Céline Gounder, Ñî¹óåú´«Ã½Ò•îl Health News’ editor-at-large for public health, discussed the findings of a recent cancer report on CBS News 24/7’s Mornings on Sept. 16. Gounder also discussed the potential of artificial intelligence to be used in developing biological weapons on CBS News’ CBS Mornings on Sept. 11.

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Ñî¹óåú´«Ã½Ò•îl Health News Georgia correspondent Briah Lumpkins discussed a conservative Georgia congressional district that has remained supportive of President Donald Trump despite rising healthcare costs on WUGA’s The Georgia Health Report on Sept. 11.

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• Read Lumpkins’ “Rising Healthcare Costs Have Hit Georgia’s Most Conservative District. But Its Politics Are Unlikely To Change.”  

Ñî¹óåú´«Ã½Ò•îl Health News Florida correspondent Daniel Chang discussed in Spanish how gun violence affects children in Florida on Radio Bilingüe’s Línea Abierta on Sept. 10.

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• Read Chang’s reporting in “Where Florida’s Gun Violence Exacts Its Biggest Toll on Black and Latino Children.”

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Still, Montana’s health department decided last year that Hailstone is no longer eligible for low-cost disability health coverage through Medicaid. The department switched her coverage to the state’s Children’s Health Insurance Program, another Medicaid program — three months before she aged out.

Before making the decision, the state didn’t seek records from the medical team treating Hailstone, according to letters from those doctors reviewed by Ñî¹óåú´«Ã½Ò•îl Health News. Rather, the administrative ruling came after state officials learned the now-19-year-old had stopped receiving Social Security disability payments. She said she did that because she hoped to get healthy enough to work and save some money — beyond what’s allowed under the tethered to those payments. But her health changes day to day, and she said for now she’s still too sick to consistently work.

Hailstone, who lives with her mom, has been able to keep Medicaid coverage while they appeal the case. She said that without Medicaid she can’t afford the treatment to manage the aftermath of her cancer.

“It feels like this process was made to make you give up,” Hailstone said.

Patients with disabilities have long struggled with administrative hoops, blunders, and confusion when trying to qualify for federally subsidized health coverage because of their illness. Now, new federal Medicaid work requirements mean states face the additional task of deciding who qualifies for a medical exemption. That means reviewing medical cases for an even larger swath of Medicaid enrollees.

Attorneys, researchers, and advocates who specialize in public aid said disability cases like Hailstone’s — though separate from the incoming work requirements — are an indication that states aren’t ready. As a result, they said, more people will be denied coverage in an opaque process.

“This will be the story of millions of people,” said Anthony Wright, who heads Families USA, a national nonprofit that advocates for ways to make healthcare more accessible.

Jon Ebelt, a spokesperson with the Montana Department of Public Health and Human Services, said the state doesn’t comment on individual Medicaid cases.

An will have to meet the new rules requiring them to prove they’re working, going to school, or volunteering to keep their Medicaid coverage, according to the Congressional Budget Office. of those enrollees live with a chronic health condition, according to KFF. Some will be excused from those rules if they can prove they’re too sick to work.

More than 5 million people are expected to lose Medicaid coverage by 2034 because of the work requirements, according to the CBO.

Work Requirements Become Law

Many Republican policymakers and the Trump administration have touted Medicaid work requirements to preserve coverage for the neediest. Congress made that national policy through last year’s One Big Beautiful Bill Act and gave states until January 2027 to implement work-for-coverage rules.

Some states are starting those checks early. Montana began in July. Nebraska initiated work requirements in May.

In the federal law creating the work requirements, Congress allowed states to exempt people who have an illness that qualifies them as “medically frail.” Many states created plans for those judgment calls, only to be surprised when federal officials released rules for the requirements that went beyond what Congress outlined, by also requiring enrollees to prove their illness makes it too hard to work.

Families USA and other organizations have argued the new rules force states to set up a patchwork of systems that, together, would be larger and more complicated than the Social Security Administration’s own disability review system. Last year, that federal program cost to administer to roughly 7 million people nationally. For comparison, Wright said, the federal law provided $200 million for states to share as they implement the work requirements. States are paying contractors millions of dollars to prepare often already flawed public aid systems to meet the new standards.

In June, 25 states over the medical frailty rules, arguing they’re too hard for patients to meet and for states to assess. That case is ongoing.

Hailstone was diagnosed with blood cancer at age 10. Her intestines tore, which led to their partial removal. As a result, her body struggles to process food and she can face severe dehydration. She said lingering side effects from her cancer treatment can leave her mind foggy and cause her hands and feet to swell enough that it’s hard to grip a fork or walk across a room.

Cancer dominated nearly half her life. It left mental scars, too.

“Some days you feel fine and then you suddenly crash,” Hailstone said.

Hailstone and her mom live in Roundup, a central Montana town of roughly 2,000 people. They regularly make the nearly two-hour round-trip drive to Billings for specialized care. She typically has three medical appointments a week to see her physical and occupational therapists and a mental health counselor.

Hailstone said she’s lucky she has her mother’s help navigating Medicaid. Her mom, Kyla Hailstone, said that the state hasn’t clearly defined how it determined her daughter’s disability status and that its appeal process has been slow and dysfunctional.

Taya Hailstone would qualify for Medicaid based on her income if she can’t prove her eligibility for disability coverage. But that would mean proving she’s too sick to meet the work requirement — putting her in the same position of having to rely on a state review of her illness.

“If I lose this, this is life-changing,” Hailstone said.

‘Things Fall Through the Cracks’

Hailstone qualified as disabled through the federal government as recently as 2024, about a year before the state said it was dropping her coverage. State officials can do their own medical review to determine whether someone meets the federal definition of a disability to access Medicaid.

“Whether that happens is always a bit of a crapshoot just based on state capacity,” said Megan Dishong, deputy director of the Montana Legal Services Association, which helps low-income people navigate public programs. “Things fall through the cracks.”

Ebelt said the state health department accepts disability decisions from the Social Security Administration. The state agency can conduct an internal disability determination if a person doesn’t have one from the SSA, but Ebelt said it doesn’t have to if a person qualifies for coverage another way.

“We are committed to treating every client with respect and helping those who are eligible receive appropriate Medicaid coverage,” Ebelt said.

Montana instituted a three-month grace period for the work requirements. State officials won’t begin disenrolling people for noncompliance until October.

a University of Michigan social policy professor who has studied bureaucratic obstacles to public benefits, said convoluted disability cases are common enough for attorneys to specialize in accessing aid.

“When we’ve designed public programs in ways that people can’t figure out whether they’re eligible without consulting lawyers, we’ve done something wrong,” Herd said. “That has huge, huge implications for what’s to come.”

Montana officials have said they’ll automatically review medical records that could help patients qualify for an exemption. Even so, the federal guidelines released in June mean patients will probably still face additional steps to guarantee an exemption.

Meanwhile, already overstretched doctors worry they’ll face the burden of judging whether someone’s illness qualifies them for a work exemption.

Dishong said that between now and October, Montana officials could offer more clarity on how the process will work. She said she’s worried the state will end up “with a slow-roll mess” instead.

“This is a problem that’s just starting,” Dishong said.

As for Hailstone, she’s now reapplying for Social Security disability payments. That aid would limit how much she can work. But it would also guarantee access to Medicaid.

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That’s partly because Halver’s mother and aunt have had breast cancer. Her age and dense breast tissue also put her at higher risk.

Halver, who lives in Vancouver, Washington, said her doctor recommended she get an annual breast MRI, six months after her yearly mammogram. The scan would serve as an additional safeguard, since breast MRIs can detect abnormalities that mammograms miss.

Case in point, actress Olivia Munn had a breast MRI in 2023 that detected an aggressive form of cancer in both breasts, even though a recent mammogram had been clear, . Like Halver, Munn said her doctor recommended the MRI after a risk assessment score showed she faced a greater-than-normal chance of developing breast cancer.

Catching breast cancer early, before it spreads, improves survival rates, according to the . After Halver’s insurer preapproved the scan, she scheduled the MRI for September.

“Luckily, they find nothing,” Halver recalled.

Then the bill came.

The Medical Service

A breast MRI — short for magnetic resonance imaging — is a preventive and diagnostic tool that captures pictures of breast tissue in higher detail than a mammogram. MRIs may be recommended for patients at an increased risk for breast cancer, including those with dense tissue, a family history of breast cancer, or certain genetic markers.

But the scans are generally not recommended for women considered at average risk, according to the , because they can also yield false positives, subjecting patients to unnecessary follow-up tests and procedures.

Breast MRIs are also used to diagnose cancer when an abnormality is detected during a mammogram, and they can determine the cancer’s stage after diagnosis.

The Bill

$1,205: After an insurance payment of $13.90, the patient was responsible for $1,191.10. The clinic also charged $65.60 for “Injectable/Oral Med,” often used to keep patients still or less anxious during the scan. Halver’s insurance covered about half of that charge.

The Billing Problem: Not Always Preventive

When Halver received the bill from Vancouver Clinic, where the MRI was conducted on Sept. 26, she was confused.

She knew that the Affordable Care Act requires health plans to cover preventive care, such as Pap smears and mammograms, at no cost to patients.

What’s more, Halver’s breast MRI had been recommended by her doctor and preapproved by Blue Cross Blue Shield of Texas, of which she is a beneficiary through her employer-sponsored plan. The whole point of it was preventive. That’s why she assumed it would cost her nothing.

To make things more confusing, requires many health insurers to cover breast MRIs.

“I’ve had many phone calls trying to understand” the bill, Halver said.

It came down to this: The U.S. Preventive Services Task Force, a panel of outside experts that advises the federal government, is charged with recommending which screenings health insurers are required to cover at no cost to patients, and preventive breast MRIs don’t fall into that category.

The task force “the current evidence is insufficient to assess the balance of benefits and harms” of breast MRIs for women with dense breast tissue “on an otherwise negative screening mammogram.”

The federal guidelines are different for patients whose mammograms detect an abnormality, said Cathy Peters, senior director of state and local campaigns at the American Cancer Society Cancer Action Network.

In these cases, Peters said, by the federal Health Resources and Services Administration specify that additional imaging, such as ultrasounds and MRIs, are preventive.

After an abnormal mammogram, these services are recommended “to address findings on the initial screening mammography” and to “complete the screening process for malignancies,” according to HRSA.

Those guidelines are a step in the right direction, but women who have not had an abnormal mammogram may end up “running into a big bill,” Peters said. This can be a deterrent when it comes to future screenings, she said, because when “you get hit with that once, you’re going to be very careful the next time you go.”

Some states have enacted laws that require insurers to cover breast MRIs, Peters said, but they generally don’t benefit patients like Halver who are enrolled in large, employer-sponsored insurance plans. These “self-insured” plans are regulated by the federal government, not by state lawmakers.

“Sadly, these state-by-state laws,” Peters said, don’t “fix the federal problem.”

The Resolution

Blue Cross Blue Shield of Texas declined to answer questions about Halver’s benefits or bill.

Halver appealed the insurer’s coverage determination, and in July she received a letter indicating that her appeal was denied.

Halver said she contacted her employer’s human resources department earlier this year and learned that mammograms are covered as a preventive screening under her health plan but breast MRIs are not. That means her annual breast MRI will be subject to deductibles, coinsurance, and other cost-sharing requirements.

In this case, the cost of Halver’s breast MRI was applied to her $3,300 annual deductible, an explanation of benefits from her insurer showed.

“I think I’m on the hook for this bill,” she said.

And because her risk of breast cancer is high, she said, “that’s a guaranteed bill every year.”

The Takeaway

If your doctor or medical provider recommends an annual breast MRI in addition to an annual mammogram, consider researching your state’s coverage rules on the . The nonprofit organization maintains a map with up-to-date information on state laws about breast cancer screenings. Depending on where you live and what type of health plan you have, preventive breast MRIs might be covered at no cost.

If it turns out you could be on the hook for a future bill, there are a few things you can do beforehand to potentially lower your out-of-pocket costs.

Ricki Fairley, co-founder of Touch, the Black Breast Cancer Alliance, recommended first finding a patient navigator at the hospital or cancer center to assist you.

She urged women to seek out resources in their communities or through national advocacy groups, including Touch, to find ways to lower screening costs. Programs funded by some states can help offset the cost of breast cancer screenings for low-income patients, Fairley said.

Beyond that, shop around for the best price. Freestanding imaging centers may charge less for a preventive breast MRI than a hospital. If possible, also consider scheduling the MRI at the end of your health plan’s deductible year. If you’ve already met your deductible, you could end up owing less out-of-pocket.

Bill of the Month is a crowdsourced investigation by Ñî¹óåú´«Ã½Ò•îl Health News and that dissects and explains medical bills. Since 2018, this series has helped many patients and readers get their medical bills reduced, and it has been cited in statehouses, at the U.S. Capitol, and at the White House. Do you have a confusing or outrageous medical bill you want to share? Tell us about it!

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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 , , 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 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 , 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 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.

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 — 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 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 . About half those profits came from immunotherapy drugs like pembrolizumab and nivolumab.

“Pembrolizumab is ,” 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.”

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, 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, 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 Ñî¹óåú´«Ã½Ò•îl Health News, said the evidence suggested that 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 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: 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 , 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 , 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.

The agency issued 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.

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Simply finding an appropriate trial can present an enormous hurdle. In a recent 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 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 , 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 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 to streamline and enhance clinical research in the United States. It included a public 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 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 . 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 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 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 ( 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 , for example. Organizations such as the and the 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 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 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.

and 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 , the founder and CEO of WSCollaborative, a healthcare consultancy. Selig is also the project lead for , 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.”

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

As a registered nurse at the University of Cincinnati Medical Center and a former Air Force medic, he knew this was a bad idea. “I made a couple of attempts to quit and they failed miserably,” said Schmidt, now 75.

Not until 2007 was he able to stop, using a newly approved prescription drug that reduced cigarette cravings. “I put them down and never went back,” he said.

Despite his years as a healthcare professional, Schmidt was unaware that lung cancer screening had become available for current and past smokers. The influential U.S. Preventive Services Task Force, an independent expert panel, recommended it in 2013.

Besides, he said, “I thought I was in the clear after all these years of not smoking.”

But in 2021, his primary care doctor, running down a list of questions at his annual Medicare wellness visit, asked whether he’d be willing to undergo a CT scan to detect lung cancer, and he agreed. A few days later, the results popped up on his patient portal: adenocarcinoma.

“It was stunning to read those words,” Schmidt recalled. “I knew what that was: cancer.”

Even with sharp declines in smoking, lung cancer remains the leading cause of cancer deaths in the United States, with  for this year, far exceeding fatal cases of colon, breast, or prostate cancer.

Yet in 2024, of the patients eligible for lung cancer screening,  — or , depending on which data researchers analyzed — were up to date on the recommended annual scans.

“Abysmally low, especially because of how deadly lung cancer is,” said Chi-Fu Jeffrey Yang, a thoracic surgeon at Mass General Brigham and the senior author of  about the screening rates.

Patients over 65 were more likely than younger people to be up to date. Still, only about a third were screened regularly, a  than received other cancer screenings. Schmidt, for instance, had dutifully undergone colonoscopies and prostate cancer tests for years.

Data from national registries shows that older adults face . “Age is a risk factor for cancer generally,” said Priti Bandi, an epidemiologist at the American Cancer Society. But seniors may also accumulate more years as smokers. About a fifth of lung cancer cases arise in people who never smoked, but smoking remains the most common cause, “even if the exposure happened much earlier in your life,” Bandi said.

Screening has been shown to save lives. In 2011,  demonstrated that annual screening with low-dose CT scans reduced lung cancer deaths by 20% compared with the chest X-rays used previously. That prompted the initial task force recommendation.

More recent European trials have found far greater reductions. In 2019, Italian researchers reported that after 10 years, patients with six years of screening had a 39% decrease in lung cancer deaths compared with those who weren’t screened.

Why, then, does screening remain so underused? “Lung cancer screening is so easy, a two-minute scan,” Yang said. “You don’t even have to put on a gown.”

One explanation: Determining eligibility gets complicated. The task force, in , recommended screening for those a) 50 to 80 years old with b) a “20 pack-year” smoking history who c) currently smoke or stopped within the past 15 years.

Both patients and doctors struggle with these criteria. Pack-year? It refers to how heavily someone smoked over time. Smoking a pack a day for 20 years creates a 20 pack-year history; so does smoking half a pack daily for 40 years.

Calculating that number is time-consuming and “challenging,” said Teva Brender, a hospitalist at the San Francisco VA Medical Center and a co-author of an  about lung cancer screening. “You might smoke a pack a day, then cut back to half a pack for two years, then stop. Then start again.”

The  probably also plays a role, sometimes making patients reluctant to disclose tobacco use. “Some people blame patients with lung cancer: ‘You did this to yourself because you smoked,’” Yang said. Screening rates also vary by state and insurance status.

Yet advances in treating lung cancer, including minimally invasive and robotic surgical procedures and increasingly effective drug therapies, mean that a diagnosis is “no longer a death sentence,” Bandi said. “The survival rate has improved dramatically.”

More than 80% of patients diagnosed in the earliest stages of the disease or more, although survival drops sharply for more advanced cancers. And screening increases the odds of finding cancer early.

Frustrated that a potentially lifesaving tool remains so underused, some doctors and organizations are calling for changes in the Preventive Services Task Force recommendations, which lead to coverage by Medicare (Medicaid coverage varies by state) and many private insurers. “The screening guidelines are too restrictive,” Yang said.

The American Cancer Society and the National Comprehensive Cancer Network have both  from their guidelines, which would make patients eligible for screening no matter how long ago they stopped smoking.

“We were disqualifying people from screening at a time when their risk was still rising,” said Robert Smith, a screening expert at the society. He and his colleagues have urged the task force to also drop the 15-year stipulation,  to back their claim.

°Õ³ó±ðÌý, dropping both the 15-year and pack-year stipulations and advocating screening for anyone who smoked for 20 years.

The task force,  from Health and Human Services Secretary Robert F. Kennedy Jr., hasn’t responded to the American Cancer Society’s analysis. Nor did it respond to a reporter’s emails asking whether it planned to revise its lung cancer screening recommendations.

Expanding eligibility so that more people can undergo screening , too. Some scans will reveal abnormalities that don’t turn out to be lung cancer, but require additional scans (or, rarely, biopsies) and cause considerable anxiety. Even with low-dose scans, repeated screenings also involve some radiation exposure.

Moreover, a recent study showed that among older adults diagnosed with metastatic lung cancer, . “If the public health goal is to reduce deaths from lung cancer through screening, it only works if you treat the people it identifies,” said Steven Woloshin, a researcher at the Dartmouth Institute for Health Policy and Clinical Practice.

For Schmidt, though, screening and treatment worked as intended. The mass found by his 2021 screening, diagnosed as stage 1 lung cancer, led to robotic surgery at the University of Cincinnati Cancer Center to remove the upper lobe of his right lung.

Surveillance scans followed every six months, then annually — until a 2025 scan revealed a small nodule in his lower lobe, another stage 1 cancer. Surgery removed that nodule, too. Schmidt now takes a targeted anticancer drug daily, a three-year regimen, while continuing regular scans.

“It did what it was supposed to do,” Schmidt said of his screening. “I feel blessed.” He tends his extensive gardens in Bright, Indiana, flies kites, and goes camping with his grandchildren. He still works several shifts a month as a fire department paramedic.

Experts cautioned, however, that lung cancer screening and treatment cannot substitute for the benefits of stopping smoking — or never having started. “The risk is lower the longer you are away from cigarettes,” Woloshin said. “But it doesn’t go to zero.”

The New Old Age is produced through a partnership with .

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

“Bemotrizinol has been used safely in Europe for decades,” Health and Human Services Secretary Robert F. Kennedy Jr. about the approval. “FDA’s action will increase competition and consumer confidence in sunscreen products.”

Nonprofits that advocate for health, such as the Environmental Working Group, and the skin care industry alike had lobbied for approval of the ingredient, which makes sunscreens sheerer and lighter on the skin than many available American options while blocking a wider spectrum of ultraviolet rays that can cause premature aging and skin cancer.

The newly approved sunscreen filter will allow companies to reformulate sunscreens to address consumers’ concerns, said Carl D’Ruiz, a senior manager at , a Swiss maker of sunscreen chemicals that applied for the FDA approval. In addition to allowing companies to offer what the FDA calls safe and effective formulations, he said, the approval will allow sunscreens that are more like sought-after South Korean brands to be sold in the U.S. by autumn.

Confidence in U.S. sunscreen has faltered on two fronts: among those concerned about what’s in the sunscreens they use and those who believe sun exposure is healthy. But will the new ingredient win the trust of Make America Healthy Again skeptics and Gen Zers intentionally tanning? RFK Jr., strikingly bronzed, has helped stoke this confusion by pledging in 2024 to fight what he called the FDA’s “war on public health” and . Under his leadership, the FDA from a plan in March to ban people under 18 from using tanning beds.

All this matters because by age 70 in the United States. It is the in the nation, where about 3.3 million people are diagnosed each year with basal and squamous cell carcinomas.

D’Ruiz said he thinks bemotrizinol, also known as BEMT, will change the dynamic. “People will talk more positively about sunscreens,” he said.

In the U.S., new sunscreen chemicals are regulated as over-the-counter drugs like aspirin or cough syrup rather than as cosmetics, as in Japan and the European Union. That means they face more elaborate testing and safety protocols, such as animal testing that runs afoul of EU laws, which is why the for bemotrizinol took nearly two decades, D’Ruiz said.

What’s “generally recognized as safe and effective,” otherwise known as “GRASE” in FDA-speak, is at the center of the American sunscreen debate. Bemotrizinol joins zinc oxide and titanium dioxide on the FDA’s .

That could help rebuild trust, said , an environmental epidemiologist at the , a nonprofit that researches the ingredients in consumer products.

“It has strong safety data,” Friedman said. “The documents submitted to the FDA to achieve ‘generally recognized as safe and effective’ include tests of irritation, sensitization to allergies, two-year animal studies for carcinogenicity, and reproductive health.”

The approval will also give consumers access to sunscreens that don’t leave as much of a white cast, she said, which makes some people hesitant to use mineral sunscreens such as zinc oxide and titanium dioxide.

Bemotrizinol’s approval won’t change the possibility of several chemicals with unclear safety profiles being added to sunscreens.

In 2019, the there was insufficient data to support a positive “generally recognized as safe and effective” determination for 12 commonly used sunscreen chemicals.

The concerns emerged after the that said some sunscreen ingredients had been found in humans’ bloodstreams. Though the industry has since phased out several of those chemicals lacking GRASE status, four are still widely used: avobenzone, homosalate, octisalate, and octinoxate.

“The European Union had that homosalate was not safe at concentrations that they were using and recommended a very low percentage — which was effectively a ban,” Friedman said. “The U.K. also issued a safety evaluation.”

Octisalate and octinoxate have been associated with disruption of the endocrine system, and octinoxate was due to concerns that it harms marine life and bleaches coral reefs.

Avobenzone breaks down when exposed to light, making it less effective, Friedman said, and has been associated with allergic reactions.

Mark Mitchnick, a pediatrician who , which is known under the brand Z-Cote, said bemotrizinol will give chemists a new tool to make sunscreens that people will want to wear.

“It’s a good UVA block,” he said. “It gives us good flexibility. In my mind, it allows you to make really good products without using avobenzone, which I think has a lot of baggage.”

Most of the UV rays people are exposed to are UVA rays that can penetrate the middle layer of the skin and cause up to 90% of skin aging, along with a smaller amount of UVB rays, which are . falls on the electromagnetic spectrum between X-rays and visible light.

Mitchnick said major companies have used chemical filters because they work better on a per-pound basis compared with mineral sunscreens made with zinc oxide and titanium dioxide. “That’s why hybrids are great — you get the best of both worlds.” He said he expects companies, including , to release hybrid products containing bemotrizinol and zinc oxide later this year.

J. Frank Nash, a senior director and research fellow at Procter & Gamble, said skepticism about sunscreen is unfortunate because properly formulated sunscreens do an excellent job blocking solar UV, “which we know is responsible for skin cancers and aging.”

He worries the industry has contributed to the trust gap by , called boosters, to mineral sunscreens, to raise sun protection factor ratings, or SPF. This leads consumers to wonder what’s in the products they’re buying.

Still, in Australia, where bemotrizinol has been used in sunscreens for years, a shows that even when regulators allow lauded UV filters, bad actors can taint a whole industry.

“People are not shunning sunscreen because they have stopped believing UV is dangerous,” said Joseph Mizikovsky, a director of the . “They are shunning it because they have lost trust in what is in the bottle.”

He applauds the FDA’s transparency with American consumers about the lack of safety data for filters without GRASE status, and FDA’s insistence on mandatory microbial testing of products.

But he said the FDA could do more to rebuild trust in sunscreens.

“My view is the FDA should move faster to ban filters that are missing safety data, and the public should focus on physical protection — shade, clothing, hats, sunglasses — with sunscreen as the last layer, not the first.”

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

“It was devastating news,” said Trisha Wise-Draper, a dermatologist at the University of Cincinnati who had patients enrolled in the trial.

“This is life or death for maybe 2,000 patients,” added Eric Whitman, medical director of the Atlantic Health System’s oncology service. A assailed the ruling, noting that it “will have a chilling effect on drug development.”

Despite the benefit to some patients, oncologists and pharmaceutical industry analysts say there were legitimate concerns about the treatment, called RP1, that may have led the FDA to reject it in any event. The company, they noted, had ignored repeated FDA suggestions that it change the design of the trial used to seek approval for the medication.

The FDA’s decision would have raised few eyebrows before the current administration took power. But Marty Makary, who took charge as commissioner 13 months ago, altered the agency’s culture and damaged the trust it had built over decades while regulating 20% of U.S. consumer spending, said Steven Grossman, a regulatory consultant and former Health and Human Services official.

“People have to speculate about the standards and processes by which the agency makes decisions,” he said. “And that uncertainty is bad for everybody — patients and sponsors and investors.”

Under Makary — who resigned this week — senior officials have or some at the behest of President Donald Trump or HHS Secretary Robert F. Kennedy Jr., ignoring the advice of agency professionals. In defending his actions, Makary often eschewed the agency’s traditionally measured language about its decisions.

In response to criticism for rejecting the melanoma treatment, for example, Makary accused its manufacturer, Replimune, of “corruption,” saying it was “engaging in corporate spin” to make the FDA look bad.

“I don’t work for Replimune. I work for the American people,” Makary said in a May 5 interview on CNBC. Kennedy backed him up during a congressional budget hearing in which Kennedy mistakenly claimed that patients in Replimune’s clinical trial had also received chemotherapy.

Makary did not respond to requests for comment.

“All the norms have been thrown out the window, so we don’t know what underlines an agency decision,” said , a former FDA staffer and Senate aide to Sen. Edward Kennedy who’s now a pharmaceutical industry consultant in Boston. “Even when there are legitimate scientific and regulatory reasons why a drug will not be approved, we’re left guessing whether it’s legitimate grounds or just a political play.”

A Doomed Cancer Drug

Melanoma is the fifth most commonly diagnosed cancer in the United States, with about 112,000 new cases each year. The American Cancer Society projects that from melanoma this year in the U.S. If Replimune’s treatment, RP1, worked as well as it did in the clinical trial, Whitman said, as many as 2,500 of those patients could be saved.

RP1 is a genetically engineered virus designed to destroy tumor cells and alert the immune system to swing into action against them. Replimune sought accelerated approval — a sort of shortcut that allows a product to enter the market while a larger confirmatory trial takes place — by presenting data that showed a third of 140 people in the trial had their tumors shrink or disappear. But the agency had warned Replimune in July that it risked denial unless it changed its development plans. In particular, the FDA noted that the trial had no control arm to compare RP1 to an approved melanoma treatment. Instead, all patients were given RP1 along with Opdivo, a type of immunotherapy.

Replimune’s scientists don’t entirely understand how the drug works, but research indicates that, in addition to destroying cancer cells, it releases chemicals that revive Opdivo’s capacity to stimulate the immune system. The company argued it would be unethical to give Opdivo alone as a control arm, because all the patients entered in the trial had already stopped getting better while taking only Opdivo or other drugs in its class.

“Having a control arm would have been unethical,” Wise-Draper said. Some of her patients responded extremely well to RP1 and no longer have evidence of melanoma, she said.

Replimune currently has a larger trial that includes a control arm, but “the bigger question is whether the company will survive,” Whitman said. The FDA-accelerated approval would have persuaded investors to provide enough cash to finish the larger trial, he said.

Replimune did not respond to repeated requests for comment. But it is firing more than half its staff and closing some operations in the wake of the FDA ruling.

RP1 wouldn’t have been the first melanoma drug approved based on a single-arm trial. Keytruda, the best-selling Merck cancer drug, was approved to treat melanoma some 12 years ago based on such a trial design. But in its denial statement, the FDA said it wasn’t convinced that the positive effects of the combination regimen were all due to RP1 and not partly to Opdivo.

Replimune arguably could have found an ethical way to set up a control arm for its treatment, Kim said. On the other hand, the FDA could have “given them a provisional yes” with accelerated approval, he said. The whole point of the three-decade-old accelerated approval program is to “take a gamble,” Kim said. The agency’s statement, stressing the company’s methodology over the result, “is a recalibration of how confident sponsors can be with similar studies,” he said.

Vinay Prasad’s Final Days at FDA

Much of the criticism of the FDA under Trump has focused on Vinay Prasad, who was fired then rehired last summer and held various leadership roles at the agency. Prasad, an oncologist known for critiquing the statistical bases of studies, repeatedly intervened in approval processes for drugs and vaccines normally decided by lower-ranking FDA professionals.

Prasad, who did not respond to requests for comment, resigned for good May 1, three weeks after the Replimune decision. “There’s this lingering question of whether this was Vinay’s last stand, or an objective decision made by careful scientists,” Kim said.

Makary ran afoul of Trump administration officials over various decisions, the last being his reluctance to approve flavored vapes for smoking cessation. Trump’s anti-abortion supporters wanted him ousted for allowing a generic form of mifepristone on the market, and for failing to speed up studies they hoped would lead to the abortion drug’s withdrawal from the market.

But in the industries regulated by the FDA, ranging from gene therapy to vaccines and cancer, officials are frustrated by the agency’s uncertain direction. In past administrations, the agency generally swung on a narrow arc between loosening and tightening requirements for drug approvals. Under Makary, “it’s been swinging in every conceivable direction,” Grossman said.

“It’s very inconsistent; it’s all over the place,” Whitman said. “The inconsistency is part of the concern.”

During his tenure, Makary made a series of categorical statements that either claim credit for progress made during earlier administrations or exaggerate the agency’s ability to move forward on goals.

For example, he set a goal of , which is considered impractical at the moment, Kim said, and moved to artificial intelligence at the FDA — prematurely, critics say. Makary and Prasad also promised to reduce the from two to one. FDA statutes require two well-controlled clinical trials for drug approvals, but exceptions to that rule are already frequent.

“The FDA is sending signals that it wants to even further reduce the evidence needed to support drug approval,” said Aaron Kesselheim, a Harvard Medical School professor and an expert on the drug industry. “Of course, if we’re talking about vaccines, the total opposite is the case. FDA has been taking real steps to make it harder to get vaccines approved.”

The FDA fired about 4,000 staffers at the start of the Trump administration. Makary promised to hire thousands back, but considering the upheavals at HHS and the FDA, these positions may be hard to fill. “What magic trick will get that done?” Grossman asked.

“The unfortunate thing is that there has been so much chaos at FDA that this Replimune decision, which may have needed to happen, has gotten mired in the controversy,” said Evan Seigerman, leader of healthcare research at BMO Capital Markets.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

“I will not go to the emergency room” — emphasis on not — were his first words after passing out, having a seizure, or regurgitating the protein smoothies I made to pass his narrowed esophagus. He said it again and again, even as fluid built up in his lungs, rendering him short of breath and prone to agonizing coughing spells. He had been a big, athletic guy, but now, in the ugly process of dying, he was looking gaunt. Ours was a precarious existence, but I understood his adamant rejection of the emergency department. Most prior visits had morphed into extended trips into a terrifying medical underworld — to a purgatory known as emergency department boarding.

I managed to keep Andrej at home while we planned for hospice, until one dreadful night at 2 a.m., when I ran out of hacks. We got into an ambulance and together headed to the hospital.

* * *

We had already learned the hard way that if you need admission to the hospital, you can remain in the emergency department — in the hallway or a curtained bay on a hard stretcher or in a makeshift holding area — for more than 24 hours, even for days, while waiting for a real hospital bed. In this limbo state, you’re technically admitted to the hospital, but still located in the physical domain of the ER. And the rules governing acceptable care and safety measures become much less clear.

In the summer of 2024, still being treated to keep his cancer at bay, Andrej had suddenly become somewhat delirious, requiring hospital admission to rule out the possibility of infection or, worse, of the cancer having spread to his brain. After we went to an emergency department near our home, in New York City, he lay trapped on a hard stretcher, with its rails up, for more than 36 hours, amid the alarms and calls for the code team, without any clues of whether it was day or night, and with access only to the few toilets shared by the dozens of patients and visitors in the emergency room. None of this helped his mental state. By the end of Day 2, he knew me — kind of — but had become convinced that the doctors were “the enemy” and that I was their paid accomplice.

After I pressed to move him to a bed “upstairs” — I meant to an inpatient ward — he was transported to a bed five floors higher. I realized too late that this was an “ED overflow area,” according to the paper sign attached to the entrance’s swinging door. A plaque in the hall identified it as a former labor and delivery floor. It had been kitted out with some of the trappings of an actual ward, such as real beds and bathrooms, but not the most important one: adequate personnel.

The space was by turns eerily quiet and wildly cacophonous. Although patients there were undergoing intimate, embarrassing procedures, rooms were gender-neutral. That first night, Andrej’s roommates were a man in a coma and an elderly French woman in a diaper and boots (no pants), who marched around her bed singing like a chanteuse. In the morning, I pestered a harried nurse and got Andrej moved to a quieter room with three beds, where two people died in three days.

The overworked staff did the best they could, but that was far from good care. My husband — who needed protein and calories but could consume only soft foods — was served chicken cutlets. When I noted to one nurse that Andrej’s soiled sheets hadn’t been changed for several days, she directed me to a linen cart so I could change them myself.

* * *

That first time, one of several extended ER stays Andrej made as a boarder, I thought perhaps we had just hit a busy time at a busy hospital. When I worked as an emergency medicine doctor a few decades ago, the ED was mostly empty at the beginning of my 7 a.m. shift. A few patients might be lingering from the day before: alcoholics who would sober up and leave, patients with a severe burn or a bad case of pneumonia who were waiting for a bed in intensive care.

In the decades since, EDs have doubled or even tripled in size. Even so, patients are piling up. When I started asking around, I quickly discovered ED boarding has become commonplace in the past five or so years and is getting worse, more or less omnipresent in hospitals. “Everyone knows about this problem, and no one cares enough to do anything about it,” Adrian Haimovich, an ED doctor at Boston’s Beth Israel Deaconess Medical Center who studies ED boarding, told me. “It’s barbaric.”

Measuring the problem has been challenging because data on ED boarding time is limited. Only this past November did the Centers for Medicare & Medicaid Services finalize a rule that would require hospitals to collect data on ED boarding times. Using what other data he could find, Haimovich has shown that boarding for more than 24 hours has increased dramatically for people 65 and older since the pandemic.

Once they enter ED boarding, patients exist in a gray zone. There has been a national push to establish “safe staffing” in EDs. Even with that, if an ED boarder has a medical complaint that needs quick attention, it’s easy for them to fall through the cracks, Haimovich said: In some hospitals, an admitting team of doctors from upstairs is responsible for the boarders stuck in the ED (but not the associated floor nurses); in others, overstretched ED medical staff must take full responsibility to care for boarders until a bed opens — and that in addition to seeing new patients. Some EDs now routinely hold more boarders — many of them quite ill — than patients being actively evaluated.

Doctors and nurses have complained bitterly about the situation, which forces them to provide inadequate care. Gabe Kelen, the director of emergency medicine at Johns Hopkins University, told me it’s creating a for emergency department staff. But doctors and department heads such as Kelen are not in control of admissions. Generally, a hospital’s administration parcels out inpatient beds, and emergency department boarding is in many ways a result of today’s business models and pressures.

* * *

When I worked as a doctor, if an ED was overwhelmed beyond capacity, the attending (that was me) typically called in to ambulance dispatch to request “diversion” — ambulances should take patients to another hospital. If a hospital got too full, the admitting office canceled elective admissions. Today, hospitals run like airlines and intentionally overbook, Kelen said. They also have fewer beds than they did a few years ago — in part because nurse (and executive) salaries have risen since the pandemic. An empty, staffed bed is a money loser, so the institution has an incentive to keep beds full and make new patients wait.

“The problem isn’t inefficiency — it’s the way health care finance is structured,” Kelen said. “Hospitals typically run on thin margins. Elective admissions are prioritized because they tend to be for lucrative procedures like heart catheterizations and joint replacements.”

Admitting patients through the emergency room has business advantages, too, even if it means they wait for a bed. The evaluation generates charges that typically run many thousands of dollars; once admitted, my husband was still billed the inpatient rate even for a stretcher in the hall. Old, sick, and dying patients are more likely to linger there in part because, after they’re in a real bed, they may take up that spot for days or weeks at a time while waiting for a bed in rehab or hospice, requiring nursing time but not the types of interventions that generate revenue.

Hospitals have tried band-aid fixes, such as bed-tracking software and discharge lounges where patients can wait for paperwork or transport home. Many do hire more doctors and nurses and orderlies in the ER to confront the overflow. But “long ED wait times and boarding have root causes that extend far beyond EDs and hospitals themselves,” Chris DeRienzo, the chief physician executive at the American Hospital Association, told me in an email. He listed the high cost of opening beds and the shortage of rehabilitation facilities, and emphasized the precarious financial situation of many hospitals.

But while Andrej waited in the overflow area, we were not thinking of any larger picture: He was sick, desperate, and still waiting for care. He lingered in boarding for four days before he got a bed. Each time he had to return to the ED, each time he faced a painful wait, he hardened his resolve to never go back.

* * *

Thunk. Crash. “Elisabeth, help!” Those were the sounds that woke me at 2 a.m.

I had fallen asleep on our bed, next to Andrej, his head raised with a foam wedge to ease his breathing and make sure food would not come up. Before I dozed off, I listened to his breathing — 30 times a minute, two times faster than normal — a sign he was struggling to get sufficient oxygen. And that racking cough. This was not good.

Now his bruised body was twisted, lying on the floor with his head against the bed frame. He’d attempted to use his walker to go to the bathroom. He was complaining of chest pain, coughing and short of breath. But he managed to get out those words: “I will not go to the ER.”

I knelt by his side in tears, telling him that I loved him but that I could not do anything more right now at home. Carlos, our super, helped me get him into bed and called EMS. I promised Andrej (against hope) that, given his condition, he would surely be quickly assigned to a real room and bed.

What happened next was a blur. I have a vague memory of paramedics arriving, putting him on the stretcher, sliding him into the ambulance, giving him oxygen. I mechanically grabbed his “do not resuscitate” form from under the refrigerator magnet and buckled myself in beside him.

Then he was in the ED, which was thrumming with activity, under the fluorescent lights, with oxygen in his nose, wearing a hospital gown, and looking gray and sick. The staff asked what was, for them, the operative question about a guy with widespread cancer: “Does he have a DNR?” Andrej asked me what was, for him, the operative question: “Did you bring my shoes?” He already wanted to leave.

An X-ray showed possible pneumonia, more tumors, and a buildup of fluid in his lungs. A medical team that covers oncology patients wrote an admitting note — he was now a boarder, again — and then retreated upstairs. They started antibiotics and gave him something to help him sleep amid the alarms and shouting. He didn’t.

When I came back the next morning — and two mornings after that — I was alarmed to see him still there on a hard stretcher, his feet dangling off the end, exhausted and in pain. “When will he be admitted to a bed?” I implored. If some of the stuff in his lungs was infectious, maybe he could be treated and get home.

Likely soon and I hear your frustration — I came to detest those two phrases.

Neighboring patients came and went 24 hours a day. Some were pleasant; some were screaming in pain or just screaming mad. Pulmonary doctors came and, in this semipublic space, used a large needle to remove three liters of fluid from Andrej’s right lung cavity.

* * *

Near the end of the Biden administration, in response to a bipartisan congressional request, the Department of Health and Human Services convened a meeting on emergency department boarding. Its report, from HHS’ Agency for Healthcare Research and Quality, came out the same month that the Trump administration took office, not long before Andrej’s fall — the last night he spent at home.

“Emergency department (ED) boarding is a public health crisis in the United States,” the report concluded. “Patients who are sick enough to require inpatient care can wait in the ED for hours, days, or even weeks.”

“Boarding contributes to increased mortality, medical errors, prolonged hospital stays, and greater dissatisfaction with care,” the report said.

The meeting proposal called for the formation of an expert panel to recommend solutions. In theory, a panel could have weighed in on key questions: Should hospitals — some of which are rich institutions — get paid an inpatient rate for boarding in the ED? Should they have to report boarding times and face penalties for excess? Should they be required to open more real beds, and should requirements for licensing be lessened? How can the country create more rehabilitation beds?

But since then, the Trump administration has dramatically cut that HHS agency’s staffing, as well as its grant programs. (Congress is still pushing to fund the agency.) The expert panel never formed, let alone offered solutions. The Centers for Medicare & Medicaid Services this year did initiate that will include voluntary reporting of boarding times in 2027, becoming mandatory in 2028. Bad marks will eventually affect Medicare reimbursement.

In an emailed statement, the Joint Commission, which certifies the nation’s hospitals, called boarding a “serious public health crisis” and “one of the most incredibly complex challenges in healthcare.” Although the organization does indirectly look at hospitals’ “ED throughput” from charts, such data is not comprehensive. Little information exists, for instance, about how many people’s last days are spent on stretchers, in hospital limbo.

None of this knowledge would have helped my dying husband. So I did what I’d promised myself I’d never do: I called a doctor friend, who called the hospital’s VIP office.

Suddenly Andrej was whisked to a real hospital room, with a bed that he could adjust to keep his head elevated, a tray he could eat from, a morphine pump, a TV, a bathroom, and a nurse call button at his side. A room with extra chairs, so his stepkids and friends could visit with gifts and mementos one last time. A room where the caring staff placed a chaise longue, where I could sleep over. That way, when he woke scared and coughing and yelling for me, I was there to hold his hand, adjust the oxygen, and push the button for an extra dose of narcotic.

Until, six days after we got in the ambulance and three days after we’d moved to this room, he woke early one morning, agitated and coughing, calling out, “Elisabeth?” I was there. But then, in a blink, he wasn’t.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

McLeod, who lives near Charleston, South Carolina, is still paying off chemotherapy bills that followed her 2017 diagnosis. She also now faces an onslaught of out-of-pocket costs for follow-up monitoring and care, including regular visits to a pulmonologist and allergist.

McLeod, 45, said she had already spent $2,500 in the first two months of the year and owes an additional $1,300 from a January colonoscopy. That’s on top of the $895 monthly premium for a health insurance plan that covers her family of six.

Those costs have led McLeod to ration her other care. Despite feeling intense chest pain since February, for example, she is putting off a CT scan and a visit to a heart specialist.

“You’re forced to pick and choose as to where your priorities really need to be,” said McLeod, director of strategic programs and partnerships at the Cancer Hope Network, a nonprofit that supports cancer patients. Even in that role, she struggles to navigate the financial aftermath of surviving the disease.

The cost of postcancer care often “keeps us hostage,” she said.

McLeod is one of nearly 19 million U.S. cancer survivors, many of whom continue to need prescriptions, doctor visits, and procedures to monitor their condition and manage posttreatment side effects. Of more than 1,200 cancer patients and survivors , about 47% said they had carried medical debt, with nearly half having owed more than $5,000, according to the American Cancer Society Cancer Action Network.

Yet health policy researchers and patient advocates said the experiences of cancer survivors reveal the limits of the Trump administration’s proposals to lower premiums, which may not help patients who accumulate large medical bills year after year. The proposals center on increasing the availability of high-deductible health plans, which have lower monthly payments but require patients to pay thousands of dollars out-of-pocket before coverage kicks in.

In addition, the administration has supported allowing insurers more leeway to sell plans that are not compliant with the Affordable Care Act. Such plans could bar people who have preexisting health conditions, like a cancer diagnosis, and exclude that ACA plans are required to cover.

The administration did not answer a request for comment on how its proposals would affect cancer survivors. But its supporters say, in general, people would have more flexibility to personalize coverage and more options for plans with lower monthly fees.

Michael Cannon, director of health policy studies at the Cato Institute, a libertarian think tank, believes patients would have better control over spending, and the option to choose what kind of care gets covered, if health plans were exempted from the ACA’s regulations. A person could opt for a plan that includes cancer treatment but not maternity care, for example.

History proves insurance coverage is not that simple, especially for people with preexisting conditions, said Jennifer Hoque, an associate policy principal with the American Cancer Society Cancer Action Network. When health plans could “pick and choose” enrollees based on preexisting conditions prior to the ACA, people needing the costliest care often struggled to find coverage, she said.

“They’re not going to choose a cancer survivor,” Hoque said of health insurers.

That was the case for Veronika Panagiotou, who said private insurers refused her coverage back in September 2013 because she had a high body mass index. Two months later, as a 25-year-old uninsured graduate student, she was diagnosed with non-Hodgkin lymphoma. The hospital treated her, she recalled, “and sent me all the bills.”

In January 2014, Panagiotou was able to buy one of the first ACA plans that went into effect. It covered chemotherapy and immunotherapy treatment, imaging, medications, hospital stays, weekly blood draws, a blood transfusion, and emergency room visits.

Now Panagiotou, 37, is cancer-free and works as director of advocacy and programs at Cancer Nation, a nonprofit advocacy group. Even though she is covered through her employer, Panagiotou said treatment-related expenses weigh heavily on her life decisions.

“Every choice I make, I think about cancer,” she said.

Chris Bond, a spokesperson for AHIP, the main health insurance trade association, said its members are working to improve access to coverage. But that can be a challenge when doctors and drugmakers are hiking prices, he said. Health plans are trying to “shield Americans from the full impact of those rising costs,” Bond said.

The Lymphoma Research Foundation has seen a 10% increase in applications to its patient aid fund this year, CEO Meghan Gutierrez said. “This trajectory suggests that financial safety nets, when they exist, are straining,” she said.

Rising prices are affecting everyone, regardless of the kind of health insurance they have, if any, said Brian Blase, president of Paragon Health Institute, a Republican-aligned think tank. “The biggest challenge for cancer patients isn’t the type of coverage,” he said. “It’s the underlying cost of care.”

Blase pointed to President Donald Trump’s as potentially helpful to cancer survivors. The Medicare Drug Price Negotiation Program, established by the Inflation Reduction Act of 2022, required the Department of Health and Human Services to negotiate prices for certain high-cost drugs, to lower prices for the federal health insurance program for people ages 65 and older. Drugs for breast, prostate, and kidney cancers are already on that list, .

Yet Hoque fears efforts to weaken ACA protections and financial support for marketplace plans will give cancer survivors — who she said tend to “hang on to insurance for dear life” — fewer options, especially between jobs or during career changes.

Erin Jones, a 31-year-old food policy researcher living in Fort Collins, Colorado, who was diagnosed with Hodgkin lymphoma as a young adult, is now cancer-free but still sees two oncologists, visits a high-risk breast clinic, and gets a breast MRI annually. Jones gets health insurance through the university where she works, and said she recently deferred acceptance to a PhD program partly due to uncertainty over affordable coverage.

“I don’t have the freedom to do the things I want to do as easily,” she said, “because I am constantly worried about health insurance.”

Costs related to surviving cancer, including monitoring for recurrence and treatment of side effects, were expected to reach $246 billion by 2030, up from $183 billion in 2015, according to .

Advancements in both detecting and curing cancer have resulted in a higher percentage of people surviving five years or more after diagnosis, according to the American Cancer Society. The number of survivors is expected to grow to more than 22 million people by 2035, .

Despite these advancements, the cost of treatment can steal the spotlight, said Ezekiel Emanuel, a co-director of the Healthcare Transformation Institute at the University of Pennsylvania and a onetime health policy adviser to former President Barack Obama.

An oncologist, Emanuel said he had observed patients make the difficult decision to delay or skip postcancer care as a result.

“Even when we triumph,” he said, “we don’t seem to be able to have a celebration.”

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .