Markian Hawryluk
The Bulletin

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.

In 2009, Brigitte Sullivan, transplant coordinator at Johns Hopkins Medical Center, knew she had a problem on her hands. Three of the venerable institution’s most high-profile transplant programs — kidney, lung and liver — had survival rates that lagged below new benchmarks required by the Medicare program.

Over a two-year period, the liver transplant program, for example, had survival rates of 77 percent to 79 percent, while the Centers for Medicare & Medicaid Services expected them to reach rates of 87 percent to 90 percent.

“We sort of justified that internally by saying we’ve got really sick patients here,” Sullivan said. “We didn’t know how serious CMS would be taking it. We’re Hopkins, we’re supposed to be doing this. Is CMS really going to shut us down?”

The Hopkins transplant teams would learn that CMS was adopting a much more hardline stance toward transplant programs. Where in the past, transplant centers with serious quality issues were often cited multiple times for poor outcomes and ethical violations, few were ever closed. Prior to 2007, the regulatory oversight of transplant centers was widely seen as having no teeth.

Now, after six years of experience with a new regulatory approach, many centers believe the CMS regulations are too punitive in nature, and that centers striving to expand access to lifesaving transplantation are being caught up in the same net as poor-quality programs.

Regulatory pressure

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.

Pulling back

The Hopkins surgeons saw themselves as a program of last resort for patients no one else would take, an innovator that would pioneer new strategies and techniques in transplantation.

“In Maryland, we have a high proportion of patients on the waiting list and low proportion of organs that are available,” Sullivan said. “So we were also being very aggressive about accepting organs that other transplant centers thought were marginal organs.”

Hopkins was able to convince CMS to grant mitigating-factor exceptions in 2009 for its kidney and lung programs but not for liver. Instead, the liver program entered into a systems improvement agreement with CMS, forcing an intense review of policies and procedures.

Immediately, Hopkins cut the number of liver transplants they would do that year from their previous annual average of 50 to only 27. They would no longer transplant patients with acute liver failure, who had a 60 percent chance of surviving for one year, well below the overall survival rate of 86 percent. They declined to transplant patients co-infected with HIV and hepatitis C, and took the sickest liver patients off their transplant list.

They also became more selective in the types of donor organs they would accept, declining organs from donors whose hearts had stopped before the organs were removed or those older than 60.

During Hopkins’ probation, 41 out of 43 patients survived liver transplant, a survival rate of 95 percent. Patients stayed an average of three days in the intensive care unit and 17 days in the hospital post-transplant, about half the time of patients in previous years. While Hopkins had achieved one of the highest liver transplant success rates in the country during that time, it was clear they were transplanting much healthier patients. And they were using higher quality organs, cutting their use of suboptimal livers from 35 to 25 percent of transplants.

Patients who no longer met the criteria for transplant were offered a second opinion at another transplant center. Of the 10 patients who were referred elsewhere, only two were successfully transplanted.

“That group that we were considering transplanting ultimately had a 20 percent one-year successful survival,” said Dr. Andrew Cameron, surgical director for the liver transplant program. “And in fact, if we had transplanted those patients, we would have been closed down.”

Cameron and Sullivan believe the Hopkins program emerged from the experience stronger, although the process took a toll. Competing transplant centers in the area publicized Hopkins’ troubles, and the program lost a significant amount of its referral base and private insurance business.

They have since resumed transplanting riskier patients, and were on pace to perform 70 liver transplants in 2013. Sullivan prints out their survival rates monthly, so the surgeons know exactly where the programs stand.

“If we know we’re getting close here, we’ve got to pull back,” she said. “We’ve got to dial back the risk-o-meter.”

That means a patient’s chance of getting a transplant at Hopkins could depend on the success of the previous transplant cases. If the program has a good run, it can take on a riskier patient. A few bad outcomes and that same patient might not get transplanted.

“Our philosophy before all this happened was we would rather give a patient a 50 percent chance of surviving with a liver transplant versus a 100 percent chance of death,” she said. “And after all this was implemented, we say we can’t use this liver on someone who only has a 50 percent chance of survival.”

Under probation

Although Hopkins was among the first programs to go through the remedial process, studies suggest many centers are resorting to similar risk aversion. In a study published last year, researchers found that kidney transplant centers that had been flagged at least once during the period from January 2007 to July 2009 reduced the volume of transplants significantly, while those centers that weren’t flagged continued to grow the number of transplants along their same pre-2007 rates.

“We can’t infer a direct cause-and-effect relationship,” said Jesse Schold, an epidemiologist with the Cleveland Clinic and lead author of the study. “But there’s a lot of anecdotal evidence and a lot of intuition that this is likely to happen, simply because transplant centers have to keep their own survival in the decision-making of their everyday function.”

Other studies have shown that centers that were flagged in the first years of the new metrics had ramped up their use of marginal kidneys in the previous years. Such kidneys have a lower overall success rate for transplant, yet still offer patients a significant benefit over staying on dialysis. Once centers were flagged, however, their use of such marginal organs quickly dropped again.

“It’s very clear that all the programs have done the math and have determined that if your outcomes are trending low into a gray zone, the best way to get out of the gray zone is to go conservative,” Cameron said. “Whether we want to say that that is an appropriate correction on the part of a center that had competency problems or was overly aggressive, or whether we see this as the problem, governmental scrutiny is resulting in fewer transplants and more conservative centers.”

In 2011, Hopkins was once again flagged for subpar outcomes, this time in its heart transplant program.

“In an effort to meet the needs of our high-risk, extremely sick population, we were taking hearts that were not pristine,” explained Dr. Glenn Whitman, a heart transplant surgeon at Hopkins. “If you wait only for absolutely perfect hearts … you’re not going to have many hearts.”

The program tightened its criteria, cutting the distance they were willing to travel for a heart and limiting transplant candidates to those who had no other health problems. Like the other centers, their volumes dropped and their survival rates went up. But Whitman wonders whether the program is playing it too safe.

“I think it’s what CMS wants, in a way,” Whitman said. “But maybe if you’re not having some people die, maybe you’re being too risk averse. Maybe we should be taking a few more risks.”

CMS officials declined to comment on the record but said the drop in volumes at flagged centers was appropriate. The agency wants to see programs step back, reassess their policies and procedures, before reintroducing risk and increasing volumes again. Some programs, they said, had ramped up volumes or risk prior to 2007, and overstretched their capabilities.

Of the 127 transplant centers flagged by CMS through August, 52 were granted exemptions, and another 24 came into compliance before the 210-day review period expired. Of the remaining, 16 shut down their transplant programs and 35 entered into improvement agreements.

Dr. Peter Stock, a transplant surgeon at the University of California, San Francisco and former chair of the United Network of Organ Sharing kidney transplant committee, agreed that centers have a disincentive to transplant higher risk patients. But he also says that given the limited supply of organs, the system must keep centers accountable.

“When centers are flagged, there’s usually a reason for it,” he said. “I know we’re trying to push the envelope but you’ve got to push it in a judicious way.”

Dr. Alan Langnas, chief of transplant surgery at the University of Nebraska Medical Center and president of the American Society of Transplant Surgeons, said CMS is using a system that was initially designed to improve performance, not be a measure of program quality.

“Unfortunately, the flagging of programs has become more punitive in nature, and I think people have gotten a little gun-shy,” he said. “The worst thing that can happen to you is you get flagged.”

Burden to patients

Many in the transplant community are concerned that the harsh penalties for falling below the survival benchmark push centers to take drastic steps to avoid getting flagged.

“You don’t need to be under threat of getting shut down, because then you have to respond in a much more extreme way, and that extreme way is risk aversion,” said Dr. Dorry Segev, a Hopkins kidney transplant surgeon. “And then you’re not doing anybody any favors.”

And when centers pull back on risk, patients often have a harder time getting a transplant.

Stephanie Rath, 44, was diagnosed with cystic fibrosis when she was 19. Living in the suburbs of Indianapolis, she had always been cared for by doctors at Indiana University Health. In 2010, she turned to IU Health to be evaluated for a lung transplant only to find the transplant center was no longer in her health plan’s network.

Unbeknownst to her, IU Health had been flagged by CMS for poor outcomes in May of 2010. Such flags often spur private insurers to pull their patients out of those centers as well.

After a two-year delay while she was treated for rectal cancer, she launched a college tour of sorts, being evaluated at the University of Pittsburgh Medical Center, University of Kentucky Transplant Center, Duke University Medical Center and Indiana University Health, which had since come back into her plan’s network. In the end, the latter two centers considered her too high-risk to transplant. She and her husband had to pack up and relocate to Pittsburgh, where she was successfully transplanted last year.

Rath understands that centers have to draw lines in terms of who they can transplant, but expressed concern they might be relying too heavily on statistics and not considering the individual.

“I’m a cystic who’s been sick all my life, and worked for 20 plus years to stay healthy and survived a really (poor) lung capacity, survived a cancer, and had multiple surgeries, monthlong hospitalizations in the ICU. I’m the overachiever. I’m the patient you want to have,” she said. “I would have been disappointed if somebody didn’t give me a chance for as hard as I’ve worked.”

Cystic fibrosis patients often get caught up in predetermined limits as centers try to maximize their survival rates. Dr. Cynthia Gries, Director of Outcomes Research in the Division of Pulmonary, Allergy and Critical Care Medicine at the University of Pittsburgh Medical Center, said many centers will not transplant patients with CF whose body mass index is under 17, yet those patients have an 80 percent one-year survival rate. Although this survival rate is lower than patients with CF and normal BMIs, it is higher than many other patients who are considered for transplant.

“Although statistically sound research is extremely important in the lung transplant field, I think it is important to step back from number crunching and consider whether our allocation decisions make clinical sense as well,” she said.

The easy transplants

The need to achieve certain survival rates has also made transplant research difficult. Researchers know their survival rates won’t be as high when they first try out new techniques. That learning curve, however, has become a liability under the new regulations.

“Some of the biggest transplant programs in this country that were moving the field forward just stopped doing clinical trials,” said Dr. Michael Abecassis, director of the transplant center at Northwestern University in Chicago.

Transplant surgeons have called on CMS to allow for a high-risk carve-out of anywhere from 5 to 20 percent of cases that could be designated as research and not counted in the survival rates. CMS could still measure the quality of transplant programs based on standard cases, but not get in the way of medical progress.

Otherwise, innovative transplant programs like those at Johns Hopkins run into regulatory problems. Hopkins pioneered the use of paired kidney donations, when a living kidney donor is incompatible with the recipient and so exchanges kidneys with another incompatible donor-and-recipient pair. They’ve also developed techniques for giving people incompatible kidneys and transplanting patients with a high level of antibodies that make finding a suitable kidney much more difficult.

Two years ago, Hopkins surgeons published research in the New England Journal showing that people who undergo desensitization for live donor kidney transplant have twice the survival benefit at eight years than those who wait for a compatible organ from a deceased donor.

“If that were a chemotherapy agent, they would be lining up across the Atlantic,” Segev said. “What happened to us performing this service? We almost got shut down by CMS.”

It took nine months of often-tense negotiations to convince CMS to exempt those transplant patients from Hopkins’ survival rate calculations. CMS officials now point to the Hopkins kidney example as proof of the flexibility in the system.

“We on the ground, having gone through that, consider it a huge side effect,” Segev said. “A lot of programs doing incompatible transplants stopped or drastically reduced their incompatible volume because of what was happening.”

Dr. Nicole Turgeon, a transplant surgeon at Emory University, found that when programs are flagged, waiting times for patients go up.

Her research suggests that centers seem to be picking and choosing which patients to transplant based on how those patients would affect the centers’ expected survival rates. Centers moved faster to transplant candidates with conditions like diabetes, hypertension, peripheral vascular disease or prior transplants, which receive extra points in the formula used to derive each center’s expected survival rates. But they were slower in transplanting older and heavier patients for whom they got no risk adjustment.

“I think the COPs have made us look a lot closer at what we’re doing, for better or for worse,” Turgeon said. “It’s allowing us to scrutinize our outcomes and maybe do better for our patients.”

It may be that programs were transplanting patients who had too low a chance of survival, putting the patient through a needless procedure and denying better transplant candidates the organ.

“On the other side of the coin, if we are doing fewer transplants or we are increasing patients’ waiting times, they could get sicker, they could no longer be transplant candidates, they could die on the waiting list,” Turgeon said.

As much as transplant surgeons bemoan the regulatory pressure, they acknowledge that the Medicare regulations have brought much-needed stability to the field. In addition to the survival metrics, the regulations require programs to have multidisciplinary teams in place to maximize patient outcomes. They require centers to engage in systematic quality improvement efforts, and to have the basic infrastructure in place for successful transplants.

“It’s supposed to level the playing field in terms of infrastructure and process,” said Dr. Janet Tuttle-Newhall, a transplant surgeon at St. Louis University Medical Center. “It’s a high-risk endeavor. You can’t do it on the cheap.”

Newhall experienced the flagging process firsthand when the SLU liver program was cited in 2012. Center officials had already recognized their outcomes had dropped below expected levels and had begun the process of reassessing their program.

Her hospital serves many of the poorer residents of St. Louis. Its patients are predominantly African-American, indigent, uninsured. They often arrive at the hospital in worse shape than their more affluent suburban neighbors, and carry many of the risk factors associated with poorer post-transplant survival.

“We call them the statistical double whammies, because they have such bad outcomes but you get no risk adjustment for not having a family member, or not having a phone, or having your insurance applied for when you get admitted with liver disease,” Newhall said. “But if we were to close, these people would not have access to transplants.”

They standardized protocols for evaluating transplant candidates and tightened criteria for the types of organs they’d accept. The number of liver transplants at the center dropped, but their survival rates rose to exceed the threshold and the program quickly came back into compliance

Still, Newhall is not convinced higher survival rates are necessarily a sign of improvement. “When I started this in 1996, the one-year survival in liver transplant was 85 percent. (In 2012), it was 92 percent. Why do you think that is?” she asked, before answering her own question.

“We’re doing easier patients.”

—Reporter: 541-617-7814,