Archive 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
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
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 2007 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
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
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 

08/18/2008

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. 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:

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

DOXORUBICIN HYDROCHLORIDE, ALL LIPID FORMULATIONS, 10 MG

ICD-9 Codes that are Covered 

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

Other Information

Other Comments 

Sources of Information

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

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

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

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

08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this LCD as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.

08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.

Revision History Explanation 

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), the content of this article is currently in effect but the article will be transferred to the J-13 contract number 13201 on November 14, 2008.

The CMS Statement of Work for the J13 Medicare Administrative Contract (MAC) requires that the contractor retain the most clinically appropriate medical policy information within the jurisdiction. This First Coast Service Options policy is being promulgated to the J13 MAC and all National Government Services jurisdictions as an article attachment to the LCD for Coverage of Drugs and Biologicals for Label and Off-Label Uses (LCD ID# L25820).

08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this article as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.

08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.

Related Documents 

Article(s)
A44930 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses - Supplemental Instructions Article

LCD(s)
L25820 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses