Intravenous Immune Globulin (IVIG) Therapy
Intravenous immune globulin may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.
IVIG (Asceniv, Bivigam, Carimune NF, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, and Privigen) may be considered medically necessary for treatment of ANY ONE of the following conditions when standard therapies have failed, become intolerable, or are contraindicated:
Autoimmune and Inflammatory Disorders
Autoimmune mucocutaneous blistering disease which is severe and progressive including pemphigus, pemphigoid, pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita, Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) when an individual has failed treatment with conventional agents such as corticosteroids, azathioprine, and cyclophosphamide.
- Dermatomyositis or polymyositis refractory to treatment with corticosteroids; in combination with other immunosuppressive agents; or
- Kawasaki disease (mucocutaneous lymph node syndrome); or
- Wegener's granulomatosis; or
- Neuromyelitis optica as an alternative for those with contraindications or lack of response to first-line treatment.
Hematologic
- Idiopathic thrombocytopenia purpura (ITP):
- Diagnosis of acute, severe ITP; and
- Alternate etiologies of thrombocytopenia have been ruled out; and
- Individual has one of the following:
- Major bleeding (e.g., life-threatening bleeding and/or clinically important mucocutaneous bleeding); or
- Severe thrombocytopenia and is at high risk for bleeding complications; or
- Severe thrombocytopenia and a slow or inadequate response to corticosteroids; or
- Severe thrombocytopenia and a predictable risk of bleeding in the future (e.g., a procedure or surgery with a high bleeding risk); or
- Treatment of chronic ITP; in individuals with BOTH of the following:
- Duration of disease has been at least six (6) months; and
- Individual has persistent thrombocytopenia despite treatment with corticosteroids and splenectomy; or
- Fetal/neonatal alloimmune thrombocytopenia; or
- Hemolytic disease of the fetus and newborn (e.g. erythroblastosis fetalis); or
- Post allogeneic bone marrow transplant setting; or
- Individuals with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia, multiple myeloma or post-transplant lymphoproliferative disorder (PLD); or
- Warm antibody autoimmune hemolytic anemia, refractory to corticosteroids and splenectomy; or
- Antiphospholipid syndrome; or
- Severe anemia due to parvovirus B19; or
Infectious Disease
- Prevention of infection in EITHER of the following:
- Prevention of infection in pre-term (less than 37 weeks gestational age) and/or low birth weight (less than 2500g) neonates; or
- Neonates predisposed to group B streptococcal infections; or
- Toxic shock syndrome caused by staphylococcal or streptococcal organisms refractory to conventional therapy; or
- HIV infected individuals; or
- Individuals with primary defective antibody synthesis; or
Neuroimmunological
- Chronic inflammatory demyelinating polyneuropathy (CIDP) in individuals with progressive symptoms for at least two (2) months when ALL of the following criteria are met:
- Progressive or relapsing motor and/or sensory dysfunction of more than one (1) limb or a peripheral nerve nature, developing over at least two (2) months; and
- Hypo- or areflexia (usually involving all four (4) limbs); and
- Nerve conduction studies strongly supportive of demyelination with at least ONE of the following (consistent with EFNS/PNS guidelines further defined in Professional Statements and Societal Positions section below:
- Motor distal latency prolongation in at least two (2) nerves; or
- Reduction of motor conduction velocity in at least two (2) nerves; or
- Prolongation of F-wave latency in at least two (2) nerves; or
- Absence of F-waves in at least two (2) nerves; or
- Motor conduction block in at least one (1) nerve; or
- Abnormal temporal dispersion in at least two (2) nerves; or
- Distal CMAP duration prolongation in at least one (1) nerve; or
- Multifocal motor neuropathy in patients with anti GM1 antibodies or conduction block; or
- Myasthenia gravis chronic, severe, refractory to standard therapy (i.e., azathioprine, steroids); or
- Guillain Barre syndrome (acute infective polyneuritis); or
- Myasthenic crisis; or
- Lambert-Eaton myasthenic syndrome when there is failure, contraindication, or intolerance to other therapies (i.e. anticholinesterase and diaminopyridine); or
- Relapsing-remitting multiple sclerosis (RRMS) when ALL the following criteria are met:
- Other therapy (e.g., interferon beta, glatiramer) has failed, become intolerable, and/or is contraindicated; and
- The individual has impaired function measured by a standard clinical scale and/or objective findings on a physical exam at the time of initial therapy; and
- Documentation of an MS exacerbation or progression (worsening) of the individual's clinical status from the visit prior to the one prompting the decision to initiate immune globulin therapy; or
- Stiff person syndrome not controlled by at least one (1) other therapy; or
Primary immune deficiency syndromes, including combined immunodeficiencies
- Individual diagnosed with primary immunodeficiencies [e.g., congenital agammaglobulinemia (total IgG less than 200mg/dl), hypogammaglobulinemia, common variable immunodeficiency (CVID), severe combined immunodeficiency, Wiskott-Aldrich syndrome, or X-linked agammaglobulinemia (XLA)]; and
- Laboratory evidence of immunoglobulin deficiency; and
- Persistent and severe infections despite treatment with prophylactic antibiotics; and
- Documented inability to mount an adequate immunologic response to inciting antigens; and
- Other unspecified disorder of immune mechanism may be given individual consideration; or
Transplantation
- Prior to solid organ transplant, for treatment of individuals at high risk of antibody-mediated rejection (AMR) after steroid or other immunosuppressant failure, including highly sensitized individuals, and those receiving an ABO incompatible organ; or
- Renal transplantation for prevention or treatment of acute humoral rejection; or
- Following solid organ transplant, for treatment of AMR.
The use of IVIG therapy not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
| 90283 |
J1459 |
J1554 |
J1556 |
J1557 |
J1561 |
| J1566 |
J1568 |
J1569 |
J1572 |
J1576 |
