2016
DOI: 10.1001/jamainternmed.2016.6520
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Association Between Changes in CMS Reimbursement Policy and Drug Labels for Erythrocyte-Stimulating Agents With Outcomes for Older Patients Undergoing Hemodialysis Covered by Fee-for-Service Medicare

Abstract: IMPORTANCE In 2011, the US Centers for Medicare & Medicaid Services (CMS) changed its reimbursement policy for hemodialysis to a bundled comprehensive payment system that included the cost of erythrocyte-stimulating agents (ESAs). Also in 2011, the US Food and Drug Administration revised the drug label for ESAs, recommending more conservative dosing in patients with chronic kidney disease. In response to concerns that these measures could have adverse effects on patient care and outcomes, the CMS and the FDA i… Show more

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Cited by 36 publications
(46 citation statements)
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“…They found no difference in cardiovascular outcomes among White fee-for-service Medicare patients on dialysis 66 years or older during the 2-year period before and after the PPS and ESA changes while an 18% reduction in cardiovascular events was observed in Black patients. Such findings suggest that different target ESA and Hb levels may be appropriate for Black dialysis patients (37).…”
Section: Anemiamentioning
confidence: 94%
“…They found no difference in cardiovascular outcomes among White fee-for-service Medicare patients on dialysis 66 years or older during the 2-year period before and after the PPS and ESA changes while an 18% reduction in cardiovascular events was observed in Black patients. Such findings suggest that different target ESA and Hb levels may be appropriate for Black dialysis patients (37).…”
Section: Anemiamentioning
confidence: 94%
“…Awareness of these reimbursement changes and their possible influence on provider practices are critical when conducting studies to address a specific clinical question. In fact, designing and conducting studies that take advantage of such policy changes can often provide compelling information regarding the effectiveness and/or safety of therapeutic interventions 22,23…”
Section: Factors To Consider When Using Medicare Data For Researchmentioning
confidence: 99%
“…If approved, CMS enters into a Data Use Agreement (DUA) with the researcher. These data have been used to describe patterns of morbidity2 and mortality3 and burden of disease,4,5 compare the effectiveness of pharmacologic therapies,6–9 examine the cost of care,1013 evaluate the effects of provider practices on the delivery of care,1417 and explore the effects of important policy changes on physician practices and patient outcomes 1823. The use of the Medicare databases as sources for epidemiologic and health outcomes research has increased substantially over time (Figure 1).…”
Section: Introductionmentioning
confidence: 99%
“…Recently, two major trends in anemia management have evolved. 27 In contrast, a broad trend has generally favored more restrictive transfusion use, manifested by increased tolerance for lower hemoglobin levels before transfusion administration. 1 Declines in ESA use were followed by an approximately10% increase in transfusion use during this same time period.…”
Section: Discussionmentioning
confidence: 99%
“…1 Declines in ESA use were followed by an approximately10% increase in transfusion use during this same time period. 27 In contrast, a broad trend has generally favored more restrictive transfusion use, manifested by increased tolerance for lower hemoglobin levels before transfusion administration. Such an approach is formally recommended by the AABB, based in large measure on the results of cardinal randomized controlled trials (RCTs).…”
Section: Discussionmentioning
confidence: 99%