L29157-LCD

Automated World Health

Local Coverage Determination (LCD) for Doxorubicin, Liposomal (Doxil/Lipodox) (L29157)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29157

LCD Title

Doxorubicin, Liposomal (Doxil/Lipodox)

Contractor's Determination Number Q2048

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 07/01/2012 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 15, Section 50

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40

CMS Manual System, Pub. 100-08, Medicare Program Integrity, Chapter 13, Section 13.1.3

Indications and Limitations of Coverage and/or Medical Necessity DOXORUBICIN, LIPOSOMAL (DOXIL/LIPODOX) - Q2048/Q2049

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.

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.

Medicare will cover Liposomal Doxorubicin 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.

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.

99999 Not Applicable

CPT/HCPCS Codes

Q2048 Injection, doxorubicin hydrochloride, liposomal, doxil, 10 mg

Q2049 Injection, doxorubicin hydrochloride, liposomal, imported lipodox, 10 mg XX000 Not Applicable

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 - 170.9 opens in new window

171.0 - 171.9 opens in new window

174.0 - 174.9 opens in new window

175.0 - 175.9 opens in new window

176.0 - 176.9 opens in

MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE - MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK - MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

new window KAPOSI'S SARCOMA SKIN - KAPOSI'S SARCOMA UNSPECIFIED SITE

183.0 - 183.9 opens in new window

MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

203.00 - 203.02 opens in new window

MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MULTIPLE MYELOMA, IN RELAPSE

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

All other diagnosis codes not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

All other diagnoses not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.

General Information

Documentations 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. This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy. 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. The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

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/.

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

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, February 2007.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with the advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number 2

Revision History Explanation Revision Number:2 Start Date of Comment Period:N/A

Start Date of Notice Period:07/01/2012 Revised Effective Date:07/01/2012

LCR B2012-055

June 2012 Connection

Explanation of Revision: Based on Change Requests 7831, 7844, and 7854, HCPCS code J9001 received a status indicator “I” (Not Valid for Medicare Purposes) and a status indicator “E5” (Not Valid for Medicare Purposes) for Ambulatory Surgical Centers (ASCs), therefore, it was deleted from the LCD and replaced with HCPCS code Q2048 under the “CPT/HCPCS Codes” and “Indications and Limitations of Coverage and/or Medical Necessity” sections of the LCD. In addition, HCPCS codes C9399/J9999 were removed and replaced with HCPCS code Q2049. Also, the “Contractor’s Determination Number” was changed from J9001 to Q2048 and the “LCD Title”

was changed from Doxorubicin, Liposomal (Doxil) to Doxorubicin, Liposomal (Doxil/Lipodox). The effective date of this revision is based on date of service.

Revision Number: 1

Start Date of Comment Period: N/A Start Date of Notice Period: 05/01/2012 Revised Effective Date: 04/24/2012

LCR B2012-046

April 2012 Connection

Explanation of Revision: Due to the recent shortage of Doxil, the Food and Drug administration (FDA) approved the importation of Lipodox to the United States on 02/21/2012. Therefore, the LCD has been revised to add HCPCS codes J9999 and C9399 (ASC only) to be used for Lipodox. The effective date of this revision is for claims processed on or after 04/24/2012, for dates of service on or after 02/21/2012.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29157) replaces LCD L25061 as the policy in notice. This document (L29157) is effective on 02/02/2009.

Reason for Change Other