Billing and Coding: Intravenous Immune Globulin (IVIG)

This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.

Abstract:

IVIG is a blood product containing human immunoglobulins specifically prepared for intravenous infusion. IVIG is used in the treatment of primary immunodeficiency diseases featuring low or dysfunctional antibody levels to prevent infection and for certain inflammatory, autoimmune and other diseases featuring to interfere with harmful antibodies and/or for blocking damage from immune cells.

Utilization:

The dose and frequency of administration should be consistent with the FDA approved package insert. When dose and/or frequency are different from the FDA approved package insert, literature support for the specific schedule chosen should be available.

Claims submitted for procedures performed at unusually frequent intervals or high dosages may be reviewed for medical necessity. If coverage of IVIG is denied, the administration and pre-administration services associated with IVIG will also be denied.

Documentation Requirements:

Medical record documentation maintained by the treating physician must clearly document the medical necessity to initiate intravenous immune globulin therapy and the continued need thereof. Required documentation of medical necessity should include:

• history and physical;
• office/progress notes(s);
• test results with written interpretation;
• accurate weight in kilograms should be documented prior to the infusion, since the dosage is based on a mg/kg dosage;
• documentation of prior treatment therapies (where appropriate or referenced by this policy);
• evidence of blood level results demonstrating a significant deficiency in gammaglobulin levels prior to initial treatment (where appropriate or referenced by this policy);
• history of recurrent and severe infections;
• current effectiveness of IVIG therapy; and
• goals and/or treatment plan

Diagnostic testing appropriate for the condition under treatment should be documented, and this may include nerve conduction study (NCS), electromyography (EMG), cerebral spinal fluid (CSF), serum immunoprotein, or biopsy (muscle-nerve). The reason for choosing IVIG as a treatment must be well supported on review of records. Previous treatment failures with alternative agents should be documented.

When used for neuromuscular disorders, when there is improvement and continued treatment is necessary, then quantitative assessment to monitor progress is required. Quantitative monitoring may use any accepted measure, such as medical research council (MRC) scale and activities of daily living (ADL) measurements. Changes in these measures must be clearly documented. Subjective or experiential improvement alone is insufficient to support continued use of IVIG.

When used for chronic neuromuscular or immunologic conditions, there should be an attempt made to wean the dosage when improvement has occurred and an attempt to discontinue IVIG infusion when improvement is sustained with dosage reduction. In addition, when improvement does not occur with IVIG, then continued infusion would not be considered reasonable or necessary.

When used for primary humoral immunodeficiencies, blood level results, which demonstrate a significant deficiency in gamma globulin levels, must be drawn before the initial treatment. A serum trough IgG level should be measured every 3 months, before the infusion, and the dose of intravenous immune globulin adjusted accordingly. Infusions are usually given every 4 weeks, but the interval should be adjusted, depending on the serum trough IgG concentrations and the patient’s clinical condition. Serum trough levels should be maintained at 400-600mg/dl, a value close to the lower limit of normal. Rarely does a patient need his or her serum trough level greater than 600 mg/dl. If greater levels are needed, documentation should support the rationale.

When used for recurrent severe infection and documented severe deficiency or absence of IgG subclass deficiency, a serum IgG subclass trough level should be monitored at least every three months prior to the dose of intravenous immune globulin, along with clinical progress of signs and symptoms for which intravenous immune globulin therapy is required.

When used for clinically significant functional deficiency of humoral immunity as evidenced by documented failure to produce antibodies to specific antigens and a history of recurrent infections, the deficient antibody(ies) should be monitored at least every 3 months, prior to the dose of intravenous immune globulin, along with clinical progress of signs and symptoms for which intravenous immune globulin therapy is required.

To initiate intravenous immunoglobulins for chronic lymphocytic leukemia with associated hypogammaglobulinemia, the IgG level should be less than 600 mg/dl, or there should be evidence of specific antibody deficiency and the presence of repeated bacterial infections.

When used for the treatment of autoimmune mucocutaneous blistering disease please refer to CMS Publication 100-03, Medicare National Coverage Decisions Manual, Chapter 1, Section 250.3.

When used for symptomatic human immunodeficiency virus (HIV), patients must be less than 13 years of age, who are immunologically abnormal with CD4+ lymphocyte count of 200/mm 3 or greater.

When used for bone marrow/stem cell transplantation, a) the recipient was seropositive for cytomegalovirus (CMV) before transplantation or b) after allogeneic transplantation for hematologic neoplasm when the donor(s) and recipient were seronegative.

When used for solid organ transplantation, the donor was seropositive and the recipient was seronegative for cytomegalovirus (CMV) before transplantation.

When used for polymyositis and dermatomyositis:

• The patient must be unresponsive to steroids and immunosuppressants; or intolerant to steroids and/or immunosuppressives; or have serious side effects from steroids and/or immunosuppressives. The IVIG will be used to decrease the doses of other drugs that are needed for treatment.
• The patient’s record must show that there was a measurable response within 6 months of use of IVIG, or its use will no longer be considered medically necessary.
• Coverage determination will require individual consideration.

When used for autoimmune mucocutaneous blistering diseases:

Patients must meet at least one of the following criteria:

• Failed conventional therapy,
• Conventional therapy is contraindicated, or
• Have rapidly progressive disease in which a clinical response could not be affected quickly enough using conventional agents. In these situations, IVIG therapy would be given along with conventional treatment(s) and the IVIG would be used only until conventional therapy could take effect.

Documentation must be available to Medicare upon request.

Coding Information:

1. When administering IVIG to patients over continuous days, providers should report each day’s dosage on a separate line of coding, using the appropriate date of service with the units reported in the NOS field of the claim form.
2. When separately identifiable evaluation and management services are provided and documented on the same day as intravenous administration, they may be billed using modifier 25.

FDA and Compendia Review:

American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD:2007

Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 09/05/2022.

FDA label information:

1. Bivigam™ [Product Information]. Boca Raton, FL. Biotest Pharmaceuticals Corporation. September 23, 2013. Available at: Bivigam-FDA. Accessed on May 17, 2019.
2. Flebogamma 5% DIF® [Product Information]. Los Angeles, CA. Grifols Biologicals, Inc. September 23, 2013. Available at: Flebogamma-FDA. Accessed on May 17, 2019.
3. Gammagard Liquid® [Product Information]. Westlake Village, CA. Baxter Healthcare Corporation. September 23, 2013. Available at: Gammagard Liquid-FDA. Accessed on May 17, 2019.
4. Gammaked™ [Product Information]. Research Triangle Park, NC. Talecris Biotherapeutics, Inc. September 2013. Available at: http://www.gammaked.com/filebin/pdf/2013-09-gammaked.pdf. Accessed on May 17, 2019.
5. Gammaplex® [Product Information]. Temecula, CA. FFF Enterprises, Inc. September 23, 2013. Available at: Gammaplex-FDA. Accessed on May 17, 2019.
6. Gamunex-C® [Product Information]. Research Triangle Park, NC. Talecris Biotherapeutics, Inc. September 23, 2013. Available at: Gamunex-C-FDA. Accessed on May 17, 2019.
7. Octagam® [Product Information]. Centreville, VA. Octapharma USA, Inc. July 11, 2014. Available at: Octagam-FDA. Accessed on May 17, 2019.
8. Privigen® [Product Information]. Kankakee, IL. CSL Behring, LLC. September 23, 2013. Available at: Privigen-FDA. Accessed on May 17, 2019
9. Asceniv™ Available at: Asceniv-FDA. Accessed on December 12/09/2020.

Lexi-Drugs Web site. http://online.lexi.com/lco/action/home. Accessed 09/05/2022.

Micromedex DrugDex® Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 09/05/2022.

National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 09/05/2022.

U.S. Food and Drug Administration label accessed on line at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 07/11/2007.