Even After “Black Box” Warning, For-Profit Dialysis Centers Used More ESAs

After a “black box” warning to use the lowest possible dose of erythropoiesis-stimulating agents (ESAs), for-profit dialysis facilities continued to prescribe higher ESA doses, according to a report in JAMA Internal Medicine.

The researchers analyzed U.S. Renal Data System data on more than 275,000 patients receiving in-center hemodialysis before and after a 2007 black box warning on ESA use. This safety directive from the U.S. Food and Drug Administration called for use of the lowest possible ESA dose to avoid the need for blood transfusion and for withholding ESAs in patients with hemoglobin levels higher than 12 g/dL. The researchers analyzed the effects of the black box warning on ESA dosing and hematocrit for both for-profit and nonprofit dialysis facilities.

At both times and across hematocrit categories, for-profit dialysis facilities used higher doses of ESAs than did nonprofit facilities, after adjustment for case mix. At for-profit centers, the median weekly ESA dose was 9020 U before the black box warning and 8322 U afterward. At nonprofit centers, the figures were 5670 U and 5063 U, respectively.

The median weekly ESA dose increased 54.7 percent for patients who switched from a nonprofit to a for-profit facility from before to after the black box warning, compared with a 50.9 percent decrease for those who switched from a for-profit to a nonprofit facility. After the warning, for-profit dialysis centers performed no better than nonprofit centers in avoiding hematocrit levels below 30 percent.

The findings suggest that “financial considerations may have played a role” in ESA dosing at for-profit centers. The authors discuss the need for ongoing monitoring of dialysis care and outcomes since implementation of the bundled reimbursement system [Ishida JH, et al. Dialysis facility profit status and compliance with a black box warning. JAMA Intern Med 2013; May 13:1–2. doi:10.1001/jamainternmed.2013.979].

July 2013 (Vol. 5, Number 7)