Hospitals Square Off Over Bone Marrow Transplants

Florida hospitals are battling about cancer treatment and the appropriate level of state regulation of bone-marrow transplants.

In one corner is Cleveland Clinic Florida Health Systems, which has tried unsuccessfully to get approval from the state to offer bone-marrow transplants and is throwing its support behind proposed changes to eliminate a key type of regulation.

And in the other corner are six Florida hospitals that argue bone-marrow transplant programs are services so complex and expensive that they rise to the level of requiring the blessing of state regulators.

Both sides squared off at an hour-long meeting Tuesday in Tallahassee, where regulators went over proposed changes to some of Florida’s certificate-of-need rules.

Certificates of need have long been a controversial issue in Florida’s health-care industry, with hospitals needing to get the regulatory approvals to add facilities and many types of programs. Cleveland Clinic Florida wants to eliminate certificate-of-need requirements for bone-marrow transplant programs.

Zeina Nahlan, director of Cleveland Clinic Florida’s Maroone Cancer Center in Broward County, said people are flocking to the hospital for treatment, including international patients.

She said the facility has had a 20 percent increase in the number of cancer patients in 2018 over the prior year and that it had received five referrals for treatment of acute leukemia patients during the stretch of days over the Thanksgiving break.

Not allowing the hospital to offer adult bone-marrow transplant procedures is a disservice to patients, Nahlan said Tuesday.

“Limiting it to few hospitals, to a few centers, I believe, is a barrier to providing comprehensive patient care,” she said adding that Cleveland Clinic Florida is connected with Cleveland Clinic’s 26 other clinical and surgical institutes.

Moreover, Nahlan said Cleveland Clinic Florida is a teaching hospital. She said not having the bone-marrow transplant program limits the hospital’s ability “to educate the next generation of physicians in cancer treatment and innovative ways to provide cancer care.”

Bone marrow transplants can be used to treat blood cancers such as leukemia or lymphoma as well as other immune-system or genetic diseases such as sickle cell. The procedures are expensive. The American Cancer Society estimates that they range in costs from $350,000 to $800,000.

There were 1,079 bone marrow transplants conducted in Florida from July 2017 to June 2018, according to a  September report. Those procedures were conducted at six hospitals: University of Miami Hospital and Clinics, Memorial Hospital West, Florida Hospital, H. Lee Moffitt Cancer Center & Research Institute Hospital, Mayo Clinic and UF Health Shands Hospital.

Representatives from those facilities attended the meeting to discuss the proposed changes and whether bone-marrow transplants are still medically complex enough to be considered “tertiary.”

Florida law defines “tertiary service” as one that due to the “high level of intensity, complexity, specialized or limited applicability, and cost,” should be limited.  The law does not, though, enumerate what those services are. Instead, that is done through rule. Since 1990, that has included bone-marrow transplants.

In  documents filed with the state, Cleveland Clinic Florida attorneys said science has advanced to the point that bone marrow transplants no longer are medically complex procedures that need to be regulated by certificate-of-need regulations.

But Mia McKown, an attorney representing Florida Hospital, argued that regardless of the scientific advancements, there’s nothing easy about bone-marrow transplants.

“The assertion that the care for BMT patients has become the norm … and no longer fulfills the criteria as a tertiary service, we believe, is just not founded by the evidence,” said McKown, a partner with Holland & Knight in Tallahassee.

UF Health Shands attorney Seann Frazier agreed and said the Legislature has twice ratified the certificate-of-need rules since they were first passed in 1990. Not all rules need to be ratified by lawmakers. Frazier said Florida courts have found that rules ratified by lawmakers carry more weight than those that aren’t.

Given that, unless lawmakers change the law or until the state presents “hard science” showing a need for change, “there’s no reason to deregulate,” he said.

While Cleveland Clinic Florida supports eliminating the CON requirement for bone-marrow transplants, that’s not the only tack the hospital is taking. The facility notified the state in October that it plans on submitting a CON application for a bone- marrow transplant program.

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