L28897

 

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.

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

22x Skilled Nursing - Inpatient (Medicare Part B only)

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

 

 

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/.

 

FCSO LCD 29208, Irinotecan (Camptosar®), 11/01/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

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.

 

 

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.

 

© Automated Clinical Guidelines, LLC 2011-2013

 

CMS LCD IRINOTECAN (CAMPTOSAR®)