L31247-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Flow Cytometry (L31247)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number

09102

Contractor Type

MAC - Part B

LCD Information

Document Information

LCD ID Number L31247

LCD Title Flow Cytometry

Contractor's Determination Number 88182

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 09/30/2010 Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: N/A

Indications and Limitations of Coverage and/or Medical Necessity

Flow cytometry (FCM) is a procedure which simultaneously measures and analyzes multiple physical characteristics of single cells, as they flow in a fluid stream through a beam of light. The light activates fluorescent molecules, resulting in light scatter, which forms a pattern that can be analyzed for cell characteristics. FCM can be used to analyze blood, body fluids, CSF, bone marrow, lymph node, tonsil, spleen and other solid organs. Information from the analyzed cells may help determine prognosis, aid in the analysis of effusions, urine, or other fluids in which cancer cells may be few or mixed with benign cells, detect metastases in lymph nodes or bone marrow, or to supplement fine needle aspiration.

The flow cytometer is made up of three main systems: fluidics, optics and electronics. The fluidic system transports particles in a stream to the laser beam. The optics system consists of lasers to illuminate the particles in the sample stream and optical filters to direct the resulting light signals to the appropriate detectors. The electronics system converts the detected light signals into electronic signals that can be processed by the computer. Some flow cytometers have a sorting feature which allows the electronic system to initiate sorting decisions to charge and deflect particles.

Indications

First Coast Service Options, Inc. (FSCO) will consider Flow cytometry for cell surface cytoplasmic, or nuclear marker medically reasonable and necessary when performed for the following indications:

• Cytopenias and Hypercellular Hematolymphoid Disorder

• Lymphomas

• Acute Leukemia

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

• Plasma Cell Disorders

• Myelodysplastic Syndromes (MDS)

• Chronic Myeloproliferative Disorders (CMPD)

• Mast Cell Neoplasms

• Paroxysmal Nocturnal Hemoglobinuria (PNH)

• Minimal Residual Disease (MRD)

• HIV Infection

• Organ Transplants

• DNA Analysis

• Carcinoma, Non-hematolymphoid Tumors

• Molar Pregnancy

• Primary Immunodeficiencies (PDS)

• Primary Platelet Disorders, Non-neoplastic

• Red Cell and White Cell Disorders, Non-neoplastci

FSCOs will consider flow cytometry-derived DNA content (ploidy),or cell proliferative activity (S-phase fraction), medically reasonable and necessary when performed for the following localized neoplasms:

• Mediastinum

• Uterus

• Ovary

• Prostate

• Bladder

• Kidney/renal

• Brain

• Gastric

• Breast

• Colon

• Rectal

• Hydatidiform mole

Limitations

FCM immunophenotypes for most common lymphomas and leukemias are well characterized. FCSO Medicare does NOT consider it medically reasonable and necessary to perform more than twenty-four (24) markers in a panel. When atypical or unusual FCM results are obtained and the selective addition of more markers are indicated, the flow report must document the specific indication for each marker over the twenty-four (24) limit. Any markers in excess of twenty-four (24) must be supported by documentation which clearly states the justification for the need for excess markers.

Flow cytometry cell cycle or DNA analysis (CPT code 88182) is indicated for a few selective groups of patients with certain carcinomas. Information obtained from flow cytometry is useful when the prognostic information will

affect treatment decisions in patients with localized disease. It is usually performed one time after a diagnosis has been made and before treatment is initiated

Coding Information

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.

999x Not Applicable

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

88182 FLOW CYTOMETRY, CELL CYCLE OR DNA ANALYSIS

88184 FLOW CYTOMETRY, CELL SURFACE, CYTOPLASMIC, OR NUCLEAR MARKER, TECHNICAL COMPONENT ONLY; FIRST MARKER

88185 FLOW CYTOMETRY, CELL SURFACE, CYTOPLASMIC, OR NUCLEAR MARKER, TECHNICAL COMPONENT ONLY; EACH ADDITIONAL MARKER (LIST SEPARATELY IN ADDITION TO CODE FOR FIRST MARKER)

88187 FLOW CYTOMETRY, INTERPRETATION; 2 TO 8 MARKERS

88188 FLOW CYTOMETRY, INTERPRETATION; 9 TO 15 MARKERS

88189 FLOW CYTOMETRY, INTERPRETATION; 16 OR MORE MARKERS

ICD-9 Codes that Support Medical Necessity

USE FOR BILLING CPT CODE 88182

151.0 - 151.9 MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

153.0 - 153.9 MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

154.1 MALIGNANT NEOPLASM OF RECTUM

164.2 MALIGNANT NEOPLASM OF ANTERIOR MEDIASTINUM

164.3 MALIGNANT NEOPLASM OF POSTERIOR MEDIASTINUM

174.0 - 174.9 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 - 175.9 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

182.0 MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS

183.0 MALIGNANT NEOPLASM OF OVARY

183.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA

185 MALIGNANT NEOPLASM OF PROSTATE

188.0 - 188.8 MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BLADDER

189.1 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS

189.2 MALIGNANT NEOPLASM OF RENAL PELVIS

191.0 - 191.9 MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE

630 HYDATIDIFORM MOLE

USE FOR BILLING CPT CODES 88184, 88185, 88187, 88188, AND 88189

042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

79.51 HUMAN T-CELL LYMPHOTROPHIC VIRUS TYPE I [HTLV-I]

79.52 HUMAN T-CELL LYMPHOTROPHIC VIRUS TYPE II [HTLV-II]

79.53 HUMAN IMMUNODEFICIENCY VIRUS TYPE 2 [HIV-2]

099.3 REITER'S DISEASE

150.0 - 150.9 MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

151.0 - 151.9 MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

153.0 - 153.9 MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

154.1 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION

154.2 MALIGNANT NEOPLASM OF RECTUM

174.0 - 174.9 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 - 175.9 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

183.0 MALIGNANT NEOPLASM OF OVARY

183.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA

185 MALIGNANT NEOPLASM OF PROSTATE

188.0 - 188.9 MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED

193 MALIGNANT NEOPLASM OF THYROID GLAND

194.0 MALIGNANT NEOPLASM OF ADRENAL GLAND

197.2 SECONDARY MALIGNANT NEOPLASM OF PLEURA

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM 200.00 - 208.92 opens in

new window RETICULOSARCOMA UNSPECIFIED SITE - UNSPECIFIED LEUKEMIA, IN RELAPSE

227.0 BENIGN NEOPLASM OF ADRENAL GLAND

233.0 CARCINOMA IN SITU OF BREAST

238.71 - 238.79 ESSENTIAL THROMBOCYTHEMIA - OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES

259.2 CARCINOID SYNDROME

273.1 MONOCLONAL PARAPROTEINEMIA

273.2 OTHER PARAPROTEINEMIAS

273.3 MACROGLOBULINEMIA

273.8 OTHER DISORDERS OF PLASMA PROTEIN METABOLISM

273.9 UNSPECIFIED DISORDER OF PLASMA PROTEIN METABOLISM

279.00 - 279.9 HYPOGAMMAGLOBULINEMIA UNSPECIFIED - UNSPECIFIED DISORDER OF IMMUNE MECHANISM

282.1 HEREDITARY SPHEROCYTOSIS

282.2 HEREDITARY ELLIPTOCYTOSIS

282.5 SICKLE-CELL TRAIT

282.60 - 282.69 SICKLE-CELL DISEASE UNSPECIFIED - OTHER SICKLE-CELL DISEASE WITH CRISIS

282.7 OTHER HEMOGLOBINOPATHIES

283.2 HEMOGLOBINURIA DUE TO HEMOLYSIS FROM EXTERNAL CAUSES

284.01 - 284.9 CONSTITUTIONAL RED BLOOD CELL APLASIA - APLASTIC ANEMIA UNSPECIFIED

285.0 SIDEROBLASTIC ANEMIA

285.22 ANEMIA IN NEOPLASTIC DISEASE

285.8 OTHER SPECIFIED ANEMIAS

285.9 ANEMIA UNSPECIFIED

287.1 QUALITATIVE PLATELET DEFECTS

287.30 - 287.39 PRIMARY THROMBOCYTOPENIA,UNSPECIFIED - OTHER PRIMARY THROMBOCYTOPENIA

287.5 THROMBOCYTOPENIA UNSPECIFIED

288.00 - 288.09 NEUTROPENIA, UNSPECIFIED - OTHER NEUTROPENIA

288.1 FUNCTIONAL DISORDERS OF POLYMORPHONUCLEAR NEUTROPHILS

288.2 GENETIC ANOMALIES OF LEUKOCYTES

288.3 EOSINOPHILIA

288.4 HEMOPHAGOCYTIC SYNDROMES

288.50 - 288.59 LEUKOCYTOPENIA, UNSPECIFIED - OTHER DECREASED WHITE BLOOD CELL COUNT

288.60 LEUKOCYTOSIS, UNSPECIFIED

288.61 LYMPHOCYTOSIS (SYMPTOMATIC)

288.62 LEUKEMOID REACTION

288.63 MONOCYTOSIS (SYMPTOMATIC)

288.64 PLASMACYTOSIS

288.65 BASOPHILIA

288.69 OTHER ELEVATED WHITE BLOOD CELL COUNT

288.8 OTHER SPECIFIED DISEASE OF WHITE BLOOD CELLS

288.9 UNSPECIFIED DISEASE OF WHITE BLOOD CELLS

289.4 HYPERSPLENISM

289.50 - 289.59 DISEASE OF SPLEEN UNSPECIFIED - OTHER DISEASES OF SPLEEN

289.83* MYELOFIBROSIS

289.9 UNSPECIFIED DISEASES OF BLOOD AND BLOOD-FORMING ORGANS

364.3 UNSPECIFIED IRIDOCYCLITIS

452 PORTAL VEIN THROMBOSIS

453.9 EMBOLISM AND THROMBOSIS OF UNSPECIFIED SITE

555.0 - 555.9 REGIONAL ENTERITIS OF SMALL INTESTINE - REGIONAL ENTERITIS OF UNSPECIFIED SITE

556.1 ULCERATIVE (CHRONIC) ENTEROCOLITIS

556.2 ULCERATIVE (CHRONIC) ILEOCOLITIS

556.3 ULCERATIVE (CHRONIC) PROCTITIS

556.4 ULCERATIVE (CHRONIC) PROCTOSIGMOIDITIS

556.5 PSEUDOPOLYPOSIS OF COLON

556.6 LEFT-SIDED ULCERATIVE (CHRONIC) COLITIS

556.7 UNIVERSAL ULCERATIVE (CHRONIC) COLITIS

556.9 ULCERATIVE COLITIS UNSPECIFIED

630 HYDATIDIFORM MOLE

696.0 PSORIATIC ARTHROPATHY

714.30 CHRONIC OR UNSPECIFIED POLYARTICULAR JUVENILE RHEUMATOID ARTHRITIS

720.0 - 720.9 ANKYLOSING SPONDYLITIS - UNSPECIFIED INFLAMMATORY SPONDYLOPATHY

785.6 ENLARGEMENT OF LYMPH NODES

789.2 SPLENOMEGALY

789.30 - 789.39 ABDOMINAL OR PELVIC SWELLING MASS OR LUMP UNSPECIFIED SITE - ABDOMINAL OR PELVIC SWELLING MASS OR LUMP OTHER SPECIFIED SITE

791.0 PROTEINURIA

795.4 OTHER NONSPECIFIC ABNORMAL HISTOLOGICAL FINDINGS

996.80 - 996.89 COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN

V08 ASYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION STATUS

V10.60 - V10.69 PERSONAL HISTORY OF UNSPECIFIED LEUKEMIA - PERSONAL HISTORY OF OTHER LEUKEMIA

V42.0 - V42.9* KIDNEY REPLACED BY TRANSPLANT - UNSPECIFIED ORGAN OR TISSUE REPLACED BY TRANSPLANT

*According to the ICD-9-CM book, diagnosis codes V42.0-V42.9 and 289.83 are secondary codes and should not be billed as a primary diagnosis.

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

The medical record must include documentation of clinical and morphologic findings, cell counts (quantitative values), and radiology and cytogenetic findings when available.

The referring/ordering physician or pathologist must provide the most specific suspected diagnosis or differential diagnosis that will allow the performing laboratory to determine an appropriate panel of cell markers. This must be documented in the orders provided to the performing laboratory.

To justify markers in excess of twenty-four (24), the final FCM report must contain the following supporting documentation:

• Clinical information summary

• Specific marker results

• Diagnosis and interpretation

• Rationale to support each marker in excess of twenty-four (24)

Documentation should support that the results of FCM will be utilized in the management of the patient’s condition.

Appendices

Utilization Guidelines

Routine use of flow cytometry absent of clinical indication for its use will be considered screening and will not be allowed.

For flow cytometry, cell cycle or DNA analysis, it is not expected that more than one unit total (given day or an episode of care) would be done for a patient with a covered indication. Therefore, utilization would be one time for a beneficiary with a given diagnosis (unless the patient had new disease) and generally should be performed before treatment is initiated.

It is not expected that more than twenty-four (24) markers (cell surface, cytoplasmic, or nuclear) will be required. When more than twenty-four (24) markers are performed, documentation should support the medical necessity of the excess markers.

Sources of Information and Basis for Decision

Basiji, D.A, Ortyn, W.E. et al (2007) Cellular image analysis and imaging by flow cytometry. Clinics in laboratory medicine (27) pp 653-670. Retrieved from http://www.labmed.theclinics.com/

Borowitz, M.J. (2008) Flow cytometry in oncologic diagnosis . In Abeloff’s Clinical Oncology, 4th ed. Chapter 17. Retrieved from MD Consult May 5, 2010.

B cells and T cells (2010, February 28). Retrieved May 5, 2010 from http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/

LCD for flow cytometry (L17742) Palmetto GBA

LCD for flow cytometry (L30161) Wisconsin Physicians Service insurance corporation Draft LCD for flow cytometry (DL30692) Palmetto GBA

Rahman, M: Introduction to flow cytometry. (May 24, 2006). Retrieved April 22, 2010 from ABD serotec website,

,http://www.bath.ac.uk/ceos/bioimaging/documents/

Tung, J.W., Heydari, K., Tirouvanziam, R., et al. (2007) Modern flow cytometry: a practical approach. Clinics in laboratory medicine. (27) pp453-468. Retrieved from http://www.labmed.theclinics.com/

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Florida Contractor Advisory Committee meeting held on June 12, 2010.

Puerto Rico and U.S.Virgin Islands Contractor Advisory Committee meeting held on June 17, 2010.

Start Date of Comment Period 05/28/2010

End Date of Comment Period 07/11/2010

Start Date of Notice Period 08/16/2010

Revision History Number Original

Revision History Explanation Revision Number Original Start Date of Comment Period:05/28/2010

Start Date of Notice Period:08/16/2010 Original Effective Date 09/30/2010

LCR B2010-066

August 2010 Update

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: 88184 descriptor was changed in Group 1 88185 descriptor was changed in Group 1 88187 descriptor was changed in Group 1 88188 descriptor was changed in Group 1 88189 descriptor was changed in Group 1

Reason for Change