Colony Stimulating Factors: Neupogen® (filgrastim), Neulasta® (pegfilgrastim), Leukine® (sargramostim),

Granix (tbo-filgrastim)

Dates Reviewed: 6/17/2009, 12/22/2009, 06/15/2010/ 7/20/2010, Last Review Date: 03/25/2014 09/2010, 12/2010, 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, Date of Origin: 10/17/2008 6/19/2012, 09/06/2012, 12/06/2012, 03/07/2013, 06/06/2013, 09/05/2013, 12/05/2013, 03/25/2014 Prior Auth Available: √ Post-Service edit: √ Medical Necessity Criteria Number: IC-0049 The medical necessity criteria was developed by ICORE Healthcare for the purpose of making clinical review determinations for requests for medications commonly used in various diseases. The clinical disciplines of oncology, hematology, rheumatology, neurology, internal medicine, pharmacy and nursing were consulted as part of the criteria development. The development followed an extensive literature search pertaining to established clinical guidelines and accepted prescribing patterns for each individual drug. The indications for the medications are consistent with FDA approved indications, CMS coverage guidelines, National Comprehensive Cancer Network (NCCN) guidelines and/or other published peer reviewed research literature.

I. Medication Description: Colony stimulating factors (CSFs) act on hematopoietic cells by binding to specific cell surface receptors thereby stimulating proliferation, differentiation, commitment, and end cell functional activation. CSFs are biosynthetic products that stimulate the development of white blood cells such as neutrophils and macrophages (infection fighting cells).

Neutropenia is defined as an absolute neutrophil count (ANC) of less than 1500/microL. The ANC is equal to the product of the white blood cell count (WBC) and the fraction of polymorphonuclear cells (PMNs) and band forms: ANC = WBC (cells/microL) x percent (PMNs + bands) ÷ 100

Absolute neutrophil Risk management count/microL

>1500 None

1000-1500 No significant risk of infection; fever can be managed on an outpatient basis

500-1000 Some risk of infection; fever can occasionally be managed on an outpatient basis

<500 Significant risk of infection; fever should always be managed on an inpatient basis with parenteral antibiotics; few clinical signs of infection

<200 Very significant risk of infection; fever should always be managed on an inpatient basis with parenteral antibiotics; few or no clinical signs of infection

Fever in a neutropenic patient is usually defined as a single temperature >38.3⁰C (101.3⁰F), or a temperature >38⁰C (100.4⁰F) sustained for more than one hour.

Page 1 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

II. Length of Authorization: Coverage is provided for 4 months and may be renewed

III. Review Criteria: Coverage for Leukine® (sargramostim) is provided in the following conditions:

Myeloid reconstitution after autologous or allogeneic Bone marrow transplant (BMT)†

Peripheral Blood Progenitor Cell (PBPC) mobilizaton and transplant†

Patient with non-myeloid malignancy o Patient is undergoing myelosuppressive chemotherapy and/or radiotherapy with an expected incidence of febrile neutropenia of 20% or greater‡; OR o Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10% or greater ‡ AND one or more of the following co-morbidities: • Elderly patients (age 65 or older) • History of recurrent febrile neutropenia from chemotherapy • Extensive prior exposure to chemotherapy • Previous exposure of pelvis, or other areas of large amounts of bone marrow, to radiation • Pre-existing neutropenia (ANC ≤ 1000/mm3) or bone marrow involvement with tumor • Patient has a condition that can potentially increase the risk of serious infection (i.e. HIV/AIDS) Infection/open wounds • Recent surgery • Poor performance status • Poor renal function • Liver dysfunction (elevated bilirubin)

Patient who experienced a neutropenic complication from a prior cycle of the same chemotherapy

Acute Myeloid Leukemia (AML) following induction or consolidation chemotherapy†

Bone Marrow Transplantation (BMT) failure or Engraftment Delay†

Coverage for Granix® (tbo-filgrastim) is provided in the following conditions:

Patient with non-myeloid malignancy†

Page 2 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

o Patient is undergoing myelosuppressive chemotherapy and/or radiotherapy with an expected incidence of febrile neutropenia of 20% or greater‡; OR o Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10% or greater‡ AND one or more of the following co-morbidities: • Elderly patients (age 65 or older) • History of recurrent febrile neutropenia from chemotherapy • Extensive prior exposure to chemotherapy • Previous exposure of pelvis, or other areas of large amounts of bone marrow, to radiation • Pre-existing neutropenia (ANC ≤ 1000/mm3) or bone marrow involvement with tumor • Patient has a condition that can potentially increase the risk of serious infection (i.e. HIV/AIDS) Infection/open wounds • Recent surgery • Poor performance status • Poor renal function • Liver dysfunction (elevated bilirubin)

Coverage for Neulasta® (pegfilgrastim) is provided in the following conditions:

Patient with non-myeloid malignancy† o Patient is undergoing myelosuppressive chemotherapy and/or radiotherapy with an expected incidence of febrile neutropenia of 20% or greater‡; OR o Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10% or greater ‡ AND one or more of the following co-morbidities: • Elderly patients (age 65 or older) • History of recurrent febrile neutropenia from chemotherapy • Extensive prior exposure to chemotherapy • Previous exposure of pelvis, or other areas of large amounts of bone marrow, to radiation • Pre-existing neutropenia (ANC ≤ 1000/mm3) or bone marrow involvement with tumor • Patient has a condition that can potentially increase the risk of serious infection (i.e. HIV/AIDS) Infection/open wounds • Recent surgery • Poor performance status • Poor renal function • Liver dysfunction (elevated bilirubin) o In all cases patients must weigh at least 45 kg to receive Neulasta®pegfilgrastim

Patient who experienced a neutropenic complication from a prior cycle of the same chemotherapy

Page 3 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

Coverage for Neupogen® (filgrastim) is provided in the following conditions:

Bone marrow transplant (BMT) †

Peripheral Blood Progenitor Cell (PBPC) mobilization and transplant†

Patient with non-myeloid malignancy† o Patient is undergoing myelosuppressive chemotherapy and/or radiotherapy with an expected incidence of febrile neutropenia of 20% or greater‡; OR o Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10% or greater‡ AND one or more of the following co-morbidities: • Elderly patients (age 65 or older) • History of recurrent febrile neutropenia from chemotherapy • Extensive prior exposure to chemotherapy • Previous exposure of pelvis, or other areas of large amounts of bone marrow, to radiation • Pre-existing neutropenia (ANC ≤ 1000/mm3) or bone marrow involvement with tumor • Patient has a condition that can potentially increase the risk of serious infection (i.e. HIV/AIDS) Infection/open wounds • Recent surgery • Poor performance status • Poor renal function • Liver dysfunction (elevated bilirubin)

Patient who experienced a neutropenic complication from a prior cycle of the same chemotherapy

Acute Myeloid Leukemia (AML) patient following induction or consolidation chemotherapy†

Bone Marrow Transplantation (BMT) failure or Engraftment Delay

Severe chronic neutropenia (ANC<500)†

Myelodysplastic Syndrome

†FDA-labeled indication(s) ‡ expected incidence of febrile neutropenia percentages for myelosuppressive chemotherapy regimens can be found in the NCCN Myeloid Growth Factors Clinical Practice Guideline at NCCN.org.

IV. Renewal Criteria: Same as initial prior authorization policy criteria

Page 4 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

V. Dosage/Administration: Indication (Drug) Dose Leukine – all indications 250mcg/m2 daily for up to 14 days Granix 5mcg/kg daily for up to 14 days Neupogen 5mcg/kg daily for up to 14 days for non-BMT/PBPC indications 10mcg/kg daily for up to 14 days for BMT/PBPC/Severe Neutropenia indications Neulasta – all indications Up to 6mg every 14 days • Do not administer within 14 days before or 24 hours after administration of a cytotoxic chemotherapy

VI. Billing/Coding Information: JCode: J2820 – Leukine (Bayer) 250, 500 mcg injection: 1 billable unit = 50 mcg J1442 - Neupogen (Amgen) 300 mcg, 480 mcg injection: 1 billable unit = 1 mcg J2505 – Neulasta (Amgen) 6 mg injection: 1 billable unit = 6 mg J1446 – Granix (Teva) 300 mcg, 480 mcg injection: 1 billable unit = 5 mcg

NDC: Leukine 250 mcg vial– 00024-5843-xx (Bayer) Leukine 500 mcg vial– 00024-5844-xx (Bayer) Neupogen 300 mcg vial– 55513-0530-xx (Amgen) Neupogen 300 mcg prefilled syringe – 55513-0924-xx (Amgen) Neupogen 480 mcg vial – 55513-0546-xx (Amgen) Neupogen 480 mcg prefilled syringe – 55513-0209-xx (Amgen) Neulasta 6 mg prefilled syringe – 55513-0190-xx (Amgen) Granix 300 mcg prefilled syringe – 63459-0910-xx (Teva) Granix 400 mcg prefilled syringe – 63459-0912-xx (Teva)

Max Units (per dose and over time): Leukine (J2820) Male 10 billable units per day Female 10 billable units per day

Neupogen (J1442) Severe Chronic Neutropenia: Male 1380 billable units per day Female 1200 billable units per day Page 5 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

BMT or PBPC: Male 1200 billable units per day Female 960 billable units per day

All other indications: Male 600 billable units per day Female 480 billable units per day

Granix (J1446) Male 120 billable units per day Female 96 billable units per day

Neulasta (J2505) Male 1 billable unit per 14 days Female 1 billable unit per 14 days

Quantity Limits Leukine 250 mcg vial: 28 vials per 14 days Leukine 500 mcg vial: 14 vials per 14 days Neupogen 300 mcg vial: 90 vials per 30 days Neupogen 300 mcg prefilled syringe: 90 syringes per 30 days Neupogen 480 mcg vial: 90 vials per 30 days Neupogen 480 mcg prefilled syringe: 90 syringes per 30 days Neulasta 6 mg prefilled syringe: 1 syringe per 14 days Granix 300 mcg: 28 syringes per 14 days Granix 480 mcg; 14 syringes per 14 days

Covered Diagnosis: Leukine 288.03 Drug induced neutropenia 996.85 Complications of transplanted bone marrow V07.8 Other specified prophylactic or treatment measure V42.81 Bone marrow replaced by transplant V42.82 Peripheral stem cells replaced by transplant V58.11 Encounter for antineoplastic chemotherapy V66.2 Convalescence following chemotherapy

Page 6 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

Granix 288.03 Drug induced neutropenia V07.8 Other specified prophylactic or treatment measure V58.11 Encounter for antineoplastic chemotherapy V66.2 Convalescence following chemotherapy Neulasta 288.03 Drug induced neutropenia V07.8 Other specified prophylactic or treatment measure V58.11 Encounter for antineoplastic chemotherapy V66.2 Convalescence following chemotherapy Neupogen 042 Human immunodeficiency virus (HIV) 205.10 Chronic myeloid leukemia, without mention of achieving remission 238.72 Low grade myelodysplastic syndrome (MDS) lesions 238.73 High grade myelodysplastic syndrome lesions 238.74 Myelodysplastic syndrome with 5q deletion 238.75 Myelodysplastic syndrome (MDS) unspecified 284.89 Other specified aplastic anemias 288.00 Neutropenia, unspecified 288.01 Congenital neutropenia 288.02 Cyclic neutropenia

288.03 Drug induced neutropenia 996.85 Complications of transplanted bone marrow V07.8 Other specified prophylactic or treatment measure V42.81 Bone marrow replaced by transplant V42.82 Peripheral stem cells replaced by transplant V58.11 Encounter for antineoplastic chemotherapy V66.2 Convalescence following chemotherapy

VII. Centers for Medicare and Medicaid Services (CMS): Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan. Page 7 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

Leukine (J2820), Neupogen (J1442), Neulasta (J2505), Granix (J1446) Jurisdiction(s): 15 NCD/LCD Document (s): L31851 ICD-9 Codes Diagnosis 140.0 MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER 140.1 MALIGNANT NEOPLASM OF LOWER LIP VERMILION BORDER 140.3 MALIGNANT NEOPLASM OF UPPER LIP INNER ASPECT 140.4 MALIGNANT NEOPLASM OF LOWER LIP INNER ASPECT 140.5 MALIGNANT NEOPLASM OF LIP UNSPECIFIED INNER ASPECT 140.6 MALIGNANT NEOPLASM OF COMMISSURE OF LIP 140.8 MALIGNANT NEOPLASM OF OTHER SITES OF LIP 140.9 MALIGNANT NEOPLASM OF LIP UNSPECIFIED VERMILION BORDER 141.0 MALIGNANT NEOPLASM OF BASE OF TONGUE 141.1 MALIGNANT NEOPLASM OF DORSAL SURFACE OF TONGUE 141.2 MALIGNANT NEOPLASM OF TIP AND LATERAL BORDER OF TONGUE 141.3 MALIGNANT NEOPLASM OF VENTRAL SURFACE OF TONGUE MALIGNANT NEOPLASM OF ANTERIOR TWO-THIRDS OF TONGUE PART 141.4 UNSPECIFIED 141.5 MALIGNANT NEOPLASM OF JUNCTIONAL ZONE OF TONGUE 141.6 MALIGNANT NEOPLASM OF LINGUAL TONSIL 141.8 MALIGNANT NEOPLASM OF OTHER SITES OF TONGUE 141.9 MALIGNANT NEOPLASM OF TONGUE UNSPECIFIED 142.0 MALIGNANT NEOPLASM OF PAROTID GLAND 142.1 MALIGNANT NEOPLASM OF SUBMANDIBULAR GLAND 142.2 MALIGNANT NEOPLASM OF SUBLINGUAL GLAND 142.8 MALIGNANT NEOPLASM OF OTHER MAJOR SALIVARY GLANDS 142.9 MALIGNANT NEOPLASM OF SALIVARY GLAND UNSPECIFIED 143.0 MALIGNANT NEOPLASM OF UPPER GUM 143.1 MALIGNANT NEOPLASM OF LOWER GUM 143.8 MALIGNANT NEOPLASM OF OTHER SITES OF GUM 143.9 MALIGNANT NEOPLASM OF GUM UNSPECIFIED 144.0 MALIGNANT NEOPLASM OF ANTERIOR PORTION OF FLOOR OF MOUTH 144.1 MALIGNANT NEOPLASM OF LATERAL PORTION OF FLOOR OF MOUTH 144.8 MALIGNANT NEOPLASM OF OTHER SITES OF FLOOR OF MOUTH

Page 8 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

144.9 MALIGNANT NEOPLASM OF FLOOR OF MOUTH PART UNSPECIFIED 145.0 MALIGNANT NEOPLASM OF CHEEK MUCOSA 145.1 MALIGNANT NEOPLASM OF VESTIBULE OF MOUTH 145.2 MALIGNANT NEOPLASM OF HARD PALATE 145.3 MALIGNANT NEOPLASM OF SOFT PALATE 145.4 MALIGNANT NEOPLASM OF UVULA 145.5 MALIGNANT NEOPLASM OF PALATE UNSPECIFIED 145.6 MALIGNANT NEOPLASM OF RETROMOLAR AREA 145.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED PARTS OF MOUTH 145.9 MALIGNANT NEOPLASM OF MOUTH UNSPECIFIED 146.0 MALIGNANT NEOPLASM OF TONSIL 146.1 MALIGNANT NEOPLASM OF TONSILLAR FOSSA MALIGNANT NEOPLASM OF TONSILLAR PILLARS (ANTERIOR) 146.2 (POSTERIOR) 146.3 MALIGNANT NEOPLASM OF VALLECULA EPIGLOTTICA 146.4 MALIGNANT NEOPLASM OF ANTERIOR ASPECT OF EPIGLOTTIS 146.5 MALIGNANT NEOPLASM OF JUNCTIONAL REGION OF OROPHARYNX 146.6 MALIGNANT NEOPLASM OF LATERAL WALL OF OROPHARYNX 146.7 MALIGNANT NEOPLASM OF POSTERIOR WALL OF OROPHARYNX 146.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF OROPHARYNX 146.9 MALIGNANT NEOPLASM OF OROPHARYNX UNSPECIFIED SITE 147.0 MALIGNANT NEOPLASM OF SUPERIOR WALL OF NASOPHARYNX 147.1 MALIGNANT NEOPLASM OF POSTERIOR WALL OF NASOPHARYNX 147.2 MALIGNANT NEOPLASM OF LATERAL WALL OF NASOPHARYNX 147.3 MALIGNANT NEOPLASM OF ANTERIOR WALL OF NASOPHARYNX 147.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NASOPHARYNX 147.9 MALIGNANT NEOPLASM OF NASOPHARYNX UNSPECIFIED SITE 148.0 MALIGNANT NEOPLASM OF POSTCRICOID REGION OF HYPOPHARYNX 148.1 MALIGNANT NEOPLASM OF PYRIFORM SINUS MALIGNANT NEOPLASM OF ARYEPIGLOTTIC FOLD HYPOPHARYNGEAL 148.2 ASPECT 148.3 MALIGNANT NEOPLASM OF POSTERIOR HYPOPHARYNGEAL WALL 148.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF HYPOPHARYNX 148.9 MALIGNANT NEOPLASM OF HYPOPHARYNX UNSPECIFIED SITE 149.0 MALIGNANT NEOPLASM OF PHARYNX UNSPECIFIED 149.1 MALIGNANT NEOPLASM OF WALDEYER'S RING Page 9 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

MALIGNANT NEOPLASM OF OTHER SITES WITHIN THE LIP AND ORAL 149.8 CAVITY MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND 149.9 ORAL CAVITY 150.0 MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS 150.1 MALIGNANT NEOPLASM OF THORACIC ESOPHAGUS 150.2 MALIGNANT NEOPLASM OF ABDOMINAL ESOPHAGUS 150.3 MALIGNANT NEOPLASM OF UPPER THIRD OF ESOPHAGUS 150.4 MALIGNANT NEOPLASM OF MIDDLE THIRD OF ESOPHAGUS 150.5 MALIGNANT NEOPLASM OF LOWER THIRD OF ESOPHAGUS 150.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED PART OF ESOPHAGUS 150.9 MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE 151.0 MALIGNANT NEOPLASM OF CARDIA 151.1 MALIGNANT NEOPLASM OF PYLORUS 151.2 MALIGNANT NEOPLASM OF PYLORIC ANTRUM 151.3 MALIGNANT NEOPLASM OF FUNDUS OF STOMACH 151.4 MALIGNANT NEOPLASM OF BODY OF STOMACH MALIGNANT NEOPLASM OF LESSER CURVATURE OF STOMACH 151.5 UNSPECIFIED MALIGNANT NEOPLASM OF GREATER CURVATURE OF STOMACH 151.6 UNSPECIFIED 151.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF STOMACH 151.9 MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE 152.0 MALIGNANT NEOPLASM OF DUODENUM 152.1 MALIGNANT NEOPLASM OF JEJUNUM 152.2 MALIGNANT NEOPLASM OF ILEUM 152.3 MALIGNANT NEOPLASM OF MECKEL'S DIVERTICULUM MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SMALL 152.8 INTESTINE 152.9 MALIGNANT NEOPLASM OF SMALL INTESTINE UNSPECIFIED SITE 153.0 MALIGNANT NEOPLASM OF HEPATIC FLEXURE 153.1 MALIGNANT NEOPLASM OF TRANSVERSE COLON 153.2 MALIGNANT NEOPLASM OF DESCENDING COLON 153.3 MALIGNANT NEOPLASM OF SIGMOID COLON 153.4 MALIGNANT NEOPLASM OF CECUM 153.5 MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS 153.6 MALIGNANT NEOPLASM OF ASCENDING COLON

Page 10 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

153.7 MALIGNANT NEOPLASM OF SPLENIC FLEXURE MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE 153.8 INTESTINE 153.9 MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE 154.0 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION 154.1 MALIGNANT NEOPLASM OF RECTUM 154.2 MALIGNANT NEOPLASM OF ANAL CANAL 154.3 MALIGNANT NEOPLASM OF ANUS UNSPECIFIED SITE MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID 154.8 JUNCTION AND ANUS 155.0 MALIGNANT NEOPLASM OF LIVER PRIMARY 155.1 MALIGNANT NEOPLASM OF INTRAHEPATIC BILE DUCTS MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR 155.2 SECONDARY 156.0 MALIGNANT NEOPLASM OF GALLBLADDER 156.1 MALIGNANT NEOPLASM OF EXTRAHEPATIC BILE DUCTS 156.2 MALIGNANT NEOPLASM OF AMPULLA OF VATER MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF GALLBLADDER 156.8 AND EXTRAHEPATIC BILE DUCTS 156.9 MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE 157.0 MALIGNANT NEOPLASM OF HEAD OF PANCREAS 157.1 MALIGNANT NEOPLASM OF BODY OF PANCREAS 157.2 MALIGNANT NEOPLASM OF TAIL OF PANCREAS 157.3 MALIGNANT NEOPLASM OF PANCREATIC DUCT 157.4 MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS 157.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF PANCREAS 157.9 MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED 158.0 MALIGNANT NEOPLASM OF RETROPERITONEUM 158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM 158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED 159.0 MALIGNANT NEOPLASM OF INTESTINAL TRACT PART UNSPECIFIED 159.1 MALIGNANT NEOPLASM OF SPLEEN NOT ELSEWHERE CLASSIFIED MALIGNANT NEOPLASM OF OTHER SITES OF DIGESTIVE SYSTEM AND 159.8 INTRA-ABDOMINAL ORGANS MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE DIGESTIVE 159.9 ORGANS AND PERITONEUM 160.0 MALIGNANT NEOPLASM OF NASAL CAVITIES

Page 11 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

MALIGNANT NEOPLASM OF AUDITORY TUBE MIDDLE EAR AND 160.1 MASTOID AIR CELLS 160.2 MALIGNANT NEOPLASM OF MAXILLARY SINUS 160.3 MALIGNANT NEOPLASM OF ETHMOIDAL SINUS 160.4 MALIGNANT NEOPLASM OF FRONTAL SINUS 160.5 MALIGNANT NEOPLASM OF SPHENOIDAL SINUS 160.8 MALIGNANT NEOPLASM OF OTHER ACCESSORY SINUSES 160.9 MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED 161.0 MALIGNANT NEOPLASM OF GLOTTIS 161.1 MALIGNANT NEOPLASM OF SUPRAGLOTTIS 161.2 MALIGNANT NEOPLASM OF SUBGLOTTIS 161.3 MALIGNANT NEOPLASM OF LARYNGEAL CARTILAGES 161.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARYNX 161.9 MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED 162.0 MALIGNANT NEOPLASM OF TRACHEA 162.2 MALIGNANT NEOPLASM OF MAIN BRONCHUS 162.3 MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG 162.4 MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG 162.5 MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG 162.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG 162.9 MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED 163.0 MALIGNANT NEOPLASM OF PARIETAL PLEURA 163.1 MALIGNANT NEOPLASM OF VISCERAL PLEURA 163.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF PLEURA 163.9 MALIGNANT NEOPLASM OF PLEURA UNSPECIFIED 164.0 MALIGNANT NEOPLASM OF THYMUS 164.1 MALIGNANT NEOPLASM OF HEART 164.2 MALIGNANT NEOPLASM OF ANTERIOR MEDIASTINUM 164.3 MALIGNANT NEOPLASM OF POSTERIOR MEDIASTINUM 164.8 MALIGNANT NEOPLASM OF OTHER PARTS OF MEDIASTINUM 164.9 MALIGNANT NEOPLASM OF MEDIASTINUM PART UNSPECIFIED MALIGNANT NEOPLASM OF UPPER RESPIRATORY TRACT PART 165.0 UNSPECIFIED MALIGNANT NEOPLASM OF OTHER SITES WITHIN THE RESPIRATORY 165.8 SYSTEM AND INTRATHORACIC ORGANS MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE 165.9 RESPIRATORY SYSTEM Page 12 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT 170.0 MANDIBLE 170.1 MALIGNANT NEOPLASM OF MANDIBLE MALIGNANT NEOPLASM OF VERTEBRAL COLUMN EXCLUDING SACRUM 170.2 AND COCCYX 170.3 MALIGNANT NEOPLASM OF RIBS STERNUM AND CLAVICLE 170.4 MALIGNANT NEOPLASM OF SCAPULA AND LONG BONES OF UPPER LIMB 170.5 MALIGNANT NEOPLASM OF SHORT BONES OF UPPER LIMB 170.6 MALIGNANT NEOPLASM OF PELVIC BONES SACRUM AND COCCYX 170.7 MALIGNANT NEOPLASM OF LONG BONES OF LOWER LIMB 170.8 MALIGNANT NEOPLASM OF SHORT BONES OF LOWER LIMB MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE 170.9 UNSPECIFIED MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF 171.0 HEAD FACE AND NECK MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF 171.2 UPPER LIMB INCLUDING SHOULDER MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF 171.3 LOWER LIMB INCLUDING HIP MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF 171.4 THORAX MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF 171.5 ABDOMEN MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF 171.6 PELVIS MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF 171.7 TRUNK UNSPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CONNECTIVE 171.8 AND OTHER SOFT TISSUE MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE 171.9 UNSPECIFIED 172.0 MALIGNANT MELANOMA OF SKIN OF LIP 172.1 MALIGNANT MELANOMA OF SKIN OF EYELID INCLUDING CANTHUS MALIGNANT MELANOMA OF SKIN OF EAR AND EXTERNAL AUDITORY 172.2 CANAL MALIGNANT MELANOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS 172.3 OF FACE 172.4 MALIGNANT MELANOMA OF SKIN OF SCALP AND NECK 172.5 MALIGNANT MELANOMA OF SKIN OF TRUNK EXCEPT SCROTUM MALIGNANT MELANOMA OF SKIN OF UPPER LIMB INCLUDING 172.6 SHOULDER

Page 13 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

172.7 MALIGNANT MELANOMA OF SKIN OF LOWER LIMB INCLUDING HIP 172.8 MALIGNANT MELANOMA OF OTHER SPECIFIED SITES OF SKIN 172.9 MELANOMA OF SKIN SITE UNSPECIFIED 174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST 174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE 174.2 BREAST MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE 174.3 BREAST MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE 174.4 BREAST MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE 174.5 BREAST 174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST 174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST 174.9 MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE 175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE 175.9 BREAST 176.0 KAPOSI'S SARCOMA SKIN 176.1 KAPOSI'S SARCOMA SOFT TISSUE 176.2 KAPOSI'S SARCOMA PALATE 176.3 KAPOSI'S SARCOMA GASTROINTESTINAL SITES 176.4 KAPOSI'S SARCOMA LUNG 176.5 KAPOSI'S SARCOMA LYMPH NODES 176.8 KAPOSI'S SARCOMA OTHER SPECIFIED SITES 176.9 KAPOSI'S SARCOMA UNSPECIFIED SITE 179 MALIGNANT NEOPLASM OF UTERUS-PART UNS 180.0 MALIGNANT NEOPLASM OF ENDOCERVIX 180.1 MALIGNANT NEOPLASM OF EXOCERVIX 180.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CERVIX 180.9 MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE 181 MALIGNANT NEOPLASM OF PLACENTA 182.0 MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS 182.1 MALIGNANT NEOPLASM OF ISTHMUS MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BODY OF 182.8 UTERUS

Page 14 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

183.0 MALIGNANT NEOPLASM OF OVARY 183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE 183.3 MALIGNANT NEOPLASM OF BROAD LIGAMENT OF UTERUS 183.4 MALIGNANT NEOPLASM OF PARAMETRIUM 183.5 MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE 183.8 ADNEXA 183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE 184.0 MALIGNANT NEOPLASM OF VAGINA 184.1 MALIGNANT NEOPLASM OF LABIA MAJORA 184.2 MALIGNANT NEOPLASM OF LABIA MINORA 184.3 MALIGNANT NEOPLASM OF CLITORIS 184.4 MALIGNANT NEOPLASM OF VULVA UNSPECIFIED SITE MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE 184.8 GENITAL ORGANS 184.9 MALIGNANT NEOPLASM OF FEMALE GENITAL ORGAN SITE UNSPECIFIED 185 MALIGNANT NEOPLASM OF PROSTATE 186.0 MALIGNANT NEOPLASM OF UNDESCENDED TESTIS 186.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED TESTIS 187.1 MALIGNANT NEOPLASM OF PREPUCE 187.2 MALIGNANT NEOPLASM OF GLANS PENIS 187.3 MALIGNANT NEOPLASM OF BODY OF PENIS 187.4 MALIGNANT NEOPLASM OF PENIS PART UNSPECIFIED 187.5 MALIGNANT NEOPLASM OF EPIDIDYMIS 187.6 MALIGNANT NEOPLASM OF SPERMATIC CORD 187.7 MALIGNANT NEOPLASM OF SCROTUM MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF MALE GENITAL 187.8 ORGANS 187.9 MALIGNANT NEOPLASM OF MALE GENITAL ORGAN SITE UNSPECIFIED 188.0 MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER 188.1 MALIGNANT NEOPLASM OF DOME OF URINARY BLADDER 188.2 MALIGNANT NEOPLASM OF LATERAL WALL OF URINARY BLADDER 188.3 MALIGNANT NEOPLASM OF ANTERIOR WALL OF URINARY BLADDER 188.4 MALIGNANT NEOPLASM OF POSTERIOR WALL OF URINARY BLADDER 188.5 MALIGNANT NEOPLASM OF BLADDER NECK 188.6 MALIGNANT NEOPLASM OF URETERIC ORIFICE

Page 15 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

188.7 MALIGNANT NEOPLASM OF URACHUS 188.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BLADDER 188.9 MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED 189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS 189.1 MALIGNANT NEOPLASM OF RENAL PELVIS 189.2 MALIGNANT NEOPLASM OF URETER 189.3 MALIGNANT NEOPLASM OF URETHRA 189.4 MALIGNANT NEOPLASM OF PARAURETHRAL GLANDS MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF URINARY 189.8 ORGANS 189.9 MALIGNANT NEOPLASM OF URINARY ORGAN SITE UNSPECIFIED MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA 190.0 RETINA AND CHOROID 190.1 MALIGNANT NEOPLASM OF ORBIT 190.2 MALIGNANT NEOPLASM OF LACRIMAL GLAND 190.3 MALIGNANT NEOPLASM OF CONJUNCTIVA 190.4 MALIGNANT NEOPLASM OF CORNEA 190.5 MALIGNANT NEOPLASM OF RETINA 190.6 MALIGNANT NEOPLASM OF CHOROID 190.7 MALIGNANT NEOPLASM OF LACRIMAL DUCT 190.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF EYE 190.9 MALIGNANT NEOPLASM OF EYE PART UNSPECIFIED 191.0 MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES 191.1 MALIGNANT NEOPLASM OF FRONTAL LOBE 191.2 MALIGNANT NEOPLASM OF TEMPORAL LOBE 191.3 MALIGNANT NEOPLASM OF PARIETAL LOBE 191.4 MALIGNANT NEOPLASM OF OCCIPITAL LOBE 191.5 MALIGNANT NEOPLASM OF VENTRICLES 191.6 MALIGNANT NEOPLASM OF CEREBELLUM NOS 191.7 MALIGNANT NEOPLASM OF BRAIN STEM 191.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRAIN 191.9 MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE 192.0 MALIGNANT NEOPLASM OF CRANIAL NERVES 192.1 MALIGNANT NEOPLASM OF CEREBRAL MENINGES 192.2 MALIGNANT NEOPLASM OF SPINAL CORD 192.3 MALIGNANT NEOPLASM OF SPINAL MENINGES Page 16 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS 192.8 SYSTEM 192.9 MALIGNANT NEOPLASM OF NERVOUS SYSTEM PART UNSPECIFIED 193 MALIGNANT NEOPLASM OF THYROID GLAND 194.0 MALIGNANT NEOPLASM OF ADRENAL GLAND 194.1 MALIGNANT NEOPLASM OF PARATHYROID GLAND MALIGNANT NEOPLASM OF PITUITARY GLAND AND 194.3 CRANIOPHARYNGEAL DUCT 194.4 MALIGNANT NEOPLASM OF PINEAL GLAND 194.5 MALIGNANT NEOPLASM OF CAROTID BODY 194.6 MALIGNANT NEOPLASM OF AORTIC BODY AND OTHER PARAGANGLIA MALIGNANT NEOPLASM OF OTHER ENDOCRINE GLANDS AND RELATED 194.8 STRUCTURES 194.9 MALIGNANT NEOPLASM OF ENDOCRINE GLAND SITE UNSPECIFIED 195.0 MALIGNANT NEOPLASM OF HEAD FACE AND NECK 195.1 MALIGNANT NEOPLASM OF THORAX 195.2 MALIGNANT NEOPLASM OF ABDOMEN 195.3 MALIGNANT NEOPLASM OF PELVIS 195.4 MALIGNANT NEOPLASM OF UPPER LIMB 195.5 MALIGNANT NEOPLASM OF LOWER LIMB 195.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH 196.0 NODES OF HEAD FACE AND NECK SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF 196.1 INTRATHORACIC LYMPH NODES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF INTRA- 196.2 ABDOMINAL LYMPH NODES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH 196.3 NODES OF AXILLA AND UPPER LIMB SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH 196.5 NODES OF INGUINAL REGION AND LOWER LIMB SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF 196.6 INTRAPELVIC LYMPH NODES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH 196.8 NODES OF MULTIPLE SITES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH 196.9 NODES SITE UNSPECIFIED 197.0 SECONDARY MALIGNANT NEOPLASM OF LUNG 197.1 SECONDARY MALIGNANT NEOPLASM OF MEDIASTINUM

Page 17 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

197.2 SECONDARY MALIGNANT NEOPLASM OF PLEURA 197.3 SECONDARY MALIGNANT NEOPLASM OF OTHER RESPIRATORY ORGANS SECONDARY MALIGNANT NEOPLASM OF SMALL INTESTINE INCLUDING 197.4 DUODENUM SECONDARY MALIGNANT NEOPLASM OF LARGE INTESTINE AND 197.5 RECTUM SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND 197.6 PERITONEUM 197.7 MALIGNANT NEOPLASM OF LIVER SECONDARY SECONDARY MALIGNANT NEOPLASM OF OTHER DIGESTIVE ORGANS 197.8 AND SPLEEN 198.0 SECONDARY MALIGNANT NEOPLASM OF KIDNEY 198.1 SECONDARY MALIGNANT NEOPLASM OF OTHER URINARY ORGANS 198.2 SECONDARY MALIGNANT NEOPLASM OF SKIN 198.3 SECONDARY MALIGNANT NEOPLASM OF BRAIN AND SPINAL CORD SECONDARY MALIGNANT NEOPLASM OF OTHER PARTS OF NERVOUS 198.4 SYSTEM 198.5 SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW 198.6 SECONDARY MALIGNANT NEOPLASM OF OVARY 198.7 SECONDARY MALIGNANT NEOPLASM OF ADRENAL GLAND 198.81 SECONDARY MALIGNANT NEOPLASM OF BREAST 198.82 SECONDARY MALIGNANT NEOPLASM OF GENITAL ORGANS 198.89 SECONDARY MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES 199.0 DISSEMINATED MALIGNANT NEOPLASM 199.1 OTHER MALIGNANT NEOPLASM OF UNSPECIFIED SITE 199.2 MALIGNANT NEOPLASM ASSOCIATED WITH TRANSPLANT ORGAN 200.00 RETICULOSARCOMA UNSPECIFIED SITE RETICULOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND 200.01 NECK 200.02 RETICULOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES 200.03 RETICULOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES RETICULOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER 200.04 LIMB RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION 200.05 AND LOWER LIMB 200.06 RETICULOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES 200.07 RETICULOSARCOMA INVOLVING SPLEEN 200.08 RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

Page 18 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

200.10 LYMPHOSARCOMA UNSPECIFIED SITE 200.11 LYMPHOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK 200.12 LYMPHOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES 200.13 LYMPHOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES LYMPHOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER 200.14 LIMB LYMPHOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION 200.15 AND LOWER LIMB 200.16 LYMPHOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES 200.17 LYMPHOSARCOMA INVOLVING SPLEEN 200.18 LYMPHOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 200.20 BURKITT'S TUMOR OR LYMPHOMA UNSPECIFIED SITE BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF HEAD 200.21 FACE AND NECK BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRATHORACIC LYMPH 200.22 NODES BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRA-ABDOMINAL 200.23 LYMPH NODES BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF 200.24 AXILLA AND UPPER LIMB BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF 200.25 INGUINAL REGION AND LOWER LIMB BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRAPELVIC LYMPH 200.26 NODES 200.27 BURKITT'S TUMOR OR LYMPHOMA INVOLVING SPLEEN BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF 200.28 MULTIPLE SITES MARGINAL ZONE LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND 200.30 SOLID ORGAN SITES MARGINAL ZONE LYMPHOMA,LYMPH NODES OF HEAD, FACE, AND 200.31 NECK 200.32 MARGINAL ZONE LYMPHOMA,INTRATHORACIC LYMPH NODES 200.33 MARGINAL ZONE LYMPHOMA, INTRAABDOMINAL LYMPH NODES MARGINAL ZONE LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER 200.34 LIMB MARGINAL ZONE LYMPHOMA, LYMPH NODES OF INGUINAL REGION 200.35 AND LOWER LIMB 200.36 MARGINAL ZONE LYMPHOMA, INTRAPELVIC LYMPH NODES 200.37 MARGINAL ZONE LYMPHOMA, SPLEEN 200.38 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

Page 19 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID 200.40 ORGAN SITES 200.41 MANTLE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK 200.42 MANTLE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES 200.43 MANTLE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES 200.44 MANTLE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB MANTLE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND 200.45 LOWER LIMB 200.46 MANTLE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES 200.47 MANTLE CELL LYMPHOMA, SPLEEN 200.48 MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, 200.50 EXTRANODAL AND SOLID ORGAN SITES PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF 200.51 HEAD, FACE, AND NECK PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRATHORACIC 200.52 LYMPH NODES PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRA-ABDOMINAL 200.53 LYMPH NODES PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF 200.54 AXILLA AND UPPER LIMB PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF 200.55 INGUINAL REGION AND LOWER LIMB PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRAPELVIC LYMPH 200.56 NODES 200.57 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, SPLEEN PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF 200.58 MULTIPLE SITES ANAPLASTIC LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL 200.60 AND SOLID ORGAN SITES ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, 200.61 AND NECK 200.62 ANAPLASTIC LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES ANAPLASTIC LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH 200.63 NODES ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND 200.64 UPPER LIMB ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL 200.65 REGION AND LOWER LIMB 200.66 ANAPLASTIC LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES 200.67 ANAPLASTIC LARGE CELL LYMPHOMA, SPLEEN

Page 20 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE 200.68 SITES LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID 200.70 ORGAN SITES 200.71 LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK 200.72 LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES 200.73 LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES 200.74 LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND 200.75 LOWER LIMB 200.76 LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES 200.77 LARGE CELL LYMPHOMA, SPLEEN 200.78 LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND 200.80 RETICULOSARCOMA UNSPECIFIED SITE OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND 200.81 RETICULOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND 200.82 RETICULOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND 200.83 RETICULOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND 200.84 RETICULOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND 200.85 RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND 200.86 RETICULOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND 200.87 RETICULOSARCOMA INVOLVING SPLEEN OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND 200.88 RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 201.00 HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF HEAD 201.01 FACE AND NECK HODGKIN'S PARAGRANULOMA INVOLVING INTRATHORACIC LYMPH 201.02 NODES HODGKIN'S PARAGRANULOMA INVOLVING INTRA-ABDOMINAL LYMPH 201.03 NODES 201.04 HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF AXILLA Page 21 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

AND UPPER LIMB HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF INGUINAL 201.05 REGION AND LOWER LIMB 201.06 HODGKIN'S PARAGRANULOMA INVOLVING INTRAPELVIC LYMPH NODES 201.07 HODGKIN'S PARAGRANULOMA INVOLVING SPLEEN HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF MULTIPLE 201.08 SITES 201.10 HODGKIN'S GRANULOMA UNSPECIFIED SITE HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF HEAD FACE 201.11 AND NECK 201.12 HODGKIN'S GRANULOMA INVOLVING INTRATHORACIC LYMPH NODES HODGKIN'S GRANULOMA INVOLVING INTRA-ABDOMINAL LYMPH 201.13 NODES HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF AXILLA AND 201.14 UPPER LIMB HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF INGUINAL 201.15 REGION AND LOWER LIMB 201.16 HODGKIN'S GRANULOMA INVOLVING INTRAPELVIC LYMPH NODES 201.17 HODGKIN'S GRANULOMA INVOLVING SPLEEN HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF MULTIPLE 201.18 SITES 201.20 HODGKIN'S SARCOMA UNSPECIFIED SITE HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND 201.21 NECK 201.22 HODGKIN'S SARCOMA INVOLVING INTRATHORACIC LYMPH NODES 201.23 HODGKIN'S SARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER 201.24 LIMB HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION 201.25 AND LOWER LIMB 201.26 HODGKIN'S SARCOMA INVOLVING INTRAPELVIC LYMPH NODES 201.27 HODGKIN'S SARCOMA INVOLVING SPLEEN 201.28 HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.40 UNSPECIFIED SITE HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.41 INVOLVING LYMPH NODES OF HEAD FACE AND NECK HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.42 INVOLVING INTRATHORACIC LYMPH NODES HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.43 INVOLVING INTRA-ABDOMINAL LYMPH NODES Page 22 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.44 INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.45 INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.46 INVOLVING INTRAPELVIC LYMPH NODES HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.47 INVOLVING SPLEEN HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.48 INVOLVING LYMPH NODES OF MULTIPLE SITES 201.50 HODGKIN'S DISEASE NODULAR SCLEROSIS UNSPECIFIED SITE HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF 201.51 HEAD FACE AND NECK HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING INTRATHORACIC 201.52 LYMPH NODES HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING INTRA- 201.53 ABDOMINAL LYMPH NODES HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF 201.54 AXILLA AND UPPER LIMB HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF 201.55 INGUINAL REGION AND LOWER LIMB HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING INTRAPELVIC 201.56 LYMPH NODES 201.57 HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING SPLEEN HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF 201.58 MULTIPLE SITES 201.60 HODGKIN'S DISEASE MIXED CELLULARITY UNSPECIFIED SITE HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF 201.61 HEAD FACE AND NECK HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING INTRATHORACIC 201.62 LYMPH NODES HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING INTRA- 201.63 ABDOMINAL LYMPH NODES HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF 201.64 AXILLA AND UPPER LIMB HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF 201.65 INGUINAL REGION AND LOWER LIMB HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING INTRAPELVIC 201.66 LYMPH NODES 201.67 HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING SPLEEN HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF 201.68 MULTIPLE SITES 201.70 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION UNSPECIFIED SITE Page 23 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH 201.71 NODES OF HEAD FACE AND NECK HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING 201.72 INTRATHORACIC LYMPH NODES HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING INTRA- 201.73 ABDOMINAL LYMPH NODES HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH 201.74 NODES OF AXILLA AND UPPER LIMB HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH 201.75 NODES OF INGUINAL REGION AND LOWER LIMB HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING INTRAPELVIC 201.76 LYMPH NODES 201.77 HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING SPLEEN HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH 201.78 NODES OF MULTIPLE SITES 201.90 HODGKIN'S DISEASE UNSPECIFIED TYPE UNSPECIFIED SITE HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF 201.91 HEAD FACE AND NECK HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING INTRATHORACIC 201.92 LYMPH NODES HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING INTRA-ABDOMINAL 201.93 LYMPH NODES HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF 201.94 AXILLA AND UPPER LIMB HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF 201.95 INGUINAL REGION AND LOWER LIMB HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING INTRAPELVIC LYMPH 201.96 NODES 201.97 HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING SPLEEN HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF 201.98 MULTIPLE SITES 202.00 NODULAR LYMPHOMA UNSPECIFIED SITE NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND 202.01 NECK 202.02 NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES 202.03 NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND 202.04 UPPER LIMB NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION 202.05 AND LOWER LIMB 202.06 NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES 202.07 NODULAR LYMPHOMA INVOLVING SPLEEN Page 24 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

202.08 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 202.10 MYCOSIS FUNGOIDES UNSPECIFIED SITE MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF HEAD FACE AND 202.11 NECK 202.12 MYCOSIS FUNGOIDES INVOLVING INTRATHORACIC LYMPH NODES 202.13 MYCOSIS FUNGOIDES INVOLVING INTRA-ABDOMINAL LYMPH NODES MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF AXILLA AND UPPER 202.14 LIMB MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF INGUINAL REGION 202.15 AND LOWER LIMB 202.16 MYCOSIS FUNGOIDES INVOLVING INTRAPELVIC LYMPH NODES 202.17 MYCOSIS FUNGOIDES INVOLVING SPLEEN 202.18 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES 202.20 SEZARY'S DISEASE UNSPECIFIED SITE 202.21 SEZARY'S DISEASE INVOLVING LYMPH NODES OF HEAD FACE AND NECK 202.22 SEZARY'S DISEASE INVOLVING INTRATHORACIC LYMPH NODES 202.23 SEZARY'S DISEASE INVOLVING INTRA-ABDOMINAL LYMPH NODES SEZARY'S DISEASE INVOLVING LYMPH NODES OF AXILLA AND UPPER 202.24 LIMB SEZARY'S DISEASE INVOLVING LYMPH NODES OF INGUINAL REGION 202.25 AND LOWER LIMB 202.26 SEZARY'S DISEASE INVOLVING INTRAPELVIC LYMPH NODES 202.27 SEZARY'S DISEASE INVOLVING SPLEEN 202.28 SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES 202.30 MALIGNANT HISTIOCYTOSIS UNSPECIFIED SITE MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF HEAD FACE 202.31 AND NECK 202.32 MALIGNANT HISTIOCYTOSIS INVOLVING INTRATHORACIC LYMPH NODES MALIGNANT HISTIOCYTOSIS INVOLVING INTRA-ABDOMINAL LYMPH 202.33 NODES MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF AXILLA AND 202.34 UPPER LIMB MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF INGUINAL 202.35 REGION AND LOWER LIMB 202.36 MALIGNANT HISTIOCYTOSIS INVOLVING INTRAPELVIC LYMPH NODES 202.37 MALIGNANT HISTIOCYTOSIS INVOLVING SPLEEN MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF MULTIPLE 202.38 SITES 202.40 LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE

Page 25 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF 202.41 HEAD FACE AND NECK LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRATHORACIC 202.42 LYMPH NODES LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRA-ABDOMINAL 202.43 LYMPH NODES LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF 202.44 AXILLA AND UPPER ARM LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF 202.45 INGUINAL REGION AND LOWER LIMB LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRAPELVIC LYMPH 202.46 NODES 202.47 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING SPLEEN LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF 202.48 MULTIPLE SITES 202.50 LETTERER-SIWE DISEASE UNSPECIFIED SITE LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF HEAD FACE AND 202.51 NECK 202.52 LETTERER-SIWE DISEASE INVOLVING INTRATHORACIC LYMPH NODES 202.53 LETTERER-SIWE DISEASE INVOLVING INTRA-ABDOMINAL LYMPH NODES LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF AXILLA AND 202.54 UPPER LIMB LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF INGUINAL 202.55 REGION AND LOWER LIMB 202.56 LETTERER-SIWE DISEASE INVOLVING INTRAPELVIC LYMPH NODES 202.57 LETTERER-SIWE DISEASE INVOLVING SPLEEN 202.58 LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES 202.60 MALIGNANT MAST CELL TUMORS UNSPECIFIED SITE MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF HEAD 202.61 FACE AND NECK MALIGNANT MAST CELL TUMORS INVOLVING INTRATHORACIC LYMPH 202.62 NODES MALIGNANT MAST CELL TUMORS INVOLVING INTRA-ABDOMINAL 202.63 LYMPH NODES MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF AXILLA 202.64 AND UPPER LIMB MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF 202.65 INGUINAL REGION AND LOWER LIMB MALIGNANT MAST CELL TUMORS INVOLVING INTRAPELVIC LYMPH 202.66 NODES 202.67 MALIGNANT MAST CELL TUMORS INVOLVING SPLEEN

Page 26 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF 202.68 MULTIPLE SITES PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND 202.70 SOLID ORGAN SITES PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND 202.71 NECK 202.72 PERIPHERAL T CELL LYMPHOMA, INTRATHORACIC LYMPH NODES 202.73 PERIPHERAL T CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER 202.74 LIMB PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION 202.75 AND LOWER LIMB 202.76 PERIPHERAL T CELL LYMPHOMA, INTRAPELVIC LYMPH NODES 202.77 PERIPHERAL T CELL LYMPHOMA, SPLEEN 202.78 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES 202.80 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF HEAD 202.81 FACE AND NECK OTHER MALIGNANT LYMPHOMAS INVOLVING INTRATHORACIC LYMPH 202.82 NODES OTHER MALIGNANT LYMPHOMAS INVOLVING INTRA-ABDOMINAL 202.83 LYMPH NODES OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF AXILLA 202.84 AND UPPER LIMB OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF 202.85 INGUINAL REGION AND LOWER LIMB OTHER MALIGNANT LYMPHOMAS INVOLVING INTRAPELVIC LYMPH 202.86 NODES 202.87 OTHER MALIGNANT LYMPHOMAS INVOLVING SPLEEN OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF 202.88 MULTIPLE SITES OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND 202.90 HISTIOCYTIC TISSUE UNSPECIFIED SITE OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND 202.91 HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF HEAD FACE AND NECK OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND 202.92 HISTIOCYTIC TISSUE INVOLVING INTRATHORACIC LYMPH NODES OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND 202.93 HISTIOCYTIC TISSUE INVOLVING INTRA-ABDOMINAL LYMPH NODES OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND 202.94 HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF AXILLA AND UPPER

Page 27 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

LIMB OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND 202.95 HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND 202.96 HISTIOCYTIC TISSUE INVOLVING INTRAPELVIC LYMPH NODES OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND 202.97 HISTIOCYTIC TISSUE INVOLVING SPLEEN OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND 202.98 HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED 203.00 REMISSION 203.01 MULTIPLE MYELOMA IN REMISSION 203.02 MULTIPLE MYELOMA, IN RELAPSE PLASMA CELL LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 203.10 REMISSION 203.11 PLASMA CELL LEUKEMIA IN REMISSION 203.12 PLASMA CELL LEUKEMIA, IN RELAPSE OTHER IMMUNOPROLIFERATIVE NEOPLASMS, WITHOUT MENTION OF 203.80 HAVING ACHIEVED REMISSION 203.81 OTHER IMMUNOPROLIFERATIVE NEOPLASMS IN REMISSION 203.82 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.00 ACHIEVED REMISSION 204.01 LYMPHOID LEUKEMIA ACUTE IN REMISSION 204.02 ACUTE LYMPHOID LEUKEMIA, IN RELAPSE CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.10 ACHIEVED REMISSION 204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION 204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE SUBACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.20 ACHIEVED REMISSION 204.21 LYMPHOID LEUKEMIA SUBACUTE IN REMISSION 204.22 SUBACUTE LYMPHOID LEUKEMIA, IN RELAPSE OTHER LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.80 ACHIEVED REMISSION 204.81 OTHER LYMPHOID LEUKEMIA IN REMISSION 204.82 OTHER LYMPHOID LEUKEMIA, IN RELAPSE UNSPECIFIED LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.90 ACHIEVED REMISSION

Page 28 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

204.91 UNSPECIFIED LYMPHOID LEUKEMIA IN REMISSION 204.92 UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 205.00 - 205.02 REMISSION - ACUTE MYELOID LEUKEMIA, IN RELAPSE CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING 205.10 ACHIEVED REMISSION 205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE MALIGNANT CARCINOID TUMOR OF THE SMALL INTESTINE, 209.00 - 209.36 UNSPECIFIED PORTION - MERKEL CELL CARCINOMA OF OTHER SITES SECONDARY NEUROENDOCRINE TUMOR, UNSPECIFIED SITE - 209.70 - 209.79 SECONDARY NEUROENDOCRINE TUMOR OF OTHER SITES CARCINOMA IN SITU OF LIP ORAL CAVITY AND PHARYNX - NEOPLASM 230.0 - 238.9 OF UNCERTAIN BEHAVIOR SITE UNSPECIFIED 239.81 NEOPLASMS OF UNSPECIFIED NATURE, RETINA AND CHOROID 239.89 NEOPLASMS OF UNSPECIFIED NATURE, OTHER SPECIFIED SITES 285.3 ANTINEOPLASTIC CHEMOTHERAPY INDUCED ANEMIA

288.00 - 288.09 NEUTROPENIA, UNSPECIFIED - OTHER NEUTROPENIA 714.1 FELTY'S SYNDROME V42.81 BONE MARROW REPLACED BY TRANSPLANT V42.82 PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT V58.11 ENCOUNTER FOR ANTINEOPLASTIC CHEMOTHERAPY V58.12 ENCOUNTER FOR IMMUNOTHERAPY FOR NEOPLASTIC CONDITION V59.3 BONE MARROW DONORS

Leukine (J2820), Neupogen (J1442), Neulasta (J2505), Granix (J1446) Jurisdiction(s): 11(M) NCD/LCD Document (s): L31799 ICD-9 Codes Diagnosis MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - OTHER 140.0 - 173.89 SPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SKIN MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - 174.0 - 204.92 UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 205.00 - 205.02 REMISSION - ACUTE MYELOID LEUKEMIA, IN RELAPSE CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING 205.10 ACHIEVED REMISSION 205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE MALIGNANT CARCINOID TUMOR OF THE SMALL INTESTINE, 209.00 - 209.36 UNSPECIFIED PORTION - MERKEL CELL CARCINOMA OF OTHER SITES SECONDARY NEUROENDOCRINE TUMOR, UNSPECIFIED SITE - 209.70 - 209.79 SECONDARY NEUROENDOCRINE TUMOR OF OTHER SITES Page 29 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

CARCINOMA IN SITU OF LIP ORAL CAVITY AND PHARYNX - NEOPLASM 230.0 - 238.9 OF UNCERTAIN BEHAVIOR SITE UNSPECIFIED 239.81 NEOPLASMS OF UNSPECIFIED NATURE, RETINA AND CHOROID 239.89 NEOPLASMS OF UNSPECIFIED NATURE, OTHER SPECIFIED SITES 285.3 ANTINEOPLASTIC CHEMOTHERAPY INDUCED ANEMIA 288.00 - 288.09 NEUTROPENIA, UNSPECIFIED - OTHER NEUTROPENIA 714.1 FELTY'S SYNDROME V42.81 BONE MARROW REPLACED BY TRANSPLANT V42.82 PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT V58.11 ENCOUNTER FOR ANTINEOPLASTIC CHEMOTHERAPY V58.12 ENCOUNTER FOR IMMUNOTHERAPY FOR NEOPLASTIC CONDITION V59.3 BONE MARROW DONORS

Neupogen (J1442) ONLY Jurisdiction(s): 5,8 NCD/LCD Document (s): L30306 ICD-9 Codes Diagnosis 042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE 202.40 LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 205.00 REMISSION 205.02 ACUTE MYELOID LEUKEMIA, IN RELAPSE 238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION 238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED 238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA 284.89 OTHER SPECIFIED APLASTIC ANEMIAS 288.00 NEUTROPENIA, UNSPECIFIED 288.01 CONGENITAL NEUTROPENIA 288.02 CYCLIC NEUTROPENIA 288.03 DRUG INDUCED NEUTROPENIA V07.8 OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE V15.3 PERSONAL HISTORY OF IRRADIATION PRESENTING HAZARDS TO HEALTH V15.9 UNSPECIFIED PERSONAL HISTORY PRESENTING HAZARDS TO HEALTH V42.81 BONE MARROW REPLACED BY TRANSPLANT V42.82 PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT

Page 30 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

V49.83 AWAITING ORGAN TRANSPLANT STATUS V87.41 PERSONAL HISTORY OF ANTINEOPLASTIC CHEMOTHERAPY

Leukine (J2820) Jurisdiction(s): 5,8 NCD/LCD Document (s): L30306 ICD-9 Codes Diagnosis 042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE MALIGNANT MELANOMA OF SKIN OF LIP - MELANOMA OF SKIN SITE 172.0 - 172.9 UNSPECIFIED HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 201.40 - 201.98* UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES NODULAR LYMPHOMA UNSPECIFIED SITE - NODULAR LYMPHOMA 202.00 - 202.08* INVOLVING LYMPH NODES OF MULTIPLE SITES LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE - LEUKEMIC 202.40 - 202.48 RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE - OTHER 202.80 - 202.88* MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.00 – 204.02* ACHIEVED REMISSION - ACUTE LYMPHOID LEUKEMIA, IN RELAPSE ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 205.00** REMISSION 205.02** ACUTE MYELOID LEUKEMIA, IN RELAPSE 238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION 238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED 238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA 284.89 OTHER SPECIFIED APLASTIC ANEMIAS 288.00 NEUTROPENIA, UNSPECIFIED 288.01 CONGENITAL NEUTROPENIA 288.02 CYCLIC NEUTROPENIA 288.03 DRUG INDUCED NEUTROPENIA 996.85 COMPLICATIONS OF TRANSPLANTED BONE MARROW V07.8 OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE V42.81 BONE MARROW REPLACED BY TRANSPLANT V42.82 PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT Page 31 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

*Must be used with primary code V42.81 ** Must be used with primary code 288.03

Neulasta (J2505) Jurisdiction(s): 5,8 NCD/LCD Document (s): L30306 ICD-9 Codes Diagnosis 288.03 DRUG INDUCED NEUTROPENIA V07.8 OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE V15.9 UNSPECIFIED PERSONAL HISTORY PRESENTING HAZARDS TO HEALTH

Granix (J1446) Jurisdiction(s): 5,8 NCD/LCD Document (s): L30306 ICD-9 Codes Diagnosis 288.03 DRUG INDUCED NEUTROPENIA V07.8 OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE V15.9 UNSPECIFIED PERSONAL HISTORY PRESENTING HAZARDS TO HEALTH

Leukine (J2820), Neupogen (J1442) ONLY Jurisdiction(s): 10(J) NCD/LCD Document (s): L30026 ICD-9 Codes Diagnosis 042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED 202.00 - 202.90 MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE UNSPECIFIED SITE MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED 203.00 REMISSION 203.02 MULTIPLE MYELOMA, IN RELAPSE ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 205.00 REMISSION 205.02 ACUTE MYELOID LEUKEMIA, IN RELAPSE ESSENTIAL THROMBOCYTHEMIA - POST-TRANSPLANT 238.71 - 238.77 LYMPHOPROLIFERATIVE DISORDER (PTLD) 238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES 288.00 - 288.04 NEUTROPENIA, UNSPECIFIED - NEUTROPENIA DUE TO INFECTION 288.09 OTHER NEUTROPENIA 288.50 LEUKOCYTOPENIA, UNSPECIFIED

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Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

288.51 LYMPHOCYTOPENIA 288.59 OTHER DECREASED WHITE BLOOD CELL COUNT 363.20 CHORIORETINITIS UNSPECIFIED V07.8 OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE V42.81 BONE MARROW REPLACED BY TRANSPLANT V42.82 PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT V42.9 UNSPECIFIED ORGAN OR TISSUE REPLACED BY TRANSPLANT V59.02 BLOOD DONORS STEM CELLS V59.3 BONE MARROW DONORS V66.2 CONVALESCENCE FOLLOWING CHEMOTHERAPY V66.5 CONVALESCENCE FOLLOWING OTHER TREATMENT

Neulasta (J2505) ONLY Jurisdiction(s): 10(J) NCD/LCD Document (s): L30026 ICD-9 Codes Diagnosis 288.00 - 288.04 NEUTROPENIA, UNSPECIFIED - NEUTROPENIA DUE TO INFECTION 288.09 OTHER NEUTROPENIA 288.50 LEUKOCYTOPENIA, UNSPECIFIED 288.51 LYMPHOCYTOPENIA 288.59 OTHER DECREASED WHITE BLOOD CELL COUNT V07.8 OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE V66.2 CONVALESCENCE FOLLOWING CHEMOTHERAPY

Granix (J1446) ONLY Jurisdiction(s): 10(J) NCD/LCD Document (s): L30026 ICD-9 Codes Diagnosis 288.00 NEUTROPENIA, UNSPECIFIED 288.03 - 288.09 DRUG INDUCED NEUTROPENIA - OTHER NEUTROPENIA

Neupogen (J1442) Granix (J1446) Jurisdiction(s): 9 (N) NCD/LCD Document (s): L29180; L29431 ICD-9 Codes Diagnosis 238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION 238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED

Page 33 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

238.77 POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD) 288.00 - 288.09 NEUTROPENIA, UNSPECIFIED - OTHER NEUTROPENIA UNSPECIFIED ADVERSE EFFECT OF UNSPECIFIED DRUG, MEDICINAL AND 995.20 BIOLOGICAL SUBSTANCE UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND 995.29 BIOLOGICAL SUBSTANCE V42.81* BONE MARROW REPLACED BY TRANSPLANT V42.82* PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT V42.9 UNSPECIFIED ORGAN OR TISSUE REPLACED BY TRANSPLANT V58.11 ENCOUNTER FOR ANTINEOPLASTIC CHEMOTHERAPY V58.69* LONG-TERM (CURRENT) USE OF OTHER MEDICATIONS V59.8 DONORS OF OTHER SPECIFIED ORGAN OR TISSUE *V42.81, V42.82, V58.69 is a secondary diagnosis code and should not be billed as the primary diagnosis

Neupogen (J1442) ONLY Jurisdiction(s):6, K NCD/LCD Document (s): A48208 ICD-9 Codes Diagnosis 042* HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE 202.40 LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF 202.41 HEAD FACE AND NECK LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRATHORACIC 202.42 LYMPH NODES LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRA-ABDOMINAL 202.43 LYMPH NODES LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF 202.44 AXILLA AND UPPER ARM LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF 202.45 INGUINAL REGION AND LOWER LIMB LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRAPELVIC 202.46 LYMPH NODES 202.47 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING SPLEEN LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF 202.48 MULTIPLE SITES PLASMA CELL LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 203.10 REMISSION 203.11 PLASMA CELL LEUKEMIA IN REMISSION OTHER IMMUNOPROLIFERATIVE NEOPLASMS, WITHOUT MENTION 203.80 OF HAVING ACHIEVED REMISSION 203.81 OTHER IMMUNOPROLIFERATIVE NEOPLASMS IN REMISSION 204.00 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING Page 34 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

ACHIEVED REMISSION 204.01 LYMPHOID LEUKEMIA ACUTE IN REMISSION 204.02 ACUTE LYMPHOID LEUKEMIA, IN RELAPSE CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.10 ACHIEVED REMISSION 204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION 204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE SUBACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.20 ACHIEVED REMISSION 204.21 LYMPHOID LEUKEMIA SUBACUTE IN REMISSION 204.22 SUBACUTE LYMPHOID LEUKEMIA, IN RELAPSE OTHER LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.80 ACHIEVED REMISSION 204.81 OTHER LYMPHOID LEUKEMIA IN REMISSION 204.82 OTHER LYMPHOID LEUKEMIA, IN RELAPSE UNSPECIFIED LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.90 ACHIEVED REMISSION 204.91 UNSPECIFIED LYMPHOID LEUKEMIA IN REMISSION 204.92 UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING 205.00 ACHIEVED REMISSION 205.01 MYELOID LEUKEMIA ACUTE IN REMISSION 205.02 ACUTE MYELOID LEUKEMIA, IN RELAPSE CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING 205.10 ACHIEVED REMISSION 205.11 MYELOID LEUKEMIA CHRONIC IN REMISSION 205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE SUBACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING 205.20 ACHIEVED REMISSION 205.21 MYELOID LEUKEMIA SUBACUTE IN REMISSION 205.22 SUBACUTE MYELOID LEUKEMIA, IN RELAPSE MYELOID SARCOMA, WITHOUT MENTION OF HAVING ACHIEVED 205.30 REMISSION 205.31 MYELOID SARCOMA IN REMISSION 205.32 MYELOID SARCOMA, IN RELAPSE OTHER MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING 205.80 ACHIEVED REMISSION 205.81 OTHER MYELOID LEUKEMIA IN REMISSION 205.82 OTHER MYELOID LEUKEMIA, IN RELAPSE UNSPECIFIED MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING 205.90 ACHIEVED REMISSION 205.91 UNSPECIFIED MYELOID LEUKEMIA IN REMISSION 205.92 UNSPECIFIED MYELOID LEUKEMIA, IN RELAPSE

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Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS 238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION 238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED 238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA 238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES 284.11 ANTINEOPLASTIC CHEMOTHERAPY INDUCED PANCYTOPENIA 284.12 OTHER DRUG INDUCED PANCYTOPENIA 284.19 OTHER PANCYTOPENIA 284.2 MYELOPHTHISIS 284.89 OTHER SPECIFIED APLASTIC ANEMIAS 284.9 APLASTIC ANEMIA UNSPECIFIED 288.00** NEUTROPENIA, UNSPECIFIED 288.01 CONGENITAL NEUTROPENIA 288.02 CYCLIC NEUTROPENIA 288.03 DRUG INDUCED NEUTROPENIA 288.04** NEUTROPENIA DUE TO INFECTION 288.09 OTHER NEUTROPENIA 288.50** LEUKOCYTOPENIA, UNSPECIFIED 288.59** OTHER DECREASED WHITE BLOOD CELL COUNT 528.01 MUCOSITIS (ULCERATIVE) DUE TO ANTINEOPLASTIC THERAPY MILD OR UNSPECIFIED PRE-ECLAMPSIA UNSPECIFIED AS TO EPISODE 642.40* OF CARE 642.41* MILD OR UNSPECIFIED PRE-ECLAMPSIA WITH DELIVERY MILD OR UNSPECIFIED PRE-ECLAMPSIA WITH DELIVERY WITH 642.42* POSTPARTUM COMPLICATION 642.43* MILD OR UNSPECIFIED PRE-ECLAMPSIA ANTEPARTUM 642.44* MILD OR UNSPECIFIED PRE-ECLAMPSIA POSTPARTUM 642.50* SEVERE PRE-ECLAMPSIA UNSPECIFIED AS TO EPISODE OF CARE 642.51* SEVERE PRE-ECLAMPSIA WITH DELIVERY SEVERE PRE-ECLAMPSIA WITH DELIVERY WITH POSTPARTUM 642.52* COMPLICATION 642.53* SEVERE PRE-ECLAMPSIA ANTEPARTUM 642.54* SEVERE PRE-ECLAMPSIA POSTPARTUM 780.61* FEVER PRESENTING WITH CONDITIONS CLASSIFIED ELSEWHERE V07.8 OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE V15.9 UNSPECIFIED PERSONAL HISTORY PRESENTING HAZARDS TO HEALTH V42.81 BONE MARROW REPLACED BY TRANSPLANT V42.82 PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT V49.83 AWAITING ORGAN TRANSPLANT STATUS V58.11 ENCOUNTER FOR ANTINEOPLASTIC CHEMOTHERAPY V58.12 ENCOUNTER FOR IMMUNOTHERAPY FOR NEOPLASTIC CONDITION V59.02 BLOOD DONORS STEM CELLS

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Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

V66.2 CONVALESCENCE FOLLOWING CHEMOTHERAPY V66.5 CONVALESCENCE FOLLOWING OTHER TREATMENT *Must be billed along with a primary code of 288.00**, 288.04**, 288.50**, or 288.59**.

Neulasta (J2505) ONLY Jurisdiction(s): 6, K NCD/LCD Document (s): A48208 ICD-9 Codes Diagnosis 284.11 ANTINEOPLASTIC CHEMOTHERAPY INDUCED PANCYTOPENIA 288.03 DRUG INDUCED NEUTROPENIA V07.8 OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE V15.9 UNSPECIFIED PERSONAL HISTORY PRESENTING HAZARDS TO HEALTH V42.82 PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT V58.11 ENCOUNTER FOR ANTINEOPLASTIC CHEMOTHERAPY V58.12 ENCOUNTER FOR IMMUNOTHERAPY FOR NEOPLASTIC CONDITION V66.2 CONVALESCENCE FOLLOWING CHEMOTHERAPY

Granix (J1446) ONLY Jurisdiction(s): 6, K NCD/LCD Document (s): A48208 ICD-9 Codes Diagnosis 288.00 NEUTROPENIA, UNSPECIFIED 288.03 DRUG INDUCED NEUTROPENIA - 288.04 NEUTROPENIA DUE TO INFECTION 288.09 OTHER NEUTROPENIA

Neulasta (J2505) ONLY Jurisdiction(s): 9 (N) NCD/LCD Document (s): L29254; L29463 ICD-9 Codes Diagnosis MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - 140.0 - 149.9 MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND ORAL CAVITY MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT 150.0 - 159.9 NEOPLASM OF ILL-DEFINED SITES WITHIN THE DIGESTIVE ORGANS AND PERITONEUM MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM 160.0 - 165.9 OF ILL-DEFINED SITES WITHIN THE RESPIRATORY SYSTEM MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT 170.0 - 176.9 MANDIBLE - KAPOSI'S SARCOMA UNSPECIFIED SITE 179 - 189.9 MALIGNANT NEOPLASM OF UTERUS-PART UNS - MALIGNANT Page 37 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

NEOPLASM OF URINARY ORGAN SITE UNSPECIFIED MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA 190.0 - 199.2 RETINA AND CHOROID - MALIGNANT NEOPLASM ASSOCIATED WITH TRANSPLANT ORGAN RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF 200.00 - 200.88 LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE - HODGKIN'S DISEASE 201.00 - 201.98 UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES NODULAR LYMPHOMA UNSPECIFIED SITE - NODULAR LYMPHOMA 202.00 - 202.08 INVOLVING LYMPH NODES OF MULTIPLE SITES MYCOSIS FUNGOIDES UNSPECIFIED SITE - MYCOSIS FUNGOIDES 202.10 - 202.18 INVOLVING LYMPH NODES OF MULTIPLE SITES SEZARY'S DISEASE UNSPECIFIED SITE - SEZARY'S DISEASE INVOLVING 202.20 - 202.28 LYMPH NODES OF MULTIPLE SITES MALIGNANT HISTIOCYTOSIS UNSPECIFIED SITE - MALIGNANT 202.30 - 202.38 HISTIOCYTOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE - LEUKEMIC 202.40 - 202.48 RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES LETTERER-SIWE DISEASE UNSPECIFIED SITE - LETTERER-SIWE DISEASE 202.50 - 202.58 INVOLVING LYMPH NODES OF MULTIPLE SITES MALIGNANT MAST CELL TUMORS UNSPECIFIED SITE - MALIGNANT 202.60 - 202.68 MAST CELL TUMORS INVOLVING LYMPH NODES OF MULTIPLE SITES PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND 202.70 - 202.78 SOLID ORGAN SITES - PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE - OTHER 202.80 - 202.88 MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED 203.00 - 203.82 REMISSION - OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.00 - 204.02 ACHIEVED REMISSION - ACUTE LYMPHOID LEUKEMIA, IN RELAPSE CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.10 - 204.12 ACHIEVED REMISSION - CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE SUBACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.20 - 204.22 ACHIEVED REMISSION - SUBACUTE LYMPHOID LEUKEMIA, IN RELAPSE OTHER LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING 204.80 - 204.82 ACHIEVED REMISSION - OTHER LYMPHOID LEUKEMIA, IN RELAPSE 209.31 MERKEL CELL CARCINOMA OF THE FACE 209.32 MERKEL CELL CARCINOMA OF THE SCALP AND NECK 209.33 MERKEL CELL CARCINOMA OF THE UPPER LIMB

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Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

209.34 MERKEL CELL CARCINOMA OF THE LOWER LIMB 209.35 MERKEL CELL CARCINOMA OF THE TRUNK 209.36 MERKEL CELL CARCINOMA OF OTHER SITES 209.75 SECONDARY MERKEL CELL CARCINOMA 273.3 MACROGLOBULINEMIA UNSPECIFIED ADVERSE EFFECT OF UNSPECIFIED DRUG, MEDICINAL AND 995.20 BIOLOGICAL SUBSTANCE UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND 995.29 BIOLOGICAL SUBSTANCE V07.8 OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE V66.2 CONVALESCENCE FOLLOWING CHEMOTHERAPY

Leukine (J2820) ONLY Jurisdiction(s): 9(N) NCD/LCD Document (s): L29391; L29275 ICD-9 Codes Diagnosis ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 205.00 - 205.92 REMISSION - UNSPECIFIED MYELOID LEUKEMIA, IN RELAPSE ESSENTIAL THROMBOCYTHEMIA - OTHER LYMPHATIC AND 238.71 - 238.79 HEMATOPOIETIC TISSUES 288.00 - 288.09 NEUTROPENIA, UNSPECIFIED - OTHER NEUTROPENIA UNSPECIFIED ADVERSE EFFECT OF UNSPECIFIED DRUG, MEDICINAL AND 995.20 BIOLOGICAL SUBSTANCE UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND 995.29 BIOLOGICAL SUBSTANCE 996.85 COMPLICATIONS OF TRANSPLANTED BONE MARROW 996.88 COMPLICATIONS OF TRANSPLANTED ORGAN, STEM CELL V42.81* BONE MARROW REPLACED BY TRANSPLANT V42.82* PERIPHERAL STEM CELLS REPLACED BY TRANSPLANT V42.9* UNSPECIFIED ORGAN OR TISSUE REPLACED BY TRANSPLANT V58.11 ENCOUNTER FOR ANTINEOPLASTIC CHEMOTHERAPY V58.44 AFTERCARE FOLLOWING ORGAN TRANSPLANT V58.69* LONG-TERM (CURRENT) USE OF OTHER MEDICATIONS V59.02 BLOOD DONORS STEM CELLS V59.3 BONE MARROW DONORS V59.8 DONORS OF OTHER SPECIFIED ORGAN OR TISSUE *V42.81, V42.82, V42.9 and V58.69 are secondary diagnosis codes and should not be billed as the primary diagnosis.

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Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

VIII. Policy Exclusions: o Treatment for diagnoses not FDA approved o All indications not described in Section III Review criteria are not covered and may be considered experimental or investigational

IX. Black Box Warnings/Contraindications: Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) Contraindications o Known hypersensitivity to E. coli protein o Hypersensitivity to pegfilgrastim or filgrastim

Leukine® (sargramostim) Contraindications o Chemotherapy and radiation therapy o Do not administer Leukine within 24 hours (before or after) chemotherapy or radiation therapy because of the potential sensitivity of rapidly dividing hematopoietic progenitor cells. o Hypersensitivity to GM-CSF, yeast-derived productsor any component of the product

X. References: 1. Leukine [package insert]. Seattle, WA; Bayer Pharmaceuticals, Inc; June 2012. Accessed February 2014. 2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) sargramostim. National Comprehensive Cancer Network, 2014. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2014. 3. Granix [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc.; July 2013. Accessed February 2014. 4. Neulasta [package insert]. Thousand Oaks, CA; Amgen Inc; May 2012. Accessed February 2014. 5. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) pegfigrastim. National Comprehensive Cancer Network, 2014. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2014. 6. Neupogen [package insert]. Thousand Oaks, CA; Amgen Inc; September 2013. Accessed February 2014. 7. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) filgrastim. National Comprehensive Cancer Network, 2014. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2014. Page 40 of 42

Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

8. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Myeloid Growth Factors. Version 2.2014. National Comprehensive Cancer Network, 2013. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2014. 9. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) tbo- filgrastim. National Comprehensive Cancer Network, 2013. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2014 10. Smith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L, Bennett CL, Cantor SB, Crawford J, Cross SJ, Demetri G, Desch CE, Pizzo PA, Schiffer CA, Schwartzberg L, Somerfield MR, Somlo G, Wade JC, Wade JL, Winn RJ, Wozniak AJ, Wolff AC. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006;24(19):3187-205. 11. Framptom JE, et al. Filgrastim: a review of its pharmacological properties and therapeutic efficacy in neutropenia. Drugs 1994;49(5):731-760 12. Ozer H, et al. 2000 Update of recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. J Clin Oncol 200;18(20):3558-3585. 13. CGS, Administrators, LLC. Local Coverage Determination (LCD): White Cell Colony Stimulating Factors (L31851). Centers for Medicare & Medicaid Services, Inc. Updated on 01/02/2014 with effective date 01/01/2014. Accessed March 2014. 14. Palmetto GBA. Local Coverage Determination (LCD): White Cell Colony Stimulating Factors (L31799). Centers for Medicare & Medicaid Services, Inc. Updated on 01/10/2014 with effective date 01/16/2014. Accessed March 2014. 15. First Coast Service Options, Inc. Local Coverage Determination (LCD): Sargramostim (GM-CSF, Leukine®) (L29391; L29275). Centers for Medicare & Medicaid Services, Inc. Updated on 09/14/2011 with effective date 10/01/2011. Accessed March. 16. Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD): Human Granulocyte/Macrophage Colony Stimulating Factors (L30306). Centers for Medicare & Medicaid Services, Inc. Updated on 02/19/2014 with effective date 03/01/2014. Accessed March 2014. 17. Cahaba Government Benefit Administrators, LLC. Local Coverage Determination (LCD): Drugs and Biologicals: Colony Stimulating Factors (L30026). Centers for Medicare & Medicaid Services, Inc. Updated on 01/28/2014 with effective date 01/01/2014. Accessed March 2014. 18. First Coast Service Options, Inc. Local Coverage Determination (LCD): G-CSF (Neupogen®, Granix™) (L29180; L29431). Centers for Medicare & Medicaid Services, Inc. Updated on 01/09/2014 with effective date 01/01/2014. Accessed March 2014. 19. First Coast Service Options, Inc. Local Coverage Determination (LCD): Pegfilgrastim (Neulasta®) (L29254; L29463). Centers for Medicare & Medicaid Services, Inc. Updated on 02/17/2013 with effective date 02/07/2013. Accessed March 2014.

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Colony Stimulating Factors: Medical Necessity Criteria Neupogen® (filgrastim), Neulasta® Number: IC-0049 (pegfilgrastim), Leukine®

(sargramostim), Granix (tbo- filgrastim) Last Review Date: 03/25/2014

20. National Government Services, Inc . Local Coverage Article: Filgrastim, Pegfilgrastim, Tbo-filgrastim (e.g., Neupogen®, Neulasta TM, Granix TM) - Related to LCD L25820 (A48208). Centers for Medicare & Medicaid Services, Inc. Updated on 01/10/2014 with effective date 01/16/2014. Accessed March 2014.

XI. Appendix:

Medicare Part B Administrative Contractor (MAC) Jurisdictions Jurisdiction Applicable State/US Territory Contractor E CA,HI, NV, AS, GU, CNMI Noridian Administrative Services (NAS) F AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Administrative Services (NAS) 5 KS, NE, IA, MO Wisconsin Physicians Service (WPS) 6 MN, WI, IL National Government Services (NGS) H LA, AR, MS, TX, OK, CO, NM Novitas Solutions 8 MI, IN Wisconsin Physicians Service (WPS) 9 (N) FL, PR, VI First Coast Service Options 10 (J) TN, GA, AL Cahaba Government Benefit Administrators 11 (M) NC, SC, VA, WV Palmetto GBA 12 (L) DE, MD, PA, NJ, DC Novitas Solutions K NY, CT, MA, RI, VT, ME, NH National Government Services (NGS) 15 KY, OH CGS Administrators, LLC

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