Patients denied transplants as donor organs are discarded

PART 1: Centers forced to focus on benchmarks rather than patients

By Markian Hawryluk / The Bulletin / @markianhawryluk


Published Jan 3, 2014 at 10:37AM / Updated Jul 7, 2014 at 12:44PM

Three-part Bulletin series.

Part 1: With the focus on survival rates, patients are being denied transplants.

Part 2: Transplant centers react to tough regulations.

Part 3: Why viable organs are being thrown out.

Patients who need organ transplants are dying even while viable organs are being thrown out, as government regulations have forced centers to focus on overall post-transplant 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.”

The dumping ground

When Ilene Herman of Weston, Fla., needed a lung transplant in 2010, her husband, Neil, a financial analyst, went straight to the numbers.

“The very first thing I did was get the data on survival rates,” he said. “We looked at the survival rates, we looked at time on the list for transplant, and we looked at the location.”

Whatever statistic they considered, the transplant center at Duke University came out on top. The Hermans had family in the region, and the transplant program was listed as a center of excellence by their insurance company.

“All things pointed to Duke,” he said.

Herman’s lungs were scarred by scleroderma, a chronic connective tissue disorder that can make breathing difficult and raise pressures in the heart.

Many transplant centers are unwilling to perform lung transplants on scleroderma patients because they incur damage to the valve at the bottom of the esophagus that keeps stomach backwash out of the throat. Stomach contents could be accidentally breathed into the lungs, damaging the organs and threatening the success of the transplant.

After two evaluations, the Duke team declined to list Herman, citing swallowing and reflux issues. Instead they referred her to the University of Pittsburgh Medical Center.

“I was 40, I had two young kids at home, and basically I had all my eggs in the basket of UPMC,” she said. “If they weren’t going to take me, I knew my only option was to go home and die.”

They packed up their car in mid-November, left their daughters, then 12 and 9, with their grandparents, and left for Pittsburgh with no intention of coming home without a new set of lungs. UPMC listed Herman for a transplant in December 2010 and successfully transplanted her the following April.

The Hermans were struck by how many patients at UPMC had been denied transplants at other centers. Patients from rural Appalachia, coal miners from West Virginia, professionals and skilled laborers, patients with pulmonary fibrosis, scleroderma and cystic fibrosis — they all ended up in Pittsburgh.

“It’s basically like UPMC is everybody’s dumping ground,” she said. “If you’ve been rejected by other places because you have a really complicated case, they will take you.”

It became clear that transplant centers across the country varied tremendously in terms of who they would list for transplant. Some centers were more aggressive and some more conservative. Eventually Herman’s husband realized his first inclination was right. It was all about the numbers.

“These entities are very, very concerned about their long-term survival rates,” he said. “They’re concerned that should their survival rates fall beneath a certain level, if they have enough adverse events, the government could temporarily or permanently shut down their program.”

Scleroderma patients, in particular, have run into roadblocks getting listed, despite some evidence that they do no worse than transplant patients with other types of lung disorders. Preliminary data from studies at the University of California, San Francisco suggests that esophageal issues do not lead to worse lung-transplant outcomes. Yet online patient bulletin boards are littered with stories of patients denied at other centers before finding refuge at UPMC.

“Obviously Pitt has had success with them, because they’re sitting across the table from me and they’re still alive,” said Herman’s husband.

After being given less than four years to live, John Keegan of Gloucester Township, N.J., whose lungs were damaged by scleroderma, was turned down by the University of Pennsylvania transplant center. He sought a second opinion at the Newark Beth Israel Hospital in New Jersey. Their transplant surgeon had recently come from UPMC and suggested that Keegan go there instead.

A pipe fitter at a refinery in South Philadelphia for 30 years, Keegan retired, got married and celebrated his 59th birthday all in one week in April 2009, then relocated to Pittsburgh the next week to wait for a transplant. He received his new lungs in September 2009.

“It’s all about their numbers. These centers are scared to death of scleroderma patients,” Keegan said. “Our survival rate is just as good as anybody else’s.”

Access denied

UPMC’s lung transplant program has never been cited for poor outcomes. Nonetheless, their success rate might be higher if they were more selective in choosing patients. In their last report, they had an 86 percent survival rate for the 108 lung transplants they performed in 2012, which was deemed “as expected” for their mix of patients. The Duke transplant program, by comparison had an 89 percent survival rate, which qualified as “above expected results” for their 145 lung transplants that year.

“It’s not rocket science. If you do someone that’s higher risk, the results are not going to be as good as someone who is not higher risk,” said Dr. Abhinav Humar, UPMC chief of transplantation. “You can be as good a surgeon or as good a program as you want, your results will never be as good.”

The evaluation metrics do take into account many patient characteristics, trying to adjust in the formula for factors that could lead to lower survival rates. But those adjustments are far from perfect and leave many transplant candidates as too great a risk to a program’s survival rates.

“If you really wanted to not do somebody, you can find just about any reason, you just have to look at it and present it to (the transplant committee) the right way,” Humar said. “So then these patients get turned down, and many of them shop around at different programs.”

UPMC can afford to take on more of these higher-risk patients, he said, because of the size of their program. Smaller programs don’t have that luxury.

“If your denominators are small, you can’t afford to have any numerators,” Humar said. “If you’re only doing 10 transplants and you have one bad outcome, that’s 10 percent, as opposed to if you’re doing 100 transplants and you have one bad outcome, that’s only 1 percent.”

That focus on survival rates has also skewed the carefully thought-out allocation policy that governs who gets the next available organ. Those allocation formulas are intended to balance a patient’s need for the organ against the best use of limited resources, and to take those decisions out of doctors’ hands. But the need to meet survival benchmarks has kept organs away from patients who might otherwise climb to the top of the list.

Alexandra Glazier, vice president and general counsel for the New England Organ Bank and chair of the Organ Procurement and Transplant Network’s Ethics Committee, said allocation policy has never been able to affect two critical decision points that determine who gets a transplant: who is put on the transplant list in the first place, and what organs to accept. Transplant programs set up their own criteria for listing, and each patient’s case is carefully considered by a transplant committee. But surveys show transplant programs have tightened their eligibility criteria in response to the 2007 Medicare regulations.

“If you don’t get on the list to begin with, it doesn’t matter how you allocate the organ, you’re not going to get a transplant,” Glazier said. “And it’s the same argument with the acceptance or decline of the organ.”

When donor organs become available, they are offered to programs that have matching candidates. But the transplant surgeons then have the discretion to turn down the organ.

“In many individual cases, the surgeon is making the decision for their particular patient,” Glazier said. “But because we’ve seen more conservative behavior in general over the country over the past several years, one has to make the logical assumption that it’s related to the regulatory pressures.”

A leveling-off

Given the complexity of the organ donation system, it’s hard to parse out the impact of the regulations on the number of transplants performed or the number of lives saved.

To some extent, the impact is blunted by the tremendous imbalance between the supply of organs and the demand for transplants. So when one center pulls back, other centers may pick up the slack. For every high-risk patient that surgeons avoid, there’s a lower risk patient further down the list they can transplant. And even marginal organs passed over by dozens of centers can wind up at the one transplant center willing to take the risk.

While the number of organs transplanted since 2007 has flattened, it’s unclear how much rates would have climbed in the absence of the new regulations. A separate and highly effective government initiative to boost organ donation ended in 2006. That program encouraged the use of marginal organs, and research on the value of such organs may have tempered centers’ willingness to use them.

And even without the need to meet survival benchmarks, centers would still have to make tough decisions about whether a transplant candidate represented a good use of a limited resource.

Nonetheless, transplant data show a clear fault line in 2007, when rates begin to level off or even decline.

• The total number of kidney transplants per year grew 16 percent from 2001 to 2006, then fell slightly in 2007, from 16,202 transplants to 15,838, and has remained flat.

• After two decades of consistent growth, the number of liver transplants declined for the first time in 2007, to 6,494 transplants from 6,651 in 2006, and continued to drop through 2012.

• The transplant rates for hearts peaked in 2007, at 78.6 per 100 wait-list years, declining to 67.8 by 2011. Meanwhile the median time to transplant has increased by 3.8 months since reaching a low in 2007.

• The total number of all organs transplanted peaked in 2006 at 31,184, and has yet to reach that level again.

“If you look back further from 1998 to 2006, every single year there was a growth in kidney transplant in the United States,” said Jesse Schold, an epidemiologist with the Cleveland Clinic. “In no year was there a decline. It’s interesting, from a broad perspective, that this flattening of transplant rates occurred right around the same time when this regulatory oversight started.”

When Schold surveyed transplant coordinators about the impact of the regulations, 81 percent said they had changed patient-selection criteria in response, 77 percent revised organ-selection criteria, and 84 percent altered clinical practice.

CMS response

Officials from the Centers for Medicare & Medicaid Services declined an on-the-record interview but indicated the regulations are intended to ensure the best use of a limited resource. The agency has taken the stance that when programs make a bad decision to transplant a patient who won’t survive, they’ve affected two patients, the one transplanted and another on the waiting list who missed out on a chance at a transplant.

Thomas Hamilton, CMS director of survey and certification, has acknowledged concerns that transplant centers could become overly risk averse, cut volume to boost survival rates or face increased costs without improvement in outcomes.

In an article published in the journal Current Opinion in Organ Transplantation last year, Hamilton said he’d heard anecdotal evidence that supports each of those concerns, but believed transplant patients were better off as a result of the regulations.

“Individuals waitlisted in those programmes cited by CMS for subpar outcomes may face lower odds of receiving a transplant at least temporarily due to the tendency of such programs to reduce volume as they regroup to improve their outcomes,” he wrote. “But people who do receive transplants from such programs have much improved prospects for post-transplant survival.”

CMS officials point to the experience of the Our Lady of Lourdes Medical Center in Camden, N.J., whose kidney transplant program was flagged for poor outcomes in 2008. The center argued to CMS that as an inner city program, it serves a population with high rates of heart disease, and that cardiovascular risk factors aren’t well accounted for in the CMS metrics. Officials asked the program to rethink the way they evaluated and treated patients with health problems prior to transplant.

“They are doing deeper cardiac inquiry and intervention where appropriate, and it is so gratifying to see, that in a program where 10 to 14 people out of every 100 died within one year, in the last year they have had zero deaths as a result of better care,” Hamilton said. “And they did not change their patient-selection criteria nor their volume.”

Another transplant program had 10 to 12 percent of kidney patients dying each year before CMS cited them for poor outcomes. After emerging from the internal review process, it has had no kidney transplant deaths over the past three years.

Those examples run counter to what researchers at Northwestern found when they looked at the cardiovascular risk of transplant patients. Prior to the implementation of the CMS regulations, programs were transplanting sicker and sicker patients each year. Then just as the CMS regulations went into effect, the trend abruptly reversed course. Kidney transplant risk dropped to pre-1995 levels, and among liver transplant patients, there was a 40 to 50 percent drop in cardiovascular risk.

“You’re not going to do your patients any good if your transplant program gets shut down, and so you have to exercise caution in whom you offer lifesaving transplantation,” said Dr. Anton Skaro, a Northwestern transplant surgeon.

Dr. Richard Freeman, a transplant surgeon at Tufts–New England Medical Center in Boston and a member of the United Network of Organ Sharing board of directors, said financial incentives from both Medicare and private insurance companies are exacerbating the situation. Centers are usually paid a bundled rate for the transplant and 90 days of post-transplant care.

“The intent there again for the program is to do the least risky patient, who’s going to be in the hospital the least amount of time and is much less likely to have complications,” he said. “Those are precisely the people who don’t need the organs so bad. The ones that need the organs are the ones that are really sick and higher risk.”

It’s the same with higher risk organs. “Even if it does work, that patient is not going to fly right out of the hospital,” he said. “Then you’re potentially putting yourself at financial risk as well.”

There is also the question of how much money the health care system wants to spend on patients at the end of life. A kidney transplant often saves money, because patients no longer require dialysis. For other organs, it may take a few years of post-transplant life for the system to break even.

Some deaths don’t count

The stark truth is that centers have little incentive to take a chance on higher-risk patients when there are plenty of transplant candidates who don’t face as many additional health issues. Centers are not penalized by Medicare when patients aren’t listed and die, or if patients die on the waiting list. But if they take a chance on a transplant and that patient dies, it could have serious ramifications for the program.

“Your death on the waiting list, though it is a number that is maintained, it is not one which CMS has penalties for,” said Dr. Andrew Cameron, a liver transplant surgeon at Johns Hopkins. “In that regard, you are encouraged to cherry pick, even among the cherry-picked group that’s made it onto the waiting list, in an effort to maintain one-year survival.”

More lives would be saved, he said, if centers could do a higher number of transplants, even if overall survival rates went down a bit as a result.

“The transplant community feels there is a group that is high risk that they’d like to transplant that they aren’t transplanting because of this need to generate benchmark outcomes,” Cameron said. “And I think the numbers would go up and that’s probably what the public wants.”

Transplant surgeons also argue that there are organs available that nobody wants to use now and will wind up discarded that could be transplanted into critically ill patients.

“It will give a good result if we say that 60 percent predicted survival is acceptable for that patient,” Cameron said. “It is stunning that we’re not doing that right now, because 60 percent is a miracle to the family and the doctors. It is unacceptable to CMS.”

That’s left transplant medicine as possibly the only place in health care where the doctor is not free to do what’s best for the patient. While financial resources may limit what doctors can do in other areas, they can take long shots to help patients with no other option. The limited supply of organs precludes transplant surgeons from taking the same approach.

Even given those limitations, many believe the CMS regulations are further limiting access to transplant for patients who have a good chance at additional years of meaningful life.

“If you have 5 percent or even 10 percent lower outcomes, you’re still doubling people’s life expectancy,” Segev, the Hopkins kidney transplant surgeon, said. He argues it is his responsibility as a health care provider and advocate for his patient to do everything in his power to transplant patients who would benefit from a transplant.

“Yet now I have to worry about my program, because if I don’t worry about my program, then none of my patients will get transplanted,” Segev said. “And that is a sad thing for the doctor-patient relationship.”

— Reporter: 541-617-7814, mhawryluk@bendbulletin.com