Some of Florida’s largest health care systems and children’s hospitals are challenging two proposed state regulations, claiming that facilities could be foreclosed from the market and that the quality of care could be compromised.
In the past two weeks, six disputes have been filed with the state department of administrative hearings. They dispute a proposed rule intended to regulate organ transplant programs and a proposed rule on pediatric cardiac services.
Tampa General Hospital and the Adventist Health System filed an appeal against the proposed organ transplant rule, while UF Health Shands and Miami’s Jackson Memorial Hospital joined forces to challenge the rule.
UF Health Shands and Jackson Memorial challenged the state’s decision to remove the patient thresholds that hospitals must meet in order to provide adult and pediatric transplantation services.
For example, under current rules, new heart transplant programs must have an annual caseload of at least 500 cardiac catheterization patients and 150 open-heart surgery patients and perform at least 12 heart transplants per year within two years. Once a program is established, a higher minimum threshold of 24 heart transplants per year is set.
In the proposed rule, the Agency for Health Care Administration would require hospitals to maintain minimum standards allowed under a federal Medicare rule. But the Medicare rule does not set minimum volume requirements for organ transplant programs in children. In addition, the minimum volume requirements in the federal rule are only required for initial approval and only need to be followed during the first year of a new transplant program.
Lawyers for UF Health Shands and Jackson said in their dispute that the state has a limited number of organ transplants and that eliminating minimum requirements could hurt care in existing programs.
Lawyers wrote in a letter dated April 22 that the “failure” of the rule to include requirements “violates” the requirement that the agency have “quality standards” for organ transplant programs.
The legal skirmishes come two years after the Republican-controlled legislature revoked the “certificate of need” regulatory process for new hospitals and complex medical services. The so-called CON process was controversial and led to legal battles between hospitals over whether new services should be allowed.
But the proposed new rules intended to replace the CON program are also proving controversial.
Johns Hopkins All Children’s Hospital, Nemours Children’s Hospitals, and Holtz Children’s Hospital at Jackson Memorial have also objected to AHCA’s proposal to regulate pediatric heart care services. While the hospitals have filed separate disputes, the three cases have been merged into one.
Lawyers for Nemours have focused on part of the proposed rule that would require hospitals or outpatient surgical centers to demonstrate that they have performed at least 100 cardiac surgeries annually, averaged over a two-year period. If they cannot meet the requirement, they will not be licensed to 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 heart care to the children of Florida. Closing the Nemours heart program would disrupt the continuity of care for the hundreds of Nemours heart surgery patients who would be displaced and forced to seek new care providers, ”wrote the hospital’s lawyer. “Closure of the cardiac surgery program may force Nemours to also close satellite heart clinics in areas lacking access to pediatric heart care, such as Melbourne, Kissimmee, Vero Beach, Panama City and Fort Walton Beach.”