Siding with a preliminary decision by state regulators, an administrative law judge Tuesday recommended denial of plans by Nemours Children’s Hospital to offer pediatric heart transplants and heart and lung transplants.
Judge W. David Watkins, in a 68-page ruling, said the Orlando hospital had not shown that it should receive certificates of need for the proposed programs.
Certificates of need, or CONs, are a key regulatory approval that hospitals need to move forward with new programs or to add facilities.
Nemours in 2016 filed three CON applications: one to provide pediatric heart transplants; one to provide pediatric heart and lung transplants; and one to provide pediatric lung transplants.
The state Agency for Health Care Administration approved the lung-transplant proposal but rejected the other two, prompting Nemours to challenge the two denials.
But in backing the Agency for Health Care Administration’s decisions, Watkins pointed to issues such as the relatively rare instances of pediatric heart and lung transplants and the availability of heart transplants at other hospitals, such as UF Health Shands Hospital in Gainesville and Johns Hopkins All Children’s Hospital in St. Petersburg.
“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 either application, Watkins wrote. “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 inconvenience.”
Watkins also said, in part, that the highly specialized procedures are expensive and that physicians and hospital staff members need to treat certain volumes of patients to remain proficient.
“Nemours failed to demonstrate that it would achieve the volumes it projected unless it takes significant volumes from other Florida providers,” Watkins wrote. “Approval of Nemours will not create transplant patients that do not exist or are not currently able to reasonably access services.”
Under administrative law, Watkins’ recommendation will go back to Agency for Health Care Administration for a final order.