Medicare’s Transplant Monitoring Defended

A top federal health official is defending Medicare’s oversight of the nation’s organ transplant system after a report last week questioning the government’s failure to act against nearly 50 transplant programs that do not meet federal standards.

“Medicare has been and remains very concerned that beneficiaries have access to a system that is both fair and safe,” Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services, wrote in a letter late Friday to Sen. Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee.

McClellan was responding to a Times investigation showing that one in five federally funded heart, liver and lung transplant programs failed to meet his agency’s benchmarks for patient survival, the number of surgeries performed or both.

Grassley had written a letter demanding an explanation from McClellan and the administrator of the Health Resources and Services Administration, which also oversees transplant issues.

“When two or more government agencies are responsible for oversight of a system, it’s important that the right hand is talking to the left, especially on matters that affect people’s lives, as is the case here,” said Jill Kozeny, a finance committee spokeswoman.

In the meantime, one of the 48 programs identified by The Times announced that it has suspended heart transplants. Henrico Doctors’ Hospital in Richmond, Va., said it halted its program June 14 -- before the newspaper’s report -- because officials determined that they were able to successfully care for heart patients without performing transplants.

In 2005, the hospital did just six heart transplants, half the number required to receive federal certification and funding.

“We have had such success, great success rates with other options,” said hospital spokeswoman Tiffany Taylor-Minor. “As more and more medical technology and medications improve, we’re just finding that we’re not doing as many transplants because of that.”

Henrico has notified Medicare of its move, but the agency has yet to pull the program’s certification, as is typical in situations like this. A Medicare spokesman said officials are reviewing the program’s status.

In his letter to Grassley, McClellan said Medicare stepped up oversight of transplant centers last year after it found that UCI Medical Center in Orange had failed to notify his agency of significant changes in its personnel and operations.

The federal government pulled UCI’s certification in November after The Times reported that more than 30 people had died awaiting new livers in 2004 and 2005 while the hospital turned down scores of organs that might have saved some of them. The hospital had also operated without a full-time liver transplant surgeon for more than a year.

In March, the federal government sent out a survey to all 236 federally funded heart, liver and lung transplant programs. It sought details about their personnel, volume, survival rates and the number of organs turned down. So far, 202 have replied.

Based on the responses, two heart transplant programs and four lung centers failed to meet the federal standard for patient survival a year after surgery. Twenty-six heart programs, five lung facilities and one liver program performed fewer than the minimum number of transplants required for federal certification.

The benchmarks vary by organ, and there are none for kidney transplants.

McClellan told Grassley that his agency expects to receive results from the remaining programs soon but would “take action” against those that did not respond.

The Times report identified a higher number of programs that were out of compliance with federal standards, but its review was based on publicly available data for all transplant centers.

Medicare’s oversight of transplant programs has been questioned before. In February 2004, an audit by the inspector general of the U.S. Department of Health and Human Services criticized the agency’s regulation of heart transplant programs.

The review found that between 1987 and 2000, 69 of the 90 Medicare-approved heart transplant programs had not met the initial federal standards for certification at least once after they were approved. But the inspector general said Medicare rarely tracked data from centers on their volume and survival rate.

Some of the 48 hospitals identified by The Times say they are making improvements that would be reflected in future statistics. Others said the number of transplants performed should not be a primary basis for assessing a program’s quality, a position endorsed by McClellan.

The heart transplant program at Ohio State University Medical Center, for instance, performed 11 solo transplants last year, one shy of the federal standard. But the program said that figure does not include a heart-lung transplant performed at the hospital last year, which would bring it into compliance.

(The heart-lung statistics are kept separately by the national transplant network and were not included in The Times’ figures.)

Regardless, Ohio State doctors said the 2005 data should not be viewed in isolation. The heart transplant program met the federal volume benchmark in the two previous years, and it has already performed 11 surgeries this year.

“Every center is going to have an unusually up year and an unusually down year,” said Dr. Benjamin Sun, chief of cardiothoracic surgery at Ohio State. “Because you’ve looked at it [during] an unusually down year isn’t a reason to indict a program.”

Ohio State’s lung transplant program was also included on The Times’ list because its patient survival rate of 67.7% fell below the federal benchmark.

A list of the programs identified by The Times as not meeting federal standards is available at www.latimes.com/transplant.