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Local Coverage Determination (LCD)

Rituximab

L35026

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L35026
Original ICD-9 LCD ID
Not Applicable
LCD Title
Rituximab
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 11/28/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be  reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, §1861(t)(2)(B) Drugs and Biologicals

Title XVIII of the Social Security Act, §1862(a)(1)(D) Investigational or Experimental

CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §§50, 50.1, 50.4.1, 50.4.2, 50.4.3, and 50.4.5 Drugs and Biologicals

 

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen." Rituximab binds specifically to the antigen CD20 (human B-lymphocyte-restricted differentiation antigen, Bp35), a hydrophobic transmembrane protein with a molecular weight of approximately 35 kD located on pre-B and mature B lymphocytes. The antigen is expressed on > 90% of B-cell Non-Hodgkin’s Lymphomas (NHL), but the antigen is not found on hematopoietic stem cells, pro-B-cells, normal plasma cells or other normal tissues.

B cells are believed to play a role in the pathogenesis of rheumatoid arthritis (RA) and associated chronic synovitis.

In Non-Hodgkin’s Lymphoma (NHL) patients, administration of rituximab resulted in depletion of circulating and tissue-based B cells.

In Wegeners Granulomatosis with Polyangiitis and Microscopic Polyangiitis patients, peripheral blood CD19 B-cells depleted to less than 10 cells/µl following the first two infusions of rituximab, and remained at that level in most (84%) patients through Month 6. By Month 12, the majority of patients (81%) showed signs of B-cell return with counts >10 cells/µL.

FDA approved uses:

1. Non–Hodgkin’s Lymphoma (NHL)

Rituximab is indicated for the treatment of patients with:

  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.

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

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

  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or other anthracycline-based chemotherapy regimens."


2. Chronic Lymphocytic Leukemia (CLL)

Rituximab is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL."

3. Rheumatoid Arthritis (RA)

Rituximab in combination with methotrexate is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more Tumor Necrosis Factor (TNF) antagonist therapies."

4.

Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
Rituximab in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)."

Accepted Off-label Uses Approved by Palmetto GBA

  • 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

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

  • 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

  • Immune or idiopathic thrombocytopenia purpura

  • Evans’ syndrome

  • Waldenstrom’s Macroglobulinemia

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

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

  • Multifocal Motor Neuropathy (MMN) second line (as a second line therapy)

  • Multiple Sclerosis, relapsing, remitting (RRMS) (as a third line therapy)

  • Neuromyelitis Optica

  • Polymyositis (as a second or third line therapy)

  • Myasthenia Gravis

  • Anti-myelin associated glycoprotein (anti-MAG) polyneuropathy

  • Graft-Versus-Host Disease (GVHD) as third line of therapy or greater

  • Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

  • Rituximab has been shown to be an effective therapy for Cryoglobulinemia and Cryoglobulinemia induced renal disease with less complications that the standard therapy with Cytoxan and plasmapheresis

  • Post-Transplant Lymphoproliferative Disorder (PTLD) 

  • Epstein-Barr Viremia (EBV) in patients at high risk for post-transplant lymphoproliferative disease (PTLD)

    • allogenic bone marrow transplant patients with prolonged T-cell immune impairment

      • such as those receiving cord blood units or ex vivo CD34 selected or T-cell-depleted hematopoietic cell grafts, or

      • patients receiving antibodies against T-cells (alemtuzumab), or

      • patients receiving high dose steroids for treatment of severe acute GVHD.

  • Autoimmune encephalitis in bone marrow transplant patients

Other off label uses will be considered for coverage at the discretion of Palmetto GBA.

 
Summary of Evidence

N/A
Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

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Group 1

Group 1 Paragraph

N/A

 Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Medical records must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the diagnoses for which these drugs are being used. Palmetto GBA would expect the disease, the type of malignancy if cancer is the diagnosis; the staging, if applicable; all prior therapy and the patient’s response to that therapy. For lymphoma patients receiving rituximab, an explanation of lymphoma type and previous treatment(s) should be maintained in the medical record. All the documentation suggested here is usually found in the history and physical or the office/progress notes and must be available to the A/B MAC on request.

If the provider is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug. The ordering/referring physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

For the off-label indication of autoimmune hemolytic anemia, in addition to the diagnosis and prior therapy requirements, other documentation required in the medical record includes: hemoglobin and hematocrit, reticulocyte count, bilirubin, liver function tests, and patient's subjective complaints.
Sources of Information
N/A
Bibliography

Bakker NA, van Imhoff GW. Post-transplant lymphoproliferative disorders: from treatment to early detection and prevention? Haematologica. 2007;92(11):1447-1450.

Capello D, Berra E, Cerri M, Gaidano G. Post-transplant lymphoproliferative disorders. Molecular analysis of histogenesis and pathogenesis. Minerva Med. 2004;95(1):53-64.

Choquet S, Leblond V, Herbrecht R, et al. Efficacy and safety of rituximab in B-cell post-transplantation lymphoproliferative disorders: results of a prospective multicenter phase 2 study. Blood. 2006;107(8):3053-3057.

Choquet S, Oertel S, LeBlond V, et al. Rituximab in the management of post-transplantation lymphoproliferative disorder after solid organ transplantation: proceed with caution. Ann Hematol. 2007;86(8):599-607.

Cohen JI. Epstein-Barr virus lymphoproliferative disease associated with acquired immunodeficiency. Medicine-(Baltimore). 1991;70(2):137-160.

Colombat P, Salles G, Brousse N, et al. Rituximab (anti-CD20 monoclonal antibody) as single first-line therapy for patients with follicular lymphoma with a low tumor burden: clinical and molecular evaluation. Blood. 2001;97(1):101-106.

Cox KL, Lawrence-Miyasaki LS, Garcia-Kennedy R, et al. An increased incidence of Epstein-Barr virus infection and lymphoproliferative disorder in young children on FK506 after liver transplantation. Transplantation. 1995;59(4):524-529.

Czyzewski K, Styczynski J, Krenska A, et al. Intrathecal therapy with rituximab in central nervous system involvement of post-transplant lymphoproliferative disorder. Leuk Lymphoma. 2013;54(3):503-506.

Doubrovina E, Oflaz-Sozmen B, Prockop SE, et al. Adoptive immunotherapy with unselected or EBV-specific T cells for biopsy-proven EBV+ lymphomas after allogeneic hematopoietic cell transplantation. Blood. 2012;119(11):2644-2656.

EBPG Expert Group on Renal Transplantation. European best practice guidelines for renal transplantation. section IV: long-term management of the transplant recipient. IV.6.1. cancer risk after renal transplantation. post-transplant lymphoproliferative disease (PTLD): prevention and treatment. Nephrol Dial Transplant. 2002;17 Suppl 4:31-33, 35-36.

Edwards JC, Szczepanski L, Szechinski J, et al. Efficacy of B-cell–targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004;350(25):2572-2581.

Elstrom RL, Andreadis C, Aqui NA, et al. Treatment of PTLD with rituximab or chemotherapy. Am J Transplant. 2006;6(3):569-576.

Garfin PM, Shapiro R. Posttransplant Lymphoproliferative Disease. Accessed on 3/6/2019.

Gordan LN, Grow WB, Pusateri A, Douglas V, Mendenhall NP, Lynch JW. Phase II trial of individualized rituximab dosing for patients with CD20-positive lymphoproliferative disorders. J Clin Oncol. 2005;23(6):1096-1102.

Gross TG, Bucuvalas JC, Park JR, et al. Low-dose chemotherapy for epstein-barr virus-positive post-transplantation lymphoproliferative disease in children after solid organ transplantation. J Clin Oncol. 2005;23(27):6481-6488.

Gross TG, Orjuela MA, Perkins SL, et al. Low-dose chemotherapy and rituximab for posttransplant lymphoproliferative disease (PTLD): a children's oncology group report. Am J Transplant. 2012;12(11):3069-3075.

Haque T, Wilkie GM, Jones MM, et al. Allogeneic cytotoxic T-cell therapy for EBV-positive posttransplantation lymphoproliferative disease: results of a phase 2 multicenter clinical trial. Blood. 2007;110(4):1123-1131.

Hartmann C, Schuchmann M, Zimmermann T. Posttransplant lymphoproliferative disease in liver transplant patients. Curr Infect Dis Rep. 2011;13(1):53-59.

Heidel F, Lipka DB, von Auer C, Huber C, Scharrer I, Hess G. Addition of rituximab to standard therapy improves response rate and progression-free survival in relapsed or refractory thrombotic thrombocytopenic purpura and autoimmune haemolytic anaemia. Thromb and Haemost. 2007;97(2)228-233.

Hoffman GS. Vasculitis treatment: is it time to change the standard of care for ANCA-associated vasculitis? Presse Med. 2013;42(4 Pt 2): 643-650.

Izadi M, Fazel M, Saadat SH, Taheri S. Radiotherapy is the best treatment method in post transplant lymphoproliferative disorders localizing in brain: a review of the literature. Ann Transplant. 2011;16(4):126-133.

Jaksch P, Wiedemann D, Kocher A, Muraközy G, Augustin V, Klepetko W. Effect of cytomegalovirus immunoglobulin on the incidence of lymphoproliferative disease after lung transplantation: single-center experience with 1157 patients. Transplantation. 2013;95(5):766-772.

Jones RB, Tervaert JW, Hauser T, et al. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med. 2010;363(3):211-220.

Kallenberg CG. Key advances in the clinical approach to ANCA-associated vasculitis. Nature Reviews: Rheumatology. 2014;10(8):484-493.

Mukhtyar C, Guillevin L, Cid MC, et al. EULAR recommendations for the management of primary small and medium vessel vasculitis. Ann Rheum Dis. 2009;68(3):310-317.

Nabors LB, Palmer CA, Julian BA, Przekwas AM, Kew CE. Isolated central nervous system posttransplant lymphoproliferative disorder treated with high-dose intravenous methotrexate. Am J Transplant. 2009;9(5):1243-1248.

National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium® (2016). Rituximab.

O’Brien S, Bernert RA, Logan JL, Lien YH. Remission of posttransplant lymphoproliferative disorder after interferon alfa therapy. J Am Soc Nephrol. 1997;8(9):1483-1489.

Pamuk G, Turgut B, Demir M, Tezcan F, Vural O. The successful treatment of refractory autoimmune hemolytic anemia with rituximab in a patient with chronic lymphocytic leukemia. American Journal of Hematology. 2006;81(8):631-633.

Parker A, Bowles K, Bradley JA, et al. Management of post-transplant lymphoproliferative disorder in adult solid organ transplant recipients - BCSH and BTS Guidelines. Br J Haematol. 2010;149(5):693-705.

Rasmussen N. The 2012 revised international Chapel Hill consensus conference nomenclature of the vasculitides. Ann Rheum Dis. 2012;71(Suppl 3):16.

Rituxan(rituximab) [package insert] Genentech, Inc. 1 DNA Way, South San Francisco, CA.

Rituxan (rituximab) prescribing information

Schönermarck U, Gross WL, de Groot K. Treatment of ANCA-associated vasculitis. Nat Rev Nephrol. 2014;10(1):25-36.

Schubert S, Renner C, Hammer M, et al. Relationship of immunosuppression to Epstein-barr viral load and lymphoproliferative disease in pediatric heart transplant patients. J Heart Lung Transplant. 2008;27(1):100-105.

Shapiro RS, Chauvenet A, McGuire W, et al. Treatment of B-cell lymphoproliferative disorders with interferon alfa and intravenous gamma globulin. N Engl J Med. 1988;318(20):1334.

Specks U, Merkel PA, Seo P, et al. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013;369(5):417-427.

Stone JH, Merkel PA, Spiera R, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363(3):221-232.

Sun Q, Burton R, Reddy V, Lucas KG. Safety of allogeneic epstein-barr virus (EBV)-specific cytotoxic T lymphocytes for patients with refractory EBV-related lymphoma. Br J Haematol. 2002;118(3):799-808.

Suryanarayan K, Natkunam Y, Berry G, Bangs CD, Cherry A, Dahl G. Modified cyclophosphamide, hydroxydaunorubicin, vincristine, and prednisone therapy for posttransplantation lymphoproliferative disease in pediatric patients undergoing solid organ transplantation. J Pediatr Hematol Oncol. 2001;23(7):452-455.

Swerdlow SH, Campo E, Harris NL, et al. World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues. Lyon, France:IARC Press;2008.

Swinnen LJ, LeBlanc M, Grogan TM, et al. Prospective study of sequential reduction in immunosuppression, interferon alpha-2B, and chemotherapy for posttransplantation lymphoproliferative disorder. Transplantation. 2008;86(2):215-222.

Taj MM, Messahel B, Mycroft J, et al. Efficacy and tolerability of high-dose methotrexate in central nervous system positive or relapsed lymphoproliferative disease following liver transplant in children. Br J Haematol. 2008;140(2):191-196.

Taylor AL, Bowles KM, Callaghan CJ, et al. Anthracycline-based chemotherapy as first-line treatment in adults with malignant posttransplant lymphoproliferative disorder after solid organ transplantation. Transplantation. 2006;82(3):375-381.

Trappe R, Oertel S, Leblond V, et al. Sequential treatment with rituximab followed by CHOP chemotherapy in adult B-cell post-transplant lymphoproliferative disorder (PTLD): the prospective international multicentre phase 2 PTLD-1 trial. Lancet Oncol. 2012;13(2):196-206.

Vose JM, Link BK, Grossbard ML, et al. Phase II study of rituximab in combination with CHOP chemotherapy in patients with previously untreated, aggressive non-hodgkin’s lymphoma. Journal of Clinical Oncology. 2001;19(2):389-397.

Ziegler JL, Drew WL, Miner RC, et al. Outbreak of burkitt’s-like lymphoma in homosexual men. Lancet. 1982;2(8299):631-633.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
11/28/2019 R26

This LCD is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Rituximab A56380 article.
  • Provider Education/Guidance
07/01/2019 R25

Under LCD Title changed title to Rituximab. The drug name "Rituxan®” was removed throughout the LCD. 

This revision is due to the Q3 2019 CPT®/HCPCS Code Update and is effective for dates of service on or after 7/1/2019.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
03/14/2019 R24

All coding located in the Coding Information section has been moved into the related Billing and Coding for Rituximab (Rituxan®) article and removed from the LCD. Under Covered ICD-10 Codes Group 2: Codes added ICD-10 codes T86.11, T86.21 and T86.31.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
03/14/2019 R23

Under Coverage Indications, Limitations, and/or Medical Necessity Accepted Off-label Uses Approved by Palmetto GBA formatting, punctuation and typographical errors were corrected throughout the policy. Acronyms were inserted where appropriate throughout the policy. Under Bibliography changes were made to citations to reflect AMA citation guidelines.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
02/06/2019 R22

Under Coverage Indications, Limitations and/or Medical Necessity – Accepted Off-label Uses Approved by Palmetto GBA added language regarding EBV viremia that includes multiple bullets and language regarding autoimmune encephalitis that includes one bullet. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes added codes B27.00, G04.81, G72.0, G72.2, G72.41, G72.49, and G72.89. Under Revision History Information – Revision 21 M05,242 should be M05.242, M06.22 should be M06.022, M06.641 should be M06.041, and M06.61 should be M06.061.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
  • Reconsideration Request
01/01/2019 R21

Revision 20 should be disregarded.

Under CPT/HCPCS Codes Group 1: Paragraph and Codes replaced J9310 with J9311 and J9312. Under CPT/HCPCS Codes Group 2: Paragraph and Codes replaced C9467 with J9312 and removed the verbiage “For Part A services only”. Under ICD-10 Codes that Support Medical Necessity Group 1: Paragraph replaced J9310 with J9311 and J9312. Under ICD-10 Codes that Support Medical Necessity the following codes were moved from Group 1 to Group 2: Codes: D59.0, D59.1, D68.4, D69.3, D69.41, D69.42, D69.49, D89.1, D89.811, D89.89, G35, G36.0, G37.0, G37.5, G60.8, G61.81, G61.82, G61.89, G62.89, G64, G70.00, G70.01, I77.6, L10.0, L10.1, L10.9, L12.0, M05.011, M05.012, M05.021, M05.022, M05.031, M05.032, M05.041, M05.042, M05.051, M05.052, M05.061, M05.062, M05.071, M05.072, M05.09, M05.10, M05.211, M05.212, M05.221, M05.222, M05.231, M05.232, M05.241, M05,242, M05.251, M05.252, M05.261, M05.262, M05.271, M05.272, M05.29, M05.30, M05.312, M05.321, M05.322, M05.331, M05.332, M05.341, M05.342, M05.351, M05.352, M05.361, M05.362, M05.371, M05.372, M05.39, M05.411, M05.412, M05.421, M05.422, M05.431, M05.432, M05.441, M05.442, M05.451, M05.452, M05.461, M05.462, M05.471, M05.472, M05.49, M05.511, M05.512, M05.521, M05.522, M05.531, M05.532, M05.541, M05.542, M05.551, M05.552, M05.561, M05.562, M05.571, M05.572, M05.59, M05.611, M05.612, M05.621, M05.622, M05.631, M05.632, M05.641, M05.642, M05.651, M05.652, M05.661, M05.662, M05.671, M05.672, M05.69, M05.70, M05.711, M05.712, M05.721, M05.722, M05.731, M05.732, M05.741, M05.742, M05.751, M05.752, M05.761, M05.762, M05.771, M05.772, M05.79, M05.811, M05.812, M05.821, M05.822, M05.831, M05.832, M05.841, M05.842, M05.851, M05.852, M05.861, M05.862, M05.871, M05.872, M05.89, M05.9, M06.011, M06.012, M06.021, M06.22, M06.031, M06.032, M06.641, M06.042, M06.051, M06.052, M06.61, M06.062, M06.071, M06.072, M06.08, M06.09, M06.1, M06.211, M06.212, M06.221, M06.222, M06.231, M06.232, M06.241, M06.242, M06.251, M06.252, M06.261, M06.262, M06.271, M06.272, M06.28, M06.29, M06.311, M06.312, M06.321, M06.322, M06.331, M06.332, M06.341, M06.342, M06.351, M06.352, M06.361, M06.362, M06.371, M06.372, M06.38, M06.39, M06.811, M06.812, M06.821, M06.822, M06.831, M06.832, M06.841, M06.842, M06.851, M06.852, M06.861, M06.862, M06.871, M06.872, M06.88, M06.89, M06.9, M30.0, M30.1, M30.2, M30.8, M31.1, M31.30, M31.31, M31.7, M32.10, M32.14, M32.19, M32.9, M33.00, M33.01, M33.02, M33.03, M33.09, M33.10, M33.11, M33.12, M33.13, M33.19, M33.20, M33.21, M33.22, M33.29, M33.93, M35.00, M35.01, M35.02, M35.03, M35.04, M35.09, N04.0, N04.1, N04.2, N05.2, N08 and N16. Under ICD-10 Codes that Support Medical Necessity Group 2: Paragraph replaced C9467 with J9312 and removed the verbiage “For Part A services only”. Under ICD-10 Codes that Support Medical Necessity Group# 2: Codes deleted C81.00, C81.01, C81.02, C81.03, C81.04, C81.05, C81.06, C81.07, C81.08, C81.09, C81.10, C81.11, C81.12, C81.13, C81.14, C81.15, C81.16, C81.17, C81.18, C81.19, C81.20, C81.21, C81.22, C81.23, C81.24, C81.25, C81.26, C81.27, C81.28, C81.29, C81.30, C81.31, C81.32, C81.33, C81.34, C81.35, C81.36, C81.37, C81.38, C81.39, C81.40, C81.41, C81.42, C81.43, C81.44, C81.45, C81.46, C81.47, C81.48, C81.49, C81.70, C81.71, C81.72, C81.73, C81.74, C81.75, C81.76, C81.77, C81.78, C81.79, C81.90, C81.91, C81.92, C81.93, C81.94, C81.95, C81.96, C81.97, C81.98, C81.99, C82.00, C82.01, C82.02, C82.03, C82.04, C82.05, C82.06, C82.07, C82.08, C82.09, C82.10, C82.11, C82.12, C82.13, C82.14, C82.15, C82.16, C82.17, C82.18, C82.19, C82.20, C82.21, C82.22, C82.23, C82.24, C82.25, C82.26, C82.27, C82.28, C82.29, C82.30, C82.31, C82.32, C82.33, C82.34, C82.35, C82.36, C82.37, C82.38, C82.39, C82.40, C82.41, C82.42, C82.43, C82.44, C82.45, C82.46, C82.47, C82.48, C82.49, C82.50, C82.51, C82.52, C82.53, C82.54, C82.55, C82.56, C82.57, C82.58, C82.59, C82.60, C82.61, C82.62, C82.63, C82.64, C82.65, C82.66, C82.67, C82.68, C82.69, C82.80, C82.81, C82.82, C82.83, C82.84, C82.85, C82.86, C82.87, C82.88, C82.89, C82.90, C82.91, C82.92, C82.93, C82.94, C82.95, C82.96, C82.97, C82.98, C82.99, C83.00, C83.01, C83.02, C83.03, C83.04, C83.05, C83.06, C83.07, C83.08, C83.09, C83.10, C83.11, C83.12, C83.13, C83.14, C83.15, C83.16, C83.17, C83.18, C83.19, C83.30, C83.31, C83.32, C83.33, C83.34, C83.35, C83.36, C83.37, C83.38, C83.39, C83.50, C83.51, C83.52, C83.53, C83.54, C83.55, C83.56, C83.57, C83.58, C83.59, C83.70, C83.71, C83.72, C83.73, C83.74, C83.75, C83.76, C83.77, C83.78, C83.79, C83.80, C83.81, C83.82, C83.83, C83.84, C83.85, C83.86, C83.87, C83.88, C83.89, C83.90, C83.91, C83.92, C83.93, C83.94, C83.95, C83.96, C83.97, C83.98, C83.99, C84.60, C84.61, C84.62, C84.63, C84.64, C84.65, C84.66, C84.67, C84.68, C84.69, C84.70, C84.71, C84.72, C84.73, C84.74, C84.75, C84.76, C84.77, C84.78, C84.79, C84.A0, C84.A1, C84.A3, C84.A4, C84.A5, C84.A6, C84.A7, C84.A8, C84.A9, C84.Z0, C84.Z1, C84.Z2, C84.Z3, C84.Z4, C84.Z5, C84.Z6, C84.Z7, C84.Z8, C84.Z9, C84.90, C84.92, C84.93, C84.94, C84.95, C84.96, C84.97, C84.98, C84.99, C85.10, C85.11, C85.12, C85.13, C85.14, C85.15, C85.16, C85.17, C85.18, C85.19, C85.20, C85.21, C85.22, C85.23, C85.24, C85.25, C85.26, C85.27, C85.28, C85.29, C85.80, C85.81, C85.82, C85.83, C85.84, C85.85, C85.86, C85.87, C85.88, C85.89, C85.90, C85.91, C85.92, C85.93, C85.94, C85.95, C85.96, C85.97, C85.98, C85.99, C86.0, C86.1, C86.2, C86.3, C86.4, C86.5, C86.6, C88.0, C88.4, C91.00, C91.01, C91.02, C91.10, C91.11, C91.12, C91.40, C91.41, C91.42, C96.4, C96.Z, C96.9 and D47.Z1. This revision is due to the Annual CPT®/HCPCS Code Update and becomes effective on 1/1/2019.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
01/01/2019 R20

Under CPT/HCPCS Codes Group# 1: Paragraph and Codes replaced J9310 with J9312. Under CPT/HCPCS Codes Group# 2: Paragraph and Codes replaced C9467 with J9311. Under ICD-10 Codes that Support Medical Necessity Group# 1: Paragraph replaced J9310 with J9312. Under ICD-10 Codes that Support Medical Necessity Group# 2: Paragraph replaced C9467 with J9311. This revision is due to the Annual CPT®/HCPCS Code Update and becomes effective on 1/1/2019.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
06/13/2018 R19

Under CMS National Coverage Policy added CMS Manual System, Pub 100-04, Medicare Claims Processing Manual, Change Request 10530, Transmittal 3996 dated March 9, 2018. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added D89.89 and G61.82 due to reconsideration requests. Under CPT/HCPCS Codes added a new Group 2: Paragraph, Group 2: Codes and added C9467 with “Note: For Part A services only - effective on 04/01/2018”. Under ICD-10 Codes that Support Medical Necessity added a new Group 2: Codes C81.01, C81.02, C81.00, C81.03, C81.04, C81.05, C81.06, C81.07, C81.08, C81.09, C81.10, C81.11, C81.12, C81.13, C81.14, C81.15, C81.16, C81.17, C81.18, C81.19, C81.20, C81.21, C81.22, C81.23, C81.24, C81.25, C81.26, C81.27, C81.28, C81.29, C81.30, C81.31, C81.32, C81.33, C81.34, C81.35, C81.36, C81.37, C81.38, C81.39, C81.40, C81.41, C81.42, C81.43, C81.44, C81.45, C81.46, C81.47, C81.48, C81.49, C81.70, C81.71, C81.72, C81.73, C81.74, C81.75, C81.76, C81.77, C81.78, C81.79, C81.90, C81.91, C81.92, C81.93, C81.94, C81.95, C81.96, C81.97, C81.98, C81.99, C82.00, C82.01, C82.02, C82.03, C82.04, C82.05, C82.06, C82.07, C82.08, C82.09, C82.10, C82.11, C82.12, C82.13, C82.14, C82.15, C82.16, C82.17, C82.18, C82.19, C82.20, C82.21, C82.22, C82.23, C82.24, C82.25, C82.26, C82.27, C82.28, C82.29, C82.30, C82.31, C82.32, C82.33, C82.34, C82.35, C82.36, C82.37, C82.38, C82.39,C82.40, C82.41, C82.42, C82.43, C82.44, C82.45, C82.46, C82.47, C82.48, C82.49, C82.50, C82.51, C82.52, C82.53, C82.54, C82.55, C82.56, C82.57, C82.58, C82.59, C82.60, C82.61, C82.62, C82.63, C82.64, C82.65, C82.66, C82.67, C82.68, C82.69, C82.80, C82.81, C82.82, C82.83, C82.84, C82.85, C82.86, C82.87, C82.88, C82.89, C82.90, C82.91, C82.92, C82.93, C82.94, C82.95, C82.96, C82.97, C82.98, C82.99, C83.00, C83.01, C83.02, C83.03, C83.04, C83.05, C83.06, C83.07, C83.08, C83.09, C83.10, C83.11, C83.12, C83.13, C83.14, C83.15, C83.16, C83.17, C83.18, C83.19, C83.30, C83.31, C83.32, C83.33, C83.34, C83.35, C83.36, C83.37, C83.38, C83.39, C83.50, C83.51, C83.52, C83.53, C83.54, C83.55, C83.56, C83.57, C83.58, C83.59, C83.70, C83.71, C83.72, C83.73, C83.74, C83.75, C83.76, C83.77, C83.78, C83.79, C83.80, C83.81, C83.82, C83.83, C83.84, C83.85, C83.86, C83.87, C83.88, C83.89, C83.90, C83.91, C83.92, C83.93, C83.94, C83.95, C83.96, C83.97, C83.98, C83.99, C84.60, C84.61, C84.62, C84.63, C84.64, C84.65, C84.66, C84.67, C84.68, C84.69, C84.70, C84.71, C84.72, C84.73, C84.74, C84.75, C84.76, C84.77, C84.78, C84.79, C84.A0, C84.A1, C84.A2, C84.A3, C84.A4, C84.A5, C84.A6, C84.A7, C84.A8, C84.A9, C84.Z0, C84.Z1, C84.Z2, C84.Z3, C84.Z4, C84.Z5, C84.Z6, C84.Z7, C84.Z8, C84.Z9, C84.90, C84.92, C84.93, C84.94, C84.95, C84.96, C84.97, C84.98, C84.99, C85.10, C85.11, C85.12, C85.13, C85.14, C85.15, C85.16, C85.17, C85.18, C85.19, C85.20, C85.21, C85.22, C85.23, C85.24, C85.25, C85.26, C85.27, C85.28, C85.29, C85.80, C85.81, C85.82, C85.83, C85.84, C85.85, C85.86, C85.87, C85.88, C85.89, C85.90, C85.91, C85.92, C85.93, C85.94, C85.95, C85.96, C85.97, C85.98, C85.99, C86.0, C86.1, C86.2, C86.3, C86.4, C86.5, C86.6, C88.0, C88.4, C91.00, C91.01, C91.02, C91.10, C91.11, C91.12, C91.40, C91.41, C91.42, C96.4, C96.Z, C96.9 and D47.Z1. Under Bibliography revisions were made to the sources to reflect AMA citation guidelines.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
  • Reconsideration Request
03/30/2018 R18

Under Coverage Indications, Limitations and/or Medical Necessity added the ® symbol where indicated. Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 code L10.1 due to a reconsideration request.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 
  • Provider Education/Guidance
  • Reconsideration Request
02/26/2018 R17 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
01/29/2018 R16 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
10/01/2017 R15

Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes L10.9, L12.0 and L10.0 due to a reconsideration request.

 At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 
  • Provider Education/Guidance
  • Reconsideration Request
10/01/2017 R14

Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes M33.00, M33.01, M33.02, M33.03, M33.09, M33.10, M33.11, M33.12, M33.13, M33.19 and M33.93. This revision is due to the 2017 Annual ICD-10 Code Updates.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 
  • Revisions Due To ICD-10-CM Code Changes
07/07/2017 R13

Under ICD-10 Codes That Support Medical Necessity added ICD-10 codes G61.81, I77.6, M05.10, M05.70, M32.10, M32.14, M32.19, and M32.9.
  • Provider Education/Guidance
  • Other
07/06/2017 R12

Under ICD-10 Codes That Support Medical Necessity added ICD-10 code D68.4.

  • Provider Education/Guidance
  • Other
06/09/2017 R11 Under Coverage Indications, Limitations and/or Medical Necessity- added bullet to Accepted Off-label Uses Approved by Palmetto GBA – to read “Rituximab has been shown to be an effective therapy for Cryoglobulinemia and Cryoglobulinemia induced renal disease with less complications that the standard therapy with Cytoxan and Plasmapheresis”. Under ICD-10 Codes that Support Medical Necessity- added codes D89.1, N08, N16.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
03/16/2017 R10 Under CMS National Coverage Policy- Added additional verbiage to Title XVIII of the SSA 1862(a)(1)(A) to include “for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” Under Coverage Indications, Limitations and/or Medical Necessity-Added quotation marks to direct quotes taken from FDA approval for Rituximab around sentence: “Rituxan (Rituximab) is a genetically…CD20 antigen.” Added italicized font to direct quote from FDA prescribing info to Second paragraph, “B cells are believed…”, third paragraph “In Non-Hodgkin’s Lymphoma (NHL) patients…” and fourth paragraph “peripheral blood CD19 B-cells depleted…”
Removed verbiage “Rituximab is indicated for the following” from Header: Rituximab is indicated for the following FDA approved uses and added bold font to “FDA approved uses:” Grammatical correction to remove additional quotation mark behind word “with” from sentence under fourth bullet under 1. Non-Hodgkin’s Lymphoma (NHL) Delete “5.” from FDA approved uses list, and made this separate heading with bold font. Under Associated Information – Documentation Requirements- Grammatical correction to change “We” to “Palmetto GBA” in sentence starting “We would expect the disease…” Changed “Palmetto GBA” to “the A/B MAC” in sentence “…must be available to Palmetto GBA on request.”
Under Sources of Information and Basis for Decision - Grammatical correction to reference listed to delete coma between last name and first initial on Kallenberg, CG. Deleted reference Twist CJ, Kjelson L, Esquivel CO, Castillo RO as unable to locate this reference online.
  • Provider Education/Guidance
  • Typographical Error
10/01/2016 R9 Under ICD-10 Codes that Support Medical Necessity the descriptions were revised for ICD-10 codes C81.10, C81.11, C81.12, C81.13, C81.14, C81.15, C81.16, C81.17, C81.18, C81.19, C81.20, C81.21, C81.22, C81.23, C81.24, C81.25, C81.26, C81.27, C81.28, C81.29, C81.30, C81.31, C81.32, C81.33, C81.34, C81.35, C81.36, C81.37, C81.38, C81.39, C81.40, C81.41, C81.42, C81.43, C81.44, C81.45, C81.46, C81.47, C81.48, C81.49, C81.70, C81.71, C81.72, C81.73, C81.74, C81.75, C81.76, C81.77, C81.78 and C81.79. This revision is due to the Annual ICD-10 Code Update and becomes effective 10/1/16.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
07/08/2016 R8 Under ICD-10 Codes that Support Medical Necessity added ICD-10 codes N04.0, N04.1, N04.2, and N05.2. Under Coverage Indications, Limitations and/or Medical Necessity revised the verbiage in the last sentence from “Other off label uses will not be covered at this time.” to read “Other off label uses will be considered for coverage at the discretion of Palmetto GBA.”
  • Provider Education/Guidance
  • Reconsideration Request
02/11/2016 R7 Under Associated Information-Documentation Requirements in the last paragraph added “includes”. Under Sources of Information and Basis for Decision all journal titles were italicized, supplement numbers were added, typographical errors were corrected, and all citations were placed in the AMA Citation format. Under Sources of Information and Basis for Decision deleted the references to the NCCN as this information is antiquated.
  • Provider Education/Guidance
  • Typographical Error
  • Other
10/01/2015 R6 Based on a reconsideration request, under Coverage Indications, Limitations and/or Medical Necessity, Accepted Off-label Uses Approved by Palmetto GBA, added “ANCA-Associated Vasculitis” and "Post-Transplant Lymphoproliferative Disorder (PTLD)". Under ICD-10 Codes that Support Medical Necessity added code D47.Z1. Note that codes M30.0, M30.2, M30.8, M31.7, M30.1, M31.30, and M31.31 which would coincide with ANCA-Associated Vasculitis were already in the policy. Under Sources of Information and Basis for Decision added references that support coverage of ANCA-Associated Vasculitis and PTLD.
  • Reconsideration Request
10/01/2015 R5 Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.1.3 LCDs consist of only “reasonable and necessary” information. All bill type and revenue codes have been removed.
  • Other (Bill type and/or revenue code removal)
10/01/2015 R4 Under CMS National Coverage Policy added section 50.1 to Pub 100-02 Chapter 15. Under Sources of Information and Basis for Decision revised some citations to follow AMA format. Corrected name of journal for article titled “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”. Based on a reconsideration request, under Coverage Indications, Limitations and/or Medical Necessity, Accepted Off-label Uses Approved by Palmetto GBA, added “Graft-Versus-Host Disease (GVHD) as third line of therapy or greater” and under ICD-10 Codes that Support Medical Necessity added code D89.811.
  • Provider Education/Guidance
  • Reconsideration Request
  • Other (Maintenance
    Annual Review)
10/01/2015 R3 Under Bill Type Codes added bill type 023x.
  • Provider Education/Guidance
10/01/2015 R2 Bill Type Codes and Revenue Codes were added to applicable sections of the LCD. This policy was converted to an A/B MAC LCD and will replace the Part A future draft LCD-DL35185.
  • Creation of Uniform LCDs Within a MAC Jurisdiction
10/01/2015 R1 Under ICD-10 Codes that Support Medical Necessity ICD-10 codes M35.00, M35.01, M35.02 M35.03, M35.04, M35.09 was added per a provider request.
  • Provider Education/Guidance
  • Request for Coverage by a Practitioner (Part B)
  • Revisions Due To ICD-10-CM Code Changes
N/A

Associated Documents

Attachments
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Related Local Coverage Documents
Articles
A56380 - Billing and Coding: Rituximab
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
11/22/2019 11/28/2019 - N/A Currently in Effect You are here
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Keywords

  • Rituximab
  • Rituxan®

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