A new law in Florida that allows doctors to perform C-sections in outpatient birthing centers has raised serious safety concerns among medical specialists, who say the procedures carry a small but real risk of life-threatening complications and should not be performed. are performed outside hospitals.
The proposed new facilities, to be called advanced birth centers, would not be able to quickly mobilize additional staff, equipment and expertise if complications suddenly arise, as a hospital would, critics noted.
“A pregnant patient who is considered low-risk one moment may suddenly need life-saving care the next,” said Dr. Cole Graves, president of the Florida region of the American College of Obstetricians and Gynecologists.
“Advanced birthing centers, even with increased regulations, cannot guarantee the level of safety that patients would have in a hospital,” he said.
Florida’s law, the first of its kind in the country, comes as the United States faces a maternal mortality rate that far exceeds that of comparable high-income countries.
Florida itself lags behind other states in maternal care, receiving a D+ grade in a recent March of Dimes report because of higher-than-average maternal mortality rates and death rates among black infants that are double those of white infants. The state has high C-section rates, and rates of premature births and infant deaths are worse than the national average.
The law states that new advanced birthing centers must be equipped with at least one operating suite and be able to transfer patients to a hospital if necessary. The measure does not say how close the hospital must be.
However, C-section complications, such as bleeding and damage to surrounding tissue, “require immediate attention and assistance from other hospital teams and resources such as intensive care units, ventilators and additional surgical assistance,” said Dr. Nandini Raghuraman, assistant professor maternal fetal medicine at Washington University in St. Louis.
“These are all the kinds of things that when we need them, we need them urgently,” he said. “Any delay can be life-threatening.”
The new law also allows advanced birth centers to care for women attempting a vaginal birth after a previous C-section, despite the fact that these births can be extremely dangerous if the uterus ruptures and massive bleeding ensues.
“You have 15 to 20 minutes before the baby’s oxygen supply stops and the baby dies or has brain damage,” said Dr. Aaron Elkin, an obstetrician in Florida. He said he supports innovation in health care, but believes patients should be informed of potential risks.
Women in labor, not just fetuses, face risks in these settings, she said: “The uterus receives 20 percent of the blood that the heart pumps when you’re in term pregnancy. In a matter of minutes, you can lose your entire blood supply.”
KFF Health News reported that a group of doctors called Women’s Care Enterprises, owned by London-based investment firm BC Partners, lobbied for the legislative change. Gov. Ron DeSandis signed the bill into law in March as part of a comprehensive health care package that included initiatives aimed at strengthening the state’s health care workforce.
The law also increased reimbursement rates for Medicaid providers, though it did not expand the program to cover all low-income residents, leaving many Floridians uninsured.
A spokesman for the investment firm did not respond when asked whether Women’s Care Enterprises had lobbied for the new law. Women’s Care Enterprises does not currently provide out-of-hospital C-section deliveries, the group said in a statement last week, and does not plan to do so.
Mathieu Bigand, director of private equity at BC Partners, and the firm’s co-head of healthcare, Michael Chang, did not respond to requests for comment. Aides to state Sen. Gayle Harrell, who sponsored the bill in the Florida Legislature, said she could not be reached.
The advanced birthing centers were promoted as a way to expand access to maternity care in the state, where many hospitals have closed their labor and delivery departments in recent years. So-called maternity care deserts have developed in rural areas outside of Florida’s major cities.
The trend is national: More than 200 hospitals across the country have closed labor and delivery units since 2011, often because they are unprofitable and harder to staff than other hospital services.
Only two of Florida’s 21 rural hospitals were still providing labor and delivery care as of April, according to a report by the Center for Healthcare Quality and Payment Reform, a national policy center.
In February, North Shore Medical Center in northern Miami-Dade County, a medically underserved area, abruptly closed its labor and delivery unit amid financial problems.
Whether advanced birthing centers will expand access to maternity care in the state is uncertain, experts said. About half of all deliveries in Florida are to women insured by Medicaid, the government health plan for low-income Americans, whose low reimbursement rates cover only a fraction of the costs and burden hospitals.
The new law requires advanced birth centers to accept Medicaid patients, but privately owned practices tend to focus on the bottom line and aim to maximize profits.
If centers limited the number of Medicaid beneficiaries they would accept and served primarily privately insured patients, facilities could draw well-insured patients from hospitals, increasing their financial challenges and exacerbating disparities.
“I don’t think this will have any effect on addressing provider shortages or maternity deserts, which tend to be in rural areas,” said Julia Strasser, director of the Jacobs Institute for Women’s Health at George Washington University.
Mary Mayhew, the executive director of the Florida Hospital Association, agreed, but said the association’s main objections to creating the advanced birth centers were safety concerns.
“There is no such thing as a low-risk C-section and it shouldn’t be done outside hospital,” Ms Mayhew said.
The proposed centers will differ from birthing centers, which are also located outside hospitals but are based on an obstetric model of care and accept only low-risk patients. Those facilities transfer any woman who might need a C-section to a hospital, said Kate Bauer, executive director of the American Association of Birth Centers.
Ms Bauer said the term “advanced birth centres” – so similar to birth centers run mainly by midwives – would muddy the waters for patients.
Advanced birth centers “are 180 degrees different from what the birth center model is,” she said. “A birth center is more than wallpaper and curtains — it’s a whole model of care.”
Nor do advanced birth centers compare in any way to ambulatory surgery facilities, which perform scheduled elective procedures, not emergency procedures, said Kara Newbury, chief advocacy officer for the Ambulatory Surgery Center Association.
Most procedures at outpatient surgery centers “can be done in less than an hour,” he said, “with the vast majority of patients leaving the same calendar day.” The procedures usually do not involve the risk of excessive blood loss. It’s rare for an outpatient surgery center to even have an agreement with a blood bank, he said.
For a small facility, maintaining blood bank supplies on site can be difficult. Blood and platelets should be readily available, but they have a short shelf life, according to Daniel Parra, a spokesman for the American Red Cross.
Conditions such as postpartum haemorrhage, which can require at least two units of red blood cells, can be fatal if not recognized and treated quickly, Mr Parra said. Dozens more units may need to be transfused if the bleeding continues or worsens, he added.
Physicians at advanced birth centers may be motivated to perform scheduled elective cesarean deliveries more often, both because of higher reimbursement rates to providers, compared with vaginal deliveries, and the ease of advance planning, said Dr. Grace Chen, an obstetrician and gynecologist who has written about C-sections.
“My concern is that it will increase the C-section rate,” Dr. Chen said. About one in three births in the United States is a cesarean section, up from one in five in 1996, even though the surgeries are associated with more complications than vaginal births and may increase the risks of future pregnancies.
Researchers have raised concerns about the quality of care in for-profit healthcare facilities owned by investment firms.
A recent analysis of 4.1 million Medicare hospitalizations found that adverse events such as falls and infections were higher in hospitals owned by for-profit private equity firms compared with a control group of hospitals, even though the privately-owned hospitals were newer and lower income patients and transferred many of the patients with complex illnesses to other facilities.
Dr. Amos Grünebaum, a professor of obstetrics and gynecology at the Zucker School of Medicine at Hofstra University, who has published studies examining the safety of different birth arrangements, said it was the first time he had ever heard of C-sections being performed outside of hospitals anywhere. in the world.
“Pregnancy is like no other situation, because you have two patients, the baby and the mother, and sometimes they need care in different ways,” said Dr. Grünebaum.
He argued that there is no such thing as a low-risk patient or a low-risk C-section.
“Every caesarean section is high risk. Period. End of story,” he said.
