David Spiegel

I wish to comment on the CMS proposal to drop the Hb > 10 mg/dL as a quality measure. While the scientific data on ESAs is unclear and both the FDA and CMS are correct that there are some safety signals, ESAs as all medicines, should be evaluated on a risk/benefit analysis. There are certainly patients who may do “better” with less ESA or no ESA and a lower Hb. However, after practicing nephrology for 20 years and caring for ESRD patients it is clear that ESAs have improved the quality of life for many patients. Whether that improvement levels off at Hb > 9 or > 10 mg/dL is unclear. ESAs have also significantly reduced (although certainly not eliminated) transfusions in ESRD patients. In this era where the care of dialysis patients is being entrusted to a small number of for-profit companies it seems unwise to eliminate a lower Hb threshold completely. While these companies try to maintain quality care, there will be increasing pressure from within the corporations to increase or maintain profits. That is what we expect of American businesses, and calling them a healthcare company doesn’t eliminate those pressures. As a regulatory agency CMS needs to help maintain the balance between quality vs. profit within for-profit healthcare. In addition, just as the hard lower target might seem unwise, one could easily argue that a young active patient with no heart disease might benefit significantly from a Hb > 12 mg/dL. In the past, physicians discussed risk-benefits with patients regarding medication treatment. Clearly, guidelines and best practices based on incomplete information did away with these discussion and gave us fixed (although moving) targets. Maybe it is time to admit that we don’t know the answer, we begin to bring our patients back into the discussion of quality/quantity of life, pay a fair value for medications, and incorporate safety measures that identifies outlying practices that under or over prescribe.