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Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half.

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Brett Kelman and Anna Werner, CBS News
Tue, 05 Dec 2023 12:30:00 +0000

Bradley Little, a physical education teacher in Arizona, was leading his class through a school hallway in 2017 when he collapsed. Little feared he was having a stroke. Or, in a sign of the times, that he’d been shot. He tried to stand, but his leg wouldn’t move.

A student ran for help. Firefighters arrived and hoisted Little onto a gurney. At the hospital, an X-ray revealed that the artificial hip implant in Little’s right leg had “suddenly and catastrophically structurally failed,” according to a lawsuit Little would later file in federal court. The implant severed at its “neck” — a 2-inch-long titanium part linking Little’s thigh to his torso.

“It looked like a laser went through it,” Little said in an interview. “It was like someone just went in there and cut it right in the middle.”

Profemur artificial hips were once considered innovative for a feature known as a “dual modular neck,” intended to modernize total hip replacement surgery. Hundreds of thousands of Americans undergo hip implant surgery each year and devices are expected to last at least 20 years, according to the American College of Rheumatology. The Profemur necks, available in an array of lengths and angles, made it easier to customize the hip implants for patients.

But the neck also proved to be a weak point. Over the past two decades, more than 750 Profemur hips like Little’s have fractured at the neck, an attorney for the manufacturer once said in court while defending the device as not defective. In interviews, patients said they were left unable to walk and in need of emergency surgery. Reports submitted to the FDA describe Profemur patients stranded in the midst of routine life, while hiking, golfing, bowling, mowing the lawn, lifting a potted plant, getting out of a chair, putting on pants, and leaning over to pick up a key.

After each break, patients endure an hours-long repair surgery that can be traumatic because the broken implant is embedded in their bone and difficult to remove, according to three orthopedic surgeons who’ve performed such a procedure. The repair surgery, which can cost tens of thousands of dollars and may not be fully reimbursed by insurance, often requires a patient’s femur to be cracked open to extract a metal stem that was inserted down its length. Lawsuits have likened removing the bone around the stem to peeling a banana.

“It’s gruesome,” said Lee E. Rubin, an orthopedic surgeon and expert on prosthetic hips at Yale University. “There’s no way around the fact that there’s a failed or broken implant in that patient’s thigh. We have to remove it.”

Many Profemur fractures in patients’ bodies could have been avoided if the manufacturer or the FDA responded to early signs of failure with more urgency, according to a months-long investigation by KFF Health News and CBS News. An FDA database shows reports of Profemur’s titanium modular necks breaking inside U.S. patients since at least 2005, but the corresponding parts were not recalled until 15 years later, if at all. Ten sizes of the titanium neck eventually were recalled in 2020 after being identified in more than 650 reports of fractures submitted to the FDA. Six other sizes of titanium necks, identified in about 75 additional fracture reports, have not been permanently recalled.

Aidin Eslam Pour, another Yale orthopedic surgeon who has studied Profemur fractures, said the manufacturer “waited too long.”

“This implant should have been pulled out of the market earlier,” he said.

Profemur’s original manufacturer, Wright Medical Technology, in 2009 switched the metal of the modular neck from titanium to a stronger cobalt-chromium alloy, FDA documents show. Then, after some of those necks also began to break, the company recalled one size but left 11 others on the market despite reports of corrosion causing the implants to fail, FDA documents show.

In total, at least 28 sizes of the Profemur artificial hips with a dual modular neck have allegedly fractured or corroded, but just 11 sizes have been permanently recalled, according to FDA data and records.

Wright Medical, a Tennessee company founded in 1950, has made implantable medical devices since at least the 1970s, according to the company website. Wright sold its hip and knee implant division, including the Profemur, to Chinese company MicroPort for $285 million in 2013, according to the Securities and Exchange Commission. Stryker Corp., one of the nation’s largest device companies, paid about $4 billion for the rest of Wright in 2020.

Wright Medical declined to comment in an email from Stryker spokesperson Jon Zimmer. MicroPort did not respond to more than a dozen requests for comment sent to its attorneys, public relations firm, and U.S. offices. MicroPort still advertises Profemur hip implants with dual modular necks on its website, where the devices are listed as “not marketed/registered in United States.”

The FDA declined to provide an official for an interview and did not answer written questions about why some Profemur sizes were not permanently recalled. In an email, FDA spokesperson Audra Harrison said medical device manufacturers are largely responsible for deciding which products to recall and when to do so, while the agency “monitors” this process and requests recalls only in “urgent situations.” In the case of the Profemur modular necks, all recalls were initiated by MicroPort, and the FDA “took action accordingly,” the agency said.

For this investigation, journalists with KFF Health News and CBS News analyzed thousands of reports of Profemur complications submitted over the past two decades to the FDA’s nationwide MAUDE database, which catalogs reports of medical device problems and malfunctions. MAUDE is unverified, incomplete, and imperfect — for example, not all device problems are properly submitted to the database, and a single issue may be reported more than once. However, the database still offers the best available perspective on medical device complications in the United States. The FDA has used MAUDE to identify device problems since the early ’90s.

KFF Health News and CBS News also reviewed about 180 lawsuits filed in federal court in the past decade alleging Profemur modular necks broke or corroded. Plaintiffs have alleged severe pain, swelling, a “debilitating lack of mobility,” and, in at least a few cases, nerve damage and neurological issues from cobalt and chromium ions leaking into their bloodstream.

Most of the lawsuits have been resolved through out-of-court settlements without Wright Medical or MicroPort publicly admitting fault, according to court filings. The remainder of the lawsuits are ongoing.

Wright Medical has denied liability in some lawsuits before settling them and has defended Profemur implants in court in the years before some of the implants were recalled for fracturing.

“A device fracture does not mean it is defective,” Wright Medical attorney Tiffany Carpenter said in federal court in 2018, according to a hearing transcript. “Devices fracture all the time.”

Collectively, the lawsuits allege that Profemur artificial hips broke or corroded at the neck in about 7½ years, on average. Profemur necks made from titanium broke on average in about 10 years while necks made from the cobalt-chromium alloy broke or corroded in just six years, the lawsuits allege.

Some plaintiffs say they got Profemur implants in both legs — then they both ended up breaking.

Mark Feld, 75, of New Hampshire, who was an avid runner, said he was implanted with Profemur artificial hips in his right and left legs in 2005 and 2008, then the right hip fractured within 10 years, according to a lawsuit he filed. Wright Medical denied liability in court filings and settled out of court for an undisclosed amount.

Feld said that because he surrendered all claims against Wright in the settlement, he could not sue again when his left implant broke in 2020 as he was walking across a bridge near his apartment.

He crawled home to call 911, he said, and was rushed to the hospital.

“I couldn’t walk across that bridge for a year,” Feld said. He now has new hip implants made by another company, but his fear lingers. “To this day, I still feel like a ticking time bomb. …  Nobody could confirm for me that it can’t happen again.”

Little, the Arizona teacher, also suffered a second Profemur break, four years after his first, according to his lawsuit, in which Wright Medical denied liability and settled out of court. Little said in an interview that this time he was teaching class on a tennis court when he felt a sensation in his left leg that reminded him of crushing an aluminum can. He said he narrowly avoided tumbling onto his students.

After his two broken hip implants and replacement surgeries, Little said, he had to stop coaching basketball and will retire from teaching at the end of this school year — four years earlier than planned. He still feels unsteady and is afraid to climb a stepladder to change a lightbulb, he said.

“I’ve been robbed of some things,” Little said. “There should be accountability for it.”

It is not publicly known how many Profemur hips have failed. According to a federal court transcript, Carpenter, the attorney for Wright Medical, said in court in 2018 that the company was aware of 768 fractures among about 353,000 Profemur necks sold. That’s a fracture rate of about 0.2%.

Other sources report a much higher rate. The Profemur devices that were permanently recalled in 2020 had a U.S. fracture rate of 2.2% — 11 times what was described in court — according to FDA documents. Peer-reviewed studies estimate fracture rates as low as 1% and as high as 6% for some Profemur models.

Even the lowest estimates are “unacceptable,” said Samo Fokter, an orthopedic surgeon and Profemur expert at University Medical Center Maribor in Slovenia.

Fokter has co-authored more than 10 peer-reviewed studies on the Profemur, including one this year, and said he implanted about 50 of them before they were known to fracture.

“This should not happen,” Fokter said. “If you put too much force on any implant, it can fracture, of course, but this is very, very rare. Not approaching 1%. It should be less than one in 100,000, let’s say.”

Like a Black Hole Developed Under Their Foot’

The Profemur’s problems originate from its “neck,” which is a metal connector between the upper components in the hip socket to a lower “stem” that is inserted into a patient’s thigh bone, according to peer-reviewed studies, court records, and expert interviews.

Historically, an artificial hip’s stem and neck were a single piece of metal. The Profemur line added a junction at the top of the stem so the neck was separate. Because these dual modular necks detached on both ends, the size and angle could be changed to better fit a patient.

But the Profemur’s additional junction was also its downfall. Rubin, one of the Yale experts, who also maintains an exhibit of the history of prosthetic hips at the university, said in some patients tiny cracks formed on the portion of the neck that slotted into the socket of the stem. Patients had no idea their implant was cracking until the neck snapped, he said.

“From a patient’s perspective, they’re walking around on what otherwise would seem like a successful hip implant,” Rubin said. “And all of a sudden, as they took a step, they could not bear weight … like a black hole had developed under their foot.”

The dual modular neck was developed by a European company, Cremascoli Ortho Group, in the ’80s, then purchased by Wright Medical in 1999 to be introduced as the Profemur in the United States. The Profemur was cleared for sale by the FDA in 2000 through the 510(k) program, which permits new medical devices to be sold without extensive testing if they are deemed to have “substantial equivalence” to other devices already on the market. Through this process, new medical devices can piggyback on a single approval for decades.

Wright Medical told the FDA that the Profemur was substantially equivalent to five existing artificial hip systems, and the agency agreed, according to FDA documents obtained through a Freedom of Information Act request. However, of those five hip systems, at least three had significantly different necks than the Profemur, Rubin said. And one was later recalled because of its high failure rate, according to the FDA.

The FDA documents state that although the Profemur is different from the older hip implants that its approval was based on, those differences were “not expected to affect the device’s safety and effectiveness.” Spokesperson Harrison said in an email that the FDA “followed the statutory framework” when the Profemur was reviewed and cleared.

Once it was cleared by the FDA, Wright touted the Profemur’s dual modular neck as a feature.

In a 2004 promotional document obtained by KFF Health News and CBS News, Wright guaranteed the “structural reliability” and “absence of fretting corrosion” at the junction of the stem and neck. Then Wright marketed the Profemur to people with an “active lifestyle,” saying the product was for patients who wanted to return to activities like golf, tennis, karate, and wrestling after their hip replacements, according to at least two dozen lawsuits filed against the company.

Wright also hired Jimmy Connors, who was the world’s top-ranked tennis player in the ‘70s, as a spokesperson.

“This hip has given me back my quality of life. It’s allowed me to do anything I did before,” Connors said on JimmysNEWHip.com, a website launched by Wright in 2006, according to screen captures of the site preserved by the Internet Archive.

When the website launched, Wright Medical knew of at least some reports of modular neck fractures. Multiple lawsuits allege the company was aware as of 2000 that some Cremascoli hips had fractured at the modular neck, and then became aware of more fractures in 2003 and 2004. The FDA database shows Wright was also aware of two Profemur implants that allegedly fractured at the neck and were returned to Wright in spring 2005.

In 2006, FDA data showed six reports of Profemur fractures that identified the neck as the part that allegedly broke. By 2007, there were 11 such reports. By 2008, there were 30.

Connors, reached on his cellphone, said Wright Medical did not inform him of Profemur fractures at the time of his endorsement or since. Connors said his own hip implant did not fracture but had to be replaced in 2012 because of other complications.

If he had been told about a fracture risk, Connors said, he might have chosen another implant.

“If I was going through it now, I’d know a lot more to ask than I did back in the first time,” Connors said.

Perry Parks, 79, who played football for the Los Angeles Rams in the ’60s, said Connors’ endorsement persuaded him to get a Profemur hip in 2007. His implant snapped six years later during a bike ride, according to his lawsuit. Wright Medical denied liability and settled out of court.

In an interview, Parks said he was lucky to be biking at the beach at the time of the break, where he tumbled into sand, instead of in traffic.

“The thing that incenses me more is that they knew this,” Parks said. “There was some intentionality here to put … profits over the health of people.”

New Metal, New Complications

In 2009, Wright Medical introduced a new version of the Profemur modular neck that once again was cleared for sale by the FDA. Agency documents show that the neck material was switched from titanium to a cobalt-chromium alloy, a stronger metal.

“That was a big mistake,” Fokter said.

While the cobalt-chromium necks were less susceptible to fracture, they created a new problem at the same junction between the neck and stem, said Fokter and the two Yale experts. Once implanted, the cobalt-chromium neck could rub against the stem’s titanium socket, leading to a form of bimetallic corrosion that can cause pain and swelling and leak small amounts of metal ions into a patient’s bloodstream, potentially causing a long list of complications, the three experts said.

Robert Rembisz, 75, a retiree in Vero Beach, Florida, alleged in an ongoing lawsuit that Profemur corrosion in his right leg caused elevated metal levels in his blood and “neurologic symptoms” including nerve damage, tinnitus, and balance and coordination problems. Wright Medical has not yet responded to the allegations in Rembisz’s lawsuit.

Rembisz added in an interview that he believes the implant hindered his memory and cognition, leading him to question whether he was suffering early signs of dementia. He provided to KFF Health News and CBS News lab reports showing the metals in his blood rising over years, with cobalt levels peaking at nearly 12 times the normal range. Rembisz said most of the symptoms faded after his implant was removed in 2021.

“The problems I developed weren’t even close to my hip,” Rembisz said. “This problem could be occurring in [other people’s] bodies as well. And they don’t even know it.”

Six years after Profemur switched metals, MicroPort recalled one size of the cobalt-chromium neck affecting about 10,500 implants, citing an “unexpected rate of postoperative fractures,” according to FDA records. But it is unknown how many could not be returned because they’d already been implanted.

Kristin Biorn had one.

Biorn, 74, of Pasadena, California, alleged in a lawsuit that this particular size of Profemur neck was implanted in her left leg in 2013 and broke within two years — four months before the recall. Wright Medical and MicroPort denied liability in her lawsuit, then settled out of court.

In an interview, Biorn said the break occurred as she was working at her burgeoning home-staging business. While putting final touches on a client’s home with her teenage son, she fell to the floor, unable to stand or crawl, she said.

“Honestly, it gives me nightmares about what could have happened had my son not been there,” Biorn said. “My phone was downstairs and there was no way I could have gotten down the stairs alone. No one was scheduled to come in for four days.”

Biorn said in her interview that it took three surgeries to fix her hip after the Profemur fracture and she was ultimately forced to close her business and retire.

She now walks with a cane.

Although MicroPort recalled one cobalt-chromium size in 2015, the company did not recall 11 other sizes made of the same metal with the same design, and some lawsuits have faulted the company for leaving “interchangeable” products on the market. MicroPort also did not at that time recall any of the titanium necks, which as of 2015 were identified in more than 500 fracture reports in FDA’s database. MicroPort recalled 10 titanium sizes in 2020.

Finally, also in 2020, MicroPort issued a sweeping recall for all available Profemur modular necks, regardless of whether they were made of titanium or cobalt-chromium, according to FDA records.

The recall was temporary so MicroPort could update the documents included in the packaging of Profemur implants. The revised documents added a “general precaution” that doctors should consider a patient’s activity level and weight before implanting them with a Profemur, and said that patients should not have “unrealistic” expectations that include “substantial walking, running, lifting, or muscle strain.”

Afterward, the recall was lifted, and the FDA once again allowed the implants to be put up for sale.

KFF Health News data editor Holly K. Hacker and CBS News producer Nicole Keller contributed to this report.

——————————
By: Brett Kelman and Anna Werner, CBS News
Title: Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half.
Sourced From: kffhealthnews.org/news/article/profemur-artificial-hips-malfunction/
Published Date: Tue, 05 Dec 2023 12:30:00 +0000

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Kaiser Health News

Dual Threats From Trump and GOP Imperil Nursing Homes and Their Foreign-Born Workers

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kffhealthnews.org – Jordan Rau, KFF Health News – 2025-06-26 04:00:00


In Alexandria, Virginia, Rev. Donald Goodness, 92, is cared for by many foreign-born nurses like Jackline Conteh from Sierra Leone, who vigilantly manages his celiac disease needs. The long-term care industry relies heavily on immigrants, with 28% of direct care workers being foreign-born. However, President Trump’s 2024 immigration crackdown, including rescinded protections and revoked work permits for refugees, threatens staffing levels. Coupled with proposed Medicaid spending cuts, nursing homes face worsening shortages and quality challenges. Many immigrant caregivers fear deportation, risking a crisis in elder care as demand rises with America’s aging population.


In a top-rated nursing home in Alexandria, Virginia, the Rev. Donald Goodness is cared for by nurses and aides from various parts of Africa. One of them, Jackline Conteh, a naturalized citizen and nurse assistant from Sierra Leone, bathes and helps dress him most days and vigilantly intercepts any meal headed his way that contains gluten, as Goodness has celiac disease.

“We are full of people who come from other countries,” Goodness, 92, said about Goodwin House Alexandria’s staff. Without them, the retired Episcopal priest said, “I would be, and my building would be, desolate.”

The long-term health care industry is facing a double whammy from President Donald Trump’s crackdown on immigrants and the GOP’s proposals to reduce Medicaid spending. The industry is highly dependent on foreign workers: More than 800,000 immigrants and naturalized citizens comprise 28% of direct care employees at home care agencies, nursing homes, assisted living facilities, and other long-term care companies.

But in January, the Trump administration rescinded former President Joe Biden’s 2021 policy that protected health care facilities from Immigration and Customs Enforcement raids. The administration’s broad immigration crackdown threatens to drastically reduce the number of current and future workers for the industry. “People may be here on a green card, and they are afraid ICE is going to show up,” said Katie Smith Sloan, president of LeadingAge, an association of nonprofits that care for older adults.

Existing staffing shortages and quality-of-care problems would be compounded by other policies pushed by Trump and the Republican-led Congress, according to nursing home officials, resident advocates, and academic experts. Federal spending cuts under negotiation may strip nursing homes of some of their largest revenue sources by limiting ways states leverage Medicaid money and making it harder for new nursing home residents to retroactively qualify for Medicaid. Care for 6 in 10 residents is paid for by Medicaid, the state-federal health program for poor or disabled Americans.

“We are facing the collision of two policies here that could further erode staffing in nursing homes and present health outcome challenges,” said Eric Roberts, an associate professor of internal medicine at the University of Pennsylvania.

The industry hasn’t recovered from covid-19, which killed more than 200,000 long-term care facility residents and workers and led to massive staff attrition and turnover. Nursing homes have struggled to replace licensed nurses, who can find better-paying jobs at hospitals and doctors’ offices, as well as nursing assistants, who can earn more working at big-box stores or fast-food joints. Quality issues that preceded the pandemic have expanded: The percentage of nursing homes that federal health inspectors cited for putting residents in jeopardy of immediate harm or death has risen alarmingly from 17% in 2015 to 28% in 2024.

In addition to seeking to reduce Medicaid spending, congressional Republicans have proposed shelving the biggest nursing home reform in decades: a Biden-era rule mandating minimum staffing levels that would require most of the nation’s nearly 15,000 nursing homes to hire more workers.

The long-term care industry expects demand for direct care workers to burgeon with an influx of aging baby boomers needing professional care. The Census Bureau has projected the number of people 65 and older would grow from 63 million this year to 82 million in 2050.

In an email, Vianca Rodriguez Feliciano, a spokesperson for the Department of Health and Human Services, said the agency “is committed to supporting a strong, stable long-term care workforce” and “continues to work with states and providers to ensure quality care for older adults and individuals with disabilities.” In a separate email, Tricia McLaughlin, a Department of Homeland Security spokesperson, said foreigners wanting to work as caregivers “need to do that by coming here the legal way” but did not address the effect on the long-term care workforce of deportations of classes of authorized immigrants.

Goodwin Living, a faith-based nonprofit, runs three retirement communities in northern Virginia for people who live independently, need a little assistance each day, have memory issues, or require the availability of around-the-clock nurses. It also operates a retirement community in Washington, D.C. Medicare rates Goodwin House Alexandria as one of the best-staffed nursing homes in the country. Forty percent of the organization’s 1,450 employees are foreign-born and are either seeking citizenship or are already naturalized, according to Lindsay Hutter, a Goodwin spokesperson.

“As an employer, we see they stay on with us, they have longer tenure, they are more committed to the organization,” said Rob Liebreich, Goodwin’s president and CEO.

Jackline Conteh spent much of her youth shuttling between Sierra Leone, Liberia, and Ghana to avoid wars and tribal conflicts. Her mother was killed by a stray bullet in her home country of Liberia, Conteh said. “She was sitting outside,” Conteh, 56, recalled in an interview.

Conteh was working as a nurse in a hospital in Sierra Leone in 2009 when she learned of a lottery for visas to come to the United States. She won, though she couldn’t afford to bring her husband and two children along at the time. After she got a nursing assistant certification, Goodwin hired her in 2012.

Conteh said taking care of elders is embedded in the culture of African families. When she was 9, she helped feed and dress her grandmother, a job that rotated among her and her sisters. She washed her father when he was dying of prostate cancer. Her husband joined her in the United States in 2017; she cares for him because he has heart failure.

“Nearly every one of us from Africa, we know how to care for older adults,” she said.

Her daughter is now in the United States, while her son is still in Africa. Conteh said she sends money to him, her mother-in-law, and one of her sisters.

In the nursing home where Goodness and 89 other residents live, Conteh helps with daily tasks like dressing and eating, checks residents’ skin for signs of swelling or sores, and tries to help them avoid falling or getting disoriented. Of 102 employees in the building, broken up into eight residential wings called “small houses” and a wing for memory care, at least 72 were born abroad, Hutter said.

Donald Goodness grew up in Rochester, New York, and spent 25 years as rector of The Church of the Ascension in New York City, retiring in 1997. He and his late wife moved to Alexandria to be closer to their daughter, and in 2011 they moved into independent living at the Goodwin House. In 2023 he moved into one of the skilled nursing small houses, where Conteh started caring for him.

“I have a bad leg and I can’t stand on it very much, or I’d fall over,” he said. “She’s in there at 7:30 in the morning, and she helps me bathe.” Goodness said Conteh is exacting about cleanliness and will tell the housekeepers if his room is not kept properly.

Conteh said Goodness was withdrawn when he first arrived. “He don’t want to come out, he want to eat in his room,” she said. “He don’t want to be with the other people in the dining room, so I start making friends with him.”

She showed him a photo of Sierra Leone on her phone and told him of the weather there. He told her about his work at the church and how his wife did laundry for the choir. The breakthrough, she said, came one day when he agreed to lunch with her in the dining room. Long out of his shell, Goodness now sits on the community’s resident council and enjoys distributing the mail to other residents on his floor.

“The people that work in my building become so important to us,” Goodness said.

While Trump’s 2024 election campaign focused on foreigners here without authorization, his administration has broadened to target those legally here, including refugees who fled countries beset by wars or natural disasters. This month, the Department of Homeland Security revoked the work permits for migrants and refugees from Cuba, Haiti, Nicaragua, and Venezuela who arrived under a Biden-era program.

“I’ve just spent my morning firing good, honest people because the federal government told us that we had to,” Rachel Blumberg, president of the Toby & Leon Cooperman Sinai Residences of Boca Raton, a Florida retirement community, said in a video posted on LinkedIn. “I am so sick of people saying that we are deporting people because they are criminals. Let me tell you, they are not all criminals.”

At Goodwin House, Conteh is fearful for her fellow immigrants. Foreign workers at Goodwin rarely talk about their backgrounds. “They’re scared,” she said. “Nobody trusts anybody.” Her neighbors in her apartment complex fled the U.S. in December and returned to Sierra Leone after Trump won the election, leaving their children with relatives.

“If all these people leave the United States, they go back to Africa or to their various countries, what will become of our residents?” Conteh asked. “What will become of our old people that we’re taking care of?”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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This article first appeared on KFF Health News and is republished here under a Creative Commons license.

The post Dual Threats From Trump and GOP Imperil Nursing Homes and Their Foreign-Born Workers appeared first on kffhealthnews.org



Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.

Political Bias Rating: Center-Left

This content primarily highlights concerns about the impact of restrictive immigration policies and Medicaid spending cuts proposed by the Trump administration and Republican lawmakers on the long-term care industry. It emphasizes the importance of immigrant workers in healthcare, the challenges that staffing shortages pose to patient care, and the potential negative effects of GOP policy proposals. The tone is critical of these policies while sympathetic toward immigrant workers and advocates for maintaining or increasing government support for healthcare funding. The framing aligns with a center-left perspective, focusing on social welfare, immigrant rights, and concern about the consequences of conservative economic and immigration policies without descending into partisan rhetoric.

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Kaiser Health News

California’s Much-Touted IVF Law May Be Delayed Until 2026, Leaving Many in the Lurch

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kffhealthnews.org – Sarah Kwon – 2025-06-25 04:00:00


California lawmakers are set to delay the state’s new IVF insurance coverage law, originally effective July 1, to January 2026. Governor Gavin Newsom requested the postponement to resolve coverage details like embryo storage and donor materials. The law mandates large employers’ health plans to cover infertility diagnosis and treatment, including up to three egg retrievals and unlimited embryo transfers, benefiting nine million people, including same-sex couples and single parents. The delay has caused uncertainty and frustration among patients and employers. If not delayed, enforcement begins July 1, but most employers renew contracts in January, delaying coverage start anyway. Lawmakers will vote soon.


California lawmakers are poised to delay the state’s much-ballyhooed new law mandating in vitro fertilization insurance coverage for millions, set to take effect July 1. Gov. Gavin Newsom has asked lawmakers to push the implementation date to January 2026, leaving patients, insurers, and employers in limbo.

The law, SB 729, requires state-regulated health plans offered by large employers to cover infertility diagnosis and treatment, including IVF. Nine million people will qualify for coverage under the law. Advocates have praised the law as “a major win for Californians,” especially in making same-sex couples and aspiring single parents eligible, though cost concerns limited the mandate’s breadth.

People who had been planning fertility care based on the original timeline are now “left in a holding pattern facing more uncertainty, financial strain, and emotional distress,” Alise Powell, a director at Resolve: The National Infertility Association, said in a statement.

During IVF, a patient’s eggs are retrieved, combined with sperm in a lab, and then transferred to a person’s uterus. A single cycle can total around $25,000, out of reach for many. The California law requires insurers to cover up to three egg retrievals and an unlimited number of embryo transfers.

Not everyone’s coverage would be affected by the delay. Even if the law took effect July 1, it wouldn’t require IVF coverage to start until the month an employer’s contract renews with its insurer. Rachel Arrezola, a spokesperson for the California Department of Managed Health Care, said most of the employers subject to the law renew their contracts in January, so their employees would not be affected by a delay.

She declined to provide data on the percentage of eligible contracts that renew in July or later, which would mean those enrollees wouldn’t get IVF coverage until at least a full year from now, in July 2026 or later.

The proposed new implementation date comes amid heightened national attention on fertility coverage. California is now one of 15 states with an IVF mandate, and in February, President Donald Trump signed an executive order seeking policy recommendations to expand IVF access.

It’s the second time Newsom has asked lawmakers to delay the law. When the Democratic governor signed the bill in September, he asked the legislature to consider delaying implementation by six months. The reason, Newsom said then, was to allow time to reconcile differences between the bill and a broader effort by state regulators to include IVF and other fertility services as an essential health benefit, which would require the marketplace and other individual and small-group plans to provide the coverage.

Newsom spokesperson Elana Ross said the state needs more time to provide guidance to insurers on specific services not addressed in the law to ensure adequate and uniform coverage. Arrezola said embryo storage and donor eggs and sperm were examples of services requiring more guidance.

State Sen. Caroline Menjivar, a Democrat who authored the original IVF mandate, acknowledged a delay could frustrate people yearning to expand their families, but requested patience “a little longer so we can roll this out right.”

Sean Tipton, a lobbyist for the American Society for Reproductive Medicine, contended that the few remaining questions on the mandate did not warrant a long delay.

Lawmakers appear poised to advance the delay to a vote by both houses of the legislature, likely before the end of June. If a delay is approved and signed by the governor, the law would immediately be paused. If this does not happen before July 1, Arrezola said, the Department of Managed Health Care would enforce the mandate as it exists. All plans were required to submit compliance filings to the agency by March. Arrezola was unable to explain what would happen to IVF patients whose coverage had already begun if the delay passes after July 1.

The California Association of Health Plans, which opposed the mandate, declined to comment on where implementation efforts stand, although the group agrees that insurers need more guidance, spokesperson Mary Ellen Grant said.

Kaiser Permanente, the state’s largest insurer, has already sent employers information they can provide to their employees about the new benefit, company spokesperson Kathleen Chambers said. She added that eligible members whose plans renew on or after July 1 would have IVF coverage if implementation of the law is not delayed.

Employers and some fertility care providers appear to be grappling over the uncertainty of the law’s start date. Amy Donovan, a lawyer at insurance brokerage and consulting firm Keenan & Associates, said the firm has fielded many questions from employers about the possibility of delay. Reproductive Science Center and Shady Grove Fertility, major clinics serving different areas of California, posted on their websites that the IVF mandate had been delayed until January 2026, which is not yet the case. They did not respond to requests for comment.

Some infertility patients confused over whether and when they will be covered have run out of patience. Ana Rios and her wife, who live in the Central Valley, had been trying to have a baby for six years, dipping into savings for each failed treatment. Although she was “freaking thrilled” to learn about the new law last fall, Rios could not get clarity from her employer or health plan on whether she was eligible for the coverage and when it would go into effect, she said. The couple decided to go to Mexico to pursue cheaper treatment options.

“You think you finally have a helping hand,” Rios said of learning about the law and then, later, the requested delay. “You reach out, and they take it back.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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This story can be republished for free (details).

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

This article first appeared on KFF Health News and is republished here under a Creative Commons license.

The post California’s Much-Touted IVF Law May Be Delayed Until 2026, Leaving Many in the Lurch appeared first on kffhealthnews.org



Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.

Political Bias Rating: Center-Left

This content is presented in a factual, balanced manner typical of center-left public policy reporting. It focuses on a progressive healthcare issue (mandated IVF insurance coverage) favorably highlighting benefits for diverse family structures and individuals, including same-sex couples and single parents, which often aligns with center-left values. At the same time, it includes perspectives from government officials, industry representatives, opponents, and patients, offering a nuanced view without overt ideological framing or partisan rhetoric. The emphasis on healthcare access, social equity, and patient impact situates the coverage within a center-left orientation.

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Kaiser Health News

Push To Move OB-GYN Exam Out of Texas Is Piece of AGs’ Broader Reproductive Rights Campaign

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kffhealthnews.org – Annie Sciacca – 2025-06-24 04:00:00


Democratic attorneys general from California, New York, and Massachusetts are pressuring medical groups to defend reproductive rights, including medication abortion, emergency abortions, and interstate travel for care amid rising abortion bans. The AMA recommended moving medical board exams out of restrictive states or making them virtual after 20 attorneys general petitioned to protect physicians from legal risks, targeting the American Board of Obstetrics and Gynecology’s in-person exams in Texas. Since Roe v. Wade’s fall, 16 states banned abortions and many restrict gender-affirming care, troubling providers fearing legal consequences. The campaign highlights coordinated efforts to safeguard reproductive and LGBTQ+ health care despite opposition from anti-abortion groups.


Democratic state attorneys general led by those from California, New York, and Massachusetts are pressuring medical professional groups to defend reproductive rights, including medication abortion, emergency abortions, and travel between states for health care in response to recent increases in the number of abortion bans.

The American Medical Association adopted a formal position June 9 recommending that medical certification exams be moved out of states with restrictive abortion policies or made virtual, after 20 attorneys general petitioned to protect physicians who fear legal repercussions because of their work. The petition focused on the American Board of Obstetrics and Gynecology’s certification exams in Dallas, and the subsequent AMA recommendation was hailed as a win for Democrats trying to regain ground after the fall of Roe v. Wade.

“It seems incremental, but there are so many things that go into expanding and maintaining access to care,” said Arneta Rogers, executive director of the Center on Reproductive Rights and Justice at the University of California-Berkeley’s law school. “We see AGs banding together, governors banding together, as advocates work on the ground. That feels somewhat more hopeful — that people are thinking about a coordinated strategy.”

Since the Supreme Court eliminated the constitutional right to an abortion in 2022, 16 states, including Texas, have implemented laws banning abortion almost entirely, and many of them impose criminal penalties on providers as well as options to sue doctors. More than 25 states restrict access to gender-affirming care for trans people, and six of them make it a felony to provide such care to youth.

That’s raised concern among some physicians who fear being charged if they go to those states, even if their home state offers protection to provide reproductive and gender-affirming health care.

Pointing to the recent fining and indictment of a physician in New York who allegedly provided abortion pills to a woman in Texas and a teen in Louisiana, a coalition of physicians wrote in a letter to the American Board of Obstetrics and Gynecology that “the limits of shield laws are tenuous” and that “Texas laws can affect physicians practicing outside of the state as well.”

The campaign was launched by several Democratic attorneys general, including Rob Bonta of California, Andrea Joy Campbell of Massachusetts, and Letitia James of New York, who each have established a reproductive rights unit as a bulwark for their state following the Dobbs decision.

“Reproductive health care and gender-affirming care providers should not have to risk their safety or freedom just to advance in their medical careers,” James said in a statement. “Forcing providers to travel to states that have declared war on reproductive freedom and LGBTQ+ rights is as unnecessary as it is dangerous.”

In their petition, the attorneys general included a letter from Joseph Ottolenghi, medical director at Choices Women’s Medical Center in New York City, who was denied his request to take the test remotely or outside of Texas. To be certified by the American Board of Obstetrics and Gynecology, physicians need to take the in-person exam at its testing facility in Dallas. The board completed construction of its new testing facility last year.

“As a New York practitioner, I have made every effort not to violate any other state’s laws, but the outer contours of these draconian laws have not been tested or clarified by the courts,” Ottolenghi wrote.

Rachel Rebouché, the dean of Temple University’s law school and a reproductive law scholar, said “putting the heft” of the attorneys general behind this effort helps build awareness and a “public reckoning” on behalf of providers. Separately, some doctors have urged medical conferences to boycott states with abortion bans.

Anti-abortion groups, however, see the campaign as forcing providers to conform to abortion-rights views. Donna Harrison, an OB-GYN and the director of research at the American Association of Pro-Life Obstetricians and Gynecologists, described the petition as an “attack not only on pro-life states but also on life-affirming medical professionals.”

Harrison said the “OB-GYN community consists of physicians with values that are as diverse as our nation’s state abortion laws,” and that this diversity “fosters a medical environment of debate and rigorous thought leading to advancements that ultimately serve our patients.”

The AMA’s new policy urges specialty medical boards to host exams in states without restrictive abortion laws, offer the tests remotely, or provide exemptions for physicians. However, the decision to implement any changes to the administration of these exams is up to those boards. There is no deadline for a decision to be made.

The OB-GYN board did not respond to requests for comment, but after the public petition from the attorneys general criticizing it for refusing exam accommodations, the board said that in-person exams conducted at its national center in Dallas “provide the most equitable, fair, secure, and standardized assessment.”

The OB-GYN board emphasized that Texas’ laws apply to doctors licensed in Texas and to medical care within Texas, specifically. And it noted that its exam dates are kept under wraps, and that there have been “no incidents of harm to candidates or examiners across thousands of in-person examinations.”

Democratic state prosecutors, however, warned in their petition that the “web of confusing and punitive state-based restrictions creates a legal minefield for medical providers.” Texas is among the states that have banned doctors from providing gender-affirming care to transgender youth, and it has reportedly made efforts to get records from medical facilities and professionals in other states who may have provided that type of care to Texans.

The Texas attorney general’s office did not respond to requests for comment.

States such as California and New York have laws to block doctors from being extradited under other states’ laws and to prevent sharing evidence against them. But instances that require leveraging these laws could still mean lengthy legal proceedings.

“We live in a moment where we’ve seen actions by executive bodies that don’t necessarily square with what we thought the rules provided,” Rebouché said.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

This article first appeared on KFF Health News and is republished here under a Creative Commons license.

The post Push To Move OB-GYN Exam Out of Texas Is Piece of AGs’ Broader Reproductive Rights Campaign appeared first on kffhealthnews.org



Note: The following A.I. based commentary is not part of the original article, reproduced above, but is offered in the hopes that it will promote greater media literacy and critical thinking, by making any potential bias more visible to the reader –Staff Editor.

Political Bias Rating: Center-Left

The article presents a viewpoint largely aligned with progressive and Democratic positions on reproductive rights and gender-affirming care. It highlights efforts led by Democratic attorneys general and the American Medical Association to protect abortion access and transgender healthcare amid restrictive state laws, portraying these actions positively. While it includes perspectives from anti-abortion advocates, their views are presented briefly and framed as opposition to the broader pro-choice initiatives. The overall tone and framing emphasize support for reproductive freedom and healthcare protections, reflecting a center-left leaning stance typical of mainstream health policy reporting sympathetic to Democratic policy goals.

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