Medicare Payment Formula Results in Some For-Profit Dialysis Chains Giving Higher Doses of Anemia Drug Than Not-For-Profit Centers, Study Finds
For-profit dialysis centers administer higher and more doses of the anemia medication Epogen, manufactured by Amgen, to kidney disease patients than non-for-profit centers, according to a study published on Wednesday in the Journal of the American Medical Association, Reuters/Los Angeles Times reports. For the study, researchers from the not-for-profit Medical Technology and Practice Patterns Institute examined the medical records of almost 160,000 severely ill kidney disease patients, about 80% of whom received treatment at for-profit dialysis centers. Dialysis centers administer Epogen, a synthetic form of the protein erythropoietin, to increase red blood cell, or hematocrit, levels in kidney disease patients, who often have low levels. At the time of the study, medical guidelines recommended hematocrit levels of between 33% and 36% for kidney disease patients. However, the study found that about one-fourth of participants who received treatment at for-profit dialysis centers had hematocrit levels of 39% or higher. According to the study, not-for-profit dialysis centers reduced doses of Epogen administered to participants after they reached recommended hematocrit levels, but for-profit centers continued to increase doses (Reuters/Los Angeles Times, 4/18). In some cases, for-profit dialysis centers administered doses of Epogen three times higher than those administered by not-for-profit centers, the study found (Chase, Wall Street Journal, 4/18).
Safety Concerns
Experts said that higher doses of Epogen might place kidney dialysis patients at increased risk for a number of side effects. Recent studies have found that high doses of Epogen and other erythropoietin medications can lead to increased risk for death, strokes and heart attacks in kidney dialysis patients, and FDA on March 9 issued a black box warning for the treatments to advise physicians that they should use only the lowest dose necessary to avoid the need for blood transfusions in anemia patients (Johnson, AP/Long Island Newsday, 4/17).
Profits From Medicare
The study indicates that for-profit dialysis centers administer higher doses of Epogen because of "financial incentives built into the federal Medicare reimbursement rate for the drug," as well as volume discounts from Amgen, the Boston Globe reports (Rowland, Boston Globe, 4/18). Medicare, which paid $2 billion in reimbursements for Epogen in 2005, spends more for the medication than any other treatment. In addition, reimbursements for Epogen account for 20% to 25% of annual revenue for for-profit dialysis centers. According to AP/Newsday, large for-profit dialysis centers, such as DaVita and Fresenius Medical Care, can negotiate volume discounts with Amgen that allow them to purchase Epogen at a price lower than the amount Medicare reimburses them for the medication, "making the drug a profit center" (AP/Long Island Newsday, 4/17). However, for-profit dialysis centers maintain that the doses of Epogen they administer are not affected by financial considerations and that a "doctor signs every single order, for every single dose" of Epogen, according to David Van Wyck, a senior associate to DaVita Chief Medical Officer Charles McAllister (Boston Globe, 4/18). McAllister added that the doses of Epogen administered by DaVita "are based on clinical science and really are done in an open, collaborative atmosphere with physicians." CMS spokesperson Ellen Griffith said that the agency this summer expects to issue a report to Congress about the reimbursement system for Epogen and plans to begin a demonstration project of a new system that would include the medication in a "bundled" rate (AP/Long Island Newsday, 4/17).
Reaction
Lead study author Mae Thamer said, "What surprised us the most is how certain chains and providers clearly were targeting (red blood cell levels) outside" the recommended levels (Reuters/Los Angeles Times, 4/18). Study co-author Dennis Cotter said, "Patients are at risk here. They needed to be reassured that the right thing is being done for them" (AP/Long Island Newsday, 4/17). Cotter added, "It's clear there is a profit incentive." House Ways and Means Subcommittee on Health Chair Pete Stark (D-Calif.) said, "This study validates that for-profit dialysis chains are putting profits before patient care" and called for changing the Medicare reimbursement system "to eliminate financial incentives for overdosing" (Wall Street Journal, 4/18). In an editorial that accompanied the study, Daniel Coyne, a kidney specialist and professor at Washington University School of Medicine, writes that physicians often leave decisions about doses of Epogen to dialysis center staff. He recommends that physicians take a larger role in efforts to limit doses of Epogen (Boston Globe, 4/18). Coyne adds that Amgen "provides rebates to facilities and chains for growth in (the drug) purchases and in patient outcomes" (Wall Street Journal, 4/18). According to Coyne, physicians "need to challenge industries that appear to be using patients as profit centers based on bad science" (Boston Globe, 4/18).
An abstract of the study is available online.