Intravenous Immunoglobulin denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for IVIg Gammagard liquid 10% (37 grams every 2 weeks). Hovaguimian and Gibbons note that management of small-fiber neuropathy depends on the underlying etiology with concurrent treatment of associated neuropathic pain. Finnerup and colleagues report that inadequate response to drug treatments constitutes a substantial unmet need in patients with neuropathic pain. Liu and colleagues report evidence suggesting that intravenous immunoglobulin (IVIg) is safe and effective as a first-line treatment for patients with small-fiber-targeting autoimmune diseases akin to Guillain-Barré and chronic inflammatory demyelinating polyneuropathy.

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested reimbursement and authorization and coverage for intravenous immunoglobulin (IVIG) treatment September 2017 to August 2018 and going forward; and requested reimbursement and authorization and coverage for Rituxan February 2018 to May 2018 and going forward. The Health Plan has denied this request indicating that the requested services at issue were and are not medically necessary for treatment of autoimmune limbic encephalitis, autism, and Asperger’s syndrome.Researchers noted that autoimmune proven encephalitis is associated with antibodies that respond to therapy for antibodies with IVIG as primary therapy treatment. IVIG is supported as reducing antibodies and improving inflammatory response.

Where the denial was upheld

Physician 1: The patient is a 23-year-old female who has experienced repeated early pregnancy losses and then underwent evaluation and treatment for recurrent loss. Evaluation included a borderline positive ANA, no evidence of thyroid antibodies, no immune reaction to her partner’s antigens and heterozygosity of MTHFR. There is no evidence the patient was tested for Factor V Leiden mutation, prothrombin gene mutation, lupus anticoagulant, or anticardiolipin antibodies (ACA).The patient was treated with IVIG, Humira, Lovenox, and low dose aspirin for her most recent pregnancy, which was carried to term.Review of the submitted clinical information reveals no documentation of significant autoimmune disease or thrombophilia. The low positive ANA (which was intermittently negative) does not cause pregnancy loss or require treatment.

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.

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 Intravenous Immunoglobulin, then check the rights and deadlines that apply to your plan.