Growing numbers of patients are deemed "too-sick-to-transplant" by liver transplant centers that don't want to run afoul of CMS quality benchmarks.
Liver transplant centers have become more risk averse, and a 2007 CMS regulatory policy may be the reason why, according to a study in the Journal of the American College of Surgeons.
As a result, many of the sickest patients—those who should be at the top of the transplant recipient list, are "de-listed" because they've been deemed "too-sick-to-transplant."
Compounding this problem is the study's other finding: Although the 2007 CMS policy was meant to boost performance and improve outcomes, it's been ineffective in achieving that goal.
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At one time, patients were "too-sick-to-transplant" based on a transplant team's clinical judgement. A person might have an infection, for instance, and be unable to endure an operation. In 2007 there was a sudden uptick of people who were de-listed.
"When you see a trend that's suddenly going on like that… you wonder whether there is something else going on," says Natasha Dolgin, PhD, of the University of Massachusetts Medical School, Worcester, lead author of the study.
That "something else" was a new CMS regulatory policy called Conditions of Participation, or CoP, which established expectations for safe, high-quality transplant services in Medicare-participating facilities. It set benchmarks for one-year survival rates for both the patient and the transplanted organ.
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And although publicly reported outcomes for transplant facilities are nothing new, the CoP used them in new ways. It used publicly reported outcomes to label some centers as "underperformers."
The consequences for failing to meet these benchmarks could be steep and included losing Medicare funding, losing private insurance coverage, and eventually, closure.
"People are trying to minimize the high risks that are inherent to transplant surgery," Dolgin says.
The researchers studied 90,765 adult (aged 18 and older) deceased donor liver transplant candidates listed at 102 transplant centers from April 2002 through December 2012.
They found that "[d]elisting abruptly increased by 16% at the time of CoP implementation, and likelihood of being delisted continued to increase by 3% per quarter thereafter."
That 16% represents more than 4,300 people taken off the transplant waiting list between mid-2007 and 2012, compared to 2,311 liver transplant candidates delisted between April 2002 and June 2007 in the study sample, according to the American College of Surgeons.
The study also showed that CoP hasn't had its intended affect.
"It was intended to be this quality improvement policy to get everyone on the same level of outcomes," Dolgin says.
Instead, "the CoP did not significantly impact one-year post-transplant mortality… Patients who could potentially benefit from transplantation are increasingly being denied this lifesaving procedure while transplant mortality rates remain unaffected," the study says.
Dolgin says the CMS policy is flawed in another way because CMS looks only at transplant outcomes; death rates for people who got a liver transplant.
CoP ignores the death rate for wait-listed candidates who did not receive transplants.
"I do think there needs to be policy change that looks for wait-list outcomes," she says.
For transplant centers, Dolgin says there's a delicate balancing act. They must not only act in the best interest of patients and but also the best interest of the center. There's pressure to maintain outcomes and to do so within budget.
Still, Dolgin says, transplant centers should be true to the mission of helping patients.
"If that means fighting with CMS every time there's something that goes wrong… it's worth fighting for," she says.
Ultimately, Dolgin says her findings should spotlight the disservice that this policy has unintentionally had upon patients who centers say are too risky to treat.
"In the end, what I care about most is patients dealing with the brunt end of this policy," she says. "It's really about patients getting access to transplantation."
Alexandra Wilson Pecci is an editor for HealthLeaders.
