Summary & Overview

CPT 0514U: Procise ADL™ Quantitative Adalimumab Immunoassay

CPT code 0514U designates the Procise ADL™ proprietary laboratory test from ProciseDx Inc., a quantitative immunoassay for measuring serum adalimumab (ADL) concentrations in patients receiving adalimumab therapy. As a PLA code, 0514U applies only to this single manufacturer-specific assay, which matters nationally for standardized reporting, lab billing specificity, and payer coverage determinations related to therapeutic drug monitoring of biologic therapies.

Key payers addressed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical use—therapeutic drug monitoring to guide adalimumab dosing or evaluate treatment failure—and the typical laboratory site-of-service for the assay. The publication also provides benchmarks on billing and reimbursement where available, notes on payer policy considerations for PLA-designated tests, and the clinical context that informs test utilization.

This summary equips laboratory administrators, coding staff, and policy analysts with the essential facts about CPT code 0514U, what it represents in clinical practice, and which major payers are relevant for coverage and billing review. Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0514UCPTProprietary Laboratory Analysestherapeutic drug monitoringadalimumabimmunoassaylaboratoryProcise ADLbiologic monitoring

Billing Code Overview

CPT code 0514U is a Proprietary Laboratory Analyses (PLA) code assigned specifically to the Procise ADL™ assay by ProciseDx Inc. The test is an immunoassay that quantitatively measures adalimumab (ADL) levels in venous serum and reports results in micrograms per milliliter (µg/mL).

Service Type: Laboratory test — therapeutic drug monitoring (quantitative immunoassay)

Typical Site of Service: Clinical laboratory or reference laboratory using venous blood specimens

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

Clinical & Coding Specifications

Clinical Context

A 42-year-old patient with moderate-to-severe Crohn disease receiving adalimumab therapy presents for routine therapeutic drug monitoring after reporting a loss of response and increased gastrointestinal symptoms. The clinician orders the Procise ADL™ immunoassay (0514U) to obtain a quantitative adalimumab serum concentration in micrograms per milliliter to guide potential dose adjustment, interval change, or evaluation for anti-drug antibodies. Venous blood is drawn in an outpatient laboratory or clinic phlebotomy suite, specimen is processed to serum, and the proprietary assay is performed in a certified clinical laboratory using the manufacturer’s platform. Results are returned to the ordering gastroenterologist or rheumatologist and reviewed in the electronic medical record; result interpretation is integrated with clinical findings and, if available, antibody testing to inform therapeutic decisions. Typical sites of service include outpatient hospital laboratory, independent clinical laboratory, or outpatient clinic-based phlebotomy services. Typical patient scenarios include patients with inflammatory bowel disease, rheumatoid arthritis, psoriatic arthritis, or other chronic inflammatory conditions treated with adalimumab who require therapeutic drug monitoring.

Coding Specifications

Modifier	Description	When to Use
`00`	Procedure/Service not further defined (placeholder)	Rarely used; typically not appended — included in raw list but not commonly applied to PLA reporting.
`22`	Increased procedural services	Use when documentation supports substantially greater complexity in handling, reporting, or interpretation of the assay beyond typical lab processing.
`26`	Professional component	Use when billing only the professional component (interpretation or result validation) separate from the technical component.
`52`	Reduced services	Use when the assay testing is partially reduced or limited compared with the full procedure.
`53`	Discontinued procedure	Use if specimen collection or assay was attempted but discontinued for documented medical reasons.
`62`	Two surgeons/Two providers	Rare for lab tests; applicable when two qualified providers share responsibility for result interpretation as documented.
`78`	Return to the operating/procedure room for related procedure by same physician	Uncommon; applicable only if subsequent related invasive procedure occurs emergently and documentation justifies modifier use.
`80`	Assistant surgeon	Not commonly used for laboratory PLA codes; included if an assistant performed a billable portion of the service per payer rules.
`QK`	Medical direction of two, three, or four assistants	Applicable only if assistants are involved in a billable interpretation or procedure under specific payer rules.
`QX`	Service performed by certified nurse-midwife or other NPP under their own State scope	Use when a non-physician practitioner performs billable components permitted by payers.
`QY`	Attending practitioner of record patient under teaching physician supervision	Use when the service is performed by a resident with attending oversight and payers accept teaching physician documentation.
`TC`	Technical component	Use when billing only the technical component of the assay (laboratory processing, instrumentation).
`TG`	Via remote telemedicine service rendered via interactive audio and video telecommunications systems	Use if result review or consultation related to the assay is delivered via real-time telehealth and payer allows modifier.

Taxonomy Code	Specialty	Notes
`2086P0203X`	Gastroenterology	Gastroenterologists commonly order adalimumab level testing for inflammatory bowel disease management.
`207R00000X`	Rheumatology	Rheumatologists order ADL level monitoring for rheumatoid arthritis and related conditions.
`208M00000X`	Dermatology	Dermatologists managing severe psoriasis on adalimumab may order therapeutic drug monitoring.
`207L00000X`	Allergy & Immunology	Allergy/immunology specialists involved in biologic management may order levels and antibody testing.
`363LF0000X`	Clinical Laboratory	Clinical laboratory specialists perform and report the proprietary assay; lab director taxonomies apply.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`K50.90`	Crohn disease, unspecified, without complications	Crohn disease is a common indication for adalimumab; drug level testing assesses therapeutic adequacy.
`K51.90`	Ulcerative colitis, unspecified, without complications	Ulcerative colitis patients on adalimumab may require monitoring of serum drug concentrations.
`M06.9`	Rheumatoid arthritis, unspecified	Rheumatoid arthritis treated with adalimumab often undergoes therapeutic drug monitoring when response changes.
`L40.0`	Psoriasis vulgaris	Moderate-to-severe plaque psoriasis treated with adalimumab may necessitate adalimumab level measurement.
`M07.3`	Psoriatic arthritis	Psoriatic arthritis patients on adalimumab use drug level testing to evaluate loss of response.
`M08.0`	Juvenile rheumatoid arthritis	Pediatric patients receiving adalimumab may require serum level monitoring for dosing decisions.
`T88.7XXA`	Unspecified adverse effect of drug or medicament, initial encounter	When loss of response or suspected adverse drug effect occurs, measuring adalimumab levels informs management.
`Z79.899`	Other long term (current) drug therapy	Documentation of chronic biologic therapy status that supports the medical necessity of therapeutic drug monitoring.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`80053`	Comprehensive metabolic panel	Common baseline laboratory panel performed concurrently with therapeutic drug monitoring to assess organ function prior to dose changes.
`36415`	Collection of venous blood by venipuncture	Represents the specimen collection procedure for the serum sample used by the `0514U` assay.
`82542`	Drug assay, other than immunoassay, qualitative or quantitative; multiple drug classes	May be ordered when additional drug level testing is needed; listed for concurrent laboratory workflows.
`83516`	Drug assay, quantitative; immunoassay, each specimen	General CPT for quantitative immunoassays — related in methodology though `0514U` is a PLA specific code.
`80305`	Drug testing, presumptive, any number of drug classes; non-quantitative immunoassay	Related when initial screening for concomitant substances is performed in broader toxicology workflows.
`99000`	Handling and/or conveyance of specimen	Administrative billing code sometimes used in complex specimen handling scenarios associated with specialized assays.

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Summary & Overview

CPT 0514U: Procise ADL™ Quantitative Adalimumab Immunoassay

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0514UCPTProprietary Laboratory Analysestherapeutic drug monitoringadalimumabimmunoassaylaboratoryProcise ADLbiologic monitoring

Billing Code Overview

Service Type: Laboratory test — therapeutic drug monitoring (quantitative immunoassay)

Typical Site of Service: Clinical laboratory or reference laboratory using venous blood specimens

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

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Modifier	Description	When to Use
`00`	Procedure/Service not further defined (placeholder)	Rarely used; typically not appended — included in raw list but not commonly applied to PLA reporting.
`22`	Increased procedural services	Use when documentation supports substantially greater complexity in handling, reporting, or interpretation of the assay beyond typical lab processing.
`26`	Professional component	Use when billing only the professional component (interpretation or result validation) separate from the technical component.
`52`	Reduced services	Use when the assay testing is partially reduced or limited compared with the full procedure.
`53`	Discontinued procedure	Use if specimen collection or assay was attempted but discontinued for documented medical reasons.
`62`	Two surgeons/Two providers	Rare for lab tests; applicable when two qualified providers share responsibility for result interpretation as documented.
`78`	Return to the operating/procedure room for related procedure by same physician	Uncommon; applicable only if subsequent related invasive procedure occurs emergently and documentation justifies modifier use.
`80`	Assistant surgeon	Not commonly used for laboratory PLA codes; included if an assistant performed a billable portion of the service per payer rules.
`QK`	Medical direction of two, three, or four assistants	Applicable only if assistants are involved in a billable interpretation or procedure under specific payer rules.
`QX`	Service performed by certified nurse-midwife or other NPP under their own State scope	Use when a non-physician practitioner performs billable components permitted by payers.
`QY`	Attending practitioner of record patient under teaching physician supervision	Use when the service is performed by a resident with attending oversight and payers accept teaching physician documentation.
`TC`	Technical component	Use when billing only the technical component of the assay (laboratory processing, instrumentation).
`TG`	Via remote telemedicine service rendered via interactive audio and video telecommunications systems	Use if result review or consultation related to the assay is delivered via real-time telehealth and payer allows modifier.

Taxonomy Code	Specialty	Notes
`2086P0203X`	Gastroenterology	Gastroenterologists commonly order adalimumab level testing for inflammatory bowel disease management.
`207R00000X`	Rheumatology	Rheumatologists order ADL level monitoring for rheumatoid arthritis and related conditions.
`208M00000X`	Dermatology	Dermatologists managing severe psoriasis on adalimumab may order therapeutic drug monitoring.
`207L00000X`	Allergy & Immunology	Allergy/immunology specialists involved in biologic management may order levels and antibody testing.
`363LF0000X`	Clinical Laboratory	Clinical laboratory specialists perform and report the proprietary assay; lab director taxonomies apply.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`K50.90`	Crohn disease, unspecified, without complications	Crohn disease is a common indication for adalimumab; drug level testing assesses therapeutic adequacy.
`K51.90`	Ulcerative colitis, unspecified, without complications	Ulcerative colitis patients on adalimumab may require monitoring of serum drug concentrations.
`M06.9`	Rheumatoid arthritis, unspecified	Rheumatoid arthritis treated with adalimumab often undergoes therapeutic drug monitoring when response changes.
`L40.0`	Psoriasis vulgaris	Moderate-to-severe plaque psoriasis treated with adalimumab may necessitate adalimumab level measurement.
`M07.3`	Psoriatic arthritis	Psoriatic arthritis patients on adalimumab use drug level testing to evaluate loss of response.
`M08.0`	Juvenile rheumatoid arthritis	Pediatric patients receiving adalimumab may require serum level monitoring for dosing decisions.
`T88.7XXA`	Unspecified adverse effect of drug or medicament, initial encounter	When loss of response or suspected adverse drug effect occurs, measuring adalimumab levels informs management.
`Z79.899`	Other long term (current) drug therapy	Documentation of chronic biologic therapy status that supports the medical necessity of therapeutic drug monitoring.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`80053`	Comprehensive metabolic panel	Common baseline laboratory panel performed concurrently with therapeutic drug monitoring to assess organ function prior to dose changes.
`36415`	Collection of venous blood by venipuncture	Represents the specimen collection procedure for the serum sample used by the `0514U` assay.
`82542`	Drug assay, other than immunoassay, qualitative or quantitative; multiple drug classes	May be ordered when additional drug level testing is needed; listed for concurrent laboratory workflows.
`83516`	Drug assay, quantitative; immunoassay, each specimen	General CPT for quantitative immunoassays — related in methodology though `0514U` is a PLA specific code.
`80305`	Drug testing, presumptive, any number of drug classes; non-quantitative immunoassay	Related when initial screening for concomitant substances is performed in broader toxicology workflows.
`99000`	Handling and/or conveyance of specimen	Administrative billing code sometimes used in complex specimen handling scenarios associated with specialized assays.