Flow Cytometry is a highly complex process by which blood, body fluids, bone marrow and tissue can be examined. It provides important immunophenotypic and DNA cycle information, of both diagnostic and prognostic interest in hemopathology, cytopathology and general surgical pathology. The technique measures multiple characteristics (cell size, internal structure, antigens, DNA, ploidy and cell cycle analysis) of single cells in a moving fluid stream. Clinical analysis and interpretations are done by an experienced physician, usually a pathologist.
HIV Infection
The status of a Human Immunodeficiency Virus- (HIV) infected patient can be monitored by the analysis of the surface antigen CD4 (a T-cell receptor for HIV). This information can contribute to a prognosis as well as medical management for that individual (e.g., the need for AZT therapy or prophylaxis). Monitoring would be considered appropriate no greater in frequency than every 3 months. (When a patient is stable, especially during the long period of clinical latency, assays would be appropriate at a frequency less often. When the patient has an acute problem or therapy change, it may be necessary to perform the test at an increased frequency.)
Leukemia or Lymphoma
Leukemias and lymphomas may be analyzed in tissue, blood or marrow. Sometimes, flow cytometry may be performed on peripheral blood and fine needle aspirate material, thus, avoiding more invasive procedures for diagnosis. The presence or absence of antigens is determined using an antibody panel for appropriate diagnosis and classification. In the great majority of cases, 20 antibody determinations are sufficient to address diagnostic and prognostic concerns. This process is usually necessary at the initial diagnostic phase, for separate hematologic malignancies or when tumor is present in several anatomic sites. After this initial diagnostic phase, flow cytometry may be indicated to determine response to therapy.
Organ Transplants
Postoperative monitoring of organ transplants may be necessary to determine early rejection, immunosuppressive therapy toxicity or differentiation of infection from allograft rejection. The cells surface marker examined is CD3. This may require repeated analysis when symptoms are expressed for the above conditions by the transplant patient.
Carcinomas
DNA analysis of tumor for ploidy and percent-S-phase cells may be necessary for a few selective patients with carcinomas. Information obtained from flow cytometry is useful when the obtained prognostic information will affect treatment decisions in patients with low stage (localized disease). This is usually performed only one time after a diagnosis has been made and before treatment is initiated.
Primary Immunodeficiencies
Primary immunodeficiencies (e.g., Lymphocyte disorders, Phagocyte disorders, Monocyte/macrophage disorder) are immune disorders that are present at birth. These conditions are quite rare. Diagnosis typically occurs at an early age due to recurrent infections with frequent failures. Initial evaluation for suspected primary immunodeficiencies includes physical exam, laboratory evaluation (e.g., CBC, platelet, WBC with differential, ESR) and may include skin testing. Flow cytometry is indicated for diagnostic purposes in the presence of established disease or when abnormal results are found in the initial evaluation.
It is expected that the initial evaluation will contain a higher number of antibody examinations than a subsequent antibody examination.
Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.
HIV Infection
The status of a Human Immunodeficiency Virus- (HIV) infected patient can be monitored by the analysis of the surface antigen CD4 (a T-cell receptor for HIV). This information can contribute to a prognosis as well as medical management for that individual (e.g., the need for AZT therapy or prophylaxis). Monitoring would be considered appropriate no greater in frequency than every 3 months. (When a patient is stable, especially during the long period of clinical latency, assays would be appropriate at a frequency less often. When the patient has an acute problem or therapy change, it may be necessary to perform the test at an increased frequency.)
Leukemia or Lymphoma
Leukemias and lymphomas may be analyzed in tissue, blood or marrow. Sometimes, flow cytometry may be performed on peripheral blood and fine needle aspirate material, thus, avoiding more invasive procedures for diagnosis. The presence or absence of antigens is determined using an antibody panel for appropriate diagnosis and classification. In the great majority of cases, 20 antibody determinations are sufficient to address diagnostic and prognostic concerns. This process is usually necessary at the initial diagnostic phase, for separate hematologic malignancies or when tumor is present in several anatomic sites. After this initial diagnostic phase, flow cytometry may be indicated to determine response to therapy.
Organ Transplants
Postoperative monitoring of organ transplants may be necessary to determine early rejection, immunosuppressive therapy toxicity or differentiation of infection from allograft rejection. The cells surface marker examined is CD3. This may require repeated analysis when symptoms are expressed for the above conditions by the transplant patient.
Carcinomas
DNA analysis of tumor for ploidy and percent-S-phase cells may be necessary for a few selective patients with carcinomas. Information obtained from flow cytometry is useful when the obtained prognostic information will affect treatment decisions in patients with low stage (localized disease). This is usually performed only one time after a diagnosis has been made and before treatment is initiated.
Primary Immunodeficiencies
Primary immunodeficiencies (e.g., Lymphocyte disorders, Phagocyte disorders, Monocyte/macrophage disorder) are immune disorders that are present at birth. These conditions are quite rare. Diagnosis typically occurs at an early age due to recurrent infections with frequent failures. Initial evaluation for suspected primary immunodeficiencies includes physical exam, laboratory evaluation (e.g., CBC, platelet, WBC with differential, ESR) and may include skin testing. Flow cytometry is indicated for diagnostic purposes in the presence of established disease or when abnormal results are found in the initial evaluation.
It is expected that the initial evaluation will contain a higher number of antibody examinations than a subsequent antibody examination.
Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review.
- Safe and effective.
- Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the clinical trials NCD are considered reasonable and necessary).
- Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
- Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member.
- Furnished in a setting appropriate to the patient’s medical needs and condition.
- Ordered and furnished by qualified personnel.
- One that meets, but does not exceed, the patient’s medical need.
- At least as beneficial as an existing and available medically appropriate alternative.
Bill Type Codes
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12X, 13X, 14X, 18X, 21X, 71X, 72X, 83X, 85X
Revenue Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
CPT/HCPCS Codes
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Note:
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Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web.
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88182©
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Cell marker study
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88184©
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Flowcytometry/ tc, 1 marker
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88185©
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Flowcytometry/tc, add-on
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88187©
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Flowcytometry/read, 2–8
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88188©
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Flowcytometry/read, 9–15
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88189©
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Flowcytometry/read, 16 & >
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Medicare Local Coverage Determination Policy
CPT Codes: 88182, 88184, 88185, 88187, 88188, 88189 LCD Description:
Flow cytometry (FCM) is a complex process to examine blood, body fluids, CSF, bone marrow, lymph node, tonsil, spleen and other solid tissues. The use of peripheral blood and fine needle aspirate material avoids more invasive procedures for diagnosis. A flow cytometer evaluates the physical and/or chemical characteristics of single cells as the cells pass individually in a fluid stream through a measuring device. Surface receptors, intracellular molecules, and DNA bind with fluorescent dyes that allow detection and evaluation.
When light of one wave length excites electrons of certain chemicals to energy levels above their ground state and upon return to ground state emits light of a longer wavelength, fluorescence is produced. A flow cytometer detects cell characteristics by measuring the fluorescence produced by fluorochromes conjugated either directly with cell components or conjugated to antibodies directed against cell components. Limitations:
Since FCM immunophenotypes for most common lymphomas and leukemias are well characterized, Noridian does NOT consider it “reasonable and necessary” to perform more than 24 markers in a panel. When atypical or unusual FCM results are obtained, the selective addition of more markers may be indicated. The flow report must document the specific indication for each marker over the 24 marker limit. The FCM report must document the specific indication for each marker over the 24-marker limit. FCM reports without clear justification for each marker over 24 will be denied.
ICD-9-CM Codes That Support Medical Necessity
The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. The following lists include only those diagnoses for which the identified CPT/HCPCS procedures are covered. If a covered diagnosis is not on the claim, the edit will automatically deny the service as not medically necessary.
Medicare is establishing the following limited coverage for CPT/HCPCS codes 88184, 88185, 88187, 88188, and 88189:
Covered for:
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042
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Human immunodeficiency virus (HIV) disease
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079.51–079.53
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Retrovirus
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197.2
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Secondary malignant neoplasm of respiratory and digestive systems, pleura
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197.6
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Secondary malignant neoplasm of respiratory and digestive systems, retroperitoneum and peritoneum
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200.00–200.08
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Reticulosarcoma
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200.10–200.18
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Lymphosarcoma
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200.20–200.28
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Burkitt’s tumor or lymphoma
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200.30–200.38
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Marginal zone lymphoma
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200.40–200.48
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Mantle cell lymphoma
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200.50–200.58
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Primary central nervous system lymphoma
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200.60–200.68
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Anaplastic large cell lymphoma
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200.70–200.78
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Large cell lymphoma
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200.80–200.88
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Other named variants
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201.00–201.08
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Hodgkin’s paragranuloma
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201.10–201.18
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Hodgkin’s granuloma
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201.20–201.28
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Hodgkin’s sarcoma
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201.40–201.48
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Lymphocytic-histiocytic predominance
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201.50–201.58
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Nodular sclerosis
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201.60–201.68
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Mixed cellularity
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201.70–201.78
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Lymphocytic depletion
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201.90–201.98
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Hodgkin’s disease
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202.00–202.08
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Nodular lymphoma
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202.10–202.18
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Mycosis fungoides
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202.20–202.28
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Szary’s disease
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202.30–202.38
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Malignant histiocytosis
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202.40–202.48
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Leukemic reticuloendotheliosis
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202.50–202.58
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Letterer-Siwe disease
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202.60–202.68
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Malignant mast cell tumors
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202.70–202.78
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Peripheral T cell lymphoma
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202.80–202.88
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Other lymphomas
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202.90–202.98
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Other and unspecified malignant neoplasms of lymphoid and histiocytic tissue
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203.00
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Multiple myeloma, without mention of having achieved remission
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203.02
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Multiple myeloma, in relapse
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203.10–203.12
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Plasma cell leukemia
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203.80–203.82
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Other immunoproliferative neoplasms
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204.00–204.02
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Acute lymphoid leukemia
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204.10–204.12
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Chronic lymphoid leukemia
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204.20–204.22
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Subacute lymphoid leukemia
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204.80–204.82
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Other lymphoid leukemia
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204.90–204.92
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Unspecified lymphoid leukemia
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205.00–205.02
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Acute myeloid leukemia
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205.10–205.12
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Chronic myeloid leukemia
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205.20–205.22
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Subacute myeloid leukemia
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205.30–205.32
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Myeloid sarcoma
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205.80–205.82
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Other myeloid leukemia
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205.90–205.92
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Unspecified myeloid leukemia
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206.00–206.02
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Acute monocytic leukemia
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206.10–206.12
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Chronic monocytic leukemia
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206.20–206.22
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Subacute monocytic leukemia
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206.80–206.82
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Other monocytic leukemia
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206.90–206.92
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Unspecified monocytic leukemia
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207.00–207.02
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Acute erythremia and erythroleukemia
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207.10–207.12
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Chronic erythremia
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207.20–207.22
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Megakaryocytic leukemia
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207.80–207.82
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Other specified leukemia
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208.00–208.02
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Acute leukemia of unspecified cell type
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208.10–208.12
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Chronic leukemia of unspecified cell type
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208.20–208.22
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Subacute leukemia of unspecified cell type
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208.80–208.82
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Other leukemia of unspecified cell type
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208.90–208.92
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Unspecified leukemia
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238.71–238.77
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Neoplasm of uncertain behavior, other lymphatic and hematopoietic tissues
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238.79
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Neoplasm of uncertain behavior, other lymphatic and hematopoietic tissues
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273.1–273.3
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Disorders of plasma protein metabolism
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273.8–273.9
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Disorders of plasma protein metabolism
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279.00–279.06
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Deficiency of humoral immunity
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279.09
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Deficiency of humoral immunity other
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279.10–279.13
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Deficiency of cell-mediated immunity
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279.19
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Deficiency of cell-mediated immunity other
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279.2–279.3
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Disorders involving the immune mechanism
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279.41
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Autoimmune lymphoproliferative syndrome
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279.49
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Autoimmune disease, not elsewhere classified
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279.8–279.9
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Disorders involving the immune mechanism
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282.7
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Other hemoglobinopathies
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283.2
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Hemoglobinuria due to hemolysis from external causes
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284.01
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Constitutional red blood cell aplasia
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284.09
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Other constitutional aplastic anemia
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284.1–284.2
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Aplastic anemia and other bone marrow failure syndromes
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284.81
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Red cell aplasia (acquired)(adult)(with thymoma)
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284.89
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Other specified aplastic anemias
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284.9
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Aplastic anemia, unspecified
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285.0
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Sideroblastic anemia
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285.22
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Anemia in neoplastic disease
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285.8–285.9
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Other and unspecified anemias
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287.30–287.33
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Primary thrombocytopenia
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287.39
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Other primary thrombocytopenia
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287.5
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Thrombocytopenia, unspecified
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288.00–288.04
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Neutropenia
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288.09
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Other neutropenia
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288.1–288.4
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Diseases of white blood cells
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288.50–288.51
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Decreased white blood cell count
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288.59
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Other decreased white blood cell count
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288.60–288.65
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Elevated white blood cell count
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288.69
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Other elevated white blood cell count
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288.8–288.9
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Diseases of white blood cells
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289.4
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Hypersplenism
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289.50–289.53
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Other diseases of spleen
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289.59
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Other diseases of spleen
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289.83
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Myelofibrosis
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289.9
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Unspecified diseases of blood and blood-forming organs
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452
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Portal vein thrombosis
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453.9
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Embolism of vein thrombosis, unspecified
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785.6
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Enlargement of lymph nodes
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789.2
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Splenomegaly
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791.0
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Proteinuria
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795.4
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Other nonspecific abnormal histological findings
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996.80–996.87
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Complications of transplanted organ
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996.89
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Complications of transplanted organ, other specified transplanted organ
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V08
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Asymptomatic human immunodeficiency virus (HIV) infection status
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V10.60–V10.63
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Personal history of malignant neoplasm , leukemia
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V10.69
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Personal history of malignant neoplasm, leukemia, other
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V10.91
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Personal history of malignant neuroendocrine tumor
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V42.0–V42.7
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Organ or tissue replaced by transplant
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V42.81–V42.84
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Organ or tissue replaced by transplant, other specified organ or tissue
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V42.89
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Organ or tissue replaced by transplant, other
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V42.9
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Unspecified organ or tissue replaced by transplant
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Medicare is establishing the following limited coverage for CPT/HCPCS code 88182:
Covered for:
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150.0–150.5
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Malignant neoplasm of esophagus
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150.8–150.9
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Malignant neoplasm of esophagus
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151.0–151.6
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Malignant neoplasm of stomach
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151.8–151.9
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Malignant neoplasm of stomach
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153.0–153.9
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Malignant neoplasm of colon
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154.0
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Malignant neoplasm of rectosigmoid junction
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154.1
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Malignant neoplasm of rectum
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174.0–174.6
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Malignant neoplasm of female breast
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174.8–174.9
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Malignant neoplasm of female breast
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175.0
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Malignant neoplasm of nipple and areola of male breast
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175.9
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Malignant neoplasm of other and unspecified sites of male breast
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183.0
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Malignant neoplasm of ovary
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183.8
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Malignant neoplasm of other specified sites of uterine adnexa
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185
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Malignant neoplasm of prostate
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188.0
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Malignant neoplasm of trigone of urinary bladder
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188.1–188.9
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Malignant neoplasm of bladder
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193
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Malignant neoplasm of thyroid gland
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194.0
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Malignant neoplasm of adrenal gland
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198.81
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Secondary malignant neoplasm of breast
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227.0
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Benign neoplasm of adrenal gland
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233.0
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Carcinoma in situ of breast
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259.2
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Carcinoid syndrome
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Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.
