Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Anemia. 
Treatment: A drug (procedure code J1437). 

The insurer denied coverage for a drug (procedure code J1437). 

The denial is upheld. 

This is an adult patient with iron deficiency anemia in the setting of gastric bypass. The treating provider had administered Monoferric, which had been deemed as not medically necessary per the insurer. 

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. There is no documentation to support that there was treatment of oral iron, for four weeks. Furthermore, the Hematocrit (Hct) that is reported was 30 and improved several days later to 31.9 prior to the Monoferric. These are not critical values. Review of the notes does not indicate a trial of oral iron replacement. 

The choice between oral and intravenous (IV) iron depends on a number of factors including the acuity of the anemia, costs, and availability of different iron replacement products, as well as the ability of the patient to tolerate oral iron preparations. 

In general, IV iron is supported in the following situations. It is appropriate for patients who are unable to tolerate gastrointestinal side effects of oral iron. IV iron may be needed for those with severe/ongoing blood loss (telangiectasias, varices). Gastric surgery (bypass, resection) that reduces gastric acid may severely impair intestinal absorption of oral iron. Malabsorption syndromes (celiac disease, Whipple's disease, bacterial overgrowth) may limit absorption of oral iron. 

For individuals who do have access to IV iron, administration may reduce the use of blood transfusion, which in turn avoids transfusion-associated risks. This was demonstrated in a systematic review and meta-analysis of trials that randomly assigned patients to IV iron versus oral iron or no iron. The administration of IV iron was associated with a lower frequency of blood transfusions (risk ratio [RR] 0.74; 95% Confidence Interval (CI) 0.62-0.88). The meta-analysis included trials in a number of conditions, including chronic kidney disease, inflammatory bowel disease, cancer, surgery, and pregnancy, among others. A number of IV iron formulations are available, including ferric carboxymaltose (FCM), ferric gluconate (FG), ferumoxytol, iron sucrose (IS), iron isomaltoside (termed ferric derisomaltose in the United States and Australia), and low molecular weight iron dextran (LMW ID). All of these formulations are equally effective in treating iron deficiency and have a similar safety profile. 

All forms of IV iron are considered equally valid and efficacious to treat iron deficiency anemia with no significant difference between formulations with regards to efficacy or safety. While Monoferric is one form of IV iron there are other formulations available that can safely deliver iron intravenously. As such the Monoferric was not necessary. 

Iron deficiency is one of the most common causes of anemia. The 2 main etiologies of iron deficiency are blood loss due to menstrual periods and blood loss due to gastrointestinal bleeding. Beyond anemia, lack of iron has protean manifestations, including fatigue, hair loss, and restless legs. The most efficient test for the diagnosis of iron deficiency is the serum ferritin. Iron replacement can be done orally, or in patients in whom oral iron is not effective or contraindicated, with intravenous iron. (DeLoughery T. G., 2017) Regarding iron replacement post bariatric surgery, as summarized in UpToDate, for repletion, "oral: 150- 200 milligrams (mg) 2-3 times per day is recommended. Parenteral iron is recommended for those who do not respond to oral supplementation." 

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 a drug (procedure code J1437) is not substantiated.