The CMS last week issued a final rule to set new hospital conditions of participation for organ transplant centers.
The rule will move Medicare-covered transplant programs toward an outcome-focused system that reflects the clinical experience, resources and commitment of the transplant program, the agency said in a written statement. It also will seek to ensure better oversight of transplant centers by advancing coordination between the CMS, the Health Resources and Services Administration, the Organ Procurement and Transplantation Network, the Scientific Registry of Transplant Recipients and state survey agencies.
But Leslie Miller, chairman of the cardiology department at 841-bed Washington (D.C.) Hospital Center, didnt see a significant number of changes in the final rule to what the CMS previously had in its criteria for transplant centers. The CMS basically reconfirmed its outcome expectations, although it did drop the minimum number of heart transplants to 10 from 12 a year. Recent data indicated that even if a center does 10 transplants, it can still achieve good outcomes, he said.
Overall, the rule represents a positive change across the board for all organ donations, Miller said. Everybody involved in the field wants the public to have confidence in these centers.
Washington Hospital Center has been embroiled in its own personal battle with the CMS over the agencys effort to decertify the centers 20-year-old heart transplant program because of low transplant volume. The center is still in discussion with the CMS on the decertification. No decision has been made yet, a spokeswoman for the center said.
Under the new final rule, all transplant centers that continue to participate in Medicare, including kidney transplant centers, are required to submit a request for initial approval. Once approved by Medicare, transplant centers are eligible for re-approval every three years, the agency stated.
This rule seems to reflect a much stronger commitment by the executive branch to improving and ensuring accountability of the organ transplant system, said Sen. Chuck Grassley (R-Iowa), ranking member of the Senate Finance Committee, in a written statement. I hope these new standards will give Medicare beneficiaries greater peace of mind, result in improved transplant care and, ultimately, save lives.
Grassley began scrutinizing federal oversight of the transplant system in the fall of 2005, after violations of organ procurement policies and other problems at medical centers in California, including 314-bed St. Vincent Medical Center in Los Angeles and 358-bed University of California Irvine Medical Center, Orange.
I remain concerned that these examples may indicate more systemic problems underlying organ procurement in this country, Grassley had written in a 2006 letter to David Walker, comptroller general of the Government Accountability Office. The Irvine transplant program closed down in 2005, after the CMS rescinded Medicare payment approval for liver transplants, a spokesman for the medical center said in an interview.
Grassley in his letter had asked the GAO to conduct a review of various organ procurement systems, including the CMS program. The report has completed the initial phases but has yet to be released, a GAO spokeswoman said.