Lahey Clinic has revamped its adult kidney transplant program after organs failed in an unexpectedly large number of patients from mid-2006 through 2009, triggering a review by the federal government.
The Centers for Medicare and Medicaid Services told Lahey in April that it would revoke the hospital’s right to perform kidney transplants on Medicare patients if it did not correct the problems by Nov. 8. The agency, which pays for kidney transplants, acted after its review showed that about twice as many kidney transplants failed than would have been expected based on the health status of the program’s patients and donors.
As a result, Burlington-based Lahey took steps to improve the program. It hired a manager to oversee quality and monitor the health of potential recipients more closely, on top of enhancements that were already underway before Medicare’s review, transplant surgeons at the hospital said.
In a letter to hospital executives late last month, Thomas Hamilton, director of survey and certification for the agency, said Lahey has made substantial improvements “to the great advantage of patients.’’ He said the hospital can continue participating in the Medicare program.
Richard Shaw, director of survey and certification for New England, said it is “a very serious event’’ for Medicare to threaten to drop a hospital from the government insurance program. But, he stressed, recent data show Lahey’s kidney transplant failure rates have returned to normal and patients should not be concerned about the quality of the program.
Lahey’s chief of surgery, Dr. Roger Jenkins, said physicians reviewed every case in detail, but that no single reason emerged for the higher-than-expected number of organ failures. In some cases, he said, surgeons transplanted a kidney that might not have been the best match for the recipient - for example, putting a small kidney in a large patient.
In other cases, surgeons operated on patients with heart disease who may have benefited from having angioplasty first to open blocked arteries - or whose cardiac problems perhaps should have disqualified them from the transplant program altogether.
“Sometimes we act with our hearts and not our brains,’’ he said.
Now, doctors evaluate patients considered to have increased risk of a transplant failure more often to make sure they are still eligible for the transplant program. After the transplant, doctors see high-risk patients for check-ups every six months, rather than every year as they do for other patients.
All patients must have an infectious disease evaluation, and the hospital tightened rules for accepting kidneys that are less desirable, such as those from elderly donors.
The Globe learned of Medicare’s review of the Lahey program through a Freedom of Information Act request.
Medicare reviewers examined the transplant program’s outcomes during two overlapping periods - July 2006 to December 2008, and July 2007 to December 2009 - and found nine kidney failures during each, when about four to five would have been expected during each period.
In most cases where kidneys failed, patients went back on dialysis or got another transplant. While some patients died, the mortality rates for kidney transplant patients at Lahey have been within the typical range.
Lahey did 44 kidney transplants in 2010, giving it 11 percent of the Massachusetts market.
In 2007, Medicare began closely overseeing results at transplant centers across the country, conducting onsite inspections every three years and reviewing outcome data every six months. This has led to a growing number of warnings to centers and debate among surgeons about whether the increased scrutiny has been good or bad for patients.
Following unfavorable Medicare reviews, Hartford Hospital in Connecticut temporarily closed its liver transplant program to hire more surgeons, while Maine Medical Center in Portland is working to improve its kidney transplant program, which is still open.
Dr. Douglas Hanto, chief of transplantation at Beth Israel Deaconess Medical Center, said Medicare’s increased oversight has forced hospitals to either spend the money to support their transplant programs and improve services for patients, or risk being shut down.
But, he said, because a program’s results are based in part on patient selection, hospitals may be rejecting risky patients who they would have accepted in the past, meaning fewer patients have access to transplants. While success rates are adjusted for the health status of patients, Hanto said those adjustments are inadequate.
Medicare “has a very big club,’’ Hanto said.
In May 2010, a man who agreed to donate part of his liver to help a sick relative died while undergoing the transplant procedure at Lahey. Such deaths are rare, but an investigation by state health officials and Medicare did not uncover any problems with the quality of care at the hospital or other deficiencies that may have led to his death.
Medicare’s Shaw said the agency’s review of the kidney program was unrelated to the death of the liver donor.
Dr. Elizabeth Pomfret, chairwoman of transplantation, said Lahey began revamping its transplant programs in 2007, in an effort to expand and improve them. The hospital created a separate transplant department, which integrated surgeons, medical doctors, and other specialists. Pomfret took over the new department in February 2009.
Jenkins, the surgery chief, said that the organ failures and Medicare review were “traumatic’’ but that the result was positive. “We were able to look at the failures that happened and come up with clear-cut changes,’’ he said.