For the second time this year, an administrative law judge Wednesday called for the rejection of a proposed pediatric heart-transplant program that would treat patients from Orlando and other areas of Central Florida.
Judge W. David Watkins, in an 82-page recommended order, said Arnold Palmer Medical Center, which is part of the Orlando Health system, did not show a need to establish another program in the state to provide relatively rare heart transplants to children.
Watkins’ ruling backed a preliminary decision by the state Agency for Health Care Administration to deny a regulatory approval known as a “certificate of need” for the Arnold Palmer program. Under administrative law, Watkins’ recommendation will go back to the Agency for Health Care Administration for a final order.
In July, Watkins made a similar recommendation to reject proposals by Nemours Children’s Hospital to establish a pediatric heart-transplant program and a pediatric heart-and-lung transplant program. The Agency for Health Care Administration issued a final order in October denying the proposals, which led Nemours to challenge the decision at the 1st District Court of Appeal.
Like in the Nemours case, Watkins pointed in his Arnold Palmer recommendation to the proximity of UF Health Shands Hospital in Gainesville, which operates a pediatric heart-transplant program. For example, he cited testimony of parents who live in Brevard County and the Lake County community of Clermont and had children undergo transplants at Shands.
“While transplantation is not an elective service, it is not done on an emergent basis,” Watkins wrote. “As noted, the number of families affected is, quite fortunately, very small. While having a child with these issues is never ‘convenient,’ the travel issues that might exist do not outweigh the weight of the evidence that fails to demonstrate a need for approval of the APMC (Arnold Palmer Medical Center) application. The Orlando area, being centrally located in Florida, is reasonably accessible to all of the existing providers. Most appear to go to Shands, which is simply not a substantial distance away. The credible evidence is that families facing these issues are able to deal with the travel issues.”
Certificates of need have long been a highly controversial issue in Florida’s health-care industry. Hospitals need to get so-called CONs before building new facilities or adding many types of programs.
At least part of the rationale for CON regulations is to avoid costly duplication of programs and services. Florida has four existing pediatric heart-transplant programs and one approved program. It does not have a program in a region that Arnold Palmer and Nemours have sought to serve --- a region made up of Seminole, Orange, Osceola, Brevard, Indian River, Okeechobee, St. Lucie, Martin, Lake and Volusia counties.
But Watkins wrote that only 32 pediatric heart transplants were performed in Florida in 2017 and that having a volume of patients improves quality of care.
“For its part, the Agency (for Health Care Administration) does not dispute that the applicant (Arnold Palmer) is a quality provider,” he wrote. “However, AHCA does maintain that approval of an unneeded sixth provider of PHT (pediatric heart transplant) services in Florida could lead to or correlate with negative patient outcomes. Given the relatively low PHT volumes statewide, and agreement that volume is positively correlated with quality and outcome in transplantation, splitting state volume among six providers could negatively impact the quality of this service, as it concerns the residents of (the Central Florida region) and Florida more broadly.”