Lawmakers deride rule on paying for Epogen

[okarol]

Lawmakers deride rule on paying for Epogen

Medicare's policy aids other use that's perilous, they say

By Christopher Rowland, Globe Staff  |  December 7, 2006

WASHINGTON -- Medicare payment policies for Amgen Inc.'s antianemia drug Epogen were criticized yesterday during a congressional hearing as "perverse" and potentially dangerous to kidney dialysis patients.

"You seriously need to consider that your payment policy is killing people," House Ways and Means Committee chairman Bill Thomas told Medicare chief medical officer Dr. Barry Straube , who flanked acting Medicare administrator Leslie V. Norwalk at a witness table.

Thomas, a California Republican who is leaving office at the end of this term, convened the hearing to scrutinize Medicare's decision to loosen its Epogen reimbursement rules in a way that allows dialysis clinics to use the drug to boost anemic patients' red blood cell counts beyond the Food and Drug Administration's recommended limits. The reimbursement policy is being questioned in light of new clinical trial evidence that shows aggressive use of antianemia drugs increases risk of fatal heart attack and strokes.

Medicare pays for dialysis for about 325,000 patients in the United States under a 1972 law, and dialysis clinics are guaranteed a profit on the Epogen they use. Last year, Medicare spending on Epogen in dialysis reached $2 billion.

Congressional critics are becoming more vocal as Epogen costs and doses, and patients' red-blood-cell counts, continue to rise. Representative Charles B. Rangel , the New York Democrat who will succeed Thomas as chairman , questioned why Medicare "would want to encourage through policy the overuse of a drug that places patient lives at risk" and is expensive.

Another Democrat on the committee, Pete Stark of California, questioned the makeup of an advisory group that helped Medicare devise its new reimbursement policy. Calling it a "cozy club," Stark said he estimated that two-thirds of the group had ties to the dialysis and drug industries.

The FDA issued an advisory last month in response to new clinical findings about anemia treatment that were published in the New England Journal of Medicine. The agency specifically cautioned doctors against exceeding the FDA limits for red-blood-cell counts.

Norwalk yesterday defended Medicare's reimbursement policy for Epogen use above FDA limits, saying flexibility is necessary to allow for variability in patient response to the drug. The agency's official position is that dialysis clinics should observe the FDA recommendations , she said.

She also denied that the agency has delayed a pilot project that could lead to meaningful reforms in the way Medicare pays for dialysis treatments. Under the proposed reform, supported this week in a report by the Government Accountability Office , dialysis-related reimbursement would be bundled into one fixed payment to clinics, removing the profit motive to administer more drugs.

Amgen officials disagreed with Thomas and Rangel that Medicare policies threaten patient safety. Although industry representatives did not address the committee, Amgen made company executives and public relations staff available to speak with reporters afterward. Amgen has never promoted use of Epogen beyond the FDA limits, said Dr. Robert Brenner , the company's senior director of medical affairs. While patients often have red blood cell counts above the FDA guidelines, they tend to be temporary rises, said Brenner.

"We don't see evidence of inappropriate use," he said.

Christopher Rowland can be reached at crowland@globe.com. 

original: http://www.boston.com/business/globe/articles/2006/12/07/lawmakers_deride_rule_on_paying_for_epogen/
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~Karol

[stauffenberg]

There is a special thread on this message board about the stupid things people who don't have personal experience with dialysis say to dialysis patients, but unfortunately, many of these same stupid people who don't know the first thing about endstage renal disease are also legislators in Washington making laws which profoundly affect the lives of dialysis patients.

The EPO issue is a good example.  What the legislators don't realize is that all dialysis patients are SEVERELY ANEMIC ALL THE TIME, and that this greatly reduces their quality of life.  In many cases, it is a reasonable clinical choice, based on an intelligent risk/benefit analysis, to raise the patient's hemoglobin to levels where the risk -- small but real -- of  heart attack or stroke from the EPO level is higher.  Which would you prefer, to live in utter exhaustion for 20 years, or to live with much greater energy for only 10 years?  Patients and doctors should have the financial ability from the government to make that balance as they choose.

[jbeany]

I had untreated or undertreated anemia for years.  3 docs later, I finally got some that put an effort into making me feel healthy, no matter how bad my kidney function really is.  If I had that much trouble getting a doctor to help, there's not a snowball's chance in heck that the legislators will care about the actual results of the laws.  It's pretty scary to think these elected idiots halfway across the country are going to be the ones deciding on how fast I can walk up stairs.

[BigSky]

If those in Congress were actually worried about dialysis patients they would push that more treatment days are paid for by medicare.   From only 3 days full payment to 4-5 or more full payment.