L29290-LCD

Automated World Health

Local Coverage Determination (LCD) for Topotecan Hydrochloride (Hycamtin®) (L29290)

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 L29290

LCD Title

Topotecan Hydrochloride (Hycamtin®)

Contractor's Determination Number J9351

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 01/01/2011 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 Change Request 7121, Transmittal 2037, Dated August 27, 2010.

Indications and Limitations of Coverage and/or Medical Necessity Topotecan Hydrochloride (Hycamtin®)-J9351

Topotecan Hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity. The cytotoxicity of topotecan is thought to be due to double strand DNA damage.

Topotecan is FDA approved for the following indications:

• Treatment of metastatic ovarian carcinoma after failure of first-line or subsequent chemotherapy

• Treatment of small cell lung carcinoma (SCLC) in patients who have responded to chemotherapy with other agents and who have relapsed more than 2 or 3 months after completion of chemotherapy

• In combination with cisplatin for the treatment of Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.

Medicare will cover Hycamtin for its FDA approved use, as well as for the treatment of the following off-labeled indicatons:

• Non-small cell carcinoma of the lung

• Myelodysplastic syndrome (MDS)

• Chronic myelomonocytic leukemia (CMML)

• Cervical carcinoma

• Primary peritoneal carcinoma

• Fallopian tube carcinoma

• Primary central nervous system lymphoma, relapsed or refractory, non-immunocompromised.

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

J9351 INJECTION, TOPOTECAN, 0.1 MG

ICD-9 Codes that Support Medical Necessity

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

162.0 - 162.9 opens in new window

180.0 - 180.9 opens in new window

183.0 - 183.9 opens in new window

MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

MALIGNANT NEOPLASM OF ENDOCERVIX - MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE

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

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

200.50 - 200.58 opens in new window

205.10 - 205.12 opens in new window

PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC MYELOID LEUKEMIA, IN RELAPSE

238.71 ESSENTIAL THROMBOCYTHEMIA

238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION

238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED

238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA

238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES

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. Back to Top

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.

For the off-label indication of primary central nervous system lymphoma, the dosing and administration protocol should be based on the FDA label.

Sources of Information and Basis for Decision

Compendia-Based Drug Bulletin. (February 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

Fisher, L. et al (2006). Prospective trial on topotecan salvage therapy in primary CNS lymphoma. Anals of Oncology 17: 1141-1145.

National Comprehensive Cancer Network (2007). Small Cell Lung Cancer. Clinical Practice Guidelines in Oncology

– V.1.2007.

National Comprehensive Cancer Network Drugs and Biologics Compendium.

Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch

Thomson Micromedex Drug Dex®, Topotecan (2009).

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, April 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 01/01/2011

Revision History Number 2

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

Start Date of Notice Period:01/01/2011 Revised Effective Date: 01/01/2011

LCR B2011-027

December 2010 Update

Explanation of Revision: Annual 2011 HCPCS Update. Deleted J9350 and added new code J9351 and descriptor to the LCD. Changed “Contractor Determination Number” to J9351. 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:07/01/2009 Revised Effective Date: 06/08/2009

LCR B2009-074

June 2009 Update

Explanation of Revision: Request to add off-label coverage for primary central nervous system lymphoma. The “Indications and Limitations of Coverage and/or Medical Necessity” section and the “ICD-9 Codes that Support Medical Necessity” sections have been revised to allow for this off-label indication. The effective date of this revision is based on date of service.

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 (L29290) replaces LCD L25078 as the policy in notice. This document (L29290) is effective on 02/02/2009.

11/21/2010 - The following CPT/HCPCS codes were deleted: J9350 was deleted from Group 1

Reason for Change