L29129

 

DENILEUKIN DIFTITOX (ONTAK®)

 

02/02/2009

 

Indications and Limitations of Coverage and/or Medical Necessity

 

DENILEUKIN DIFTITOX (ONTAK(R))- J9160

• Ontak is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose:

o Malignant cells express the CD25 component of the IL-2 receptor.

(Safety and efficacy of Ontak inpatients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor have not been examined.)

CPT/HCPCS Codes

 

 

J9160 INJECTION, DENILEUKIN DIFTITOX, 300 MICROGRAMS

 

 

ICD-9 Codes that Support Medical Necessity

 

 

202.10 MYCOSIS FUNGOIDES UNSPECIFIED SITE

202.11 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.12 MYCOSIS FUNGOIDES INVOLVING INTRATHORACIC LYMPH NODES

202.13 MYCOSIS FUNGOIDES INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.14 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.15 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.16 MYCOSIS FUNGOIDES INVOLVING INTRAPELVIC LYMPH NODES

202.17 MYCOSIS FUNGOIDES INVOLVING SPLEEN

202.18 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES

202.20 SEZARY'S DISEASE UNSPECIFIED SITE

202.21 SEZARY'S DISEASE INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.22 SEZARY'S DISEASE INVOLVING INTRATHORACIC LYMPH NODES

202.23 SEZARY'S DISEASE INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.24 SEZARY'S DISEASE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.25 SEZARY'S DISEASE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.26 SEZARY'S DISEASE INVOLVING INTRAPELVIC LYMPH NODES

202.27 SEZARY'S DISEASE INVOLVING SPLEEN

202.28 SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES

202.70 PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

202.71 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

202.72 PERIPHERAL T CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

202.73 PERIPHERAL T CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

202.74 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

202.75 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.76 PERIPHERAL T CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

202.77 PERIPHERAL T CELL LYMPHOMA, SPLEEN

202.78 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

202.80 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE

202.81 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.82 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRATHORACIC LYMPH NODES

202.83 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.84 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.85 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.86 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRAPELVIC LYMPH NODES

202.87 OTHER MALIGNANT LYMPHOMAS INVOLVING SPLEEN

202.88 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES

 

 

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:

 

Denileukin diftitox is a fusion protein designed to direct the cytocidal action of diphtheria toxin to cells which express the IL-2 receptor.

 

 

Sources of Information and Basis for Decision

 

Compendia-Based Drug Bulletin. (November 2006). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

 

FCSO LCD29129. Denileukin Diftitox (Ontak®), 02/02/2009. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

National Cancer Institute (2006). Mycosis Fungoides and the Sézary syndrome (PDQ®): Treatment. U.S. National Institute of Health. Retrieved February 28, 2007 from http://www.cancer.gov/

 

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

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, February 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 2009-2013

 

CMS LCD DENILEUKIN DIFTITOX (ONTAK®)