A new law in Florida allowing doctors to perform cesarean sections in outpatient birthing 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 hospitals.

The proposed new facilities, to be called advanced birth centers, will not be able to rapidly mobilize extra staff, equipment and expertise should complications suddenly occur, as a hospital would, critics noted.

“A pregnant patient who is considered low risk in one moment can suddenly need lifesaving care in the next,” said Dr. Cole Greves, the Florida district chairman for the American College of Obstetricians and Gynecologists.

“Advanced birth centers, even with increased regulations, cannot guarantee the level of safety patients would receive within a hospital,” he 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 those of comparable high-income countries.

Florida itself lags other states in maternal care, getting a D+ grade in a recent March of Dimes report because of higher than average maternal mortality rates and mortality rates among Black babies that are double those of white infants. The state has high rates of C-sections, and rates of preterm births and infant deaths are worse than the national average.

The law stipulates that the new advanced birth centers will have to be equipped with at least one surgical suite and be able to transfer patients to a hospital if necessary. The measure does not say how near the hospital must be.

Yet C-section complications, like bleeding and damage to surrounding tissue, “require immediate attention and assistance from other hospital teams, and resources like an intensive care unit, ventilators and additional surgical assistance,” said Dr. Nandini Raghuraman, an assistant professor of maternal fetal medicine at Washington University in St. Louis.

“These are all the kinds of things that when we do need them, we need them emergently,” she said. “Any delay may be life-threatening.”

The new law also permits advanced birth centers to care for women attempting a vaginal delivery after a previous cesarean delivery, despite the fact that these births can be extremely dangerous if the uterus ruptures and massive bleeding ensues.

“You have 15 to 20 minutes until the oxygen supply to the baby stops and the baby dies or suffers brain damage,” said Dr. Aaron Elkin, a Florida obstetrician. He said he supports health care innovation but thinks patients must be informed of potential hazards.

Women in labor, not just fetuses, face risks in these settings, he said: “The uterus gets 20 percent of the blood that the heart is pumping when you are at term pregnancy. In minutes, you can lose your entire blood supply.”

KFF Health News reported that a physicians’ group called Women’s Care Enterprises, owned by the London-based investment firm BC Partners, lobbied for the legislative change. Gov. Ron DeSantis signed the bill into law in March as part of a comprehensive health care package that included initiatives aimed at bolstering the state’s health care force.

The law also raised reimbursement rates for Medicaid providers, though 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 deliveries outside a hospital setting, the group said in a statement last week, nor does it foresee doing so.

Mathieu Bigand, a director of private equity at BC Partners, and the firm’s co-head of health, 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 was not reachable.

Advanced birth 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 grown in rural areas outside Florida’s major cities.

The trend is a national one: 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 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, abruptly closed its labor and delivery unit amid financial problems.

Whether advanced birth 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 put a strain on hospitals.

The new law requires advanced birth centers to accept Medicaid patients, but private equity-owned practices tend to focus on the bottom line and aim to maximize profits.

If the centers were to cap the number of Medicaid beneficiaries they would accept and primarily serve privately insured patients, the facilities might draw well-insured patients from hospitals, adding to their financial challenges and exacerbating inequities.

“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 of Women’s Health at George Washington University.

Mary Mayhew, the chief executive of the Florida Hospital Association, agreed, but said the association’s main objections to the creation of the advanced birth centers involved safety concerns.

“There’s no such thing as a low-risk C-section, and they should not be done 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 a midwifery model of care and only accept low-risk patients. Those facilities transfer any woman who may need a cesarean section to a hospital, said Kate Bauer, executive director of the American Association of Birth Centers.

Ms. Bauer said that the term “advanced birth centers” — so similar to the birthing 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 a whole model of care.”

Nor are advanced birth centers comparable in any way to ambulatory care surgery facilities, which perform scheduled elective procedures, not emergency procedures, said Kara Newbury, chief advocacy officer for the Ambulatory Surgery Center Association.

Most procedures in outpatient surgical centers “can be done in less than an hour,” she said, “with the vast majority of patients leaving the same calendar day.” Procedures typically do not involve the risk of excessive blood loss. It is rare for a outpatient surgical center to even have an agreement with a blood bank, she said.

For a small facility, maintaining blood bank inventories on site can be challenging. Blood and platelets must be immediately available, yet they have a short shelf life, according to Daniel Parra, a spokesman for the American Red Cross.

Conditions like postpartum hemorrhage, which may require at least two units of red blood cells, can be deadly if not rapidly recognized and treated, Mr. Parra said. Dozens of additional units may have to be transfused if bleeding continues or worsens, he added.

Physicians at advanced birth centers may be incentivized to perform planned elective cesarean section deliveries more frequently, both because of higher reimbursement rates to providers, compared with vaginal births, and the convenience of advance scheduling, said Dr. Grace Chen, an obstetrician and gynecologist who has written about cesarean sections.

“My worry is it will drive up 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 can increase the risks of future pregnancies.

Researchers have raised concerns about the quality of care at profit-driven health care facilities owned by investment firms.

A recent analysis of 4.1 million Medicare hospitalizations found that adverse events like falls and infections were higher at hospitals owned by for-profit private equity firms compared with a control group of hospitals, even though the hospitals acquired by private equity had younger and fewer low-income patients, and transferred many of the patients with complicated 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 varying birth settings, said it was the first time that he had ever heard of cesarean sections performed outside hospitals anywhere in the world.

“Pregnancy is not like any other situation, because you have two patients, the baby and the mother, and sometimes they need to be cared for 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,” he said.

Source link: https://www.nytimes.com/2024/06/15/health/ceseareans-outpatient-florida.html