L28994

 

TOSITUMOMAB AND IODINE I 131 TOSITUMOMAB (BEXXAR®) THERAPY

 

02/02/2009

 

Indications and Limitations of Coverage and/or Medical Necessity

 

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:

o Marrow involvement is less than 26 percent.

And

o Platelet count is 100,000 cells/mm3 or greater.

And

o 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.

 

 

13x Hospital Outpatient

85x 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

0340 Nuclear medicine-general classification

0341 Nuclear medicine-diagnostic

0342 Nuclear medicine-therapeutic

0349 Nuclear medicine-other

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

G3001 ADMINISTRATION AND SUPPLY OF TOSITUMOMAB, 450 MG

A9545 IODINE I-131 TOSITUMOMAB, THERAPEUTIC, PER TREATMENT DOSE

79403 RADIOPHARMACEUTICAL THERAPY, RADIOLABELED MONOCLONAL ANTIBODY BY INTRAVENOUS INFUSION

 

 

ICD-9 Codes that Support Medical Necessity

 

 

HCPCS codes A9544, A9545, G3001

200.00 RETICULOSARCOMA UNSPECIFIED SITE

200.01 RETICULOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK

200.02 RETICULOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES

200.03 RETICULOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES

200.04 RETICULOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

200.05 RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.06 RETICULOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES

200.07 RETICULOSARCOMA INVOLVING SPLEEN

200.08 RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

200.10 LYMPHOSARCOMA UNSPECIFIED SITE

200.11 LYMPHOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK

200.12 LYMPHOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES

200.13 LYMPHOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES

200.14 LYMPHOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

200.15 LYMPHOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.16 LYMPHOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES

200.17 LYMPHOSARCOMA INVOLVING SPLEEN

200.18 LYMPHOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

200.20 BURKITT'S TUMOR OR LYMPHOMA UNSPECIFIED SITE

200.21 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK

200.22 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES

200.23 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES

200.24 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

200.25 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.26 BURKITT'S TUMOR OR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES

200.27 BURKITT'S TUMOR OR LYMPHOMA INVOLVING SPLEEN

200.28 BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

200.30 MARGINAL ZONE LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.31 MARGINAL ZONE LYMPHOMA,LYMPH NODES OF HEAD, FACE, AND NECK

200.32 MARGINAL ZONE LYMPHOMA,INTRATHORACIC LYMPH NODES

200.33 MARGINAL ZONE LYMPHOMA, INTRAABDOMINAL LYMPH NODES

200.34 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.35 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.36 MARGINAL ZONE LYMPHOMA, INTRAPELVIC LYMPH NODES

200.37 MARGINAL ZONE LYMPHOMA, SPLEEN

200.38 MARGINAL ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

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

200.50 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.51 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

200.52 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRATHORACIC LYMPH NODES

200.53 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

200.54 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.55 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.56 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, INTRAPELVIC LYMPH NODES

200.57 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, SPLEEN

200.58 PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

200.60 ANAPLASTIC LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.61 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

200.62 ANAPLASTIC LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

200.63 ANAPLASTIC LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

200.64 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.65 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.66 ANAPLASTIC LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

200.67 ANAPLASTIC LARGE CELL LYMPHOMA, SPLEEN

200.68 ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

200.70 LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

200.71 LARGE CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

200.72 LARGE CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

200.73 LARGE CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

200.74 LARGE CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

200.75 LARGE CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.76 LARGE CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

200.77 LARGE CELL LYMPHOMA, SPLEEN

200.78 LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES

200.80 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA UNSPECIFIED SITE

200.81 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK

200.82 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRATHORACIC LYMPH NODES

200.83 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES

200.84 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

200.85 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

200.86 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING INTRAPELVIC LYMPH NODES

200.87 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING SPLEEN

200.88 OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

202.00 NODULAR LYMPHOMA UNSPECIFIED SITE

202.01 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.02 NODULAR LYMPHOMA INVOLVING INTRATHORACIC LYMPH NODES

202.03 NODULAR LYMPHOMA INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.04 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.05 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.06 NODULAR LYMPHOMA INVOLVING INTRAPELVIC LYMPH NODES

202.07 NODULAR LYMPHOMA INVOLVING SPLEEN

202.08 NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

202.80 OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE

202.81 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.82 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRATHORACIC LYMPH NODES

202.83 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.84 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.85 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.86 OTHER MALIGNANT LYMPHOMAS INVOLVING INTRAPELVIC LYMPH NODES

202.87 OTHER MALIGNANT LYMPHOMAS INVOLVING SPLEEN

202.88 OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES

 

Documentation 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.

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.

 

Treatment Logic

• 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.

 

Sources of Information and Basis for Decision

 

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

 

FCSO LCD 29291, Tositumomab and Iodine I 131 Tositumomab (BEXXAR®) Therapy

02/02/2009. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

© Automated Clinical Guidelines, LLC 2009-2014

 

CMS LCD TOSITUMOMAB AND IODINE I 131 TOSITUMOMAB (BEXXAR®) THERAPY