Summary & Overview
CPT 0065U: BioPlex 2200 RPR Assay for Syphilis Treatment Management
Headline: New PLA CPT code 0065U identifies the BioPlex™ 2200 RPR Assay for syphilis management
Lead: CPT code 0065U is a Proprietary Laboratory Analyses (PLA) code designated for the BioPlex™ 2200 RPR Assay by Bio–Rad® Laboratories, an immunoassay that detects nontreponemal antibodies (rapid plasma reagin) to aid in syphilis treatment management. The code clarifies billing for a single manufacturer-specific laboratory test used in diagnostic and therapeutic monitoring of syphilis.
What this represents and why it matters: PLA code 0065U formalizes billing for a unique, non-generic laboratory assay, enabling standardized reporting and payer review for a test that supports syphilis treatment decisions. Nationally, PLA codes affect how proprietary assays are tracked, priced, and reimbursed across clinical laboratories and hospital labs.
Key payers covered: Analysis addresses major national payers including Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
What readers will learn: The publication outlines the clinical context of the BioPlex™ 2200 RPR Assay, expected sites of service, payer coverage considerations, commonly used modifiers, and where to find related procedural and billing guidance. It also summarizes implications for laboratory billing workflows and documentation requirements. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0065U is a Proprietary Laboratory Analyses (PLA) code for the BioPlex™ 2200 RPR Assay from Bio–Rad® Laboratories. The code applies to a single, manufacturer-specific laboratory test: an immunoassay that detects the nontreponemal antibody rapid plasma reagin (RPR) in patient specimens to aid in syphilis treatment management.
Service Type: Laboratory diagnostic immunoassay for nontreponemal antibody (RPR) testing
Typical Site of Service: Clinical laboratory or hospital laboratory
Clinical & Coding Specifications
Clinical Context
A 34-year-old pregnant patient presents to an obstetrics clinic for routine prenatal screening and reports a history of prior treated syphilis five years ago. The obstetrician orders serologic testing to evaluate current disease activity and to guide treatment decisions. A venous blood sample is collected at the clinic and sent to the laboratory for the BioPlex™ 2200 RPR Assay, reported under 0065U. The laboratory performs the automated immunoassay for the nontreponemal antibody (rapid plasma reagin) and returns a quantitative result with interpretation to the ordering provider. Results are used by the obstetrician or infectious disease consultant to determine whether retreatment, additional confirmatory treponemal testing, or follow-up titers are needed as part of syphilis treatment management.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Use when no special circumstances apply to the service. |
11 | Professional component | Use if reporting only the professional interpretation component and the test has split components. |
26 | Professional component | Use when billing only the physician interpretation portion of a service, if applicable. |
52 | Reduced services | Use when the laboratory performs a reduced service compared with the full procedure. |
53 | Discontinued procedure | Use if testing was started but discontinued for medical reasons prior to completion. |
59 | Distinct procedural service | Not listed in the provided modifiers; excluded per input constraints. |
62 | Two surgeons | Use when two qualified practitioners perform components of the service (rare for lab testing); typically not used. |
78 | Unplanned return to OR | Not typically applicable to this lab assay; included in list of available modifiers but generally not used. |
90 | Reference (outside) laboratory | Use when the test is performed by an external reference laboratory and the billing reflects referral arrangements. |
AD | Advanced beneficiary notice | Use when the patient is informed and accepts financial responsibility for a non-covered service. |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery | Not typically applicable for a laboratory assay; rarely used. |
QK | Clinical laboratory performing non-waived testing | Use to indicate services furnished by a CLIA-certified laboratory performing high-complexity testing when required by payer policy. |
QX | CLIA-waived laboratory testing by personnel | Use to indicate specific personnel qualifications when required by payer policy. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Obstetrics & Gynecology | Ordering provider for prenatal and pregnancy-related syphilis testing. |
| 208000000X | Infectious Disease | Specialist interpreting serology for syphilis management. |
| 207L00000X | Family Medicine | Primary care provider ordering syphilis screening and follow-up. |
| 334H00000X | Pathology & Clinical Laboratory | Laboratory director or pathologist overseeing testing and interpretation. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
A52.0 | Early syphilis, primary | Active infection where RPR testing is used for diagnosis and treatment monitoring. |
A52.1 | Early syphilis, secondary | Active infection with serologic monitoring via nontreponemal tests like RPR. |
A52.9 | Late syphilis, unspecified | Follow-up serology used to assess prior treatment response or reinfection. |
O98.8 | Other maternal infectious and parasitic diseases complicating pregnancy, childbirth and the puerperium | Prenatal syphilis screening and monitoring of treatment in pregnancy. |
Z11.3 | Encounter for screening for infections with a predominantly sexual mode of transmission | Routine screening context where RPR testing is ordered. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
80055 | General health panel (e.g., metabolic function tests) | Often ordered during prenatal visits alongside infectious disease screening; not specific to syphilis but may be batched on the same specimen. |
86592 | Syphilis serological test (qualitative) | A manual or alternative RPR test that may be used for comparison or historical testing; can be performed before or alongside a PLA assay depending on lab workflow. |
86631 | Syphilis antibody, treponemal (e.g., FTA-ABS, TP-PA) | Treponemal confirmatory testing used to confirm reactive RPR results or to establish prior treated infection. |
81162 | Infectious agent detection by nucleic acid (qualitative or quantitative) | In some workflows, nucleic acid tests for sexually transmitted infections may be ordered concurrently, though not specific for syphilis serology. |
99000 | Handling and/or conveyance of specimen | Administrative or handling codes that may apply to specimen transport to a reference laboratory performing 0065U. |