Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's disease

Treatment: Injection of Infliximab (J1745) in a hospital setting

The insurer denied coverage for an injection of Infliximab (J1745) in a hospital setting
The denial is overturned

This case involves a male who was diagnosed with Crohn's disease and was started on a short course of prednisone after a flareup. He continued to make slow steady progress despite some setbacks. Progress notes stated the patient was taking 15 mg of prednisone twice daily. Recent blood work showed normal sedimentation rate, normal C-reactive protein (CRP), normal blood count, and normal chemistries. He was having 1-2 bowel movements each day without blood or mucus. He reported no history of fever or joint pains, and his general health had been good. The plan was to continue weaning prednisone by about 5 mg (milligrams) every week. He was due for his next Remicade (Infliximab) infusion. The patient presented to the hospital to receive an Infliximab injection to control his Crohn's disease. The patient received a notice of adverse determination stating that criteria was not met given that the drug must have been approved under the plan clinical criteria. It stated that the drug must be given by certain medical personnel, with the patient needing to be watched very closely in the hospital setting. If a problem occurred when the drug was given, treatment needed to be given in the hospital setting.  An appeal was submitted, stating that the patient transferred care and was initially doing well on 700 mg of infliximab every 6 weeks. He experienced a flareup and continued to require close monitoring and a work-up of Crohn's disease. The patient has a history of high antibody formation and was at risk for infusion reactions. It was determined that it was not safe for the patient to be given infusions at home. This review pertains to the denial of coverage for injection of Infliximab (J1745) in a hospital setting. 

The injection of Infliximab (J1745) in a hospital setting was considered medically necessary for this patient. The Food and Drug Administration notes that infliximab is indicated for pediatric Crohn's disease to reduce the signs and symptoms while inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. Literature has noted that in comparing the infusion of biologic agents in the home as opposed to receiving the treatment in a hospital setting, evidence was found that patients were receiving suboptimal outcomes with home infusions compared to hospital infusions. This did not result in significant savings compared with office infusions. The information provided for the review noted that the patient was receiving infliximab injections every 6 weeks with benefit in controlling his Crohn's disease. The physician clearly stated that because the patient has a history of high antibody formation and was at risk for infusion reactions, it was imperative that he received infusions in the hospital setting. The patient was due for an infusion at that time, and the administration of the infliximab was appropriate to prevent and/or control any adverse side effects from the treatment. Based upon the provided information, the injection of infliximab in a hospital setting was medically necessary. As such, the prior determination is overturned.

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

The insurer's denial of coverage for injection of Infliximab (J1745) in a hospital setting, is overturned. Medical Necessity is substantiated.