CPT 80280 Vedolizumab Assay Reimbursement | OpenPayer

Summary & Overview

CPT 80280: Vedolizumab Quantitative Assay

CPT code 80280 represents a laboratory test that quantitatively measures vedolizumab level in a patient specimen. Vedolizumab is a gastrointestinal-selective monoclonal antibody targeting integrin alpha-4 beta-7 (LPAM1); measuring drug concentration informs therapeutic drug monitoring and can guide treatment decisions in inflammatory bowel disease management. Nationally, availability of validated quantitative assays and appropriate coding affect billing, clinical reporting, and access to therapeutic monitoring services.

Key payers addressed in typical commercial and public coverage environments include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Coverage policies and payment for specialty immunoassays vary by payer and by clinical indication.

Readers will find a concise explanation of the clinical context for CPT code 80280, the service setting and typical laboratory workflow, and an outline of payer coverage landscape. The publication provides benchmark and policy-relevant content about coding and billing for vedolizumab quantitative assays, clinical indications for drug-level testing, and operational considerations for labs offering this service. Data not available in the input will be identified as such where relevant.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicareCPT 80280vedolizumabtherapeutic drug monitoringimmunoassayclinical laboratorygastroenterologybiologic monitoringlaboratory medicinedrug level testing

Billing Code Overview

CPT code 80280 describes a laboratory procedure in which a lab analyst quantifies the concentration of vedolizumab in a patient specimen. Vedolizumab is a therapeutic monoclonal antibody that targets integrin alpha-4 beta-7 (LPAM1) to produce a gastrointestinal-selective anti-inflammatory effect.

Service Type: Therapeutic drug monitoring / quantitative immunoassay

Typical Site of Service: Clinical laboratory or hospital laboratory

Data not available in the input.

Clinical & Coding Specifications

Clinical Context

A 42-year-old patient with moderately active Crohn disease managed with vedolizumab presents for routine therapeutic drug monitoring. The gastroenterology clinician orders a trough vedolizumab level to assess drug exposure and guide management because the patient reports persistent symptoms despite scheduled infusions. The blood specimen is collected immediately before the next infusion at an outpatient infusion suite or clinical laboratory. The specimen is sent to the clinical laboratory where a lab analyst performs the quantitative assay for vedolizumab level. Results are reported to the ordering provider and may be used alongside clinical assessment and inflammatory markers to decide whether dosing adjustments, interval changes, or switching therapy are indicated.

Service Type: Quantitative therapeutic drug monitoring laboratory assay for vedolizumab (technical/analytical component).
Typical Site of Service: Outpatient infusion center laboratory or clinical reference laboratory performing specialty immunoassays.
Typical Workflow: Order placed by gastroenterologist → timed trough blood draw at infusion visit → specimen accessioning and processing in lab → performance of vedolizumab quantitative assay by lab analyst (CPT 80280) → result verification and reporting to ordering provider.

Coding Specifications

Modifier	Description

CPT 80340: Multiple Antiepileptic Drug Assay (4–6 Agents)

CPT-80180-MYCOPHENOLIC-ACID-LEVEL-TESTING

CPT 80180: Mycophenolic Acid Level Testing

CPT-80197-TACROLIMUS-QUANTITATION-LAB-ASSAY

CPT 80197: Tacrolimus Quantitation, Technical Laboratory Assay

CPT-80346-BENZODIAZEPINE-PANEL-LABORATORY-TESTING

CPT 80346: Benzodiazepine Panel — Laboratory Analysis

CPT-80336-TRICYCLIC-AND-CYCLIC-ANTIDEPRESSANT-TESTING

CPT 80336: Tricyclic and Cyclic Antidepressant Testing

CPT-80198-THEOPHYLLINE-QUANTITATION-LAB-TEST

CPT 80198: Theophylline Quantitation Laboratory Test

CPT-80343-ANTIPSYCHOTICS-PANEL-4-TO-6-DRUGS

CPT 80343: Antipsychotics Panel, Detection of 4–6 Drugs

CPT-80163-FREE-DIGOXIN-BLOOD-LEVEL

CPT 80163: Free Digoxin Blood Level

CPT-80194-QUINIDINE-QUANTITATIVE-ASSAY

CPT 80194: Quinidine Quantitative Assay

CPT-80342-ANTIPSYCHOTIC-DRUG-TESTING-1-TO-3-DRUGS

CPT 80342: Antipsychotic Drug Testing for One to Three Drugs

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Taxonomy Code	Specialty	Notes
207RH0000X	Pathology & Clinical Laboratory	Clinical laboratory directors and pathologists oversee assay validation and result review.
207K00000X	Clinical Laboratory	Medical technologists and lab analysts perform the technical assay.
207LP2900X	Immunology	Specialists in immunologic assays and therapeutic drug monitoring perform complex immunoassays.
2080P0006X	Gastroenterology	Ordering clinicians who request vedolizumab level testing to guide therapy.
207L00000X	Medical Laboratory Technician	Personnel who execute specimen processing and perform testing under supervision.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`K50.90`	Crohn disease, unspecified, without complications	Common indication for vedolizumab therapy and for monitoring trough levels to assess treatment adequacy.
`K51.90`	Ulcerative colitis, unspecified, without complications	Vedolizumab is indicated for ulcerative colitis; levels guide therapeutic decisions.
`K50.00`	Crohn disease of small intestine without complications	Localized Crohn disease presentation for which vedolizumab may be prescribed and monitored.
`K51.20`	Ulcerative (chronic) pancolitis without complications	Severe colonic disease where vedolizumab use and level monitoring can inform management.
`R19.4`	Change in bowel habit	Symptom that may prompt trough level testing when present despite therapy.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`80280`	Vedolizumab level, quantitative	Primary code describing the laboratory analytic measurement performed by the lab analyst.
`36415`	Collection of venous blood by venipuncture	Commonly performed immediately before infusion to obtain the specimen for vedolizumab level testing.
`80053`	Comprehensive metabolic panel	Frequently ordered alongside therapeutic drug monitoring to assess baseline chemistry and safety.
`82550`	Drug assay, qualitative; multiple drug classes (e.g., immunoassay)	Represents other laboratory drug assays that may be performed in the same laboratory workflow.
`82542`	Drug assay, presumptive, any number of drug classes; e.g., immunoassay	May be performed for concurrent medication monitoring or interference checks.

`26`	Professional component	Use when only the professional component (interpretation, result validation) is billed separately from the technical component.
`TC`	Technical component	Use when billing only the technical component of the laboratory test performed by the facility.
`90`	Reference (outside) laboratory	Use when the test is performed by an outside or third‑party laboratory under arrangement.
`91`	Repeat clinical diagnostic test	Use when exact repeat testing on the same day is performed for confirmation or quality control.
`59`	Distinct procedural service	Use when multiple services on the same day are distinct and should be reported separately.
`76`	Repeat procedure by same provider	Use when the laboratory repeats the test by the same laboratory on a separate occasion.
`77`	Repeat procedure by another provider	Use when another laboratory repeats the test and separate reporting is required.
`22`	Increased procedural services	Use when substantially greater work is required for specimen handling, validation, or complex testing beyond typical assay complexity.
`52`	Reduced services	Use when the test performed is partially reduced or not completed as originally intended.
`90`	Reference (outside) laboratory	(listed again for emphasis) indicates testing performed by an outside reference lab.
`91`	Repeat clinical diagnostic test	(duplicate as commonly applied) indicates repeated measurement for accuracy/quality control.

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