Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Long COVID-19

Treatment: Gammunex-C (40 gram/ 400 milliliter [ml] vial, procedure code J1561)

The insurer denied coverage for Gammunex-C (40 gram/ 400 milliliter [ml] vial, procedure code J1561)

The denial is upheld 

This case pertains to a patient needing review of intravenous immunoglobulin (IVIG) for treatment of long COVID symptoms.

The patient presented for follow-up related to cognitive difficulties. The patient has a long history of immunodeficiency. The patient has ongoing cognitive difficulties, brain fogging, headaches, and neuropathy. The patient's brain magnetic resonance imaging (MRI) showed subcortical white matter changes more consistent with small vessel disease and/or human immunodeficiency virus (HIV)-associated white matter changes. On neuropsychological testing, the patient had some problems with executive functions. Impression was possible long COVID versus HIV-associated neurological disorder. The patient notes since getting COVID, they have had to quit their job due to frequent gaps in memory. The recommendation from the patient's provider is for a trial of intravenous immunoglobulin (IVIG) since there have been several case reports with good effect. 

The provider sent an undated letter of appeal due to denial of IVIG. The provider notes the IVIG therapy is crucial to preventing further neurological damage and improving the patient's overall well-being. 

On another undated letter, the provider sent a request for practice matched appeal for the recent denial of IVIG. The provider notes that IVIG has demonstrated immunomodulatory and anti-inflammatory properties that can address the underlying immune dysregulation and inflammatory processes commonly seen in long COVID. 

The insurer sent a letter denying coverage of IVIG. They noted the provider ordered the drug for memory problems due to COVID. The drug can be approved for certain health conditions including, but not limited to multiple myeloma, hypogammaglobulinemia, or dermatomyositis. The information provided for review did not indicate the patient with one of these conditions. 

"There is a paucity of literature on the judicious use of IVIG during COVID-19 and in response to the post-infectious sequelae thereof. Furthermore, the proposed guidelines are not intended to be reflective of its use over or above other established immune modulatory therapies (1)." IVIG is indicated therapy in several neurological disorders with an etiopathogenesis related to the post-infectious autoimmune sequela of COVID-19. "One case-control study is limited by its size and its retrospective character. Thus, it is hypothesis-building but does not prove the efficacy of IVIG in post-COVID. The substantial difference between the three groups nevertheless suggests that IVIG might be a candidate approach for post-COVID that requires further evaluation in randomized controlled trials (2)."

The review of clinical and literature found many studies linking the use of IVIG in the treatment of long COVID. The studies are small and nonconclusive. The decision to deny IVIG for the treatment of long COVID in this patient is upheld. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Gammunex-C (40 gram/ 400 milliliter [ml] vial, procedure code J1561) services is not substantiated.