NN&I - January 2012

Renal Policy January 2012 Nephrology News Issues 33 week a 83 fall in new ESA orders to 11 per patient year and a decline in new IV iron orders to 14 per patient year after an initial increase to ensure adequate repletion Patient hemoglobin level rose 8 to 124 g dL while the coefficient of variation fell 23 to 58 All cause mortality was 118 overall with 2971 patient years of follow up The severity of anemia decreased and so did care costs IV iron costs did rise 62 to 731 per treatment But ESA costs fell 32 to 3322 per treatment Overall treatment costs fell 24 from 5350 to 4053 excluding reduced staff time needs and other indirect savings Ameliorating anemia is only an interim step The eventual endpoint is to develop a more effective approach to reduce cardiovascular events and death in patients with renal disease Reducing such events will we hypothesize mitigate disease complexity and complications and ultimately lower the overall patient treatment costs www NephrologyNews com e g hospitalizations The exemplar is Professor Hannelore Hampl MD and her colleagues in Berlin Over the past 30 years they have pioneered a remarkably systematic and successful multidisciplinary approach for hemodialysis patients to 1 reduce cardiovascular events and death 2 regress left ventricular hypertrophy 3 achieve full correction of renal anemia to prevent reactive thrombocytosis and 4 maximize ESA responsiveness to minimize their required dose and costs 20 25 Despite a mean hemoglobin of 146 g dL mean TSAT 468 well outside the CMS QIP threshold and FDA black box warning the Berlin mortality rate from cardiac events is a mere 5 and the all cause figure is 132 The results are real and a cause for casting out long established assumptions about what is possible among dialysis patients see Tables 1 and 2 Remarkably the Berlin ESA dose was 85 less than in the Normal Hematocrit Study cited in the FDAs recent black box warning and achieved far better results 26 Summary We are eager to explore how Hampls findings might best apply to our own patients The ability to innovate to move the boundaries of knowledge forward is essential to improve patient care and to ensure our financial viability as a regional patient care organization Ultimately we believe our own survival depends on our ability to take on and manage the clinical and financial responsibilities for the whole patient However CMS has quashed such practice based efforts by perversely targeting hemoglobin levels in the name of quality improvement rather than the abusive use of ESAs The QIPs mandatory financial penalties for higher hemoglobin undermines the financial foundations of our research At the same time and despite its dubious basis the FDA black box warning raises the specter of untoward medico legal liabilities Let CMS hold providers accountable for results that matter to patients that bear directly on costs CMS already generates meaningful dialysis provider benchmarks in its annual facility reports It increasingly holds us accountable for costs through bundling and perhaps in the offing global capitation Let the QIP reflect what matters most mortality morbidity and hospitalizations But do not implement benchmarks of dubious clinical origin that distort if not wholly undermine our ability to deliver better and more cost effective care to our patients Otherwise we all lose patients providers and CMS References 1 FDA Food and Drug Administration Drug Table 1 Anemia correction and iron parameters among dialysis patients in Berlin Result Units Baseline Follow up p value Epoietin β IU kg week 153 68 0001 Hemoglobin g dL 114 146 0001 IV iron mg month 355 156 0001 TSAT 272 468 001 modified from Hampl H et al Am J Nephrol 25 211 2005 Table 2 Hemodynamic variables echocardiographic results outcome among dialysis patients in Berlin Result Units Baseline Follow up p value Pre HD systolic BP mm Hg 153 132 001 Pre HD diastolic BP mm Hg 87 81 001 NYHA class class 28 196 001 Left ventricular mass index LVMI g m2 1594 1325 0001 LV ejection fraction LVEF 602 658 001 LV end diastolic diameter LVMI mm 54 522 005 Intraventricular septum thickness mm 116 106 001 LV posterior wall thickness mm 108 99 001 All cause mortality 132 Cardiac mortality 5 modified from Hampl H et al Am J Nephrol 25 211 2005