L29087-LCD

Automated World Health

Local Coverage Determination (LCD) for Bortezomib (Velcade®) (L29087)

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 L29087

LCD Title

Bortezomib (Velcade®)

Contractor's Determination Number J9041

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 04/12/2012 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 Manual, Chapter 15, Section 50.1-50.4.3

CMS Manual System, Pub 100-04, Medicare Claims Processing Manual, Chapter 17, Section 10; 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

Bortezomib (Velcade®) is an antineoplastic agent which inhibits the activity of the 26S proteasome. It exhibits cytotoxicity to various malignant cells, including myeloma and lymphoma cells. Bortezomib is given by intravenous injection (IV).

Bortezomib is FDA approved for injection for the following indications:

• Treatment of patient with multiple myeloma.

• Treatment of patients wtih mantle cell lymphoma who have received at least one prior therapy. Bortezomib is covered for its FDA approved indications, as well as for the following off-labeled indications:

• Treatment of relapsed or refractory B-Cell Non-Hodgkin’s lymphoma specifically; follicular lymphoma.

• Induction therapy for multiple myeloma patients in combination with one or more drugs (NCCN, Multiple Myeloma, V.1.2007).

Route of Administration

Per the National Comprehensive Cancer Network (NCCN) Drugs and Biologicals Compendia the off label use of bortezomib for subcutaneous administration (SQ) is indicated for multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy. Therefore, both IV and SQ administration are allowed for this indication.

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.

999x Not Applicable

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 J9041 INJECTION, BORTEZOMIB, 0.1 MG

ICD-9 Codes that Support Medical Necessity

200.40 MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.41 MANTLE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

200.42 MANTLE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

200.43 MANTLE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

200.44 MANTLE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.45 MANTLE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.46 MANTLE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

200.47 MANTLE CELL LYMPHOMA, SPLEEN

200.48 MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

202.00 - 202.08 opens in NODULAR LYMPHOMA UNSPECIFIED SITE - NODULAR LYMPHOMA INVOLVING LYMPH

NODES OF MULTIPLE SITES

202.70 - 202.78 opens in PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN

SITES - PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

202.80 - 202.88 opens in OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE - OTHER MALIGNANT LYMPHOMAS

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

238.6 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLASMA CELLS

Diagnoses that Support Medical Necessity n/A

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

• Documentation in the medical record must support that bortezomib is administered for an indication specified in this LCD and all applicable coverage criteria must be clearly documented.

• When a portion of the drug is discarded, the medical record must clearly show the amount administered and the amount wasted.

• 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 indications/medical need for using the chemotherapy drug in the order.

• Documentation must be available to Medicare upon request.

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.

The dose and frequency of administration should be consistent with the FDA product information. More than one

3.5 mg single dose vial would not be expected to be billed for each date of service. Based on the J9041 code descriptor, 0.1 mg is equal to one billed service. Therefore, up to 35 billed services are allowed.

Sources of Information and Basis for Decision

Compendia-Based Drug Bulletin, Feb. 2008 Update. The Association of Community Cancer Centers. Available online @ http://www.accc-cancer.org.

Fisher, R. I., Wilmot, J. P. (2005). Mantle Cell Lymphoma: At Last, Some Hope for Successful Innovative Treatment Strategies. Journal Clinical Oncology, 23(4): 657-658.

Food and Drug Administration (FDA) approval letter NDA 21-602/S-015 and approval label, June 20, 2008.

Goy, A., Hagemeister, F., McLaughlin, P., Pro, B., Romaguera, J. E., & Younes, A. (2005). Phase II Study of Proteosome Inhibitor Bortezomib in Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma. Journal of Clinical Oncology, 23 (4): 667-675.

Moreau, P., Pylypenko, H., Grosicki,S., Karamanesht, L., Leleu, X., Grishunina, M., Rehtman, G., Maslink, Z., Robak, T., Shubina, A., Arnulf, B., Kropff, M., Cavet, J., Esseeltine, D., Feng, H., Girgis, S., Van De Velde, H., Deraedt, W., Harousseau, J., et al. (2011) Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomized, phase 3, non-inferiority study, The Lancet Oncology, 12, (5): 431- 440.

National Comprehensive Cancer Network, Inc. (2006). Multiple Myeloma. NCCN Clinical Practice Guidelines In Oncology – V.1.2007.

NCCN Drugs & Biologicals Compendium. (2011) website for Borezomib (Velcade). National Comprehensive Cancer Network. Retrieved 12/15/11 from http://www.nccn.org/professionals/drug_compendium/mainpage.aspx

O’Connor, O.A., MacGregor-Cortelli, B., Moskowitz, C., Muzzy, J., Stubblefield, M. & Wright, J. (2005). Phase II Clinical Experience With the Novel Proteosome Inhibitor Bortezomib in Patients With Indolent Non-Hodgkin’s Lymphoma and Mantle Cell Lymphoma. Journal of Clinical Oncology, 23 (4): 676-684.

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:05/01/2012 Revision Effective Date:04/12/2012

LCR B2012-043

April 2012 Connection

Explanation of Revision: Under the “ICD-9 Codes that Support Medical Necessity” section diagnosis codes 203.10, 203.12, 203.80, 203.82, 238.6 were added as off-label diagnoses related to the indication of multiple myeloma per the NCCN compendia for the administration route of subcutaneous injection and intravenous injection. In addition, the “CMS National Coverage Policy” and “Sources of Information and Basis of Decision” sections were updated. 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:12/01/2011 Revision Effective Date: 11/01/2011

LCR B2011-110

November 2011 Connection

Explanation of Revision: The “Indications and Limitations Coverage and /or Medical Necessity” section of the LCD section was revised to add the off label subcutaneous route of administration (SQ) and indications. In addition, the “Sources of Information and Basis for Decision section was updated. The revision is effective for claims processed on or after 11/01/2011 for dates of service on or after 09/06/2011.

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 (L29087) replaces LCD L21643 as the policy in notice. This document (L29087) is effective on 02/02/2009.

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