In Oregon, The Bend Bulletin has a three part series (pointed out to me by Ben Hippen) on the difficulties of regulating transplant centers, and the sometimes counterproductive incentives that are introduced (in an effort to counteract other bad incentives that hospitals may have).
UPMC, the University of Pittsburgh Medical Center, comes out looking very good, incidentally.
Patients denied transplants as donor organs are discarded
PART 1: Centers forced to focus on benchmarks rather than patients
By Markian Hawryluk
"Patients who need organ transplants are dying even while viable organs are being thrown out, as government regulations have forced transplant centers to focus on overall survival rates instead of the well-being of individual patients.
"The rules implemented by the Medicare program, which pays for the vast majority of organ transplants in the U.S., evaluate transplant centers based on the one-year patient and organ survival rates after transplant. Centers that fall below benchmarks could be shut down or forced into a lengthy and expensive remedial process.
That has prompted many centers to choose healthier patients and higher quality organs to transplant. High-risk patients that could pull down a center’s overall survival rate are often unable to get on the transplant list, or end up dying on the waiting list as centers pass on marginal but still usable kidneys, livers and lungs. And the decades-long growth in the number of transplants performed in the U.S. has plateaued since the regulations were implemented.
“The side effect has been to turn people risk averse,” said Dr. Dorry Segev, a transplant surgeon at Johns Hopkins Medical Center, “to the point where patients who would benefit from transplant are being denied transplants, and to the point where organs that are beneficial to patients are discarded.”
The regulations have caused centers to take a hard look at their quality-improvement mechanisms and how they evaluate patients and organs for transplant.
Programs became acutely aware of their survival rates, which began to climb after the rules went in effect in 2007.
The percentage of hearts still beating one year after transplant hit an all-time high of 91 percent in 2010, up from 88 percent in 2003; 85 percent of transplant lungs were still breathing, up from 80 percent in 2003. Deceased donor kidney transplants have achieved an astonishing 93 percent success rate.
"Transplant surgeons routinely credit the regulations with strengthening the transplant system and for the most part, improving the quality of care for transplant patients.
“There is no question we have a healthier system and a more monitored system than we did before these regs came out,” said Dr. Michael Abecassis, director of the transplant center at Northwestern University in Chicago.
The unintended consequence, he said, is that centers are “cherry-picking” their patients.
“Patients might die and not get transplanted even though they may have an 80 percent chance of survival,” Abecassis said. “If the target is 90 percent, or you’re going to get flagged, you may look at 80 and say, ‘I’m not going to do that.’ Well, if you’re the patient, it’s 80 versus zero. Then 80 is pretty good.”
"Before the regulations went into effect, the number of transplants in the U.S. had grown each year. But in 2007, the first year centers were being held to the survival benchmarks, the number of transplants dropped and has remained flat ever since."
Transplant centers pull back to avoid sanctions
PART 2: High-risk patients can put programs in jeopardy
"The new regulations, known as the Medicare Conditions of Participation, or COPs, were finalized in 2005 after a series of highly public transplant scandals. Reports of wait-list irregularities, diversions of organs and major medical errors spurred CMS officials to step in and establish regulations for what primarily had been a self-regulated field.
"CMS, the largest purchaser of transplants in the world (with the possible exception of China), adopted metrics originally developed by the transplant industry itself. Years earlier, the United Network for Organ Sharing’s Organ Procurement and Transplant Network had set up a flagging system to help identify and improve programs with subpar results.
But while that flagging system relied on peer review and public disclosure, the CMS regulations threaten to shut down centers that don’t improve.
Centers whose number of patient deaths or organ failures exceed 150 percent of what would be expected for their mix of patients are flagged. Multiple flags within a 21⁄2-year period trigger CMS action.
Centers then have 210 days in which to explain the mitigating factors that led to their low survival rates. If programs can improve by the end of that period, they are allowed to continue operating as usual. In other cases, CMS will acknowledge the mitigating circumstances and grant exceptions.
The centers that can’t improve quickly or convince CMS to grant an exception are given three options: shut down voluntarily, shut down involuntarily, or enter into a systems improvement agreement, or SIA. Through August 2012, 127 of the nation’s 330 transplant centers were flagged twice and investigated by CMS, including the programs at Hopkins.
Transplantable organs go to waste
PART 3: Centers feel regulatory pressure to avoid non-ideal organs
"Transplant programs may have to make do with more marginal organs going forward. Ideal organs generally come from young, healthy individuals who incur a traumatic death. Those types of donors are becoming less common, due to gains in highway safety and medical advances that can save accident victims from brain death. A Canadian study released in October found that the percentage of patients with brain injuries who eventually were declared brain dead fell from a high of 9.6 percent in 2004, to 2.2 percent in 2010.
"Donations after brain death accounts for half of kidney transplants, three-quarters of liver transplants, 90 percent of lungs, and all hearts. But that is changing.
"An increasing proportion of organs are coming from patients whose hearts stopped beating before the other organs could be recovered, or from older, sicker donors. Both categories of organs have a lower chance of surviving one year after transplant.
“We are seeing more and more organs sitting in that category of marginal organs,” Alexander said.
"Expanded-criteria donor kidneys (ECD), for example, have an 82 percent one-year survival rate, compared with 90 percent for a standard-criteria kidney. A kidney procured from a brain-dead donor has a 91 percent one-year survival rate, while those recovered from donors after cardiac death (DCD) have an 89 percent rate.
"When patients are listed for transplant, they are usually presented with a menu of organ types, each with different risk profiles, and asked to choose what types of organs they would accept. When organs become available, doctors and transplant coordinators decide whether they are willing to transplant that organ into that patient and whether to pass on that offer to the patient.
"Studies show that in aggregate, transplant candidates who accept ECD kidneys do better over the long run than patients who wait on dialysis for a more ideal kidney. While standard kidneys last an average of 10 years post-transplant, ECD kidneys average five.
"Yet marginal and high-risk organs are routinely turned down. An analysis of organ sharing data by surgeons at the University of California, San Francisco, found that 84 percent of patients who died waiting for a liver had received at least one organ offer and an average of six offers. Most were declined by the surgeons due to donor age or quality of organ.
“Wait-list deaths are not simply due to lack of donor organs as many of us assume,” lead author Dr. John Roberts said, citing the stigma of non-ideal livers.
"When surgeons become more selective about marginal organs, it can quickly result in a snowball effect. When an organ becomes available it is offered electronically to centers in the region and across the country. The more centers decline an organ, the more surgeons with patients lower down the list begin to wonder why the organ has been passed on so many times. And with each refusal, the time the organ sits on ice and degrades in quality increases. Kidneys can still be transplanted up to 48 hours after being put on ice, livers less than a day. If no center is willing to take a chance, eventually the organ is simply thrown out.
“Our system is pretty slow,” Roberts said. “It works well for good organs. It doesn’t work that well to get not-so-good organs broadly distributed.”