L28994-LCD

Automated World Health

Local Coverage Determination (LCD) for Tositumomab and Iodine I 131

Tositumomab (BEXXAR®) Therapy (L28994)

Contractor Information

Contractor Name

First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28994

LCD Title

Tositumomab and Iodine I 131 Tositumomab (BEXXAR®) Therapy

Contractor's Determination Number ABEXXAR

Primary Geographic Jurisdiction 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 02/16/2009 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 Manual System, Pub 100-02, Medicare Benefit Policy, Chapter 1, Section 30

CMS Manual System Publication 100-20 (Change Request 2914)

Indications and Limitations of Coverage and/or Medical Necessity

The Bexxar® therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) is an anti-neoplastic radioimmunotherapeutic monoclonal antibody-based regimen composed of the monoclonal antibody, Tositumomab, and the radiolabeled monoclonal antibody, Iodine I 131 Tositumomab.

The Bexxar® therapeutic regimen is administered in two discrete steps: the dosimetric and therapeutic steps. Each step consists of a sequential infusion of Tositumomab followed by Iodine I 131 Tositumomab. The therapeutic step is administered 7-14 days after the dosimetric step.

Medicare will consider the Bexxar® therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab) medically necessary for the treatment of patients with CD20 positive, follicular, non-Hodgkin’s lymphoma, with and without transformation, whose disease is refractory to rituximab and has relapsed following chemotherapy. The following criteria must be met:

1. Marrow involvement is less than 26 percent; and

2. Platelet count is 100,000 cells/mm3 or greater; and

3. Neutrophil count is 1,500 cells/mm3 or greater.

The use of any radioactive material requires full compliance with Nuclear Regulatory Commission (NRC) regulations.

CPT code 77370 (special physics consultation) may be billed as part of the Bexxar® therapeutic regimen with supporting documentation of medical necessity, such as combined dose calculation in a patient who has had prior radiation treatments.

The Bexxar® therapeutic regimen is not indicated for the initial treatment of patients with CD20 positive non- Hodgkin’s lymphoma.

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.

013x Hospital Outpatient 085x Critical Access Hospital

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.

0333 Radiology therapeutic-radiation therapy 034X Nuclear medicine-general classification

0636 Drugs requiring specific identification-detailed coding (eff 3/92)

CPT/HCPCS Codes Dosimetric Step: 77300

BASIC RADIATION DOSIMETRY CALCULATION, CENTRAL AXIS DEPTH DOSE CALCULATION, TDF, NSD, GAP CALCULATION, OFF AXIS FACTOR, TISSUE INHOMOGENEITY FACTORS, CALCULATION OF NON- IONIZING RADIATION SURFACE AND DEPTH DOSE, AS REQUIRED DURING COURSE OF TREATMENT, ONLY WHEN PRESCRIBED BY THE TREATING PHYSICIAN

78804 RADIOPHARMACEUTICAL LOCALIZATION OF TUMOR OR DISTRIBUTION OF RADIOPHARMACEUTICAL AGENT(S); WHOLE BODY, REQUIRING 2 OR MORE DAYS IMAGING

A9544 IODINE I-131 TOSITUMOMAB, DIAGNOSTIC, PER STUDY DOSE G3001 ADMINISTRATION AND SUPPLY OF TOSITUMOMAB, 450 MG

Therapeutic Step:

79403 RADIOPHARMACEUTICAL THERAPY, RADIOLABELED MONOCLONAL ANTIBODY BY INTRAVENOUS INFUSION

A9545 IODINE I-131 TOSITUMOMAB, THERAPEUTIC, PER TREATMENT DOSE G3001 ADMINISTRATION AND SUPPLY OF TOSITUMOMAB, 450 MG

ICD-9 Codes that Support Medical Necessity HCPCS Codes A9544, A9545, G3001

200.00 - 200.88 RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF

LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE

SITES

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

NODES OF MULTIPLE SITES

202.80 - 202.8 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE - OTHER MALIGNANT

LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES

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

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 marrow involvement, platelet count, and neutrophil count, as well as an explanation of the lymphoma type and previous treatment(s), should be maintained in the medical record.

Appendices

Utilization Guidelines The Bexxar® therapeutic regimen is intended as a single course of treatment. The safety of multiple courses of the Bexxar® therapeutic regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.

Sources of Information and Basis for Decision

Corixa Corporation. (2003). Prescribing information. This document was utilized to determine the indications and

limitations of coverage. 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.

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:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28994) replaces LCD L16650 as the policy in notice. This document (L28994) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

Reason for Change