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Diabetics tied up as Medicare contractors split on kidney treatment
By Guy Boulton of the Journal Sentinel Dec. 25, 2012
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Susan McInerney, a diabetic since childhood, has been on dialysis for six years, waiting and hoping for a kidney transplant.
The odds are not encouraging. McInerney, 51, is among the 15% of patients with high levels of antibodies, lessening her chances of finding a suitable match for a transplant.
For much of the past year, she placed her hopes in a treatment that can lower antibody levels in some patients and enable them to have kidney transplants.
"It was my saving grace," she said. "I was thinking of it in that way."
McInerney had been told that Medicare would pay for the treatment. Medicare covers dialysis patients after four months or, if they have insurance, after 30 months.
Medicare does cover the treatment in some parts of the country, including California and Illinois. It was covered in Michigan, where McInerney lives, until last summer.
Whether to cover the treatment - intravenous immunoglobulin, or IVIG - is left to the regional contractors that process Medicare claims.
The previous contractor for Michigan covered the treatment. But last summer, the contract for Michigan and Indiana went to a unit of Wisconsin Physicians Service Insurance Corp. in Madison.
WPS determined the treatment was experimental and therefore not covered by Medicare.
Doctors at the University of Michigan and Indiana University challenged that decision. Both had patients, such as McInerney, who were candidates for the treatment.
"This treatment saves lives," said Tim Taber, a professor and medical director of transplant nephrology at Indiana University. "There is a reason to do it."
Yet several transplant centers have stopped providing the specific type of treatment - high-dose IVIG - used at the two academic medical centers. Also, some doctors and studies question the treatment's effectiveness.
Whether Medicare should cover the treatment is an example of the knotty decisions that can determine what care patients receive.
Who decides?
Medicare must cover medical services that are "reasonable and necessary." But determining what is "reasonable and necessary" is rarely straightforward. Much of what doctors do is not supported by solid evidence, especially new treatments.
In some cases, coverage decisions are made at the national level. But many are left to regional contractors, such as WPS, that process Medicare claims.
The result: Medicare may cover a treatment in one state and not another.
The cost of the treatment is borne by Medicare, and WPS doesn't have a financial stake in its decisions on what to cover.
But processing Medicare claims is a huge business for WPS. The company processed 168.3 million claims - more than 600,000 on average each weekday. It also oversaw payments of more than $39.5 billion for more than 10 million people covered by the federal program in its last fiscal year.
WPS could not comment because the doctors at the University of Michigan and Indiana University have asked the company to reconsider its decision on IVIG treatment.
Taber from Indiana University and others met with WPS in Madison on Wednesday to make their case for covering the treatment.
He estimates that the treatment works in less than one-third of the patients at Indiana University's center. But 15% to 20% of the people on dialysis die each year. For many people, he said, the treatment is their best hope for a transplant.
"It's not a home run," Taber said. "But it's one of the few things you can do for patients."
That's how McInerney saw it.
"I have no choice," she said.
Three days a week, she goes to a dialysis center, typically arriving around 11 a.m. and leaving around 3:30 p.m. The dialysis treatments not only take up much of the day but also leave her fatigued.
"It's pretty much a lost day," McInerney said.
High risk, high cost
More than 90,000 people nationwide are on waiting lists for kidney transplants. Perfect matches are rare, and gauging chances of a body rejecting a kidney or other organ hinges on an array of complex factors.
Roughly a third of the people on the waiting list have antibodies as a result of blood transfusions, previous transplants or pregnancies that increase the risk of their body rejecting a donor kidney.
The obstacle is greatest for about 15% of the patients, such as McInerney, who have very high levels of antibodies.
The wait for a kidney is long for all patients. It is even longer for patients with high levels of antibodies. For some, the wait is futile.
For more than a decade, doctors have used treatments involving intravenous immunoglobulin to "desensitize" patients with high levels of antibodies. The most widely used is low-dose IVIG with plasmapheresis, a process that removes antibodies from the blood. That treatment is used when a patient has a living donor. Other centers, including those in Indiana and Michigan, use high-dose IVIG, either with or without the drug rituximab.
The treatment is expensive. Cedars-Sinai Medical Center in Los Angeles, one of the pioneers in high-dose IVIG, puts the cost at $20,000 to $25,000, based on two treatments, plus one dose of rituximab. But the cost can triple or quadruple depending on the protocol used by the medical center.
Neither the University of Indiana nor the University of Michigan could provide estimates on the cost.
The University of Indiana said it gives patients IVIG twice a month for four to six months. The University of Michigan said it gives the treatment once a month for six months, and then at nine and 12 months. The first two treatments include rituximab. It will continue the treatment for an additional 12 months if it is working after the first year.
Keeping a patient on dialysis costs $80,000 to $100,000 a year, and the cost of IVIG treatment isn't an issue. Medicare also is barred from taking costs into account when determining whether a treatment should be covered.
Effectiveness in question
The issue is whether the treatment is experimental and whether it works.
Cedars-Sinai Medical Center has had the most success: 60% to 70% of patients get transplants within one year of receiving the treatment, and most within six months, according to Stanley Jordan, medical director of the medical center's kidney transplant program.
Jordan was "incredulous," he said, when told that WPS had decided to not cover the treatment.
"To me, this is unconscionable that this would happen, because it is basically forcing the people to spend the rest of their lives on dialysis," said Jordan, a professor at the David Geffen School of Medicine at the University of California, Los Angeles.
At the University of Michigan, six of the 10 patients who have completed the therapy received transplants, according to Chad Abbott, a registered nurse at the transplant center.
That success has evaded other transplant centers, and few academic medical centers are offering high-dose IVIG to patients.
University of Wisconsin Hospitals and Clinics, for instance, stopped providing the treatment several years ago, said Arjang Djamali, chief of nephrology and an associate professor at the UW School of Medicine and Public Health.
He doesn't question the programs at the University of Michigan and Indiana University.
"In their hands, it works, and I respect that," Djamali said.
He also believes that Medicare should consider covering the treatment at those centers.
"They are experts I respect," he said. "If they say that they have good outcomes with such strategies, we should trust them."
Not for everyone
A study published in August in Transplantation concluded that high-dose IVIG isn't effective - a contention that doctors at Cedars-Sinai have challenged in a letter accepted by the journal for publication.
The treatment has a higher rate of side effects, including acute rejection. The side effects can be treated but have their own complications. The treatment also requires expertise and judgment, particularly in selecting patients and timing a transplant, according to Taber and other doctors.
Supporters readily acknowledge the treatment doesn't work for everyone.
Taber, who has taken two trips to Madison to press WPS to reconsider the decision, said Medicare and health insurers don't deny coverage for a cancer drug because it is not always effective.
Denying coverage for a treatment for one set of dialysis patients, though, doesn't evoke the same emotions as denying coverage for a cancer drug, even one with limited effectiveness.
WPS has 90 days to make a decision on the appeal by Indiana University and the University of Michigan.
For now, McInerney is pinning her hopes on getting on waiting lists in other states to increase her chances of finding a match. She plans to go to Chicago in January to enroll in the program affiliated with the Northwestern University Feinberg School of Medicine.
"I am a fighter," McInerney said, "and I am going fight this."
http://www.jsonline.com/business/diabetics-tied-up-as-medicare-contractors-split-on-kidney-treatment-807u0vj-184772511.html