WAIANAE, Hawai‘i — Native Hawaiians will need to comply with new work requirements to qualify for Medicaid after being excluded from exemptions carved out for other Indigenous groups, an omission that clinicians fear will exacerbate the challenges the marginalized population already faces in getting healthcare.

In 43 states and the District of Columbia, President Donald Trump’s signature One Big Beautiful Bill Act will require most adults to work, go to school or enter a training program, or volunteer for at least 80 hours a month. Native Americans and Alaska Natives are exempt from the mandates, which take effect in January.

Of the nearly 700,000 Native Hawaiians in the U.S., around 47% live in Hawai‘i. Within the contiguous United States, California, Washington, Nevada, Texas, and Oregon have the largest populations of Native Hawaiians.

Hawaiʻi’s Medicaid administrator, Meredith Nichols, said the Centers for Medicare & Medicaid Services didn’t respond to the state’s request to include an exemption for Native Hawaiians but said she believes the decision came down to the population’s lack of recognition as a tribal nation. Hawai‘i has about 390,000 Medicaid enrollees, 15% of whom identify as Native Hawaiian, Nichols said.

“We know that when we’ve asked similar questions in the past, it all comes down to federal recognition,” she said.

Hawaiʻi health administrators met with Trump administration officials in June. Some unsuccessfully pushed to add an exemption to the new law, which would need congressional approval.

White House spokesperson Kush Desai did not respond to requests for comment. In a statement, CMS spokesperson Timothy Foster confirmed that the agency met with 16 health centers in Hawai‘i about Medicaid changes but didn’t respond to other questions.

Barriers to Care

Native Hawaiians face many of the same health disparities as Native Americans and Alaska Natives, including higher risks during pregnancy, higher infant mortality rates, and higher rates of being uninsured than the white population. And in Hawaiʻi, Native Hawaiians have the second-lowest life expectancy among ethnic groups after other Pacific Islanders.

Kapono Chong-Hanssen is the medical director of Ho‘ōla Lāhui, the Native Hawaiian healthcare system on Kaua‘i that also serves the privately owned island of Ni‘ihau, whose 170 full-time residents are predominantly Native Hawaiian. Chong-Hanssen said he anticipates many of his patients will no longer receive the care they need once the new work requirements take effect.

Chong-Hanssen says new Medicaid work requirements will erode the trust healthcare providers worked hard to build among Native Hawaiian patients. (Ashley Mizuo/KFF Health News) Ho‘ōla Lāhui, the Native Hawaiian healthcare system on Kaua‘i, operates out of multiple locations, including its clinic in Waimea on the west side of the island. Kaua‘i and Ni‘ihau were impacted by Hurricane Lowell this week, forcing Ho‘ōla Lāhui to temporarily close facilities. (Ashley Mizuo/KFF Health News)

The new requirements will erode the trust healthcare providers worked hard to build among Native Hawaiian patients, who, in response to historical disenfranchisement, are more likely to disengage and “throw the whole system out” when they run into barriers, Chong-Hanssen said. “It just flies in the face of everything that we’re trying to do.”

Beyond medical services, Medicaid covers transportation expenses when patients travel between islands for care. A round-trip ticket between Kaua‘i and O‘ahu, for example, can cost hundreds of dollars.

Congress placed over 200,000 acres of land in a trust for Hawaiian homesteads in 1921 to bring Hawaiians back to their native lands after the U.S. backed the 1893 illegal overthrow of the Hawaiian kingdom. Nearly 30,000 Native Hawaiians are still waiting for land, while, as of the 2020 census, more than 34,000 people lived on Hawaiian homelands. The homesteads are often far from Honolulu, where most health services are located.

Waianae Coast Comprehensive Health Center primarily serves the west side of O‘ahu, which is home to the island’s largest Native Hawaiian population, near four Hawaiian homesteads.

Waianae Coast Comprehensive Health Center CEO Rich Bettini (right) and Vice President Leinaala Kanana demonstrate how to use pods throughout the campus that connect patients via phone to an employee who will help them submit needed information and applications to the state’s Medicaid program. (Ashley Mizuo/KFF Health News)

The center’s vice president, Leinaala Kanana, said that many of its patients are geographically isolated and that few jobs are available in the area. Patients also have trouble securing transportation to get to work or finding affordable childcare.

The center’s CEO, Rich Bettini, said Hawai‘i’s high living costs and depressed wages have pushed many people into homelessness, creating another barrier to complying with the new Medicaid requirements. Native Hawaiian and Pacific Islanders make up about 60% of O‘ahu’s homeless population. The center estimated about 2,800 of its patients may be affected by the requirements, half of whom are Native Hawaiian.

The annual “cost of living for a family of four in Hawaiʻi on O‘ahu is $100,000-plus. The average income of our patients is under $30,000 a year,” he said. “That is an enormous gap.”

‘Bigger Fish To Fry’

Native Hawaiians face obstacles to being granted the same exemptions as other Indigenous groups. While several federal laws refer to Native Hawaiians as an Indigenous group, they are not among the 575 tribes recognized by the federal government. Federal recognition can be granted either by Congress or administratively through a process established by the Department of the Interior. Native Hawaiians remain divided about whether they would even want federal recognition, with some fearing it would jeopardize their ability to restore Hawaiian independence.

Laws governing Medicaid also don’t acknowledge Native Hawaiians, aside from the 2021 American Rescue Plan Act, signed by former President Joe Biden. In the covid-era law, the federal government fully reimbursed Native Hawaiian health centers for Medicaid services for two years. However, all the qualifying Native Hawaiian health centers were in Hawai‘i, where fewer than half of Native Hawaiians in the country now live.

The federal government fully reimburses Indian Health Service and tribal facilities for healthcare services provided to Native Americans and Alaska Natives. Native Hawaiian healthcare systems instead receive the same reimbursement rate as in the rest of Hawaiʻi.

Waianae Coast Comprehensive Health Center CEO Rich Bettini said Hawai‘i’s high cost of living and depressed wages have pushed many people into homelessness, creating another barrier for Native Hawaiians to comply with new Medicaid requirements. (Ashley Mizuo/KFF Health News)

Keolamaikalani Dean, the CEO of the King Lunalilo Trust, which provides services for Native Hawaiian elders, pointed to the new Medicaid requirements as just one of many federal policies limiting Native Hawaiians’ healthcare.

“It’s horrible as a policy, but there are bigger fish to fry,” he said.

Dean said he’d rather advocate for giving Native Hawaiian healthcare systems the same full Medicaid reimbursement that the Indian Health Service receives. The change would have greater impact on patients seeking care, he said.

Native Hawaiian advocates said they have been overextended as they work to guard against an onslaught of threats to revoke other federal funding by the Trump administration.

In Trump’s proposed 2027 budget, cuts to Native Hawaiian programs cited the group’s lack of federal recognition as a “tribal nation.” The proposed cuts coincide with lawsuits from conservative groups challenging Native Hawaiian education programs and long-standing legislation that provides homestead land to some Native Hawaiians at almost no cost, alleging the programs racially discriminate against other groups.

Papa Ola Lōkahi, a nonprofit that oversees the Native Hawaiian healthcare systems in the state, declined to comment for this article. The group is involved in a lawsuit filed by a conservative group aiming to stop a university scholarship for Native Hawaiians pursuing healthcare careers.

U.S. Rep. Jill Tokuda (D-Hawaiʻi) viewed the exclusion of Native Hawaiians from the exemptions to Medicaid work requirements as an attempt to further erode Native Hawaiians’ Indigenous status, pointing to recent challenges by the Trump administration and lawsuits.

“These are not one-offs,” Tokuda said. “This is a targeted, coordinated attack to undercut the Indigenous status of Native Hawaiians.”

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.

TROY, N.Y. — Like many residents of this aging industrial city on the Hudson River, Starletta Washington was stunned when she heard Troy’s last remaining hospital planned to close its birthing center.

“It was devastating,” said Washington, who heads the local YWCA. Washington was born at the hospital and had her children there. She couldn’t believe families would now have to get to a hospital half an hour away or face the prospect of an emergency delivery.

“Nobody else was going to be born in the city of Troy unless they were born on a city bus, in the back of a cab, or, disgustingly, on the side of the street?” Washington said. “Blew my mind.”

Troy wasn’t the first community to face this prospect. Since 2010, hospitals have closed hundreds of maternity units as cities and towns shrink and hospitals consolidate into larger systems.

Troy found a more hopeful ending.

Elected officials from both major parties joined patient advocates, mothers, midwives, doulas, and community leaders like Washington to challenge Trinity Health, the large Catholic health system that owns Troy’s hospital and birthing center. The campaign even united Planned Parenthood and the Catholic diocese.

“Whether you were Republican or Democrat, or if you didn’t vote, it literally brought everyone together,” said Carmella Mantello, the city’s Republican mayor. “Everyone just said, ‘We can’t let this happen.’”

Carmella Mantello, the Republican mayor of Troy, New York, says even nonprofit hospitals seem to have become more corporate. “The whole hospital scene has changed,” she says. (Hannah Norman/KFF Health News) Starletta Washington, who heads the YWCA in Troy, was born at the hospital where Burdett Birth Center is located. Like many in the community, she says she was blindsided by Trinity Health’s plan to close the center. (Hannah Norman/KFF Health News)

Throughout the country, healthcare remains a flash point as politicians square off ahead of November’s elections. But in many places, Americans are also quietly finding common ground.

In this small city, residents were brought together by frustration over large, corporate health systems that can seem to put profits over patients. And they resolved to work together to keep critical medical services in their community.

A Community Institution

Babies have been delivered at Samaritan Hospital on a hill above Troy since this city’s once bustling factories produced most of America’s shirt collars a century ago.

More recently, Samaritan’s Burdett Birth Center had become a model for patient-focused care. Midwives and doulas work alongside OB-GYNs and support mothers who want to avoid a delivery by cesarean section unless necessary.

Patient safety advocates have pushed for years to reduce surgical deliveries, which can lead to complications. At Burdett, only about a quarter of newborns are delivered by C-section, compared with about a third statewide, according to 2025 hospital data. Burdett also had fewer preterm births and fewer babies with low birth weights.

“I wouldn’t go anywhere else,” said Lidia Zambrano-Madera, who gave birth to both her children at Burdett with the help of a midwife.

Lidia Zambrano-Madera, a Troy resident, gave birth to both her children at the Burdett Birth Center with the help of a midwife. “I wouldn’t go anywhere else,” she says. (Jayana Espinoza)

For Zambrano-Madera, who recently opened a children’s play center in Troy, Burdett offered another advantage: It was just five minutes from home.

But three years ago, Trinity Health, a multibillion-dollar Michigan-based hospital system, said the birth center was losing money and would close. Families from Troy and surrounding Rensselaer County would have to deliver at another Trinity hospital in Albany, up to a half-hour’s drive away. The hospitals are branded under St. Peter’s Health Partners in the Albany region.

“We’ve been frantic about trying not to cut the care at the bedside,” said Steven Hanks, a physician who oversees Trinity hospitals in New York and New England. “But, you know, you get to a point where you can only consolidate so much. You can only spread people so thin, and then you have to start taking harder looks at your actual services.”

Corporate Backlash

Trinity’s plans — news of which broke in a local newspaper — came without warning, surprising the obstetrical staff and community leaders. They set off a firestorm.

Within days, midwives, mothers, community leaders, and politicians held a rally at the YWCA in downtown Troy. Others would follow. Volunteers led by doulas and midwives made T-shirts and handed out pink “Save Burdett” signs at the local farmers market.

Activists were outraged that the hospital hadn’t adequately assessed the impact of the closure, particularly on low-income families. They conducted a community survey that found 1 in 4 Troy residents didn’t have access to a car and would have trouble getting to Albany.

The campaign drew on deep connections that many residents had to Burdett. “They realized what a gem Burdett is, and what a great community service they provide,” said Jessica Hayek, a doula and birth educator who helped lead the campaign.

Jessica Hayek, a doula and birth educator, helped lead the campaign to stop Trinity Health from closing the Burdett Birth Center. She says Michigan-based Trinity didn’t appreciate how important the center was to the Troy community. (Hannah Norman/KFF Health News)

Hayek and others also tapped into deep-seated frustration with Trinity, a healthcare behemoth that operates 91 hospitals and last year recorded more than $25 billion in revenue and a healthy operating margin that topped 5%.

“Trinity Health is in the Midwest, and they are not in the community,” Hayek said. “So when you’re looking at just the numbers from an office in the Midwest somewhere, they’re not looking at the benefit that this place has on the community.”

Hayek describes herself as a liberal Democrat. But Trinity’s focus on its bottom line also irked many Republicans, including Mantello, who was the City Council president at the time.

“The whole hospital scene has changed,” Mantello said. “It was very personable. You had nurses and doctors who were able to give more care and spend more time with patients.” Now, by contrast, many hospitals have what she described as a “more corporate type of atmosphere.”

Even the Catholic bishop decried the planned closure of the birthing center as out of step with the values of his faith and the hospital system’s.

“Nothing is more central to the Catholic healthcare mission than supporting life and all those who bring it into the world,” Bishop Edward Scharfenberger said after Trinity announced the closure plan. Scharfenberger has since retired.

A Bipartisan Solution

Despite the backlash, Trinity Health executives for months insisted they had no choice. The system even sued the state to push through the closure.

Ultimately, though, powerful state officials, including New York Attorney General Letitia James, a Democrat, joined the fight to save the birthing center, launching an investigation into the proposed closure and hosting a daylong hearing in Troy.

State Assembly member John T. McDonald III, a Democrat who represents Troy, worked with Republican elected officials, including the county executive and the state senator representing Troy, to secure $5 million in state funding to help keep Burdett open.

 “You had a Democrat and a bunch of Republicans all working together on the same issue,” McDonald said, “because, at the end of the day, our job is to listen to what the public has to say.”

Community leaders, politicians, midwives, doulas, and families from Troy rallied for months to stop the Burdett Birth Center from closing, including at the state Capitol in Albany. (Katherine Bruno/Upper Hudson Planned Parenthood) Community volunteers in Troy celebrated the success of their campaign to save the Burdett Birth Center by adding a yellow tag to the pink protest signs. (Hannah Norman/KFF Health News)

Nearly a year after announcing the closure, Trinity reversed itself and said Burdett would remain open.

Lois Uttley, a New York City-based researcher and activist who has worked with communities facing hospital consolidation, said Troy’s success reflects a growing bipartisan suspicion of corporate healthcare organizations.

“The executives of these health systems will tell the community that joining a big health system will be good, that the quality of care will improve, that efficiencies will mean they can keep the costs low,” Uttley said. “But what I have seen over the last 30 years of work is that those promises often are broken.”

As hospitals close or downsize, she said, communities are catching on. “They’re becoming more skeptical.”

There’s another, more hopeful lesson in Troy’s success, said McDonald, the state lawmaker.

“If we take down our swords,” he said, “and put out our arms, maybe we can get something done.”

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.

AUSTIN, Texas — Musician Zack Morgan jokes that when he lost his corporate job in 2015, it was like being pushed off a cliff. For years, he said, he’d been playing both sides of the Austin coin: tech worker by day, funk keyboardist by night.

“Maybe this is my sign to try the full-time music thing,” Morgan recalled thinking. “Step one in that was: Get health insurance again.”

Austin bills itself as “the Live Music Capital of the World,” but it can be unaffordable for the artists who provide the city with its cultural cachet — and help drive its tourism revenue.

Morgan has supported himself by patching together gigs with a number of bands. To help pay for health insurance, he turned to a local nonprofit, the Health Alliance for Austin Musicians, or HAAM.

“That’s part of being able to make this whole thing work,” Morgan said.

HAAM subsidizes the monthly insurance premiums of local musicians who purchase plans through the Affordable Care Act marketplace. To fund the roughly $4 million program, it works with Central Health, a public agency that provides healthcare resources for low-income residents of Austin and surrounding Travis County. Many of the performing artists pay $0 toward monthly premiums.

After more than a decade, including through the coronavirus pandemic, the assistance program has become an established and reliable financial support for Austin’s musician community.

This year, after Congress failed to extend pandemic-era subsidies, premiums skyrocketed for many ACA plans. A recent report found that 5 million people nationwide had dropped the coverage. HAAM helped blunt the impact for its members. It has emerged as a potential model for other cities hoping to make healthcare more affordable for key populations and industries.

Morgan plays keyboard with pop singer Ruthie Craft at the Saxon Pub in Austin on July 27. (Ysa Mendoza/KUT News)

A Growing Idea

Texas had the highest uninsured rate among states, with 19% of people age 64 and under uninsured, as of 2024.

Even before the launch of the ACA marketplace in 2014, HAAM had spent a decade connecting musicians with free and low-cost care at clinics and hospitals in and around Austin. But roughly 85% of HAAM members remained uninsured, leaving them exposed when traveling to gigs in other cities and states.

“When the Affordable Care Act came out, and we knew it was here to stay, it really made sense for us to start getting our musicians fully insured,” said Rachel Blair, HAAM’s chief strategy officer.

Similar nonprofits in other U.S. cities with strong live music cultures, such as Seattle, New Orleans, and Nashville, Tennessee, help musicians get medical care. With the advent of the ACA, some of these organizations began helping musicians navigate the sometimes complex enrollment process for the online marketplaces, though they stopped short of pitching in on premiums.

But the team at HAAM recognized that without direct support to help pay premiums, many of their members would still struggle to retain coverage.

“When you think about the average HAAM member making about $30,000 a year, there’s no way that they would be able to spend a third of their income on healthcare,” Blair said.

The organization’s membership has grown by 77% to more than 3,300 people since HAAM began offering premium assistance, and more than 90% of members are now insured.

To help subsidize costs for members, HAAM partnered with Central Health, which is Travis County’s public hospital district — a type of health agency in Texas charged with using tax dollars to fund safety net healthcare for low-income residents. Central Health also operates the nonprofit Sendero Health Plans, which offers marketplace insurance to Travis County residents.

To qualify, HAAM members must enroll in one of Sendero’s silver-level, or benchmark, plans. If their income is between one and two times the federal poverty level, Central Health pays the balance of their monthly premium after federal tax credits are applied. For members who fall above that income range, HAAM offers a more limited subsidy, covering 50% of their premium balances.

Each year, the Health Alliance for Austin Musicians hosts the HAAM Day Music Festival, its annual event to raise money to help local musicians afford insurance premiums and other healthcare services. Bands play in common spaces across the city, from grocery stores to the Texas Capitol steps. (Shunya Carroll/KUT News)

In 2017, HAAM helped set up a similar program in Denton, a college town north of Dallas that has served as a testing ground for successful musicians, from Meat Loaf to Norah Jones.

The Denton Music and Arts Collaborative works differently: It connects members with an independent insurance agent who helps them find the best health plan for their needs. The nonprofit then offers members a monthly subsidy of $100.

The subsidies are a way of keeping Denton’s culture of jazz and “weird art rock” alive, said the collaborative’s president, Jennifer Kapinos.

“More and more people were maybe graduating college and leaving and going to find better opportunities in other places,” Kapinos said. “People who had lived here a long time suddenly were finding it harder and harder to afford to be here.”

In Austin, other sectors have been watching HAAM’s work. In 2025, Good Work Austin, a nonprofit that advocates for restaurant workers, launched a small pilot program with Central Health to help local food workers enroll in Sendero plans and cover their premiums.

Kit Abney Spelce, vice president of operations for Central Health, said partnering with an advocacy group focused on a particular workforce is key because simply announcing “free insurance for you” doesn’t mean people will sign up.

“We are very much dependent on our partner entity to go out and connect with the community, to have that relationship and that trust,” she said.

Navigating Federal Headwinds

Though premium payments often increase year over year, the 2026 plan year was particularly expensive, increasing by 58% on average.

Citing medical and pharmacy costs, Sendero raised rates by an average of 16% for its enrollees. At the same time, Congress allowed the pandemic-era enhanced premium tax credits to expire, reducing the federal subsidies that many marketplace customers relied on.

“Our premiums for our members went up 60% from one year to the next,” Blair said.

HAAM stepped up its fundraising into 2026, but it wasn’t enough to cover everyone who requested assistance. They had to turn away hundreds of qualified people. Still, they were able to buffer existing members, said Spelce with Central Health.

“We’re going to make sure their monthly premium is paid every month,” she said.

Austin-based Latin-folk singer Gina Chavez plays on the steps of the Texas Capitol in 2025 for the HAAM Day Music Festival, an annual fundraiser for the Health Alliance for Austin Musicians. (Shunya Carroll/KUT News)

A Viable, if Limited, Model

Beyond the eligible musicians they turned away in 2026, another population remains out of HAAM’s coverage reach for premium assistance: Austin’s poorest residents.

Under the ACA, the marketplace plans that HAAM helps subsidize are for low- and middle-income earners, but the people with the very lowest incomes — below 100% of the federal poverty level, set at about $15,000 — are supposed to be covered by expanded Medicaid.

But Texas is one of 10 states that chose not to expand Medicaid after the ACA became law, so many of the poorest Texans remain uncovered.

With no federal subsidies available for that group, HAAM and Central Health have tried to develop separate solutions for this subpopulation. Central Health has its Medical Access Program, an alternative to health insurance that gives low-income, uninsured people access to a network of local care providers. HAAM has also established relationships with primary care providers to serve its uninsured members — but Blair acknowledges it’s not an equivalent benefit to what Medicaid expansion would offer.

“It’s not a very sustainable solution, especially when there’s a really good alternative,” Blair said.

This article is from a partnership that includes KUT, 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.

A group of Democratic lawmakers is calling for the Trump administration to suspend a new surveillance program it quietly launched to collect the personal and identifiable health data of Americans who visit emergency rooms.

KFF Health News first reported that the Consumer Product Safety Commission — a federal agency tasked with monitoring injuries from household items — was pressuring hospitals to provide a private company with personally identifiable health information for analysis. The rollout of the program has inspired broad pushback from hospitals and privacy advocates.

The CPSC’s goal is to obtain millions of Americans’ medical records from emergency rooms for most injuries, even when a consumer product is not involved, internal emails and documents reviewed by KFF Health News revealed. The agency instructed hospitals to share detailed patient information for more than 10,000 types of injuries or conditions, such as vaccine reactions, suicide attempts, or stingray stabs.

The scope of data CPSC is collecting far exceeds the agency’s mission and should be immediately suspended, Massachusetts Sen. Ed Markey, who sits on the Senate Health, Education, Labor, and Pensions Committee, and other House and Senate Democrats wrote in a letter to CPSC acting Chairman Peter Feldman.

“This unprecedented and sweeping effort to collect identifiable patient data is untethered from the Commission’s statutory mission and authority, and is ripe for misuse by an administration that has repeatedly sought access to Americans’ most personal information,” the letter stated. “Americans should be able to seek medical care without fear that their personal health information will be swept into a federal database and repurposed for political ends.”

Among other Democrats signing the letter were Sen. Richard Blumenthal of Connecticut, Rep. Jan Schakowsky of Illinois, and Sen. Ron Wyden of Oregon, the ranking member of the Senate Finance Committee.

CPSC spokesperson Steve Roney did not answer several questions about the program and the call for it to be suspended.

“We received the letter, and will respond directly, through the appropriate channels,” he said in a statement.

The CPSC is one of several agencies that have launched broad acquisitions of Americans’ sensitive medical records during Trump’s second term. The Office of Personnel Management has requested federal workers’ sensitive health information. Health and Human Services Secretary Robert F. Kennedy Jr. deputized at least one private organization to collect more medical records for his studies on vaccines and autism.

The CPSC has operated a voluntary program for decades that enables trained hospital workers based in about 70 hospitals nationwide to report injuries involving consumer products, called the National Electronic Injury Surveillance System, or NEISS. Compared with the current initiative, the agency’s data collection has historically been far narrower, and previously requested patients’ identifiable information, generally for follow-up, in fewer than 1% of cases.

Without public notice, CPSC staffers overhauled the program early this year — rebranding it as NEISS-R — and told hospital executives that participation is mandatory, requiring they report far more identifiable patient details from more injuries to a private company called Konza Health. The Kansas-based company won a five-year contract last year worth up to $15.9 million with the CPSC.

In emails and contract language reviewed by KFF Health News, Konza representatives described hospital participation as “mandatory” or “required.” Emails sent this year by CPSC chief data officer Elizabeth Puchek said hospitals would need to apply for an exemption from participation or face penalties. Those penalties, for what’s called unlawful “information blocking,” were established in a federal data-sharing regulation designed to make sure patients could access their medical records. The agency’s website reiterated that threat, claiming information-blocking regulations require hospitals “to make electronic health information (EHI) available to public health authorities, such as CPSC, upon request, unless a specific exception applies.”

The power play inspired widespread resistance. The American Hospital Association sent a letter in August asking for modifications to the program, citing “confusion and concern about the scope of patient information” demanded by the agency.

Now the agency is backtracking, removing in recent weeks mentions of “information blocking” penalties from its public page.

The CPSC’s Feldman, a Trump appointee, said in an interview last month with Nextgov/FCW that the new program would “remain a voluntary” one.

The Democrats highlighted these discrepancies and changes, also noting that the agency has bypassed regulations and failed to publicly lay out any detailed plan for its data collection, as required by law.

“The Commission has since quietly removed the information blocking rationale from its public NEISS webpage, without any public correction or acknowledgment that the claim it spent months promoting was without basis,” the letter said. “This reversal does not undo the coercion hospitals experienced, but rather raises the question of whether the Commission’s purported legal justifications were ever more than post-hoc cover for an agenda that had little to do with its statutory authority.” The Democrats’ letter asks CPSC to respond by Sept. 18.

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.

In the thick of his competitive reelection race in Michigan, Republican Rep. Tom Barrett joined Health and Human Services Secretary Robert F. Kennedy Jr. at a sprawling 400-acre apple orchard, farm, and winery. They touted Trump administration efforts to improve the American diet, including the removal of some artificial dyes from processed foods.

“We had a great discussion about healthy options for all Americans and taking back control of our healthcare,” Barrett said in a June Instagram post, after sampling the farm’s apple cider.

Like the focus on artificial dyes, however, many of the administration’s highest-profile health initiatives rely on voluntary agreements. The goals, such as lower drug prices and nutrition classes for doctors, have widespread appeal, cutting across party lines and economic divisions.

But the administration-industry deals lack the enforcement teeth of more traditional federal regulation. Their details are vague, and minimal oversight makes it hard to monitor progress. In some cases, the administration has claimed victories that have yet to materialize.

Republicans consider the dealmaking a winning strategy. It fits with the party’s anti-regulatory stance, they say, and enables the administration to quickly forge agreements President Donald Trump and his allies can tout as accomplishments. In the run-up to the midterm elections, some, like Barrett, hope to woo voters by trumpeting the Trump administration’s efforts to shape health policy.

The practice also raises questions. Though the deals are announced with great fanfare — often during televised events on stages, with live audiences — there’s little documentation or follow-through, creating doubts about whether the administration’s health agenda will lead to lasting change or unravel once the political attention fades.

The distinction could prove important to voters as Republicans defend their health records in November’s midterm elections.

“These deals are often not transparent, so there’s no way for the public to judge how meaningful they are,” said Larry Levitt, executive vice president for health policy at KFF, a health information nonprofit that includes KFF Health News.

Dealing With Dyes

The push to remove certain artificial dyes from food and drugs, for example, was a headline grabber. In April 2025, Kennedy strode onto an HHS stage to announce deals with food makers. He was flanked by young children and mothers holding placards reading “Make America Healthy Again.”

He and former FDA commissioner Marty Makary drew a standing ovation from an audience selected by Kennedy’s staff as they said companies had pledged to phase out all petroleum-based synthetic dyes from the nation’s food supply and medicines. They targeted nine synthetic dyes for removal.

Voters love the idea of stopping the use of such dyes. In a nationally representative March survey by Consumer Reports, 72% of adults said they were at least somewhat concerned about synthetic dyes, and two-thirds said companies should be required to phase them out.

A year after making the first announcement at HHS, Kennedy declared victory during a discussion at the Conservative Political Action Conference, an annual political event.

“We’ve gotten rid of the nine synthetic-based food dyes,” he said.

Not quite. At the initial HHS event, federal officials said companies would voluntarily stop using six specific synthetic dyes by the end of this year. (The administration has also revoked or proposed revoking authorization for two other synthetic food dyes.)

Later, the FDA on its website quietly changed the deadline to the end of 2027. So, most are still in use.

In fact, the FDA posted a list of 27 companies it said had made voluntary pledges as of December 2025 to remove six synthetic dyes from products such as Doritos and Kellogg’s Froot Loops. More than a year and a half later, seven food makers — fewer than 30% of those who bought in — had met their promised goals.

Many major food makers, such as the Coca-Cola Co. and Unilever, have made “no concrete commitments” to remove the synthetic dyes, according to Consumer Reports. In addition, no pharmaceutical companies have publicly said they have plans to remove dyes from drugs.

“It’s just all talk,” said Leslie Dach, who chairs Protect Our Care, a healthcare advocacy group that supports the Affordable Care Act. “They just govern for a day of publicity, and then it’s over. None of it happens. Yet the people don’t know because they have busy lives, so they think, ‘Just look at all these initiatives.’”

In fact, the administration loosened labeling requirements, allowing companies to say their products contain no artificial colors — as long as they don’t use petroleum-based dyes. Previously, food makers could not make that claim unless their products contained no added colors. Some food dyes made from natural ingredients can contain contaminants and may pose their own health risks, such as diabetes.

“The federal government hasn’t taken any regulatory action on food dyes, for the most part, since the beginning of this administration,” said Melanie Benesh, vice president for government affairs at the Environmental Working Group, an advocacy group.

HHS said the voluntary approach has yielded significant action, including commitments to remove synthetic dyes from products sold in schools for the 2026–27 school year.

“HHS and the FDA are moving forward with clear timelines and concrete industry commitments, with major changes expected in foods served in schools during the coming school year and across full product portfolios by the end of 2027,” HHS spokesperson Emily Hilliard said in an email.

At the same CPAC convention event, Kennedy said “the MCAT testing companies are going to put nutrition on the MCAT for the first time, so the students will actually want to do it.” MCAT refers to the Medical College Admission Test, an exam required for admission to medical schools.

Again, not quite.

The Association of American Medical Colleges administers the MCAT. Spokesperson Stuart Heiser said Kennedy misspoke and may have meant to refer to a test taken by students to be licensed as doctors.

An Insurance Deal Falls Short of Promises

Kennedy again took to the HHS stage in June 2025, this time with Centers for Medicare & Medicaid Services Administrator Mehmet Oz, to make what was billed as a game-changing announcement. Major insurers, they said, had agreed to reduce the volume of healthcare services subject to prior authorization, a practice widely used by the insurance industry that often requires patients or their medical teams to seek preapproval before undergoing treatment.

The administration said 80% of insurers pledged changes to preauthorization requirements for 80% of diseases and injuries by January 2026. The administration also promised “public dashboards” to track progress.

“It will happen very quickly,” Oz said at the event. “Necessary care will be delivered when it’s needed, in the right way.”

As of July, months past that January target date, health plans had reduced prior authorization for medical services by about 11%, according to AHIP, the insurer trade group. But no public dashboards have debuted to track the deal, and some insurers that signed the pledge last summer told KFF Health News this year that they will not implement all the promised reforms as outlined by AHIP.

Hilliard did not respond to questions about the pace of progress.

The American Medical Association, in a 2025 web-based survey, asked 1,000 practicing doctors whether they believed the voluntary pledges would make a meaningful difference. Only 1 in 3 said they believed they would.

Insurers made a similar promise in 2018, during the previous Trump administration. The next year, more than 80% of doctors said the number of prior authorization requests for drugs and medical services had been increasing, based on another AMA survey.

Meanwhile, the administration is testing an artificial intelligence-powered prior authorization system for Medicare, the federal health program for people 65 and older or with disabilities. In six states, Medicare beneficiaries must get preapproval for a few treatments that CMS considers to have little clinical benefit and to be susceptible to fraud or waste, including skin substitutes and knee arthroscopy for arthritis. The program began in January, the same deadline insurers had set for curtailing preauthorization delays.

Deals and Deregulation

The healthcare industry’s voluntary agreements appeal to voters who feel government regulation drives up costs and places unnecessary burdens on businesses, some supporters say.

“Secretary Kennedy is the antithesis of a public health industry that uses coercion over communication — and has demonstrated this by taking the time and effort to push voluntary initiatives over the typical approach of governmental mandates,” said David Mansdoerfer, a political consultant who was a political appointee at HHS in Trump’s first term.

But voluntary agreements with the health industry can prove ineffective. Former President Jimmy Carter in 1977 proposed a legislative plan to curb rising hospital costs. Hospitals fought back, and Congress rejected the proposal, instead favoring a voluntary approach desired by the industry. It ultimately failed once public attention faded.

One upside: Deals are fast. Enacting a federal regulation can take two to three years. And some health analysts say the tempo of the agreements advanced by Kennedy and Trump may help take voters’ attention off the Trump administration’s inability so far to produce a long-promised health plan.

Instead, Republicans can point to the array of accords reached with industry, including the administration’s voluntary arrangement with drugmakers to cut prices so they’re in line with lower amounts charged in peer countries. The White House calls it the “most-favored-nation” prescription drug pricing policy.

Seventeen companies, including Pfizer and AstraZeneca, announced agreements with the administration to lower prices for Medicaid enrollees and cash-paying consumers using TrumpRx, a narrow, government-run consumer platform.

Many details remain unknown, but the lower prices apply only to new drugs and existing drugs available through Medicaid. And prices at TrumpRx aren’t as low as out-of-pocket prices for most consumers with insurance. But the voluntary deals appeal to an industry that has railed against mandatory approaches drugmakers deride as harmful price controls.

“Each company makes its own decisions about how it prices medicines, and our industry is committed to working with the Trump administration to ensure Americans have access to affordable medicines,” said Chanse Jones, a spokesperson for PhRMA, a pharmaceutical industry trade group.

Policies that lead to reductions in drug prices typically worry investors because profits also can drop. But rather than seeing their stock prices fall after the agreements were announced, the drugmakers saw largely positive market reactions.

Analysts say that’s partly because the deals are narrow in scope, largely exist only in principle, and don’t apply to existing drugs used by the more than 200 million Americans with commercial or private health insurance.

The Trump administration, however, is claiming success.

“The most-favored-nation agreements on drug prices that we just did are delivering the largest drug price cuts in history,” Trump said in June at a Mack Trucks plant in Pennsylvania. “That alone should win us the midterms.”

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.

One year into its creation, a $50 billion federal program aimed at improving rural healthcare lacks transparency, which could make it difficult to protect against fraud, identify successful projects, and ensure the program delivers on its promise to transform the system.

Transparency “is really important to help protect the integrity of the program, ensure funds are reaching the communities they’re meant to serve,” said Maya Sandalow, director of health policy for the Bipartisan Policy Center, a nonprofit think tank.

The federal government and states are compelled by public records laws to share documents when requested. But those requests can take months to fulfill, making their release too late for meaningful oversight as states rush to spend their allotments under tight federal deadlines.

In the meantime, the Centers for Medicare & Medicaid Services — which oversees the Rural Health Transformation Program — and some states aren’t proactively sharing information about where the funding is going and how it will be used.

CMS spokesperson Timothy Foster said the agency “will publish an annual report on state progress.”

States’ individual reports to CMS are “intended to be” shared upon request, but the agency won’t be proactively publishing the individual state reports, according to a CMS document.

Foster didn’t respond to questions about whether the agency will share examples of projects that are and aren’t working or create a tracker of funding recipients, award amounts, and what organizations plan to do with their funding — ideas that health and government transparency advocates have requested.

Instead, much of the program’s transparency thus far has been up to state governments, and “the level of details that states have publicized really varies,” said Sandalow, who co-wrote a recent paper on how the federal government can strengthen the rural health program, including through transparency.

Some states are sharing information with lawmakers, holding public meetings, and explaining where organizations plan to invest their money.

Others are more secretive, with multiple states declining to release public records in response to KFF Health News’ requests. Mississippi’s governor vetoed a transparency-related bill, West Virginia holds closed-door advisory meetings, and a South Dakota official wrote that he hoped CMS would keep its application from public view.

“I just don’t believe in all this secrecy,” said Mississippi state Sen. Hob Bryan, who chairs his chamber’s public health committee. “If they’re not up to something nefarious, why do they have to do it all in secret?”

Bryan, a Democrat, said there’s bipartisan concern about the lack of transparency in his state.

Reaching Rural Patients

Congressional Republicans created the five-year Rural Health Transformation Program last summer as an eleventh-hour sweetener to President Donald Trump’s signature One Big Beautiful Bill Act. The money was intended to offset concerns about the outsize fallout anticipated in rural communities from the law, which is expected to reduce overall Medicaid spending by more than $900 billion over a decade.

Sandalow said some states may be struggling to share information since they’re busy rushing to hire staff and meet the program’s tight deadlines, including an annual report due Aug. 31.

In the meantime, a slew of media outlets, nonprofits, and businesses are stepping in to make it easier for the public to track the rural health program.

KFF Health News is collecting states’ applications and approved plans and budgets, not all of which have been posted on state websites.

Rural Health Payout Tracking Applications for Rural Health Transformation Funds

KFF Health News is working to collect and post complete application materials, by state, here and will update this repository as new materials, released in response to public records requests, arrive.

Dec. 4, 2025 Rural Health Payout Tracking State Rural Health Transformation Plans

KFF Health News is working to collect and post approved plans as more states respond to emails and public records requests for their documents.

July 27, 2026

And several health nonprofits and companies have created trackers that describe states’ rural health initiatives, post funding opportunities, or list award recipients. But some resources are available only through paid services, aimed at helping businesses interested in applying for money.

Sandalow said previous federal programs “tend to draw attention for gaps in transparency and oversight rather than for doing it well.”

As an example, she pointed to the lack of oversight and transparency with the CARES Act and other covid relief programs, which saw fraud and improper payments.

In March, CMS published proposed quarterly and annual state reporting requirements for the rural health program, and a notice seeking comments. At least three groups replied with letters expressing concerns about transparency.

CMS should share states’ progress reports, funding recipients, and what organizations plan to do with their awards, wrote Zachary Gaumer, the Bipartisan Policy Center’s vice president for health policy.

Sharing this information would make it easier to track progress, identify successful programs that other states may want to replicate, and “ensure funds reach the rural communities they are intended to serve,” he wrote.

Molly Smith, group vice president for public policy at the American Hospital Association, asked CMS “to be as detailed as possible” about the “final destinations of these funds, given the complexity of the grant funding process.”

In her letter, Charlene MacDonald, who leads the Federation of American Hospitals, noted that some funding recipients, such as large health systems and academic medical centers, will be distributing their awards to other entities.

CMS should collect those “downstream subrecipients,” wrote MacDonald, whose group represents for-profit hospitals and healthcare systems.

Without this information, she said, it will be difficult to know if “funding is reaching the rural hospitals, providers, and communities primarily intended to benefit from the program.”

It can also be difficult to know which for-profit companies are being paid with rural health money.

For example, Nevada and Kansas have listed hospitals and other health facilities that received funding to purchase telehealth, scanning devices, and other health technology. But the states list only some of the companies from which recipients will buy those products.

States won’t have to report “downstream” funding in their August reports to CMS but will have to do so for all future reports, according to the agency’s recently finalized reporting requirements.

The CMS documents say states must list subrecipients that receive subawards as well as vendors or contractors paid by an organization using rural health funding. Although states must report how much money these downstream recipients receive, they don’t have to describe which specific services or products the recipient is providing.

DIY Dashboards

As groups ask CMS to share more information, some states have created their own rural health spending dashboards or recipient lists, with varying levels of detail.

Alaska, Kansas, Oklahoma, and other states list which organizations receive funding, their award amounts, and detailed descriptions of how recipients will spend the money.

Florida and Nebraska, however, are among the states that don’t share what awardees plan to do with their funding.

New Hampshire is posting recipient contracts that detail projects and their budgets on its Rural Health Transformation Program website. Some other states have uploaded contracts and grants on general procurement or award databases, which can be difficult to navigate.

Ohio, Virginia, and New Jersey have used press releases to announce awards. But the announcements aren’t posted on their Rural Health Transformation Program websites, which could make it difficult to find this information.

Many states created advisory groups to provide transparency and accountability for their programs. Most committees host public meetings and upload minutes, recordings, or other materials from the discussions.

But the West Virginia Department of Health won’t share what’s discussed in its rural health advisory panel’s closed-door meetings, according to spokesperson Gailyn Markham.

“The panel is intended to serve as an informal forum for discussion and feedback among invited participants and program staff,” Markham said.

South Dakota, North Dakota, and Mississippi are among the states without advisory committees.

In response to public records requests, South Dakota released a nearly completely redacted version of its budget for the rural health program while Mississippi declined to release its budget.

Mississippi’s governor said he vetoed a transparency-related bill because it would “create an unnecessary layer of bureaucracy” that would have slowed the award process, which could cause the state to lose out on future funds. Mississippi is “an incredible outlier in all this secrecy,” Bryan, the state lawmaker, told KFF Health News.

Sandalow said it’s important for states to publish the impact of their rural health projects, adding that CMS should share which rural health projects are and aren’t working.

She said national and state health organizations are creating networks and holding conferences to help spread this information. States should “be able to learn from each other, get a sense of lessons learned and best practices, and then be able to pivot their initiatives accordingly,” Sandalow said.

Michael Cannon, who oversees health policy studies at the libertarian Cato Institute, said people should know how their $50 billion in taxes is being spent on the rural health program, and whether state projects are making rural patients healthier.

If investors put that much money into a project, there is “no way” they “would let the recipients of those funds get away with the shoddy approach to transparency and accountability that the states are taking,” 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.

California is weighing stiff penalties for hospitals and other healthcare entities that don’t stay under state spending limits, potentially levying hundreds of millions of dollars in fines if these providers don’t take steps to rein in rising healthcare costs.

If the state Office of Health Care Affordability adopts the fines next week, hospitals, medical groups, insurers, and others could face penalties that amount to as much as 125% of the total they spend above the state’s annual growth targets.

The penalty proposal comes after healthcare entities in California were asked to limit growth by 3.5% last year and ramp down to 3% by 2029. Seven hospitals that state officials consider particularly expensive face even smaller growth targets: 1.8% in 2026, dropping to 1.6% by 2029.

Consumer advocates argue that state financial deterrents are critical to bring relief to millions of Californians struggling with high insurance premiums and out-of-pocket expenses. Hospitals accounted for 40% of the increase in U.S. health spending from 2022 to 2024, compared with 11% from retail prescription drugs. But adding teeth to those targets sets up a fight with the powerful hospital industry, which has a pending lawsuit challenging the spending limits as unreasonable. Hospitals warned that they will cut back on vital services, including in emergency rooms, obstetrics, and behavioral health.

Healthcare industry representatives said the state affordability office hasn’t accounted for year-to-year volatility or other factors beyond the industry’s control, such as rising minimum wages, state earthquake retrofit requirements, and expensive new drugs.

“They’re building the plane while flying it,” said Ben Johnson, group vice president for financial policy at the California Hospital Association. “We know improvements in affordability are needed, but we have serious questions about how and about what the unintended consequences could be under OHCA’s rather stringent approaches.”

When calculating penalties, California regulators would consider various factors, including a healthcare entity’s financial situation, its market impact, and the gravity and number of offenses, according to a board presentation in June. And entities would first be given opportunities to implement performance improvement plans to bring their spending into line before penalties are imposed. For those that don’t comply, the board is considering penalties of $10,000 a day or a flat $500,000.

The penalties, which the affordability office’s eight-member board is required by state law to adopt, are slated for discussion, and a potential vote, at the board’s Aug. 26 meeting. The soonest healthcare providers would be subject to penalties is 2028, because it’s expected it will take two years to collect and publicly report spending data to measure against the 2026 targets. The state is still collecting data on how entities performed against the 2025 targets, which aren’t enforceable, according to Andrew DiLuccia, a spokesperson for the California Department of Health Care Access and Information.

States Set Targets

California is one of at least eight states that have set spending targets as part of an expanding effort to curb soaring healthcare spending across the nation. Connecticut, Massachusetts, Oregon, and Rhode Island have also authorized the use of some type of financial penalty. The specifics of each vary widely, although so far no state has applied them.

A survey last year by the California Health Care Foundation found that 4 out of 10 state residents said they had medical debt, and 6 in 10 reported that they or a family member had skipped or delayed medical care in the previous 12 months because of cost. Nationwide, about half of adults say it is difficult to afford healthcare costs.

After Rosalyn Book got stiches on her chin, the elementary school teacher received a $15,000 ER bill from a local hospital, despite having insurance. Many teachers in her district leave because they can’t afford the cost of healthcare and insurance premiums, she said.

“The healthcare charges are just insanity, and what we get as patients for the care, it’s not the best either,” said Book, president of the Monterey Bay Teachers Association. “If you’re a working, regular individual in terms of how much you make, the cost of living and especially the healthcare is just not doable.”

Meanwhile, hospitals are warning there’s a risk of more closures. According to Yale University’s Health Care Affordability Lab, 17 hospitals have closed in the state since 2016, compared with only six openings.

Hospitals and other healthcare providers have said the proposed multimillion-dollar penalties are too steep and could destabilize their operations at a time when they’re facing funding challenges, including massive federal cuts to Medicaid, the end of enhanced federal subsidies for Affordable Care Act plans, and a sharp rise in uninsured patients. The One Big Beautiful Bill Act, passed by congressional Republicans and signed by President Donald Trump last summer, is expected to reduce federal Medicaid spending by more than $900 billion — including by $30 billion in California — and increase the rolls of the uninsured in the U.S. by 10 million people over a decade.

Johnson said hospitals raise prices on commercial payers to offset the expense of treating uninsured patients, as well as patients on Medicaid and Medicare, which can reimburse care providers at rates that fall short of treatment costs.

In addition, said Anete Millers, vice president of legal and regulatory affairs at the California Association of Health Plans, tax increases on managed-care plans recently approved by state legislators to offset federal Medicaid cuts will force plans to increase their prices for consumers.

“Some spending pressures originate outside of the control of health plans and are the result of public policy decisions rather than underlying changes in healthcare utilization or efficiency,” she told the affordability office’s board at the June meeting.

Kristof Stremikis, the director of market analysis and insight at the nonprofit California Health Care Foundation, acknowledged that external forces can drive costs but said that plenty of unnecessary spending is within the healthcare system’s control, such as administrative waste and duplicative tests and procedures. Almost 25% of U.S. healthcare spending is considered wasteful, according to research published in JAMA.

Elizabeth Mitchell, a former Office of Health Care Affordability board member whose term ended in May, agreed.

“Every business has external challenges,” she said. “The hospital industry has not taken accountability to actually manage costs. I have heard those excuses for decades, and at some point, they have to make changes.”

First Step To Bring Down Costs

An analysis of five states with cost growth benchmarks, published in June, found that some have succeeded in modestly slowing healthcare spending, particularly those with enforcement mechanisms. However, spending growth in most states has still exceeded the targets set. 

Jeremy Vandehey, a consultant with the Peterson-Milbank Program for Sustainable Health Care Costs, said setting benchmarks and collecting data to analyze which entities meet them is only a first step. Armed with information about what and who is driving up costs, states are more empowered to take additional action, such as imposing penalties or regulating prices, to bring down costs, he said.

“I don’t think anybody in any state is declaring victory on healthcare costs, but I wouldn’t say that that means the programs are a failure,” Vandehey said. “In all of these states, there’s much more robust conversations happening about, OK, we haven’t solved our cost crisis, so we need additional action.”

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.

The ongoing debate over the U.S. health system shouldn’t be based on whether the government or the private sector is the dominant player, billionaire entrepreneur Mark Cuban said this week. The bigger issue, he said, is whether the system’s participants are transparent about what they charge and what they pay.

“I’m not opposed to single-payer or universal healthcare at all,” Cuban said Aug. 18 in an interview with KFF Health News. But “when you don’t know all the costs, when there’s no transparency, it’s impossible to determine if it’s a better solution or not,” he said.

Cuban’s remarks came on the heels of primary election victories by progressive supporters of “Medicare for All” — most notably Abdul El-Sayed, who recently clinched the Democratic Senate nomination in Michigan.

The former majority owner of the Dallas Mavericks and a former investor on the hit TV show Shark Tank, Cuban changed the way generic prescription drugs are sold in 2022 by co-founding Mark Cuban Cost Plus Drugs. The website, which posts all its costs and takes a blanket 15% markup, sells thousands of medications, often at deep discounts compared with buying through private insurance plans or self-pay pharmacies.

“We took the transparent path for an industry where there was zero transparency,” Cuban said. “Everybody else prices to the market; we price to what we thought was fair.”

Cuban said that, in thinking about the broader problems facing the U.S. healthcare system, the key is to rebuild trust. “Trust really is a formula,” he said. “Trust equals transparency divided by self-interest.”

One way to build trust, he said, is to give consumers incentives to find the best price for nonemergency health services. Cuban said that means every medical purchase should count toward health insurance deductibles and out-of-pocket maximums, which is not currently the case.

He also advocates breaking up some of the vertically integrated health companies that have grown so large — owning insurers, care providers, and the companies that serve them — that they can dictate their prices. “If you break up these big, huge conglomerates, everything changes. The price of everything drops like a rock,” he said.

But so far, only a few lawmakers have been brave enough to push that goal, Cuban said, citing the Break Up Big Medicine Act co-sponsored by senators Josh Hawley of Missouri, a Republican, and Elizabeth Warren of Massachusetts, a Democrat.

In the end, Cuban said, what matters is not who is running the system but whether all the cards are on the table — in particular, whether the terms of healthcare contracts are public. Whether it’s the government or private businesses doing the negotiating, “if you don’t know how the deals are structured, it’s impossible to negotiate better ones.”

The interview was part of the “How Would You Fix It?” series featuring Julie Rovner, KFF Health News’ chief Washington correspondent and host of the What the Health? podcast.

An abbreviated version of this interview aired Aug. 20 in Episode 460 of What the Health? From KFF Health News: “Headless FDA Gets a New Nominee.”

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.

Evelyn Griffin had led a life out of the spotlight until she testified at the Louisiana Statehouse five years ago and experienced what she called her “great awakening.”

The state health department wanted to add covid vaccines to the school immunization schedule, a move no state has ever implemented. Robert F. Kennedy Jr., then known as a leading vaccine skeptic, had already claimed the covid shot was “the deadliest vaccine ever made” during a poster board presentation at the legislative hearing.

Griffin, a longtime OB-GYN, relied on nearly identical images during her own blistering testimony against the proposal. After the hearing, she expected splashy headlines about Kennedy’s assertions, shifting the public debate over covid policies and vaccines. But that did not happen; one news outlet dismissed him as a promulgator of propaganda. Griffin was shocked.

That is “when I saw how the world worked,” she recalled in a podcast interview. Griffin said she and her husband, a vascular surgeon, decided to take action and “shine light on things.”

Now, Kennedy is the nation’s health secretary, and Griffin holds prominent roles that position her to help carry out his vision.

Last September, Kennedy appointed her to ACIP, the advisory panel for federal immunization policy, where she voted to recommend limiting access to covid vaccines and ending universal newborn immunizations for hepatitis B, steps that a federal judge has blocked. In December, Gov. Jeff Landry of Louisiana, a conservative Republican and an ally of President Donald Trump’s, named Griffin as the state’s surgeon general.

That makes her the top public health physician in Louisiana, which has the worst health outcomes among states.

She is an unconventional choice. Griffin has no background or specialty training in infectious diseases or public health. She is aligned with alternative health movements — including Make America Healthy Again, or MAHA — and has hosted some speakers promoting fringe medical views.

Griffin declined interview requests for this article. “My vision as Louisiana’s surgeon general is to help shift our healthcare system toward preventing disease, not just managing or treating it,” she said in a statement.

Eight months into her tenure, she has yet to make major changes at the health department. She has faced hurdles in her efforts to tighten access to vaccines and limit public health powers, testifying on several bills that legislators rejected.

Still, Griffin’s political rise reflects the gains of Kennedy’s vaccine agenda at the state level, a vital testing ground for laws aimed at eroding government mandates. State officials have enormous power to set health policy and beat back infectious disease outbreaks. While Griffin’s post is largely a bully pulpit, she could spur real change by advising the governor, state health secretary, and lawmakers.

Some public health and infectious disease experts warned that if Griffin eventually succeeded in curtailing the state’s authority, illnesses and deaths could escalate and Louisiana could be hamstrung in a future pandemic. At one vaccine panel meeting last year, she said it was “unclear” whether vaccines were linked to autism, as Kennedy has suggested. When asked by The New York Times, she declined to say whether she believed any vaccines should be mandated for schoolchildren.

“Someone who has expressed the views she has, who’s now in a public policy position, is very dangerous,” said Georges Benjamin, the chief executive of the American Public Health Association.

But Kirk Milhoan, a pastor and pediatric cardiologist who serves as chair of the federal vaccine panel, defended Griffin as an “excellent choice” for surgeon general. “No one should be afraid of Dr. Evelyn Griffin having the heart’s desire to take care of the population of Louisiana,” he said in an interview.

While Griffin is on a learning curve as a political novice, she has signaled big ambitions.

She called for “dramatic transformational change” during a public meeting in January, promising to focus on women’s health, rural health, and the root causes of disease. An accompanying slide presentation said Louisiana would lead through “family, faith, and fearlessness.”

Griffin, 49, often cites her family background in explaining her trajectory.

She was born Ewelina Bulczynski under Communist rule in Poland in 1976. When she was 5, her family defected to a refugee camp in Austria before immigrating to Canada. She and her two brothers later came to the United States to practice as physicians. She has credited this history with giving her a “different perspective” as a doctor and influencing her skepticism of government mandates.

“My parents escaped Communist Poland so that we could come here for the freedoms, such as medical freedom, that this country has,” she told Louisiana lawmakers in 2022.

Evelyn Griffin, Louisiana’s surgeon general, and her husband, Joseph Griffin, attend a wellness event sponsored by the Northshore Alternative Health Alliance in Mandeville, Louisiana, in June. (Christiana Botic for The New York Times)

She met her husband, Joseph Griffin, while they attended Ross University School of Medicine, then located in Dominica. After residency programs in New Orleans, they settled in Baton Rouge and raised two children.

People who have known Griffin during her 20-year career delivering babies and treating women described her as a kind, caring, and smart physician. “Patients loved her,” said Francis Dauterive, who worked with her.

In the years before the pandemic, Griffin had noticed a rise in chronic health problems among her patients. She began studying how nutrition and lifestyle choices could treat and prevent illness, and pursued online training in functional medicine. She started an Instagram account filled with images of jackfruit sloppy Joes and vegan jambalaya, her dog lounging on a yoga mat, and her backyard strawberry plants.

She also learned of Barbara O’Neill, a Christian wellness figure popular on social media. O’Neill was barred in 2019 from giving medical advice in Australia after claiming that cancer was caused by a fungus and could be treated with baking soda, and that vaccines caused “an epidemic of ADHD, autism, epilepsy and cot death.” In a 2025 podcast, Griffin called O’Neill a “sage” teacher who was ostracized for focusing on lifestyle solutions to medical issues. She said she kept O’Neill’s advice for a healthy life — including exercise, sunshine, and trust in God — posted on her fridge.

But it was the pandemic that transformed her career. In speeches and interviews, she said she began to question public health guidance and that of her former employer, Ochsner Health, Louisiana’s largest health system, on masking, vaccines, and mandates.

Griffin wanted to share research with colleagues that wasn’t “mainstream” science, as she put it, studies she said were from contacts in Europe on early covid treatments. Griffin was repeatedly rebuffed, she said.

Eventually, she resigned. “I’m going to stick to my principles,” she later recalled thinking. She now works at the Baton Rouge General health system. Ochsner officials declined to comment.

Louisiana had been hit hard by the pandemic. By December 2021, more than 14,000 people had died from covid. That summer, the Delta surge had killed six pregnant women there over two months, and maternal health organizations were urging vaccination.

But in her testimony to lawmakers that December, Griffin had questioned the vaccine’s safety after health officials had reported rare adverse reactions. She invoked a public health catastrophe: The drug thalidomide, prescribed during pregnancy in Europe (and tested in the United States) in the 1950s, had left thousands of babies with missing or malformed limbs. She also reminded lawmakers of the Nuremberg trials, where Nazi collaborators had been sentenced to death for medical experimentation.

“So everyone has to be on notice when making these types of decisions,” Griffin said, looking at the politicians. The state later dropped plans to require covid vaccines for students.

Griffin and her husband have since embedded themselves in Louisiana’s right-leaning alternative health communities. They have espoused views that, amid the swirl of social-media-fueled wellness trends, pandemic backlash, and widespread dismay over Americans’ poor health, have become ascendant in the second Trump presidency.

Jay Luneau (top center), a Democrat in Louisiana’s Senate, questions Griffin in May about a bill to prohibit businesses and schools from mandating new vaccines or other medical interventions. (Christiana Botic for The New York Times)

Griffin returned to the state Capitol over the next three years to testify for favored causes, including bills supported by Health Freedom Louisiana, a group aligned with Kennedy. One would have expanded access to ivermectin, an antiparasitic drug popular among vaccine skeptics, though numerous studies have shown it is ineffective in treating covid, and another would have banned future government health mandates, which Griffin has called “a slippery slope.” Neither got out of committee. She also testified in support of a ban on gender-transition treatments for minors, which became law.

After the U.S. Supreme Court overturned Roe v. Wade in 2022 and Louisiana’s near-total abortion ban took effect, Griffin became an ally of Louisiana Right to Life, the state’s leading anti-abortion group. She recorded videos arguing that the law did not impede pregnancy care. The ban was later found to delay miscarriage treatment and lead to unnecessary cesarean sections, according to doctors and reproductive rights groups.

Griffin and her husband struck up a friendship with Tony Spell, the pastor of Life Tabernacle Church in Baton Rouge, sometimes joining him for Bible study. Pastor Spell refused to shut his evangelical church during the pandemic, leading to criminal charges that were overturned by the Louisiana Supreme Court. Griffin called him “an absolute hero.”

Benjamin Clapper, executive director of Louisiana Right to Life (center left), speaks to Griffin at the Louisiana Capitol in May. (Christiana Botic for The New York Times) Tony Spell, the pastor at Life Tabernacle Church in Baton Rouge, is friends with Griffin and her husband. (Christiana Botic for The New York Times)

She has spoken at annual health freedom gatherings on the church’s sprawling grounds and launched her own wellness events there two years ago. Guests have talked about backyard gardening, naturopathic medicine, the benefits of doulas and raw milk — a passion of Kennedy’s — which recently sickened nearly a dozen Louisiana residents.

One speaker, an OB-GYN, said contraception encouraged abortion. Another, an ophthalmologist, questioned the safety of wireless technology, as has Griffin. Quoting O’Neill, the Australian wellness figure, Griffin warned the crowd to “stay away from sunscreen,” adding there were “lots and lots of chemicals” in it.

Spirituality is “the foundation for health,” she said during the event in 2025, and some of her speakers have presented faith in Jesus as essential to being healthy. At the 2024 gathering, Sean Troxclair, an internist who is now her deputy, said that when he was “injured” by a vaccine, “I got with Jesus.” He added, “If you’re not with him, no matter what you do, you’re not going to get better.”

In written comments to the Times, Griffin said that faith was not a prerequisite for good health, and that she “may not share every perspective presented” by her speakers.

Griffin’s appointment is among Gov. Landry’s wider efforts to move Louisiana, already a deeply red state, further to the right. He has supported a crackdown on doctors who mail abortion pills to Louisiana patients and a lawsuit against the Food and Drug Administration to stop the practice nationwide. The U.S. Supreme Court said the pills could still be sent by mail while the FDA case continues in the lower courts.

The governor’s first appointee as surgeon general, Ralph Abraham, another supporter of Kennedy’s, blocked his staff from promoting any vaccines amid an outbreak of whooping cough that killed two babies.

Griffin has begun her tenure more quietly, seeking ties with the state’s medical community while trying to find her place in a health department hierarchy where the secretary still wields much of the power.

Griffin and her deputy, Sean Troxclair (right), attend a women’s wellness event at the Louisiana Capitol in May. (Christiana Botic for The New York Times)

For her staff, she’s recruited figures from wellness and vaccine-skeptical circles, including Troxclair and Kathleen Willis, an internist who has questioned the safety of the childhood vaccine schedule, as has Trump.

A surprising presence in the department is Griffin’s husband, whom she’s called “like-minded.” Though he is not employed by the agency, he has joined her appointments with state and federal officials and participated in department meetings, sometimes providing feedback or asking questions, according to two people present at the sessions. Griffin has also placed him on a Medicaid advisory subcommittee. Griffin said in a statement that he was “not involved in formal decision-making.”

Bruce Greenstein, the state health secretary, introduced the couple during a public meeting in January, saying, “We basically get two doctors for the price of one.” In May, Griffin’s husband joined the governor on a contentious trip to Greenland, which Trump has periodically threatened to control.

Griffin’s beliefs represent a shift away from public health policies that prioritize the protection of the wider community in favor of ones that prioritize individual choice. Like Kennedy, she has said this is necessary to restore faith in public health systems battered by the anger over pandemic restrictions.

Such a reframing of the government’s role would upend long-standing public health principles and risk harming society’s most vulnerable, said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

“Are we in no way responsible for people who we are going to sit next to on a bus or get into a crowded elevator?” he asked. “Do we have no sense of responsibility to other members of society?”

Florida’s former health secretary and surgeon general, Scott Rivkees, whose successor tried to roll back vaccine mandates, said rising vaccine skepticism was already contributing to outbreaks of measles and whooping cough. “This is something that our country will regret as we start seeing our sons, daughters, neighbors, friends, cousins, pay the price,” he said in an interview.

Even though Griffin has allied herself with some lawmakers in the Republican-controlled legislature, she testified on three bills this year that failed to proceed. One would have created new informed-consent requirements for vaccines — including banning mothers from agreeing to vaccines for 12 hours after giving birth, when Griffin said hormones and other factors could impede their thinking.

Another would have significantly limited the government’s ability to require vaccines, testing, or masks in a future outbreak, mandates that Griffin testified infringed on individual rights and were discriminatory. A third bill, her own proposal, would have given her office sweeping access to all medical records in the state, which are now protected by medical privacy laws.

Gov. Landry did not publicly push for the measures, a sign that they may not be priorities for his administration. A majority of Louisiana voters support school vaccine mandates, according to polls by Louisiana Families for Vaccines and the Center for Individual Freedom. Most proposals to weaken vaccine laws also failed in other states this year.

Since her appointment, Griffin has traveled the state to meet with residents. In June, she and her husband wandered through a wellness event, sponsored by the Northshore Alternative Health Alliance, in Mandeville. She had been invited to give the keynote address by Abigail Licatino, a member of Health Freedom Louisiana who has said that vaccines cause “most” autism.

Booths featured local farmers, reiki practitioners, functional medicine doctors, chiropractors, spiritual healers, and purveyors of peptides, supplements, and IV treatments. The event represented some of the “holistic approaches” Griffin said she planned to highlight as surgeon general.

In speeches before her appointment, Griffin had offered a far-reaching vision. While conventional medicine would still play an indispensable role, she said, the current health system was failing Americans and would “collapse.” The health freedom and wellness movements would help show “the path forward.”

The New York Times’ Kitty Bennett, Sheelagh McNeill, and Kirsten Noyes contributed research for this article.

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.

The Host Julie Rovner KFF Health News @jrovner @julierovner.bsky.social Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, "What the Health?" A noted expert on health policy issues, Julie is the author of the critically praised reference book "Health Care Politics and Policy A to Z," now in its third edition.

Heidi Overton, a physician and White House domestic policy adviser, is President Donald Trump’s choice to be the next head of the Food and Drug Administration. Overton, an abortion opponent and supporter of Trump’s proposed changes to the childhood vaccine schedule, has made enemies while working on health policy from the White House and could face some tough questioning from senators.

Meanwhile, prescription drug prices are dropping for some people, and the wholesale retailer Costco is entering the Medicare market. Still, overall, the problem of healthcare being too expensive remains stubbornly hard to solve.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico Magazine, Shefali Luthra of The 19th, and Alice Miranda Ollstein of Politico.

Panelists Joanne Kenen Johns Hopkins University and Politico @JoanneKenen @joannekenen.bsky.social Read Joanne's bio. Shefali Luthra The 19th @shefali.bsky.social Read Shefali's stories. Alice Miranda Ollstein Politico @AliceOllstein @alicemiranda.bsky.social Read Alice's stories.

Among the takeaways from this week’s episode:

• Trump’s selection of Overton to lead the FDA is prompting concerns from a diverse crowd of skeptics that includes Sen. Bill Cassidy (R-La.) and adherents to the Make America Healthy Again movement. Her lack of managerial experience and history of controversial writings could be liabilities during the confirmation process, though Trump has a decent track record of clearing nominees through a hesitant Senate.
• Grant money continues to be held up at the National Institutes of Health pending political reviews, and new reporting sheds light on “zombie programs” at the Centers for Disease Control and Prevention, where money has been appropriated but there’s no staff to use it. Plus, the trend of declining childhood immunizations continues, with vaccine exemptions for kindergartners jumping to another high.
• New data shows the largest drop in prescription drug prices since the 1960s, and while the Trump administration is taking credit, it’s unclear what exactly caused it. Meanwhile, the federal government is investigating major health companies for allegedly dodging taxes or engaging in anticompetitive practices. And the wholesaler Costco is getting into the health insurance game, partnering with a nonprofit insurer to provide Medicare Advantage or Medigap plans in a few states.

Also this week, as part of the “How Would You Fix It?” series, Rovner interviews billionaire businessman Mark Cuban, who has already reshaped the generic drug market and now has his eye on the rest of the healthcare system.

Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too: 

Julie Rovner: Mother Jones’ “The Orwellian Company Behind ICE’s New Electric Shock Gloves,” by Sophie Hurwitz.

Shefali Luthra: The 19th’s “Tik Tok’s Fake GLP-1 Market Preys on Women Trying To Lose Weight,” by Barbara Rodriguez.

Alice Miranda Ollstein: The Texas Observer’s “Texas Maternal Mortality Committee’s Next Report Will Skip Post-‘Roe’ Deaths. Lawmakers Suspect Political Influence,” by Mary Tuma.

Joanne Kenen: Politico’s “AI Slop Is Swamping a House Office That Drafts US Laws,” by Owen Dahlkamp.

Also mentioned in this week’s podcast:

• NOTUS’ “‘Graveyard for Grants’: NIH Is Holding Up Medical Research Funding,” by Paige Winfield Cunningham.
• The Associated Press’ “The CDC Has Zombie Programs. Congress Funds Them, but Few People Are Left To Do the Work,” by Mike Stobbe.
• KFF Health News’ “Kennedy’s Quiet Hunt for Autism Culprits Stalls as Trump Orders Baseless Changes to Childhood Shots,” by Amanda Seitz and Stephanie Armour.
• The Wall Street Journal’s “Costco Sells Vacations, Gas and, Soon, Medicare Plans,” by Anna Wilde Mathews.
• Stat’s “Epic’s Alleged Anticompetitive Practices Under Scrutiny From Federal, State Investigators,” by Casey Ross and Brittany Trang.
• Stat’s “UnitedHealth Faces IRS Probe Over Potential Tax Avoidance,” by Bob Herman.

Credits Zach Dyer Audio producer Taylor Cook Audio producer Emmarie Huetteman Editor

Click here to find all our podcasts.

And subscribe to “What the Health? From KFF Health News” on Apple Podcasts, Spotify, the NPR app, YouTube, Pocket Casts, or wherever you listen to podcasts.

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.

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.

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.”

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.

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.

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.

Nurse Crystal Dhooghe is used to dealing with blood and broken bones in the emergency room. But she didn’t expect to witness so much violence against her own colleagues.

“I’ve seen nurses get shoved, pushed, scratched. The biggest one is bitten,” said Dhooghe, who works at Henry Ford Genesys Hospital in Grand Blanc, Michigan.

The prevalence of workplace violence in healthcare has fueled strikes in states such as Louisiana, New York, Pennsylvania, Rhode Island, and Michigan, where Dhooghe and many of her co-workers have been on the picket line since Labor Day last year.

“People will question me and be like, ‘Why are you still working in a place if you’re treated like this?’” said Dhooghe, who gets by on strike benefits and working extra shifts at another hospital. The problem, she said, is that other hospitals aren’t any better. “It’s the same everywhere I go.”

In a statement, Henry Ford Health spokesperson Dana Jay acknowledged violence against healthcare workers is a “national epidemic” and said the health system’s efforts to address the problem include metal detectors, armed security officers trained to make “misdemeanor arrests,” and de-escalation training.

“We have zero tolerance for violence of any kind,” said Jay, asserting the strike is not about safety but is instead “simply an economic strike.”

Nationwide, hospital workers are seven times as likely to be injured on the job due to violent acts as members of the general working population, according to the most recent data available from the Bureau of Labor Statistics. The outcry over workplace violence in healthcare is pitting workers’ demands for better compensation and staffing against hospital operators pressured to cut costs.

‘A Powder Keg’

Violent outbursts are so common that they’ve been dramatized on the popular medical TV series The Pitt. “Emergency rooms right now are like a powder keg,” said Rachel Odes, an assistant professor at the University of Wisconsin-Madison School of Nursing.

In hospitals, a combative or violent patient is known as a “code gray.” Outbursts can be spontaneous and unpredictable, making some almost impossible to prevent. But research shows the risk of violence increases when hospitals are understaffed or employees are insufficiently trained or experienced.

Mental health worker Andrew Kimball-Mirzaie said he got hurt in February 2024 at Butler Hospital in Providence, Rhode Island.

Andrew Kimball-Mirzaie, a mental health worker at Butler Hospital in Providence, Rhode Island, who says he was assaulted by a patient, participated in a three-month strike in spring and summer 2025. (Lynn Arditi)

He’d been working at the private psychiatric hospital for about six weeks and said he hadn’t yet worked in the ER. He said he was sent there to “monitor” a man in his 20s who was waiting for an inpatient bed.

The patient was alone in a back room watching a Knicks basketball game on TV, he recalled. Kimball-Mirzaie said he got the patient a drink and a snack. They were watching the game when, suddenly, he said, the patient stood up and punched him in the face. He said the assault left him with a concussion and broken nose. His injuries were documented in the hospital’s incident log.

“I understand that there is an inherent danger with the job,” Kimball-Mirzaie said. He doesn’t blame the patient, who was very ill at the time. “We should have had at least another staff member with us,” he said, “and I should have been adequately trained on the unit.”

The attack emboldened Kimball-Mirzaie to join some 700 other unionized Butler workers last spring and summer in a months-long strike, which forced the hospital to close nearly half of its beds. Service Employees International Union 1199 New England declared the strike a win.

Employees received wage increases that union leaders said would enable the hospital to attract and retain more staff. The hospital also agreed to provide financial support for workers violently injured on the job. And the hospital and union agreed to jointly fund a “time bank” to supplement workers’ compensation for injured workers who need more time to recover.

But five months later, a nurse supervisor at Butler had to call 911 because an unarmed patient in the hospital’s ER was assaulting staff. According to the police report, by the time police arrested the patient, he’d injured two nurses, a security guard, and a police officer.

“Butler recognizes the importance of being proactive in protecting those who provide care,” Mary Marran, Butler’s president and chief operating officer, said in a statement. She added that hospital leadership meets regularly with staff to review safety measures and “identify opportunities to strengthen protection for everyone.”

The patient was charged with four counts of felony assault, including against the two nurses.

The American Hospital Association has said punishment is key to preventing violence. It has been lobbying Congress to make assaulting healthcare workers a federal crime that would carry up to 10 years in prison. At least 45 states, including Michigan and Rhode Island, have enacted similar laws. But workplace safety experts say there is no evidence that such laws have reduced the incidence of violence against healthcare workers.

Catherine Maynard, a nurse at Butler Hospital, speaks at a union rally at the State House in Providence, Rhode Island, on May 23, 2025. (Steve Ahlquist)

Calls for ‘Safe Staffing’

Striking healthcare workers around the country often have demanded “safe staffing” instead of stronger punishments for patients who cause injuries.

The rise in violence against healthcare workers has caught the attention of the Joint Commission, the accreditation organization for more than 80% of U.S. hospitals and health systems. The commission released national performance goals that took effect in January and require hospitals to be properly staffed and that staff be trained “to provide safe, quality care.”

But no federal law limits the number of patients in a nurse’s care across healthcare settings, despite the nation’s largest nurses union, National Nurses United, having pressed for a national standard since 2018. Hospitals must “safely staff all units” to enable nurses to “provide the care that patients need before they get agitated or disoriented,” said Jane Thomason, lead industrial hygienist for National Nurses United.

Some states have passed their own staffing laws. Only California has enacted broad mandatory nurse staffing ratios, which research shows were associated with lower mortality rates and likely higher retention. Oregon enacted a staffing law, with exceptions. Legislators in Massachusetts and New Jersey have introduced similar bills, but they have failed to advance to floor votes.

The American Hospital Association opposes mandatory minimum nurse staffing ratios in hospitals, saying they would “remove real-time clinical judgment and flexibility,” compound staffing shortages, and potentially force some hospitals to turn away patients or delay care, spokesperson Colleen Kincaid said. And she pointed to California, whose new emergency nurse staffing ratios for psychiatric hospitals reportedly forced bed closures in at least four counties.

“There are a lot of other things you can do to prevent workplace violence than just increasing staffing levels,” said Jordan Barab, who was a deputy assistant secretary of labor for the Occupational Safety and Health Administration during the Obama administration and helped develop OSHA’s 2016 guidelines for healthcare and social service workers.

Barab said hospitals can, for example, train employees in de-escalation, install metal detectors, or have specially trained security guards on-site so staff don’t have to wait for police to arrive when an incident happens.

Debbie Berkowitz, a worker safety and health policy expert at Georgetown University, said the health provisions in congressional Republicans’ One Big Beautiful Bill Act will squeeze hospitals’ budgets in the next few years.

When funding dries up, she said, “protecting workers is going to be the first thing that gets cut.”

This article is from a partnership that includes 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.

Tammy Chalala, a retired dietitian in New York, was thrilled with the results of her cataract surgeries, which left her with close to 20/20 vision.

She said she paid nearly $4,000 out-of-pocket for her two surgeries last year because she opted to have her doctor use a laser to assist with the procedure.

Chalala, 69, chose that method over the traditional scalpel after doing research online and consulting with her doctors, believing it would give her the best outcome. “It seemed like the better option,” she said.

Cataract surgery — one of the most common operations paid for by Medicare — typically leaves enrollees owing a few hundred dollars. Some patients pay more to have their vision corrected during the procedure.

But, like Chalala, a growing number of those patients are paying even more out-of-pocket simply because they agree to have their doctor use a laser rather than the scalpel method.

Both methods are safe and can significantly reduce or eliminate the need for patients to wear glasses.

However, many doctors say the laser helps make more precise cuts than the scalpel. The laser method gives patients more options, they say, and recoups more revenue as Medicare has gradually cut what it pays doctors for cataract surgery.

Others, such as Oliver Schein, an ophthalmologist at Johns Hopkins Medicine, point out the strong financial incentive to use the laser, as the equipment can cost a practice up to $500,000.

Schein said his colleagues used the laser a few years after it came out but did not see any benefit over traditional cataract surgery. Still, the laser doesn’t cause harm and provides patients with good results.

“That’s a powerful combination for a surgeon,” Schein said. But in the end, he added, most patients believe paying more will yield a better result.

Medicare pays doctors about $520 for a standard cataract procedure, down about 20% in the past decade. The fee includes pre- and postoperative visits.

While Medicare generally prohibits doctors from billing patients above what the government program pays, doctors are allowed to bill patients extra when using the laser only when it is used to improve vision, because most vision correction is not covered by traditional Medicare.

Specifically, doctors may bill patients when using the laser to insert premium lenses or fix astigmatism. Doctors typically charge $1,000 to $3,000 per eye for use of the laser.

Medicare enrollees also pay out-of-pocket for the premium lenses that can eliminate their need for reading or distance glasses, with charges ranging from $1,000 to $4,000.

Private insurers, including those operating Medicare Advantage plans, typically follow Medicare benefit rules.

Research shows the laser does not provide better outcomes than the scalpel for a standard cataract procedure.

The American Academy of Ophthalmology, the world’s largest organization of eye physicians and surgeons, says on its website: “Studies do not show that laser surgery results in fewer complications. Also, studies haven’t found that laser surgery provides better outcomes.”

Nearly 12% of the 5 million annual cataract surgeries performed nationally are laser-assisted, and that number has been growing, according to the St. Louis-based ophthalmic market data company Market Scope.

“It’s a win-win for patient and doctor,” said Kevin Miller, a UCLA ophthalmology professor. “Doctor makes a little more money on top of the Medicare reimbursement; the industry gets money to develop new technology; and society benefits because these patients are not going for eyeglasses anymore.”

By age 80, more than half of Americans have had cataracts, a condition that causes blurred vision and poor night vision. Most cataracts develop slowly as part of the aging process when proteins and fibers in the eye’s lens break down and clump together.

Doctors for decades have used scalpels to perform cataract surgery, which involves removing the cataract and replacing the cloudy natural lens with a clear artificial one.

Barbara Cobuzzi, 71, a medical billing consultant with traditional Medicare coverage, needed cataract surgery last year. When her eye doctor in New Jersey recommended she get the surgery using a laser at a cost to her of $1,500 per eye, she went looking for a second opinion. “I felt like he was trying to pull a fast one.”

Cobuzzi said the second doctor performed her procedure without a laser, and she was happy with the results, including no longer needing glasses for distance vision.

“Doctors are using the laser as a moneymaker,” she said.

Vance Thompson, an ophthalmologist who is a past president of the American Society of Cataract and Refractive Surgery, said some patients want the laser because it provides a more precise way of doing the surgery, while others choose it to avoid the need for glasses.

He said he talks to patients about the advantages of the laser and lets them decide which method is right for them. “They deserve to be educated on all their options,” Thompson said.

He said about half his patients at his Sioux Falls, South Dakota, practice choose the laser, up from about 10% a decade ago.

The laser is not suitable for all patients, though, including those who have corneal scarring or a small pupil, Thompson said.

It’s challenging to illustrate the benefit of the laser because traditional cataract surgery is already safe and effective, with low infection rates, said Barrett Eubanks, a U.S.-trained ophthalmologist in Toronto.

He said he’s found that, compared with the older method, using the laser makes it easier to implant premium lenses or remove certain types of cataracts. That’s because the laser can make the exact cut it’s programmed to make, unlike the human hand.

Miller, the UCLA ophthalmologist, said the laser helps bring money to his practice as Medicare reimbursement continues to decline. “One of the problems with ophthalmology is everybody is scrambling to keep the lights on,” he said.

Miller said his practice has offered laser cataract surgery for several years. He compares the choice to buying a Toyota Camry or buying a Lexus. “Both will get you where you want to go, but one will get you there with a premium feel and leather seats,” he said.

He said his patients know they can choose the surgery without a laser. “We do not pressure anybody to do anything,” Miller said.

At his practice in an affluent part of Los Angeles, he said, 80% of patients opt for laser cataract surgery. “What you buy with a laser is precision and reproducibility, as every laser cut looks exactly the same,” he said. “It does not make vision better.”

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.

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.

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.

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.

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.