Local Coverage Determination (LCD)

Lab: Flow Cytometry

L34513

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Contractor Information

LCD Information

Document Information

LCD ID
L34513
LCD Title
Lab: Flow Cytometry
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 04/08/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1862(a)(7) states Medicare will not cover any services or procedures associated with routine physical checkups.

42 CFR §410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.

CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §110.23, Stem Cell Transplantation

CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, §3.4.1.3, Diagnosis Code Requirements

CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, §3.6.2.3, Limitation of Liability Determinations

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Flow cytometry (FCM) is a complex process to examine blood, body fluids, cerebrospinal fluid (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.

Indications

Cytopenias and Hypercellular Hematolymphoid Disorders

Hematolymphoid neoplasia can present with cytopenias (anemia, leukopenia and/or thrombocytopenia) or elevated leukocyte counts. If medical review and preliminary laboratory testing fails to reveal a cause, bone marrow aspiration and biopsy are indicated to rule out an infiltrative process or a stem cell disorder. FCM is essential to evaluate hematolymphoid lineages. Although anemia commonly occurs in nonneoplastic diseases, anemia alone should not automatically trigger FCM.

FCM may be useful in hypercellular hematolymphoid disorders to differentiate reactive conditions from neoplastic conditions. In the absence of blasts, neutrophilic leukocytosis is not generally an indication for FCM. Isolated polycythemia and basophilia are not sufficient to warrant FCM.

Lymphomas

In the current World Health Organization (WHO) classification, all non-Hodgkin lymphomas (NHLs) are distinct clinicopathologic entities defined by their clinical features, morpholology, immunophenotype and, where appropriate, their genetic abnormalities. Immunophenotyping by FCM allows multiparameter evaluation of single cells and the ability to work on very small samples.

Most new cases of suspected NHL undergo initial immunophenotypic analysis as part of the routine handling of a specimen. A standard lymphoma panel is designed to identify abnormal populations of B cells, T cells and/or NK cells. A standard lymphoma panel might include a combination of markers from the following categories: T cells (CD2, CD3, CD4, CD5, CD7, CD8); B cells (CD19, CD20, CD23); Kappa and Lambda surface immunoglobulins light chains; plasma cells (CD38 and CD138); CALLA (CD10); CD45; CD56: FMC-7, CD103, CD11c, CD13, CD14, CD15, CD16 and CD34.

The immunophenotypes of lymphomas are widely known and FCM allows appropriate classification of most cases. However, atypical patterns occur and pose significant diagnostic difficulties where aberrant antigen expression patterns must be reconciled with morphology. Additional markers may be required to characterize the abnormal population of cells including markers of immature cells (HLA-DR), B cells (CD22) and myeloid cells (CD14, CD15, CD33, CD64, CD117).

Acute Leukemia

The diagnosis and management of acute leukemia depends on the detection, identification and characterization of leukemic cells. The identification of leukemic cells is straightforward in most occasions. However, each acute leukemia subgroup has heterogeneous biologic characteristics, many of which are associated with a different response to therapy.

As part of a routine diagnostic workup, most suspected acute leukemia cases undergo initial multiparameter immunophenotypic analysis, combined with morphology, cytochemistry, cytogenetics, and molecular biology.

A standard acute leukemia FCM panel is designed to determine whether leukemic blasts are of myeloid or lymphoid origin, and then to further classify the neoplastic cells (myeloid blasts, B lymphoblasts, abnormal promyelocytes, monoblasts, etc). An acute leukemia panel might include a combination of cell markers from the following categories: stem cell lineage (CD34), immature cell lineage (HLA-DR, CD 10); T cell (CD2, CD3, CD4, CD5, CD7 and CD8); B cell (CD19, CD20); myeloid cell (CD13, CD14, CD15, CD33, CD64 and CD117); CD38, CD45, and CD56.

When the routine panel is insufficient to characterize the leukemic cells, additional antibodies including erythroid markers (CD71 and glycophorin A), megakaryocytic markers (CD41, CD61) or cytoplasmic markers may be indicated.

Chronic Lymphocytic Leukemia (CLL) & Other Chronic Lymphoproliferative Diseases (CLPD)

The history, physical exam (lymphadenopathy, splenomegaly and/or hepatomegaly), laboratory findings (lymphocytosis, granulocytopenia, anemia, thrombocytopenia), and lymphocyte morphology are suggestive of CLL. The diagnosis is established by paradoxical co-expression of CD5 on peripheral lymphocytes that express B cell markers (CD19, CD20, CD21 and CD23) with Kappa or Lambda immunoglobulin light chain restriction. Additional markers such as CD38 and ZAP70 may provide important prognostic information.

FCM can distinguish CLL, the peripheral counterpart of small lymphocytic lymphoma, often diagnosed in lymph node biopsies, from other indolent lymphocytic malignancies including prolymphocytic leukemia, Waldenstrom’s macroglobulinemia, leukemic phase of lymphomas, hairy cell leukemia, T-cell CLL, adult T-cell leukemia, large granulocytic leukemia and cutaneous T-cell lymphoma and natural killer (NK) disorders including KIR expression.

Plasma Cell Disorders

Plasma cell disorders are often identified through a combination of clinical, laboratory studies (urine or serum gamma globulins), morphologic, and radiologic findings. FCM immunophenotyping is useful to identify abnormal plasma cells, and the distinction between lymphoid and plasma cell neoplasms, and between reactive plasma cells and neoplastic plasma cells.

The initial FCM workup for a plasma cell disorder may include the basic lymphoma panel markers with additional markers such as CD28 and CD117.

Myelodysplastic Syndromes (MDS)

The gold standard for an MDS diagnosis is assessment of bone marrow smears for dysplastic changes. FCM may assist in MDS determination through the identification of abnormal maturing myeloid cells. An abnormal phenotype by FCM is a minimal diagnostic MDS criteria to establish a definitive diagnosis.

MDS has a definite risk and rate of progression to acute leukemia. Standard FCM leukemia panels are indicated to evaluate progression and onset of leukemia.

Chronic Myeloproliferative Disorders (CMPD)

Although genetic (Philadelphia chromosome and BCR/abl) and molecular studies (Jak 2) are the accepted cornerstone for the identification and classification of CMPDs, FCM may assist in the distinction from reactive hematopoietic proliferations and is important in the enumeration of blasts in the distinction from acute leukemia and an accelerated phase of CMPD.

CMPD also has a definite risk and rate of progression to acute leukemia. Standard FCM leukemia panels are indicated to evaluate progression and onset of leukemia.

Mast Cell Neoplasms

Mast cell neoplasms are uncommon disorders. Mast cells coexpress multiple markers including CD9, CD33, CD45, CD68, CD117, but also lack several myelomonocytic antigens including CD14, CD15, CD16 and most T- and B- cells antigens. Neoplastic mast cells have a similar antigen profile, but also can coexpress CD2 and CD25, which help in distinguishing malignant mast cells from mastocytosis.

Paroxysmal Nocturnal Hemoglobinuria (PNH)

PNH is a rare clonal hematopoietic disorder of stem cells. This condition is caused by genetic mutation that results in the absence of over a dozen surface antigens on red and white blood cells. FCM can diagnose PNH by assessing both the red and white blood cells for the absence of these antigens.

Minimal Residual Disease (MRD)

FCM analysis for MRD must identify phenotypic features characteristic of the disease of interest. The MRD flow analysis should not rely on an exact match between the phenotype of the residual disease and the original diagnostic specimen because phenotypes can change over time and with treatment. The antibody combinations should be chosen to maximize detection of disease, limit the impact of phenotypic variation, and permit detection of disease following antibody directed therapy.

Human Immunodeficiency Virus (HIV) Infection

HIV-1 infection causes significant changes in the number of CD4 and CD8 positive lymphocytes. CD4 count falls roughly 30% while CD8 count increases within 6 months after seroconversion, causing a decrease in the CD4/CD8 ratio

Following HIV-1 diagnosis, FCM should include enumeration of mature T cells (CD3), helper T cells (CD4) and suppressor T cells (CD8) to ensure all major T cell subsets are accounted for (the sum of helper CD4 and suppressor CD8 T cells is roughly close to the total number of CD3 positive T cells). This ensures that the absolute CD4 is not artificially decreased due to sample degradation or other artifact.

A WBC count with differential also needs to be performed to calculate the absolute CD4 count (absolute lymphocyte count times CD4%).

Organ Transplants

In order to differentiate early rejection, immunosuppressive therapy toxicity or infection, FCM may be indicated to monitor postoperative organ transplants. CD3 is useful to monitor the effectiveness of certain immunosuppressive therapies. When the transplant patient demonstrates symptoms for the above conditions, repeated analysis may be required.

DNA Analysis

Carcinoma, Non-hematolymphoid Tumors

DNA analysis of tumor for ploidy and percent S-phase cells may be necessary for a few selective patients with carcinomas. When the obtained prognostic information will affect treatment decisions in patients with low stage (localized) disease, FCM results are useful.

Molar Pregnancy

FCM is useful to evaluate molar and partial molar pregnancies. Using a method to quantify DNA, similar to that used for evaluation of carcinomas, partial moles (triploid), can be distinguished from normal placenta and complete molar (diploid) pregnancies.

Primary Immunodeficiencies (PIDS)

PIDs are rare disorders that reflect inherited abnormalities in the development and maturation of cells responsible for immune function. More than 120 inherited immunodeficiency disorders are currently recognized. Affected individuals are prone to repeated infections, allergies, autoimmune disorders, and malignancies. Diagnosis typically occurs at an early age.

FCM may be indicated for diagnostic purposes and is usually limited to T (CD3, CD4, CD8), B (CD20) and NK cell (CD56) markers. Additional disease specific markers may be indicated.

Primary Platelet Disorders, Non-neoplastic

FCM is used for platelet analysis in quantitative and qualitative disorders such as Glanzmann Thrombasthenia (GT) and Bernard-Soulier Disease (B-S). GT is a rare inherited or acquired platelet disorder. Hereditary GT is defined by platelets with decreased expression or absence of the GPIIa/GPIIIb receptor. This receptor is responsible for the initial platelet plug at the site of endothelial injury. Absence of the receptor may result in increased bleeding.

Acquired GT is likely an autoimmune phenomenon with the presence of GPIIb/GPIIIa blocking antibodies. FCM may be used to determine the functional effect and identity the molecular targets of these antibodies.

B-S is another rare inherited disorder that prevents the initial binding of platelets at the site of endothelial injury by absence of or presence of abnormal surface GPIa/V/IX receptor. Abnormalities of this receptor prevent attachment of platelets to subendothelial or free von Willebrand’s factor with subsequent tendency to bleed.

FCM may be used to measure antibodies directed at specific loci of the GPIa/V/IX receptor, which include GPIb (CD42b), GPIX (CD42a), and GPV (CD42d). FCM is also used to assess the size of platelets in the initial evaluation of B-S disease. In B-S disease, platelets are generally larger than normal. FCM can distinguish B-S platelets from fragmented RBCs and debris by antibodies directed to the GPIb/IX/V receptor.

Red Cell and White Cell Disorders, Non-neoplastic

FCM is a valuable tool to establish abnormal or defective red blood cell, leukocyte and lymphocyte surface receptors, transmembrane molecules, and intracellular DNA. It may be used in acquired and congenital red cell conditions such as in quantifying fetomaternal hemorrhage and hereditary spherocytosis, hereditary elliptocytosis, and hereditary persistence of fetal hemoglobin in the context of compound hemoglobinopathy syndromes.

FCM is a sensitive and specific method to identify leukocyte receptor abnormalities for the diagnosis of chronic granulomatous disease and CD11b deficiency. It is an efficient method to identify lymphocytes HLA B27 associated with uveitis, ankylosing spondylitis, Reiter’s syndrome and sacroiliitis.

Limitations:

Since FCM immunophenotypes for most common lymphomas and leukemias are well characterized, Palmetto GBA 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.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

General Information

Associated Information

Documentation Requirements:

Laboratories and physicians that request FCM studies MUST provide legible documentation of clinical and morphologic findings, cell counts (quantitative values), radiology and cytogenetic findings when available.

The referring physician or pathologist MUST provide the most specific suspected diagnosis or differential diagnosis to allow the performing laboratory to determine an appropriate panel of cell markers.

The performing laboratory MUST select an appropriate panel of cell markers for the suspected diagnosis.

Since Palmetto GBA expects the need for markers in excess of 24 to be rare, providers must include the following documentation to justify additional marker selection with their redetermination request:

    • clinical information summary
    • specific marker results
    • diagnosis and interpretation
    • rationale to support each additional marker in excess of 24

Redeterminations filed without this specific final report information shall be denied as not reasonable or necessary.

A flow cytometry report listing the antibodies performed and the percentage and expressed markers does NOT meet this documentation requirement for initial redetermination consideration or for the appeal process.

Hospital and reference labs must ensure the documentation in the medical record justifies the selection of the billed cell markers.

Flow cytometry is a dynamic field. Palmetto GBA will evaluate requests for coverage extension that are supported by peer reviewed literature.

Compliance with the provisions listed in this policy will be subject to postpayment data analysis and subsequent medical review. Failure to document and maintain supporting medical information in the patient’s record or in the FCM report may result in overpayments and/or RAC referral.

Utlization Guildlines

Medicare does not expect to see labs routinely perform more than 24 markers per specimen.

Comprehensive marker panels used to indiscriminately “screen” specimens, regardless of the submitted suspected diagnosis, are not considered reasonable and necessary.

An FCM performed more than every 3 months to monitor stable HIV infection is not considered reasonable or necessary. More frequent studies may be indicated if a patient develops drug resistance and needs to be treated with another antiviral(s).

DNA analysis for selected patients with carcinomas may be appropriate ONLY once after diagnosis and before treatment is initiated.

Palmetto GBA expects the initial flow evaluation to contain a greater number of antibody determinations than a subsequent follow-up study. MDS and CMPD are general exceptions because these disorders are at risk for developing leukemia. Progression to leukemia may necessitate cytoplasmic markers.

Sources of Information

N/A

Bibliography

Basso G, Lanza F, Orfao A, et al. Flow cytometric immunophenotyping of acute lymphoblastic leukemia: Is the time ready for consensus the guidelines? Journal of Biological Regulators and Homeostatic Agents. 2002;16(4):257-258. 

Centers for Disease Control and Prevention. 1997 Revised Guidelines for performing CD4+ T-cell determinations in persons infected with human immunodeficiency virus(HIV). MMWR. 1997;46(RR-2):1-29.

Craig FE, Foon KA. Flow cytometric immunophenotyping for hematologic neoplasms. Blood. 2008;111(8):3941-3967.

Giannini S, Cecchetti L, Mezzasoma AM, Gresele P. Diagnosis of Platelet-type von Willebrand Disease by flow cytometry. Haematologica. 2010;95(6):1021-1024.

Illoh OC. Current applications of flow cytometry in the diagnosis of primary immunodeficiency diseases. Arch Pathol Lab Med. 2004;128(1):23-31.

Kaleem Z. Flow cytometric analysis of lymphomas: current status and usefulness. Arch Pathol Lab Med. 2006;130(12):1850-1858.

Stetler-Stevenson M, Davis B, Wood B, Braylan R. 2006 Bethesda International Consensus Conference on flow cytometric immunophenotyping of hematolymphoid neoplasia. Cytometry Part B: Clinical Cytometry. 2007;72B(S1):S3.

Olteanu H, Karandikar NJ, McKenna RW, Xu Y. Differential usefulness of various markers in the flow cytometric detection of paroxysmal nocturnal hemoglobinuria in blood and bone marrow. American Journal of Clinical Pathology. 2006;126(5):781-788.

Swerdlow SH, Campo E, Harris NL, et al, eds. World Health Organization Classification of Tumors of Haematopoietic and Lymphoid Tissues. IARC Press, Lyon. 2008.

Wood BL. Flow cytometric diagnosis of myelodysplasia and myeloproliferative disorders. Journal of Biological Regulators and Homeostatic Agents. 2004;18(2):141-145.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
04/08/2021 R15

References were moved from the Sources of Information section to the Bibliography section and related verbiage was revised as appropriate. Formatting, punctuation and typographical errors were corrected, and acronyms were defined where appropriate throughout the policy.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
10/31/2019 R14

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Lab: Flow Cytometry A55717 Article. Typographical errors were corrected throughout the policy.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
08/22/2019 R13

All coding located in the Coding Information section has been moved into the related Billing and Coding: Lab: Flow Cytometry A55717 article and removed from the LCD.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
01/17/2019 R12

Added "Lab" to the title.

  • Other
10/01/2018 R11

Under ICD-10 Codes that Support Medical Necessity Group1: Codes deleted ICD-10 code C96.2. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes C44.1021, C44.1022, C44.1091, C44.1092, C44.1121, C44.1122, C44.1191, C44.1192, C44.1221, C44.1222, C44.1291, C44.1292, C44.1921, C44.1922, C44.1991, C44.1992. This revision is due to the Annual ICD-10 Code Update. 

  • Revisions Due To ICD-10-CM Code Changes
02/26/2018 R10 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
01/29/2018 R9 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
12/14/2017 R8

Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes Z85.72, effective 10/01/2015.

  • Typographical Error
10/01/2017 R7

 Under ICD-10 Codes that Support Medical Necessity Group1: Codes deleted ICD-10 code C96.2.  Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes C96.20, C96.21, C96.22, C96.29, D47.01, D47.02.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To ICD-10-CM Code Changes
03/16/2017 R6 Under CMS National Coverage Policy for Title XVIII of the Social Security Act, §1862(a)(1)(A) revised the verbiage to read “allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member” , for Title XVIII of the Social Security Act, §1862(a)(7) revised the verbiage to read “states Medicare will not cover any services or procedures associated with routine physical checkups”, for 42 CFR §410.32 revised the verbiage to read “Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions” and for CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §110.8.1, Stem Cell Transplantation, deleted §110.8.1 as this section is obsolete and replaced with §110.23.
  • Provider Education/Guidance
10/01/2016 R5 Under ICD-10 Codes That Support Medical Necessity: Group 1 added ICD-10 code D47.Z2. Under ICD-10 Codes That Support Medical Necessity: Group 1 updated the code descriptions for ICD-10 codes C81.10, C81.11, C81.12, C81.13, C81.14, C81.15, C81.16, C81.17, C81.18, C81.19, C81.20, C81.21, C81.22, C81.23, C81.24, C81.25, C81.26, C81.27, C81.28, C81.29, C81.30, C81.31, C81.32, C81.33, C81.34, C81.35, C81.36, C81.37, C81.38, C81.39, C81.40, C81.41, C81.42, C81.43, C81.44, C81.45, C81.46, C81.47, C81.48, C81.49, C81.70, C81.71, C81.72, C81.73, C81.74, C81.75, C81.76, C81.77, C81.78, and C81.79. This revision is due to the Annual ICD-10 Code Update.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
03/17/2016 R4 Under CMS National Coverage Policy added Part 2 to the following: CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, §110.8.1. Under Coverage Indications, Limitations and/or Medical Necessity in the first paragraph added the verbiage for the abbreviation CSF. Under Coverage Indications, Limitations and/or Medical Necessity-Lymphoma in the first paragraph added the verbiage for the abbreviation WHO and corrected “CD11b” to read “CD11c” in the last sentence of the second paragraph. Under Coverage Indications, Limitations and/or Medical Necessity-Acute Leukemia corrected “CD 17” to read “CD 117” in the last sentence of the third paragraph. Under Coverage Indications, Limitations and/or Medical Necessity-Mast Cell Neoplasms added “s” to “help” in the last sentence. Under ICD-10 Codes That Support Medical Necessity-Group 1: Paragraph deleted the Note. Under Sources of Information and Basis for Decision corrected the title for the following cited journals to now read: Centers for Disease Control and Prevention. 1997 Revised Guidelines for performing CD4+ T-cell determinations in persons infected with human immunodeficiency virus (HIV). MMWR. 1997;46(RR-2):1-29 and Stetler-Stevenson M, Davis B, Wood B, Braylan R. 2006 Bethesda International Consensus Conference on flow cytometric immunophenotyping of hematolymphoid neoplasia. Cytometry Part B: Clinical Cytometry. 2007;72B(S1):S3. The spelling was corrected for Biological in the last journal citation.
  • Provider Education/Guidance
  • Typographical Error
  • Other
10/01/2015 R3 Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.1.3 LCDs consist of only “reasonable and necessary” information. All bill type and revenue codes have been removed.
  • Other (Bill type and/or revenue code removal)
10/01/2015 R2 Under ICD-10 Codes That Support Medical Necessity added ICD-10 codes inadvertently omitted from the LCD:

M02.30

C15.3
C15.4
C15.5
C15.8
C15.9
C16.0
C16.4
C16.3
C16.2
C16.5
C16.6
C16.8
C16.9
C17.0
C17.1
C17.2
C17.8
C17.9
C18.3
C18.4
C18.6
C18.7
C18.0
C18.1
C18.2
C18.5
C18.8
C18.9
C19
C20
C21.1
C21.0
C21.8
C22.0
C22.2
C22.7
C22.8
C22.9
C23
C24.0
C24.1
C25.0
C25.1
C25.2
C25.7
C25.8
C25.9
C48.0
C48.1
C48.8
C48.2
C26.0
C26.1
C26.9
C30.0
C30.1
C31.0
C31.1
C31.2
C31.3
C31.8
C31.9
C32.0
C32.1
C32.2
C32.3
C32.8
C32.9
C33
C34.00
C34.10
C34.2
C34.30
C34.80
C34.90
C38.
C37
C38.1
C38.2
C38.8
C38.3
C39.0
C39.9
C41.0
C41.2
C41.3
C40.00
C40.10
C41.4
C40.20
C40.30
C41.9
C49.0
C49.10
C49.20
C49.3
C49.4
C49.5
C49.6
C47.8
C49.8
C49.9
C44.00
C44.01
C44.02
C44.09
C44.101
C44.111
C44.121
C44.191
C44.201
C44.211
C44.221
C44.291
C44.300
C44.301
C44.309
C44.310
C44.311
C44.319
C44.320
C44.321
C44.329
C44.390
C44.391
C44.399
C44.40
C44.41
C44.42
C44.49
C44.500
C44.501
C44.509
C44.510
C44.511
C44.519
C44.520
C44.521
C44.529
C44.590
C44.591
C44.599
C44.601
C44.611
C44.621
C44.691
C44.701
C44.711
C44.721
C44.791
C44.80
C44.81
C44.82
C44.89
C44.90
C44.91
C44.92
C44.99
C50.019
C50.119
C50.219
C50.319
C50.419
C50.519
C50.619
C50.819
C50.919
C50.029
C50.929
C55
C53.0
C53.1
C53.8
C53.9
C58
C54.1
C54.2
C54.3
C54.9
C54.0
C54.8
C56.9
C57.4
C52
C51.0
C51.1
C51.2
C51.9
C57.7
C57.8
C57.9
C61
C62.00
C62.10
C62.90
C60.0
C60.1
C60.2
C60.9
C63.00
C63.10
C63.2
C60.8
C63.7
C63.8
C63.9
C67.0
C67.1
C67.2
C67.3
C67.4
C67.5
C67.6
C67.7
C67.8
C67.9
C64.9
C65.9
C66.9
C68.0
C68.1
C68.8
C68.9
C69.40
C69.60
C69.50
C69.00
C69.10
C69.20
C69.30
C69.80
C69.90
C71.0
C71.1
C71.2
C71.3
C71.4
C71.5
C71.6
C71.7
C71.8
C71.9
C72.50
C70.0
C70.9
C72.0
C72.1
C70.1
C72.9
C73
C74.90
C75.0
C75.1
C75.2
C75.3
C75.4
C75.5
C75.8
C75.9
C76.40
C76.50
C77.9
C78.00
C79.00
C79.60
C79.70
C80.0
C80.1
D45
D35.00
D05.90
D37.030
D37.031
D37.032
D37.039
D37.01
D37.02
D37.04
D37.05
D37.1
D37.2
D37.4
D37.5
D37.6
D48.3
D48.4
D37.8
D37.9
D38.0
D38.1
D38.2
D38.5
D38.6
D39.0
D39.10
D39.8
D39.9
D40.10
D40.0
D40.8
D40.9
D41.4
D48.1
D48.5
D48.60
D48.7
E34.0
D89.1
E88.09
D80.1
D80.0
D83.9
D80.7
D81.9
D84.9
D84.1
M35.9
D58.0
D58.1
D56.9
D56.0
D56.1
D56.2
D56.3
D56.5
D57.3
D57.1
D57.00
D57.20
D57.219
D57.80
D57.819
D56.4
D58.2
D59.5
D59.6
D59.8
D59.9
D60.9
D61.9
D64.0
D64.1
D64.2
D64.3
D64.4
D64.89
D64.9
D69.1
D69.41
D69.42
D69.3
D69.49
D69.6
D70.9
D70.0
D70.4
D70.1
D70.2
D70.3
D70.8
D71
D72.0
D72.1
D76.2
D76.3
D72.819
D72.818
D72.829
D72.823
D72.824
D72.828
D72.89
D72.9
D73.9
D57.02
D57.212
D57.412
D73.81
D73.3
D73.4
D73.5
D73.89
D75.9
H20.9
I81
I82.91
K50.00
K50.10
K50.80
K50.90
K51.80
K51.20
K51.30
K51.40
K51.50
K51.00
K51.90
O01.9
L40.54
L40.59
M08.00
M45.9
M46.00
M46.1
M49.80
M46.80
M46.90
R80.9
R89.7
Z95.3
Z94.9
Z76.82
Z03.89
  • Provider Education/Guidance
  • Other (ICD-10 conversion)
10/01/2015 R1 Under CMS National Coverage Policy changed verbiage for 42 CFR §410.32(d)(3) to now read “42 CFR §410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements)”. Added “(NCD)” to title of Medicare National Coverage Determinations Manual. Under Sources of Information and Basis for Decision completed page numbers and changed capitalization of titles of journal articles to maintain consistency.
  • Provider Education/Guidance
  • Other (Maintenance
    Annual Validation)

Associated Documents

Attachments
N/A
Related Local Coverage Documents
Articles
A55717 - Billing and Coding: Lab: Flow Cytometry
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
03/31/2021 04/08/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Flow Cytometry

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