High-profile Florida hospitals are lining up to battle over a new state proposal about approving organ transplant programs.
Nemours Children’s Hospital last week moved to intervene at the state Division of Administrative Hearings to support a proposed transplant programs rule issued in August by the Florida Agency for Health Care Administration. That came after Memorial Healthcare System in Broward County and AdventHealth Orlando intervened to support the proposed rule.
Tampa General Hospital, UF Health Shands Hospital in Gainesville and Jackson Memorial Hospital in Miami filed challenges last month to the rule, alleging it does not include adequate safeguards for quality of care.
Administrative Law Judge Joshua Pratt has scheduled a three-day hearing, starting Dec. 17, to consider the consolidated challenges.
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The proposed rule and challenges came after years of debate and disputes about approving transplant programs. The proposal rule, in part, would revise standards for hospitals that want to begin providing such procedures. — and continue providing them after getting initial approvals.
While Tampa General, UF Health Shands and Jackson Memorial have raised arguments about potential effects on quality of care, Nemours, Memorial Healthcare and AdventHealth said in their motions to intervene that the proposal rule emerged after a committee worked on the issue.
“The committee met and participated in a good faith, healthy debate over the particulars to be included in the transplantation licensure rule,” Nemours attorneys wrote. “All parties were given an opportunity to participate and to persuade other committee members to their points of view.”
Tampa General, UF Health Shands and Jackson Memorial provide procedures such as heart, liver, lung and kidney transplants. In the challenges, they argued that the proposed rule does not require minimum numbers of transplant procedures each year to ensure proficiency and that the proposal could have spin-off effects on hospitals already providing transplants.
“Additionally, the proliferation of low-volume, low-quality programs endangers existing programs, like Shands and Jackson, by siphoning off patients from existing programs,” UF Health Shands and Jackson argued in a joint petition. “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.”
Memorial Healthcare and AdventHealth said in their motions to intervene that they have transplant programs.
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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 AHCA to adopt licensure standards for organ transplant programs that were separate from the certificate of need process, according to documents filed at the Division of Administrative Hearings. 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.
An initial proposed transplant programs 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 challenges filed last 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.
But in moving to intervene in the case, Nemours, Memorial Healthcare and AdventHealth each said the proposed rule is a “valid exercise of delegated legislative authority.”
