Summary & Overview

CPT 0002U: Urine Metabolomic Polyp Risk Assay (PolypDX™)

CPT code 0002U identifies the PolypDX™ Proprietary Laboratory Analyses (PLA) test: a urine-based multianalyte assay with algorithmic analysis (MAAA) that quantifies three metabolites via liquid chromatography–tandem mass spectrometry and reports risk for precancerous adenomatous polyps. Nationally, PLA codes like 0002U matter because they represent manufacturer- or lab-specific diagnostics that can affect coverage decisions, utilization tracking, and laboratory reimbursement frameworks for novel molecular diagnostics.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find context on the clinical purpose of the test, typical site-of-service considerations, and the implications of PLA coding for payer coverage and claims processing. The publication summarizes benchmarking and policy-related topics relevant to proprietary diagnostics, including how such codes fit into existing laboratory billing workflows and the operational steps payers use to evaluate clinical utility and coverage.

This executive summary orients clinicians, practice managers, and payers to the code's clinical function, common billing environment, and the areas to examine for reimbursement and policy alignment. Data not available in the input: payer-specific coverage determinations, utilization rates, associated taxonomies, and ICD-10 diagnoses.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0002UCPTPLAmultianalyte-assaymass-spectrometryurine-diagnosticmolecular-diagnosticslaboratory-billing

Billing Code Overview

CPT code 0002U is a Proprietary Laboratory Analyses (PLA) code that describes a single, manufacturer-specific laboratory test: the PolypDX™ test from Atlantic Diagnostic Laboratories, LLC and Metabolomic Technologies Inc. The test is a multianalyte assay with algorithmic analysis (MAAA) that uses liquid chromatography with tandem mass spectrometry to measure three specific metabolites in a urine specimen and applies an algorithm incorporating patient data and test results to report a patient's risk for precancerous adenomatous polyps.

Service type: Laboratory diagnostic test (MAAA) using mass spectrometry on urine specimen

Typical site of service: Clinical laboratory or reference laboratory

Clinical & Coding Specifications

Clinical Context

A 58-year-old average-risk patient presents to a primary care clinic for routine colorectal cancer screening discussion. The patient prefers noninvasive testing and has no active urinary tract infection, nephrolithiasis, or gross hematuria. The clinician orders the PolypDX™ urine-based assay (0002U) to assess the patient’s risk for precancerous adenomatous polyps. A urine specimen is collected at the outpatient clinic or a specimen collection center and shipped to the performing laboratory (Atlantic Diagnostic Laboratories, LLC / Metabolomic Technologies Inc.). The laboratory performs liquid chromatography with tandem mass spectrometry to quantify three urinary metabolites, applies an algorithmic analysis incorporating patient data, and returns a risk report indicating likelihood of clinically significant adenomatous polyps. Results inform the ordering clinician’s decision regarding need and timing for diagnostic colonoscopy and surveillance.

Coding Specifications

Modifier	Description	When to Use
`00`	Default/identifies the primary procedure	Rarely used; report as the unmodified service when no other modifier applies.
`11`	Multiple procedure or increased procedural service	Use if `0002U` is the only service and payer requires explicit primary procedure indicator.
`26`	Professional component	Use when only the professional component (interpretation/analysis) is reported by a physician or qualified professional separate from the testing lab.
`52`	Reduced services	Use if testing was partially performed or abbreviated per payer-specific rules.
`53`	Discontinued procedure	Use if specimen collection or testing was begun but stopped for documented medical reasons.
`59`*	Not listed in provided modifiers; not included.	Not applicable.
`62`	Two surgeons	Rarely applicable; use only when two qualified providers share reporting responsibilities for the service interpretation.
`78`	Return to OR for related procedure	Not applicable to laboratory-only services; generally not used.
`80`	Assistant surgeon	Not applicable to lab testing; generally not used.
`82`	Assistant surgeon when qualified resident not available	Not applicable to lab testing.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery	Not applicable to lab testing.
`QK`	Medical direction of two, three, or four concurrent anesthesia procedures	Not applicable.
`QX`	CRNA service with medical direction	Not applicable.
`QY`	Medical direction of one CRNA by an anesthesiologist	Not applicable.
`TC`	Technical component	Use when the performing laboratory bills only the technical component (the analytic testing) and the ordering clinician bills separately for interpretation, if applicable.

Taxonomy Code	Specialty	Notes
`208000000X`	Pathology	Laboratories and pathologists oversee biochemical assay validation and result interpretation oversight.
`208100000X`	Clinical Laboratory	Clinical laboratory professionals perform the analytic testing and report generation.
`207Q00000X`	Family Medicine	Primary care clinicians commonly order this urine-based colorectal screening adjunct for average-risk patients.
`207R00000X`	Internal Medicine	Internists order and act on results to refer for colonoscopy or surveillance.
`207V00000X`	Gastroenterology	Gastroenterologists interpret risk reports in the context of screening and schedule diagnostic colonoscopy.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`Z12.11`	Encounter for screening for malignant neoplasm of colon	Primary screening indication for ordering a noninvasive risk assay such as `0002U`.
`Z80.0`	Family history of malignant neoplasm of digestive organs	Family history may prompt additional noninvasive testing or earlier screening.
`R19.5`	Other fecal abnormalities	Abnormal stool findings may lead a clinician to order adjunctive risk assessment tests.
`K63.5`	Polyp of colon	Detection of increased risk for adenomatous polyps is directly relevant to this assay's purpose.
`R19.7`	Diarrhea, unspecified	Gastrointestinal symptoms may lead to screening or diagnostic evaluation including noninvasive tests.
`Z03.89`	Encounter for observation for other suspected diseases and conditions	Used when monitoring and risk stratification are required prior to definitive diagnostic procedures.
`R19.4`	Change in bowel habit	Symptom that can prompt ordering of tests to evaluate for colonic pathology, including PolypDX™.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`81162`	Genetic testing for colorectal cancer risk (familial) — sequence analysis	Not directly related to PolypDX™; may be ordered in patients with family history or hereditary risk evaluation.
`81000`	Urinalysis, by dipstick or tablet reagent; nonautomated, without microscopy	Pre-analytical urinalysis may be performed prior to sending a urine specimen to ensure specimen suitability.
`36415`	Collection of venous blood by venipuncture	May be used in parallel if additional blood-based tests are ordered during the same visit.
`45378`	Colonoscopy, flexible sigmoidoscopy with biopsy, single or multiple	Diagnostic follow-up for a positive PolypDX™ result indicating increased risk for adenomatous polyps.
`G0105`	Colorectal cancer screening; colonoscopy on high risk patients (at facility)	May be used when colonoscopy is indicated based on risk assessment in certain payor contexts.
`G0121`	Colorectal cancer screening; screening colonoscopy on individual at average risk (facility)	May be the subsequent procedure after positive noninvasive risk testing.

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Summary & Overview

CPT 0002U: Urine Metabolomic Polyp Risk Assay (PolypDX™)

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0002UCPTPLAmultianalyte-assaymass-spectrometryurine-diagnosticmolecular-diagnosticslaboratory-billing

Billing Code Overview

Service type: Laboratory diagnostic test (MAAA) using mass spectrometry on urine specimen

Typical site of service: Clinical laboratory or reference laboratory

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Modifier	Description	When to Use
`00`	Default/identifies the primary procedure	Rarely used; report as the unmodified service when no other modifier applies.
`11`	Multiple procedure or increased procedural service	Use if `0002U` is the only service and payer requires explicit primary procedure indicator.
`26`	Professional component	Use when only the professional component (interpretation/analysis) is reported by a physician or qualified professional separate from the testing lab.
`52`	Reduced services	Use if testing was partially performed or abbreviated per payer-specific rules.
`53`	Discontinued procedure	Use if specimen collection or testing was begun but stopped for documented medical reasons.
`59`*	Not listed in provided modifiers; not included.	Not applicable.
`62`	Two surgeons	Rarely applicable; use only when two qualified providers share reporting responsibilities for the service interpretation.
`78`	Return to OR for related procedure	Not applicable to laboratory-only services; generally not used.
`80`	Assistant surgeon	Not applicable to lab testing; generally not used.
`82`	Assistant surgeon when qualified resident not available	Not applicable to lab testing.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery	Not applicable to lab testing.
`QK`	Medical direction of two, three, or four concurrent anesthesia procedures	Not applicable.
`QX`	CRNA service with medical direction	Not applicable.
`QY`	Medical direction of one CRNA by an anesthesiologist	Not applicable.
`TC`	Technical component	Use when the performing laboratory bills only the technical component (the analytic testing) and the ordering clinician bills separately for interpretation, if applicable.

Taxonomy Code	Specialty	Notes
`208000000X`	Pathology	Laboratories and pathologists oversee biochemical assay validation and result interpretation oversight.
`208100000X`	Clinical Laboratory	Clinical laboratory professionals perform the analytic testing and report generation.
`207Q00000X`	Family Medicine	Primary care clinicians commonly order this urine-based colorectal screening adjunct for average-risk patients.
`207R00000X`	Internal Medicine	Internists order and act on results to refer for colonoscopy or surveillance.
`207V00000X`	Gastroenterology	Gastroenterologists interpret risk reports in the context of screening and schedule diagnostic colonoscopy.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`Z12.11`	Encounter for screening for malignant neoplasm of colon	Primary screening indication for ordering a noninvasive risk assay such as `0002U`.
`Z80.0`	Family history of malignant neoplasm of digestive organs	Family history may prompt additional noninvasive testing or earlier screening.
`R19.5`	Other fecal abnormalities	Abnormal stool findings may lead a clinician to order adjunctive risk assessment tests.
`K63.5`	Polyp of colon	Detection of increased risk for adenomatous polyps is directly relevant to this assay's purpose.
`R19.7`	Diarrhea, unspecified	Gastrointestinal symptoms may lead to screening or diagnostic evaluation including noninvasive tests.
`Z03.89`	Encounter for observation for other suspected diseases and conditions	Used when monitoring and risk stratification are required prior to definitive diagnostic procedures.
`R19.4`	Change in bowel habit	Symptom that can prompt ordering of tests to evaluate for colonic pathology, including PolypDX™.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`81162`	Genetic testing for colorectal cancer risk (familial) — sequence analysis	Not directly related to PolypDX™; may be ordered in patients with family history or hereditary risk evaluation.
`81000`	Urinalysis, by dipstick or tablet reagent; nonautomated, without microscopy	Pre-analytical urinalysis may be performed prior to sending a urine specimen to ensure specimen suitability.
`36415`	Collection of venous blood by venipuncture	May be used in parallel if additional blood-based tests are ordered during the same visit.
`45378`	Colonoscopy, flexible sigmoidoscopy with biopsy, single or multiple	Diagnostic follow-up for a positive PolypDX™ result indicating increased risk for adenomatous polyps.
`G0105`	Colorectal cancer screening; colonoscopy on high risk patients (at facility)	May be used when colonoscopy is indicated based on risk assessment in certain payor contexts.
`G0121`	Colorectal cancer screening; screening colonoscopy on individual at average risk (facility)	May be the subsequent procedure after positive noninvasive risk testing.