NN&I - January 2012

Renal Policy Commentary Perpetuating sub optimal care CMS QIPs and the hemoglobin myth Stephen P Pollak PhD Jonathan A Lorch MD FACP Victor E Pollak MD FACP FRCPE Abstract As the new Centers for Medicare Medicaid Services Quality Incentive Program takes effect the implications are enormous for dialysis patients Contrary to its intention the Quality Incentive Program with its upper hemoglobin limit may well stifle innovative practice based research and practical approaches to anemia management An opportunity to move away from an excessive preoccupation with ESAs to substantially improve patient outcomes and to do so at a much lower cost may well be lost to patients providers and CMS as a result Introduction The new end stage renal disease QIP reflects a flawed understanding of disease complexity reinforced by three problematic randomized controlled trials Rather than promote a more relevant and effective care approach one that provides more value for payers and dialysis patients alike the QIP will stifle clinical understanding and innovation raise care costs and greatly harm patients Our concern is the upper achieved hemoglobin Hb bound of 12 g dL We have been pioneering a new approach to anemia through a program of practice based research and continuous quality improvement Our data based outcomes oriented methods are patient not population driven achievement not target driven and focused on addressing individual needs over time The results so far include much improved outcomes and fewer drug inputs than national and international norms see Figure 1 But the financial penalties under the QIP program give us little choice We exceed the QIP upper threshold Our work must stop we must downgrade our care Achieved hemoglobin vs ESA dose In fairness to CMS the U S Food and Drug Administration has long warned about the dangers of using ESAs to target higher hemoglobin levels For chronic kidney disease patients it warned in June 2011 that providers should reduce or interrupt ESA use when hemoglobin levels exceed either 11 g dL for dialysis patients or 10 g dL for non dialysis CKD patients 1 Seven days later CMS proposed the 2013 QIP raising financial penalties for hemoglobin above 12 g dL while eliminating those for hemoglobins below 10 g dL The new black box warning for Amgens Epogen asserts that using ESAs to target higher hemoglobin levels can increase the risk for stroke heart attack heart failure blood clots and death The FDA cites three randomized target trials as evidence Each RCT sought to establish the ESA dosing regimen required to achieve a distinct hemoglobin target Patients who responded poorly to the ESAs or not at Dr Stephen P Pollak is Executive Director of the Rogosin Health Action Institute and Chief Innovation Officer of the Rogosin Institute based in New York Dr Lorch is Associate Professor of Clinical Medicine Weill Medical College of Cornell University and Chief Medical Officer of the Dialysis Division at the Rogosin Institute Dr Victor E Pollak is Emeritus Professor of Internal Medicine University of Cincinnati and Professor of Clinical Medicine University of Colorado He is also senior vice president and medical director of MIQS Inc based in Boulder Colo Figure 1 An international perspective Achieved hemoglobin vs ESA dose Nephrology News Issues January 2012 Subscribe to our free eNewsletter at www NephrologyNews com 30