L28777

 

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.

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

 

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 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 2013

 

CMS LCD ALEMTUZUMAB (CAMPATH®)