A new law in Florida that allows doctors to perform C-sections in outpatient birth centers has raised serious safety concerns among medical experts, who say the procedures carry a small but real risk of life-threatening complications and should not be undertaken outside outside hospitals.
The proposed new facilities, to be called advanced birth centers, will not be able to quickly mobilize extra staff, equipment and expertise if complications suddenly arise, as a hospital would, critics noted.
“A pregnant patient who is considered low risk at one moment may suddenly need life-saving care the next,” said Dr. Cole Greves, Florida district president for the American College of Obstetricians and Gynecologists.
“Advanced birth centers, even with more stringent regulations, cannot guarantee the level of safety that patients would receive inside a hospital,” she said.
Florida's law, the first of its kind in the nation, comes as the United States grapples with a maternal mortality rate that far exceeds that of comparable high-income countries.
Florida itself lags other states in maternal care, earning a D+ grade in a recent March of Dimes report due to higher-than-average maternal mortality rates and mortality rates among black infants that are double those of white children. The state has high C-section rates and rates of premature births and infant deaths are worse than the national average.
The law stipulates that new advanced birth centers must be equipped with at least one operating room and be able to transfer patients to hospital if necessary. The provision 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 an intensive care unit, ventilators and additional surgical assistance,” Dr. said. Nandini Raghuraman, assistant professor of maternal-fetal medicine at Washington University in St. Louis.
“These are all kinds of things that when we need them, we need them emergently,” he said. “Any delay can be life-threatening.”
The new law also allows advanced birth centers to care for women who attempt a vaginal birth after a previous cesarean 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 suffers brain damage,” said Dr. Aaron Elkin, a Florida obstetrician. He said he supports innovation in healthcare, but believes patients should be informed of the potential risks.
Women in labor, not just fetuses, are at risk in these settings, he said: “The uterus receives 20% of the blood that the heart pumps when you're at full term. In just a few 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, has been lobbying for the legislative change. Gov. Ron DeSantis signed the bill in March as part of a comprehensive health care package that included initiatives to strengthen the state's health care force.
The law also increased reimbursement rates for Medicaid providers, although it did not expand the program to cover all low-income residents, leaving many Floridians uninsured.
A representative 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 cesarean sections outside of the hospital setting, the group said in a statement last week, nor does it plan to.
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 it was out of reach.
The advanced birth centers have been promoted as a way to expand access to maternity care in the state, where many hospitals have closed labor and delivery departments in recent years. So-called maternity care deserts have grown in rural areas outside Florida's major cities.
The trend is nationwide: More than 200 hospitals across the country have closed labor and delivery units since 2011, often because they are unprofitable and have more difficulty staffing 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 from 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, suddenly closed its labor and delivery unit due to financial problems.
It's unclear whether advanced birth centers will expand access to maternity care in the state, experts say. About half of all births in Florida involve women insured by Medicaid, the government health plan for low-income Americans, whose low reimbursement rates cover only a fraction of the costs and put a strain on hospitals.
The new law requires advanced birth centers to accept Medicaid patients, but privately owned practices tend to be bottom-line focused and aim to maximize profits.
If centers were to limit the number of Medicaid beneficiaries they would accept and serve primarily privately insured patients, facilities could lure well-insured patients from hospitals, increasing their financial challenges and exacerbating inequities.
“I don't think this will have any effect on the provider shortage or the maternity desert, which tends to be in rural areas,” said Julia Strasser, director of the Jacobs Institute of Women's Health at George Washington University.
Mary Mayhew, CEO of the Florida Hospital Association, agreed, but said the association's main objections to the creation of advanced birth centers involve safety concerns.
“There is no such thing as a low-risk caesarean section and they should not be performed outside of a hospital,” Ms Mayhew said.
The proposed centers will be distinct from birth centers, which are also located outside hospitals but are based on an obstetric model of care and accept only low-risk patients. These facilities transfer any woman who may 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 centers” — so similar to birth centers run primarily by midwives — would muddy the waters for patients.
Advanced birth centers “are 180 degrees different from what the birth center model is all about,” she said. “A birth center is more than just wallpaper and curtains – it's an entire model of care.”
Nor are advanced birth centers comparable in any way to outpatient surgical facilities, which perform scheduled elective procedures, not emergency procedures, said Kara Newbury, chief advocacy officer for the Association of Ambulatory Surgery Centers.
Most procedures at ambulatory surgical centers “can be performed in less than an hour,” he said, “with the vast majority of patients leaving on the same calendar day.” The procedures typically do not carry the risk of excessive blood loss. It's rare for an ambulatory surgery center to also have an agreement with a blood bank, she said.
For a small facility, maintaining on-site blood bank inventories can be difficult. Blood and platelets must be immediately available, but have a short shelf life, according to Daniel Parra, a spokesman for the American Red Cross.
Conditions such as postpartum hemorrhage, which can require at least two units of red blood cells, can be deadly if not recognized and treated quickly, Parra said. You may need to transfuse dozens of additional units if the bleeding continues or worsens, she added.
Doctors at advanced birth centers may be incentivized to perform scheduled elective cesarean sections more frequently, both because of higher reimbursement rates to providers, compared to vaginal births, and because of the convenience of scheduling ahead, Dr. Grace said Chen, an obstetrician and gynecologist who has written about cesarean 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, although the surgeries are associated with more complications than vaginal births and can increase the risks of future pregnancies.
Researchers have raised concerns about the quality of healthcare in profit-driven healthcare facilities owned by investment companies.
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 than in a control group of hospitals, even though the hospitals acquired by private equity were younger and less low-level. income patients and have transferred many of the patients with complicated diseases to other facilities.
Dr. Amos Grünebaum, a professor of obstetrics and gynecology at Hofstra University's Zucker School of Medicine who has published studies examining the safety of different birth settings, said it was the first time he had heard of cesarean sections being performed at outside of hospitals everywhere. in the world.
“Pregnancy is not a situation like any other, because there are two patients, the baby and the mother, and sometimes they need to be treated in different ways,” Dr. Grünebaum said.
He argued that there is no such thing as a low-risk patient or a low-risk C-section.
“Every C-section is high risk. Period. End of story,” she said.