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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. 
  
Medicare rules also allow the plan to use step therapy. This is the process of beginning drug therapy for a 
medical condition with "preferred" (or more cost-effective) on-formulary drug alternative(s) and progressing to 
other drug therapies only as necessary. A plan must grant an exception to its step therapy rules if it determines 
that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must 
show that the step therapy drugs: have been ineffective in treating the enrollee; or are likely to be ineffective or 
adversely affect the drug's effectiveness or patient compliance; or are likely to cause an adverse reaction or 
other harm to the enrollee.  
 
Medicare Advantage plans should ensure that new step therapy requirements do not disrupt ongoing Part B 
drug therapies for enrollees. Step therapy may only be applied to new prescriptions or administrations of Part B 
drugs for enrollees that are not actively receiving the affected medication. You can find this information at 42 
CFR Sections 422.2 and 422.136. 
 
The rules say that the use of intravenous immune globulin (IVIG) should be reserved for patients with serious 
defects of antibody function. The goal is to provide immune globulin to those who lack it. Medicare will 
provide coverage for IVIG when it is used in treatment of the following conditions: 
 
    Primary immunodeficiency. 
    Immune-mediated Thrombocytopenia (ITP). 
    Kawasaki disease. 
    Human Immunodeficiency Virus (HIV) (for pediatric use only). 
    Bone marrow transplantation. 
    Chronic B-cell lymphocytic leukemia. 
 
IVIG can replace missing antibodies and decrease infection in primary immune deficiency and chronic 
lymphocytic leukemia, increase platelets in idiopathic thrombocytopenic purpura, prevent complications in 
Kawasaki disease and possibly decrease morbidity in some other conditions. 
 
 IVIG is the preferred treatment method for patients who require immediate increase in intravascular 
immunoglobulin antibody levels and are unable to produce sufficient amounts of Immunoglobulin G (IgG) 
antibodies. The therapeutic effect of IVIG is immediate, well tolerated and less likely to produce side effects if 
infused at the properly indicated rate(s). Sensitivity to these reactions is usually related to the infusion rate. 
Caution should be exercised in the administration of IVIG; reactions may cause a rapid fall in blood pressure 
and clinical anaphylaxis. 
 
Please refer to the National Coverage Determination (NCD) 250.3 for coverage details for IVIG treatment of 
Autoimmune Mucocutaneous Blistering Diseases.  
  
In addition to the NCD coverage, there are other preparations of IVIG available: 
 
    RhoD immune globulin for use in preventing postpartum Rhesus isoimmunization. 
    Cytomegalovirus immune globulin for use in treating or preventing cytomegaloviral disease in transplant 
recipients. 
    Hepatitis B immune globulin intravenous for use in treating or prevention of hepatitis B recurrence following 
liver transplantation in hepatitis B surface antigen (HBsAG)-positive liver transplant patients. (FDA approved 
April 6, 2007) 
 
You can find this information in Medicare's Local Coverage Determination (LCD): Intravenous Immune 
Globulin (IVIG) (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. The health 
plan contract says that they have a link that will take you to a list of Part B Drugs that may be subject to Step 
Therapy. You can find this information in Chapter 4 on page 91 of the plan's 2022 Evidence of Coverage.