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DESCRIPTIONImmune globulin is an antibody-containing solution obtained from the pooled plasma of healthy blood donors. There are several different commercial preparations available. Intravenous immune globulin (IVIg) therapy is used to provide antibodies to patients who are susceptible to disease for which there is no immunization.
Prior authorization is required.
Primary immune deficiency syndromes, including combined immunodeficiencies.
Acute Humoral Rejection
Autoimmune Mucocutaneous Blistering Diseases, in patients with severe, progressive disease despite treatment with conventional agents (corticosteroids, azathioprine, cyclophosphamide, etc.)
Autoimmune and inflammatory disorders
* FDA-labeled indications
IVIg is considered not medically necessary as a treatment of relapsing/remitting multiple sclerosis.
Intravenous immune globulin therapy is considered investigational, including, but not limited to, the following conditions:
Subcutaneous Immune Globulin (SCIg) Therapy
SCIg may be considered medically necessary for the treatment of primary immunodeficiencies (FDA-labeled indications) including congenital agammaglobulinemia, hypogammaglobulinemia, common variable immunodeficiency (CVID), severe combined immunodeficiency, Wiskott-Aldrich syndrome, and X-linked agammaglobulinemia (XLA).
Other applications of SCIg therapy are considered investigational, including, but not limited to chronic inflammatory demyelinating polyneuropathy (CIDP).
POLICY GUIDELINESPrimary Immunodeficiency Syndromes. The diagnosis of immunodeficiency and post immunization titers must be taken in context with the clinical presentation of the patient, and may vary dependent on the type of vaccine given and the prior immunization history of the patient. The following parameters are examples of criteria for diagnosis of the primary immunodeficiency syndromes.
According to a 2010 national guideline from Canada on immune globulin for primary immune deficiency, although higher trough levels of IVIg may be associated with clinical response; the goal of IVIg dose increases should be to improve clinical effectiveness and not merely to increase trough levels.
Acute, severe ITP may be defined by the following parameters:
Patients with chronic inflammatory demyelinating neuropathy (CIDP) should meet the diagnostic criteria established by the American Academy of Neurology, particularly if the patient also is diagnosed with chronic fatigue syndrome. (See Appendix A for the diagnostic criteria.) In addition, by intravenous immunoglobulin infusion (IVIg), treatment should be limited to CIDP patients who do not respond to initial therapy with prednisone and are experiencing serious clinical worsening. In patients treated for chronic diseases, such as CIDP, multifocal motor neuropathy, and dermatomyositis, the effect of IVIg is transitory and therefore periodic infusions of IVIg are needed to maintain treatment effect. The frequency of transfusions is titrated to the treatment response; typically, biweekly or monthly infusions are needed.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY8/1997: Approved by Medical Policy Advisory Committee (MPAC)
8/1999: Revisions approved by MPAC
11/1999: Revisions approved by Pharmacy & Therapeutics (P & T) Committee
5/2001: Reviewed by MPAC; IgIV considered medically necessary for CIDP
1/30/2002: Venoglobulin I® deleted from ITP; Venoglobulin S®, Gammagond SD, Polygam SD added to Kawasaki syndrome
2/15/2002: Investigational definition added
5/1/2002: Type of Service and Place of Service deleted
5/29/2002: Code Reference section updated
11/6/2002: Prior authorization required
3/25/2003: Policy section revised, "CLL with frequent infections" deleted, CPT code range 90281-90399 deleted
7/2003: Reviewed by MPAC, Policy section aligned with BCBSA, treatment dosage information deleted, ICD-9 diagnosis code ranges 356.0-356.9, 493.00-493.91, 203.00-203.81, 714.0-714.9 listed separately, ICD-9 diagnosis code 695.4 deleted covered codes, ICD-9 diagnosis code 203.00-203.81, 288.0, 493.00-493.91 moved to non-covered codes, ICD-9 diagnosis code 493.92 added non-covered codes
10/13/2004: Code Reference section updated, CPT code 90780, 90781 deleted covered codes, ICD-9 diagnosis code 279.00, 279.04, 279.05, 279.12, 279.2, 357.82, 358.01, 776.1, V42.0, V42.1, V42.6, V42.7, V42.83 added covered codes, ICD-9 diagnosis code 357.0, 446.1 description revised, ICD-9 diagnosis 358.0 5th digit added, HCPCS J0850 added covered codes, HCPCS J1561 effective deletion date added, HCPCS J1562 deleted, non-covered ICD-9 diagnosis code 203.00-203.81, 288.0, 493.00-493.91, 493.92, 710.0, 714.0-714.9 deleted
11/11/05: Policy description revised: Intravenous immune globulin (IgIV) changed to (IVIg). Policy section language revised: Preferred provider changed to Accredo; telephone # changed from 1-866-591-9075 to 1-866-240-3373; fax # changed from 1-866-591-9094 to 1-800-711-3526. Policy section description revised for intravenous immune globulin therapy diagnoses related to medical necessity. Added paragraph for intravenous immune globulin therapy. Deleted under intravenous immune gloublin therapy: agammaglobulinemia - primary humoral, hypogammaglobulinemia - primary humoral immundeficiency, bacterial infections associated with B-Cell chronic lymphocytic leukemia (CLL), HIV-ITP with severe bleeding using pooled nonspecific IVIG preparations, prevention of infection in HIV-infected children(Gamimune N® only), solid organ transplant recipients at risk for cytomegalovirus infections and pneumonia (Cytogam® only). Vital capacity less than 1L, dysphagia associated with aspiration and inability to ambulate 100 feet without assistance deleted from definition of myasthenia gravis. Deleted hereditary and idiopathic peripheral neuropathy, bone marrow transplant patients; and relapsing/remitting multiple sclerosis. Policy section description revised for polymyositis under the intravenous immune globulin therapy section related to investigational diagnoses; added chronic progressive multiple sclerosis. Code Reference section updated: 5th digit added to ICD9 diagnosis code 287.31, description revised; HCPCS codes J1564, Q9941-Q9944 added, J1561 deleted.
11/2005: Approved by Pharmacy & Therapeutics (P & T) Committee
3/14/2006: Coding updated. HCPCS 2006 revisions added to policy
3/20/2006: Policy reviewed, no changes
7/27/2006: Policy revised. Revisions approved by Medical Policy Advisory Committee (MPAC)
6/14/2007: Code Reference section updated per quarterly HCPCS and Category III revisions
12/19/2007: Coding updated per 2008 CPT/HCPCS revisions
1/18/2008: Policy revised to add "Policy" section on SCIg and maternal-fetal tolerance
1/21/2008: Code reference section revised; CPT 90284 and HCPCS J1562 added to covered codes. Added non-covered codes table; CPT 86021, 86355, 86357, 86360, 86361, and 86849 added to non-covered codes for techniques to investigate immunologic abnormalities affecting maternal-fetal tolerance. Policy named changed from "Intravenous Immune Globulin (IVIg)" to "Immune Globulin Replacement Therapy".
9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied
1/1/2009:Accredo preferred provider information removed. BCBSMS information added.
1/6/2009: Policy reviewed, the following specifically listed under investigational:
4/23/2009: ICD-9 code 340 deleted from covered table
10/11/2010: Updated the Code Reference section to remove 86360 and 86361 from the non-covered codes table.
02/28/1011: Added new HCPCS codes J1559 and J1599 to the Code Reference section.
01/17/2012: Policy statement reformatted for clarity purposes. Add the following as medically necessary indications: Acute Humoral Rejection, Autoimmune Mucocutaneous Blistering Diseases, warm antibody autoimmune hemolytic anemia, refractory to corticosteroids and immunosuppressive agents, anti-phospholipid syndrome, and toxic shock syndrome. Added the following indications to the investigational policy statement: complex regional pain syndrome, Alzheimer’s disease, IGG sub-class deficiency, and sepsis. Deleted the statement regarding laboratory tests to investigate immunologic abnormalities affecting maternal-fetal tolerance. Policy guidelines updated regarding laboratory testing. Deleted the Non-Covered codes table. Deleted outdated references from the Sources section.
04/09/2013: Policy reviewed. Added neonatal sepsis and Crohn's disease as investigational indications. Removed deleted codes J1567 and Q4087 - Q4092 from the Code Reference section.
11/15/2013: Policy statement updated to add severe anemia due to parvovirus B19 as medically necessary. Added opsoclonus-myoclonus, birdshot retinopathy, epidermolysis bullosa acquisita, necrotizing fasciitis, and polyradiculoneuropathy (other than CIDP) as investigational indications.
10/30/2014: Policy reviewed. Updated the criteria for patients with primary immunodeficiency syndromes to include laboratory evidence of immunoglobulin deficiency. Removed Kawasaki disease from the list of Infectious diseases. Added prevention of infection in preterm (<37 weeks’ gestational age) and/or low-birth weight (<2500g) neonates as medically necessary. Added hemophagocytic lymphohistiocytosis as another name for hemophagocytic syndrome. Added the following investigational statement: Other applications of SCIg therapy are considered investigational, including, but not limited to chronic inflammatory demyelinating polyneuropathy (CIDP).
SOURCE(S)Blue Cross Blue Shield Association Policy # 8.01.05
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.