Tampa General Hospital, Broward Health Challenge State Over NICU Rules

Two major hospitals are challenging new rules drawn up by Gov. Ron DeSantis’ administration after state lawmakers stripped away regulations that limited what types of services hospitals could offer.

One of the hospitals challenging the rules - Broward Health Medical Center - is part of the North Broward Hospital District, which decided this week to hire Shane Strum, DeSantis’ chief of staff, as its CEO.

Broward Health Medical Center and Tampa General Hospital have asked an administrative law judge to strike down rules that deal with neonatal intensive care units. They contend the changes would lock them out of the market, and their attorneys argue, put their physician residency training programs at risk.

The legal skirmish comes less than two years after the Republican-controlled Legislature repealed the “certificate of need” regulatory process for new hospitals and complex medical services.

In separate filings at the state Division of Administrative Hearings, attorneys for the hospitals argued the new rules should be invalidated because they are vague and the state Agency for Health Care Administration overstepped its authority from the Legislature.

Florida currently has three types of neonatal intensive care units: Level I, Level II and Level III. The new rules would create a fourth type of unit, Level IV, but would limit the elite licensure category to hospitals that have already earned a Level III designation and “have the capability to provide continuous onsite surgical repair of complex congenital or acquired conditions in neonates.”

Another section of the rules would require hospitals with Level IV units to “maintain continuous availability of complex neonatal surgery, including pediatric cardiac services.”

Broward Health Medical Center has a 34-bed Level III unit, and Tampa General operates a 58-bed Level III unit. Neither facility, though, has pediatric open-heart capability and, under the rules, wouldn’t qualify for a Level IV unit.

Tampa General attorneys said in their challenge that pediatric cardiac services cannot be provided without obtaining a separate license under rules AHCA is still in the process of developing.

“This would substantially delay, or even render unfeasible, the establishment of Level IV programs at any hospital that does not currently have a pediatric cardiac services program,” Tampa General attorneys wrote in their Feb.1 filing.

Tampa General is a teaching hospital that supports the University of South Florida College of Medicine. The hospital has fellowship programs in neonatology and maternal-fetal medicine. It also is one of 12 state-recognized regional perinatal intensive care centers where women with high-risk pregnancies go to receive care.

““The newly created Level IV NICU will become the level of care where the most seriously ill neonates in Florida will be treated. However, because Tampa General does not currently have a pediatric cardiac services program, Tampa General would not meet the rule’s requirements to provide this level of care. Absent Level IV status, the highest-risk and most complex obstetrical and neonatal patients would likely bypass Tampa General and instead be referred to other hospitals with a Level IV NICU,” the hospital’s attorneys wrote. “The loss of this segment of the neonatal patient population would threaten Tampa General’s teaching mission. “

The changes to how the state regulates neonatal intensive-care units comes as the number of premature babies born in the United States is on the rise. One in 10 babies born in the United States in 2019 was premature, or before 37 weeks of pregnancy, according to the federal Centers for Disease Control and Prevention.That was the fifth consecutive year of rising premature birth rates, the CDC reported.

The legal tussle over neonatal intensive care units is the first since the Legislature in 2019 eliminated the certificate of need requirements for building hospitals and adding “tertiary” services. The process was long controversial and led to legal fights between hospitals over whether new facilities and services should be allowed.

But the dispute about NICU rules was not a surprise.

“They are making substantive changes, so it is not unexpected or surprising that there would be (legal) challenges,” said Mia McKown, a partner in Holland & Knight’s Tallahassee office who specializes in health care law. “If an entity has issues, this is the time they would be raising those objections.”

While the Legislature did away with the so-called CON process for hospitals in 2019, it decided to temporarily keep in place a CON rule for Level III neonatal intensive care units. That rule requires hospitals wanting to establish Level III units to have at least 1,500 live births per year. The rule also requires the units to have a minimum of 15 beds.

The state did not have facility standards for Level II or Level III units until 2018, when the Legislature directed the Agency for Health Care Administration to pass rules. AHCA published rules in March 2019, but they were never formally adopted.

In December, nearly two years after the rules were published, the agency announced it was revising them. The new rules did not include the 15-bed requirement or the 1,500-live birth requirement for Level III units. They also created the Level IV neonatal intensive care designation.

In their challenge, attorneys for Broward Health Medical Center alleged several reasons that the rules should be declared invalid, including the lack of a statement of estimated regulatory costs. Such statements are required when proposed rules would increase business’ costs by more than $200,000 in the aggregate within a year after implementation.

Administrative Law Judge John Newton has ordered the cases consolidated and has scheduled a three-day hearing in April.

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