The company’s fortunes cratered as demand for Covid-19 vaccines plummeted. But it was busy working on something else.

from NYT > Health https://ift.tt/B9fZnik

Northwestern University economist Chuck Manski studies decision-making amid uncertainty. That prepared him better than many other cancer patients to decide whether to stay on an immunotherapy treatment that was making him very ill.

For six months in 2022, Manski received monthly infusions of nivolumab to fight advanced melanoma. The drug ruined his thyroid gland, he said, requiring him to go on a special medication for the rest of his life, and caused severe dryness in his eyes, lips, and mouth. The FDA’s protocol for the drug called for an entire year of treatment, but Manski said his oncologist couldn’t explain why. It’s FDA-approved, “so that’s what we use,” she said.

By that point, Manski showed no cancer signs or symptoms, and after reading a lot of medical journal articles, he concluded that the intense side effects probably meant the treatment had done about all it could do.

“She couldn’t tell me a year was the optimal dose. Nobody could,” he said in a June interview from Spain, where he received an award for his economics work. “So I made my own diagnosis. I took myself off.”

Manski’s decision was in line with what doctors in Canada, Israel, Sweden, and other countries were already doing: giving lower doses of nivolumab, sold under the brand name Opdivo, and of a similar drug, pembrolizumab (Keytruda), or giving them for shorter periods or over longer intervals than the FDA recommended. In India, oncologists found that as little as one-twelfth of the labeled dosage of nivolumab had a powerful impact on several cancers.

“There is incredible uncertainty in drug dosing,” Manski said.

His experience impelled him to join an informal yet determined community of researchers, doctors, and patients pushing for extra studies to help patients and doctors find the right dosage for an array of cancer drugs. They point to evidence suggesting that taking smaller doses of some cancer drugs, or remaining on them for shorter periods, could save billions of dollars and prevent some of the worst side effects.

In a recent KFF survey, 43% of U.S. adults said they had skipped their medication in the past year because of cost. A Vanderbilt University study of Medicare enrollees released in 2022 found that 30% of cancer drug prescriptions went unfilled at the pharmacy.

But dose-optimization studies rarely occur after the early stages of a drug’s development, or once it’s on the market. By then, few parties in the U.S. healthcare system — beyond patients — have a stake in learning that a lower dosage could work as well while causing less harm.

Pharmaceutical companies have shown little interest in dialing back recommended dosages. Once they set the price for a drug, the more sales, the more profit. One study that examined 29 expensive cancer drugs estimated that if minimum necessary dosages had been used in 2024, the U.S. healthcare system could have saved roughly $31 billion.

“Decisions aren’t always made with the best needs of the patients in mind. The bottom line is another reason,” said Matthew Goetz, a breast cancer researcher at the Mayo Clinic Comprehensive Cancer Center.

A photo of two IV bags as someone receives immunotherapy medication for melanoma treatment. The leftmost IV bag has "nivolumab" written on it.
Doctors in other countries have been giving patients lower doses of nivolumab or giving them for shorter periods or over longer intervals than the FDA recommends. (George Frey/Bloomberg via Getty Images)

Merck last year sold nearly $32 billion worth of pembrolizumab, a drug that’s FDA-approved for more than 40 cancer conditions. It accounted for almost half of Merck’s drug sales. Bristol Myers Squibb, meanwhile, brought in $10 billion from nivolumab, which works similarly to pembrolizumab in tweaking the immune system. Three important but often toxic breast cancer drugs — Ibrance, Verzenio, and Kisqali — boosted revenue at Pfizer, Eli Lilly, and Novartis by $4.1 billion, $5.7 billion, and $4.8 billion, respectively.

Pembrolizumab is usually prescribed at a fixed dosage; nivolumab is sometimes prescribed at a fixed dosage, sometimes based on the patient’s weight. If the patient is dosed less than what’s on the label, drugmakers generally get less money. And they aren’t the only ones who lose out.

Through a federal program known as 340B, created in 1992 to subsidize the treatment of low-income patients, hospitals that treat a certain percentage of low-income patients can buy drugs at a steep discount, while charging insurers or patients more. For Medicare patients, doctors are paid an additional 6% of the drug’s average price for each infusion.

From 2010 to 2024, cancer drug revenue to doctors and hospitals increased from about $9 billion to nearly $36 billion, according to research by Aaron Mitchell of the Memorial Sloan Kettering Cancer Center. About half those profits came from immunotherapy drugs like pembrolizumab and nivolumab.

“Pembrolizumab is the lifeblood of American hospitals,” said Mark Ratain, a professor of medicine and chief hospital pharmacologist at University of Chicago Medicine. “That’s why you don’t see hospitals in this country running to do trials that test lower doses.”

A man stands in a garden area outside of his home. Foliage is seen blurred in the foreground.
Mark Ratain, a University of Chicago oncologist and clinical pharmacologist, battles what he sees as unnecessarily high dosages of high-cost cancer drugs such as Keytruda and Opdivo. (Taylor Glascock for KFF Health News)

Merck spokesperson Julie Cunningham said the drug’s dosage recommendations were based on extensive testing. “In a life-threatening and challenging disease such as cancer, it is critical that the dosing for a cancer therapy is established through well-designed clinical trials,” she said. “Changes in dose or duration that have not been similarly studied may potentially compromise the therapeutic effect.”

Still, some oncologists start their patients off slowly on any of a variety of cancer drugs, although there may be concerns about lawsuits by a patient or their survivors over a prescription of lower-than-labeled dosages.

Kathy Miller, a professor of oncology at the Indiana University School of Medicine, routinely starts metastatic breast cancer patients with 400 milligrams of Kisqali daily for three weeks (with one week off), rather than the 600 milligrams recommended on the label. Sometimes patients ask for the standard dosage.

“I have to tell them, ‘I don’t want to kill you,’” she said.

Insurers routinely challenge her lower-dosage prescriptions, Miller said, presumably because price rebates from the drug company are set to the standard dosage. To avoid endless phone battles with insurers, she prescribes 600 milligrams but tells her patients to take only two of the 200-mg pills and save the third for the next cycle.

Follow the Cures — And the Money

On May 31, at the annual meeting of the American Society of Clinical Oncology, or ASCO, at Chicago’s McCormick Place convention center, most of the audience of 8,000 rose in a prolonged standing ovation for the experimental drug daraxonrasib. Patients with pancreatic cancer who took the drug, according to the study presented that day, lived nearly twice as long — a median of 13 months — as those receiving chemotherapy.

The next day, in a slightly smaller hall, Amol Patel, a medical oncologist from New Delhi, discussed studies in various cancers in which 20- or 40-mg doses of nivolumab biweekly — one-sixth or one-twelfth the recommended dosage — gave Indian patients several months to a year longer survival than patients who underwent chemotherapy, and with fewer side effects.

Fewer than 100 people attended Patel’s talk.

The ingenious development of daraxonrasib was big news, since pancreatic cancer has been a death sentence until now. But from a global perspective, the news out of India might be just as important.

At the ASCO meeting, “the focus is always on the shiny new drug,” said Daniel Goldstein, an oncologist and drug policy researcher at the Rabin Medical Center in Israel who has fought for a decade, with some success, to lower pembrolizumab dosages in hospitals there and in other countries. “It can be quite lonely to be us,” he said, adding that he’s seen increasing appreciation of his work.

The data from India offered a glimpse of what could be. However, the studies Patel referred to compared ultralow-dosage immunotherapy to older chemo drugs; none compared ultralow doses against standard nivolumab or pembrolizumab treatments. In India, this would be a sterile exercise, because full-dose treatments are beyond the reach of any but the very wealthy, said Vanita Noronha, an oncologist at Tata Memorial Hospital in Mumbai.

Bristol Myers Squibb, or BMS, has a program to make its drugs available in lower-income countries. But the company hasn’t been involved in the lower-dose nivolumab trials and, in a statement to KFF Health News, said the evidence suggested that nivolumab at a lower dosage or shorter duration harmed patients.

While not all U.S. oncologists agree with BMS’ assertion, the Indian data is, to most, a mere curiosity. “Can we really give 20 milligrams as opposed to 240?” asked Jessica Bauman of the Fox Chase Cancer Center in Philadelphia. “The only way we know for sure is a randomized study between the low dose and the highest.”

And such trials are unlikely to occur. That means only poorer countries are going to host “this groundbreaking research,” said Ratain, who is also a cancer doctor at the University of Chicago Medical Center. “The Indians may have better immunotherapy than we do.”

Clinicians in Europe, where maximizing healthcare dollars has long been a priority, have taken a middle course, studying lower, but not ultralow, doses of immunotherapy.

Pulmonologist Michel van den Heuvel at Utrecht University is leading a study comparing the standard nivolumab dosage for lung cancer patients with one that is as much as 50% lower. He also considered giving the low doses half as frequently, but that would have raised ethical concerns and led to a more cumbersome research protocol, van den Heuvel said.

In the United States, researchers led by a group at the Dana-Farber Cancer Institute are taking another tack: evaluating whether patients who’ve done well on 27 weeks of pembrolizumab can stop taking it, rather than doing the additional six months per FDA protocol.

At the Veterans Health Administration, which has more leeway in testing money-saving medical procedures, doctors saved $1.5 million, about 10% of the previous pembrolizumab cost, over two years at three Veterans Affairs hospitals where they implemented a pilot program to dose patients less frequently, said Garth Strohbehn, a University of Michigan oncologist who also works at the VA.

It saves money and requires fewer visits for veterans who often live hours from the hospital, he said. “It also helps other patients because it opens more slots for infusion.”

Julie Gralow, ASCO’s executive vice president and chief medical officer, has made testing dosage a priority. She’s working with scientists in India on an ambitious clinical trial to compare standard nivolumab with four lower dosage levels.

She’s also leading an $11 million trial, supported by the federally funded Patient-Centered Outcomes Research Institute, to see whether breast cancer patients can be effectively started on lower doses of the drugs Kisqali and Ibrance, which, along with Verzenio, are in a class of key breast cancer drugs known as CDK4/6 inhibitors.

“We want to maintain efficacy. But we also want patients to have excellent quality of life,” she said. Especially for patients with advanced cancers, where absolute cure is unlikely, “it’s our job to make sure we’re not compromising quality of life with higher doses that are unnecessary.”

In 2021, at Ratain’s urging, Richard Pazdur, who led the FDA’s cancer drug division for many years, launched Project Optimus, intended to get companies to conduct dosing studies that are more precise before launching the large clinical trials they use to obtain FDA approval for new drugs.

An exterior shot of the Food and Drug Administration headquarters.
The FDA usually can’t compel a drugmaker to conduct dose-ranging studies after a drug is approved, and by law the agency does not influence drug pricing, says Emily Hilliard, a Department of Health and Human Services spokesperson. (Valerie Plesch/Bloomberg via Getty Images)

The agency issued nonbinding guidelines for dosing studies in 2024 and has incorporated Project Optimus principles into the approval process for new cancer drugs, said Health and Human Services spokesperson Emily Hilliard. For example, two dosing regimens were evaluated for each of four lung cancer drugs (fam-trastuzumab deruxtecan, tarlatamab, zongertinib, sunvozertinib), and the lower dose with fewer toxicities was approved in each case, she said.

The FDA usually can’t compel a drugmaker to conduct dose-ranging studies after a drug’s approval, Hilliard noted. And by law the agency does not influence drug pricing, she said.

Future drugs should have better dosage information, Bauman said, but “newer drugs will probably be just as expensive at lower doses.”

Financial Toxicity

Verzenio’s side effects made Allegra Warfield feel so sick, tired, and bewildered, she said, that she considered suicide. She switched to Kisqali, which was tolerable until last September, when coverage of the drug stopped despite her monthly premium payment of $6,000. The cash price for Kisqali was at least $16,000 a month.

After fighting her insurer for three months, Warfield, 42, sold her house and belongings in Palm Desert, California, and moved with her fiancé to Durham, North Carolina, where they’d found what they considered a reasonable insurance plan.

The cancer, the side effects, and the unpayable bills were bad enough. The lack of good answers for her treatment made everything worse, she said.

“I was left to research these medications on Facebook and Reddit. The only people talking about the daily reality of these drugs were other patients,” she said. “But I wanted the studies. I wanted practical guidance.”

Stories like these launched a new life mission for Kelly Shanahan, who was an OB-GYN in South Lake Tahoe, California, until side effects from a breast cancer drug caused her to lose sensation in her hands. Unable to practice medicine, Shanahan became a patient advocate who works with a group called the Patient-Centered Dosing Initiative. In 2021, Shanahan developed profound fatigue (“worse than caring for a newborn baby while being on call in my solo practice”) within a few weeks of going on Ibrance. Lowering the dosage caused her worst symptoms to lift, she said.

After gathering countless anecdotes, her group has approached drug companies seeking data — so far with little success — that might indicate what percentage of patients have needed dosage reductions, and how they fare on lower doses.

“If going down two dose levels cuts effectiveness by 50%, patients need to know that while making decisions. If it doesn’t, they need to know that,” Shanahan said — even if it means “the companies won’t make as much money.”

Shanahan suggested the data could be found in clinical trials and postmarket studies. But if drug companies won’t provide the necessary studies, Manski said, governments should.

“The knowledge to be gained is a common good,” he said.

A photo of Chuck Mansku standing in his home.
Manski’s research, focused on how people deal with conditions of uncertainty, helped him decide whether to stay on a melanoma treatment after it caused severe side effects. (Taylor Glascock for KFF Health News)

Has an insurance company or pharmacy benefit manager refused to cover a drug an oncologist recommended or prescribed for you or a loved one because the cancer is unusual or rare and lacks clear guidelines? Click here to contact KFF Health News’ reporting team.

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.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.



from KFF Health News https://ift.tt/YaXmw4P
If multiple antidepressants haven’t helped, there are other avenues to explore.

from NYT > Health https://ift.tt/6Yzegta
Dr. David Morens, a former N.I.H. official, admitted to attempts to conceal emails that discussed the origins of the pandemic.

from NYT > Health https://ift.tt/FOX8g2k

Connecting people with clinical trials is complicated — even if people identify a promising match, there’s a slew of potentially thorny factors, including geographic incompatibility, and financial and time considerations.

Simply finding an appropriate trial can present an enormous hurdle. In a recent online survey of more than 2,000 adults, 71% of patients with chronic conditions said they would be likely to participate in a clinical trial if given the chance. But two-thirds said that their healthcare provider had never discussed clinical trials with them. According to one study using data from 2020, just 9% of adults reported ever being invited to participate in a clinical trial.

Clinical trials are essential to the development of new and effective medical treatments. But gathering the real-world human data necessary to win Food and Drug Administration approval for drugs, devices, and other interventions can be an arduous task. By one estimate, up to 86% of clinical trials don’t meet their recruitment targets during the trial time frame.

Getting people signed up isn’t the only challenge.

“Recruitment is one thing — retention is another,” said Alan Balch, executive board chair at the Patient Advocate Foundation, which has a clinical trial search tool and maintains extensive educational materials online. “Every touchpoint is an opportunity for access and affordability to be a problem.”

The need to improve patient participation in clinical trials is not a new concern, but it’s attracting new interest.

In June, the Department of Health and Human Services announced an effort to streamline and enhance clinical research in the United States. It included a public request for information about whether to modify federal rules that currently deter some trial sponsors from paying clinical trial participants for expenses such as travel and lodging.

In July, a group of nearly 200 patient advocacy and public health groups sent a letter to the Senate sponsors of the Clinical Trial Modernization Act, urging its passage. The bill would allow trial sponsors to cover trial participants’ medical costs, such as insurance deductibles and copays, and nonmedical expenses like travel and childcare. It would also exclude up to $2,000 in financial support for clinical trial participation from federal taxes, so people wouldn’t risk losing their eligibility for Medicaid or other income-based programs if they signed on.

While these efforts to improve clinical trials and patient participation are ongoing, here are answers to some questions about how the system works now and what patients can do if they want to take part.

Why Be a Guinea Pig? Understand the Facts

In some trials, some participants are given a new drug or therapy that’s being investigated while others receive a placebo with no physical effect.

But there are many types of clinical trials. Some test different drug combinations, for example. They can test medical devices, preventive measures such as vaccines, or lifestyle changes. Others test ways to screen for or diagnose medical conditions.

For people with very serious illnesses, a clinical trial may offer the best hope for extending their life or improving their quality of life.

“Cancer is often a fatal disease, and clinical trials offer an opportunity to try something that may or may not be better,” said Mark Fleury, the policy principal for emerging science at the American Cancer Society Cancer Action Network. “If you know the existing standard of care has an average survival of eight months, you want something with a better opportunity.”

In addition, even if patients don’t receive the therapy being tested in the clinical trial, they are monitored closely throughout and receive the gold standard of care, which they might not receive elsewhere, patient advocates said.

Some people decide to participate in trials to aid in advancing science.

Jim Taylor’s wife, Geri, died of Alzheimer’s disease two years ago, more than a decade after her diagnosis in 2012. The couple became advocates for people with the disease, and Taylor is continuing that effort. He’s currently participating in three observational Alzheimer’s trials that are employing cognitive tests and scans to track how his brain is changing compared with the brains of people who’ve been diagnosed with the disease.

“The reason I’ve done it is so I can explain to people, with some authenticness and experience, what a trial is like,” he said.

Finding a Clinical Trial

Despite widespread interest in clinical trial participation, most patients don’t know how to find one.

They can’t necessarily count on their doctors for help. According to an online survey of just over 500 primary care physicians in March, sponsored by the Patient Advocate Foundation, even though 86% of respondents said they were somewhat or very likely to refer their patients to a trial, only 37% had ever done so. When doctors did discuss clinical trials with their patients, it was usually because they had asked about them (67%), they weren’t responding to standard treatment (65%), or their disease was progressing (55%).

But for time-strapped doctors, identifying clinical trials for which patients might be eligible isn’t a simple task. A community oncologist, for example, would typically have to conduct a search using one of the available clinical trial search engines (clinicaltrials.gov is the most comprehensive), type in all the patient’s characteristics, look at the trials that might be appropriate, and call the site to ask whether the trial is still open, Fleury said.

“And if they’re successful, what happens? They lose their patient,” he said.

Patients may have an even tougher time searching for trials on their own. Some patient advocacy groups have in-person or online navigators that can help people identify trials they might be eligible for.

The American Cancer Society has a clinical trial matching service, for example. Organizations such as the Arthritis Foundation and the National Multiple Sclerosis Society have information about disease-specific trials on their websites.

If a hospital or health facility is part of a clinical trial, patients there are often best positioned to enroll. Patients can ask their doctor or the facility for more information.

“Most recruitment for a trial happens at the site where the trial is happening,” Balch said.

There’s a Trial, but You Can’t Enroll

Much of the clinical research in the U.S. is conducted at large, often urban, academic medical centers. It can be tough for patients to enroll in a trial at a site unless they live nearby or are already being treated there, according to clinical trial experts.

To participate in a trial, people generally have to meet periodically with the researchers conducting it. They may also need to get regular blood draws or imaging, or to answer questionnaires to monitor their progress.

“The number one barrier keeping patients out of trials is a lack of onsite clinical trials,” Fleury said.

A 2019 study that examined 8,893 cancer patients’ participation in clinical trials found that more than half (55.6%) didn’t have an available trial for their type and stage of cancer at the medical facility where they were being treated. An additional 21.5% didn’t meet the eligibility criteria for an available trial.

If a patient identifies a clinical trial at a viable location and wants to be considered, the patient should contact the trial recruiters directly and ask them, Balch said.

“That’s just the beginning,” he said. Patients also need to find out whether they meet a trial’s eligibility requirements and whether it’s covered by insurance, and to consider how they’re going to pay for any medical or nonmedical costs.

Recently there’s been a lot of interest in decentralized access to clinical trials, so patients could do at least some of the trial tasks at home or at their local cancer center, for example.

“It’s not common yet,” Balch said. But if decentralization grows, he said, it will open up the opportunity to more patients — and more representative groups of patients.

There’s a Trial, but You Can’t Afford It

If someone participates in a clinical trial, the trial sponsor picks up the tab for costs stemming directly from the trial, including the drug or device being investigated.

In addition, under the Affordable Care Act, most commercial health plans are required to cover routine patient costs associated with participating in a clinical trial.

But that doesn’t mean members won’t owe anything. They are generally still responsible for any deductibles, copays, or coinsurance amounts for the routine care that they receive during a clinical trial. And the ACA doesn’t require plans to have out-of-network benefits. That means if a clinical trial is sponsored by a provider that is out of someone’s provider network, the plan might not cover those costs.

Medicare and Medicaid have similar requirements for coverage of routine clinical trial costs.

For some patients, incidental expenses can put participation in a clinical trial out of financial reach. Participants may face costs for travel to the trial site, parking, lodging, childcare, or taking time off work.

“There shouldn’t be an added set of concerns and disincentives around costs and financial toxicity,” said Wendy Selig, the founder and CEO of WSCollaborative, a healthcare consultancy. Selig is also the project lead for Equitable Access to Clinical Trials, which aims to eliminate incidental costs for patients in trials.

Some trial sponsors pay for incidental expenses but might not make that clear up front to patients who are considering participating.

Patients should take the initiative and ask, Selig said. “There may in fact be help, and you should take advantage of it if it’s available.”

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.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.



from KFF Health News https://ift.tt/pRJQd9E

It had been a rough few months. Cynthia Tompkins was hospitalized in May for osteomyelitis — a bone infection — then spent six weeks in a rehabilitation facility. “It was a struggle,” she said. “I didn’t bounce back too well.”

Tompkins returned to her home in San Diego, but she was still taking antibiotics, along with a host of other drugs for diabetes, pain, and blood clots. The deaths of her husband the previous year and her closest friend more recently had sapped her spirits.

In early July, a new symptom appeared: violent vomiting three times within about 24 hours. “I was so depleted,” she said. “I got weaker and weaker.” A friend who was visiting her called an ambulance.

“It’s the last place you think you want to go, the ER,” said Tompkins, 75, a retired teacher and family program director. She anticipated spending hours on an uncomfortable stretcher in a chilly hallway. Arriving at the emergency department at UC San Diego Health in La Jolla early in the morning, “I was in a knot,” she said.

But the place upended Tompkins’ expectations. Since 2022, this and every other adult ER in San Diego has been accredited as a geriatric emergency department, redesigned to address the specific risks and needs of older patients. It’s an approach, recent studies show, that can reduce hospital admissions and deaths among older adults and lower costs.

“They took me right to a room,” Tompkins said. She was transferred to a gurney with a thicker mattress to prevent bedsores and given blankets. “I got an IV right away because I needed fluids,” she said.

She was pleased that the small, curtained room, with sound-absorbing walls to lower the cacophony of emergency care, had a cushioned chair for her friend, who would stay with her, and a window looking out on trees.

The window served a medical purpose, too. Patients “can see whether it’s day or night,” said Denise Valenzuela, the geriatric emergency nurse assigned to Tompkins. “It prevents delirium,” the sudden change in mental status that can arise in hospitalized older patients and increase dementia risk.

Before long, “I just felt a calmness,” Tompkins said. “I felt, I’m where I need to be right now.”

Since 2017, the American College of Emergency Physicians has accredited 624 such geriatric emergency departments across the United States, including 73 in Department of Veterans Affairs medical centers. “A fairly exponential rate of growth,” said Kevin Biese, the emergency doctor who directs the Geriatric Emergency Department Collaborative.

Few of these units are restricted to older patients. Instead, like the ER in La Jolla, they serve all ages but incorporate senior-friendly practices and protocols in an environment aimed at staving off disorientation, falls, and other elder hazards. They’re classified from Level 1, for those fulfilling the highest number of criteria, to Level 3.

Adults 75 and older visit the emergency room at a higher rate than any other age group except infants: 76 visits per 100 people in 2022. Yet standard emergency care “wasn’t correctly designed for the needs of older adults,” Biese said.

The mission of a traditional ER is to speedily identify the central problem and either fix it or admit the patient to the hospital for ongoing care. “We ask, ‘What’s your chief complaint?’” Biese said. “You fell down the stairs and broke your leg.”

Older patients rarely arrive with a single ailment, however. Like Tompkins, most contend with several chronic conditions, take multiple prescriptions, and need a variety of tests and assessments. Trained geriatric emergency teams focus not only on the broken leg but on determining what caused the fall, and how to prevent another one.

“An emergency department doesn’t routinely screen for delirium” and cognitive impairment, said Ula Hwang, an emergency doctor and researcher at NYU Langone Health. “But it’s one of the first things geriatric emergency departments will do,” along with a careful review of all the patient’s medications.

Geriatric ERs also try to counter sensory impairment, another contributor to delirium, by distributing reading glasses and sound-amplifying devices. They dim glaring lights and offer eye masks and earplugs to promote sleep. If Tompkins had forgotten her walker, the unit would have lent her one.

These ERs also aim to address a rising concern in emergency departments: hours or even days spent “boarding,” when admitted patients wait for open beds before they can leave the ER.

“Prolonged boarding has increased among older adults,” said Cameron Gettel, an emergency doctor and researcher at the Yale School of Medicine, referring to waits that last over three hours. He is a co-author of a study on the topic published in Health Affairs Scholar.

Spending more time boarding isn’t merely uncomfortable or inconvenient. Researchers studied patients 75 and older in emergency departments across France. They found that those kept there overnight before moving to an inpatient ward had a higher in-hospital mortality rate (15.7%) than those admitted to a ward before midnight (11.1%). Overnight boarding was associated with more falls and infections, too.

What geriatric emergency staffers prefer, however, is to help patients avoid hospitalization altogether. “Admission may not be the best thing for an older adult,” Hwang said. “It might be the worst.”

Hospital patients, she said, are exposed to infections, staff errors, and the rapid deconditioning that accompanies days spent in bed. All pose a greater threat to older patients.

Previous studies have found reduced admissions from geriatric emergency departments, but most of those studies involved one or two hospitals. Now, Hwang and her team have used nationwide data from the federal “Health and Retirement Study” and Medicare claims for nearly 4,600 adults age 65 or up, comparing those treated in geriatric emergency departments with a matched group seen in standard ERs.

The differences were stark: Patients in the geriatric units had a 39% lower likelihood of hospital admission and a 38% reduction in mortality over 30 days. The geriatric ERs also saved Medicare up to about $3,000 a visit, according to an earlier study Hwang led.

So having more than 600 accredited geriatric emergency departments nationwide represents both great strides and — in a country with more than 5,000 emergency departments — missed opportunities, Biese said.

“I’d encourage people to ask why their hospitals don’t have an accredited GED,” he added, referring to a geriatric emergency department. “We should demand that.”

In La Jolla, Tompkins began feeling stronger. The intravenous fluids supplied anti-nausea medication and corrected the electrolyte abnormalities that her lab work revealed. She was able to sip water and juice and eat a few graham crackers.

A battery of other screens and scans found no serious concerns. After completing a geriatric assessment, Valenzuela, the nurse, suspected Tompkins hadn’t been eating well and was taking medications on a mostly empty stomach.

By about 6 p.m., Tompkins and her doctor agreed she could return home. She left the hospital with numbers to call for further help, and several staff members checked in by phone to see how she was doing.

Better, was her answer. “They took care of the whole me and put me on the right track,” Tompkins said. “I’m progressing. It’s slow, but I’m OK.”

The New Old Age is produced through a partnership with The New York Times.

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.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.



from KFF Health News https://ift.tt/qVhfCvX

SAN FRANCISCO — At a Walgreens in this city’s bustling Japantown neighborhood, pharmacist Margaret On stocks two boxes of long-acting insulin pens from California’s new prescription drug label, CalRx, emblazoned with the state’s iconic grizzly bear.

Although she hasn’t dispensed any, On plans to keep them on hand. “It’s good to have if a patient comes in and doesn’t have health insurance,” she said. “Or just in case of emergencies.”

Seven months after the launch of its own low-cost insulin brand, state health officials said California has distributed more than 120,000 five-pen packs of insulin glargine priced at $55 each, significantly less than the $89 to $411 that the state says most popular brand names charge before any retail markups or consumer discounts.

While it represents a tiny amount of the state’s insulin pipeline, it marks the first time a state is competing against the three biggest insulin drugmakers — Eli Lilly, Sanofi, and Novo Nordisk — under its own prescription drug label. CalRx, Gov. Gavin Newsom’s experimental initiative, has dual aims: to act as an emergency supplier for people who are uninsured or can’t afford their prescriptions, and to disrupt the nation’s deep-pocketed pharmaceutical industry, which cost the U.S. $467 billion in 2024, the federal government reported in June.

Newsom, a Democrat considering a presidential run in 2028, is expected to make healthcare a central pillar of his national platform as he concludes his second and final term as governor. To create the state brand of generic drugs, California inked a $50 million contract with Civica, a Utah-based nonprofit drugmaker, to develop the CalRx insulin, known as a biosimilar. Though major distributors make the drug available in pharmacies around the state, uptake has been limited.

Newsom’s goal is to saturate the insulin market and offer generic versions of drugs either high in cost or low in supply, or that can improve public health. The state is also distributing free naloxone, used in a nasal spray to reverse opioid overdoses, and trying to bring albuterol inhalers to public schools for students with asthma emergencies. In the next two years, the state plans to launch epinephrine injectables, commonly known by the brand name EpiPen, which are used to treat severe allergic reactions, as well as a state-branded medication to treat tuberculosis.

Before he leaves office in January, Newsom said, he wants to add generic GLP-1 medications to compete with brand-name drugs such as Ozempic and Wegovy. The drugs have exploded in popularity, but employers have raised concerns about their cost.

Taking on drug costs is a winning political issue for both Democrats and Republicans, who have for years tried to rein in soaring healthcare spending as Americans feel the pinch of high prices at pharmacy counters, in doctors’ offices, and from health insurance premiums. The U.S. spends roughly twice as much per capita on prescription drugs as other industrialized countries. Six in 10 adults in the U.S. say they’re worried about being able to afford their prescription drug costs, according to a poll last winter by KFF, and 4 in 10 say they’ve tried to save money such as by skipping doses and not filling prescriptions.

In February, President Donald Trump launched TrumpRx to potentially lower out-of-pocket costs for consumers. But TrumpRx doesn’t produce drugs; rather, it directs consumers to find more affordable medications with coupons or on drugmakers’ websites. Newsom, in contrast, is trying to drive down the underlying price of medicines by increasing the manufacturing and availability of generic drugs.

While some people with diabetes may benefit from CalRx insulin, California’s generic drug effort is largely symbolic at this time, said Geoffrey Joyce, director of health policy at the Schaeffer Center at the University of Southern California. “There is some value, but it’s for a very limited number of drugs for just a fraction of the population,” Joyce said.

And TrumpRx isn’t helping at a large scale either, Joyce added, because many medications it advertises have cheaper generic versions available elsewhere. It would be better, he said, to develop large-scale initiatives that tackle key drivers of the high cost of drugs, for rare cancers for instance, and produce safer and higher-quality medicines.

“What you really need is a national effort that focuses on vulnerabilities like supply shortages and increasing the supply of generic products for higher-priced drugs,” Joyce said.

Market Disruptor

CalRx aims to make insulin more affordable and accessible for the nearly 3.7 million California adults diagnosed with diabetes. Newsom last year singled out the three major drugmakers that control more than 90% of the global insulin market, while also targeting intermediaries known as pharmacy benefit managers for promoting higher-priced drugs over cheaper generic alternatives.

Patients with health insurance often receive discounts at the pharmacy counter and do not pay sticker prices, yet those discount programs can be hard to navigate and patients can face restrictions. While drugmakers and pharmacy benefit managers said they’ve already initiated $35-a-month caps on out-of-pocket costs and pass price discounts on to consumers, Newsom argues that consumers still struggle to afford their medications.

He has criticized pharmaceutical companies for gouging Californians and contended that the industry’s discounting schemes don’t adequately address inflated prescription drug spending, which in the U.S. rose 7.9% in the most recent reporting year.

In his announcement last year that CalRx insulin would go on sale in January 2026, Newsom said the industry had been using discounts to distract consumers from solutions that could bring overall prices own. “One of the things that all of us should be increasingly concerned about is announcements around caps, announcements around discounts,” he said.

In January, California joined dozens of other states in setting insulin price caps. It also passed a law attempting to ban price inflation practices by pharmacy benefit managers.

Representatives for drug companies and pharmacy benefit managers said insulin is largely an affordable medicine in the U.S., arguing that consumers have benefited from discounts.

“While insulin prices, set solely by pharma companies, may be high in some instances, the amount patients are paying out of pocket has declined significantly,” said Christine Rex, senior director of state public affairs for the Pharmaceutical Care Management Association, which represents pharmacy benefit managers.

Reid Porter, a spokesperson for Pharmaceutical Research and Manufacturers of America, which represents brand-name drugmakers, said PBMs have driven up costs for consumers by excluding lower-cost medicines from their lists of covered drugs. “Too often, patients face a system in which insurers and PBMs exclude coverage of those medicines on formularies because of supply-chain incentives,” he said.

Where To Find CalRx Insulin

CalRx insulin has been slow to reach pharmacies around the state, and in interviews, patient advocates said many people with diabetes aren’t aware it’s an option.

In Sacramento, pharmacist Sharon Ngo, who works at a Safeway pharmacy, was surprised to learn that California had a long-acting insulin product on the market. She didn’t know that CalRx insulin was interchangeable with Lantus, which was on back order for roughly two weeks.

“I had no idea this was available,” she said as she took notes on a pad of paper. “We’re going to give this a try.”

CalRx insulin has a suggested retail price of $55 a pack and is available with or without insurance. California has inked deals with four health insurers to cover CalRx insulin on their health plan formularies, potentially making it cheaper, depending on copays. They include Anthem Blue Cross, Blue Shield of California, the Valley Health Plan for Santa Clara County employees, and the Federal Employees Health Benefits Program, according to the state Department of Health Care Access and Information.

A box of CalRx insulin.
Pharmacist Margaret On keeps two boxes of California’s new generic insulin product under the CalRx brand on hand in case of emergencies. (Angela Hart/KFF Health News)

Elizabeth Landsberg, the department’s director, said the state is working to get more insurers to cover CalRx insulin and to provide it at more pharmacies. The state doesn’t know how many boxes have been dispensed. However, Landsberg said it was more meaningful that the state had reached agreements with three major pharmaceutical wholesalers to distribute its product in California. Currently, CalRx insulin is available on Amazon and at Costco, as well as at some retail and grocery store pharmacies including CVS, Walgreens, and Walmart.

“What we’re really trying to do is change market behavior and offer both affordable and transparent pricing,” Landsberg said. “The rebates and discounts are hard for consumers to understand and can change at any time, so we are trying to be straightforward and say, ‘Let’s not play this shell game anymore.’”

Allan Coukell, chief government affairs and public policy officer at Civica, said the company first partnered with the state on long-acting insulin that helps patients keep blood sugar steady for 24 hours or more. Next, it plans to help California develop rapid-acting insulin, which is used to pull elevated glucose down within minutes, to compete with brand names such as Humalog and NovoLog.

Health insurance companies welcomed the state’s efforts, in part because they could help save money they pay out on prescriptions.

“Making this drug available is really about helping people improve their health,” said Paul Markovich, CEO of Blue Shield of California’s parent company. “And the more supply we can get on the market, the more we can get rid of the profit motives in the pharmaceutical industry.”

One July afternoon in the Southern California city of Corona, Chris Noble went to a CVS pharmacy to get a box of CalRx insulin. The pharmacist didn’t have any on hand, but Noble, a healthcare organizer with Type 1 diabetes, was told he could get a prescription filled in 24 hours.

“I have insurance, but I see myself using this if I’m traveling and something happens like my insulin pump malfunctions,” he said. “Now I know I can go to a CVS and get insulin within a day.”

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.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.



from KFF Health News https://ift.tt/HTWGfMR
Dr. Evelyn Griffin is pushing for more emphasis on wellness and prevention. She has also aligned with the MAHA movement in fighting government mandates and questioning the safety of some vaccines.

from NYT > Health https://ift.tt/eCMEVgK
The Trump administration delayed a rule last year that could have sped up the effort to pinpoint the source of the contamination. Critics charge that food safety oversight has eroded overall.

from NYT > Health https://ift.tt/rpxSNmV

Céline Gounder, KFF Health News’ editor-at-large for public health, discussed Americans’ skepticism toward public health experts and President Donald Trump’s executive order on childhood vaccines on CBS News 24/7 and CBS News’ CBS Mornings, respectively, on Aug. 11.

On Aug. 10, Gounder discussed the risks and benefits of egg freezing on CBS Mornings.

Gounder also discussed organ donation and scientists’ creation of new viruses with AI on CBS Mornings and CBS News 24/7, respectively, on Aug 7.


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.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.



from KFF Health News https://ift.tt/Sx1r7bt
His disclosure in an interview revived a key question about sobriety: whether someone who once drank dangerously can ever drink moderately.

from NYT > Health https://ift.tt/zfAG2ea
Turn that burning resentment into insight and motivation.

from NYT > Health https://ift.tt/708LGJo

“No more operations,” he said.

It was mid-January 2026, and my then-73-year-old husband, Mike Salmon, had just started bouncing back from a three-month ordeal of three operations related to aortic aneurysms, sepsis, and a terrifying descent into delirium tied to a stay in the intensive care unit. Now, after another potentially fatal aortic aneurysm and ambulance ride, the doctors clustered around his hospital bed said the fix involved two more major, risky operations.

If Mike did nothing, the aneurysm or sepsis would likely kill him, they predicted. How soon? “Weeks,” one doctor said. “I’m astonished I’ve made it this far,” Mike said. So, abruptly, we were shunted onto hospice care — the dead-end spur of the American medical system.

Hospice agencies manage care for patients expected to die within six months. They don’t provide curative procedures or drugs. Instead, they aim to help families make terminally ill patients comfortable, typically at home, as an illness reaches its inevitable conclusion. Families provide most of the day-to-day care, and 85% have suggested they are very satisfied with their hospice’s services, which include supplies of drugs and medical equipment, and visits from nurses, therapists, and aides.

More than 1.9 million Americans were enrolled in hospice in the last fiscal year. Over 80% of those patients stayed on hospice until they died — within four weeks, on average. But each year, about 6% of patients are kicked out because a hospice doctor decides they have stabilized or improved enough that they are no longer likely to die in the next six months.

In May, Mike joined that select group. His experience in and out of the hospice system revealed surprising lessons about how families can manage care. And getting removed from hospice revealed a little-known process that can represent a welcome respite for families like ours — but can be devastating for patients with serious chronic illnesses.

Here’s what we learned in our four months on and off hospice.

Check before you choose.

“Choose one.” A hospital nurse handed me a list of local hospice agencies. The sooner we signed up, the sooner Mike could go home. Stunned by the suddenness of Mike’s health emergency, I just pointed to the name at the top of the alphabetical list, assuming they were pretty much the same.

Big mistake. Medicare sets basic standards for the hospice agencies it reimburses, but some agencies are understaffed or poorly run. Amy Tucci, president of the Hospice Foundation of America, noted that some agencies provide extra therapy, aide support, and other services.

The problems with the organization I had chosen started immediately. Staffers were often late. They entered inaccurate medical information on Mike’s paperwork and didn’t make corrections when alerted. Medicare allows you to quit or change agencies, so I asked neighbors for recommendations.

That was a good start, but Kristina Newport, chief medical officer of the American Academy of Hospice and Palliative Medicine, said I should also have checked the quality ratings on Medicare’s Care Compare site and the National Hospice Locator. Those sites would have alerted me to our first agency’s low ratings. Ideally, Newport said, patients or caregivers should call their area’s top-rated agencies to find those that provide the services you need, such as staff members who speak the patient’s native language, provide spiritual care that aligns with the patient’s beliefs, or are stationed nearby to arrive quickly in an emergency.

The local, long-established nonprofit that neighbors recommended handled the transfer seamlessly. Its staff was punctual, accurate, and kind. The chef’s kiss after we switched: A nurse from the original company we chose called to say she hoped I hadn’t initiated the change because of “concerns about our care of your mother.”

Some people get better on hospice.

Research hasn’t yet fully explored why, but some people actually see their health improve under hospice care. Studies have found, for example, that hospice patients with congestive heart failure or lung cancer live about a month longer, on average, than similar patients in the standard medical system.

Terry Bertholet, who teaches courses on elder law and hospice care at the University of Connecticut, said many patients benefit from hospice’s careful pain management and from leaving hospitals, where they risk infection and overtreatment. Returning home allowed Mike to get up and walk without waiting hours for an overworked nurse to unplug a bunch of monitors, and to enjoy real food. Also, the hospice nurse gave him medicine to help him sleep through the night. He soon started regaining weight and strength.

You can flunk out of hospice for not dying quickly enough.

Medicare and many other insurers pay for hospice services only for patients whom physicians certify are likely to die within six months of the most recent assessment (not the date of enrollment), so hospice staffers regularly reassess patients. Medicare audits agencies to check for fraud and demands repayment of funds provided for care of patients its auditors deem have not proved to be terminal. Hospices, good and bad, worry about their bottom lines and Medicare’s fraud audits. They may feel pressure to discharge patients who threaten the organization’s finances, even though such discharges can remove important care. “Medicare is worried about fraud and abuse, not about people not getting enough care,” Bertholet said.

Especially for diagnoses with uncertain prognoses — such as dementia — if a patient improves or even stabilizes, hospice physicians might discharge the patient because they can no longer certify a likelihood of death within six months.

For some lucky reason, Mike’s aneurysm and sepsis held off. By early May, his wounds had healed, and his strength had improved enough that he returned to gardening, playing bridge, and whipping up his signature lattice-topped blueberry-cinnamon pies. While we appreciated the convenience of the nurse’s visits and the drug and medical supply delivery, we realized Mike no longer needed care, so we agreed with our agency’s decision to discharge him.

For patients suffering from more debilitating diseases, discharges can be a “nightmare,” said Krista Harrison, a hospice researcher at the University of California-San Francisco. Discharges often happen quickly. Medicare requires that patients be given a minimum of two days’ notice.

When Harrison’s father-in-law, suffering from a neurodegenerative disease similar to Parkinson’s, was discharged because his health seemed to plateau, the family scrambled to replace and pay for hospice-provided equipment such as a hospital bed and oxygen supply, and they had to quickly find and hire aides to replace the hospice aides. “Just getting his prescriptions reestablished and filled was a big deal,” she said. Her father-in-law died six weeks after discharge, she said.

Do your homework to ensure appropriate care.

Arming yourself with information about your risks and rights can help you get the hospice care you need when you need it.

  • Know your diagnosis. Discharges are unlikely for most cancer patients. But patients with dementia, heart disease, and Parkinson’s often plateau. So they are disproportionately likely to be discharged, UCSF’s Harrison said.
  • Choose a highly rated hospice. Research shows for-profit hospice agencies are more likely to discharge patients than nonprofits. Medicare’s Care Compare site will alert you to which is which.
  • Keep your own records. Caregivers who can document, say, a patient’s growing need for eating assistance can help hospice staff approve continuing care, or build a stronger appeal, UCSF’s Harrison said.
  • Keep your family doctor more informed. Doctors “don’t have the financial interest” the hospice faces and could help you dispute a discharge, Bertholet advised.
  • Appeal quickly. Hospice agencies must provide information on appealing a discharge. But you must file the appeal (online or by phone) by noon on the day before the termination date, which may mean you have only a few hours if you’ve been given the minimum two days’ notice, said Wey-Wey Kwok, a senior attorney for the Center for Medicare Advocacy.
  • Reenroll. Patients can try reenrolling in hospice at any time. Another hospice agency may take you immediately. Or you can wait until the patient’s health declines and try reenrolling with your original hospice agency, the Hospice Foundation’s Tucci advised.

That last option is our plan. For now, Mike and I are enjoying these unexpected bonus days. But whenever fate catches up with him, Mike said, he’s comforted to know he’ll get good care from the hospice’s staff. “They’ll try to improve the quality of what time I have left,” he said.

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

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.



from KFF Health News https://ift.tt/fmH62iS
New York State’s generous health plan for working-class people was hit hard by federal funding cuts. More than 400,000 people are now looking for new coverage or living without it.

from NYT > Health https://ift.tt/fnDLz2W
The city of Belém in northern Brazil was overwhelmed by an outbreak of dengue two years ago. An all-out municipal effort has reduced cases and may offer lessons to American cities.

from NYT > Health https://ift.tt/E1uLAkK

MACY, Neb. — Erica Carter is passionate about her job, and she has seven acres of flowers and vegetables to show for it.

Carter’s specialty is reeling in grants to support students in the Omaha Nation school district, where she is a finance manager. One paid for the garden that sits next to the district’s campus. Another allowed the school system, in one of Nebraska’s lowest-income counties, to pay students to maintain it.

“They’re out in the sun. They’re watering plants,” she said. “It’s the first time they get a paycheck in their life.”

Carter, 41, is paralyzed from the chest down, an injury she’s lived with since a fall in her early 20s. It didn’t slow her down as she built her accounting career and got a master’s degree in human resource management.

But in November 2023, Carter — who lives in Sioux City, Iowa — got a letter from Iowa’s Department of Health and Human Services. It said that her income was too high for her to stay on Medicaid and that she might lose her benefits in two weeks if she didn’t take action.

States are scrambling to get ready for a new federal requirement to double-check that many people on Medicaid qualify for the benefit, by showing they are working, volunteering, or studying at least 80 hours per month. Politicians’ focus on requiring work has angered many people with disabilities who have Medicaid and say current policies that apply to them have the opposite effect — making them choose between working or receiving benefits.

‘I Have No Options’

When Carter got the letter, she was making $110,000 a year, well above Iowa’s 2023 income limit for working people with disabilities: $36,450 for a household of one.

“I had no time at all to prepare,” she said. “I had a decision to make.”

At the time, Carter got her health coverage through Iowa’s Medicaid for Employed People With Disabilities, a buy-in program that allows working disabled Iowans to pay part of their income to the state to maintain access to Medicaid benefits. Forty-seven states offer Medicaid buy-in programs, but most restrict eligibility through limits on income and assets.

For years, disability rights advocates have pushed state legislatures to change the limits, arguing they prevent people like Carter from accepting raises or building savings, for fear of losing crucial medical benefits. Massachusetts, Minnesota, New Jersey, and Rhode Island have eliminated such limits over the past five years.

To keep her Medicaid coverage, Carter would’ve had to find a job paying her far less than she was making. Or she could drop her Medicaid coverage and enroll in the school district’s health plan. But that plan didn’t cover many of the disability-related expenses that Medicaid did.

Carter decided to keep her job and leave the Medicaid buy-in program. In the end, the decision felt like a no-brainer, she said.

“I like getting up and going to work every day, and I really like what I do,” she said. “Why would I throw that away?”

Erica Carter in her wheelchair seated next to a playground.
Carter says she has helped write grants for projects such as a student-run garden and a new playground for the Omaha Nation public school district in Nebraska. She chose to give up her Medicaid coverage rather than quit her job as a district finance manager when her income surpassed the cap allowed for beneficiaries in an Iowa program for workers with disabilities. (Natalie Krebs/Iowa Public Radio)

But it’s been hard on her finances. Carter said she now spends about $35,000 a year out-of-pocket for expenses her old plan covered, such as the nurse who visits her three times a week, modifications to her car, and wheelchair repairs.

“I had the motors go out on my wheelchair,” she said. “So that was like $4,000 to fix.”

Over the next year, Carter picked up extra jobs and cashed in some of her retirement savings.

“I want to pay my own way. I don’t mind paying taxes,” she said. She doesn’t want to hide her income, either. “I just want an option,” she said. “I have no options right now.”

A Program Intended To Encourage Work

Congress approved the option for states to create Medicaid buy-in programs in the 1990s, intending to incentivize more people with disabilities to work. Iowa was one of the first states to adopt the program.

According to state data, 11,640 Iowans were participating in the buy-in program as of late January, or 1.7% of all Medicaid recipients in Iowa.

The income caps have inched up since Carter got her letter. Iowa’s limit, set at 250% of the federal poverty level, is $39,900 for a household of one this year.

The rules also restrict recipients from accumulating too much in assets. The current cap is $12,000 for an individual or $24,000 for a married couple, excluding some assets, such as a primary home or vehicle.

Carlyn Crowe, the public policy manager at the Iowa Developmental Disabilities Council, said the limits can prevent disabled Iowans from reaching their goals. “Work full-time and be able to buy a house, live in the community, buy a car,” she said. “Those limits placed on what they can earn and save are keeping them from doing that.”

Crowe’s organization, which has counterparts in every state, is federally funded and advocates for people with disabilities. In Iowa, such advocates have asked legislators to drop the hard limits on income and assets. Instead, they suggest that disabled Iowans pay 6% of their income to buy into the Medicaid program, an approach modeled after a 2024 Tennessee law that created a Medicaid buy-in program with no income and asset limits. (Tennessee is waiting on federal approval before starting its program.)

In recent years, these efforts have built bipartisan support and gained traction. An Iowa House committee unanimously advanced a bill in 2025 to remove the income and asset caps, but the bill died after failing to move forward during this spring’s legislative session.

State legislatures now face federal reductions in Medicaid spending estimated at more than $900 billion over 10 years, as part of the One Big Beautiful Bill Act.

Alice Burns, an associate director of KFF’s Program on Medicaid and the Uninsured, said the specific worry is that buy-in programs, though they’re a small part of the larger Medicaid system, could increase overall Medicaid spending if eligibility changes.

“The premiums charged in buy-in programs are nowhere near close to the expected costs of covering people,” Burns said. (KFF is a health policy research, polling, and news organization that includes KFF Health News.)

Focusing on initial cost increases is myopic, said Daniel Van Sant, the director of disability policy at The Harkin Institute at Iowa’s Drake University. More workers mean additional income tax revenue for states. It also enables some people with disabilities to earn enough to transition off other government assistance programs, such as the Supplemental Nutrition Assistance Program.

“Three, five, seven years from now, you may be recouping those expenses by having people be able to work their way off,” Van Sant said.

Falling Through the Cracks

Iowa lawmakers tried a more modest adjustment during this year’s legislative session. Instead of removing the income limit entirely, they introduced legislation that would raise the cap to 300% of the federal poverty level and exempt pension accounts and a spouse’s income, among other things, from the asset cap.

In the end, the provision was stripped from a wide-ranging public assistance bill. If it had passed, the new income limit would have been one of the highest in the country for a buy-in program, according to KFF.

Alex Watters, a former City Council member in Sioux City who was paralyzed from the chest down after a diving accident, told state lawmakers during a hearing in February that the proposal was a step in the right direction, but not enough.

“I fear that we’re going to lose people to other states,” said Watters, who added that he was considering moving to Minnesota, which never had an income cap and eliminated asset caps for its Medicaid buy-in program in 2024.

Even if Iowa had raised its income limit, Carter would still have been ineligible.

Carter remains committed to her primary job at the school district. She plans to keep working there and taking on additional jobs, seven days a week, so she can pay for her medical needs and continue helping students.

Erica Carter is seen next to the cafeteria in a school building.
Carter makes her way through the cafeteria at the Omaha Nation Public Schools campus, where she works as a finance manager. (Natalie Krebs/Iowa Public Radio)

This article is from a partnership that includes Iowa Public Radio, 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.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.



from KFF Health News https://ift.tt/Zz9CIte
Transgender rights advocates said the new rule would face a legal challenge.

from NYT > Health https://ift.tt/UF9idaK

Thomas Zordani flew from his home in Denver to Phoenix for a consultation with a Mayo Clinic neurosurgeon, hoping to find out what could be done to treat his debilitating headaches after worrisome brain scan findings.

When making the appointment, Zordani said, he’d been told the clinic was in his insurer’s network. Upon arrival, Zordani was summoned to the clinic’s financial office and told he had to make a $5,000 preservice deposit, because Mayo had since determined it did not accept his insurance. He was automatically designated “self-pay,” even though his plan had out-of-network benefits.

Not having that kind of cash on hand — and angry on principle — he refused. His appointment was canceled.

“I was so livid,” Zordani said, recalling that day in early April 2024. He later learned that Mayo had sent a message to him in his insurance carrier’s patient portal shortly before his visit with an estimate of the cost: $565, not the larger amount it later demanded.

Traditionally, patients usually receive bills for their share only after getting treatment. But what Zordani faced is becoming increasingly common — hospitals or other medical providers seeking prepayments.

“We regret that this individual’s experience did not meet the high standard of communication we strive to provide when helping our patients understand their insurance coverage and financial responsibility,” Andrea Kalmanovitz, Mayo’s communications director, said in an emailed statement. “When prospective patients don’t have clarity that Mayo Clinic is not in-network with their health plan, unexpected pre-service deposit requests may result.”

Mayo’s website says it requires prepayments in a variety of cases, including for “noncontracted” — also known as out-of-network — insurance plans.

The trend of hospitals asking for money up front represents a double whammy for patients.

Medical providers are collecting larger shares of what patients might owe at a time when rising deductibles mean patients are owing more for care. The preservice charge could be all or part of a remaining deductible, for example, or a sizable percentage of what the visit or treatment might cost. Those deductibles go up when hospital prices, drug costs, and labor expenses increase, as insurers try to slow premium growth by shifting more costs to patients.

People are “basically being asked to self-insure,” said Richard Gundling, a senior vice president at the Healthcare Financial Management Association, an organization for finance professionals.

As that happens, hospitals figure more patients will have trouble meeting those deductibles, so they want to get as much up front as possible.

“Things like preservice deposits and those kinds of moves are probably going to become more and more likely,” said Chip Kahn, a visiting senior fellow at KFF and the American Enterprise Institute and former president and CEO of the Federation of American Hospitals. “That will make it harder on the provider, the clinician, and harder on the patients.”

The deposits can’t be viewed in isolation, Gundling said: It’s a bigger issue than just hospitals asking for money up front. The challenge, he said, is: “How do we maintain access to care when more patients can’t absorb the level of out-of-pocket costs?”

Already, consumers are increasingly worried about paying for healthcare. A recent KFF health tracking poll found that lower out-of-pocket costs ranked as the top change insured adults would like to see from their coverage plans. KFF is a health information nonprofit that includes KFF Health News.

The average deductible in family coverage offered by employers is $3,762 per person, according to KFF, while the average deductible in Affordable Care Act plans jumped 37% this year to a similar amount, $3,786.

A Consumer Concern

Community Health Advocates, a health insurance consumer assistance program in New York state, hears from people who are concerned about prepayments, said Diane Spicer, a supervising attorney.

“We see this mostly with insured folks who are seeking out-of-network care but who have out-of-network coverage,” Spicer said, “and also sometimes for care that is not covered.”

Just how many hospitals collect what are often called point-of-service payments is not known, according to Kodiak Solutions, a technology company that provides services to health systems to help manage their revenue.

“But it is becoming more and more the center of many of our conversations with health systems,” said Matt Szaflarski, a vice president leading Kodiak’s revenue cycle intelligence team.

In addition to Mayo, Baltimore-based Johns Hopkins Medicine’s website says that “it is our policy to collect all amounts owed before services are rendered” for non-emergency care. University of Texas-affiliated MD Anderson in Houston, one of the nation’s premier cancer treatment centers, says patients who pay for their own care “will be asked to pay an initial deposit determined by the care center, based on the type of cancer.”

On average, hospitals collect about a quarter of what they expect the patient will owe, Szaflarski said, based on what they estimate the insurer will pay — a percentage that has grown in recent years.

For example, if a person is coming in for imaging and the insurer will reimburse $1,000 for that scan, the hospital will seek $250 from the patient up front, he said. “That used to be closer to $150.”

It also varies by hospital, and sometimes by state.

“The state of Indiana has some of the lowest cash collections in the country. They are Midwest nice,” Szaflarski said. He added that California and Texas are among those that collect more.

Even as hospitals increasingly collect more upfront payments, however, their uncollected debt is also rising, according to data Kodiak collected from more than 2,300 hospitals nationwide.

A Kodiak report in June said that’s because of a “fundamental shift” in coverage as plans “increasingly feature higher deductibles, greater coinsurance, and more complex cost-sharing structures: all elements that increase the nominal patient responsibility without improving—and often reducing—the probability of collection.”

While many hospitals are doing fine, some, especially in rural areas, have thin margins — and things could soon tighten further as cuts to ACA and Medicaid funding lead to more people being uninsured.

As a result, hospitals “have to be concerned” about every cost-sharing dollar, Kahn said.

After Zordani returned to Denver, he said, it took a while to find another specialist. He eventually had a procedure in late June 2024, at a Denver hospital not affiliated with Mayo, to fix a spinal fluid leak.

The following fall, he filed a complaint against Mayo in Arizona civil court. He was awarded $47,500 in economic damages and attorney fees after an arbitrator in September 2025 determined Mayo violated a state consumer fraud law because it failed to reach him to say that his plan was not in-network before he traveled. Mayo’s statement to KFF Health News did not include any reference to the settlement.

“Had they notified me in timely fashion as required, I would not have flown there,” Zordani said. He’s still angry that the clinic didn’t ask his permission before designating his care as self-pay, which meant he wasn’t going to use his insurance, and he’s still unclear on how they calculated the $5,000 preservice amount.

When Do Consumers Have to Make Preservice Payments?

There is one clear rule: In emergency situations, hospitals that accept federal Medicare financing cannot, by law, demand upfront payment before stabilizing a patient who arrives at an ER, said Matthew Fiedler, a senior fellow and health policy researcher at the Brookings Institution.

Other consumer protections are less clear.

Patients who get in-network care may have some recourse in their contracts with their insurers, so they should check the fine print, experts told KFF Health News.

“In out-of-network settings, I’m not aware of any barriers that would prevent a provider from doing this,” Fiedler said of preservice deposits.

How those amounts are calculated also appears widely up to the provider and can be opaque.

“They could just say $1,500 and you’d be like, ‘Oh, is that 10%, or is that how much is left on my deductible?’” said Patricia Kelmer, senior director of healthcare campaigns at PIRG, a national federation of independent consumer advocacy groups.

Yet, she added, the patient might be scheduling three months in advance, so the provider wouldn’t know how much was left on the deductible. She recommends consumers ask for an itemized bill and call their insurer to find out whether it has rules regarding the charges.

Also unclear are how and when patients get their money back if they overpay.

Overpayments can happen if patients don’t require the services originally estimated or when insurers pay other bills first, such as the anesthesiology cost or a surgeon’s fees. If those payments are counted toward a patient’s deductible, yet the patient had already made a prepayment to the hospital for the expected deductible, they’ve now paid too much to the hospital.

How soon they get their money back can vary and can depend on state laws, though a small number of states directly address the issue. As of this year, Florida requires medical providers to reimburse patients within 30 days of a determination of an overpayment. Some states, including Maryland, prohibit certain hospitals from requiring prepayment simply to avoid offering financial assistance.

After alleging that some patients had to wait more than a year to get reimbursed, Arizona Attorney General Kris Mayes recently brought a suit under state consumer protection laws against SimonMed Imaging, which has 170 locations in 10 states.

In a settlement, SimonMed agreed to issue refunds within an average of 60 days.

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.

This article first appeared on KFF Health News and is republished here under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.



from KFF Health News https://ift.tt/rJkvq8n

Health

Moderna’s Shift to Cancer Company Lifts Stock Up 177%

The company’s fortunes cratered as demand for Covid-19 vaccines plummeted. But it was busy working on something else. from NYT > Health...

loading...

Search This Blog

Popular Posts