Automated World Health
L29157
DOXORUBICIN, LIPOSOMAL (DOXIL/LIPODOX)
01/01/2013
Indications and Limitations of Coverage and/or Medical Necessity
DOXORUBICIN, LIPOSOMAL (DOXIL/LIPODOX) - J9002/Q2049
Liposomal Doxorubicin is FDA approved for the following medical conditions:
• For the treatment of AIDS-related Kaposi’s sarcoma in patients with disease that has progressed on prior combination chemotherapy or patients who are intolerant of such therapy.
• For the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
Liposomal Doxorubicin is covered for its FDA approved uses, as well as for the treatment of the following off-labeled indications:
• Breast carcinoma.
• Sarcomas.
• Multiple myeloma.
• Primary peritoneal carcinoma.
• Fallopian tube carcinoma.
CPT/HCPCS Codes
J9002 INJECTION, DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL, DOXIL, 10 MG
Q2049 INJECTION, DOXORUBICIN HYDROCHLORIDE, LIPOSOMAL, IMPORTED LIPODOX, 10 MG
ICD-9 Codes that Support Medical Necessity
158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM
158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED
170.0 MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE
170.1 MALIGNANT NEOPLASM OF MANDIBLE
170.2 MALIGNANT NEOPLASM OF VERTEBRAL COLUMN EXCLUDING SACRUM AND COCCYX
170.3 MALIGNANT NEOPLASM OF RIBS STERNUM AND CLAVICLE
170.4 MALIGNANT NEOPLASM OF SCAPULA AND LONG BONES OF UPPER LIMB
170.5 MALIGNANT NEOPLASM OF SHORT BONES OF UPPER LIMB
170.6 MALIGNANT NEOPLASM OF PELVIC BONES SACRUM AND COCCYX
170.7 MALIGNANT NEOPLASM OF LONG BONES OF LOWER LIMB
170.8 MALIGNANT NEOPLASM OF SHORT BONES OF LOWER LIMB
170.9 MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED
171.0 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK
171.2 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF UPPER LIMB INCLUDING SHOULDER
171.3 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF LOWER LIMB INCLUDING HIP
171.4 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF THORAX
171.5 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF ABDOMEN
171.6 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF PELVIS
171.7 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF TRUNK UNSPECIFIED
171.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CONNECTIVE AND OTHER SOFT TISSUE
171.9 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE 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
175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST
175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST
176.0 KAPOSI'S SARCOMA SKIN
176.1 KAPOSI'S SARCOMA SOFT TISSUE
176.2 KAPOSI'S SARCOMA PALATE
176.3 KAPOSI'S SARCOMA GASTROINTESTINAL SITES
176.4 KAPOSI'S SARCOMA LUNG
176.5 KAPOSI'S SARCOMA LYMPH NODES
176.8 KAPOSI'S SARCOMA OTHER SPECIFIED SITES
176.9 KAPOSI'S SARCOMA 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
203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
203.01 MULTIPLE MYELOMA IN REMISSION
203.02 MULTIPLE MYELOMA, 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:
• Doxorubicin is an anthracycline cytotoxic antibiotic.
• Liposomal Doxorubicin is Doxorubicin encapsulated in long-circulating liposomes.
• Liposomes are microscopic vesicles composed of a phospholipid bilayer that are capable of encapsulating active drugs.
• Once within the tumor, the active ingredient Doxorubicin is presumably available to be released locally as the liposomes degrade and become permeable in situ.
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 LCD 29157, Doxorubicin, Liposomal (Doxil/Lipodox), 01/01/2013. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.
National Comprehensive Cancer Network (2007). Ovarian Cancer. Clinical Practice Guidelines in Oncology – V.1.2007.
Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch
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 2013
CMS LCD DOXORUBICIN, LIPOSOMAL (DOXIL/LIPODOX)