CAM 120

Flow Cytometry

Category:Laboratory   Last Reviewed:April 2019
Department(s):Medical Affairs   Next Review:April 2020
Original Date:January 2016    

Background 
Flow cytometry is a powerful technology that is able to analyze multiple characteristics of cells simultaneously. It is used for a variety of purposes, including diagnosis of leukemia and lymphoma, cell identification and quantification (such as in individuals with HIV), identification of therapeutic targets and identification of prognostic markers.

Despite the widespread use of flow cytometry, standard approaches to selection of reagents and technology are lacking. As a result, the number of reagents used for the initial and secondary evaluation of cell markers can vary widely across laboratories.

Policy 
Application of medical necessity criteria is dependent upon an individual’s benefit coverage at the time of the request.

  1. Flow cytometry immunophenotyping of cell surface markers meets coverage criteria for any of the following conditions:
    • Cytopenias, lymphomas, leukemia and lymphoproliferative disorders or myelodysplastic syndrome; or
    • B-cell monitoring for immunosuppressive disorders; or
    • T-cell monitoring for HIV infection and AIDS; or
    • Mast cell neoplasms; or
    • Paroxysmal nocturnal hemoglobinuria; or
    • Post-operative monitoring of members who have undergone organ transplantation; or
    • Plasma cell disorders; or
    • Primary Immunodeficiencies, (PIDs) and PIDs involving T;  
    • Hypercellular Hematolymphoid (Disorders)
    • Chronic Lymphocytic Leukemia (CLL)
    • Chronic Myeloproliferative Disorders (CMPD)
    • Minimal Residual Disease (MRD)
    • Molar pregnancy
    • Primary Platelet Disorders, Non-neoplastic
    • Red Cell and White Cell Disorders, Non-neoplastic
  2. The following reimbursement limitations will apply for flow cytometry:
    • For flow cytometric immunophenotyping for the assessment of potential hematolymphoid neoplasia, use codes 88184-88189.
    • Code 88184 should be used for the first marker and is reimbursable as a single unit.
    • Code 88185 should be used for each additional marker, and is reimbursable up to 24 units. Note that medical necessity for the number of markers tested must be included in the medical record.
    • Additional units of 88185 (i.e., greater than 24 units) require prior authorization, based on documented medical necessity.
    • In patients with a neoplasm with an established immunophenotype, subsequent tests for that neoplasm should be limited to diagnostically relevant markers.
    • Codes 88187, 88188 and 88189 should not be used together in any combination. They are mutually exclusive and reimbursable as a single unit only. 
    • Codes 88187-88189 should not be used in conjunction with codes 86355, 86356, 86357, 86359, 86360, 86361, 86367.
    • Use codes 86355, 86356, 86357, 86359, 86360, 86361 or 86367 for cell enumeration. These codes are reimbursable as single units only. 

Policy Guidelines 
In 2006, a panel of subject matter experts was convened to define the clinical indications that warrant use of flow cytometry as well as the identity of the reagents that should be used in the initial and secondary evaluations for those conditions. The output of that gathering was the "2006 Bethesda International Consensus Recommendations on the Immunophenotypic Analysis of Hematolymphoid Neoplasia by Flow Cytometry."

The panel indicated that flow cytometry is useful for the evaluation of cytopenias, elevated leukocyte count, observation of atypical cells or blasts and evaluation of body fluids, plasmacytosis or monoclonal gammopathy, organomegaly and tissue masses and certain patient monitoring indications.

The Bethesda recommendations indicate that flow cytometry is not indicated for mature neutrophilia, polyclonal hypergammaglobulinemia, polycythemia, thrombocytosis and basophilia because "they are usually not associated with hematolymphoid malignancy or associated with hematolymphoid neoplasms that are not detectable by" flow cytometry.

The Bethesda recommendations also indicate that selection of reagents for the initial evaluation panel should be based on specimen type (peripheral blood, bone marrow, tissue, etc.), clinical information and cell morphology studies. They identify initial panels for specific indications that range from a total of 4 reagents to a maximum of 12 reagents.

For secondary evaluation, where the initial evaluation is not conclusive or informative, the Bethesda recommendations again identify groups of reagents that should be used, based on indication. The secondary panels ranged from 5 to 23 reagents.

Specific recommendations for the initial evaluation were:

  • B cells: CD5, CD10, CD19, CD20, CD45, Kappa, Lambda
  • T cells and NK cells: CD2, CD3, CD4, CD5, CD7, CD8, CD45, CD56
  • Myelomonocytic cells: CD7, CD11b, CD13, CD14, CD15, CD16, CD33, CD34, CD45, CD56, CD117, HLA-DR
  • Myelomonocytic cells (limited): CD13, CD33, CD34, CD45
  • Plasma cells CD19, CD38, CD45, CD56 

For secondary evaluation, the Bethesda recommendations were:

  • B cells: CD9, CD11c, CD15, CD22, cCD22, CD23, CD25, CD13, CD33, CD34, CD38, CD43, CD58, cCD79a, CD79b, CD103, FMC7, Bcl-2, cKappa, cLambda, TdT, Zap-70, cIgM
  • T cells and NK cells: CD1a, cCD3, CD10, CD16, CD25, CD26, CD30, CD34, CD45RA, CD45RO, CD57, ab-TCR, gd-TCR, cTIA-1, T-beta chain isoforms, TdT
  • Myelomonocytic cells: CD2, CD4, CD25, CD36, CD38, CD41, CD61, cCD61, CD64, CD71, cMPO, CD123, CD163, CD235a
  • Plasma cells: CD10, CD117, CD138, cKappa, cLambda

References 

  1. BH Davis, JT Holden, MC. Bene, MJ. Borowitz, RC. Braylan, D Cornfield, W Gorczyca, R Lee, R Maiese, A Orfao, D Wells, BL Wood, and M Stetler-Stevenson. "2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia: Medical Indications" Cytometry Part B (Clinical Cytometry) 72B:S5–S13 (2007).
  2. M Brown and C Wittwer. "Flow Cytometry: Principles and Clinical Applications in Hematology," Clin Chem, August 2000 vol. 46 no. 8 1221-1229.
  3. BL Wood, M Arroz, D Barnett, J DiGiuseppe, B Greig, SJ Kussick, T Oldaker, M Shenkin, E Stone, and P Wallace. "2006 Bethesda International Consensus Recommendations on the Immunophenotypic Analysis of Hematolymphoid Neoplasia by Flow Cytometry: Optimal Reagents and Reporting for the Flow Cytometric Diagnosis of Hematopoietic Neoplasia," Cytometry Part B (Clinical Cytometry) 72B:S14–S22 (2007).

Coding Section

Codes  Number  Description 
CPT  88182  Flow Cytometry, cell cycle or DNA analysis 
  88184  Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; first marker 
  88185  each additional marker (List separately in addition to code for first marker) 
  88187  Flow cytometry, interpretation; 2 to 8 markers 
  88188  9 to 15 markers 
  88189  16 or more markers 
  88199  Unlisted cytopathology procedure 
  86355  B cells, total count
  86356  Mononuclear cell antigen, quantitative (e.g., flow cytometry), not otherwise specified, each antigen 
  86357  Natural killer (NK) cells, total count 
  86359  T cells; total count 
  86360  Absolute CD4 and CD8 count, including ratio 
  86361  Absolute CD4 count 
  86367  Stem cells (e.g., CD34), total count 
ICD-10-CM  C43.111 – C43.122 Malignant melanoma of right upper eyelid, including canthus
  O01.0 Classic hydatidiform mole - Hydatidiform mole, unspecified
  O01.1 Incomplete and partial hydatidiform mole
  D04.10 Carcinoma in situ of skin of eyelid, including canthus
  All D37 codes   Neoplasm of uncertain behavior of oral cavity and digestive organs 
  D81.30 (EFFECTIVE 10/01/2019)  Adenosine deaminase deficiency, unspecified 
  D81.31 (EFFECTIVE 10/01/2019)  Severe combined immunodeficiency due to adenosine deaminase deficiency 
  D81.32 (EFFECTIVE 10/01/2019) Adenosine deaminase 2 deficiency 
  D81.39 (EFFECTIVE 10/01/2019)  Adenosine deaminase 2 deficiency 
  R89.7 Abnormal histological findings in specimens from other organs, systems and tissues
  E88.09  Other disorders of plasma-protein metabolism, not elsewhere classified

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2015 Forward     

09/24/2019 

Updated coding. No other changes made. 

04/02/2019 

Annual review, no change to policy intent. Updating coding. 

04/18/2018 

Annual review, no change to policy intent. 

04/25/2017 

Updated category to Laboratory. No other changes. 

04/17/2017 

Annual review, no change to policy intent. 

01/31/2017 

Interim review, updating the number of allowable units of 88185 to be 24 and any numbers greater than 24 will require prior authorization. 

01/03/2017 

Annual review, no change to policy intent. 

04/11/2016 

Interim review to add additional diagnoses that are medically necessary. 

12/21/2015

NEW POLICY

 


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