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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 immune serums (immune globulin) provide passive immunity to infectious disease. The 
protection will be of rapid onset, but of short duration (1-3 months). Immune sera are obtained from pooled 
  
  human plasma of either general population donors or hyperimmunized donors. It may be administered either by 
intravenous (IV) or intramuscular (IM) injection. 
A. Immune globulin is available in broad-spectrum form, or disease-specific hyperimmune serum. 
1. Gamma Globulin; intramuscular immune globulin (IG), Gamma Globulin, immune serum 
globulin (ISG), Gamastan, Gammar, is indicated for the following conditions: 
1. Hepatitis A exposure. 
2. Measles (Rubeola): for a susceptible patient (has not been vaccinated or had measles and 
is at high risk for complication) who has been exposed less than 3 days prior to 
treatment. 
3. Rubella: for a woman in early pregnancy, who is exposed to the virus and does not have 
immunity. 
4. Varicella: for passive immunization in immunosuppressed patients when varicella zoster 
immunoglobulin is not available. 
5. Immunoglobulin deficiency: for prevention of serious infection when circulating IgG 
levels are low. Prophylactic therapy, especially against infections due to encapsulated 
bacteria, is often effective in Bruton-type, sex-linked congenital agammaglobulinemia, 
agammaglobulinemia associated with thymoma, and acquired agammaglobulinemia. 
2. Specific hyperimmune serum globulin includes several different disease-specific drugs. 
1. Hepatitis B serum is indicated post-exposure for transient prevention of hepatitis B 
infection. 
2. Rabies serum is indicated post-exposure for transient prevention of rabies infection when 
the patient has not been completely immunized with the vaccination. 
3. Vaccinia serum is indicated for transient prevention of, or modification of aberrant 
infections induced by vaccinia (smallpox) vaccine, the vaccinia virus, such as eczema 
vaccinatum, some cases of progressive vaccinia, and possibly ocular vaccinia. 
4. Varicella-zoster serum is indicated for transient prevention of varicella-zoster infection 
in exposed, susceptible individuals who have a greater risk of complications from 
varicella. Documentation in the progress notes must indicate one of the following 
complicating conditions to verify medical necessity: 
- Personal history of leukemia or lymphoma 
- HIV infection 
- Current immunosuppressive therapy 
- A newborn with exposure to chickenpox (the documentation must indicate why the 
newborn is at increased risk; e.g., if the mother was exposed within 5 days of delivery). 
5. Tetanus serum is indicated for transient protection against tetanus post-exposure to 
tetanus. Documentation in the progress notes must identify the following: 
- The wound is other than a clean minor wound, and the date of the injury; 
- The active immunization with tetanus toxoid is unknown or uncertain; or 
- The patient has received either less than 2 prior doses of tetanus toxoid; or 2 prior doses 
of tetanus toxoid, but there has been a delay of 24 hours or more between the time of 
injury and the initiation of tetanus prophylaxis. 
6. Cytomegalovirus (CMV) immune globulin intravenous (CMV-IGIV) (human) per vial is 
indicated for the prophylaxis of cytomegalovirus disease associated with transplantation 
of kidney, lung, liver, heart, stem cell, and pancreas. In transplants of these organs other 
than kidney from CMV seropositive donors into seronegative recipients, prophylactic 
CMV-IGIV should be considered in combination with ganciclovir. 
7. Hepatitis B immune globulin (HepaGam B) intramuscular, 0.5 ml is indicated for the 
treatment of acute exposure to blood containing Hepatitis B Surface Antigen (HBsAg), 
perinatal exposure of infants born to HBsAg positive mothers, sexual exposure to 
HBsAg-positive persons, and household exposure to persons with acute HBV infection. 
8. HepaGam B intravenously is indicated for the prevention of Hepatitis B recurrence 
following a liver transplantation, in HBsAg-positive liver transplant patients. 9. Crotalidae polyvalent immune FAB (OVINE), (CroFab) 
CroFab is indicated for the management of patients with minimal or moderate 
envenomation from North American rattlesnakes, copperheads, and cottonmouths/water 
moccasins. Early use of CroFab (within 6 hours of snakebite) is advised to prevent 
clinical deterioration and the occurrence of systemic coagulation abnormalities. 
B. 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 (AIHA). 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 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 Chapter 1, 
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. 
C. Subcutaneous immune globulin (Hyqvia) 
1. Hyqvia is an immune globulin with a recombinant human hyaluronidase indicated for the 
treatment of Primary Immunodeficiency (PI) in adults. This includes, but is not limited to, 
common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital 
agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. 
Hyqvia is administered subQ on an infusion pump which has the ability to titrate the flow rate 
up or down if required to improve tolerability. 
 
You can find this information in the 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.