Trump administration proposes weakening rules governing organ transplant centers

The Trump administration has proposed scrapping the rule the Centers for Medicare and Medicaid Services used to cut off funding for heart transplants at Baylor St. Luke’s Medical Center in Houston. (Elizabeth Conley/Houston Chronicle)

The Trump administration this week proposed eliminating a decade-old regulation that puts hospitals at risk of losing their Medicare funding if too many of their patients die or suffer organ failure after receiving transplants.

The rule the government is proposing to scrap is the same one that led the Centers for Medicare and Medicaid Services to cut off funding last month for heart transplants at Baylor St. Luke’s Medical Center in Houston after an investigation by ProPublica and the Houston Chronicle revealed an outsized number of patient deaths and complications in recent years.

The proposal was unveiled Monday as part of the White House’s push to “cut the red tape” and do away with “burdensome regulation” that officials said put paperwork ahead of patients. In a speech announcing the proposed changes, CMS Administrator Seema Verma said the agency’s existing policies have “put lives in danger.”

“We are proposing to remove those inefficiencies to reduce the amount of time patients have to wait, so that they can begin healing,” Verma said.

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The proposal, now subject to public comment and revision before it is finalized, surprised many transplant physicians who have long called for relaxed federal oversight. They’ve argued that the rules requiring that hospitals meet certain survival thresholds for transplants discourage them from taking on risky patients or accepting less-than-perfect organs, lengthening the time patients spend on the waiting list.

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The concerns

Some experts, however, said the proposal would not help patients because it would weaken the government’s authority to hold transplant programs accountable if they fail to provide safe patient care. The regulation was put in place in 2007 after a series of scandals at transplant programs revealed lax federal oversight. Several transplant programs had compiled abysmal patient survival statistics for years while continuing to receive Medicare funding.

Even though it has the authority to do so, Medicare rarely terminates programs for poor outcomes. It is far more common for the government to force underperforming programs into systems improvement agreements in which hospitals agree to make certain changes and be subject to stepped-up oversight.

Medicare bypassed that process and cut off funding for heart transplants at St. Luke’s in August after the hospital’s one-year patient survival rate fell below national norms from 2014 to mid-2016. A few St. Luke’s cardiologists grew so concerned that they started sending some of their patients to other hospitals for transplants.

St. Luke’s has appealed its Medicare termination, saying, “we do not believe CMS’ recent decisions reflect our ongoing progress and accomplishments to improve the quality of our care.” A spokeswoman said officials are still reviewing the Medicare proposal and declined to comment.

RELATED: Fed regs on surgical outcomes have led hospitals to deny patients life-saving organ transplants

“CMS will continue to collect the data on each transplant program’s performance with regards to patient and graft survival,” the agency said in the statement. “These data, rather than being a stand-alone measure, will be used as a component of the survey process to further inform and direct the survey.”

'Unintended consequences'

If the proposed regulatory change had been in place previously, it’s not clear whether St. Luke’s would have faced punitive action from Medicare.

“I am probably in the minority in the transplant community, but I think, based on what is proposed, this is a bad idea,” said Laura Aguiar, an Arizona-based transplant consultant who has spent years helping programs improve their outcomes to stave off Medicare penalties. “I have been around long enough to remember that there were very valid reasons why CMS, in the George W. Bush administration, took the steps they took in implementing all of this.”

Since the rules were put in place 11 years ago, the percentage of patients who survive at least one year after receiving heart, kidney, lung and other organ transplants has increased nationally. But some experts say those gains have come at a cost.

RELATED: CMS proposes rule to streamline Medicare compliance

Jesse Schold, a researcher at the Cleveland Clinic, has spent years chronicling what he calls the “unintended consequences” of holding transplant programs accountable for poor outcomes. Even though CMS relies on data that has been adjusted to ensure that programs aren’t punished for treating sicker patients or accepting riskier donor organs, Schold said the rules have created a perception that programs need to turn away some ailing patients and reject less-than-ideal organs in order to meet outcome targets.

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