L29193-LCD

Automated World Health

Local Coverage Determination (LCD) for Ibritumomab Tiuxetan (Zevalin ®) Therapy (L29193)

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 L29193

LCD Title

Ibritumomab Tiuxetan (Zevalin ®) Therapy

Contractor's Determination Number ZEVALIN

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 04/03/2012 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

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

CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3.

Indications and Limitations of Coverage and/or Medical Necessity

Ibritumomab tiuxetan (Zevalin®) is an immunoconjugate resulting from a bond between the monoclonal antibody ibritumomab and the linker-chelator tiuxetan.

Medicare will consider use of Ibrumomab tiuxetan (Zevalin) as medically reasonable and necessary for the following FDA uses.

• Non-Hodgkin’s Lymphoma (NHL)

• For previously untreated follicular non-Hodgkin’s lymphoma (NHL) in patients who achieve a partial or complete response to first-line chemotherapy.

• For relapsed or refractory low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL) including patients with rituximab refractory follicular (NHL).

Ibritumomab Tiuxetan (Zevalin ®) therapy is intended and considered to be a single course treatment regime. The efficacy, safety, and toxicity of multiple courses of the therapy have not been established and more than one course of treatment is considered not reasonable and necessary. In addition, doses of Y-90 Zevalin greater than 32 mCi are considered excessive and are, therefore, not medically necessary. This therapy is contraindicated in patients with platelet counts <100,000/mm3.

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

For the therapeutic (Y-90 Zevalin) component of the therapy:

79403 RADIOPHARMACEUTICAL THERAPY, RADIOLABELED MONOCLONAL ANTIBODY BY INTRAVENOUS INFUSION

A9543 YTTRIUM Y-90 IBRITUMOMAB TIUXETAN, THERAPEUTIC, PER TREATMENT DOSE, UP TO 40 MILLICURIES

ICD-9 Codes that Support Medical Necessity HCPCS code A9543

200.00 - 200.88 opens in RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF

new window

LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE

SITES

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

new window

NODES OF MULTIPLE SITES

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

new window

LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES

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 policy.

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 policy.

General Information

Documentations Requirements

Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of this therapy by clearly indicating the condition for which this drug is being used. This documentation is usually found in the history and physical, pathology report or in the office/progress notes. The patient’s weight and platelet count, as well as an explanation of the lymphoma type and previous treatment(s), should also be maintained in the medical record.

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.

Refer to the FDA prescribing information for appropriate dosing and administration schedules.

Sources of Information and Basis for Decision

Food and Drug Administration (FDA) drug label for Zevalin®, 2011.

IDEC Pharmaceuticals Corporation. (2002). Package insert. This document was utilized to determine the indications and limitations of coverage.

Spectrum Pharmaceuticals (2009). Zevalin prescribing information.

Witzig, T., Gordon, L., Cabanillas, F., et al. (2002). Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patient with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma. Journal of Clinical Oncology 20(10), 2453-2463. This article supports the appropriate indications for this therapy.

Zevalin Prescribing Information (March 2008). Cell Therapeutics, Inc. 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 05/01/2010

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 Revised Effective Date: 04/03/2012

LCR B2012-040

April 2012 Connection

Explanation of Revision: Under the “Indications and Limitations of Coverage and /or Medical Necessity” section, language was revised and updated with current, FDA indications. Under CPT/HCPCS Codes section codes 78802, 78804, and A9542 were removed. Under “ICD-9 Codes That Support Medical Necessity” section reference to A9542 was removed. In addition, “CMS National Coverage Policy”, “Utilization Guidelines”, and Sources of Information and Basis for Decision sections were updated. The effective date of this revision is for claims processed on or after 04/03/2012, for dates of service on or after 11/18/2011. The prior approved version of this LCD displayed on the CMS MCD from 04/05/2012 through 04/19/2012 with the incorrect Revision Effective Date of 03/29/2012. This version corrects the Revision Effective Date to 04/03/2012. No other changes have been made in this revision.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:05/01/2010 Revised Effective Date 09/03/2009

LCR B2010-036

April 2010 Update

Explanation of Revision: Added new FDA indication for previously untreated follicular NHL to the indications and limitations of coverage. Revisions will be effective for dates of service on or after 9/3/2009 for claims processed on or after 04/06/2010.

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 B2009-044FL LCR B2009-045PR/VI

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 (L29193) replaces LCD L13835 as the policy in notice. This document (L29193) is effective on 02/02/2009.

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

78802 descriptor was changed in Group 1 78804 descriptor was changed in Group 1

Reason for Change Other