Summary & Overview

CPT 0609U: ClarityDX Prostate PSA Algorithm-Based Risk Score

CPT code 0609U designates the proprietary ClarityDX Prostate test from Protean BioDiagnostics and Nanostics Inc. This PLA code covers a lab test that measures total and free PSA in serum or plasma and integrates those values with clinical inputs to produce an algorithm‑based probability score for clinically significant prostate cancer. As a PLA, 0609U is specific to a single manufacturer’s test, which affects billing, coding clarity, and payer coverage review nationally. Key payers reviewed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of the test’s clinical purpose and service setting, plus national coverage and billing considerations relevant to a proprietary laboratory assay. The publication outlines benchmark elements and typical reimbursement contexts for single-source PLA tests, highlights clinical implications of algorithm‑based PSA reporting for prostate cancer risk stratification, and summarizes common policy themes payers use when evaluating new proprietary diagnostics. Data not available in the input is noted where applicable; the focus remains on code definition, clinical context, and the landscape of payer coverage considerations for CPT code 0609U.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0609UCPTProprietary Laboratory AnalysesPSAProstate CancerLaboratoryAlgorithm-Based TestProtean BioDiagnosticsNanostics

Billing Code Overview

CPT code 0609U is a Proprietary Laboratory Analyses (PLA) code that applies only to the single test identified as ClarityDX Prostate from Protean BioDiagnostics and Nanostics Inc. The test uses immunoassays to measure total and free prostate–specific antigen (PSA) levels in serum or plasma and combines those laboratory results with clinical information to generate an algorithm‑based probability score for clinically significant prostate cancer.

Service type: Laboratory — proprietary algorithm-based PSA assay

Typical site of service: Clinical laboratory or hospital outpatient laboratory; specimen collected in outpatient clinic or phlebotomy setting

Data not available in the input for modifiers, associated taxonomies, ICD-10 diagnoses, related codes, and service line.

Clinical & Coding Specifications

Clinical Context

A 62-year-old man with a history of rising prostate-specific antigen (PSA) values and an equivocal digital rectal exam presents for further risk stratification. His urologist orders the proprietary blood-based test 0609U (ClarityDX Prostate) to measure total and free PSA by immunoassay and to generate an algorithm-based probability score for clinically significant prostate cancer. Blood is drawn in an outpatient clinic or ambulatory lab; serum or plasma specimens are sent to the performing laboratory (Protean BioDiagnostics/Nanostics Inc.) under appropriate chain-of-custody and handling instructions. The laboratory performs the immunoassays, combines the assay results with the supplied clinical variables (for example age, prior biopsy history, family history), and reports a probability score to guide shared decision-making about the need for prostate biopsy, imaging, or continued surveillance. Typical sites of service include outpatient clinic, ambulatory surgical center laboratory draw station, or independent clinical laboratory where venipuncture and specimen transport occur.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use if billing physician reports the professional interpretation component separately (rare for PLA tests where lab performs assay and reporting).
`TC`	Technical component	Use if billing entity provides only the technical component (assay performance) and professional interpretation is reported separately.
`59`	Distinct procedural service	Use when another distinct, separately codable service is provided the same day that is unrelated to the PLA test.
`91`	Repeat clinical diagnostic laboratory test	Use when the same lab test is repeated on the same day for confirmation of a result.
`QW`	CLIA waived test	Not typical for this PLA; do not append unless the performing test is classified as CLIA waived.
`GQ`	Telehealth origin via asynchronous telecommunications system	Use when specimen collection or result review occurs via asynchronous telehealth mechanisms per payer policy.
`GY`	Item or service statutorily excluded, does not meet definition of Medicare benefit	Use when payer determines the PLA is excluded under specific coverage rules.
`XE`	Separate encounter, distinct from other encounters on same day	Use when specimen collection or interpretation occurs in a separate encounter distinct from other services.
`XU`	Unusual non-overlapping service	Use when the lab test represents an unusual, separate service not overlapping with other billed services.

Taxonomy Code	Specialty	Notes
207Q00000X	Urology	Ordering and interpreting clinicians for prostate cancer risk assessment.
2080S00000X	Medical Oncology	May use results when evaluating prostate cancer risk and management.
2085R0200X	Clinical Laboratory Testing	Performing laboratory specialty for complex immunoassay and algorithmic PLA testing.
207L00000X	Family Medicine	Primary care clinicians ordering risk stratification testing as part of screening or referral.
208000000X	Pathology	May be involved in test validation, result interpretation coordination, or reflex testing pathways.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`R97.2`	Elevated prostate specific antigen [PSA]	Primary indication for ordering `0609U` to further risk-stratify elevation in PSA.
`N40.0`	Enlarged prostate with lower urinary tract symptoms	Benign prostatic hyperplasia can raise PSA; test helps distinguish benign causes from clinically significant cancer.
`N42.9`	Disorder of prostate, unspecified	Non-specific prostate symptoms where additional risk assessment with `0609U` may be useful.
`Z12.5`	Encounter for screening for malignant neoplasm of prostate	Used when `0609U` is ordered as part of prostate cancer screening/risk assessment pathways.
`C61`	Malignant neoplasm of prostate	Used when assessing probability of clinically significant cancer or in pre-treatment risk stratification.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0512U`	Measurement of circulating tumor DNA or other proprietary molecular test (example PLA)	Other proprietary laboratory analyses (PLAs) that may be ordered in parallel for prostate cancer risk or molecular profiling; shown as an example of accompanying specialized assays.
`81002`	Urinalysis, non-automated, without microscopy	Pre-test or concurrent urinalysis may be performed to rule out urinary infection before biopsy decisions informed by `0609U`.
`81025`	Urine pregnancy test, by visual color comparison methods (for female patients)	Not typical for male prostate testing; included only when required by institutional pre-analytic workflows in mixed populations.
`36415`	Collection of venous blood by venipuncture	Commonly performed at the drawing site to obtain serum or plasma for `0609U` testing.
`88305`	Level IV surgical pathology, gross and microscopic examination	If the `0609U` result leads to prostate biopsy, pathology coding for biopsy specimens would include codes like `88305`.
`76872`	Transrectal ultrasound, prostate, with biopsy guidance	Performed when a high probability score from `0609U` prompts image-guided prostate biopsy.

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Summary & Overview

CPT 0609U: ClarityDX Prostate PSA Algorithm-Based Risk Score

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0609UCPTProprietary Laboratory AnalysesPSAProstate CancerLaboratoryAlgorithm-Based TestProtean BioDiagnosticsNanostics

Billing Code Overview

Service type: Laboratory — proprietary algorithm-based PSA assay

Typical site of service: Clinical laboratory or hospital outpatient laboratory; specimen collected in outpatient clinic or phlebotomy setting

Data not available in the input for modifiers, associated taxonomies, ICD-10 diagnoses, related codes, and service line.

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use if billing physician reports the professional interpretation component separately (rare for PLA tests where lab performs assay and reporting).
`TC`	Technical component	Use if billing entity provides only the technical component (assay performance) and professional interpretation is reported separately.
`59`	Distinct procedural service	Use when another distinct, separately codable service is provided the same day that is unrelated to the PLA test.
`91`	Repeat clinical diagnostic laboratory test	Use when the same lab test is repeated on the same day for confirmation of a result.
`QW`	CLIA waived test	Not typical for this PLA; do not append unless the performing test is classified as CLIA waived.
`GQ`	Telehealth origin via asynchronous telecommunications system	Use when specimen collection or result review occurs via asynchronous telehealth mechanisms per payer policy.
`GY`	Item or service statutorily excluded, does not meet definition of Medicare benefit	Use when payer determines the PLA is excluded under specific coverage rules.
`XE`	Separate encounter, distinct from other encounters on same day	Use when specimen collection or interpretation occurs in a separate encounter distinct from other services.
`XU`	Unusual non-overlapping service	Use when the lab test represents an unusual, separate service not overlapping with other billed services.

Taxonomy Code	Specialty	Notes
207Q00000X	Urology	Ordering and interpreting clinicians for prostate cancer risk assessment.
2080S00000X	Medical Oncology	May use results when evaluating prostate cancer risk and management.
2085R0200X	Clinical Laboratory Testing	Performing laboratory specialty for complex immunoassay and algorithmic PLA testing.
207L00000X	Family Medicine	Primary care clinicians ordering risk stratification testing as part of screening or referral.
208000000X	Pathology	May be involved in test validation, result interpretation coordination, or reflex testing pathways.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`R97.2`	Elevated prostate specific antigen [PSA]	Primary indication for ordering `0609U` to further risk-stratify elevation in PSA.
`N40.0`	Enlarged prostate with lower urinary tract symptoms	Benign prostatic hyperplasia can raise PSA; test helps distinguish benign causes from clinically significant cancer.
`N42.9`	Disorder of prostate, unspecified	Non-specific prostate symptoms where additional risk assessment with `0609U` may be useful.
`Z12.5`	Encounter for screening for malignant neoplasm of prostate	Used when `0609U` is ordered as part of prostate cancer screening/risk assessment pathways.
`C61`	Malignant neoplasm of prostate	Used when assessing probability of clinically significant cancer or in pre-treatment risk stratification.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0512U`	Measurement of circulating tumor DNA or other proprietary molecular test (example PLA)	Other proprietary laboratory analyses (PLAs) that may be ordered in parallel for prostate cancer risk or molecular profiling; shown as an example of accompanying specialized assays.
`81002`	Urinalysis, non-automated, without microscopy	Pre-test or concurrent urinalysis may be performed to rule out urinary infection before biopsy decisions informed by `0609U`.
`81025`	Urine pregnancy test, by visual color comparison methods (for female patients)	Not typical for male prostate testing; included only when required by institutional pre-analytic workflows in mixed populations.
`36415`	Collection of venous blood by venipuncture	Commonly performed at the drawing site to obtain serum or plasma for `0609U` testing.
`88305`	Level IV surgical pathology, gross and microscopic examination	If the `0609U` result leads to prostate biopsy, pathology coding for biopsy specimens would include codes like `88305`.
`76872`	Transrectal ultrasound, prostate, with biopsy guidance	Performed when a high probability score from `0609U` prompts image-guided prostate biopsy.