Summary & Overview

CPT 0091U: FirstSightCRC™ Blood-Based CTC and cfDNA Test

CPT code 0091U designates the FirstSightCRC™ proprietary laboratory test from CellMax Life, a blood-based assay that isolates circulating tumor cells (CTCs) and cell-free DNA (cfDNA) to report a positive or negative result for colorectal adenoma or cancer. As a PLA code, 0091U applies exclusively to this single manufacturer's test and is used by laboratories and payers to identify the specific proprietary assay.

This national overview covers coverage and payment context for major payers including Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and the Medicare program. The publication summarizes which payers include the test in coverage policies or laboratory benefit schedules, typical sites of service, and billing practice considerations tied to a PLA code.

Readers will learn the clinical purpose of the assay, the service setting and specimen type, and how the PLA designation affects coding clarity and payer recognition. The report highlights benchmarking items and policy developments relevant to proprietary molecular diagnostics, provides practical guidance on documentation and claims reporting for the laboratory service, and identifies areas where payers may require additional clinical evidence or prior authorization. Data not available in the input.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0091UCPTProprietary Laboratory Analysismolecular diagnosticscirculating tumor cellscell-free DNAcolorectal cancer screeninglaboratory servicesPLA code

Billing Code Overview

CPT code 0091U is a Proprietary Laboratory Analyses (PLA) code assigned to the FirstSightCRC™ test from CellMax Life. The test isolates and analyzes circulating tumor cells (CTCs) and cell–free DNA from a whole blood specimen and reports results as positive or negative for adenoma or cancer.

Service type: Laboratory — proprietary molecular diagnostic test

Typical site of service: Clinical laboratory or outpatient blood collection site

Clinical & Coding Specifications

Clinical Context

A typical patient is an average-risk adult or a patient with intermediate risk for colorectal neoplasia who declines or is unable to undergo colonoscopy, or in whom a noninvasive triage test is requested. The patient presents to a primary care clinician or gastroenterology clinic for colorectal cancer screening or evaluation of nonspecific lower gastrointestinal symptoms (for example, intermittent rectal bleeding, change in bowel habits, unexplained weight loss, or iron-deficiency anemia). A blood specimen (whole blood) is collected in an outpatient phlebotomy setting or clinic, labeled, and shipped to the performing laboratory under appropriate chain-of-custody conditions. The FirstSightCRC™ test from CellMax Life isolates circulating tumor cells and cell-free DNA from the specimen; the laboratory performs proprietary analysis and reports a binary result (positive or negative for adenoma or cancer). Results are returned to the ordering clinician who uses them to guide need for diagnostic colonoscopy or further evaluation. Typical site of service is an outpatient clinic, ambulatory phlebotomy center, or commercial laboratory specimen collection site. Typical patient scenario: a 58-year-old patient who declines stool-based screening or colonoscopy and elects blood-based screening; sample is collected during a routine office visit and sent to the performing laboratory for processing and reporting.

Coding Specifications

Modifier	Description	When to Use
`22`	Increased procedural services	Use when work, time, or technical effort for the laboratory procedure is substantially greater than typical for the test and documentation supports increased complexity.
`52`	Reduced services	Use when a specimen collection or processing step for the test was partially reduced or not completed but payment is still appropriate.
`53`	Discontinued procedure	Use when specimen collection or processing is started but discontinued for clinical reasons prior to completion.
`AD`	Physician assistant, autonomous billing	Use when services related to ordering, specimen collection, or coordination are furnished and billed by a qualified physician assistant under applicable rules.
`QK`	Medical direction of two or more assistants at surgery (QK) — lab context rarely used	Use only if specific payor instructions map this modifier to delegated supervision of ancillary personnel involved in specimen handling (rare).
`QX`	CRNA service with medical direction by physician	Use only if a certified registered nurse anesthetist provides sedation services tied to specimen collection and billing requires this modifier (uncommon for this test).
`QY`	Medical direction of one CRNA by an anesthesiologist	Use only in the narrow situations where anesthesia services associated with specimen collection are billed and require the modifier.

Taxonomy Code	Specialty	Notes
207Q00000X	Family Medicine	Primary care clinicians who order screening tests and coordinate follow-up.
207R00000X	Internal Medicine	Internists who evaluate symptoms and order noninvasive colorectal screening tests.
207L00000X	Gastroenterology	Specialists who interpret results and arrange diagnostic colonoscopy when indicated.
263R00000X	Clinical Laboratory	Laboratory specialties responsible for performing the proprietary test and reporting results.
363A00000X	Phlebotomy Technician	Personnel who perform outpatient blood collection and specimen handling.

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 colorectal cancer blood test.
`R19.5`	Other fecal abnormalities	May prompt noninvasive testing when stool-based tests are inconclusive or not performed.
`K92.1`	Melena	Symptom that may trigger evaluation for colorectal neoplasia and ordering of noninvasive tests when immediate endoscopy is deferred.
`D50.9`	Iron deficiency anemia, unspecified	Iron-deficiency anemia in adults may prompt colorectal cancer evaluation including noninvasive triage testing.
`R19.5`	Change in bowel habit (Note: represented by `R19.4` for other symptoms of bowel and defecation)	Symptom-based reason to perform noninvasive blood-based testing as part of initial evaluation.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Commonly performed immediately prior to sending a whole blood specimen for the FirstSightCRC™ test; used for outpatient sample collection.
`99000`	Handling and/or conveyance of specimen for transfer from patient to laboratory (list separately in addition to services)	May be reported when specific facility or courier handling fees apply separate from the laboratory PLA test.
`G2023`	Specimen collection for pathological examination (non-specific) — (Note: payer-specific code examples)	May be used by some payors for specimen collection or transport billing when local policies require a G-code; check payor rules.
`81479`	Unlisted molecular pathology procedure	Sometimes used historically for novel laboratory tests before PLA codes existed; relates as an alternative if PLA code not recognized by a payor.
`99070`	Supplies and materials provided by physician over and above those usually included with the service	Used when additional specialized collection materials or kits required for the proprietary test are supplied and separately billable.