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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. 
 
Medicare may cover the use of an FDA-approved drug or biological if it is safe and effective and otherwise 
reasonable and necessary for the patient. Food and Drug Administration (FDA) approved drugs used for 
indications other than what is indicated on the official label may be covered if the use is determined to be 
medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or 
accepted standards of medical practice. 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, Sections 
50.4.1 and 50.4.2. 
 
The rules say that off-label indications for intravenous immune globulin (IVIG) products will be considered 
medically reasonable and necessary in the following situations: 
1. Multiple myeloma for recurrent infections with hypogammaglobulinemia and subprotective antibody 
levels following immunization against diphtheria, tetanus or pneumococcal infection 
2. Following treatment of lymphoma utilizing B-cell depleting therapies for recurrent infections with 
hypogammaglobulinemia and subprotective antibody levels following immunization against diphtheria, 
tetanus or pneumococcal infection 
3. Recipients of hematopoietic stem cell transplants with severe combined immunodeficiency (SCID) or 
other primary immunodeficiencies who are functionally agammaglobulinemic because of weak B-cell 
engraftment 
4. Recipients of allogeneic hematopoietic stem cell transplantation with chronic graft versus host disease 
(GVHD), recurring bacterial infections, and subprotective antibody levels following immunization 
against diphtheria, tetanus or pneumococcal infection 
5. Human Leukocyte Antigen (HLA) and ABO desensitization protocols for the prevention of acute 
humoral rejection in renal transplantation 
6. The treatment of antibody mediated solid organ transplant rejection in combination with rituximab and 
plasma exchange (PE) 
7. Treatment of hypogammaglobulinemia in solid organ transplants 
8. Autoimmune hemolytic anemia (AIHA) when other treatment approaches have failed 
9. Systemic capillary leak syndrome (SCLS) 
10. Guillain-Barre syndrome (GBS) in adults 11. Moderate to severe myasthenia gravis (MG) 
12. Lambert-Eaton myasthenic syndrome (LEMS) in individuals who fail to respond or do not tolerate 
other treatments 
13. Relapsing-remitting multiple sclerosis (MS) 
14. Neuromyelitis optica (Devic syndrome) in individuals with severe relapses not responding to 
corticosteroids and who are not candidates for PE 
15. Stiff-person syndrome (also referred to as stiff-man syndrome) 
16. Treatment of autoimmune encephalitis, once infection is ruled out, as an alternative in patients who fail 
to respond or do not tolerate other treatments 
17. Treatment of Susac syndrome in combination with high-dose intravenous corticosteroids 
18. Severe forms of polymyositis resistant to treatment with glucocorticosteroids and immunosuppressants 
19. Severe forms of inclusion body myositis with dysphagia and individuals are otherwise treatment-
resistant 
20. Immune mediated necrotizing myopathy resistant to treatment with glucocorticosteroids and 
immunosuppressants 
21. Overlap syndrome with myositis including anti-synthetase syndrome resistant to treatment with 
glucocorticosteroids and immunosuppressants 
22. Severe systemic lupus erythematosus (SLE) in individuals who fail to respond or do not tolerate other 
treatments 
23. Biopsy-proven autoimmune mucocutaneous blistering diseases in individuals who fail to respond or do 
not tolerate other treatments and individuals with rapidly progressive disease requiring a faster response 
than conventional therapy (i.e., pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous 
membrane pemphigoid and epidermolysis bullosa acquisita) 
24. Toxic epidermal necrolysis (TEN) 
25. Stevens-Johnson syndrome 
26. Severe scleromyxedema 
27. Thyroid eye disease, also referred to as Graves disease in patients who have failed treatment with 
teprotumumab or have contraindications to the use of teprotumumab 
You can find this information in Local Coverage Determination (LCD): Immune Globin (L35093). 
 
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.