IVIG Therapy denials: what the review data shows
Independent reviewers have decided 385 published cases where an insurer denied IVIG Therapy — and they overturned the insurer 49.1% of the time. A denial for IVIG Therapy is a starting position, not a final answer.
Conditions behind ivig therapy denials
| Category | Decisions | Overturned |
|---|---|---|
| Autoimmune Disease | 51 | 56.9% |
| Multiple Sclerosis | 31 | 25.8% |
| Peripheral Neuropathy | 23 | 82.6% |
| Epilepsy | 6 | 83.3% |
| Pregnancy | 6 | 0% |
| Miscarriage | 6 | 0% |
| Lupus | 5 | 40% |
| Myasthenia Gravis | 5 | 80% |
| Skin Lesion | 3 | 100% |
What the insurer actually argued
| Reason given | Decisions | Overturned |
|---|---|---|
Medical Necessity The plan said the care wasn’t medically necessary. The most common fight, and the most winnable. | 283 | 49.8% |
Experimental/Investigational The plan called the treatment unproven. These turn on published evidence, so the appeal is a literature argument. | 102 | 47.1% |
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.
Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage intravenous immune globulin (IVIG) Gammaplex 25 mg daily x four days (loading dose), then 25 mg daily x two days every four weeks for 12 weeks. Standard treatment of small fiber neuropathy is dependent on the underlying etiology. Small fiber neuropathy patients often suffer from devastating pain and have a severely reduced quality of life. In addition to the typical small fiber neuropathy-related complaints (neuropathic pain and autonomic symptoms such as dry mouth, dry eyes, micturition problems or bowel dysfunction), anxiety, depression, sleeping problems and fatigue may also influence quality-of-life expectations according to Brouwer and colleagues.
Where the denial was upheld
Physician 1The patient is a 49-year-old woman diagnosed with chronic fatigue syndrome attributed to Epstein-Barr virus (EBV) infection. The submitted information does not provide corroborating historical or serologic evidence supporting the infection. The patient has a 30-year history of arthritis without documented deformity or synovitis. She currently experiences diffuse body aches including all joints with 15 minutes of morning stiffness. In addition, the patient has photosensitivity, Raynaud’s and alopecia. Her exam apparently revealed four tender points with no evidence of inflammatory arthritis or systemic lupus erythematosus (SLE) features. She has a low normal C4 with negative ANA, Ro, La dsDNA, normal ESR and CBC with an elevated parvovirus B-19 IgG and negative IgM. The patient has been treated with NSAIDS, narcotic analgesics, and anxiolytics.
Physician 1The patient is a 40-year-old woman who achieved pregnancy through in vitro fertilization. She has a history of polycystic ovary syndrome. The patient has an elevated antinuclear antibody (ANA) titer of 2.3 and is on progesterone. There is an apparent history of miscarriage; however, there are no details regarding the number of miscarriages, at what gestational age, and whether there were previous successful pregnancies. A request has been made for intravenous immune globulin (IVIG) therapy. The Health Plan has denied authorization for IVIG therapy on the basis it is considered experimental.IVIG therapy is unproven in the treatment of recurrent miscarriage. It has not yet been shown to be beneficial in randomized, controlled studies. In addition, there is no evidence that this patient’s prior loss is in relation to the autoimmune event.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California outcomes — every state runs an equivalent external review, but the rates here are California’s. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for IVIG Therapywhen you appeal: reviewers routinely find that denials like yours didn’t hold up.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · DERIVED AGGREGATE STATISTICS ONLY · METHODOLOGY