Diagnosis: Crohn's Disease.
Treatment: Lab Work/Blood Tests- therapeutic drug monitoring.
The insurer denied Lab Work/Blood Tests- therapeutic drug monitoring.
The determination is overturned.

This patient has a past medical history significant for fistulizing ileocolonic Crohn's disease status/post (s/p) end-to-end anastomosis, currently on a weekly dose of Humira and low-dose methotrexate therapy. They were recently admitted for suspected Crohn's flare characterized by diarrhea, requiring hospitalization. Subsequent work-up revealed computed tomography (CT) scan findings of ileocolitis, colonic infection by Shigella and Cryptosporidium in the setting of chronic immunosuppression, elevated liver function test (LFT), which led to discontinuation of the methotrexate. In addition, the patient's inflammatory bowel disease (IBD) history is noted for history failure of Mercaptopurine (6-MP) monotherapy and of autoantibody formation to Humira, which led to increased dosing of Humira with combination therapy with methotrexate. The patient is currently on Humira monotherapy. The gastrointestinal (GI) provider is currently requesting rechecking Humira drug levels. At issue is the proposed health service or treatment laboratory services.

The proposed health service/treatment laboratory service is likely to be more beneficial than any standard treatment for the insured life threatening or disabling condition or disease.

Unfortunately, this patient is at a high risk for complication based on prior history of failure of multiple immunosuppressive agents. Furthermore, they have experienced repeat Crohn's flare, secondary to pharmacokinetics failure of Humira secondary to autoantibody formation to Humira resulting in loss of response of Humira. It is clinically significant to determine (the presence and concentration of autoantibody formation). This clinical information is necessary to continue with Humira or switch in-class or out-class anti-tumor necrosis factor (TNF) agents. Failure to determine autoantibody formation may lead to the selection of suboptimal immunosuppression and increase complications, leading to increased mortality and morbidity.