Based on accumulating evidence, in 2007 the FDA issued a “black box” warning recommending avoidance of Hb levels greater than 12 g/dL, and the Centers for Medicare and Medicaid Services made an NCD to limit coverage of ESAs for non-renal disease indications, which was implemented in 2008 (Center for Medicare and Medicaid Services, 2007; US Food and Drug Administration, 2007b, 2017). The gene discussed is GSTM1; the disease is kidney disorder.