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Arkansas Led the Nation in Measuring Obesity in Kids. Did It Help?

Kaiser Health News:States - April 11, 2024

LITTLE ROCK, Ark. — Sixth-grade boys were lining up to be measured in the Mann Arts and Science Magnet Middle School library. As they took off their shoes and emptied their pockets, they joked about being the tallest.

“It’s an advantage,” said one. “You can play basketball,” said another. “A taller dude can get more girls!” a third student offered.

Everyone laughed. What they didn’t joke about was their weight.

Anndrea Veasley, the school’s registered nurse, had them stand one by one. One boy, Christopher, slumped as she measured his height. “Chin up slightly,” she said. Then Veasley asked him to stand backward on a scale so he didn’t see the numbers. She silently noted his height as just shy of 4 feet, 7 inches, and his weight as 115.6 pounds.

His parents later would be among thousands to receive a letter beginning, “Many children in Arkansas have health problems caused by their weight.” The letter includes each student’s measurements as well as their calculated body mass index, an indicator of body fat. The BMI number categorizes each child as “underweight,” “normal,” “overweight,” or “obese.” Christopher’s BMI of 25.1 put him in the range of obesity.

In 2003, Arkansas became the first state to send home BMI reports about all students as part of a broader anti-obesity initiative. But in the 20 years since, the state’s childhood obesity rates have risen to nearly 24% from 21%, reflecting a similar, albeit higher, trajectory than national rates. During the pandemic, the state obesity rate hit a high of more than 26%.

Still, at least 23 states followed Arkansas’ lead and required height and weight assessments of students. Some have since scaled back their efforts after parents raised concerns.

One school district in Wyoming used to include a child’s BMI score in report cards, a practice it has since stopped. Ohio allows districts to opt in, and last year just two of 611 school districts reported BMI information to the state. And Massachusetts stopped sending letters home. Even Arkansas changed its rules to allow parents to opt out.

Multiple studies have shown that these reports, or “fat letters” as they’re sometimes mockingly called, have had no effect on weight loss. And some nutritionists, psychologists, and parents have criticized the letters, saying they can lead to weight stigma and eating disorders.

BMI as a tool has come under scrutiny, too, because it does not consider differences across racial and ethnic groups, sex, gender, and age. In 2023, the American Medical Association called the BMI “imperfect” and suggested it be used alongside other tools such as visceral fat measurements, body composition, and genetic factors.

All that highlights a question: What purpose do BMI school measurements and letters serve? Nearly 20% of American children were classified as obese just before the pandemic — up from only 5% some 50 years ago — and lockdowns made the problem worse. It’s unclear what sorts of interventions might reverse the trend.

Joe Thompson, a pediatrician who helped create Arkansas’ program and now leads the Arkansas Center for Health Improvement, said BMI letters are meant to be a screening tool, not a diagnostic test, to make parents aware if their child is at risk of developing serious health issues, such as heart disease, diabetes, and respiratory problems.

Sharing this information with them is critical, he said, given that many don’t see it as a problem because obesity is so prevalent. Arkansas is also a rural state, so many families don’t have easy access to pediatricians, he said.

Thompson said he’s heard from many parents who have acted on the letters. “To this day, they are still our strongest advocates,” he said.

The program also led to new efforts to reduce obesity. Some school districts in Arkansas have instituted “movement breaks,” while others have added vegetable gardens, cooking classes, and walking trails. One district sought funding for bicycles. The state does not study whether these efforts are working.

Researchers say the BMI data also serves an important purpose in illuminating population-level trends, even if it isn’t helpful to individuals.

Parents are generally supportive of weighing children in school, and the letters have helped increase their awareness of obesity, research shows. At the same time, few parents followed up with a health care provider or made changes to their child’s diet or physical activity after getting a BMI letter, several other studies have found.

In what is considered the gold-standard study of BMI letters, published in 2020, researchers in California found that the letters home had no effect on students’ weight. Hannah Thompson, a University of California-Berkeley assistant professor who co-authored the study, said most parents didn’t even remember getting the letters. “It’s such a tiny-touch behavioral intervention,” she said.

Arkansas now measures all public school students in even grades annually — except for 12th graders because by that stage, the pediatrician Joe Thompson said, the students are “beyond the opportunities for schools to have an impact.” The change also came after many boys in one school wore leg weights under their jeans as a prank, he said.

Kimberly Collins, 50, remembers being confused by the BMI letters sent to her from the Little Rock School District stating that all her children were considered overweight, and that one daughter was classified as obese.

“It offended me as a mama,” she said. “It made me feel like I wasn’t doing my job.”

She didn’t think her children looked overweight and the family pediatrician had never brought it up as a concern.

Hannah Thompson, the researcher from California, said that’s the biggest problem with BMI letters: Parents don’t know what to do with the information. Without support to help change behavior, she said, the letters don’t do much.

“You find out your child is asthmatic, and you can get an inhaler, right?” she said. “You find out that your child is overweight and where do you even go from there? What do you do?”

Kevin Gee, a professor at the University of California-Davis, who has studied BMI letters, said the mailings miss cultural nuances. In some communities, for example, people prefer their children to be heavier, associating it with comfort and happiness. Or some eat foods that they know aren’t very nutritious but are an important way of expressing love and traditions.

“There’s a lot of rich contextual pieces that we know influences rates of obesity,” Gee said. “And so how do we balance that information?”

Collins’ daughter, now 15, said that as she’s grown older she increasingly feels uncomfortable about her weight. People stare at her and sometimes make comments. (Collins’ mother asked that her daughter’s name not be published because of her age and the sensitive nature of the subject.)

“On my birthday, I went to get my allergy shots and one of the nurses told me, ‘You are getting chubbier,’” she said. “That didn’t make me feel the best.”

Collins said it pains her to see her soft-spoken daughter cover herself with her arms as if she’s trying to hide. The teenager has also begun sneaking food and avoids the mirror by refusing to turn on the bathroom light, Collins said. The girl signed up for tennis but stopped after other children made fun of her, her mother said.

Looking back, Collins said, while she wishes she had paid more attention to the BMI letters, she also would have liked practical suggestions on what to do. Collins said she had already been following the short list of recommended healthy practices, including feeding her children fruits and vegetables and limiting screen time. She isn’t sure what else she could have done.

Now everyone has an opinion on her daughter’s weight, Collins said. One person told her to put a lock on the fridge. Another told her to buy vegan snacks. Her mother bought them a scale.

“It’s a total uphill climb,” Collins said with a sigh.

This article was produced as a part of a project for the Spencer Education Journalism Fellowship.

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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An Arm and a Leg: Attack of the Medicare Machines

Kaiser Health News:Medicaid - April 10, 2024

Covering the American health care system means we tell some scary stories. This episode of “An Arm and a Leg” sounds like a real horror movie. 

It uses one of Hollywood’s favorite tropes: machines taking over. And the machines belong to the private health insurance company UnitedHealth Group. 

Host Dan Weissmann talks to Stat News reporter Bob Herman about his investigation into Medicare Advantage plans that use an algorithm to make decisions about patient care. The algorithm is owned by a subsidiary of UnitedHealth Group.

Herman tells Weissmann that some of UnitedHealth’s own employees say the algorithm creates a “moral crisis” in which care is unfairly denied.

Scary stuff! Such reporting even has caught the eye of powerful people in government, putting Medicare Advantage plans under scrutiny.

Dan Weissmann @danweissmann Host and producer of "An Arm and a Leg." Previously, Dan was a staff reporter for Marketplace and Chicago's WBEZ. His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting. Credits Emily Pisacreta Producer Adam Raymonda Audio Wizard Ellen Weiss Editor Click to open the Transcript Transcript: Son of Medicare: Attack of the Machines

Note: “An Arm and a Leg” uses speech-recognition software to generate transcripts, which may contain errors. Please use the transcript as a tool but check the corresponding audio before quoting the podcast.

Dan: Hey there–

So this is kind of a horror story. But it’s not quite the kind of story it might sound like at first.

Because at first, it might sound like a horror story about machines taking over, making all the decisions– and making terrible, horrifying choices. Very age-of-Artificial Intelligence.

But this is really a story about decisions made by people. For money.

It’s also kind of a twofer sequel– like those movies that pit two characters from earlier stories against each other. Like Godzilla vs King Kong, or Alien vs Predator.

Although in this case, I’ve gotta admit, the two monsters are not necessarily fighting each other.

Let’s get reacquainted with them. 

On one side, coming back from our very last episode, we’ve got Medicare Advantage: This is the version of Medicare that’s run by private insurance companies. 

It’s got a bright and appealing side, compared to the traditional Medicare program run by the federal government, because: It can cost a lot less, month to month — saving people money on premiums. And it often comes with extra benefits, like dental coverage, which traditional Medicare doesn’t offer. [I know.]

But Medicare Advantage can have a dark side, which is basically: Well, you end up dealing with private insurance companies for the rest of your life. You need something — a test, a procedure, whatever — they might decide not to cover it.

Which can be scary. 

Our other returning monster — am I really calling them a monster? — well, last time we talked about them, in 2023, we had an expert calling them a behemoth. That’s United HealthGroup. You might remember, they’re not only one of the biggest insurance companies 

— and maybe not-coincidentally the very biggest provider of Medicare Advantage plans —

they’ve also got a whole other business– under the umbrella name Optum. And Optum has spent the last bunch of years buying up a gazillion other health care companies of every kind. 

That includes medical practices — they employ more doctors than anyone else, by a huge margin. It includes surgery centers, and home-health companies, and every kind of middleman company you can imagine that works behind the scenes — and have their hands in a huge percentage of doctor bills and pharmacy visits. 

A few years ago, United bought a company called NaviHealth, which provides services to insurance companies that run Medicare Advantage plans. 

NaviHealth’s job is to decide how long someone needs to stay in a nursing home, like if you’re discharged from a hospital after surgery, but you’re not ready to go home yet.

And the horror story– the stories, as dug up by reporters — starts after United bought NaviHealth.

And according to their reports, it involves people getting kicked out of those nursing homes who aren’t ready to go home. 

People getting sent home who can’t walk up the stairs in their house. Who can’t walk at all. Who are on feeding tubes. People who NaviHealth’s own employees are saying, “Wait. This person isn’t ready to go home.”

But their new bosses have told them: You’re not really making these decisions anymore. 

This is where machines do enter the picture.

NaviHealth’s distinctive offering has always been its proprietary algorithm– an algorithm that makes predictions about how long any given patient might need to stay. 

Before United bought the company, that algorithm was used as a guide, a first-guess. Humans weighed in with their own judgment about what patients needed.

After United bought the company, people inside have told reporters, that changed: The new owners basically told their employees, If the algorithm says someone can go home after x days, that’s when we’re cutting them off.

 Like pretty much any horror movie, this story’s got people running around trying to tell everyone: HEY, WATCH OUT! THERE’S SOMETHING BIG AND DANGEROUS HAPPENING HERE.

And in this case, they’ve actually gotten the attention of some people who might have the power to do something about it. Now, what those people will do? We don’t know yet. 

And, by the way: Yes, I said at the end of our last episode that we’d be talking about Medicaid this time around. That’s coming! But for now, strap in for this one. 

This is An Arm and a Leg, a show about why health care costs so freaking much, and what we can maybe do about it. I’m Dan Weissmann. I’m a reporter, and I like a challenge. So our job on this show is to take one of the most enraging, terrifying, depressing parts of American life, and bring you something entertaining, empowering, and useful.

So. I said that, like every horror movie, this one has people who are seeing what’s going on and are trying to warn everybody?

Like those movies, we’re gonna follow one of those people, watch them discover the problem, see how deep it goes, and start ringing alarm bells. Let’s meet our guy.

Bob Herman: My name is Bob Herman. I’m a reporter at STAT News

Dan: Stat is an amazing medical news publication. Bob covers the business of medicine there. Bob started working on this story in November 2022, after talking to a source who runs nursing homes. Bob’s source was complaining about Medicare Advantage. 

Bob Herman: There were a lot of payment denials. They just weren’t able to get paid. And just offhandedly, the source mentioned like, um, you know, and they’re attributing everything to this algorithm. This algorithm said, You know, only 17 days for our patients and then time’s up and I went running to Casey Ross 

Dan: Casey is a reporter at Stat who focuses on tech and AI in healthcare. Bob said, hey, what do you think of this? Wanna team up?

Bob Herman: And he was hooked.

Dan: They started talking to people who worked at nursing homes, talking to experts, and talking to families. And it was clear: They were onto something. 

Bob Herman: It took so many families by surprise to be like, what do you mean we’re going home? The, you know, my husband, my wife, my grandma, my grandpa, they can’t go to the bathroom on their own. Like, what do you? It was just, it was so confusing to people. It seemed like such a, a cold calculation,

Dan: One person they ended up talking with was Gloria Bent. Her husband Gary was sent to a nursing home for rehab after brain surgery for cancer. He was weak. He couldn’t walk. And he had something called “left neglect”: His brain didn’t register that there was a left side of his body. Here’s Gloria testifying before a Senate committee about how — when Gary arrived at the nursing home — the first thing he got was a discharge date. That is…

Gloria Bent: Before the staff of the facility could even evaluate my husband or develop a plan of care, I was contacted by someone who identified themselves as my Navi Health Care Coordinator

Dan: Gloria says when she told the nursing home staff she’d heard from NaviHealth, they groaned. And told her what to expect. 

Gloria Bent: I was told that I had just entered a battlefield, that I could expect a series of notices of denial of Medicare payment accompanied by a discharge date that would be two days after I got that notice.

Dan: Yeah, they said she’d get two days notice. Gloria says the nursing home staff told her she’d have 24 hours to appeal each of those, but even if she won, the denials would keep coming. In fact, they said,

Gloria Bent: If we won a couple of appeals, then we could expect that the frequency with which these denials were going to come would increase.

Dan: All of which happened. NaviHealth started issuing denials July 15, 2022, after Gary had been at the home for a month.

Gloria appealed. She told senators what the doctor who evaluated the appeal found: Gary couldn’t  walk. He couldn’t even move — like from bed to a chair — without help from two people.. That reviewer took Gloria’s side.

Her husband’s next denial came a week after the first. Gloria won that appeal too. She says the reviewer noted that Gary needed maximum assistance with activities of daily living. 

The third denial came four days later, and this time Gloria lost. 

Gary came home in an ambulance: As Gloria testified, he couldn’t get into or out of a car without assistance from someone with special training. 

And when he got into the ambulance, he had a fever. The next morning, he wound up in another ambulance — headed to a hospital with meningitis. He lost a lot of the functioning he’d picked up at the nursing home. 

He died at home a few months later. When Gloria testified in the Senate, all of it was still fresh. She told them that as awful as Gary’s illness and decline had been, the fights with insurance were an added trauma.

Gloria Bent: This should not be happening to families and patients. It’s cruel. Our family continues to struggle with the question that I hear you asking today. Why are people who are looking at patients only on paper or through the lens of an algorithm

making decisions that deny the services judged necessary by health care providers who know their patients.

Dan: Bob Herman calls Gloria’s story heartbreaking, like so many others he’s seen. 

And his attention goes to one part of Gloria’s story beyond denial-by-algorithm. 

Because: It’s not just one denial. It’s that series of denials. You can appeal, but as Gloria testified, the denials speed up. And you have to win every single time. The company only has to win once. 

I mean, unless you’re ready to get a lawyer and take your chances in court– which, in addition to being a major undertaking, also means racking up nursing home bills and legal bills you may never get reimbursed for, while the court process plays out. 

Bob Herman: This appeal system is designed in such a way that people will give up. If you have a job, you know, even if you don’t, and you’re, and you’re also trying to take care of a family member, um, it’s a rigorous monotonous process that will chew people up and spit them out and then the people are inevitably going to give up. And I think in some ways insurers know that.

Dan: Going out on a limb to say: I think so too. So Bob and Casey’s first story on NaviHealth came out in March of 2023. They were the characters in the movie who go, “HEY, I THINK THERE’S SOMETHING REALLY BAD HAPPENING HERE.”

And people started paying attention. Like the U.S. Senate. which held that hearing where Gloria Bent told her story. 

And like the federal agency that runs Medicare — the Centers for Medicare and Medicaid Services, CMS. 

CMS finalized a rule that told insurers: You can’t deny care to people just from using an algorithm. 

And something else happened too: Bob and Casey started suddenly getting a lot MORE information. 

Bob Herman: We received so many responses from people and it just opened the floodgates for former employees, just patients and family members, just everyone across the board.

Dan: And not just former employees. Current employees. And what they learned was: There was absolutely a strategy at work in how this algorithm was being used. It was strategy some people on the inside didn’t feel good about. 

And this strategy got developed after United HealthGroup — and its subsidiary, Optum– bought NaviHealth in 2020. And here’s what NaviHealth employees started telling Casey and Bob about that strategy.

Bob Herman: For some of us, it’s creating this moral crisis. Like we know that we are having to listen to an algorithm to essentially kick someone out of a nursing home, even though we know that they can barely walk 20 feet.

Dan: What Bob and Casey learned from insiders– and how it connects to United’s role as a health care behemoth– that’s next.

This episode of An Arm and a Leg is produced in partnership with KFF Health News. That’s a nonprofit newsroom covering healthcare in America. Their reporters do amazing work, and I’m honored to work with them. We’ll have a little more about KFF Health News at the end of this episode.

So, NaviHealth — the company with the algorithm — got started in 2015.. And the idea behind it was to use data to get people home faster from nursing homes if they didn’t actually need to be there. 

Because there was a lot of evidence that some people were being kept longer than they needed. 

Bob Herman: There is some validity to the idea that there’s, there’s wasteful care in Medicare, like, you know, there’s been cases in the past proving that people stay in a nursing home for way longer than is necessary. And obviously there’s financial incentives for nursing homes to keep people as long as possible. 

Dan: Traditional Medicare does have limits on nursing home care — but if you need “post-acute care” — help getting back on your feet after leaving a hospital traditional Medicare pays in full for 20 days– pretty much no questions asked. One of the selling points of Medicare Advantage — like selling points to policy nerds and politicians — was that it could cut waste, by asking those kinds of questions. NaviHealth and its algorithm were designed to help Medicare Advantage plans ask those questions in a smart way. 

Bob Herman: There were… a lot of believers within NaviHealth that were like, okay, I think we’re doing the right thing. We’re trying to make sure people get home sooner because who doesn’t want to be at home.  

Dan: And as those employees told Bob and Casey: Before United and Optum came in, the algorithm had been there as a guide — a kind of first guess — but not the final word. 

NaviHealth has staff people who interact directly with patients. And back in the day, the pre-United day, Bob and Casey learned that those staff could make their own judgments. 

Which made sense, because the algorithm doesn’t know everything about any individual case. It’s just making predictions based on the data it has.

Bob Herman: And there was just, just this noticeable change after United and OptiMentor that it felt more rigid. There’s no more variation. 

Dan: If the algorithm says you go, you are pretty much going.

Bob Herman: United has said, no, that’s not the case, but obviously these documents and other communications that we’ve gotten kind of say otherwise.

Dan: Because these employees weren’t just talking. They were sharing. Internal memos. Emails. Training materials. All making clear: The company wanted people shipped out on the algorithm’s timetable. 

Bob Herman: Documents came in showing that like this was a pretty explicit strategy. You know, UnitedHealth was telling its employees. Listen, we have this algorithm. We think it’s really good. So when it tells you how many, how many days someone should be in a nursing home, stick to it.

Dan: Stick to it or maybe be fired. Bob and Casey got documents — employee performance goals– saying: How close you stick to the algorithm’s recommendations? That’s part of how we’re evaluating your job performance. 

Bob Herman: It’s okay. Algorithm said 17 days, you better not really go outside of that because your job is on the line. 

Dan: Here’s how closely people were expected to stick to it. In 2022, employee performance goals shared with STAT showed that workers were expected to keep actual time in nursing homes to within three percent of what the algorithm said it should be. Across the board.

So, say you had 10 patients, and the algorithm said they each should get 10 days. That’s 100 days. Your job was to make sure that the total actual days for those patients didn’t go past 103 days.

Then, in 2023, the expectations got more stringent: Stay within one percent of the algorithm’s predictions. 10 patients, the algorithm says 100 days total? Don’t let it get past a hundred and one. 

Bob Herman: Like that is, almost nothing. Like what, what, your hands are tied. If you’re that employee, what are you going to do? Are you going to get fired? Are you going to do what you’re told?

Dan: And one person who ended up talking, to did get fired. 

Bob Herman: Correct. Yes. Uh, Amber Lynch did get fired And what she said was what we had also heard just more broadly was it, it created this internal conflict, like, Oh my God, what I’m doing doesn’t feel right. 

Dan: Amber Lynch was a case manager. She told Bob and Casey about onepatient who couldn’t climb the stairs in his home after knee surgery. But the algorithm said he was ready. Amber’s supervisor said, “Have you asked the nursing home staff if they’ve tried to teach him butt bumping?” Amber grit her teeth and made the suggestion to the rehab director.

Amber Lynch: And she looked at me like I had two heads. She’s like, he is 78 years old. He’s not going to do that. He’s not safe to climb the stairs yet. He’s not doing it. We’re not going to have it butt bump the stairs.

Dan: Amber told Bob and Casey that when she got fired, it was partly for failing to hit the one percent target and partly for being late with paperwork– which she told Bob and Casey she fell behind because her caseload was so heavy.

She wasn’t the only one with that complaint. 

Bob and Casey’s story shows another NaviHealth case manager– not named in the story because they’re still on the job — in their home office, struggling to keep up. 

That week, they were supposed to work with 27 patients and their families. Gather documents, hold meetings. Another week, shortly before, they’d had 40 patients. 

“Do you think I was able to process everything correctly and call everyone correctly the way I was supposed to?” the case manager asked. “No. It’s impossible. No one can be that fast and that effective and capture all of the information that’s needed.”

Bob and Casey watched this case manager fill out a digital form, feeding the algorithm the information it asked for on a man in his 80s with heart failure, kidney disease, diabetes and trouble swallowing, who was recovering from a broken shoulder. 

A few minutes later, the computer spat out a number: 17 days. 

The case manager didn’t have a lot of time or leeway to argue, but they were skeptical that the algorithm could get that number exactly right based on only the data it had. 

And what data is the algorithm working with? What’s it comparing the data on any given patient TO? Bob Herman says that’s a big question.

Bob Herman: It’s something that for sure, like Casey and I, it’s been bothering us. Like, what, how is this whole system? Like, what is it based on? And we were never really given straight answers on that. NaviHealth and Optum and United have said it’s based on millions of patient records over time. The sources of that, it’s, it’s a little unclear, where all that’s coming from. 

Dan: Bob and Casey talked with an expert named Ziad Obermeyer, a professor at the University of California Berkeley School of Public Health, who is not anti-algorithm. He actually builds algorithmic tools for decision making in public health. 

AND he’s done research showing that some widely-used algorithms just scale up and automate things like racial bias.

He told Bob and Casey: Using an algorithm based on how long other, earlier patients have stayed in a nursing home — that’s not a great idea.

Because people get forced out of nursing homes, in his words, “because they can’t pay or because their insurance sucks.” He said, “So the algorightm is basically learning all the inequalities of our current system.”

And leaving aside that kind of bias, it seems unlikely to Bob that any algorithm could predict exactly what every single patient will need every single time. 

No matter how much data it’s got, it’s predicting from averages.

Bob Herman: It reminds me of, like, a basketball game where let’s say someone averages 27 points per game. They don’t have 27 points every single, the game they go out there. It just varies from time to time.

Dan: But the NaviHealth algorithm doesn’t have to be right every time for United to make money using it. 

Using it to make decisions can allow United to boost profits coming and going.

Bob Herman: United health and the other insurance companies that use Navi health. Are using this technology to more or less kick people out of nursing homes before they’re ready. And that is the claims denial side where it’s like, okay, let’s save as much money as we can instead of having to pay it to a nursing home.

Dan: And that’s just one side of it. The insurance side. Claims denial. But United isn’t just in the insurance business. 

United’s Optum side is in every other part of health care. 

Including — in the years since United took over NaviHealth — home health services. The kind of services you’re likely to need when you leave a nursing home.

In 2022, Optum bought one top home health company in what one trade publication called a “monster, jaw-dropping mega-deal” — more than 5 billion dollars. In 2023, Optum made a deal to buy a second mega-provider. 

Bob and Casey’s story says NaviHealth’s shortening nursing home stays is integral to United’s strategy for these acquisitions. It does seem to open up new opportunities.

Bob Herman: You’re out of the nursing home because our algorithm said so. Now we’re going to send you to a home health agency or we’re going to send some home health aides into your home. And by the way, we own them. 

Dan: Oh, right, because: If you’re in a Medicare Advantage plan, your insurer can tell you which providers are covered. 

Bob Herman: So the real question becomes, how much is United potentially paying itself?

Dan: That is: How much might United end up taking money out of one pocket — the health insurance side — and paying itself into another pocket, Optum’s home-health services?

We don’t know the answer to how much United is paying itself in this way, or hoping to. And United has said its insurance arm doesn’t favor its in-house businesses.

But it seems like a reasonable question to ask. Actually, it’s a question the feds seem to be asking.

Optum hasn’t wrapped up its purchase of that second home-health company yet, and in February 2024, the Wall Street Journal and other outlets reported that the U.S. Department of Justice had opened an anti-trust investigation. 

And you don’t have to be in a Medicare Advantage plan run by United to get kicked out of a nursing home on an algorithm’s say-so. 

Bob Herman says NaviHealth sells its algorithm-driven services to other big insurance companies 

He says, put together, the companies that use NaviHealth cover as many as  15 million people — about half of everybody in Medicare Advantage.

Bob Herman: Odds are, if you’re in a Medicare Advantage plan, there’s a, there’s a really good shot that your coverage policies, if you get really sick and need nursing home care, for example, or any kind of post acute care, an algorithm could be at play at some point.

Dan: This is the dark side of Medicare Advantage. 

Bob Herman: Everyone loves their Medicare Advantage plan when they first sign up, right? Because it’s offering all these bells and whistles. It’s, here’s a gym membership. It’s got dental and vision, which regular Medicare doesn’t have. And it’s also just, it’s, it’s cheaper. Like, if it’s just from a financial point of view, if, if you’re a low income senior, How do you turn it down? There’s, there’s so many plans that offer like free, there’s no monthly premiums in addition to all the bells and whistles. But Nobody understands the trade offs , When you’re signing up for Medicare and Medicare Advantage, you’re on the healthier side of, of being a senior, right?

Dan: And none of us can count on staying healthy forever. When you sign up for Medicare  you’re signing up your future self — whether that’s ten or twenty or more years out. That future you, might really need good medical care. 

And at that point, as we explained in our last episode, if Medicare Advantage isn’t working for you, you may not be able to get out of it.

Bob Herman: You could potentially not fully get the care that you need. We shouldn’t assume that, that this couldn’t happen to us because it can. 

Dan: So, yeah. Kind of a horror story. But: Unlike some horror movies, when Bob and Casey started publishing their stories, they started getting people’s attention.

We mentioned the new rules from the feds and the senate hearings after Bob and Casey’s first story in March 2023

Later in the year, when Bob and Casey published their story with documents and stories from inside NaviHealth, a class-action lawsuit got filed.

Since then, CMS has said it will step up audits under its new rules. 

Bob Herman: There was a memo that CMS sent out to Medicare advantage plans that said, Hey, listen, we’re telling you again, do not deny care solely on any AI or algorithms. Like just don’t do it. 

Dan: And in February 2024, the Senate held another hearing. 

Here’s Senator Elizabeth Warren at that hearing, saying these CMS rules aren’t enough. We need stronger guardrails.

Elizabeth Warren: Until CMS can verify that AI algorithms reliably adhere to Medicare coverage standards by law, then my view on this is CMS should prohibit insurance companies from using them in their MA plans for coverage decisions. They’ve got to prove they work before they put them in place.

Dan: So people — people with at least some power– are paying some attention. 

Bob Herman: I don’t think this is necessarily going to escape. Political scrutiny for a while. 

Dan: So, basically, the story isn’t over. 

This isn’t one of those horror movies where the monster’s been safely defeated at the end, and everybody just starts cleaning up the mess. And it’s not one where the monster is just on the loose, unleashing the apocalypse. 

Because it’s not a movie. There’s no ending. There’s just all of us trying to figure out what’s going on, and what we can maybe do about it.

One last thing: I got a lot of emails after our last episode, where we laid out a lot of information about Medicare Advantage and traditional Medicare. Most of it was along the lines of, Thank you! That was really helpful! Which made me feel really good.

And we got a couple notes about things we could have done better. Especially this: We said Traditional Medicare leaves you on the hook for 20 percent of everything, without an out of pocket limit. 

Which is true — but only for Medicare Part B: Doctor visits, outpatient surgeries and tests. Which can add up, for sure.

Medicare Part A — if you’re actually hospitalized — covers most services at 100 percent, after you meet the deductible. In 2024 that’s one thousand, six hundred thirty-two dollars. 

Thanks to Clarke Lancina for pointing that out. 

There have been a bunch of other, amazing notes in my inbox recently, and I want to say: Please keep them coming. 

If you go to arm and a leg show dot com, slash, contact, whatever you type there goes straight to my inbox. You can attach stuff too: documents… voice memos. 

Please let me hear from you. That’s arm and a leg show dot com, slash contact.

I’ll catch you in a few weeks. 

Till then, take care of yourself.

This episode of an arm and a leg was produced by me, Dan Weissmann, with help from Emily Pisacreta, and edited by Ellen Weiss. 

Adam Raymonda is our audio wizard. Our music is by Dave Weiner and blue dot sessions. Extra music in this episode from Epidemic Sound.

Gabrielle Healy is our managing editor for audience. She edits the first aid kit newsletter. 

Bea Bosco is our consulting director of operations. Sarah Ballama is our operations manager. 

And Arm and a Leg is produced in partnership with KFF Health News. That’s a national newsroom producing in depth journalism about healthcare in America and a core program at KFF, an independent source of health policy research, polling and journalism. 

Zach Dyer is senior audio producer at KFF Health News. He’s editorial liaison to this show. 

And thanks to the Institute for Nonprofit News for serving as our fiscal sponsor, allowing us to accept tax exempt donations. You can learn more about INN at INN. org. 

Finally, thanks to everybody who supports this show financially– you can join in any time at arm and a leg show dot com, slash, support — and thanks for listening.

“An Arm and a Leg” is a co-production of KFF Health News and Public Road Productions.

To keep in touch with “An Arm and a Leg,” subscribe to the newsletter. You can also follow the show on Facebook and the social platform X. And if you’ve got stories to tell about the health care system, the producers would love to hear from you.

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Congress Likely to Kick the Can on Covid-Era Telehealth Policies

Kaiser Health News:States - April 10, 2024

Nearly two hours into a Capitol Hill hearing focused on rural health, Rep. Brad Wenstrup emphatically told the committee’s five witnesses: “Hang with us.”

Federal lawmakers face a year-end deadline to solidify or scuttle an array of covid-era payment changes for telehealth services that include allowing people to stay in their homes to see a doctor or therapist.

During the hearing in early March, Wenstrup and other House members offered personal anecdotes on how telehealth, home visits, and remote monitoring helped their patients, relatives, and constituents. Wenstrup, a Republican from Ohio who is also a podiatric surgeon and a retired Army reservist, told the audience: “Patients are less anxious and heal better when they can be at home.”

Most of the proposals focus on how Medicare covers telehealth services. But the rules affect patients on all types of insurance plans because typically private insurers and some government programs follow Medicare’s example. Without congressional action, virtual health care services like audio-only calls or meeting online with specialty doctors — such as an occupational therapist — could end. The bills would also continue to allow rural health clinics and other health centers to offer telehealth services while waiving a requirement for in-person mental health visits.

Telehealth use ballooned in the early months of the covid-19 pandemic and grew into a household term. The practice has become a popular issue for lawmakers on both sides of the aisle.

In one U.S. Census Bureau survey conducted from April 2021 to August 2022, Medicare and Medicaid enrollees reported using telehealth visits the most — 26.8% and 28.3%, respectively. The survey of nearly 1.2 million adults also found that Black patients and those earning less than $25,000 reported high rates of telehealth use. Notably, people of color were more likely to use audio-only visits.

Ensuring access to telehealth services “is the best public policy,” said Debbie Curtis, a vice president of McDermott+Consulting, a Washington, D.C.-based health care lobbying firm. “It’s the best business outcome. It’s the best patient care outcome.”

But it’s a presidential election year and Congress is a “deadline-driven organization,” Curtis said. She expects that Congress will be “kicking the can” past the November election.

Kyle Zebley, senior vice president of public policy at the American Telemedicine Association who also lobbies on Capitol Hill, said Congress “might well be in that lame-duck period.” “This is no way to run a health care system on a popular bipartisan issue,” he said.

In January, lawmakers — including senators from Mississippi and South Dakota — sent a letter to the Biden administration urging the White House to work quickly with Congress to ensure payments continue for Medicare patients who use telehealth, “especially for rural and underserved communities.”

Maya Sandalow, a senior policy analyst for the Bipartisan Policy Center, a Washington, D.C.-based think tank, said lawmakers and policymakers are likely to consider a temporary extension of the payments rather than permanent changes.

“Research is still coming out that covers more recent years than the acute effects of the pandemic,” Sandalow said. The center expects to release policy recommendations in the coming months.

Questions being considered include which kind of health care services are best for audio-only and video visits. Sandalow said researchers are also weighing how telehealth can “expand access to affordable, high-quality care while ensuring in-person options remain for patients.”

In North Dakota, Sanford Health’s David Newman said virtual care is often the only way some of his patients in the western part of the state can get sub-specialty care, such as with behavioral health.

Newman, an endocrinologist and Sanford’s medical officer of virtual care, said 10% to 20% of his patients are seen virtually during the summer, as compared with about 40% in the winter months because “the weather can be so bad” that roads are impassable.

In winters past, Newman would sit around “doing nothing for a day” because patients couldn’t visit him. Now, he has a full clinic using telehealth technology.

“I tell my patients that if you can make a restaurant reservation or if you can order a pizza online, you can do a virtual visit,” Newman said.

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Doctors Take On Dental Duties to Reach Low-Income and Uninsured Patients

Kaiser Health News:States - April 10, 2024

DENVER — Pediatrician Patricia Braun and her team saw roughly 100 children at a community health clinic on a recent Monday. They gave flu shots and treatments for illnesses like ear infections. But Braun also did something most primary care doctors don’t. She peered inside mouths searching for cavities or she brushed fluoride varnish on their teeth.

“We’re seeing more oral disease than the general population. There is a bigger need,” Braun said of the patients she treats at Bernard F. Gipson Eastside Family Health Center, which is part of Denver Health, the largest safety-net hospital in Colorado, serving low-income, uninsured, and underinsured residents.

Braun is part of a trend across the United States to integrate oral health into medical checkups for children, pregnant women, and others who cannot afford or do not have easy access to dentists. With federal and private funding, these programs have expanded in the past 10 years, but they face socioeconomic barriers, workforce shortages, and the challenge of dealing with the needs of new immigrants.

With a five-year, $6 million federal grant, Braun and her colleagues have helped train 250 primary care providers in oral health in Colorado, Montana, Wyoming, and Arizona. Similar projects are wrapping up in Illinois, Michigan, Virginia, and New York, funded by the federal Health Resources and Services Administration’s Maternal and Child Health Bureau. Beyond assessment, education, and preventive care, primary care providers refer patients to on- or off-site dentists, or work with embedded dental hygienists as part of their practice.

“Federally qualified health centers have a long history of co-locating dental services within their systems,” Braun said. “We’re taking that next step where care is not just co-located, meaning, say, we’re upstairs and dental is downstairs, but we’re integrated so that it becomes part of the same visit for the patient.”

Having doctors, nurses, and physician assistants who assess oral health, make referrals, and apply fluoride at community health centers is critical for the many children who lack access to dental care, said Tara Callaghan, director of operations for the Montana Primary Care Association, which represents 14 federally qualified health centers and five Urban Indian organizations.

“Providing these services during medical visits increases the frequency of fluoride application,” Callaghan said, and “improves parents’ knowledge of caring for their child’s teeth.” But obstacles remain.

Because of Montana’s large geographic area and small population, recruiting dental professionals is difficult, Callaghan said. Fifty of the state’s 56 counties are designated dental shortage areas and some counties don’t have a single dentist who takes Medicaid, she added. Montana ranks near the bottom for residents having access to fluoridated water, which can prevent cavities and strengthen teeth.

Pediatric dental specialists, in particular, are scarce in rural areas, with families sometimes driving hours to neighboring counties for care, she said.

Embedding dental hygienists with medical doctors is one way to reach patients in a single medical visit.

Valerie Cuzella, a registered dental hygienist, works closely with Braun and others at Denver Health, which serves nearly half of the city’s children and has embedded hygienists in five of its clinics that see children.

State regulations vary on which services hygienists can provide without supervision from a dentist. In Colorado, Cuzella can, among other things, independently perform X-rays and apply silver diamine fluoride, a tool to harden teeth and slow decay. She does all this in a cozy corner office.

Braun and Cuzella work so closely that they often finish each other’s sentences. Throughout the day they text each other, taking advantage of brief lulls when Cuzella can pop into an exam room to check for gum disease or demonstrate good brushing habits. Braun herself takes similar opportunities to assess oral health during her exams, and both focus on educating parents.

Medical and dental care have traditionally been siloed. “Schools are getting better at interprofessional collaboration and education, but by and large we train separately, we practice separately,” said Katy Battani, a registered dental hygienist and assistant professor at Georgetown University.

Battani is trying to bridge the divide by helping community health centers in nine states — including California, Texas, and Maryland — integrate dental care into prenatal visits for pregnant women. Pregnancy creates opportunities to improve oral health because some women gain dental coverage with Medicaid and see providers at least once a month, Battani said.

In Denver, housing instability, language barriers, lack of transportation, and the “astronomical cost” of dentistry without insurance make dental care inaccessible for many children, the migrant community, and seniors, said Sung Cho, a dentist who oversees the dental program at STRIDE Community Health Center, serving the Denver metro area.

STRIDE tries to overcome these barriers by offering interpretation services and a sliding pay scale for those without insurance. That includes people like Celinda Ochoa, 35, of Wheat Ridge, who waited at STRIDE Community Health Center while her 15-year-old son, Alexander, had his teeth cleaned. He was flagged for dental care during a past medical checkup and now he and his three siblings regularly see a dentist and hygienist at STRIDE.

One of Ochoa’s children has Medicaid dental coverage, but her three others are uninsured, and they couldn’t otherwise afford dental care, said Ochoa. STRIDE offers an exam, X-rays, and cleaning for $60 for the uninsured.

In the past year, Cho has seen an influx of migrants and refugees who have never seen a dentist before and need extensive care. Medical exams for refugees at STRIDE increased to 1,700 in 2023 from 1,300 in 2022, said Ryn Moravec, STRIDE’s director of development. She estimates the program has seen 800 to 1,000 new immigrants in 2024.

Even with growing needs, Cho said the Medicaid “unwinding” — the process underway to reexamine post-pandemic eligibility for the government program that provides health coverage for people with low incomes and disabilities — has created financial uncertainty. He said he worries about meeting the upfront costs of new staff and of replacing aging dental equipment.

At STRIDE’s Wheat Ridge clinic, two hygienists float between dental and pediatrics as part of the medical-dental integration. Yet Cho said he needs more hygienists at other locations to keep up with demand. The pandemic created bottlenecks of need that are only now being slowly cleared, particularly because few dentists take Medicaid. If they do accept it, they often limit the number of Medicaid patients they’ll take, said Moravec. Ideally, STRIDE could hire two hygienists and three dental assistants, Moravec said.

In 2022, Colorado enacted a law to alleviate workforce shortages by allowing dental therapists — midlevel providers who do preventive and restorative care — to practice. But Colorado does not have any schools to train or accredit them.

Before age 3, children are scheduled to see a pediatrician for 12 well visits, a metric that medical and dental integration capitalizes on, particularly for at-risk children. As part of Braun’s program in the Rocky Mountain region, providers have applied more than 17,000 fluoride varnishes and increased the percentage of children 3 and younger who received preventive oral health care to 78% from 33% in its first 2½ years.

Callaghan, at the Montana Primary Care Association, witnesses that on the ground at community health centers in Montana. “It’s about leveraging the fact that kids see their medical provider for a well-child visit much more often and before they see their dental provider — if they have one.”

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Médicos de atención primaria asumen tareas de dentista para ayudar a pacientes vulnerables

Kaiser Health News:States - April 10, 2024

DENVER.- Un lunes reciente, la pediatra Patricia Braun y su equipo atendieron a unos 100 niños en una clínica comunitaria. Administraron vacunas contra la gripe y trataron infecciones de oído. Pero Braun también hizo algo que la mayoría de los médicos de atención primaria no hacen. Revisó las bocas de los pacientes en busca de caries o cepilló sus dientes con barniz de flúor.

“Estamos viendo más enfermedades bucodentales que en el resto de la población. La necesidad es mayor”, dijo Braun sobre los pacientes que trata en el Centro de Salud Familiar Bernard F. Gipson Eastside, que forma parte de Denver Health, el mayor hospital de la red social de Colorado, que atiende a residentes con bajos ingresos, sin seguro de salud o con seguro insuficiente.

Braun forma parte de una tendencia en todo el país que consiste en integrar la salud dental en los chequeos médicos de niños, embarazadas y otras personas que no pueden permitirse o no tienen fácil acceso a los dentistas.

Con financiación federal y privada, estos programas se han ampliado en los últimos 10 años, pero se enfrentan a barreras socioeconómicas, escasez de personal calificado y el reto de atender las necesidades de los nuevos inmigrantes.

Con una subvención federal de cinco años y $6 millones, Braun y sus colegas han ayudado a formar a 250 proveedores de atención primaria en salud bucodental en Colorado, Montana, Wyoming y Arizona.

En Illinois, Michigan, Virginia y Nueva York se están ultimando proyectos similares, financiados por la Oficina de Salud Maternoinfantil (MCHB) de la Administración de Recursos y Servicios de Salud (HRSA).

Además de la evaluación, la educación y la atención preventiva, los proveedores de atención primaria envían a los pacientes a dentistas internos o externos, o trabajan con higienistas dentales integrados en sus consultas.

“Los centros de salud federales tienen un largo historial de servicios dentales integrados en sus sistemas”, afirmó Braun. “Nosotros estamos dando el siguiente paso, en el que la atención no sólo es compartida, es decir, nosotros estamos en el piso de arriba y los dentistas en el de abajo, sino que está integrada en la misma visita del paciente”.

Contar con médicos, enfermeras y auxiliares que evalúen la salud bucodental, hagan derivaciones y apliquen flúor en los centros de salud comunitarios es fundamental para muchos niños que no tienen acceso a la atención dental, dijo Tara Callaghan, directora de operaciones de la Asociación de Atención Primaria de Montana, que representa a 14 centros de salud calificados a nivel federal y a cinco organizaciones Urban Indian.

“Ofrecer estos servicios durante las visitas médicas aumenta la frecuencia de aplicación del flúor”, señaló Callaghan, y “mejora el conocimiento de los padres sobre el cuidado de los dientes de sus hijos”. Pero sigue habiendo obstáculos.

Según Callaghan, debido a la gran extensión geográfica y a la escasa población de Montana, la contratación de profesionales dentales es difícil. Cincuenta de los 56 condados del estado están designados como zonas de escasez dental y algunos no tienen ni un solo dentista que acepte Medicaid, añadió. Montana ocupa uno de los últimos puestos en cuanto al acceso de los residentes al agua fluorada, que puede prevenir las caries y fortalecer los dientes.

Callaghan indicó que, concretamente, los especialistas en odontología pediátrica escasean en las zonas rurales, y las familias a veces tienen que conducir horas hasta los condados vecinos para recibir atención.

Tener higienistas dentales con los médicos es una forma de llegar a los pacientes en una sola visita.

La higienista dental Valerie Cuzella colabora estrechamente con Braun y otros profesionales de Denver Health, que atiende a casi la mitad de los niños de la ciudad y ha incorporado higienistas en cinco de sus clínicas infantiles.

Las normativas estatales varían en cuanto a los servicios que los higienistas pueden prestar sin la supervisión de un dentista. En Colorado, Cuzella puede, entre otras cosas, realizar radiografías de forma independiente y aplicar fluoruro de plata y diamina, una herramienta para endurecer los dientes y frenar la caries. Todo esto lo hace en un acogedor despacho situado en una esquina.

Braun y Cuzella trabajan tan estrechamente que a menudo una termina la frase de la otra. A lo largo del día se envían mensajes de texto, aprovechando las breves pausas en las que Cuzella puede asomarse a una sala de chequeos para detectar enfermedades de las encías o enseñar buenos hábitos de cepillado. También Braun aprovecha oportunidades similares para evaluar la salud bucodental durante sus exámenes, y ambas se centran en educar a los padres.

Tradicionalmente, la atención médica y la odontológica han estado separadas. “Las facultades están mejorando la colaboración y la formación interprofesional, pero en general nos formamos, y ejercemos, por separado”, afirmó Katy Battani, higienista dental y profesora de la Universidad Georgetown.

Battani trata de zanjar esta brecha ayudando a centros de salud comunitarios en nueve estados —entre ellos California, Texas y Maryland— a integrar la atención dental en las visitas prenatales. El embarazo crea oportunidades para mejorar la salud bucodental porque algunas mujeres obtienen cobertura dental con Medicaid y ven a los proveedores al menos una vez al mes, explicó Battani.

En Denver, la inestabilidad de la vivienda, las barreras del idioma, la falta de transporte y el “costo astronómico” de la odontología sin seguro hacen que la atención dental sea inaccesible para muchos niños, la comunidad inmigrante y las personas mayores, explicó Sung Cho, dentista que supervisa el programa dental del Centro de Salud Comunitario STRIDE, en el área metropolitana de Denver.

STRIDE intenta superar estas barreras ofreciendo servicios de interpretación y una escala móvil de pagos para quienes no tienen seguro.

Esto incluye a personas como Celinda Ochoa, de 35 años y residente en Wheat Ridge, que fue a STRIDE para que le hicieran una limpieza dental a su hijo Alexander, de 15 años. Alexander fue seleccionado para el cuidado dental durante un chequeo médico y ahora él y sus tres hermanos ven regularmente a un dentista e higienista en el centro.

Uno de los hijos de Ochoa tiene cobertura dental de Medicaid, pero los otros tres no tienen seguro, y nunca podrían permitirse la atención dental, dijo Ochoa. STRIDE ofrece un examen, radiografías y limpieza por $60 para los que no tienen seguro.

En el último año, Cho ha sido testigo del aumento de inmigrantes y refugiados que nunca habían visto a un dentista antes y necesitan una atención exhaustiva. Los exámenes médicos para los refugiados en STRIDE aumentaron de 1,300 en 2022 a 1,700 en 2023, dijo Ryn Moravec, director de desarrollo de STRIDE. Calcula que el programa ha atendido entre 800 y 1,000 nuevos inmigrantes en 2024.

Incluso con las crecientes necesidades, Cho señaló que el proceso de Medicaid en curso —que reexamina la elegibilidad post-pandemia para el programa gubernamental que proporciona cobertura de salud a las personas con bajos ingresos y discapacidades— ha creado incertidumbre económica. Dijo que le preocupa hacer frente a los costos iniciales de nuevo personal y de sustitución de equipos dentales obsoletos.

En la clínica de STRIDE en Wheat Ridge, dos higienistas trabajan entre odontología y pediatría como parte de la integración médico-dental. Sin embargo, Cho aseguró que necesita más higienistas en otros centros para satisfacer la demanda.

La pandemia creó cuellos de botella que sólo ahora se están resolviendo lentamente, sobre todo porque pocos dentistas aceptan Medicaid. Y, si lo aceptan, a menudo limitan el número de pacientes del programa, dijo Moravec. Idealmente, STRIDE podría contratar a dos higienistas y tres asistentes dentales, añadió.

En 2022, Colorado promulgó una ley para aliviar la escasez de personal que permite incorporar terapeutas dentales: proveedores de nivel medio que proporcionan atención preventiva y restauradora. Pero Colorado no tiene ninguna escuela para formarlos o acreditarlos.

Antes de los 3 años, los niños deben ir al pediatra para 12 visitas de control, una métrica que aprovecha la integración médica y dental, sobre todo para los niños en situación de riesgo. Como parte del programa de Braun en la región de las Montañas Rocosas, se han aplicado más de 17,000 barnices de flúor y ha aumentado el porcentaje de niños de 3 años o menos que recibieron atención bucodental preventiva al 78%, del 33% en los primeros 2 años y medio.

Callaghan, de la Asociación de Atención Primaria de Montana, es testigo de ello en los mismos centros de salud comunitarios del estado. “Se trata de aprovechar el hecho de que los niños ven a su proveedor médico para una visita rutinaria mucho más a menudo, antes de ver a su proveedor dental, si es que lo tienen”.

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During Second Chance Month, HRSA Takes Policy Action, Releases First-Ever Funding Opportunity for Health Centers to Support Transitions in Care for People Leaving Incarceration

HHS Gov News - April 09, 2024
Latest policy makes clear HRSA-funded Health Centers can provide health care services prior to release from incarceration

Becerra Joins the Fray Over Reproductive Rights

Kaiser Health News:States - April 09, 2024

Health and Human Services Secretary Xavier Becerra is racking up frequent-flier miles as he hopscotches the country to highlight health issues the White House hopes will become pivotal for voters this year — none more so than reproductive rights. 

No woman today should fear [not having] access to the care that she needs. President Biden has made that clear,” Becerra said last Tuesday in Fort Lauderdale, Fla.

It was a timely visit. The day before, the state’s Supreme Court greenlit an abortion rights ballot measure that Democrats hope will drive turnout in November, while also upholding the six-week abortion ban signed into law by Gov. Ron DeSantis (R) last year. The ban takes effect May 1.

Becerra called the law “medical apartheid” in remarks following a field hearing House Democrats held in Fort Lauderdale on reproductive health care. The Democrats sought to highlight the GOP’s role in abortion bans that most Americans oppose.  

He drew a line connecting the Supreme Court’s 2022 decision overturning Roe v. Wade to recent state efforts to restrict fertility treatment and access to contraception.

“At the end of the day, Roe was about all of us and our care,” he said. “It was not simply about abortion.”

It wasn’t the first time this year that the secretary has arrived somewhere at an opportune moment. He traveled to Alabama in February in the wake of that state’s Supreme Court ruling declaring that embryos created through in vitro fertilization are children. He held a roundtable with IVF patients and framed the court’s decision as an assault on reproductive freedom. 

The week before he visited Florida, Becerra was in South Carolina, one of 14 states with severe abortion restrictions and among those with the highest maternal mortality rates.

Two days later, Becerra appeared in Michigan, one of the most competitive states in the upcoming presidential election, where he boasted about the Biden administration’s efforts to lower prescription drug prices and joined Gov. Gretchen Whitmer (D) for another roundtable on reproductive rights.

Becerra, a former California attorney general and House member, is a fluent Spanish speaker whose travels include a “National Latino Health Tour” — a key demographic for Biden’s reelection hopes. Becerra’s remarks often cover other Biden health priorities, including lowering drug prices, increasing mental health access, boosting funding for cancer research, and improving health insurance coverage and health equity.

“From Colorado, I head over to New Mexico,” Becerra said as he left the Florida event. “We’re going to go everywhere we need to go.”

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City-Country Mortality Gap Widens Amid Persistent Holes in Rural Health Care Access

Kaiser Health News:States - April 09, 2024

In Matthew Roach’s two years as vital statistics manager for the Arizona Department of Health Services, and 10 years previously in its epidemiology program, he has witnessed a trend in mortality rates that has rural health experts worried.

As Roach tracked the health of Arizona residents, the gap between mortality rates of people living in rural areas and those of their urban peers was widening.

The health disparities between rural and urban Americans have long been documented, but a recent report from the Department of Agriculture’s Economic Research Service found the chasm has grown in recent decades. In their examination, USDA researchers found rural Americans from the ages of 25 to 54 die from natural causes, like chronic diseases and cancer, at wildly higher rates than the same age group living in urban areas. The analysis did not include external causes of death, such as suicide or accidental overdose.

The research analyzed Centers for Disease Control and Prevention death data from two three-year periods — 1999 through 2001 and 2017 through 2019. In 1999, the natural-cause mortality rate for people ages 25 to 54 in rural areas was only 6% higher than for city dwellers in the same age bracket. By 2019, the gap widened to 43%.

The researchers found the expanding gap was driven by rapid growth in the number of women living in rural places who succumb young to treatable or preventable diseases. In the most rural places, counties without an urban core population of 10,000 or more, women in this age group saw an 18% increase in natural-cause mortality rates during the study period, while their male peers experienced a 3% increase.

Within the prime working-age group, cancer and heart disease were the leading natural causes of death for both men and women in both rural and urban areas. Among women, the incidence of lung disease in remote parts of the nation grew the most when compared with rates in urban areas, followed by hepatitis. Pregnancy-related deaths also played a role, accounting for the highest rate of natural-cause mortality growth for women ages 25 to 54 in rural areas.

The negative trends for rural non-Hispanic American Indian and Alaska Native people were especially pronounced. The analysis shows Native Americans 25 to 54 years old had a 46% natural-cause mortality rate increase over those two decades. Native women had an even greater mortality rate jump, 55%, between the two studied time periods, while the rate for non-Hispanic White women went up 23%.

The rural-urban gap grew in all regions across the nation but was widest in the South.

The increased mortality rates are an indicator of worsening population health, the study authors noted, which can harm local economies and employment.

As access to and quality of health services in rural areas continue to erode, rural health experts said, the USDA findings should spur stronger policies focused on rural health.

Alan Morgan, CEO of the National Rural Health Association, said he found the report “shocking,” though, “unfortunately, not surprising.”

The disparity warrants greater attention from state and national leaders, Morgan said.

The study does not address causes for the increase in mortality rates, but the authors note that differences in health care resources could compromise the accessibility, quality, and affordability of care in rural areas. Hospitals in small and remote communities have long struggled, and continued closures or conversions limit health care services in many places. The authors note that persistently higher rates of poverty, disability, and chronic disease in rural areas, compounded by fewer physicians per capita and the closure of hospitals, affect community health.

Roach said his past job as an epidemiologist included working with social vulnerability indexes, which factor in income, race, education, and access to resources like housing to get a sense of a community’s resilience against adverse health outcomes. A map of Arizona shows that rural counties and reservations have some of the highest vulnerability rankings.

Janice C. Probst, a retired professor at the University of South Carolina whose work focused on rural health, said many current rural health efforts are focused on sustaining hospitals, which she noted are essential sources of health care. But she said that may not be the best way to address the inequities.

“We may have to take a community approach,” said Probst, who reviewed the report before its release. “Not how do we keep the hospital in the community, but how do we keep the community alive at all?”

The disparities among demographics stood out to Probst, along with something else. She said the states with the highest rates of natural-cause mortality in rural areas included South Carolina, Mississippi, Georgia, Alabama, and others that have not expanded Medicaid, the joint federal and state health insurance program for low-income people, though there are efforts to expand it in some states, particularly Mississippi.

It’s an observation the USDA researchers make as well.

“Regionally, differences in State implementation of Medicaid expansion under the 2010 Affordable Care Act could have increased implications for uninsured rural residents in States without expansions by potentially influencing the frequency of medical care for those at risk,” they wrote.

Wesley James, founding executive director of the Center for Community Research and Evaluation, at the University of Memphis, said state lawmakers could address part of the problem by advocating for Medicaid expansion in their states, which would increase access to health care in rural areas. A large group of people want it, but politicians aren’t listening to their needs, he said. James also reviewed the report before it was published.

According to KFF polling, two-thirds of people living in nonexpansion states want their state to expand the health insurance program.

Morgan added the study focused on deaths that occurred prior to the covid-19 pandemic, which had a devastating effect in rural areas.

“Covid really changed the nature of public health in rural America,” he said. “I hope that this prompts Congress to direct the CDC to look at rural-urban life expectancies during covid and since covid to get a handle on what we’re actually seeing nationwide.”

In Arizona, the leading cause of death for people 45 to 64 in 2021 in both rural and urban areas was covid, according to Roach.

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After Public Push, CMS Curbs Health Insurance Agents’ Access to Consumer SSNs

Until last week, the system that is used to enroll people in federal Affordable Care Act insurance plans inadvertently allowed access by insurance brokers to consumers’ full Social Security numbers, information brokers don’t need.

That raised concerns about the potential for misuse.

The access to policyholders’ personal information was one of the problems cited in a KFF Health News article describing growing complaints about rogue agents enrolling people in ACA coverage, also known as Obamacare, or switching consumers’ plans without their permission in order to garner the commissions. The consumers are often unaware of the changes until they go to use their plan and find their doctors are not in the new plan’s network or their drugs are not covered.

Agent Joshua Brooker told KFF Health News it was relatively easy for agents to access full Social Security numbers through the federal insurance marketplace’s enrollment platforms, warning that “bad eggs now have access to all this private information about an individual.”

On April 1, the morning the article was posted on NPR’s website, Brooker said, he got a call from the Centers for Medicare & Medicaid Services questioning the accuracy of his comments.

A CMS representative told him he was wrong and that the numbers were hidden, Brooker said April 7. “I illustrated that they were not,” he said.

After he showed how the information could be accessed, “the immediate response was a scramble to patch what was acknowledged as ‘problematic,’” Brooker posted to social media late last week.

Brooker has followed the issue closely as chair of a marketplace committee for the National Association of Benefits and Insurance Professionals, a trade group.

After some phone calls with CMS and other technical experts, Brooker said, the federal site and direct enrollment partner platforms now mask the first six digits of the SSNs.

“It was fixed Wednesday evening,” Brooker told KFF Health News. “This is great news for consumers.”

An April 8 written statement from CMS said the agency places the highest priority on protecting consumer privacy.

“Upon learning of this system vulnerability, CMS took immediate action to reach out to the direct enrollment platform where vulnerability was identified to make sure it was addressed,” wrote Jeff Wu, acting director of the Center for Consumer Information & Insurance Oversight at CMS.

He added that the Social Security numbers were not accessible through routine use of the platform but were in a portion of the site called developer tools. “This issue does not impact healthcare.gov,” Wu wrote.

Brooker’s concern about Social Security numbers centered on access by licensed agents to existing policyholder information though the federal marketplace, not including the parts of healthcare.gov used by consumers, who cannot access anything but their own accounts.

While consumers can enroll on their own, many turn to agents for assistance. There are about 70,000 licensed agents nationwide certified to use the healthcare.gov site or its partner enrollment platforms. They must meet certain training and licensing requirements to do so. Brooker has been quick to say it is a minority of agents who are causing the problem.

But agents increasingly are frustrated by what they describe as a sharp increase during the second half of 2023 and into 2024 of unscrupulous rivals switching people from one plan to another, or at least switching the “agent of record” on the accounts, which directs the commission to the new agent. Wu’s statements have so far not included requested information on the number of complaints about unauthorized switching, or the number of agents who have been sanctioned as a result.

The changes shielding the Social Security numbers are helpful, Brooker said, but won’t necessarily slow unauthorized switching of plans. Rogue agents can still switch an enrollee’s plan with simply their name, date of birth, and state of residence, despite rules that require agents to collect written or recorded consent from consumers before making any changes.

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El tipo de alimentación está vinculado a tasas más altas de preeclampsia en latinas

Kaiser Health News:States - April 08, 2024

Para las latinas embarazadas, la elección de los alimentos podría reducir el riesgo de preeclampsia, un tipo especialmente peligroso de hipertensión. Un nuevo estudio muestra que es más probable que una dieta basada en preferencias alimentarias culturales, en lugar de las guías oficiales, ayude a prevenir esta enfermedad.

Investigadores de la Escuela de Medicina Keck de la USC encontraron que una combinación de grasas sólidas, granos refinados y queso se relacionaba con mayores tasas de preeclampsia entre un grupo de latinas de bajos ingresos de Los Ángeles. Por el contrario, las mujeres que consumían vegetales, frutas y comidas preparadas con aceites saludables tenían menos probabilidades de desarrollar la enfermedad.

La combinación de vegetales, frutas y aceites saludables, como el de oliva, mostró una correlación más fuerte con tasas más bajas de preeclampsia que el Índice de Alimentación Saludable-2015, una lista de recomendaciones nutricionales diseñadas por el Departamento de Agricultura de Estados Unidos (USDA) y el Departamento de Salud y Servicios Humanos (HHS).

El estudio, publicado en la edición de febrero de la revista de la Asociación Americana del Corazón (AHA), proporcionó información importante sobre qué combinaciones de alimentos afectan a las latinas embarazadas, explicó Luis Maldonado, investigador principal y becario postdoctoral del Departamento de Ciencias de la Población y Salud Pública de USC Keck. El trabajo sugiere que las recomendaciones dietéticas para estas latinas deberían incorporar más alimentos propios de sus culturas, apuntó.

“Muchos estudios que se han realizado con mujeres embarazadas en general han sido predominantemente blancos [no hispanos], y la dieta está muy ligada a la cultura”, dijo Maldonado. “Tu cultura puede facilitar cómo comes porque sabes cuál es tu comida favorita”.

En Estados Unidos, se estima que la preeclampsia ocurre en aproximadamente el 5% de los embarazos, y está entre las principales causas de morbilidad materna, según los Centros para el Control y Prevención de Enfermedades (CDC). Suele presentarse durante el tercer trimestre de gestación y está asociada con la obesidad, la hipertensión y la enfermedad renal crónica, entre otras afecciones.

No hay una forma de curar o predecir la preeclampsia. La enfermedad puede dañar el corazón y el hígado, y causar otras complicaciones tanto para la madre como para el bebé, incluido el parto prematuro e incluso la muerte.

Las tasas de preeclampsia han aumentado en las últimas dos décadas a nivel nacional. En California, aumentaron un 83%, y las tasas de hipertensión un 78% entre 2016 y 2022, según los datos más recientes disponibles, y son más altas entre los residentes negros y los habitantes de las islas del Pacífico.

Maldonado dijo que el 12% de las 451 mujeres latinas que participaron en el estudio desarrollaron preeclampsia, un número que representa casi el doble del promedio nacional. Más de la mitad de las participantes, de 28 años promedio, tenían factores de riesgo antes de embarazarse, como índice de masa corporal alto y diabetes.

Maldonado y su equipo utilizaron datos del Maternal and Developmental Risks from Environmental and Social Stressors Center, un grupo de investigación de la USC que estudia los efectos de las exposiciones ambientales y disparadores sociales de estrés en la salud de las madres y sus hijos.

Las participantes, que eran predominantemente latinas de bajos ingresos de Los Ángeles, completaron dos cuestionarios sobre su dieta durante el tercer trimestre de sus embarazos. Los investigadores identificaron dos patrones alimenticios significativos: uno en el que los alimentos más consumidos eran vegetales, aceites, frutas, granos enteros y yogur; y un segundo en el que la dieta de las mujeres consistía principalmente en grasas sólidas, granos refinados, queso, azúcar agregado y carne procesada.

El grupo de mujeres que siguió el primer patrón nutricional tuvo una tasa más baja de preeclampsia que el que se ajustó al segundo patrón.

Cuando Maldonado y su equipo buscaron una correlación entre tasas más bajas de preeclampsia y el Índice de Alimentación Saludable-2015, encontraron que no era estadísticamente significativa excepto en las mujeres que tenían sobrepeso antes del embarazo.

El Índice de Alimentación Saludable incluye combinaciones de nutrientes y alimentos, como lácteos y ácidos grasos. Maldonado dijo que se necesita más investigación para determinar el perfil exacto de frutas, vegetales y aceites que podría beneficiar a las mujeres latinas.

Cuando se trata de la dieta, el mensaje y las recomendaciones adecuadas son vitales para ayudar a las latinas embarazadas a tomar decisiones informadas, expresó A. Susana Ramírez, profesora asociada de comunicación de salud pública en la Universidad de California-Merced.

Ramírez ha realizado estudios sobre por qué los mensajes de alimentación saludable, aunque bien intencionados, no han tenido éxito en las comunidades hispanas. Encontró que estos mensajes han llevado a algunos latinos a creer que la comida mexicana es menos saludable que la comida estadounidense.

Ramírez dijo que necesitamos pensar en promover dietas que sean relevantes para una población particular. “Ahora entendemos que la dieta es tremendamente importante para la salud, y por lo tanto, en la medida en que cualquier asesoramiento nutricional sea culturalmente acorde, esto mejorará la salud en general”, dijo Ramírez.

Esta historia fue producida por KFF Health News, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

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Rising Complaints of Unauthorized Obamacare Plan-Switching and Sign-Ups Trigger Concern

Kaiser Health News:Insurance - April 08, 2024

Federal and state regulators aren’t doing enough to stop the growing problem of rogue health insurance brokers making unauthorized policy switches for Affordable Care Act policyholders, say consumers, agents, nonprofit enrollee assistance groups, and other insurance experts.

“We think it’s urgent and it requires a lot more attention and resources,” said Jennifer Sullivan, director of health coverage access for the Center on Budget and Policy Priorities.

The Centers for Medicare & Medicaid Services, which oversees the ACA, “has acknowledged the issue,” said former Oklahoma insurance commissioner John Doak. “But it appears their response is inadequate.”

The reactions follow a KFF Health News article outlining how licensed brokers’ easy access to policyholder information on healthcare.gov has led unscrupulous agents to switch people’s policies without express permission. Those agents can then take the commission that comes with signing a new customer. Dozens of people and insurance brokers responded to the earlier report recounting similar situations.

Some switched policyholders end up in plans that don’t include their doctors or the medications they regularly take, or come with higher deductibles than their original coverage choice. If their income or eligibility for premium tax credits is misrepresented, some people end up owing back taxes.

Agents whose clients have been affected say the switches ramped up last year and are continuing into 2024, although quantifying the problem continues to be difficult. The problem seems concentrated on the federal healthcare.gov website, which is the marketplace where people in 32 states buy ACA plans, which are also known as Obamacare. CMS declined to provide the number of complaints that have been filed.

Even so, CMS representatives said during a December committee meeting of the National Association of Insurance Commissioners that they were “acutely aware” of the problem and were working on solutions.

A similar NAIC gathering was held in March. During those meetings, state regulators urged CMS officials to look for unauthorized switches, rather than reacting only to filed complaints. State regulators also want the agency to tell them sooner about agents or brokers under investigation, and to be provided with the number of affected consumers in their regions.

In an April 4 written statement to KFF Health News, Jeff Wu, acting director of CMS’ Center for Consumer Information & Insurance Oversight, pointed to the agency’s sharp prohibition on agents enrolling people or changing their plans without getting written or recorded consent, and said his team is “analyzing potential additional system controls to block unauthorized or fraudulent activity.”

It is also working with state regulators and large broker agencies, Wu wrote, to identify “the most effective ways to root out bad actors.” He also said more agents and brokers are being suspended or terminated from healthcare.gov.

Wu did not provide, however, a tally of just how many have been sanctioned.

Low-income consumers are often targeted, possibly because they qualify for zero-premium plans, meaning they might not know they’ve been switched or enrolled because they aren’t paying a monthly bill.

Also, rules took effect in 2022 that allow low-income residents to enroll at any time of the year, not just during the annual open enrollment period. While the change was meant to help people who most need to access coverage, it has had the unintended effect of creating an opportunity for this scheme to ramp up.

“There have been bad apples out there signing people up and capturing the commissions to do so for a while, but it’s exacerbated in the last couple of years, turning it from a few isolated incidents to something more common,” said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University.

Many victims don’t know they’ve been switched until they try to use their plans — either because agents changed the policy without talking to them or because the consumer unknowingly enrolled by responding to online advertisements promising gift cards, government subsidies, or free health insurance.

The challenge now is how federal regulators and their counterparts in the states can thwart the activity without diminishing enrollment — a top priority for the marketplace. In fact, Obamacare’s record-breaking enrollment figures are being touted prominently in President Joe Biden’s reelection campaign.

Thwarting the switches “really comes down to oversight and enforcement,” Corlette said. “As soon as regulators identify someone who is engaged in unauthorized plan-switching or enrollment, they need to cut them off immediately.”

That isn’t simple.

For starters, consumers or their agents must report suspected problems to state and federal regulators before investigations are launched.

Such investigations can take weeks and states generally don’t have access to complaints until federal investigators finish an inquiry, state regulators complained during the NAIC meetings.

Doak attended the December meeting, where he urged federal regulators to look for patterns that might indicate unauthorized switching — such as policyholders’ coverage being changed multiple times in a short period — and then quickly initiate follow-up with the consumer.

“All regulators have a duty to get on top of this issue and protect the most vulnerable consumers from unknowingly having their policies moved or their information mistreated,” Doak told KFF Health News. He is now executive vice president of government affairs for Insurance Care Direct, a health insurance brokerage.

Being more proactive requires funding.

Wu said the agency’s administrative budget has remained nearly flat for 13 years even as enrollment has grown sharply in the ACA and the other health programs it oversees.

And the complaint process itself can be cumbersome because it can involve different state or federal agencies lacking coordination.

Even after complaints are filed, state or federal officials follow up directly with the consumer, who might have limited English proficiency, lack an email address, or simply not answer their phone — which can stall or stop a resolution, said Katie Roders Turner, executive director of the Family Healthcare Foundation, a Tampa Bay, Florida, nonprofit that helps people enroll or deal with problems that arise with their plans.

Suggested improvements include creating a central form or portal for complaints and beefing up safeguards on the healthcare.gov site to prevent such unauthorized activity in the first place. 

Currently, licensed agents need only a name, date of birth, and state of residence to access policyholder information and make changes. That information is easy to obtain.

States that run their own marketplaces — there are 18 and the District of Columbia — often require more information, such as a one-time passcode sent to the consumer, who then gives it to their chosen agent.

In the meantime, the frustration is increasing.

Lauren Phillips, a sales agent in Georgia, said she reached out to an agent in Florida who was switching one of her clients, asking her to stop. When it happened again to the same client, she reported it to regulators.

“Their solution was for me to just watch the policy and fix it if it happens again, which is not a viable solution, “Phillips said.

Recently, after noticing the client’s policy had been switched again, she reported it and changed it back. When she checked two mornings later, the policy had been terminated.

“Now my client has no insurance at all,” Phillips said. “They say they are working on solutions. But here we are in the fourth month of the year and agents and consumers are still suffering at the hands of these terrible agents.”

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Ten Doctors on FDA Panel Reviewing Abbott Heart Device Had Financial Ties With Company

When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn’t disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database.

One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A third member of the committee worked on research supported by more than $180,000 from the company.

The government database, called “Open Payments,” records financial relationships between doctors and certain other health care providers and the makers of drugs and medical devices. KFF Health News found records of Abbott payments associated with 10 of the 14 voting members of the FDA advisory panel, which was weighing clinical evidence for a heart device called TriClip G4 System. The money, paid from 2016 through 2022 — the most recent year for which the database shows payments — adds up to about $650,000.

The panel voted almost unanimously that the benefits of the device outweigh its risks. Abbott announced on April 2 that the FDA had approved TriClip, which is designed to treat leakage from the heart’s tricuspid valve.

The Abbott payments illustrate the reach of medical industry money and the limits of transparency at the FDA. They also shed light on how the agency weighs relationships between people who serve on its advisory panels and the makers of drugs and medical devices that those committees review as part of the regulatory approval process.

The payments do not reflect wrongdoing on the part of the agency, its outside experts, or the device manufacturer. The database does not show that any of the payments were related directly to the TriClip device.

But some familiar with the process, including people who have served on FDA advisory committees, said the payments should have been disclosed at the Feb. 13 meeting — if not as a regulatory requirement, then in the interest of transparency, because the money might call into question committee members’ objectivity.

“This is a problem,” Joel Perlmutter, a former FDA advisory committee member and a professor of neurology at Washington University School of Medicine in St. Louis, said by email. “They should or must disclose this due to bias.”

The Open Payments database records several kinds of payments from drug and device makers. One category, called “associated research funding,” supports research in which a physician is named a principal investigator in the database. Another category, called “general payments,” includes consulting fees, travel expenses and meals connected to physicians in the database. The money can flow from manufacturers to third parties, such as hospitals, universities, or other corporate entities, but the database explicitly connects doctors by name to the payments.

At the public meeting to consider the TriClip device, an FDA official announced that committee members had been screened for potential financial conflicts of interest and found in compliance with government requirements.

FDA spokesperson Audra Harrison said by email that the agency doesn’t comment on matters related to individual advisory committee members.

“The FDA followed all appropriate procedures and regulations in vetting these panel members and stands firmly by the integrity of the disclosure and vetting processes in place,” she said. “This includes ensuring advisory committee members do not have, or have the appearance of, a conflict of interest.”

Abbott “has no influence over who is selected to participate in FDA advisory committees,” a spokesperson for the company, Brent Tippen, said in a statement.

Diana Zuckerman, president of the National Center for Health Research, a think tank, said the FDA shouldn’t have allowed recipients of funding from Abbott in recent years to sit in judgment of the Abbott product. The agency takes too narrow a view of what should be disqualifying, she said.

One committee member was Craig Selzman, chief of the Division of Cardiothoracic Surgery at the University of Utah. The Open Payments database connects to Selzman about $181,000 in associated research funding from Abbott to the University of Utah Hospitals & Clinics.

Asked in an interview if a reasonable person could question the impartiality of committee members based on the Abbott payments, Selzman said: “People from the outside looking in would probably say yes.”

He noted that Abbott’s money went to the university, not to him personally. Participating in industry-funded clinical trials benefits doctors professionally, he said. He added: “There’s probably a better way to provide transparency.”

The FDA has a history of appointing people to advisory committees who had relationships with manufacturers of the products under review. For example, in 2020, the doctor who chaired an FDA advisory committee reviewing Pfizer’s covid-19 vaccine had been a Pfizer consultant.

Appearance Issues

FDA advisory committee candidates, selected to provide expert advice on often complicated drug and device applications, must complete a confidential disclosure report that asks about current and past financial interests as well as “anything that would give an ‘appearance’ of a conflict.”

The FDA has discretion to decide whether someone with an “appearance issue” can serve on a panel, according to a guidance document posted on the agency’s website. Relationships more than a year in the past generally don’t give rise to appearance problems, according to the document, unless they suggest close ties to a company or involvement with the product under review. The main question is whether financial interests would cause a reasonable person to question the member’s impartiality, the document says.

The FDA draws a distinction between appearance issues and financial conflicts of interest. Conflicts of interest occur when someone chosen to serve on an advisory committee has financial interests that “may be impacted” by their work on the committee, an FDA explainer says.

If the FDA finds a conflict of interest but still wants the applicant on a panel, it can issue a public waiver. None of the panelists voting on TriClip received a waiver.

The FDA’s approach to disclosure contrasts with rules for conferences at which doctors earn credit for continuing medical education. For example, for a recent conference in Boston on technology for treatment of heart failure, including TriClip, the group holding the meeting directed speakers to include in their slide presentations disclosures going back 24 months.

Those disclosures — naming companies from which speakers had received consulting fees, grant support, travel expenses, and the like — also appeared on the conference website.

Unbridled Enthusiasm

The FDA has designated TriClip a “breakthrough” device with “the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease” compared with current treatments, an agency official, Megan Naber, told the advisory committee.

Naber said that for breakthrough devices, the “totality of data must still provide a reasonable assurance of safety and effectiveness” but the FDA “may be willing to accept greater uncertainty” about the balance of risks and benefits.

In a briefing paper for the advisory committee, FDA staff pointed out findings from a clinical trial that didn’t reflect well on TriClip. For example, patients treated with TriClip had “numerically higher” mortality and heart failure hospitalization rates during the 12 months after the procedure compared with a control group, according to the report. Tippen, the Abbott spokesperson, didn’t respond to a request for comment on those findings.

The committee voted 14-0 that TriClip was safe for its intended use. The panel voted 12-2 that the device was effective, and it voted 13-1 that the benefits of TriClip outweighed the risks.

The committee member to whom the database attributes the most money from Abbott, Paul Hauptman, cast one of the votes against the device on effectiveness and the sole vote against the device on the bottom-line question of its risks versus benefits.

Hauptman said during the meeting that the question of safety was “very, very clear” but added: “I just felt the need to pull back a little bit on unbridled enthusiasm.” Who will benefit from the device, he said, “needs better definition.”

Hauptman, dean of the University of Nevada-Reno School of Medicine, is connected to 268 general payments from Abbott totaling about $197,000 in the Open Payments database. Some payments are listed as going to an entity called Keswick Cardiovascular.

Hauptman said in an email that he followed FDA guidance and added, “My impartiality speaks for itself based on my vote and critical comments.”

Some committee members voted in favor of the device despite concerns.

Marc Katz, chief of the Division of Cardiothoracic Surgery at the Medical University of South Carolina, is linked to 77 general payments totaling about $53,000 from Abbott and worked on research supported by about $10,000 from the company, according to Open Payments.

“I voted yes for safety, no for effectiveness, but then caved and voted yes for the benefits outweighing the risks,” he said in the meeting.

In an email, he said of his Abbott payments: “All was disclosed and reviewed by the FDA.” He said that he “can be impartial” and that he “openly expressed … concerns about the treatment.”

Mitchell Krucoff, a professor at Duke University School of Medicine, is connected to 100 general payments totaling about $105,000. Some went to a third party, HPIC Consulting. He also worked on research supported by about $51,000 from Abbott, according to Open Payments.

He said during the meeting that he voted in favor of the device on all three questions and added that doctors have “a lot to learn” once it’s on the market. For instance: By using the device to treat patients now, “do we set people up for catastrophes later?”

In an email, Krucoff said he completed a “very thorough conflict of interest screening by FDA for this panel,” which focused not only on Abbott but also on “any work done/payments received from any other manufacturer with devices in this space.”

John Hirshfeld Jr., an emeritus professor of medicine at the University of Pennsylvania, is linked by the database to six general payments from Abbott totaling $6,000. Two of the payments linked to him went to a nonprofit, the Cardiovascular Research Foundation, according to the database. He voted yes on all three questions about TriClip but said at the meeting that he “would have liked to have seen more rigorous data to support efficacy.”

In an email, Hirshfeld said he disclosed the payments to the FDA. The agency did not deem him to have a conflict because he had no stake in Abbott’s success and his involvement with the company had ended, he said. Through the conflict-of-interest screening process, he said, he had been excluded from prior advisory panels.

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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Cada vez mueren más menores por sobredosis. ¿Podrían los pediatras ayudar más?

Kaiser Health News:States - April 08, 2024

Un joven de 17 años, con el pelo rubio desgreñado, se subió a la balanza del Centro de Salud Familiar Tri-River de Uxbridge, en Massachusetts.

Después que lo pesaran, caminó hacia un consultorio decorado con calcomanías de planetas y personajes de dibujos animados. Una enfermera le tomó la presión arterial. Un pediatra le preguntó por sus estudios, su vida familiar y sus amigos.

Parecía un examen de rutina para adolescentes, de los miles que se hacen a diario en consultas pediátricas en el país. Hasta que el doctor Safdar Medina le preguntó:

“¿Tienes deseos de consumir opioides?”. El paciente negó con la cabeza.

“¿Ninguno, en absoluto?”, volvió a preguntar Medina para confirmar.

“Ninguno”, respondió el adolescente, llamado Sam, con voz tranquila pero segura.

(En este artículo sólo se utiliza el nombre de pila de Sam porque, si se publicara su apellido, en el futuro podría ser discriminado en la búsqueda de vivienda y empleo por haber consumido drogas).

El doctor Medina está tratando a Sam por su adicción a estas drogas. Le receta un medicamento llamado buprenorfina, que reduce las ansias de consumir las píldoras de opioides más peligrosas y adictivas. Los análisis de orina de Sam no muestran signos de Oxycontin o Percocet, las pastillas que él compraba en Snapchat y que alimentaron su adicción.

“Lo que realmente me enorgullece de tí, Sam, es tu esfuerzo por estar mejor”, lo felicitó Medina, que trabaja en el UMass Memorial Health.

La Academia Americana de Pediatría recomienda ofrecer buprenorfina a los adolescentes adictos a los opiáceos. Sin embargo, según los resultados de una encuesta, solo el 6% de los pediatras informa haberlo hecho alguna vez.

De hecho, al mismo tiempo que las recetas de buprenorfina para adolescentes fueron disminuyendo, se duplicaron las muertes por sobredosis en niños y adolescentes entre 10 y 19 años. Estas sobredosis, junto con los envenenamientos accidentales por opioides en niños pequeños, se han convertido en la tercera causa de muerte infantil en Estados Unidos.

“Estamos realmente lejos de donde deberíamos estar y nos encontramos bastante atrasados en varios aspectos”, comentó Scott Hadland, jefe de Medicina para Adolescentes del Hospital General de Niños de Massachusetts y coautor de una encuesta entre pediatras sobre el tratamiento de adicciones.

Los resultados de las entrevistas mostraron que muchos pediatras no creen tener ni la formación adecuada ni el personal necesario para atender pacientes con adicciones, aunque Medina y otros médicos que sí lo hacen afirmaron que no han tenido que contratar más personal.

Algunos entrevistados explicaron que no atienden un número de pacientes que justifique formarse en esa especialización y otros piensan que la atención de adictos no es responsabilidad de la Pediatría.

“Gran parte de esas ideas son producto de la educación que reciben los médicos”, dijo Deepa Camenga, directora asociada al área pediátrica del Programa de Medicina de Adicciones de la Escuela de Medicina de Yale. “Como se considera algo muy especializado, no está incluido en la formación médica habitual”, explicó.

Camenga y Hadland mencionaron que las escuelas de Medicina y los programas de residencia pediátrica están trabajando para incorporar información sobre trastornos por consumo de sustancias a los planes de estudio. Esto incluye cómo abordar el consumo de drogas y alcohol con niños y adolescentes.

Sin embargo, los programas de estudio no cambian lo suficientemente rápido como para ayudar a la cantidad de jóvenes que luchan contra una adicción y mucho menos a los que mueren después de tomar una sola pastilla.

Es una paradoja perversa y mortífera: mientras disminuye el consumo de drogas entre los adolescentes, las muertes asociadas a las drogas han aumentado.

La principal causa es la falsificación de pastillas de Xanax, Adderall o Percocet, adulteradas con fentanilo, un poderoso opioide. Casi el 25% de las muertes recientes por sobredosis en jóvenes de 10 a 19 años se atribuyeron a estas pastillas.

“El fentanilo y las pastillas falsificadas realmente están complicando nuestros esfuerzos para frenar las sobredosis”, dijo Andrew Terranella, experto en Medicina de adicción y prevención de sobredosis en adolescentes de los Centros para el Control y Prevención de Enfermedades (CDC). “Muchas veces, estos jóvenes sufren una sobredosis sin siquiera darse cuenta de lo que están tomando.”

Terranella, que ejerce en Tucson, Arizona, opina que los pediatras pueden ayudar mucho si refuerzan la detección del consumo de drogas en sus pacientes y conversan con ellos sobre los riesgos.

También sugiere que receten más naloxona, el aerosol nasal que puede revertir una sobredosis. Está disponible sin receta, pero Terranella cree que una receta médica puede tener más relevancia para los pacientes.

De vuelta en el consultorio, Sam estaba a punto de recibir su primera inyección de Sublocade, una forma de buprenorfina que dura 30 días. Está cambiando a las inyecciones porque no le gusta el sabor de Suboxone, unas tiras orales de buprenorfina que debía disolver debajo de su lengua. Las escupía antes de recibir una dosis completa.

Muchos médicos prefieren recetar las inyecciones porque los pacientes no tienen que recordar tomarlas todos los días. Pero la inyección es dolorosa y Sam se sorprendió cuando le dijeron que se la aplicarían en el vientre durante 20-30 segundos.

“¿Ya casi terminamos?”, preguntó Sam, mientras una enfermera le pedía que respirara hondo. Cuando terminó, el personal bromeó en voz alta diciendo que incluso los adultos suelen decir palabrotas cuando les ponen esa inyección. Sam dijo que no sabía que eso estaba permitido. Lo que más lo preocupaba era si un dolor residual podría interferir con los planes que tenía esa noche.

“¿Cree que podré hacer snowboard esta noche?”, le preguntó al doctor.

“Estoy absolutamente seguro de que podrás hacer snowboard esta noche”, lo tranquilizó Medina.

Sam iba a ir con un nuevo amigo. Hacer nuevos amigos y cortar lazos con su antiguo círculo social de adolescentes que consumen drogas ha sido una de las cosas más difíciles, dijo Sam, desde que entró en rehabilitación hace 15 meses.

“Hay que concentrase en encontrar la gente adecuada”, dijo Sam. “Ese sería mi mayor consejo”.

Para Sam, encontrar un tratamiento contra la adicción en un consultorio repleto de rompecabezas, juguetes y libros ilustrados no ha sido tan extraño como imaginaba.

Su madre, Julie, lo había acompañado a la consulta. Dice que está agradecida de que la familia haya encontrado un médico que entiende a los adolescentes y a las adicciones.

Antes de empezar a ir el Centro de Salud Familiar Tri-River, Sam estuvo siete meses en tratamiento residencial y ambulatorio, sin que le ofrecieran buprenorfina para ayudarlo a controlar los impulsos de consumir y prevenir las recaídas. Sólo uno de cada cuatro tratamientos residenciales para jóvenes la ofrece. Cuando Sam volvió a sentir fuertes deseos de consumir opioides, un consejero le sugirió a Julie que llamara a Medina.

“Dios mío, ojalá hubiera traído a Sam aquí hace dos o tres años”, dijo Julie. “¿Habría cambiado lo que sucedió? No lo sé, pero hubiera sido un nivel de atención más adecuado para él”.

A algunos padres y pediatras les preocupa administrar buprenorfina a un adolescente, ya que puede producir efectos secundarios, incluida la dependencia a largo plazo. Los pediatras que la recetan evalúan el efecto de los posibles efectos secundarios en relación con la amenaza de una sobredosis de fentanilo.

“En esta época, en la que los jóvenes mueren a un ritmo realmente sin precedentes por sobredosis de opiáceos, es fundamental que salvemos vidas”, afirmó Hadland. “Y sabemos que la buprenorfina es un medicamento que salva vidas”, agregó.

El tratamiento de una adicción le puede insumir mucho tiempo a un pediatra. Sam y Medina se envían mensajes de texto varias veces a la semana y el pediatra recalca que no comparte ningún intercambio que Sam haya pedido que fuera confidencial.

Medina dice que tratar el trastorno por consumo de sustancias es una de las cosas más gratificantes que hace. “Si podemos solucionarlo”, dice, “habremos formado un adulto que ya no tendrá que preocuparse por estos problemas de por vida”.

Este artículo es producto de una asociación que incluye a WBUR, NPR y 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 Assess the Risks of Bird Flu and the Impacts of Medicaid ‘Unwinding’

Kaiser Health News:Insurance - April 06, 2024

KFF Health News senior fellow and editor-at-large for public health Céline Gounder discussed bird flu on CBS News’ “CBS Mornings” on April 2.

El Tímpano reporter Jasmine Aguilera, who has been reporting in collaboration with KFF Health News and California Healthline, discussed how Hispanic communities are affected by the process of Medicaid “unwinding” on Radio Bilingüe on April 4.

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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More Kids Are Dying of Drug Overdoses. Could Pediatricians Do More to Help?

Kaiser Health News:States - April 05, 2024

A 17-year-old boy with shaggy blond hair stepped onto the scale at Tri-River Family Health Center in Uxbridge, Massachusetts.

After he was weighed, he headed for an exam room decorated with decals of planets and cartoon characters. A nurse checked his blood pressure. A pediatrician asked about school, home life, and his friendships.

This seemed like a routine teen checkup, the kind that happens in thousands of pediatric practices across the U.S. every day — until the doctor popped his next question.

“Any cravings for opioids at all?” asked pediatrician Safdar Medina. The patient shook his head.

“None, not at all?” Medina said again, to confirm.

“None,” said the boy named Sam, in a quiet but confident voice.

Only Sam’s first name is being used for this article because if his full name were publicized he could face discrimination in housing and job searches based on his prior drug use.

Medina was treating Sam for an addiction to opioids. He prescribed a medication called buprenorphine, which curbs cravings for the more dangerous and addictive opioid pills. Sam’s urine tests showed no signs of the Percocet or OxyContin pills he had been buying on Snapchat, the pills that fueled Sam’s addiction.

“What makes me really proud of you, Sam, is how committed you are to getting better,” said Medina, whose practice is part of UMass Memorial Health.

The American Academy of Pediatrics recommends offering buprenorphine to teens addicted to opioids. But only 6% of pediatricians report ever doing do, according to survey results.

In fact, buprenorphine prescriptions for adolescents were declining as overdose deaths for 10- to 19-year-olds more than doubled. These overdoses, combined with accidental opioid poisonings among young children, have become the third-leading cause of death for U.S. children.

“We’re really far from where we need to be and we’re far on a couple of different fronts,” said Scott Hadland, the chief of adolescent medicine at Mass General for Children and a co-author of the study that surveyed pediatricians about addiction treatment.

That survey showed that many pediatricians don’t think they have the right training or personnel for this type of care — although Medina and other pediatricians who do manage patients with addiction say they haven’t had to hire any additional staff.

Some pediatricians responded to the survey by saying they don’t have enough patients to justify learning about this type of care, or don’t think it’s a pediatrician’s job.

“A lot of that has to do with training,” said Deepa Camenga, associate director for pediatric programs for the Yale Program in Addiction Medicine. “It’s seen as something that’s a very specialized area of medicine and, therefore, people are not exposed to it during routine medical training.”

Camenga and Hadland said medical schools and pediatric residency programs are working to add information to their curricula about substance use disorders, including how to discuss drug and alcohol use with children and teens.

But the curricula aren’t changing fast enough to help the number of young people struggling with an addiction, not to mention those who die after taking just one pill.

In a twisted, deadly development, drug use among adolescents has declined — but drug-associated deaths are up.

The main culprits are fake Xanax, Adderall, or Percocet pills laced with the powerful opioid fentanyl. Nearly 25% of recent overdose deaths among 10- to 19-year-olds were traced to counterfeit pills.

“Fentanyl and counterfeit pills is really complicating our efforts to stop these overdoses,” said Andrew Terranella, the Centers for Disease Control and Prevention’s expert on adolescent addiction medicine and overdose prevention. “Many times these kids are overdosing without any awareness of what they’re taking.”

Terranella said pediatricians can help by stepping up screening for — and having conversations about — all types of drug use.

He also suggests pediatricians prescribe more naloxone, the nasal spray that can reverse an overdose. It’s available over the counter, but Terranella, who practices in Tucson, Arizona, believes a prescription may carry more weight with patients.

Back in the exam room, Sam was about to get his first shot of Sublocade, an injection form of buprenorphine that lasts 30 days. Sam is switching to the shots because he didn’t like the taste of Suboxone, oral strips of buprenorphine that he was supposed to dissolve under his tongue. He was spitting them out before he got a full dose.

Many doctors also prefer to prescribe the shots because patients don’t have to remember to take them every day. But the injection is painful. Sam was surprised when he learned that it would be injected into his belly over the course of 20-30 seconds.

“Is it almost done?” Sam asked, while a nurse coaches him to breathe deeply. When it was over, staffers joked out loud that even adults usually swear when they get the shot. Sam said he didn’t know that was allowed. He’s mostly worried about any residual soreness that might interfere with his evening plans.

“Do you think I can snowboard tonight?” Sam asked the doctor.

“I totally think you can snowboard tonight,” Medina answered reassuringly.

Sam was going with a new buddy. Making new friends and cutting ties with his former social circle of teens who use drugs has been one of the hardest things, Sam said, since he entered rehab 15 months ago.

“Surrounding yourself with the right people is definitely a big thing you want to focus on,” Sam said. “That would be my biggest piece of advice.”

For Sam, finding addiction treatment in a medical office jammed with puzzles, toys, and picture books has not been as odd as he thought it would be.

He mom, Julie, had accompanied him to this appointment. She said she’s grateful the family found a doctor who understands teens and substance use.

Before he started visiting the Tri-River Family Health Center, Sam had seven months of residential and outpatient treatment — without ever being offered buprenorphine to help control cravings and prevent relapse. Only 1 in 4 residential programs for youth offer it. When Sam’s cravings for opioids returned, a counselor suggested Julie call Medina.

“Oh my gosh, I would have been having Sam here, like, two or three years ago,” Julie said. “Would it have changed the path? I don’t know, but it would have been a more appropriate level of care for him.”

Some parents and pediatricians worry about starting a teenager on buprenorphine, which can produce side effects including long-term dependence. Pediatricians who prescribe the medication weigh the possible side effects against the threat of a fentanyl overdose.

“In this era, where young people are dying at truly unprecedented rates of opioid overdose, it’s really critical that we save lives,” said Hadland. “And we know that buprenorphine is a medication that saves lives.”

Addiction care can take a lot of time for a pediatrician. Sam and Medina text several times a week. Medina stresses that any exchange that Sam asks to be kept confidential is not shared.

Medina said treating substance use disorder is one of the most rewarding things he does.

“If we can take care of it,” he said, “We have produced an adult that will no longer have a lifetime of these challenges to worry about.”

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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Dietary Choices Are Linked to Higher Rates of Preeclampsia Among Latinas

Kaiser Health News:States - April 05, 2024

For pregnant Latinas, food choices could reduce the risk of preeclampsia, a dangerous type of high blood pressure, and a diet based on cultural food preferences, rather than on U.S. government benchmarks, is more likely to help ward off the illness, a new study shows.

Researchers at the USC Keck School of Medicine found that a combination of solid fats, refined grains, and cheese was linked to higher rates of preeclampsia among a group of low-income Latinas in Los Angeles. By contrast, women who ate vegetables, fruits, and meals made with healthy oils were less likely to develop the illness.

The combination of vegetables, fruits, and healthy oils, such as olive oil, showed a stronger correlation with lower rates of preeclampsia than did the Healthy Eating Index-2015, a list of dietary recommendations designed by the U.S. Department of Agriculture and the Department of Health and Human Services.

The study, published in February by the Journal of the American Heart Association, yielded important information on which food combinations affect pregnant Latinas, said Luis Maldonado, the lead investigator and a postdoctoral scholar at the Department of Population and Public Health Sciences at USC Keck. It suggests that dietary recommendations for pregnant Latinas should incorporate more foods from their culture, he said.

“A lot of studies that have been done among pregnant women in general have been predominantly white, and diet is very much tied to culture,” Maldonado said. “Your culture can facilitate how you eat because you know what your favorite food is.”

Preeclampsia is estimated to occur in about 5% of pregnancies in the U.S. and is among the leading causes of maternal morbidity, according to the Centers for Disease Control and Prevention. It typically occurs during the third trimester of pregnancy and is associated with obesity, hypertension, and chronic kidney disease, among other conditions.

There isn’t a way to cure or predict preeclampsia. The disease can damage the heart and liver and lead to other complications for both the mother and the baby, including preterm birth and even death.

Rates of preeclampsia have increased in the past two decades nationally. In California, rates of preeclampsia increased by 83% and hypertension by 78% from 2016 to 2022, according to the most recent data available, and the conditions are highest among Black residents and Pacific Islanders.

Maldonado said 12% of the 451 Latina women who participated in the study developed preeclampsia, a number almost twice the national average. More than half of the participants, who averaged 28 years old, had pre-pregnancy risks, such as diabetes and high body mass index.

Maldonado and his team used data from the Maternal and Developmental Risks from Environmental and Social Stressors Center, a USC research group that studies the effects of environmental exposures and social stressors on the health of mothers and their children.

The subjects, who were predominantly low-income Latinas in Los Angeles, completed two questionnaires about their diet during the third trimester of their pregnancy. The researchers identified two significant patterns of eating: one in which the most consumed foods were vegetables, oils, fruits, whole grains, and yogurt; and a second in which the women’s diet consisted primarily of solid fats, refined grains, cheese, added sugar, and processed meat.

Women who followed the first eating pattern had a lower rate of preeclampsia than those who followed the second.

When Maldonado and his team tested for a correlation between lower rates of preeclampsia and the Healthy Eating Index-2015, they found it was not statistically significant except for women who were overweight before pregnancy.

The Healthy Eating Index includes combinations of nutrients and foods, like dairy and fatty acids. Maldonado said more research is needed to determine the exact profile of fruits, vegetables, and oils that could benefit Latina women.

When it comes to diet, the right messaging and recommendations are vital to helping pregnant Latinas make informed decisions, said A. Susana Ramírez, an associate professor of public health communication at the University of California-Merced.

Ramírez has conducted studies on why healthy-eating messages, while well intended, have not been successful in Hispanic communities. She found that the messaging has led some Latinos to believe that Mexican food is unhealthier than American food.

Ramírez said we need to think about promoting diets that are relevant for a particular population. “We understand now that diet is enormously important for health, and so to the extent that any nutrition counseling is culturally consonant, that will improve health overall,” Ramírez said.

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

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

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Biden Is Right About $35 Insulin Cap but Exaggerates Prior Costs for Medicare Enrollees

Kaiser Health News:Insurance - April 05, 2024

Insulin for Medicare beneficiaries “was costing 400 bucks a month on average. It now costs $35 a month.”

President Joe Biden, in a March 22 speech

The cost of insulin in the United States has risen considerably in recent years, with some estimates finding that Americans have paid around 10 times as much for the drug as people in other developed countries.

But recent changes by the federal government and drug manufacturers have started to drive insulin prices down, something President Joe Biden often mentions at campaign events.

Biden told the crowd at a March 19 campaign reception in Reno, Nevada, that he’s fought for years to allow Medicare to negotiate with drug companies.

“How many of you know someone who needs insulin?” Biden asked. “OK, well, guess what? It was costing 400 bucks a month on average. It now costs $35 a month.”

We’ve heard Biden make this point several times on the campaign trail — in other instances, he has said beneficiaries were paying “as much as” $400 a month — so we wanted to look into it.

The Inflation Reduction Act, which Biden signed in 2022, caps out-of-pocket insulin costs at $35 a month for Medicare enrollees. The cap took effect in 2023. In response, three drug manufacturers said they planned to reduce the price of insulin to $35 through price caps or savings programs.

The legislation also helped patients by clarifying how much they would have to pay for insulin and other drugs.

But Biden overstated the average monthly cost that Medicare beneficiaries were paying before the law.

One government estimate for out-of-pocket insulin costs found that people with diabetes enrolled in Medicare or private insurance paid an average of $452 a year — not a month, as Biden said. That’s according to a December 2022 report by the Department of Health and Human Services using 2019 data. Uninsured users, however, paid more than twice as much on average for the drug, or about $996 annually.

About Half of US Insulin Users Are on Medicare

More than 37 million Americans have diabetes, and more than 7 million of them need insulin to control their blood sugar levels and prevent dangerous complications. Of the Americans who take the drug, about 52% are on Medicare.

It’s unlikely that many Medicare enrollees were paying the $400 out-of-pocket monthly average Biden referred to, though it could be on target for some people, especially if they’re uninsured, drug pricing experts told us.

“It would be more accurate to say that it could cost people on Medicare over $400 for a month of insulin, but the average cost would have been quite a bit lower than $400 on Medicare,” said Stacie Dusetzina, a health policy professor at Vanderbilt University School of Medicine.

Medicare Part D, also called the Medicare prescription drug benefit, helps beneficiaries pay for self-administered prescriptions. The benefit has several phases, including a deductible, an initial coverage phase, a coverage gap phase, and catastrophic coverage. What Medicare beneficiaries pay for their prescriptions often depends on which phase they’re in.

“It is confusing, because the amount that a person was supposed to pay jumps around a lot in the Part D benefit,” Dusetzina said. For example, she said, Medicare beneficiaries would be more likely to pay $400 a month for insulin during months when they hadn’t yet met their deductible.

Mariana Socal, an associate scientist at Johns Hopkins Bloomberg School of Public Health, said it’s also difficult to estimate insulin’s precise cost under Medicare because individual prices hinge on other factors, such as how many other prescription medications patients take.

“Because the Medicare program has multiple instances where the patient is required to pay a coinsurance (percentage of the drug’s cost) to get their drug, it is very likely that patients were paying much more than $35 per month, on average, before the cap established by the Inflation Reduction Act went into effect,” Socal wrote in an email.

There are different ways to administer insulin, including through a pump, inhaler, or pen injector filled with the medicine.

In a 2023 report, HHS researchers estimated that about 37% of insulin fills for Medicare enrollees cost patients more than $35, and 24% of fills exceeded $70. Nationally, the average out-of-pocket cost for insulin was $58 per fill, typically for a 30-day supply, the report found. Patients with private insurance or Medicare paid about $63 per fill, on average.

For people with employer-sponsored insurance, the average monthly out-of-pocket spending on insulin in 2019 was $82, according to a report published in October 2021 by the Health Care Cost Institute, a nonprofit that studies health care prices. The study found that the majority of patients were spending an average of $35 a month, or lower, on the drug. But among the “8.7% of individuals in the highest spending category,” the median monthly out-of-pocket spending on insulin was about $315, the study said.

Our Ruling

Biden said Medicare beneficiaries used to pay an average of $400 per month for insulin and are now paying $35 per month.

The Inflation Reduction Act capped the monthly price of insulin at $35 for Medicare enrollees, starting in 2023. The change built in price predictability and helped insulin users save hundreds of dollars a year.

However, most Medicare enrollees were not paying a monthly average of $400 before these changes, according to experts and government data. Costs vary, so it is possible some people paid that much in a given month, depending on their coverage phase and dosage.

Research has shown that patients with private insurance or Medicare often paid more than $35 a month for their insulin, sometimes much more, but not as high as the $400 average Biden cited.

We rate Biden’s statement Half True.

PolitiFact copy chief Matthew Crowley contributed to this report.

our sources

WhiteHouse.gov, “Remarks by President Biden at a Campaign Event | Reno, NV,” video, March 19, 2024

U.S. Department of Health and Human Services, “New HHS Report Finds Major Savings for Americans Who Use Insulin Thanks to President Biden’s Inflation Reduction Act,” Jan. 24, 2023

U.S. Department of Health and Human Services, “Insulin Affordability and the Inflation Reduction Act: Medicare Beneficiary Savings by State and Demographics,” revised Oct. 26, 2023

Bloomberg Law, “Insulin Costs Remain Top Target Beyond Biden’s Drug Price Cuts,” Oct. 26, 2023

The American Diabetes Association, “State Insulin Copay Caps,” accessed March 28, 2024

NPR, “Eli Lilly Cuts the Price of Insulin, Capping Drug at $35 per Month Out-of-Pocket,” March 1, 2023

WhiteHouse.gov, “FACT SHEET: President Biden’s Cap on the Cost of Insulin Could Benefit Millions of Americans in All 50 States,” March 2, 2023

Health Care Cost Institute, “Capping Out-of-Pocket Spending on Insulin Would Lower Costs for a Substantial Proportion of Commercially Insured Individuals,” Oct. 15, 2021

Centers for Disease Control and Prevention, “National Diabetes Statistics Report,” updated November 2023

KFF, “Insulin Out-of-Pocket Costs in Medicare Part D,” July 28, 2022

KFF Health News, “America Worries About Health Costs — And Voters Want to Hear From Biden and Republicans,” March 8, 2024

USA Facts, “A Cap on Insulin Costs Benefits Millions of Americans With Diabetes,” April 15, 2023

The Associated Press, “Insider Q&A: What’s Behind Rising Insulin Prices?” Aug. 5, 2018

USA Today, “Insulin $35 Cap Price Now in Effect, Lowering Costs for Many Americans With Diabetes,” Jan. 3, 2024

Email interview with Mariana Socal, associate scientist at Johns Hopkins Bloomberg School of Public Health, March 28, 2024

Email interview with Stacie Dusetzina, professor of health policy at Vanderbilt University, March 29, 2024

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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