Automated World Health
L29055
ALEMTUZUMAB (CAMPATH®)
Indications and Limitations of Coverage and/or Medical Necessity
ALEMTUZUMAB (CAMPATH®)- J9010
Medicare will cover Alemtuzumab for:
• Its FDA approved use.
• As well as for the following off-labeled indication:
First-line monotherapy for the treatment of progressive, B-cell chronic lymphocytic leukemia.
CPT/HCPCS Codes
J9010 INJECTION, ALEMTUZUMAB, 10 MG
ICD-9 Codes that Support Medical Necessity
204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION
204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE
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:
• Alemtuzumab (Campath®) is a monoclonal antibody, which causes the lysis of lymphocytes by binding to CD52, a highly expressed antigen that is present on the surface of all B- and T-cell lymphocytes.
• Alemtuzumab (Campath®) is FDA approved as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
Sources of Information and Basis for Decision
Clinical Pharmacology (Compendium), Alemtuzumab, January 2011.
Compendia-Based Drug Bulletin. (November 2006). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.
FCSO LCD 29055, Alemtuzumab (Campath®). The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.
National Cancer Institute. (2007). Chronic Lymphocytic Leukemia (PDQ®): Treatment. U.S. National Institutes of Health. [On-Line]. Available: http://www.cancer.gov/
NCCN Drugs & Biologics Compendium™, Alemtuzumab, January 2011.
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, February 2007.
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.
CMS LCD ALEMTUZUMAB (CAMPATH®)
L29055