Local Coverage Determination (LCD): Erythropoiesis Stimulating Agents (L29168)

Home About CMS Newsroom Center FAQs Archive Share Help Email Print Learn about your healthcare options Medicare Medicaid/CHIP Medicare-Medicaid Coordination Private Insurance Innovation Center Regulations & Guidance Research, Statistics, Data & Systems Outreach & Education OVERVIEW ADVANCED SEARCH INDEXES REPORTS DOWNLOADS BASKET (0) Contextual Help is Off Page Help Back to Document ID Search Results Local Coverage Determination (LCD): Erythropoiesis Stimulating Agents (L29168) Select the Print Record, Add to Basket or Email Record buttons to print the record, to add it to your basket or to email the record. Section Navigation Select Section Expand All Collapse All Contractor Information Contractor Name First Coast Service Options, Inc. Contract Number 09102 Contract Type MAC - Part B LCD Information Document Information LCD ID L29168 LCD Title Erythropoiesis Stimulating Agents Jurisdiction Florida Original Effective Date For services performed on or after 02/02/2009 AMA CPT/ADA CDT Copyright Statement CPT only copyright 2002-2013 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Revision Effective Date For services performed on or after 02/23/2013 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 10/01/2010 Notice Period End Date N/A CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See 1869(f)(1)(A)(i) of the Social Security Act. Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual System, Pub 100-02, Medicare Benefit Policy, Chapter 11, Section 90 CMS Manual System, Pub 100-02, Medicare Benefit Policy, Chapter 15, Section 50 CMS Manual System, Pub 100-04, Medicare Claims Processing, Transmittal 1212, Change Request 5480, dated March 30, 2007 CMS National Coverage Decision, CAG #000383N, The use of Erythropoiesis Stimulating Agents in Cancer and Related Neoplastic Conditions, Issued July 30, 2007. CMS Manual System, Pub 100-03, CMS National Coverage, Chapter 1, Part 2, Section 110.21 CMS Manual System, Pub 100-04, Medicare Claims Processing, Chapter 17, Section 80.8, 80.9, 80.10 and 80.12 Medicare Change Request 5699, transmittal 1412, dated January 11, 2008 Medicare Change Request 5818, transmittals 80 and 1413, dated January 14, 2008 CMS Manual System, Pub 100-04, Transmittal 2450, Change Request 7831, dated April 26, 2012 CMS Manual System, Pub 100-04, Transmittal 2481, Change Request 7844, dated June 1, 2012 CMS Manual System, Pub 100-04, Transmittal 2582, Change Request 8050, dated November 2, 2012. Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity Epoetin alfa (Epogen and Procrit ) and Darbepoetin alfa (Aranesp ) are erythropoetin analogs produced in the Chinese hamster overy, that are 165 amino acid gylcoproteins manufactured by recombinant DNA technology. Epoetin alfa has the same amino acid sequence of naturally occurring erythropoietin. Darbepoetin has 2 additional 5 N-linked oligosaccharide chains, which slows its clearance, making its half- life 2-3 times longer than that of epoetin alfa, thus allowing less frequent subcutaneous or intravenous injections. Erythropoietin is a specialized cytokein that is produced by the kidneys and stimulates the proliferation of red blood cells in the bone marrow. Erythropoietin is released into the blood stream in response to hypoxia. In response to the hypoxia, the erythropoietin interacts with the progenitor cells to increase the production of red blood cells. This LCD will outline the indications and limitations for Erythropoesis stimulating agents (ESAs) for Renal and Non-renal indications. Indications: Epoetin alfa (Procrit and Epogen ) Epoetin alfa is covered for the following FDA approved, labeled, indications: Anemia due to Chronic Kidney Disease. Epoetin alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion. Anemia due to Zidovudine in HIV-infected patients. Epoetin alfa is indicated for the treatment of anemia due to zidovudine administered at 4200 mg/week HIV-infected patients with endogenous serum erythropoietin levels of 500 munits/ml. Reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Epoetin alfa is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin >10 to 13 g/dl who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. Epoetin alfa is not indicated for patients who are willing to donate autologous blood preoperatively. Anemia due to chemotherapy in patients with cancer. Coverage for this indication is outlined in the NCD issued on 7/30/07 for ESAs in cancer and related neoplastic conditions and is summarized under the limitations section of this LCD. In addition to the FDA labeled indications, epoetin alfa is covered for the following off-label indications: For the treatment of anemia associated with myelodysplastic syndrome (MDS). Patients usually present with variable clinical features depending on the MDS classification and the degree of disordered hematopoiesis with anemia. Common complaints or symptoms are fatigue, pallor, infection and bleeding or bruising. Diagnosis is usually confirmed by bone marrow aspiration and/or biopsy. For the purposes of this LCD, Chronic Myelomonocytic Leukemia (CMML) will be considered a form of MDS and as such the anemia associated with it may be eligible for coverage if the indications and limitations outlined in this LCD for MDS are met. Providers must use the ICD-9 codes listed in the LCD for MDS to code for CMML. If the physician cannot classify the patient with one of the MDS diagnosis codes, then the patient does not meet the criteria for CMML and coverage will not have been met. For the treatment of anemia associated with the management of hepatitis C. The use of epoetin alfa has been shown to be effective in treatment of anemia in patients with hepatitis C virus infection who are being treated with the combination of ribavarin and interferon alfa or ribavarin and peginterferon alfa For the treatment of chronic anemia associated Rheumatoid Arthritis (RA). The patient must have been previously diagnosed with RA using the American College of Rheumatology criteria. Patients are usually on antimetabolite (e.g., Methotrexate) which causes the anemia.

Darbepoetin alfa (Aranesp ) Darbepoetin alfa is covered for the following FDA approved, labeled, indications: Anemia due to chronic kidney disease (CKD). Aranesp is indicated for the treatment of anemia due to CKD, including patients on dialysis and patients not on dialysis. Anemia due to chemotherapy in patients with cancer. Coverage for this indication is outlined in the NCD issued on 7/30/07 for ESAs in cancer and related neoplastic conditions and is summarized in the limitations section of this LCD. In addition to the FDA labeled indications, Darbepoetin alfa is covered for the following off-label indications: For the treatment of anemia associated with myelodysplastic syndrome (MDS). Patients usually present with variable clinical features depending on the MDS classification and the degree of disordered hematopoiesis with anemia. Common complaints or symptoms are fatigue, pallor, infection and bleeding or bruising. Diagnosis is usually confirmed by bone marrow aspiration and/or biopsy. For the purposes of this LCD, Chronic Myelomonocytic Leukemia (CMML) will be considered a form of MDS and as such the anemia associated with it may be eligible for coverage if the indications and limitations outlined in this LCD for MDS are met. Providers must use the ICD-9 codes listed in the LCD for MDS to code for CMML. If the physician cannot classify the patient with one of the MDS diagnosis codes, then the patient does not meet the criteria for CMML and coverage will not have been met. Peginesatide (OMONTYS ) On February 23, 2013 the U.S. Food and Drug Administration (FDA) issued a voluntary nationwide recall of all lots of Omontys (peginesatide) injection by Affymax, Inc.and Takeda Pharmaceuticals Company Limited. The companies have also issued a letter to health care professionals indicating that no new or existing patients should receive OMONTYS (peginesatide). Peginesatide is covered for the following FDA approved labeled, indications: Anemia due to chronic kidney disease (CKD). Peginesatide is indicated for the treatment of anemia due to CKD in adult patients on dialysis. Limitations ESAs are not indicated for use: 1.) In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy 2.) In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. 3.) In patients scheduled for surgery who are willing to donate autogolous blood (applies to epotein alfa products only-epogen and Procrit) 4.) In patients undergoing cardiac or vascular surgery (applies to epoetin alfa products only-epogen and Procrit) 5.) As a substitute for RBC transfusions in patients who require immediate correction of anemia. Prior to initiating ESA therapy, other causes of anemia should be ruled out and managed if present. Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Other causes could also be iron deficiency, underlying infectious, inflammatory or malignant processes, occult blood loss, underlying hematologic diseases, hemolysis, aluminum intoxication, osteitis fibrosa cystica or Pure Red blood Cell Aplasia. Epoetin alfa, Darbepoetin alfa, and Peginesatide are contraindicated in patients with uncontrolled hypertension. Epoetin alfa is also contraindicated in patients with known hypersensitivity to mammalian cell-derived products and to Albumin (Human). Darbepoetin alfa is contraindicated in patients with known hypersensitivity to the active substance or any of the excipients of darbepoetin alfa. Peginesatide is not indicated and is not recommended for use: In patients with CKD not on dialysis In patients receiving treatment for cancer and whose anemia is not due to CKD For patients in the ESRD program: Generally, ESRD patients with symptomatic anemia considered for initiation of EPO/Aranesp therapy should have a hematocrit less than 30 or hemoglobin less than 10; ESRD patients who have been receiving EPO/Aranesp therapy should have a hematocrit between 30 and 36.Refer to Pub 100-02, Chapter 11, Section 90 and Pub 100-02, Chapter 15, Section 50.5.2 for further discussion. The FDA has issued a black box warning for ESAs. The Black Box Warning reads as follows: Chronic Kidney Disease: In controlled trials, patients experienced greater risk for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesisstimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dl. No trial has identified a hemoglobin target, ESA dose, or dosing strategy that does not increase these risks. Use the lowest epoetin alfa, darbepoetin alfa or peginesatide dose sufficient to reduce the need for red blood cell (RBC) transfusion. Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense epoetin alfa to patients with cancer. To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions. Use ESAs only for anemia from myelosuppressive chemotherapy. ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue following the completion of a chemotherapy course.

Perisurgery Due to increased risk of deep vein thrombosis (DVT), DVT prohylaxis is recommended]. Renal failure: Patients experienced greater risk for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5vs 11.3g/dL; 14 vs. 10g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dl. CMS issued a National Coverage Decision for ESAs for non-esrd use. The following limitations have been imposed by the NCD and are effective for services on or after 7/30/2007: ESA treatment is not reasonable and necessary for the following clinical conditions: o Any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, iron deficiency, hemolysis, bleeding or bone marrow fibrosis; o The anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML), or erythroid cancers; o The anemia of cancer not related to cancer treatment; o Anemia associated only with radiotherapy; o Prophylactic use to prevent chemotherapy-induced anemia; o Prophylactic use to reduce tumor hypoxia; o Patients with erythropoietin-type resistance due to neutralizing antibodies; and o Anemia due to cancer treatment if patients have uncontrolled hypertension CMS has also determined that ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia is only reasonable and necessary under the following specified conditions: 1. The hemoglobin level immediately prior to initiation or maintenance of ESA treatment is <10 g/l (or the Hematocrit is <30%) 2. The starting dose for ESA treatment is the recommended FDA label starting dose, no more than 150 U/kg/three times weekly for epoetin and 2.25 mcg/kg/weekly for Darbepoetin alfa. Equivalent doses may be given over other approved time periods. 3. Maintenance of ESA therapy is the starting dose if the hemoglobin level remains below 10 g/dl (or Hematocrit is <30%) 4 weeks after initiation of therapy and the rise in hemoglobin is 1g/dL (or Hematocrit is 3%). 4. For patients whose hemoglobin rise <1 g/dl (Hematocrit rise <3%) compared to pretreatment baseline over 4 weeks of treatment and whose hemoglobin level remains <10 g/dl after 4 weeks of treatment (or the hematocrit <30%), the recommended FDA label starting dose may be increased once by 25%. Continued use of the drug is not reasonable or necessary if the hemoglobin rises <1 g/dl (Hematocrit is <3%) compared to pretreatment baseline by 8 weeks of treatment. 5. Continued administration of the drug is not reasonable and necessary if there is a rapid rise in hemoglobin > 1g/dl (Hematocrit is <30%). Continuation and reinstitution of ESA therapy must include a dose reduction of 25% from the previously administered dose. 6. ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen. Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 999x Not Applicable Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. 99999 Not Applicable CPT/HCPCS Codes

Group 1 Paragraph: N/A Group 1 Codes: J0881 J0882 J0885 J0886 J0890 INJECTION, DARBEPOETIN ALFA, 1 MICROGRAM (NON-ESRD USE) INJECTION, DARBEPOETIN ALFA, 1 MICROGRAM (FOR ESRD ON DIALYSIS) INJECTION, EPOETIN ALFA, (FOR NON-ESRD USE), 1000 UNITS INJECTION, EPOETIN ALFA, 1000 UNITS (FOR ESRD ON DIALYSIS) INJECTION, PEGINESATIDE, 0.1 MG (FOR ESRD ON DIALYSIS) ICD-9 Codes that Support Medical Necessity Group 1 Paragraph: J0881 List 1 The diagnosis codes listed below require the use of the EC modifier when submitting claims for J0881. In addition, diagnosis codes marked with an * require a dual diagnosis. The dual diagnosis rule is outlined below. Dual diagnosis rule: 1.) 403.01, 403.11, 403.91, 404.02, 404.03, 404.12, 404.13, 404.92, 404.93, 585.1, 585.2, 585.3, 585.4, 585.5 or 585.9 AND 285.21 must be billed together. Group 1 Codes: 238.71 ESSENTIAL THROMBOCYTHEMIA 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 273.3 MACROGLOBULINEMIA 285.21* ANEMIA IN CHRONIC KIDNEY DISEASE 403.01* HYPERTENSIVE CHRONIC KIDNEY DISEASE, MALIGNANT, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 403.11* HYPERTENSIVE CHRONIC KIDNEY DISEASE, BENIGN, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 403.91* HYPERTENSIVE CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.02* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.03* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.12* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.13* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.92* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.93* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 585.1* CHRONIC KIDNEY DISEASE, STAGE I 585.2* CHRONIC KIDNEY DISEASE, STAGE II (MILD) 585.3* CHRONIC KIDNEY DISEASE, STAGE III (MODERATE) 585.4* CHRONIC KIDNEY DISEASE, STAGE IV (SEVERE) 585.5* CHRONIC KIDNEY DISEASE, STAGE V 585.9* CHRONIC KIDNEY DISEASE, UNSPECIFIED Group 1 Medical Necessity ICD-9 Codes Asterisk Explanation: ** Diagnosis codes marked with an * require a dual diagnosis. Group 2 Paragraph: J0881 List 2 The following diagnosis codes require the use of the EA modifier when submitting claims for J0881. In addition, ALL diagnosis codes listed below require a dual diagnosis. The dual diagnosis rule is outlined below. Dual Diagnosis Rule 1.) ALL diagnosis codes listed below for J0881 List 2 require a dual diagnosis in addition to the EA modifier. Diagnosis code 285.3 AND one of the malignancy codes listed below MUST be billed together. All codes listed below except for 285.3 are malignancy codes. Group 2 Codes:

140.0-149.9 MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - MALIGNANT NEOPLASM OF ILL- DEFINED SITES WITHIN THE LIP AND ORAL CAVITY 150.0-159.9 MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE DIGESTIVE ORGANS AND PERITONEUM 160.0-165.9 MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE RESPIRATORY SYSTEM 170.0-176.9 MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE - KAPOSI'S SARCOMA UNSPECIFIED SITE 179-189.9 MALIGNANT NEOPLASM OF UTERUS-PART UNS - MALIGNANT NEOPLASM OF URINARY ORGAN SITE UNSPECIFIED 190.0-199.2 MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA RETINA AND CHOROID - MALIGNANT NEOPLASM ASSOCIATED WITH TRANSPLANT ORGAN 200.00-200.88 RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES 201.00-201.98 HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES 202.00-202.98 NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES 203.00-203.82 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE 204.00-204.92 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE 209.00-209.03 MALIGNANT CARCINOID TUMOR OF THE SMALL INTESTINE, UNSPECIFIED PORTION - MALIGNANT CARCINOID TUMOR OF THE ILEUM 209.10-209.17 MALIGNANT CARCINOID TUMOR OF THE LARGE INTESTINE, UNSPECIFIED PORTION - MALIGNANT CARCINOID TUMOR OF THE RECTUM 209.20-209.29 MALIGNANT CARCINOID TUMOR OF UNKNOWN PRIMARY SITE - MALIGNANT CARCINOID TUMOR OF OTHER SITES 209.30-209.36 MALIGNANT POORLY DIFFERENTIATED NEUROENDOCRINE CARCINOMA, ANY SITE - MERKEL CELL CARCINOMA OF OTHER SITES 209.70-209.79 SECONDARY NEUROENDOCRINE TUMOR, UNSPECIFIED SITE - SECONDARY NEUROENDOCRINE TUMOR OF OTHER SITES 230.0-234.9 CARCINOMA IN SITU OF LIP ORAL CAVITY AND PHARYNX - CARCINOMA IN SITU SITE UNSPECIFIED 235.0-235.9 NEOPLASM OF UNCERTAIN BEHAVIOR OF MAJOR SALIVARY GLANDS - NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED RESPIRATORY ORGANS 236.0-236.99 NEOPLASM OF UNCERTAIN BEHAVIOR OF UTERUS - NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED URINARY ORGANS 237.0-237.9 NEOPLASM OF UNCERTAIN BEHAVIOR OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT - NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED PARTS OF NERVOUS SYSTEM 238.0 NEOPLASM OF UNCERTAIN BEHAVIOR OF BONE AND ARTICULAR CARTILAGE 238.1 NEOPLASM OF UNCERTAIN BEHAVIOR OF CONNECTIVE AND OTHER SOFT TISSUE 238.2 NEOPLASM OF UNCERTAIN BEHAVIOR OF SKIN 238.3 NEOPLASM OF UNCERTAIN BEHAVIOR OF BREAST 238.4 POLYCYTHEMIA VERA 238.5 NEOPLASM OF UNCERTAIN BEHAVIOR OF HISTIOCYTIC AND MAST CELLS 238.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS 238.8 NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER SPECIFIED SITES 238.9 NEOPLASM OF UNCERTAIN BEHAVIOR SITE UNSPECIFIED 239.0-239.9 NEOPLASM OF UNSPECIFIED NATURE OF DIGESTIVE SYSTEM - NEOPLASM OF UNSPECIFIED NATURE SITE UNSPECIFIED 285.3 ANTINEOPLASTIC CHEMOTHERAPY INDUCED ANEMIA Group 3 Paragraph: J0885 List 1 The diagnosis codes listed below require the use of the EC modifier when submitting claims for J0885. In addition, diagnosis codes marked with an * require a dual diagnosis. The dual diagnosis rules are outlined below. Dual diagnosis rules: 1.) 403.01, 403.11, 403.91, 404.02, 404.03, 404.12, 404.13, 404.92, 404.93, 585.1, 585.2, 585.3, 585.4, 585.5 or 585.9 AND 285.21 must be billed together. 2.) 042, 070.54, 070.70, V07.8 or 714.0 AND 285.29 or 285.9 must be billed together. Group 3 Codes: 042* HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE 070.54* CHRONIC HEPATITIS C WITHOUT HEPATIC COMA 070.70* UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA

238.71 ESSENTIAL THROMBOCYTHEMIA 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 273.3 MACROGLOBULINEMIA 285.21* ANEMIA IN CHRONIC KIDNEY DISEASE 285.29* ANEMIA OF OTHER CHRONIC DISEASE 285.9* ANEMIA UNSPECIFIED 403.01* HYPERTENSIVE CHRONIC KIDNEY DISEASE, MALIGNANT, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 403.11* HYPERTENSIVE CHRONIC KIDNEY DISEASE, BENIGN, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 403.91* HYPERTENSIVE CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.02* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.03* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.12* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.13* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.92* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 404.93* HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE 585.1* CHRONIC KIDNEY DISEASE, STAGE I 585.2* CHRONIC KIDNEY DISEASE, STAGE II (MILD) 585.3* CHRONIC KIDNEY DISEASE, STAGE III (MODERATE) 585.4* CHRONIC KIDNEY DISEASE, STAGE IV (SEVERE) 585.5* CHRONIC KIDNEY DISEASE, STAGE V 585.9* CHRONIC KIDNEY DISEASE, UNSPECIFIED 714.0* RHEUMATOID ARTHRITIS V07.8* OTHER SPECIFIED PROPHYLACTIC OR TREATMENT MEASURE Group 3 Medical Necessity ICD-9 Codes Asterisk Explanation: ** Diagnosis codes marked with an * require a dual diagnosis. Group 4 Paragraph: J0885 List 2 The following diagnosis codes require the use of the EA modifier when submitting claims for J0885. In addition, ALL diagnosis codes listed below require a dual diagnosis. The dual diagnosis rule is outlined below. Dual Diagnosis Rule 1.) ALL diagnosis codes listed below for J0885 List 2 require a dual diagnosis in addition to the EA modifier. Diagnosis code 285.3 AND one of the malignancy codes listed below MUST be billed together. All codes listed below except for 285.3 are malignancy codes. Group 4 Codes: 140.0-149.9 150.0-159.9 160.0-165.9 170.0-176.9 179-189.9 190.0-199.2 200.00-200.88 201.00-201.98 MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - MALIGNANT NEOPLASM OF ILL- DEFINED SITES WITHIN THE LIP AND ORAL CAVITY MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE DIGESTIVE ORGANS AND PERITONEUM MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE RESPIRATORY SYSTEM MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE - KAPOSI'S SARCOMA UNSPECIFIED SITE MALIGNANT NEOPLASM OF UTERUS-PART UNS - MALIGNANT NEOPLASM OF URINARY ORGAN SITE UNSPECIFIED MALIGNANT NEOPLASM OF EYEBALL EXCEPT CONJUNCTIVA CORNEA RETINA AND CHOROID - MALIGNANT NEOPLASM ASSOCIATED WITH TRANSPLANT ORGAN RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES

202.00-202.98 NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES 203.00-203.82 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE 204.00-204.92 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE 209.00-209.03 MALIGNANT CARCINOID TUMOR OF THE SMALL INTESTINE, UNSPECIFIED PORTION - MALIGNANT CARCINOID TUMOR OF THE ILEUM 209.10-209.17 MALIGNANT CARCINOID TUMOR OF THE LARGE INTESTINE, UNSPECIFIED PORTION - MALIGNANT CARCINOID TUMOR OF THE RECTUM 209.20-209.29 MALIGNANT CARCINOID TUMOR OF UNKNOWN PRIMARY SITE - MALIGNANT CARCINOID TUMOR OF OTHER SITES 209.30-209.36 MALIGNANT POORLY DIFFERENTIATED NEUROENDOCRINE CARCINOMA, ANY SITE - MERKEL CELL CARCINOMA OF OTHER SITES 209.70-209.79 SECONDARY NEUROENDOCRINE TUMOR, UNSPECIFIED SITE - SECONDARY NEUROENDOCRINE TUMOR OF OTHER SITES 230.0-234.9 CARCINOMA IN SITU OF LIP ORAL CAVITY AND PHARYNX - CARCINOMA IN SITU SITE UNSPECIFIED 235.0-235.9 NEOPLASM OF UNCERTAIN BEHAVIOR OF MAJOR SALIVARY GLANDS - NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED RESPIRATORY ORGANS 236.0-236.99 NEOPLASM OF UNCERTAIN BEHAVIOR OF UTERUS - NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED URINARY ORGANS 237.0-237.9 NEOPLASM OF UNCERTAIN BEHAVIOR OF PITUITARY GLAND AND CRANIOPHARYNGEAL DUCT - NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER AND UNSPECIFIED PARTS OF NERVOUS SYSTEM 238.0 NEOPLASM OF UNCERTAIN BEHAVIOR OF BONE AND ARTICULAR CARTILAGE 238.1 NEOPLASM OF UNCERTAIN BEHAVIOR OF CONNECTIVE AND OTHER SOFT TISSUE 238.2 NEOPLASM OF UNCERTAIN BEHAVIOR OF SKIN 238.3 NEOPLASM OF UNCERTAIN BEHAVIOR OF BREAST 238.4 POLYCYTHEMIA VERA 238.5 NEOPLASM OF UNCERTAIN BEHAVIOR OF HISTIOCYTIC AND MAST CELLS 238.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS 238.8 NEOPLASM OF UNCERTAIN BEHAVIOR OF OTHER SPECIFIED SITES 238.9 NEOPLASM OF UNCERTAIN BEHAVIOR SITE UNSPECIFIED 239.0-239.9 NEOPLASM OF UNSPECIFIED NATURE OF DIGESTIVE SYSTEM - NEOPLASM OF UNSPECIFIED NATURE SITE UNSPECIFIED 285.3 ANTINEOPLASTIC CHEMOTHERAPY INDUCED ANEMIA Group 5 Paragraph: The following list applies to J0882, J0886, and J0890 only. A dual diagnosis is required for all claims billing J0882, J0886, or J0890. Dual Diagnosis Rule: * 285.21 and 585.6 must be billed together. Group 5 Codes: 285.21* ANEMIA IN CHRONIC KIDNEY DISEASE 585.6* END STAGE RENAL DISEASE Group 5 Medical Necessity ICD-9 Codes Asterisk Explanation: ** Diagnosis codes marked with an * require a dual diagnosis. ICD-9 Codes that DO NOT Support Medical Necessity Paragraph: Any diagnosis not listed under ICD-9 CM codes that support medical necessity Codes: XX000 Not Applicable General Information Associated Information Documentation Requirements This is not an all- inclusive list. Providers are responsible for ensuring that all requirements outlined in the LCD are documented clearly and support the medical necessity for ESA therapy. The medical record must reflect that the patient meets all requirements for coverage outlined in this LCD. The medical record must contain a history and

physical that includes the following information: most recent blood pressure and evidence that patients with elevated blood pressure are being adequately controlled, weight in Kg, date and results of Hct and Hgb level prior to the initiation of ESA therapy, assessment that rules out other causative factors of anemia or if causative factors are present, that they have been managed and that it is still necessary to initiate ESA therapy. The dosage and route of administration must be documented. The medical record must support that Hgb and Hct levels are documented at the frequencies outlined for each indication and that doses are being titrated or withheld/re-initiated according to the indications, limitations and utilization guidelines outlined in the LCD. In addition to the above, the following are documentation requirements that are specific to certain indications. Prior to and during ESA therapy for CKD patients, the patient s iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/ml For HIV-infected patients with anemia related to Zidovudine treatment, the medical record must contain the endogenous erythropoietin level (prior to transfusion). If levels are > 500mUnits.mL, patients are unlikely to respond to therapy with epoetin alfa. The patient s current dose of Zidovudine should be documented in the medical record. For patients with anemia related to anemia of Hepatitis C, the medical record must support that the patient is being treated with the combination of ribavarin and interferon alfa or ribavarin and peginterferon alfa. For patients with RA, the medical record must show that the patient has been diagnosed with RA using the American College of Rheumatology criteria. Patients are usually on an anti-metabolite (e.g., Methotrexate), which causes the anemia. If the anemia is caused by factors other than an antimetabolite, the medical record should justify the initiation of ESA therapy and that the causative factor cannot be managed without ESA therapy. For patients with MDS, the medical record must contain a bone marrow biopsy or aspiration report confirming a diagnosis of MDS. For cancer patients with anemia related to chemotherapy, the date of the last chemotherapy treatment must be documented. A course of chemotherapy includes the 8 weeks following the last dose of chemotherapy for that course of treatment. After 8 weeks, ESA treatment is not medically necessary. For cancer patients with anemia related to myelosuppressive chemotherapy, the medical record should support that the provider is enrolled in the ESA APPRISE Oncology Program and meets the program requirements. Utilization Guidelines It is expected that these drugs will be given in accordance with accepted standards of medical practice. It is also expected that these drugs will be given in accordance with the listed guidelines found on the FDA approved product labels, unless instructions are otherwise noted in this LCD. For additional prescribing information, refer to the FDA approved product labels. For all patients with CKD receiving ESAs: When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change. Do not increase the dose more frequently than once every 4 weeks. Decrease in dose can occur more frequently. Avoid frequent dose adjustments. If the hemoglobin rises rapidly (e.g., more than 1 g/dl in any 2-week period), reduce the dose of ESA by 25% or more as needed to reduce rapid responses. For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dl after 4 weeks of therapy, increase the dose by 25%. For patients who do not respond adequately over a 12 week escalation period, increasing the ESA dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia Discontinue the ESA if responsiveness does not improve. To initiate ESA therapy for other covered indications in this LCD, except for preoperative use and for anemia in cancer patients on chemotherapy, the patient must have a documented anemia as evidenced by symptoms and a Hct of < 33% or a Hgb < 11 g/dl, unless there is medical documentation showing the need for ESA therapy despite a Hct of >32.9 or a Hgb >10.9 g/dl. It may be medically necessary for a patient to initiate ESA therapy when the patient exhibits signs and symptoms such as extreme weakness and fatigue, cold intolerance, tachycardia, pulmonary distress, hypotension, angina, congestive heart failure, etc., which is caused by the anemic condition and Hct is >32.9 % and the Hgb is >10.9 g/dl. For anemia in cancer patients on chemotherapy, please refer to the National Coverage Decision language found under the limitations section of this LCD for coverage requirements. In order to prescribe and/or dispense ESAs to patients with cancer and anemia due to myelosuppressive chemotherapy, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program requirements. Dosage and Administration requirements: Epoetin alfa (Procrit and Epogen) Treatment of anemia for CKD patients on dialysis: Initiate Epoetin alfa treatment when the hemoglobin level is less than 10 g/dl. If the hemoglobin level approaches or exceeds 11 g/dl, reduce or interrupt the dose of epoetin alfa. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. The intravenous route is recommended for patients on dialysis. Treatment of anemia for CKD patients not on dialysis: Consider initiating epoetin alfa treatment only when the hemoglobin level is less than 10 g/dl and the following considerations apply: o The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and, o Reducing the risk of allimmunization and/or other RBC transfusion-related risks is a goal

If the hemoglobin level exceeds 10 g/dl, reduce or interrupt the dose of epoetin alfa, and use the lowest dose of epoetin alfa sufficient to reduce the need for RBC transfusions. The recommended starting dose for adult patients is 50-100 Units/kg 3 times weekly intravenously or subcutaneously. Treatment of anemia in Zidovudine-treated HIV-infected patients: Starting Dose: The recommended starting dose in adults is 100 Units/kg as an intravenous or subcutaneous injection 3 times per week. Dose Adjustment: If hemoglobin does not increase after 8 weeks of therapy, increase epoetin alfa dose by approximately 50-100 Units/kg at 4 to 8 week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 Units/kg. Withhold the epoetin alfa if hemoglobin exceeds 12 g/dl. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dl. Discontinue epoetin alfa if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks. Reduction of allogenic blood transfusions in surgery patients Prior to initiating epoetin alfa therapy a hemoglobin level should be obtained to establish that it is greater than 10 and less than or equal 13 g/dl. The recommended epoetin alfa regimens are: 300 Units/kg per day subcutaneously for 14 days total: administered daily for 10 days before surgery, on the day of surgery and for 4 days after surgery. 600 Units/kg subcutaneously in 4 doses administered 21, 14 and 7 days before surgery and on the day of surgery. Treatment of anemia in cancer patients on chemotherapy: For therapy initiation, dose adjustments and maintenance doses see the National Coverage Decision language found under the limitations section of this LCD. Anemia associated with myelodysplastic syndrome (MDS) and anemia associated with Rheumatoid Arthritis The recommended starting dose of epoetin alfa is 150 units/kg subcutaneously three times weekly or 40,000 units subcutaneously weekly. Dose modification three times weekly dosing: o Reduce dose by 25% when the hemoglobin approaches 12 g/dl or when the hemoglobin increases > 1 g/dl in any two week period. o Withhold the dose when the hemoglobin exceeds 12 g/dl, until the hemoglobin falls below 11 g/dl and restart the dose at 25% below the previous dose. o Increase the dose to 300 units/kg three times weekly if the response is not satisfactory (no reduction in transfusion requirements or rise in hemoglobin) after 8 weeks to achieve and maintain the lowest hemoglobin level sufficient to avoid the need for red blood cell transfusion and not to exceed 12 g/dl. Dose modification weekly dosing: o Reduce dose by 25% when the hemoglobin approaches 12 g/dl or increases >1 g/dl in any 2 weeks o Withhold dose if the hemoglobin exceeds 12 g/dl, until the hemoglobin falls below 11 g/dl, and restart the dose at 25% below the previous dose. o The dose may be increased to 60,000 units subcutaneously weekly if the response is not satisfactory (no reduction in transfusion requirements or rise in hemoglobin) after 8 weeks to achieve and maintain the lowest hemoglobin level sufficient to avoid the need for red blood cell transfusion and not to exceed 12 g/dl. The off-label maintenance dosing schedule for MDS patients: 120,000 units subcutaneously once every three weeks to maintain the target hemoglobin. This dosing schedule must not be used as and initial dosing schedule. The hemoglobin should not exceed 12 g/dl. The patient should already be receiving epoetin alfa and responding to the therapy as evidenced by Hgb rising at least 2 g/dl, not exceeding 12 g/dl. Treatment of chronic anemia associated with the management of Hepatitis C: The usual dose for this indication is 40,000 units subcutaneously once weekly. Darbepoetin alfa (Aranesp) Treatment of chronic kidney disease(ckd): Patients on dialysis: Initiate Aranesp treatment when the hemoglobin level is less than 10 g/dl If the hemoglobin level approaches or exceeds 11 g/dl, reduce or interrupt the dose of Aranesp. The recommended starting dose is 0.45 mcg/kg intravenously or subcutaneously as a weekly injection or 0.75 mcg/kg once every 2 weeks as appropriate. The intravenous route is recommended for patients on dialysis. Patients not on dialysis: Consider initiating Aranesp treatment only when the hemoglobin level is less than 10 g/dl and the following considerations apply: o The rate of hemoglobin decline indicates the likelihood of reporting RBC transfusion and,

o Reducing the risk of alloimmunization and/or other RBC transfusion-related risk is a goal. If the hemoglobin level exceeds 10 g/dl, reduce or interrupt the dose of Aranesp, and use the lowest dose of Aranesp sufficient to reduce the need for RBC transfusion. The recommended starting dose is 0.45 mcg /kg body weight intravenously or subcutaneously given once at four weeks intervals as appropriate. For conversion from Epoetin alfa to Aranesp for CKD patients on or off dialysis, refer to the Aranesp FDA approved product label for doses and tables. Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy: For therapy initiation, dose adjustments and maintenance doses see the National Coverage Decision language found under the limitations section of this LCD. Anemia associated with myelodysplastic syndrome (MDS): The recommended starting dose for MDS patients is similar to those for FDA approved indications found in the package insert and outlined in this LCD for darbepoetin alfa. Refer to the package insert for additional dose adjustment or maintenance dose schedules. Doses should be reduced to maintain Hgb levels 12 g/dl. Hemoglobin levels that increase to or approach 12 g/dl should be reduced by approximately 25%. If hemoglobin levels continue to increase above 12 g/dl, doses should be temporarily withheld until the hemoglobin begins to decrease, at which time the therapy can be reinitiated at a dose approximately 25% below the previous dose. A rise in hemoglobin >1 g/dl in any two week period requires the dose to be reduced by 25%. Peginesatide (OMONTYS ) Treatment of anemia for CKD patients on dialysis: Initiate Peginesatide treatment when the hemoglobin level is less than 10 g/dl. The recommended starting dose for the treatment of anemia in patients who are not currently treated with an ESA is 0.04 mg/kg body weight administered as a single intravenous or subcutaneous injection once monthly If the hemoglobin level approaches or exceeds 11 g/dl, reduce or interrupt the dose of peginesatide. After a dose has been withheld and once the hemoglobin begins to decrease, peginesatide may be restarted at a dose approximately 25% below the previously administered dose. For conversion from Epoetin Alfa and Darbepoetin Alfa to Peginesatide in patients with CKD on dialysis, refer to the Peginesatide FDA approved product label for doses and tables. Sources of Information and Basis for Decision ACCC drug database (2007) Darbepoetin alfa (Systemic). ACCC drug database (2007) Epoetin alfa (systemic) Amgen (2008) Prescribing information, Darbepoetin alfa and Epogen. Located at www.amgen.com Amgen (2011) Prescribing information, Darbepoetin alfa (Aranesp ) and Epogen. Aranesp Effective in Low-Intermediate Risk MDS, University of Florida Shands Cancer Center. www.ufscc.ufl.edu/cancernews on 5/18/2005. Centocor Ortho Biotech Products, L.P. (2011). Prescribing information, Procrit. Dear Health Care Professional Letter (8/7/2008)located at www.amgen.com, www.fda.gov and www.orthobiotech.com Food and Drug Administration. FDA Alert 11/16/2007, 2/16/2007 and 3/9/2007. Eryhtropoiesis Stimulating Agents (ESA). www.fda.gov/cder/drug/infopage/rhe/default.htm Food and Drug Administration. (2012). OMONTYS (peginesatide) prescribing information. Retrieved from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm? fuseaction=search.set_current_drug&applno=202799&drugname=omontys&activeingred=peginesatide%20acetate&sponsorapplicant=affymax Gotlib, J. (2005). Myelodysplatic Syndrome (MDS): ASH 2005 Update. Retrieved from http://www.anco-online.org/gotlibppt.pdf Ortho Biotech Products, LP (2008). Prescribing information Procrit. Located at www.orthobiotech.com U.S. Food and Drug Administration (FDA) website prescribing information and approval letter for Eryhtropoiesis Stimulating Agents (ESA). On February 23, 2013 recall. Revision History Information Please note: The Revision History information included in this LCD prior to 1/24/2013 will now display with a Revision History Number of "R1" at the bottom of this table. All new Revision History information entries completed on or after 1/24/2013 will display as a row in the Revision History section of the LCD and numbering will begin with "R2".

REVISION HISTORY DATE REVISION HISTORY NUMBER REVISION HISTORY EXPLANATION REASON(S) FOR CHANGE 02/23/2013 R2 Revision number: 7 Publication: April 2013 Connection LCR B2013-056 Public Education/Guidance Explanation of revision: The LCD has been revised under the Indications section for Peginesatide (OMONTYS ) based on the U.S. Food and Drug Administration (FDA) recently issuing a voluntary nationwide recall of all lots of Omontys (peginesatide) injection by Affymax, Inc. and Takeda Pharmaceuticals Company Limited effective February 23, 2013. In addition, the Sources of Information and Basis for Decision section of the LCD was updated. The effective date of this revision is based on date of service. Associated Documents Attachments Draft LCD Comment Summary code guide 1/1/13 Coding Guideline effec 7/1/13 (PDF - 123 KB ) Related Local Coverage Documents Article(s) A49092 - J0881 Erythropoiesis stimulating agents revision to the LCD A48461 - J0881: Erythropoiesis Stimulating Agents Clarification on correct modifier use Related National Coverage Documents N/A Public Version(s) Updated on 04/18/2013 with effective dates 02/23/2013 - N/A Some older versions have been archived. Please visit the MCD Archive Site to retrieve them. Keywords N/A Read the LCD Disclaimer Get Help with File Formats and Plug-Ins Submit Feedback 85 Home A federal government website managed by the Centers for Medicare & Medicaid Services 7500 Security Boulevard, Baltimore, MD 21244 CMS & HHS Websites Tools Helpful Links Medicare.gov MyMedicare.gov StopMedicareFraud.gov Acronyms Contacts FAQs Web Policies & Important Links Privacy Policy Plain Language Receive Email Updates Medicaid.gov Glossary Freedom of Information Act InsureKidsNow.gov Archive No Fear Act

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Local Coverage Article: J0881 Erythropoiesis stimulating agents revision to the LCD (A49092) Contractor Information Contractor Name First Coast Service Options, Inc. opens in new window Contractor Number 09102 Contractor Type MAC - Part B Article Information General Information Article ID Number A49092 Article Type Article Key Article No Article Title J0881 Erythropoiesis stimulating agents revision to the LCD AMA CPT / ADA CDT Copyright Statement CPT only copyright 2002-2013 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Primary Geographic Jurisdiction Florida Original Article Effective Date 04/21/2009 Article Revision Effective Date Article Text LCD ID number: L29168 (Florida) LCD ID number: L29339 (Puerto Rico/U.S. Virgin Islands) The local coverage determination (LCD) for the erythropoiesis stimulating agents was effective for services rendered on or after February 2, 2009, for Florida and on or after March 2, 2009, for Puerto Rico and the U.S. Virgin Islands. Since that time, the LCD has been revised. Since the implementation of the national coverage decision (NCD) 110.21 for non-esrd use of erythropoiesis stimulating agents (ESAs) in cancer and related Printed on 3/25/2014. Page 1 of 4

conditions, First Coast Service Options Inc (FCSO) has encountered various issues surrounding the coding of the covered and non-covered indications outlined in the LCD. Although FCSO has handled these coding issues on a case by case basis as they were brought to our attention, FCSO has determined that the coding rules as outlined needed to be streamlined in order to make it easier for providers to submit accurately. To address this, FCSO posted the LCD for ESAs for notice and comment from February 20, 2009-April 6, 2009 and presented the draft LCD to the Carrier Advisory Committee (CAC) at our March meetings in Florida and Puerto Rico. The language opened up for comment was limited to the ICD-9-CM codes that support medical necessity and the second set of ICD-9-CM codes bulleted out in the coding guidelines. This article serves to outline the final decisions made by FCSO, which take into account all comments received. This article will also serve to summarize all the rules for billing non-esrd ESAs (CPT codes J0881 and J0885) implemented since April 7, 2008, and how they apply to this newly revised LCD. Any questions on this LCD should be submitted to the medical policy department at medical.policy@fcso.com. The lists of ICD-9 codes that support medical necessity for J0881 and J0885 have been revised to now include two (2) lists of ICD-9-CM codes for each HCPCS code. The two lists for J0881 and J0885 now outline which ESA modifier (EA or EC) must be billed with the ICD-9-CM codes and any dual diagnosis requirement for the ICD-9- CM codes. These modifier designation and dual diagnosis rules are found at the beginning of each list for J0881 and J0885. ICD-9-CM codes that require a dual diagnosis are designated with an *. In addition, the coding guidelines attachment for the LCD has been revised to instruct providers how to bill for certain non-covered indications outlined in NCD 110.21. This change is outlined in more detail below. All other language and coding have not changed due to this revision. Coding changes made as a result of the CAC process: J0881 (This list does not require a dual diagnosis.) The following ICD-9-CM codes require the EA modifier: 140.0-149.9, 150.0-159.9, 160.0-165.9, 170.0-176.9, 179-189.9, 190.0-199.2, 200.00-200.88, 201.00-201.98, 202.00-202.98, 203.00-203.82, 204.00-204.92, 209.00-209.03, 209.10-209.17, 209.20-209.29, 209.30, 230.0-234.9, 235.0-235.9, 236.0-236.99, 237.0-237.9, 238.0, 238.1, 238.2, 238.3, 238.4, 238.5, 238.6, 238.8, 238.9, or 239.0-239.9 J0881 (This list does not require a dual diagnosis.) The following ICD-9-CM codes require the EC modifier: 238.71, 238.72, 238.73, 238.74, 238.75, 238.76, or 273.3. J0881 The following ICD-9-CM codes require an EC modifier and a dual diagnosis (*): 285.21* and one of the following must be billed together: 403.01*, 403.11*, 403.91*, 404.02*, 404.03*, 404.12*, 404.13*, 404.92*, 404.93*, 585.1*, 585.2*, 585.3*, 585.4*, 585.5*, or 585.9*. J0885 (This list does not require a dual diagnosis.) The following ICD-9-CM codes require the EA modifier: 140.0-149.9, 150.0-159.9, 160.0-165.9, 170.0-176.9, 179-189.9, 190.0-199.2, 200.00-200.88, 201.00-201.98, 202.00-202.98, 203.00-203.82, 204.00-204.92, 209.00-209.03, 209.10-209.17, 209.20-209.29, 209.30, 230.0-234.9, 235.0-235.9, 236.0-236.99, 237.0-237.9, 238.0, 238.1, 238.2, 238.3, 238.4, 238.5, 238.6, 238.8, 238.9, or 239.0-239.9 J0885 (This list does not require a dual diagnosis.) The following ICD-9-CM codes require the EC modifier: 238.71, 238.72, 238.73, 238.74, 238.75, 238.76, or 273.3,. J0885 The following ICD-9-CM codes require the EC modifier and a dual diagnosis (*):285.21* and one of the following must be billed together: 403.01*, 403.11*, 403.91*, 404.02*, 404.03*, 404.12*, 404.13*, 404.92*, 404.93*, 585.1*, 585.2*, 585.3*, 585.4*, 585.5*, or 585.9*. 285.29 or 285.9 and one of the following must be billed together: 042*, 070.54*, 070.70*, 714.0*, or V07.8*. Coding guideline changes made as a result of LCD revision: As of January 1, 2008, the following are nationally non-covered indications for non-esrd ESAs that report ESA modifier EC. These are not to be reported with any other ESA modifier. Because no specific ICD-9-CM code exists for these indications listed, FCSO will identify these non-covered conditions with ICD-9-CM code V49.89. This will Printed on 3/25/2014. Page 2 of 4

indicate the ESA was given for a nationally non-covered condition as identified in business requirement 5818.1.1 of change request (CR) 5818. - Any anemia in cancer or cancer treatments patients due to bone marrow fibrosis - Anemia of cancer not related to cancer treatment - Prophylactic use to prevent chemotherapy-induced anemia - Prophylactic use to reduce tumor hypoxia - Patients with erythropoietin-type resistance due to neutralizing antibodies, and - Anemia due to cancer treatments if patients have uncontrolled hypertension Please see end of article for additional list of nationally non-covered indications identified in the NCD for non- ESRD ESA use. Summary of non-esrd ESA coverage based on CR 5818 and 5699 implemented on April 7, 2008 Effective January 1, 2008, all claims reporting non- ESRD ESAs (HCPCS codes J0881 and J0885) are required to report one of the following modifiers (based on CR 5699): - EA: ESA, anemia, chemo induced - EB: ESA anemia, radio-induced - EC: ESA anemia, non-chemo/radio The EA modifier should only be reported when the ESA is being given for anemia resulting from myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. Anemia that is not related to the administration of chemotherapy for one of the listed covered cancer conditions is noncovered per the NCD. Therefore it is inappropriate to append the EA modifier to those ESA claims. These ESA administrations should be identified with ICD-9-CM code V49.89 (as instructed in the coding guideline of the LCD) and the EC modifier should be appended. The EC modifier should only be reported for those covered indications outlined in the LCD under ICD-9 codes that support medical necessity for HCPCS codes J0881 and J0885 where the anemia being treated is nonchemo/radio induced. The provider must also append the EC modifier for those nationally non-covered conditions outlined in the NCD and the coding guideline of the LCD. The non-covered ICD-9-CM codes that correspond to the nationally non-covered indications are noted in the coding guideline. If one of the non-covered ICD-9-CM codes and the EC modifier are billed with J0881 or J0885, the ESA will be denied. The EB modifier is non-covered. If billed with an ESA, the claim will be denied. Effective January 1, 2008, all claims reporting ESAs J0881, J0882, J0885, or J0886 must report the most recent hemoglobin or hematocrit readings. For non-esrd ESAs J0881 and J0885 reporting the EA modifier (anemia that is related chemotherapy), the hemoglobin or hematocrit are required to be below a certain level in order for the service to be medically necessary. Contractors are instructed, per CR 5818 to deny ESA services that report J0881 or J0885 with and EA modifier when Hgb is > 10.0g/L or the Hct is > 30%. There is no exception to this requirement, and there is no 4-week window at initiation where providers can report a level above 10.0 g/l or 30% and have the service paid. The entire discussion surrounding ESA administration for cancer conditions is outlined in the LCD and NCD 110.21. Additional non-covered indications as identified in NCD 110.21 for non-esrd ESA use are listed below. The ESA services for J0881 and J0885 when reported with an EC modifier will be denied when the following ICD-9-CM codes are reported: - Any anemia in cancer or cancer treatment patients due to folate deficiency 281.2, - B-12 deficiency 281.1, 281.3, - Iron deficiency 280.0-280.9, - hemolysis 282.0, 282.2, 282.9, 283.0, 283.10, 283.19, 283.2, 283.9, - bleeding 280.0, 285.1, - anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML) 205.00-205.21, 205.80-205.91,and - erythroid cancers (207.00-207.81) Resources for information on ESA coverage: The complete NCD can be accessed in section 110.21 of Publication (Pub.) 100-03, Medicare National Coverage Determinations (NCD) Manual, and claims processing instructions can be accessed in Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, sections 80.8-80.12 and through the following link: Printed on 3/25/2014. Page 3 of 4

http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=110.21&ncd_version=1&basket=ncd%3a110%2e21%3a1%3 AErythropoiesis+Stimulating+Agents+%28ESAs%29+in+Cancer+and+Related+Neoplastic+Conditions CR 5818, transmittal 80 and 1413, dated January 14, 2008 can be accessed through the following links: http://www.cms.hhs.gov/transmittals/downloads/r1413cp.pdf http://www.cms.hhs.gov/transmittals/downloads/r80ncd.pdf CR 5699, transmittal 1412, dated January 11, 2008 can be accessed through the following link: http://www.cms.hhs.gov/transmittals/downloads/r1412cp.pdf Effective date This revision is effective for services rendered on or after June 30, 2009. FCSO LCDs are available through the CMS Medicare Coverage Database. Coding Information No Coding Information has been entered in this section of the article. Other Information There is no Other Information for this article. All Versions Updated on 04/24/2009 with effective dates 04/21/2009 - N/A Read the Article Disclaimer opens in new window Printed on 3/25/2014. Page 4 of 4

Local Coverage Article for J0881: Erythropoiesis Stimulating Agents Clarification on correct modifier use Share Help Email Print Close Window Local Coverage Article: J0881: Erythropoiesis Stimulating Agents Clarification on correct modifier use (A48461) Section Navigation Select Section Expand All Collapse All Contractor Information Contractor Name First Coast Service Options, Inc. Contractor Number 09102 Contractor Type MAC - Part B Article Information General Information Article ID Number A48461 Article Type Article Key Article No Primary Geographic Jurisdiction Florida Original Article Effective Date 02/02/2009 Article Revision Effective Date Article Title J0881: Erythropoiesis Stimulating Agents Clarification on correct modifier use AMA CPT / ADA CDT Copyright Statement CPT only copyright 2002-2013 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association. Article Text LCD ID Number: L5984 It has come to the attention of First Coast Service Options (FCSO) that providers are applying the incorrect modifiers when billing erythropoiesis stimulating agents (ESAs) J0881 (Injection, darbepoetin alfa, 1 mcg (non-esrd use) and J0885 (Injection, epoetin alfa, (for non-esrd use), 1000 units. This article serves to outline the appropriate use of the modifiers for non-esrd ESA administration and the appropriate ICD-9 CM diagnosis codes for each modifier. Effective 01/01/2008 all claims reporting non- ESRD ESAs J0881 and J0885 are required to report one of the following modifiers: EA: ESA, anemia, chemo induced EB: ESA anemia, radio-induced EC: ESA anemia, non-chemo/radio The EA modifier should only be reported when the ESA is being given for anemia resulting from myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. The corresponding covered ICD-9 CM codes that would apply to the EA modifier are as follows: http://www.cms.gov/...tabase/details/article-details.aspx?articleid=48461&ver=2&contrid=197&contrver=1&lcdid=29168&docid=l29168&searchtype=advanced&ispopup=y&[3/11/2014 6:04:46 PM]

Local Coverage Article for J0881: Erythropoiesis Stimulating Agents Clarification on correct modifier use 140.0-149.9, 150.0-159.9, 160.0-165.9, 170.0-176.9, 179-189.9, 190.0-199.1, 200.0-200.88, 201.00-201.98, 202.00-202.98, 203.00-203.81, 204.00-204.91, 230.0-234.9, 235.0-235.9, 236.0-236.99, 237.0-237.9, 238.0, 238.1, 238.2, 2383, 238.4, 238.5, 238.6, 238.8, 238.9, 239.0-239.9, 273.3. The corresponding anemia code must also be billed. The dual diagnosis rule is outlined in the LCD. Any other covered diagnosis code listed in the LCD for J0881 or J0885 will be denied if billed with the EA modifier. The EC modifier should only be reported for those covered indications outlined in the LCD for J0881 and J0885 where the anemia being treated is nonchemo/radio induced. FSCO has discovered that providers are billing the EC modifier for one of the covered cancer diagnosis codes listed above under the EA modifier instructions. By appending the EC modifier to a cancer diagnosis code, the provider is stating that the anemia for that cancer condition is not related to chemotherapy. Anemia of cancer not related to cancer treatment is a nationally non-covered condition per the NCD issued by CMS for non-esrd ESA use. The following are the appropriate ICD-9 CM diagnosis codes that would apply when billing the EC modifier: For J0881 -- 238.71, 238.72, 238.73, 238.74, 238.75, 238.76, 273.3, 585.1, 585.2, 585.3, 585.4, 585.5, 585.9 For J0885 -- 042, 070.54, 070.70, 238.71, 238.72, 238.73, 238.74, 238.75, 238.76, 273.3, 585.1, 585.2, 585.3, 585.4, 585.5, 585.9, V07.8, 714.0 The corresponding anemia code must also be billed. The dual diagnosis rule is outlined in the LCD. The EB modifier is non-covered. If billed with and ESA the claim will be denied. All other conditions of coverage are outlined in the LCD and corresponding coding guideline. First Coast Service Options, Inc. LCDs are available through the CMS Medicare Coverage Database. If providers have questions regarding coverage of ESAs, please send correspondence to medical.policy@fcso.com. Coding Information No Coding Information has been entered in this section of the article. Other Information Revision History Explanation added the following ICD-9 codes to the diagnosis list for J0881 and J0885 for the EC modifier as they were erroneously ommitted: 585.1, 585.2, 585.3, 585.4, 585.5, 585.9 All Versions Updated on 01/28/2009 with effective dates 02/02/2009 - N/A Read the Article Disclaimer Get Help with File Formats and Plug-Ins Submit Feedback www Home A federal government website managed by the Centers for Medicare & Medicaid Services 7500 Security Boulevard, Baltimore, MD 21244 CMS & HHS Websites Medicare.gov Tools Acronyms Helpful Links Web Policies & Important Links http://www.cms.gov/...tabase/details/article-details.aspx?articleid=48461&ver=2&contrid=197&contrver=1&lcdid=29168&docid=l29168&searchtype=advanced&ispopup=y&[3/11/2014 6:04:46 PM]

Local Coverage Article for J0881: Erythropoiesis Stimulating Agents Clarification on correct modifier use MyMedicare.gov StopMedicareFraud.gov Medicaid.gov InsureKidsNow.gov HealthCare.gov Contacts FAQs Glossary Archive Privacy Policy Plain Language Freedom of Information Act No Fear Act HHS.gov Receive Email Updates HHS.gov/Open Inspector General USA.gov Help with file formats & plug-ins http://www.cms.gov/...tabase/details/article-details.aspx?articleid=48461&ver=2&contrid=197&contrver=1&lcdid=29168&docid=l29168&searchtype=advanced&ispopup=y&[3/11/2014 6:04:46 PM]

Coding Guidelines J0881 Erythropoiesis Stimulating Agents.4 FIRST COAST SERVICE OPTIONS LOCAL COVERAGE DETERMINATION CODING GUIDELINES LCD Database ID Number L29168 Florida L29339 Puerto Rico/Virgin Islands Contractor Name First Coast Service Options, Inc. Contractor Number 09102 Florida 09202 Puerto Rico 09302 Virgin Islands LCD Title Erythropoiesis Stimulating Agents Coding Guidelines J0881 and J0885 are intended for use for patients who are Non-ESRD and are not yet on dialysis. J0881 and J0885 are also intended for use with patients who meet the other indications outlined in the LCD. J0882, J0886 and J0890 are intended for use only with patients who are ESRD and on dialysis. Per Change Request 5699 the following requirements are effective on 1/1/2008: Effective 1/1/2008 all claims billing for the administration of an ESA (HCPCS J0881, J0882, J0885 and J0886) must report the most recent hematocrit or hemoglobin reading. Effective 1/1/2008 all non-esrd claims reporting J0881 or J0885 must begin reporting one of the following modifiers: EA: ESA, anemia, chemo induced (ICD-9-CM codes identified in list 2 for J0881 and J0885) EB: ESA anemia, radio-induced EC: ESA anemia, non-chemo/radio (ICD-9-CM codes identified in list 1 for J0881 and J0885) Claims that do not report either a Hgb or Hct and one of the three ESA modifiers will be returned to the provider. ESAs administered for more than one of the indicated therapies are billed as separate line items. Only one of the three ESA modifiers may be reported at the line item level. A complete discussion of the Hgb and Hct Reporting requirements can be found in CMS manual System, Pub 100-04, Medicare Claims Processing, Chapter 17, Sections 80.8, 80.9 and 80.10, Change Request 5699, Transmittal 1413, dated January 11, 2008. For reporting requirements related to the National Coverage Decision for ESA use in Cancer and related conditions, please refer to Change Request 5818, transmittals 80 and 1413. The following is a summary of reporting requirements: Form Date: 12/22/08 Page 1 of 3 1-3.2.41 MP Part B FL Draft LCD

Coding Guidelines J0881 Erythropoiesis Stimulating Agents.4 Effective for DOS on or after 1/1/2008, non-esrd ESA claims that report the ESA modifier EC (ESA, anemia, non-chemo/radio and one of the following ICD-9 codes will be denied: Any anemia in cancer or cancer treatment patients due to folate deficiency 281.2, B-12 deficiency 281.1, 281.3, Iron deficiency 280.0-280.9, hemolysis 282.0, 282.2, 282.9, 283.0, 283.10, 283.19, 283.2, 283.9, bleeding 280.0, 285.1, anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML) 205.00-205.21, 205.80-205.91, and erythroid cancers (207.00-207.81) *Please note the above are nationally non-covered indications as outlined in the National Coverage Decision on ESAs in cancer and cancer related conditions. Effective for DOS on or after 1/1/2008, non-esrd ESA claims that report the ESA modifier EC (ESA, anemia, non-chemo/radio and one of the following conditions will be denied: Any anemia in cancer or cancer treatments patients due to bone marrow fibrosis Anemia of cancer not related to cancer treatment Prophylactic use to prevent chemotherapy-induced anemia Prophylactic use to reduce tumor hypoxia Patients with erythropoietin-type resistance due to neutralizing antibodies Anemia due to cancer treatments if patients have uncontrolled hypertension *Please note the above are nationally non-covered indications as outlined in the National Coverage Decision on ESAs in cancer and cancer related conditions. Because no specific ICD-9-CM codes exist for the indications listed out in the above group, this contactor will identify these non-covered conditions with ICD-9-CM code V49.89 when submitted on claims billing J0881 or J0885 and the EC modifier. This will indicate that the ESA was given for a nationally non-covered condition identified in business requirement 5818.1.1 for Change Request 5818. Effective for DOS on or after 1/1/2008, non-esrd ESA claims that report HCPCS J0881 and J0885 billed with ESA modifier EB (ESA, anemia, radio-induced) will be denied. Effective for DOS on or after 1/1/2008, non-esrd ESA claims for HCPCS J0881 and J0885 billed with modifier EA (ESA, anemia, chemo-induced) for anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia will be denied when the reported Hemoglobin is > 10.0g/dL or the Hematocrit reported is > 30.0%, whether the patient is in the initiation phase or maintenance phase of treatment. Also, ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regime. A complete discussion of the National Coverage Decision can be found in CMS Manual System, Pub 100-03, Chapter 1, Section 110.21 and CMS annual System, Pub 100-04, Medicare Claims Processing Manual, Chapter 17, Section 80.12.The related Change Request for this NCD is Transmittals 80 and 1412, Change Request 5818, dated January 14, 2008. All claims not meeting medical necessity guidelines in this LCD should have the service billed with modifier -GA or -GZ. The GA modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny a service as not reasonable and necessary and they do have an ABN signed by the beneficiary on file. A Medicare Advanced Beneficiary Notice (ABN), Form CMS-R-131, should be signed by the beneficiary to indicate that he/she accepts responsibility for payment. The GZ modifier should be used when physicians, practitioners, or suppliers want to indicate that they expect that Medicare will deny an item or service as not reasonable and necessary and they have not had an Advance Beneficiary Notification (ABN) signed by the beneficiary. Form Date: 12/22/08 Page 2 of 3 1-3.2.41 MP Part B FL Draft LCD

Coding Guidelines J0881 Erythropoiesis Stimulating Agents.4 If the service is - appropriate CPT/HCPCS code with the -GY modifier. An ABN should not be used. A waiver such as the Notice of Exclusions from Medicare Benefits (NEMB) Form CMS-20007 may be used. The NEMB Form CMS-20007 is available online at http://www.cms.hhs.gov/medicare/bni/ or http://www.cms.hhs.gov/cmsforms/cmsforms/list.asp. Chronic Renal Failure Patients (ESRD on dialysis and ESRD not on dialysis) For the purpose of this LCD, the term not on dialysis refers to patients that are not on a regular course of maintenance dialysis. For patients who need occasional rescue dialysis, it would be appropriate to bill J0881 or J0885, since these patients are not on a regular course of maintenance dialysis. For patients with ESRD who are on dialysis, a diagnosis of 285.21 and a diagnosis of 585.6 must be billed with procedure code J0882, J0886 or J0890. For patients with ESRD who are not on dialysis, a diagnosis code of 285.21 and a diagnosis of 403.01, 403.11, 403.91, 404.02, 404.03, 404.12, 404.13, 404.92, 404.93, 585.1, 585.2, 585.3, 585.4, 585.5 or 585.9, must be billed with procedure code J0881 or J0885. The EC modifier is also required. Additional information for J0885: *285.29 or *285.9 and one of the following must be billed: 042, 070.54, 070.70, V07.8 or 714.0. The EC modifier is also required. A course of chemotherapy includes the eight (8) weeks following the last dose of chemotherapy for that course. Comments N/A Revision History Date Revision 07/01/2013 4-Revision to the Coding Guidelines section. Language was removed. The effective date of this revision is based on process date. 01/01/2013 3-Annual 2013 HCPCS Update. HCPCS code Q2047 was deleted and replaced with HCPCS code J0890. The effective date of this revision is based on date of service. 07/01/2012 2- Revision to add HCPCS code Q2047. The effective date of this revision is based on date of service. 06/30/2009 1 - Revision to update coding requirements for J0881 and J0885. The effective date of this revision is based on date of service. 02/02/2009 Florida 03/02/2009 Puerto Rico/Virgin Islands Original Document formatted: 08/20/2013 (MB/et) Form Date: 12/22/08 Page 3 of 3 1-3.2.41 MP Part B FL Draft LCD