Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hypogammaglobulinemia.
Treatment: Gammagard injections.
The insurer denied coverage for Gammagard injections.
The denial is overturned.

The patient has a history of nonfamilial hypogammaglobulinemia. She was being diagnosed with four sinus infections a year and had history of Coronavirus disease (COVID). Chronic sinusitis was confirmed with sinus computerized tomography (CT) scans. 

The patient underwent laboratory testing that showed her gamma globulin level was low at 0.5, immunoglobulin G (IgG) level was low at 475 and a free lambda level of 0.53. 

The patient underwent septoplasty, resections of inferior turbinates and endoscopic sinus surgery. 

The patient, again, had COVID. She then had ear pain and tympanic membrane (TM) perforation. The patient was diagnosed with hypogammaglobulinemia. 

The provider recommended Gammagard infusions to prevent further infections. 

An adverse determination letter stated that "the information provided does not document that the patient has an impaired antibody response to vaccination with a pneumococcal vaccine. Coverage of immune globulin products is not allowed unless the member has a weak antibody response to the pneumococcal polysaccharide vaccine." 

The patient has hypogammaglobulinemia in the setting of recurrent multiple and severe sinus infections, which indicated correction of the hypogammaglobulinemia with Gammagard. Gammagard injections are considered medically necessary for this patient. 

Diagnostic criteria for hypogammaglobulinemia by the European Society of immunodeficiency (ESID) require a substantial decrease in IgG concentration defined by at least two standard deviations below the average for the age group. The range for healthy adults is from 8 to 12 grams per liter (g/L). The most commonly recognized clinical feature is recurrent infection. Regularly scheduled treatment with high doses of immunoglobulin treatments, intravenous (IVIG) or subcutaneous Immunoglobulin (SCIG), leads to improved outcomes, including fewer hospitalizations and severe infections. 

"Immunoglobulins are widely used in both, immunodeficient patients, to provide antibodies to prevent viral and bacterial infections (replacement therapy), and in patients with autoimmune and inflammatory diseases, mediating immunomodulation and attenuating inflammatory responses." (Frenzel, W. et al. 2016) 

"Hypogammaglobulinemia is a disorder caused by low serum immunoglobulin or antibody levels. Immunoglobulins are the main components of the humoral immune response and able to recognize antigens to trigger a biological response and eradicate the infectious source. Hypogammaglobulinemia is the most common primary immunodeficiency and encompasses a majority of immune-compromised patients. In order to avoid the high morbidity and mortality associated with this condition, it must be promptly diagnosed and treated. The evaluation consists of lab tests, clinical findings, vaccination response, and genetic testing. Treatment is IVIG transfusions, antibiotics, and glucocorticoids." (Huq, M., Bhatnagar, N. K., & Hostoffer, R. W. 2022) 

"Immunoglobulin replacement is the basis of treatment for hypogammaglobulinemia, reducing sequelae from the respective immunological defect (4,25)." (Pimenta, F., Palma, S., Constantino-Silva, R. N., & Grumach, A. S. 2019) 

The health plan did not act reasonably with sound medical judgment in the best interest of the patient. 

The insurer's denial of coverage for Gammagard injections is overturned. Medical Necessity is substantiated.