As the administration works to expand gun rights, hospitals and community groups have lost funding, and reports on preventing firearm injuries have vanished from government websites.

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

Jude Pare and his partner, Diane Tix, live in rural Minnesota until temperatures dip below freezing, when they take refuge in Arizona for the winter. While away, their mail is forwarded. But Pare, 77, said he didn’t receive any warning from his Medicare prescription drug plan that his $0 monthly premium was about to increase.

So he didn’t know he had a bill to pay. After he and Tix returned home to Minnesota in April, they got a letter from Wellcare, the insurer that provided his drug plan, saying his coverage had been terminated after three months of unpaid premiums totaling $28.80. Under Medicare’s rules, he can’t enroll in a plan again until the fall, for coverage beginning in 2027.

Pare takes Xarelto, a blood thinner that reduces his risk of strokes, blood clots, and pulmonary embolism. “He could bleed to death without it,” Tix said. A 90-day supply of the drug costs about $1,800 using a coupon from GoodRx, a discount drug website, she said.

Pare is among tens of thousands of Medicare beneficiaries who were on Wellcare’s Value Script drug plan who will likely go without prescription drug coverage for the rest of the year because they didn’t pay premiums for three months.

Next year, thousands more people in 32 states and Washington, D.C., who are enrolled in zero-premium drug plans from Wellcare and other insurance companies may find themselves in the same situation if their premiums go up and they don’t realize it, according to a KFF Health News analysis of drug plan data. Premiums and other changes for 2027 will be unveiled in September.

Going without medication can be life-threatening, especially for Medicare beneficiaries. Nearly 90% take one or more prescription drugs, according to the Centers for Disease Control and Prevention. Almost half live with four or more chronic health conditions that can cause functional or cognitive impairments.

By the time Jude Pare and his partner, Diane Tix, found out he owed $28.80 for three months of drug plan premiums, his coverage had been canceled. He is among tens of thousands of Medicare beneficiaries who will likely go without prescription drug coverage for the rest of the year after their drug plans were canceled. (Diane Tix)

Congress added prescription drug coverage to Medicare in 2003. But the coverage is administered by commercial insurance companies, which compete fiercely with one another for the business of about 56 million Medicare beneficiaries enrolled in drug plans.

Zero-dollar or very low monthly premiums have helped make Wellcare’s Value Script the bestselling stand-alone prescription drug plan in Medicare, with nearly 6 million customers across the U.S., according to government data. But in 26 states and Washington, D.C., some Value Script members who didn’t have to pay a premium last year were caught off guard by increases in 2026.

After a two-month grace period — which Wellcare extended to three — Medicare drug plans can drop customers who don’t pay their premiums, no matter how small the amount. Some members who lost their coverage in Nevada, for example, owed as little as $8.10 for three months, according to a KFF Health News analysis of Medicare drug plan data.

Wellcare terminated coverage for about 140,000 Value Script beneficiaries in April, according to a person with knowledge of the matter who was not authorized to speak publicly about it and feared reprisals at work for doing so. About 40,000 of the people who were dropped may be able to enroll in new coverage immediately because they have low incomes and receive financial assistance through a program Medicare calls “Extra Help.”

Multiple state officials said they had heard the same disenrollment figures, including Nevada’s insurance commissioner, Ned Gaines, who chairs the National Association of Insurance Commissioners’ senior issues task force; Rebecca Gouty, director of the State Health Insurance Assistance Program in West Virginia; and Tim Smolen, director of Washington state’s Statewide Health Insurance Benefits Advisors. The West Virginia and Washington initiatives are part of the federally funded State Health Insurance Assistance Program, or SHIP, which provides free, unbiased help navigating Medicare.

Surprise Bills

The Centers for Medicare & Medicaid Services, which oversees Medicare drug plans, declined to provide the number of Value Script members who lost coverage due to unpaid premiums. “The agency does not publicly provide plan-specific disenrollment figures or state-level breakdowns related to the non-payment of premiums,” Christopher Krepich, a spokesperson, said in a written statement to KFF Health News.

Centene Corp., Wellcare’s parent company, also declined to provide disenrollment numbers.

“We recognize how disruptive a loss of coverage can be and are committed to helping members understand their options,” said Sarah Baiocchi, senior vice president for specialty and prescription drug plans at Centene. She acknowledged that “some members in our Value Script plan experienced a premium for the first time, or for the first time in several years.”

Baiocchi said all Value Script members received a CMS-required annual notice of changes in September, before the premium increases took effect.

A version of the booklet sent to members in two states and Washington, D.C., is 21 pages long. The new premium is mentioned on pages 3 and 8, along with changes to out-of-pocket costs and how to find updates on covered drugs and network pharmacies.

The company also informed members about 2026 premium changes through phone calls, text messages, regular mail, or email, Baiocchi said.

People who are dropped are not able to reenroll or join another drug plan until the start of the open enrollment period this fall for coverage beginning Jan. 1, unless they qualify for an exception, Krepich said. And because they will have gone without coverage for at least 63 days, they could be hit with a permanent late-enrollment penalty that increases every year for the rest of their lives.

“Medicare should be doing something about this so that we can go ahead and get coverage now,” said Wayne Bennett, 74, who lives in Durham, North Carolina.

In May, he found out that Wellcare had canceled his Value Script plan because he hadn’t paid his $3.60 monthly premiums. He takes nine prescription drugs to treat his blood pressure, glaucoma, chronic obstructive pulmonary disease, and other health problems. He filled most of his prescriptions — including several at no cost — before he lost coverage. He doesn’t know what he’ll have to pay when his supply runs out.

Gouty, the West Virginia program head, said many Medicare beneficiaries arrange for their monthly drug plan premium to be automatically deducted from their Social Security benefits, and that many likely thought that choice remained in place until they changed it.

“They didn’t realize that when the plan was a zero premium in 2025, that stopped the Social Security premium deduction and they would have had to reelect it for 2026,” Gouty said.

In other words, even if they mistakenly thought the premium was still zero, Medicare beneficiaries would have needed to somehow allow Social Security to make deductions — something the agency doesn’t do — or set up a payment plan through their bank or credit card in case payment was necessary.

“That sounds goofy,” Tix said.

Centene’s Baiocchi blamed the Social Security Administration for the problem: “We believe this was a key driver of non-payment disenrollments and subsequent complaints.”

Spokespeople for the agency referred questions about the matter to CMS.

Krepich said legal requirements for drug plan enrollment and disenrollment limit what CMS can do to help beneficiaries who lose coverage for not paying their premiums.

‘Pretty Upset’

Now that Pare has no prescription drug coverage, his doctor replaced his blood thinner medication with a much less expensive drug that should be just as effective. Pare paid $111 for four other medications that used to be free under his Value Script plan. He hasn’t had to refill four more prescriptions yet and doesn’t know what they will cost, Tix said.

If Wellcare members knew about the premium increases, they could have set up direct billing or an automatic payment plan early this year before the payment grace period ended April 1. But they would have been able to fill prescriptions during the grace period, so if they didn’t see Wellcare’s notices, they likely assumed there was no problem with their coverage.

Bennett, the North Carolina man, said Wellcare used to send him text messages with health tips and reminders when it was time to pick up a prescription. He didn’t know his premium had increased from $0 to $3.60 until it was too late.

An older man with white hair stands with his arms crossed.
Wayne Bennett lost his Medicare drug coverage because he didn’t pay the premium, which was free last year but — without his knowing — went up this year. “Medicare should be doing something about this so that we can go ahead and get coverage now,” he says. (Wayne Bennett)

“I was pretty upset,” he said, when he called the company. “The premium wasn’t that much, and I was ready to pay it right off the bat. I had my credit card out ready to make the payment.”

The customer service representative wouldn’t let him pay because his coverage had been canceled, Bennett said.

Hoping to restore it, Bennett called Senior PharmAssist, a Durham nonprofit that advises Medicare beneficiaries and is one of more than 2,200 SHIP sites across the country. He was told he must wait until January to restart his drug coverage, said the group’s executive director, Gina Upchurch.

He doesn’t qualify for the “Extra Help” low-income subsidy or meet other CMS criteria for a special enrollment period, which would allow him to change drug plans during the year. CMS typically allows midyear switches for beneficiaries who, for example, move out of their plan’s service area, experience a natural disaster, or get help paying for drugs from a state program.

Senior PharmAssist was able to help one of its participants join another drug plan after she lost Value Script coverage because she is in North Carolina’s pharmacy assistance program for people with HIV/AIDS and has limited income, Upchurch said.

A further exception allows any Medicare beneficiary to enroll at any time in a drug plan that has earned five stars, the top grade in Medicare’s performance ratings. However, there are no five-star Medicare drug plans available to the general public. Only two insurers offer five-star plans, and only for retirees from certain employers. Their combined enrollment is about 8,700 as of June 1, according to the insurers.

But Upchurch, with more than two decades of Medicare expertise, doesn’t blame beneficiaries for not paying attention or for assuming Wellcare’s messages were bogus. Older adults are particularly vulnerable to identity theft and other scams and are often advised to ignore junk mail and calls from telemarketers.

Since Value Script members such as Bennett continued to get their prescriptions filled during the payment grace period, “why wouldn’t they think this was a scam?” Upchurch asked. “They are constantly bombarded by people selling them something that’s illegitimate or trying to scam them.”

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/medicare/medicare-drug-plans-part-d-small-premium-increases-disenrollments-wellcare/">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;">

<img id="republication-tracker-tool-source" src="https://kffhealthnews.org/?republication-pixel=true&post=2253783&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">

from KFF Health News https://ift.tt/Zz2Ps3X
Popular communication methods for nonspeaking autistic people have ignited a fierce debate over what counts as evidence of hidden cognitive abilities.

from NYT > Health https://ift.tt/GCyLFuJ
0:00 0:00
Produced in partnership with: Download
Speed
Embed this player

Too sick to work? You may have to prove it. Next year, Medicaid recipients will have to start showing documentation such as a doctor’s note to avoid a new work requirement. KFF Health News correspondent Sam Whitehead broke down the rule and exceptions on WAMU’s Health Hub on July 1.

A man with white hair stands behind a lectern with the seal of the President of the United States on it, and speaks into a microphone.
Centers for Medicare & Medicaid Services Administrator Mehmet Oz. (Daniel Heuer/Bloomberg via Getty Images)

Study, work, or volunteer: That’s what many people will have to do to keep their Medicaid starting next year, according to new rules issued by the Trump administration. But consumer advocates worry the new requirements will catch many recipients flat-footed.

KFF Health News correspondent Sam Whitehead joined WAMU’s Health Hub on July 1 to explain who will be affected, who can get an exemption, and what enrollees can start doing now to prepare.

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/medicaid/wamu-health-hub-audio-medicaid-work-rule-requirement-tips-coverage/">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;">

<img id="republication-tracker-tool-source" src="https://kffhealthnews.org/?republication-pixel=true&post=2254150&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">

from KFF Health News https://ift.tt/H36FN7n
The makers of nicotine pouches are building new plants and expanding to meet demand. While influencers claim health benefits, experts warn the products can be highly addictive.

from NYT > Health https://ift.tt/2ACnit6
The neurobiologist Erich Jarvis studies the few species capable of speech. He has long hoped to genetically engineer an animal that can make new calls.

from NYT > Health https://ift.tt/XBUvrN2
The neurobiologist Erich Jarvis studies the few species capable of speech. He has long hoped to genetically engineer an animal that can make new calls.

from NYT > Health https://ift.tt/efwlkh8
Public health experts said there were more cases than usual of the disease caused by cyclospora, which is spread through contaminated food and drink.

from NYT > Health https://ift.tt/8lTA5rj
While relief could come to the Great Lakes and the far Northeast over the weekend, the Mid-Atlantic and Southeast will stay hot.

from NYT > Health https://ift.tt/42Dx51w

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.”

A screenshot of a CVN video of a woman with shoulder-length light hair and glasses looks into a computer camera. Underneath the video image is the text "Whitfield v. St. Louis Children's Hospital, et al." and "2024-10-07".
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.

This <a target="_blank" href="https://kffhealthnews.org/health-industry/infant-formula-adverse-events-nec-baby-deaths-fda-reporting/">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;">

<img id="republication-tracker-tool-source" src="https://kffhealthnews.org/?republication-pixel=true&post=2236395&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">

from KFF Health News https://ift.tt/RbFug34

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;">

<img id="republication-tracker-tool-source" src="https://kffhealthnews.org/?republication-pixel=true&post=2254240&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">

from KFF Health News https://ift.tt/rgoEeaF
New research shows that tolerance has become so strong that common treatments for opioid addiction are no longer effective for many patients.

from NYT > Health https://ift.tt/aDKgfsx
In moving to ban a potent synthetic version of kratom, the president’s team paved the way for more sales for makers of rival botanic supplements, who had aggressively lobbied for the change.

from NYT > Health https://ift.tt/5smtqL1

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.

An exterior photo of Plumas Charter School.
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.

A green binder labelled "Children & Youth Behavioral Health."
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.

Two binders rest on a shelf. The left one is labelled "Carelon." The one of the right is labelled "Qualifacts."
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

A photo of a street lined with small shops in a Northern California mountain town. Fog rises over the treetops in the distance.
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;">

<img id="republication-tracker-tool-source" src="https://kffhealthnews.org/?republication-pixel=true&post=2251609&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">

from KFF Health News https://ift.tt/tWw48vM

Health

Trump Administration Guts Efforts to Prevent Gun Violence, Suppressing Reports

As the administration works to expand gun rights, hospitals and community groups have lost funding, and reports on preventing firearm injuri...

loading...

Search This Blog

Popular Posts