TALLAHASSEE — Three major hospital systems have challenged a new state proposal about approving organ-transplant programs, alleging it does not include adequate safeguards for quality of care.
Tampa General Hospital, UF Health Shands Hospital in Gainesville and Jackson Memorial Hospital in Miami filed the challenges after the Florida Agency for Health Care Administration in August issued a proposed rule for transplant programs. The challenges, filed this month at the state Division of Administrative Hearings, came after years of debate and disputes about approving transplant programs.
Tampa General, UF Health Shands and Jackson provide procedures such as heart, liver, lung and kidney transplants. The proposed rule, in part, would revise standards for hospitals that want to begin providing such procedures. — and continue providing them after getting initial approvals.
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“For instance, the proposed rule does not require an organ transplant program to perform a minimum number of transplants each year, which would provide assurance to patients that the program’s physicians and staff are experienced and have performed this complicated procedure enough to be proficient,” Tampa General’s petition at the Division of Administrative Hearings said. “Nor is there a minimum outcome standard that would compare each transplant program’s actual outcomes to their expected outcomes. As a result, if this proposed rule were adopted, the agency would have no authority to take any action against an organ transplant program that is performing only one or two transplants per year with minimally experienced staff, or that has substantially worse patient outcomes compared to what was expected.”
A joint petition filed by UF Health Shands and Jackson raised similar arguments, while also saying the proposed rule could have spin-off effects on hospitals already performing transplants.
“Additionally, the proliferation of low-volume, low-quality programs endangers existing programs, like Shands and Jackson, by siphoning off patients from existing programs,” the UF Health Shands and Jackson petitions said. “This is highly concerning for existing programs, since there are only a limited number of organ transplant cases in the state of Florida. Decreasing the volume of organ transplant patients for existing programs could impact the programs’ viability and quality of care.”
Florida long used what is known as a “certificate of need” process to determine whether hospitals should offer transplant procedures. While supporters said the process helped ensure quality of care and hold down costs, opponents argued it created artificial barriers in the health-care system and limited competition.
The Legislature in 2018 passed a law directing the Agency for Health Care Administration to adopt licensure standards for organ-transplant programs that were separate from the certificate of need process, according to the petition filed this month by UF Health Shands and Jackson. In 2019, the Legislature repealed the certificate of need process.
The moves came after disputes about approval of transplant programs — and a broader push by lawmakers to eliminate certificate of need processes.
The petition filed by UF Health Shands and Jackson said that with the “elimination of the certificate of need process for transplants, the new licensure standards for organ transplant programs became even more important, since they would now be the only governing licensure standards over organ transplant programs in the state of Florida, laying out for both new applicants and existing programs the standards to establish and maintain an organ transplant program.”
An initial proposed rule drew opposition, including from Tampa General, UF Health Shands and Jackson, and was ultimately withdrawn in 2021. The new proposal was filed Aug. 19.
The petitions filed this month raised a series of arguments under administrative law, including that the proposed rule is an “invalid exercise of delegated legislative authority.” Part of that argument, for example, is whether the proposed rule carries out requirements of the 2018 law to include quality-of-care standards.
