Hypogammaglobulinemia denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Gammagard intravenous immune globulin infusions (35 grams infused every four weeks for six months). Hypogammaglobulinemia may occur in persons with systemic lupus erythematosus (SLE) and is a potential risk factor for infection. Researchers note that SLE patients have an intrinsically dysfunctional immune system which is exacerbated by disease activity and leaves them vulnerable to infection. Management of hypogammaglobulinemia in persons with SLE should be individualized and tailored to a patient’s individual risk of infection.

This patient is a 55-year-old female with a history of non-Hodgkin’s lymphoma treated with high-dose chemotherapy and stem cell rescue. Low IgG levels dating back several years were reported by her provider. The patient had recurrent infections following treatment and IVIG therapy was initiated in 2002. Her provider indicates that the frequency and severity of the infections has decreased with continuing IVIG therapy. It does not appear from the record that IgG levels were monitored regularly. The patient has requested reimbursement for previous IVIG therapy and on-going authorization. The Health Plan denied the request based upon a determination that the therapy was/is not medically necessary in this clinical setting. Many lymphoma patients never recover in terms of immunoglobulin production even when remission is achieved.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for IVIG immunoglobulin replacement therapy. The Health Plan has denied this request indicating that the requested treatment is not medically necessary for treatment of the enrollee’s hypogammaglobulinemia and common variable immunodeficiency (CVID).At issue in this case is whether the requested IVIG immunoglobulin replacement therapy is medically necessary for treatment of the patient’s medical condition.In this case, the patient has evidence of hypogammaglobulinemia. Although stated there have been recurrent infections, per the practice parameters there is no supporting documentation: (chest x-ray (CXR); computed tomography (CT) chest; CT sinus; pharmacy antibiotic records; or antibiotic log) to confirm this.

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 patient’s hypogammaglobulinemia. The submitted documentation does not support the medical necessity of the requested medication. According to the Health Plan’s 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.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving hypogammaglobulinemia, then check the rights and deadlines that apply to your plan.