Article for Doxorubicin, Liposomal (Doxil) – Related to LCD L25820 (A47585)

Contractor Information

Contractor Name 

National Government Services, Inc.  

Contractor Number 

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Contractor Type 

Carrier

Fiscal Intermediary

MAC – Part A

MAC – Part B

Article Information

Article ID Number 

A47585 

Article Type 

Article

Key Article 

Yes

Article Title 

Doxorubicin, Liposomal (Doxil) – Related to LCD L25820 

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2008 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.

Primary Geographic Jurisdiction 

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Original Article Effective Date 

07/18/2008

Article Revision Effective Date 

01/01/2009

Article Text 

This article defines coding and coverage for doxorubicin, liposomal including off-label indications. National Government Services Local Coverage Determination (LCD) “Coverage of Drugs and Biologicals for Label and Off-Label Uses” allows coverage for off-label indications only if the United States Pharmacopeia Drug Information (USP-DI), the American Hospital Formulary Services (AHFS) and/or Thomson Healthcare DrugPoints® (as described in the LCD) define such indications or if National Government Services has published an article or LCD expanding such coverage. Effective for dates of service on or after 11/25/2008, American Hospital Formulary Services (AHFS), Clinical Pharmacology, NCCN Drugs and Biologics Compendium and/or Thomson Micromedex DrugDex® compendium has replaced the USP-DI and Thomson Healthcare DrugsPoints®. Providers may request approval for additional off-label indications by submitting this request in writing with supporting medical literature. The aforementioned National Government Services LCD, which describes the requirements for such a request, can be accessed on our contractor Web site at www.NGSMedicare.com or on the Medicare Coverage Database at www.cms.hhs.gov/mcd.

Abstract:
Doxorubicin is an anthracycline cytotoxic antibiotic. Liposomal doxorubicin is doxorubicin excapsulated 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.

Indications:
Liposomal doxorubicin is 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.
• breast carcinoma
• multiple myeloma

Indications expanded by this article

• sarcomas
• primary peritoneal carcinoma
• fallopian tube carcinoma

Coding Guidelines:

For claims submitted to the carrier or Part B MAC:

Doxorubicin should be billed using chemotherapy administration codes and is payable in the following places of service: office (11), skilled nursing home for patients in a Part A stay (31) [if the drug is supplied by the facility, no claims for the drug should be submitted to the Part B carrier.], nursing facility for patients not in a Part A stay (32) and independent clinic (49) only when supplied as an “incident to” service by the physician.

Coverage Topic 

Chemotherapy (Inpatient)
Chemotherapy (Outpatient)
Prescription Drugs

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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

11x	Hospital-inpatient (including Part A)
13x	Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
85x	Special facility or ASC surgery-rural primary care hospital (eff 10/94)

CPT/HCPCS Codes 

J9001

INJECTION, DOXORUBICIN HYDROCHLORIDE, ALL LIPID FORMULATIONS, 10 MG

ICD-9 Codes that are Covered 

158.0	MALIGNANT NEOPLASM OF Retroperitoneum
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
201.40 - 201.48	HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF MULTIPLE SITES
201.50 - 201.58	HODGKIN'S DISEASE NODULAR SCLEROSIS UNSPECIFIED SITE - HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF MULTIPLE SITES
201.60 - 201.68	HODGKIN'S DISEASE MIXED CELLULARITY UNSPECIFIED SITE - HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF MULTIPLE SITES
201.70 - 201.78	HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH NODES OF MULTIPLE SITES
201.90 - 201.98	HODGKIN'S DISEASE UNSPECIFIED TYPE UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES
202.10 - 202.18	MYCOSIS FUNGOIDES UNSPECIFIED SITE - MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES
202.20 - 202.28	SEZARY'S DISEASE UNSPECIFIED SITE - SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES
203.00	MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
203.01	MULTIPLE MYELOMA IN REMISSION
203.02	MULTIPLE MYELOMA, IN RELAPSE
203.10	Plasma Cell leukemia WITHOUT MENTION OF HAVING ACHIEVED REMISSION
203.80	Other immunoproliferative neoplasms WITHOUT MENTION OF HAVING ACHIEVED REMISSION
238.1	NEOPLASM OF UNCERTAIN BEHAVIOR OF CONNECTIVE AND OTHER SOFT TISSUE
238.6	NEOPLASM OF UNCERTAIN BEHAVIOR OF Plasma CellS

Other Information

Other Comments 

Sources of Information

American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD: 2007.

Clinical Pharmacology

First Coast Policy # L25061, Doxorubicin, Liposomal (Doxil)

NCCN Drugs and Biologics Compendium accessed at: http://www.nccn.org/

Thomson Micromedix DrugDex® accessed at: http://www.thomsonhc.com/home/dispatch

Thomson Healthcare DrugPoints® at http://www.thomsonhc.com/home/dispatch

United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.

Revision History Explanation 

Article published January 2009: Source of revision – Internal: The “Article Text” and “Sources of Information” have been revised to include compendia recognized by CMS based on Change Request 6191 (Compendia as Authoritative Sources for Use in the Determination of a Medically Accepted Indication of Drugs and Biologicals Used Off-Label in an Anti-Cancer Chemotherapeutic Regimen, effective 11/25/2008). This article has been reviewed using all listed compendia and has been revised to add ICD-9-CM codes, 158.0, 201.40-201.48, 201.50-201.58, 201.60-201.68, 201.70-201.78, 201.90-201.98, 202.10-202.18, 202.20-202.28, 203.10, 203.80, 238.1 and 238.6 to the “ICD-9-CM Codes That Support Medical Necessity” section of the article effective for dates of service on or after 11/25/2008. Based on the annual HCPCS update for 2009, the description for CPT/HCPCS code J9001 was changed. Minor changes were made to reflect current template language.

Article published October 2008: Source of revision – Internal (annual ICD-9-CM code updates for 2009). The “ICD-9-CM Codes That Support Medical Necessity” section of the article is modified as follows: the description for ICD-9-CM code 203.00 has been modified. ICD-9-CM code 203.02 has been added.

This article is effective for all National Government Services jurisdictions on July 18, 2008 with these exceptions: for Connecticut – Part B the article is effective on August 1, 2008; for Upstate New York – Part B, the article is effective on September 1, 2008; and for New York and Connecticut – Part A, the article is effective on November 14, 2008. For New York – Part A (contract 00308