Summary & Overview
CPT 0328U: CareView360 Urine Drug Screen with LC–MS/MS ADE Risk Assessment
CPT code 0328U designates the CareView360 proprietary urine assay from Newstar Medical Laboratories LLC. This PLA code covers an LC–MS/MS–based screen for 120+ drugs and metabolites, includes specimen validity testing, and provides an algorithmic interpretation identifying risk for significant adverse drug events (ADEs). As a PLA, the code applies to a single, manufacturer-specific test and is important for payers and clinicians who manage medication safety, substance use monitoring, and complex pharmacotherapy oversight.
Key national payers in scope include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise briefing on clinical purpose, typical settings, and payer coverage landscape, followed by operational benchmarks and policy considerations relevant to laboratory billing and proprietary test adoption. The publication summarizes coding specifics, common modifiers, and typical service lines, and outlines what to expect in terms of documentation and reporting for an ADE-risk urine toxicology panel.
This summary is intended to inform health system administrators, laboratory directors, and billing teams about the code’s clinical context, payer relevance, and the types of analyses included with the test. Data not available in the input will be identified in detailed sections where applicable.
Billing Code Overview
CPT code 0328U is a Proprietary Laboratory Analyses (PLA) code for the CareView360 test from Newstar Medical Laboratories LLC. The assay screens a urine specimen for 120 or more drugs and metabolites using liquid chromatography with tandem mass spectrometry (LC–MS/MS). Results include an algorithmic interpretation that reports the presence or absence of risk for a significant adverse drug event (ADE). The procedure also includes specimen validity testing.
Service Type: Laboratory — Proprietary Urine Drug Screen with Algorithmic ADE Risk Assessment
Typical Site of Service: Clinical laboratory or independent diagnostic testing facility (urine specimen collection typically occurs in outpatient or ambulatory settings)
Clinical & Coding Specifications
Clinical Context
A typical patient is a 45–70-year-old adult monitored for polypharmacy and potential adverse drug events after hospital discharge or during chronic pain management. The clinician orders the 0328U CareView360 urine drug screen when a comprehensive, high-sensitivity assessment of prescribed, over-the-counter, and illicit substances is needed to evaluate medication adherence, detect unreported drug exposures, or identify interactions and risk for a significant adverse drug event (ADE). A urine specimen is collected in an outpatient laboratory, hospital outpatient phlebotomy, or ambulatory surgery center. Specimen validity testing is performed to assess collection integrity. The sample is analyzed by the proprietary LC–MS/MS panel identifying 120+ drugs and metabolites. Results include an algorithmic interpretation that reports presence or absence of risk for a significant ADE, which is routed to the ordering clinician for medication reconciliation and clinical decision-making. Typical workflow steps: collection with chain-of-custody or standard urine collection, specimen accessioning and validity testing, LC–MS/MS analysis at Newstar Medical Laboratories LLC, algorithmic report generation (CareView360), results release to the ordering provider, and clinical follow-up if high-risk drug combinations or unexpected substances are detected.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Procedure code | Typically not reported as a modifier; placeholder in some systems |
22 | Increased procedural services | When additional work beyond the typical test is documented and justified (rare for PLA tests) | Use when extensive additional, documented work is performed by the laboratory beyond standard assay processing
26 | Professional component | When only the professional component (interpretation/reporting) is billed separately from the technical component | Use if a separate billing for the laboratory professional interpretation is required and the technical component is billed by another entity
52 | Reduced services | When the service performed is partially reduced or not fully completed | Use if specimen quantity/quality limits full panel testing and a reduced panel is performed
53 | Discontinued procedure | When testing is started but discontinued due to preanalytic failures or patient/collection issues | Use if testing cannot be completed after initiation for valid clinical reasons
62 | Two surgeons/dual billing analog for complex lab interpretations | Rare for laboratory procedures; may denote co-signed complex interpretive work | Use only if two independent laboratories or professionals contribute equally to the interpretive report and payer allows
78 | Unplanned return to the operating/procedure room | Not typically applicable to this laboratory test | Included for completeness; generally not used
80 | Assistant at surgery | Not applicable to outpatient laboratory testing | Not used for this PLA code
82 | Assistant not available | Not applicable | Not used for this PLA code
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services when performed with direct billing | When an advanced practice clinician orders, collects, or documents patient counseling tied to the test and payer requires this modifier for billing | Use per payer rules when AP providers bill under their own NPI for associated services
QK | Medical direction of two, three, or four concurrent anesthesia procedures | Not applicable | Not used for this laboratory code
QX | Qualified nonphysician anesthetist with CRNA | Not applicable | Not used for this laboratory code
QY | Medical direction of one CRNA by an anesthesiologist | Not applicable | Not used for this laboratory code
TC | Technical component | When only the technical component (the laboratory processing and analysis) is billed | Use when the performing laboratory bills the technical component and another entity bills the professional interpretation
TG | Via interactive telemedicine services | When specimen collection or result interpretation occurs in a telehealth/telemedicine context and payer accepts this modifier | Use if the ordering or interpreting service is delivered via telehealth per payer policy
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207Q00000X | Clinical Laboratory Technologist/Technician | Performs specimen processing and LC–MS/MS assay execution |
207L00000X | Pathology | Pathologists may provide oversight, interpretation, and sign-out of complex toxicology results
363LP0800X | Toxicology | Clinical toxicologists interpret complex panels and algorithmic ADE risk reports
363A00000X | Addiction Medicine | Clinicians in addiction medicine commonly order comprehensive drug panels to monitor therapy adherence and safety
208D00000X | Family Medicine | Primary care clinicians order broad drug testing for medication management and risk assessment
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
Z91.49 | Other recorded drug allergy status | Used when documenting adverse reactions or allergy history that motivates detailed drug exposure testing |
R78.89 | Other specified abnormal findings of blood chemistry | Used when abnormal drug-related laboratory findings or suspicion of toxic exposure prompts comprehensive testing
F11.20 | Opioid dependence, uncomplicated | Common indication for monitoring medication adherence and detecting illicit opioid use during treatment
F11.10 | Opioid abuse, uncomplicated | Used when evaluating suspected opioid misuse or recent illicit use
T88.7XXA | Unspecified adverse effect of drug or medicament, initial encounter | Used when assessing for a suspected adverse drug event where comprehensive toxicology is required
Z51.81 | Encounter for therapeutic drug monitoring | Used when monitoring medications with narrow therapeutic indices or complex regimens where drug-drug interactions risk ADEs
Z79.899 | Other long term (current) drug therapy | Used to document patients on multiple chronic medications where polypharmacy assessment via this panel is clinically indicated
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
81005 | Urinalysis; automated test with microscopy | Provides basic urinalysis information often collected at the same visit as urine drug testing for specimen assessment and clinical context |
80305 | Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; qualitative | Rapid presumptive urine drug screens may be used initially before confirmatory LC–MS/MS testing like 0328U
80307 | Drug test(s), definitive, any number of drug classes; definitive drug testing, e.g., chromatographic confirmation | Represents definitive confirmation methods; 0328U is a PLA definitive LC–MS/MS panel and serves a similar role with proprietary interpretation
99000 | Handling and/or conveyance of specimen for transport to another laboratory (if used) | May be used if the specimen is transported from the collection site to the reference lab performing 0328U
99001 | Handling and/or conveyance of specimen for transport to another lab (if distinct) | Alternate handling code for logistic steps in the workflow