JACKSON, Ga. — Ed Whitehouse stood alongside a state highway in rural Butts County, Georgia, and surveyed acres of rolling fields and forests near Interstate 75. Instead of farmland and trees, he envisioned a hospital.
Whitehouse, a consultant for a local healthcare company that wants to build a hospital there with at least 150 beds, said the group could break ground within a year. The idea, he said, is to provide medical services beyond those currently provided by Wellstar Sylvan Grove Medical Center, an aging, nonprofit "critical access" hospital that offers limited services, including emergency care, rehabilitation, wound care, and imaging.
But it took a new law, pushed by the state's powerful Republican lieutenant governor, Burt Jones, to clear the way for construction. The land is partly owned by his father, Bill Jones, a successful businessman whose interest in developing a hospital in his home county drew attention from state Democrats and the hospital industry.
The situation has been portrayed as "this billionaire entrepreneur, Bill Jones, exploiting the legal system through his son, imposing his will on people and trying to cash in," Whitehouse said. "Nothing could be further from the truth."
Woven through the drama in Butts County are arcane but consequential rules that require state approval for hospital construction and expansion. The rules, used nearly nationwide until the 1980s, require potential builders to apply for permission for new projects. State officials evaluate need based on criteria such as population growth and existing hospital capacity.
This year, Georgia lawmakers joined several other states in targeting those "certificate of need," or CON, regulations for dramatic change. Some states have exempted certain medical providers from the process; others have been more dramatic, including South Carolina, which is sunsetting most of its rules.
Attempts to pave the way for a new hospital in Butts County show how debate over certificate of need laws can intensify as legislatures try to reconcile the often conflicting priorities of politicians, the health care industry, and communities.
The laws have been criticized for limiting competition, and some health care analysts, like Matthew Mitchell, a senior research fellow at West Virginia University, feel everyday people may get the short end of the stick.
"This kind of a regulation is often there because powerful businesses want them," Mitchell said, "not because they protect consumers."
Bill Jones, a 79-year-old former state legislator, supported a 2022 legislative push to open a new hospital in Butts County. But the effort ran into formidable opposition from Wellstar Health System, which operates Sylvan Grove and 10 other hospitals in Georgia.
"As a nonprofit health system, we are always exploring partnerships that expand our mission of enhancing wellbeing in the communities we serve," said Matthew O'Connor, a Wellstar spokesperson. "Our analysis indicates that another hospital in this area is not needed at this time."
This year, Georgia Democrats thought they could leverage Republicans' interest in loosening the rules to gain support for Medicaid expansion. But Democrats were outnumbered in the legislature, and lawmakers eased several rules without that trade-off.
For example, certain hospital projects in rural counties are now exempt. Jones' project and his home county look likely to benefit.
Burt Jones, Georgia's lieutenant governor, who is being investigated for his role as a fake elector for Donald Trump in the 2020 presidential election, maintains his push for changes to the rules isn't about helping his father.
"It will give people access to health care in a reasonable travel time and convenience for them as well," Burt Jones said.
Bill Jones has used Butts County as the home base to build his business network, which includes petroleum distribution, retail convenience stores, and fast-food restaurants. In a recent interview, he complained about media coverage of his son's legislative connection to the hospital project.
He said his interest in opening another local hospital is about community need and, at least in part, stems from his personal experience. His wife gets medical services at Emory Healthcare, more than 40 miles away in Atlanta.
"You're not going to get the attention you need medically" at the 25-bed Sylvan Grove hospital in Jackson, he said. "Health care ought not to be about politics."
But the lieutenant governor had to be somewhat aware that legislation he was pushing could be seen as financially benefiting a close family member, said Josh McLaurin, a Democratic state senator whose district runs from Atlanta into its northern suburbs. Fellow members of the Democratic Party were encouraged to support the certificate of need bill, even though the GOP has a majority in the Georgia Legislature, he said.
"If they want Democrats on board on a bill they could probably pass without our votes, that tends to suggest that there's a concern about the narrative," McLaurin said.
Hospital industry lobbyists, aware of the Jones-Butts County connection, watched the debate with fear of wholesale repeal of the certificate of need laws, which ultimately didn't happen.
The final bill doesn't name Butts County specifically. But it does exempt "a new general acute care hospital in a rural county" from having to obtain a certificate of need. With a population of about 27,000, Butts County meets the definition of "rural" outlined in Georgia law.
Now, the small local company for which Whitehouse works — Interstate Health Systems, which is partly owned by Bill Jones — is moving forward. Land is being cleared for medical office buildings, potentially to lure providers to the area.
Whitehouse said major hospital systems already operating in Georgia are interested in partnering on construction and operation of a new facility.
Members of the Butts County Hospital Authority, which oversees Sylvan Grove, declined to comment. But last year, county commissioners passed a resolution encouraging the hospital authority to pursue a new facility.
Byrd Garland, a retired attorney and former hospital authority member, said he'd appreciate any project that gives people local access to health care, "so they don't have to drive an hour or two hours to get to it."
Garland said he's received both good and bad care at Sylvan Grove, and sometimes would rather make the trek to Atlanta to a better-resourced hospital.
"You get that kind of mindset when you've grown up out here in this medical desert that we're in now," he said.
ATLANTA — At the shuttered Atlanta Medical Center, a "Stronger Together" mural sends a hopeful message near a summer spray of hydrangeas. The campus was mostly quiet on a recent weekend, since AMC closed almost two years ago. A lone security vehicle sat behind a chain-link fence, and pedestrians passed by without even a glance.
In the town of Cuthbert, some 160 miles away, the Southwest Georgia Regional Medical Center also remains shut after closing four years ago, another Southern hospital casualty in a region dotted with them. Even a smaller facility replacing the former Cuthbert hospital "would be tremendous for the county," said Steve Whatley, chair of the Randolph County Hospital Authority.
The two hospitals — one inner-city, the other rural — faced some of the same financial pressures, including not having enough patients with private insurance.
This year, they also shared the attention of some of Georgia's most powerful lawmakers. Legislation signed in April by Gov. Brian Kemp, a Republican, included a provision pushed by U.S. Sen. Jon Ossoff, a Democrat.
The law amends the state's "certificate of need" system, which allows existing hospitals and other health facilities to block would-be competitors' plans to expand by arguing there's insufficient need for their services.
Certificate of need laws exist in 35 states and Washington D.C., according to the National Conference of State Legislatures. The hospital industry, especially nonprofit facilities, generally support the rules, and have argued they reduce health care costs and preserve access to quality medical services. Under CON requirements, health providers must obtain approval from the state before offering some new services or before building or expanding facilities.
Whether the laws improve care or reduce costs is questionable, researchers have found, and critics say more competition would decrease spending by insurers and consumers. In 2018, the Trump administration issued a report recommending that states repeal or revise their certificate of need requirements, arguing they increase health care costs.
"The evidence is pretty darn overwhelming that CON laws don't achieve the initially stated goals of increasing access, lowering costs, and improving quality," said Matthew Mitchell, a senior research fellow at West Virginia University.
Dan Sullivan, a Georgia-based consultant who often helps hospitals and other medical providers in their effort to preserve the laws, said that by limiting the number of providers offering very specialized health services, such as organ transplants, states can better maintain high quality of care.
Certificate of need laws can reduce fraud, Sullivan said. Florida repealed its certificate of need requirements for hospitals and many other health providers following the Trump administration's recommendation. Fraud accelerated in the state after regulations were phased out, he said.
"At least when you file a CON, there's at least a minimum of investigation," Sullivan said.
He argued another benefit of the laws is that they frequently mandate a baseline level of charity care.
Other Southern states recently peeled back their certificate of need laws. Tennessee's legislature passed a bill this year exempting more medical providers from needing to apply for a certificate. North Carolina rolled back some restrictions in an overhaul that paved the way for Medicaid expansion last year. South Carolina made a significant change to its rules last year.
This year, Republicans in Georgia's legislature attempted to repeal the state's certificate of need rules. The effort fell short in the face of fervent hospital opposition.
The narrower legislation that Kemp signed would instead ease the rules for building rural hospitals and exempts a potential new hospital that would partner with Morehouse School of Medicine, one of the country's few historically Black medical schools.
That could potentially fill much of the gap left by Atlanta Medical Center's closing.
Hospital industry officials said Morehouse would probably need a well-heeled partner, and Atrium Health, part of Charlotte, North Carolina-based Advocate Health, may be a logical match. The growth-oriented nonprofit health system has partnered with Morehouse Healthcare to run a clinic in East Point, south of Atlanta, and has a growing presence in the state. Both Morehouse and Atrium declined to discuss a potential hospital partnership with KFF Health News.
The shuttered AMC main campus, meanwhile, is ensnared in a moratorium the city imposed on redeveloping the site — a response to the jolting decision by its owner, Wellstar Health System, to close the hospital.
In 2022, Mayor Andre Dickens issued an executive order temporarily halting any new development on the site. He has criticized the "unusually abrupt closure of one of Atlanta's most important medical centers."
Atlanta's city council extended the ban another 120 days in June.
A new inner-city hospital "would be a heavy lift financially," said Josh Berlin, CEO of rule of three, an Atlanta-based health care consulting firm. That's because it would draw largely from the area's high level of uninsured and Medicaid patients. Georgia is one of 10 states that have not fully expanded Medicaid, and thus has a high rate of uninsured patients.
"You've got a community that is struggling to find care in the wake of the Atlanta Medical Center closure," he said.
Grady Memorial Hospital and other Atlanta facilities have seen a bump in patient volume since the closure of AMC. Grady is regularly deemed "dangerously overcrowded" in one state dashboard.
The need to handle additional patients has sped up expansion plans for Grady, including adding more than 150 beds, said its chief strategy officer, Shannon Sale. "We knew that was going to be needed over time. The Atlanta Medical Center closure sped up that process," she said.
In southwestern Georgia, plans are more modest.
Community leaders, including Whatley, are awaiting the results of a feasibility study that is expected to propose a downsized "rural emergency hospital," a new federal designation that directs extra funding to eligible facilities.
The program guarantees hospitals in rural communities extra Medicare payments and an additional payment of about $3.2 million a year if they close costly inpatient services and offer only emergency and outpatient care.
Ossoff won almost $12 million in three different appropriations bills to support a rural emergency hospital in Cuthbert. He said he met with state leaders to secure the provision in the Georgia certificate of need bill that would allow it to reopen. Southwest Georgia Regional Medical Center would also have to get an exemption from federal officials to qualify for a rural emergency hospital because of its closing date.
"This is a very challenging thing to do, and we've still got significant hurdles to clear," Ossoff told KFF Health News.
Even if it reopens, the Cuthbert facility will face the same pressures that led to its shuttering in the first place — what Ossoff called "failures of state policy." At the time, he cited Georgia's decision not to fully expand Medicaid in the wake of the closure.
Brenda Clark, who works in a wellness center across the street from the closed Cuthbert hospital, said some locals are skeptical about the facility reopening.
"It's much needed. People are hoping and praying we get it back," she said. But "there are some people who say, ‘We'll believe it when we see it.'"
Trisha Byers left behind one crucial item when she moved to North Carolina last year to be closer to her family after suffering a brain injury: health insurance.
In Massachusetts, Byers, 39, was enrolled in Medicaid, the government health program that covers low-income people. But she was ineligible in North Carolina, which had not yet expanded Medicaid coverage under the Affordable Care Act. She said she racked up thousands of dollars in unpaid emergency room bills while uninsured for several months after her move.
Then in December, North Carolina joined 39 other states and Washington, D.C., in widening Medicaid eligibility to include adults with incomes up to 138% of the federal poverty level, or $20,783 for an individual.
"I could finally get all the doctor appointments I needed," said Byers, one of more than 500,000 North Carolinians who gained coverage.
The North Carolina expansion came amid the biggest upheaval in Medicaid's nearly six-decade history. Since April 2023 — when protections that had blocked states from disenrolling Medicaid beneficiaries during the pandemic expired — states have disenrolled more than 24 million people whom they said no longer qualified or had failed to renew coverage.
This Medicaid "unwinding" led to fears that the number of people without insurance would spike. But it also coincided with moves in more than a dozen states to expand health coverage for lower-income people, including children, pregnant women, and the incarcerated.
These expansions will mitigate the effects of the unwinding to some degree, though it's still unclear how much. Five states have not finished culling their rolls, and the effect on the uninsured rate won't be clear until the U.S. Census Bureau releases official figures in September of next year.
"The pandemic was destructive and concerning and clearly demonstrated that Medicaid is so crucially important for our national safety net," said Jennifer Babcock, senior vice president for Medicaid policy at the Association for Community Affiliated Plans, a trade group representing nonprofit health insurers that cover people on Medicaid. "These expansions are incredibly meaningful."
Unwinding-era expansions include:
South Dakota, like North Carolina, expanded Medicaid coverage under the Affordable Care Act last year. About 22,000 people enrolled in the first eight months.
In July, Oregon launched a Medicaid-like coverage option for those who earn too much to qualify for Medicaid under federal limits. The plan is available to all adults with incomes between 138% and 200% — up to $30,120 for an individual — of the federal poverty level. More than 50,000 people have enrolled so far, Oregon officials say.
In January, a new federal law required states to allow children to stay covered under Medicaid for at least a year after signing up. Several states are going beyond that: Oregon, New Mexico, and Washington, for example, allow children to stay covered up to age 6. California passed legislation to expand continuous eligibility for children up to age 4 but has not yet implemented the policy.
Three states widened income eligibility for children to qualify for Medicaid: Arizona, Maine, and North Dakota.
This year, Utah began offering a Medicaid-like coverage option for children regardless of immigration status, though the program is capped at about 2,000 children.
Several states expanded coverage for pregnant women. Nevada, North Dakota, and Tennessee widened income eligibility to make it easier for pregnant women to qualify for Medicaid. Alabama and Maryland expanded eligibility to cover those who are pregnant regardless of immigration status. And Maine, Oregon, and Vermont extended postpartum coverage to 12 months, up from two. With those changes, 47 states now offer one year of postpartum coverage.
In June, five states — Illinois, Kentucky, Oregon, Utah, and Vermont — received approval from the Biden administration to extend Medicaid coverage to incarcerated people up to 90 days before their release. Those states will join several states, including California, Massachusetts, Montana, and Washington, in offering that coverage.
States, which split funding of Medicaid with the federal government, typically expand Medicaid eligibility during times of economic growth when they have more revenue. But several other factors have contributed to the expansion trend. These include heightened awareness over rising maternal mortality rates and new restrictions on abortion, which have reinforced the need for expansions for pregnant women, said Allison Orris, a senior fellow with the left-leaning Center on Budget and Policy Priorities.
In particular, the pandemic showed how important health coverage is to ensure people's health and communities' safety from infectious diseases, Orris said. "It is not surprising to see states look at their Medicaid programs and find ways to strengthen in the midst of the unwinding," she said.
For example, while federal Medicaid funding cannot be used for people living in the country unlawfully, a small but growing number of states have used their money to expand coverage to residents lacking legal status.
During the pandemic, as a requirement to gain extra federal funding, states were prohibited from cutting off Medicaid coverage even for those no longer eligible. The experience showed states the benefits of keeping people enrolled, rather than churning them in and out as their income fluctuates, Orris said. It also brought the nation's uninsured rate to a record-low 7.7%.
Some advocates fear the unwinding of that pandemic-era policy will reverse key gains. A KFF survey published in April found 23% of adults reported being uninsured after they were disenrolled from Medicaid in 2023. A Centers for Disease Control and Prevention report released Aug. 6 found the uninsured rate rose to 8.2% in the first quarter of 2024, from 7.7% in the same quarter in 2023.
Enrollment increased by about 23 million people during the pandemic. As of Aug. 1, with about 85% of the unwinding completed, roughly 14.8 million people have been removed from Medicaid rolls. As a result, it's unlikely the uninsured rate will rise as sharply as some advocates feared a year ago, said Jennifer Tolbert, deputy director of the Program on Medicaid and the Uninsured at KFF, a health information nonprofit that includes KFF Health News.
"We have seen some amazing coverage expansion in places like Oregon and California," said Ben Anderson, deputy senior director of health policy at Families USA, a consumer advocacy group. "But if you live in Texas, Florida, and Georgia, since the pandemic your health coverage has been disrupted in ways that were preventable by state leaders." Those three states are among the 10 that have chosen not to expand Medicaid under the ACA.
Still, Anderson said, the effect of the expansions, even in a limited number of states, will ensure some people can better afford health care and avoid medical debt.
The unwinding process has been rife with fumbling, particularly in states that didn't steer enough resources to connect people with coverage. A study by the federal Government Accountability Office released in July revealed a Centers for Medicare & Medicaid Services' finding that almost all states made mistakes that led to eligible individuals losing Medicaid coverage.
The recent Medicaid expansions provide examples of how some states prioritize health coverage, particularly for certain vulnerable groups.
Tricia Brooks, a Medicaid expert at Georgetown University, noted that some states are "targeting little pockets of coverage and doing it for a variety of reasons."
Getting and keeping children insured means they are more likely to have a regular health provider and be ready to learn in school, she said. "There is no doubt there is a return on investment," she said.
Medicaid advocates wonder, though, whether a second Trump administration would curtail coverage expansions. Republicans have signaled they do not want to extend the federal subsidies that reduce what lower-income people pay for ACA marketplace plans and that are scheduled to expire in 2025.
"We are bracing for that potential impact," said Erin Delaney, director of healthcare policy at the Progressive Policy Institute.
n 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said.
"Use of this device may cause serious injuries or death," an FDA notice about the recall said.
But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure.
In a notice, the manufacturer explained, "Abbott is not removing product from commercial distribution." Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.
When it comes to medical devices, recalls can include not only "removals," in which the device is removed from where it is used or sold, but also "corrections," which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.
"It's very oxymoronic," said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. "A recall makes it sound like it's recalled. But that is not actually what it means."
Though the FDA and federal regulations call these actions recalls, they might be described more aptly as "non-recalls." And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed, and Getinge have had recalls that left them in use.
Safeguarding the Public
Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?
There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets, and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs, or replacements. The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.
In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don't remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.
From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.
Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.
"When deciding whether a recall warrants device removal from the field, the FDA considers the frequency and severity of adverse events, effectiveness of the corrective actions that have been executed, and the benefits and risks of preserving patient access to the device," FDA spokesperson Audra Harrison said.
Where recalled devices have already been implanted, "removal" doesn't necessarily mean removing them from patients' bodies. "When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place," the FDA website says.
The FDA allowed the recalled MitraClip devices to remain in use "because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm's recall strategy was appropriate and adequate," Harrison said.
The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.
Abbott, the maker of MitraClip, said the device has been proven safe and effective "based on more than 20 years of clinical evidence and has profoundly improved the lives of people living with mitral regurgitation," a condition in which blood flows backward through the heart's mitral valve. The condition can lead to heart failure and death.
"With MitraClip, we're addressing the needs of people with MR who often have no other options," company spokesperson Brent Tippen said.
Speaking of the MitraClip recalls, Redberg said, "So hard to imagine these are effective actions in protecting patients."
In 2021, for Medtronic's StealthStation S7 cranial software, the company and the FDA sent a different message.
StealthStation is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain — for instance, to biopsy or cut out tumors. Drawing from CT scans, MRIs, and other imaging, it's meant to show the location of the surgical instruments.
In connection with a Class I November 2021 recall, the FDA website said potential inaccuracies in a biopsy depth gauge could result in "life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death."
The FDA website explained what Medtronic was doing about it.
"The recalling firm will provide a warning and instructional placard to be applied to impacted systems," the website said. "Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring," it advised doctors.
In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company's primary concern, and certain issues "can be safely and effectively remedied with a correction on site."
Richard Everson, a neurosurgeon and an assistant professor at UCLA, noted that the 2021 recall allowed doctors to continue using unaffected StealthStation features, a benefit for patients and facilities depending on them.
"But, I mean, then you could ask, ‘Well, why don't they just disable the view [of the brain] that's bugged?'" Everson said. "Why would they give you the option of looking at an inaccurate one?"
"That's kind of a strange solution," he said.
The FDA lists the 2021 recall as still open, explaining "not all products have been corrected or removed."
That recall was not the last word on problems with StealthStation. Since then, the manufacturer has submitted adverse event reports to the FDA describing trouble in cases involving various versions of StealthStation.
In a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they "had almost no speech for two days," according to a Medtronic report. In the report, Medtronic said there was "insufficient information to determine the relationship of the software to the reported issue."
In a February 2024 case, after brain surgery, an MRI found that the operation "missed the tumor" and that other tissue was removed instead, according to a report Medtronic submitted to the FDA. In the report, Medtronic said that when a company representative tested the system, it performed as intended.
In March 2024, Medtronic recalled versions of StealthStation S8 without removing them from hospitals. The company said at the time that it would provide a software update.
"Software updates are available to correct the anomalies identified in the 2021 S7 and 2024 S8 recalls and are actively being deployed," Medtronic's Winkels told KFF Health News in a July email. "While the software updates for the 2021 S7 recall are complete in the US, they remain ongoing in some international regions."
In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of "destruction of the impeller blades," which could cause "low flow" and "embolization of the fractured impeller material," an entry on the FDA website said.
"Clinicians are cautioned to position the Impella system carefully in patients," the FDA website said, among other instructions.
The updated instructions "provide technical guidance to mitigate the risk of rare complications," Abiomed spokesperson Ryan Carbain said. There were no product removals and no reports of adverse events "related to product design or manufacturing," Carbain said.
Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps made by Getinge of Sweden, have failed persistently, according to FDA records.
The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found.
In a May 2024 letter to health care providers, the FDA said that, in the previous 12 months, it had received almost 3,000 adverse event reports related to the balloon pumps. It was referring to reports of malfunctions and cases in which the products might have caused or contributed to a death or injury. Of those, 15 reportedly involved serious injury or death, the FDA said.
During the summer of 2023, the FDA noted that "alternative treatments are limited" and said the devices could continue to be used.
But, in May, the FDA changed its stance. The agency advised health care facilities to "transition away from these devices and seek alternatives, if possible."
"These recommendations are based on our continued concerns" that the manufacturer "has not sufficiently addressed the problems and risks with these recalled devices."
Getinge sent KFF Health News written answers from Elin Frostehav, the company's president of Acute Care Therapies.
"There is no question that we would have liked to have solved these issues in full much earlier," she said.
As a result of the FDA's May action, the company "immediately paused proactive marketing" of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.
"We are working with the agency to finalize remediation and product update solutions," Frostehav said.
'Known Possible Complications'
Abbott's MitraClip system includes tiny clips implanted in the heart's mitral valve and the equipment used to implant them. The apparatus features a steering mechanism with hand controls and a catheter that is threaded through a major vein, typically from an incision in the groin, to place one or more clips in the heart.
Worldwide, more than 200,000 people have been treated with MitraClip, according to an Abbott website.
The 2016 MitraClip recall described cases in which "the user was unable to separate the implantable Clip from the delivery system."
In a news release at the time, Abbott said it had "received a small number of reports" in which that happened.
Those cases "resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem," the FDA said in a 2016 notice. "There was one patient death in these cases as a result of severe comorbidities following surgery."
Years later, something similar happened.
In February 2021, a clip was implanted in an 81-year-old patient but the doctor couldn't separate the clip from the delivery system, according to a report Abbott filed with the FDA. The patient was transferred to surgery, where the delivery system "had to be cut down in order to detach the clip."
The patient then underwent an operation to replace the mitral valve, and, hours later, the patient was brought back to surgery to address bleeding, the report said.
The patient "coded" the next day and died from an aortic bleed, the report said.
In the report to the FDA, the manufacturer blamed "case-specific circumstances."
"Cardiac arrest, hemorrhage and death are listed" in the device instructions "as known possible complications associated with mitraclip procedures," the company said. "There is no indication of a product issue with respect to manufacture, design or labeling."
The third MitraClip recall, initiated in September 2022, cited an "increase in clip locking malfunctions."
Most of the reported malfunctions were not associated with adverse outcomes, the FDA said then. Treatment with MitraClip "remains within the anticipated risk levels," the company told customers.
As with the two earlier recalls, the third advised doctors to follow the device's instructions. But the 2022 recall identified a contributing factor: the way the device was made.
"Abbott has identified a contributing cause … as a change in the material properties of one of the Clip locking components," the company said in a 2022 letter to customers.
"Abbott is working on producing new lots with updated manufacturing processing and raw material," the company wrote. In the same letter, Abbott told doctors that, in the meantime, they could use the devices they had in stock.
Six days later, a clip opened while locked and a patient died, according to a report the manufacturer submitted to the FDA.
"There is no evidence that death was related to the device but it was likely related to the procedure," Abbott wrote.
Now, almost two years later, the 2022 recall remains open, according to the FDA website, and "not all products have been corrected or removed."
KFF Health News data editor Holly K. Hacker contributed to this report.
If you've had an experience with a medical device and would like to tell KFF Health News about it, click here to contact our reporting team.
MOUND BAYOU, Miss. — In the center of this historically Black city, once deemed "the jewel of the Delta" by President Theodore Roosevelt, dreams to revitalize an abandoned hospital building have all but dried up.
An art deco sign still marks the main entrance, but the front doors are locked, and the parking lot is empty. These days, a convenience store across North Edwards Avenue is far busier than the old Taborian Hospital, which first shut down more than 40 years ago.
Myrna Smith-Thompson, who serves as executive director of the civic group that owns the property, lives 100 miles away in Memphis, Tennessee, and doesn't know what's to become of the deteriorating building.
"I am open to suggestions," said Smith-Thompson, whose grandfather led a Black fraternal organization now called the Knights and Daughters of Tabor. In 1942, that group established Taborian Hospital, a place staffed by Black doctors and nurses that exclusively admitted Black patients, during a time when Jim Crow laws barred them from accessing the same health care facilities as white patients.
"This is a very painful conversation," said Smith-Thompson, who was born at Taborian Hospital in 1949. "It's a part of my being."
A similar scenario has played out in hundreds of other rural communities across the United States, where hospitals have faced closure over the past 40 years. In that regard, the story of Mound Bayou's hospital isn't unique.
But there's more to this hospital closure than the loss of inpatient beds, historians say. It's also a tale of how hundreds of Black hospitals across the U.S. fell casualty to social progress.
The Civil Rights Act of 1964 and the enactment of Medicare and Medicaid in 1965 benefited millions of people. The federal campaign to desegregate hospitals, culminating in a 1969 court case out of Charleston, South Carolina, guaranteed Black patients across the South access to the same health care facilities as white patients. No longer were Black doctors and nurses prohibited from training or practicing medicine in white hospitals. But the end of legal racial segregation precipitated the demise of many Black hospitals, which were a major source of employment and a center of pride for Black Americans.
"And not just for physicians," said Vanessa Northington Gamble, a medical doctor and historian at George Washington University. "They were social institutions, financial institutions, and also medical institutions."
In Charleston, staff members at a historically Black hospital on Cannon Street started publishing a monthly journal in 1899 called The Hospital Herald, which focused on hospital work and public hygiene, among other topics. When Kansas City, Missouri, opened a hospital for Black patients in 1918, people held a parade. Taborian Hospital in Mound Bayou included two operating rooms and state-of-the-art equipment. It's also where famed civil rights activist Fannie Lou Hamer died in 1977.
"There were Swedish hospitals. There were Jewish hospitals. There were Catholic hospitals. That's also part of the story," said Gamble, author of "Making a Place for Ourselves: The Black Hospital Movement, 1920-1945."
"But racism in medicine was the main reason why there was an establishment of Black hospitals," she said.
By the early 1990s, Gamble estimated, there were only eight left.
"It has ripple effects in a way that affect the fabric of the community," said Bizu Gelaye, an epidemiologist and program director of Harvard University's Mississippi Delta Partnership in Public Health.
Researchers have largely concluded that hospital desegregation improved the health of Black patients over the long term.
One 2009 study focusing on motor vehicle accidents in Mississippi in the '60s and '70s found that Black people were less likely to die after hospital desegregation. They could access hospitals closer to the scene of a crash, reducing the distance they would have otherwise traveled by approximately 50 miles.
An analysis of infant mortality, published in 2006 by economists at the Massachusetts Institute of Technology, found that hospital desegregation in the South substantially helped close the mortality gap between Black and white infants. That's partly because Black infants suffering from illnesses such as diarrhea and pneumonia got better access to hospitals, the researchers found.
A new analysis, recently accepted for publication in the Review of Economics and Statistics, suggests that racism continued to harm the health of Black patients in the years after hospital integration. White hospitals were compelled to integrate starting in the mid-1960s if they wanted to receive Medicare funding. But they didn't necessarily provide the same quality of care to Black and white patients, said Mark Anderson, an economics professor at Montana State University and co-author of the paper. His analysis found that hospital desegregation had "little, if any, effect on Black postneonatal mortality" in the South between 1959 and 1973.
Nearly 3,000 babies were born at Taborian Hospital before it closed its doors in 1983. The building remained vacant for decades until 10 years ago, when a $3 million federal grant helped renovate the facility into a short-lived urgent care center. It closed again only one year later amid a legal battle over its ownership, Smith-Thompson said, and has since deteriorated.
"We would need at least millions, probably," she said, estimating the cost of reopening the building. "Now, we're back where we were prior to the renovation."
In 2000, the hospital was listed as one of the most endangered historic places in Mississippi by the Mississippi Heritage Trust. That's why some people would like to see it reopened in any capacity that ensures its survival as an important historical site.
Hermon Johnson Jr., director of the Mound Bayou Museum, who was born at Taborian Hospital in 1956, suggested the building could be used as a meeting space or museum. "It would be a huge boost to the community," he said.
Meanwhile, most of the hospital's former patients have died or left Mound Bayou. The city's population has dropped by roughly half since 1980, U.S. Census Bureau records show. Bolivar County ranks among the poorest in the nation and life expectancy is a decade shorter than the national average.
A community health center is still open in Mound Bayou, but the closest hospital is in Cleveland, Mississippi, a 15-minute drive.
Mound Bayou Mayor Leighton Aldridge, also a board member of the Knights and Daughters of Tabor, said he wants Taborian Hospital to remain a health care facility, suggesting it might be considered for a new children's hospital or a rehabilitation center.
"We need to get something back in there as soon as possible," he said.
Smith-Thompson agreed and feels the situation is urgent. "The health care services that are available to folks in the Mississippi Delta are deplorable," she said. "People are really, really sick."
A bill pending in California's legislature to ratchet up oversight of private equity investments in healthcare is receiving enthusiastic backing from consumer advocates, labor unions, and the California Medical Association, but drawing heavy fire from hospitals concerned about losing a potential funding source.
The legislation, sponsored by Attorney General Rob Bonta, would require private equity groups and hedge funds to notify his office of planned purchases of many types of healthcare businesses and obtain its consent. It also reinforces state laws that bar nonphysicians from directly employing doctors or directing their activities, which is a primary reason for the doctor association's support.
Private equity firms raise money from institutional investors such as pension funds and typically acquire companies they believe can be run more profitably. Then they look to boost earnings and sell the assets for multiples of what they paid for them.
That can be good for future retirees and sometimes for mismanaged companies that need a capital infusion and a new direction. But critics say the profit-first approach isn't good for healthcare. Private equity deals in the sector are coming under increased scrutiny around the country amid mounting evidence that they often lead to higher prices, lower-quality care, and reduced access to core health services.
Opponents of the bill, led by the state's hospital association, the California Chamber of Commerce, and a national private equity advocacy group, say it would discourage much-needed investment. The hospital industry has already persuaded lawmakers to exempt sales of for-profit hospitals from the proposed law.
"We preferred not to make that amendment," Bonta said in an interview. "But we still have a strong bill that provides very important protections."
The legislation would still apply to a broad swath of medical businesses, including clinics, physician groups, nursing homes, testing labs, and outpatient facilities, among others. Nonprofit hospital deals are already subject to the attorney general's review.
A final vote on the bill could come this month if a state Senate committee moves it forward.
Nationally, private equity investors have spent $1 trillion on healthcare acquisitions in the past decade, according to a report by The Commonwealth Fund. Physician practices have been especially attractive to them, with transactions growing sixfold in a decade and often leading to significant price increases. Other types of outpatient services, as well as clinics, have also been targets.
In California, the value of private equity healthcare deals grew more than twentyfold from 2005 to 2021, from less than $1 billion to $20 billion, according to the California healthcare Foundation. Private equity firms are tracking the pending legislation closely but so far haven't slowed investment in California, according to a new report from the research firm PitchBook.
Multiple studies, as well as a series of reports by KFF Health News, have documented some of the difficulties created by private equity in healthcare.
Research published last December in the Journal of the American Medical Association showed a larger likelihood of adverse events such as patient infections and falls at private equity hospitals compared with others. Analysts say more research is needed on how patient care is being affected but that the impact on cost is clear.
"We can be almost certain that after a private equity acquisition, we're going to be paying more for the same thing or for something that's gotten worse," said Kristof Stremikis, director of Market Analysis and Insight at the California Healthcare Foundation.
Most private equity deals in healthcare are below the $119.5 million threshold that triggers a requirement to notify federal regulators, so they often slide under the government radar. The Federal Trade Commission is stepping up scrutiny, and last year it sued a private equity-backed anesthesia group for anticompetitive practices in Texas.
Lawmakers in several other states, including Connecticut, Minnesota, and Massachusetts, have proposed legislation that would subject private equity deals to greater transparency.
Not all private equity firms are bad operators, said Assembly member Jim Wood, a Democrat from Healdsburg, but review is essential: "If you are a good entity, you shouldn't fear this."
The bill would require the attorney general to examine proposed transactions to determine their impact on the quality and accessibility of care, as well as on regional competition and prices.
Critics note that private equity deals are often financed with debt that is then owed by the acquired company. In many cases, private equity groups sell off real estate to generate immediate returns for investors and the new owners of the property then charge the acquired company rent.
That was a factor in the financial collapse of Steward Health Care, a multistate hospital system that was owned by the private equity firm Cerberus Capital Management from 2010 to 2020, according to a report by the Private Equity Stakeholder Project, a nonprofit that supports the California bill. Steward filed for Chapter 11 bankruptcy in May. "Almost all of the most distressed U.S. healthcare companies are owned by private equity firms," according to another study by the group.
Opponents of the legislation argue it would dampen much-needed investment in an industry with soaring operating costs. "Our concern is that it will cut off funding that can improve healthcare," said Ned Wigglesworth, a spokesperson for Californians to Protect Community healthcare, a coalition of groups fighting the legislation. The prospect of having to submit to a lengthy review by the attorney general, he said, would create "a chilling effect on private funders."
Proponents of private equity investment point to what they say are notable successes in California healthcare.
Children's Choice Dental Care, for example, said in a letter to state senators that it logs over 227,000 dental visits annually, mostly with children on Medi-Cal, the health insurance program for low-income Californians. "We have been able to expand to 25 locations, because we have been able to access capital from a private equity firm," the group wrote.
Ivy Fertility, with clinics in California and eight other states, said in a letter to state senators that private investment has expanded its ability to provide fertility treatments at a time when demand for them is increasing.
Researchers note that private equity investors are hardly alone when it comes to healthcare profiteering, which extends even to nonprofits. Sutter Health, a major nonprofit hospital chain, for example, settled for $575 million in a lawsuit brought by then-Attorney General Xavier Becerra, for unfair contracting and pricing.
"It's helpful to look at ownership classes like private equity, but at the end of the day we should look at behavior, and anyone can do the things that private equity firms do," said Christopher Cai, a physician and health policy researcher at Harvard Medical School. He added, though, that private equity investors are "more likely to engage in financially risky or purely profit-driven behavior."
The growth in Medicare Advantage enrollment is due to a number of factors, including the availability of plans that charge no premium (other than the Part B premium), and extra benefits offered by most Medicare Advantage plans.
This article was published on Monday, August 8, 2024 in KFF Health News.
Medicare Advantage enrollment has been on a steady climb for the past two decades following changes in policy designed to encourage a robust role for private plan options in Medicare. After a period of some instability in terms of plan participation and enrollment, The Medicare Modernization Act of 2003 created stronger financial incentives for plans to participate in the program throughout the country and renamed private Medicare plans Medicare Advantage. In 2024, 32.8 million people are enrolled in a Medicare Advantage plan, accounting for more than half, or 54 percent, of the eligible Medicare population, and $462 billion (or 54%) of total federal Medicare spending (net of offsetting receipts, such as premiums). Medicare Advantage enrolls a disproportionate share of people of color in Medicare as well as an increasing number of dual eligible beneficiaries. The average Medicare beneficiary in 2024 has access to 43 Medicare Advantage plans, the same as in 2023, but more than double the number of plans offered in 2018.
The growth in Medicare Advantage enrollment is due to a number of factors, including the availability of plans that charge no premium (other than the Part B premium), and extra benefits offered by most Medicare Advantage plans. Nearly all Medicare Advantage plans offer some benefits not included in traditional Medicare, such as coverage of dental, vision, or hearing services, often for no additional premium. Medicare beneficiaries are also drawn to the financial protection that comes with an out-of-pocket limit, which Medicare Advantage plans are required to provide, while traditional Medicare has no out-of-pocket cap on spending. On the other hand, Medicare Advantage plans have limited provider networks and apply cost management tools such as prior authorization, which traditional Medicare does not.
Generally, research shows that Medicare pays more to private Medicare Advantage plans for enrollees than their costs would be in traditional Medicare. The Medicare Payment Advisory Commission (MedPAC) reports that plans receive payments from CMS that are 122% of spending for similar beneficiaries in traditional Medicare, on average, translating to an estimated $83 billion in higher spending in 2024. As Medicare Advantage takes on a more dominant presence in the Medicare program, and with current payments to plans higher for Medicare Advantage than for traditional Medicare for similar beneficiaries, policymakers have become increasingly focused on how well Medicare’s current payment methodology for Medicare Advantage is working to enhance efficiency and hold down beneficiary costs and Medicare spending.
To better understand trends in the growth of the program, this brief provides current information about Medicare Advantage enrollment, by plan type and firm, and shows how enrollment varies by state and county. A second, companion analysis describes Medicare Advantage premiums, out-of-pocket limits, supplemental benefits offered, and prior authorization requirements in 2024. This analysis does not provide detailed information by enrollee characteristics, such as race/ethnicity, income, or dual status, because that information is not available.
Highlights for 2024:
More than half (54%) of eligible Medicare beneficiaries are enrolled in Medicare Advantage in 2024. The share of Medicare beneficiaries in Medicare Advantage plans varies across states, ranging from 2% to 63%. In 7 states, AL, CT, MI, HI, ME, FL, RI (and Puerto Rico), 60% or more of all Medicare beneficiaries are enrolled in Medicare Advantage plans, an increase from 3 states in 2023.
More than one-third (37%) of Medicare beneficiaries live in a county where at least 60 percent of all Medicare beneficiaries are enrolled in Medicare Advantage plans. Three counties (excluding those in Puerto Rico) enroll 80% or more of Medicare beneficiaries in Medicare Advantage plans: Monroe County, NY (Rochester; 82%), Starr, Texas (81%), and Miami-Dade County, Florida (80%). At the same time, 8 percent of all Medicare beneficiaries nationwide live in a county with relatively low enrollment, where less than one third of all Medicare beneficiaries are enrolled in Medicare Advantage plans. The wide variation in county enrollment rates reflect several factors, such as differences in firm strategy, urbanicity of the county, Medicare payment rates, number of Medicare beneficiaries, health care use patterns, and historical Medicare Advantage market penetration.
Medicare Advantage enrollment is highly concentrated among a small number of firms, with UnitedHealthcare and Humana accounting for nearly half (47%) of all Medicare Advantage enrollees nationwide. In more than a quarter of all U.S. counties (29%; or 931 counties), these two firms account for at least 75 percent of Medicare Advantage enrollment. Since 2017, the market share for UnitedHealthcare and CVS Health has increased (25% to 29% and 8% to 12%, respectively), Humana (18%) and Cigna (2%) have held steady, while other firms’ share of total enrollment has slightly decreased (Blue Cross Blue Shield (BCBS) affiliates, Kaiser Permanente, and Centene). Small firms (which each account for less than 2% of enrollment) have a smaller share of the market in 2024 than in 2017 (19% to 16%).
More than half of eligible Medicare beneficiaries are enrolled in Medicare Advantage in 2024
In 2024, more than half (54%) of eligible Medicare beneficiaries – 32.8 million people out of 61.2 million Medicare beneficiaries with both Medicare Parts A and B – are enrolled in Medicare Advantage plans. Medicare Advantage enrollment as a share of the eligible Medicare population has jumped from 19% in 2007 to 54% in 2024 (Figure 1).
Between 2023 and 2024, total Medicare Advantage enrollment grew by about 2.1 million beneficiaries, or 7 percent – a similar growth rate as the prior year (8%). The Congressional Budget Office (CBO) projects that the share of all Medicare beneficiaries enrolled in Medicare Advantage plans will rise to 64% by 2034 (Figure 2).
In 2024, nearly two-thirds of Medicare Advantage enrollees are in individual plans that are open for general enrollment.
More than 6 in 10 Medicare Advantage enrollees (62%), or 20.5 million people, are in plans generally available to all beneficiaries for individual enrollment (Figure 3). That is an increase of 0.9 million enrollees compared to 2023. Individual plans have declined as a share of total Medicare Advantage enrollment since 2010 (71%).
More than 6.6 million Medicare beneficiaries are enrolled in special needs plans in 2024, more than double the enrollment in 2019.
More than 6.6 million Medicare beneficiaries are enrolled in special needs plans (SNPs). SNPs restrict enrollment to specific types of beneficiaries with significant or relatively specialized care needs, or who qualify because they are eligible for both Medicare and Medicaid. Enrollment in SNPs increased by 16 percent between 2023 and 2024, and accounts for 20 percent of total Medicare Advantage enrollment in 2024, an increase from 12 percent in 2010. Since 2019, SNP enrollment has more than doubled from 2.92 million to 6.64 million (Figure 4). This increase is due in part to the increasing number of SNP plans available on average and more dual eligible individuals having access to these plans.
Most SNP enrollees (88%) are in plans for beneficiaries dually enrolled in both Medicare and Medicaid (D-SNPs). Another 10 percent of SNP enrollees are in plans for people with severe chronic or disabling conditions (C-SNPs) and 2 percent are in plans for beneficiaries requiring a nursing home or institutional level of care (I-SNPs).
While D-SNPs are designed specifically for dually-eligible individuals, 1.2 million Medicare beneficiaries with full Medicaid benefits were enrolled in Medicare Advantage plans generally available to all beneficiaries (not designed specifically for this population) in 2021, while 2.3 million full dual eligible individuals were in D-SNPs. D-SNPs have increasingly become the main source of Medicare Advantage coverage for dual eligible individuals.
SNP enrollment varies across states. In the District of Columbia and Puerto Rico, SNP enrollees comprise about half of all Medicare Advantage enrollees (49% in DC and 51% in PR). In nine states, SNP enrollment accounts for at least a quarter of Medicare Advantage enrollment: 46% in MS, 34% in AR, 33% in LA and NY, 28% in FL and GA, and 25% in CT, SC and AL.
C-SNP enrollment in 2024 (about 675,000 people) is 45% higher than it was in 2023 – an increase of about 210,000 enrollees. Nearly all (97%) C-SNP enrollees are in plans for people with diabetes or cardiovascular conditions in 2024. Enrollment in I-SNPs has been increasing slightly, with approximately 115,000 enrollees in 2024, up from about 103,000 in 2023.
Slightly less than one in five (17% or about 5.7 million) Medicare Advantage enrollees are in a group plan offered to retirees by an employer or union.
Group enrollment as a share of total Medicare Advantage enrollment has fluctuated between 17% to 20% since 2010, but the actual number has increased from 1.8 million in 2010 to 5.7 million in 2024 (Figure 5). With a group plan, an employer or union contracts with an insurer and Medicare pays the insurer a fixed amount per enrollee to provide benefits covered by Medicare. For example, 13 states provide health insurance benefits to their Medicare-eligible retirees exclusively through Medicare Advantage plans.
As with other Medicare Advantage plans, employer and union group plans may provide additional benefits and/or lower cost sharing than traditional Medicare and are eligible for bonus payments if they obtain required quality scores. The employer or union (and sometimes the retiree) may also pay an additional premium for these supplemental benefits. Group enrollees comprise a quarter or more of Medicare Advantage enrollees in nine states: Alaska (100%), Michigan (38%), New Jersey (33%), West Virginia (31%), Maryland (30%), Illinois (29%), Vermont (27%), Kentucky (26%), and Connecticut (25%).
The share of Medicare beneficiaries in Medicare Advantage plans varies by state and county
The share of Medicare beneficiaries in Medicare Advantage plans varies across states, ranging from 2% to 63%.
In 30 states, Medicare Advantage enrollees account for more than half of all Medicare beneficiaries, including in 7 states, AL, CT, MI, HI, ME, FL, RI (and Puerto Rico) where 60% or more of all Medicare beneficiaries are enrolled in Medicare Advantage plans (Figure 6). In contrast, Medicare Advantage enrollment is relatively low (less than 40%) in 13 states, including five states with less than 30% of beneficiaries enrolled in a Medicare Advantage plan – AK, MD, ND, SD, and WY – all of which (beside MD) are mostly rural. Overall, Puerto Rico has the highest Medicare Advantage penetration, with 95 percent of Medicare beneficiaries enrolled in a Medicare Advantage plan. A decade ago, the share of Medicare beneficiaries in Medicare Advantage plans did not exceed 50 percent in any state (other than Puerto Rico).
The share of Medicare beneficiaries enrolled in Medicare Advantage varies widely across counties.
For example, in Florida, 60% of all Medicare beneficiaries in the state are enrolled in Medicare Advantage, ranging from 21% in Monroe County (Key West) to 80% in Miami-Dade County (Figure 7). In Ohio, 57% of all Medicare beneficiaries are enrolled in Medicare Advantage, with the share ranging from 32% in Mercer County (Celina) to 69% in Stark County (Canton).
In 2024, more than a third (37%) of Medicare beneficiaries live in a county where at least 60 percent of all Medicare beneficiaries in that county are enrolled in Medicare Advantage plans (618 counties). That is substantially more than in 2010 when just 3 percent of the Medicare population lived in a county where 60 percent or more of Medicare beneficiaries were enrolled in a Medicare Advantage plan (83 counties). Many counties with high Medicare Advantage penetration are centered around relatively large, urban areas, such as Monroe County, NY (82%), which includes Rochester, and Allegheny County, PA (74%), which includes Pittsburgh. In contrast, 8 percent of Medicare beneficiaries live in a county where less than one third of all Medicare beneficiaries in that county are enrolled in Medicare Advantage plans (849 counties). Counties with relatively low enrollment tend to be less populated rural areas. However, others, such Montgomery County, MD (27%) and Suffolk, NY (31%), which includes much of Long Island, are in more populous areas. (This county-level analysis excludes Medicare Advantage enrollment in Connecticut. See methods for more details.)
Variation in the share of eligible Medicare beneficiaries who are enrolled in a Medicare Advantage plan is explained by a combination of factors, including firm-level strategies to target particular geographic areas, the urbanicity of the county and state, variation in Medicare payment rates, the number and characteristics of people eligible for Medicare, health care use patterns, and the historical Medicare Advantage market penetration.
Medicare Advantage enrollment is highly concentrated among a small number of firms
The average Medicare beneficiary is able to choose from Medicare Advantage plans offered by 8 firms in 2024, one fewer than in 2023 and 2022, and one-third of beneficiaries (33%) can choose among Medicare Advantage plans offered by 10 or more firms.
UnitedHealthcare and Humana account for nearly half of all Medicare Advantage enrollees nationwide in 2024.
Despite most beneficiaries having access to plans operated by several different firms, Medicare Advantage enrollment is highly concentrated among a small number of firms. UnitedHealthcare, alone, accounts for 29% of all Medicare Advantage enrollment in 2024, or 9.4 million enrollees. Together, UnitedHealthcare and Humana (18%) account for nearly half (47%) of all Medicare Advantage enrollees nationwide, the same as in 2023. In more than a quarter of counties (29%; or 931 counties), these two firms account for at least 75% of Medicare Advantage enrollment. These counties include East Baton Rouge (Baton Rouge), LA (81%), Clark County (Las Vegas), NV (79%), Travis County (Austin), FL (78%), and El Paso County (Colorado Springs), CO (76%). (Again, this county-level analysis does not include Connecticut.)
BCBS affiliates (including Anthem BCBS plans) account for 14% of enrollment, and four firms (CVS Health, Kaiser Permanente, Centene, and Cigna) account for another 23% of enrollment in 2024.
UnitedHealthcare and Humana have consistently accounted for a relatively large share of Medicare Advantage enrollment.
UnitedHealthcare has had the largest share of Medicare Advantage enrollment and largest growth in enrollment since 2010, increasing from 20 percent of all Medicare Advantage enrollment in 2010 to 29 percent in 2024. Humana has also had a high share of Medicare Advantage enrollment, though its share of enrollment has grown more slowly, from 16 percent in 2010 to 18 percent in 2024. BCBS plans share of enrollment has been more constant over time but has declined moderately since 2014.
CVS Health, which purchased Aetna in 2018, has seen its share of enrollment double from 6 percent in 2010 to 12 percent in 2024. Kaiser Permanente now accounts for 6 percent of total enrollment, a moderate decline as a share of total Medicare Advantage enrollment since 2010 (9%), mainly due to the growth of enrollment in plans offered by other insurers and only a modest increase in enrollment growth for Kaiser Permanente over that time. However, for those insurers that have seen declines in their overall share of enrollment, the actual number of enrollees for each insurer is larger than it was in 2010.
By absolute numbers, CVS Health had the largest growth in plan year enrollment, increasing by 758,000 beneficiaries between March 2023 and March 2024. Humana had the second largest growth in plan year enrollment, with an increase of about 472,000 beneficiaries between March 2023 and March 2024. UnitedHealthcare plans had the third highest growth in plan year enrollment, increasing by 456,000 beneficiaries – the first time in 8 years it did not have the largest plan growth among all firms. BCBS plans had the fourth largest growth in plan enrollment with an increase of about 283,000, followed by Kaiser Permanente, increasing by about 45,000 beneficiaries between March 2023 and March 2024. However, Centene had fewer enrollees, with enrollment declining by about 202,000 between March 2023 and March 2024.
Meredith Freed, Jeannie Fuglesten Biniek, and Tricia Neuman are with KFF. Anthony Damico is an independent consultant.
After the 36-year-old was diagnosed with stage 3 breast cancer in December, she learned that there weren't any cancer services in her community of Del Rio, a town of 35,000 near the Texas-Mexico border.
To get treatment, she and her husband, Manuel, must drive nearly three hours east to San Antonio. So they set an alarm for 4 a.m., which allows for just enough time to roll out of bed, brush their teeth, and begin the long drive navigating dark roads while watching for deer.
About an hour before they arrive at the cancer clinic, the couple pulls over to quickly eat fast food in the car. The break gives Herlinda time to apply ointment on the port where the needle for her chemotherapy will be inserted.
"It numbs the area, so when I get to the infusion room the needle won't hurt," she said.
For rural patients, getting cancer treatment close to home has always been difficult. But in recent years, chemotherapy deserts have expanded across the United States, with 382 rural hospitals halting services from 2014 to 2022, according to a report published this year by Chartis, a health analytics and consulting firm.
Texas led that list, with 57 rural hospitals — nearly half of those statewide that had offered chemotherapy — cutting the service by 2022, according to the analysis. Rural hospitals in states like Texas, which hasn't expanded Medicaid, have been more likely to close, according to data from the Cecil G. Sheps Center for Health Services Research.
To keep the doors open, financially strapped facilities in small communities nationwide continue to shed basic health care services, like obstetrics and chemotherapy, said Michael Topchik, executive director of the Chartis Center for Rural Health.
"The data are staggering," Topchik said. "Can you imagine feeling that sick, and having to drive an hour in each direction, or maybe more each direction, several times a week?"
Loss of chemotherapy services can signal other gaps in cancer care, such as a shortage of local specialty physicians and nurses, which is bad news for patients, said Marquita Lewis-Thames, an assistant professor at Northwestern University in Chicago whose research covers rural cancer care.
Rural patients are less likely to survive at least five years after a cancer diagnosis compared with their urban counterparts, concluded a study co-authored by Lewis-Thames and published in JAMA Network Open in 2022. While the rural-urban survival gap narrowed over the nearly 40 years researchers studied, the disparity persisted across most racial and ethnic groups, with only a few exceptions, she said.
Many cancer drugs are now given orally and can be taken at home, but some treatments for breast, colon, and other common cancers must still be administered intravenously inside a medical facility. Even distances of an hour or two each way can strain patients who already may be coping with nausea, diarrhea, and other side effects, physicians and patient advocates said.
"It's pretty uncomfortable for some of these patients who may have bone metastases or have significant muscular pain and have to sit in the car that long and hit road bumps," said Shivum Agarwal, a family physician who practices in rural communities an hour west of Fort Worth, Texas.
Plus, travel can cost much more than filling the gas tank.
"Usually it requires an able-bodied family member taking off a whole day or at least half a day from work," Agarwal said. "So, there's a big economic cost for the family."
In this sense, the Sanchez family is fortunate. Herlinda's mother drives four hours from Abilene to Del Rio to watch the couple's youngest children, their 2-year-old twins.
Cancer infusions can last as long as eight hours on top of the travel time, causing significant financial and logistical challenges, said Erin Ercoline, executive director of the San Antonio-based ThriveWell Cancer Foundation. The nonprofit provides adult patients with financial assistance, including for gaps in insurance and transportation-related costs. It has helped cover gasoline for Sanchez, who received her final round of chemotherapy in late June. The financial assistance will also pay for her hotel when she travels for breast surgery this month.
Not all rural hospitals are ending chemotherapy. Childress Regional Medical Center, a 39-bed hospital in West Texas, is constructing a 6,000-square-foot center for patients who need infusions for cancer and other diagnoses, including multiple sclerosis and rheumatology.
The infusion area, which started with two chairs in 2013 and now has four, will grow to 10 chairs and have more patient privacy when it opens next year. The next-nearest infusion center in this sprawling region is an hour or more away, which discourages some patients from seeking care, said Childress' CEO, Holly Holcomb.
"We've had a handful of patients say, ‘If you can't do it here, I'm not doing it,'" Holcomb said. She credits the federal 340B drug discount program for enabling the remote hospital to provide infusion drugs.
Hospitals that qualify for 340B can buy outpatient drugs at steep discounts. The program provides "a huge kickstand for rural hospitals," said Topchik, of Chartis Center. Hospitals can use the savings to buoy or expand services provided to the community, he said.
But some patients are not daunted by long drives and travel costs.
"I'm from the country, so small is better — it's just more personable," said Dennis Woodward, 69, who lives in Woodson, Texas. He has a type of non-Hodgkin lymphoma and chooses to make a two-hour drive to Childress. He had first visited an oncology clinic in Abilene about an hour away. The clinicians were nice, but "I felt like a number," he said.
After his first appointment at Childress this year, his oncologist, Fred Hardwicke, walked him over to meet the nurses who would administer the medicine, Woodward recalled.
Most Fridays during Herlinda Sanchez's chemotherapy, Manuel would nap in the car. But during her final treatment in June, he stayed nearby, counting down the hours.
Several family members joined Herlinda when she rang the bell later that afternoon to signal the end of her treatment.
"I don't want to be in San Antonio no more," said Herlinda, a mother of four who does administrative work at Laughlin Air Force Base near Del Rio. "I'm looking forward to the break."
When Kamala Harris was California's top prosecutor, she was concerned that mergers among hospitals, physician groups, and health insurers could thwart competition and lead to higher prices for patients. If she wins the presidency in November, she'll have a wide range of options to blunt monopolistic behavior nationwide.
The Democratic vice president could influence the Federal Trade Commission and instruct the departments of Justice and Health and Human Services to prioritize enforcement of antitrust laws and channel resources accordingly. Already, the Biden administration has taken an aggressive stance against mergers and acquisitions. In his first year in office, President Joe Biden issued an executive order intended to intensify antitrust enforcement across multiple industries, including health care.
Under Biden, the FTC and DOJ have fought more mergers than they have in decades, often targeting health care deals.
"What Harris could do is set the tone that she is going to continue this laser focus on competition and health care prices," said Katie Gudiksen, a senior health policy researcher at University of California College of the Law, San Francisco.
The Harris campaign didn't respond to a request for comment.
For decades, the health industry has undergone consolidation despite government efforts to maintain competition. When health systems expand, adding hospitals and doctor practices to their portfolios, they often gain a large enough share of regional health care resources to command higher prices from insurers. That results in higher premiums and other health care costs for consumers and employers, according to numerous studies.
Health insurers have also consolidated in recent decades, leaving only a handful controlling most markets.
Health care analysts say it's possible for Harris to slow the momentum of consolidation by blocking future mergers that could lead to higher prices and lower-quality care. But many of them agree the consolidation that has already taken place is an inescapable feature of the U.S. health care landscape.
"It's hard to unscramble the eggs," said Bob Town, an economics professor at the University of Texas.
There were nearly 1,600 hospital mergers in the U.S. from 1998 to 2017 and 428 hospital and health system mergers from 2018 to 2023, according to a KFF study. The percentage of community hospitals that belong to a larger health system rose from 53 in 2005 to 68 in 2022. And in another sign of market concentration, as of January, well over three-quarters of the nation's physicians were employed by hospitals or corporations, according to a report produced by Avalere Health.
Despite former President Donald Trump's hostility to regulation as a candidate, his administration was active on antitrust efforts — though it did allow one of the largest health care mergers in U.S. history, between drugstore chain CVS Health and the insurer Aetna. Overall, Trump's Justice Department was more aggressive on mergers than past Republican administrations.
Harris, as California's attorney general from 2011 to 2017, jump-started health care investigations and enforcement.
"She pushed back against anticompetitive pricing," said Rob Bonta, California's current attorney general, who is a Democrat.
One of Harris' most impactful decisions was a 2012 investigation into whether consolidation among hospitals and physician practices gave health systems the clout to demand higher prices. That probe bore fruit six years later after Harris' successor, Xavier Becerra, filed a landmark lawsuit against Sutter Health, the giant Northern California hospital operator, for anticompetitive behavior. Sutter settled with the state for $575 million.
In 2014, Harris was among 16 state attorneys general who joined the FTC in a lawsuit to dismantle a merger between one of Idaho's largest hospital chains and its biggest physician group. In 2016, Harris joined the U.S. Department of Justice and 11 other states in a successful lawsuit to block a proposed $48.3 billion merger between two of the nation's largest health insurers, Cigna and Anthem.
Attempts to give the state attorney general the power to nix or impose conditions on a wide range of health care mergers have been fiercely, and successfully, opposed by California's hospital industry. Most recently, the hospital industry persuaded state lawmakers to exempt for-profit hospitals from pending legislation that would subject private equity-backed health care transactions to review by the attorney general.
A spokesperson for the California Hospital Association declined to comment.
As attorney general of California, Harris' work was eased by the state's deep-blue political hue. Were she to be elected president, she could face a less hospitable political environment, especially if Republicans control one or both houses of Congress. In addition, she could face opposition from powerful health care lobbyists.
Though it often gets a bad rap, consolidation in health care also confers benefits. Many doctors choose to join large organizations because it relieves them of the administrative headaches and financial burdens of running their own practices. And being absorbed into a large health system can be a lifeline for financially troubled hospitals.
Still, a major reason health systems choose to expand through acquisition is to accumulate market clout so they can match consolidation among insurers and bargain with them for higher payments. It's an understandable reaction to the financial pressures hospitals are under, said James Robinson, a professor of health economics at the University of California-Berkeley.
Robinson noted that hospitals are required to treat anyone who shows up at the emergency room, including uninsured people. Many hospitals have a large number of patients on Medicaid, which pays poorly. And in California, they face a series of regulatory requirements, including seismic retrofitting and nurse staffing minimums, that are expensive. "How are they going to pay for that?" Robinson said.
At the federal level, any effort to blunt anticompetitive mergers would depend in part on how aggressive the FTC is in pursuing the most egregious cases. FTC Chair Lina Khan has made the FTC more proactive in this regard.
Last year, the FTC and DOJ jointly issued new merger guidelines, which suggested the federal government would scrutinize deals more closely and take a broader view of which ones violate antitrust laws. In September, the FTC filed a lawsuit against an anesthesiology group and its private equity backer, alleging they had engaged in anticompetitive practices in Texas to drive up prices.
Still, many transactions don't come to the attention of the FTC because their value is below its $119.5 million reporting threshold. And even if it heard about more deals, "it is very underresourced and needing to be very selective in which mergers they challenge," said Paul Ginsburg, a professor of the practice of health policy at the University of Southern California's Sol Price School of Public Policy.
Khan's term ends in September 2024, and Harris, if elected, could try to reappoint her, though her ability to do so may depend on which party controls the Senate.
Harris could also promote regulations that discourage monopolistic behaviors such as all-or-nothing contracting, in which large health systems refuse to do business with insurance companies unless they agree to include all their facilities in their networks, whether needed or not. That behavior was one of the core allegations in the Sutter case.
She could also seek policies at the Department of Health and Human Services, which runs Medicare and Medicaid, that encourage competition.
Bonta, California's current attorney general, said that, while there are bad mergers, there are also good ones. "We approve them all the time," he said. "And we approve them with conditions that address cost and that address access and that address quality."
He expects Harris to bring similar concerns to the presidency if she wins.
JACKSONVILLE, Fla. — Facing an ultracompetitive market in one of the nation's fastest-growing cities, UF Health is trying a new way to attract patients: a combination emergency room and urgent care center.
In the past year and a half, UF Health and a private equity-backed company, Intuitive Health, have opened three centers that offer both types of care 24/7 so patients don't have to decide which facility they need.
Instead, doctors there decide whether it's urgent or emergency care —the health system bills accordingly — and inform the patient of their decision at the time of the service.
"Most of the time you do not realize where you should go — to an urgent care or an ER — and that triage decision you make can have dramatic economic repercussions," said Steven Wylie, associate vice president for planning and business development at UF Health Jacksonville. About 70% of patients at its facilities are billed at urgent care rates, Wylie said.
Emergency care is almost always more expensive than urgent care. For patients who might otherwise show up at the ER with an urgent care-level problem — a small cut that requires stitches or an infection treatable with antibiotics — the savings could be hundreds or thousands of dollars.
While no research has been conducted on this new hybrid model, consumer advocates worry hospitals are more likely to route patients to costlier ER-level care whenever possible.
For instance, some services that trigger higher-priced, ER-level care at UF Health's facilities — such as blood work and ultrasounds — can be obtained at some urgent care centers.
"That sounds crazy, that a blood test can trigger an ER fee, which can cost thousands of dollars," said Cynthia Fisher, founder and chair of PatientRightsAdvocate.org, a patient advocacy organization.
For UF Health, the hybrid centers can increase profits because they help attract patients. Those patient visits can lead to more revenue through diagnostic testing and referrals for specialists or inpatient care.
Offering less expensive urgent care around-the-clock, the hybrid facilities stand out in an industry known for its aggressive billing practices.
On a recent visit to one of UF Health's facilities about 15 miles southeast of downtown, several patients said in interviews that they sought a short wait for care. None had sat in the waiting room more than five minutes.
"Sometimes urgent care sends you to the ER, so here you can get everything," said Andrea Cruz, 24, who was pregnant and came in for shortness of breath. Cruz said she was being treated as an ER patient because she needed blood tests and monitoring.
"It's good to have a place like this that can treat you no matter what," said Penny Wilding, 91, who said she has no regular physician and was being evaluated for a likely urinary tract infection.
UF Health is one of about a dozen health systems in 10 states partnering with Intuitive Health to set up and run hybrid ER-urgent care facilities. More are in the works; VHC Health, a large hospital in Arlington, Virginia, plans to start building one this year.
Intuitive Health was established in 2008 by three emergency physicians. For several years the company ran independent combination ER-urgent care centers in Texas.
Then Altamont Capital Partners, a multibillion-dollar private equity firm based in Palo Alto, California, bought a majority stake in Intuitive in 2014.
Soon after, the company began partnering with hospitals to open facilities in states including Arizona, Indiana, Kentucky, and Delaware. Under their agreements, the hospitals handle medical staff and billing while Intuitive manages administrative functions — including initial efforts to collect payment, including checking insurance and taking copays — and nonclinical staff, said Thom Herrmann, CEO of Intuitive Health.
Herrmann said hospitals have become more interested in the concept as Medicare and other insurers pay for value instead of just a fee for each service. That means hospitals have an incentive to find ways to treat patients for less.
And Intuitive has a strong incentive to partner with hospitals, said Christine Monahan, an assistant research professor at the Center on Health Insurance Reforms at Georgetown University: Facilities licensed as freestanding emergency rooms — as Intuitive's are — must be affiliated with hospitals to be covered by Medicare.
At the combo facilities, emergency room specialists determine whether to bill for higher-priced ER or lower-priced urgent care after patients undergo a medical screening. They compare the care needed against a list of criteria that trigger emergency-level care and bills, such as the patient requiring IV fluids or cardiac monitoring.
Inside its combo facilities, UF posts a sign listing some of the urgent care services it offers, including treatment for ear infections, sprains, and minor wounds. When its doctors determine ER-level care is necessary, UF requires patients to sign a form acknowledging they will be billed for an ER visit.
Patients who opt out of ER care at that time are charged a triage fee. UF would not disclose the amount of the fee, saying it varies.
UF officials say patients pay only for the level of care they need. Its centers accept most insurance plans, including Medicare, which covers people older than 65 and those with disabilities, and Medicaid, the program for low-income people.
But there are important caveats, said Fisher, the patient advocate.
Patients who pay cash for urgent care at UF's hybrid centers are charged an "all-inclusive" $250 fee, whether they need an X-ray or a rapid strep test, to name two such services, or both.
But if they use insurance, patients may have higher cost sharing if their health plan is charged more than it would pay for stand-alone urgent care, she said.
Also, federal surprise billing protections that shield patients in an ER don't extend to urgent care centers, Fisher said.
Herrmann said Intuitive's facilities charge commercial insurers for urgent care the same as if they provided only urgent care. But Medicare may pay more.
While urgent care has long been intended for minor injuries and illnesses and ERs are supposed to be for life- or health-threatening conditions, the two models have melded in recent years. Urgent care clinics have increased the scope of injuries and conditions they can treat, while hospitals have taken to advertising ER wait times on highway billboards to attract patients.
Intuitive is credited with pioneering hybrid ER-urgent care, though its facilities are not the only ones with both "emergency" and "urgent care" on their signs. Such branding can sometimes confuse patients.
While Intuitive's hybrid facilities offer some price transparency, providers have the upper hand on cost, said Vivian Ho, a health economist at Rice University in Texas. "Patients are at the mercy of what the hospital tells them," she said.
But Daniel Marthey, an assistant professor of health policy and management at Texas A&M University, said the facilities can help patients find a lower-cost option for care by avoiding steep ER bills when they need only urgent-level care. "This is a potentially good thing for patients," he said.
Marthey said hospitals may be investing in hybrid facilities to make up for lost revenue after federal surprise medical billing protections took effect in 2022 and restricted what hospitals could charge patients treated by out-of-network providers, particularly in emergencies.
"Basically, they are just competing for market share," Marthey said.
UF Health has placed its new facilities in suburban areas near freestanding ERs owned by competitors HCA Healthcare and Ascension rather than near its downtown hospital in Jacksonville. It is also building a fourth facility, near The Villages, a large retirement community more than 100 miles south.
"This has been more of an offensive move to expand our market reach and go into suburban markets," Wylie said.
Though the three centers are not state-approved to care for trauma patients, doctors there said they can handle almost any emergency, including heart attacks and strokes. Patients needing hospitalization are taken by ambulance to the UF hospital about 20 minutes away. If they need to follow up with a specialist, they're referred to a UF physician.
"If you fall and sprain your leg and need an X-ray and crutches, you can come here and get charged urgent care," said Justin Nippert, medical director of two of UF's combo centers. "But if you break your ankle and need it put back in place it can get treated here, too. It's a one-stop shop."