Large, for-profit dialysis facilities appear to administer higher than necessary amounts of a medication for treating anemia in patients with kidney disease, compared to nonprofit facilities, according to a study in the April 18 issue of JAMA.
Anemia, a common complication of chronic kidney disease and end-stage renal disease (ESRD), occurs when there are too few red blood cells or the red blood cells are deficient in hemoglobin. The drug epoetin can be administered to increase red blood cell count to an appropriate range, and this is measured by hematocrit levels (the percentage of blood that is comprised of red blood cells).
"By 2005, 99 percent of in-center hemodialysis patients received epoetin treatment for their anemia," the authors write. "Today, epoetin therapy is the largest single Medicare drug expenditure totaling $1.8 billion in 2004 (an increase of 17 percent from 2003) and epoetin comprised 11 percent of all Medicare ESRD costs." The type of facility (profit, chain, and affiliation status) at which a patient receives dialysis may affect epoetin dosing patterns. Since 1991, epoetin payment has been based on the amount of drug administered, creating a financial incentive for increased use of this therapy, according to background information in the article. Several trials have failed to show a benefit of increasing hematocrit levels above the recommended range, while other trials have suggested possible adverse effects.
Mae Thamer, Ph.D., of the Medical Technology and Practice Patterns Institute, Bethesda, Md., and colleagues conducted a study to examine the relationship between organizational status and epoetin dosing. The researchers used the U.S. Renal Data System to identify 159,522 adult Medicare-eligible, end-stage renal disease patients who were receiving in-center hemodialysis during November and December 2004. The authors developed models to estimate the average epoetin dose and dose adjustment by profit, chain, and affiliation status.
Compared with patients in nonprofit dialysis facilities (n = 28,199), patients in large for-profit dialysis chain facilities (n = 106,116) were consistently administered the highest doses of epoetin regardless of anemia status. Dosing adjustments differed by type of facility. On average, compared with nonprofit facilities, for-profit facilities increased epoetin doses 3-fold for patients with hematocrit levels of less than 33 percent and also increased the doses among patients with hematocrit levels in the recommended target of 33 percent to 36 percent, especially in the largest for-profit chain facilities. The greatest difference in dosing practice patterns between facilities was found among patients with hematocrit levels of less than 33 percent.
"Our results indicate that facility ownership and chain status have a strong effect on epoetin dosing practice patterns. Compared with other facility types, we found that large for-profit chains administered higher epoetin doses, used higher dose increases, and had higher achieved hematocrit levels, as well as a larger proportion of patients above the upper limit of hematocrit level (target of 36 percent was recommended by the National Kidney Foundation and the U.S. Food and Drug Administration during the time of our study)," the authors write.
"In conclusion, these findings suggest that reimbursement policy and clinical performance measures may provide incentives for dialysis facilities, in particular for-profit facilities, to target hematocrit levels exceeding those recommended by the clinical guidelines. As existing guidelines are reevaluated, it will be important for policy makers to design an epoetin reimbursement policy that provides an incentive to achieve desired clinical outcomes while optimizing epoetin usage."
Editorial: Use of Epoetin in Chronic Renal Failure
In an accompanying editorial, Daniel W. Coyne, M.D., of the Washington University School of Medicine, St. Louis, comments on the study on epoetin use in dialysis treatment centers.
"An unanswered question in the study by Thamer et al is why would nephrologists prescribe so much more epoetin, and make such dubious dosing decisions, when caring for patients at certain for-profit chains compared with patients treated at nonprofit facilities. Most nephrologists do not own dialysis facilities or profit from increased erythropoiesis stimulating agent [ESA; such as epoetin] use by facilities or chains."
"Another important question is why for-profit dialysis chain facilities permit such management and whether they actually encourage or even orchestrate such management," Dr. Coyne writes. "A third key question is whether anemia treatment guidelines for patients with renal failure should promote more prudent management."
"The FDA has stated that the goal of ESA therapy is to reduce transfusions, and the risks and benefits in choosing to use an ESA must be carefully weighed for each patient. Because the FDA is responsible for drug safety, it is important that clinicians adhere to its recommendations."