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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 intravenous immune globulin (Sandoglobulin, Venoglobulin-I, Privigen, Gamunex, Octagam,
Gammagard liquid, Flebogamma/Flebogamma DIF, Carimune, Gammaplex, Bivigam) provides immediate
antibody levels. IVIG 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 Centers for Medicare and Medicaid Services, Local Coverage Determination
(LCD): Immune Globulins (L34771).
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.