Intravenous Immunoglobulin (IVIG)

LCD Information Document Information Source LCD ID N/A LCD ID L34580 Original ICD-9 LCD ID Not Applicable LCD Title Intravenous Immunoglobulin (IVIG) Proposed LCD in Comment Period N/A Source Proposed LCD DL34580 Opens in a new window Original Effective Date For services performed on or after 10/01/2015 Revision Effective Date For services performed on or after 04/04/2024 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 08/20/2020 Notice Period End Date 10/03/2020 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. 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Issue Issue Description This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity. Issue - Explanation of Change Between Proposed LCD and Final LCD CMS National Coverage Policy Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.42 CFR §411.15(a) and (k) Particular services excluded from coverage.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, §20.5.1 Coverage of Outpatient Therapeutic Services Incident to a Physician’s Service Furnished on or After August 1, 2000, and Before January 1, 2010.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 8, §50.5 Drugs and Biologicals.CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 13, §110 Physician Services and §120 Services and Supplies Furnished “Incident to” Physician’s Services. CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals, §50.1 Definition of Drug or Biological, §50.2 Determining Self-Administration of Drug or Biological, §50.3 Incident To Requirements, §50.4.1 Approved Use of Drug, §50.4.2 Unlabeled Use of Drug, §50.4.3 Examples of Not Reasonable and Necessary, §50.4.5 Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen, §50.4.6 Less Than Effective Drug, and §200 Nurse Practitioner (NP) Services. CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, §250.3 Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases. Coverage Indications, Limitations, and/or Medical Necessity Intravenous Immune Globulin (IVIG) Opens in a new window is a solution of human immunoglobulins specifically prepared for intravenous infusion. Immunoglobulins contain a broad range of antibodies that act specifically against bacterial and viral antigens. INDICATIONS: Treatment of primary immunodeficiency syndromes associated with defects in humoral immunity to replace or boost immunoglobulin G (IgG) Treatment of idiopathic thrombocytopenic purpura (ITP) when a rapid rise in the platelet count is required such as prior to surgery, to control excessive bleeding, or to defer or avoid splenectomy Treatment of Kawasaki disease, in conjunction with aspirin Prevention of recurrent bacterial infections in patients with hypogammaglobulinemia associated with B-cell chronic lymphocytic leukemia (CLL) Decreasing risk of acute graft versus host disease, associated interstitial pneumonia, and infections after bone marrow transplant in the first 100 days after transplantation Reducing the risk of severe bacterial infections in human immunodeficiency virus (HIV) infected children with a CD4 count of greater than 200 to 400 Second-line treatment of certain autoimmune myopathies Treatment of adults with Guillain-Barré syndrome diagnosed within the first 2 weeks of illness Treatment of hyperimmunoglobulinemia E syndrome and Lambert-Eaton myasthenic syndrome (LEMS) Treatment of multifocal motor neuropathy (MMN) Treatment of relapsing-remitting multiple sclerosis Treatment of chronic parvovirus B19 infection and severe anemia associated with bone marrow suppression and pure red cell aplasia Treatment of progressive pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, and epidermolysis bullosa acquisita in patients that have failed conventional treatment and patients in whom conventional therapy is otherwise contraindicated For coverage criteria of autoimmune mucocutaneous blistering diseases, please see CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §250.3 Treatment of stiff person syndrome Treatment of myasthenia gravis (MG) in patients who have profound, rapidly progressive and/or potentially life-threatening muscular weakness and are refractory to, or intolerant of cholinesterase inhibitors, corticosteroids and azathioprine Prevention and/or treatment of organ rejection in patients sensitized to living or cadaveric organ donors Schonlein-Henoch Treatment of paraneoplastic visual loss Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in patients meeting the necessary criteria Treatment of multiple myeloma for the prevention of life-threatening infections due to reduced gamma globulins Summary of Evidence IVIG has been used for many years in the treatment of immunodeficiency disease. As the knowledge of these diseases has improved and expanded, the use of IVIG has proportionally grown. With this, the body of literature supporting the use of IVIG in these situations has equally grown. The literature supports the use of IVIG in acute situations such as prevention of infections in patients with solid organ and bone marrow transplants, myeloma, leukemia, and HIV infections as well as in the acquired and genetic immunodeficiency syndromes such as CIDP. Additionally, the use in blocking damage by toxic antibodies in Guillain-Barré syndrome, pemphigus and its variants has been shown to be effective. Analysis of Evidence (Rationale for Determination) IVIG is an important adjunct or primary treatment in multiple situations where immunoglobulin abnormalities cause complications because of decreased or toxic antibodies. As shown in the Bibliography, there is a significant literature base to support its use in these situations. This contractor will continue to monitor the literature for additional uses of IVIG as they develop.

Intravenous Immune Globulin (IVIG) is a solution of human immunoglobulins specifically prepared for intravenous infusion. Immunoglobulins contain a broad range of antibodies that act specifically against bacterial and viral antigens. INDICATIONS: Treatment of primary immunodeficiency syndromes associated with defects in humoral immunity to replace or boost immunoglobulin G (IgG) Treatment of idiopathic thrombocytopenic purpura (ITP) when a rapid rise in the platelet count is required such as prior to surgery, to control excessive bleeding, or to defer or avoid splenectomy Treatment of Kawasaki disease, in conjunction with aspirin Prevention of recurrent bacterial infections in patients with hypogammaglobulinemia associated with B-cell chronic lymphocytic leukemia (CLL) Decreasing risk of acute graft versus host disease, associated interstitial pneumonia, and infections after bone marrow transplant in the first 100 days after transplantation Reducing the risk of severe bacterial infections in human immunodeficiency virus (HIV) infected children with a CD4 count of greater than 200 to 400 Second-line treatment of certain autoimmune myopathies Treatment of adults with Guillain-Barr é syndrome diagnosed within the first 2 weeks of illness Treatment of hyperimmunoglobulinemia E syndrome and Lambert-Eaton myasthenic syndrome (LEMS) Treatment of multifocal motor neuropathy (MMN) Treatment of relapsing-remitting multiple sclerosis Treatment of chronic parvovirus B19 infection and severe anemia associated with bone marrow suppression and pure red cell aplasia Treatment of progressive pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, and epidermolysis bullosa acquisita in patients that have failed conventional treatment and patients in whom conventional therapy is otherwise contraindicated For coverage criteria of autoimmune mucocutaneous blistering diseases, please see CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §250.3 Treatment of stiff person syndrome Treatment of myasthenia gravis (MG) in patients who have profound, rapidly progressive and/or potentially life-threatening muscular weakness and are refractory to, or intolerant of cholinesterase inhibitors, corticosteroids and azathioprine Prevention and/or treatment of organ rejection in patients sensitized to living or cadaveric organ donors Schonlein-Henoch Treatment of paraneoplastic visual loss Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in patients meeting the necessary criteria Treatment of multiple myeloma for the prevention of life-threatening infections due to reduced gamma globulins