L28942

 

OXALIPLATIN (ELOXATIN)

 

12/10/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Oxaliplatin (Eloxatin)-J9263

 

Oxaliplatin will be considered medically reasonable and necessary when provided for its FDA approved use, as well as for the treatment of the following off-labeled indications:

• In combination with 5-FU/LV or capecitabine for first line treatment of:

o Nonresectable.

o Advanced.

o Metastatic colon or rectal/carcinoma.

• With infusional 5-FU/LV for first line treatment of

o Colon.

o Small intestine cancer. (Adjuvant FOLFOX therapy).

• For colon cancer, stage II, adjuvant treatment in combination with 5-fluorouracil/leucovorin.

• In combination with other FDA approved or CMS approved compendia supported chemotherapy drugs for the treatment of pancreatic carcinoma.

• For the treatment of advanced/metastatic gastric carcinoma in combination with irinotecan or fluorouracil with leucovorin or folinic acid.

• In combination with other FDA approved or CMS approved compendia supported chemotherapy regimens

o For the treatment of esophageal cancer.

o For the treatment of relapsed or refractory non-Hodgkin lymphoma (including diffuse large B-cell lymphoma).

• For extrahepatic cholangiocarcinomas, in combination with capecitabine, fluorouracil, or gemcitabine as primary treatment for unresectable or metastatic disease or as secondary or adjuvant treatment in patients with resected disease with positive regional lymph nodes.

• For gallbladder cancer, as primary treatment in combination with capecitabine, fluorouracil, or gemcitabine for patients with unresectable or metastatic disease.

• For intrahepatic cholangiocarcinomas, in combination with capecitabine, fluorouracil, or gemcitabine as primary treatment for unresectable or metastatic disease or as adjuvant treatment for resected disease with microscopic surgical margins (R1 resection) or residual local disease (R2 resection).

• For non-Hodgkin lymphoma (NHL):

o Peripheral T-Cell Lymphoma for second-line therapy for relapsed or refractory angioimmunoblastic T-cell lymphoma.

o Peripheral T-cell lymphoma not otherwise specified.

o Anaplastic large cell lymphoma.

o Enteropathy-associated T-cell lymphoma in candidates for transplant as a component of GemOx (gemcitabine and oxaliplatin) regimen- 2A category.

• For NHL

o Follicular Lymphoma for second-line.

o subsequent therapy for refractory.

o Progressive disease in patients with the indications for treatment as a component of GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab 2A category.

• For NHL

o Gastric MALT Lymphoma for second-line therapy for recurrent or progressive disease in patients with the indications for treatment as a component of GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab 2A category.

• For NHL

o Mantle Cell Lymphoma for Second-line therapy for relapsed, refractory, or progressive disease as a component of GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab 2A category.

• For NHL

o Mycosis Fungoides (MF)/Sezary Syndrome (SS) Chemotherapy for tumors with histologic evidence of large cell transformation and aggressive growth rate as a component of GemOx (gemcitabine and oxaliplatin) regimen in candidates for transplant or as a single agent in noncandidates for transplant with either:

 Stage IA-IIA MF with histologic evidence of folliculotropic or large cell transformation or stage IIB with generalized extent tumor, transformed, and/or folliculotropic disease in combination with skin-directed therapy.

 Stage IV non-Sezary or visceral disease.

• For NHL

o Nongastric MALT Lymphoma for second-line therapy for recurrent stage I-II disease.

o For progressive disease in patients with the indications for treatment as a component of GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab 2A category.

• For NHL

o Splenic Marginal Zone Lymphoma for second-line therapy for progressive disease in patients with the indications for treatment as a component of GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab 2A category.

• For NHL

o Diffuse Large B-Cell Lymphoma for second-line therapy for relapsed.

o Refractory disease as a component of GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab 2A category.

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.

 

 

13x Hospital Outpatient

21x Skilled Nursing - Inpatient (Including Medicare Part A)

23x Skilled Nursing - Outpatient

85x 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.

 

 

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

CPT/HCPCS Codes

 

 

J9263 INJECTION, OXALIPLATIN, 0.5 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

 

150.0 MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS

150.1 MALIGNANT NEOPLASM OF THORACIC ESOPHAGUS

150.2 MALIGNANT NEOPLASM OF ABDOMINAL ESOPHAGUS

150.3 MALIGNANT NEOPLASM OF UPPER THIRD OF ESOPHAGUS

150.4 MALIGNANT NEOPLASM OF MIDDLE THIRD OF ESOPHAGUS

150.5 MALIGNANT NEOPLASM OF LOWER THIRD OF ESOPHAGUS

150.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED PART OF ESOPHAGUS

150.9 MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

151.0 MALIGNANT NEOPLASM OF CARDIA

151.1 MALIGNANT NEOPLASM OF PYLORUS

151.2 MALIGNANT NEOPLASM OF PYLORIC ANTRUM

151.3 MALIGNANT NEOPLASM OF FUNDUS OF STOMACH

151.4 MALIGNANT NEOPLASM OF BODY OF STOMACH

151.5 MALIGNANT NEOPLASM OF LESSER CURVATURE OF STOMACH UNSPECIFIED

151.6 MALIGNANT NEOPLASM OF GREATER CURVATURE OF STOMACH UNSPECIFIED

151.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF STOMACH

151.9 MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

152.0 MALIGNANT NEOPLASM OF DUODENUM

152.1 MALIGNANT NEOPLASM OF JEJUNUM

152.2 MALIGNANT NEOPLASM OF ILEUM

152.3 MALIGNANT NEOPLASM OF MECKEL'S DIVERTICULUM

152.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF SMALL INTESTINE

152.9 MALIGNANT NEOPLASM OF SMALL INTESTINE UNSPECIFIED SITE

153.0 MALIGNANT NEOPLASM OF HEPATIC FLEXURE

153.1 MALIGNANT NEOPLASM OF TRANSVERSE COLON

153.2 MALIGNANT NEOPLASM OF DESCENDING COLON

153.3 MALIGNANT NEOPLASM OF SIGMOID COLON

153.4 MALIGNANT NEOPLASM OF CECUM

153.5 MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS

153.6 MALIGNANT NEOPLASM OF ASCENDING COLON

153.7 MALIGNANT NEOPLASM OF SPLENIC FLEXURE

153.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE

153.9 MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

154.0 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION

154.1 MALIGNANT NEOPLASM OF RECTUM

154.2 MALIGNANT NEOPLASM OF ANAL CANAL

154.3 MALIGNANT NEOPLASM OF ANUS UNSPECIFIED SITE

154.8 MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

155.1 MALIGNANT NEOPLASM OF INTRAHEPATIC BILE DUCTS

156.0 MALIGNANT NEOPLASM OF GALLBLADDER

156.1 MALIGNANT NEOPLASM OF EXTRAHEPATIC BILE DUCTS

156.2 MALIGNANT NEOPLASM OF AMPULLA OF VATER

156.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF GALLBLADDER AND EXTRAHEPATIC BILE DUCTS

156.9 MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE

157.0 MALIGNANT NEOPLASM OF HEAD OF PANCREAS

157.1 MALIGNANT NEOPLASM OF BODY OF PANCREAS

157.2 MALIGNANT NEOPLASM OF TAIL OF PANCREAS

157.3 MALIGNANT NEOPLASM OF PANCREATIC DUCT

157.4 MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS

157.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF PANCREAS

157.9 MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED

200.30 MARGINAL ZONE LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.31 MARGINAL ZONE LYMPHOMA,LYMPH NODES OF HEAD, FACE, AND NECK

200.32 MARGINAL ZONE LYMPHOMA,INTRATHORACIC LYMPH NODES

200.33 MARGINAL ZONE LYMPHOMA, INTRAABDOMINAL LYMPH NODES

200.34 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.35 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.36 MARGINAL ZONE LYMPHOMA, INTRAPELVIC LYMPH NODES

200.37 MARGINAL ZONE LYMPHOMA, SPLEEN

200.38 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

200.40 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.41 MANTLE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

200.42 MANTLE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

200.43 MANTLE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

200.44 MANTLE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.45 MANTLE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.46 MANTLE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

200.47 MANTLE CELL LYMPHOMA, SPLEEN

200.48 MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

200.60 ANAPLASTIC LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.61 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

200.62 ANAPLASTIC LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

200.63 ANAPLASTIC LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

200.64 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.65 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.66 ANAPLASTIC LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

200.67 ANAPLASTIC LARGE CELL LYMPHOMA, SPLEEN

200.68 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

200.70 LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.71 LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

200.72 LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

200.73 LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

200.74 LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.75 LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.76 LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

200.77 LARGE CELL LYMPHOMA, SPLEEN

200.78 LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

202.00 NODULAR LYMPHOMA UNSPECIFIED SITE

202.01 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.02 NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES

202.03 NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.04 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.05 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.06 NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES

202.07 NODULAR LYMPHOMA INVOLVING SPLEEN

202.08 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

202.10 MYCOSIS FUNGOIDES UNSPECIFIED SITE

202.11 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.12 MYCOSIS FUNGOIDES INVOLVING INTRATHORACIC LYMPH NODES

202.13 MYCOSIS FUNGOIDES INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.14 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.15 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.16 MYCOSIS FUNGOIDES INVOLVING INTRAPELVIC LYMPH NODES

202.17 MYCOSIS FUNGOIDES INVOLVING SPLEEN

202.18 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES

202.80 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE

202.81 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.82 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRATHORACIC LYMPH NODES

202.83 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.84 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.85 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.86 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRAPELVIC LYMPH NODES

202.87 OTHER MALIGNANT LYMPHOMAS INVOLVING SPLEEN

202.88 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

 

 

Documentation Requirements

• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used.

o This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy.

o This documentation is usually found in the history and physical or in the office/progress notes.

• If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.

o The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

Treatment Logic

• Oxaliplatin (Eloxatin ®) is an organoplatinum agent and is used as a chemotherapeutic agent.

• Oxaliplatin (Eloxatin ®) is FDA approved for injection in combination with infusional 5-Fluorouracil/Leucovorin (5FU/LV) for the treatment of advanced carcinoma of the colon or rectum.

• Oxaliplatin (Eloxatin ®) is FDA approved for injection in combination with infusional 5-fluorouracil/leucovorin (5-FU/LV) for the adjunctive treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor.

• The indication is based on an improvement in disease-free survival, with no demonstrated benefit in overall survival after median follow up of 4 years.

 

Sources of Information and Basis for Decision

 

Al-Batran, S., Hartmann, J., Probst, S., Schmalenberg, H., Hollerbach, S., Hofheinz, R., et al. (2008). Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: A study of the Arbeitsgemeinschaft Internistische Onkologie. Journal of Clinical Oncology 26:1435-1442.

 

Cheeseman, S., Joel, S., Chester, J., Wilson, G., Dent, J., Richards, J., et al. (2002). A “modified de Gramont” regiment of fluorouracil, alone and with oxaliplatin, for advanced colorectal cancer. British Journal of Cancer; 87: 393-399.

 

Clinical Pharmacology Compendia. Oxaliplatin (2009).

 

Compendia-Based Drug Bulletin. (February 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

 

Cunningham, D., Starling, N., Rao, S., Iveson, T., Nicolson, M., Coxon, F., et al. (2008). Capecitabine and oxaliplatin for advanced esophagogastric cancer. New England Journal of Medicine 358:1.

 

FCSO LCD 29248, Oxaliplatin (Eloxatin®), 12/10/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Louvet, C., Labianca, R., Hammel, P., Lledo, G., Zampino, M.G., Andre´, T., et al. (2005). Gemcitabine in Combination with Oxaliplatin Compared with Gemcitabine Alone in Locally Advanced or Metastatic Pancreatic Cancer: Results of a GERCOR and GISCAD Phase III Trial. Journal of Clinical Oncology, 23:3509-3516.

 

National Comprehensive Cancer Network (2006). Pancreatic Adenocarcinoma. Clinical Practice Guidelines in Oncology – V.1.2006.

 

National Comprehensive Cancer Network (2011). Diffuse Large B-Cell Lymphoma. NCCN Guidelines-Version 1. 2011

 

NCCN Drugs & Biologicals Compendium® (2012). Oxaliplatin for Hepatobiliary Cancers and NHL Lymphoma. National Comprehensive Cancer Network. Accessed on October 2-8, 2012. http://www.nccn.org/professionals/drug_compendium/content/contents.asp.

 

NCCN Drugs & Biologics Compendium. (2008). Oxaliplatin for esophageal cancer. National Comprehensive Cancer Network. Retrieved January 13, 2009, from http://www.nccn.org/professionals/drug_compendium/mainpage.aspx.

 

NCCN Drugs & Biologics Compendium. (2011). Oxaliplatin for NHL-Diffuse large B-cell lymphoma.

 

Oxaliplatin, indications, Non-Hodgkins Lymphoma (2012). Clinical Pharmacology. Retrieved November 12, 2012 from http://www.clinicalpharmacology.com/?epm=2_1

 

Oxaliplatin, indications, head and neck cancer. (2007). Clinical Pharmacology. Retrieved January 13, 2009, from http://www.clinicalpharmacology.com/?epm=2_1.

 

Oxaliplatin (EloxatinTM) package insert (2002) Sanofi-Synthelabo, Inc., New York. This document was utilized to determine the indications and limitations of coverage.

 

Scheithauer W, Kornek G, Raderer, M., Ulrich-Pur, H., Fiebiger, W., Gedlicka, C., et al. (2002) Randomized multicenter phase II trial of oxaliplatin plus irinotecan versus raltitrexed as first-line treatment in advanced colorectal cancer. Journal of Clinical Oncology 20(1): 165-172.

 

Souglakos, J., Mavroudis, D., Kakolyris, S., Kourousis, C., Vardakis, N., Androulakis, N., et al. (2002). Triplet combination with irinotecan plus oxaliplatin plus continuous-infusion fluorouracil and leucovorin as first-line treatment in metastatic colorectal cancer: a multicenter phase II trial. Journal of Clinical Oncology 20(11):2651-2657.

 

Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, March 2007.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

© Automated Clinical Guidelines, LLC 2012-2013

 

CMS LCD OXALIPLATIN (ELOXATIN)