Summary & Overview
CPT 0337U: CELLSEARCH Circulating Multiple Myeloma Cell (CMMC) Test
CPT code 0337U designates a Proprietary Laboratory Analyses (PLA) test for the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Test from Menarini Silicon Biosystems Inc. The test identifies, isolates, and counts circulating multiple myeloma cells from a peripheral blood specimen, supporting noninvasive disease monitoring and management for patients with multiple myeloma. As a PLA code, 0337U is unique to a single manufacturer's test, which has implications for coding specificity and payer coverage determinations nationally.
Key payers covered in the analysis include Aetna, Blue Cross Blue Shield, Cigna, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical purpose and service setting, information on payer coverage patterns and common billing modifiers, and context about how PLA codes are applied in laboratory billing. The publication summarizes benchmark indicators for adoption and reimbursement where available, highlights policy considerations relevant to proprietary laboratory tests, and outlines practical coding notes for reporting 0337U for the CELLSEARCH® CMMC Test. Data not available in the input is identified where applicable.
Billing Code Overview
CPT code 0337U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Test from Menarini Silicon Biosystems Inc. The noninvasive laboratory test uses a specialized instrument to identify, isolate, and count circulating multiple myeloma cells (CMMC) from a peripheral blood specimen to help manage patients with multiple myeloma (MM).
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Service Type: Proprietary laboratory analysis for detection and enumeration of circulating multiple myeloma cells.
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Typical Site of Service: Clinical laboratory or reference laboratory processing peripheral blood specimens.
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a confirmed diagnosis of multiple myeloma is undergoing routine disease monitoring during and after systemic therapy. The oncology team orders the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Test to noninvasively quantify circulating multiple myeloma cells in a peripheral blood specimen. The patient presents to an outpatient oncology infusion center or a hospital outpatient lab for a standard venous blood draw. The specimen is processed on the proprietary instrument at the performing laboratory, which identifies, isolates, and counts CMMC to help assess tumor burden, response to therapy, and minimal residual disease trends. Results are reported to the treating hematologist/oncologist and incorporated into clinical decision checkpoints alongside serum free light chain assays, bone marrow biopsies when indicated, imaging, and clinical exam findings. Typical workflow steps: order entry by the oncologist; patient check-in at outpatient lab/infusion center; venipuncture and specimen labeling; transport to performing laboratory; analysis on CELLSEARCH® platform; result verification and electronic reporting to the treating team for incorporation into the patient’s management plan.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when reporting only the professional interpretation component if separated from the technical component. |
52 | Reduced services | Use when the test is partially reduced or not performed to full extent. |
53 | Discontinued procedure | Use when specimen collection or testing is started but discontinued for patient-related or technical reasons. |
59 is not in the provided list and therefore not included | ||
62 | Two surgeons | Use when two different practitioners of record share primary responsibility; rarely applicable but included for multi-specialty procedural contexts. |
78 | Return to operating room for a related procedure | Use when a related invasive procedure requiring return to the OR occurs; rarely applicable in this lab test context. |
80 | Assistant surgeon | Use when an assistant surgeon is documented for a related invasive procedure; rarely applicable. |
82 | Assistant surgeon (when not available under 80) | Use when a qualified resident or assistant provided assistance and 80 is not appropriate. |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery | Use when an advanced practice clinician assists during a related surgical procedure. |
QK | Medical direction of two, three, or four concurrent anesthesia procedures | Use only when anesthesia services are part of the clinical episode; generally not applicable to the lab test itself. |
QX | CRNA service with medical direction by a physician | Use when CRNA services are furnished and medically directed; not typical for this lab test. |
QY | Medical direction of one certified registered nurse anesthetist by an anesthesiologist | Use in anesthesia contexts associated with related procedures. |
TC | Technical component | Use when reporting only the technical component (laboratory processing and analysis) of the test. |
SH | Diagnostic services furnished under an approved rural health clinic or federally qualified health center (FQHC) | Use when applicable to the site of service. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RH0000X | Hematology & Oncology | Treating physicians ordering and interpreting results. |
207L00000X | Pathology | Laboratory physicians responsible for clinical laboratory oversight and interpretation when applicable. |
363L00000X | Clinical Laboratory | Performing laboratory entities that process proprietary tests. |
208000000X | Internal Medicine | Hospitalists or internists involved in inpatient monitoring of multiple myeloma patients. |
208800000X | Hematology | Hematologists who manage malignant plasma cell disorders. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
| Data not available in the input. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0337U | CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Test — proprietary laboratory analysis identifying, isolating, and counting circulating multiple myeloma cells from peripheral blood | Primary PLA code for the specific proprietary test performed by Menarini Silicon Biosystems; used to quantify CMMC for disease monitoring. |
36415 | Collection of venous blood by venipuncture | Performed immediately before 0337U to obtain the peripheral blood specimen for analysis. |
86316 | Immunoassay for tumor markers (e.g., free light chains) | Common concurrent laboratory test ordered to evaluate disease activity in multiple myeloma alongside 0337U. |
88305 | Level IV surgical pathology, gross and microscopic examination (single or multiple specimens) | Performed when a concurrent bone marrow biopsy or tissue specimen requires pathologic evaluation to correlate with circulating cell findings. |
87045 | Culture, bacterial, screening method; urine — not applicable to blood but included when infection evaluation is concurrent | Rarely related; typically not part of routine myeloma monitoring but may be ordered if infection is suspected. |
96413 | Chemotherapy administration, intravenous infusion, up to 1 hour, single or initial substance/drug | Often part of the overall clinical episode; 0337U results may be used for monitoring therapy response during chemotherapy cycles. |