Heart Transplant Program Could Lose Certification

Federal officials have alerted Washington Hospital Center that its heart transplant program could lose approval and millions of dollars in Medicare funding within 30 days because surgeons performed so few of the operations in the past two years.

Unless the hospital can make corrections that persuade the government to reverse course, the immediate Washington area will be left with only one cardiac transplant center, itself under scrutiny from regulators.

In a letter sent late Tuesday, the Centers for Medicare and Medicaid Services informed Washington Hospital Center that its five transplants per year in 2005 and 2006 fell well below the threshold of 12 procedures required yearly for certification. Moreover, "given the lack of meaningful transplant experience," CMS did not consider data on patients' survival sufficient to judge overall results. "We are unable to gauge outcomes of the program," the letter noted.

The action comes amid stepped-up oversight of transplant centers nationally after criticism that the government has allowed many to continue despite serious, longstanding deficiencies. Three additional hospitals -- in California, Connecticut and Nebraska -- received the same notice this week for their heart programs, federal officials said. Several dozen other facilities, including Inova Fairfax Hospital, face further evaluation that could lead to decertification. Inova Fairfax performed only four heart transplants in 2006.

Such a decision does not force an institution to stop doing transplants, but it cuts off federal reimbursement and usually discourages private insurers from covering the life-saving procedure, which can cost as much as $400,000, according to experts.

Washington Hospital Center had mounted a strong defense of its program's future last spring and summer, saying in response to regulators' initial warnings that a new cardiology chairman of international stature and a "400 percent increase in financial and other resources" would turn things around.

Yesterday, chief medical officer Janis Orlowski offered an equally vigorous rebuttal, saying she was "concerned and surprised" by the federal agency's move. "CMS is making a mistake," she said. "We have told them we have no intention of closing our heart transplant program."

Although the hospital's 2006 total was low, all five transplants took place in the last five months of the year. "I felt we were really ramping up," Orlowski said. "We have spent time and money. We have brought people in." She stressed that quality should count for as much as quantity; the program's one-year patient survival rate stands at 100 percent, she said.

"I'm not sure how you can argue with 100 percent survival," she continued. "I'd like someone to show me how that becomes a bad number."

Orlowski said she and top officials would respond immediately and submit the required corrective plan addressing past problems, staffing issues and target dates for short- and long-term goals. Doing so would stop the 30-day clock.

Even so, the federal letter specifies, any Medicare beneficiaries among the fewer than a dozen patients now on the facility's heart transplant waiting list should be told of their potential financial liability should the program lose certification.

The hospital performed no heart transplants in January.

Herb Kuhn, the Medicare and Medicaid centers' acting deputy administrator, said in an interview yesterday that nothing specific triggered the move against Washington Hospital Center.

He would not address the kind of changes or support that would ensure the transplant program's continuation. "I don't want to prejudge what more details they can offer us," Kuhn said.

Transplant programs bring prominence to their institutions, which critics say is one reason they are so seldom closed. In mid-December, Inova Fairfax Hospital made that rare decision and ended its liver transplant program after administrators concluded that it could not overcome a steep drop in procedures.

Washington Hospital Center began heart transplantation in 1987, several months after Inova Fairfax. Both programs -- once among four locally -- have struggled with too few patients in recent years.

By comparison, Johns Hopkins Hospital and the University of Maryland Medical Center in Baltimore each performed 16 cardiac transplants in 2006. In Charlottesville, the University of Virginia Medical Center transplanted 12 hearts.