A new Florida law allowing doctors to perform C-sections in outpatient birthing centers is raising serious safety concerns among medical experts, who say the procedures should not be performed outside of hospitals because they carry a small but real risk of life-threatening complications.
Critics said the new facilities, to be called advanced birthing centers, would not be able to mobilize additional staff, equipment and expertise as quickly as hospitals can if complications suddenly arise.
“One minute a pregnant woman may be considered low risk, and the next minute she could suddenly need life-saving care,” said Dr. Cole Greaves, president of the Florida region of the American College of Obstetricians and Gynecologists.
“Advanced birthing centers, even with increased regulations, cannot guarantee the same level of safety that patients receive in a hospital,” he said.
Florida's law is the first of its kind in the nation and comes as the United States grapples with a maternal mortality rate that far exceeds comparable high-income countries.
Florida lags behind other states in maternal and child health, receiving a D+ in a recent March of Dimes report for dismal maternal and child health outcomes for black women. The state has high C-section rates and worse rates of premature births and infant mortality than the national average.
The law states that new advanced birth centers must have at least one operating room and be able to transfer patients to a hospital if necessary. The measure does not say how close the hospital must be.
But complications from a C-section, such as bleeding or damage to surrounding tissue, “require immediate response and support from other hospital teams, resources such as an intensive care unit, ventilators and additional surgical support,” said Dr. Nandini Raghu Raman, an assistant professor of maternal-fetal medicine at Washington University in St. Louis.
“These are the kinds of things that are needed urgently when they are needed,” she said. “Any delay could be life-threatening.”
The new law also allows skilled birthing centers to care for women who attempt vaginal birth after a C-section, even though C-section births are extremely dangerous if the uterus ruptures and heavy bleeding occurs.
“You have 15 to 20 minutes before the baby's oxygen is cut off and he or she will die or suffer brain damage,” said Dr. Aaron Elkin, a Florida obstetrician who supports medical innovation but believes patients need to be informed of the potential dangers.
In these situations, not only the unborn baby but also the birthing woman is at risk, he says: “At full term, 20 percent of the blood the heart pumps goes to the uterus. Within minutes, that entire blood supply can be lost.”
KFF Health News reported that a physicians group called Women's Care Enterprises, owned by London-based investment firm BC Partners, lobbied for the change in the law, which Gov. Ron DeSantis signed into law in March as part of a comprehensive health care package that included efforts aimed at strengthening the state's health care capacity.
The law also increased reimbursement rates for Medicaid providers, but did not expand the program to cover all low-income residents, leaving many Floridians uninsured.
Representatives for the investment firm did not respond to questions about whether Women's Care Enterprises had lobbied for the new law. Women's Care Enterprises does not currently perform C-sections outside of hospitals and has no plans to do so in the future, the group said in a statement last week.
Matthew Bigand, director of private equity at BC Partners, and Michael Chang, co-chair of the firm's health practice, did not respond to requests for comment. An aide to state Sen. Gayle Harrell, who introduced the bill in the Florida Legislature, said Harrell could not be reached.
In Florida, where many hospitals have closed their delivery units in recent years, skilled birth centers have been promoted as a way to expand access to obstetric care, particularly in rural areas outside major Florida cities, known as obstetric care deserts.
The trend is nationwide: Since 2011, more than 200 hospitals across the country have closed delivery rooms, often because they are unprofitable and harder to staff than other hospital services.
As of April, only two of Florida's 21 rural hospitals still offered maternity care, according to a report by the Center for Healthcare Quality and Payment Reform, a national policy center.
In February, North Shore Medical Center in underserved northern Miami-Dade County suddenly closed its delivery room due to financial difficulties.
Experts say it's unclear whether the advanced birthing centers will expand access to obstetric care in Florida. About half of all births in the state are to women enrolled in Medicaid, the government health insurance program for low-income Americans, but its low reimbursement rates only cover a fraction of the costs, putting a strain on hospitals.
New laws require advanced birth centers to accept Medicaid patients, but private equity-owned health care organizations tend to be bottom-line focused and intent on maximizing profits.
Limiting the number of Medicaid beneficiaries these centers accept and serving primarily privately insured patients could lead these facilities to draw well-insured patients from hospitals, increasing financial difficulties and exacerbating inequalities.
“I don't think this will do anything to address the provider shortages and birth deserts that are so prevalent in rural areas,” said Julia Strasser, director of the Jacobs Institute for Women's Health at George Washington University.
Mary Mayhew, CEO of the Florida Hospital Association, agreed, but said her organization is primarily opposed to advanced birthing centers because of safety concerns.
“There is no such thing as a low-risk C-section and it should never be done outside of a hospital,” Mayhew said.
The proposed centers would be different from birth centers, which are also outside hospitals but based on the midwifery model and only take in low-risk patients. Kate Bauer, executive director of the American Association of Birth Centers, said the facilities would transfer women who need C-sections to hospitals.
Bauer said the term “advanced birth center” is very similar to birth centers run primarily by midwives and would be confusing for patients.
Advanced birth centers are “180 degrees different from the birth center model,” she says. “Birth centers aren't just wallpaper and curtains. They're a holistic model of care.”
And Kara Newberry, chief advocacy officer for the Ambulatory Surgery Center Association, said advanced birth centers simply can't be compared to outpatient surgery facilities, which perform scheduled, elective surgeries rather than emergency procedures.
Most surgeries at ambulatory surgery centers “take less than an hour, and the vast majority of patients are discharged the same day,” she says. The surgeries don't typically involve risk of excessive bleeding; ambulatory surgery centers rarely even have arrangements with blood banks, she says.
Keeping an on-site blood bank stocked can be a challenge for smaller facilities: Blood and platelets need to be readily available but have a short shelf life, said Daniel Parra, a spokesman for the American Red Cross.
Conditions such as postpartum hemorrhage, which requires at least two units of red blood cells, can be fatal if not quickly recognized and treated, Parra said, adding that if the bleeding continues or worsens, dozens of additional units of red blood cells may need to be transfused.
Dr. Grace Chen, an obstetrician-gynecologist who has written books on Cesarean sections, said doctors at advanced birth centers may be motivated to perform planned elective Cesarean deliveries more frequently, both because of higher provider reimbursement rates compared with vaginal births and because of the convenience of being able to schedule them in advance.
“I'm worried that C-section rates will rise,” Dr. Chen said. About one-third of births in the United States are by C-section, up from one-fifth in 1996, even though C-sections carry more complications than vaginal births and can increase risks to future pregnancies.
Researchers have raised concerns about the quality of care at for-profit medical facilities owned by investment companies.
A recent analysis of 4.1 million Medicare inpatients found that hospitals owned by for-profit private equity firms had higher rates of adverse events, such as falls and infections, than control hospitals, even though the hospitals acquired by private equity firms served younger, less low-income patients, and transferred many of their more complex patients to other facilities.
Dr. Amos Gruenebaum, a professor of obstetrics and gynecology at Hofstra University's Zucker School of Medicine, who has published studies examining the safety of different birthing environments, said he had never heard of a C-section being performed outside of a hospital anywhere in the world.
“Pregnancy is different from other situations because there are two patients – the baby and the mother – who sometimes need to be cared for in different ways,” Dr. Gruenebaum said.
He argued that there is no such thing as a low-risk patient or a low-risk C-section.
“Any C-section is risky. Period. Period,” he said.
