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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 say that Medicare may cover a drug or biological if it is safe and effective and otherwise reasonable 
and necessary. You can find this rule in the Centers for Medicare and Medicaid Services, Internet Only 
Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.1. 
 
The rules say FDA approved uses: 
 
1. NonHodgkins 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) (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 
    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-Hodgkins 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 
    Waldenstroms 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. You can find this rule 
in Medicare's Local Coverage Determination (LCD): Rituximab (L35026). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.