Summary & Overview
CPT 0322U: NPDX ASD Test Panel III, Plasma Metabolomic LC–MS/MS
CPT code 0322U identifies a proprietary laboratory test — the NPDX ASD Test Panel III from Stemina Biomarker Discovery, NeuroPointDX. The assay uses liquid chromatography–tandem mass spectrometry (LC–MS/MS) to quantify metabolism-related plasma compounds and applies an algorithm to report a positive or negative metabolic profile associated with autism spectrum disorder (ASD). As a PLA code, 0322U applies only to this single manufacturer-specific test and is used in claims to distinguish this proprietary diagnostic panel.
Key payers included in this national analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find concise benchmarks for coverage and coding practices, an overview of clinical context for metabolomic testing in ASD evaluation, and notes on claim submission considerations tied to the PLA designation. The publication summarizes how payers treat manufacturer-specific laboratory assays, common billing practices for proprietary panels, and the implications of algorithm-based binary reporting (positive/negative) for medical necessity and documentation. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0322U is a Proprietary Laboratory Analyses (PLA) code specific to a single laboratory test: the NPDX ASD Test Panel III from Stemina Biomarker Discovery, NeuroPointDX division. The test uses liquid chromatography with tandem mass spectrometry (LC–MS/MS) to measure metabolism-related chemical compounds in a plasma specimen and reports algorithm-driven results as positive or negative for a metabolic profile associated with autism spectrum disorder (ASD).
Service type: Laboratory — Proprietary diagnostic metabolomic panel performed on plasma using LC–MS/MS.
Typical site of service: Clinical laboratory or reference laboratory setting; specimen collection may occur in outpatient clinics or phlebotomy centers.
Clinical & Coding Specifications
Clinical Context
A pediatric or young-adult patient presents to a developmental-behavioral pediatrics or pediatric neurology clinic for evaluation of delayed social communication, restricted/repetitive behaviors, and/or regression in language. After standard developmental screening and diagnostic assessment raises concern for autism spectrum disorder (ASD), the clinician orders the proprietary NPDX ASD Test Panel III (0322U) from Stemina Biomarker Discovery, NeuroPointDX division to evaluate a plasma metabolic profile that may support biochemical subtype identification. A fasting or non-fasting peripheral blood draw is performed in an outpatient laboratory, ambulatory clinic, or reference laboratory phlebotomy site; the plasma specimen is processed and shipped per the manufacturer’s instructions to the performing laboratory. The laboratory uses liquid chromatography–tandem mass spectrometry (LC–MS/MS) and an algorithmic analysis to classify the metabolic profile as positive or negative for an ASD-associated signature. Results are returned to the ordering clinician and incorporated into the diagnostic synthesis and care planning discussion with the patient’s caregivers. Typical sites of service include outpatient hospital-based laboratories, independent clinical reference laboratories, and ambulatory clinic laboratory draw stations. The service type is a proprietary laboratory analysis (PLA) molecular/metabolomic diagnostic test.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Procedure code exempt from modifier reporting (placeholder) | Use only if payer/system requires a default code indicating no modifier; rare for PLA codes. |
26 | Professional component | Use when reporting only the professional interpretation component separate from the technical laboratory processing. |
TC | Technical component | Use when reporting only the technical component (laboratory testing, specimen handling, instrumentation). |
52 | Reduced services | Use if the laboratory performed a limited version of the test or partial panel for clinical reasons. |
53 | Discontinued procedure | Use when testing was started but discontinued for clinical reasons and must be reported per payer rules. |
59 | Data not provided in input | Data not available in the input. |
62 | Two surgeons/paired provider team (applicable provider modifier) | Use when two qualified laboratory directors or co-signed professional interpretations are required and permitted by payer rules. |
78 | Unplanned return to the operating/procedure room (not typical) | Rarely applicable; used only if regulatory billing rules require reporting of an unplanned repeat specimen collection during the same encounter. |
80 | Assistant at surgery (not typical) | Rarely applicable; used only if an assistant’s professional time is separately billable for the professional interpretation. |
QK | Medical direction of two or more technicians (CLA/CPT lab context) | Use if the physician medical director directs multiple laboratory technicians for the test in accordance with CMS rules. |
QX | Modifier for CLIA-waived personnel (delegation) | Use when testing or specimen processing involved CLIA-qualified personnel under a QX arrangement, per payer guidelines. |
QY | Medical supervision by a physician (supervising) | Use when physician supervision meets specific payer-defined criteria for lab testing. |
AS | Patient unable to tolerate procedure (anesthesia not used) | Use if blood draw could not be completed because the patient could not tolerate venipuncture and that status must be reported. |
TC | Technical component | Use when only the laboratory technical work is billed by the performing lab. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Pediatric Neurology | Clinicians who evaluate children for ASD and may order metabolomic testing. |
| 207RC0000X | Developmental-Behavioral Pediatrics | Specialists who frequently order ASD diagnostic adjunct testing. |
| 208000000X | Pathology-Laboratory Medicine | Laboratory directors and pathologists responsible for oversight of LC–MS/MS assays and reporting. |
| 207L00000X | Pediatric Medicine | General pediatricians ordering confirmatory or adjunct testing as part of ASD evaluation. |
| 390200000X | Clinical Molecular Genetics | Laboratory specialists who develop and validate proprietary metabolomic algorithms and oversee analytic validity. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
F84.0 | Autistic disorder | Primary diagnostic code for patients evaluated for ASD where the NPDX ASD Test Panel III may be adjunctively used. |
F84.9 | Pervasive developmental disorder, unspecified | Used when clinical features suggest ASD-spectrum disorder but specific subtype not assigned; test may aid evaluation. |
R62.0 | Delayed milestone in childhood | Applied when developmental delays prompt metabolic and diagnostic workup including specialized assays. |
F80.1 | Expressive language disorder | Used when language regression or delay is part of the clinical presentation prompting further metabolic testing. |
R47.01 | Aphasia | Applied when speech/language impairment is present and metabolic contributors are considered in the differential. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
81002 | Urinalysis, by dipstick or tablet reagent; with microscopy | Performed if metabolic screening includes urine studies as adjuncts to plasma metabolomics in broader metabolic workup. |
36415 | Collection of venous blood by venipuncture | Commonly performed immediately prior to 0322U for plasma specimen collection. |
80053 | Comprehensive metabolic panel (CMP) | May be ordered alongside to assess baseline metabolic and organ function prior to or concurrent with specialized metabolomic testing. |
82542 | Creatine kinase (CK); isoenzymes | Additional metabolic/neuromuscular lab that may be part of a broader neurometabolic evaluation in selected patients. |
83735 | Vitamin B12; methylmalonic acid (MMA), LC-MS/MS | Common adjunctive LC–MS/MS metabolic tests that may be ordered in conjunction with proprietary metabolomic panels. |