Archive Article for Rituximab (Rituxan®) – Related to LCD L25820 (A46093)

Archive Article for Rituximab (Rituxan®) – Related to LCD L25820 (A46093)

Contractor Information

Contractor Name

National Government Services, Inc.

Contractor Number

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Contractor Type

Carrier

Fiscal Intermediary

MAC – Part A

MAC – Part B

Article Information

Article ID Number

A46093

Article Type

Article

Key Article

Yes

Article Title

Rituximab (Rituxan®) – Related to LCD L25820

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2007 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.

Primary Geographic Jurisdiction

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Original Article Effective Date

12/01/2007

Article Revision Effective Date

08/18/2008

Article Text

This article defines coding and coverage for rituximab including off-label indications. National Government Services Local Coverage Determination (LCD) “Coverage of Drugs and Biologicals for Label and Off-Label Uses” allows coverage for off-label indications only if the United States Pharmacopeia Drug Information (USP-DI), the American Hospital Formulary Services (AHFS) and/or Thomson Healthcare DrugPoints® (as described in the LCD) define such indications or if National Government Services has published an article or LCD expanding such coverage. Providers may request approval for additional off-label indications by submitting this request in writing with supporting medical literature. The aforementioned National Government Services LCD, which describes the requirements for such a request, can be accessed on our contractor Web site at www.NGSMedicare.com or on the Medicare Coverage Database at www.cms.hhs.gov/mcd.

Abstract:
Rituximab is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant lymphocytes.

Indications:
Rituximab is FDA approved for:

Non-Hodgkin’s Lymphoma is indicated:

for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, non-Hodgkin’s lymphoma; or
as first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy regimens; or
as first-line treatment of follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma in combination with CVP chemotherapy; or
for the treatment of low-grade, CD20-positive, B-cell non-Hodgkin’s lymphoma in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP (cyclophosphamide, vincristine, and prednisolone) chemotherapy.

Rheumatoid Arthritis:

When used in combination with methotrexate to reduce the signs and symptoms in adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

Rituximab is also used in combination with Ibritumomab tiuxetan for both the diagnostic (treatment planning) and therapeutic administrations.

Graft-versus-host disease, chronic, steroid-refractory

Evans syndrome, refractory to immunosuppressive therapy

Systemic lupus erythematosus, refractory to immunosuppressive therapy

Hodgkin’s disease, CD20-positive, as monotherapy

Post-transplant lymphoproliferative disorder

Wengener’s granulomatosis (severe), refractory, in combination with corticosteroids

Indications expanded by this Article:

Immune or Idiopathic Thrombocytopenic Purpura:

Rituximab is covered for those patients with immune or idiopathic thrombocytopenic purpura who have failed steroid treatment and splenectomy.

Chronic Lymphocytic Leukemia

Waldenstrom’s Macroglobulinemia

Autoimmune Hemolytic Anemia:

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

Follicular Lymphoma:

Rituximab is covered for use in first-line treatment, as a single agent, in combination with the CHOP regimen, or in combination with other agents active in this disease.

Effective for dates of service on or after 07/18/2008 coverage for rituximab has been expanded:

For treatment of vascular rejection in cardiac transplantation and treatment for refractory kidney transplant rejection.
Thrombotic microangiopathy

Coding Guidelines:

For claims submitted to the carrier:

Rituximab should be billed using chemotherapy administration codes and is payable in the following places of service: office (11), skilled nursing home for patients in a Part A stay (31) [if the drug is supplied by the facility, no claims for the drug should be submitted to the Part B carrier], nursing facility for patients not in a Part A stay (32) and independent clinic (49) only when supplied as an “incident to” service by the physician.

Coverage Topic

Chemotherapy (Inpatient)
Chemotherapy (Outpatient)
Prescription Drugs

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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

11x	Hospital-inpatient (including Part A)
13x	Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
85x	Special facility or ASC surgery-rural primary care hospital (eff 10/94)

CPT/HCPCS Codes

J9310

RITUXIMAB, 100 MG

ICD-9 Codes that are Covered

200.00 - 200.08	RETICULOSARCOMA UNSPECIFIED SITE - RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.10 - 200.18	LYMPHOSARCOMA UNSPECIFIED SITE - LYMPHOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.20 - 200.28	BURKITT'S TUMOR OR LYMPHOMA UNSPECIFIED SITE - BURKITT'S TUMOR OR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
200.30 - 200.38	MARGINAL ZONE LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - MARGINAL ZONE LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.40 - 200.48	MANTLE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - MANTLE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.50 - 200.58	PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.60 - 200.68	ANAPLASTIC LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - ANAPLASTIC LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.70 - 200.78	LARGE CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES - LARGE CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
200.80 - 200.88	OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
201.00 - 201.08	HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE - HODGKIN'S PARAGRANULOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
201.10 - 201.18	HODGKIN'S GRANULOMA UNSPECIFIED SITE - HODGKIN'S GRANULOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
201.20 - 201.28	HODGKIN'S SARCOMA UNSPECIFIED SITE - HODGKIN'S SARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
201.40 - 201.48	HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC-HISTIOCYTIC PREDOMINANCE INVOLVING LYMPH NODES OF MULTIPLE SITES
201.50 - 201.58	HODGKIN'S DISEASE NODULAR SCLEROSIS UNSPECIFIED SITE - HODGKIN'S DISEASE NODULAR SCLEROSIS INVOLVING LYMPH NODES OF MULTIPLE SITES
201.60 - 201.68	HODGKIN'S DISEASE MIXED CELLULARITY UNSPECIFIED SITE - HODGKIN'S DISEASE MIXED CELLULARITY INVOLVING LYMPH NODES OF MULTIPLE SITES
201.70 - 201.78	HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION UNSPECIFIED SITE - HODGKIN'S DISEASE LYMPHOCYTIC DEPLETION INVOLVING LYMPH NODES OF MULTIPLE SITES
201.90 - 201.98	HODGKIN'S DISEASE UNSPECIFIED TYPE UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES
202.00 - 202.08	NODULAR LYMPHOMA UNSPECIFIED SITE - NODULAR LYMPHOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
202.40 - 202.48	LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE - LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.80 - 202.88	OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE - OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES
202.90 - 202.98	OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE UNSPECIFIED SITE - 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
238.79	OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES
273.3	MACROGLOBULINEMIA
283.0	AUTOIMMUNE HEMOLYTIC ANEMIAS
287.30	PRIMARY THROMBOCYTOPENIA,UNSPECIFIED
287.31	IMMUNE THROMBOCYTOPENIC PURPURA
287.32	EVANS’ SYNDROME
287.33	CONGENITAL AND HEREDITARY THROMBOCYTOPENIC PURPURA
287.39	OTHER PRIMARY THROMBOCYTOPENIA
446.4	WEGENER'S GRANULOMATOSIS
446.6	THROMBOTIC MICROANGIOPATHY
585.6	END STAGE RENAL DISEASE
710.0	SYSTEMIC LUPUS ERYTHEMATOSUS
710.1	SYSTEMIC SCLEROSIS
714.0	RHEUMATOID ARTHRITIS
714.1	FELTY'S SYNDROME
714.2	OTHER RHEUMATOID ARTHRITIS WITH VISCERAL OR SYSTEMIC INVOLVEMENT
714.81	RHEUMATOID LUNG
996.81	COMPLICATIONS OF TRANSPLANTED KIDNEY
996.83	COMPLICATIONS OF TRANSPLANTED HEART
996.85	COMPLICATIONS OF TRANSPLANTED BONE MARROW
V10.61	PERSONAL HISTORY OF LYMPHOID LEUKEMIA
V10.71	PERSONAL HISTORY OF LYMPHOSARCOMA AND RETICULOSARCOMA
V10.79	PERSONAL HISTORY OF OTHER LYMPHATIC AND HEMATOPOIETIC NEOPLASMS
V42.0	KIDNEY REPLACED BY TRANSPLANT
V42.1	HEART REPLACED BY TRANSPLANT

Other Information

Other Comments

Sources of Information

AHFS Drug Information, American Society of Health-System Pharmacists, Inc. Bethesda, MD. 2007.

AdmisaStar Federal fiscal intermediary LCD Illinois [L13291], Indiane [L13287], Kentucky [L13293], Ohio [L13294].

Becker YT, Becker BN, Pirsch JD, Sollinger HW. Rituximab as Treatment for Refractory Kidney Transplant Rejection. Am Jnl of Transpant. 2004; 4:996-1001.

Donauer J, Wilpert J, Geyer M, et al. ABO-Incompatible Kidney Transplantation using Antigen-Specific Immunoadsorption and Ritusimab: A Single Center Experience. Xenotransplantation. 2006; 13:108-110.

Fakhouri F, Vernant JP, Veyradier A, et al. Efficiency of Curative and Prophylactic Treatment with Rituximab in ADAMTS13-deficient Thrombotic Thrombocytopenic Purpura: A Study of 11 Cases. Blood. 2005;106(6):1932-1937.

Garrett HE Jr, Duvall-Seaman D, Helsley B, Groshart K. Treatment of Vascular Rejection with Ritusimab in Cardiac Transplantation. Jnl of Heart and Lung Transplantation. 2005; 24(9):1337-1342.

Gloor JM, DeGoey SR, Pineda AA, et al. Overcoming a Positive Crossmatch in Living-Donor Kidney Transplantation. American Journal of Transplantation. 2004; 3:1017-1023.

Gutterman LA, Kloster B, Tsai HM. Rituximab Therapy for Refractory Thrombotic Thrombocytopenic Purpur