CPT 0219U: Sentosa SQ HIV-1 Genotyping Assay (NGS)

CPT code 0219U designates the Sentosa® SQ HIV–1 Genotyping Assay, a proprietary next‑generation sequencing (NGS) laboratory test that detects HIV‑1 mutations in reverse transcriptase, integrase, and protease regions. As a PLA code tied to a specific manufacturer, it identifies a unique diagnostic service used in HIV resistance profiling and clinical management. Nationally, proprietary NGS assays like this are important for precision antiviral therapy and public health surveillance because they provide high‑resolution mutation detection that can influence treatment selection.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise national overview of coverage and billing context for 0219U, including payer benchmarks where available, common billing considerations, and clinical context for use of NGS‑based HIV genotyping. The publication summarizes how the code is used in laboratory settings, typical sites of service, and what stakeholders should expect when encountering this manufacturer‑specific assay in claims. Data not available in the input is noted where applicable.

Billing Code Overview

CPT code 0219U is a Proprietary Laboratory Analyses (PLA) code that describes the Sentosa® SQ HIV–1 Genotyping Assay by Vela Diagnostics USA Inc. This next generation sequencing (NGS)–based laboratory test analyzes patient specimens, typically plasma, to detect HIV‑1 genomic mutations in the reverse transcriptase, integrase, and protease regions. The code represents a single manufacturer‑specific genomic assay used for HIV‑1 resistance testing and variant detection.

Service Type: Laboratory — Proprietary NGS HIV‑1 Genotyping Assay

Typical Site of Service: Clinical laboratory or reference laboratory; specimen collection commonly performed in outpatient clinics or hospital outpatient settings

Clinical Context

A 42-year-old person with known HIV-1 infection presents for evaluation of virologic failure after a change in antiretroviral therapy. The patient has a detectable plasma viral load (>200 copies/mL) and requires genotypic resistance testing to guide selection of a revised regimen. A plasma specimen is collected in the outpatient infectious disease clinic or ambulatory infusion center and sent to the clinical laboratory performing the Sentosa® SQ HIV–1 Genotyping Assay. The laboratory performs next‑generation sequencing (NGS) of the reverse transcriptase, integrase, and protease regions to detect resistance‑associated mutations. Results are reported to the ordering clinician to inform selection of integrase, protease, and reverse transcriptase inhibitors. Typical sites of service include hospital outpatient laboratories, independent clinical reference laboratories, and ambulatory infectious disease clinics that coordinate specimen collection and send-out testing.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier (default)	Use when no special circumstance applies to the service.
`26`	Professional component	Use when billing only the professional interpretation component, if applicable and reportable.

Taxonomy Code	Specialty	Notes
207RH0000X	Infectious Disease	Ordering clinicians who manage HIV care and interpret genotyping results.
207K00000X	Internal Medicine	Primary care physicians who manage HIV patients and order resistance testing.
261QM0800X	Pathology and Laboratory Medicine	Laboratory directors and pathologists overseeing molecular diagnostic testing.
3336A0200X	Clinical Laboratory	Clinical laboratory technologists and molecular diagnostics specialists performing NGS assays.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`B20`	Human immunodeficiency virus [HIV] disease	Primary diagnosis for patients with HIV requiring resistance testing when virologic failure or treatment change is present.
`Z21`	Asymptomatic human immunodeficiency virus [HIV] infection status	Relevant for patients with HIV under monitoring who may require baseline or follow-up resistance testing.
`B37.7`	Candidiasis of vulva and vulvovaginal area (example opportunistic infection)	Represents opportunistic infections that may coexist in patients with advanced disease; supports need for comprehensive management including resistance testing.
`R75`	Inconclusive laboratory evidence of human immunodeficiency virus	May prompt repeat testing and genotyping if clinical suspicion or partial test results suggest resistance.
`Z79.899`	Other long term (current) drug therapy	Indicates chronic antiretroviral therapy; genotyping is often performed when therapy fails or to select alternative agents.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Performed prior to sending plasma specimen for the Sentosa® SQ HIV‑1 Genotyping Assay.
`87536`	Infectious agent detection by nucleic acid (DNA or RNA); quantification, HIV-1, viral load	Often ordered before or alongside genotyping to confirm level of viremia and determine if genotyping is indicated.
`0000U`	Proprietary Laboratory Analyses example code (placeholder)	Other PLA codes may be billed for alternative HIV genotyping assays performed by different manufacturers; used for cross-reference in workflow.
`S3722`	Communication technology-based service (specimen management/collection)	Used by some facilities for coordination of specimen collection and reporting; adjunct to laboratory testing workflow.

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Summary & Overview