Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Iron deficiency anemia in the setting of prior gastric bypass surgery.

Treatment: Normal saline solution infusion, 250 millimeters, intravenous therapy/prophylaxis/Dx 1st to 1 hour.

The insurer denied coverage for the normal saline solution infusion, 250 millimeters, intravenous therapy/prophylaxis/Dx 1st to 1 hour.

The denial is overturned.

This is a female patient with a history of gastric bypass with iron deficiency anemia.  The patient's lab work showed a hemoglobin level of 8 and a ferritin level of 1.  The treating provider administered therapy with intravenous (IV) Venofer.

Per Lewis et al. (2020), "Bariatric surgery may increase the risk of iron, vitamin B12, folate and copper deficiencies, which can cause [anemia]."  As per Sandvik et al. (2020), "Clinical information was available for all patients at baseline and for 553/644 patients at 5 years; laboratory results were available for 540/644 patients at baseline and 411/644 patients after 5 years...verall, 187/483 (38.7%) women and 9/161 (5.6%) men were given intravenous iron treatment in the observation period.  From baseline to 5 years, mean [hemoglobin] decreased by 0.3 g/dL [grams per deciliter] in both men and women.   [Anemia] occurred in 18/311 (5.8%) women and 9/100 (9%) men at 5 years.  Depleted iron stores (ferritin 15 g/L [grams per liter]) were seen among 44/323(13.6%) women and 3/102 (2.9%) men, and low iron stores (ferritin 1650 g/L) occurred in 144/326 (44.6%) women and 38/102 (37.3%) men 5 years after [Roux-en-Y Gastric Bypass (RYGB)]." 

Per Malone et al. (2013), "Iron management was inadequate. Hematologic values often were deficient for sustained periods.  Initially, few patients received intravenous iron after oral iron failure, many received no iron supplementation, and there was high use of blood transfusions.  Subsequently, administration of intravenous iron was beneficial." As per DeFilipp et al. (2013), "Before treatment, all 23 patients were iron deficient (average ferritin 6 ng/mL [nanograms per milliliter]) and anemic (average hemoglobin 9.4 g/dL).  By 3 months, the average ferritin and hemoglobin had increased to 269 ng/mL and 12.3 g/dL, respectively.  The hemoglobin levels remained stable throughout the follow-up period.  The iron stores were adequately replaced in most patients.  Four patients required a repeat infusion by 1 year, because the ferritin levels had decreased to <15 ng/mL.  The probability of remaining in an iron replete state was 84.6% (95% confidence interval 78-91.2%).  One patient required warm compresses for superficial phlebitis.  No other significant adverse events were reported."               

Based on the review of the medical record and literature, this patient has evidence of iron deficiency anemia in the setting of prior gastric bypass surgery.  These patients have known iron malabsorption and replacement with oral iron is inadequate for their treatment.  It is recommended that these patients be given IV iron for the treatment of iron deficiency anemia up front.  At this time, any formulation of IV iron is appropriate in this setting and there is no medical preference of one formulation over another.  Venofer is an acceptable form of IV iron and would be appropriate in this setting.  For administration of IV iron it is necessary to administer it in 250 milliliters (ml) normal saline solution infusion, and Venofer over 30-60min.

The normal saline solution infusion, 250 millimeters, intravenous therapy/prophylaxis/Dx 1st to 1 hour, is considered medically necessary for this patient.

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.
                                          
The carrier's denial of coverage for the normal saline solution infusion, 250 millimeters, intravenous therapy/prophylaxis/Dx 1st to 1 hour should be overturned.  The medical necessity is substantiated.