L28827

 

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.

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

 

 

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 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

 

CMS LCD DOXORUBICIN, LIPOSOMAL (DOXIL/LIPODOX)