2006, Oct 06
Organ Transplant Centers Face Federal Scrutiny
 

By Susan Levine

A number of long-standing heart transplant centers in the Washington, D.C. region have fallen under federal scrutiny due to the fact that they have done too few operations in recent years, repeatedly performing less than half of the minimum considered necessary to maintain surgical skills and patient care.

At Washington Hospital Center, which touts its extensive cardiac services, just five people got new hearts in four of the past five years. At Inova Fairfax Hospital, where the Washington area's first heart transplant was heralded in 1986, doctors did only two such procedures last year. In 1996, each logged 16.

The programs at these facilities and at Virginia Commonwealth University Medical Center in Richmond are among more than three dozen nationwide that have been asked to account for often sharp decreases in adult heart, lung and liver transplants. Some trace problems to changes in leadership. Others cite difficulties getting donor organs. However small the programs, virtually all defend their quality.

But critics say little justifies the chronic shortcomings. And in advance of a sweeping revision of the government's transplant regulations expected by January, the heightened oversight has raised questions about how many of the country's programs should be allowed to continue.

At stake are patient safety and access to lifesaving operations, along with the highly marketable prestige of transplant programs -- a factor that helps explain why even seriously lagging programs stay in the business.

"There's a lot of hubris in this," said liver surgeon Goran Klintmalm, chairman of the Baylor Regional Transplant Institute in Dallas.

Federal regulators acknowledge that their past response to deficiencies has been minimal at best. Several facilities have also failed to meet the government's criteria for patient survival rates, with at least a third of transplant recipients dying within a year. They've suffered few repercussions.

No longer. The U.S. Centers for Medicare & Medicaid Services, which oversees the nation's federally approved transplant centers, is ready to order corrections and even pull certifications, cutting millions of dollars in government funding. Because many private insurers are unwilling to cover expensive transplant procedures in uncertified centers, such measures could force some to close.

"We are prepared to take actions against those we consider to be egregious performers," said Donald Romano, a director in the Center for Medicare Management. He would not identify any in that category but said that there would be little delay: "The actions we take, we will be taking soon."

To be approved by Medicare, transplant centers are required to perform a certain number of operations per year and to achieve certain survival rates. The relationship between volume and outcome is supported generally by studies; more procedures help to ensure surgical competency and better patient results.

Those standards vary by organ: at least 12 transplants a year for adult heart and liver programs, with one-year survival rates of 73 and 77 percent, respectively. For lungs, the minimum is 10 transplants and a 69 percent survival rate.

Dozens of the nation's 242 certified adult transplant centers keep missing those marks. Most are cardiac programs, which continued to proliferate in the 1990s, even as the availability of donor hearts, unlike livers and lungs, began to drop. New drugs and alternative interventions that helped avert transplants exacerbated the pressures. By 2000, a report by the federal inspector general said, the percentage of centers deemed poor performers had risen significantly.

"A perfect storm," said Keith Horvath, director of cardiothoracic surgery at Suburban Hospital in Bethesda.

The Washington area once had four facilities competing for adult heart transplants, as cities such as Philadelphia still do. Only two remain in the Washington region, at Inova Fairfax and Washington Hospital Center, and their diminished programs have meant that locally recovered organs are being sent elsewhere. Sixteen of 27 hearts were "exported" in 2005, including to Baltimore, where Johns Hopkins Hospital and the University of Maryland Medical Center recorded 30 cardiac transplants between them.

Yet there's no doubt that a metropolitan area of several million people can support two centers, said Shashank Desai, who was wooed in the spring from the Hospital of the University of Pennsylvania to lead Inova Fairfax's heart failure and transplant program.

Although some local residents travel for a transplant -- to Baltimore and Charlottesville, for example, usually because of physician referrals or the centers' reputations -- Desai is convinced that the low volumes and waiting lists in the Washington area indicate how many people with failing hearts are not getting the care they need.

"This is absolutely an underserved area," he said.

Doctors at Inova Fairfax and Washington Hospital Center say that their heart transplant programs fell behind. But they say both institutions have made major commitments in the past year that should set the stage for a rebound, and they expect the government to give them time to bring that about.

The two programs' trajectories are similar. By the late 1990s, each was waning, as some surgeons focused on other procedures or moved on. With less interest in transplants from the hospitals' other cardiologists and no robust programs addressing heart failure, the trend persisted. Inova Fairfax lost two insurers because of its track record.

"Only in retrospect do you see the decline," said heart surgeon Stephen Boyce of Washington Hospital Center, which spent a couple of years recruiting a new cardiology chairman to reverse the slide. The new leader's midsummer arrival was part of "a 400 percent increase in financial and other resources," the hospital told federal regulators. "This increase will have a significant positive effect" on the transplant program's future, it said.

Current heart transplant survival rates at both institutions exceed the government's 73 percent benchmark, holding at or exceeding 80 percent one year after surgery. "It was never an issue of quality control," Boyce said.

Until June, two cardiac transplant centers in Richmond faced similar numbers, each performing an average of five procedures a year. Henrico Doctors' Hospital concluded that a turnaround was doubtful. "We definitely weren't going to meet the [Medicare] criteria," said Sheldon Maguire, the facility's administrative director of cardiovascular services.

As the hospital contemplated what was best for the long term, it decided to concentrate on treating heart failure patients and leave transplants to others. It suspended its program.

VCU Medical Center has already benefited from that decision, and the flow of patients from its neighbor likely will push its volume into double digits. Even without that boost, said Sheldon Retchin, chief executive of VCU Health System, surgeons perform more transplants than statistics from the medical center alone indicate, because they also do transplants at the local veterans hospital -- a point that VCU leaders have made to Medicare officials.

If there is prestige in having a transplant program, there's added stature in transplanting multiple organs. Inova Fairfax bills itself as the most active center in the Washington area, and it is the only hospital between Baltimore and Charlottesville that handles hearts, livers and lungs.

But only the lung program has held its own in the past decade. Liver transplants at Inova Fairfax have declined more than 70 percent since peaking at 53 procedures in 1996, which officials attribute to a turnover in leadership. This year, the hospital had two unusual patient deaths, one during and one immediately after surgery. Officials say an internal review found no link between them and no fundamental errors in care. At least two more liver transplants have taken place since without complications.

Turning a program around takes time, often years. Even steadying an otherwise solid program is no quick feat.

When lung transplant volumes and survival rates dropped steeply at Johns Hopkins Hospital in 2003, "we really struggled," program medical director Jonathan Orens said. Turmoil within the Baltimore area's organ procurement organization made donor lungs difficult to get. "We had patients who were really dying," he said. "We felt compelled to get them transplants."

So the doctors pushed the limits, accepting far sicker patients and less pristine organs. The outcomes, skewed further by the small numbers of surgeries, gave everyone pause. The hospital has since hired additional surgical and nursing specialists and, both with donor organs and transplant candidates, decided to risk less.

"We have become a little more selective," Orens said. "When we looked at that experience, it scared us."

Although nearly 10,000 adult hearts, lungs and livers were transplanted nationwide in 2005, some doctors think that the scores of centers out of compliance with at least one Medicare standard indicate that the country has too many programs. They fear that gravely ill patients are being put in greater jeopardy.

"We have to balance the number of centers with the cost involved and the quality involved," said Barry Straube, a transplant nephrologist and the Medicare and Medicaid centers' chief medical officer. "It appears to me we have more programs than we absolutely need."

Since last October, when the Los Angeles Times reported on serious violations at two California liver transplant centers, U.S. Senate finance chairman Charles E. Grassley (R-Iowa) has pressed for increased monitoring and enforcement. In a letter sent last month to top health officials, Grassley questioned the government's reliance on patient complaints and hospital self-reporting to identify problems.

Critics say Medicare could have acted more assertively. Straube and others say that regulations cobbled together over two decades limited the agency's ability to sanction troubled programs.

A rewrite of the rules is due to be completed this year. Rather than judge all centers by the same measure, Medicare would compare their actual survival rates to the rates expected based on the severity of their patients' pre-transplant conditions. Depending on the deviation allowed, Medicare estimates that at least 10 percent of programs would be decertified.

The agency also has proposed reducing the standard for minimum surgeries to nine transplants in 30 months, less than a third of the 12 transplants now required per year. The plan has been controversial.

"Too low," said Robert Robbins, a Stanford University medical professor and president of the International Society for Heart & Lung Transplantation. To do the operations well, he said, "you have to have a massive team" trained not just to operate but to manage a patient through complications that may follow. His threshold is "at least one transplant a month to keep your team sharp."

From Dallas, where the Baylor University Medical Center has one of the biggest liver transplant programs, Klintmalm was more disparaging. "It's preposterous," he said of a reduced benchmark. "I wouldn't take my car to be serviced by someone who repaired [nine] cars over the past three years. Would anyone do that?"


 



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