess adherence, drug exposure, potential drug interactions, or unexpected toxicity before continuing or adjusting oral therapy. Typical sites of service include outpatient oncology clinics, ambulatory surgical centers for oncology care, physician offices, and independent clinical laboratories. Typical supporting documentation includes the order, indication in the medical record, specimen collection time, collection method (capillary vs venous), and signed report from the performing laboratory.

Coding Specifications

Modifier	Description	When to Use
`00`	Default; no modifier	Use when no other modifier applies and the standard PLA service is furnished.

Taxonomy Code	Specialty	Notes
207L00000X	Hematology & Oncology	Ordering and interpreting oncologists who monitor oral oncolytics.
207RC0000X	Medical Oncology	Medical oncologists managing systemic oral chemotherapy and monitoring drug levels.
208000000X	Pathology	Pathologists overseeing laboratory testing quality and interpretation when applicable.
363A00000X	Clinical Laboratory	Clinical laboratory directors or specialists responsible for performing LC–MS/MS assays.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C18.9`	Malignant neoplasm of colon, unspecified	Common primary diagnosis for patients receiving oral fluoropyrimidines or other oral oncology agents monitored by this assay.
`C50.912`	Malignant neoplasm of unspecified site of left female breast	Breast cancer patients receiving oral agents (eg, capecitabine, cyclin-dependent kinase inhibitors) may require drug monitoring.
`C34.90`	Malignant neoplasm of unspecified part of unspecified bronchus or lung	Lung cancer patients on oral targeted therapies may be monitored for drug presence and levels.
`C77.0`	Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck	Metastatic disease context where oral therapies are used and adherence/exposure monitoring is relevant.
`Z79.899`	Other long term (current) drug therapy	Indicates chronic use of oral systemic therapy where periodic drug monitoring is appropriate.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Venous specimen collection commonly used to obtain serum or plasma for the LC–MS/MS assay.
`36416`	Collection of capillary blood specimen (eg, finger stick)	Capillary collection option for outpatient or point-of-care blood sampling for this test.
`80053`	Comprehensive metabolic panel	Commonly ordered alongside drug monitoring to assess organ function (liver, kidney) that affects oral oncolytic metabolism.
`84295`	Drug monitoring; other (therapeutic drug monitoring)	General drug monitoring code sometimes used in related workflows; note `0110U` is a PLA code specific to Oral OncolyticAssuranceRX and is reported in addition.
`88360`	Immunohistochemistry (IHC) for tumor markers	Tumor marker testing performed in parallel for therapeutic decision making, not directly substitutive but part of oncology lab workflow.

OpenPayer

Summary & Overview