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December 8, 2020

Parenteral Iron Therapy Article

This coverage article addresses the use of parenteral iron preparations in the following non-dialysis related clinical presentations. This is separate from and does not address or apply to parenteral iron preparations in the beneficiary with end-stage renal disease (ESRD) on hemodialysis, covered in NCD 110.10.

Medicare benefits regarding parenteral drug use are defined in the Internet Only Manual 100-02: Chapter 15: Section 50.4.3 (1) that defines "reasonable and necessary" concerning drugs: "Medication given by injection (parenterally) is not covered if standard medical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration."

The usual method for administering iron preparations is by the oral route, except in dialysis patients in whom vascular access is already present. Medicare does not cover intravenous iron outside of dialysis patients unless there is a medical reason that precludes oral administration. Parenteral iron is associated with a higher cost, need for supervised treatment, and risk of anaphylaxis or other allergic reaction. While observational studies report increases infectious complications and mortality using parenteral iron, this has not been reproduced in randomized control trials, systematic review, and meta-analysis (3). There is little data to suggest a reduction in blood transfusions or improved health outcomes from the parenteral route as compared to oral outside of chronic kidney disease on hemodialysis (4). Therefore, in most circumstances, oral iron is the preferred route. When oral iron is not tolerated or effective, and iron deficiency anemia is documented in the medical record, parenteral iron therapy may be considered reasonable and necessary.

Oral iron therapy is considered "not tolerated" when the patient has demonstrated significant side effects, typically gastrointestinal, and compliance with oral regime is no longer feasible. Delayed-release formulation, enteric-coated iron tablets, alternating days, reduced dosing, or less frequent dosing schedules may improve tolerance. A trial of oral iron should be over a minimum of six weeks, and efforts to reduce side effects must be documented in the record (4).

Effective treatment of iron deficiency results in the resolution of symptoms, modest reticulocytosis (peaking in 7 to 10 days), and normalization of the hemoglobin level in six to eight weeks and continues until ferritin transferrin saturation normalizes (2). Oral iron therapy is considered "not effective" if, after 6-8 weeks, there is a failure to improve iron indices despite compliance with oral iron regimes. This would be most commonly seen in conditions where iron absorption is limited due to pathological or anatomical conditions, such as malabsorption syndromes, inflammatory bowel disease (IBD), short bowel/short gut syndrome, or after gastric bypass surgery. Studies suggest less than 25% of patients with IBD would not tolerate oral preparations. They have similar repletion rates, so there is currently not supporting literature to support the parenteral route without other indications in this population (2, 5).

If the provider determines they do not have 6-8 weeks for a trial of oral iron, the rationale must be documented in the medical record.

References:

  1. Internet Only Manual 100-02: Chapter 15: Section 50.4.3External PDF
  2. Salim SA, Cheungpasitporn W, Elmaraezy A, et al. Infectious complications and mortality associated with the use of IV iron therapy: a systematic review and meta-analysis. International urology and nephrology. 2019;51(10):1855-1865. doi:10.1007/s11255-019-02273-4
  3. Rizvi S, Schoen RE. Supplementation with oral vs. intravenous iron for anemia with IBD or gastrointestinal bleeding: is oral iron getting a bad rap? The American journal of gastroenterology. November 2011:1872-1879. doi:10.1038/ajg.2011.232
  4. de Silva AD, Mylonaki M, Rampton DS. Oral iron therapy in inflammatory bowel disease: usage, tolerance, and efficacy. Inflamm Bowel Dis. 2003;9(5):316.

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