L29229-LCD

Automated World Health

Local Coverage Determination (LCD) for Mitoxantrone Hydrochloride (L29229)

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 L29229

LCD Title

Mitoxantrone Hydrochloride

Contractor's Determination Number J9293

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

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 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 cancer (initial palliative treatment) in combination with corticosteroids;

• Acute nonlymphocytic (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.

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

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

175.0 - 175.9 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

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. This source defined the indications and limitations of this drug.

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). This drug defined the FDA approved and off-labeled indications for this drug.

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:02/02/2009

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 (L29229) replaces LCD L5950 as the policy in notice. This document (L29229) is effective on 02/02/2009.

Reason for Change