L29271

 

RITUXIMAB (RITUXAN®)

 

06/08/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Rituximab (Rituxan®)–J9310

 

Rituximab is FDA approved for the treatment of the following indications:

• Non-Hodgkin’s Lymphoma (NHL)

o Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy.

o Patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell, NHL as a single agent.

o Previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP or other anthracycline-based chemotherapy regimens.

o Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent after first-line treatment with CVP chemotherapy.

• Rheumatoid Arthritis (RA)

o In combination with methotrexate to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately-to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

• Chronic Lymphocytic Leukemia (CLL)

o In combination with fludarabine and cyclophosphamide (Fc), for the treatment of patients with previously untreated and previously treated CD20-positive CLL.

• Wegener’s Granulomatosis and Microscopic Polyangiitis

o In combination with glucocorticoids, for the treatment of adult patients with Wegener’s Granulomatosis (WG) and Microscopic Polyangiitis (MPA)

• Medicare will consider the use of Rituximab as medically reasonable and necessary for the FDA approved uses as well as the following off-labeled indications:

o Second-line or salvage therapy 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 in combination with bendamustine.

o Low grade or follicular CD20-positive, B-cell non-Hodgkin’s lymphomas (re-induction treatment appropriate for responders and patients with stable disease).

o Intermediate and high grade NHL when used as a single agent, in combination with a CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) chemotherapy regimen, or in combination with other agents active in the disease.

o Immune or idiopathic thrombocytopenia purpura.

o Evans’ syndrome.

o Waldenström’s Macroglobulinemia.

o For the treatment of refractory thrombotic thrombocytopenic purpura (TTP) for patients who do not respond to plasmapheresis.

o Autoimmune hemolytic anemia.

o Rituximab is covered for those patients with autoimmune hemolytic anemia condition that is refractory to conventional treatment. (e.g., corticosteroid treatment and splenectomy).

LIMITATIONS

• Diagnosis code 340 (Multiple Sclerosis) is not a covered diagnosis given its use has not been demonstrated to be a standard of care, and claims can be denied as not medically reasonable and necessary.

• MAC J9 will address individual consideration for claims with this diagnosis and records may be requested for prepayment review.

• The documentation must clearly support that the patient was refractory to standard treatments and that no reasonable alternative treatments were available.

• The record should clearly outline the indication (diagnostic criteria) and medical need (episode of care).

 

CPT/HCPCS Codes

 

J9310 INJECTION, RITUXIMAB, 100 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

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

201.40 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE UNSPECIFIED SITE

201.41 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF HEAD FACE AND NECK

201.42 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING INTRATHORACIC LYMPH NODES

201.43 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING INTRA-ABDOMINAL LYMPH NODES

201.44 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

201.45 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

201.46 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING INTRAPELVIC LYMPH NODES

201.47 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING SPLEEN

201.48 HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE 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

202.10 MYCOSIS FUNGOIDES UNSPECIFIED SITE

202.11 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.12 MYCOSIS FUNGOIDES INVOLVING INTRATHORACIC LYMPH NODES

202.13 MYCOSIS FUNGOIDES INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.14 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.15 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.16 MYCOSIS FUNGOIDES INVOLVING INTRAPELVIC LYMPH NODES

202.17 MYCOSIS FUNGOIDES INVOLVING SPLEEN

202.18 MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES

202.20 SEZARY'S DISEASE UNSPECIFIED SITE

202.21 SEZARY'S DISEASE INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.22 SEZARY'S DISEASE INVOLVING INTRATHORACIC LYMPH NODES

202.23 SEZARY'S DISEASE INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.24 SEZARY'S DISEASE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.25 SEZARY'S DISEASE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.26 SEZARY'S DISEASE INVOLVING INTRAPELVIC LYMPH NODES

202.27 SEZARY'S DISEASE INVOLVING SPLEEN

202.28 SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES

202.30 MALIGNANT HISTIOCYTOSIS UNSPECIFIED SITE

202.31 MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.32 MALIGNANT HISTIOCYTOSIS INVOLVING INTRATHORACIC LYMPH NODES

202.33 MALIGNANT HISTIOCYTOSIS INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.34 MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.35 MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.36 MALIGNANT HISTIOCYTOSIS INVOLVING INTRAPELVIC LYMPH NODES

202.37 MALIGNANT HISTIOCYTOSIS INVOLVING SPLEEN

202.38 MALIGNANT HISTIOCYTOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES

202.40 LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE

202.41 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.42 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRATHORACIC LYMPH NODES

202.43 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.44 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF AXILLA AND UPPER ARM

202.45 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.46 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING INTRAPELVIC LYMPH NODES

202.47 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING SPLEEN

202.48 LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES

202.50 LETTERER-SIWE DISEASE UNSPECIFIED SITE

202.51 LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.52 LETTERER-SIWE DISEASE INVOLVING INTRATHORACIC LYMPH NODES

202.53 LETTERER-SIWE DISEASE INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.54 LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.55 LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.56 LETTERER-SIWE DISEASE INVOLVING INTRAPELVIC LYMPH NODES

202.57 LETTERER-SIWE DISEASE INVOLVING SPLEEN

202.58 LETTERER-SIWE DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES

202.60 MALIGNANT MAST CELL TUMORS UNSPECIFIED SITE

202.61 MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.62 MALIGNANT MAST CELL TUMORS INVOLVING INTRATHORACIC LYMPH NODES

202.63 MALIGNANT MAST CELL TUMORS INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.64 MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.65 MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.66 MALIGNANT MAST CELL TUMORS INVOLVING INTRAPELVIC LYMPH NODES

202.67 MALIGNANT MAST CELL TUMORS INVOLVING SPLEEN

202.68 MALIGNANT MAST CELL TUMORS INVOLVING LYMPH NODES OF MULTIPLE SITES

202.70 PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES

202.71 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK

202.72 PERIPHERAL T CELL LYMPHOMA, INTRATHORACIC LYMPH NODES

202.73 PERIPHERAL T CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES

202.74 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB

202.75 PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.76 PERIPHERAL T CELL LYMPHOMA, INTRAPELVIC LYMPH NODES

202.77 PERIPHERAL T CELL LYMPHOMA, SPLEEN

202.78 PERIPHERAL T CELL LYMPHOMA, 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

202.90 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE UNSPECIFIED SITE

202.91 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF HEAD FACE AND NECK

202.92 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING INTRATHORACIC LYMPH NODES

202.93 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING INTRA-ABDOMINAL LYMPH NODES

202.94 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB

202.95 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

202.96 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING INTRAPELVIC LYMPH NODES

202.97 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING SPLEEN

202.98 OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES

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

273.3 MACROGLOBULINEMIA

283.0 AUTOIMMUNE HEMOLYTIC ANEMIAS

287.31 IMMUNE THROMBOCYTOPENIC PURPURA

287.32 EVANS’ SYNDROME

446.0 POLYARTERITIS NODOSA

446.4 WEGENER'S GRANULOMATOSIS

446.6 THROMBOTIC MICROANGIOPATHY

714.0 RHEUMATOID ARTHRITIS

714.1 FELTY'S SYNDROME

714.2 OTHER RHEUMATOID ARTHRITIS WITH VISCERAL OR SYSTEMIC INVOLVEMENT

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

 

 

Documentation Requirements

• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used.

o This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy.

o 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.

o The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

• For patients receiving Rituximab, an explanation of lymphoma type and previous treatment(s) should be maintained in the patient’s medical record.

• For the off-label indication of autoimmune hemolytic anemia, in addition to the above documentation requirements, the following documentation must be supported in the medical record:

o Hgb and Hct.

o Reticulocyte count.

o Bilirubin.

o Hepatoglobulin.

o Indirect and direct hepatoglobulintests.

o Patient’s subjective complaints.

 

Utilization Guidelines

• Dosage for the off label indication of autoimmune hemolytic anemia is as follows: 375 mg/m2 once weekly for four consecutive weeks.

• See the Food and Drug Administration (FDA) drug label for recommended dosages for specific FDA indications.

• Rituximab (Rituxan®) is supplied as a 100mg/10mL and 500mg/50mL solution in a single-use vial.

 

Treatment Logic

• Rituxan (Rituxan®) is a monoclonal antibody that targets a specific protein, known as CD20, on the surface of immune cells known as B-cells.

• Rituxan binds to CD20 and is believed to work with the body’s own immune system to attack and kill the marked B-cells.

 

Sources of Information and Basis for Decision

 

Clinical Pharmacology (www.clinicalpharmacology.com) April 2012.

 

Colombat, et al., (2001). Rituximab (anti-CD20 monoclonal antibody) as a single first-line therapy for patients with follicular lymphoma with a low tumor burden: clinical and molecular evaluation. Blood, 97(1), 101-106. This article supports off-labeled indications (1st line therapy) for this drug.

 

Compendia-Based Drug Bulletin. (February 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

 

FCSO LCD 29271, Rituximab (Rituxan®), 06/08/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Foran, J., Rohatiner, A., Cunningham, D., Popescu, R., Solal-Celiqny, P., Ghielmini, M., et al., (2000). European phase II study of Rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantle cell lymphoma, immunocytoma, and small B-cell lymphocytic lymphoma. Journal of Clinical Oncology, 18(2), 317-324.

 

Genentech. (2010). Rituxan prescribing information.

 

Heidel, F., Lipka, D., et al. (2007). Addition of Rituximab to standard therapy improves response rate and progression-free survival in relapsed or refractory thrombotic thrombocytopenia purpura and autoimmune haemolytic anaemia. Thrombosis and haemostasis 97(2)228-233.

 

National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium ® (2012). Rituximab.

 

National Comprehensive Cancer Network (2012). Hodgkin Lymphoma: Principles of systemic therapy. Clinical Practice Guidelines in Oncology- Version 1.2012, HODG-B, 2.

 

National Comprehensive Cancer Network (2007). Non-Hodgkin’s Lymphomas. Clinical Practice Guidelines in Oncology – V.1.2007.

 

Pamuk, G., Turgut, B., et al. (2006). The successful treatment of refractory autoimmune hemolytic anemia with rituximab in a patient with chronic lymphocytic leukemia. American Journal of Hematology, 81: 631-633.

 

Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, January 2008.

 

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

 

U.S. Food and Drug Administration, Department of Health and Human Services, FDA News Release, April 19, 2011.

 

Vose, J., Link, B., Grossbard, M., Czuczman, M., Grillo-Lopez, A., Gilman, P., et al., (2001). Phase II study of Rituximab in combination with CHOP chemotherapy in patients with previously untreated, aggressive non-Hodgkin’s lymphoma. Journal of Clinical Oncology, 19(2), 389-397.

 

Wood, A.M. (2001). Rituximab: An innovative therapy for non-Hodgkin’s lymphoma. American Journal of Health System Pharmacy, 58(3), 215-232.

 

 

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