Automated World Health
L29208
IRINOTECAN (CAMPTOSAR®)
11/01/2011
Indications and Limitations of Coverage and/or Medical Necessity
Irinotecan (Camptosar®)-J9206
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
CPT/HCPCS Codes
J9206 INJECTION, IRINOTECAN, 20 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
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
162.0 MALIGNANT NEOPLASM OF TRACHEA
162.2 MALIGNANT NEOPLASM OF MAIN BRONCHUS
162.3 MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG
162.4 MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG
162.5 MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG
162.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG
162.9 MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED
174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST
174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST
174.2 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST
174.3 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST
174.4 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST
174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST
174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST
174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST
174.9 MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE
180.0 MALIGNANT NEOPLASM OF ENDOCERVIX
180.1 MALIGNANT NEOPLASM OF EXOCERVIX
180.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CERVIX
180.9 MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE
183.0 MALIGNANT NEOPLASM OF OVARY
183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE
183.3 MALIGNANT NEOPLASM OF BROAD LIGAMENT OF UTERUS
183.4 MALIGNANT NEOPLASM OF PARAMETRIUM
183.5 MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS
183.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA
183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE
191.0 MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES
191.1 MALIGNANT NEOPLASM OF FRONTAL LOBE
191.2 MALIGNANT NEOPLASM OF TEMPORAL LOBE
191.3 MALIGNANT NEOPLASM OF PARIETAL LOBE
191.4 MALIGNANT NEOPLASM OF OCCIPITAL LOBE
191.5 MALIGNANT NEOPLASM OF VENTRICLES
191.6 MALIGNANT NEOPLASM OF CEREBELLUM NOS
191.7 MALIGNANT NEOPLASM OF BRAIN STEM
191.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRAIN
191.9 MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE
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
• 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.
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.
11/01/2011
The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.
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.