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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 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 . 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 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.”

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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 .

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 , 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.”

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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.

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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.

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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.

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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.

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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.

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“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 .

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.”

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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.

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“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.

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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 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.

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The FDA documents 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.

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“This hip has given me back my quality of life. It's 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.

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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.

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“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.

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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.”

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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.

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“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.

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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 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.

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——————————
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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https://www.biloxinewsevents.com/californias-ambitious-medicaid-experiment-gets-tripped-up-in-implementation/

Kaiser Health News

Medicaid ‘Unwinding’ Decried as Biased Against Disabled People

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Daniel Chang
Tue, 14 May 2024 09:00:00 +0000

Jacqueline Saa has a genetic condition that leaves her unable to stand and walk on her own or hold a job. Every weekday for four years, Saa, 43, has relied on a home aide to help her cook, bathe and dress, go to the doctor, pick up medications, and accomplish other tasks.


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Have you or someone you know with disabilities unexpectedly lost Medicaid benefits since April 2023? Tell us about it here.

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She received coverage through Florida's Medicaid program until it abruptly stopped at the end of March, she said.

“Every day the anxiety builds,” said Saa, who lost her home health aide for 11 days, starting April 1, despite being eligible. The has since restored Saa's home health aide service, but during the gap she leaned on her mother and her 23- and 15-year-old daughters, while struggling to regain her Medicaid benefits.

“It's just so much to worry about,” she said. “This is a health care system that's supposed to help.”

Medicaid's home and community-based services are designed to help people like Saa, who have disabilities and need help with everyday activities, stay out of a nursing facility. But people are losing benefits with little or no notice, getting bad advice when they call for information, and facing major disruptions in care while they wait for the issue to get sorted out, according to attorneys and advocates who are hearing from patients.

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In Colorado, Texas, and Washington, D.C., the National Health Program, a nonprofit that advocates for low-income and underserved people, has filed civil rights complaints with two federal agencies alleging discrimination against people with disabilities. The group has not filed a lawsuit in Florida, though its attorneys say they've heard of many of the same problems there.

Attorneys nationwide say the special needs of disabled people were not prioritized as states began to review eligibility for Medicaid enrollees after a pandemic-era mandate for coverage expired in March 2023.

“Instead of monitoring and ensuring that people with disabilities could make their way through the , they sort of treated them like everyone else with Medicaid,” said Elizabeth Edwards, a senior attorney for the National Health Law Program. Federal law puts an “obligation on states to make sure people with disabilities don't get missed.”

At least 21 million people nationwide have been disenrolled from Medicaid since states began eligibility redeterminations in spring 2023, according to a KFF analysis.

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The unwinding, as it's known, is an immense undertaking, Edwards said, and some states did not take extra steps to set up a special telephone line for those with disabilities, for example, so people could renew their coverage or contact a case manager.

As states prepared for the unwinding, the Centers for Medicare & Medicaid Services, the federal agency that regulates Medicaid, advised states that they must give people with disabilities the help they need to benefit from the program, including specialized communications for people who are deaf or blind.

The Florida Department of Children and Families, which verifies eligibility for the state's Medicaid program, has a specialized team that processes applications for home health services, said Mallory McManus, the department's communications director.

People with disabilities disenrolled from Medicaid services were “properly noticed and either did not respond timely or no longer met financial eligibility requirements,” McManus said, noting that people “would have been contacted by us up to 13 times via phone, mail, email, and text before processing their disenrollment.”

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Allison Pellegrin of Ormond Beach, Florida, who lives with her sister Rhea Whitaker, who is blind and cognitively disabled, said that never happened for her .

“They just cut off the benefits without a call, without a letter or anything stating that the benefits would be terminating,” Pellegrin said. Her sister's home health aide, whom she had used every day for nearly eight years, stopped service for 12 days. “If I'm getting everything else in the mail,” she said, “it seems weird that after 13 times I wouldn't have received one of them.”

Pellegrin, 58, a sales manager who gets health insurance through her employer, took time off from work to care for Whitaker, 56, who was disabled by a severe brain injury in 2006.

Medicaid reviews have been complicated, in part, by the fact that eligibility works differently for home health services than for general coverage, based on federal regulations that give states more flexibility to determine financial eligibility. Income limits for home health services are higher, for instance, and assets are counted differently.

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In Texas, a parent in a household of three would be limited to earning no more than $344 a month to qualify for Medicaid. And most adults with a disability can qualify without a dependent child and be eligible for Medicaid home health services with an income of up to $2,800 a month.

The state was not taking that into consideration, said Terry Anstee, a supervising attorney for community integration at Disability Rights Texas, a nonprofit advocacy group.

Even a brief lapse in Medicaid home health services can fracture relationships that took years to build.

“It may be very difficult for that person who lost that attendant to find another attendant,” Anstee said, because of workforce shortages for attendants and nurses and high demand.

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Nearly all states have a waiting list for home health services. About 700,000 people were on waiting lists in 2023, most of them with intellectual and developmental disabilities, according to KFF data.

Daniel Tsai, a deputy administrator at CMS, said the agency is committed to ensuring that people with disabilities receiving home health services “can renew their Medicaid coverage with as little red tape as possible.”

CMS finalized a rule this year for states to monitor Medicaid home health services. For example, CMS will now track how long it takes for people who need home health care to receive the services and will require states to track how long people are on waitlists.

Staff turnover and vacancies at local Medicaid agencies have contributed to backlogs, according to complaints filed with two federal agencies focused on civil rights.

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The District of Columbia's Medicaid agency requires that case managers help people with disabilities complete renewals. However, a complaint says, case managers are the only ones who can help enrollees complete eligibility reviews and, sometimes, they don't do their jobs.

Advocates for Medicaid enrollees have also complained to the Federal Trade Commission about faulty eligibility systems developed by Deloitte, a global consulting firm that contracts with about two dozen states to design, implement, or operate automated benefits .

KFF Health News found that multiple audits of Colorado's eligibility system, managed by Deloitte, uncovered errors in notices sent to enrollees. A 2023 review by the Colorado Office of the State Auditor found that 90% of sampled notices contained problems, some of which violate the state's Medicaid rules. The audit blamed “flaws in system design” for populating notices with incorrect dates.

Deloitte declined to comment on specific state issues.

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In March, Colorado officials paused disenrollment for people on Medicaid who received home health services, which includes people with disabilities, after a “system update” led to wrongful terminations in February.

Another common problem is people being told to reapply, which immediately cuts off their benefits, instead of appealing the cancellation, which would ensure their coverage while the claim is investigated, said attorney Miriam Harmatz, founder of the Florida Health Justice .

“What they're being advised to do is not appropriate. The best way to protect their legal rights,” Harmatz said, “is to file an appeal.”

But some disabled people are worried about having to repay the cost of their care.

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Saa, who lives in Davie, Florida, received a letter shortly before her benefits were cut that said she “may be responsible to repay any benefits” if she lost her appeal.

The state should presume such people are still eligible and preserve their coverage, Harmatz said, because income and assets for most beneficiaries are not going to increase significantly and their conditions are not likely to improve.

The Florida Department of Children and Families would not say how many people with disabilities had lost Medicaid home health services.

But in Miami-Dade, Florida's most populous county, the Alliance for Aging, a nonprofit that helps older and disabled people apply for Medicaid, saw requests for help jump from 58 in March to 146 in April, said Lisa Mele, the organization's director of its Aging and Disability Resources Center.

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“So many people are calling us,” she said.

States are not tracking the numbers, so “the impact is not clear,” Edwards said. “It's a really complicated struggle.”

Saa filed an appeal March 29 after learning from her social worker that her benefits would expire at the end of the month. She went to the agency but couldn't stand in a line that was 100 people deep. Calls to the state's Medicaid eligibility review agency were fruitless, she said.

“When they finally connected me to a customer service representative, she was literally just reading the same explanation letter that I've read,” Saa said. “I did everything in my power.”

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Saa canceled her home health aide. She lives on limited Social Security disability income and said she could not afford to pay for the care.

On April 10, she received a letter from the state saying her Medicaid had been reinstated, but she later learned that her plan did not home health care.

The day, Saa said, advocates put her in touch with a point person at Florida's Medicaid agency who restored her benefits. A home health aide showed up April 12. Saa said she's thankful but feels anxious about the future.

“The toughest part of that period is knowing that that can happen at any time,” she said, “and not because of anything I did wrong.”

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Have you or someone you know with disabilities unexpectedly lost Medicaid benefits since April 2023? Tell KFF Health News about it here.

KFF Health News correspondents Samantha Liss and Rachana Pradhan contributed to this report.

——————————
By: Daniel Chang
Title: Medicaid ‘Unwinding' Decried as Biased Against Disabled People
Sourced From: kffhealthnews.org/news/article/medicaid-unwinding-people-with-disabilities-home-health-benefits/
Published Date: Tue, 14 May 2024 09:00:00 +0000

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https://www.biloxinewsevents.com/nursing-homes-wield-pandemic-immunity-laws-to-duck-wrongful-death-suits/

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Nursing Homes Wield Pandemic Immunity Laws To Duck Wrongful Death Suits

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Fred Schulte, KFF Health News
Tue, 14 May 2024 09:00:00 +0000

In early 2020, with reports of outbreaks making dire headlines, Trever Schapers worried about her father's safety in a nursing home in Queens.

She had delighted in watching her dad, John Schapers, blow out the candles on his 90th birthday cake that February at the West Lawrence Care Center in the New York City borough. Then the home went into lockdown.

Soon her father was dead. The former union painter spiked a fever and was transferred to a hospital, where he tested positive for covid, his daughter said, and after two weeks on a ventilator, he died in May 2020.

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But when Trever Schapers sued the nursing home for negligence and wrongful death in 2022, a judge dismissed the case, citing a New York law hastily passed early in the pandemic. It granted immunity to medical providers for “harm or damages” from an “act or omission” in treating or arranging care for covid. She is appealing the .

“I feel that families are being ignored by judges and courts not recognizing that something needs to be done and changed,” said Schapers, 48, who works in the medical field. “There needs to be accountability.”

The nursing home did not return calls seeking comment. In a court filing, the home argued that Schapers offered no evidence that the home was “grossly negligent” in treating her father.

More than four years after covid first raged through many U.S. nursing homes, hundreds of lawsuits blaming patient deaths on negligent care have been tossed out or languished in the courts amid contentious legal battles.

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Even some nursing homes that were shut down by health officials for violating safety standards have claimed immunity against such suits, court records show. And some families that allege homes kept them in the dark about the health of their loved ones, even denying there were cases of covid in the building, have had their cases dismissed.

Schapers alleged in a complaint to state health officials that the nursing home failed to advise her that it had admitted covid-positive from a nearby hospital in March 2020. In early April, she received a call telling her the facility had some covid-positive residents.

“The call I received was very alarming, and they refused to answer any of my questions,” she said.

About two weeks later, a social worker called to say that her father had a fever, but the staff did not test him to confirm covid, according to Schapers' complaint.

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The industry says federal health officials and lawmakers in most states granted medical providers broad protection from lawsuits for good faith actions during the health emergency. Rachel Reeves, a senior vice president with the American Association, an industry trade group, called covid “an unprecedented public health crisis brought on by a vicious virus that uniquely targeted our population.”

In scores of lawsuits, however, family members allege that nursing homes failed to secure enough protective gear or tests for staffers or residents, haphazardly mixed covid-positive patients with other residents, failed to follow strict infection control protocols, and brazenly misled frightened families about the severity of covid outbreaks among patients and staff.

“They trusted these facilities to take care of loved ones, and that trust was betrayed,” said Florida attorney Lindsey Gale, who has represented several families suing over covid-related deaths.

“The grieving process people had to go through was horrible,” Gale said.

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A Deadly Toll

KFF Health News found that more than 1,100 covid-related lawsuits, most alleging wrongful death or other negligent care, were filed against nursing homes from March 2020 through March of this year.

While there's no full accounting of the outcomes, court filings show that judges have dismissed some suits outright, citing state or federal immunity provisions, while other cases have been settled under confidential terms. And many cases have stalled due to lengthy and costly arguments and appeals to hash out limits, if any, of immunity protection.

In their defense, nursing homes initially cited the federal Public Readiness and Emergency Preparedness Act, which Congress passed in December 2005. The law liability protection from claims for deaths or injuries tied to vaccines or “medical countermeasures” taken to prevent or treat a disease during national emergencies.

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The PREP Act steps in once the secretary of Health and Human Services declares a “public health emergency,” which happened with covid on March 17, 2020. The emergency order expired on May 11, 2023.

The law carved out an exception for “willful misconduct,” but proving it occurred can be daunting for families — even when nursing homes have long histories of violating safety standards, infection controls.

Governors of at least 38 states issued covid executive orders, or their legislatures passed laws, granting medical providers at least some degree of immunity, according to one consumer group's tally. Just how much legal protection was intended is at the crux of the skirmishes.

Nursing homes answered many negligence lawsuits by getting them removed from state courts into the federal judicial system and asking for dismissal under the PREP Act.

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For the most part, that didn't work because federal judges declined to hear the cases. Some judges ruled that the PREP Act was not intended to shield medical providers from negligence caused by inaction, such as failing to protect patients from the coronavirus. These rulings and appeals sent cases back to state courts, often after long delays that left families in legal limbo.

“These delays have been devastating,” said Jeffrey Guzman, a New York City attorney who represents Schapers and other families. He said the industry has fought “tooth and nail” to “fight these people getting their day in court.”

Empire State Epicenter

New York, where covid hit early and hard, is ground zero for court battles over nursing home immunity.

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Relatives of residents have filed more than 750 negligence or wrongful death cases in New York counties since the start of the pandemic, according to court data KFF Health News compiled using the judicial reporting service Courthouse News Service. No other area comes close. Chicago's Cook County, a jurisdiction where private lawyers for years have aggressively sued nursing homes alleging poor infection control, recorded 121 covid-related cases.

Plaintiffs in hundreds of New York cases argue that nursing homes knew early in 2020 that covid would pose a deadly threat but largely failed to gird for its impact. Many suits cite inspection reports detailing chronic violations of infection control standards in the years preceding the pandemic, court records show. Responses to this strategy vary.

“Different judges take different views,” said Joseph Ciaccio, a New York lawyer who has filed hundreds of such cases. “It's been very mixed.”

Lawyers for nursing homes counter that most lawsuits rely on vague allegations of wrongdoing and “boilerplate” claims that, even if true, don't demonstrate the kind of gross negligence that would override an immunity claim.

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New York lawmakers added another wrinkle by repealing the immunity statute in April 2021 after Attorney General Letitia James noted the law could give nursing homes a free pass to make “financially motivated decisions” to cut costs and put patients at risk.

So far, appeals courts have ruled lawmakers didn't specify that the repeal should be made retroactive, thus stymying many negligence cases.

“So these cases are all wasting the courts' time and preventing cases that aren't barred by immunity statutes from being resolved sooner and clogging up the court system that was already backlogged from COVID,” said attorney Anna Borea, who represents nursing homes.

Troubled Homes Deflect Suits

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Some nursing homes that paid hefty fines or were ordered by health officials to shut down at least temporarily because of their inadequate response to covid have claimed immunity against suits, court records show.

Among them is Andover Subacute and Rehabilitation nursing home in New Jersey, which made national headlines when authorities found 17 bodies stacked in a makeshift morgue in April 2020.

Federal health officials fined the facility $220,235 after issuing a critical 36-page report on covid violations and other deficiencies, and the state halted admissions in February 2022.

Yet the home has won court pauses in at least three negligence lawsuits as it appeals lower court rulings denying immunity under the federal PREP Act, court records show. The operators of the home could not be reached for comment. In court filings, they denied any wrongdoing.

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In Oregon, health officials suspended operations at Healthcare at Foster Creek, calling the Portland nursing home “a serious danger to the public health and safety.” The May 2020 order cited the home's “consistent inability to adhere to basic infection control standards.”

Bonnie Richardson, a Portland lawyer, sued the facility on behalf of the family of Judith Jones, 75, who had dementia and died in April 2020. Jones' was among dozens of covid-related deaths at that home.

“It was a very hard-fought battle,” said Richardson, who has since settled the case under confidential terms. Although the nursing home claimed immunity, her clients “wanted to know what happened and to understand why.” The owners of the nursing home provided no comment.

No Covid Here

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Many families believe nursing homes misled them about covid's relentless spread. They often had to settle for window visits to connect with their loved ones.

Relatives of five patients who died in 2020 at the Sapphire Center for Rehabilitation and Nursing in the Flushing neighborhood in Queens filed lawsuits accusing the home's operators of keeping them in the dark.

When they phoned to check on elderly , they either couldn't get through or were told there was “no COVID-19 in the building,” according to one court affidavit.

One woman grew alarmed after visiting in February 2020 and seeing nurses wearing masks “below their noses or under their chin,” according to a court affidavit.

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The woman was shocked when the home relayed that her mother had died in April 2020 from unknown causes, perhaps “from depression and not eating,” according to her affidavit.

A short time later, news media reported that dozens of Sapphire Center residents had died from the virus — her 85-year-old mother among them, she argued in a lawsuit.

The nursing home denied liability and won dismissal of all five lawsuits after citing the New York immunity law. Several families are appealing. The nursing home's administrator declined to comment.

Broadening Immunity

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Nursing home operators also have cited immunity to foil negligence lawsuits based on falls or other allegations of substandard care, such as bedsores, with little obvious connection to the pandemic, court records show.

The family of Marilyn Kearney, an 89-year-old with a “history of dementia and falls,” sued the Watrous Nursing Center in Madison, Connecticut, for negligence. Days after she was admitted in June 2020, she fell in her room, fracturing her right hip and requiring surgery, according to court filings.

She died at a local hospital on Sept. 16, 2020, from sepsis attributed to dehydration and malnutrition, according to the suit.

Her family argued that the 45-bed nursing home failed to assess her risk of falling and develop a plan to prevent that. But Watrous fired back by citing an April 2020 declaration by Connecticut Gov. Ned Lamont, a Democrat, granting health care professionals or facilities immunity from “any injury or death alleged to have been sustained because of the individual's or health care facility's acts or omissions undertaken in good faith while providing health care services in support of the state's COVID-19 response.”

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Watrous denied liability and, in a motion to dismiss the case, cited Lamont's executive order and affidavits that argued the home did its best in the throes of a “public health crisis, the likes of which had never been seen before.” The operators of the nursing home, which closed in July 2021 because of covid, did not respond to a request for comment. The case is pending.

Attorney Wendi Kowarik, who represents Kearney's family, said courts are wrestling with how much protection to afford nursing homes.

“We're just beginning to get some guidelines,” she said.

One pending Connecticut case alleges that an 88-year-old man died in October 2020 after experiencing multiple falls, sustaining bedsores, and dropping more than 30 pounds in the two months he lived at a nursing home, court records state. The nursing home denied liability and contends it is entitled to immunity.

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So do the owners of a Connecticut facility that cared for a 75-year-old woman with obesity who required a lift to get out of bed. She fell on April 26, 2020, smashing several teeth and fracturing bones. She later died from her injuries, according to the suit, which is pending.

“I think it is really repugnant that providers are arguing that they should not be held accountable for falls, pressure sores, and other outcomes of gross neglect,” said Richard Mollot, executive director of the Long Term Care Community Coalition, which advocates for patients.

“The did not declare open season on nursing home residents when it implemented COVID policies,” he said.

Protecting the Vulnerable

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Since early 2020, U.S. nursing homes have reported more than 172,000 residents' deaths, according to Centers for Medicare & Medicaid Services data. That's about 1 in 7 of all recorded U.S. covid deaths.

As it battles covid lawsuits, the nursing home industry says it is “struggling to recover due to ongoing labor shortages, inflation, and chronic government underfunding,” according to Reeves, the trade association executive.

She said the American Health Care Association has advocated for “reasonable, limited liability protections that defend staff and providers for their good faith efforts” during the pandemic.

“Caregivers were doing everything they could,” Reeves said, “often with limited resources and ever-changing information, in an effort to protect and care for residents.”

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But patients' advocates remain wary of policies that might bar the courthouse door against grieving families.

“I don't think we want to continue to enact laws that reward nursing homes for bad care,” said Sam Brooks, of the Coalition for the Protection of Residents of Long-Term Care Facilities, a patient advocacy group.

“We need to keep that in mind if, God forbid, we have another pandemic,” Brooks said.

Bill Hammond, a senior fellow at the Empire Center for Public Policy, a nonpartisan New York think tank, said policymakers should focus on better strategies to protect patients from infectious outbreaks, rather than leaving it up to the courts to sort out liability years later.

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“There is no serious effort to have that conversation,” Hammond said. “I think that's crazy.”

——————————
By: Fred Schulte, KFF Health News
Title: Nursing Homes Wield Pandemic Immunity Laws To Duck Wrongful Death Suits
Sourced From: kffhealthnews.org/news/article/nursing-home-pandemic-immunity-wrongful-death-lawsuits/
Published Date: Tue, 14 May 2024 09:00:00 +0000

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Kaiser Health News

First Responders, Veterans Hail Benefits of Psychedelic Drugs as California Debates Legalization

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Bernard J. Wolfson
Mon, 13 May 2024 09:00:00 +0000

Wade Trammell recalls the time he and his fellow firefighters responded to a highway crash in which a beer truck rammed into a pole, propelling the truck's engine through the cab and into the driver's abdomen.

“The guy was up there screaming and squirming. Then the cab caught on fire,” Trammell says. “I couldn't move him. He burned to death right there in my arms.”

Memories of that gruesome death and other traumatic incidents he had witnessed as a firefighter in Mountain View, California, didn't seem to bother Trammell for the first seven years after he retired in 2015. But then he started crying a lot, drinking heavily, and losing sleep. At first, he didn't understand why, but he would later to he was suffering from post-traumatic stress disorder.

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After therapy failed to improve his mental well-being, he heard about the potential benefits of psychedelic drugs to help first responders with PTSD.

Last July, Trammell went on a retreat in Puerto Vallarta, Mexico, organized by The S.I.R.E.N. Project, a nonprofit that advocates the use of psychedelics and other alternative medicines to help first responders. He took psilocybin mushrooms and, the next day, another psychedelic derived from the toxic secretions of the Sonoran Desert toad. The experience, he says, produced an existential shift in the way he thinks of the terrible things he saw as a firefighter.

“All that trauma and all that crap I saw and dealt with, it's all very temporary and everything goes back into the universe as energy,” Trammell says.

Abundant research has shown that psychedelics have the potential to produce lasting relief from depression, anxiety, PTSD, addiction, and other mental health conditions. Many universities around the United States have programs researching psychedelics. But experts warn that these powerful drugs are not for everybody, especially those with a history of psychosis or cardiovascular problems.

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Most psychedelic drugs are prohibited under federal law, but California may soon join a growing number of local and governments allowing their use.

A bill working its way through the California Legislature, would allow the therapeutic use of psilocybin; mescaline; MDMA, the active ingredient in ecstasy; and dimethyltryptamine, the active ingredient in ayahuasca, a plant-based psychoactive tea. The drugs could be purchased and ingested in approved locations under the supervision of facilitators, who would undergo and be licensed by a new state board. The facilitators would need a professional health credential to qualify.

The bill, co-sponsored by Sen. Scott Wiener (D-San Francisco), Assembly member Marie Waldron (R-San Diego), and several other lawmakers, follows last year's unsuccessful effort to decriminalize certain psychedelics for personal use. Gov. Gavin Newsom, a Democrat, vetoed that bill, though he extolled psychedelics as “an exciting frontier” and asked for new legislation with “regulated treatment guidelines.”

Wiener says the new bill was drafted with Newsom's request in mind. It is supported by some and first responder groups and opposed by numerous law enforcement agencies.

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One potential roadblock is the state's budget deficit, pegged at between $38 billion and $73 billion. Newsom and legislative may choose not to launch a new initiative when they are cutting existing programs. “That is something we'll certainly grapple with,” Wiener says.

The legislation, which is making its way through committees, would require the new board to begin accepting facilitator license applications in April 2026. The system would look somewhat like the one in Oregon, which allows the use of psilocybin mushrooms under the guidance of state-licensed facilitators at psilocybin service centers. And like Oregon, California would not allow for the personal use or possession of psychedelics; the drugs would have to be purchased and consumed at the authorized locations.

Colorado, following the passage of a ballot initiative in 2022, is creating a system of regulated “healing centers,” where people will be able to legally consume psilocybin mushrooms and some other psychedelics under the supervision of licensed facilitators. Colorado's law allows for the personal use and possession of a handful of psychedelics.

In California, the of Oakland, San Francisco, Berkeley, Santa Cruz, and Arcata have effectively decriminalized many psychedelics, as have other cities around the United States, including Ann Arbor, Michigan; Cambridge, ; Detroit; Minneapolis; Seattle; and Washington, D.C.

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Psychedelics such as psilocybin, ayahuasca, and peyote have been used for thousands of years by Indigenous populations in Latin America and the current-day United States. And some non-Indigenous groups use these substances in a spiritual way.

The Church of Ambrosia, with locations in San Francisco and Oakland, considers psilocybin mushrooms, also known as magic mushrooms, a sacrament. “Mushrooms affect the border between this world and the next, and allow people to connect to their soul,” says Dave Hodges, founder and pastor of the church.

Hodges was behind an unsuccessful attempt to get an initiative on the California ballot this year that would have decriminalized the possession and use of mushrooms. He hopes it will qualify for the 2026 ballot.

The pending California legislation is rooted in studies showing psychedelics can be powerful agents in mental health treatment.

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Charles Grob, a psychiatry professor at the of California-Los Angeles School of Medicine who has researched psychedelics for nearly 40 years, led a study that found synthetic psilocybin could help reduce end-of-life anxiety in patients with advanced-stage cancer.

Grob says MDMA is good for couples counseling because it facilitates communication and puts people in touch with their feelings. And he conducted research in Brazil that showed ayahuasca used in a religious context helped people overcome alcoholism.

But Grob warns that the unsupervised use of psychedelics can be dangerous and says people should undergo mental and medical health screenings before ingesting them. “There are cases of people going off the rails. It's a small minority, but it can happen, and when it does happen it can be very frightening,” Grob says.

Ken Finn, past president of the American Board of Pain Medicine, says that psychedelics have a number of side effects, including elevated blood pressure, high heart rate, and vomiting, and that they can trigger “persistent psychosis” in a small minority of users. Legal drugs also pose risks, he says, “but we have much better guardrails on things like prescriptions and over-the-counter medications.” He also worries about product contamination and says manufacturers would need to be tightly regulated.

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Another potential problem is health equity. Since insurance would not these sessions, at least initially, they would likely attract people with disposable income. A supervised psilocybin journey in Oregon, for example, can cost more than $2,500.

Many people who have experienced psychedelics corroborate the research results. Ben Kramer, a former Marine who served in Afghanistan and now works as a psilocybin facilitator in Beaverton, Oregon, says a high-dose mushroom session altered his worldview.

“I relived the first time I was ever shot at in Afghanistan,” he says. “I was there. I had this overwhelming love and compassion for the guy who was shooting at me, who was fighting for what he believed in, just like I was.”

Another characteristic of psychedelic therapy is that just a few sessions can potentially produce lasting results.

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Trammell, the retired firefighter, hasn't taken psychedelics since that retreat in Mexico 10 months ago. “I just felt like I kind of got what I needed,” he says. “I've been fine ever since.”

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

——————————
By: Bernard J. Wolfson
Title: First Responders, Veterans Hail Benefits of Psychedelic Drugs as California Debates Legalization
Sourced From: kffhealthnews.org/news/article/first-responders-veterans-psychedelic-drugs-california-legalization/
Published Date: Mon, 13 May 2024 09:00:00 +0000

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