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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 intravenous immune globulin (IVIG) is covered if all of the following criteria are met: 
 
1. It is an approved pooled plasma derivative for the treatment of primary immune deficiency disease; and 
2. The patient has a diagnosis of primary immune deficiency disease; and 
3. The IVIG is administered in the home; and 
4. The treating practitioner has determined that administration of the IVIG in the patients home is medically 
appropriate. 
 
You can find this rule in the Local Coverage Article (LCA) - Intravenous Immune Globulin - Policy Article 
(A52509) - Effective January 1, 2020. 
 
The rules say that Gammagard may be indicated for the following conditions: 
 
1. Immunodeficiency Syndrome: to include congenital agammaglobulinemia such as x-linked 
agammaglobulinemia, common variable hypoglobulinemia, x-linked immunodeficiency with hyper IGM, 
combined immunodeficiency. 
2. Primary thrombocytopenia. 
3. Alloimmune thrombocytopenia, refractoriness to platelet transfusions. Routine use is not indicated. IVIG 
may have a role in patients with severe thrombocytopenia of documented immune basis for whom other 
modalities are unsuccessful or contraindicated. 
4. Post-transfusion purpura. IVIG may be considered as first-line therapy in severely affected patients. 
5. Lymphoid Leukemia with either hypogammaglobulinemia or recurrent bacterial infections. 
6. Autoimmune hemolytic anemia. Routine use is not indicated. IVIG may have a role in patients with warm-
type AIHA that does not respond to corticosteroids. 
7. Immune-mediated neutropenia. Routine use is not indicated. IVIG may have a role in severe illness that does 
not respond to other modalities or when the latter are contraindicated. 
8. Multiple Myeloma. Routine use is not indicated. It may have a role in patients with stable (plateau phase) 
disease and high risk of recurrent infections. 
 9. Pediatric intractable epilepsy. Routine use is not indicated. IVIG may have a role in certain syndromes as a 
last resort, especially in patients who may be candidates for surgical resection. 
10. Guillain-Barre syndrome. IVIG is recommended as an equivalent alternative to plasma exchange in 
children and adults. 
11. Myasthenia gravis (MG). Routine use is not indicated. IVIG may be considered in patients with severe MG 
to treat acute severe decompensation when other treatments have been unsuccessful or are contraindicated. 
12. Eaton-Lambert Syndrome. This is an immune-mediated, myasthenia-like syndrome. Treatment with IVIG 
is directed at decreasing the autoimmune response. 
13. Polyneuropathy, chronic inflammatory demyelinating. IVIG is recommended as an equivalent alternative to 
plasma exchange in adults. 
14. Multifocal motor neuropathy. The routine use of IVIG is not usually recommended. IVIG may be 
considered in patients who have progressive, symptomatic multifocal motor neuropathy that has been 
diagnosed on the basis of electrophysiologic findings that rule out other possible conditions that may not 
respond to this treatment. 
15. Dermatomyositis. Routine use is not indicated. IVIG may be used for patients with severe active illness for 
whom other interventions have been unsuccessful or intolerable. 
16, Polymyositis. Routine use is not indicated. IVIG may be used for patients with severe active illness for 
whom other interventions have been unsuccessful or intolerable. 
17. Systemic lupus erythematosus (SLE). Routine use is not indicated. IVIG may be used for patients with 
severe active SLE for whom other interventions have been unsuccessful or intolerable. 
18. Systemic sclerosis dermatomyositis overlap syndrome. Routine use is not indicated. IVIG may be used for 
patients with severe active illness for whom other interventions have been unsuccessful or intolerable. 
19. Kawasaki disease. 
20. Severe Vasculitic Syndromes, systemic (polyarteritis nodosa), Churg-Strauss Vasculitis and livedoid 
vasculitis (atrophie blanche). Evidence does not support routine use of IVIG. IVIG may be used for patients 
with severe active illness for whom other interventions have been unsuccessful or intolerable. 
21. Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome. Evidence does not support routine use of 
IVIG. It will be covered if it is refractory to conventional therapy. 
22. Pemphigoid gestationis that is refractory to conventional therapy. 
23. Pyoderma gangrenosum that is refractory to conventional therapy. 
24. Neonatal alloimmune thrombocytopenia. Routine use of IVIG is not recommended. It is recommended in 
severely thrombocytopenic, symptomatic neonates who are at high risk of developing intracranial hemorrhage 
when other interventions have been unsuccessful, become intolerable, or are contra-indicated. 
25. IVIG may be indicated for high-risk pregnant women who have had a history of a previously affected infant 
with fetal-neonatal thrombocytopenia. 
26. Wiskott-Aldrich Syndrome. 
27. Anemia due to pure red cell aplasia. 
28. Human Immunodeficiency Virus (HIV) infection. IVIG will be covered for patients infected with HIV to 
reduce significant bacterial infection when all of the following coverage indicators are present: a) age less than 
13 years old; b) evidence of either qualitative or quantitative humoral immunologic defects and c) current 
bacterial infections, despite appropriate antimicrobial prophylaxis. Dosage Guidelines: 400 mg/kg body weight 
given every 28 days. 
29. Autoimmune mucocutaneous blistering disease is covered by a National Coverage Determination (See PUB 
100-3: Medicare National Coverage Determination Manual Chapter1, Part 4 Section 250.3). 
30. Stiff-man syndrome. IVIG may be used for patients with severe active illness for whom other interventions 
have been unsuccessful or intolerable. 
31. Desensitization for a pre-kidney transplantation in patients with a panel reactive antibody (PRA) of 80% or 
below. Use in patients with a PRA of 81-100% is considered to be experimental/ investigation and is therefore 
not covered. Post transplantation to prevent rejection remains covered without regard to antibody levels. 
32. Scleromyxedema, mucinosis of the skin, focal mucinosis, lichen myxedematosus, or reticular erythematous 
mucinosis.  
 You can find this rule in the Local Coverage Determination (LCD) - Immune Globulins (L34771) - Effective 
October 1, 2020.  
 
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.