L28993

 

TOPOTECAN HYDROCHLORIDE (HYCAMTIN®)

 

01/01/2011

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Topotecan Hydrochloride (Hycamtin®)-J9351

• Topotecan is FDA approved for the following indications:

o Treatment of metastatic ovarian carcinoma after failure of first-line or subsequent chemotherapy.

o Treatment of small cell lung carcinoma (SCLC) in patients who have responded to chemotherapy with other agents and who have relapsed more than 2 or 3 months after completion of chemotherapy.

o In combination with cisplatin for the treatment of Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.

 

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

o Non-small cell carcinoma of the lung.

o Myelodysplastic syndrome (MDS).

o Chronic myelomonocytic leukemia (CMML).

o Cervical carcinoma.

o Primary peritoneal carcinoma.

o Fallopian tube carcinoma.

o Primary central nervous system lymphoma, relapsed or refractory, non-immunocompromised.

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

 

 

J9351 INJECTION, TOPOTECAN, 0.1 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

 

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM 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

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

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

200.50 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.51 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

200.52 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRATHORACIC LYMPH NODES

200.53 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

200.54 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.55 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.56 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRAPELVIC LYMPH NODES

200.57 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, SPLEEN

200.58 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.11 MYELOID LEUKEMIA CHRONIC IN REMISSION

205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE

238.71 ESSENTIAL THROMBOCYTHEMIA

238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION

238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED

238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA

238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES

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.

Utilization Guidelines

• For the off-label indication of primary central nervous system lymphoma, the dosing and administration protocol should be based on the FDA label.

 

Treatment Logic

• Topotecan Hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.

• The cytotoxicity of topotecan is thought to be due to double strand DNA damage.

 

Sources of Information and Basis for Decision

 

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

 

FCSO LCD 29290, Topotecan Hydrochloride (Hycamtin®), 01/01/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Fisher, L. et al (2006). Prospective trial on topotecan salvage therapy in primary CNS lymphoma. Anals of Oncology 17: 1141-1145.

 

National Comprehensive Cancer Network (2007). Small Cell Lung Cancer. Clinical Practice Guidelines in Oncology – V.1.2007.

 

National Comprehensive Cancer Network Drugs and Biologics Compendium.

 

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

 

Thomson Micromedex Drug Dex®, Topotecan (2009).

 

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. 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 2011-2013

 

CMS LCD TOPOTECAN HYDROCHLORIDE (HYCAMTIN®)