Stringent transplant rules are unveiled

Times Staff Writers

Under pressure to tighten oversight of the nation’s transplant centers, federal health officials unveiled strict new standards Thursday that could force dozens of organ programs to give up precious federal funding or have it pulled from them.

The rules come after a series of scandals in California in the last 18 months have embarrassed regulators and exposed serious gaps in the monitoring of the nation’s transplant system.

The U.S. Centers for Medicare and Medicaid Services hopes the regulations, which took more than two years to finalize, will prevent “poor or marginal performers” from continuing to receive federal funding, according to a report accompanying the new rules.


“We believe that implementing the requirements ... will result in a decrease in patient deaths” and failures of transplanted organs, Medicare officials wrote.

The rules are to take effect in 90 days. According to a Times analysis, about 64 transplant programs -- nearly 13% of the nation’s total -- would lose their approval and funding if the government strictly applied its new rules today. That includes about 29 centers for heart transplants, 21 for kidney, seven for liver, six for lung and one for intestinal transplants.

Each of the programs failed at least one of the new Medicare standards -- for volume, patient survival or organ survival. The agency currently certifies about 500 transplant centers.

In releasing the regulations, officials also pledged to enforce them -- which they have acknowledged they did not do well previously. Before, transplant programs were more or less on the honor system, asked to turn themselves in if they fell short.

Last June, a Times investigation found that one in five federally funded liver, heart and lung transplant centers failed to meet minimum Medicare standards, either not performing enough procedures to ensure competency or having too many patients die after transplants.

In response to the newspaper’s inquiries, the agency conducted a review of the transplant programs it funds, ultimately threatening several with an immediate loss of money if they did not submit acceptable plans for improvement.


Some transplant professionals Thursday welcomed the new rules as a means to hone a system weakened by substandard centers. Although nearly 100,000 people nationwide currently await organs, it is not programs that are in short supply but the organs themselves.

“I very strongly believe we have far too many programs,” said Dr. Goran Klintmalm, head of the Baylor Regional Transplant Institute in Dallas. “What is the right number? I don’t know, but I can tell you that I don’t think that the patients or the services to the patients would suffer” if low-performing centers closed.

“I’ll tell you,” he added, “I think it will help to improve outcomes.”

Medicare officials said they would consider mitigating factors that could cause a program to have trouble meeting the new rules, including the lack of other transplant centers in the area.

The new rules require that:

* Transplant programs, with rare exceptions, perform an average of 10 transplants a year to receive and keep their Medicare funding.

* Programs’ organ and patient survival rates at least match expected survival rates, taking into account the national average and the unique characteristics of each program’s patients and donors. Such statistics are calculated by a federal contractor.

* Programs reveal to potential recipients how many of their patients -- and the organs they have transplanted -- survive at least a year after surgeries and how many were expected to. They must also notify patients if they fall below Medicare standards.


* Any program served by a single transplant surgeon notify patients that the surgeon might not be available at the time an organ becomes available. It must also state whether provisions have been made to find a substitute surgeon.

* Programs immediately alert Medicare if they are not able to meet any of these standards.

Under the old rules, heart and liver centers were required to perform 12 transplants annually, while lung and intestine centers had to perform 10. Kidney centers had to strive for 15 within four years of being open, although that was not rigidly enforced. Centers also had to meet specific survival rates, without taking into account patient or organ conditions.

According to Medicare, some critics objected to sharing program statistics with potential patients, saying the data were too complicated. But federal officials said they “expect a transplant center to provide guidance to patients and families” in finding and interpreting the center’s success rates, according to the report released Thursday.

Recent scandals involving California transplant centers have shown the need for increased oversight of transplantation, experts say.

In November 2005, UCI Medical Center in Orange closed its liver transplant program the day The Times reported that it did not have a full-time transplant surgeon and that it had been turning down a disproportionately high number of organs as patients died on its waiting list.

Then in May 2006, Kaiser Permanente closed its kidney transplant program in San Francisco after a series of stories in The Times found that it had endangered hundreds of patients, in some cases delaying critical surgeries or losing track of patients altogether. In August, Kaiser agreed to pay a $2-million fine to the California Department of Managed Health Care and contribute $3 million to promote organ donation in the state.


After the new rules take effect, transplant centers will have six months to seek approval for their programs. Programs that do not meet the standards will be allowed a “reasonable time period,” which was not specified, to develop corrective plans.

Once approved, programs will be reviewed every three years for compliance.

Medicare officials believe that the new regulations will result in “up to 2% or approximately 10 centers” a year losing their certification.

California transplant programs that now fail to meet at least one of the new standards include the heart unit at Sutter Memorial Hospital in Sacramento, the liver unit at USC University Hospital in Los Angeles and the kidney program at Arrowhead Regional Medical Center in Colton.

Arrowhead officials say the new rules do not worry them. Although the hospital has performed fewer than 10 kidney transplants on average in each of the last three years, it performed 14 in 2006 and is positioned to do even more this year, said Holly Ramos, associate hospital administrator of professional services. “Given that we are the safety net hospital for San Bernardino County, there’s absolutely a need for our program,” she said.

The new Medicare rules can be found at https://www.cms.hhs .gov/Certificationand Complianc/20_Transplant .asp#TopOfPage.