Medicare National and Local Coverage Determination Policy LA

Transcription

1 Medicare National and Local Coverage Determination Policy LA 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 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 LA Allergy Testing Assays for Vitamins and Metabolic Function Blood Folic Acid Serum Assays for Vitamins and Metabolic Function C-Reactive Protein HS Assays for Vitamins and Metabolic Function Carnitine Assays for Vitamins and Metabolic Function Cell Function Assay with Stimulation and Lymphocyte Transformation Assays for Vitamins and Metabolic Function Fibrinogen Assays for Vitamins and Metabolic Function Homocysteine Assays for Vitamins and Metabolic Function Assay Lipoprotein PLA2 Assays for Vitamins and Metabolic Function Vitamin B-6 Assays for Vitamins and Metabolic Function Vitamin B 12 Assays for Vitamins and Metabolic Function Vitamin D 1, 25-dihydroxy Assays for Vitamins and Metabolic Function Vitamin D, 25-hydroxy (Includes Fractions, If Performed) Assays for Vitamins and Metabolic Function - Non-Covered Tests\Frequency Biomarkers for Oncology Biomarkers Overview Flow Cytometry Frequency of Laboratory Tests Glucose Testing Frequency of Laboratory Tests Lipids Frequency of Laboratory Tests Thyroid Testing Molecular Diagnostics: Genitouriinary Infectious Disease Testing Qualitative Drug Screening Services That Are Not Reasonable and Necessary QuestDiagnostics.com 08/13/2015

2 L35771 Allergy Testing (Page 1 of 3) CPT Code: 82785, LCD Description: In order for allergy testing to be considered reasonable and necessary by Medicare, antigens must meet all the following criteria - skin testing must be performed based on history and physical exam, proven efficacy as demonstrated through scientifically valid medical studies published in peer-review journal, and exist in the patient's environment with a reasonable probability of exposure. ICD-9-CM Codes that Support Medical Necessity The Allergy 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. FOR CPTs AND Aspergillosis Other Atopic Dermatitis And Related Conditions Allergic Urticaria Dermatographic Urticaria Toxic Effect Of Venom Toxic Effect Of Latex OTHER ANAPHYLACTIC Reaction Anaphylactic Reaction Due To Unspecified Food Anaphylactic Reaction Due To Peanuts Anaphylactic Reaction Due To Crustaceans Anaphylactic Reaction Due To Fruits And Vegetables Anaphylactic Reaction Due To Tree Nuts And Seeds Anaphylactic Reaction Due To Fish Anaphylactic Reaction Due To Food Additives Anaphylactic Reaction Due To Milk Products Anaphylactic Reaction Due To Eggs Anaphylactic Reaction Due To Other Specified Food V12.00* Personal History Of Unspecified Infectious And Parasitic Disease V67.59 Other Follow-up Examination *Note: V12.00 Personal History of infectious and parasitic disease should be used for recurrent pyogenic infections. 08/13/15

3 L35771 Allergy Testing (Page 2 of 3) CPT Code: 82785, LCD Description: In order for allergy testing to be considered reasonable and necessary by Medicare, antigens must meet all the following criteria - skin testing must be performed based on history and physical exam, proven efficacy as demonstrated through scientifically valid medical studies published in peer-review journal, and exist in the patient's environment with a reasonable probability of exposure. ICD-9-CM Codes that Support Medical Necessity The Allergy 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 Acute Conjunctivitis Unspecified Acute Atopic Conjunctivitis Vernal Conjunctivitis Other Chronic Allergic Conjunctivitis Acute Serous Otitis Media Other And Unspecified Chronic Nonsuppurative Otitis Media Unspecified Otitis Media Acute Maxillary Sinusitis Acute Frontal Sinusitis Acute Ethmoidal Sinusitis Acute Sphenoidal Sinusitis Other Acute Sinusitis Acute Sinusitis Unspecified 462 Acute Pharyngitis 463 Acute Tonsillitis Acute Laryngitis Without Obstruction Acute Laryngitis With Obstruction Supraglottitis Unspecified Without Obstruction Supraglottitis Unspecified With Obstruction Acute Bronchitis Polyp Of Nasal Cavity Other Polyp Of Sinus Unspecified Nasal Polyp Chronic Maxillary Sinusitis Chronic Frontal Sinusitis FOR CPT ONLY Chronic Ethmoidal Sinusitis Allergic Rhinitis Due To Pollen Allergic Rhinitis Due To Other Allergen Allergic Rhinitis Cause Unspecified Hypertrophy Of Nasal Turbinates Other Disease Of Nasal Cavity And Sinuses Extrinsic Asthma Unspecified Extrinsic Asthma With Status Asthmaticus Extrinsic Asthma With (Acute) Exacerbation Intrinsic Asthma Unspecified Intrinsic Asthma With Status Asthmaticus Intrinsic Asthma With (Acute) Exacerbation Chronic Obstructive Asthma Unspecified Chronic Obstructive Asthma With Status Asthmaticus Chronic Obstructive Asthma With (Acute) Exacerbation Exercise-induced Bronchospasm Cough Variant Asthma Asthma Unspecified Asthma Unspecified Type With Status Asthmaticus Asthma Unspecified With (Acute) Exacerb Other Specified Gastritis (Without Hemorrhage) Other Atopic Dermatitis And Related Conditions Dermatitis Due To Food Taken Internally Unspecified Pruritic Disorder Allergic Urticaria 08/13/15

4 L35771 Allergy Testing (Page 3 of 3) CPT Code: 82785, LCD Description: In order for allergy testing to be considered reasonable and necessary by Medicare, antigens must meet all the following criteria - skin testing must be performed based on history and physical exam, proven efficacy as demonstrated through scientifically valid medical studies published in peer-review journal, and exist in the patient's environment with a reasonable probability of exposure. ICD-9-CM Codes that Support Medical Necessity The Allergy 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. FOR CPT ONLY Idiopathic Urticaria Other Specified Urticaria Unspecified Urticaria Respiratory Abnormality Other Cough Toxic Effect Of Venom Other Anaphylactic Reaction Angioneurotic Edema Not Elsewhere Classified Unspecified Adverse Effect Of Unspecified Drug, Medicinal And Biological Substance Other Drug Allergy Unspecified Adverse Effect Of Other Drug, Medicinal And Biological Substance Allergy Unspecified Not Elsewhere Classified Anaphylactic Reaction Due To Administration Of Blood And Blood Products Anaphylactic Reaction Due To Vaccination Anaphylactic Reaction Due To Other Serum Other Serum Reaction Due To Administration Of Blood And Blood Products Other Serum Reaction Due To Vaccination Other Serum Reaction V14.0 Personal History Of Allergy To Penicillin V14.1 Personal History Of Allergy To Other Antibiotic Agent V14.2 Personal History Of Allergy To Sulfonamides V14.3 Personal History Of Allergy To Other Anti-infective Agent V14.4 Personal History Of Allergy To Anesthetic Agent V14.5 Personal History Of Allergy To Narcotic Agent V14.6 Personal History Of Allergy To Analgesic Agent V14.7 Personal History Of Allergy To Serum Or Vaccine V14.8 Personal History Of Allergy To Other Specified Medicinal Agents V14.9 Personal History Of Allergy To Unspecified Medicinal Agent V15.01 Personal History Of Allergy To Peanuts V15.02 Personal History Of Allergy To Milk Products V15.03 Personal History Of Allergy To Eggs V15.04 Personal History Of Allergy To Seafood V15.05 Personal History Of Allergy To Other Foods V15.06 Allergy To Insects And Arachnids V15.07 Personal History Of Allergy To Latex V15.08 Personal History Of Allergy To Radiographic Dye V15.09 Personal History Of Other Allergy Other Than To Medicinal Agents 08/13/15

5 Medicare Local Coverage Determination Policy - LA L36214 Assays for Vitamins and Metabolic Function Blood Folic Acid Serum CPT Code: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. Utilization Guidelines: Folate (82746) can be tested up to four times per year for malabsorption syndromes (579.9) or deficiency disorders (266.2, and 281.2). ICD-9-CM Codes that Support Medical Necessity The Vitamin Assay Blood Folic Acid Serum 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 Whipple's Disease 261 Nutritional Marasmus 262 Other Severe Protein-Calorie Malnutrition Malnutrition Of Moderate Degree Arrested Development Following Protein-Calorie Malnutrition Other Protein-Calorie Malnutrition - Unspecified Protein-Calorie Malnutrition Other B-Complex Deficiencies Disturbances Of Sulphur-Bearing Amino-Acid Metabolism Pernicious Anemia - Other Specified Megaloblastic Anemias Not Elsewhere Classified Unspecified Deficiency Anemia Thrombocytopenia Unspecified Senile Dementia Uncomplicated Other And Unspecified Alcohol Dependence Continuous Drinking Behavior - Other And Unspecified Alcohol Dependence Episodic Drinking Behavior Alzheimer's Disease Other Extrapyramidal Diseases And Abnormal Movement Disorders Idiopathic Progressive Polyneuropathy Unspecified Idiopathic Peripheral Neuropathy Glossitis Glossodynia Achlorhydria Regional Enteritis Of Small Intestine - Regional Enteritis Of Small Intestine With Large Intestine Regional Enteritis Of Unspecified Site Celiac Disease - Pancreatic Steatorrhea Other Specified Intestinal Malabsorption - Unspecified Intestinal Malabsorption Memory Loss * Other General Symptoms *Note: Use code to identify altered mental status Abnormality Of Gait Lack Of Coordination Disturbance Of Skin Sensation V12.1 Personal History Of Nutritional Deficiency V45.11 Renal Dialysis Status V45.3 Postsurgical Intestinal Bypass Or Anastomosis Status V58.11 Encounter For Antineoplastic Chemotherapy V58.69 Long-Term (Current) Use Of Other Medications

6 L36214 Assays for Vitamins and Metabolic Function C-Reactive Protein HS CPT Codes: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. Utilization Guidelines: Medicare will not cover more than two high-sensitivity C-reactive protein (86141) tests per year per beneficiary. This allows for baseline testing and six-month follow-up tests for statin therapeutic management. ICD-9-CM Codes that Support Medical Necessity The Vitamin Assays C Reactive Protein is determined to be medically necessary by Medicare only when they are 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 Pure Hypercholesterolemia Coronary atherosclerosis of native coronary artery

7 Medicare Local Coverage Determination Policy LA L32614 Assays for Vitamins and Metabolic Function Assay of Carnitine CPT Code: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. Utilization Guidelines: Carnitine (82379) may be tested up to three times per year to account for baseline assay followed by evaluations at sixmonth increments (adapted from Levocarnitine NCD). ICD-9-CM Codes that Support Medical Necessity The Vitamin Assay Carnitine 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 Primary Carnitine Deficiency - Other Secondary Carnitine Deficiency Anemia In Chronic Kidney Disease Hypotension Of Hemodialysis

8 L36214 Assays for Vitamins and Metabolic Function Cell Function Assay with Stimulation and Lymphocyte Transformation CPT Codes: and LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. CD-9-CM Codes that Support Medical Necessity The Vitamin Assays Cell Function with Stimulation and Lymphocyte Transformation tests are determined to be medically necessary by Medicare only when they are 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 Immunodeficiency With Predominant T-Cell Defect Unspecified - Nezelof's Syndrome Complications Of Transplanted Kidney - Complications Of Transplanted Organ, Stem Cell V42.0 Kidney Replaced By Transplant V42.1 Heart Replaced By Transplant V42.6 Lung Replaced By Transplant V42.7 Liver Replaced By Transplant V42.81 Bone Marrow Replaced By Transplant V42.83 Pancreas Replaced By Transplant V42.84 Organ Or Tissue Replaced By Transplant Intestines

9 L36214 Assays for Vitamins and Metabolic Function Fibrinogen CPT Code: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. Utilization Guidelines: Fibrinogen (85385) may be tested up to four times per year for low platelet diagnoses ( , , , 287.5). ICD-9-CM Codes that Support Medical Necessity The Vitamin Assay Fibrinogen 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 Congenital Deficiency Of Other Clotting Factors Defibrination Syndrome - Acquired Coagulation Factor Deficiency Primary Thrombocytopenia,Unspecified - Congenital And Hereditary Thrombocytopenic Purpura Posttransfusion Purpura Other Secondary Thrombocytopenia Thrombocytopenia Unspecified Abnormal Coagulation Profile

10 L32614 Assays for Vitamins and Metabolic Function Assay of Homocystine CPT Code: LCD Description: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. ICD-9-CM Codes that Support Medical Necessity The Vitamin Assay - Homocysteine 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 Whipple's Disease 261 Nutritional Marasmus 262 Other Severe Protein-Calorie Malnutrition Malnutrition Of Moderate Degree Arrested Development Following Protein-Calorie Malnutrition Other Protein-Calorie Malnutrition - Unspecified Protein-Calorie Malnutrition Other B-Complex Deficiencies Disturbances Of Sulphur-Bearing Amino-Acid Metabolism Pernicious Anemia - Other Specified Megaloblastic Anemias Not Elsewhere Classified Unspecified Deficiency Anemia Thrombocytopenia Unspecified Senile Dementia Uncomplicated Other And Unspecified Alcohol Dependence Continuous Drinking Behavior - Other And Unspecified Alcohol Dependence Episodic Drinking Behavior Alzheimer's Disease Other Extrapyramidal Diseases And Abnormal Movement Disorders Idiopathic Progressive Polyneuropathy Unspecified Idiopathic Peripheral Neuropathy Glossitis Glossodynia Achlorhydria Regional Enteritis Of Small Intestine - Regional Enteritis Of Small Intestine With Large Intestine Regional Enteritis Of Unspecified Site Celiac Disease - Pancreatic Steatorrhea Other Specified Intestinal Malabsorption - Unspecified Intestinal Malabsorption Memory Loss * Other General Symptoms *Note: Use code to identify altered mental status Abnormality Of Gait Lack Of Coordination Disturbance Of Skin Sensation V12.1 Personal History Of Nutritional Deficiency V45.11 Renal Dialysis Status V45.3 Postsurgical Intestinal Bypass Or Anastomosis Status V58.11 Encounter For Antineoplastic Chemotherapy V58.69 Long-Term (Current) Use Of Other Medications 05/01/13

11 L36214 Assays for Vitamins and Metabolic Function Assay Lipoprotein PLA2 CPT Codes: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. Utilization Guidelines: The same frequency edit (two tests per year per beneficiary) will be applied to Lipoprotein-associated phospholipase A 2 (Lp- PLA 2 ) used in the management of patients with coronary artery disease. ICD-9-CM Codes that Support Medical Necessity The Vitamin Lipoprotein PLA2 test is determined to be medically necessary by Medicare only when they are 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 Diabetes Mellitus Without Mention Of Complication, Type Ii Or Unspecified Type, Not Stated As Uncontrolled Diabetes Mellitus Without Mention Of Complication, Type Ii Or Unspecified Type, Uncontrolled Pure Hypercholesterolemia Pure Hyperglyceridemia Mixed Hyperlipidemia Hyperchylomicronemia Other And Unspecified Hyperlipidemia Coronary Atherosclerosis Of Native Coronary Artery Coronary Atherosclerosis Due To Calcified Coronary Lesion

12 L36214 Assays for Vitamins and Metabolic Function Assay of Vitamin B-6 CPT Code: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. ICD-9-CM Codes that Support Medical Necessity The Vitamin Assay Vitamin B-6 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 Vitamin B6 Deficiency Sideroblastic Anemia Other Extrapyramidal Diseases And Abnormal Movement Disorders Unspecified Idiopathic Peripheral Neuropathy Glossitis 3

13 L36214 Assays for Vitamins and Metabolic Function Vitamin B-12 CPT Code: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. Utilization Guidelines: Vitamin B-12 (82607) can be tested up to four times per year for malabsorption syndromes (579.9) or deficiency disorders (266.2, and 281.2). Vitamin B-12 (82607) can only be tested more frequently than four times per year for postsurgical malabsorption (579.3). ICD-9-CM Codes that Support Medical Necessity The Vitamin Assay Vitamin B-12 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 Whipple's Disease 261 Nutritional Marasmus 262 Other Severe Protein-Calorie Malnutrition Malnutrition Of Moderate Degree Arrested Development Following Protein-Calorie Malnutrition Other Protein-Calorie Malnutrition - Unspecified Protein-Calorie Malnutrition Other B-Complex Deficiencies Disturbances Of Sulphur-Bearing Amino-Acid Metabolism Pernicious Anemia - Other Specified Megaloblastic Anemias Not Elsewhere Classified Unspecified Deficiency Anemia Thrombocytopenia Unspecified Senile Dementia Uncomplicated Other And Unspecified Alcohol Dependence Continuous Drinking Behavior - Other And Unspecified Alcohol Dependence Episodic Drinking Behavior Alzheimer's Disease Other Extrapyramidal Diseases And Abnormal Movement Disorders Idiopathic Progressive Polyneuropathy Unspecified Idiopathic Peripheral Neuropathy Glossitis Glossodynia Achlorhydria Regional Enteritis Of Small Intestine - Regional Enteritis Of Small Intestine With Large Intestine Regional Enteritis Of Unspecified Site Celiac Disease - Pancreatic Steatorrhea Other Specified Intestinal Malabsorption - Unspecified Intestinal Malabsorption Memory Loss * Other General Symptoms *Note: Use code to identify altered mental status Abnormality Of Gait Lack Of Coordination Disturbance Of Skin Sensation V12.1 Personal History Of Nutritional Deficiency V45.11 Renal Dialysis Status V45.3 Postsurgical Intestinal Bypass Or Anastomosis Status V58.11 Encounter For Antineoplastic Chemotherapy V58.69 Long-Term (Current) Use Of Other Medications

14 Medicare Local Coverage Determination Policy - LA L36214 Assays for Vitamins and Metabolic Function Vitamin D 1 25-dihydroxy (Includes Fractions if Performed) CPT Codes: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. ICD-9-CM Codes that Support Medical Necessity The Vitamin Assays Vitamin D, 25-hydroxy and Vitamin D1. 25-dihydroxy tests - are determined to be medically necessary by Medicare only when they are 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 Hyperparathyroidism, Unspecified - Secondary Hyperparathyroidism, Non-Renal Other Hyperparathyroidism Hypoparathyroidism Rickets Active Osteomalacia Unspecified Unspecified Vitamin D Deficiency Disorders Of Phosphorus Metabolism Hypocalcemia - Hypercalcemia Chronic Kidney Disease, Stage III (Moderate) - End Stage Renal Disease Secondary Hyperparathyroidism (Of Renal Origin) Osteoporosis Unspecified - Disuse Osteoporosis Other Osteoporosis Disorder Of Bone And Cartilage Unspecified

15 L36214 Assays for Vitamins and Metabolic Function Vitamin D 25-hydroxy (Includes Fractions if Performed) CPT Codes: LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. Utilization Guidelines: 25-OH Vitamin D-3 (82306) may be tested up to four times per year for Vitamin D deficiencies ( ). ICD-9-CM Codes that Support Medical Necessity The Vitamin Assays Vitamin D, 25-hydroxy and Vitamin D1. 25-dihydroxy tests - are determined to be medically necessary by Medicare only when they are 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 Hyperparathyroidism, Unspecified - Secondary Hyperparathyroidism, Non-Renal Other Hyperparathyroidism Hypoparathyroidism Rickets Active Osteomalacia Unspecified Unspecified Vitamin D Deficiency Disorders Of Phosphorus Metabolism Hypocalcemia - Hypercalcemia Chronic Kidney Disease, Stage III (Moderate) - End Stage Renal Disease Secondary Hyperparathyroidism (Of Renal Origin) Osteoporosis Unspecified - Disuse Osteoporosis Other Osteoporosis Disorder Of Bone And Cartilage Unspecified

16 L32614 Assays for Vitamins and Metabolic Function Non-Covered Services/Frequency Limitations CPT Codes: 82180, 84252, 84255, 84425, 84446, 84590, 84591, 84597, LCD Description: Vitamin or micronutrient testing may not be used for routine screening. Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors. Utilization Guidelines: Limited coverage is not being established, at this time, for CPT codes 82180, 84252, 84425, 84446, and Medicare will not cover more than one test per year, per beneficiary. Non Covered Codes Assays of selenium Assays of vitamin testing, not otherwise classified Functional Intracellular Analysis Total Antioxidant Function Frequency Limitations Assay of ascorbic acid Assay of vitamin b Assay of vitamin b Assay of vitamin e Assay of vitamin a Assay of vitamin k

17 Medicare Local Coverage Determination Policy LA L34796 Biomarkers for Oncology (Page 1 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 1 Medicare is establishing the following limited coverage for colorectal cancer molecular biomarkers (also including the small intestine): KRAS (12/13) KRAS codon KRAS codon NRAS BRAF PIK3CA MSI by PCR MLH1 promoter hypermethylation 81292, 81293, Group 1 Codes MALIGNANT NEOPLASM OF DUODENUM MALIGNANT NEOPLASM OF JEJUNUM MALIGNANT NEOPLASM OF ILEUM MALIGNANT NEOPLASM OF MECKEL'S DIVERTICULUM MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SMALL INTESTINE MALIGNANT NEOPLASM OF SMALL INTESTINE UNSPECIFIED SITE MALIGNANT NEOPLASM OF HEPATIC FLEXURE MALIGNANT NEOPLASM OF TRANSVERSE COLON MALIGNANT NEOPLASM OF DESCENDING COLON MALIGNANT NEOPLASM OF SIGMOID COLON MALIGNANT NEOPLASM OF CECUM MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS MALIGNANT NEOPLASM OF ASCENDING COLON MALIGNANT NEOPLASM OF SPLENIC FLEXURE MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE 06/05/15

18 L34796 Biomarkers for Oncology (Page 2 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 2 Medicare is establishing the following limited coverage for non-small cell lung carcinoma (NSCLC) molecular biomarkers: EGFR KRAS (12/13) KRAS codon KRAS codon BRAF Group 2 Codes 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 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 06/05/15

19 L34796 Biomarkers for Oncology (Page 3 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 3 Medicare is establishing the following limited coverage for melanoma molecular biomarkers: BRAF KIT NRAS Group 3 Codes MALIGNANT MELANOMA OF SKIN OF LIP MALIGNANT MELANOMA OF SKIN OF EYELID INCLUDING CANTHUS MALIGNANT MELANOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL MALIGNANT MELANOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE MALIGNANT MELANOMA OF SKIN OF SCALP AND NECK MALIGNANT MELANOMA OF SKIN OF TRUNK EXCEPT SCROTUM MALIGNANT MELANOMA OF SKIN OF UPPER LIMB INCLUDING SHOULDER MALIGNANT MELANOMA OF SKIN OF LOWER LIMB INCLUDING HIP MALIGNANT MELANOMA OF OTHER SPECIFIED SITES OF SKIN MELANOMA OF SKIN SITE UNSPECIFIED 06/05/15

20 L34796 Biomarkers for Oncology (Page 4 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 4 Medicare is establishing the following limited coverage for brain molecular biomarkers: BRAF EGFR MGMT IDH IDH PIK3CA PTEN 81321, 81322, 81323, CIMP Group 4 Codes MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES MALIGNANT NEOPLASM OF FRONTAL LOBE MALIGNANT NEOPLASM OF TEMPORAL LOBE MALIGNANT NEOPLASM OF PARIETAL LOBE MALIGNANT NEOPLASM OF OCCIPITAL LOBE MALIGNANT NEOPLASM OF VENTRICLES MALIGNANT NEOPLASM OF CEREBELLUM NOS MALIGNANT NEOPLASM OF BRAIN STEM MALIGNANT NEOPLASM OF OTHER PARTS OF BRAIN MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE 06/05/15

21 L34796 Biomarkers for Oncology (Page 5 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 5 Medicare is establishing the following limited coverage for thyroid molecular biomarkers, for either documented, presumed or indeterminate malignancy: BRAF KRAS 81275, 81403, HRAS NRAS PIK3CA RET PAX8/PPARG Group 5 Codes 193 MALIGNANT NEOPLASM OF THYROID GLAND 226 BENIGN NEOPLASM OF THYROID GLANDS NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED ENDOCRINE GLANDS NONTOXIC UNINODULAR GOITER NONTOXIC MULTINODULAR GOITER CYST OF THYROID 06/05/15

22 L34796 Biomarkers for Oncology (Page 6 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 6 Medicare is establishing the following limited coverage for uterus/ovary/fallopian tube/peritoneum molecular biomarkers: AKT BRAF KRAS 81275, 81403, MLH1 promoter hypermethylation 81292, 81293, MSI by PCR PIK3CA PTEN 81321, 81322, 81323, TP Group 6 Codes MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED 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 FALLOPIAN TUBE MALIGNANT NEOPLASM OF BROAD LIGAMENT OF UTERUS MALIGNANT NEOPLASM OF PARAMETRIUM MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE 06/05/15

23 L34796 Biomarkers for Oncology (Page 7 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 7 Medicare is establishing the following limited coverage for urinary tract molecular biomarkers: MSI by PCR MLH1 promoter hypermethylation 81292, 81293, Group 7 Codes 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 06/05/15

24 L34796 Biomarkers for Oncology (Page 8 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 8 Medicare is establishing the following limited coverage for prostate cancer molecular biomarkers: PROGENSA PCA3 Assay Group 8 Codes 185 MALIGNANT NEOPLASM OF PROSTATE HYPERTROPHY (BENIGN) OF PROSTATE WITHOUT URINARY OBSTRUCTION AND OTHER LOWER URINARY TRACT (LUTS) HYPERTROPHY (BENIGN) OF PROSTATE WITH URINARY OBSTRUCTION AND OTHER LOWER URINARY TRACT SYMPTOMS (LUTS) NODULAR PROSTATE WITHOUT URINARY OBSTRUCTION NODULAR PROSTATE WITH URINARY OBSTRUCTION BENIGN LOCALIZED HYPERPLASIA OF PROSTATE WITHOUT URINARY OBSTRUCTION AND OTHER LOWER URINARY TRACT SYMPTOMS (LUTS) BENIGN LOCALIZED HYPERPLASIA OF PROSTATE WITH URINARY OBSTRUCTION AND OTHER LOWER URINARY TRACT SYMPTOMS LUTS) CYST OF PROSTATE HYPERPLASIA OF PROSTATE, UNSPECIFIED, WITHOUT URINARY OBSTRUCTION AND OTHER LOWER URINARY SYMPTOMS LUTS) HYPERPLASIA OF PROSTATE, UNSPECIFIED, WITH URINARY OBSTRUCTION AND OTHER LOWER URINARY SYMPTOMS (LUTS) Group 9 Medicare is establishing the following limited coverage for gastrointestinal stromal tumor molecular biomarkers: KIT PDGFRA Group 9 Codes NEOPLASM OF UNCERTAIN BEHAVIOR OF CONNECTIVE AND OTHER SOFT TISSUE 06/05/15

25 L34796 Biomarkers for Oncology (Page 9 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 10 Medicare is establishing the following limited coverage for acute lymphoid leukemia (ALL) molecular biomarkers: BCR/ABL , 81207, ABL1 (kinase domain) IGH TCRB TCRG TP MLL/AF E2A/PBX ETV6/RUNX Group 10 Codes ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION LYMPHOID LEUKEMIA ACUTE IN REMISSION ACUTE LYMPHOID LEUKEMIA, IN RELAPSE 06/05/15

26 L34796 Biomarkers for Oncology (Page 10 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 11 Medicare is establishing the following limited coverage for acute myeloid leukemia (AML, and including acute promyelocytic leukemia) molecular biomarkers: PML/RARA IDH RUNX1/RUNX1T IDH CBFB/MYH DNMT3A FLT3 ITD JAK2 (p.v617f) FLT3 D JAK2 (exon 12) NPM MPL KRAS 81275, 81403, DEK/CAN NRAS ASXL KIT EZH CEBPA TET Group 11 Codes ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION MYELOID LEUKEMIA ACUTE IN REMISSION ACUTE MYELOID LEUKEMIA, IN RELAPSE 06/05/15

27 L34796 Biomarkers for Oncology (Page 11 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 12 Medicare is establishing the following limited coverage for hairy cell leukemia molecular biomarkers: IGH somatic hypermutation IGH Group 12 Codes LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF HEAD FACE AND NECK LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRATHORACIC LYMPH NODES LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRA-ABDOMINAL LYMPH NODES LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF AXILLA AND UPPER ARM LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRAPELVIC LYMPH NODES LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING SPLEEN LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES Group 13 Medicare is establishing the following limited coverage for aplastic anemia molecular biomarkers: TCRB TCRG Group 13 Codes CONSTITUTIONAL RED BLOOD CELL APLASIA OTHER CONSTITUTIONAL APLASTIC ANEMIA RED CELL APLASIA (ACQUIRED) (ADULT) (WITH THYMOMA) OTHER SPECIFIED APLASTIC ANEMIAS APLASTIC ANEMIA UNSPECIFIED 06/05/15

28 L34796 Biomarkers for Oncology (Page 12 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 14 Medicare is establishing the following limited coverage for Burkitt s lymphoma molecular biomarkers: IGH TP Group 14 Codes BURKITT'S TUMOR OR LYMPHOMA UNSPECIFIED SITE BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES BURKITT'S TUMOR OR LYMPHOMA INVOLVING SPLEEN BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 06/05/15

29 L34796 Biomarkers for Oncology (Page 13 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 15 Medicare is establishing the following limited coverage for myeloproliferative diseases (MPD - essential thrombocytosis [ET], myelofibrosis & polycythemia vera [PV]) molecular biomarkers: BCR/ABL , 81207, JAK2 (p.v617f) JAK2 (exon 12) MPL CALR CSF3R ASXL TET EZH Group 15 Codes POLYCYTHEMIA VERA ESSENTIAL THROMBOCYTHEMIA MYELOFIBROSIS WITH MYELOID METAPLASIA MYELOFIBROSIS 06/05/15

30 L34796 Biomarkers for Oncology (Page 14 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 16 Medicare is establishing the following limited coverage for chronic myeloid leukemia (CML) and chronic myelomonocytic leukemia (CMML) molecularbiomarkers: KRAS 81275, NRAS BCR/ABL , 81207, ABL1 (kinase domain) FLT3 ITD FLT3 D KIT JAK2 (p.v617f) JAK2 (exon 12) Group 16 Codes CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION MYELOID LEUKEMIA CHRONIC IN REMISSION CHRONIC MYELOID LEUKEMIA, IN RELAPSE 06/05/15

31 L34796 Biomarkers for Oncology (Page 15 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 17 Medicare is establishing the following limited coverage for chronic lymphoid leukemia (CLL) molecular biomarkers: IGH IGH somatic hypermutation ATM TP Group 17 Codes CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION LYMPHOID LEUKEMIA CHRONIC IN REMISSION CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE Group 18 Medicare is establishing the following limited coverage for follicular lymphoma molecular biomarkers: IGH/BCL Group 18 Codes NODULAR LYMPHOMA UNSPECIFIED SITE NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES NODULAR LYMPHOMA INVOLVING SPLEEN NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 06/05/15

32 L34796 Biomarkers for Oncology (Page 16 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 19 Medicare is establishing the following limited coverage for Hypereosinophilia Syndrome (HES) molecular biomarkers: KIT (including p.d816v) FIP1L1/PDGFRA Fusion Group 19 Codes EOSINOPHILIA Group 20 Medicare is establishing the following limited coverage for mantle cell lymphoma molecular biomarkers: CCND1/IGH Group 19 Codes MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES MANTLE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK MANTLE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES MANTLE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES MANTLE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB MANTLE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB MANTLE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES MANTLE CELL LYMPHOMA, SPLEEN MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES 06/05/15

33 L34796 Biomarkers for Oncology (Page 17 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 21 Medicare is establishing the following limited coverage for mastocytosis molecular biomarkers: KIT (including p.d816v) FIP1L1/PDGFRA Fusion TCRG Group 21 Codes MALIGNANT MAST CELL TUMORS UNSPECIFIED SITE MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF HEAD FACE AND NECK MALIGNANT MAST CELL TUMORS INVOLVING INTRATHORACIC LYMPH NODES MALIGNANT MAST CELL TUMORS INVOLVING INTRA-ABDOMINAL LYMPH NODES MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB MALIGNANT MAST CELL TUMORS INVOLVING INTRAPELVIC LYMPH NODES MALIGNANT MAST CELL TUMORS INVOLVING SPLEEN MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF MULTIPLE SITES 06/05/15

34 L34796 Biomarkers for Oncology (Page 18 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 22 Medicare is establishing the following limited coverage for T-cell prolymphocytic leukemia molecular biomarkers: TCRB TCRG Group 22 Codes UNSPECIFIED LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION UNSPECIFIED LEUKEMIA IN REMISSION UNSPECIFIED LEUKEMIA, IN RELAPSE 06/05/15

35 L34796 Biomarkers for Oncology (Page 19 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 23 Medicare is establishing the following limited coverage for myelodysplastic syndrome (MDS) molecular biomarkers: FLT3 ITD IDH FLT3 D DNMT3A NPM JAK2 (p.v617f) KRAS 81275, 81403, JAK2 (exon 12) NRAS MPL KIT ASXL CEBPA EZH IDH TET Group 23 Codes LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS MYELODYSPLASTIC SYNDROME WITH 5Q DELETION MYELODYSPLASTIC SYNDROME, UNSPECIFIED 06/05/15

36 L34796 Biomarkers for Oncology (Page 20 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 24 Medicare is establishing the following limited coverage for cytogenomic microarray analysis (81406), or alternatively a single nucleotide polymorphism (SNP) array for the same testing, whose resultant mutation identifications are used in the diagnosis/prognosis of various hematological malignancies. Group 24 Codes MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION MULTIPLE MYELOMA IN REMISSION MULTIPLE MYELOMA, IN RELAPSE CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION ACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION MONOCYTIC LEUKEMIA ACUTE IN REMISSION ACUTE MONOCYTIC LEUKEMIA, IN RELAPSE CHRONIC MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS MYELODYSPLASTIC SYNDROME WITH 5Q DELETION MYELODYSPLASTIC SYNDROME, UNSPECIFIED POLYCLONAL HYPERGAMMAGLOBULINEMIA MONOCLONAL PARAPROTEINEMIA 06/05/15

37 L34796 Biomarkers for Oncology (Page 21 of 21) CPT Codes: 81206, 81207, 81208, 81210, 81235, 81245, 81246, 81261, 81263, 81270, 81275, 81287, 81292, 81293, 81294, 81301, 81310, 81313, 81315, 81321, 81322, 81323, 81340, 81342, 81350, 81400, 81401, 81402, 81403, 81404, 81405, 81406, 81407, 81408, 81435, 81436, LCD Description: This current document focuses upon selected testing in oncology, with some emphasis upon applying the revised 2015 CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Group 25 Medicare is establishing the following limited coverage for Myeloma gene expression profile (MyPRS) (81479): Group 25 Codes * MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION * MULTIPLE MYELOMA, IN RELAPSE Note: should be reported after initial diagnosis has been made and should be reported if there has been a relapse with a change in treatment planned. 06/05/15

38 L33638 Biomarkers Overview (Page 1 of 6) CPT Codes: 81161, 81200, 81201, 81202, 81203, 81205, 81209, 81211, 81212, 81213, 81214, 81215, 81216, 81217, 81220, 81221, 81222, 81223, 81224, 81225, 81226, 81227, 81240, 81241, 81242, 81243, 81244, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81260, 81265, 81266, 81267, 81268, 81280, 81281, 81282, 81290, 81291, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81302, 81303, 81304, 81317, 81318, 81319, 81321, 81322, 81323, 81324, 81325, 81326, 81330, 81331, 81332, 81355, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, LCD Description: This current LCD focuses upon selected testing in oncology, with some emphasis upon applying the revised 2013 (and 2014) CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Covered Codes Apc gene full sequence Apc gene known fam variants Apc gene dup/delet variants Brca1&2 seq & com dup/del Brca1&2 185&5385&6174 var Brca1&2 uncom dup/del var Brca1 full seq & com dup/del Brca1 gene known fam variant Brca2 gene full sequence Brca2 gene known fam variant F2 gene F5 gene

39 L33638 Biomarkers Overview (Page 2 of 6 ) CPT Codes: 81161, 81200, 81201, 81202, 81203, 81205, 81209, 81211, 81212, 81213, 81214, 81215, 81216, 81217, 81220, 81221, 81222, 81223, 81224, 81225, 81226, 81227, 81240, 81241, 81242, 81243, 81244, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81260, 81265, 81266, 81267, 81268, 81280, 81281, 81282, 81290, 81291, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81302, 81303, 81304, 81317, 81318, 81319, 81321, 81322, 81323, 81324, 81325, 81326, 81330, 81331, 81332, 81355, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, LCD Description: This current LCD focuses upon selected testing in oncology, with some emphasis upon applying the revised 2013 (and 2014) CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Covered Per LCD Biomarkers for Oncology Mlh 1 gene full seq Mlh 1 gene known variants Mlh 1 gene dup/delete variant Microsatellite instability Pten gene full sequence Pten gene known fam variant Pten gene dup/delet variant

40 L33638 Biomarkers Overview (Page 3 of 6 ) CPT Codes: 81161, 81200, 81201, 81202, 81203, 81205, 81209, 81211, 81212, 81213, 81214, 81215, 81216, 81217, 81220, 81221, 81222, 81223, 81224, 81225, 81226, 81227, 81240, 81241, 81242, 81243, 81244, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81260, 81265, 81266, 81267, 81268, 81280, 81281, 81282, 81290, 81291, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81302, 81303, 81304, 81317, 81318, 81319, 81321, 81322, 81323, 81324, 81325, 81326, 81330, 81331, 81332, 81355, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, LCD Description: This current LCD focuses upon selected testing in oncology, with some emphasis upon applying the revised 2013 (and 2014) CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Covered If Age Less Than G6pc gene Gba gene Gjb2 gene full sequence Gjb2 gene known fam variants Gjb6 gene com variants Hexa gene Mcoln1 gene

41 L33638 Biomarkers Overview (Page 4 of 6) CPT Codes: 81161, 81200, 81201, 81202, 81203, 81205, 81209, 81211, 81212, 81213, 81214, 81215, 81216, 81217, 81220, 81221, 81222, 81223, 81224, 81225, 81226, 81227, 81240, 81241, 81242, 81243, 81244, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81260, 81265, 81266, 81267, 81268, 81280, 81281, 81282, 81290, 81291, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81302, 81303, 81304, 81317, 81318, 81319, 81321, 81322, 81323, 81324, 81325, 81326, 81330, 81331, 81332, 81355, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, LCD Description: This current LCD focuses upon selected testing in oncology, with some emphasis upon applying the revised 2013 (and 2014) CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Covered If Age Less Than Pmp22 gene dup/delet Pmp22 gene full sequence Pmp22 gene known fam variant

42 L33638 Biomarkers Overview (Page 5 of 6) CPT Codes: 81161, 81200, 81201, 81202, 81203, 81205, 81209, 81211, 81212, 81213, 81214, 81215, 81216, 81217, 81220, 81221, 81222, 81223, 81224, 81225, 81226, 81227, 81240, 81241, 81242, 81243, 81244, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81260, 81265, 81266, 81267, 81268, 81280, 81281, 81282, 81290, 81291, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81302, 81303, 81304, 81317, 81318, 81319, 81321, 81322, 81323, 81324, 81325, 81326, 81330, 81331, 81332, 81355, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, LCD Description: This current LCD focuses upon selected testing in oncology, with some emphasis upon applying the revised 2013 (and 2014) CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Covered If Age Less Than Fancc gene Hfe gene Hba1/hba2 gene Msh2 gene full seq Msh2 gene known variants Msh2 gene dup/delete variant Msh6 gene full seq Msh6 gene known variants Msh6 gene dup/delete variant Pms2 gene full seq analysis Pms2 known familial variants Pms2 gene dup/delet variants Serpina1 gene

43 L33638 Biomarkers Overview (Page 6 of 6) CPT Codes: 81161, 81200, 81201, 81202, 81203, 81205, 81209, 81211, 81212, 81213, 81214, 81215, 81216, 81217, 81220, 81221, 81222, 81223, 81224, 81225, 81226, 81227, 81240, 81241, 81242, 81243, 81244, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81260, 81265, 81266, 81267, 81268, 81280, 81281, 81282, 81290, 81291, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81302, 81303, 81304, 81317, 81318, 81319, 81321, 81322, 81323, 81324, 81325, 81326, 81330, 81331, 81332, 81355, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, LCD Description: This current LCD focuses upon selected testing in oncology, with some emphasis upon applying the revised 2013 (and 2014) CPT molecular coding format. The official NIH definition of a biomarker is: "a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes pathogenic processes, or pharmacologic response to a therapeutic intervention. Non Covered Codes Dmd dup/delet analysis Aspa gene Bckdhb gene Blm gene Cftr gene com variants Cftr gene known fam variants Cftr gene dup/delet variants Cftr gene full sequence Cftr gene intron poly t Fmr1 gene detection Non Covered Codes Fmr1 gene characterization Ikbkap gene Long qt synd gene full sequence Long qt synd known fam var Long qt syn gene dup/dlt var Mecp2 gene full seq Mecp2 gene known variant Mecp2 gene dup/delet variant Smpd1 gene common variants Snrpn/ube3a gene

44 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 1 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 HUMAN T-CELL LYMPHOTROPHIC VIRUS TYPE I [HTLV-I] - HUMAN IMMUNODEFICIENCY VIRUS TYPE 2 [HIV-2] REITER'S DISEASE MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF LOWER THIRD OF ESOPHAGUS MALIGNANT NEOPLASM OF OTHER SPECIFIED PART OF ESOPHAGUS MALIGNANT NEOPLASM OF ESOPHAGUS UNSPEC SITE MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF GREATER CURVATURE OF STOMACH UNSPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF STOMACH 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 MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

45 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 2 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 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

46 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 3 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 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

47 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 4 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 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 COCCYX SOFT TISSUE OF ABDOMEN

48 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 5 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 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

49 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 6 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 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

50 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 7 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 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 UNSPECIFIED SITES OF MALE BREAST

51 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 8 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 179 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 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 181 MALIGNANT NEOPLASM OF PLACENTA

52 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 9 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 MALIGNANT NEOPLASM OF FEMALE GENITAL ORGAN SITE UNSPECIFIED 185 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 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

53 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 10 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 193 MALIGNANT NEOPLASM OF THYROID GLAND MALIGNANT NEOPLASM OF ADRENAL GLAND 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

54 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 11 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 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

55 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 12 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF MULTIPLE SITES ANAPLASTIC LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

56 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 13 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE - HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S GRANULOMA UNSPECIFIED SITE - HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S SARCOMA UNSPECIFIED SITE - HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S DISEASE NODULAR SCLEROSIS UNSPECIFIED SITE - HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S DISEASE MIXED CELLULARITY UNSPECIFIED SITE - HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH NODES OF MULTIPLE SITES

57 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 14 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 HODGKIN'S DISEASE UNSPECIFIED TYPE UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES NODULAR LYMPHOMA UNSPECIFIED SITE - NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES MYCOSIS FUNGOIDES UNSPECIFIED SITE - MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES SEZARY'S DISEASE UNSPECIFIED SITE - SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES MALIGNANT HISTIOCYTOSIS UNSPECIFIED SITE - MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE - LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES LETTERER-SIWE DISEASE UNSPECIFIED SITE - LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES MALIGNANT MAST CELL TUMORS UNSPECIFIED SITE - MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF MULTIPLE SITES PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE - OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES

58 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 15 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MULTIPLE MYELOMA, IN RELAPSE PLASMA CELL LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - PLASMA CELL LEUKEMIA, IN RELAPSE OTHER IMMUNOPROLIFERATIVE NEOPLASMS, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE LYMPHOID LEUKEMIA, IN RELAPSE CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE SUBACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - SUBACUTE LYMPHOID LEUKEMIA, IN RELAPSE OTHER LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER LYMPHOID LEUKEMIA, IN RELAPSE UNSPECIFIED LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE

59 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 16 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE MYELOID LEUKEMIA, IN RELAPSE CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC MYELOID LEUKEMIA, IN RELAPSE SUBACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - SUBACUTE MYELOID LEUKEMIA, IN RELAPSE MYELOID SARCOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MYELOID SARCOMA, IN RELAPSE OTHER MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER MYELOID LEUKEMIA, IN RELAPSE UNSPECIFIED MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - UNSPECIFIED MYELOID LEUKEMIA, IN RELAPSE ACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE MONOCYTIC LEUKEMIA, IN RELAPSE CHRONIC MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC MONOCYTIC LEUKEMIA, IN RELAPSE SUBACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - SUBACUTE MONOCYTIC LEUKEMIA, IN RELAPSE OTHER MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER MONOCYTIC LEUKEMIA, IN RELAPSE

60 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 17 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 UNSPECIFIED MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - UNSPECIFIED MONOCYTIC LEUKEMIA, IN RELAPSE ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, IN RELAPSE CHRONIC ERYTHREMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC ERYTHREMIA, IN RELAPSE MEGAKARYOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MEGAKARYOCYTIC LEUKEMIA, IN RELAPSE OTHER SPECIFIED LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER SPECIFIED LEUKEMIA, IN RELAPSE ACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE CHRONIC LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE SUBACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - SUBACUTE LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE OTHER LEUKEMIA OF UNSPECIFIED CELL TYPE, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER LEUKEMIA OF UNSPECIFIED CELL TYPE, IN RELAPSE

61 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 18 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 UNSPECIFIED LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - UNSPECIFIED LEUKEMIA, IN RELAPSE BENIGN NEOPLASM OF ADRENAL GLAND CARCINOMA IN SITU OF BREAST NEOPLASM OF UNCERTAIN BEHAVIOR OF MAJOR SALIVARY GLANDS - NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPEC RESPIRATORY ORGANS NEOPLASM OF UNCERTAIN BEHAVIOR OF UTERUS NEOPLASM OF UNCERTAIN BEHAVIOR OF OVARY NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED FEMALE GENITAL ORGANS NEOPLASM OF UNCERTAIN BEHAVIOR OF TESTIS NEOPLASM OF UNCERTAIN BEHAVIOR OF PROSTATE NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED MALE GENITAL ORGANS NEOPLASM OF UNCERTAIN BEHAVIOR OF BLADDER NEOPLASM OF UNCERTAIN BEHAVIOR OF CONNECTIVE AND OTHER SOFT TISSUE NEOPLASM OF UNCERTAIN BEHAVIOR OF SKIN NEOPLASM OF UNCERTAIN BEHAVIOR OF BREAST ESSENTIAL THROMBOCYTHEMIA - POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD) OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER SPECIFIED SITES CARCINOID SYNDROME MONOCLONAL PARAPROTEINEMIA - MACROGLOBULINEMIA OTHER DISORDERS OF PLASMA PROTEIN METABOLISM - UNSPECIFIED DISORDER OF PLASMA PROTEIN METABOLISM

62 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 19 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 HYPOGAMMAGLOBULINEMIA UNSPECIFIED - COMMON VARIABLE IMMUNODEFICIENCY OTHER DEFICIENCY OF HUMORAL IMMUNITY IMMUNODEFICIENCY WITH PREDOMINANT T-CELL DEFECT UNSPECIFIED - NEZELOF'S SYNDROME OTHER DEFICIENCY OF CELL-MEDIATED IMMUNITY COMBINED IMMUNITY DEFICIENCY UNSPECIFIED IMMUNITY DEFICIENCY AUTOIMMUNE LYMPHOPROLIFERATIVE SYNDROME AUTOIMMUNE DISEASE, NOT ELSEWHERE CLASSIFIED GRAFT-VERSUS-HOST DISEASE, UNSPECIFIED - ACUTE ON CHRONIC GRAFT-VERSUS-HOST DISEASE OTHER SPECIFIED DISORDERS INVOLVING THE IMMUNE MECHANISM - UNSPECIFIED DISORDER OF IMMUNE MECHANISM HEREDITARY SPHEROCYTOSIS 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

63 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 20 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 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 PRIMARY THROMBOCYTOPENIA,UNSPECIFIED - CONGENITAL AND HEREDITARY THROMBOCYTOPENIC PURPURA OTHER PRIMARY THROMBOCYTOPENIA THROMBOCYTOPENIA UNSPECIFIED NEUTROPENIA, UNSPECIFIED - NEUTROPENIA DUE TO INFECTION OTHER NEUTROPENIA FUNCTIONAL DISORDERS OF POLYMORPHONUCLEAR NEUTROPHILS - HEMOPHAGOCYTIC SYNDROMES LEUKOCYTOPENIA, UNSPECIFIED - LYMPHOCYTOPENIA OTHER DECREASED WHITE BLOOD CELL COUNT LEUKOCYTOSIS, UNSPECIFIED BASOPHILIA OTHER ELEVATED WHITE BLOOD CELL COUNT OTHER SPECIFIED DISEASE OF WHITE BLOOD CELLS - UNSPECIFIED DISEASE OF WHITE BLOOD CELLS

64 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 21 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 HYPERSPLENISM DISEASE OF SPLEEN UNSPECIFIED - NEUTROPENIC SPLENOMEGALY OTHER DISEASES OF SPLEEN MYELOFIBROSIS UNSPECIFIED DISEASES OF BLOOD AND BLOOD- FORMING ORGANS UNSPECIFIED IRIDOCYCLITIS 452 PORTAL VEIN THROMBOSIS EMBOLISM AND THROMBOSIS OF UNSPECIFIED SITE REGIONAL ENTERITIS OF SMALL INTESTINE - REGIONAL ENTERITIS OF SMALL INTESTINE WITH LARGE INTESTINE REGIONAL ENTERITIS OF UNSPECIFIED SITE ULCERATIVE (CHRONIC) ENTEROCOLITIS - UNIVERSAL ULCERATIVE (CHRONIC) COLITIS ULCERATIVE COLITIS UNSPECIFIED 630 HYDATIDIFORM MOLE PSORIATIC ARTHROPATHY CHRONIC OR UNSPECIFIED POLYARTICULAR JUVENILE RHEUMATOID ARTHRITIS ANKYLOSING SPONDYLITIS - SACROILIITIS NOT ELSEWHERE CLASSIFIED INFLAMMATORY SPONDYLOPATHIES IN DISEASES CLASSIFIED ELSEWHERE OTHER INFLAMMATORY SPONDYLOPATHIES UNSPECIFIED INFLAMMATORY SPONDYLOPATHY ENLARGEMENT OF LYMPH NODES SPLENOMEGALY ABDOMINAL OR PELVIC SWELLING MASS OR LUMP UNSPECIFIED SITE - ABDOMINAL OR PELVIC SWELLING MASS OR LUMP GENERALIZED

65 Medicare Local Coverage Determination Policy LA Flow Cytometry (L33526) (Page 22 of 22) Testing performed by Quest Diagnostics Nichols Institute CPT Codes: 88182, 88184, 88185, 88187, 88188, 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 ABDOMINAL OR PELVIC SWELLING MASS OR LUMP OTHER SPECIFIED SITE PROTEINURIA OTHER NONSPECIFIC ABNORMAL HISTOLOGICAL FINDINGS COMPLICATIONS OF UNSPECIFIED TRANSPLANTED ORGAN - COMPLICATIONS OF TRANSPLANTED ORGAN INTESTINE COMPLICATIONS OF TRANSPLANTED ORGAN, STEM CELL COMPLICATIONS OF OTHER SPECIFIED TRANSPLANTED ORGAN V08 ASYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION STATUS V V10.63 PERSONAL HISTORY OF UNSPECIFIED LEUKEMIA - PERSONAL HISTORY OF MONOCYTIC LEUKEMIA V10.69 PERSONAL HISTORY OF OTHER LEUKEMIA V V42.7 KIDNEY REPLACED BY TRANSPLANT - LIVER REPLACED BY TRANSPLANT V 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

66 L32731 Frequency of Laboratory Tests Glucose Testing CPT Codes: 82948, LCD Description: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services. LCD Frequency Limit: Once per month. Acceptable Reasons (ICD-9-CM Codes) for Exceeding the LCD Maximum: Uncontrolled Diabetes MellitusThyrotoxicosis Codes pertaining to the above bullets: /01/13

67 Medicare Local Coverage Determination Policy LA L32731 Frequency of Laboratory Tests - Lipids CPT Codes: 80061, 82465, 83718, 83721, LCD Description: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services. LCD Frequency Limit: No more than every two months for any test (e.g. triglycerides, LDL cholesterol), whether ordered in a panel or separately ordered. Acceptable Reasons (ICD-9-CM Codes) for Exceeding the LCD Maximum: Pancreatitis V58,69 Inability To Stabilize Lipid-Lowering Drug Dosing V58.69 Adverse Reaction To Lipid-Lowering Drug 05/01/13

68 L32731 Frequency of Laboratory Tests Thyroid Testing CPT Codes: 84436, 84439, 84443, LCD Description: This LCD imposes utilization guideline limitations. Despite Medicare's allowing up to these maximums, each patient s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient s medical record. Medicare expects that patients will not routinely require the maximum allowable number of services. LCD Frequency Limit: Four times a year for most patients, except for selected endocrine presentations. Acceptable Reasons (ICD-9-CM Codes) for Exceeding the LCD Maximum: Inability To Stabilize Thyroid Medication Dosing Thyrotoxicosis Concurrent Endocrinopathies Hypothyroidism Codes pertaining to the above bullets: V /01/13

69 Medicare Local Coverage Determination Policy - LA L33644 Molecular Diagnostics: Genitourinary Infectious Disease esting T (Page 1 of 7) CPT Codes: 87480, 87490, 87491, 87510, 87590, 87591, LCD Description: Molecular diagnostic testing provides sensitive, specific and timely (i.e., relative to that of traditional culture-based methods) identification of diverse biological entities, including microorganisms and tumors. The current LCD will focus upon coverage of the more prevalent (typical) bacterial and fungal organisms (per the eight organism-specific CPT codes, ranging from to 87660) which are encountered for the majority of gynecological infectious presentations. Conversely, there are less typically encountered (rare) pathogens for which genitourinary (GU) microbiological evaluations (i.e., sometimes including panel testing) are less well-established and even investigational. In this context, medical review, educational outreach, etc. will be conducted on an as-needed basis. ICD-9-CM Codes that Support Medical Necessity Genitourinary Infectious Disease tests are determined to be medically necessary by Medicare only when they are 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 Trachoma Initial Stage - Trachoma Active Stage Trachoma Unspecified Inclusion Conjunctivitis Unspecified Diseases Of Conjunctiva Due To Chlamydiae - Unspecified Diseases Of Conjunctiva Due To Viruses Gonococcal Infection (Acute) Of Lower Genitourinary Tract Gonococcal Infection (Acute) Of Upper Genitourinary Tract Site Unspecified - Gonococcal Salpingitis Specified As Acute Other Gonococcal Infection (Acute) Of Upper Genitourinary Tract Gonococcal Infection Chronic Of Lower Genitourinary Tract Chronic Gonococcal Infection Of Upper Genitourinary Tract Site Unspecified - Gonococcal Salpingitis (Chronic) Other Chronic Gonococcal Infection Of Upper Genitourinary Tract Gonococcal Conjunctivitis (Neonatorum) - Gonococcal Keratitis Other Gonococcal Infection Of Eye Gonococcal Arthritis - Gonococcal Spondylitis Other Gonococcal Infection Of Joint 12/05/13

70 Medicare Local Coverage Determination Policy - LA L33644 Molecular Diagnostics: Genitourinary Infectious Disease esting T (Page 2 of 7) CPT Codes: 87480, 87490, 87491, 87510, 87590, 87591, LCD Description: Molecular diagnostic testing provides sensitive, specific and timely (i.e., relative to that of traditional culture-based methods) identification of diverse biological entities, including microorganisms and tumors. The current LCD will focus upon coverage of the more prevalent (typical) bacterial and fungal organisms (per the eight organism-specific CPT codes, ranging from to 87660) which are encountered for the majority of gynecological infectious presentations. Conversely, there are less typically encountered (rare) pathogens for which genitourinary (GU) microbiological evaluations (i.e., sometimes including panel testing) are less well-established and even investigational. In this context, medical review, educational outreach, etc. will be conducted on an as-needed basis. ICD-9-CM Codes that Support Medical Necessity Genitourinary Infectious Disease tests are determined to be medically necessary by Medicare only when they are 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 Gonococcal Infection Of Pharynx - Gonococcal Infection Of Anus And Rectum Gonococcal Keratosis (Blennorrhagica) - Gonococcal Peritonitis Gonococcal Infection Of Other Specified Sites Lymphogranuloma Venereum Reiter's Disease Other Nongonococcal Urethritis Chlamydia Trachomatis Other Venereal Diseases Due To Chlamydia Trachomatis Unspecified Site - Other Venereal Diseases Due To Chlamydia Trachomatis Peritoneum Other Venereal Diseases Due To Chlamydia Trachomatis Other Specified Site Candidiasis Of Vulva And Vagina - Candidiasis Of Other Urogenital Sites Urogenital Trichomoniasis Unspecified - Trichomonal Prostatitis Other Urogenital Trichomoniasis Trichomoniasis Of Other Specified Sites - Trichomoniasis Unspecified Neutropenia, Unspecified - Neutropenia Due To Infection Other Neutropenia Bandemia Other Specified Disease Of White Blood Cells 12/05/13

71 Medicare Local Coverage Determination Policy - LA L33644 Molecular Diagnostics: Genitourinary Infectious Disease esting T (Page 3 of 7) CPT Codes: 87480, 87490, 87491, 87510, 87590, 87591, LCD Description: Molecular diagnostic testing provides sensitive, specific and timely (i.e., relative to that of traditional culture-based methods) identification of diverse biological entities, including microorganisms and tumors. The current LCD will focus upon coverage of the more prevalent (typical) bacterial and fungal organisms (per the eight organism-specific CPT codes, ranging from to 87660) which are encountered for the majority of gynecological infectious presentations. Conversely, there are less typically encountered (rare) pathogens for which genitourinary (GU) microbiological evaluations (i.e., sometimes including panel testing) are less well-established and even investigational. In this context, medical review, educational outreach, etc. will be conducted on an as-needed basis. ICD-9-CM Codes that Support Medical Necessity Genitourinary Infectious Disease tests are determined to be medically necessary by Medicare only when they are 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 Chronic Lymphadenitis Neutropenic Splenomegaly Myelofibrosis Acute Conjunctivitis Unspecified Acute Follicular Conjunctivitis - Other Mucopurulent Conjunctivitis Chronic Conjunctivitis Unspecified - Chronic Follicular Conjunctivitis Cystitis In Diseases Classified Elsewhere Urethritis Unspecified - Urethral Syndrome Nos Acute Prostatitis Other Specified Inflammatory Diseases Of Prostate - Prostatitis Unspecified Orchitis Epididymitis And Epididymo-Orchitis With Abscess Orchitis And Epididymitis Unspecified - Orchitis And Epididymitis In Diseases Classified Elsewhere Other Specified Disorders Of Male Genital Organs Acute Salpingitis And Oophoritis Salpingitis And Oophoritis Not Specified As Acute Subacute Or Chronic - Chronic Or Unspecified Parametritis And Pelvic Cellulitis Pelvic Peritoneal Adhesions Female (Postoperative) (Postinfection) 12/05/13

72 Medicare Local Coverage Determination Policy - LA L33644 Molecular Diagnostics: Genitourinary Infectious Disease esting T (Page 4 of 7) CPT Codes: 87480, 87490, 87491, 87510, 87590, 87591, LCD Description: Molecular diagnostic testing provides sensitive, specific and timely (i.e., relative to that of traditional culture-based methods) identification of diverse biological entities, including microorganisms and tumors. The current LCD will focus upon coverage of the more prevalent (typical) bacterial and fungal organisms (per the eight organism-specific CPT codes, ranging from to 87660) which are encountered for the majority of gynecological infectious presentations. Conversely, there are less typically encountered (rare) pathogens for which genitourinary (GU) microbiological evaluations (i.e., sometimes including panel testing) are less well-established and even investigational. In this context, medical review, educational outreach, etc. will be conducted on an as-needed basis. ICD-9-CM Codes that Support Medical Necessity Genitourinary Infectious Disease tests are determined to be medically necessary by Medicare only when they are 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 Other Specified Inflammatory Disease Of Female Pelvic Organs And Tissues - Unspecified Inflammatory Disease Of Female Pelvic Organs And Tissues Cervicitis And Endocervicitis Vaginitis And Vulvovaginitis Unspecified Vaginitis And Vulvovaginitis In Diseases Classified Elsewhere Cyst Of Bartholin's Gland Abscess Of Bartholin's Gland Other Abscess Of Vulva Ulceration Of Vulva Unspecified Ulceration Of Vulva In Diseases Classified Elsewhere Mucositis (Ulcerative) Of Cervix, Vagina, And Vulva Other Inflammatory Disease Of Cervix, Vagina And Vulva Unspecified Inflammatory Disease Of Cervix Vagina And Vulva Infertility Female Of Tubal Origin Other Specified Disorders Of Female Genital Organs 683 Acute Lymphadenitis 12/05/13

73 Medicare Local Coverage Determination Policy LA L33644 Molecular Diagnostics: Genitourinary Infectious Disease Test ing (Page 5 of 7) CPT Codes: 87480, 87490, 87491, 87510, 87590, 87591, LCD Description: Molecular diagnostic testing provides sensitive, specific and timely (i.e., relative to that of traditional culture-based methods) identification of diverse biological entities, including microorganisms and tumors. The current LCD will focus upon coverage of the more prevalent (typical) bacterial and fungal organisms (per the eight organism-specific CPT codes, ranging from to 87660) which are encountered for the majority of gynecological infectious presentations. Conversely, there are less typically encountered (rare) pathogens for which genitourinary (GU) microbiological evaluations (i.e., sometimes including panel testing) are less well-established and even investigational. In this context, medical review, educational outreach, etc. will be conducted on an as-needed basis. ICD-9-CM Codes that Support Medical Necessity Genitourinary Infectious Disease tests are determined to be medically necessary by Medicare only when they are 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 Unspecified Infective Arthritis Site Unspecified - Unspecified Infective Arthritis Involving Multiple Sites Unspecified Polyarthropathy Or Polyarthritis Site Unspecified - Unspecified Polyarthropathy Or Polyarthritis Involving Multiple Sites Unspecified Monoarthritis Site Unspecified - Unspecified Monoarthritis Involving Other Specified Sites Unspecified Arthropathy Site Unspecified - Unspecified Arthropathy Involving Multiple Sites Pain In Joint Site Unspecified - Pain In Joint Involving Multiple Sites Synovitis And Tenosynovitis Unspecified Other Tenosynovitis Of Hand And Wrist - Tenosynovitis Of Foot And Ankle Other Synovitis And Tenosynovitis Neonatal Conjunctivitis And Dacryocystitis Fever, Unspecified - Fever Presenting With Conditions Classified Elsewhere Rash And Other Nonspecific Skin Eruption Enlargement Of Lymph Nodes Dysuria Urinary Hesitancy - Straining On Urination Urethral Discharge Abdominal Pain Unspecified Site - Abdominal Pain Generalized 12/05/13

74 Medicare Local Coverage Determination Policy LA L33644 Molecular Diagnostics: Genitourinary Infectious Disease Test ing (Page 6 of 7) CPT Codes: 87480, 87490, 87491, 87510, 87590, 87591, LCD Description: Molecular diagnostic testing provides sensitive, specific and timely (i.e., relative to that of traditional culture-based methods) identification of diverse biological entities, including microorganisms and tumors. The current LCD will focus upon coverage of the more prevalent (typical) bacterial and fungal organisms (per the eight organism-specific CPT codes, ranging from to 87660) which are encountered for the majority of gynecological infectious presentations. Conversely, there are less typically encountered (rare) pathogens for which genitourinary (GU) microbiological evaluations (i.e., sometimes including panel testing) are less well-established and even investigational. In this context, medical review, educational outreach, etc. will be conducted on an as-needed basis. ICD-9-CM Codes that Support Medical Necessity Genitourinary Infectious Disease tests are determined to be medically necessary by Medicare only when they are 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 Unspecified Infective Arthritis Site Unspecified - Unspecified Infective Arthritis Involving Multiple Sites Unspecified Polyarthropathy Or Polyarthritis Site Unspecified - Unspecified Polyarthropathy Or Polyarthritis Involving Multiple Sites Unspecified Monoarthritis Site Unspecified - Unspecified Monoarthritis Involving Other Specified Sites Unspecified Arthropathy Site Unspecified - Unspecified Arthropathy Involving Multiple Sites Pain In Joint Site Unspecified - Pain In Joint Involving Multiple Sites Synovitis And Tenosynovitis Unspecified Other Tenosynovitis Of Hand And Wrist - Tenosynovitis Of Foot And Ankle Other Synovitis And Tenosynovitis Neonatal Conjunctivitis And Dacryocystitis Fever, Unspecified - Fever Presenting With Conditions Classified Elsewhere Rash And Other Nonspecific Skin Eruption Enlargement Of Lymph Nodes Dysuria Urinary Hesitancy - Straining On Urination Urethral Discharge Abdominal Pain Unspecified Site - Abdominal Pain Generalized 12/05/13

75 Medicare Local Coverage Determination Policy LA L33644 Molecular Diagnostics: Genitourinary Infectious Disease Testing (Page 7 of 7) CPT Codes: 87481, LCD Description: Molecular diagnostic testing provides sensitive, specific and timely (i.e., relative to that of traditional culture-based methods) identification of diverse biological entities, including microorganisms and tumors. The current LCD will focus upon coverage of the more prevalent (typical) bacterial and fungal organisms (per the eight organism-specific CPT codes, ranging from to 87660) which are encountered for the majority of gynecological infectious presentations. Conversely, there are less typically encountered (rare) pathogens for which genitourinary (GU) microbiological evaluations (i.e., sometimes including panel testing) are less well-established and even investigational. In this context, medical review, educational outreach, etc. will be conducted on an as-needed basis. Utilization Guidelines: No more than two individual microorganisms may be concurrently billed for CPT and ICD-9-CM Codes that Support Medical Necessity Genitourinary Infectious Disease tests are determined to be medically necessary by Medicare only when they are 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 and are considered on a case by case basis. 12/05/13

76 L34352 Qualitative Drug Screening (Page 1 of 2) CPT Codes: G0431, G0434 LCD Description: A qualitative drug screen may be indicated with a symptomatic patient when the history is unreliable, with a multiple-drug ingestion, with a patient in delirium or coma, for the identification of specific drugs, and to indicate when antagonists may be used. The clinical utility of drug screens in the emergency setting may be limited because patient management decisions are unaffected since most therapy for drug poisonings is symptom directed and supportive. Utilization Guidelines: Drug screening for medico-legal purposes (e.g., court-ordered drug screening) or for employment purposes (e.g., as a pre-requisite for employment or as a requirement for continuation of employment) is not covered. ICD-9-CM Codes that Support Medical Necessity The Qualitative Drug Screening 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 Acidosis Simple Type Schizophrenia Unspecified State Disorganized Type Schizophrenia Unspecified State Catatonic Type Schizophrenia Unspecified State Paranoid Type Schizophrenia Unspecified State Opioid Type Dependence Continuous Use Unspecified Drug Dependence Unspecified Use Other Mixed Or Unspecified Drug Abuse Unspecified Use Generalized Convulsive Epilepsy Without Intractable Epilepsy Generalized Convulsive Epilepsy With Intractable Epilepsy Grand Mal Status Epileptic Epilepsy Unspecified Without Intractable Epilepsy Epilepsy Unspecified With Intractable Epilepsy Atrioventricular Block Unspecified First Degree Atrioventricular Block Mobitz (Type) Ii Atrioventricular Block Other Second Degree Atrioventricular Block Long Qt Syndrome Paroxysmal Supraventricular Tachycardia Paroxysmal Ventricular Tachycardia Coma Alteration Of Consciousness Other Hallucinations Other Convulsions Altered Mental Status Poisoning By Antiallergic And Antiemetic Drugs Poisoning By Opium (Alkaloids) Unspecified Poisoning By Heroin Poisoning By Methadone Poisoning By Other Opiates And Related Narcotics Poisoning By Salicylates Poisoning By Aromatic Analgesics Not Elsewhere Classified Poisoning By Pyrazole Derivatives Poisoning By Propionic Acid Derivatives Poisoning By Hydantoin Derivatives Poisoning By Barbiturates 03/25/13

77 L34352 Qualitative Drug Screening (Page 2 of 2) CPT Codes: G0431, G0434 LCD Description: A qualitative drug screen may be indicated with a symptomatic patient when the history is unreliable, with a multiple-drug ingestion, with a patient in delirium or coma, for the identification of specific drugs, and to indicate when antagonists may be used. The clinical utility of drug screens in the emergency setting may be limited because patient management decisions are unaffected since most therapy for drug poisonings is symptom directed and supportive. Utilization Guidelines: Drug screening for medico-legal purposes (e.g., court-ordered drug screening) or for employment purposes (e.g., as a pre-requisite for employment or as a requirement for continuation of employment) is not covered. ICD-9-CM Codes that Support Medical Necessity The Qualitative Drug Screening 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 Poisoning By Chloral Hydrate Group Poisoning By Paraldehyde Poisoning By Paraldehyde Poisoning By Bromine Compounds Poisoning By Methaqualone Compounds Poisoning By Glutethimide Group Poisoning By Mixed Sedatives Not Elsewhere Classified Poisoning By Other Sedatives And Hypnotics Poisoning By Unspecified Sedative Or Hypnotic Poisoning By Antidepressant, Unspecified Poisoning By Monoamine Oxidase Inhibitors Poisoning By Selective Serotonin And Norepinephrine Reuptake Inhibitors Poisoning By Selective Serotonin Reuptake Inhibitors Poisoning By Tetracyclic Antidepressants Poisoning By Tricyclic Antidepressants Poisoning By Other Antidepressants Poisoning By Phenothiazine-Based Tranquilizers Poisoning By Butyrophenone-Based Tranquilizers Poisoning By Other Antipsychotics Neuroleptics And Major Tranquilizers Poisoning By Benzodiazepine-Based Tranquilizers Poisoning By Other Tranquilizers Poisoning By Psychodysleptics (Hallucinogens) Poisoning By Psychostimulant, Unspecified Poisoning By Caffeine Poisoning By Amphetamines Poisoning By Methylphenidate Poisoning By Other Psychostimulants Poisoning By Other Specified Psychotropic Agents Poisoning By Unspecified Psychotropic Agent Poisoning By Cocaine Poisoning By Other Central Nervous System Stimulants Poisoning By Cardiotonic Glycosides And Drugs Of Similar Action 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 03/25/13

78 Medicare Local Coverage Determination Policy LA L31686 Services That Are Not Reasonable and Necessary CPT Codes: LCD Description: Inclusion of a service or procedure in this non-coverage LCD indicates that the service is considered to be not reasonable and necessary and claims reporting the service will be denied as such. Lipoprotein, direct measurement; VLDL cholesterol (procedure code 83719) is considered a non-covered code. NCEP recommendations do not include monitoring of VLDL levels for treatment of elevated cholesterol as risk factors for coronary and vascular atherosclerosis. Non-Covered Codes Assay of blood lipoprotein