ST. LOUIS — Inside the more than 600 Catholic hospitals across the country, not a single nun can be found occupying a chief executive suite, according to the Catholic Health Association.

Nuns founded and led those hospitals in a mission to treat sick and poor people, but some were also shrewd business leaders. Sister Irene Kraus, a former chief executive of Daughters of Charity National Health System, was famous for coining the phrase “no margin, no mission.” It means hospitals must succeed — generating enough revenue to exceed expenses — to fulfill their original mission.

The Catholic Church still governs the care that can be delivered to millions in those hospitals each year, using religious directives to ban abortions and limit contraceptives, in vitro fertilization, and medical aid in dying.

But over time, that focus on margins led the hospitals to transform into behemoths that operate for-profit subsidiaries and pay their executives millions, according to hospital tax filings. These institutions, some of which are for-profit companies, now look more like other megacorporations than like the charities for the destitute of yesteryear.

The absence of nuns in the top roles raises the question, said M. Therese Lysaught, a Catholic moral theologist and professor at Loyola University Chicago: “What does it mean to be a Catholic hospital when the enterprise has been so deeply commodified?”

The St. Louis area serves as the de facto capital of Catholic hospital systems. Three of the largest are headquartered here, along with the Catholic hospital lobbying arm. Catholicism is deeply rooted in the region’s culture. During Pope John Paul II’s only U.S. stop in 1999, he led Mass downtown in a packed stadium of more than 100,000 people.

For a quarter century, Sister Mary Jean Ryan led SSM Health, one of those giant systems centered on St. Louis. Now retired, the 86-year-old said she was one of the last nuns in the nation to lead a Catholic hospital system.

Ryan grew up Catholic in Wisconsin and joined a convent while in nursing school in the 1960s, surprising her family. She admired the nuns she worked alongside and felt they were living out a higher purpose.

“They were very impressive,” she said. “Not that I necessarily liked all of them.”

Indeed, the nuns running hospitals defied the simplistic image often ascribed to them, wrote John Fialka in his book “Sisters: Catholic Nuns and the Making of America.”

“Their contributions to American culture are not small,” he wrote. “Ambitious women who had the skills and the stamina to build and run large institutions found the convent to be the first and, for a long time, the only outlet for their talents.”

This was certainly true for Ryan, who climbed the ranks, working her way from nurse to chief executive of SSM Health, which today has hospitals in Illinois, Missouri, Oklahoma, and Wisconsin.

The system was founded more than a century ago when five German nuns arrived in St. Louis with $5. Smallpox swept through the city and the Sisters of St. Mary walked the streets offering free care to the sick.

Their early foray grew into one of the largest Catholic health systems in the country, with annual revenue exceeding $10 billion, according to its 2023 audited financial report. SSM Health treats patients in 23 hospitals and co-owns a for-profit pharmacy benefit manager, Navitus, that coordinates prescriptions for 14 million people.

But Ryan, like many nuns in leadership roles in recent decades, found herself confronted with an existential crisis. As fewer women became nuns, she had to ensure the system’s future without them.

When Ron Levy, who is Jewish, started at SSM as an administrator, he declined to lead a prayer in a meeting, Ryan recounted in her book, “On Becoming Exceptional.”

“Ron, I’m not asking you to be Catholic,” she recalled telling him. “And I know you’ve only been here two weeks. So, if you’d like to make it three, I suggest you be prepared to pray the next time you’re asked.”

Levy went on to serve SSM for more than 30 years — praying from then on, Ryan wrote.

In Catholic hospitals, meetings are still likely to start with a prayer. Crucifixes often adorn buildings and patient rooms. Mission statements on the walls of SSM facilities remind patients: “We reveal the healing presence of God.”

Above all else, the Catholic faith calls on its hospitals to treat everyone regardless of race, religion, or ability to pay, said Diarmuid Rooney, a vice president of the Catholic Health Association. No nuns run the trade group’s member hospitals, according to the lobbying group. But the mission that compelled the nuns is “what compels us now,” Rooney said. “It’s not just words on a wall.”

The Catholic Health Association urges its hospitals to evaluate themselves every three years on whether they’re living up to Catholic teachings. It created a tool that weighs seven criteria, including how a hospital acts as an extension of the church and cares for poor and marginalized patients.

“We’re not relying on hearsay that the Catholic identity is alive and well in our facilities and hospitals,” Rooney said. “We can actually see on a scale where they are at.”

The association does not share the results with the public.

At SSM Health, “our Catholic identity is deeply and structurally ingrained” even with no nun at the helm, spokesperson Patrick Kampert said. The system reports to two boards. One functions as a typical business board of directors while the other ensures the system abides by the rules of the Catholic Church. The church requires the majority of that nine-member board to be Catholic. Three nuns currently serve on it; one is the chair.

Separately, SSM also is required to file an annual report with the Vatican detailing the ways, Kampert said, “we deepen our Catholic identity and further the healing ministry of Jesus.” SSM declined to provide copies of those reports.

From a business perspective, though, it’s hard to distinguish a Catholic hospital system like SSM from a secular one, said Ruth Hollenbeck, a former Anthem insurance executive who retired in 2018 after negotiating Missouri hospital contracts. In the contracts, she said, the difference amounted to a single paragraph stating that Catholic hospitals wouldn’t do anything contrary to the church’s directives.

To retain tax-exempt status under Internal Revenue Service rules, all nonprofit hospitals must provide a “benefit” to their communities such as free or reduced-price care for patients with low incomes. But the IRS provides a broad definition of what constitutes a community benefit, which gives hospitals wide latitude to justify not needing to pay taxes.

On average, the nation’s nonprofit hospitals reported that 15.5% of their total annual expenses were for community benefits in 2020, the latest figure available from the American Hospital Association.

SSM Health, including all of its subsidiaries, spent proportionately far less than the association’s average for individual hospitals, allocating roughly the same share of its annual expenses to community efforts over three years: 5.1% in 2020, 4.5% in 2021, and 4.9% in 2022, according to a KFF Health News analysis of its most recent publicly available IRS filings and audited financial statements.

A separate analysis from the Lown Institute think tank placed five Catholic systems — including the St. Louis region’s Ascension — on its list of the 10 health systems with the largest “fair share” deficits, which means receiving more in tax breaks than what they spent on the community. And Lown said three St. Louis-area Catholic health systems — Ascension, SSM Health, and Mercy — had fair share deficits of $614 million, $235 million, and $92 million, respectively, in the 2021 fiscal year.

Ascension, Mercy, and SSM disputed Lown’s methodology, arguing it doesn’t take into account the gap between the payments they receive for Medicaid patients and the cost of delivering their care. The IRS filings do.

But, Kampert said, many of the benefits SSM provides aren’t reflected in its IRS filings either. The forms reflect “very simplistic calculations” and do not accurately represent the health system’s true impact on the community, he said.

Today, SSM Health is led by longtime business executive Laura Kaiser. Her compensation in 2022 totaled $8.4 million, including deferred payments, according to its IRS filing. Kampert defended the amount as necessary “to retain and attract the most qualified” candidate.

By contrast, SSM never paid Ryan a salary, giving instead an annual contribution to her convent of less than $2 million a year, according to some tax filings from her long tenure. “I didn’t join the convent to earn money,” Ryan said.

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

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“Right To Try” experimental drug program saved “thousands and thousands of lives”

Former President Donald Trump on Aug. 30

Former President Donald Trump has boasted in recent months about “Right To Try,” a law he signed in 2018. It’s aimed at boosting terminally ill patients’ access to potentially lifesaving medications not yet approved by the Food and Drug Administration.

“We have things to fight off diseases that will not be approved for another five or six years that people that are very sick, terminally ill, should be able to use. But there was no mechanism for doing it,” Trump said Aug. 30, speaking in Washington, D.C., to supporters of the conservative parental rights advocacy group Moms for Liberty.

He also said that because of Right To Try, “we have saved thousands and thousands of lives.”

Trump similarly praised the program during an Aug. 17 rally in Pennsylvania, in a podcast interview with a conservative commentator, and during his Republican National Convention acceptance speech: “Right To Try is a big deal,” Trump said then.

Medical experts who’ve studied the experimental treatment program, however, say there’s no evidence to support Trump’s claims. These experts say Right To Try weakened regulations intended to protect patients.

What Is Right To Try?

The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right To Try Act, aka Right To Try, passed Congress on a bipartisan basis and was signed into law in 2018. It sought to streamline the process for getting potentially lifesaving drugs that weren’t yet FDA-approved to terminally ill patients. The speed matters; industry groups say it takes 10 to 15 years on average for a new medicine to reach pharmacy shelves.

However, a similar FDA program, the expanded access pipeline, sometimes called “compassionate use,” has existed since the 1970s, and became law in 1987.

And that is the root of many criticisms of Right To Try.

“Right To Try is basically ‘expanded access light,’” said Alison Bateman-House, a medical ethicist who researches access to investigational medical products at New York University’s Grossman School of Medicine.

Right To Try caters to fewer patients than expanded access and offers them fewer treatments, Bateman-House said.

Easing Access or Erasing Safeguards?

Patients must meet specific, but different, criteria to qualify for either experimental medication program.

To qualify for expanded use, patients must have a “serious or immediately life-threatening disease or condition” for which there is no “comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition,” according to government regulations. Clinical trials must be infeasible for the patients, and the use of these drugs must not interfere with any in-progress studies. Also, the potential benefits must justify the risks, according to the prescribing physicians.

Then, after identifying a treatment, the patient’s doctor must receive approval from its manufacturer, the FDA, and the institutional review board overseeing the medication’s clinical trials.

The FDA said these steps exist so the agency can “fairly weigh the risks and benefits” of the medication and protect the patient’s safety. The agency also collects data about the drugs’ clinical impact on the patient and any adverse effects to inform the wider approval process for the drug.

Right To Try sought to hasten this approval process. Under the new program, for instance, a doctor must merely identify an experimental medication and receive authorization to use it from the manufacturer. In most cases, the FDA has no authority to approve or deny the application, and there’s no review board process to navigate.

But, because of the Right To Try program’s definitions, fewer patients and fewer medicines qualify.

Under Right To Try, patients must have a “life-threatening” disease or condition, not just “serious,” as with expanded access. Experimental medications are available only after they’ve completed Phase 1 clinical trials; treatments accessed through the expanded access program can be administered during a Phase 1 study.

Right To Try, which includes liability protections for manufacturers and prescribing physicians, also weakens requirements that govern how doctors disclose experimental medications’ risks to patients, leaving informed consent undefined. And it prevents the FDA from using information about how patients tolerate the drugs to “delay or adversely affect the review or approval of such drug(s),” unless top officials justify the benefit to public health in writing.

Supporters say Right To Try is an example of successful deregulation and claim that its more efficient approval process saved lives. But critics see this as a key reason for concern, because it “opens up the opportunity of exploiting desperate patients,” said Holly Fernandez Lynch, a bioethicist who studies pharmaceutical policy at the University of Pennsylvania’s Perelman School of Medicine.

Government data shows regulatory agencies weren’t the main hurdle patients faced when seeking experimental drugs. The FDA almost always approved expanded access applications, and quickly by government standards.

According to a 2018 FDA report on the expanded access program, the FDA authorized 99% of the roughly 9,000 requests it received in the previous five years, approving emergency requests for experimental medications in less than one day on average. More recent data shows that approval trend has continued, even as the number of applications has grown each year.

In rare cases in which the FDA didn’t automatically approve requests, regulators often didn’t deny them, but recommended tweaks to the requested dosage to address safety and effectiveness concerns.

Right To Try by the Numbers

The FDA does not share detailed information about the number of doses provided or patients treated under Right To Try. Instead, it posts only an annual summary showing how many drugs have been approved under the program. The agency says that since Right To Try began in 2018 it has approved 16 treatments: 12 from 2018 to 2022 and four last year.

The FDA declined to provide additional information about the number of Right To Try requests or approvals.

Although the 16 medications approved through Right To Try were possibly provided to more than one patient each, experts said it’s extremely unlikely thousands of patients were involved, as Trump said.

Trump’s claim represents an “egregious overestimate of the number of people who are using Right To Try,” said Fernandez Lynch, noting she believes the real numbers are “very, very low.”

The Trump campaign did not respond to multiple inquiries about the source of the former president’s statistics. Karoline Leavitt, the campaign’s national press secretary, told KFF Health News that in a second term “President Trump will of course remain open to other pathways to expand ‘Right to Try’ to save more American lives.”

It remains unclear how Trump might expand the program, though the conservative Goldwater Institute is advocating for “Right To Try 2.0,” which it claims will let patients receive individualized therapeutics.

Experts noted such drugs are already accessible through the expanded access program.

Meanwhile, evidence shows that the high price of experimental treatments, which are sometimes available through certain drug company programs but not typically covered by insurance, is a greater hurdle to patients than regulatory guardrails are.

“I don’t think that people are having a problem with the FDA blocking access to individualized therapeutics,” Bateman-House said. “I think the problem is that individualized therapeutics are incredibly expensive, and there’s only a very small number of researchers in the country who know how to make them.”

Our Ruling

Trump has claimed throughout the campaign that his Right To Try program is novel and has saved thousands of lives. But a similar program has existed for decades, and there is no evidence Right To Try has had anywhere close to the impact Trump said it has had.

Neither the Trump campaign nor Right To Try advocates provided evidence to back claims of widespread benefit. And government data shows only 16 medications have been approved under the program in its first six years, with no accounting of how many patients used those medications or their clinical outcomes.

Moreover, public health experts have said Right To Try weakens patient protections and fails to address the true barriers to experimental medications.

We rate Trump’s claim False.

our sources:

21 CFR §50.20

21 USC §360bbb-0a

Congressional Research Service, “Expanded Access and Right To Try: Access to Investigational Drugs,” March 16, 2021

Food and Drug Administration, “Expanded Access,” Feb. 28, 2024

Food and Drug Administration, “Expanded Access (Compassionate Use) Submission Data,” May 2, 2024

Food and Drug Administration, “Expanded Access Program Report,” May 2018

Food and Drug Administration, “Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers, Guidance for Industry,” November 2022

Food and Drug Administration, “FDA Fact Sheet: Right To Try,” accessed Sept. 29, 2024

Food and Drug Administration, “Right To Try,” Jan. 23, 2023

Food and Drug Administration, “Right To Try Annual Reporting Summary,” June 6, 2024

Goldwater Institute, “Right To Try for Individualized Treatments (Right To Try 2.0),” accessed Sept. 29, 2024

Goldwater Institute, “Right To Try Is Working,” accessed Sept. 29, 2024

Goldwater Institute, “The Right To Try,” Oct. 5, 2014

Goldwater Institute, “What Is Right To Try?” accessed Sept. 29, 2024

Los Angeles Times, Marc Hayutin obituary, June 14, 2019

Phone interview with Alison Bateman-House, assistant professor at New York University’s Grossman School of Medicine, Sept. 24, 2024

Phone interview with Holly Fernandez Lynch, associate professor of medical ethics and law at the University of Pennsylvania Perelman School of Medicine, Sept. 17, 2024

PhRMA, “Research & Development Policy Framework,” accessed Sept. 29, 2024

Roll Call, “Speech: Donald Trump Holds a Political Rally in Wilkes-Barre, Pennsylvania,” Aug. 17, 2024

The Singju Post, “Full Transcript: Trump Addresses Moms for Liberty 2024 Summit,” Aug. 31, 2024

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

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On the campaign trail, both former President Donald Trump and Vice President Kamala Harris are eager to portray themselves as guardians of Medicare. Each presidential candidate accuses the other of backing spending cuts and other policies that would damage the health insurance program for older Americans.

But the election’s outcome could alter the very nature of the nearly 60-year-old federal program. More than half of Medicare beneficiaries are already enrolled in plans, called Medicare Advantage, run by commercial insurers, and if Trump wins, that proportion is expected to grow — perhaps dramatically.

Trump and many congressional Republicans have already taken steps to aggressively promote Medicare Advantage. And Project 2025, a political wish list produced by the conservative Heritage Foundation for the next presidency, calls for making insurer-run plans the default enrollment option for Medicare.

Such a change would effectively privatize the program, because people tend to stick with the plans they’re initially enrolled in, health analysts say. Trump has repeatedly tried to distance himself from Project 2025, though the document’s authors include numerous people who worked in his first administration.

Conservatives say Medicare beneficiaries are better off in the popular Advantage plans, which offer more benefits than the traditional, government-run program. Critics say increasing insurers’ control of the program would trap consumers in health plans that are costlier to taxpayers and that can restrict their care, including by imposing onerous prior authorization requirements for some procedures.

“Traditional Medicare will wither on the vine,” said Robert Berenson, a former official in the Jimmy Carter and Bill Clinton administrations who’s now a senior fellow at the Urban Institute, a left-leaning research group.

While the fate of Medicare has gotten scant attention so far in the campaign, the different visions under Trump versus Harris indicate the high stakes.

A candidate’s position on protecting Medicare and Social Security is the most important health care issue, or among the most important, in determining 63% of Americans’ vote in the presidential election, according to a September poll by Gallup and West Health, a family of nonprofit and nonpartisan organizations focused on health care and aging.

Medicare, which covers about 66 million people, is funded largely by payroll taxes. At age 65, most Americans are automatically enrolled in Medicare coverage for hospitalization and doctor visits, known as Part A and Part B, though others must sign up. Consumers must also sign up for other aspects of Medicare, specifically drug coverage (Part D) and supplemental plans from insurers that pay for costs that aren’t covered by traditional Medicare, such as extended stays in skilled nursing facilities and cost sharing.

People on Medicare pay premiums plus as much as 20% of the cost of their care.

Medicare Advantage plans typically combine coverage for hospital and outpatient care and prescriptions, while eliminating the 20% coinsurance requirement and capping customers’ annual out-of-pocket costs. Many of the plans don’t charge an extra monthly premium, though some carry a deductible — an amount patients must pay each year before coverage kicks in.

Sometimes the plans throw in extras like coverage for eye exams and glasses or gym memberships.

However, they control costs by limiting patients to networks of approved doctors and hospitals, with whom the plans negotiate payment rates. Some hospitals and doctors refuse to do business with some or all Medicare Advantage plans, making those networks narrow or limited. Traditional Medicare, in comparison, is accepted by nearly every hospital and doctor.

Medicare’s popularity is one reason both candidates are pledging to enhance it. Last month, Harris released a plan that would add benefits including care for hearing and vision, and long-term in-home health care. The costs would be covered by savings from expanding Medicare’s negotiations with drugmakers, reducing fraud, and increasing discounts drugmakers pay for certain brand-name drugs in the program, according to Harris’ campaign.

Trump’s campaign said he would prioritize home care benefits and support unpaid family caregivers through tax credits and reduced red tape.

The Trump campaign also noted enhancements to Medicare Advantage plans during his tenure as president, such as increasing access to telehealth and expanding supplemental benefits for seniors with chronic diseases.

But far less attention has been paid to whether to give even more control of Medicare to private insurers. Joe Albanese, a senior policy analyst at Paragon Health Institute, a right-leaning research group, said “a Trump administration and GOP Congress would be more friendly” to the idea.

The concept of letting private insurers run Medicare isn’t new. Former House Speaker Newt Gingrich, a Republican, asserted in 1995 that traditional Medicare would fade away if its beneficiaries could pick between the original program and private plans.

The shift to Medicare Advantage was accelerated by legislation in 2003 that created Medicare’s drug benefit and gave private health plans a far greater role in the program.

Lawmakers thought private insurers could better contain costs. Instead, the plans have cost more. In 2023, Medicare Advantage plans cost the government and taxpayers about 6% — or $27 million — more than original Medicare, though some research shows they provide better care.

The Trump administration promoted Medicare Advantage in emails during the program’s open enrollment period each year, but support for the privately run plans has become bipartisan as they have grown.

“It helps inject needed competition into a government-run program and has proven to be more popular with those who switch,” said Roger Severino, lead architect of Project 2025’s section on the Department of Health and Human Services. He served as director of HHS’ civil rights office during the Trump administration.

But enrollees who want to switch back to traditional Medicare may not be able to. If they try to buy supplemental coverage for the 20% of costs Medicare doesn’t cover, they may find they have to pay an unaffordable premium. Unless they enroll in the plans close to the time they first become eligible for Medicare, usually at age 65, insurers selling those supplemental plans can deny coverage or charge higher premiums because of preexisting conditions.

“More members of Congress are hearing from constituents who are horrified and realize they are trapped in these plans,” said Andrea Ducas, vice president of health policy at the Center for American Progress, a liberal public policy organization.

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

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