Iron is an essential component in hematopoiesis and, as such, should supplement ESA treatment. In 1989, the introduction of ESAs led to a renewed interest in parenteral iron therapy. After initiation of ESA therapy, functional iron deficiency occurred in almost every patient as the result of the non-physiologic administration of ESA.1
By 1997, reports showed that maintaining serum ferritin and percent transferrin saturation levels above 100 ng/mL and 20% resulted in reaching and maintaining better target Hb levels and/or lowering the dose of ESA required. Oral iron was used initially, but it was poorly tolerated and only marginally effective, so IV iron was employed to treat these patients. Virtually all hemodialysis patients receiving ESA should be treated with IV iron.
ESA treatment alone will rapidly deplete iron stores leading to functional iron deficiency and the production of iron-poor RBCs (iron-deficient erythropoiesis).
When administered with ESAs, IV iron prevents both absolute and functional iron deficiency and serves to minimize the dose of ESA needed to achieve target range Hb level.
Under the current Committees for Medicare and Medicaid Services (CMS) Coverage Determinations governing usage of ESA, if iron deficiency is present, ESAs are contraindicated until iron repletion has been accomplished.
The conundrum is that there is no ICD10 code for either functional iron deficiency or iron-restricted erythropoiesis, which for all intents and purposes is the same thing. Clearly, the lack of codes for functional iron deficiency creates a problem in hematology and oncology practices where these drugs are widely used in that they may limit reimbursement for both ESAs and intravenous iron.
The current guidance from CMS restrict payment if ESA and IV iron is given on the same day. Although inexplicable at first, as this regulation clearly increases the number of office visits outside of dialysis centers, where the regulation does not apply, given the requirement for iron repletion prior to ESA usage, if Iron deficiency anemia, unspecified (D50. 9) is placed on a billing form, the ESA will not be paid for. On the other hand, if (D50. 9) is not placed on the billing form, the IV iron will not be reimbursed. Providers are urged to consult with billing and coding professionals within their institution as well as their regional Medicare Administrative Contractor. Single dose intravenous iron replacement with 1 gram of iron based on an transferrin saturation less than 20% at the time of an initial or subsequent visit may be the most practical course of action to both appropriately mange clinical care for the patient and optimize coverage and reimbursement.