Dialysis Patient Outcomes Not Worse After Bundling, ESA Label Changes

Study finds no increased risk of major adverse cardiovascular events and death.
Study finds no increased risk of major adverse cardiovascular events and death.

Older patients undergoing hemodialysis (HD) covered by fee-for-service Medicare did not have increased risks of major adverse cardiovascular events and death after 2011, when the federal government implemented a bundled payment policy for dialysis services and the FDA revised drug labeling for erythropoiesis-stimulating agents (ESAs), according to a new study.

The study, published online ahead of print in JAMA Internal Medicine by Cunlin Wang, MD, PhD, of the FDA's Center for Drug Evaluation and Research in Silver Spring, Maryland, and colleagues, also showed that the risk of stroke decreased and the rate of blood transfusions increased modestly. Black patients had substantial decreases in the risks of major adverse cardiovascular events (MACE) and death.

In 2011, the Centers for Medicare & Medicaid Services (CMS) implemented a prospective payment system in which dialysis providers are paid a fixed amount that includes the cost of ESAs. The FDA label changes advised more conservative dosing for patients with chronic kidney disease. It removed a specific desired hemoglobin target and strengthened warnings of the greater risk of death and serious cardiovascular events associated with a hemoglobin target level greater than 11 g/dL. In response to concerns that these changes could adversely impact HD patient care, CMS and FDA in 2012 started a collaboration to evaluate the effect of these changes on patient outcomes.

“Our study provides an example of how the CMS and the FDA can collaborate to assess the effect of reimbursement policies and drug labeling changes on public health,” the investigators concluded.

For their retrospective cohort study, Dr Wang and colleagues looked at the outcomes of 69,718 incident HD patients aged 66 years and older and were enrolled in Medicare parts A, B, or D for at least 12 months prior to HD initiation from January 1, 2008 and December 31, 2013. The investigators divided patients into 2 cohorts based on their date of HD initiation: a pre-policy cohort (initiated HD January 1, 2008, to December 31, 2009) and a post-policy cohort (initiated HD July 1, 2011, to June 30, 2013), excluding January 1, 2010, to June 30, 2011, as a transition period.

Compared with patients in the pre-policy period, those in the post-policy period had similar risks of MACE, death, hospitalized congestive heart failure, and venous thromboembolism and a significant 23% decreased risk of stroke. Results also showed that the use of ESAs decreased and the risk of blood transfusion increased by 9%.

Black patients in the post-policy period had a significant 18% decreased risk of MACE and 18% decreased risk of death from any cause.

In an accompanying editorial, Robert Steinbrook, MD, of Yale School of Medicine in New Haven, Connecticut, noted that the new study adds to a recent report by Glenn Chertow, MD, and colleagues in the Journal of the American Society of Nephrology (2016;27:3129-3138) that also found a decreased risk of stroke for dialysis patients in the post-policy period, as well as decreased rates of venous thromboembolic disease and heart failure. These studies “document a win-win for patient safety, public health, and the financial stability” of the federal end-stage renal disease program, Dr. Steinbrook wrote.

The CMS and FDA “should continue to collaborate to study the effects of changes in prescribing information and reimbursement policies on public health and the costs of medical care,” he stated.

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