Automated World Health
Local Coverage Determination (LCD) for Mitoxantrone Hydrochloride (L28931)
Contractor Information
Contractor Name
First Coast Service Options, Inc. opens in new window
Contractor Number 09101
Contractor Type MAC - Part A
LCD Information
Document Information
LCD ID Number L28931
LCD Title
Mitoxantrone Hydrochloride
Contractor's Determination Number AJ9293
Primary Geographic Jurisdiction opens in new window Florida
Oversight Region Region IV
AMA CPT/ADA CDT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association.
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 02/16/2009 Original Determination Ending Date
Revision Effective Date
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 administratice 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 Manuals, Pub 100-02, Chapter 1, Section 30-30.5
CMS Manuals, Pub 100-02, Chapter 15, Section 50
CMS Manuals, Pub 100-04, Chapter 17, Section10
CMS Manuals, Pub 100-08, Chapter 13, Section 13.1.3
Indications and Limitations of Coverage and/or Medical Necessity
Mitoxantrone hydrochloride (Novantrone®) is an anthracenedione, which inhibits DNA and RNA synthesis.
Mitoxantrone hydrochloride is FDA approved for treatment of the following:
• Advanced symptomatic hormone-refractory prostate carcinoma (initial palliative treatment) in combination with corticosteroids;
• Acute non-lymphocytic (including myelocytic, promyelocytic, monocytic, and erythoid) leukemia in adults (used in combination with other agents); and
• Secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis.
Medicare will cover Mitoxantrone hydrochloride for its FDA approved uses, as well as for the treatment of the following off-labeled indications:
• Breast carcinoma including locally advanced and metastatic
• Recurrent acute lymphocytic leukemia in adults
• Non-Hodgkin’s lymphomas
• Hepatoma in adults
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.
013x Hospital Outpatient
021x Skilled Nursing - Inpatient (Including Medicare Part A) 023x Skilled Nursing - Outpatient
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
J9293 INJECTION, MITOXANTRONE HYDROCHLORIDE, PER 5 MG
ICD-9 Codes that Support Medical Necessity
155.0 - 155.2 opens in new window
174.0 - 174.9 opens in new window
MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY
MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE
175.0 - 175.9 opens in new window
MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST
185 MALIGNANT NEOPLASM OF PROSTATE
200.00 - 200.88 opens in new window
202.00 - 202.98 opens in new window
204.00 - 204.02 opens in new window
205.00 - 205.02 opens in new window
206.00 - 206.02 opens in new window
207.00 - 207.02 opens in new window
RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES
ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE LYMPHOID LEUKEMIA, IN RELAPSE
ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE MYELOID LEUKEMIA, IN RELAPSE
ACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
- ACUTE MONOCYTIC LEUKEMIA, IN RELAPSE
ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, IN RELAPSE
340 MULTIPLE SCLEROSIS
Diagnoses that Support Medical Necessity N/A
ICD-9 Codes that DO NOT Support Medical Necessity N/A
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity N/A
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 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 N/A
Sources of Information and Basis for Decision
Compendia-Based Drug Bulletin, August 2004. Vol. 13 No. 3. The Association of Community Cancer Centers.
Lichtman, S.M., Kolitz, J., Budman, D.R., et al: Treatment of Aggressive Non-Hodgkin’s Lymphoma In Elderly Patients with Thiotepa, Novantrone (Mitoxantrone), Vincristine, Prednisone (TNOP). American Journal Clinical Oncology. 2001 Aug.; 24(4):360-2.
The United States Pharmacopeia Drug Information (USP DI) (March 2005) Oncology Drug Information The Association of Community Cancer Centers (ACCC).
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 Original
Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A
Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009
LCR A2009-
December 2008 Bulletin
This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).
For Florida (00090) this LCD (L28931) replaces LCD L849 as the policy in notice. This document (L28931) is effective on 02/16/2009.
8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 21 was changed 8/1/2010 - The description for Bill Type Code 23 was changed
8/1/2010 - The description for Revenue code 0636 was changed
Reason for Change
Related Documents
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All Versions
Updated on 08/01/2010 with effective dates 02/16/2009 - N/A Updated on 08/01/2010 with effective dates 02/16/2009 - N/A Updated on 11/29/2008 with effective dates 02/16/2009 - N/A Read the LCD Disclaimer opens in new window