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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that the following are FDA approved uses for Rituximab (Rituxan): 
 
1. NonHodgkins Lymphoma (NHL) 
Rituximab is indicated for the treatment of patients with: 
A. Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. 
B. 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. 
C. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent 
after first-line CVP chemotherapy. 
D. 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) (Wegeners Granulomatosis) and Microscopic Polyangiitis (MPA) 
Rituximab in combination with glucocorticoids, is indicated for the treatment of adult patients with 
Granulomatosis with Polyangiitis (GPA) (Wegeners Granulomatosis) and Microscopic Polyangiitis (MPA)."  
Accepted Off-label Uses Approved by Palmetto GBA: 
A. 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 
B. Low grade or follicular CD20-positive, B-cell non-Hodgkins lymphomas (re-induction treatment 
appropriate for responders and patients with stable disease) 
C. 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 
D. Immune or idiopathic thrombocytopenia purpura 
E. Evans syndrome 
F. Waldenstroms Macroglobulinemia 
G. For the treatment of refractory thrombotic thrombocytopenic purpura (TTP) for patients who do not 
respond to plasmapheresis 
H. 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) 
I. Multifocal Motor Neuropathy (MMN) second line (as a second line therapy) 
J. Multiple Sclerosis, relapsing, remitting (RRMS) (as a third line therapy) 
K. Neuromyelitis Optica 
L. Polymyositis (as a second or third line therapy) 
M. Myasthenia Gravis 
N. Anti-myelin associated glycoprotein (anti-MAG) polyneuropathy 
O. Graft-Versus-Host Disease (GVHD) as third line of therapy or greater 
P. Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis 
Q. 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 
R. Post-Transplant Lymphoproliferative Disorder (PTLD)  
S. Epstein-Barr Viremia (EBV) in patients at high risk for post-transplant lymphoproliferative disease 
(PTLD) 
a) allogenic bone marrow transplant patients with prolonged T-cell immune impairment 
i. such as those receiving cord blood units or ex vivo CD34 selected or T-cell-depleted 
hematopoietic cell grafts, or 
ii. patients receiving antibodies against T-cells (alemtuzumab), or 
iii. patients receiving high dose steroids for treatment of severe acute GVHD. 
T. Autoimmune encephalitis in bone marrow transplant patients 
 
Other off label uses will be considered for coverage at the discretion of Palmetto GBA. 
You can find these rules in the Local Coverage Determination (LCD) for Rituximab, L35026. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.