L29208-LCD

Automated World Health

Local Coverage Determination (LCD) for Irinotecan (Camptosar®) (L29208)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29208

LCD Title

Irinotecan (Camptosar®)

Contractor's Determination Number J9206

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 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 11/01/2011 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. 100-02, Medicare Benefit Policy, Chapter 15, Section 50

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40

CMS Manual System, Pub. 100-08, Medicare Program Integrity, Chapter 13, Section 13.1.3

Indications and Limitations of Coverage and/or Medical Necessity Irinotecan (Camptosar®)-J9206

Irinotecan, also known as CPT-11, is an analog of camptothecin, a plant alkaloid. It inhibits the enzyme, topoisomerase I, which is necessary for DNA replication.

Irinotecan is FDA approved for the following indications:

• As a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum.

• For patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Medicare will cover Irinotecan for its FDA approved use, as well as for the treatment of the following off-labeled indications:

• Carcinoma of small intestine

• Non small-cell lung carcinoma (alone or in combination for the treatment of locally advanced and/or metastatic stage IIIB or IV NSCLC)

• Small-cell lung carcinoma, extensive-stage small-cell lung cancer, first line treatment, in combination with cisplatin

• Cervical carcinoma

• Pancreatic carcinoma

• Advanced esophageal carcinoma

• Metastatic gastric carcinoma

• Primary brain tumor

• Epithelial ovarian cancer for platinum-resistant or platinum-refractory patients

• Metastatic breast cancer, refractory

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

J9206 INJECTION, IRINOTECAN, 20 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

162.0 - 162.9 opens in new window

174.0 - 174.9 opens in new window

180.0 - 180.9 opens in new window

183.0 - 183.9 opens in new window

191.0 - 191.9 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

MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

MALIGNANT NEOPLASM OF ENDOCERVIX - MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE

MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE

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.

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

Cloughesy, T., Filka, E., Nelson, G., Kabbinavar, F., Friedman, H., Miller, L., et al. (2002). Phase II study of Irinotecan Treatment for Recurrent Malignant Glioma Using an Every-3-Week Regimen. American Journal of Clinical Oncology, 25(2), 204-208.

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

Lima,C., Savarese, D., Bruckner, H., Dudek, A., Eckardt, J., Hainsworth, J., et al. (2002). Irinotecan plus Gemcitabine induces both radiographic and CA 19-9 tumor marker responses in patients with previously untreated advanced pancreatic cancer. Journal of Clinical Oncology, 20(5), 1182-1191.

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

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, April 2007.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD 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 12/04/2008

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:12/01/2011 Revised Effective Date:11/01/2011

LCR B2011-109

November 2011 Connection

Explanation of Revision: This LCD was revised, based on an external request, to add off-label indication metastatic breast cancer, refractory under the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD and added ICD-9-CM diagnosis codes 174.0 - 174.9 under the “ICD-9 Codes that Support Medical Necessity” section of the LCD. 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:02/02/2009

LCR B2009-

December 2008 Bulletin

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

For Florida (00590) this LCD (L29208) replaces LCD L25072 as the policy in notice. This document (L29208) is effective on 02/02/2009.

Reason for Change