L32493-LCD

Automated World Health

Local Coverage Determination (LCD) for Bendamustine hydrochloride (Treanda®) (L32493)

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 L32493

LCD Title

Bendamustine hydrochloride (Treanda®)

Contractor's Determination Number J9033

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 06/12/2012 Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (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 represent quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02 Medicare Benefit Policy Manual, Chapter 15, Section 50.4.5

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Chapter 1, Section 110.17

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Sections 10; 20; & 40 CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3 Social Security Act Section 1861 (t)(2)(B)

Indications and Limitations of Coverage and/or Medical Necessity

Bendamustine hydrochloride (Treanda®) is a bifunctional mechlorethamine derivative with alkylator and antimetabolite activities. The exact mechanism of action remains unknown, however, bendmustine hydrochloride appears to act primarily as an alkylator. It is believed to inhibit DNA, RNA and protein synthesis and subsequently apoptosis.

Bendamustine is approved by the Food and Drug Administration (FDA) for injection for the treatment of patients with the following indications:

• Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established.

• Indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Medicare will consider the use of bendamustine hydrochloride (Treanda®) as medically reasonable and necessary for the FDA approved uses as well as the following off-labeled indications per the National Comprehensive Cancer Network (NCCN):

• Hodgkin Lymphoma- Classical Hodgkin lymphoma (Second-line or salvage therapy as a single agent with or without radiation therapy (RT) prior to autologous stem cell rescue for progressive disease or for relapsed disease in patients initially treated with chemotherapy with or without RT)

• Hodgkin Lymphoma- Lymphocyte predominant Hodgkin lymphoma (Second-line or salvage therapy as a single agent or in combination with rituximab with or without RT prior to autologous stem cell rescue for progressive disease or for relapsed disease in patients initially treated with chemotherapy with or without RT.)

• Multiple myeloma (Salvage therapy on or off clinical trials as a single agent for disease relapse or for progressive or refractory disease)

• Waldenström’s macroglobulinemia/Lymphoplasmacytic lymphoma (Used with or without rituximab as primary therapy, salvage therapy for disease that does not respond to primary therapy or for progressive or relapsed disease)

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.

CPT/HCPCS Codes

J9033 INJECTION, BENDAMUSTINE HCL, 1 MG

ICD-9 Codes that Support Medical Necessity

200.00 -

200.88 opens in new window

201.40 -

201.48 opens in new window

201.50 -

201.58 opens in new window

201.60 -

201.68 opens in new window

201.70 -

201.78 opens in new window

201.90 -

201.98 opens in new window

202.00 -

202.98 opens in new window

RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF MULTIPLE SITES

HODGKIN'S DISEASE NODULAR SCLEROSIS UNSPECIFIED SITE - HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF MULTIPLE SITES

HODGKIN'S DISEASE MIXED CELLULARITY UNSPECIFIED SITE - HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF MULTIPLE SITES

HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH NODES OF MULTIPLE SITES

HODGKIN'S DISEASE UNSPECIFIED TYPE UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE 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

203.00 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

203.02 MULTIPLE MYELOMA, IN RELAPSE

203.10 PLASMA CELL LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

203.12 PLASMA CELL LEUKEMIA, IN RELAPSE

203.80 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

203.82 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE

204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

204.11 LYMPHOID LEUKEMIA CHRONIC IN REMISSION

204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE

238.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS

273.3 MACROGLOBULINEMIA

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

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 documenting the clinical indications for which these drugs are being used. The documentation usually indicates the type of cancer, 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 ordering/referring 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

Clinical Pharmacology (www.clinicalpharmacology.com) November 2011.

Knauf, W., Lissichkov, T., Aldaoud, A., Liberati, A., Loscertales, J., Herbrecht, R., Juliusson, G., Postner, G., Gercheva, L., Goranov, S., Becker, M., Fricke, H., Huguet, F., Giudice, I., Klein, P., Tremmel, L., Merkle, K., Montillo, M., (2009). Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. Journal of Clinical Oncolocy, 27, (26), 4378-4384. doi: 10.1200/JCO.2008.20.8389

LCDs or policies from other Medicare contractors and Private Insurers

National Comprehensive Cancer Network (2011). Non-hodgkin’s lymphomas. NCCN clinical practice guidelines in oncology-V.4.2011. Retrieved from http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf

NCCN Drug Compendium (www.nccn.org), January 2012.

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

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 advisory groups, which includes representatives from numerous societies including Hematology and Oncology.

Florida Contractor Advisory Committee Meeting held on February 25, 2012.

Puerto Rico/U.S. Virgin Islands Contractor Advisory Committee Meeting held on March 1, 2012.

Start Date of Comment Period 02/09/2012

End Date of Comment Period 03/24/2012

Start Date of Notice Period 04/27/2012

Revision History Number Original

Revision History Explanation Revision Number: Original Start Date of Comment Period:02/09/2012

Start Date of Notice Period:04/27/2012 Original Effective Date: 06/12/2012

LCR B2012-051

April 2012 Connection

Reason for Change Coverage Change (actual change in medical parameters)