Summary & Overview
CPT 0064U: Syphilis Total & RPR Immunoassay Panel
CPT code 0064U is a Proprietary Laboratory Analyses (PLA) CPT code for the BioPlex™ 2200 Syphilis Total & RPR Assay, a single immunoassay panel that measures total treponemal antibody and non-treponemal rapid plasma reagin (RPR) antibody to support syphilis diagnosis and treatment management. PLA codes like 0064U identify manufacturer‑ or lab‑specific tests and matter nationally because they affect laboratory billing transparency, payer coverage decisions, and the integration of novel diagnostics into clinical pathways.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a compact review of what 0064U represents clinically, the typical site of service, and which payers commonly evaluate coverage for PLA laboratory tests. The publication outlines benchmarks and policy-relevant considerations such as PLA code implications for claims processing, how payers may apply coverage criteria for proprietary syphilis assays, and typical billing contexts in which 0064U appears. Clinical context on the assay’s dual treponemal and non‑treponemal targets is included to clarify when the test is used in diagnosis and treatment monitoring.
Data not available in the input includes specific payer coverage policies, reimbursement rates, detailed denial patterns, associated taxonomies, and ICD-10 diagnosis pairings.
Billing Code Overview
CPT code 0064U is a Proprietary Laboratory Analyses (PLA) code for the BioPlex™ 2200 Syphilis Total & RPR Assay from Bio–Rad® Laboratories. This single immunoassay panel evaluates both total treponemal antibody and non-treponemal rapid plasma reagin (RPR) antibody in a patient specimen to aid in syphilis diagnosis or treatment management.
Service Type: Laboratory—serologic infectious disease testing (syphilis panel)
Typical Site of Service: Clinical laboratory or reference laboratory performing diagnostic serologic testing.
Clinical & Coding Specifications
Clinical Context
A 28-year-old sexually active patient presents to an outpatient community sexual health clinic with concerns of recent high-risk exposure and new genital lesions. The clinician obtains a sexual history, performs a focused physical exam, and orders laboratory testing for sexually transmitted infections. The clinic collects a serum specimen and submits it to the on-site or reference laboratory for the BioPlex™ 2200 Syphilis Total & RPR Assay. The test performs a single immunoassay panel that simultaneously evaluates total treponemal antibodies and non-treponemal rapid plasma reagin (RPR) reactivity to aid in the diagnosis of syphilis or to monitor treatment response. Typical workflow steps: sample collection, specimen labeling, laboratory accessioning, automated running of the BioPlex™ 2200 instrument, result verification by laboratory personnel, and electronic reporting of combined treponemal and non-treponemal results to the ordering clinician for interpretation and treatment planning. Typical sites of service include outpatient clinics, public health/STI clinics, physician offices, and clinical laboratories. The service type is a laboratory diagnostic assay (Proprietary Laboratory Analyses).
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Placeholder for standard reporting | Use when no specific modifier applies and the payer requires explicit reporting of baseline modifier; generally not used clinically. |
| 11 | Professional component | Use when only the professional component (interpretation) of a combined service is reported by the performing physician or lab professional. |
| 26 | Professional component | Use when reporting only the professional component of a test if allowed by payer (interpretation/consult). |
| 90 | Reference (outside) laboratory | Use when the test was performed by an outside/reference laboratory and the billing provider is reporting reference lab services. |
| TC | Technical component | Use when billing only the technical component of the assay (laboratory instrument, supplies, technician time) separate from professional interpretation. |
| 52 | Reduced services | Use when the test is performed but at a reduced scope or yields limited data due to specimen quality or partial processing. |
| 53 | Discontinued procedure | Use when testing was started but discontinued for documented medical reasons before completion. |
| 59 | Distinct procedural service | Not in provided list; omitted to comply with input. |
| 90 | Reference (duplicated) | Duplicate entry omitted; single 90 retained above. |
| 82 | Assistant surgeon (when qualified resident unavailable) | Rarely used for laboratory tests; not typically applicable but included among available modifiers when surgical assistance is billed in same encounter. |
| 22 | Increased procedural services | Use when test processing required substantially greater effort or complexity beyond the typical assay (documented and supported). |
| 23 | Unusual anesthesia | Not applicable to lab testing; avoid use for this procedure. |
| 52 | Reduced services (duplicated) | Duplicate omitted; single 52 retained above. |
| 90 | Reference laboratory (final) | See single 90 entry above. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Infectious Disease | Specialists who interpret complex serologic panels and manage syphilis diagnosis and treatment. |
| 207L00000X | Pathology | Laboratory directors and pathologists overseeing test validation, verification, and reporting. |
| 208000000X | Family Medicine | Primary care clinicians who order syphilis testing in outpatient settings. |
| 208D00000X | Obstetrics & Gynecology | OB/GYN clinicians ordering syphilis screening for prenatal care or symptomatic patients. |
| 208000000X | Internal Medicine | Internists managing STI screening and follow-up, including treatment monitoring. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
A53.9 | Syphilis, unspecified | Primary code for suspected or confirmed syphilis when stage is not specified; directly indicates clinical need for treponemal and non-treponemal testing. |
| A52.9 | Late syphilis, unspecified | Used when monitoring or diagnosing later stages of syphilis; serologic testing guides staging and management. |
| A51.9 | Early syphilis, unspecified | Applied for early-stage syphilis evaluation; serologic panel helps confirm diagnosis. |
| Z11.3 | Encounter for screening for infections with a predominantly sexual mode of transmission | Used for routine STI screening including syphilis in asymptomatic patients; justifies ordering the assay. |
| O98.8 | Other specified infectious and parasitic diseases complicating pregnancy, childbirth and the puerperium | Used in prenatal screening contexts where syphilis testing is required to protect maternal and fetal health. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
80061 | Lipid panel; includes total cholesterol, HDL, LDL, triglycerides | Data not available in the input. |
| 86631 | Antibody; Treponema pallidum (syphilis) | Used as a standalone treponemal antibody test in workflows where separate treponemal testing is billed instead of the proprietary PLA. |
| 86592 | Antigen or antibody detection by immunoassay, each procedure; qualitative or semiquantitative | Represents general immunoassay methodology; may be billed for similar non-proprietary immunoassays when PLA code is not used. |
| 87481 | Infectious agent antigen detection by nucleic acid (e.g., Chlamydia trachomatis), amplified probe technique | Example of other STI molecular tests commonly ordered concurrently in the same encounter (screening panel). |
| 36415 | Collection of venous blood by venipuncture | Performed prior to running the BioPlex™ assay to obtain the serum specimen. |
| 99000 | Handling and/or conveyance of specimen to a laboratory | Represents logistical specimen handling often associated with laboratory testing in some payer systems. |