Summary & Overview

CPT 0101U: ColoNext® 17-Gene Hereditary Colon Cancer Sequencing Panel

CPT code 0101U designates the ColoNext® proprietary laboratory test from Ambry Genetics®, a genomic sequencing panel that assesses 17 genes linked to hereditary colon cancer disorders. As a PLA code, 0101U is tied to a single manufacturer's test and is used when that specific assay is performed. Nationally, PLA codes like 0101U are important because they standardize reporting for unique commercial laboratory tests that inform genetic risk assessment, clinical decision-making, and cascade testing in families.

This analysis considers major national payers including Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of payer coverage patterns, common billing practices, and the clinical context that drives utilization of hereditary colorectal cancer panels. The publication also outlines typical sites of service and the service type associated with 0101U, helping stakeholders understand where and how the test is delivered.

The report presents benchmarks for utilization and reimbursement where available, summarizes relevant policy and coding guidance affecting PLA tests, and situates 0101U within broader trends in genetic testing and precision medicine.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0101UCPTProprietary Laboratory AnalysesGenetic testingHereditary colorectal cancerGenomic sequencing panelColoNext

Billing Code Overview

CPT code 0101U is a Proprietary Laboratory Analyses (PLA) code that applies specifically to the ColoNext® test from Ambry Genetics®. The code represents a genomic sequencing analysis panel that evaluates 17 genes associated with hereditary colon cancer disorders.

Service type: Genetic testing — genomic sequencing panel for hereditary colorectal cancer risk
Typical site of service: Clinical laboratory or outpatient specimen collection site

Clinical & Coding Specifications

Clinical Context

A typical patient is an adult with a personal or family history suggestive of hereditary colorectal cancer syndrome (for example, early-onset colorectal cancer, multiple colorectal adenomas, or a known pathogenic variant in a first-degree relative). A colorectal surgeon, gastroenterologist, or genetic counselor orders the ColoNext® genomic sequencing panel to evaluate germline variants across 17 genes associated with hereditary colon cancer (e.g., APC, MLH1, MSH2, MSH6, PMS2, EPCAM). A phlebotomy encounter or saliva kit collection is performed in an outpatient clinic, hospital outpatient laboratory, or genetics laboratory where the specimen is shipped to Ambry Genetics® for testing. Results are returned to the ordering clinician; a genetic counselor typically reviews positive or uncertain results with the patient to discuss implications for surveillance, cascade testing of relatives, and potential referral for surgical or medical management. Billing is submitted under Proprietary Laboratory Analyses code 0101U with applicable modifiers to indicate component, provider, or unusual circumstances.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when only the professional interpretation component is reported separately from the technical component for the laboratory test.
`TC`	Technical component	Use when only the technical component (laboratory processing and analysis) is being billed.
`52`	Reduced services	Use when the laboratory performs a reduced or partial service relative to the full test.
`53`	Discontinued procedure	Use when specimen processing is started but discontinued for documented medical reasons.
`59`	Distinct procedural service	Data not available in the input.
`62`	Two surgeons	Use when two surgeons of different specialties share responsibility for specimen collection or case management relevant to testing.
`76`	Repeat procedure by same physician	Data not available in the input.
`77`	Repeat procedure by another physician	Data not available in the input.
`90`	Reference (outside) laboratory	Data not available in the input.
`AS`	Accredited lab performing test	Use when the test is performed by an independent laboratory meeting accreditation standards (e.g., Ambry Genetics®).
`QK`	CLIA waived test performed at mobile unit	Data not available in the input.
`QX`	CLIA moderate complexity performed by a non-waived CLIA-certified lab	Use when billing needs to note performance credentials for the performing facility or personnel.
`QY`	CLIA moderate complexity performed by the ordering physician	Use if the ordering physician's lab performed the moderate complexity testing components.
`SH`	Joint venture provider billing	Use when a joint venture arrangement affects billing for the testing service.

Taxonomy Code	Specialty	Notes
`207L00000X`	Colorectal Surgery	Surgeons ordering genetic testing for surgical planning and risk assessment.
`207K00000X`	Gastroenterology	Gastroenterologists ordering hereditary cancer panels for early-onset or multiple polyps.
`2080P0206X`	Medical Genetics	Clinical geneticists and genetic counselors who interpret results and manage cascade testing.
`208D00000X`	Clinical Laboratory	Laboratory directors and pathologists overseeing test performance and reporting.
`367A00000X`	Genetic Counseling	Genetic counselors who obtain consent, collect family history, and deliver results.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`Z15.09`	Genetic susceptibility to other malignant neoplasm	Indicates known family history or carrier status prompting hereditary colon cancer panel testing.
`Z80.0`	Family history of malignant neoplasm of digestive organs	Used when family history of colorectal cancer prompts germline testing.
`C18.9`	Malignant neoplasm of colon, unspecified	Personal history of colon cancer where germline testing is indicated for hereditary risk evaluation.
`Z85.038`	Personal history of other malignant neoplasm of large intestine	For surveillance and consideration of germline testing after prior colorectal cancer.
`K63.5`	Polyp of colon	Multiple or early-onset polyps may prompt genetic panel testing for polyposis syndromes.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0101U`	ColoNext®; genomic sequencing panel for 17 genes associated with hereditary colon cancer	Primary Proprietary Laboratory Analysis code for this test.
`84163`	Beta‑2‑microglobulin; blood test	May be ordered as part of an oncologic laboratory workup in parallel with genetic risk assessment.
`88360`	Morphometric analysis; tumor cell percentage estimation	May be performed on tumor tissue when somatic testing or tumor profiling is considered alongside germline testing.
`36415`	Collection of venous blood by venipuncture	Frequently performed to obtain the specimen sent to the reference laboratory for `0101U`.
`99000`	Handling and/or conveyance of specimen for transfer from patient to lab (historical/unlisted)	May apply where additional specimen handling or transport services are billed; local payer rules determine acceptability.