A prominent U.S. senator asked federal officials Thursday to explain why they haven't acted against nearly 50 transplant centers nationwide that fail to meet federal benchmarks for patient survival and the number of transplants performed.
Sen. Charles E. Grassley, an Iowa Republican and chairman of the Finance Committee, made the request in letters to the administrators of two federal agencies that oversee the nation's transplantation system after The Times reported Thursday that one in five federally funded transplant programs do not meet one or both of the standards.
"I have been increasingly concerned about the oversight of the organ procurement and transplantation system," Grassley wrote to the heads of the U.S. Centers for Medicare and Medicaid Services and the Health Resources and Services Administration.
It is the fourth time in the last year that Grassley has ordered investigations or demanded answers after Times reports detailing dangerous lapses in oversight of the national transplantation system. Three transplant centers in California have closed since September after their problems came to light.
"I am troubled by the implication that the problems recently identified at specific facilities in California may be indicative of problems at facilities elsewhere," Grassley wrote.
Grassley had previously asked the Government Accountability Office to conduct a comprehensive review of the organ procurement and transplantation oversight system. The GAO was asked to determine whether the federal agencies were able to effectively oversee transplantation nationwide.
Medicare officials are reviewing all certified transplant programs to ensure they are meeting the rules.
In March, the agency sent a letter to all programs asking for data on transplants performed, survival rates, staffing and information on significant changes.
A preliminary review of the responses has found about 25 programs that are seriously out of compliance with the rules, one official told The Times. Some of the substandard programs could be subject to immediate decertification.
Other programs may be asked to write corrective-action plans.
In addition, the agency is creating new rules that would establish more detailed oversight of transplant centers. The guidelines won't be finalized until next year.
Medicare spokesman Peter Ashkenaz said officials had not seen Grassley's letter and could not comment specifically on it. He said the agency would work with Grassley to address his questions.
Dr. Jean Emond, chief of transplantation services at New York Presbyterian Hospital/Columbia University Medical Center, said he is troubled that Medicare hasn't enforced its rules. In the early 1990s, when Medicare first began funding liver transplants, he said, certification was a "badge of honor."
"It meant you had better results," Emond said.
The prestige faded away as Medicare approved more centers and failed to enforce its rules.
"I'm delighted to meet and exceed benchmarks," Emond said. "The implication that you can fail to meet them and there be no consequences is a little demoralizing for those who like to think we're committed to being the best we can be."