Local Coverage Determination (LCD): Erythropoietin Stimulating Agents (ESA) (L34165)

Transcription

1 Centers for Medicare & Medicaid Services < Return to Previous Page Print Message: If you are experiencing issues printing this page, then please click Return to Previous Page and select the 'Need a PDF?' button. You can now print the page from the new popup window. OVERVIEW ADVANCED SEARCH INDEXES REPORTS DOWNLOADS BASKET (0) Contextual Help is Off Page Help Back to Document ID Search Results Local Coverage Determination (LCD): Erythropoietin Stimulating Agents (ESA) (L34165) Contractor Information Contractor Name Noridian Healthcare Solutions, LLC Contract Number Contract Type A and B MAC Jurisdiction J - E LCD Information Document Information LCD ID L34165 Original ICD-9 LCD ID L33356 LCD Title Erythropoietin Stimulating Agents (ESA) AMA CPT / ADA CDT / AHA NUBC Copyright Statement CPT only copyright 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. UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS MANUAL, 2014, is copyrighted by American Hospital Association ( AHA ), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL may be reproduced, sorted in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior express, written consent of AHA. Health Forum reserves the right to change the copyright notice from time to time upon written notice to Company. Jurisdiction American Samoa California - Entire State Guam Hawaii Nevada Northern Mariana Islands Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date N/A Revision Ending Date N/A Retirement Date N/A Notice Period Start Date N/A Notice Period End Date N/A CMS National Coverage Policy Language quoted from the CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR [b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review a NCD. See 1869(f)(1)(A)(i) of the Social Security Act. Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Title XVIII of the Social Security Act, 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act, 1881(b)(1) allows payment for services furnished to individuals who have been determined to have end stage renal

2 disease. Title XVIII of the Social Security Act, 1881(b)(11)(B)(I) allows payment for erythropoietin provided by a physician. CMS Manual System, Pub , Medicare Benefit Policy Manual, Chapter 1, 30 Drugs and Biologicals CMS Manual System, Pub , Medicare Benefit Policy Manual, Chapter 6, 30 Drugs and Biologicals CMS Manual System, Pub , Medicare Benefit Policy Manual, Chapter 11, 30.1 Frequency of Dialysis Sessions, 30.4 Drugs and Biologicals, 30.5 ESRD Composite Payment Rates and 90 Epoetin (EPO) CMS Manual System, Pub , Medicare Benefit Policy Manual, Chapter 15, 50 Drugs and Biologicals, 50.1 Definition of Drug or Biological, 50.2 Determining Self-Administration of Drug or Biological, 50.3 Incident-to Requirements, Approved Use of Drug, Examples of Not Reasonable and Necessary, Erythropoietin (EPO), Requirements for Medicare Coverage for EPO and Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use CMS Manual System, Pub , Medicare National Coverage Determinations Manual, Chapter 1, Part 2, Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 6, 10.1 Consolidated Billing Requirement for SNFs, 20.2 Services Excluded from Part A PPS Payment, ESRD Services and Coding Applicable to Dialysis Services Provided in a Renal Dialysis Facility (RDF) or Home CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 8, 10.5 Hospital Services, 50 In-Facility Dialysis Bill Processing Procedures, 50.3 Required Information for In-Facility Claims Paid Under the Composite Rate and the ESRD PPS, Requirement For Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs), 60.4 Epoetin Alfa (EPO), Epoetin Alfa (EPO) Facility Billing Requirements, Payment Amount for Epoetin Alfa (EPO), Epoetin Alfa (EPO) Provided in the Hospital Outpatient Departments, 60.7 Darbepoetin Alfa (Aranesp ) for ESRD Patients, Darbepoetin Alfa (Aranesp ) Facility Billing Requirements, Payment Amount for Darbepoetin Alfa (Aranesp ), Payment for Darbepoetin Alfa (Aranesp ) in the Hospital Outpatient Department, Required Billing Information for Method I Claims, 90 Method II Billing, 90.5 Method II Support Services Billed to the Intermediary by the Facility, Billable Revenue Codes Under Method II and Unbillable Revenue Codes Under Method II CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 17, 10 Payment Rules for Drugs and Biologicals, Injections Furnished to ESRD Beneficiaries, 80.8 Reporting of Hematocrit and/or Hemoglobin Levels, 80.9 Required Modifiers for ESAs Administered to Non-ESRD Patients, Hospitals Billing for Epoetin Alfa (EPO) and Darbepoetin Alfa (Aranesp) for Non-ESRD Patients, Requirement for Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs), and Claims Processing Rules for ESAs Administered to Cancer Patients for Anti-Anemia Therapy CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 25, 75 General Instructions for Completion of Form CMS-1450 for Billing (UB-04) CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 27, 80.8 ESRD Maintenance Transaction Error Codes Medicare National Coverage Determinations/Decision Memo CAG-00383N, July 30, 2007 CMS Manual System, Pub , One Time Notification, Transmittal 477, dated April 24, 2009, Change Request 6338 Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity An erythropoietin stimulating agent (ESA) is an analog of erythropoietin. ESAs are biologically engineered hormones produced by recombinant DNA technology. Erythropoietin analogs contain the identical amino acid sequence as naturally occurring erythropoietin, and have the same biological effect. Primarily, the kidneys produce erythropoietin in response to hypoxia. Both erythropoietin and ESAs stimulate the bone marrow to form new red blood cells. They are used to treat anemia by elevating or maintaining the red blood cell level (as demonstrated by the hematocrit and/or hemoglobin levels), therefore decreasing anemia and the need for transfusions. Darbepoetin alfa (brand name Aranesp ), an erythropoietin analog, differs from recombinant human erythropoietin alfa (brand name Epogen or Procrit ) in having two additional N-glycosylation sites, which slows its clearance and makes its half-life twothree times longer, allowing less frequent injections. This policy will apply to new ESAs as they are approved. Since darbepoetin alfa and epoetin alfa have a similar mode of action and their structures differ only by the number of N-linked oligosaccharides on the protein, this policy does not distinguish differences for on or off-label indications and contraindications, except for pre treatment of selective surgery where blood loss is anticipated. Several off-label uses are well-accepted clinically, as indicated by inclusion in various compendia. However, a contraindication for either ESA is binding on both. In March 2007, the FDA issued new warnings against target Hgb levels above 12 gm/dl (36% Hct) for all patients. The FDA also issued specific warnings against off-label use in cancer patients whose anemia is not directly linked to chemotherapy. The FDA also reminded physicians that the main endpoint in studies for on-label indications has been avoidance or reduction in transfusions. The LCD contains descriptions of specific coverage guidelines and documentation that supports medical necessity for individual patients. CMS has a national coverage decision on both renal and non-renal uses of ESAs. This local decision elaborates on the NCD and covers some additional indications. Erythropoietin analogs are covered for the following indications: 1. Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis; 2. Treatment of significant anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy; 3. Treatment of anemia induced by AZT and/or other Nucleoside Reverse Transcriptase Inhibitors (NRTI) used in treatment of HIV/AIDS; 4. Treatment of selected patients with anemia related to myelodysplastic syndrome; 5. Preoperative adjuvant therapy (epoetin alfa only);

3 The following causes of anemia should be considered, documented, and corrected (when possible) before starting erythropoietin analog therapy for any of the covered indications: Iron deficiency Underlying infection or inflammatory process Underlying hematological disease Hemolysis Vitamin deficiencies (e.g. folic acid or B12) Blood loss Aluminum intoxication The ESA treatment is not reasonable and necessary for beneficiaries with certain clinical conditions, either because of a deleterious effect of the ESA on their underlying disease or because the underlying disease increases their risk of adverse effects related to ESA use. These conditions include: any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, iron deficiency, hemolysis, bleeding, or bone marrow fibrosis; the anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML), or erythroid cancers; the anemia of cancer not related to cancer treatment; any anemia associated only with radiotherapy; 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 treatment if patients have uncontrolled hypertension. There are rare patients whose cardiac, pulmonary or other medical diseases warrant the use of ESAs to maintain a hemoglobin/hematocrit (Hgb/Hct) higher than the target level discussed in this LCD. Documentation to support this practice must be available upon request. This does not apply to ESA therapy for anemia related to cancer chemotherapy, which follows the rules mandated by the National Coverage Decision. During therapy with an erythropoietin analog, many patients will eventually require supplemental iron. For these patients, stores of iron should be regularly monitored to ensure transferrin saturation greater than 20% and/or serum ferritin levels greater than 100 ng/ml, in order to guide appropriate supplementation. For patients receiving chemotherapy for non-myeloid malignancies, the goal of therapy is to maintain the Hgb/Hct at 10/30%. ESA therapy will not be reimbursed when the Hgb/Hct is greater than 10/30%. For all other indications, the goal of therapy is to maintain a stable Hgb/Hct, with a target of gm/dl / 30%-36%. Doses must be titrated according to the patient s response. Erythropoietin analog therapy need not be stopped completely simply due to the achievement of the target Hgb/Hct. However, judicious, appropriately timed dose adjustments are expected to prevent inappropriate increases in Hgb/Hct levels. ESAs may be administered by intravenous or subcutaneous routes. The dosage may be dependent on several factors including the availability of iron stores, the baseline Hgb/Hct, and the presence of concurrent medical problems. Although subcutaneous medications are generally considered to be self-administered and therefore not covered, erythropoietin analogs are covered regardless of route of administration when used within the ESRD benefit or for chronic kidney disease patients not yet on dialysis who meet the conditions below. Coverage Criteria: A. For End Stage Renal Disease (ESRD) patients on dialysis: 1. Diagnosis of end stage renal disease; 2. Anemia of ESRD should be treated to maintain a Hgb level of gm/dl or a Hct of 30%-36%. B. For chronic kidney disease patients NOT on dialysis: 1. Anemia of chronic kidney disease should be treated to maintain the Hgb level of gm/dl or a Hct of 30%-36%. 2. Serum creatinine equal to or greater than 2.5, creatinine clearance less than 60 ml/min, or glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2. C. For patients with non-myeloid malignancies where anemia is due to the effect of chemotherapy: 1. Anemia with Hgb/Hct less than 10 / 30% at initiation of therapy. 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/1 time weekly for darbepoetin alpha. Equivalent doses may be given over other approved time periods. 3. Maintenance of ESA therapy is the starting dose if the Hgb level remains below 10 gm/dl (or Hct is < 30%) 4 weeks after initiation of therapy and the rise in Hgb is 1gm/dl (Hct 3%). 4.For patients whose Hgb rises <1 gm/dl (Hct rise <3%) compared to pretreatment baseline over 4 weeks of treatment and whose Hgb level remains <10 gm/dl after the 4 weeks of treatment (or the Hct is <30%), the recommended FDA label starting dose may be increased once by 25%. Continued

4 use of the drug is not reasonable and necessary if the Hgb rises <1 gm/dl (Hct rise <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 Hgb > 1 gm/dl (Hct >3%) over 2 weeks of treatment unless the Hgb remains below or subsequently falls to <10 gm/dl(or the Hct is <30%). Continuation and reinstitution of ESA therapy must include a dose reduction of 25% from the previously administered dose. 6. The FDA labeling states that ESAs are indicated for treatment of anemia of malignancy when receiving concomitant chemotherapy, which means during an established course of planned chemotherapy. It will also cover ESAs for eight weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen. D. For patients with anemia related to AZT and/or other Nucleoside Reverse Transcriptase Inhibitors (NRTI) therapy for HIV/AIDS: 1. The goal of therapy is to maintain a stable Hgb/Hct, with a Hgb target of gm/dl or a Hct of 30%-36% E. For patients with myelodysplastic syndrome: 1. Low risk myelodysplasia 2. Pretreatment *erythropoietin levels of 500 or less 3. The goal of therapy is to avoid transfusions by maintaining a stable Hgb/Hct, with a target of gm/dl / 30%-36%. If after two months of treatment, there is no significant increase in Hgb/Hct and/or a significant decrease in transfusion requirements, erythropoietin analogs therapy should be stopped. *For ESA therapy initiated on or after 12/1/2007, this A/B MAC requires an EPO level less than or equal to 500 IU/L. F. Preoperative adjuvant therapy: epoetin alfa for patients who: 1. Are undergoing hip or knee surgery; 2. Have an anemia with a Hgb between 10 and 13 gm/dl; 3. Are not a candidate for autologous blood transfusion; 4. Are expected to lose more than two units of blood; and 5. Have been evaluated to ensure that their anemia is due to chronic disease. NOTE: This ESA LCD is for Epoetin and Darbepoetin Alfa only. Other products that may be used for anemia of ESRD will be covered for their FDA approved indications. 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. 012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient 022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient 071x Clinic - Rural Health 072x Clinic - Hospital Based or Independent Renal Dialysis Center 077x Clinic - Federally Qualified Health Center (FQHC) 085x Critical Access Hospital 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. *Revenue code 0636 relates to HCPCS code. Indicate HCPCS code J0885 in Form Locator 44 of the UB-04 form. The specified units of service to be reported are to be in thousands (1000s), rounded to the nearest thousand.

5 Revenue codes only apply to providers who bill these services to Part A Pharmacy - Erythropoietin (EPO)<10,000 units 0635 Pharmacy - Erythropoietin (EPO)>=10,000 Units 0636 Pharmacy - Drugs Requiring Detailed Coding CPT/HCPCS Codes Group 1 Paragraph: N/A Group 1 Codes: J0881 INJECTION, DARBEPOETIN ALFA, 1 MICROGRAM (NON-ESRD USE) J0882 INJECTION, DARBEPOETIN ALFA, 1 MICROGRAM (FOR ESRD ON DIALYSIS) J0885 INJECTION, EPOETIN ALFA, (FOR NON-ESRD USE), 1000 UNITS J0886 INJECTION, EPOETIN ALFA, 1000 UNITS (FOR ESRD ON DIALYSIS) Q4081 INJECTION, EPOETIN ALFA, 100 UNITS (FOR ESRD ON DIALYSIS) ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: It is the responsibility of the provider to code to the highest level specified in the ICD-10-CM (e.g., to the fourth through eighth character). The correct use of an ICD-10-CM code listed below does not assure coverage of a service. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this determination. For Patients on Dialysis (Both diagnoses must be on claim.) Group 1 Codes: ICD-10 CODES DESCRIPTION D63.1 Anemia in chronic kidney disease N18.6 End stage renal disease Group 2 Paragraph: For patients with chronic kidney disease (not yet on dialysis) and anemia must include D63.1 (anemia in chronic kidney disease)and one other listed diagnosis. Group 2 Codes: ICD-10 CODES DESCRIPTION I12.0 Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease I12.9* Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease I13.0* Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease I13.10* Hypertensive heart and chronic kidney disease without heart failure, with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease I13.11 Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease I13.2 Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease N18.3 Chronic kidney disease, stage 3 (moderate) N18.4 Chronic kidney disease, stage 4 (severe) N18.5 Chronic kidney disease, stage 5 Group 2 Medical Necessity ICD-10 Codes Asterisk Explanation: **Note: Patients with stage I and II chronic kidney disease do not meet the creatinine clearance or GFR requirements in coverage criteria B. Group 3 Paragraph: Patients with anemia related to treatment with zidovudine and/or other Nucleoside Reverse Transcriptase Inhibitors (NRTI) for HIV disease must have D61.1-D61.3 or D61.89 (other specified aplastic anemia - due to drugs) and B20. Group 3 Codes: ICD-10 CODES DESCRIPTION B20 Human immunodeficiency virus [HIV] disease Group 4 Paragraph: For patients with anemia related to chemotherapy, claims must be reported with ICD-10-CM codes D61.1-D61.3, D61.89 (other

6 specified aplastic anemia) or D64.81 (antineoplastic chemotherapy induced anemia) representing the anemia related to chemotherapy, plus the non-myeloid malignancy for which the chemotherapy was administered. (Note: C92.00, C92.91, C93.00, C93.91, C94.00, C95.91 are myeloid malignancies which are excluded from coverage.) Group 4 Codes: ICD-10 CODES DESCRIPTION C00.0 Malignant neoplasm of external upper lip C00.1 Malignant neoplasm of external lower lip C00.3 Malignant neoplasm of upper lip, inner aspect C00.4 Malignant neoplasm of lower lip, inner aspect C00.8 Malignant neoplasm of overlapping sites of lip C01 Malignant neoplasm of base of tongue C02.0 Malignant neoplasm of dorsal surface of tongue C02.1 Malignant neoplasm of border of tongue C02.2 Malignant neoplasm of ventral surface of tongue C02.4 Malignant neoplasm of lingual tonsil C02.8 Malignant neoplasm of overlapping sites of tongue C03.0 Malignant neoplasm of upper gum C03.1 Malignant neoplasm of lower gum C04.0 Malignant neoplasm of anterior floor of mouth C04.1 Malignant neoplasm of lateral floor of mouth C04.8 Malignant neoplasm of overlapping sites of floor of mouth C05.0 Malignant neoplasm of hard palate C05.1 Malignant neoplasm of soft palate C05.2 Malignant neoplasm of uvula C05.8 Malignant neoplasm of overlapping sites of palate C06.0 Malignant neoplasm of cheek mucosa C06.1 Malignant neoplasm of vestibule of mouth C06.2 Malignant neoplasm of retromolar area C06.89 Malignant neoplasm of overlapping sites of other parts of mouth C07 Malignant neoplasm of parotid gland C08.0 Malignant neoplasm of submandibular gland C08.1 Malignant neoplasm of sublingual gland C09.0 Malignant neoplasm of tonsillar fossa C09.1 Malignant neoplasm of tonsillar pillar (anterior) (posterior) C09.8 Malignant neoplasm of overlapping sites of tonsil C10.0 Malignant neoplasm of vallecula C10.1 Malignant neoplasm of anterior surface of epiglottis C10.2 Malignant neoplasm of lateral wall of oropharynx C10.3 Malignant neoplasm of posterior wall of oropharynx C10.4 Malignant neoplasm of branchial cleft C10.8 Malignant neoplasm of overlapping sites of oropharynx C11.0 Malignant neoplasm of superior wall of nasopharynx C11.1 Malignant neoplasm of posterior wall of nasopharynx C11.2 Malignant neoplasm of lateral wall of nasopharynx C11.3 Malignant neoplasm of anterior wall of nasopharynx C11.8 Malignant neoplasm of overlapping sites of nasopharynx C12 Malignant neoplasm of pyriform sinus C13.0 Malignant neoplasm of postcricoid region C13.1 Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect C13.2 Malignant neoplasm of posterior wall of hypopharynx C13.8 Malignant neoplasm of overlapping sites of hypopharynx C14.2 Malignant neoplasm of Waldeyer's ring C14.8 Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx C15.3 Malignant neoplasm of upper third of esophagus C15.4 Malignant neoplasm of middle third of esophagus C15.5 Malignant neoplasm of lower third of esophagus C15.8 Malignant neoplasm of overlapping sites of esophagus C16.0 Malignant neoplasm of cardia

7 C16.1 Malignant neoplasm of fundus of stomach C16.2 Malignant neoplasm of body of stomach C16.3 Malignant neoplasm of pyloric antrum C16.4 Malignant neoplasm of pylorus C16.8 Malignant neoplasm of overlapping sites of stomach C17.0 Malignant neoplasm of duodenum C17.1 Malignant neoplasm of jejunum C17.2 Malignant neoplasm of ileum C17.3 Meckel's diverticulum, malignant C17.8 Malignant neoplasm of overlapping sites of small intestine C18.0 Malignant neoplasm of cecum C18.1 Malignant neoplasm of appendix C18.2 Malignant neoplasm of ascending colon C18.3 Malignant neoplasm of hepatic flexure C18.4 Malignant neoplasm of transverse colon C18.5 Malignant neoplasm of splenic flexure C18.6 Malignant neoplasm of descending colon C18.7 Malignant neoplasm of sigmoid colon C18.8 Malignant neoplasm of overlapping sites of colon C19 Malignant neoplasm of rectosigmoid junction C20 Malignant neoplasm of rectum C21.1 Malignant neoplasm of anal canal C21.2 Malignant neoplasm of cloacogenic zone C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal C22.0 Liver cell carcinoma C22.1 Intrahepatic bile duct carcinoma C22.2 Hepatoblastoma C22.3 Angiosarcoma of liver C22.4 Other sarcomas of liver C22.7 Other specified carcinomas of liver C22.9 Malignant neoplasm of liver, not specified as primary or secondary C23 Malignant neoplasm of gallbladder C24.0 Malignant neoplasm of extrahepatic bile duct C24.1 Malignant neoplasm of ampulla of Vater C24.8 Malignant neoplasm of overlapping sites of biliary tract C25.0 Malignant neoplasm of head of pancreas C25.1 Malignant neoplasm of body of pancreas C25.2 Malignant neoplasm of tail of pancreas C25.3 Malignant neoplasm of pancreatic duct C25.4 Malignant neoplasm of endocrine pancreas C25.7 Malignant neoplasm of other parts of pancreas C25.8 Malignant neoplasm of overlapping sites of pancreas C26.1 Malignant neoplasm of spleen C26.9 Malignant neoplasm of ill-defined sites within the digestive system C30.0 Malignant neoplasm of nasal cavity C30.1 Malignant neoplasm of middle ear C31.0 Malignant neoplasm of maxillary sinus C31.1 Malignant neoplasm of ethmoidal sinus C31.2 Malignant neoplasm of frontal sinus C31.3 Malignant neoplasm of sphenoid sinus C31.8 Malignant neoplasm of overlapping sites of accessory sinuses C32.0 Malignant neoplasm of glottis C32.1 Malignant neoplasm of supraglottis C32.2 Malignant neoplasm of subglottis C32.3 Malignant neoplasm of laryngeal cartilage C32.8 Malignant neoplasm of overlapping sites of larynx C33 Malignant neoplasm of trachea C34.01 Malignant neoplasm of right main bronchus

8 C34.02 Malignant neoplasm of left main bronchus C34.11 Malignant neoplasm of upper lobe, right bronchus or lung C34.12 Malignant neoplasm of upper lobe, left bronchus or lung C34.2 Malignant neoplasm of middle lobe, bronchus or lung C34.31 Malignant neoplasm of lower lobe, right bronchus or lung C34.32 Malignant neoplasm of lower lobe, left bronchus or lung C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung C37 Malignant neoplasm of thymus C38.0 Malignant neoplasm of heart C38.1 Malignant neoplasm of anterior mediastinum C38.2 Malignant neoplasm of posterior mediastinum C38.4 Malignant neoplasm of pleura C38.8 Malignant neoplasm of overlapping sites of heart, mediastinum and pleura C40.01 Malignant neoplasm of scapula and long bones of right upper limb C40.02 Malignant neoplasm of scapula and long bones of left upper limb C40.11 Malignant neoplasm of short bones of right upper limb C40.12 Malignant neoplasm of short bones of left upper limb C40.21 Malignant neoplasm of long bones of right lower limb C40.22 Malignant neoplasm of long bones of left lower limb C40.31 Malignant neoplasm of short bones of right lower limb C40.32 Malignant neoplasm of short bones of left lower limb C40.81 Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb C40.82 Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb C41.0 Malignant neoplasm of bones of skull and face C41.1 Malignant neoplasm of mandible C41.2 Malignant neoplasm of vertebral column C41.3 Malignant neoplasm of ribs, sternum and clavicle C41.4 Malignant neoplasm of pelvic bones, sacrum and coccyx C43.0 Malignant melanoma of lip C43.11 Malignant melanoma of right eyelid, including canthus C43.12 Malignant melanoma of left eyelid, including canthus C43.21 Malignant melanoma of right ear and external auricular canal C43.22 Malignant melanoma of left ear and external auricular canal C43.31 Malignant melanoma of nose C43.39 Malignant melanoma of other parts of face C43.4 Malignant melanoma of scalp and neck C43.51 Malignant melanoma of anal skin C43.52 Malignant melanoma of skin of breast C43.59 Malignant melanoma of other part of trunk C43.61 Malignant melanoma of right upper limb, including shoulder C43.62 Malignant melanoma of left upper limb, including shoulder C43.71 Malignant melanoma of right lower limb, including hip C43.72 Malignant melanoma of left lower limb, including hip C43.8 Malignant melanoma of overlapping sites of skin C4A.0 Merkel cell carcinoma of lip C4A.11 Merkel cell carcinoma of right eyelid, including canthus C4A.12 Merkel cell carcinoma of left eyelid, including canthus C4A.21 Merkel cell carcinoma of right ear and external auricular canal C4A.22 Merkel cell carcinoma of left ear and external auricular canal C4A.31 Merkel cell carcinoma of nose C4A.39 Merkel cell carcinoma of other parts of face C4A.4 Merkel cell carcinoma of scalp and neck C4A.51 Merkel cell carcinoma of anal skin C4A.52 Merkel cell carcinoma of skin of breast C4A.59 Merkel cell carcinoma of other part of trunk C4A.61 Merkel cell carcinoma of right upper limb, including shoulder C4A.62 Merkel cell carcinoma of left upper limb, including shoulder

9 C4A.71 Merkel cell carcinoma of right lower limb, including hip C4A.72 Merkel cell carcinoma of left lower limb, including hip C4A.8 Merkel cell carcinoma of overlapping sites C44.02 Squamous cell carcinoma of skin of lip C44.09 Other specified malignant neoplasm of skin of lip C Squamous cell carcinoma of skin of right eyelid, including canthus C Squamous cell carcinoma of skin of left eyelid, including canthus C Other specified malignant neoplasm of skin of right eyelid, including canthus C Other specified malignant neoplasm of skin of left eyelid, including canthus C Squamous cell carcinoma of skin of right ear and external auricular canal C Squamous cell carcinoma of skin of left ear and external auricular canal C Other specified malignant neoplasm of skin of right ear and external auricular canal C Other specified malignant neoplasm of skin of left ear and external auricular canal C Squamous cell carcinoma of skin of nose C Squamous cell carcinoma of skin of other parts of face C Other specified malignant neoplasm of skin of nose C Other specified malignant neoplasm of skin of other parts of face C44.42 Squamous cell carcinoma of skin of scalp and neck C44.49 Other specified malignant neoplasm of skin of scalp and neck C Squamous cell carcinoma of anal skin C Squamous cell carcinoma of skin of breast C Squamous cell carcinoma of skin of other part of trunk C Other specified malignant neoplasm of anal skin C Other specified malignant neoplasm of skin of breast C Other specified malignant neoplasm of skin of other part of trunk C Squamous cell carcinoma of skin of right upper limb, including shoulder C Squamous cell carcinoma of skin of left upper limb, including shoulder C Other specified malignant neoplasm of skin of right upper limb, including shoulder C Other specified malignant neoplasm of skin of left upper limb, including shoulder C Squamous cell carcinoma of skin of right lower limb, including hip C Squamous cell carcinoma of skin of left lower limb, including hip C Other specified malignant neoplasm of skin of right lower limb, including hip C Other specified malignant neoplasm of skin of left lower limb, including hip C44.82 Squamous cell carcinoma of overlapping sites of skin C44.89 Other specified malignant neoplasm of overlapping sites of skin C45.0 Mesothelioma of pleura C45.1 Mesothelioma of peritoneum C45.2 Mesothelioma of pericardium C45.7 Mesothelioma of other sites C46.0 Kaposi's sarcoma of skin C46.1 Kaposi's sarcoma of soft tissue C46.2 Kaposi's sarcoma of palate C46.3 Kaposi's sarcoma of lymph nodes C46.4 Kaposi's sarcoma of gastrointestinal sites C46.51 Kaposi's sarcoma of right lung C46.52 Kaposi's sarcoma of left lung C46.7 Kaposi's sarcoma of other sites C47.0 Malignant neoplasm of peripheral nerves of head, face and neck C47.11 Malignant neoplasm of peripheral nerves of right upper limb, including shoulder C47.12 Malignant neoplasm of peripheral nerves of left upper limb, including shoulder C47.21 Malignant neoplasm of peripheral nerves of right lower limb, including hip C47.22 Malignant neoplasm of peripheral nerves of left lower limb, including hip C47.3 Malignant neoplasm of peripheral nerves of thorax C47.4 Malignant neoplasm of peripheral nerves of abdomen C47.5 Malignant neoplasm of peripheral nerves of pelvis C47.8 Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system C48.0 Malignant neoplasm of retroperitoneum C48.1 Malignant neoplasm of specified parts of peritoneum

10 C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck C49.11 Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder C49.12 Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder C49.21 Malignant neoplasm of connective and soft tissue of right lower limb, including hip C49.22 Malignant neoplasm of connective and soft tissue of left lower limb, including hip C49.3 Malignant neoplasm of connective and soft tissue of thorax C49.4 Malignant neoplasm of connective and soft tissue of abdomen C49.5 Malignant neoplasm of connective and soft tissue of pelvis C49.8 Malignant neoplasm of overlapping sites of connective and soft tissue C Malignant neoplasm of nipple and areola, right female breast C Malignant neoplasm of nipple and areola, left female breast C Malignant neoplasm of nipple and areola, right male breast C Malignant neoplasm of nipple and areola, left male breast C Malignant neoplasm of central portion of right female breast C Malignant neoplasm of central portion of left female breast C Malignant neoplasm of central portion of right male breast C Malignant neoplasm of central portion of left male breast C Malignant neoplasm of upper-inner quadrant of right female breast C Malignant neoplasm of upper-inner quadrant of left female breast C Malignant neoplasm of upper-inner quadrant of right male breast C Malignant neoplasm of upper-inner quadrant of left male breast C Malignant neoplasm of lower-inner quadrant of right female breast C Malignant neoplasm of lower-inner quadrant of left female breast C Malignant neoplasm of lower-inner quadrant of right male breast C Malignant neoplasm of lower-inner quadrant of left male breast C Malignant neoplasm of upper-outer quadrant of right female breast C Malignant neoplasm of upper-outer quadrant of left female breast C Malignant neoplasm of upper-outer quadrant of right male breast C Malignant neoplasm of upper-outer quadrant of left male breast C Malignant neoplasm of lower-outer quadrant of right female breast C Malignant neoplasm of lower-outer quadrant of left female breast C Malignant neoplasm of lower-outer quadrant of right male breast C Malignant neoplasm of lower-outer quadrant of left male breast C Malignant neoplasm of axillary tail of right female breast C Malignant neoplasm of axillary tail of left female breast C Malignant neoplasm of axillary tail of right male breast C Malignant neoplasm of axillary tail of left male breast C Malignant neoplasm of overlapping sites of right female breast C Malignant neoplasm of overlapping sites of left female breast C Malignant neoplasm of overlapping sites of right male breast C Malignant neoplasm of overlapping sites of left male breast C51.0 Malignant neoplasm of labium majus C51.1 Malignant neoplasm of labium minus C51.2 Malignant neoplasm of clitoris C51.8 Malignant neoplasm of overlapping sites of vulva C52 Malignant neoplasm of vagina C53.0 Malignant neoplasm of endocervix C53.1 Malignant neoplasm of exocervix C53.8 Malignant neoplasm of overlapping sites of cervix uteri C54.0 Malignant neoplasm of isthmus uteri C54.1 Malignant neoplasm of endometrium C54.2 Malignant neoplasm of myometrium C54.3 Malignant neoplasm of fundus uteri C54.8 Malignant neoplasm of overlapping sites of corpus uteri C56.1 Malignant neoplasm of right ovary C56.2 Malignant neoplasm of left ovary C57.01 Malignant neoplasm of right fallopian tube

11 C57.02 Malignant neoplasm of left fallopian tube C57.11 Malignant neoplasm of right broad ligament C57.12 Malignant neoplasm of left broad ligament C57.21 Malignant neoplasm of right round ligament C57.22 Malignant neoplasm of left round ligament C57.3 Malignant neoplasm of parametrium C57.7 Malignant neoplasm of other specified female genital organs C57.8 Malignant neoplasm of overlapping sites of female genital organs C58 Malignant neoplasm of placenta C60.0 Malignant neoplasm of prepuce C60.1 Malignant neoplasm of glans penis C60.2 Malignant neoplasm of body of penis C60.8 Malignant neoplasm of overlapping sites of penis C61 Malignant neoplasm of prostate C62.01 Malignant neoplasm of undescended right testis C62.02 Malignant neoplasm of undescended left testis C62.11 Malignant neoplasm of descended right testis C62.12 Malignant neoplasm of descended left testis C63.01 Malignant neoplasm of right epididymis C63.02 Malignant neoplasm of left epididymis C63.11 Malignant neoplasm of right spermatic cord C63.12 Malignant neoplasm of left spermatic cord C63.2 Malignant neoplasm of scrotum C63.7 Malignant neoplasm of other specified male genital organs C63.8 Malignant neoplasm of overlapping sites of male genital organs C64.1 Malignant neoplasm of right kidney, except renal pelvis C64.2 Malignant neoplasm of left kidney, except renal pelvis C65.1 Malignant neoplasm of right renal pelvis C65.2 Malignant neoplasm of left renal pelvis C66.1 Malignant neoplasm of right ureter C66.2 Malignant neoplasm of left ureter C67.0 Malignant neoplasm of trigone of bladder C67.1 Malignant neoplasm of dome of bladder C67.2 Malignant neoplasm of lateral wall of bladder C67.3 Malignant neoplasm of anterior wall of bladder C67.4 Malignant neoplasm of posterior wall of bladder C67.5 Malignant neoplasm of bladder neck C67.6 Malignant neoplasm of ureteric orifice C67.7 Malignant neoplasm of urachus C67.8 Malignant neoplasm of overlapping sites of bladder C68.0 Malignant neoplasm of urethra C68.1 Malignant neoplasm of paraurethral glands C68.8 Malignant neoplasm of overlapping sites of urinary organs C69.01 Malignant neoplasm of right conjunctiva C69.02 Malignant neoplasm of left conjunctiva C69.11 Malignant neoplasm of right cornea C69.12 Malignant neoplasm of left cornea C69.21 Malignant neoplasm of right retina C69.22 Malignant neoplasm of left retina C69.31 Malignant neoplasm of right choroid C69.32 Malignant neoplasm of left choroid C69.41 Malignant neoplasm of right ciliary body C69.42 Malignant neoplasm of left ciliary body C69.51 Malignant neoplasm of right lacrimal gland and duct C69.52 Malignant neoplasm of left lacrimal gland and duct C69.61 Malignant neoplasm of right orbit C69.62 Malignant neoplasm of left orbit C69.81 Malignant neoplasm of overlapping sites of right eye and adnexa

12 C69.82 Malignant neoplasm of overlapping sites of left eye and adnexa C70.0 Malignant neoplasm of cerebral meninges C70.1 Malignant neoplasm of spinal meninges C71.0 Malignant neoplasm of cerebrum, except lobes and ventricles C71.1 Malignant neoplasm of frontal lobe C71.2 Malignant neoplasm of temporal lobe C71.3 Malignant neoplasm of parietal lobe C71.4 Malignant neoplasm of occipital lobe C71.5 Malignant neoplasm of cerebral ventricle C71.6 Malignant neoplasm of cerebellum C71.7 Malignant neoplasm of brain stem C71.8 Malignant neoplasm of overlapping sites of brain C72.0 Malignant neoplasm of spinal cord C72.1 Malignant neoplasm of cauda equina C72.21 Malignant neoplasm of right olfactory nerve C72.22 Malignant neoplasm of left olfactory nerve C72.31 Malignant neoplasm of right optic nerve C72.32 Malignant neoplasm of left optic nerve C72.41 Malignant neoplasm of right acoustic nerve C72.42 Malignant neoplasm of left acoustic nerve C72.59 Malignant neoplasm of other cranial nerves C73 Malignant neoplasm of thyroid gland C74.01 Malignant neoplasm of cortex of right adrenal gland C74.02 Malignant neoplasm of cortex of left adrenal gland C74.11 Malignant neoplasm of medulla of right adrenal gland C74.12 Malignant neoplasm of medulla of left adrenal gland C75.0 Malignant neoplasm of parathyroid gland C75.1 Malignant neoplasm of pituitary gland C75.2 Malignant neoplasm of craniopharyngeal duct C75.3 Malignant neoplasm of pineal gland C75.4 Malignant neoplasm of carotid body C75.5 Malignant neoplasm of aortic body and other paraganglia C7A.010 Malignant carcinoid tumor of the duodenum C7A.011 Malignant carcinoid tumor of the jejunum C7A.012 Malignant carcinoid tumor of the ileum C7A.020 Malignant carcinoid tumor of the appendix C7A.021 Malignant carcinoid tumor of the cecum C7A.022 Malignant carcinoid tumor of the ascending colon C7A.023 Malignant carcinoid tumor of the transverse colon C7A.024 Malignant carcinoid tumor of the descending colon C7A.025 Malignant carcinoid tumor of the sigmoid colon C7A.026 Malignant carcinoid tumor of the rectum C7A.090 Malignant carcinoid tumor of the bronchus and lung C7A.091 Malignant carcinoid tumor of the thymus C7A.092 Malignant carcinoid tumor of the stomach C7A.093 Malignant carcinoid tumor of the kidney C7A.094 Malignant carcinoid tumor of the foregut NOS C7A.095 Malignant carcinoid tumor of the midgut NOS C7A.096 Malignant carcinoid tumor of the hindgut NOS C7A.098 Malignant carcinoid tumors of other sites C7A.1 Malignant poorly differentiated neuroendocrine tumors C7A.8 Other malignant neuroendocrine tumors C76.0 Malignant neoplasm of head, face and neck C76.1 Malignant neoplasm of thorax C76.2 Malignant neoplasm of abdomen C76.3 Malignant neoplasm of pelvis C76.41 Malignant neoplasm of right upper limb C76.42 Malignant neoplasm of left upper limb

13 C76.51 Malignant neoplasm of right lower limb C76.52 Malignant neoplasm of left lower limb C76.8 Malignant neoplasm of other specified ill-defined sites C78.01 Secondary malignant neoplasm of right lung C78.02 Secondary malignant neoplasm of left lung C78.1 Secondary malignant neoplasm of mediastinum C78.2 Secondary malignant neoplasm of pleura C78.39 Secondary malignant neoplasm of other respiratory organs C78.4 Secondary malignant neoplasm of small intestine C78.5 Secondary malignant neoplasm of large intestine and rectum C78.6 Secondary malignant neoplasm of retroperitoneum and peritoneum C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct C78.89 Secondary malignant neoplasm of other digestive organs C79.01 Secondary malignant neoplasm of right kidney and renal pelvis C79.02 Secondary malignant neoplasm of left kidney and renal pelvis C79.11 Secondary malignant neoplasm of bladder C79.19 Secondary malignant neoplasm of other urinary organs C79.2 Secondary malignant neoplasm of skin C79.31 Secondary malignant neoplasm of brain C79.32 Secondary malignant neoplasm of cerebral meninges C79.49 Secondary malignant neoplasm of other parts of nervous system C79.51 Secondary malignant neoplasm of bone C79.52 Secondary malignant neoplasm of bone marrow C79.61 Secondary malignant neoplasm of right ovary C79.62 Secondary malignant neoplasm of left ovary C79.71 Secondary malignant neoplasm of right adrenal gland C79.72 Secondary malignant neoplasm of left adrenal gland C79.81 Secondary malignant neoplasm of breast C79.82 Secondary malignant neoplasm of genital organs C79.89 Secondary malignant neoplasm of other specified sites C80.2 Malignant neoplasm associated with transplanted organ C81.01 Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of head, face, and neck C81.02 Nodular lymphocyte predominant Hodgkin lymphoma, intrathoracic lymph nodes C81.03 Nodular lymphocyte predominant Hodgkin lymphoma, intra-abdominal lymph nodes C81.04 Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.05 Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.06 Nodular lymphocyte predominant Hodgkin lymphoma, intrapelvic lymph nodes C81.07 Nodular lymphocyte predominant Hodgkin lymphoma, spleen C81.08 Nodular lymphocyte predominant Hodgkin lymphoma, lymph nodes of multiple sites C81.09 Nodular lymphocyte predominant Hodgkin lymphoma, extranodal and solid organ sites C81.11 Nodular sclerosis classical Hodgkin lymphoma, lymph nodes of head, face, and neck C81.12 Nodular sclerosis classical Hodgkin lymphoma, intrathoracic lymph nodes C81.13 Nodular sclerosis classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.14 Nodular sclerosis classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.15 Nodular sclerosis classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.16 Nodular sclerosis classical Hodgkin lymphoma, intrapelvic lymph nodes C81.17 Nodular sclerosis classical Hodgkin lymphoma, spleen C81.18 Nodular sclerosis classical Hodgkin lymphoma, lymph nodes of multiple sites C81.19 Nodular sclerosis classical Hodgkin lymphoma, extranodal and solid organ sites C81.21 Mixed cellularity classical Hodgkin lymphoma, lymph nodes of head, face, and neck C81.22 Mixed cellularity classical Hodgkin lymphoma, intrathoracic lymph nodes C81.23 Mixed cellularity classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.24 Mixed cellularity classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.25 Mixed cellularity classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.26 Mixed cellularity classical Hodgkin lymphoma, intrapelvic lymph nodes C81.27 Mixed cellularity classical Hodgkin lymphoma, spleen C81.28 Mixed cellularity classical Hodgkin lymphoma, lymph nodes of multiple sites C81.29 Mixed cellularity classical Hodgkin lymphoma, extranodal and solid organ sites

14 C81.31 Lymphocyte depleted classical Hodgkin lymphoma, lymph nodes of head, face, and neck C81.32 Lymphocyte depleted classical Hodgkin lymphoma, intrathoracic lymph nodes C81.33 Lymphocyte depleted classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.34 Lymphocyte depleted classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.35 Lymphocyte depleted classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.36 Lymphocyte depleted classical Hodgkin lymphoma, intrapelvic lymph nodes C81.37 Lymphocyte depleted classical Hodgkin lymphoma, spleen C81.38 Lymphocyte depleted classical Hodgkin lymphoma, lymph nodes of multiple sites C81.39 Lymphocyte depleted classical Hodgkin lymphoma, extranodal and solid organ sites C81.41 Lymphocyte-rich classical Hodgkin lymphoma, lymph nodes of head, face, and neck C81.42 Lymphocyte-rich classical Hodgkin lymphoma, intrathoracic lymph nodes C81.43 Lymphocyte-rich classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.44 Lymphocyte-rich classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.45 Lymphocyte-rich classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.46 Lymphocyte-rich classical Hodgkin lymphoma, intrapelvic lymph nodes C81.47 Lymphocyte-rich classical Hodgkin lymphoma, spleen C81.48 Lymphocyte-rich classical Hodgkin lymphoma, lymph nodes of multiple sites C81.49 Lymphocyte-rich classical Hodgkin lymphoma, extranodal and solid organ sites C81.71 Other classical Hodgkin lymphoma, lymph nodes of head, face, and neck C81.72 Other classical Hodgkin lymphoma, intrathoracic lymph nodes C81.73 Other classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.74 Other classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.75 Other classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.76 Other classical Hodgkin lymphoma, intrapelvic lymph nodes C81.77 Other classical Hodgkin lymphoma, spleen C81.78 Other classical Hodgkin lymphoma, lymph nodes of multiple sites C81.79 Other classical Hodgkin lymphoma, extranodal and solid organ sites C82.01 Follicular lymphoma grade I, lymph nodes of head, face, and neck C82.02 Follicular lymphoma grade I, intrathoracic lymph nodes C82.03 Follicular lymphoma grade I, intra-abdominal lymph nodes C82.04 Follicular lymphoma grade I, lymph nodes of axilla and upper limb C82.05 Follicular lymphoma grade I, lymph nodes of inguinal region and lower limb C82.06 Follicular lymphoma grade I, intrapelvic lymph nodes C82.07 Follicular lymphoma grade I, spleen C82.08 Follicular lymphoma grade I, lymph nodes of multiple sites C82.09 Follicular lymphoma grade I, extranodal and solid organ sites C82.11 Follicular lymphoma grade II, lymph nodes of head, face, and neck C82.12 Follicular lymphoma grade II, intrathoracic lymph nodes C82.13 Follicular lymphoma grade II, intra-abdominal lymph nodes C82.14 Follicular lymphoma grade II, lymph nodes of axilla and upper limb C82.15 Follicular lymphoma grade II, lymph nodes of inguinal region and lower limb C82.16 Follicular lymphoma grade II, intrapelvic lymph nodes C82.17 Follicular lymphoma grade II, spleen C82.18 Follicular lymphoma grade II, lymph nodes of multiple sites C82.19 Follicular lymphoma grade II, extranodal and solid organ sites C82.31 Follicular lymphoma grade IIIa, lymph nodes of head, face, and neck C82.32 Follicular lymphoma grade IIIa, intrathoracic lymph nodes C82.33 Follicular lymphoma grade IIIa, intra-abdominal lymph nodes C82.34 Follicular lymphoma grade IIIa, lymph nodes of axilla and upper limb C82.35 Follicular lymphoma grade IIIa, lymph nodes of inguinal region and lower limb C82.36 Follicular lymphoma grade IIIa, intrapelvic lymph nodes C82.37 Follicular lymphoma grade IIIa, spleen C82.38 Follicular lymphoma grade IIIa, lymph nodes of multiple sites C82.39 Follicular lymphoma grade IIIa, extranodal and solid organ sites C82.41 Follicular lymphoma grade IIIb, lymph nodes of head, face, and neck C82.42 Follicular lymphoma grade IIIb, intrathoracic lymph nodes C82.43 Follicular lymphoma grade IIIb, intra-abdominal lymph nodes C82.44 Follicular lymphoma grade IIIb, lymph nodes of axilla and upper limb

15 C82.45 Follicular lymphoma grade IIIb, lymph nodes of inguinal region and lower limb C82.46 Follicular lymphoma grade IIIb, intrapelvic lymph nodes C82.47 Follicular lymphoma grade IIIb, spleen C82.48 Follicular lymphoma grade IIIb, lymph nodes of multiple sites C82.49 Follicular lymphoma grade IIIb, extranodal and solid organ sites C82.51 Diffuse follicle center lymphoma, lymph nodes of head, face, and neck C82.52 Diffuse follicle center lymphoma, intrathoracic lymph nodes C82.53 Diffuse follicle center lymphoma, intra-abdominal lymph nodes C82.54 Diffuse follicle center lymphoma, lymph nodes of axilla and upper limb C82.55 Diffuse follicle center lymphoma, lymph nodes of inguinal region and lower limb C82.56 Diffuse follicle center lymphoma, intrapelvic lymph nodes C82.57 Diffuse follicle center lymphoma, spleen C82.58 Diffuse follicle center lymphoma, lymph nodes of multiple sites C82.59 Diffuse follicle center lymphoma, extranodal and solid organ sites C82.61 Cutaneous follicle center lymphoma, lymph nodes of head, face, and neck C82.62 Cutaneous follicle center lymphoma, intrathoracic lymph nodes C82.63 Cutaneous follicle center lymphoma, intra-abdominal lymph nodes C82.64 Cutaneous follicle center lymphoma, lymph nodes of axilla and upper limb C82.65 Cutaneous follicle center lymphoma, lymph nodes of inguinal region and lower limb C82.66 Cutaneous follicle center lymphoma, intrapelvic lymph nodes C82.67 Cutaneous follicle center lymphoma, spleen C82.68 Cutaneous follicle center lymphoma, lymph nodes of multiple sites C82.69 Cutaneous follicle center lymphoma, extranodal and solid organ sites C82.81 Other types of follicular lymphoma, lymph nodes of head, face, and neck C82.82 Other types of follicular lymphoma, intrathoracic lymph nodes C82.83 Other types of follicular lymphoma, intra-abdominal lymph nodes C82.84 Other types of follicular lymphoma, lymph nodes of axilla and upper limb C82.85 Other types of follicular lymphoma, lymph nodes of inguinal region and lower limb C82.86 Other types of follicular lymphoma, intrapelvic lymph nodes C82.87 Other types of follicular lymphoma, spleen C82.88 Other types of follicular lymphoma, lymph nodes of multiple sites C82.89 Other types of follicular lymphoma, extranodal and solid organ sites C83.01 Small cell B-cell lymphoma, lymph nodes of head, face, and neck C83.02 Small cell B-cell lymphoma, intrathoracic lymph nodes C83.03 Small cell B-cell lymphoma, intra-abdominal lymph nodes C83.04 Small cell B-cell lymphoma, lymph nodes of axilla and upper limb C83.05 Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb C83.06 Small cell B-cell lymphoma, intrapelvic lymph nodes C83.07 Small cell B-cell lymphoma, spleen C83.08 Small cell B-cell lymphoma, lymph nodes of multiple sites C83.09 Small cell B-cell lymphoma, extranodal and solid organ sites C83.11 Mantle cell lymphoma, lymph nodes of head, face, and neck C83.12 Mantle cell lymphoma, intrathoracic lymph nodes C83.13 Mantle cell lymphoma, intra-abdominal lymph nodes C83.14 Mantle cell lymphoma, lymph nodes of axilla and upper limb C83.15 Mantle cell lymphoma, lymph nodes of inguinal region and lower limb C83.16 Mantle cell lymphoma, intrapelvic lymph nodes C83.17 Mantle cell lymphoma, spleen C83.18 Mantle cell lymphoma, lymph nodes of multiple sites C83.19 Mantle cell lymphoma, extranodal and solid organ sites C83.31 Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck C83.32 Diffuse large B-cell lymphoma, intrathoracic lymph nodes C83.33 Diffuse large B-cell lymphoma, intra-abdominal lymph nodes C83.34 Diffuse large B-cell lymphoma, lymph nodes of axilla and upper limb C83.35 Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb C83.36 Diffuse large B-cell lymphoma, intrapelvic lymph nodes C83.37 Diffuse large B-cell lymphoma, spleen C83.38 Diffuse large B-cell lymphoma, lymph nodes of multiple sites

16 C83.39 Diffuse large B-cell lymphoma, extranodal and solid organ sites C83.51 Lymphoblastic (diffuse) lymphoma, lymph nodes of head, face, and neck C83.52 Lymphoblastic (diffuse) lymphoma, intrathoracic lymph nodes C83.53 Lymphoblastic (diffuse) lymphoma, intra-abdominal lymph nodes C83.54 Lymphoblastic (diffuse) lymphoma, lymph nodes of axilla and upper limb C83.55 Lymphoblastic (diffuse) lymphoma, lymph nodes of inguinal region and lower limb C83.56 Lymphoblastic (diffuse) lymphoma, intrapelvic lymph nodes C83.57 Lymphoblastic (diffuse) lymphoma, spleen C83.58 Lymphoblastic (diffuse) lymphoma, lymph nodes of multiple sites C83.59 Lymphoblastic (diffuse) lymphoma, extranodal and solid organ sites C83.71 Burkitt lymphoma, lymph nodes of head, face, and neck C83.72 Burkitt lymphoma, intrathoracic lymph nodes C83.73 Burkitt lymphoma, intra-abdominal lymph nodes C83.74 Burkitt lymphoma, lymph nodes of axilla and upper limb C83.75 Burkitt lymphoma, lymph nodes of inguinal region and lower limb C83.76 Burkitt lymphoma, intrapelvic lymph nodes C83.77 Burkitt lymphoma, spleen C83.78 Burkitt lymphoma, lymph nodes of multiple sites C83.79 Burkitt lymphoma, extranodal and solid organ sites C83.81 Other non-follicular lymphoma, lymph nodes of head, face, and neck C83.82 Other non-follicular lymphoma, intrathoracic lymph nodes C83.83 Other non-follicular lymphoma, intra-abdominal lymph nodes C83.84 Other non-follicular lymphoma, lymph nodes of axilla and upper limb C83.85 Other non-follicular lymphoma, lymph nodes of inguinal region and lower limb C83.86 Other non-follicular lymphoma, intrapelvic lymph nodes C83.87 Other non-follicular lymphoma, spleen C83.88 Other non-follicular lymphoma, lymph nodes of multiple sites C83.89 Other non-follicular lymphoma, extranodal and solid organ sites C84.01 Mycosis fungoides, lymph nodes of head, face, and neck C84.02 Mycosis fungoides, intrathoracic lymph nodes C84.03 Mycosis fungoides, intra-abdominal lymph nodes C84.04 Mycosis fungoides, lymph nodes of axilla and upper limb C84.05 Mycosis fungoides, lymph nodes of inguinal region and lower limb C84.06 Mycosis fungoides, intrapelvic lymph nodes C84.07 Mycosis fungoides, spleen C84.08 Mycosis fungoides, lymph nodes of multiple sites C84.09 Mycosis fungoides, extranodal and solid organ sites C84.11 Sezary disease, lymph nodes of head, face, and neck C84.12 Sezary disease, intrathoracic lymph nodes C84.13 Sezary disease, intra-abdominal lymph nodes C84.14 Sezary disease, lymph nodes of axilla and upper limb C84.15 Sezary disease, lymph nodes of inguinal region and lower limb C84.16 Sezary disease, intrapelvic lymph nodes C84.17 Sezary disease, spleen C84.18 Sezary disease, lymph nodes of multiple sites C84.19 Sezary disease, extranodal and solid organ sites C84.41 Peripheral T-cell lymphoma, not classified, lymph nodes of head, face, and neck C84.42 Peripheral T-cell lymphoma, not classified, intrathoracic lymph nodes C84.43 Peripheral T-cell lymphoma, not classified, intra-abdominal lymph nodes C84.44 Peripheral T-cell lymphoma, not classified, lymph nodes of axilla and upper limb C84.45 Peripheral T-cell lymphoma, not classified, lymph nodes of inguinal region and lower limb C84.46 Peripheral T-cell lymphoma, not classified, intrapelvic lymph nodes C84.47 Peripheral T-cell lymphoma, not classified, spleen C84.48 Peripheral T-cell lymphoma, not classified, lymph nodes of multiple sites C84.49 Peripheral T-cell lymphoma, not classified, extranodal and solid organ sites C84.61 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of head, face, and neck C84.62 Anaplastic large cell lymphoma, ALK-positive, intrathoracic lymph nodes C84.63 Anaplastic large cell lymphoma, ALK-positive, intra-abdominal lymph nodes

17 C84.64 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of axilla and upper limb C84.65 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of inguinal region and lower limb C84.66 Anaplastic large cell lymphoma, ALK-positive, intrapelvic lymph nodes C84.67 Anaplastic large cell lymphoma, ALK-positive, spleen C84.68 Anaplastic large cell lymphoma, ALK-positive, lymph nodes of multiple sites C84.69 Anaplastic large cell lymphoma, ALK-positive, extranodal and solid organ sites C84.71 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of head, face, and neck C84.72 Anaplastic large cell lymphoma, ALK-negative, intrathoracic lymph nodes C84.73 Anaplastic large cell lymphoma, ALK-negative, intra-abdominal lymph nodes C84.74 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of axilla and upper limb C84.75 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of inguinal region and lower limb C84.76 Anaplastic large cell lymphoma, ALK-negative, intrapelvic lymph nodes C84.77 Anaplastic large cell lymphoma, ALK-negative, spleen C84.78 Anaplastic large cell lymphoma, ALK-negative, lymph nodes of multiple sites C84.79 Anaplastic large cell lymphoma, ALK-negative, extranodal and solid organ sites C84.Z1 Other mature T/NK-cell lymphomas, lymph nodes of head, face, and neck C84.Z2 Other mature T/NK-cell lymphomas, intrathoracic lymph nodes C84.Z3 Other mature T/NK-cell lymphomas, intra-abdominal lymph nodes C84.Z4 Other mature T/NK-cell lymphomas, lymph nodes of axilla and upper limb C84.Z5 Other mature T/NK-cell lymphomas, lymph nodes of inguinal region and lower limb C84.Z6 Other mature T/NK-cell lymphomas, intrapelvic lymph nodes C84.Z7 Other mature T/NK-cell lymphomas, spleen C84.Z8 Other mature T/NK-cell lymphomas, lymph nodes of multiple sites C84.Z9 Other mature T/NK-cell lymphomas, extranodal and solid organ sites C85.21 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of head, face, and neck C85.22 Mediastinal (thymic) large B-cell lymphoma, intrathoracic lymph nodes C85.23 Mediastinal (thymic) large B-cell lymphoma, intra-abdominal lymph nodes C85.24 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of axilla and upper limb C85.25 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of inguinal region and lower limb C85.26 Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes C85.27 Mediastinal (thymic) large B-cell lymphoma, spleen C85.28 Mediastinal (thymic) large B-cell lymphoma, lymph nodes of multiple sites C85.29 Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites C85.81 Other specified types of non-hodgkin lymphoma, lymph nodes of head, face, and neck C85.82 Other specified types of non-hodgkin lymphoma, intrathoracic lymph nodes C85.83 Other specified types of non-hodgkin lymphoma, intra-abdominal lymph nodes C85.84 Other specified types of non-hodgkin lymphoma, lymph nodes of axilla and upper limb C85.85 Other specified types of non-hodgkin lymphoma, lymph nodes of inguinal region and lower limb C85.86 Other specified types of non-hodgkin lymphoma, intrapelvic lymph nodes C85.87 Other specified types of non-hodgkin lymphoma, spleen C85.88 Other specified types of non-hodgkin lymphoma, lymph nodes of multiple sites C85.89 Other specified types of non-hodgkin lymphoma, extranodal and solid organ sites C86.0 Extranodal NK/T-cell lymphoma, nasal type C86.1 Hepatosplenic T-cell lymphoma C86.2 Enteropathy-type (intestinal) T-cell lymphoma C86.3 Subcutaneous panniculitis-like T-cell lymphoma C86.4 Blastic NK-cell lymphoma C86.5 Angioimmunoblastic T-cell lymphoma C86.6 Primary cutaneous CD30-positive T-cell proliferations C88.0 Waldenstrom macroglobulinemia C88.2 Heavy chain disease C88.3 Immunoproliferative small intestinal disease C88.4 Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma] C88.8 Other malignant immunoproliferative diseases C90.00 Multiple myeloma not having achieved remission C90.01 Multiple myeloma in remission C90.02 Multiple myeloma in relapse C90.10 Plasma cell leukemia not having achieved remission

18 C90.11 Plasma cell leukemia in remission C90.12 Plasma cell leukemia in relapse C90.20 Extramedullary plasmacytoma not having achieved remission C90.21 Extramedullary plasmacytoma in remission C90.22 Extramedullary plasmacytoma in relapse C90.30 Solitary plasmacytoma not having achieved remission C90.31 Solitary plasmacytoma in remission C90.32 Solitary plasmacytoma in relapse C91.00 Acute lymphoblastic leukemia not having achieved remission C91.01 Acute lymphoblastic leukemia, in remission C91.02 Acute lymphoblastic leukemia, in relapse C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission C91.11 Chronic lymphocytic leukemia of B-cell type in remission C91.12 Chronic lymphocytic leukemia of B-cell type in relapse C91.30 Prolymphocytic leukemia of B-cell type not having achieved remission C91.31 Prolymphocytic leukemia of B-cell type, in remission C91.32 Prolymphocytic leukemia of B-cell type, in relapse C91.40 Hairy cell leukemia not having achieved remission C91.41 Hairy cell leukemia, in remission C91.42 Hairy cell leukemia, in relapse C91.50 Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission C91.51 Adult T-cell lymphoma/leukemia (HTLV-1-associated), in remission C91.52 Adult T-cell lymphoma/leukemia (HTLV-1-associated), in relapse C91.60 Prolymphocytic leukemia of T-cell type not having achieved remission C91.61 Prolymphocytic leukemia of T-cell type, in remission C91.62 Prolymphocytic leukemia of T-cell type, in relapse C91.A0 Mature B-cell leukemia Burkitt-type not having achieved remission C91.A1 Mature B-cell leukemia Burkitt-type, in remission C91.A2 Mature B-cell leukemia Burkitt-type, in relapse C91.Z0 Other lymphoid leukemia not having achieved remission C91.Z1 Other lymphoid leukemia, in remission C91.Z2 Other lymphoid leukemia, in relapse C96.0 Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis C96.2 Malignant mast cell tumor C96.4 Sarcoma of dendritic cells (accessory cells) C96.A Histiocytic sarcoma C96.Z Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue D47.0 Histiocytic and mast cell tumors of uncertain behavior D47.1 Chronic myeloproliferative disease D47.Z1 Post-transplant lymphoproliferative disorder (PTLD) D48.0 Neoplasm of uncertain behavior of bone and articular cartilage D48.1 Neoplasm of uncertain behavior of connective and other soft tissue D48.2 Neoplasm of uncertain behavior of peripheral nerves and autonomic nervous system D48.3 Neoplasm of uncertain behavior of retroperitoneum D48.4 Neoplasm of uncertain behavior of peritoneum D48.5 Neoplasm of uncertain behavior of skin D48.61 Neoplasm of uncertain behavior of right breast D48.62 Neoplasm of uncertain behavior of left breast D48.7 Neoplasm of uncertain behavior of other specified sites Q85.01 Neurofibromatosis, type 1 Q85.02 Neurofibromatosis, type 2 Q85.03 Schwannomatosis Q85.09 Other neurofibromatosis Z51.11 Encounter for antineoplastic chemotherapy Z51.12 Encounter for antineoplastic immunotherapy Group 5 Paragraph: Patients with anemia related to Myelodysplastic Syndrome

19 Group 5 Codes: ICD-10 CODES DESCRIPTION D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality D46.9 Myelodysplastic syndrome, unspecified Group 6 Paragraph: Preoperative use in specified patients. Must have an anemia diagnosis (Note: D63.8 (anemia of other chronic disease) or D64.9 (anemia unspecified)) and other specified prophylactic measure diagnosis. (Anemia must be primary diagnosis). Group 6 Codes: ICD-10 CODES DESCRIPTION Z41.8 Encounter for other procedures for purposes other than remedying health state ICD-10 Codes that DO NOT Support Medical Necessity Group 1 Paragraph: [C92.00 C92.91] [C93.00 C93.91] [C94.00 C94.81] [C95.00 C95.91] Group 1 Codes: N/A ICD-10 Additional Information General Information Associated Information Documentation Requirements Listing of ICD-10-CM codes contained in this LCD does not assure coverage of the specific service. Coverage criteria specified in this LCD shall be applied to determine appropriate reimbursement. Medical record documentation must be legible, maintained in the patient s medical record, and meet the criteria contained in this LCD. Medical records such as a physician s (or nonphysician practitioner's) order must be made available upon request of this A/B MAC. Documentation the provider is to maintain in the patient s medical record include: patient s weight in kilograms; erythropoietin analog units administered per kilogram of body weight; and medical justification for administration of erythropoietin analogs exceeding usual doses. Documentation supporting the indication for erythropoietin analogs administration must be made available upon the request of this A/B MAC; for all patients, this includes Hgb/Hct and documentation of adequate iron stores. Additional information is determined by indication. Regular reporting of Hgb/Hct is needed to show monitoring of ESA dose. The most recent Hgb/Hct must be reported on the claim. Dialysis Patients dialysis schedule, Hgb/Hct immediately prior to billing period. For ESRD patients on home dialysis, the following additional information must be maintained in the medical record and available to this A/B MAC upon request: a care plan; evidence of home monitoring (including a record of the erythropoietin analog supplied to the patient and a record of dose administration); patient instructions; and patient selection protocol. Non-dialysis Patients: Chronic renal failure patients: serum creatinine, creatinine clearance, or glomerular filtration rate (GFR) supporting a diagnosis of chronic renal failure. Patients with myelodysplastic syndrome: *bone marrow biopsy report, date of initiation of erythropoietin analog therapy, and response to erythropoietin analog administration (change in Hgb/Hct and/or transfusion requirements). *For patients on ESA therapy for MDS, initiated prior to 12/01/2007, this A/B MAC requires that a physician s statement that the patient does have MDS be included in the medical record. For ESA therapy initiated on or after 12/01/2007, a copy of the actual bone marrow report must be included in the medical record. MDS cannot be diagnosed definitively until a bone marrow biopsy is performed to confirm the diagnosis. Sources of Information and Basis for Decision Aranesp [package insert]. Thousand Oaks, CA: Amgen, Inc; The American Society of Hematology (ASH) Comments to the Centers for Medicare and Medicaid Services on coverage for Erythropoiesis Stimulating Agents (ESAs) filed electronically on April 12, Canon JL, Vansteenkiste J, Bodoky G, et al. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. Journal of the National Cancer Institute. 2006;98(4): Drueke TB, Locatelli F, Clyne N, et al. Normalization of Hemoglobin Level in Patients with Chronic Kidney Disease and Anemia. (CREATE Trial). NEJM.

20 2006;355(20): Epogen [package insert]. Thousand Oaks, CA: Amgen, Inc; Eschbach JW. Iron requirements in erythropoietin therapy. Best Pract Res Clin Haematol. 2005;18(2): Kotasek D, Steger G, Faught W, et al. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study. European Journal of Cancer. 2003;39(14): NKF K/DOQI Clinical Practice Guidelines for Anemia in Chronic Kidney Disease: Update Other Medicare contractors, specialty societies, and specialty consultants. Parfrey PS. Target Hemoglobin Level for EPO Therapy in CKD. American Journal of Kidney Diseases. 2006;47(1): Pujade-Lauraine E, Richard AJ, Sapède C, Hayward C. Erythropoietic agents in anaemic patients with cancer: a retrospective observational survey of epoetin alpha, epoetin beta and darbepoetin alpha use in routine clinical practice. Oncology Reports. 2005;14(4): Schwartzberg LS, Yee LK, Senecal FM, et al. A randomized comparison of every-2-week Darbepoetin alfa and weekly Epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer. The Oncologist. 2004;9(6): Singh AK, Szczech L, Tang KL, et al. Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease. (CHOIR). NEJM. 2006;355(20): Stasi R, Amadori S, Littlewood TJ, Terzoli E, Newland AC, Provan D. Management of cancer-related anemia with Erythropoietic agents: doubts, certainties, and concerns. The Oncologist. 2005;10(7): Stein RS, Abels RI, Krantz SB. Pharmacologic Doses of Recombinant Human Erythropoietin in the Treatment of Myelodysplastic Syndromes. Blood. 1991;78(7): U.S. Food and Drug Administration Center for Drug Evaluation and Research. Information on Erythropoiesis Stimulating Agents (ESA). Feb 16, Wintrobe's Clinical Hematology. 10th ed. Lippincott Williams & Wilkins. 1999; Updated Sources Aranesp [package insert]. Thousand Oaks, CA: Amgen, Inc; Epogen [package insert]. Thousand Oaks, CA: Amgen, Inc; Revision History Information N/A Back to Top Associated Documents Attachments Coding Guidelines-Erythropoietin (a comment and response document) (PDF KB ) Related Local Coverage Documents N/A Related National Coverage Documents N/A Public Version(s) Updated on 03/31/2014 with effective dates 10/01/ N/A N/A Keywords

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22 Erythropoietin Stimulating Agents (ESA) Supplemental Instructions Article The information in this Supplemental Instructions Article contains coding or other guidelines that complement the Local Coverage Determination (LCD) for Erythropoietin Stimulating Agents (ESA). The LCD can be accessed on our contractor Web site. It can also be found on the Medicare Coverage Database. Coding Guidelines: Effective January 1, 2012, renal dialysis facilities are required to report hematocrit or hemoglobin levels on all ESRD claims irrespective of ESA administration. Effective for services provided on or after April 1, 2006, for claims reporting hematocrit or hemoglobin levels exceeding the monitoring threshold, the dose shall be reduced by 25% over the preceding month. Providers may report that a dose reduction did occur in response to the reported elevated hematocrit or hemoglobin level by adding a GS modifier on the claim. The definition of the GS modifier continues to be defined as: Dosage of EPO or Darbepoetin Alfa has been reduced and maintained in response to hematocrit or hemoglobin level. Thus, for claims reporting a hematocrit level or hemoglobin level exceeding the monitoring threshold without the GS modifier, CMS will reduce the dosage reported on the claim by 25%. The excess dosage is considered to be not reasonable and necessary. Providers are reminded that the patient s medical records should reflect hematocrit/hemoglobin levels and any dosage reduction reported on the claim during the same time period for which the claim is submitted. Effective for claims submitted on or after January 1, 2012 with dates of services on or after January 1, 2012, all providers billing for injections of ESA for ESRD beneficiaries must include the modifier JA on the claim to indicate an intravenous administration or modifier JB to indicate a subcutaneous administration. ESRD claims containing ESA administrations that are submitted without the route of administration modifiers will be returned to the provider for correction. Renal dialysis facilities claim including charges for administrations of the ESA by both methods must report separate lines to identify the number of administration provided using each method. CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 8, Requirement for Providing Route of Administration Codes for Erythropoiesis Stimulating Agents (ESAs). Effective for dates of service provided on and after January 1, 2008, requests for payments or claims for EPO for ESRD patients receiving dialysis in renal dialysis facilities reporting a hematocrit level exceeding 39.0% (or hemoglobin exceeding 13.0g/dL) shall also include modifier ED or EE. Claims reporting neither modifier or both modifiers will be returned to the provider for correction. The definition of modifier ED is The hematocrit level has exceeded 39.0% (or hemoglobin level has exceeded 13.0g/dL) 3 or more consecutive billing cycles immediately prior to and including the current billing cycle. The definition of modifier EE is The hematocrit level has exceeded 39.0% (or hemoglobin level has exceeded 13.0g/dL) less than 3 consecutive billing cycles immediately prior to and including the current billing cycle. The GS modifier continues to be

23 defined as stated above. Providers may continue to report the GS modifier when the reported hematocrit or hemoglobin levels exceed the monitoring threshold for less than 3 months and a dose reduction has occurred. When both modifiers GS and EE are included, no reduction in the reported dose will occur. Claims reporting a hematocrit or hemoglobin level exceeding the monitoring threshold and the ED modifier shall have an automatic 50% reduction in the reported dose applied, even if the claim also reports the GS modifier. Effective January 1, 2008, all non-esrd claims billing HCPCS J0881 and J0885 must begin reporting one of the following modifiers: EA: ESA, anemia, chemo-induced EB: ESA, anemia, radio-induced EC: ESA, anemia, non-chemo/radio Effective January 1, 2008, the following claims must report the most recent hematocrit or hemoglobin reading: All claims billing for the administration of an ESA (HCPCS J0881, J0882, J0885, J0886 and Q4081). For institutional claims the hemoglobin reading is reported with a value code 48 and a hematocrit reading is reported with the value code 49. Claims not reporting a value code 48 or 49 will be returned to the provider. Effective for claims with dates of service on and after January 1, 2008, non-esrd ESA services for HCPCS J0881 or J0885 billed with modifier EC (ESA, anemia, non-chemo/radio) shall be denied when any one of the following diagnosis codes is present on the claim: any anemia in cancer or cancer treatment patients due to folate deficiency (D52.0, D52.1, D52.8, D52.9) B-12 deficiency (D51.1, D51.2, D51.3, D51.8, D53.1) iron deficiency (D50.0, D50.1, D50.8, D50.9) hemolysis (D55.0, D55.1, D58.0, D58.9, D59.0, D59.1, D59.2, D59.4, D59.5, D59.6, D59.8, D59.9) bleeding (D50.0, D62) anemia associated with the treatment of acute and chronic myelogenous leukemias (CML, AML) (C92.00, C92.01, C92.02, C92.10, C92.11, C92.12, C92.20, C92.21, C92.40, C92.41, C92.42, C92.50, C92.51, C92.52, C92.60, C92.61, C92.62, C92.A0, C92.A1, C92.A2, C92.Z0, C92.Z1, C92.Z2, C92.90, C92.91) or erythroid cancers (C94.00, C94.01, C94.02, C94.20, C94.21, C94.22, C94.30,C94.31, C94.80, C94.81, D45) Effective for claims with dates of service on and after January 1, 2008, contractors shall deny non- ESRD ESA services for HCPCS J0881 or J0885 billed with modifier EC (ESA, anemia, nonchemo/radio) for: any anemia in cancer or cancer treatment 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

24 patients with erythropoietin-type resistance due to neutralizing antibodies, and anemia due to cancer treatment if patients have uncontrolled hypertension Effective for claims with dates of service on and after January 1, 2008, contractors shall deny non- ESRD ESA services for HCPCS J0881 or 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 when a hemoglobin 10.0 g/dl or greater or hematocrit 30.0% or greater is reported. Procedure codes may be subject to Correct Coding Initiative (CCI) edits or OPPS packaging edits. Please refer to CCI and OPPS requirements prior to billing Medicare.