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

Review of the submitted records indicates the patient has received IVIG for a history of recurrent sinusitis and low pneumococcal titers. A letter from Dr. Stein dated 11/27/00 indicates the patient was initially seen by Dr. Stein on 8/21/00 with a history of year around allergic rhinitis, frequent infections and low pneumococcal titers. It is stated the patient has a past medical history of pneumonia in 1971 and 1999 Physical examination was normal. Allergy skin testing by prick technique was unremarkable and follow-up intradermal tests were negative with strongly positive histamine control. A CT scan of the sinuses provided no evidence of acute infection. The letter indicates the patient had seen an otolaryngologist who advised there was a need for sinus surgery. Pneumococcal titers revealed four out of four pneumococcal serotypes nonprotective with poor response to vaccination suggesting possible functional hypogammaglobulinemia with inability to respond to polysaccharide organism.Initial impressions included perennial non-allergic rhinitis (vasomotor rhinitis), chronic sinusitis, recurring infections with lack of pneumococcal protection and eustachian tube dysfunction.Review of pneumococcal antibodies (provided on physicians lab flow sheet) indicates the following:1.10/99: 1 of 6 titers within normal unimmunized range; normal immunoglobulins,  normal IgE, normal tetanus and diphtheria antibodies2.8/00: 3 of 4 titers within normal unimmunized range, below normal immunized range; 1 of 4 titers within normal post-immunized range3.9/00: pneumovax #1 given4.10/00: 1 of 4 titers within normal unimmunized range, remaining 3 titers: 2 close to unimmunized normal range, 1 low; 4 of 4 titers low post-immunized range5.pneumovax #2 given6.11/00: 3 of 4 titers within normal unimmunized range, 4 of 4 titers low post-immunized range7.11/00: pneumovax #3 given8.1/01: IV gammaglobulin commenced 9.5/01: 7 of 12 titers within normal post-immunized range, all 12 titers within normal unimmunized range10.6/01: 1 of 4 titers within normal post-immunized range11.9/01: 2 of 4 titers within normal unimmunized range, 4 of 4 titers low post-immunized range12.10/02: 4 of 4 within normal post-immunized range13.1/03: normal immunoglobulins; 14 pneumococcal titers: difficult to read - appear within normal range14.4/04 and 8/04: IgG: within normal range15.8/04: 14 pneumococcal titers: within normal pre- and post-immunized rangeA letter from the patient dated 3/29/05 states: With monthly gamma treatments, I went from having 8+ sinus, bronchial, and pneumonia infections per year to 1 or 2 per year. Without Gamma, I stay sick constantlyThe Health Plan has denied authorization for the requested therapy.The submitted records indicate the patient suffers from respiratory tract infections, including sinusitis and bronchitis. The patients provider maintains the patient's complaints are related to an underlying diagnosis of functional hypogammaglobulinemia, based on varying laboratory findings of poor response to pneumococcal vaccine. The submitted records do not document a clinical history diagnostic of an immunodeficiency syndrome, i.e., history of recurrent infections with unusual organisms (yeast, fungus, pathogenic bacteria, etc.), potentially life-threatening infections, infections which fail to respond to standard antibiotic therapy, lung disease, or episodes of unexplained sepsis. There are no positive nasal cultures or other laboratory findings to document bacterial infection. It should be noted that patients with immunodeficiency disorders who have sinopulmonary infections generally suffer from complications of these infections, including osteomyelitis, sinus abscesses, and bronchiectasis. Other conditions generally found in immunodeficient patients include skin abscesses, pyodermas, and gastrointestinal complications such as chronic diarrhea and rectal abscesses. Review of the submitted records indicates the patient's infections are limited to recurrent respiratory tract infections.The patients provider indicates the patient had undergone an ENT evaluation and sinus surgery was recommended, indicating the patient may have anatomic causes for her recurrent sinus disease. In addition to the above, therapy with IVIG is not generally accepted for the treatment of chronic sinusitis. Moreover, the patient's total IgG, IgA and IgM were consistently normal. There is no record of measurement of IgG subclasses. Replacement therapy with IVIG is indicated when IgG concentrations are less than 400 (usually in the <250 range).Based upon the information set forth above, I have determined the requested therapy is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.