A Mom Said Infant Formula Killed Her Baby. The Manufacturer Didn’t Tell the FDA.

In September 2016, a distraught mother sent infant formula maker Mead Johnson a message:

“REMOVE ME FROM YOUR LIST!!!! DO NOT EMAIL OR MAIL ME ANY MORE!

“It is because of your animal based pre-term artificial baby food crap that you peddle to hospital NICU’s that my son is dead from NEC.”

The mother was referring to neonatal intensive care units and necrotizing enterocolitis, an often fatal condition in which intestinal tissue can die and allow infection to spread through the body of an infant born prematurely.

In an internal memo, Mead Johnson cited its “extensive quality and safety checks” and concluded there was “not a reasonable possibility” that the formula caused the baby’s death. “No further investigation is needed. This file can be closed,” the memo said.

And with that decision, the company narrowed the chance that the mother’s anguish could draw attention to any danger the formula might pose to other infants.

The mother’s email and the company’s memo assessing it were used as evidence in the court cases Watson v. Mead Johnson and Whitfield v. St. Louis Children’s Hospital, et al.

When doctors, hospitals, parents, or others alert manufacturers that babies got sick or died while receiving infant formula, what happens next is left largely to manufacturers such as Abbott Laboratories and Mead Johnson Nutrition, giants of the industry.

Mead Johnson’s handling of the mother’s email showed how that can play out.

Under federal rules, if a complaint about an infant formula — such as a report of an adverse event — shows a possible health hazard, the company must investigate.

But it doesn’t always have to inform the government agency that oversees the safety of infant formula.

A company must complete an investigation and notify the Food and Drug Administration within 15 days only if it finds “a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant’s death.”

If that happened even once over more than a quarter century, the FDA could find no record of it, according to information obtained through public records requests.

‘Never Reported’

Under the Freedom of Information Act, KFF Health News asked the FDA for all notifications that manufacturers of infant formula sent the agency per the regulatory requirement since Jan. 1, 2020. The agency’s Human Foods Program “did not receive any,” Kimberly Jones, a government information specialist at the FDA, responded in March.

KFF Health News then asked the FDA to go back decades further — to Jan. 1, 2000. “After a diligent search of our files, we did not locate any responsive records,” Jones wrote on May 5.

The FDA’s search results were consistent with court testimony.

John Wallingford, a paid expert witness for Abbott, testified in a Missouri court in October 2024 that Abbott had never reported a single death under any regulation for preterm infant formula.

Wallingford clarified that he was not referring to adverse events in clinical trials, which are studies used for research and development and are subject to different procedures. Abbott informed the FDA about adverse events that occurred during a clinical trial, Wallingford testified.

John Wallingford, an expert witness for Abbott Laboratories, testified in 2024 that, outside of clinical trials, the company had never reported to the FDA that there was a reasonable possibility a death was caused by an Abbott preterm formula, according to a transcript posted by the Missouri Court of Appeals Eastern District in an appeal of the Whitfield v. St. Louis Children’s Hospital case.

Christina Valentine testified in a 2024 deposition that she never sent the FDA a report of death from NEC during her seven years as Mead Johnson’s medical director for North America. In the deposition, used in the Whitfield case, she said she never concluded there was a reasonable possibility that an infant’s death from NEC might have been related to a Mead Johnson product.

As medical director for North America, she was responsible for signing off on those determinations, she testified in the Watson trial.

In the deposition, Valentine said she wasn’t sure whether anyone else at the company sent a death report to the FDA.

In late May and mid-June, Mead Johnson spokesperson Jen O’Neill added to the picture.

“Where there is a physician report that includes an opinion that one of our products caused NEC in a preterm infant, we have treated that as a ‘reasonable possibility of a causal relationship,’ and we submitted an adverse event report to the FDA,” she wrote.

“These physician reports were generally made by plaintiffs’ paid experts, with which we disagree,” she wrote.

O’Neill left unclear whether events Mead Johnson reported to the FDA were raised in lawsuits and, if so, whether the company reported them to the FDA before they surfaced in litigation.

Asked repeatedly when Mead Johnson filed the reports, O’Neill didn’t say.

It’s unclear why the FDA found no record of them.

Nor would O’Neill say whether the company submitted one related to the distraught mother’s September 2016 complaint.

That mother’s name wasn’t publicly disclosed in the court record containing her complaint.

“[P]rior to the current litigation, we received very few reports relating to our products and NEC and even fewer for which our investigation uncovered any evidence supporting a reasonable possibility of a causal relationship,” O’Neill wrote.

Industry personnel have reacted to some complaints with circular reasoning, as shown by court records from the Watson, Whitfield, and Gill v. Abbott Laboratories cases. Company personnel didn’t think their products caused harm, and they didn’t view new cases as evidence of harm, records show.

‘Reprehensible’ Conduct

About 2,300 newborns died of necrotizing enterocolitis in the United States from 2017 through 2023, the equivalent of almost one per day, according to a KFF Health News analysis of a government data set for those years. The database doesn’t attempt to explain what caused those babies to develop NEC, and it doesn’t count babies who survived NEC.

A wave of lawsuits has alleged that infant formula made by Abbott or Mead Johnson harmed or killed preterm babies by causing or contributing to cases of NEC. As of late January, 1,760 NEC lawsuits were pending against Abbott, company spokesperson Scott Stoffel said, clarifying a disclosure in a regulatory filing.

This article is based largely on transcripts, deposition videos, and exhibits from three court cases that went to trial in 2024. The lawsuits were filed by parents of babies who suffered or died from NEC.

Abbott and Mead Johnson have denied fault. They, along with various medical authorities including federal regulatory agencies and the American Academy of Pediatrics, have said that, when nutritional needs can’t be met with human milk, formula is vital.

One of the cases, Watson v. Mead Johnson, led to a $60 million judgment against Mead Johnson. Another, Gill v. Abbott, led to a $495 million judgment against Abbott. The third, Whitfield v. St. Louis Children’s Hospital, et al., led to a jury verdict in favor of Abbott and Mead Johnson, but the judge found errors and misconduct on the part of defense counsel, faulted his own performance, and ruled the plaintiff was entitled to a new trial.

The judge’s ruling in the Whitfield case is on appeal.

On May 5, a Missouri appeals court upheld the $495 million judgment against Abbott, saying “we find Abbott’s conduct significantly reprehensible.”

“Throughout the trial, the jury heard evidence that Abbott knew its formula posed significant risks to preterm infants weighing under 1500g yet made little effort to mitigate that risk,” the court wrote.

On June 12, an Illinois appeals court reversed the $60 million judgment against Mead Johnson and sent the case back for a new trial. The trial court risked prejudicing the jury by improperly admitting evidence about Mead Johnson’s finances, including its revenues, profits, and executive compensation, the appeals court said.

In addition, the trial judge gave the jury erroneous instructions, the appeals court ruled. Any negligence on Mead Johnson’s part hinged on a failure to warn, and the company’s duty was not to warn the mother in that case of any danger, as she had claimed, but rather to warn doctors, the appeals court ruled.

In April, after another trial, a jury in Chicago ordered Abbott to pay four plaintiffs a total of $70 million. Abbott is contesting that verdict and the Missouri appeals court’s decision.

In at least four cases, judges have granted summary judgment in favor of Abbott — ruling for the company before the lawsuits reached trial.

‘Branding NICU Babies’

Abbott makes Similac products, and Mead Johnson makes the Enfamil line.

The two companies have vied to place their products in neonatal intensive care units, which serve as entry points to hospital contracts and the retail market, KFF Health News reported in a March article based largely on records from court cases.

For instance, a Mead Johnson slide deck for a 2020 national sales meeting — later used in the Whitfield trial — outlined a plan for “Branding NICU Babies.”

A Mead Johnson slide for a 2020 national sales meeting outlined a plan for “Branding NICU Babies.” The slide featured a product for babies born prematurely transitioning to home. The slide deck was used in the Whitfield v. St. Louis Children’s Hospital lawsuit.

The litigation opened a wider window into the business and regulation of infant formula, including adverse event reports.

“Abbott complies with all applicable FDA regulations on adverse event reporting, including by keeping detailed records of every single complaint/adverse event report Abbott receives and investigating NEC complaints,” Stoffel said in November. “FDA routinely conducts audits that include Abbott’s adverse event investigations and reporting as part of its active regulation of infant nutrition.”

Mead Johnson’s O’Neill echoed that.

“Our adverse event reporting complies with all applicable regulatory requirements,” O’Neill said in a November statement to KFF Health News. “The FDA audits Mead Johnson on an annual basis and has never identified any issue about our approach to reporting.”

The reports the company filed with the FDA were submitted through the agency’s regional office in Detroit, she said.

It’s unclear whether the FDA looked in Detroit.

FDA rules require manufacturers to send written confirmations to a central office in the Washington area that oversees infant formula and other foods.

Asked if the company sent them to that office, O’Neill did not answer.

KFF Health News requested an interview with Mead Johnson to clarify its statements about how it handled adverse event reports. The company did not grant one.

Plaintiffs have used internal documents from the companies to allege that, in house, people have long recognized a correlation between NEC and the use of preterm formulas made from cow’s milk.

For example, in a 2010 research proposal shown in a deposition used in the Gill case, Abbott scientists wrote that NEC “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.”

An Abbott document from 2010 said necrotizing enterocolitis “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.” The document was displayed in deposition video clips KFF Health News obtained from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

A Mead Johnson document used in the Whitfield lawsuit cited “80% necrotizing enterocolitis (NEC) risk reduction when human milk is used in place of formula.”

Abbott has argued that correlation does not equal causation.

“Numerous studies and NEC authorities have made clear that preterm infant formula does not cause NEC; it’s the absence of human milk that increases NEC risk rather than anything harmful in formula,” Abbott spokesperson Stoffel said.

The FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health weighed in with a joint statement in October 2024, saying, “There is no conclusive evidence that preterm infant formula causes NEC” and “there is strong evidence that human milk is protective against NEC.”

Mead Johnson’s O’Neill said the scientific consensus is that there is no established causal link between the use of specialized preterm hospital nutrition products and NEC.

O’Neill cited a statement by the American Academy of Pediatrics saying the causes of NEC “are multifaceted and not completely understood.”

In a legal brief filed with an Illinois appeals court in the Watson case, the company said “the NEC related risks” of a formula for preterm infants “are the subject of medical debate.”

Managing Potential Warnings

Court records from lawsuits shed light on how the manufacturers have managed potential warnings from the field.

Fabrizis Suarez, who was director of medical safety and surveillance at Abbott from 2006 to 2023, said in a January 2024 deposition used in the Gill and Whitfield cases that he knew of no instance in which Abbott notified the FDA that a baby had died of NEC that could have been caused by Abbott’s formula for preterm infants.

There were numerous cases in which healthcare providers told Abbott they believed the formula caused the NEC, but Abbott disagreed every time, Suarez testified.

Abbott tracks and reviews every NEC report it receives and looks for patterns, Suarez testified.

Fabrizis Suarez, identifying himself as director of medical safety and surveillance at Abbott from 2006 to 2023, testified in a January 2024 deposition about Abbott’s handling of adverse event reports. KFF Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

Courtney Colombo, who identified herself in a March 2024 deposition used in the Gill and Whitfield cases as director of postmarketing medical safety and surveillance at Abbott, likewise testified that she knew of no instance in which Abbott reported to any regulatory authority anywhere in the world that one of its preterm infant formulas was possibly related to a death caused by NEC.

Abbott wasn’t hiding complaints from the FDA, according to testimony from Wallingford, a paid expert witness on regulatory matters who spent 10 years at the FDA. The complaints were in company files FDA inspectors reviewed during annual inspections, he said in the Whitfield case.

Wallingford also testified that inspections are not a replacement for reporting infant deaths.

Questioning Wallingford in court, plaintiff’s lawyer Kevin Carnie Jr. invoked the cliché about the fox guarding the henhouse.

Wallingford declined to comment for this article. Valentine and Colombo did not respond to messages sent via LinkedIn. Valentine and Suarez did not respond to letters mailed to addresses that appeared to be associated with them. A letter to Colombo with signature required, sent to an address apparently associated with her, was returned unopened.

Not Publicly Reported

Adverse event reports can prompt the FDA to take action to protect the public.

For example, in 2011, the FDA warned parents, caregivers, and healthcare providers not to feed SimplyThick, a thickening gel, to premature infants fitting a particular profile. The product, used to manage swallowing difficulties, might cause NEC, the FDA said.

The FDA first learned about possible problems with SimplyThick from physicians, according to an FDA document that an attorney for Abbott, Sierra Elizabeth, read from during the Whitfield trial.

The stakes for companies and consumers are high.

A finding under the “reasonable possibility” standard could trigger a product recall, said Martin Hahn, a regulatory attorney for Mead Johnson.

The FDA’s handling of adverse event reports for infant formulas — and fortifiers, which are used to nutritionally supplement a mother’s milk when babies are born prematurely — contrasts with its handling of reports about drugs and medical devices.

The FDA posts manufacturers’ adverse event reports on drugs and medical devices online in databases available to the public.

But the notifications manufacturers are required to submit about formulas and fortifiers are not publicly reported, said Emily Hilliard, a spokesperson for the Department of Health and Human Services, which includes the FDA.

In addition, the FDA’s reporting requirements for drugs and medical devices are, in key ways, more demanding than those for infant formula.

Device makers must report not just deaths but also “serious injuries” that the product “may have caused or contributed to.”

Drugmakers are required to report any “serious and unexpected” adverse event, “whether or not considered drug related.” That goes beyond fatal or life-threatening events.

The FDA also maintains a public database about dietary supplements, foods, and infant formulas, among other products, that includes voluntary reports from consumers and healthcare practitioners.

KFF Health News searched that database and found one death report that mentioned NEC and a formula made for premature or low-birth-weight babies.

The search turned up seven other reports of infant deaths that mentioned NEC and fortifiers designed for premature or low-birth-weight babies. One of those reports, obtained by KFF Health News through the Freedom of Information Act, said three preterm babies at the same hospital had NEC and died within a month of one another in 2024.

The FDA cautions that reports are not verified and do not prove causation.

A former attorney for Abbott now leads the FDA.

Before becoming the FDA’s deputy commissioner for food last year and being named acting head of the agency in May, Kyle Diamantas represented Abbott in the Gill and Whitfield lawsuits, court records show.

Diamantas “complies with all applicable ethics laws and regulations,” said Hilliard, the HHS spokesperson. “That included a specific recusal related to Abbott Laboratories, which concluded in January 2026.”

“During that period, Mr. Diamantas voluntarily recused himself from all matters involving infant formula to avoid any appearance of partiality,” Hilliard said.

‘No Health Hazard’

KFF Health News asked the FDA a series of questions for this article. The agency left many unanswered.

“Infant formula safety is a top priority of the FDA given the vulnerability of the intended population,” Hilliard said.

KFF Health News asked Abbott and Mead Johnson for data on all infant death reports the companies received and those they forwarded to the FDA. Neither company provided that information.

Court records provide fragmentary data.

Abbott lawyer Elizabeth said in court that, before Wallingford took the stand as an expert witness, the company gave him 789 complaint files from 2005 through 2022 that contained the search term “NEC.”

When Wallingford went through the files, he found about 130 that mentioned death and NEC, he testified.

If Similac Special Care products for preterm infants were a problem, and if only 1% of adverse events led to a report, “you would expect to see tens of thousands of complaints,” Wallingford testified.

In 2010, a registered dietitian at a Cincinnati hospital notified Abbott that three babies had died of NEC shortly after starting on an Abbott formula. The dietitian thought there might be a correlation, according to an internal Abbott summary of the complaint shown during Colombo’s deposition. The babies, who were about 17 days old, had no complications other than prematurity, the summary said.

After reviewing the complaint, Abbott’s Colombo wrote, as shown in a deposition video, that she found “NO OTHER REPORTS OF DEATH AND NO TRENDS FOR NEC REPORTED BY OTHER FACILITIES ASSOCIATED WITH THIS STOCK CODE.”

“PREVIOUS COMPLAINT HISTORY INDICATES NO HEALTH HAZARD,” she concluded.

Courtney Colombo, who identified herself in a March 2024 deposition as director of postmarketing medical safety and surveillance at Abbott, testified about Abbott’s response to a report that three babies had died of NEC shortly after starting on an Abbott formula. KFF Health News obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

As for Mead Johnson, Valentine “testified that NEC was not one of the top adverse event complaints for Enfamil premature formulas of the 68 received between 2015-2019,” O’Neill, the company spokesperson, told KFF Health News.

Valentine — who was Mead Johnson Nutrition’s medical director for North America from 2014 to 2021 and parent company Reckitt’s chief medical officer from 2022 to 2023, according to a LinkedIn profile — signed off on the decision to close the 2016 file on the distraught mother’s complaint, according to an exhibit and her deposition testimony played in the Whitfield trial.

When she signed off, Mead Johnson didn’t know which of its products the complaint involved, Valentine said in the deposition.

Asked about it during the Watson trial in February 2024, Valentine testified that, in light of the mother’s request never to contact her again, it wouldn’t have been appropriate to call her back for more information.

Valentine “testified that she believes that the Mead Johnson complaint team appropriately investigated reports of death from NEC based on the information provided,” Mead Johnson’s O’Neill said.

Valentine also testified that the FDA encourages infant formula companies to send in all adverse event reports and that nothing prevented Mead Johnson from doing so.

As reflected in an email thread used in the Watson case, Valentine reacted skeptically in 2019 when a colleague told her a particular hospital wanted to exit its contract with Mead Johnson.

“They had 3 cases of NEC since they started using our formulas. They had 0 cases when they were with Abbott,” the colleague reported.

Valentine agreed to follow up but added: “Sad but please reassure them we are not seeing this with our formula … so no science basis for sure.”

Christina Valentine, who was Mead Johnson Nutrition’s director of medical affairs for North America, testified that she approved the decision to close the company’s file on a 2016 complaint about a baby’s death. (CVN courtroom video from the Whitfield v. St. Louis Children's Hospital, et al., trial.)

Share your story with us: Do you have experience with necrotizing enterocolitis (NEC) or infant formula that you’d like to share? We’d like to hear from you. Click here to contact the 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.

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New Disease Threats Follow Trump Administration’s Health Program Cuts

As beachgoers flock to water during the busy July Fourth weekend, danger could be lurking in some areas.

Researchers this spring discovered flesh-eating bacteria in water in several coastal locations across New York’s Long Island, and town officials in the Hamptons vacation destination posted an alert about the findings. Eight people in Florida have been infected this year, and Mississippi health officials in June urged people to take precautions.

About 1 in 5 people infected by the bacteria die, sometimes within a day or two of becoming ill, according to a Centers for Disease Control and Prevention fact sheet. The bacteria, Vibrio vulnificus, can enter open wounds and cause tissue death and systemic sepsis.

“Many people with Vibrio vulnificus infection can get seriously ill and need intensive care or limb amputation,” the CDC says.

The risk of such public threats is mounting because climate change is expanding the territory of certain pathogens, but researchers say there’s another concern. The Trump administration has cut investments in programs and agencies that prevent, track, and respond to health hazards the federal government is now confronting.

Consider the reemergence of screwworm, which can infest and kill livestock, in the U.S. in June. The U.S. Department of Agriculture lost 18% of its workforce in the first six months of 2025, according to a report from the USDA’s Office of Inspector General, and the agency’s winnowed-down inspection service is helping lead the response to the parasite.

Or malaria. A freeze on foreign aid disrupted international malaria prevention efforts, and new federal guidance in May warned that the U.S. is vulnerable to the reintroduction of the infectious disease.

And when it comes to Vibrio, the Trump administration began removing hundreds of deep-sea instruments that monitor ocean waters and yield data that helps predict conditions that can allow the bacteria to flourish. Researchers have used the data to study Vibrio, which can multiply rapidly when water temperatures and salinity increase.

“It is important to track coastal temperatures, and that will relate to the distributions of Vibrio,” said Christopher Gobler, a professor in the School of Marine and Atmospheric Sciences at New York’s Stony Brook University, though he added that there are also other sources of data for researchers.

The Trump administration reversed its plan to dismantle the ocean monitoring system following bipartisan opposition to the effort in Congress.

But it’s still curtailing Vibrio surveillance. The life-threatening species that’s found in water can also sicken or kill people who eat contaminated seafood, such as raw oysters infected with the bacteria. And infections from Vibrio vulnificus linked to consuming raw or undercooked shellfish have been increasing as the presence of other pathogens in food decrease.

Since 1995, 10 states have participated in a federal program called the Foodborne Disease Active Disease Surveillance Network, or FoodNet. The program, with the CDC, monitors and track cases of foodborne illness caused by eight specific pathogens, including Vibrio. But last year the Trump administration stopped requiring those states to report on all but two pathogens, which means states no longer must report cases to the CDC.

Federal officials deny the moves are putting Americans at risk, saying the CDC continues to monitor these pathogens through other national surveillance systems to ensure ongoing visibility into disease trends and outbreaks.

Meanwhile, some former health leaders say the ramifications of sweeping cuts to health agencies and global prevention programs are becoming more apparent, undermining U.S. response efforts and initiatives that aim to safeguard the country from diseases.

“We are letting down defenses that were necessary to protect against microbial threats,” said Tom Frieden, a former CDC director who is now president and chief executive of Resolve to Save Lives, which works to stop preventable disease. “Instead of protecting, we’re doing the opposite.”

Do Limited Resources Mean Higher Risks?

The administration defends its actions, including massive layoffs at government health agencies, as necessary to eliminate wasteful spending.

The Department of Health and Human Services “is advancing the most significant public health reforms in a generation focused on prevention, accountability, scientific transparency, and better health outcomes,” agency spokesperson Emily Hilliard said in an email. “The Department is putting American families at the center of public health decision-making.”

Evidence suggests health risks are rising even as the Trump administration pulls back on resources for research, detection, and response.

Early in his administration, President Donald Trump opted to freeze and review work on global health programs. Trump’s cost-reduction effort, led by billionaire Elon Musk, also dismantled the U.S. Agency for International Development.

As a result, work was disrupted on the President’s Malaria Initiative, a George W. Bush-era program aimed at combating malaria in hard-hit countries that is credited with saving more than 11 million lives. USAID had invested more than $9 billion in the program since 2005.

In addition, 80% of USAID grants for global malaria programs were targeted for termination, according to KFF, an independent research group that includes KFF Health News. The report didn’t include data on the total value of those specific malaria grants.

And the spending freeze halted research for more effective malaria vaccines. The administration dissolved the CDC’s Division of Parasitic Diseases and Malaria, shuffling staffers to other divisions and interrupting work on the disease. HHS didn’t respond to an email asking how many staff members had been moved.

The life-threatening infectious disease spread by mosquitos was eradicated from the U.S. in 1951. But the CDC’s updated guidance on investigating domestic cases warned in May that “the country remains susceptible to malaria reintroduction.”

An outbreak in 2023 resulted in 10 people in Arkansas, Florida, Maryland, and Texas becoming infected locally, and mosquitoes capable of transmitting malaria are found throughout most of the country.

“The majority of U.S. residents lack protective immunity against malaria, rendering persons susceptible to severe illness and death if infected,” the CDC said in the May report.

HHS declined to comment on any of the specific cuts but said the CDC works with domestic and international partners to reduce the burden of malaria and prevent its reestablishment in the U.S.

It’s not just cuts to funding that are raising health risks, say researchers and former health officials. Significant staffing cuts mean there are fewer people working on preventing or tracking diseases, they say.

“Yes, the programs have been cut in terms of reduction in staff, but I would say, equally important, you have reductions in expertise,” said Jeanne Marrazzo, CEO of the Infectious Diseases Society of America. “It’s irreplaceable.”

Screwworm is a species of parasitic blowfly producing larvae that can enter open wounds and devour tissue, infecting people and animals. Like malaria, it has long been eliminated in the U.S., and disease monitoring efforts have been key to keeping it out.

The cuts at USAID stripped more than $300 million from the United Nations’ Food and Agriculture Organization, which focuses on global food security and the monitoring of zoonotic diseases such as screwworm.

In the wake of the administration’s cost-cutting initiatives, more than 20,000 employees are gone from the USDA, which develops and implements agriculture policy and provides resources to producers of livestock vulnerable to the parasite.

On June 3, the first new case of screwworm in the U.S. was confirmed, and there have now been more than a dozen animals infected with parasite. An expanding outbreak could devastate the cattle industry.

Agriculture Secretary Brooke Rollins has denied that any staffing cuts during the Trump administration have led to screwworm’s return. Instead, she has blamed the Biden administration, saying it didn’t do enough to prevent reintroduction into the U.S. Rollins said on X that “uncontrolled illegal migration” under the previous Biden administration was partly to blame, providing no evidence.

The USDA did not respond to an email seeking comment.

Ashish Jha, a doctor who served as the White House covid response coordinator during the Biden administration, said there’s no truth to the claim that immigrants lacking legal status have brought screwworm into the U.S.

Investments in tracking and combating diseases have suffered, he said, because HHS Secretary Robert F. Kennedy Jr. is prioritizing the prevention of chronic disease at the expense of efforts to curtail infectious disease.

“Who doesn’t want a healthier country? It sounds great, but it’s kind of a bait and switch,” Jha said. “They’re doing the opposite. They’re letting down our defenses that are necessary to protect us against microbial threats.”

HHS’ Hilliard disagreed, saying Kennedy’s actions are making the agency more effective.

“Secretary Kennedy is delivering that reform by streamlining operations, reducing redundancies, and returning HHS to pre-pandemic staffing levels,” she said. “At the same time, he is dismantling policies and incentives that contributed to a nationwide chronic disease epidemic.”

Surveillance Gaps

Jha pointed to Trump’s decision to withdraw the U.S. from the World Health Organization, which coordinates global responses to public health issues and crises, and to the dismantling of USAID.

The pullback has had implications for the Ebola outbreak in the Democratic Republic of Congo, aid workers say.

Without the same amount of funding from USAID, the International Rescue Committee, which partners to deliver front-line health, surveillance, and outbreak preparedness activities in Congo, curtailed its programs.

“Funding cuts have left the region dangerously exposed,” Heather Reoch Kerr, IRC’s country director for Congo, said in a statement.

The outbreak is roughly 7,000 miles away, but its spread has the U.S. on alert, with stepped-up surveillance and entry restrictions on airline travelers. Federal officials have said that the dismantling of USAID hasn’t hampered detection or response.

“The U.S. government continues to move aggressively to contain the Ebola outbreak at its source in order to protect the American people and prevent further international spread,” the State Department said in a May 23 statement.

Trump’s decision to disengage with the WHO was criticized by health leaders following a hantavirus outbreak this spring on a cruise ship that had set sail from Argentina. Some said the federal response was too slow, and they questioned why the president suggested creating a costly new global disease surveillance system rather than sticking with the WHO — especially, they say, when the U.S. is cutting back on the surveillance programs it already has.

The federal government has tracked Vibrio cases as part of the FoodNet program, which aims in part to identify and curtail outbreaks. Reporting on cases of Vibrio is now optional.

Close to half of the cases of foodborne illness caused by Vibrio vulnificus have resulted in death, and some within 24 hours after consumption of tainted shellfish such as raw oysters. The bacteria can multiply rapidly, leading to septic shock and blistering skin lesions. The pathogen is becoming increasingly resistant to antibiotics.

The CDC estimates that about 80,000 cases of Vibrio infection occur annually, with infections from the most severe species, Vibrio vulnificus, steadily rising. Over the past five years, that species has led to 429 cases due to infections of open wounds and 135 cases from contaminated food.

“The more surveillance you get, you can connect the dots,” said Bill Marler, a Seattle-area food safety lawyer. “If a tree falls in the woods and you don’t hear it, did the tree fall? It’s easier not to report diseases. Then they can say, ‘Look at how safe our food supply is.’”

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 <a target="_blank" href="https://kffhealthnews.org/public-health/new-disease-threats-follow-trump-administrations-health-program-cuts/">article</a&gt; first appeared on <a target="_blank" href="https://kffhealthnews.org">KFF Health News</a> and is republished here under a <a target="_blank" href="https://creativecommons.org/licenses/by-nc-nd/4.0/">Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="https://kffhealthnews.org/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

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Newsom Vowed To Transform Kids’ Mental Health. Many California Schools Are Still Waiting.

If you or someone you know may be experiencing a mental health crisis, contact the 988 Suicide & Crisis Lifeline by dialing or texting “988.”

QUINCY, Calif. — When Taletha Washburn and the staff at Plumas Charter School first heard that California wanted to help schools treat more kids struggling with mental health, it felt like a well-timed remedy for a rural community where families struggle to find care.

Getting the program funding up and running, however, has proved difficult.

Employees spent two years “spinning our wheels,” attending state-led webinars, filling out countless forms, and researching electronic health record systems to prepare, said Washburn, the school’s executive director. When they reached out for assistance, she said, they waited months for a state response.

The school received its first reimbursement check in April. Washburn said the school has been reimbursed $8,000 and has at least $12,000 in outstanding claims. For a program Washburn had thought could be a game changer in her small rural town, it’s been a disappointing bust.

Plumas Charter is among roughly 1,000 public schools, community colleges, and universities that participate in Gov. Gavin Newsom’s first-in-the-nation initiative requiring that health insurance companies reimburse them for on-campus behavioral healthcare. California schools have been adding counselors, therapists, and psychiatrists to provide services where young people spend most of their time, making mental health treatment more accessible to kids whose families might have spent months waiting to see private therapists.

Five years after the program’s launch, Washburn and other California school officials say they have encountered a rollout fraught with inadequate guidance from the state, an incomplete billing infrastructure, a lack of standardized forms, and persistent delays signing up and getting paid. More than half of California’s school systems and colleges don’t participate in the billing program. Of those that do, fewer than one-fifth had filed claims as of June 1, according to the latest state data.

Plumas Charter School students have experienced trauma from the covid-19 pandemic and recent wildfires. (Christine Mai-Duc/KFF Health News)

Plumas Charter School Executive Director Taletha Washburn says the school’s experiences navigating the state’s new behavioral health billing program soured it on the initiative. (Christine Mai-Duc/KFF Health News)

The program hasn’t come close to bringing in the half-billion dollars in promised revenue to cover the salaries of thousands of counselors, therapists, and wellness coaches, many of whom school districts hired with a deluge of federal covid pandemic funding. As a result, schools across California have issued thousands of pink slips amid local budget cuts.

“One of the things that makes people hate government is when we make a promise and then we struggle to keep that promise because we can’t get the administrative part of it up and running,” said state lawmaker Dawn Addis, a former special education teacher and Democrat who has criticized the program’s slow implementation.

Newsom’s office declined to make the governor available for an interview for this article. At a May press conference to release his final state budget proposal, the Democratic governor pointed to the “unprecedented” initiative, saying “no other state in the nation has done more.”

“We have a lot more work to do to deal with the crisis of our time,” Newsom said. “Making investments in wellness, not just physical health, but mental health for our kids, is a good investment.”

He did not answer when asked whether he considered the program a success.

Tom Insel, the former head of the National Institute of Mental Health, who has advised Newsom, said the rocky rollout, in many ways, reflects the groundbreaking nature of what California is trying to do. Still, given the level of investment so far, he too had expected clearer evidence of dramatic improvement.

“What we struggle with in California is: We spend the money, but we don’t always see the outcomes. It’s sobering to realize, especially as an advocate, that you could actually get the programs, get the money, get everything that you want from the policy side, but the execution just isn’t there.”

A First-in-the-Nation Plan?

In 2021, 1 in 10 high school students nationwide said they’d attempted suicide, by then the second-leading cause of death for young people ages 10 to 24.

In response, Newsom announced a $4.4 billion “Master Plan for Kids’ Mental Health,” promising an overhaul of California’s behavioral health system that he said would be transformative. National mental health experts said Newsom’s initiative was the most ambitious attempt of any state to tackle a youth mental health crisis that had metastasized during the pandemic.

The state funneled $730 million in one-time funding into workforce efforts, such as campaigns to recruit mental health workers and programs to repay student loans. An additional $220 million has gone to facilitate partnerships between local governments and school officials, and $381 million was distributed in grants to schools and community groups for facilities or services, according to an analysis of program funding by KFF Health News.

The state has spent roughly $532 million to date on digital apps designed to connect families with counseling and provide a consultation service for primary care physicians handling behavioral health issues outside their expertise, while an additional $232 million has gone toward state operations and program evaluations.

And the state has added 1,855 school counselors since 2021, according to statistics from the American School Counselor Association, which in recent years has integrated mental health into professional standards. That’s well below the 10,000 Newsom had pledged by the end of this year as part of his initiative.

The “flagship” component of Newsom’s Children and Youth Behavioral Health Initiative focused on schools and was designed to increase behavioral health services on campus — at no cost to families. Schools would be able to bill health insurers, who would be required to reimburse them.

Some $1.3 billion — nearly a third of the total investment — has gone toward setting up campus wellness centers, new billing infrastructure, and beefing up school-based mental health support in other ways.

Filing claims became an administrative nightmare for schools unfamiliar with the complex world of medical billing.

Plumas Charter School staffers collected paperwork, webinar printouts, and other documents over the two years it took them to enroll and start billing for services in the Children and Youth Behavioral Health Initiative. (Christine Mai-Duc/KFF Health News)

In February 2025, when the Fresno County Office of Education launched its medical billing, it felt “like building the plane while flying it,” Trina Frazier, assistant superintendent of student services, told lawmakers in a public hearing a couple of months later. The delays were so acute that lawmakers last year authorized $20 million in grants to Fresno and 170 other school systems so they wouldn’t have to lay off newly hired mental health staffers while waiting for reimbursements.

Anaheim Elementary School District in Orange County, which state officials called a “champion” of the program, has recouped more than $1.1 million since its 23 campuses began billing student insurance in February 2025, said program specialist Shirley Diaz.

Still, that accounts for less than 30% of the behavioral health services the district has provided to students over that time. It’s not just the complexity of medical billing that has hampered the claims process. Parents have also been reluctant to provide health insurance information in the largely Latino district, where residents have been fearful of immigration raids carried out by the Trump administration.

To help administer claims across California, the state signed a $65 million contract with Carelon Behavioral Health, a service operated by Elevance Health, one of the nation’s largest health insurers. But schools have struggled to get claims cleared, and many have spent hundreds of thousands of dollars hiring outside vendors to troubleshoot and bill claims.

As of June 1, the Boston-based administrator has approved about 232,100 claims totaling more than $11.3 million to 186 school districts and educational agencies, according to the Department of Health Care Services.

That’s a small fraction of the thousands of entities the state had hoped would participate and far from the $500 million a year state officials told schools the program could eventually provide for school-based mental health services.

“We probably were given the impression that this was going to happen more quickly and now there’s this reality of a kind of slow growth,” said Amy Blackshaw, behavioral health project director for the California School-Based Health Alliance.

Binders full of documentation for the Children and Youth Behavioral Health Initiative sit in the office of Maggie Hennessy, business manager for Plumas Charter School. (Christine Mai-Duc/KFF Health News)

Carelon contract manager Christina Kim declined to comment to KFF Health News and referred questions to the state. Autumn Boylan, deputy director of the Office of Strategic Partnerships at DHCS, said staff members incorporated early feedback from school districts and extended claim deadlines, loosened onboarding requirements, and hosted webinars and office hours. But changes of this magnitude, she said, take time.

“We’re trying to help the school districts increase their scale,” Boylan told lawmakers at a May 4 hearing. “It’s not a problem of claims being submitted and not paid. It’s a problem of claims not yet being submitted for payment.”

Boylan noted the volume of reimbursements has increased exponentially since the first claims were filed in November 2024.

Meanwhile, children and youths continue to struggle and have trouble accessing care. In 2024, nearly 14% of those ages 12-17, for example, reported delaying or skipping mental healthcare because they couldn’t get an appointment, while 1 in 4 teens said they did so because of cost, up from roughly 6.5% the previous year, according to data from the California Health Interview Survey.

The share of young adults 18-24 who reported ever seriously considering suicide has stabilized but remains higher than pre-pandemic, according to the annual survey, conducted by the UCLA Center for Health Policy Research.

And while the suicide rate among Californians ages 12-25 has dropped from its high in 2021, this mirrors national trends, and state rates for female and Black youths increased from 2023 to 2024. “We have to have high expectations that when we invest in the magnitude of billions as this program did, we would have results to show,” said Assembly member David Alvarez, a Democrat in San Diego.

Other states have taken note of California’s implementation difficulties, some adopting a few strategies rather than the dozens California chose to roll out at once, said Sharon Hoover, formerly the co-director of the National Center for School Mental Health at the University of Maryland. Illinois, for instance, has focused on universal mental health screenings for schoolchildren while Colorado has expanded coverage of some behavioral health services for youths who lack a formal diagnosis.

“It’s always hard to be first, and someone has to be brave enough and hopeful enough to take that leap,” Hoover said.

Launching its reimbursement program before billing infrastructure was in place, Hoover said, created momentum but also posed challenges to school districts and providers. Still, she added, Newsom’s focus on prevention and early intervention became one of the biggest national policy shifts in years.

“We’re going to look back on this thinking it was one of the most progressive actions in the history of public systems,” said Alex Briscoe, a principal at the nonprofit Public Works Alliance who has pushed for system reform in kids’ mental health. “We spent a significant amount of money preparing for it. I just don’t think we did that very well or strategically.”

Rural Schools Struggle Most

Quincy, California, at the heart of what’s known as the “Lost Sierra,” is a remote Northern California town where kids’ behavioral health needs are high and wait times to get help are long. (Christine Mai-Duc/KFF Health News)

Students at Plumas Charter School had endured a relentless wave of trauma by fall 2021. Wildfires, covid shutdowns, and, weeks into the school year, a car accident that killed a classmate and left two others severely injured. Teachers saw signs of depression, anxiety, and frequent outbursts among their K-12 students. Nine kids that year reported considering suicide, an all-time high.

So, the school hired a full-time therapist and wellness coach with temporary federal funds.

Senior Will Coelho wasn’t there for any of it, but by the time he arrived in the remote California logging town of Quincy a year later, he’d been through plenty of his own loss.

Days before the pandemic lockdowns, a friend had died in a horrific murder-suicide. Isolated at home, Coelho struggled to process his grief, he said. That year, his stepfather became increasingly violent and, after a bitter, years-long custody fight, Coelho left the Central Valley to move in with his dad in the remote town in Northern California, just weeks before starting high school.

One day, he found himself chatting with a faculty adviser, the new kid half-joking about therapy. At her suggestion, Coelho started seeing the school therapist weekly, on campus and free of charge.

“It has had a large impact on the way I process emotions and my outlook on life,” he said.

Behind the scenes, school officials struggled with how they would continue to cover the therapist’s salary.

Twice, the state rejected the school’s application to the state’s landmark billing program, telling school officials they hadn’t met all the requirements, such as having sufficient systems to bill private insurers and collect student insurance information.

When school staffers flagged difficulties filing claims online, Washburn added, state officials suggested they submit paper claims instead.

The experience has soured Washburn and her staff on the program, which she said doesn’t work for small rural districts like hers where the human resources director is also the office business manager, and the faculty member who manages discipline also teaches PE.

DHCS spokesperson Tony Cava said that many charter schools are small and wouldn’t be expected to participate. While charter schools make up about half of eligible entities, Cava said, they serve only 12% of California’s students.

Lawmakers who represent small, rural districts have argued the program should be able to serve all kids. Early this year, Addis proposed legislation that would give intensive technical help to school officials who need it.

Even if it passes, it may be too late to help Plumas Charter. Washburn is unsure her school will reap enough revenue to pay for their therapist. “In theory, this should be a good program,” Washburn said. “We’re too small, and our funds are too limited to just keep waiting.”

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 <a target="_blank" href="https://kffhealthnews.org/mental-health/newsom-children-mental-health-initiative-schools-left-waiting/">article</a&gt; first appeared on <a target="_blank" href="https://kffhealthnews.org">KFF Health News</a> and is republished here under a <a target="_blank" href="https://creativecommons.org/licenses/by-nc-nd/4.0/">Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="https://kffhealthnews.org/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

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He Dreamed of Becoming a Physician Assistant. New Loan Rules May Thwart Him.

Benjamin Pinckney, 46, has dreamed of becoming a physician assistant since just after his 20th birthday.

He had been targeted by a drive-by shooter in Jacksonville, Florida, and hospitalized with two gunshot wounds. During his weeklong hospitalization, he said, a physician assistant changed the course of his life by visiting his hospital bed each day and warning him that Black men with gunshot wounds often end up paralyzed — or worse.

“I used to run the streets, you know, on the wrong sides of the track,” Pinckney said. “He made me promise that I would never come into his ER that way again. That was the last conversation we had, right before I was discharged.”

His goal since then has been to become a physician assistant. Pinckney, who spent most of his career working for New York City’s Department of Sanitation and as an Army Reserve medic, recently took a step toward achieving it. In May, he graduated with departmental honors from Lehman College with a Bachelor of Science degree.

After moving from New York to Prince George’s County, Maryland, he’d planned on applying for physician assistant school this year. But now, he’s worried his dream may be thwarted by new student loan rules.

Starting July 1, the amount of money graduate students will be allowed to borrow from the federal government will be capped. The new student loan limits are part of the GOP’s tax-and-spending legislation known as the One Big Beautiful Bill Act, which President Donald Trump signed into law last year.

The caps are intended to curb the cost of higher education and student loan debt, according to the Trump administration.

But critics widely agree the new limits are too low, especially for students allowed to borrow only $20,500 a year in federal loans due to the law’s controversial definition of a “professional degree.” On June 24, a federal judge temporarily blocked the Department of Education from enforcing that definition. Still, for many students, the new caps won’t cover the combined cost of tuition, housing, and living expenses.

This could leave hundreds of thousands of students who borrow money for graduate school each year at the mercy of private lenders with higher interest rates and fewer repayment options.

Pinckney wants to go to graduate school to become a physician assistant but doesn’t know how he will finance his education as new student loan limits go into effect. (Erica S. Lee for KFF Health News)

Pinckney earned his Bachelor of Science degree from Lehman College this spring. (Erica S. Lee for KFF Health News)

Pinckney estimates he paid at least 90% of his undergraduate tuition out-of-pocket. (Erica S. Lee for KFF Health News)

Some experts and students also worry that the limits will threaten efforts to diversify the healthcare workforce by deterring minorities and people from low-income households from applying to graduate programs. A drop in incoming students could worsen existing rural and primary care shortages, they argue.

Many politicians and loan experts have acknowledged that the cost of higher education needs to be addressed. But the new federal loan limits are “just not going to achieve that goal,” said Todd Pickard, president of the American Academy of Physician Associates, one of several organizations that have sued the Department of Education over the rules.

“It’d be like if you had a hangnail and I cut your whole arm off instead of just taking care of your hangnail,” Pickard said. “The treatment doesn’t match the problem.”

‘A Rock and a Hard Place’

Students working toward what the law describes as “professional degrees” — including trainee doctors, dentists, pharmacists, and chiropractors — will be allowed to borrow up to $200,000 total, and no more than $50,000 a year.

Meanwhile, the median cost of attending a public medical school is nearly $300,000 over four years, while the median cost of a private medical school education exceeds $400,000, according to the Association of American Medical Colleges.

The caps were set even lower for those pursuing other “graduate” degrees, who face a $100,000 borrowing limit for federal loans over the course of their degree programs. The annual limit for this category of students is only $20,500. Students pursuing physical therapy, physician assistant, and nursing degrees were originally included in this group. But according to new guidance issued by the Department of Education on Monday, some of these students will at least temporarily be able to borrow up to the higher limit, according to The Associated Press.

The Department of Education, which has been sued by clinician trade groups and about two dozen states over the new rules, did not respond to questions for this article.

As the law was written, a physician assistant student who completed their degree within the average two to three years would not have been eligible to borrow the full $100,000. Meanwhile, physician assistants typically start their careers with an average debt of $112,000, meaning some could be forced to finance their education with higher-interest private loans.

“I feel like I’m between a rock and a hard place,” said Olivia Trull, 24, who is scheduled to begin the physician assistant program at Northwest University in Kirkland, Washington, this summer. The 28-month program costs $137,000, with about $62,000 in tuition and fees estimated for the first year, she said. That doesn’t include living expenses.

Before the court order, Trull said she qualified for the maximum annual allotment under the new rules of $20,500 in federal loans during her first year of graduate school. The balance would need to be financed through a private lender.

She anticipated she would need up to $100,000 in private loans to finance her graduate degree and would face loan payments of more than $3,000 a month when she was done.

“I have to actually sit down and have a conversation with myself,” Trull said, to consider “if I want to be drowning in debt for the next 10 years of my life.” One private bank offered her a loan with an interest rate of nearly 14%, she said.

Pinckney, who said he finished his undergraduate degree with about $10,000 in federal student loan debt, said some of his friends who have already applied for private student loans have been quoted interest rates as high as 13%. Meanwhile, interest rates for federal loans for graduate students, which are set annually, are currently about 8-9%. Federal loans also offer more flexible repayment options than private loans typically do.

In May, 25 states and the District of Columbia filed a federal lawsuit against the Department of Education over the new rules. The complaint described the law’s “professional degree” definition as “arbitrary and capricious.”

In a separate federal lawsuit filed in June, the American Academy of Physician Associates and the PA Education Association alleged that the new rules deny students the loan amounts needed to attend physician assistant schools. They argue that PA students should be able to access the higher loan limits available to students in medical school and other professional degree programs. (While “physician assistant” and “physician associate” typically refer to the same role, the AAPA adopted the title “physician associate” in 2021 because of “concern that ‘assistant’ does not reflect the important role of PAs in delivering high-quality healthcare to patients.”)

Meanwhile, Trump administration officials have contended the cost of graduate school is too high across the board. Education Secretary Linda McMahon, speaking before a House committee in May about the new limits, said, “It is our overall goal to bring down the cost of college and education.”

Indeed, some experts acknowledge that the new limits may be helpful in bringing down costs. The federal Grad PLUS loan program, established by Congress 20 years ago, did not cap the amount graduate students could borrow in federal loans. That program was eliminated in the One Big Beautiful Bill Act.

“There is considerable evidence that people borrowed more than they really needed to go to school,” said Sandy Baum, a higher education economist and a senior fellow at the Urban Institute.

Already, some graduate programs have lowered tuition prices, Baum said. In May, for example, the University of California-Irvine announced it would lower the cost of its MBA programs by tens of thousands of dollars to fall below the new federal lending thresholds.

And yet Baum doesn’t anticipate many other schools will follow suit.

“I don’t think we’re going to see some dramatic decline in prices,” she said. “I think some programs could close down because they can’t manage.”

‘Tears Have Been Shed’

The new lending limits will also disproportionately affect Black students, Baum said, because they have historically borrowed more than white and Hispanic students.

For some students who borrowed money to finance their undergraduate degrees, the new limits will hit especially hard. Under the new rules, they will be subject to a lifetime limit of $257,000 in federal student loans.

“There will be students who can’t enroll,” Baum said.

Andrei Robu, 26, a medical student at the Medical University of South Carolina, leads the Financial Literacy Interest Group on the Charleston campus. He said many of his peers are worried that the lending limits will make the student body less diverse.

He is also concerned that, because the demand for acceptance into medical school is already so high, schools could prioritize entrance for students from wealthy backgrounds and “still fill up their classes.”

“That’s just not what we want in our physician workforce,” said Robu, who isn’t subject to the new rules as a current student. “We want to represent the population of the country at large.”

Jasmine Vasquez, 26, who has been accepted into the physician assistant program at South College in Atlanta, decided to defer her enrollment until 2027, partly to see if her financing options change. She is worried about taking on too much debt from a private bank.

“Tears have been shed multiple times,” said Vasquez, who is due to give birth in September. “It’s nothing that’s within my control.”

Betsy Mayotte, president of the Institute for Student Loan Advisors, expects the new rules will force some graduates into bankruptcy when they can’t afford to repay private loans.

First, though, she expects enrollment numbers to drop and some graduate programs to close because they can’t recruit enough students. Completion rates will also drop, she expects, as students run into federal loan limits partway through their degree programs.

Beyond that, she predicts healthcare graduates will seek jobs in high-paying specialties, exacerbating shortages in rural and underserved communities.

“They’re going to go where they can make the most money,” Mayotte said.

Pinckney has spent most of his career working for New York City’s Department of Sanitation. But he has dreamed of becoming a physician assistant since he was treated for gunshot wounds at a Jacksonville, Florida, hospital in 1999. (Erica S. Lee for KFF Health News)

Pinckney said he is “not really sure” what the future holds. He paid for most of his undergraduate education by working while he was in school, but that’s typically not possible for full-time physician assistant students.

He has considered applying to a biomedical science graduate program instead, which he estimated would cost about $30,000 — an amount that’s “a lot more doable,” he said. It would allow him to potentially work in a lab or in pharmaceuticals, he said. It’s still aligned with medicine, he said, but it wouldn’t help him realize his goal of working with patients.

“Maybe this thing will blow over,” he said of the new federal loan limits. In the meantime, he’s holding out hope.

“If I can influence one person’s life, that would be my way of paying him forward for what he did,” he said, referring to the physician assistant who inspired him back in 1999. “It’s very hard to pivot from that dream.”

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 <a target="_blank" href="https://kffhealthnews.org/health-industry/physician-assistant-professional-graduate-degrees-student-loan-limits/">article</a&gt; first appeared on <a target="_blank" href="https://kffhealthnews.org">KFF Health News</a> and is republished here under a <a target="_blank" href="https://creativecommons.org/licenses/by-nc-nd/4.0/">Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="https://kffhealthnews.org/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

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She Struggled To Get a Lifesaving Drug Even After Insurers Vowed To Help

LADUE, Mo. — Over four consecutive days in January, Margaret Hvatum ran a 5K, a 10K, a half-marathon, and a full marathon. The 70-year-old covered a combined distance that’s nearly equivalent to running the length of Manhattan four times. 

By the end of the month, she was in a hospital bed.

Hvatum, a part-time computer science professor, has a weakened immune system due to a rare condition known as primary immunodeficiency, which makes it difficult for her body to fight infections. Prior to her 2005 diagnosis, she had four bouts of shingles, a painful rash caused by a virus.

For more than a decade she relied on an expensive medicine to treat her chronic condition — and relied on her insurance to pay for it.

Then the denial letters came.

The Medical Service

To give her weakened immune system a boost, she relies on Hizentra, which is made up of antibodies collected from donated blood plasma.

At her home, near St. Louis, Hvatum can administer the complex medicine herself. She uses a large syringe to draw the medicine from a vial and loads the syringe into a plastic apparatus that looks like a toy Nerf gun. She cranks a blue plastic dial that triggers a steady drip of the medicine, and it snakes through plastic tubing until it enters her leg through a needle.

The Bill

$8,141.94: The full charges for a 28-day supply of Hizentra without insurance coverage.

After her Medicare Advantage plan through Humana denied payment for the drug in January, she missed several weekly doses.

The Billing Problem: Prior Authorization

Hvatum got tangled up in the controversial process known as prior authorization, which often requires patients or their medical team to get an insurance company’s approval before obtaining medicines or treatment. 

At the start of the year, after Hvatum switched Medicare Advantage plans, she received a letter saying that Humana, her new carrier, had denied her “prior authorization prescription request” for Hizentra. The authorization from her previous insurer didn’t carry over. 

Without the medicine, Hvatum developed a urinary tract infection that sent her to the emergency room on Jan. 30. Though it is a common infection, her doctor advised her to go there because people with her condition can get sick and deteriorate quickly, she said. 

That ER visit turned into an overnight hospital stay. That turned into hospital charges of more than $18,000, and again her insurance denied payment, saying this time that she wasn’t sick enough to require hospital care.

Hvatum’s experience with prior authorization is not unique.

Medicare Advantage plans reviewed nearly 53 million prior authorization requests in 2024, according to KFF. That’s equivalent to nearly two reviews for every person enrolled in the program.

It’s common for Medicare Advantage plans to deny payment for care — which helps them make a profit, said Carrie Graham, director of the Medicare Policy Initiative at Georgetown University’s Center on Health Insurance Reforms.

The government pays a monthly sum to Medicare Advantage insurers to cover care for each member. “They make a profit if the care that person receives in that year is less than the amount they receive,” Graham said.

More than half of eligible Medicare beneficiaries choose Medicare Advantage insurance coverage. In 2026, roughly 35 million selected one of these private policies offered by insurance companies.

Humana is a dominant player in the space. Nearly half of all Medicare Advantage enrollees nationwide are covered by UnitedHealth Group or Humana, according to KFF.

The killing of UnitedHealthcare CEO Brian Thompson prompted renewed scrutiny of prior authorization. Last summer, months after his death, the nation’s largest insurers, including Humana, signed a pledge that outlined a handful of commitments to ease the burden on patients.

For example, insurers vowed to reduce the number of services that would require prior authorization approval. They also promised to reduce delays by honoring existing prior authorizations for a 90-day period when patients switched plans.

That’s not what happened in Hvatum’s case.

Humana said this pledge to honor existing approvals comes with limitations. “These commitments are for medical services only and do not apply to prescription medications,” spokesperson Mark Taylor said.  

Humana declined to comment on the specifics of Hvatum’s case, even though she agreed to waive her privacy rights, giving the insurer permission to comment.

While acknowledging that the prior authorization process can be deeply frustrating for patients, Humana said it “builds important checks and balances into the healthcare system by verifying that treatments and care delivery are in the best interest of patient safety and quality of care, while safeguarding taxpayer dollars.”

In July 2025, Humana said it would remove one-third of prior authorization requirements for outpatient services.

“We are committed to making the process faster and more seamless for patients and providers,” Humana said in a statement Taylor provided to KFF Health News.

The Resolution

Hvatum appealed, and Humana in late January reversed its initial payment denial for Hizentra, enabling her to afford her medicine again.

But the approval came with a catch: It expires at the end of the year, after which she would need to obtain approval all over again.

Hvatum has since switched to a different drug — and she might not stick around for any more medical-bill fights like this one. She and her husband are considering a move to Norway, a place with universal healthcare. He is a citizen there, which could give her a path to public health coverage.

Running is Margaret Hvatum’s outlet, maybe an obsession. And it keeps her healthy. Scores of medals and trophies are tucked about her home. After her Humana Medicare Advantage plan denied coverage of a medicine she needs for a chronic condition, she felt that her insurer had failed her. (Samantha Liss/KFF Health News)

The industry’s promises to change are too little, too late for Hvatum. 

By her account, she has done her part. Running is her outlet, maybe an obsession, and it keeps her healthy. Scores of medals and trophies are tucked about her home. Some sit on a white wicker end table, next to family photos, candles, and framed St. Louis Cardinals memorabilia. Above a large bay window in the kitchen, medals hang from ribbons of all colors, made to look almost like custom window drapery.

“I have done everything I possibly can to be healthy,” Hvatum said, sitting at her dining room table in her running gear. Her printed T-shirt read, “If found on ground, please drag across the finish line.”

The Takeaway

Data shows patients should appeal prior authorizations, because those who do often get their denials reversed, Graham said. In fact, 81% of Medicare Advantage appeals were partially or fully overturned in 2024, according to KFF.

Relatively few people appeal, because “it’s an exhausting process,” Graham said. It puts the onus on patients — and doctors get frustrated, too.

It’s not just Medicare Advantage plans that subject enrollees to prior authorization approvals. It’s prevalent in other types of coverage, and it has prompted blowback from the public. Graham believes the public outcry instigated the industry’s pledge to change.

Hvatum is well versed in filing appeals. She submitted another appeal to Humana after the insurer denied payment for her January hospital stay. Humana again reversed its denial of payment in her case.

Hvatum blames Humana for her January trip to the hospital. Had Humana approved her Hizentra, she said, she could have avoided hospital care altogether.

In March, she had a stroke. Humana denied coverage of that hospital stay, too.

Humana determined that it was not reasonable for the physician who admitted Hvatum to think she would need to stay at least two nights, the threshold for approval. “You had a small stroke,” Humana’s denial letter stated.

Hvatum noted the letter was dated March 25, two days after she was hospitalized. Humana reversed its denial two weeks after Hvatum appealed.

“They love to send you the denials fast,” Hvatum said. “Approvals take longer.”

Bill of the Month is a crowdsourced investigation by KFF Health News and The Washington Post’s Well+Being that dissects and explains medical bills. Since 2018, this series has helped many patients and readers get their medical bills reduced, and it has been cited in statehouses, at the U.S. Capitol, and at the White House. Do you have a confusing or outrageous medical bill you want to share? Tell us about it!

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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