Medicare National and Local Coverage Determination Policy IN

Medicare National and Local Coverage Determination Policy – IN Policies in this MLCP Reference Guide apply to testing performed at a Quest Diagnostics...
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Medicare National and Local Coverage Determination Policy – IN Policies in this MLCP Reference Guide apply to testing performed at a Quest Diagnostics facility and apply to Medicare National Coverage Determination Policy. This diagnosis code reference guide is provided as an aid to physicians and office staff in determining when an ABN (Advance Beneficiary Notice) is necessary. Diagnosis codes must be applicable to the patient’s symptoms or conditions and must be consistent with documentation in the patient’s medical record. Quest Diagnostics does not recommend any diagnosis codes and will only submit diagnosis information provided to us by the ordering physician or his/her designated staff. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Please note this document has been updated with National Medicare changes effective 7/1/2015 • Click here for National MLCP Policies Tool Document contains information on National Medicare Limited Coverage Policies • • • • • • • • • • • • • • • • • • • • • • •

Alpha-Fetoprotein Blood Counts Blood Glucose Testing Carcinoembryonic Antigen Collagen Crosslinks - Any Method Digoxin Therapeutic Drug Assay Fecal Occult Blood Gamma Glutamyl Transferase Glycated Hemoglobin - Glycated Protein Hepatitis Panel/Acute Hepatitis Panel Human Chorionic Gonadotropin Human Immunodeficiency Virus (HIV) Testing (Diagnosis) Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring) Lipids Testing Partial Thromboplastin Time (PTT) Prostate Specific Antigen Prothrombin Time (PT) Serum Iron Studies Thyroid Testing Tumor Antigen by Immunoassay CA 15-3 CA 27.29 Tumor Antigen by Immunoassay CA 19-9 Tumor Antigen by Immunoassay CA-125 Urine Culture, Bacterial

• Click policy below for Local MLCP Policy Tool Document contains the below Medicare Local Limited Coverage Policies for lab testing performed in Indiana. •Allergy Testing and Immunotherapy •Circulating Tumor Cell Marker Assays •Cytogenetic Studies •Drug Testing •Flow Cytometry •Molecular Diagnostic Testing •Vitamin D Assay Testing

QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated:

09/08/2015

Medicare Local Coverage Determination Policy (IN) Data Source: http://www.wpsmedicare.com

Data Source: www.cms.gov

Allergy Testing and Allergy Immunotherapy (L30471) Page 1 of 2 Testing performed by Quest Diagnostics Nichols Institute CPT Code: 86003 LCD Description: These tests include the performance and evaluation of selective cutaneous and mucous membrane tests in correlation with history, physical examination, and other observations of the patient. The tests are performed to determine body sensitivity and reaction to the antigen for the purpose of diagnosing the presence of allergic reaction to antigenic stimuli. The number of tests performed should be judicious and dependent upon the history, physical finding and clinical judgment. All patients should not necessarily receive the same tests or the same number of sensitivity tests. Intradermal tests are injections of small amounts of antigen into the superficial layers of the skin. ICD-9-CM Codes that Support Medical Necessity Allergy testing is determined to be medically necessary by Medicare only when it is ordered for patients with one of the conditions listed below. ICD-9-CM codes that support medical necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. 117.3 ASPERGILLOSIS 372.05 ACUTE ATOPIC CONJUNCTIVITIS 372.14 OTHER CHRONIC ALLERGIC CONJUNCTIVITIS 381.10 CHRONIC SEROUS OTITIS MEDIA SIMPLE OR UNSPECIFIED 381.19 OTHER CHRONIC SEROUS OTITIS MEDIA 381.3 OTHER AND UNSPECIFIED CHRONIC NONSUPPURATIVE OTITIS MEDIA 381.4 NONSUPPURATIVE OTITIS MEDIA NOT SPECIFIED AS ACUTE OR CHRONIC 381.50 - 381.52 EUSTACHIAN SALPINGITIS UNSPECIFIED - CHRONIC EUSTACHIAN SALPINGITIS 381.81 DYSFUNCTION OF EUSTACHIAN TUBE 382.9 UNSPECIFIED OTITIS MEDIA 466.0 ACUTE BRONCHITIS 471.0 POLYP OF NASAL CAVITY 471.8 OTHER POLYP OF SINUS 472.0 CHRONIC RHINITIS 474.00 - 474.02 CHRONIC TONSILLITIS - CHRONIC TONSILLITIS AND ADENOIDITIS 474.10 - 474.12 HYPERTROPHY OF TONSIL WITH ADENOIDS - HYPERTROPHY OF ADENOIDS ALONE 477.0 ALLERGIC RHINITIS DUE TO POLLEN 477.1 ALLERGIC RHINITIS DUE TO FOOD 477.2 ALLERGIC RHINITIS, DUE TO ANIMAL (CAT) (DOG) HAIR AND DANDER 477.8 ALLERGIC RHINITIS DUE TO OTHER ALLERGEN 477.9 ALLERGIC RHINITIS CAUSE UNSPECIFIED 478.11 NASAL MUCOSITIS (ULCERATIVE) 478.19 OTHER DISEASE OF NASAL CAVITY AND SINUSES 493.00 EXTRINSIC ASTHMA UNSPECIFIED 493.01 EXTRINSIC ASTHMA WITH STATUS ASTHMATICUS 493.02 EXTRINSIC ASTHMA WITH (ACUTE) EXACERBATION 493.10 INTRINSIC ASTHMA UNSPECIFIED 493.11 INTRINSIC ASTHMA WITH STATUS ASTHMATICUS 493.12 NTRINSIC ASTHMA WITH (ACUTE) EXACERBATION 493.20 CHRONIC OBSTRUCTIVE ASTHMA UNSPECIFIED QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2015 Quest Diagnostics Incorporated. All rights reserved

Last Updated:

09/08/15

Medicare Local Coverage Determination Policy (IN) Data Source: http://www.wpsmedicare.com

Data Source: www.cms.gov

Allergy Testing and Allergy Immunotherapy (L30471) Page 2 of 2 Testing performed by Quest Diagnostics Nichols Institute CPT Code: 86003 LCD Description: These tests include the performance and evaluation of selective cutaneous and mucous membrane tests in correlation with history, physical examination, and other observations of the patient. The tests are performed to determine body sensitivity and reaction to the antigen for the purpose of diagnosing the presence of allergic reaction to antigenic stimuli. The number of tests performed should be judicious and dependent upon the history, physical finding and clinical judgment. All patients should not necessarily receive the same tests or the same number of sensitivity tests. Intradermal tests are injections of small amounts of antigen into the superficial layers of the skin. ICD-9-CM Codes that Support Medical Necessity Allergy testing is determined to be medically necessary by Medicare only when it is ordered for patients with one of the conditions listed below. ICD-9-CM codes that support medical necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. 493.21 CHRONIC OBSTRUCTIVE ASTHMA WITH STATUS ASTHMATICUS 493.22 CHRONIC OBSTRUCTIVE ASTHMA WITH (ACUTE) EXACERBATION 493.82 COUGH VARIANT ASTHMA 493.90 ASTHMA UNSPECIFIED 493.91 ASTHMA UNSPECIFIED TYPE WITH STATUS ASTHMATICUS 493.92 ASTHMA UNSPECIFIED WITH (ACUTE) EXACERBATION 518.6 ALLERGIC BRONCHOPULMONARY ASPERGILLIOSIS 691.8 OTHER ATOPIC DERMATITIS AND RELATED CONDITIONS 692.9 CONTACT DERMATITIS AND OTHER ECZEMA UNSPECIFIED CAUSE 693.0 DERMATITIS DUE TO DRUGS AND MEDICINES TAKEN INTERNALLY 693.1 DERMATITIS DUE TO FOOD TAKEN INTERNALLY 693.8 DERMATITIS DUE TO OTHER SPECIFIED SUBSTANCES TAKEN INTERNALLY 693.9 DERMATITIS DUE TO UNSPECIFIED SUBSTANCE TAKEN INTERNALLY 708.0 ALLERGIC URTICARIA 708.3 DERMATOGRAPHIC URTICARIA 708.8 OTHER SPECIFIED URTICARIA 708.9 UNSPECIFIED URTICARIA 781.1 DISTURBANCES OF SENSATION OF SMELL AND TASTE 782.1 RASH AND OTHER NONSPECIFIC SKIN ERUPTION 786.07 WHEEZING 989.5 TOXIC EFFECT OF VENOM 989.82 TOXIC EFFECT OF LATEX 995.0 OTHER ANAPHYLACTIC REACTION 995.1 ANGIONEUROTIC EDEMA NOT ELSEWHERE CLASSIFIED 995.27 OTHER DRUG ALLERGY 995.3 ALLERGY UNSPECIFIED NOT ELSEWHERE CLASSIFIED 995.60 - 995.69 ANAPHYLACTIC REACTION DUE TO UNSPECIFIED FOOD - ANAPHYLACTIC REACTION DUE TO OTHER SPECIFIED FOOD 995.7 OTHER ADVERSE FOOD REACTIONS NOT ELSEWHERE CLASSIFIED V15.09 PERSONAL HISTORY OF OTHER ALLERGY OTHER THAN TO MEDICINAL AGENTS V67.59 OTHER FOLLOW-UP EXAMINATION QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2011 Quest Diagnostics Incorporated. All rights reserved

Last Updated:

09/08/15

Medicare Local Coverage Determination Policy (IN) Circulating Tumor Cell Marker Assays (L32218)

Data Source: www.cms.com

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 86152, 86153 LCD Description: This is a coverage policy for the CellSearch (Veridex) circulating tumor cell (CTC) assay. All other methods for circulating tumor cell detection, including PCR (RTPCR) Assays, are non-covered. CTCs represent the point in the metastatic process of solid tumors when cells from a primary tumor invade, detach, disseminate, colonize and proliferate in a distant site. Detection of elevated CTCs during therapy is an accurate indication of subsequent rapid disease progression and mortality in breast, colorectal and prostate cancer. Therefore, CTC will be limited to metastatic breast, colorectal and prostate cancer. CTC testing for all other malignant diagnoses will be denied as not reasonable and necessary. The CellSearch assay, an independent predictor of progression-free survival and overall survival in patients with metastatic breast, colorectal and prostate cancer, involves the automated immunomagnetic selection of CTCs based on an anti-EpCAM antibody cell capture. To perform this assay, a 7.5 ml aliquot of blood is incubated with EpCAM antibody-covered ferroparticles (nanotechnology). Circulating epithelial cells that express EpCAM are isolated in a magnetic field without centrifugation. The supernatant containing unbound cells is removed. The enriched cell samples are labeled with a fluorescent nuclei acid dye and two monoclonal antibodies (CD 45 and Cytokeratin 8, 18, 19), each tagged with distinct fluorescent compounds. The stained cells are then analyzed on a fluorescence microscope. Digital fluorescent images are interpreted by a technician as CTCs if the cell has a nucleus, expresses keratin (EpCAM and CK) and does not express CD45. The assay is reported as a numerical result where more than 5 cells per 7.5 ml of whole blood predicts worse prognosis in patients with known recurrent breast and prostate cancer, and more than 3 cells are predictive of shorter progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer.

153.0 - 153.9 154.0 - 154.8 174.0 - 174.9 175.0 - 175.9 185

malignant neoplasm of hepatic flexure - malignant neoplasm of colon unspecified site malignant neoplasm of rectosigmoid junction - malignant neoplasm of other sites of rectum rectosigmoid junction and anus malignant neoplasm of nipple and areola of female breast - malignant neoplasm of breast (female) unspecified site malignant neoplasm of nipple and areola of male breast - malignant neoplasm of other and unspecified sites of male breast malignant neoplasm of prostate

QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Cytogenetic Studies (L30487) Testing performed by Quest Diagnostics Nichols Institute

Data Source: www.cms.gov

CPT Codes 88230, 88233, 88235, 88237, 88239, 88240, 88241, 88245, 88248, 88249, 88261, 88262, 88263, 88264, 88267, 88269, 88271, 88272, 88273, 88274, 88275, 88280, 88283, 88285, 88289, 88291, 88299 LCD Description:. Cytogenetics is the study of chromosomes by light or fluorescent microscopy. Cytogenetic testing is used to study an individual s chromosome makeup. The term karyotyping refers to the arrangement of nuclear chromosomes in order from the largest to the smallest to analyze their number and structure. Variations in chromosome number or structure can produce a variety of clinical findings, including abnormalities of growth and intellect, congenital anomalies and, in the case of sex chromosome abnormalities ambiguous gender. Cytogenetic testing determines the number of chromosomes, defines the chromosome and examines the individual chromosomes for structural abnormalities such as deletions, duplications and translocations. ICD – 9-CM Codes that Support Medical Necessity Cytogenetic Analysis is determined to be medically necessary by Medicare only when it is ordered for patients with one of the conditions listed below. ICD-9-CM codes that support medical necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. Constitutional Cytogenetic Studies 88230, 88235, 88262, 88267, 88269, 88283, 88289 228.1 256.39 257.8 259.0 289.81 289.83 299.00-299.11 317-319 334.8 388.5 606.0 606.1 611.1 628.9 630-631.8 632 634.00-634.92 646.33 653.70

653.71 653.73 655.10-655.13 655.20-655.23 656.40 656.41 656.43 656.50 656.51 656.53 656.60 656.61 656.63 657.00-657.03 658.00-658.03 659.50-659.63 740.0-759.9 764.90-764.99 779.9

783.40 783.41 783.42 783.43 792.3 796.5 V13.61-V13.69 V18.4 V18.51 V18.61 V18.9 V19.5 V23.2 V23.81-V23.82 V28.0-V28.4 V83.01 V83.02 V83.81 V83.89

Acquired (cancer) chromosome studies 88230, 88237, 88239, 88262, 88271, 88272, 88273, 88274, 88275, 88283 143.9 152.1-152.8 158.0 162.0-165.9 170.0-170.9 171.0-171.9 173.00-173.99 173.9 174.0-174.9 175.0-175.9 188.0-188.9 189.0-189.9 190.1 191.0-191.9 192.3 197.0-197.8 198.0-198.89

200.00-202.98 203.00-203.02 203.10-203.12 203.80-203.82 204.00-204.02 204.10-204.12 204.20-204.22 204.80-204.82 204.90-204.92 205.00-205.92 206.00-206.92 207.00-207.82 208.00-208.02 208.10-208.12 208.20-208.22 208.80-208.82 208.90-208.92

209.00-209.69 223.3 225.2 230.0 231.0 232.9 233.0 233.30-233.39 233.7 233.9 234.0 236.7 238.4 238.5 238.6 238.71-238.79 239.2

239.3 239.4 273.1 273.3 281.0-281.9 284.01-284.09 284.19 284.2-284.9 285.0-285.9 287.30-287.39 287.5 288.09 288.50-288.59 288.60-288.69 289.89

Syndromes that predispose to malignancy 88230, 88245, 88248, 88249, 88283 284.01 284.09 334.8 757.39 759.89

QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Drug Testing (L32450) Testing performed by Quest Diagnostics Nichols Institute

Data Source: www.cms.gov

CPT Codes 80102, G0431, G0434 LCD Description: A qualitative drug screen is used to detect the presence of a drug in the body. A blood or urine sample may be used. However, urine is the best specimen for broad qualitative screening, as blood is relatively insensitive for many common drugs, including psychotropic agents, opioids, and stimulants. Common methods of drug analysis include chromatography, immunoassay, chemical ("spot") tests, and spectrometry. ICD-9-CM Codes that Support Medical Necessity: Qualitative Drug Testing is determined to be medically necessary by Medicare only when it is ordered for patients with one of the conditions listed below. ICD-9-CM codes that support medical necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. CPT Codes: G0431, G0434, G6058 276.2 ACIDOSIS 295.00 - 295.30 SIMPLE TYPE SCHIZOPHRENIA UNSPECIFIED STATE - PARANOID TYPE SCHIZOPHRENIA UNSPECIFIED STATE 304.01 OPIOID TYPE DEPENDENCE CONTINUOUS USE 304.90 UNSPECIFIED DRUG DEPENDENCE UNSPECIFIED USE 305.90 OTHER MIXED OR UNSPECIFIED DRUG ABUSE UNSPECIFIED USE 345.10 - 345.11 GENERALIZED CONVULSIVE EPILEPSY WITHOUT INTRACTABLE EPILEPSY - GENERALIZED CONVULSIVE EPILEPSY WITH INTRACTABLE EPILEPSY 345.3 GRAND MAL STATUS EPILEPTIC 345.90 - 345.91 EPILEPSY UNSPECIFIED WITHOUT INTRACTABLE EPILEPSY - EPILEPSY UNSPECIFIED WITH INTRACTABLE EPILEPSY 426.10 - 426.13 ATRIOVENTRICULAR BLOCK UNSPECIFIED - OTHER SECOND DEGREE ATRIOVENTRICULAR BLOCK 426.82 LONG QT SYNDROME 427.0 - 427.1 PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA - PAROXYSMAL VENTRICULAR TACHYCARDIA 780.01 COMA 780.09 ALTERATION OF CONSCIOUSNESS OTHER 780.1 HALLUCINATIONS 780.39 OTHER CONVULSIONS 780.97 ALTERED MENTAL STATUS 963.0 POISONING BY ANTIALLERGIC AND ANTIEMETIC DRUGS 965.00 - 965.09 POISONING BY OPIUM (ALKALOIDS) UNSPECIFIED - POISONING BY OTHER OPIATES AND RELATED NARCOTICS 965.1 POISONING BY SALICYLATES 965.4 POISONING BY AROMATIC ANALGESICS NOT ELSEWHERE CLASSIFIED 965.5 POISONING BY PYRAZOLE DERIVATIVES 965.61 POISONING BY PROPIONIC ACID DERIVATIVES 966.1 POISONING BY HYDANTOIN DERIVATIVES 967.0 - 967.9 POISONING BY BARBITURATES - POISONING BY UNSPECIFIED SEDATIVE OR HYPNOTIC 969.00 - 969.9 POISONING BY ANTIDEPRESSANT, UNSPECIFIED - POISONING BY UNSPECIFIED PSYCHOTROPIC AGENT 970.81 POISONING BY COCAINE 972.1 POISONING BY CARDIOTONIC GLYCOSIDES AND DRUGS OF SIMILAR ACTION 977.9 POISONING BY UNSPECIFIED DRUG OR MEDICINAL SUBSTANCE V15.81 PERSONAL HISTORY OF NONCOMPLIANCE WITH MEDICAL TREATMENT PRESENTING HAZARDS TO HEALTH V58.69 LONG-TERM (CURRENT) USE OF OTHER MEDICATIONS V71.09 OBSERVATION OF OTHER SUSPECTED MENTAL CONDITION ********The following CPT codes are Non-Covered by Medicare 80300, 80301, 80302, 80303, 80304 ****** QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Data Source: www.cms.gov

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 1 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE 079.51 - 079.53 HUMAN T-CELL LYMPHOTROPHIC VIRUS TYPE I [HTLV-I] - HUMAN IMMUNODEFICIENCY VIRUS TYPE 2 [HIV-2] 099.3 REITER'S DISEASE 150.0 - 150.5 MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS MALIGNANT NEOPLASM OF LOWER THIRD OF ESOPHAGUS 150.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED PART OF ESOPHAGUS 150.9 MALIGNANT NEOPLASM OF ESOPHAGUS UNSPEC SITE 151.0 - 151.6 MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF GREATER CURVATURE OF STOMACH UNSPECIFIED 151.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF STOMACH 151.9 MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

152.0 152.1 152.2 152.8 152.9 153.0 - 153.9 154.0 154.1 154.2 154.3 154.8

MALIGNANT NEOPLASM OF DUODENUM MALIGNANT NEOPLASM OF JEJUNUM MALIGNANT NEOPLASM OF ILEUM MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SMALL INTESTINE MALIGNANT NEOPLASM OF SMALL INTESTINE UNSPECIFIED SITE MALIGNANT NEOPLASM OF HEPATIC FLEXURE MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION MALIGNANT NEOPLASM OF RECTUM MALIGNANT NEOPLASM OF ANAL CANAL MALIGNANT NEOPLASM OF ANUS UNSPECIFIED SITE MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated:

05/06/15

Data Source: www.cms.gov

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 2 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 155.0 155.2 156.0 156.1 156.2 157.0 157.1 157.2 157.8 157.9 158.0 158.8 158.9

MALIGNANT NEOPLASM OF LIVER PRIMARY MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY MALIGNANT NEOPLASM OF GALLBLADDER MALIGNANT NEOPLASM OF EXTRAHEPATIC BILE DUCTS MALIGNANT NEOPLASM OF AMPULLA OF VATER MALIGNANT NEOPLASM OF HEAD OF PANCREAS MALIGNANT NEOPLASM OF BODY OF PANCREAS MALIGNANT NEOPLASM OF TAIL OF PANCREAS MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF PANCREAS MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED MALIGNANT NEOPLASM OF RETROPERITONEUM MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

159.0 159.1 159.8 159.9 160.0 160.1 160.2 160.3 160.4 160.5 160.8

MALIGNANT NEOPLASM OF INTESTINAL TRACT PART UNSPECIFIED MALIGNANT NEOPLASM OF SPLEEN NOT ELSEWHERE CLASSIFIED MALIGNANT NEOPLASM OF OTHER SITES OF DIGESTIVE SYSTEM AND INTRA-ABDOMINAL ORGANS MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE DIGESTIVE ORGANS AND PERITONEUM MALIGNANT NEOPLASM OF NASAL CAVITIES MALIGNANT NEOPLASM OF AUDITORY TUBE MIDDLE EAR AND MASTOID AIR CELLS MALIGNANT NEOPLASM OF MAXILLARY SINUS MALIGNANT NEOPLASM OF ETHMOIDAL SINUS MALIGNANT NEOPLASM OF FRONTAL SINUS MALIGNANT NEOPLASM OF SPHENOIDAL SINUS MALIGNANT NEOPLASM OF OTHER ACCESSORY SINUSES

QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated:

05/06/15

Data Source: www.cms.gov

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 3 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 160.9 161.0 161.1 161.2 161.3 161.8 161.9 162.0 162.2 162.3 162.4 162.5 162.8

MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED MALIGNANT NEOPLASM OF GLOTTIS MALIGNANT NEOPLASM OF SUPRAGLOTTIS MALIGNANT NEOPLASM OF SUBGLOTTIS MALIGNANT NEOPLASM OF LARYNGEAL CARTILAGES MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARYNX MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED MALIGNANT NEOPLASM OF TRACHEA MALIGNANT NEOPLASM OF MAIN BRONCHUS MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG

162.9 163.0 163.1 163.8 163.9 164.0 164.2 164.3 164.8 164.9 165.0

MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED MALIGNANT NEOPLASM OF PARIETAL PLEURA MALIGNANT NEOPLASM OF VISCERAL PLEURA MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF PLEURA MALIGNANT NEOPLASM OF PLEURA UNSPECIFIED MALIGNANT NEOPLASM OF THYMUS MALIGNANT NEOPLASM OF ANTERIOR MEDIASTINUM MALIGNANT NEOPLASM OF POSTERIOR MEDIASTINUM MALIGNANT NEOPLASM OF OTHER PARTS OF MEDIASTINUM MALIGNANT NEOPLASM OF MEDIASTINUM PART UNSPECIFIED MALIGNANT NEOPLASM OF UPPER RESPIRATORY TRACT PART UNSPECIFIED

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Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 4 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 165.8 165.9 170.0 170.2 170.3 170.4 170.5 170.6

MALIGNANT NEOPLASM OF OTHER SITES WITHIN THE RESPIRATORY SYSTEM AND INTRATHORACIC ORGANS MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE RESPIRATORY SYSTEM MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE MALIGNANT NEOPLASM OF VERTEBRAL COLUMN EXCLUDING SACRUM AND COCCYX MALIGNANT NEOPLASM OF RIBS STERNUM AND CLAVICLE MALIGNANT NEOPLASM OF SCAPULA AND LONG BONES OF UPPER LIMB MALIGNANT NEOPLASM OF SHORT BONES OF UPPER LIMB MALIGNANT NEOPLASM OF PELVIC BONES SACRUM AND COCCYX

170.7 170.8 170.9 171.0 171.2 171.3 171.4 171.5

MALIGNANT NEOPLASM OF LONG BONES OF LOWER LIMB MALIGNANT NEOPLASM OF SHORT BONES OF LOWER LIMB MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF UPPER LIMB INCLUDING SHOULDER MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF LOWER LIMB INCLUDING HIP MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF THORAX MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF ABDOMEN

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Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 5 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 171.6 171.7 171.8 171.9 173.00 173.01 173.02 173.09 173.10

MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF PELVIS MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF TRUNK UNSPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CONNECTIVE AND OTHER SOFT TISSUE MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP BASAL CELL CARCINOMA OF SKIN OF LIP SQUAMOUS CELL CARCINOMA OF SKIN OF LIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP UNSPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS

173.11 173.12 173.19 173.20 173.21 173.22 173.29 173.30

BASAL CELL CARCINOMA OF EYELID, INCLUDING CANTHUS SQUAMOUS CELL CARCINOMA OF EYELID, INCLUDING CANTHUS OTHER SPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL BASAL CELL CARCINOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL SQUAMOUS CELL CARCINOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

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Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 6 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 173.31 173.32 173.39 173.40 173.41 173.42 173.49 173.50

BASAL CELL CARCINOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE SQUAMOUS CELL CARCINOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE UNSPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK BASAL CELL CARCINOMA OF SCALP AND SKIN OF NECK SQUAMOUS CELL CARCINOMA OF SCALP AND SKIN OF NECK OTHER SPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF TRUNK, EXCEPT SCROTUM

173.51 173.52 173.59 173.60 173.61 173.62 173.69 173.70

BASAL CELL CARCINOMA OF SKIN OF TRUNK, EXCEPT SCROTUM SQUAMOUS CELL CARCINOMA OF SKIN OF TRUNK, EXCEPT SCROTUM OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF TRUNK, EXCEPT SCROTUM UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF UPPER LIMB, INCLUDING SHOULDER BASAL CELL CARCINOMA OF SKIN OF UPPER LIMB, I NCLUDING SHOULDER SQUAMOUS CELL CARCINOMA OF SKIN OF UPPER LIMB, INCLUDING SHOULDER OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF UPPER LIMB, INCLUDING SHOULDER UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LOWER LIMB, INCLUDING HIP

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Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 7 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 173.71 173.72 173.79 173.80 173.81 173.82 173.89 173.90

BASAL CELL CARCINOMA OF SKIN OF LOWER LIMB, INCLUDING HIP SQUAMOUS CELL CARCINOMA OF SKIN OF LOWER LIMB, INCLUDING HIP OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LOWER LIMB, INCLUDING HIP UNSPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SKIN BASAL CELL CARCINOMA OF OTHER SPECIFIED SITES OF SKIN SQUAMOUS CELL CARCINOMA OF OTHER SPECIFIED SITES OF SKIN OTHER SPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SKIN UNSPECIFIED MALIGNANT NEOPLASM OF SKIN, SITE UNSPECIFIED

173.91 173.92 173.99 174.0 - 174.6

174.8 174.9 175.0 175.9

BASAL CELL CARCINOMA OF SKIN, SITE UNSPECIFIED SQUAMOUS CELL CARCINOMA OF SKIN, SITE UNSPECIFIED OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN, SITE UNSPECIFIED MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

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Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 8 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 176.0 176.1 176.2 176.3 176.4 176.5 176.8 176.9 179 180.0 180.1 180.8 180.9 181

KAPOSI'S SARCOMA SKIN KAPOSI'S SARCOMA SOFT TISSUE KAPOSI'S SARCOMA PALATE KAPOSI'S SARCOMA GASTROINTESTINAL SITES KAPOSI'S SARCOMA LUNG KAPOSI'S SARCOMA LYMPH NODES KAPOSI'S SARCOMA OTHER SPECIFIED SITES KAPOSI'S SARCOMA UNSPECIFIED SITE MALIGNANT NEOPLASM OF UTERUS-PART UNS MALIGNANT NEOPLASM OF ENDOCERVIX MALIGNANT NEOPLASM OF EXOCERVIX MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CERVIX MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE MALIGNANT NEOPLASM OF PLACENTA

182.0 182.1 182.8 183.0 183.8 184.0 184.1 184.2 184.3 184.4 184.8

MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS MALIGNANT NEOPLASM OF ISTHMUS MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BODY OF UTERUS MALIGNANT NEOPLASM OF OVARY MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA MALIGNANT NEOPLASM OF VAGINA MALIGNANT NEOPLASM OF LABIA MAJORA MALIGNANT NEOPLASM OF LABIA MINORA MALIGNANT NEOPLASM OF CLITORIS MALIGNANT NEOPLASM OF VULVA UNSPECIFIED SITE MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE GENITAL ORGANS

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Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 9 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 184.9 185 186.0 186.9 187.1 187.2 187.3 187.4 187.5 187.6 187.7 187.8

MALIGNANT NEOPLASM OF FEMALE GENITAL ORGAN SITE UNSPECIFIED MALIGNANT NEOPLASM OF PROSTATE MALIGNANT NEOPLASM OF UNDESCENDED TESTIS MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED TESTIS MALIGNANT NEOPLASM OF PREPUCE MALIGNANT NEOPLASM OF GLANS PENIS MALIGNANT NEOPLASM OF BODY OF PENIS MALIGNANT NEOPLASM OF PENIS PART UNSPECIFIED MALIGNANT NEOPLASM OF EPIDIDYMIS MALIGNANT NEOPLASM OF SPERMATIC CORD MALIGNANT NEOPLASM OF SCROTUM MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF MALE GENITAL ORGANS

187.9 188.0 - 188.9

189.0 189.1 189.2 189.3 189.4 189.8 189.9

MALIGNANT NEOPLASM OF MALE GENITAL ORGAN SITE UNSPECIFIED MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS MALIGNANT NEOPLASM OF RENAL PELVIS MALIGNANT NEOPLASM OF URETER MALIGNANT NEOPLASM OF URETHRA MALIGNANT NEOPLASM OF PARAURETHRAL GLANDS MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF URINARY ORGANS MALIGNANT NEOPLASM OF URINARY ORGAN SITE UNSPECIFIED

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Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 10 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 190.0 - 190.9

191.0 - 191.9

192.0 192.1 192.2 192.3 192.8 192.9 193 194.0

MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA RETINA AND CHOROID MALIGNANT NEOPLASM OF EYE PART UNSPECIFIED MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE MALIGNANT NEOPLASM OF CRANIAL NERVES MALIGNANT NEOPLASM OF CEREBRAL MENINGES MALIGNANT NEOPLASM OF SPINAL CORD MALIGNANT NEOPLASM OF SPINAL MENINGES MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS SYSTEM MALIGNANT NEOPLASM OF NERVOUS SYSTEM PART UNSPECIFIED MALIGNANT NEOPLASM OF THYROID GLAND MALIGNANT NEOPLASM OF ADRENAL GLAND

194.1 194.3 194.4 194.5 194.6 194.8 194.9 195.0 - 195.5 195.8 196.0

MALIGNANT NEOPLASM OF PARATHYROID GLAND MALIGNANT NEOPLASM OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT MALIGNANT NEOPLASM OF PINEAL GLAND MALIGNANT NEOPLASM OF CAROTID BODY MALIGNANT NEOPLASM OF AORTIC BODY AND OTHER PARAGANGLIA MALIGNANT NEOPLASM OF OTHER ENDOCRINE GLANDS AND RELATED STRUCTURES MALIGNANT NEOPLASM OF ENDOCRINE GLAND SITE UNSPECIFIED MALIGNANT NEOPLASM OF HEAD FACE AND NECK MALIGNANT NEOPLASM OF LOWER LIMB MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF HEAD FACE AND NECK

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Data Source: www.cms.gov

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 11 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 196.1 196.2 196.3 196.5

196.6 196.8 196.9 197.0

SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF INTRATHORACIC LYMPH NODES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF INTRA-ABDOMINAL LYMPH NODES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF AXILLA AND UPPER LIMB SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF INGUINAL REGION AND LOWER LIMB SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF INTRAPELVIC LYMPH NODES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF MULTIPLE SITES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES SITE UNSPECIFIED SECONDARY MALIGNANT NEOPLASM OF LUNG

197.1 197.2 197.3 197.4 197.5 197.6 198.0 - 198.7

198.81 198.82

SECONDARY MALIGNANT NEOPLASM OF MEDIASTINUM SECONDARY MALIGNANT NEOPLASM OF PLEURA SECONDARY MALIGNANT NEOPLASM OF OTHER RESPIRATORY ORGANS SECONDARY MALIGNANT NEOPLASM OF SMALL INTESTINE INCLUDING DUODENUM SECONDARY MALIGNANT NEOPLASM OF LARGE INTESTINE AND RECTUM SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM SECONDARY MALIGNANT NEOPLASM OF KIDNEY SECONDARY MALIGNANT NEOPLASM OF ADRENAL GLAND SECONDARY MALIGNANT NEOPLASM OF BREAST SECONDARY MALIGNANT NEOPLASM OF GENITAL ORGANS

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05/06/15

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 12 of 22)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 198.89 199.0 199.1 200.00 - 200.08

200.10 - 200.18

200.20 - 200.28

200.30 - 200.38

SECONDARY MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES DISSEMINATED MALIGNANT NEOPLASM OTHER MALIGNANT NEOPLASM OF UNSPECIFIED SITE RETICULOSARCOMA UNSPECIFIED SITE RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES LYMPHOSARCOMA UNSPECIFIED SITE LYMPHOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES BURKITT'S TUMOR OR LYMPHOMA UNSPECIFIED SITE BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES MARGINAL ZONE LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - MARGINAL ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

200.40 - 200.48 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES 200.50 - 200.58 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF MULTIPLE SITES 200.60 - 200.68 ANAPLASTIC LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES 200.70 - 200.78 LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

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05/06/15

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 13 of 22)

Data Source: www.cms.gov

TestINg performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 200.80 - 200.88 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 201.00 - 201.08 HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 201.10 - 201.18 HODGKIN'S GRANULOMA UNSPECIFIED SITE - HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 201.20 - 201.28 HODGKIN'S SARCOMA UNSPECIFIED SITE - HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

201.40 - 201.48 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF MULTIPLE SITES 201.50 - 201.58 HODGKIN'S DISEASE NODULAR SCLEROSIS UNSPECIFIED SITE - HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF MULTIPLE SITES 201.60 - 201.68 HODGKIN'S DISEASE MIXED CELLULARITY UNSPECIFIED SITE - HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF MULTIPLE SITES 201.70 - 201.78 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH NODES OF MULTIPLE SITES

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Last Updated:

05/06/15

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 14 of 22)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 201.90 - 201.98 HODGKIN'S DISEASE UNSPECIFIED TYPE UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES 202.00 - 202.08 NODULAR LYMPHOMA UNSPECIFIED SITE - NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 202.10 - 202.18 MYCOSIS FUNGOIDES UNSPECIFIED SITE - MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES 202.20 - 202.28 SEZARY'S DISEASE UNSPECIFIED SITE - SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES 202.30 - 202.38 MALIGNANT HISTIOCYTOSIS UNSPECIFIED SITE MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES

202.40 - 202.48 LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE - LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES 202.50 - 202.58 LETTERER-SIWE DISEASE UNSPECIFIED SITE LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES 202.60 - 202.68 MALIGNANT MAST CELL TUMORS UNSPECIFIED SITE MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF MULTIPLE SITES 202.70 - 202.78 PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES 202.80 - 202.88 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES

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Last Updated:

05/06/15

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 15 of 22)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 202.90 - 202.98 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE UNSPECIFIED SITE OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES 203.00 - 203.02 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MULTIPLE MYELOMA, IN RELAPSE 203.10 - 203.12 PLASMA CELL LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - PLASMA CELL LEUKEMIA, IN RELAPSE 203.80 - 203.82 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE

204.00 - 204.02 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE LYMPHOID LEUKEMIA, IN RELAPSE 204.10 - 204.12 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE 204.20 - 204.22 SUBACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - SUBACUTE LYMPHOID LEUKEMIA, IN RELAPSE 204.80 - 204.82 OTHER LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER LYMPHOID LEUKEMIA, IN RELAPSE 204.90 - 204.92 UNSPECIFIED LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE

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Last Updated:

05/06/15

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 16 of 22)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 205.00 - 205.02 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE MYELOID LEUKEMIA, IN RELAPSE 205.10 - 205.12 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC MYELOID LEUKEMIA, IN RELAPSE 205.20 - 205.22 SUBACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - SUBACUTE MYELOID LEUKEMIA, IN RELAPSE 205.30 - 205.32 MYELOID SARCOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MYELOID SARCOMA, IN RELAPSE 205.80 - 205.82 OTHER MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER MYELOID LEUKEMIA, IN RELAPSE

205.90 - 205.92 UNSPECIFIED MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - UNSPECIFIED MYELOID LEUKEMIA, IN RELAPSE 206.00 - 206.02 ACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE MONOCYTIC LEUKEMIA, IN RELAPSE 206.10 - 206.12 CHRONIC MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC MONOCYTIC LEUKEMIA, IN RELAPSE 206.20 - 206.22 SUBACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - SUBACUTE MONOCYTIC LEUKEMIA, IN RELAPSE 206.80 - 206.82 OTHER MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER MONOCYTIC LEUKEMIA, IN RELAPSE

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Last Updated:

05/06/15

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 17 of 22)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 206.90 - 206.92 UNSPECIFIED MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION UNSPECIFIED MONOCYTIC LEUKEMIA, IN RELAPSE 207.00 - 207.02 ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, IN RELAPSE 207.10 - 207.12 CHRONIC ERYTHREMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC ERYTHREMIA, IN RELAPSE 207.20 - 207.22 MEGAKARYOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MEGAKARYOCYTIC LEUKEMIA, IN RELAPSE 207.80 - 207.82 OTHER SPECIFIED LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER SPECIFIED LEUKEMIA, IN RELAPSE

208.00 - 208.02 ACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION ACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE 208.10 - 208.12 CHRONIC LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION CHRONIC LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE 208.20 - 208.22 SUBACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION SUBACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE 208.80 - 208.82 OTHER LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION OTHER LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE

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Last Updated:

05/06/15

Data Source: www.cms.gov

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 18 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 208.90 - 208.92 UNSPECIFIED LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - UNSPECIFIED LEUKEMIA, IN RELAPSE 227.0 BENIGN NEOPLASM OF ADRENAL GLAND 233.0 CARCINOMA IN SITU OF BREAST 235.0 - 235.9 NEOPLASM OF UNCERTAIN BEHAVIOR OF MAJOR SALIVARY GLANDS - NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPEC RESPIRATORY ORGANS 236.0 NEOPLASM OF UNCERTAIN BEHAVIOR OF UTERUS 236.2 NEOPLASM OF UNCERTAIN BEHAVIOR OF OVARY 236.3 NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED FEMALE GENITAL ORGANS 236.4 NEOPLASM OF UNCERTAIN BEHAVIOR OF TESTIS 236.5 NEOPLASM OF UNCERTAIN BEHAVIOR OF PROSTATE 236.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED MALE GENITAL ORGANS

236.7 238.1

NEOPLASM OF UNCERTAIN BEHAVIOR OF BLADDER NEOPLASM OF UNCERTAIN BEHAVIOR OF CONNECTIVE AND OTHER SOFT TISSUE 238.2 NEOPLASM OF UNCERTAIN BEHAVIOR OF SKIN 238.3 NEOPLASM OF UNCERTAIN BEHAVIOR OF BREAST 238.71 - 238.77 ESSENTIAL THROMBOCYTHEMIA - POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD) 238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES 238.8 NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER SPECIFIED SITES 259.2 CARCINOID SYNDROME 273.1 - 273.3 MONOCLONAL PARAPROTEINEMIA MACROGLOBULINEMIA 273.8 - 273.9 OTHER DISORDERS OF PLASMA PROTEIN METABOLISM - UNSPECIFIED DISORDER OF PLASMA PROTEIN METABOLISM

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05/06/15

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 19 of 22)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 279.00 - 279.06 HYPOGAMMAGLOBULINEMIA UNSPECIFIED - COMMON VARIABLE IMMUNODEFICIENCY 279.09 OTHER DEFICIENCY OF HUMORAL IMMUNITY 279.10 - 279.13 IMMUNODEFICIENCY WITH PREDOMINANT T-CELL DEFECT UNSPECIFIED - NEZELOF'S SYNDROME 279.19 OTHER DEFICIENCY OF CELL-MEDIATED IMMUNITY 279.2 COMBINED IMMUNITY DEFICIENCY 279.3 UNSPECIFIED IMMUNITY DEFICIENCY 279.41 AUTOIMMUNE LYMPHOPROLIFERATIVE SYNDROME 279.49 AUTOIMMUNE DISEASE, NOT ELSEWHERE CLASSIFIED 279.50 - 279.53 GRAFT-VERSUS-HOST DISEASE, UNSPECIFIED - ACUTE ON CHRONIC GRAFT-VERSUS-HOST DISEASE 279.8 - 279.9 OTHER SPECIFIED DISORDERS INVOLVING THE IMMUNE MECHANISM - UNSPECIFIED DISORDER OF IMMUNE MECHANISM 282.0 HEREDITARY SPHEROCYTOSIS

282.1 282.40 282.43 282.44 282.45 282.46 282.47 282.5 282.60 - 282.64 282.68 282.69 282.7 283.2 283.9

HEREDITARY ELLIPTOCYTOSIS THALASSEMIA, UNSPECIFIED ALPHA THALASSEMIA BETA THALASSEMIA DELTA-BETA THALASSEMIA THALASSEMIA MINOR HEMOGLOBIN E-BETA THALASSEMIA SICKLE-CELL TRAIT SICKLE-CELL DISEASE UNSPECIFIED - SICKLE-CELL/HB C DISEASE WITH CRISIS OTHER SICKLE-CELL DISEASE WITHOUT CRISIS OTHER SICKLE-CELL DISEASE WITH CRISIS OTHER HEMOGLOBINOPATHIES HEMOGLOBINURIA DUE TO HEMOLYSIS FROM EXTERNAL CAUSES ACQUIRED HEMOLYTIC ANEMIA UNSPECIFIED

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05/06/15

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 20 of 22)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 284.01 284.09 284.11 284.12 284.19 284.2 284.81 284.89 284.9 285.0 285.22 285.8 - 285.9 287.1

CONSTITUTIONAL RED BLOOD CELL APLASIA OTHER CONSTITUTIONAL APLASTIC ANEMIA ANTINEOPLASTIC CHEMOTHERAPY INDUCED PANCYTOPENIA OTHER DRUG INDUCED PANCYTOPENIA OTHER PANCYTOPENIA MYELOPHTHISIS RED CELL APLASIA (ACQUIRED) (ADULT) (WITH THYMOMA) OTHER SPECIFIED APLASTIC ANEMIAS APLASTIC ANEMIA UNSPECIFIED SIDEROBLASTIC ANEMIA ANEMIA IN NEOPLASTIC DISEASE OTHER SPECIFIED ANEMIAS - ANEMIA UNSPECIFIED QUALITATIVE PLATELET DEFECTS

287.30 - 287.33 PRIMARY THROMBOCYTOPENIA,UNSPECIFIED CONGENITAL AND HEREDITARY THROMBOCYTOPENIC PURPURA 287.39 OTHER PRIMARY THROMBOCYTOPENIA 287.5 THROMBOCYTOPENIA UNSPECIFIED 288.00 - 288.04 NEUTROPENIA, UNSPECIFIED - NEUTROPENIA DUE TO INFECTION 288.09 OTHER NEUTROPENIA 288.1 - 288.4 FUNCTIONAL DISORDERS OF POLYMORPHONUCLEAR NEUTROPHILS - HEMOPHAGOCYTIC SYNDROMES 288.50 - 288.51 LEUKOCYTOPENIA, UNSPECIFIED - LYMPHOCYTOPENIA 288.59 OTHER DECREASED WHITE BLOOD CELL COUNT 288.60 - 288.65 LEUKOCYTOSIS, UNSPECIFIED – BASOPHILIA 288.69 OTHER ELEVATED WHITE BLOOD CELL COUNT 288.8 - 288.9 OTHER SPECIFIED DISEASE OF WHITE BLOOD CELLS UNSPECIFIED DISEASE OF WHITE BLOOD CELLS

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Data Source: www.cms.gov

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 21 of 22) Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 289.4 HYPERSPLENISM 289.50 - 289.53 DISEASE OF SPLEEN UNSPECIFIED - NEUTROPENIC SPLENOMEGALY 289.59 OTHER DISEASES OF SPLEEN 289.83 MYELOFIBROSIS 289.9 UNSPECIFIED DISEASES OF BLOOD AND BLOODFORMING ORGANS 364.3 UNSPECIFIED IRIDOCYCLITIS 452 PORTAL VEIN THROMBOSIS 453.9 EMBOLISM AND THROMBOSIS OF UNSPECIFIED SITE 555.0 - 555.2 REGIONAL ENTERITIS OF SMALL INTESTINE - REGIONAL ENTERITIS OF SMALL INTESTINE WITH LARGE INTESTINE 555.9 REGIONAL ENTERITIS OF UNSPECIFIED SITE 556.0 - 556.6 ULCERATIVE (CHRONIC) ENTEROCOLITIS - UNIVERSAL ULCERATIVE (CHRONIC) COLITIS 556.9 ULCERATIVE COLITIS UNSPECIFIED

630 696.0 714.30

HYDATIDIFORM MOLE PSORIATIC ARTHROPATHY CHRONIC OR UNSPECIFIED POLYARTICULAR JUVENILE RHEUMATOID ARTHRITIS 720.0 - 720.2 ANKYLOSING SPONDYLITIS - SACROILIITIS NOT ELSEWHERE CLASSIFIED 720.81 INFLAMMATORY SPONDYLOPATHIES IN DISEASES CLASSIFIED ELSEWHERE 720.89 OTHER INFLAMMATORY SPONDYLOPATHIES 720.9 UNSPECIFIED INFLAMMATORY SPONDYLOPATHY 785.6 ENLARGEMENT OF LYMPH NODES 789.2 SPLENOMEGALY 789.30 - 789.37 ABDOMINAL OR PELVIC SWELLING MASS OR LUMP UNSPECIFIED SITE - ABDOMINAL OR PELVIC SWELLING MASS OR LUMP GENERALIZED

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Last Updated:

05/06/15

Medicare Local Coverage Determination Policy – IN Flow Cytometry (L33526) (Page 22 of 22)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute 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 are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. This list was compiled from the Medical Local Coverage Determination Policy. An ICD-9-CM book should be used as a complete reference. 789.39

ABDOMINAL OR PELVIC SWELLING MASS OR LUMP OTHER SPECIFIED SITE 791.0 PROTEINURIA 795.4 OTHER NONSPECIFIC ABNORMAL HISTOLOGICAL FINDINGS 996.80 - 996.87 COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF TRANSPLANTED ORGAN INTESTINE 996.88 COMPLICATIONS OF TRANSPLANTED ORGAN, STEM CELL 996.89 COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN V08 ASYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION STATUS V10.60 - V10.63 PERSONAL HISTORY OF UNSPECIFIED LEUKEMIA PERSONAL HISTORY OF MONOCYTIC LEUKEMIA

V10.69 V42.0 - V42.7

PERSONAL HISTORY OF OTHER LEUKEMIA KIDNEY REPLACED BY TRANSPLANT - LIVER REPLACED BY TRANSPLANT V42.81 - V42.84 BONE MARROW REPLACED BY TRANSPLANT - ORGAN OR TISSUE REPLACED BY TRANSPLANT INTESTINES V42.89 OTHER SPECIFIED ORGAN OR TISSUE REPLACED BY TRANSPLANT V42.9 UNSPECIFIED ORGAN OR TISSUE REPLACED BY TRANSPLANT V49.83 AWAITING ORGAN TRANSPLANT STATUS V58.44 AFTERCARE FOLLOWING ORGAN TRANSPLANT V71.1 OBSERVATION FOR SUSPECTED MALIGNANT NEOPLASM

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05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing( L33219) (Page 1 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 1 Paragraph: CPT codes 81201, 81202, 81203 81210, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81317, 81318, 81319, and 81403, 81405, 81406 (that meet coverage criteria as indications for testing for lynch syndrome). V12.72 should be used to denote any of the polyposis conditions as described under Indications and Limitations section. 151.0 – 151.6 MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF GREATER CURVATURE OF STOMACH UNSPECIFIED 151.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF STOMACH 151.9 MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE 152.0 – 152.3 MALIGNANT NEOPLASM OF DUODENUM - MALIGNANT NEOPLASM OF MECKEL'S DIVERTICULUM 152.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SMALL INTESTINE 152.9 MALIGNANT NEOPLASM OF SMALL INTESTINE UNSPECIFIED SITE 153.0 MALIGNANT NEOPLASM OF HEPATIC FLEXURE 153.1 MALIGNANT NEOPLASM OF TRANSVERSE COLON 153.2 MALIGNANT NEOPLASM OF DESCENDING COLON 153.3 MALIGNANT NEOPLASM OF SIGMOID COLON 153.4 MALIGNANT NEOPLASM OF CECUM 153.5 MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS 153.6 MALIGNANT NEOPLASM OF ASCENDING COLON 153.7 MALIGNANT NEOPLASM OF SPLENIC FLEXURE 153.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE 153.9 MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE 153.9 MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE 154.0 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION 154.1 MALIGNANT NEOPLASM OF RECTUM 154.2 MALIGNANT NEOPLASM OF ANAL CANAL QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 2 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 1 Paragraph Continued: CPT codes 81201, 81202, 81203 81210, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81317, 81318, 81319, and 81403, 81405, 81406 (that meet coverage criteria as indications for testing for lynch syndrome). V12.72 should be used to denote any of the polyposis conditions as described under Indications and Limitations section. 154.8 MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS 155.0 – 155.2 MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY 156.1 MALIGNANT NEOPLASM OF EXTRAHEPATIC BILE DUCTS 156.9 MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE 157.0 – 157.4 MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS 157.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF PANCREAS 157.9 MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED 158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM 158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED 179 MALIGNANT NEOPLASM OF UTERUS-PART UNS 182.0 MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS 182.1 MALIGNANT NEOPLASM OF ISTHMUS 182.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BODY OF UTERUS 183.0 MALIGNANT NEOPLASM OF OVARY 183.2 – 183.5 MALIGNANT NEOPLASM OF FALLOPIAN TUBE - MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS 183.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA 183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE 189.0 – 189.2 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS - MALIGNANT NEOPLASM OF URETER 189.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF URINARY ORGANS

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Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 3 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 1 Paragraph Continued: CPT codes 81201, 81202, 81203 81210, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81317, 81318, 81319, and 81403, 81405, 81406 (that meet coverage criteria as indications for testing for lynch syndrome). V12.72 should be used to denote any of the polyposis conditions as described under Indications and Limitations section.

191.0 – 191.9 MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE 197.5 SECONDARY MALIGNANT NEOPLASM OF LARGE INTESTINE AND RECTUM V10.00 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF UNSPECIFIED SITE IN GASTROINTESTINAL TRACT V10.05 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF LARGE INTESTINE V10.06 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RECTUM RECTOSIGMOID JUNCTION AND ANUS V10.42 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF OTHER PARTS OF UTERUS V10.43 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF OVARY V10.53 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RENAL PELVIS V10.59 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF OTHER URINARY ORGANS V10.85 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BRAIN V12.72 PERSONAL HISTORY OF COLONIC POLYPS CPT 81210 172.0 - 172.9 MALIGNANT MELANOMA OF SKIN OF LIP - MELANOMA OF SKIN SITE UNSPECIFIED

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Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 4 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 2 Paragraph: 81301, 88342 153.0 - 153.9 MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE V10.05 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF LARGE INTESTINE V10.06 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RECTUM RECTOSIGMOID JUNCTION AND ANUS V10.42 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF OTHER PARTS OF UTERUS Group 3 Paragraph: CPT codes 81211, 81212, 81213, 81214, 81215 and 81217 and meet the coverage criteria for BRCA1 and BRCA2 gene mutation testing. 158.0 MALIGNANT 158.8 MALIGNANT 174.0 MALIGNANT 174.1 MALIGNANT 174.2 MALIGNANT 174.3 MALIGNANT 174.4 MALIGNANT 174.5 MALIGNANT 174.6 MALIGNANT 174.8 MALIGNANT 174.8 MALIGNANT 174.9 MALIGNANT 175.0 MALIGNANT 175.9 MALIGNANT

NEOPLASM OF RETROPERITONEUM NEOPLASM OF SPECIFIED PARTS OF PERITONEUM NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 5 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 3 Paragraph: continued CPT codes 81211, 81212, 81213, 81214, 81215 and 81217 and meet the coverage criteria for BRCA1 and BRCA2 gene mutation testing. 183.0 MALIGNANT NEOPLASM OF OVARY 183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE 233.0 CARCINOMA IN SITU OF BREAST V10.3 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST V10.43 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF OVARY Group 4 Paragraph: CPT 81235 162.0 – 162.9 MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED 163.0 – 163.9 MALIGNANT NEOPLASM OF PARIETAL PLEURA - MALIGNANT NEOPLASM OF PLEURA UNSPECIFIED Group 5 Paragraph: CPT codes 81270 and 81403 (that meet coverage criteria for JAK2 testing). 204.00 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION 204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE 205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 238.4 POLYCYTHEMIA VERA 238.71 ESSENTIAL THROMBOCYTHEMIA 238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA 238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES 238.9 NEOPLASM OF UNCERTAIN BEHAVIOR SITE UNSPECIFIED 288.51 LYMPHOCYTOPENIA288.61 LYMPHOCYTOSIS (SYMPTOMATIC) 288.8 OTHER SPECIFIED DISEASE OF QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 6 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 3 Paragraph: continued CPT codes 81211, 81212, 81213, 81214, 81215 and 81217 and meet the coverage criteria for BRCA1 and BRCA2 gene mutation testing. 183.0 MALIGNANT NEOPLASM OF OVARY 183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE 233.0 CARCINOMA IN SITU OF BREAST V10.3 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BREAST V10.43 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF OVARY Group 4 Paragraph: CPT 81235 162.0 – 162.9 MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED 163.0 – 163.9 MALIGNANT NEOPLASM OF PARIETAL PLEURA - MALIGNANT NEOPLASM OF PLEURA UNSPECIFIED Group 5 Paragraph: CPT codes 81270 and 81403 (that meet coverage criteria for JAK2 testing). 204.00 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION 204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE 205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 238.4 POLYCYTHEMIA VERA 238.71 ESSENTIAL THROMBOCYTHEMIA 238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA 238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES 238.9 NEOPLASM OF UNCERTAIN BEHAVIOR SITE UNSPECIFIED 288.51 LYMPHOCYTOPENIA288.61 LYMPHOCYTOSIS (SYMPTOMATIC) 288.8 OTHER SPECIFIED DISEASE OF DISEASE OF WHITE BLOOD CELLS 453.0 BUDD-CHIARI SYNDROME QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 7 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 6 Paragraph: CPT code 81381 when meeting coverage criteria 042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE V08 ASYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION STATUS Group 7 Paragraph: Multiple codes exist for the various molecular tests for lymphoma and leukemia. The appropriate code should be selected from the most current manual. The following diagnosis codes meet coverage criteria as indications for molecular testing of lymphoma and leukemia, so long as documentation of medical necessity for the specific test in question is present in the medical record, as noted elsewhere in this LCD. 81206, 81207, 81208 and 81403 (that meet coverage criteria as indications for testing for BCR/ABL fusion gene ). Group 7 Codes: 200.40 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES 200.41 MANTLE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK 200.42 MANTLE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES 200.43 MANTLE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES 200.44 MANTLE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB 200.45 MANTLE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 200.46 MANTLE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES 200.47 MANTLE CELL LYMPHOMA, SPLEEN 200.48 MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES 200.70 LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES 200.71 LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK 200.72 LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES 200.73 LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES 200.74 LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB 200.75–200.76 LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB - LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES 200.77 LARGE CELL LYMPHOMA, SPLEEN 200.78 LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 8 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 7 Paragraph Continued: Multiple codes exist for the various molecular tests for lymphoma and leukemia. The appropriate code should be selected from the most current manual. The following diagnosis codes meet coverage criteria as indications for molecular testing of lymphoma and leukemia, so long as documentation of medical necessity for the specific test in question is present in the medical record, as noted elsewhere in this LCD. 81206, 81207, 81208 and 81403 (that meet coverage criteria as indications for testing for BCR/ABL fusion gene ). Group 7 Codes: 202.00 NODULAR LYMPHOMA UNSPECIFIED SITE 202.01 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 202.02 NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES 202.03 NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES 202.04 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB 202.05 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB 202.06 NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES 202.07 NODULAR LYMPHOMA INVOLVING SPLEEN 202.08 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 204.00 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.01 LYMPHOID LEUKEMIA ACUTE IN REMISSION 204.02 ACUTE LYMPHOID LEUKEMIA, IN RELAPSE 204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION 204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE 204.20 SUBACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.21 LYMPHOID LEUKEMIA SUBACUTE IN REMISSION 204.22 SUBACUTE LYMPHOID LEUKEMIA, IN RELAPSE 204.80 OTHER LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 9 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 7 Paragraph Continued: Multiple codes exist for the various molecular tests for lymphoma and leukemia. The appropriate code should be selected from the most current manual. The following diagnosis codes meet coverage criteria as indications for molecular testing of lymphoma and leukemia, so long as documentation of medical necessity for the specific test in question is present in the medical record, as noted elsewhere in this LCD. 81206, 81207, 81208 and 81403 (that meet coverage criteria as indications for testing for BCR/ABL fusion gene ). Group 7 Codes: 204.81 OTHER LYMPHOID LEUKEMIA IN REMISSION 204.82 OTHER LYMPHOID LEUKEMIA, IN RELAPSE 204.90 UNSPECIFIED LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 204.91 UNSPECIFIED LYMPHOID LEUKEMIA IN REMISSION 204.92 UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE 205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.01 MYELOID LEUKEMIA ACUTE IN REMISSION 205.02 ACUTE MYELOID LEUKEMIA, IN RELAPSE 205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.11 MYELOID LEUKEMIA CHRONIC IN REMISSION 205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE 205.20 SUBACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.21 MYELOID LEUKEMIA SUBACUTE IN REMISSION 205.22 SUBACUTE MYELOID LEUKEMIA, IN RELAPSE 205.30 MYELOID SARCOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.31 MYELOID SARCOMA IN REMISSION 205.32 MYELOID SARCOMA, IN RELAPSE 205.80 OTHER MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.81 OTHER MYELOID LEUKEMIA IN REMISSION QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 10 of 11)

Data Source: www.cms.gov

TestingSlide 37 performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 7 Paragraph Continued: Multiple codes exist for the various molecular tests for lymphoma and leukemia. The appropriate code should be selected from the most current manual. The following diagnosis codes meet coverage criteria as indications for molecular testing of lymphoma and leukemia, so long as documentation of medical necessity for the specific test in question is present in the medical record, as noted elsewhere in this LCD. 81206, 81207, 81208 and 81403 (that meet coverage criteria as indications for testing for BCR/ABL fusion gene ). Group 7 Codes: 205.82 OTHER MYELOID LEUKEMIA, IN RELAPSE 205.90 UNSPECIFIED MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 205.91 UNSPECIFIED MYELOID LEUKEMIA IN REMISSION 205.92 UNSPECIFIED MYELOID LEUKEMIA, IN RELAPSE 206.00 ACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 206.01 MONOCYTIC LEUKEMIA ACUTE IN REMISSION 206.02 ACUTE MONOCYTIC LEUKEMIA, IN RELAPSE 206.10 CHRONIC MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 206.11 MONOCYTIC LEUKEMIA CHRONIC IN REMISSION 206.12 CHRONIC MONOCYTIC LEUKEMIA, IN RELAPSE 206.20 SUBACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 206.21 MONOCYTIC LEUKEMIA SUBACUTE IN REMISSION 206.22 SUBACUTE MONOCYTIC LEUKEMIA, IN RELAPSE 206.80 OTHER MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 206.81 OTHER MONOCYTIC LEUKEMIA IN REMISSION 206.82 OTHER MONOCYTIC LEUKEMIA, IN RELAPSE 206.90 UNSPECIFIED MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 206.91 UNSPECIFIED MONOCYTIC LEUKEMIA IN REMISSION 206.92 UNSPECIFIED MONOCYTIC LEUKEMIA, IN RELAPSE QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Molecular Diagnostic Testing (L33219) (Page 11 of 11)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 81201, 81202, 81203, 81206, 81207, 81208, 81210, 81211, 81212, 81213, 81214, 81217, 81226, 81235, 81270, 81275, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318, 81319, 81381, 81403, 81405, 81406, 88342, 88363

LCD Description: Genetic tests for cancer are only a covered benefit for a beneficiary with a personal history of an illness, injury, or signs/symptoms thereof (i.e. clinically affected). A person with a personal history of a relevant cancer is a clinically affected person, even if the cancer is considered cured. Genetic testing is considered a non-covered screening test for patients unaffected by a relevant illness, injury, or signs/symptoms thereof. . ICD-9-CM Codes that Support Medical Necessity: Molecular Diagnostic Testing is potentially medically reasonable and necessary “therapy-directing” genetic tests, either currently available or in the development “pipeline” for emerging use in the coming months and years. Many questions remain, among them the lack of – and difficulty in establishing – good medical literature support of medical necessity; lack of standardized testing protocols; lack of good data for establishing patient-selection criteria; absence of test-specific CPT coding, which we believe to be essential for future development of this potentially monumental enhancement to patient care. Providers are reminded that we will allow payment for such tests, either those currently available or those to be brought into use in the future, based on applicable approval such as FDA labeling, if such exists, CLIA and appropriate Medicare regulations and its standards of medical reasonableness and necessity. Group 7 Paragraph Continued: Multiple codes exist for the various molecular tests for lymphoma and leukemia. The appropriate code should be selected from the most current manual. The following diagnosis codes meet coverage criteria as indications for molecular testing of lymphoma and leukemia, so long as documentation of medical necessity for the specific test in question is present in the medical record, as noted elsewhere in this LCD. 81206, 81207, 81208 and 81403 (that meet coverage criteria as indications for testing for BCR/ABL fusion gene ). Group 7 Codes: 208.00 ACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 208.01 LEUKEMIA OF UNSPECIFIED CELL TYPE ACUTE IN REMISSION 208.02 ACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE 208.10 CHRONIC LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 208.11 LEUKEMIA OF UNSPECIFIED CELL TYPE CHRONIC IN REMISSION 208.12 CHRONIC LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE 208.20 SUBACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 208.21 LEUKEMIA OF UNSPECIFIED CELL TYPE SUBACUTE IN REMISSION 208.22 SUBACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE 208.80 OTHER LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 208.81 OTHER LEUKEMIA OF UNSPECIFIED CELL TYPE IN REMISSION 208.82 OTHER LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE 208.90 UNSPECIFIED LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION 208.91 UNSPECIFIED LEUKEMIA IN REMISSION 208.92 UNSPECIFIED LEUKEMIA, IN RELAPSE 288.69 OTHER ELEVATED WHITE BLOOD CELL COUNT 288.8 OTHER SPECIFIED DISEASE OF WHITE BLOOD CELLS

QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Vitamin D Assay Testing (L31076) (Page 1 of 2)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 82306, 82652 LCD Description: Vitamin D is a hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. An excess of vitamin D may lead to hypercalcemia. Vitamin D deficiency may lead to a variety of disorders. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for these services. ICD-9-CM Codes that Support Medical Necessity The Vitamin D Assay test is determined to be medically necessary by Medicare only when it is ordered for patients with one of the conditions listed below. ICD-9-CM codes that support medical necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided. CPT 82306 010.00–018.96 Primary Tuberculous complex unspecified examination – Unspecified Miliary Tuberculosis Tubercle bacilli not found by bacteriological or histological examination but tuberculosis confirmed by other methods (Inoculation of animals) 135 Sarcoidosis 252.00-252.9 Hyperparathyroidism, unspecified – Unspecified disorder of Parathyroid Gland 268.0– 268.9 Rickets Active-Unspecified Vitamin D Deficiency 275.3 Disorders of Phosphorus Metabolism 275.41 Hypocalcemia 275.42 Hypercalcemia 277.00-277.09 Cystic Fibrosis without Meconium Ileus-Cystic Fibrosis with other manifestations 278.8 Other Hyperalimentation 359.5 Myopathy in Endocrine Diseases classified elsewhere 555.0-555.9 Regional Enteritis of Small Intestine-Regional Enteritis of unspecified site 556.0-556.9 Ulcerative (Chronic)Enterocolitis-Ulcerative Colitis unspecified 571.2 Alcoholic Cirrhosis of Liver 571.5 Cirrhosis of Liver without Alcohol 571.6 Biliary Cirrhosis 571.8 Other Chronic Nonalcoholic Liver Disease 579.0-579.9 Celiac Disease-Unspecified Intestinal Malabsorption 585.3 Chronic Kidney Disease Stage III (Moderate)

585.4 Chronic Kidney Disease Stage IV (Severe) 585.5 Chronic Kidney Disease Stage V 585.6 End Stage Renal Disease 588.81 Secondary Hyperparathyroidism (of renal origin 649.20-649.24 Bariatric surgery status complicating pregnancy, childbirth, or the puerperium, unspecified as to episode of care or not applicable-bariatric surgery status complicating pregnancy, childbirth, or the puerperium, postpartum condition or complication 696.1 Other Psoriasis and similar disorders 701.0 Circumscribed Scleroderma 710.0 Systemic Lupus Erythematosus 710.3 Dermatomyositis 729.1 Myalgia and Myositis unspecified 731.0 Osteitis Deformans without bone tumor 733.00-733.09 Osteoporosis unspecified-other osteoporosis 733.90 Disorder of bone and cartilage unspecified 756.51 Osteogenesis Imperfecta 756.52 Osteopetrosis 949.2-949.5 Blisters with epidermal loss due to burn (second degree) unspecified site-Deep necrosis of underlying tissues due to burn (deep third degree unspecified site with loss of a body part) V45.86 Bariatric Surgery status V58.65 Long Term (current) use of steroids V58.69 Long Term (current) use of other medications

QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

Medicare Local Coverage Determination Policy (IN) Vitamin D Assay Testing (L31076) (Page 2 of 2)

Data Source: www.cms.gov

Testing performed by Quest Diagnostics Nichols Institute CPT Code: 82306, 82652 LCD Description: Vitamin D is a hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. An excess of vitamin D may lead to hypercalcemia. Vitamin D deficiency may lead to a variety of disorders. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for these services. ICD-9-CM Codes that Support Medical Necessity The Vitamin D Assay test is determined to be medically necessary by Medicare only when it is ordered for patients with one of the conditions listed below. ICD-9-CM codes that support medical necessity are listed, but it is not enough to link the procedure code to a correct payable ICD-9-CM code. The diagnosis must be present for the procedure to be paid and the procedure must be reasonable and medically necessary for that diagnosis. Documentation within the patient’s medical record must support the medical necessity for the test(s) provided.

CPT 82652 010.00–018.96 Primary Tuberculous complex unspecified examination – Unspecified Miliary Tuberculosis Tubercle bacilli not found by bacteriological or histological examination but tuberculosis confirmed by other methods (Inoculation of animals) 135 Sarcoidosis 200.30-200.38 Marginal Zone Lymphoma, unspecified site, extranodal and solid organ sites-Marginal Zone Lymphoma, lymph nodes of multiple sites 202.10-202.28 Mycosis Fungoides unspecified site-Sezary’s Disease involving lymph nodes of multiple sites 252.00-252.9 Hyperparathyroidism, unspecified – Unspecified disorder of Parathyroid Gland 268.0 Rickets Active 278.8 Other Hyperalimentation 585.3 Chronic Kidney Disease Stage III (Moderate) 585.4 Chronic Kidney Disease Stage IV (Severe) 585.5 Chronic Kidney Disease Stage V 585.6 End Stage Renal Disease 588.81 Secondary Hyperparathyroidism (of renal origin) 756.51 Osteogenesis Imperfecta 756.52 Osteopetrosis

QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2012 Quest Diagnostics Incorporated. All rights reserved

Last Updated: 05/06/15

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