Some of Florida’s largest health care systems and children’s hospitals are challenging two proposed state rules, alleging that facilities could get shut out of the market and quality of care could be harmed.
Six challenges have been filed in the state Division of Administrative Hearings during the past two weeks. They challenge a proposed rule meant to regulate organ transplant programs and a proposed rule about pediatric cardiac services.
Tampa General Hospital and Adventist Health System filed challenges to the proposed organ-transplant rule, while UF Health Shands and Miami’s Jackson Memorial Hospital joined together in another challenge to the rule.
UF Health Shands and Jackson Memorial took issue with the state’s decision to scrap patient thresholds that hospitals must meet to offer adult and pediatric transplant services.
Under current rules, for instance, new heart-transplant programs are required to have annual caseloads of at least 500 cardiac catheterization patients and 150 open-heart surgery patients and, within two years, be performing at least 12 heart transplants annually. A higher minimum threshold of 24 heart transplants per year is set once a program is established.
In the proposed rule, Agency for Health Care Administration would require that hospitals maintain minimum volume standards authorized under a federal Medicare rule. But the Medicare rule doesn’t contain minimum volume requirements for pediatric organ transplant programs. Additionally, the minimum volume requirements in the federal rule are only required for initial approval and only have to be followed during the first year of a new transplant program.
Attorneys for UF Health Shands and Jackson said in their challenge that the state has a limited number of organ transplants and that eliminating minimum requirements could harm care at existing programs.
Attorneys wrote in an April 22 brief that the rule’s “failure” to include the requirements “contravenes” a requirement that the agency have “quality of care standards” for organ transplant programs.
The legal skirmishes come two years after the Republican-controlled Legislature repealed the “certificate of need” regulatory process for new hospitals and complex medical services. The so-called CON process was controversial and led to legal fights between hospitals over whether new services should be allowed.
But the proposed new rules meant to replace the CON program also are proving controversial.
Johns Hopkins All Children's Hospital, Nemours Children's Hospitals and Holtz Children’s Hospital at Jackson Memorial also filed challenges to the AHCA proposal regulating pediatric cardiac-care services. While the hospitals filed separate challenges, the three cases have been consolidated into one.
Attorneys for Nemours took aim at part of the proposed rule that would require hospitals or ambulatory surgical centers to demonstrate they have performed at least 100 cardiac surgical procedures annually, averaged over a 2-year period. If they cannot meet the requirement they wouldn’t be relicensed for the service under the proposed rule.
“Nemours has invested tens of millions of dollars in both infrastructure and human capital to provide the highest quality pediatric cardiac care to the children of Florida. Closure of the Nemours cardiac program would disrupt continuity of care for the hundreds of Nemours cardiac surgery patients who would be displaced and forced to find new providers,” attorney for the hospital wrote. “Closure of the cardiac surgery program may force Nemours to also close satellite cardiac clinics located in areas where access to pediatric cardiac care had been lacking, such as Melbourne, Kissimmee, Vero Beach, Panama City, and Fort Walton Beach.”