Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A patient requested authorization and coverage for nine (9) visits of gamma globulin 10 cc injections. The Health Plan has denied this request indicating that the requested medication regimen is not medically necessary for treatment of the patients hypogammaglobulinemia. The submitted documentation does not support the medical necessity of the requested medication. According to the Health Plans guideline, immune globulin infusion is indicated for the diagnosis of hypogammaglobulinemia and recurrent bacterial infection associated with B-lymphocytes cell chronic when the following criteria are met. The patient must have a documented history of recurrent bacterial infection or an active infection not responding to antimicrobial therapy and documentation that total immunoglobulin (IgG) is less than 500 mg/dL. IgG sub-class deficiency (IgG1, IgG2, IgG3, IgG4) is diagnosed when the following are met. One or more serum IgG subclasses are below the lower limit of the age adjusted laboratory reference range, or are more than two standard deviations below the age-adjusted mean, a history of recurrent sinopulmonary infections, requiring antibiotic therapy, and a lack of, or inadequate response to immunization. The patients primary humoral immunodeficiency, common variable immunodeficiency is determined when there is a history of recurrent sinopulmonary infections requiring antibiotic therapy. However, there is a lack of, or inadequate response to immunization in this case. The available laboratory data submitted by the provider included a laboratory IgG total level of 1070 (range 690-1610), IgG 3 level of 19.3 (Range: 20-110) in September 2008; and total IgG level of 884 (Range 694-1618) and IgG 3 level of 380 (Range 382-929) on 3/28/18. The provider's letter indicated that the patient had a history of IgG subclass deficiency and a history of multiple infection.  However, there were no clinical progress notes submitted in the past years prior to initiation of immune globulin treatment showing what types of infections or what treatments were offered and the outcome of the treatments.  Furthermore, there are no records showing antibody challenge study with pre-vaccination and post-vaccination titer evaluations. The patient also indicated that the provider had performed previous evaluations. However, these results and recommendations are not available in the information submitted for review. Selective antibody deficiency with normal serum IgG concentrations is a deficiency of specific antibody response to polysaccharide antigens with intact response to protein antigens and normal serum level of IgG and IgG subclass.  The available records show that the total IgG level is normal with low IgG 3 level. However, there is no study of the specific antibody response to polysaccharide to support the diagnosis of selective antibody deficiency or IgG subclass deficiency disorder to qualify for immune globulin therapy. Therefore, nine (9) visits of gamma globulin 10 cc injections are not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication regimen is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in internal medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.