Government

Anemia treatment varies between profits, nonprofits

A potential link between epoetin prescribing patterns and Medicare reimbursement levels attracts congressional attention.

By David Glendinning — Posted May 7, 2007

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Physicians at for-profit dialysis centers consistently order higher doses of an expensive anemia drug for their Medicare patients when compared with nonprofit centers, according to a new study.

The report, which appeared in the April 18 Journal of the American Medical Association, compared the two types of dialysis centers based on how much epoetin therapy they prescribed to increase red blood cell levels in their kidney disease patients. When compared with nonprofit centers, for-profit facilities administered higher doses of epoetin, increased successive doses to a greater degree and achieved higher hematocrit levels in their patients -- in many cases well above recommended limits.

The results have potential patient safety implications. A pair of studies released last November found an increased risk of heart attacks, strokes and other adverse cardiovascular events in patients whose hematocrit levels were raised too high. The Food and Drug Administration responded in March by issuing a "black-box" warning for epoetin agents. It called on physicians to use the lowest dose needed to avoid blood transfusions.

For-profit dialysis centers might be prescribing higher levels of the drug because of how Medicare pays for the medication and determines the quality of a center's anemia care, according to the JAMA study.

"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," the authors stated.

Other doctors insist that money is not the reason for these differences.

In 2004, Medicare paid $1.8 billion for dialysis-related epoetin, which the drug manufacturer Amgen sells under the brand name Epogen. This is more than the program spends for any other drug. Other brand-name versions of the medication are used to treat cancer patients and others.

The program generally reimburses dialysis centers more for epoetin than it costs them to obtain it, and large dialysis chains often can secure even deeper discounts from Amgen. Because of this, the medications are a major source of profit for the facilities, profit that can be increased even more by boosting doses, the JAMA study found.

Removing this financial incentive likely would result in a large drop in the dosing levels currently maintained by dialysis centers, said Dennis Cotter, president of the Medical Technology and Practice Patterns Institute and one of the study's authors. Taking away the ability to profit off the epoetin by bundling Medicare drug reimbursements with dialysis administration payments, for example, could result in for-profit facilities decreasing their total dosing levels by as much as half, he said.

"The incentives will be 180 degrees from where they are now on anemia treatment," Cotter said. "You'll see less epoetin and more iron, nutrition and fitness therapy."

Most nephrologists do not work for a dialysis facility in which they have an ownership stake. But many often approve standing treatment orders that essentially hand over management of kidney disease patient therapies to anemia managers employed by the for-profit chains, said Daniel W. Coyne, MD, a kidney specialist in St. Louis.

In this way, doctors could be unconsciously aiding dialysis centers in maximizing profits offered by the Medicare payment system.

"Physicians need to challenge industries that appear to be using patients as profit centers based on bad science," he said in an editorial accompanying the JAMA study.

House Ways and Means health subcommittee Chair Pete Stark (D, Calif.) seized upon the round of recent studies and the FDA warning. In an April 19 letter to colleagues, he said Medicare must revise its epoetin payment policy to help protect patients from adverse events.

"Epogen administration should be based on what is best for the patient, not dependent on the profit motives of the dialysis facility at which a patient is treated," Stark wrote.

The Centers for Medicare & Medicaid Services plans to launch a pilot program this summer that explores bundling dialysis drug and administration payments, but the agency does not yet have any plans to make such revisions universal, a spokesman said.

Other factors at play

Several physicians dismissed the implication that Medicare payments and profit margins are influencing clinical decisions on epoetin.

"I would take exception to the notion that physicians would ever step over the line of propriety and use money as the reason for putting a patient at risk," said William L. Henrich, MD, president of the American Society of Nephrology. Instead, the second potential reason the study cites for the dosing differences -- the effect of Medicare's quality measurement guidelines -- is the more likely factor at play, he said.

Since 1994, CMS has recommended that dialysis facilities get at least 70% of their kidney disease patients to a hematocrit level higher than 33%. For-profit centers likely were motivated more strongly by this incentive and the public reporting of results that went along with it, Dr. Henrich said.

Now that more evidence is starting to appear about the effects of epoetin use, more recent dosing data than those from 2004 likely will show a downward correction as physicians balance the obvious increased quality of life offered by the drug with the lesser-known potential safety concerns associated with too much use, said Thomas DuBose, MD, past president of the society. "This is not the first time that conventional wisdom preceded evidence," he said.

Physicians representing the largest dialysis chains said doctors at for-profit facilities continue to do an excellent job using epoetin to help manage a major chronic disease, in most cases better than at nonprofit centers.

J. Michael Lazarus, MD, chief medical officer for Fresenius Medical Care, and David VanWyck, MD, senior associate to DaVita Inc.'s chief medical officer, rejected outright Dr. Coyne's hypothesis about financial incentives. Doctors make dosing decisions that greatly enhance patient quality of life based on the best clinical guidelines and free of any profit-making pressure from management, they said.

"In the end, it's clinical performance that matters to physicians," Dr. VanWyck said. "Everything else is just a distraction."

The wide variation in the way patients respond to the epoetin therapy means that some patients are bound to need more medication or to exceed recommended limits on occasion regardless of facility type.

"It's very difficult to get most of your patients in that very tight target," Dr. Lazarus said. "This is not an exact science."

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ADDITIONAL INFORMATION

Treatment inequity

The Medical Technology and Practice Patterns Institute investigated epoetin therapy for nearly 160,000 Medicare-eligible patients with kidney disease during November and December 2004. At the time, National Kidney Foundation clinical guidelines called for physicians to aim for hematocrit levels between 33% and 36% for these patients. The study found that a larger portion of patients at for-profit dialysis centers exceeded the range.

Percent of patients
Hematocrit level For-profit centers Nonprofit centers
<30% 6% 7%
30% to 33% 12% 14%
33% to 36% 28% 32%
36% to 39% 31% 30%
39%+ 23% 17%

Source: Journal of the American Medical Association, April 18

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