Hospitals across the United States are throwing away less-than-perfect organs and denying the sickest people lifesaving transplants out of fear that poor surgical outcomes will result in a federal crackdown.
As a result, thousands of patients are losing the chance at surgeries that could significantly prolong their lives, and the altruism of organ donation is being wasted.
"It's gut-wrenching and mind-boggling," said Dr. Adel Bozorgzadeh, a transplant surgeon at UMass Memorial Medical Center in Worcester, Mass.
He coauthored a recent study that showed a sharp uptick in the number of people dropped from organ transplant waiting lists since the federal government set transplant standards in 2007. These standards are tied to federal hospital ratings and Medicare funding, which is the main payer for transplants and a key source of income for hospitals. And hospitals' ability to meet those standards helps determine their reputation within the medical community. Surgeries involving imperfect organs and extremely ill patients are more risky, so hospitals that do many of them run the risk of poor outcomes that may hurt their performance on the standards.
Soon after the study was published in April, the Centers for Medicare and Medicaid Services changed its benchmarks to give hospitals — and surgeries — more leeway to fail. But patients and doctors are still uneasy about the erosion of one of transplantation's fundamental principles: The sicker you are, the higher you move up the waiting list for donated organs.
"This has been a nightmare, a very expensive nightmare," said Kathy Barnes, whose husband, James, has been denied a liver transplant by three hospitals, but who is on the waiting list at UMass Memorial.
"Why won't they do it?" she asked. "It seems like some of them are just looking for an excuse to say no, and I don't understand that."
The study by Bozorgzadeh, published by the American College of Surgeons, found that the increasing reluctance to perform transplants on the sickest patients is directly tied to the onset of the standards enforced by CMS. In the first five years after adoption of the standards, more than 4,300 transplant candidates were removed from waiting lists by hospitals. That's up 86 percent from the 2,311 patients delisted in the five years prior to the regulation.
Bozorgzadeh said the federal regulations are turning transplantation into a numbers game that makes it harder to help patients who deserve a fighting chance.
"If you have young guy who has a 100 percent chance of dying, but only a 30 percent chance of dying with a transplant, you would say, 'What the hell, give the guy a chance,'" even if the operation might be risky, he said. "But if I make an argument like that, I will be under pressure from all these other stakeholders who would penalize me."
The number of organs being tossed out has also increased because of concerns that their imperfections could lead to bad outcomes. Last year, 3,159 donated kidneys were discarded, up 20 percent from 2007, according to federal data.
"To me, it just doesn't make any sense," said Howard Nathan, chief executive of a Gift of Life Donor Program based in Philadelphia. "We have hundreds of thousands of people on dialysis. And you have these kidneys available that would work … but transplant centers are afraid to use them because they might pull their results down."
The trend also has a financial impact — not just on the patients, but on American taxpayers.
As federal regulators have noted, it costs the Medicare program more in the long run to keep patients with ailing kidneys on dialysis than to give them organ transplants. Transplant patients also tend to live longer and have a better quality of life.
High-risk doesn't always mean failure
Sometimes, the calculus that makes a patient risky on paper doesn't pan out.
Michael Coyle was initially turned down for a liver transplant in 2015. Suffering from repeated and lengthy hospitalizations, he said he was on the verge of giving up on medical treatment until his niece, an operating room nurse, helped him find a different transplant center.
"She was the one who really got me going," said Coyle, 76 of North Attleboro, Mass. "I had told my wife that we would go home and just try to live the the best we could. And I was prepared to do that, but my niece wouldn't allow it."
Partly in response to situations like Coyle's, CMS relaxed sanctions on transplant centers that failed to meet standards, which are based on numbers of failed transplants and one-year survival rates and calculated through yearly national averages and risk profiles specific to a hospital.
For those that remained within 185 percent of the standard, the violation would be deemed a "standard-level" deficiency, which typically leads to closer monitoring, rather than a "condition-level" violation that puts funding from Medicare in jeopardy.
For the eight years until the standards were relaxed, 145 transplant centers were cited for deficiencies and given a chance to make corrections. Most did, but 17 programs didn't, and lost Medicare funding.
In a memo explaining its policy revisions, CMS acknowledged that its regulations were putting hospitals in a vicious cycle — by performing fewer risky surgeries, they improved their overall outcomes, setting the bar that much higher for all other hospitals to meet. The end result was an ever-shrinking margin of error.
By 2014, the memo noted, the rates of failed kidney transplants allowable under the rules had dropped to 7.9 for every 100 transplants, a 26 percent drop in the number of allowable losses since 2007. In addition, one-year patient survival rates were also increasing for kidney, heart, and liver transplant patients, which also had the effect of raising the performance bar even higher.
Meanwhile, the memo also flagged concerns about organs going unused, citing the 20 percent increase in discarded kidneys.
"We are concerned that transplant programs may be avoiding the use of certain available organs that they believe may adversely affect the program's outcome statistics," CMS's memo stated.
Being okay with imperfect organs
Many patients would gladly accept organs that are discarded because of real or perceived imperfections, said Nathan, of Gift of Life. But decisions to reject those organs by transplant centers don't give them that opportunity. In general, centers are seeking organs free of disease and certain biomarkers that could impair function or cause complications after surgery.
Studies have repeatedly raised questions about whether organs are being tossed out unnecessarily. A 2014 study published by the American Society of Nephrology noted, for example, that transplant centers often relied on low-quality biopsy results as the basis for rejecting kidneys. Another study published in Circulation, the journal of the American Heart Association, found no association between survival rates and the presence of a biomarker that is commonly used as a rationale for rejection.
That journal Circulation study, published in June, stated, "Although numerous organs are not accepted for transplantation for valid reasons, it is also true that many centers are unwilling to take risks on donor hearts, especially in the current climate where institutional outcomes are publicly available."
Jesse Schold, a staff member in Cleveland Clinic's department of quantitative health sciences, said the rejections are exacerbating the shortage of organs for patients who desperately need them. "Unfortunately, the candidate population has continued to increase over time," he said. "Even if one patient is not afforded the opportunity [to receive a transplant], there are 10 lined up behind them."
In many cases, patients seeking transplants are unaware of the forces working against them or how to be effective advocates for themselves. In addition to those who are removed from waiting lists, others are told they aren't healthy enough to be put on the list in the first place, leaving them to face inevitable death or to seek help from another transplant center.
Barnes, 53, has been turned away by transplant centers in Charleston, S.C., Jacksonville, Fla., and Durham, N.C., according to his wife, Kathy. She said her husband — who cannot speak or walk due to complications of liver disease — has been repeatedly told that he is too sick to get a transplant. He is now on a waiting list at UMass Memorial, whose performance on liver transplants has allowed it to take riskier patients. But after all the travel and rejections, Kathy Barnes said, her family is running out of time and money.
"We've been back and forth to all these hospitals, staying overnight and driving," she said. "It's very costly. We've had some friends do fundraisers and things for us, but we've gotten behind on our mortgage. I can't believe we've lasted this long."
She added that her husband has consented to receiving a liver that could result in other complications in order to move up the list. "Nowadays, if you do develop HIV, you can treat that. If you develop Hepatitis C, you can treat that," Kathy Barnes said. Her husband could still be delisted if his condition significantly worsens or he becomes too weak to undergo surgery. So far, he is holding out hope his name will rise to the top of the list soon.
Coyle, the patient who has already received a transplant, said he was told by doctors at Beth Israel Deaconess Medical Center last year that he was not a viable candidate for a transplant. He said he left the hospital thinking he had six months to a year to live, until his niece helped to connect him to the program at UMass Memorial. He said he does not harbor ill against Beth Israel for declining to provide a transplant, noting that he was extremely ill when he was admitted last year with severe kidney and liver problems.
"It's hard to get upset when they got my kidneys back in order," Coyle said.
Jennifer Kritz, a spokeswoman for Beth Israel, declined to discuss Coyle's case because of federal privacy rules. But she said in a statement that the hospital uses dozens of criteria to evaluate transplant candidates, including age, cardiac function, frailty, and ability to comply with medication instructions, among other factors. "Decisions regarding candidacy are made in the best interest of the patient and are based on the likelihood of a successful outcome for that patient after transplantation," the statement said.
Coyle said he underwent a battery of tests at UMass Memorial before the hospital agreed to put him on its transplant waiting list. It was about 10 weeks later — after having fluid drained from his gut multiple times — that he got the call he had been waiting for. Doctors in Worcester told him they had a liver for him.
"I got up there and they said, 'It's not a perfect liver. You can turn it down if you want to.' And I said, 'What the hell would I turn it down for?'"
Since the successful surgery, Coyle has had some setbacks. He was hospitalized for 17 days after catching a virus, and then he broke a rib when he fell against a lawn chair. But he said he's been able to spend time with his family and enjoy the rhythms of summer.
"I was able to I get back down to the Cape and put my feet in the water," Coyle said on a recent afternoon. "I couldn't go in the water, but I put my feet in. It's one day at a time, but it's nice. I feel good."
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