L28942-LCD

Automated World Health

Local Coverage Determination (LCD) for Oxaliplatin (Eloxatin®) (L28942)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28942

LCD Title

Oxaliplatin (Eloxatin®)

Contractor's Determination Number AJ9263

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

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.

Original Determination Effective Date

For services performed on or after 02/16/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/25/2012 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-2, Medicare Benefit Policy Manual, Chapter 1, Section 30-30.1

CMS Manual System, Pub. 100-2, Medicare Benefit Policy Manual, Chapter 15, Section 50

CMS Manual System, Pub. 100-4, Medicare Claims Processing Manual, Chapter 17, Sections 10, 20 and 40 CMS Manual System, Pub. 100-4, Medicare Claims Processing Manual, Chapter 23, Section 20.9-20.96 CMS Manual System, Pub. 100-8, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3

Social Security Act, Section 1861 (t)(b)

Indications and Limitations of Coverage and/or Medical Necessity Oxaliplatin (Eloxatin®)- J9263

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.

Medicare will consider Oxaliplatin 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 nonresectable advanced or metastatic colon or rectal carcinoma.

• With infusional 5-FU/LV for first line treatment of colon or 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 for the treatment of esophageal cancer.

. In combination with other FDA approved or CMS approved compendia supported chemotherapy regimens for the treatment of relapsed or refractory non-Hodgkin lymphoma (including diffuse large B-cell lymphoma).

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.

013x Hospital Outpatient

021x Skilled Nursing - Inpatient (Including Medicare Part A) 023x Skilled Nursing - Outpatient

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.

0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

J9263 INJECTION, OXALIPLATIN, 0.5 MG

ICD-9 Codes that Support Medical Necessity

150.0 - 150.9 opens in new window

151.0 - 151.9 opens in new window

152.0 - 152.9 opens in new window

153.0 - 153.9 opens in new window

154.0 - 154.8 opens in new window

157.0 - 157.9 opens in new window

202.80 - 202.88 opens in new window

MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

MALIGNANT NEOPLASM OF DUODENUM - MALIGNANT NEOPLASM OF SMALL INTESTINE UNSPECIFIED SITE

MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

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

MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED

OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE - OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

All other diagnosis codes not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

All other diagnoses not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD. Back to Top

General Information

Documentations 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. This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy. 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. The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

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.

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 & 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, head and neck cancer. (2007). Clinical Pharmacology. Retrieved January 13, 2009, from http://www.clinicalpharmacology.com/default.asp?failcode=userlogout.

Oxaliplatin (Eloxatin™) 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 2002 Jan; 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 2008.

Advisory Committee Meeting Notes This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 03/01/2009

Revision History Number 2

Revision History Explanation Revision Number:2 Start Date of Comment Period:N/A

Start Date of Notice Period:02/01/2012 Revised Effective Date: 01/25/2012

LCR A2012-021

January 2012 Connection

Explanation of Revision: Under the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD for off-labeled indications, relapsed or refractory NHL, including diffuse large B-cell lymphoma, was added as an indication when used with other FDA or CMS approved compendia supported chemotherapy regimens. Under the “ICD-9 Codes that Support Medical Necessity” section of the LCD, diagnosis code range

202.80 – 202.88 was added. In addition, the “Sources of Information and Basis for Decision” section was updated. The effective date of this LCD revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:03/01/2009 Revised Effective Date: 03/19/2009

LCR A2009-038

March 2009 Bulletin

Explanation of Revision: The “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD was revised to update verbiage and add the off-label indication of esophageal cancer. Under the “ICD-9 Codes that Support Medical Necessity” section, diagnosis code range 150.0-150.9 was added. In addition, the “Sources of Information and Basis for Decision” section was updated. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-034FL LCR A2009-036PR/VI

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28942) replaces LCD L25121 as the policy in notice. This document (L28942) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 21 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0636 was changed

Reason for Change Coverage Change (actual change in medical parameters) ICD9 Addition/Deletion