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

Nature of Statutory Criteria/Case Summary: an enrollee has requested authorization and coverage for intravenous immunoglobulin (IVIG) therapy and epidural steroid injection. Findings:  The physician reviewer found that there is a lack of supporting documentation such as chest x-rays, chest computed topography, sinus computed topography, pharmacy antibiotic records or antibiotic log to confirm this diagnosis. A single set of laboratory results show a low total IgG, but there is no repeat of laboratory work up to confirm. Moreover, there is a lack of evaluations for other signs of protein loss, and there is no specific antibody titers of pre- and post- vaccination titers. The records provided do not clearly evaluate the patients ability to respond to infections or lack thereof as required for the diagnosis of common variable immunodeficiency (CVID). In this case, the patients immune status has not fully been evaluated.  Also, there is no documentation of other therapies used and failed such as aggressive treatment of comorbid conditions, vaccination with either of the pneumococcal vaccines, or trial of prophylactic antibiotics in the patient.  The diagnosis of CVID requires a significantly reduced total serum concentrations of immunoglobulin, low IgA and/or IgM, poor or absent response to immunization and exclusion of other immunodeficiency states or causes.  In this case, the patient is reported to have low total IgG, but the other criteria of CVID have not been met. The treatment of hypogammaglobulinemia with replacement immunoglobulin is debatable.  The medical literature recommends treatment which includes immunization with conjugated pneumococcal vaccine, aggressive treatment of other conditions predisposing to recurrent sinopulmonary infections (e,g., asthma, allergic rhinitis), increased vigilance and appropriate antibiotic therapy for infections, prophylactic antibiotics and IVIG/SCIG. IVIG is a pooled blood product and there is some evidence to indicate significant risks involved in the administration of IVIG.  This includes thrombosis, renal dysfunction, acute failure and infection.  In addition, the medical evidence does not support that IVIG is safe and effective for this patient. The records fail to demonstrate a primary immunodeficiency related to antibody deficiency. As for the requested epidural injection, the physician reviewer found that a recent meta-analysis by Chou and colleagues on the use of epidural steroid injections (ESI) and spinal stenosis note the following, There were no clear effects of epidural corticosteroid injections for spinal stenosis. They concluded that epidural corticosteroid injections for radiculopathy were associated with immediate reductions in pain and function. Moreover, they concluded that benefits of these injections were small and not sustained. There was no effect on long-term surgery risk. In this case, the patient has a history of low back pain radiating down her legs, described as both radiculopathy and sciatica. However, her physical examination is not consistent with radiculopathy as there is no specific dermatomal abnormalities in spite of changes noted in the MRI. This patients records do not demonstrate radiculopathy. The medical evidence shows that epidural injections are not recommended for spinal stenosis and have limited benefits in sciatica. Final Result: The reviewer determined that the requested services are 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 with sub-specialty certification internal medicine and allergy and immunology 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.