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Paid Sick Leave Sticks After Many Pandemic Protections Vanish

Kaiser Health News:States - May 09, 2024

Bill Thompson’s wife had never seen him smile with confidence. For the first 20 years of their relationship, an infection in his mouth robbed him of teeth, one by one.

“I didn’t have any teeth to smile with,” the 53-year-old of Independence, Missouri, said.

Thompson said he dealt with throbbing toothaches and painful swelling in his face from abscesses for years working as a cook at Burger King. He desperately needed to see a dentist but said he couldn’t afford to take time off without pay. Missouri is one of many states that do not require employers to provide paid sick leave.

So, Thompson would swallow Tylenol and push through the pain as he worked over the hot grill.

“Either we go to work, have a paycheck,” Thompson said. “Or we take care of ourselves. We can’t take care of ourselves because, well, this vicious circle that we’re stuck in.”

In a nation that was sharply divided about government health mandates during the covid-19 pandemic, the public has been warming to the idea of government rules providing for paid sick leave.

Before the pandemic, 10 states and the District of Columbia had laws requiring employers to provide paid sick leave. Since then, Colorado, New York, New Mexico, Illinois, and Minnesota have passed laws offering some kind of paid time off for illness. Oregon and California expanded previous paid leave laws. In Missouri, Alaska, and Nebraska, advocates are pushing to put the issue on the ballot this fall.

The U.S. is one of nine countries that do not guarantee paid sick leave, according to data compiled by the World Policy Analysis Center.

In response to the pandemic, Congress passed the Emergency Paid Sick Leave and Emergency Family and Medical Leave Expansion acts. These temporary measures allowed employees to take up to two weeks of paid sick leave for covid-related illness and caregiving. But the provisions expired in 2021.

“When the pandemic hit, we finally saw some real political will to solve the problem of not having federal paid sick leave,” said economist Hilary Wething.

Wething co-authored a recent Economic Policy Institute report on the state of sick leave in the United States. It found that more than half, 61%, of the lowest-paid workers can’t get time off for an illness.

“I was really surprised by how quickly losing pay — because you’re sick — can translate into immediate and devastating cuts to a family’s household budget,” she said.

Wething noted that the lost wages of even a day or two can be equivalent to a month’s worth of gasoline a worker would need to get to their job, or the choice between paying an electric bill or buying food. Wething said showing up to work sick poses a risk to co-workers and customers alike. Low-paying jobs that often lack paid sick leave — like cashiers, nail technicians, home health aides, and fast-food workers — involve lots of face-to-face interactions.

“So paid sick leave is about both protecting the public health of a community and providing the workers the economic security that they desperately need when they need to take time away from work,” she said.

The National Federation of Independent Business has opposed mandatory sick leave rules at the state level, arguing that workplaces should have the flexibility to work something out with their employees when they get sick. The group said the cost of paying workers for time off, extra paperwork, and lost productivity burdens small employers.

According to a report by the National Bureau of Economic Research, once these mandates go into effect, employees take, on average, two more sick days a year than before a law took effect.

Illinois’ paid time off rules went into effect this year. Lauren Pattan is co-owner of the Old Bakery Beer Co. there. Before this year, the craft brewery did not offer paid time off for its hourly employees. Pattan said she supports Illinois’ new law but she has to figure out how to pay for it.

“We really try to be respectful of our employees and be a good place to work, and at the same time we get worried about not being able to afford things,” she said.

That could mean customers have to pay more to cover the cost, Pattan said.

As for Bill Thompson, he wrote an op-ed for the Kansas City Star newspaper about his dental struggles.

“Despite working nearly 40 hours a week, many of my co-workers are homeless,” he wrote. “Without health care, none of us can afford a doctor or a dentist.”

That op-ed generated attention locally and, in 2018, a dentist in his community donated his time and labor to remove Thompson’s remaining teeth and replace them with dentures. This allowed his mouth to recover from the infections he’d been dealing with for years. Today, Thompson has a new smile and a job — with paid sick leave — working in food service at a hotel.

In his free time, he’s been collecting signatures to put an initiative on the November ballot that would guarantee at least five days of earned paid sick leave a year for Missouri workers. Organizers behind the petition said they have enough signatures to take it before the voters.

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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Readout of HHS Secretary Xavier Becerra’s Remarks at the Sickle Cell Disease Trailblazers Event

HHS Gov News - May 08, 2024
Secretary Becerra’s Remarks at the Sickle Cell Disease Trailblazers Event

Biden-Harris Administration Acts to Improve Access to Kidney Transplants

HHS Gov News - May 08, 2024
Proposed model would break down silos of care in kidney transplant process

Biden’s Nursing Home Staffing Rule Surfaces Horror Stories

The Biden administration’s plan to set minimum staffing levels for nursing homes prompted comments from more than 46,500 people and organizations — including residents of homes and nurses with harrowing stories about conditions inside.

  • One resident purchased a bullhorn with a siren to get nurses’ and aides’ attention because he was often left sitting in his own stool, one commenter recounted.
  • Nurses at one facility declared a “med holiday,” according to a dietitian, and threw away all the drugs for a shift because they didn’t have time to pass them out.
  • A day shift nurse found a resident choking on vomit and having seizures after a night when there had been only one nurse and one aide on duty — for 100 residents.

Hundreds of comments like these cemented the resolve of officials at the Centers for Medicare and Medicaid Services last month to stick to plans to set minimum numbers of registered nurses and nurse aides for homes, despite the industry’s insistence it’s infeasible. CMS added a third mandate for minimum total staffing.

The agency also toughened requirements for the self-assessments each home must perform to determine whether they have enough skilled workers to properly care for their residents. The assessment can mean a home with residents who are especially ill or in need of extensive assistance should exceed minimum staffing mandates.

President Biden’s crackdown on nursing home staffing is among the most significant health-care regulatory moves he’s pursuing in what could be his last year in the White House. That it comes in an election year, when the president is counting on improving his support among older voters and their families, only raises the stakes — though nursing homes have until 2026 to come into compliance. Labor unions representing nurses and aides have strongly backed the plan.

Still, CMS rebuffed calls from resident advocates to require all nursing homes to meet the new requirements.

The industry as well as rank-and-file nurses raised concerns about finding enough staff to meet the new federal requirement. A licensed practical nurse from rural Minnesota wrote: “We currently offer sign on bonuses, referral bonuses, higher wages than we have ever had, and still no applications are received.”

CMS is allowing nursing homes exemptions from the staffing minimums if they are in areas with workforce shortages. CMS also will allow homes to request an exemption from one of the toughest mandates in the regulation: having a registered nurse on-site around-the-clock. If they’re in an area with a shortage of RNs, they can request to have one on-site for just 16 hours a day. (That’s still double the existing requirement.) CMS estimates that a quarter of the nation’s 15,000 nursing homes will end up obtaining exemptions from part or all of the staffing rules

The final regulation hasn’t entirely pleased anyone. Most advocates for patients still think the staffing minimums are too low and will allow some homes to continue to provide substandard care. And the nursing home industry says it can’t find or afford the extra staff — and its lobbyists are working Congress, and probably the White House should Biden lose, to overturn the rules.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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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Forget Ringing the Button for the Nurse. Patients Now Stay Connected by Wearing One.

Kaiser Health News:States - May 08, 2024

HOUSTON — Patients admitted to Houston Methodist Hospital get a monitoring device about the size of a half-dollar affixed to their chest — and an unwitting role in the expanding use of artificial intelligence in health care.

The slender, battery-powered gadget, called a BioButton, records vital signs including heart and breathing rates, then wirelessly sends the readings to nurses sitting in a 24-hour control room elsewhere in the hospital or in their homes. The device’s software uses AI to analyze the voluminous data and detect signs a patient’s condition is deteriorating.

Hospital officials say the BioButton has improved care and reduced the workload of bedside nurses since its rollout last year.

“Because we catch things earlier, patients are doing better, as we don’t have to wait for the bedside team to notice if something is going wrong,” said Sarah Pletcher, system vice president at Houston Methodist.

But some nurses fear the technology could wind up replacing them rather than supporting them — and harming patients. Houston Methodist, one of dozens of U.S. hospitals to employ the device, is the first to use the BioButton to monitor all patients except those in intensive care, Pletcher said.

“The hype around a lot of these devices is they provide care at scale for less labor costs,” said Michelle Mahon, a registered nurse and an assistant director of National Nurses United, the profession’s largest U.S. union. “This is a trend that we find disturbing,” she said.

The rollout of BioButton is among the latest examples of hospitals deploying technology to improve efficiency and address a decades-old nursing shortage. But that transition has raised its own concerns, including about the device’s use of AI; polls show the public is wary of health providers relying on it for patient care.

In December 2022 the FDA cleared the BioButton for use in adult patients who are not in critical care. It is one of many AI tools now used by hospitals for tasks like reading diagnostic imaging results.

In 2023, President Joe Biden directed the Department of Health and Human Services to develop a plan to regulate AI in hospitals, including by collecting reports of patients harmed by its use.

The leader of BioIntelliSense, which developed the BioButton, said its device is a huge advance compared with nurses walking into a room every few hours to measure vital signs. “With AI, you now move from ‘I wonder why this patient crashed’ to ‘I can see this crash coming before it happens and intervene appropriately,’” said James Mault, CEO of the Golden, Colorado-based company.

The BioButton stays on the skin with an adhesive, is waterproof, and has up to a 30-day battery life. The company says the device — which allows providers to quickly notice deteriorating health by recording more than 1,000 measurements a day per patient — has been used on more than 80,000 hospital patients nationwide in the past year.

Hospitals pay BioIntelliSense an annual subscription fee for the devices and software.

Houston Methodist officials would not reveal how much the hospital pays for the technology, though Pletcher said it equates to less than a cup of coffee a day per patient.

For a hospital system that treats thousands of patients at a time — Houston Methodist has 2,653 non-ICU beds at its eight Houston-area hospitals — such an investment could still translate to millions of dollars a year.

Hospital officials say they have not made any changes in nurse staffing and have no plans to because of implementing the BioButton.

Inside the hospital’s control center for virtual monitoring on a recent morning, about 15 nurses and technicians dressed in scrubs sat in front of large monitors showing the health status of hundreds of patients they were assigned to monitor.

A red checkmark next to a patient’s name signaled the AI software had found readings trending outside normal. Staff members could click into a patient’s medical record, showing patients’ vital signs over time and other medical history. These virtual nurses, if you will, could contact nurses on the floor by phone or email, or even dial directly into the patient’s room via video call.

Nutanben Gandhi, a technician who was watching 446 patients on her monitor that morning, said that when she gets an alert, she looks at the patient’s health record to see if the anomaly can be easily explained by something in the patient’s condition or if she needs to contact nurses on the patient’s floor.

Oftentimes an alert can be easily dismissed. But identifying signs of deteriorating health can be tough, said Steve Klahn, Houston Methodist’s clinical director of virtual medicine.

“We are looking for a needle in a haystack,” he said.

Donald Eustes, 65, was admitted to Houston Methodist in March for prostate cancer treatment and has since been treated for a stroke. He is happy to wear the BioButton.

“You never know what can happen here, and having an extra set of eyes looking at you is a good thing,” he said from his hospital bed. After being told the device uses AI, the Montgomery, Texas, man said he has no problem with its helping his clinical team. “This sounds like a good use of artificial intelligence.”

Patients and nurses alike benefit from remote monitoring like the BioButton, said Pletcher of Houston Methodist.

The hospital has placed small cameras and microphones inside all patient rooms enabling nurses outside to communicate with patients and perform tasks such as helping with patient admissions and discharge instructions. Patients can include family members on the remote calls with nurses or a doctor, she said.

Virtual technology frees up on-duty nurses to provide more hands-on help, such as starting an intravenous line, Pletcher said. With the BioButton, nurses can wait to take routine vital signs every eight hours instead of every four, she said.

Pletcher said the device reduces nurses’ stress in monitoring patients and allows some to work more flexible hours because virtual care can be done from home rather than coming to the hospital. Ultimately it helps retain nurses, not drive them away, she said.

Sheeba Roy, a nurse manager at Houston Methodist, said some members of the nursing staff were nervous about relying on the device and not checking patients’ vital signs as often themselves. But testing has shown the device provides accurate information.

“After we implemented it, the staff loves it,” Roy said.

Serena Bumpus, chief executive officer of the Texas Nurses Association, said her concern with any technology is that it can be more burdensome on nurses and take away time with patients.

“We have to be hypervigilant in ensuring that we are not leaning on this to replace the ability of nurses to critically think and assess patients and validate what this device is telling us is true,” Bumpus said.

Houston Methodist this year plans to send the BioButton home with patients so the hospital can better track their progress in the weeks after discharge, measuring the quality of their sleep and checking their gait.

“We are not going to need less nurses in health care, but we have limited resources and we have to use those as thoughtfully as we can,” Pletcher said. “Looking at projected demand and seeing the supply we have coming, we will not have enough to meet demand, so anything we can do to give time back to nurses is a good thing.”

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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Three People Shot at Super Bowl Parade Grapple With Bullets Left in Their Bodies

Kaiser Health News:States - May 08, 2024

James Lemons, 39, wants the bullet removed from his thigh so he can go back to work.

Sarai Holguin, a 71-year-old woman originally from Mexico, has accepted the bullet lodged near her knee as her “compa” — a close friend.

The Injured They Were Injured at the Super Bowl Parade. A Month Later, They Feel Forgotten.

In the first of our series “The Injured,” a Kansas family remembers Valentine’s Day as the beginning of panic attacks, life-altering trauma, and waking to nightmares of gunfire. Thrown into the spotlight by the shootings, they wonder how they will recover.

Read More

Mireya Nelson, 15, was hit by a bullet that went through her jaw and broke her shoulder, where fragments remain. She’ll live with them for now, while doctors monitor lead levels in her blood for at least two years.

Nearly three months after the Kansas City Chiefs Super Bowl parade shooting left at least 24 people injured, recovery from those wounds is intensely personal and includes a surprising gray area in medicine: whether the bullets should be removed.

Medical protocol offers no clear answer. A 2016 survey of surgeons found that only about 15% of respondents worked at medical facilities that had policies on bullet removal. Doctors in the U.S. often leave bullets buried deep in a person’s body, at least at first, so as not to cause further trauma.

But as gun violence has emerged as a public health epidemic, some researchers wonder if that practice is best. Some of the wounded, like James Lemons, are left in a precarious place.

“If there’s a way to get it out, and it’s safely taken out, get it out of the person,” Lemons said. “Make that person feel more secure about themselves. And you’re not walking around with that memory in you.”

Lemons, Holguin, and Nelson are coping in very different ways.

Pain Became a Problem

Three days after the Chiefs won the Super Bowl, Lemons drove the 37 miles from Harrisonville, Missouri, to downtown Kansas City to celebrate the victory. The warehouse worker was carrying his 5-year-old daughter, Kensley, on his shoulders when he felt a bullet enter the back of his right thigh.

Gunfire erupted in the area packed with revelers, prosecutors later said, after a “verbal confrontation” between two groups. Detectives found “multiple 9mm and .40 caliber spent shell casings” at the scene. Lemons said he understood immediately what was happening.

“I know my city. We’re not shooting off fireworks,” he said.

Lemons shielded Kensley’s face as they fell to the ground so she wouldn’t hit the concrete. His first thought was getting his family — also including his wife, Brandie; 17-year-old daughter, Kallie; and 10-year-old son, Jaxson — to safety.

“I’m hit. But don’t worry about it,” Lemons recalled telling Brandie. “We gotta go.”

He carried Kensley on his shoulders as the family walked a mile to their car. His leg bled through his pants at first then stopped, he said. It burned with pain. Brandie insisted on driving him to the hospital but traffic was at a standstill so she put on her hazard lights and drove on the wrong side of the road.

“She’s like: ‘I’m getting you to a hospital. I’m tired of people being in my way,’” Lemons recalled. “I’ve never seen my wife like that. I’m looking at her like, ‘That’s kinda sexy.’”

Lemons clapped and smiled at his wife, he said, to which she replied, “What are you smiling for? You just got shot.” He stayed in quiet admiration until they were stopped by a sheriff, who summoned an ambulance, Lemons said.

He was taken to the emergency room at University Health, which admitted 12 patients from the rally, including eight with gunshot wounds. Imaging showed the bullet barely missed an artery, Lemons said. Doctors cleansed the wound, put his leg in a brace, and told him to come back in a week. The bullet was still in his leg.

“I was a little baffled by it, but I was like, ‘OK, whatever, I’ll get out of here,’” Lemons recalled.

When he returned, doctors removed the brace but explained they often leave bullets and fragments in the body — unless they grow too painful.

“I get it, but I don’t like that,” Lemons said. “Why wouldn’t you take it out if you could?”

University Health spokesperson Leslie Carto said the hospital can’t comment on individual patient care because of federal privacy laws.

Surgeons typically do remove bullets when they encounter them during surgery or they are in dangerous locations, like in the spinal canal or risking damage to an organ, said Brendan Campbell, a pediatric surgeon at Connecticut Children’s.

Campbell also chairs the Injury Prevention and Control Committee of the American College of Surgeons’ Committee on Trauma, which works on firearm injury prevention.

LJ Punch, a trauma surgeon by training and the founder of the Bullet Related Injury Clinic in St. Louis, said the origins of trauma care also help explain why bullets are so often left.

“Trauma care is war medicine,” Punch said. “It is set to be ready at any moment and any time, every day, to save a life. It is not equipped to take care of the healing that needs to come after.”

In the survey of surgeons, the most common reasons given for removing a bullet were pain, a palpable bullet lodged near the skin, or an infection. Far less common were lead poisoning and mental health concerns such as post-traumatic stress disorder and anxiety.

What patients wanted also affected their decisions, the surgeons said.

Lemons wanted the bullet out. The pain it caused in his leg radiated up from his thigh, making it difficult to move for more than an hour or two. Working his warehouse job was impossible.

“I gotta lift 100 pounds every night,” Lemons recalled telling his doctors. “I gotta lift my child. I can’t work like this.”

He has lost his income and his health insurance. Another stroke of bad luck: The family’s landlord sold their rental home soon after the parade, and they had to find a new place to live. This house is smaller, but it was important to keep the kids in the same school district with their friends, Lemons said in an interview in Kensley’s pink bedroom, the quietest spot to talk.

They’ve borrowed money and raised $6,500 on GoFundMe to help with the deposit and car repairs, but the parade shooting has left the family in a deep financial hole.

Without insurance, Lemons worried he couldn’t afford to have the bullet removed. Then he learned his surgery would be paid for by donations. He set up an appointment at a hospital north of the city, where a surgeon took measurements on his X-ray and explained the procedure.

“I need you to be involved as much as I’m going to be involved,” he remembered being told, “because — guess what — this ain’t my leg.”

The surgery is scheduled for this month.

‘We Became Friends’

Sarai Holguin isn’t much of a Chiefs fan, but she agreed to go to the rally at Union Station to show her friend the best spot to see the players on stage. It was an unseasonably warm day, and they were standing near an entrance where lots of police were stationed. Parents had babies in strollers, kids were playing football, and she felt safe.

A little before 2 p.m., Holguin heard what she thought were fireworks. People started running away from the stage. She turned to leave, trying to find her friend, but felt dizzy. She didn’t know she’d been shot. Three people quickly came to her aid and helped her to the ground, and a stranger took off his shirt and made a tourniquet to put on her left leg.

Holguin, a native of Puebla, Mexico, who became a U.S. citizen in 2018, had never seen so much chaos, so many paramedics working under such pressure. They were “anonymous heroes,” she said.

She saw them working on Lisa Lopez-Galvan, a well-known DJ and 43-year-old mother of two. Lopez-Galvan died at the scene, and was the sole fatality at the parade. Holguin was rushed to University Health, about five minutes from Union Station.

There doctors performed surgery, leaving the bullet in her leg. Holguin awoke to more chaos. She had lost her purse, along with her cellphone, so she couldn’t call her husband, Cesar. She had been admitted to the hospital under an alias — a common practice at medical centers to begin immediate care.

Her husband and daughter didn’t find her until about 10 p.m. — roughly eight hours after she’d been shot.

“It has been a huge trauma for me,” Holguin said through an interpreter. “I was injured and at the hospital without doing anything wrong. [The rally] was a moment to play, to relax, to be together.”

Holguin was hospitalized for a week, and two more outpatient surgeries quickly followed, mostly to remove dead tissue around the wound. She wore a wound VAC, or vacuum-assisted closure device, for several weeks and had medical appointments every other day.

Campbell, the trauma surgeon, said wound VACs are common when bullets damage tissue that isn’t easily reconstructed in surgery.

“It’s not just the physical injuries,” Campbell said. “Many times it’s the emotional, psychological injuries, which many of these patients take away as well.”

The bullet remains near Holguin’s knee.

“I’m going to have it for the rest of my life,” she said, saying she and the bullet became “compas,” close friends.

“We became friends so that she doesn’t do any bad to me anymore,” Holguin said with a smile.

Punch, of the Bullet Related Injury Clinic in St. Louis, said some people like Holguin are able to find a way to psychically live with bullets that remain.

“If you’re able to make a story around what that means for that bullet to be in your body, that gives you power; that gives you agency and choice,” Punch said.

Holguin’s life changed in an instant: She’s using a walker to get around. Her foot, she said, acts “like it had a stroke” — it dangles, and it’s difficult to move her toes.

The most frustrating consequence is that she cannot travel to see her 102-year-old father, still in Mexico. She has a live camera feed on her phone to see him, but that doesn’t offer much comfort, she said, and thinking about him brings tears.

She was told at the hospital that her medical bills would be taken care of, but then lots of them came in the mail. She tried to get victim assistance from the state of Missouri, but all the forms she had were in English, which made them difficult to comprehend. Renting the wound VAC alone cost $800 a month.

Finally she heard that the Mexican Consulate in Kansas City could help, and the consul pointed her to the Jackson County Prosecutor’s Office, with which she registered as an official victim. Now all of her bills are being paid, she said.

Holguin isn’t going to seek mental health treatment, as she believes one must learn to live with a given situation or it will become a burden.

“I have processed this new chapter in my life,” Holguin said. “I have never given up and I will move on with God’s help.”

‘I Saw Blood on My Hands’

Mireya Nelson was late to the parade. Her mother, Erika, told her she should leave early, given traffic and the million people expected to crowd into downtown Kansas City, but she and her teenage friends ignored that advice. The Nelsons live in Belton, Missouri, about a half hour south of the city.

Mireya wanted to hold the Super Bowl trophy. When she and her three friends arrived, the parade that had moved through downtown was over and the rally at Union Station had begun. They were stuck in the large crowd and quickly grew bored, Mireya said.

Getting ready to leave, Mireya and one of her friends were trying to call the driver of their group, but they couldn’t get cell service in the large crowd.

Amid the chaos of people and noise, Mireya suddenly fell.

“I saw blood on my hands. So then I knew I got shot. Yeah, and I just crawled to a tree,” Mireya said. “I actually didn’t know where I got shot at, at first. I just saw blood on my hands.”

The bullet grazed Mireya’s chin, shot through her jaw, broke her shoulder, and left through her arm. Bullet fragments remain in her shoulder. Doctors decided to leave them because Mireya had already suffered so much damage.

Mireya’s mother supports that decision, for now, noting they were just “fragments.”

“I think if it’s not going to harm her the rest of her life,” Erika said, “I don’t want her to keep going back in the hospital and getting surgery. That’s more trauma to her and more recovery time, more physical therapy and stuff like that.”

Bullet fragments, particularly ones only skin-deep, often push their way out like splinters, according to Punch, although patients aren’t always told about that. Moreover, Punch said, injuries caused by bullets extend beyond those with damaged tissue to the people around them, like Erika. He called for a holistic approach to recover from all the trauma.

“When people stay in their trauma, that trauma can change them for a lifetime,” Punch said.

Mireya will be tested for lead levels in her blood for at least the next two years. Her levels are fine now, doctors told the family, but if they get worse she will need surgery to remove the fragments, her mother said.

Campbell, the pediatric surgeon, said lead is particularly concerning for young children, whose developing brains make them especially vulnerable to its harmful effects. Even a tiny amount of lead — 3.5 micrograms per deciliter — is enough to report to state health officials, according to the Centers for Disease Control and Prevention.

Mireya talks about cute teenage boys’ being “fine” but also still wears Cookie Monster pajamas. She appears confused by the shootings, by all the attention at home, at school, from reporters. Asked how she feels about the fragments in her arm, she said, “I don’t really care for them.”

Mireya was on antibiotics for 10 days after her hospital stay because doctors feared there was bacteria in the wound. She has had physical therapy, but it’s painful to do the exercises. She has a scar on her chin. “A dent,” she said, that’s “bumpy.”

“They said she was lucky because if she wouldn’t have turned her head in a certain way, she could be gone,” Erika said.

Mireya faces a psychiatric evaluation and therapy appointments, though she doesn’t like to talk about her feelings.

So far, Erika’s insurance is paying the medical bills, though she hopes to get some help from the United Way’s #KCStrong fund, which raised nearly $1.9 million, or a faith-based organization called Unite KC.

Erika doesn’t want a handout. She has a job in health care and just got a promotion.

The bullet has changed the family’s life in big ways. It is part of their conversation now. They talk about how they wish they knew what kind of ammunition it was, or what it looked like.

“Like, I wanted to keep the bullet that went through my arm,” Mireya said. “I want to know what kind of bullet it was.” That brought a sigh from her mom, who said her daughter had watched too many episodes of “Forensic Files.”

Erika beats herself up about the wound, because she couldn’t protect her daughter at the parade.

“It hits me hard because I feel bad because she begged me to get off work and I didn’t go there because when you have a new position, you can’t just take off work,” Erika said. “Because I would have took the bullet. Because I would do anything. It’s mom mode.”

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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Final Rule to Establish First-Ever Regulations for Adult Protective Services

HHS Gov News - May 07, 2024
Federal regulations to adult protective services

An NIH Genetics Study Targets a Long-Standing Challenge: Diversity

In his 2015 State of the Union address, President Barack Obama announced a precision medicine initiative that would later be known as the All of Us program. The research, now well underway at the National Institutes of Health, aims to analyze the DNA of at least 1 million people across the United States to build a diverse health database.

The key word there is “diverse.” So far, the program has collected more than 560,000 DNA samples, and nearly half of participants identify as being part of a racial or ethnic minority group.

NIH researchers strategically partnered with community health centers, faith-based groups, and Black fraternities and sororities to recruit people who have been historically underrepresented in biomedical research.

“We are actually looking to overrepresent” these previously marginalized groups, explained Martin Mendoza, director of health equity for All of Us, which will continue to enroll participants through at least 2026, when researchers intend to evaluate the next phases of the project.

Their success to date is remarkable for a few reasons. Participation in biomedical research is typically low in diversity. And when it comes to genetics research specifically, diversity has been nearly nonexistent.

Since the completion more than 20 years ago of the Human Genome Project, which mapped most human genes for the first time, nearly 90 percent of genomics studies have been conducted using DNA from participants of European descent, research shows.

Humans of all races and ethnicities are 99 percent genetically identical. But even small differences in our DNA can have a profound impact on our health.

Here’s an example: A few years ago, researchers found that some Black patients had been misdiagnosed with a potentially fatal heart condition called hypertrophic cardiomyopathy because they’d tested positive for genetic variants that were thought to be harmful. But it turns out the variants, more common among Black Americans than among White Americans, are likely harmless. The diagnosis, though, is life-altering — patients with hypertrophic cardiomyopathy have traditionally been discouraged from competing in sports, for example.

Such misdiagnoses can be avoided if “even modest numbers of people from diverse populations are included in sequence databases,” NIH wrote.

Easier said than done. A genetics research project underway in South Carolina called In Our DNA SC is struggling to recruit enough Black participants. The scientists behind the project said two years ago they aimed to collect samples reflecting the diversity of the state, where 27 percent of residents identify as Black or African American.

“We’d like to be a lot more diverse,” said Daniel Judge, principal investigator for the study and a cardiovascular genetics specialist at the Medical University of South Carolina.

To date, only about 12 percent of participants who provided socio-demographic data identify as Black. An additional 5 percent identify as belonging to another racial minority.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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What’s Keeping the US From Allowing Better Sunscreens?

Kaiser Health News:States - May 07, 2024

When dermatologist Adewole “Ade” Adamson sees people spritzing sunscreen as if it’s cologne at the pool where he lives in Austin, Texas, he wants to intervene. “My wife says I shouldn’t,” he said, “even though most people rarely use enough sunscreen.”

At issue is not just whether people are using enough sunscreen, but what ingredients are in it.

The Food and Drug Administration’s ability to approve the chemical filters in sunscreens that are sold in countries such as Japan, South Korea, and France is hamstrung by a 1938 U.S. law that requires sunscreens to be tested on animals and classified as drugs, rather than as cosmetics as they are in much of the world. So Americans are not likely to get those better sunscreens — which block the ultraviolet rays that can cause skin cancer and lead to wrinkles — in time for this summer, or even the next.

Sunscreen makers say that requirement is unfair because companies including BASF Corp. and L’Oréal, which make the newer sunscreen chemicals, submitted safety data on sunscreen chemicals to the European Union authorities some 20 years ago.

Steven Goldberg, a retired vice president of BASF, said companies are wary of the FDA process because of the cost and their fear that additional animal testing could ignite a consumer backlash in the European Union, which bans animal testing of cosmetics, including sunscreen. The companies are asking Congress to change the testing requirements before they take steps to enter the U.S. marketplace.

In a rare example of bipartisanship last summer, Sen. Mike Lee (R-Utah) thanked Rep. Alexandria Ocasio-Cortez (D-N.Y.) for urging the FDA to speed up approvals of new, more effective sunscreen ingredients. Now a bipartisan bill is pending in the House that would require the FDA to allow non-animal testing.

“It goes back to sunscreens being classified as over-the-counter drugs,” said Carl D’Ruiz, a senior manager at DSM-Firmenich, a Switzerland-based maker of sunscreen chemicals. “It’s really about giving the U.S. consumer something that the rest of the world has. People aren’t dying from using sunscreen. They’re dying from melanoma.”

Every hour, at least two people die of skin cancer in the United States. Skin cancer is the most common cancer in America, and 6.1 million adults are treated each year for basal cell and squamous cell carcinomas, according to the Centers for Disease Control and Prevention. The nation’s second-most-common cancer, breast cancer, is diagnosed about 300,000 times annually, though it is far more deadly.

Dermatologists Offer Tips on Keeping Skin Safe and Healthy

– Stay in the shade during peak sunlight hours, 10 a.m. to 4 p.m. daylight time.– Wear hats and sunglasses.– Use UV-blocking sun umbrellas and clothing.– Reapply sunscreen every two hours.You can order overseas versions of sunscreens from online pharmacies such as Cocooncenter in France. Keep in mind that the same brands may have different ingredients if sold in U.S. stores. But importing your sunscreen may not be affordable or practical. “The best sunscreen is the one that you will use over and over again,” said Jane Yoo, a New York City dermatologist.

Though skin cancer treatment success rates are excellent, 1 in 5 Americans will develop skin cancer by age 70. The disease costs the health care system $8.9 billion a year, according to CDC researchers. One study found that the annual cost of treating skin cancer in the United States more than doubled from 2002 to 2011, while the average annual cost for all other cancers increased by just 25%. And unlike many other cancers, most forms of skin cancer can largely be prevented — by using sunscreens and taking other precautions.

But a heavy dose of misinformation has permeated the sunscreen debate, and some people question the safety of sunscreens sold in the United States, which they deride as “chemical” sunscreens. These sunscreen opponents prefer “physical” or “mineral” sunscreens, such as zinc oxide, even though all sunscreen ingredients are chemicals.

“It’s an artificial categorization,” said E. Dennis Bashaw, a retired FDA official who ran the agency’s clinical pharmacology division that studies sunscreens.

Still, such concerns were partly fed by the FDA itself after it published a study that said some sunscreen ingredients had been found in trace amounts in human bloodstreams. When the FDA said in 2019, and then again two years later, that older sunscreen ingredients needed to be studied more to see if they were safe, sunscreen opponents saw an opening, said Nadim Shaath, president of Alpha Research & Development, which imports chemicals used in cosmetics.

“That’s why we have extreme groups and people who aren’t well informed thinking that something penetrating the skin is the end of the world,” Shaath said. “Anything you put on your skin or eat is absorbed.”

Adamson, the Austin dermatologist, said some sunscreen ingredients have been used for 30 years without any population-level evidence that they have harmed anyone. “The issue for me isn’t the safety of the sunscreens we have,” he said. “It’s that some of the chemical sunscreens aren’t as broad spectrum as they could be, meaning they do not block UVA as well. This could be alleviated by the FDA allowing new ingredients.”

Ultraviolet radiation falls between X-rays and visible light on the electromagnetic spectrum. Most of the UV rays that people come in contact with are UVA rays that can penetrate the middle layer of the skin and that cause up to 90% of skin aging, along with a smaller amount of UVB rays that are responsible for sunburns.

The sun protection factor, or SPF, rating on American sunscreen bottles denotes only a sunscreen’s ability to block UVB rays. Although American sunscreens labeled “broad spectrum” should, in theory, block UVA light, some studies have shown they fail to meet the European Union’s higher UVA-blocking standards.

“It looks like a number of these newer chemicals have a better safety profile in addition to better UVA protection,” said David Andrews, deputy director of Environmental Working Group, a nonprofit that researches the ingredients in consumer products. “We have asked the FDA to consider allowing market access.”

The FDA defends its review process and its call for tests of the sunscreens sold in American stores as a way to ensure the safety of products that many people use daily, rather than just a few times a year at the beach.

“Many Americans today rely on sunscreens as a key part of their skin cancer prevention strategy, which makes satisfactory evidence of both safety and effectiveness of these products critical for public health,” Cherie Duvall-Jones, an FDA spokesperson, wrote in an email.

D’Ruiz’s company, DSM-Firmenich, is the only one currently seeking to have a new over-the-counter sunscreen ingredient approved in the United States. The company has spent the past 20 years trying to gain approval for bemotrizinol, a process D’Ruiz said has cost $18 million and has advanced fitfully, despite attempts by Congress in 2014 and 2020 to speed along applications for new UV filters.

Bemotrizinol is the bedrock ingredient in nearly all European and Asian sunscreens, including those by the South Korean brand Beauty of Joseon and Bioré, a Japanese brand.

D’Ruiz said bemotrizinol could secure FDA approval by the end of 2025. If it does, he said, bemotrizinol would be the most vetted and safest sunscreen ingredient on the market, outperforming even the safety profiles of zinc oxide and titanium dioxide.

As Congress and the FDA debate, many Americans have taken to importing their own sunscreens from Asia or Europe, despite the risk of fake products.

“The sunscreen issue has gotten people to see that you can be unsafe if you’re too slow,” said Alex Tabarrok, a professor of economics at George Mason University. “The FDA is just incredibly slow. They’ve been looking at this now literally for 40 years. Congress has ordered them to do it, and they still haven’t done it.”

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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Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge

When doctors began using the drug sotorasib in 2021 with high expectations for its innovative approach to attacking lung cancer, retired medical technician Don Crosslin was an early beneficiary. Crosslin started the drug that July. His tumors shrank, then stabilized.

But while the drug has helped keep him alive, its side effects have gradually narrowed the confines of his life, said Crosslin, 76, who lives in Ocala, Florida: “My appetite has been minimal. I’m very weak. I walk my dogs and get around a bit, but I haven’t been able to golf since last July.”

He wonders whether he’d do better on a lower dose, “but I do what my oncologist tells me to do,” Crosslin said. Every day, he takes eight of the 120-milligram pills, sold under Amgen’s brand name Lumakras.

Crosslin’s concern lies at the heart of an FDA effort to make cancer drugs less toxic and more effective. Cancer drug trials are structured to promote high doses, which then become routine patient care. In the face of evidence that thousands of patients become so ill that they skip doses or stop taking the drugs — thereby risking resurgence of their cancers — the FDA has begun requiring companies to pinpoint the right dosage before they reach patients.

The initiative, Project Optimus, launched in 2021 just as Amgen was seeking to market sotorasib. At the time, the FDA’s leading cancer drug regulator, Richard Pazdur, co-authored an editorial in the New England Journal of Medicine that said Amgen’s trials of the $20,000-a-month drug were “hampered by a lack of robust dose exploration.”

The FDA conditionally approved sotorasib but required Amgen to conduct a study comparing the labeled dosage of 960 mg with a dosage of 240 mg. The trial, published in November, showed that the 960-mg dose may have given patients a month more of life, on average, but caused more severe side effects than the lower dose.

Amgen is keeping the 960-mg dosage as it conducts further tests to get final approval for the drug, spokesperson Elissa Snook said, adding that the dose showed superiority in one study. Whether medically justified or not, the heavier dosage allows the company to protect 75% of its revenue from the drug, which brought in nearly $200 million in the United States last year.

And there appears to be nothing the FDA can do about it.

“There’s a gap in FDA’s authority that results in patients getting excess doses of a drug at excess costs,” said Mark Ratain, a University of Chicago oncologist who has pushed for more accurate cancer drug dosing. “We should do something about this.”

Deciding on Dosage

It may be too late for the FDA to change the sotorasib dosage, although in principle it could demand a new regimen before granting final approval, perhaps in 2028. Under Project Optimus, however, the agency is doing something about dosage guidelines for future drugs. It is stressing dose optimization in its meetings with companies, particularly as they prepare to test drugs on patients for the first time, spokesperson Lauren-Jei McCarthy said.

“When you go in front of FDA with a plan to approve your drug now, they are going to address dosing studies,” said Julie Gralow, chief medical officer of the American Society of Clinical Oncology. “A lot of companies are struggling with this.”

That’s largely because the new requirements add six months to a year and millions in drug development costs, said Julie Bullock, a former FDA drug reviewer who advocated for more extensive dosing studies and is now senior vice president at Certara, a drug development consultancy.

In part, Project Optimus represents an effort to manage the faults of the FDA’s accelerated approval process, begun in 1992. While the process gets innovative drugs to patients more quickly, some medicines have proved lackluster or had unacceptable side effects.

That’s especially true of the newer pills to treat cancer, said Donald Harvey, an Emory University pharmacology professor, who has led or contributed to more than 100 early-phase cancer trials.

A study released last month in the Journal of the American Medical Association showed that 41% of the cancer drugs granted accelerated approval from 2013 to 2017 did not improve overall survival or quality of life after five years.

Many of these drugs flop because they must be given at toxic dosages to have any effect, Harvey said, adding that sotorasib might work better if the company had found an appropriate dosage earlier on.

“Sotorasib is a poster child for incredibly bad development,” Harvey said. The drug was the first to target the KRAS G12C mutation, which drives about 15% of lung cancers and was considered “undruggable” until University of California-San Francisco chemist Kevan Shokat figured out how to attack it in 2012.

Given the specificity of sotorasib’s target, Harvey said, Amgen could have found a lower dosage. “Instead, they followed the old model and said, ‘We’re going to push the dose up until we see a major side effect.’ They didn’t need to do that. They just needed more experience with a lower dose.”

The 960-mg dose “is really tough on patients,” said Yale University oncologist and assistant professor Michael Grant. “They get a lot of nausea and other GI side effects that are not pleasant. It hurts their quality of life.”

The FDA noted in its review of sotorasib that in phase 1 studies tumors shrank when exposed to as little as a fifth of the 960-mg daily dose Amgen selected. At all doses tested in that early trial, the drug reached roughly the same concentrations in the blood, which suggested that at higher doses the drug was mostly just intensifying side effects like diarrhea, vomiting, and mouth sores.

For most classes of drugs, companies spend considerable time in phases 1 and 2 of development, homing in on the right dosage. “No one would think of dosing a statin or antibiotic at the highest tolerable dose,” Ratain said.

Things are different in cancer drug creation, whose approach originated with chemotherapy, which damages as many cancer cells as possible, wrecking plenty of healthy tissue in the bargain. Typically, a company’s first series of cancer drug trials involve escalating doses in small groups of patients until something like a quarter of them get seriously ill. That “maximum tolerated dose” is then employed in more advanced clinical trials, and goes on the drug’s label. Once a drug is approved, a doctor can “go off-label” and alter the dosage, but most are leery of doing so.

Patients can find the experience rougher than advertised. During clinical trials, the side effects of the cancer drug osimertinib (Tagrisso) were listed as tolerable and manageable, said Jill Feldman, a lung cancer patient and advocate. “That killed me. After two months on that drug, I had lost 15 pounds, had sores in my mouth and down my throat, stomach stuff. It was horrible.”

Some practitioners, at least, have responded to the FDA’s cues on sotorasib. In the Kaiser Permanente health system, lung cancer specialists start with a lower dose of the drug, spokesperson Stephen Shivinsky said.

Smaller Doses — And Revenue

Amgen was clearly aware of the advantages of the 240-mg dosage before it sought FDA approval: It filed a provisional patent application on that dosage before the agency gave breakthrough approval for the drug at 960 mg. The company doesn’t appear to have disclosed the patent filing to investors or the FDA. McCarthy said the FDA was prohibited by law from discussing the particulars of its sotorasib regulation plans.

Switching to a 240-mg dosage could register a huge hit to Amgen’s revenue. The company markets the drug at more than $20,000 for a month of 960-mg daily doses. Each patient who could get by with a quarter of that would trim the company’s revenue by roughly $180,000 a year.

Amgen declined to comment on the patent issue or to make an official available to discuss the dosage and pricing issues.

Crosslin, who depends on Social Security for his income, couldn’t afford the $3,000 a month that Medicare required him to pay for sotorasib, but he has received assistance from Amgen and a charity that covers costs for patients below a certain income.

While the drug has worked well for Crosslin and other patients, its overall modest impact on lung cancer suggests that $5,000, rather than $20,000, might be a more appropriate price, Ratain said.

In the company’s phase 3 clinical trial for advanced lung cancer patients, sotorasib kept patients alive for about a month longer than docetaxel, the current, highly toxic standard of care. Docetaxel is a generic drug for which Medicare pays about $1 per injection. The trial was so unconvincing that the FDA sent Amgen back to do another.

Ratain, a staunch critic of Amgen’s handling of sotorasib, told Centers for Medicare & Medicaid Services officials at a recent meeting that they should pay for sotorasib on a basis of 240 mg per day. But CMS would do that only “if there is a change in the drug’s FDA-approved dosage,” spokesperson Aaron Smith said.

Drug companies generally don’t want to spend money on trials like the one the FDA ordered on sotorasib. In 2018, Ratain and other researchers used their institutions’ funding to conduct a dosing trial on the prostate cancer drug abiraterone, marketed under the brand name Zytiga by Johnson & Johnson. They found that taking one 250-mg pill with food was just as effective as taking four on an empty stomach, as the label called for.

Although J&J hasn’t changed the Zytiga label, the evidence generated in that trial was strong enough for the standards-setting National Comprehensive Cancer Network to change its recommendations.

Post-marketing studies like that one are hard to conduct, Emory’s Harvey said. Patients are reluctant to join a trial in which they may have to take a lower dosage, since most people tend to believe “the more the better,” he said.

“It’s better for everyone to find the right dose before a drug is out on the market,” Harvey said. “Better for the patient, and better for the company, which can sell more of a good drug if the patients aren’t getting sick and no longer taking it.”

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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Biden Team’s Tightrope: Reining In Rogue Obamacare Agents Without Slowing Enrollment

President Joe Biden counts among his accomplishments the record-high number of people, more than 21 million, who enrolled in Obamacare plans this year. Behind the scenes, however, federal regulators are contending with a problem that affects people’s coverage: rogue brokers who have signed people up for Affordable Care Act plans, or switched them into new ones, without their permission.

Fighting the problem presents tension for the administration: how to thwart the bad actors without affecting ACA sign-ups.

Complaints about these unauthorized changes — which can cause affected policyholders to lose access to medical care, pay higher deductibles, or even incur surprise tax bills — rose sharply in recent months, according to brokers who contacted KFF Health News and federal workers who asked not to be identified.

Ronnell Nolan, president and CEO of the trade association Health Agents for America, said her group has suggested to the Centers for Medicare & Medicaid Services that it add two-factor authentication to healthcare.gov or send text alerts to consumers if an agent tries to access their accounts. But the agency told her it doesn’t always have up-to-date contact information.

“We’ve given them a whole host of ideas,” she said. “They say, ‘Be careful what you wish for.’ But we don’t mind going an extra step if you can stop this fraud and abuse, because clients are being hurt.”

Some consumers are pursued when they respond to misleading social media marketing ads promising government subsidies, but most have no idea how they fell victim to plan-switching. Problems seem concentrated in the 32 states using the federal exchange.

Federal regulators have declined to say how many complaints about unauthorized sign-ups or plan switches they’ve received, or how many insurance agents they’ve sanctioned as a result. But the problem is big enough that CMS says it’s working on technological and regulatory solutions. Affected consumers and agents have filed a civil lawsuit in federal district court in Florida against private-sector firms allegedly involved in unauthorized switching schemes.

Biden has pushed hard to make permanent the enhanced subsidies first put in place during the covid pandemic that, along with other steps including increased federal funding for outreach, helped fuel the strong enrollment growth. Biden contrasts his support for the ACA with the stance of former President Donald Trump, who supported attempts to repeal most of the law and presided over funding cuts and declining enrollment.

Most proposed solutions to the rogue-agent problem involve making it more difficult for agents to access policyholder information or requiring wider use of identity questions tied to enrollees’ credit history. The latter could be stumbling blocks for low-income people or those with limited financial records, said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University.

“That is the knife edge the administration has to walk,” said Corlette, “protecting consumers from fraudulent behavior while at the same time making sure there aren’t too many barriers.”

Jeff Wu, acting director of the Center for Consumer Information & Insurance Oversight, said in a statement that the agency is evaluating options on such factors as how effective they would be, their impact on consumers’ ability to enroll, and how fast they could be implemented.

The agency is also working closely, he wrote, with insurance companies, state insurance departments, and law enforcement “so that agents violating CMS rules or committing fraud face consequences.” And it is reaching out to states that run their own ACA markets for ideas.

That’s because Washington, D.C., and the 18 states that run their own ACA marketplaces have reported far fewer complaints about unauthorized enrollment and plan-switching. Most include layers of security in addition to those the federal marketplace has in place — some use two-factor authentication — before agents can access policyholder information.

California, for example, allows consumers to designate an agent and to “log in and add or remove an agent at will,” said Robert Kingston, interim director of outreach and sales for Covered California, the state’s ACA marketplace. The state can also send consumers a one-time passcode to share with an agent of their choice. Consumers in Colorado and Pennsylvania can similarly designate specific agents to access their accounts.

By contrast, agents can more easily access policyholder information when using private-sector websites that link them to the federal ACA market — all they need is a person’s name, date of birth, and state of residence — to enroll them or switch their coverage.

CMS has approved dozens of such “enhanced direct enrollment” websites run by private companies, which are designed to make it easier and faster for agents certified to offer insurance through healthcare.gov.

Rules went into effect last June requiring agents to get written or recorded consent from clients before enrolling them or changing their coverage, but brokers say they’re rarely asked to produce the documentation. If CMS makes changes to healthcare.gov — such as adding passcodes, as California has — it would need to require all alternative-enrollment partners to do the same.

The largest is San Francisco-based HealthSherpa, which assisted 52% of active enrollments nationally for this year, said CEO George Kalogeropoulos.

The company has a 10-person fraud investigation team, he said, which has seen “a significant spike in concerns about unauthorized switching.” They report problems to state insurance departments, insurance carriers, and federal regulators “and refer consumers to advocates on our team to make sure their plans are corrected.”

Solutions must be “targeted,” he said. “The issue with some of the solutions proposed is it negatively impacts the ability of all consumers to get enrolled.”

Most people who sign up for ACA plans are aided by agents or platforms like HealthSherpa, rather than doing it themselves or seeking help from nonprofit organizations. Brokers don’t charge consumers; instead, they receive commissions from insurers participating in state and federal marketplaces for each person they enroll in a plan.

While California officials say their additional layers of authentication have not noticeably affected enrollment numbers, the state’s recent enrollment growth has been slower than in states served by healthcare.gov.

Still, Covered California’s Kingston pointed to a decreased number of uninsured people in the state. In 2014, when much of the ACA was implemented, 12.5% of Californians were uninsured, falling to 6.5% in 2022, according to data compiled by KFF. That year, the share of people uninsured nationwide was 8%.

Corlette said insurers have a role to play, as do states and CMS.

“Are there algorithms that can say, ‘This is a broker with outlier behavior’?” Insurance companies could then withhold commissions “until they can figure it out,” she said.

Kelley Schultz, vice president of commercial policy at AHIP, the trade association for large insurance companies, said sharing more information from the government marketplace about which policies are being switched could help insurers spot patterns.

CMS could also set limits on plan switches, as there is generally no legitimate need for multiple changes in a given month, Schultz said.

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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Treasury Releases Social Security and Medicare Trustees Reports

HHS Gov News - May 06, 2024
Released the annual Social Security and Medicare Trustees Reports

La gripe aviar es mala para las aves de corral y las vacas lecheras. No es una amenaza grave para la mayoría de nosotros… por ahora

Los titulares explotaron después que el Departamento de Agricultura confirmara que el virus de la gripe aviar H5N1 ha infectado a vacas lecheras en todo el país.

Las pruebas han detectado el virus en el ganado en nueve estados, principalmente en Texas y Nuevo México, y más recientemente en Colorado, dijo Nirav Shah, director principal adjunto de los Centros para el Control y Prevención de Enfermedades (CDC), en un evento del 1 de mayo.

Otros animales, y al menos una persona en Texas, también se infectaron con el H5N1. Pero lo que más temen los científicos es si el virus se propagara de manera eficiente de persona a persona. Eso no ha sucedido y podría no suceder. Shah dijo que los CDC consideran que el brote de H5N1 “es un riesgo bajo para el público en general en este momento”.

Los virus evolucionan y los brotes pueden cambiar rápidamente. “Como con cualquier brote importante, esto se mueve a la velocidad de un tren bala”, dijo Shah. “De lo que hablamos ahora es de un instantánea de ese tren que se mueve rápidamente”. Lo que quiere decir es que lo que hoy se sabe sobre la gripe aviar H5N1 seguramente cambiará.

Con eso en mente, KFF Health News explica lo que se necesita saber ahora.

¿Quién contrae el virus que causa la gripe aviar?

Principalmente las aves. Sin embargo, en los últimos años, el virus de la gripe aviar H5N1 ha estado saltando cada vez más de las aves a los mamíferos en todo el mundo. La creciente lista, de más de 50 especies, incluye focas, cabras, zorrinos, gatos y perros salvajes en un zoológico en el Reino Unido. Al menos 24,000 leones marinos murieron en brotes de gripe aviar H5N1 en Sudamérica el año pasado.

Lo que hace que el brote actual en el ganado sea inusual es que se está propagando rápidamente de vaca a vaca, mientras que los otros casos, excepto las infecciones de leones marinos, parecen limitados. Los investigadores saben esto porque las secuencias genéticas de los virus H5N1 extraídos de las vacas este año eran casi idénticas entre sí.

El brote de ganado también preocupa porque agarró al país desprevenido. Los investigadores que examinan los genomas del virus sugieren que originalmente se transmitió de las aves a las vacas a finales del año pasado en Texas, y desde entonces se ha propagado entre muchas más vacas de las que se han examinado.

“Nuestros análisis muestran que esto ha estado circulando en vacas durante unos cuatro meses, bajo nuestras narices”, dijo Michael Worobey, biólogo especializado en evolución de la Universidad de Arizona en Tucson.

¿Es este el comienzo de la próxima pandemia?

Aún no. Pero es algo que vale la pena considerar porque una pandemia de gripe aviar sería una pesadilla. Más de la mitad de las personas infectadas por cepas anteriores del virus de la gripe aviar H5N1 de 2003 a 2016 murieron.

Incluso si las tasas de mortalidad resultan ser menos severas para la cepa H5N1 que circula actualmente en el ganado, las repercusiones podrían implicar muchas personas enfermas y hospitales demasiado abrumados para manejar otras emergencias médicas.

Aunque al menos una persona se infectó con el H5N1 este año, el virus no puede provocar una pandemia en su estado actual.

Para alcanzar este horrible estatus, un patógeno necesita enfermar a muchas personas en varios continentes. Y para lograrlo, el virus H5N1 necesitaría infectar a toneladas de personas. Eso no sucederá a través de saltos ocasionales del virus de los animales de granja a las personas. Más bien, el virus debe adquirir mutaciones para propagarse de persona a persona, como la gripe estacional, como una infección respiratoria transmitida principalmente por el aire cuando las personas tosen, estornudan y respiran.

Como aprendimos de covid-19, los virus transmitidos por el aire son difíciles de frenar.

Eso aún no ha sucedido. Sin embargo, los virus H5N1 ahora tienen muchas oportunidades para evolucionar a medida que se replican dentro de los organismos de miles de vacas. Como todos los virus, mutan a medida que se replican, y las mutaciones que mejoran la supervivencia del virus se transmiten a la próxima generación. Y debido a que las vacas son mamíferos, los virus podrían estar mejorando en reproducirse dentro de células más cercanas a las nuestras que las de las aves.

La evolución de un virus de gripe aviar listo para una pandemia podría facilitarse por una especie de superpoder que poseen muchos virus. Es decir, a veces intercambian sus genes con otras cepas en un proceso llamado recombinación.

En un estudio publicado en 2009, Worobey y otros investigadores rastrearon el origen de la pandemia del virus de la gripe porcina H1N1 en eventos en los que diferentes virus que causaban esta gripe, la gripe aviar y la gripe humana mezclaban y combinaban sus genes dentro de cerdos que se estaban infectando simultáneamente. Los cerdos no necesitan estar involucrados esta vez, advirtió Worobey.

¿Comenzará una pandemia si una persona bebe leche contaminada con el virus?

Aún no. La leche de vaca, así como la leche en polvo y la fórmula infantil, que se venden en tiendas se consideran seguras porque la ley requiere que toda la leche vendida comercialmente sea pasteurizada. Este proceso de calentar la leche a altas temperaturas mata bacterias, virus y otros microorganismos.

Las pruebas han identificado fragmentos de virus H5N1 en la leche comercial, pero confirman que los fragmentos del virus están muertos y, por lo tanto, son inofensivos.

Sin embargo, la leche “cruda” no pasteurizada ha demostrado contener virus H5N1 vivos, por eso la Administración de Drogas y Alimentos (FDA) y otras autoridades sanitarias recomiendan firmemente a las personas que no la tomen, porque podrían enfermarse de gravedad o algo peor.

Pero, aún así, es poco probable que se desate una pandemia porque el virus, en su forma actual, no se propaga eficientemente de persona a persona, como lo hace, por ejemplo, la gripe estacional.

¿Qué se debe hacer?

¡Mucho! Debido a la falta de vigilancia, el Departamento de Agricultura (USDA) y otras agencias han permitido que la gripe aviar H5N1 se propague en el ganado, sin ser detectada. Para hacerse cargo de la situación, el USDA recientemente ordenó que se sometan a pruebas a todas las vacas lecheras en lactancia antes que los ganaderos las trasladen a otros estados, y que se informen los resultados de las pruebas.

Pero al igual que restringir las pruebas de covid a los viajeros internacionales a principios de 2020 permitió que el coronavirus se propagara sin ser detectado, testear solo a las vacas que se mueven entre estados dejaría pasar muchos casos.

Estas pruebas limitadas no revelarán cómo se está propagando el virus entre el ganado, información que los ganaderos necesitan desesperadamente para frenarlo. Una hipótesis principal es que los virus se están transfiriendo de una vaca a la siguiente a través de las máquinas utilizadas para ordeñarlas.

Para aumentar las pruebas, Fred Gingrich, director ejecutivo de la American Association of Bovine Practitioners, dijo que el gobierno debería ofrecer fondos a los ganaderos para que informen casos y así tengan un incentivo para hacer pruebas. De lo contrario, dijo, informar solo daña la reputación por encima de las pérdidas financieras.

“Estos brotes tienen un impacto económico significativo”, dijo Gingrich. “Los ganaderos pierden aproximadamente el 20% de su producción de leche en un brote porque los animales dejan de comer, producen menos leche, y parte de esa leche es anormal y no se puede vender”.

Gingrich agregó que el gobierno ha hecho gratuitas las pruebas de H5N1 para los ganaderos, pero no han presupuestado dinero para los veterinarios que deben tomar muestras de las vacas, transportar las muestras y presentar los documentos. “Las pruebas son la parte menos costosa”, explicó.

Si las pruebas en las granjas siguen siendo esquivas, los virólogos aún pueden aprender mucho analizando secuencias genómicas del virus H5N1 de muestras de ganado. Las diferencias entre las secuencias cuentan una historia sobre dónde y cuándo comenzó el brote actual, el camino que recorre y si los virus están adquiriendo mutaciones que representan una amenaza para las personas.

Sin embargo, esta investigación vital se ha visto obstaculizada porque el USDA publica los datos incompletos y con cuentagotas, dijo Worobey.

El gobierno también debería ayudar a los criadores de aves de corral a prevenir brotes de H5N1, ya que estos matan a muchas aves y representan una amenaza constante de potenciales saltos de especies, dijo Maurice Pitesky, especialista en enfermedades de aves de la Universidad de California-Davis.

Las aves acuáticas como los patos y los gansos son las fuentes habituales de brotes en granjas avícolas, y los investigadores pueden detectar su proximidad mediante el uso de sensores remotos y otras tecnologías. Eso puede significar una vigilancia rutinaria para detectar signos tempranos de infecciones en aves de corral, usar cañones de agua para ahuyentar a las bandadas migratorias, reubicar animales de granja o llevarlos temporalmente a cobertizos. “Deberíamos estar invirtiendo en prevención”, dijo Pitesky.

Bien, no es una pandemia, pero ¿qué podría pasarle a las personas que contraigan la gripe aviar H5N1 de este año?

Realmente nadie lo sabe. Solo una persona en Texas fue diagnosticada con la enfermedad este año, en abril. Esta persona trabajaba con vacas lecheras, y tuvo un caso leve con una infección en el ojo. Los CDC se enteraron de esto debido a su proceso de vigilancia. Las clínicas deben alertar a los departamentos de salud estatales cuando diagnostican a trabajadores agrícolas con gripe, utilizando pruebas que detectan virus de la influenza en general.

Los departamentos de salud estatales luego confirman la prueba y, si es positiva, envían una muestra de la persona a un laboratorio de los CDC, donde se verifica específicamente la presencia del virus H5N1. “Hasta ahora hemos recibido 23”, dijo Shah. “Todos menos uno resultaron negativos”.

Agregó que funcionarios del departamento de salud estatal también están monitoreando a alrededor de 150 personas que han pasado tiempo alrededor de ganado. Están en contacto con estos trabajadores agrícolas con llamadas telefónicas, mensajes de texto o visitas en persona para ver si desarrollan síntomas. Y si eso sucede, les harán pruebas.

Otra forma de evaluar a los trabajadores agrícolas sería testear su sangre en busca de anticuerpos contra el virus de la gripe aviar H5N1; un resultado positivo indicaría que podrían haberse infectado sin saberlo. Pero Shah dijo que los funcionarios de salud aún no están haciendo este trabajo.

“El hecho de que hayan pasado cuatro meses y aún no hayamos hecho esto no es una buena señal”, dijo Worobey. “No estoy muy preocupado por una pandemia en este momento, pero deberíamos comenzar a actuar como si no quisiéramos que sucediera”.

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Rompiendo una promesa: déficit en California podría frenar aumentos a cuidadores de personas con discapacidades

SACRAMENTO, California – Las familias de personas con discapacidades intelectuales y del desarrollo dicen que el gobernador Gavin Newsom no está cumpliendo con un aumento programado para los trabajadores que cuidan de sus seres queridos.

Sus defensores advierten sobre posibles demandas contra el estado si los servicios para estas personas se vuelven más difíciles de conseguir.

El gobernador demócrata apela al déficit presupuestario del estado para postergar por un año los aumentos salariales de unos 150,000 trabajadores que cuidan a personas con alguna discapacidad. De este modo, ahorrará aproximadamente $613 millones en fondos estatales.

Pero esta medida significa, a la vez, que el estado dejará de percibir aproximadamente $408 millones adicionales que provienen de reembolsos de Medicaid. Esto supondrá una reducción del financiamiento de más de $1,000 millones.

Algunos legisladores afirman que no cumplir con el aumento prometido disparará la rotación de los trabajadores y así quedarán más puestos vacantes, lo que dejará a miles de niños y adultos con discapacidades sin servicios críticos tanto en su hogar como en centros residenciales.

Los defensores de las personas con discapacidad advierten que esta medida podría violar el Acta Lanterman, una ley emblemática de California que establece que el estado debe proporcionar servicios y recursos a las personas con discapacidad y a sus familias.

Felisa Strickland, una mujer de 60 años que vive en Santa Bárbara, lleva más de un año buscando un programa diurno para su hija Lily, de 23 años, quien tiene autismo y parálisis cerebral. “Newsom está rompiendo una promesa y esta situación está generando muchos problemas de salud física y mental para las personas. También representa una carga de estrés innecesaria para quienes, como yo, somo padres mayores que cuidamos de nuestros hijos”.

Los trabajadores que cuidan a personas que viven con discapacidad, también llamados profesionales de apoyo directo, atienden diariamente a niños y adultos con discapacidades intelectuales y del desarrollo, como autismo, parálisis cerebral y epilepsia. Sus cuidados los ayudan a mantenerse independientes y facilitan que se integren mejor a sus comunidades.

En California, más de 400,000 personas que viven con discapacidad necesitan asistencia. Esa franja de la población va en aumento, del mismo modo que ocurre con los adultos mayores. No está claro cuál es la dimensión de la escasez de cuidadores porque el estado no ha publicado datos sobre la fuerza laboral. Como en general la demanda de estos trabajadores crece, algunos expertos predicen que hacia 2030 faltarán entre 600,000 y 3,2 millones de profesionales de apoyo directo.

Los defensores explican que California paga a la mayoría de los proveedores entre $16 y $ 20 por hora, lo que se ajusta al salario mínimo del estado pero no llega a lo que algunos economistas consideran una remuneración digna.

En 2021, el estado se había comprometido a aumentar los salarios. Lo hizo después de detectar una brecha de $1,800 millones entre las tarifas que cobraban las organizaciones sin fines de lucro contratadas para ofrecer cuidados y los aranceles que se consideraban adecuados.

Hasta ahora, California ha aportado alrededor de la mitad del total de esa suma, la mayor parte de la cual se destinó a aumentar los salarios y las prestaciones. Los trabajadores esperaban otro aumento salarial en julio, de entre $2 y $4 la hora, pero Newsom propuso que fuera postergado.

Además, las organizaciones sin fines de lucro señalan que California ha vuelto más difícil retener a los trabajadores en tareas de cuidado después que aumentara los salarios en otros sectores vinculados a los servicios y la salud.

Newsom aprobó un salario mínimo de $20 para los empleados de restaurantes de comida rápida, que entró en vigencia en abril. Además, el año anterior había llegado a un acuerdo con los sindicatos y los hospitales para que los salarios de los trabajadores de salud subieran a un mínimo de $25 por hora.

Ricardo Zegri asegura que la cadena de restaurantes de comida rápida Taco Bell le pagaría más que los $19 por hora que gana como supervisor de trabajadores de cuidado para personas con alguna discapacidad.

“Cada vez que cobro el sueldo, tenemos una discusión en casa sobre el pago de cuáles facturas necesitamos priorizar y si es hora de que empiece a buscar un empleo donde me paguen más”, dijo Zegri, que tiene un segundo trabajo como músico en el área de la Bahía de San Francisco.

Newsom quiere preservar iniciativas de salud clave, incluida la expansión estatal de Medi-Cal a inmigrantes de bajos ingresos independientemente de su estatus legal, y CalAIM, un ambicioso experimento de $12,000 millones para transformar Medi-Cal en una aseguradora de salud y un proveedor de servicios sociales.

Sin embargo, el retraso en las tarifas para brindar atención a personas con discapacidades es el mayor ahorro en el presupuesto de Salud y Servicios Humanos, ya que Newsom y los líderes legislativos buscan recortes, demoras y cambios en la financiación para cerrar un déficit estimado de entre $38,000 millones y $73,000 millones.

Decenas de legisladores de ambos partidos están pidiendo a Newsom y a los líderes legislativos que mantengan el aumento prometido. Stephanie Nguyen, integrante de la Asamblea y demócrata de Elk Grove, firmó una carta de respaldo a ese reclamo.

Aunque los legisladores están negociando con la administración, dijeron que es muy poco probable que se revierta la decisión de dejar para más adelante el aumento de sueldo. “Todo el mundo tiene que perder algo”, dijo Nguyen.

Krystyne McComb, vocera del Departamento de Servicios de Desarrollo, admitió que este año, con la postergación del aumento, California perdería fondos federales. Pero aseguró que los volverá a recuperar cuando restablezca el plan, en 2025.

El departamento no respondió a las preguntas sobre cómo piensa retener a los trabajadores ni cómo se cubrirían los puestos vacantes.

El sistema de servicios de discapacidad puede colapsar a partir de la postergación del aumento salarial que propone el gobernador Newsom, afirma Jordan Lindsey, director ejecutivo de Arc of California, una organización de defensa de los derechos de las personas con discapacidad que opera en todo el estado.

Las familias dicen que California ya no cumple con los servicios que necesitan. Strickland dejó su trabajo para cuidar de su hija Lily pero asegura que “no es razonable esperar que alguien cuide de otra persona 24 horas al día, siete días a la semana”.

Lily se graduó de la escuela secundaria y en 2022 terminó un programa que prepara a jóvenes con discapacidades para la transición a la vida adulta. Estaba deseando apuntarse a un programa diurno para hacer nuevos amigos, pero aún no ha encontrado vacante.

Debido a la escasez de trabajadores, Lilly sólo recibe los cuidados de un profesional de apoyo directo en su casa durante cuatro horas a la semana. Le paga unos $16 la hora.

El tiempo en que Lily está con el cuidador, su comportamiento cambia y vuelve a ser la persona feliz que era antes, explica Strickland.

“El sistema ya está en crisis”, afirma. “Hay montones y montones de personas que pasan el día sentadas en su casa porque no tienen a dónde ir”.

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California propone ampliar subsidios de seguros de salud a todos los inmigrantes adultos

Marisol Pantoja Toribio se encontró un bulto en el pecho a principios de enero. Sin seguro y viviendo en California sin papeles, y sin su familia, la normalmente despreocupada mujer de 43 años se dio cuenta pronto de lo limitadas que eran sus opciones.

“Yo dije, ¿Qué voy a hacer? …. “, recordó emocionada. Inmediatamente le preocupó que pudiera tener cáncer. “Iba y venía: tengo [cáncer], no tengo, sí tengo, no tengo”. Y si estaba enferma, agregó, no podría trabajar ni pagar el alquiler. Al no tener seguro de salud, Pantoja Toribio no podía pagar para averiguar si tenía una enfermedad grave.

A partir de este año, Medi-Cal, el programa de Medicaid de California, se amplió para incluir a los inmigrantes que no tienen residencia legal, algo que podría haber funcionado perfectamente para Pantoja Toribio, que ha vivido en la ciudad de Brentwood, en el Área de la Bahía, durante tres años. Pero su solicitud de Medi-Cal fue rechazada rápidamente porque, como trabajadora agrícola que gana $16 la hora, sus ingresos anuales de unos $24,000 eran demasiado altos para calificar para el programa.

California es el primer estado en ampliar Medicaid a todos los adultos que reúnan los requisitos, independientemente de su estatus migratorio, una medida celebrada por los activistas de la salud y por líderes políticos de todo el estado. Pero muchos inmigrantes sin estatus legal permanente, especialmente los que viven en zonas de California donde el costo de vida es más alto, ganan demasiado dinero como para calificar para Medi-Cal.

El estado paga la factura de la expansión de Medi-Cal, pero la ley federal prohíbe a los que llama “indocumentados” recibir subsidios de seguros u otros beneficios de la Ley de Cuidado de Salud a Bajo Precio (ACA), dejando a muchos empleados, sin opciones viables médico.

Ahora, los mismos activistas de salud que lucharon por la expansión de Medi-Cal dicen que el siguiente paso para lograr la equidad en salud es ampliar Covered California, el mercado estatal de ACA, a todos los inmigrantes adultos mediante la aprobación de la AB 4.

“Hay personas en este estado que trabajan y son la columna vertebral de tantos sectores de nuestra economía y contribuyen con su trabajo e incluso con sus impuestos … pero están excluidos de nuestra red de seguridad social”, dijo Sarah Dar, directora del Centro de Política de Inmigración de California, una de las dos organizaciones que patrocinan el proyecto de ley, denominado #Health4All.

Para calificar para Medi-Cal, una persona no puede ganar más del 138% del nivel federal de pobreza, que actualmente es de cerca de $21,000 al año para un individuo. Una familia de tres miembros tendría que ganar menos de $35,632 al año.

Para las personas que superan esos umbrales, el mercado de Covered California ofrece varios planes de salud, a menudo con subsidios federales y estatales, con primas tan bajas como $10 al mes. La esperanza es crear lo que los activistas llaman un “mercado espejo” en el sitio web de Covered California para que a los inmigrantes, independientemente de su estatus, se les pueda ofrecer los mismos planes de salud que serían subvencionados sólo por el estado.

A pesar de la mayoría demócrata en la Legislatura, el proyecto de ley podría tener dificultades para ser aprobado, ya que el estado se enfrenta a un déficit presupuestario previsto para el próximo año de entre $38 mil millones y $73 mil millones. El gobernador Gavin Newsom y líderes legislativos anunciaron un paquete de $17 mil millones para empezar a reducir la brecha, pero parece inevitable que se produzcan recortes significativos en el gasto.

No está claro cuánto costaría extender Covered California a todos los inmigrantes, según el miembro de la Asamblea Joaquín Arambula, demócrata de Fresno que presentó el proyecto de ley.

El Centro de Política de Inmigración estima que la creación del mercado costaría al menos $15 millones. Si el proyecto de ley se aprueba, los patrocinadores tendrían que asegurar la financiación de los subsidios, que podrían ascender a miles de millones de dólares anuales.

“Es un momento difícil para pedir nuevos gastos”, señaló Dar. “El costo de la puesta en marcha del mercado espejo es una cifra relativamente baja. Así que tenemos esperanzas de que aún esté dentro de lo posible”.

Arambula dijo que es optimista en cuanto a que el estado continuará liderando en la mejora del acceso a la salud para los inmigrantes que no tienen residencia legal.

“Creo que seguiremos adelante, ya que estamos trabajando para hacer de ésta una California para todos”, expresó.

El proyecto de ley fue aprobado por la Asamblea en julio pasado en una votación de 64-9 y ahora falta la acción del Comité de Asignaciones del Senado, según la oficina de Arambula.

Se calcula que unas 520,000 personas en California podrían optar por un plan de Covered California si tuvieran un estatus legal, según el centro de investigación laboral de la Universidad de California-Berkeley. Pantoja Toribio, que emigró sola desde México huyendo de una relación abusiva, dijo que tuvo suerte. Se enteró de las opciones alternativas de atención médica cuando hizo su visita semanal a un banco de alimentos en Hijas del Campo, una organización de defensa de los trabajadores agrícolas del condado de Contra Costa, donde le dijeron que podría calificar para un plan que ayuda a personas de bajos ingresos a través de Kaiser Permanente.

Pantoja Toribio aplicó, justo antes que se cerrara el plazo de inscripción a finales de enero. Gracias al plan, supo que el bulto que tenía en el pecho no era canceroso.

“Diosito me oyó”, exclamó. “Gracias a Dios”.

Esta historia fue producida por KFF Health News, que publica California Healthline, un servicio editorialmente independiente de la 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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HHS Office on Women’s Health Announces Final Phase Winners for HHS Hypertension Innovator Award Competition

HHS Gov News - May 06, 2024
The national competition was created to identify and reward innovative programs that ensure women receive appropriate monitoring and follow-up.

Could Better Inhalers Help Patients, and the Planet?

Kaiser Health News:States - May 06, 2024

Miguel Divo, a lung specialist at Brigham and Women’s Hospital in Boston, sits in an exam room across from Joel Rubinstein, who has asthma. Rubinstein, a retired psychiatrist, is about to get a checkup and hear a surprising pitch — for the planet, as well as his health.

Divo explains that boot-shaped inhalers, which represent nearly 90% of the U.S. market for asthma medication, save lives but also contribute to climate change. Each puff from an inhaler releases a hydrofluorocarbon gas that is 1,430 to 3,000 times as powerful as the most commonly known greenhouse gas, carbon dioxide.

“That absolutely never occurred to me,” said Rubinstein. “Especially, I mean, these are little, teeny things.”

So Divo has begun offering a more eco-friendly option to some patients with asthma and other lung diseases: a plastic, gray cylinder about the size and shape of a hockey puck that contains powdered medicine. Patients suck the powder into their lungs — no puff of gas required and no greenhouse gas emissions.

“You have the same medications, two different delivery systems,” Divo said.

Patients in the United States are prescribed roughly 144 million of what doctors call metered-dose inhalers each year, according to the most recently available data published in 2020. The cumulative amount of gas released is the equivalent of driving half a million gas-powered cars for a year. So, the benefits of moving to dry powder inhalers from gas inhalers could add up.

Hydrofluorocarbon gas contributes to climate change, which is creating more wildfire smoke, other types of air pollution, and longer allergy seasons. These conditions can make breathing more difficult — especially for people with asthma and chronic obstructive pulmonary disease, or COPD — and increase the use of inhalers.

Divo is one of a small but growing number of U.S. physicians determined to reverse what they see as an unhealthy cycle.

“There is only one planet and one human race,” Divo said. “We are creating our own problems and we need to do something.”

So Divo is working with patients like Rubinstein who may be willing to switch to dry powder inhalers. Rubinstein said no to the idea at first because the powder inhaler would have been more expensive. Then his insurer increased the copay on the metered-dose inhaler so Rubinstein decided to try the dry powder.

“For me, price is a big thing,” said Rubinstein, who has tracked health care and pharmaceutical spending in his professional roles for years. Inhaling the medicine using more of his own lung power was an adjustment. “The powder is a very strange thing, to blow powder into your mouth and lungs.”

But for Rubinstein, the new inhaler works and his asthma is under control. A recent study found that some patients in the United Kingdom who use dry powder inhalers have better asthma control while reducing greenhouse gas emissions. In Sweden, where the vast majority of patients use dry powder inhalers, rates of severe asthma are lower than in the United States.

Rubinstein is one of a small number of U.S. patients who have made the transition. Divo said that, for a variety of reasons, only about a quarter of his patients even consider switching. Dry powder inhalers are often more expensive than gas propellant inhalers. For some, dry powder isn’t a good option because not all asthma or COPD sufferers can get their medications in this form. And dry powder inhalers aren’t recommended for young children or elderly patients with diminished lung strength.

Also, some patients using dry powder inhalers worry that without the noise from the spray, they may not be receiving the proper dose. Other patients don’t like the taste powder inhalers can leave in their mouths.

Divo said his priority is making sure patients have an inhaler they are comfortable using and that they can afford. But, when appropriate, he’ll keep offering the dry powder option.

Advocacy groups for asthma and COPD patients support more conversations about the connection between inhalers and climate change.

“The climate crisis makes these individuals have a higher risk of exacerbation and worsening disease,” said Albert Rizzo, chief medical officer of the American Lung Association. “We don’t want medications to contribute to that.”

Rizzo said there is work being done to make metered-dose inhalers more climate-friendly. The United States and many other countries are phasing down the use of hydrofluorocarbons, which are also used in refrigerators and air conditioners. It’s part of the global attempt to avoid the worst possible impacts of climate change. But inhaler manufacturers are largely exempt from those requirements and can continue to use the gases while they explore new options.

Some leading inhaler manufacturers have pledged to produce canisters with less potent greenhouse gases and to submit them for regulatory review by next year. It’s not clear when these inhalers might be available in pharmacies. Separately, the FDA is spending about $6 million on a study about the challenges of developing inhalers with a smaller carbon footprint.

Rizzo and other lung specialists worry these changes will translate into higher prices. That’s what happened in the early to mid-2000s when ozone-depleting chlorofluorocarbons (CFCs) were phased out of inhalers. Manufacturers changed the gas in metered-dose inhalers and the cost to patients nearly doubled. Today, many of those re-engineered inhalers remain expensive.

William Feldman, a pulmonologist and health policy researcher at Brigham and Women’s Hospital, said these dramatic price increases occur because manufacturers register updated inhalers as new products, even though they deliver medications already on the market. The manufacturers are then awarded patents, which prevent the production of competing generic medications for decades. The Federal Trade Commission says it is cracking down on this practice.

After the CFC ban, “manufacturers earned billions of dollars from the inhalers,” Feldman said of the re-engineered inhalers.

When inhaler costs went up, physicians say, patients cut back on puffs and suffered more asthma attacks. Gregg Furie, medical director for climate and sustainability at Brigham and Women’s Hospital, is worried that’s about to happen again.

“While these new propellants are potentially a real positive development, there’s also a significant risk that we’re going to see patients and payers face significant cost hikes,” Furie said.

Some of the largest inhaler manufacturers, including GSK, are already under scrutiny for allegedly inflating prices in the United States. Sydney Dodson-Nease told NPR and KFF Health News that the company has a strong record for keeping medicines accessible to patients but that it’s too early to comment on the price of the more environmentally sensitive inhalers the company is developing.

Developing affordable, effective, and climate-friendly inhalers will be important for hospitals as well as patients. The Agency for Healthcare Research and Quality recommends that hospitals looking to shrink their carbon footprint reduce inhaler emissions. Some hospital administrators see switching inhalers as low-hanging fruit on the list of climate-change improvements a hospital might make.

But Brian Chesebro, medical director of environmental stewardship at Providence, a hospital network in Oregon, said, “It’s not as easy as swapping inhalers.”

Chesebro said that even among metered-dose inhalers, the climate impact varies. So pharmacists should suggest the inhalers with the fewest greenhouse gas emissions. Insurers should also adjust reimbursements to favor climate-friendly alternatives, he said, and regulators could consider emissions when reviewing hospital performance.

Samantha Green, a family physician in Toronto, said clinicians can make a big difference with inhaler emissions by starting with the question: Does the patient in front of me really need one?

Green, who works on a project to make inhalers more environmentally sustainable, said that research shows a third of adults diagnosed with asthma may not have the disease.

“So that’s an easy place to start,” Green said. “Make sure the patient prescribed an inhaler is actually benefiting from it.”

Green said educating patients has a measurable effect. In her experience, patients are moved to learn that emissions from the approximately 200 puffs in one inhaler are equivalent to driving about 100 miles in a gas-powered car. Some researchers say switching to dry powder inhalers may be as beneficial for the climate as a patient adopting a vegetarian diet.

One of the hospitals in Green’s health care network, St. Joseph’s Health Centre, found that talking to patients about inhalers led to a significant decrease in the use of metered-dose devices. Over six months, the hospital went from 70% of patients using the puffers, to 30%.

Green said patients who switched to dry powder inhalers have largely stuck with them and appreciate using a device that is less likely to exacerbate environmental conditions that inflame asthma.

This article is from a partnership that includes WBUR, NPR, and KFF Health News.

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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Journalists Delve Into Climate Change, Medicaid ‘Unwinding,’ and the Gap in Mortality Rates

Kaiser Health News:States - May 04, 2024

KFF Health News senior correspondent Samantha Young discussed Medicaid and climate change on KCBS Radio’s “On-Demand” podcast on April 29.

KFF Health News contributor Andy Miller discussed Medicaid unwinding on WUGA’s “The Georgia Health Report” on April 26.

KFF Health News Nevada correspondent Jazmin Orozco Rodriguez discussed mortality rates in rural America on The Daily Yonder’s “The Yonder Report” on April 24.

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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