Investigation Archives - Ñî¹óåú´«Ã½Ò•îl Health News /tag/investigation/ Ñî¹óåú´«Ã½Ò•îl Health News produces in-depth journalism on health issues and is a core operating program of KFF. Fri, 18 Sep 2026 09:20:50 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.10 /wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=32 Investigation Archives - Ñî¹óåú´«Ã½Ò•îl Health News /tag/investigation/ 32 32 257378068 The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done. /health-industry/fda-approval-drugs-medical-devices-postmarket-studies-safety-delays-amgen-tavneos/ Fri, 18 Sep 2026 09:00:00 +0000 /?p=2275664 When the FDA was deciding whether to approve the drug Tavneos several years ago to treat a set of , agency experts argued that would be a mistake, according to .

One problem cited: The manufacturer had provided only

As it often does, the FDA in 2021 approved the drug with a proviso: It required the manufacturer to conduct an additional years-long safety study once the drug was on the market.

Today, like many similar “postmarket” studies mandated by the FDA, that additional study is delayed, according to a . As of last fall, only 21 of the planned 300 patients had been enrolled, the FDA said in an and .

Meanwhile, the FDA has dozens of cases of “possibly” or “probably causally associated” with the drug. That was one of the potential side effects the postmarket study was meant to evaluate.

Tavneos illustrates the perils of the FDA’s approach to many drugs and medical devices — and the frequent lapses in follow-through.

A Ñî¹óåú´«Ã½Ò•îl Health News analysis of Food and Drug Administration data found hundreds of postmarket studies listed as delayed. In some cases, the work was delayed by more than a decade or the manufacturer was still developing a plan for the study.

As a result of delays, patients, doctors, and others could be left in a fog about the risks and benefits of the drugs or devices, even as they stake their money, their health, or their lives on the products.

Postmarket study requirements “have often proven toothless,” said cardiologist , an associate professor of medicine at the University of California-San Francisco who has published .

The FDA’s reliance on postmarket studies reflects a balancing act.

Making new treatments available faster can save or improve lives, especially when patients with grim prognoses and no good options have little to lose. The full risks and benefits may be revealed only over the long term, and when therapies are used by far more people than even large clinical trials enroll.

But relying on post-approval studies to resolve questions risks exposing patients to products that do more harm than good. Whoever is paying the bills — patients, insurance companies, employers, or government health programs such as Medicare and Medicaid — can end up wasting money and rewarding manufacturers for useless or risky products.

“Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it’s going to lead to a lot of uncertainty,” Dhruva said.

Trump administration policy changes designed to hasten drugs through FDA review could leave more riding on postmarket studies, medical researchers say.

For example, in February, that “the default requirement” for agency approvals will be one clinical trial instead of two.

Reducing pre-approval testing “will inevitably put a lot of pressure on the post-approval system,” said , a professor at Harvard Medical School who postmarket studies.

FDA officials said the new policy would “substantially reduce costs” for manufacturers and “speed drugs to market.” Writing in The New England Journal of Medicine, they denied the change would compromise safety or efficacy, saying that “erroneous conclusions may be reached even with two, three, or four studies.”

In response to questions for this article, a spokesperson for the Department of Health and Human Services, which includes the FDA, said postmarket studies can experience delays for legitimate reasons. “Assessing the significance of any delay requires a case-specific review,” said the spokesperson, Emily Hilliard.

The fact that a study is delayed “should not be treated as evidence that a product has an unresolved safety or effectiveness issue,” Hilliard said.

Amgen, the company that makes Tavneos, is still working on the postmarket research the FDA mandated, company spokesperson Alison Chartan said, adding, “We remain committed to completing this important study.”

An aerial photo shows a large company headquarters with various buildings.
Amgen’s headquarters in Thousand Oaks, California, in May 2023. (Mario Tama/Getty Images)

Behind Schedule

An FDA database downloaded by Ñî¹óåú´«Ã½Ò•îl Health News in August tracks the progress of postmarket studies that makers of — such as vaccines and gene therapies — were required to perform or promised to perform.

The database showed almost 600 were running behind schedule.

Of those, more than 250 originally had final reports due before July 31, 2026 — the date that, according to an FDA webpage, the database last had been updated.

About a third of ongoing studies were listed as delayed.

In some cases, the FDA has granted extensions. In others, it has denied them. And in rare instances, the products were discontinued before the studies ran their course.

Postmarket studies can involve clinical trials or other analyses of patient data. They can look at safety or efficacy. A product can be the subject of more than one postmarket study.

The nearly 600 delayed studies involved almost 350 products, Ñî¹óåú´«Ã½Ò•îl Health News found.

The FDA has defined delayed as . That can mean off track or overdue.

As of August, other FDA databases tracking listed dozens of postmarket studies as behind schedule.

Products included:

The CustomFlex Artificial Iris, a prosthesis implanted in the eye in place of damaged, defective, or congenitally missing irises. The protocol for a study in children was accepted in 2019, the database said. The study was meant to follow patients for five years. According to an FDA page downloaded in August, zero patients were enrolled.

Barbara Fant of Clinical Research Consultants, to whom the FDA’s 2018 letter approving the product was addressed, said the rarity of an eye disease called aniridia poses challenges for post-approval studies. The German manufacturer, the U.S. distributor, and Clinical Research Consultants are working with the FDA to identify alternative ways to fulfill the postmarket requirements, Fant said.

“Confirming the long-term safety of the device remains a top priority for both the study team and FDA,” Fant said.

Paxlovid, a treatment for covid. A study to assess its safety in pregnant women was originally to be completed by the end of 2024, the FDA database said. “The trial completion and final report milestones were missed,” the database said.

Pfizer, the manufacturer, is working with the FDA and remains committed to “submitting results as soon as practicable,” Pfizer spokesperson Jerica Pitts said.

The Scandinavian Total Ankle Replacement system. The device and the original protocol for the clinical trial were approved in 2009. The study was meant to include a minimum of 500 subjects, the database said, but the actual number enrolled was 142. Almost half those patients had one or more adverse events, with dozens of “reoperations,” “revisions,” or “removals,” the database said.

Rachel Colloff and Cristina Pasquino — spokespeople for Enovis, which markets STAR Ankle — did not respond to multiple inquiries. Jenny Braga, a spokesperson for Stryker, which previously sold the product, did not answer questions about the postmarket study.

Oxaydo (originally named Oxecta), a form of the potentially addictive opioid painkiller oxycodone . When the FDA approved it in 2011, it required the manufacturer, , to conduct a postmarket study to assess whether it reduces “misuse and abuse, and their consequences: overdose, death and addiction.” The final report was originally scheduled to be submitted in 2016.

The FDA database listing the study as delayed said the agency “issued a failure to respond letter” in 2022.

Today the issue may be all but moot.  

Control of the product passed from company to company over the years until 2023, when Acura Pharmaceuticals said in a that patents on Oxaydo would begin expiring that year and it didn’t intend to continue marketing the drug.

According to another FDA database, Oxaydo .

The FDA has enforcement powers and uses them “where appropriate,” HHS’ Hilliard said. She did not provide requested details, and she did not answer questions about the studies listed above.

Delay Can Pay

For manufacturers, delay can pay, Harvard’s Kesselheim said. While postmarket studies are ongoing, companies can continue to sell the products.

“Medicare and Medicaid spent more than $18 billion from 2018 to 2021 for accelerated approval drugs with incomplete confirmatory trials past their original planned completion dates,” the HHS Office of Inspector General .

The FDA can demand postmarket studies for a variety of reasons, including to address concerns that arise after a product has been approved. Some look at uses not covered by the original approval, and some are meant to shed light on that are already known.

In April, when it approved Foundayo, a weight loss drug made by Eli Lilly, the FDA required the company to conduct additional research to assess a variety of concerns, including “retained gastric contents,” “major adverse cardiovascular events,” and “drug-induced liver injury,” as well as effects of exposure during pregnancy, such as “major congenital malformations,” “spontaneous abortions,” and “stillbirths.”

The FDA said it approved the drug under the new Commissioner’s National Priority Voucher program, intended for products that “.” The program strives for an “” review, the FDA has said — one to two months, instead of six months or more with other expedited pathways.

“Postmarketing requirements and enhanced safety monitoring are a routine part of the FDA’s approach to evaluating newly approved medicines,” Eli Lilly spokesperson Kristiane Silva Bello said, “including ongoing monitoring in areas identified during clinical development.”

‘False Hope’

The FDA waded into a world of uncertainty in 2016 when it granted accelerated approval to a drug for Duchenne muscular dystrophy, a degenerative disease that primarily affects boys, disabling them at a young age and ultimately killing them.

Agency scientists had found that the drug, Exondys 51, was unproven and argued against greenlighting it.

Ellis Unger, then a senior drug evaluation official at the FDA, that “thousands of patients and their families would be given false hope in exchange for hardship and risk.”

The manufacturer, Sarepta Therapeutics, . “A clinical benefit of EXONDYS 51 has not been established,” it said when the drug, also known by the generic name eteplirsen, was approved.

The drug, the first FDA-approved treatment for Duchenne muscular dystrophy, targeted a subset of patients with the disease.

The FDA required Sarepta to conduct further studies and it could withdraw approval if postmarket trials failed to verify a clinical benefit or were “not conducted with due diligence.”

Unger issued a warning of his own: “FDA has not succeeded in withdrawing the marketing of a single drug for lack of verification of clinical benefit following accelerated approval. The reality is that if eteplirsen is given accelerated approval, it is highly likely to remain on the market indefinitely, irrespective of whether or not efficacy is verified.”

Sarepta was originally required to submit a final report on a postmarket study by a May 2021 deadline, according to an FDA database and a 2016 FDA letter to the company.

Almost a decade after the drug was approved, and more than five years after that deadline, the study was listed in an FDA database as delayed.

“The final report milestone was missed, because the sponsor requested milestone extensions due to study delays,”  the database said.

Meanwhile, in 2022 the website ranked Exondys 51 as the second-most expensive drug in the U.S., at an annual cost of $750,000 to $1.5 million.

Last year, the drug generated for Sarepta, according to a company presentation to investors.

Sarepta found it difficult to recruit patients for the postmarket clinical trial, company spokesperson Tracy Sorrentino said. The target population is small, patients were hesitant to enroll, and Sarepta was competing with other clinical trials for participants, Sorrentino said.

The study has been fully enrolled since 2023, Sorrentino said, and the company plans to provide an initial look at the data late this year.

‘M²¹²Ô¾±±è³Ü±ô²¹³Ù±ð»å’

A pair of hands holds a bottle of Amgen's drug Tavneos.
Amgen is the maker of the drug Tavneos. (Hannah Yoon/Bloomberg via Getty Images)

Amgen has cited similar challenges, even as Tavneos generated $459 million in global sales last year.

When an approved treatment is available, patients may be reluctant to enroll in a study in which they could be given a placebo, Amgen’s Chartan said.

The clinical trial supposed to be done . As of July 24, just 49 patients had been enrolled, Chartan said.

The FDA has said the study was to include , and each patient enrolled must be followed for five years, said Hilliard, the HHS spokesperson.

Tavneos was approved to treat severe cases of a group of diseases — known by the shorthand ANCA-associated vasculitis — in which, as the explains, the immune system inflicts potentially fatal damage on blood vessels and organs. 

“As of January 2026, estimated real-world exposure” to Tavneos “exceeds 25,000 patient-years globally, consisting of over 6,500 in the United States and 19,000 abroad,” Amgen has said. (For context, one patient taking a drug for five years would amount to five “patient-years.”)

A clinical trial sponsored by ChemoCentryx to secure approval of Tavneos failed to prove it was effective, the FDA now alleges. Instead of disclosing that outcome to the FDA, company personnel “” the , the FDA alleged in an to Amgen.

Amgen, the parent company of ChemoCentryx, has denied the results were manipulated and has said the data “.”

Nonetheless, the recently of Tavneos.

The FDA is trying to , and Amgen is fighting that effort.

The company has a lot riding on the outcome. Tavneos can cost more than $220,000 per year, according to the , and when Amgen in 2022 for $3.7 billion, Tavneos was the only drug ChemoCentryx had brought to market.

In a June , Amgen said the benefits of Tavneos outweigh the risks.

The FDA disagrees.

The FDA “can no longer conclude that there is, or has ever been, a valid demonstration of substantial evidence of effectiveness for TAVNEOS,” .

Citing 76 cases of DILI — — the agency said it was “increasingly concerned about the safety profile of TAVNEOS.” Without proof of effectiveness, at least for its approved use, “the drug’s benefits its known risks,” the FDA wrote.

Data reporter Maia Rosenfeld contributed to this report.

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2275664
A State Gave Sheriffs 20% of Its Opioid Settlement Cash. We Followed the Money. /public-health/louisiana-sheriffs-opioid-settlement-spending-addiction-law-enforcement/ Thu, 27 Aug 2026 09:00:00 +0000 /?p=2277190

Ñî¹óåú´«Ã½Ò•îl Health News worked with three Louisiana news outlets — , , and — to ask all 64 sheriffs in the state how they’ve spent their opioid settlement funds. The responses were shared and presented in a data table for all four newsrooms to use. Reporters then conducted individual reporting for separate articles.

Every state is from companies accused of flooding the nation with prescription painkillers and fueling overdose deaths. But only one state is directing 20% of those payouts to sheriffs — the largest carve-out for law enforcement nationwide.

In Louisiana, sheriffs are elected, do not serve at the pleasure of another local official, and have independent budgets. They’re also not required to proactively report to the public or another authority how they spend billions in opioid settlement cash.

Short of filing public records requests or waiting for official audits, that has made it difficult for the average person to track the windfall. Many consider the dollars to be “blood money” and believe the spirit of the settlements is to spend it all on abating the addiction crisis.

Ñî¹óåú´«Ã½Ò•îl Health News worked with three Louisiana news outlets — , , and — to track those dollars. The newsrooms contacted all 64 Louisiana sheriffs over five months, often filing public records requests, to produce the first detailed accounting of millions spent.

The findings include:

  • Thirty-eight sheriffs reported spending more than $8.1 million total. Much of it went to crime-fighting equipment, such as surveillance cameras and drug detection products, though smaller amounts funded mobile apps, addiction treatment in jails, and educational programs for youth.
  • $5.4 million, about 66% of reported spending, was deemed inappropriate by a three-person review panel. The panel, assembled by Ñî¹óåú´«Ã½Ò•îl Health News and its partners, included a Louisiana resident in recovery who lost his son to a fentanyl overdose, an addiction medicine doctor, and a public health policy analyst who has been tracking settlement dollars since 2022. They judged the expenditures using their professional and personal expertise. Expenditures the panel disapproved of included salaries and overtime pay for homicide detectives and officers conducting jail shakedowns to find contraband.
  • $4.7 million, nearly 60% of reported spending, went to items or services that other states say should not be purchased with opioid cash. Six states have , such as technology to extract data from cellphones and automated external defibrillators, which are . Although Louisiana does not have its own “unallowable” list, the state’s — a five-member body that advises sheriffs and parishes but does not control the money — said it has shared the guidance from other states.
  • Nine sheriffs stood out for promising uses: All of their expenditures, totaling nearly $1.8 million, were deemed appropriate by the review panel and allowable in other states. These included providing addiction treatment in jail, training officers to respond to overdoses, and increasing public awareness of addiction resources.
  • Twenty sheriffs did not provide their expenditures, leaving roughly $10.7 million that hidden from public view. The Jefferson Parish Sheriff’s Office, which covers an area just outside New Orleans and was allotted the highest amount — nearly $4 million through 2025 — did not respond to more than a dozen calls and emails.

Nationwide, debates over law enforcement’s role with opioid settlement money have been underway since the funds began flowing significantly in 2022 and have continued as the pool of money has grown. Purdue Pharma, , finalized its this year, and various settlements are set to pay out for an additional decade-plus.

Since the earliest days, these dollars have been viewed across government agencies and the private sector as a pot of gold for which many are vying.

Law enforcement agencies are part of this scrum. They say seizing drugs and arresting dealers save lives, but that costs money and the addiction crisis has burdened their budgets. However, many recovery advocates staunchly oppose any opioid cash flowing to what they see as the .

Since there are few guardrails on how the money is spent, decisions often come down to how local politicians and residents see addiction and what type of approach they believe will be effective in combating it.

Louisiana provides a natural experiment to see which priorities prevail when money is handed directly to sheriffs.

First Public Look at How Louisiana Sheriffs Have Spent Over $8M in Opioid Settlement Cash

In Louisiana, sheriffs receive 20% of the state's opioid settlement cash — the largest carve-out for law enforcement nationwide. But since sheriffs are not required to proactively report how they spend the money, it's hard to track. Reporters from Ñî¹óåú´«Ã½Ò•îl Health News, The Current, Gulf States Newsroom, and Verite News contacted all 64 sheriffs to uncover spending details. <br><br> Click column headings to sort the table.

Note: In some cases, the amount of money spent exceeds the amount allocated because sheriffs may have reported spending that included their 2026 allocations or because sheriffs combined their opioid settlement dollars with the share received by parish governments or other funding sources. Descriptions of spending are based on emails or phone calls with the sheriffs' offices and have been lightly edited. <br> Source: The money allocated to sheriffs was obtained by summing values for years 1-5, representing 2021-2025, from the Louisiana Opioid Abatement Task Force’s <a href="; target="_blank" style="color:#0071ce">public spreadsheet</a>. Data on money spent was collected by Ñî¹óåú´«Ã½Ò•îl Health News, The Current, Gulf States Newsroom, and Verite News. • <a href="/download-the-data-louisiana-sheriffs-opioid-settlement-expenditures/&quot; target="_blank" style="color:#0071ce">Download the data.</a> <br> Credit: Ñî¹óåú´«Ã½Ò•îl Health News' Lydia Zuraw and Aneri Pattani, The Current’s Alena Maschke, Gulf States Newsroom’s Drew Hawkins, and Verite News’ Katie Jane Fernelius

The state’s agreement with parishes and sheriffs receiving settlement cash contains broad categories for , including “law enforcement expenditures relating to the opioid epidemic.”

But even if the sheriffs’ spending is legal, that doesn’t mean it’s appropriate or effective, addiction and public health experts say.

“What’s happening here is they have a lot of money and they want to distribute it to all the wrong places,” said Danny Bolner Jr., a Jefferson Parish resident who has been in recovery from addiction for more than two decades and lost his 28-year-old son to a fentanyl overdose in 2016. On the panel that reviewed expenditures, Bolner represented the view of families who have lost loved ones to the crisis.

The purchase of drones and vehicles struck a nerve for him. He’d prefer for opioid cash to support programs that educate youth about healthy ways to process emotions, provide job training to people in recovery, and distribute overdose reversal medications.

“This money is what we have to save lives,” he said. If sheriffs use it in other ways, the finite pot “is going to be gone and then they won’t have nothing to help.”

A man in a beige brimmed hat and patterned blue short-sleeve shirt stands in a park near a lake and looks at the camera.
Danny Bolner Jr. is a Jefferson Parish, Louisiana, resident who has been in recovery from addiction for more than two decades. Bolner lost his 28-year-old son to a fentanyl overdose in 2016. (Christiana Botic/Verite News and CatchLight Local/Report for America)

A Safe, a Scanner, and Surveillance Cameras

For , a public health policy analyst and national opioid settlement expert who was a member of the review panel, determining if expenditures fit the spirit of the settlements often centered on whether they facilitated arrests or prevented overdoses.

“The impetus of this opioid settlement money is to spend on innovative ways to not let this happen again,” she said, referring to the overdose crisis that has claimed since 2000. She said sheriffs should be asking, “How could we use this to reinvest in the community, not just build up our office?”

Many of the sheriffs’ equipment purchases didn’t meet her bar.

For example, the East Baton Rouge Sheriff’s Office bought a safe to store evidence from opioid investigations and a scanner for their traffic division to identify narcotics in hidden compartments. The Terrebonne Parish Sheriff’s Office spent $465,000 on , which are automated license plate readers that capture data about passing vehicles and share them with law enforcement agencies nationwide. The Bossier Parish Sheriff’s Office purchased 130 body cameras and 50 dash cameras.

Sheriffs already receive taxpayer dollars and federal grants to buy law enforcement tools, Christensen said. Opioid cash, which is finite and has a specific purpose, should not be used for that, she and the other reviewers said. In fact, some states don’t allow it.

13 Louisiana Sheriffs Spent 100% of Opioid Settlement Money Inappropriately, per an Expert Panel

The expenditures were reviewed by Tricia Christensen, a public health policy analyst who has been tracking opioid settlement spending since 2022; Stephen Loyd, an addiction medicine doctor and a person in recovery who serves as West Virginia's drug czar; and Danny Bolner Jr., a person in recovery who lost his son to a fentanyl overdose and is raising his son’s daughter in Jefferson Parish, Louisiana. A majority vote determined which expenditures were appropriate. <br><br> The map depicts the percentage of money each sheriff spent on expenditures disapproved by the reviewers.

Note: The reviewers voted on the propriety of each expenditure based on their own views of the purpose of opioid settlement money. The rates of opioid-involved deaths are age-adjusted. Rates based on counts <5 were suppressed by the Louisiana Department of Health to protect privacy. "Opioid-involved deaths" include deaths in which opioids were present in the body and/or contributed to death, even if they were not the sole cause of death. <br> Sources: Settlement spending and reviewer opinions collected by Ñî¹óåú´«Ã½Ò•îl Health News, The Current, Gulf States Newsroom, and Verite News; opioid-involved death rates from the Louisiana Department of Health <br> Credit: Ñî¹óåú´«Ã½Ò•îl Health News' Lydia Zuraw and Aneri Pattani, The Current’s Alena Maschke, Gulf States Newsroom’s Drew Hawkins, and Verite News’ Katie Jane Fernelius

But taxpayer money may not cover everything sheriffs need, said , executive director of the Louisiana Sheriffs’ Association. “Our budgets are overloaded,” he said.

Complex investigations to dismantle drug trafficking syndicates can require advanced equipment, , a spokesperson for the East Baton Rouge Sheriff’s Office, wrote in a statement.

“While treatment and recovery services are indispensable components of addressing opioid addiction, they address the consequences of addiction after these drugs have already reached our community,” she wrote. “Law enforcement has a different, but equally essential, responsibility: preventing those deadly drugs from reaching potential victims in the first place.”

First Lt. Blake Tabor, a spokesperson for the Terrebonne sheriff’s office, similarly wrote, “Our role as a law enforcement agency is primarily focused on disrupting the criminal activity that fuels addiction in our community.” That effort complements other entities’ work in prevention, treatment, and recovery, he added.

The Bossier Parish Sheriff’s Office declined to comment.

Where Public Health Meets Public Safety

Not all sheriffs spent the money on enforcement.

Acadia Parish Sheriff directed all his settlement cash to provide treatment in jail. He said he hopes to break cycles of addiction and crime.

“I want people back into society, being productive,” he said.

Research shows for opioid use disorder behind bars and .

In St. Martin Parish, settlement funds helped launch a of officers that connects people with substance use disorders or related mental illness to treatment, said Chester Cedars, chief legal counsel for its sheriff’s office. Officers also try to coordinate support services for family members and assist with questions around paying for care.

“We’re not clinicians,” Cedars said, but we “serve as a broker” between people who need services and those who provide them.

, an addiction medicine doctor and the West Virginia drug czar, who was the third member of the review panel, said he loved the comprehensive nature of the program. Addiction “is a family issue,” he said. “Every time that phone rings, it’s a potential family crisis.”

A view from above of a plaque in the ground just in front of a bench that reads "Spread your wings and look down upon us, Daniel. Maw maw & Papa Dan," with images of two praying angles, a tractor, and a pig. Two people sit on the bench to either side of the plaque and their feet are in the frame.
Bolner and his granddaughter sit on a bench dedicated to his son and her father, Daniel, at Lafreniere Park in Metairie, Louisiana. Daniel died of a fentanyl overdose in 2016 on his 28th birthday. (Christiana Botic/Verite News and CatchLight Local/Report for America)

It’s not a coincidence that these parishes earned top marks from the reviewers. Cedars is the former chair of the , and Gibson is the current chair. That’s the body meant to guide others on priority uses of settlement cash.

Cedars was clear that the St. Martin sheriff’s office was not using “one penny for any enforcement activity,” because that’s not what the settlement “intended to accomplish.”

Gibson was more hesitant, saying the legal guidelines are broad and “I’m not here to criticize anybody.”

He has advised about a dozen sheriffs who have reached out with questions, but he knows they’re not required to heed his guidance.

A from the Louisiana Legislative Auditor found that the task force has no teeth to enforce its recommendations.

If people want stronger guardrails on the opioid cash, state lawmakers need to enact new rules, Gibson said.

Stepping Up Oversight

The Louisiana state legislature in May calling for the legislative auditor to review how all parishes and sheriffs are handling their opioid settlement money and report to lawmakers prior to the 2027 legislative session.

State Sen. , a Republican who co-authored the resolution, said the goal is to shed light on where dollars are flowing, if jurisdictions are spending them at all, and which funded programs are effective.

With that information, Myers said, he and others could “absolutely” introduce bills “to tighten up how funding is spent.”

Louisiana Sheriffs Spent $4.7M in Opioid Settlement Cash on Items, Activities Deemed Unallowable in Other States

Six states — <a href="; target="_blank" style="color:#0071ce">California</a>, <a href="; target="_blank" style="color:#0071ce">Indiana</a>, <a href="; target="_blank" style="color:#0071ce">Kansas</a>, <a href="; target="_blank" style="color:#0071ce">Michigan</a>, <a href="; target="_blank" style="color:#0071ce">South Carolina</a>, and <a href="; target="_blank" style="color:#0071ce">Virginia</a> — have created lists of items and services that they say opioid settlement funds should not be spent on, including surveillance cameras and vehicles. Although Louisiana does not have its own "unallowable" list, the state's Opioid Abatement Task Force said it has shared other states' guidance with some sheriffs. Yet nearly 60% of the sheriffs' spending involves items found on such lists.

Note: Unallowable lists may not be legally binding in each state but are considered strong guidance. <br> Source: Data collection by Ñî¹óåú´«Ã½Ò•îl Health News, The Current, Gulf States Newsroom, and Verite News <br> Credit: Ñî¹óåú´«Ã½Ò•îl Health News' Lydia Zuraw and Aneri Pattani

Meanwhile, the Louisiana Opioid Abatement Task Force is trying to strengthen its oversight.

Curtis Nelson is executive counsel for the Louisiana Opioid Abatement Administration Corporation, a nonprofit that supports the task force. He said the body is seeking quotes from accountants to conduct ongoing forensic audits of parishes and sheriffs. The goal is to audit 10 to 15 entities annually, starting with those receiving the most money. If the audits turn up misuse, the task force could withhold future payments from those parishes or sheriffs, Nelson said.

The task force is also exploring creating its own unallowable list, like those in other states, Nelson said.

Louisiana Gov. Jeff Landry and Attorney General Liz Murrill did not respond to questions about whether they’d support an unallowable list or take other actions to address opioid settlement spending.

But many advocates are hopeful that an unallowable list could curb spending they found concerning.

“You’re keeping them on the track when you tell them what they can’t use it for,” said Bolner, the Jefferson Parish resident who lost his son to overdose and is raising his son’s daughter.

While he awaits greater oversight for sheriffs, Bolner plans to continue the work he’s been doing for years: distributing overdose reversal medications at schools, hospitals, and bars; participating in grief support groups with other families; and showing up at community events to raise awareness about addiction. He said he’ll keep speaking with sheriffs and parishes about what he considers the best use of settlement money.

“If I save one life, it’s accomplished,” he said.

Methodology

Reporters from Ñî¹óåú´«Ã½Ò•îl Health News, The Current, Gulf States Newsroom, and Verite News worked together to contact all 64 sheriffs’ offices in Louisiana and ask how they’d spent opioid settlement funds. The outreach involved dozens of emails and phone calls from March to July.

If a sheriff’s office did not respond or did not provide specific dollar amounts spent on programs or services, it was labeled “Did not provide expenditures.” All other responses were summarized in a data table.

The amount of settlement money each sheriff’s office received through 2025 was obtained from the Louisiana Opioid Abatement Task Force’s . Allocations for years 1 through 5 were summed, representing 2021 through 2025.

In the few cases in which a sheriff’s office reported spending more money than the task force said it had been allocated, it was often because the sheriff’s office had combined its share of opioid settlement dollars with the share received by the parish government or another funding source. Some sheriffs may have also reported money spent from their 2026 allocation.

Once all the data was collected, the reporters used two methods to analyze the results.

For the first, the reporters created an unduplicated list of expenditures and de-identified them by removing the sheriffs’ offices names. That list was shared with three reviewers: , a public health policy expert who has been tracking opioid settlement spending since 2022; , an addiction medicine doctor and a person in recovery who previously served as chair of Tennessee’s Opioid Abatement Council and is currently West Virginia’s drug czar; and Danny Bolner Jr., a person in recovery from addiction who lost his son to a fentanyl overdose and is raising his son’s daughter in Jefferson Parish, Louisiana.

Each reviewer voted on each expenditure description as an appropriate or inappropriate use of opioid settlement money. The majority vote determined the final designation.

Reporters calculated how much of the money spent by each sheriff’s office went to expenditures the review panel deemed inappropriate. This value was divided by the total spent to determine the percentage of expenditures deemed inappropriate by the panel. The second approach to analyzing the sheriffs’ spending was as follows: Six states (, , , , , and ) have created lists of items and services that they say opioid settlement funds should not be spent on, often known as “unallowable lists.” Ñî¹óåú´«Ã½Ò•îl Health News calculated how much money spent by each Louisiana sheriff’s office went to expenditures on one of these lists. This value was divided by the total spent to determine the percentage of expenditures that would have been unallowable or not recommended in one or more of these states.


The Current’s Alena Maschke, Gulf States Newsroom’s Drew Hawkins, and Verite News’ Katie Jane Fernelius contributed to the database featured in this article.

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2277190
Where Florida’s Gun Violence Exacts Its Biggest Toll on Black and Latino Children /public-health/florida-gun-violence-kids-data-analysis-jacksonville-black-latino-disparities/ Tue, 25 Aug 2026 09:00:00 +0000 /?p=2278230 JACKSONVILLE, Fla. — Just west of the St. Johns River, which divides this sprawling city racially and economically, 2-year-old A’mahri Robinson was murdered in his mother’s arms.

Ladonna Johnson was rocking A’mahri to sleep in March when he was shot in the head with a gun she kept for protection.

A’mahri loved going outdoors and taking rides in his pull-along wagon. His mother called the toddler “sweet” and “affectionate.” When he was around, she said, “you just felt love.”

The child was close with Steven Dodson Jr., his mother’s boyfriend, who had reached for the gun during an argument. Dodson, 21, in June to murder and aggravated child abuse and was sentenced to life in prison.

A’mahri died in one of Florida’s most violent places for children: Jacksonville. This city has three ZIP codes that rank among the 10 worst in the state for firearm injuries involving children.

A photo of a two-year-old standing outside.
Two-year-old A’mahri Robinson was murdered while in his mother’s arms in March. (Ladonna Johnson)

Every year, hundreds of children are hospitalized in Florida with gunshot wounds, and overwhelmingly, they come from a tiny number of ZIP codes, an exclusive analysis of hospital data by Ñî¹óåú´«Ã½Ò•îl Health News and The Trace found.

Hospital billing data obtained from the Florida Agency for Health Care Administration shows that from 2018 to 2024 more than 4,000 children 17 or younger were hospitalized for firearm injuries — a rate of about 1.5 a day.

The newsrooms gathered data that the state’s hospitals use to collect payments from insurance companies or the government. The information does not identify patients but includes details about where they lived and their age, race, and other demographics.

The number of children killed in Jacksonville has grown so large that , Families of Slain Children, built a “Wall of Compassion” memorial listing hundreds of people killed by gunfire in the city. Memorial organizers have stood up a second wall nearby that is filling with names.

A photo shows a length of white wall on a square of grass. Crosses line the top of the wall. Names are written on the wall.
The Jacksonville nonprofit Families of Slain Children has built a memorial called the “Wall of Compassion” that lists the names of hundreds of people who have been killed by gun violence in the city. (Daniel Chang/Ñî¹óåú´«Ã½Ò•îl Health News)

The numbers reflect how Florida’s long history of racial discrimination and permissive gun laws undermine public health, said researchers, public officials, community activists, and grieving parents.

Jacksonville kids were shot most often in racially segregated neighborhoods — a legacy from the early 20th century of state-sanctioned discrimination in housing, banking, and investment. These areas today are plagued by pollution from defunct city-run trash incinerators, garbage-strewn lots, dilapidated housing, poverty, and other problems that local leaders have been promising to fix for more than 50 years.

Nearly all the Florida ZIP codes with the highest rates of firearm injuries for children have large Black or Latino populations.

Perhaps nowhere is the toll of gun violence more evident than at UF Health Jacksonville, a safety net hospital and the only Level I trauma center in northeastern Florida.

As chief of acute care surgery, sees firsthand the toll exacted by guns.

“You see it day in and day out,” Madbak said. “I’m working tonight, and I suspect I’ll see a couple victims.”

A table of Florida zip codes with city and county columns, ranked by the number of under-18 gunshot wound patients from 2018 through 2024. A column of the rate of U18 GSW patients per 100k children per year is shaded blue, darker for higher rates, lighter for lower ones.

Florida ZIP Codes With Highest Youth Gunshot Wound Hospitalizations

A table of Florida zip codes with city and county columns, ranked by the number of under-18 gunshot wound patients from 2018 through 2024. A column of the rate of U18 GSW patients per 100k children per year is shaded blue, darker for higher rates, lighter for lower ones.

ZIP codes with 1-10 youth GSW hospitalizations over the 2018-2024 period are omitted due to privacy laws.<br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

, a UF Health pediatrician and former health director for Duval County, which includes Jacksonville, said state and local leaders have failed to address what he called the “root causes” of preventable firearm injuries and deaths, such as poverty, lack of opportunity, and neglect.

“The bottom line is nobody gives a flying f— about these young men,” Goldhagen said.

Gun violence victims and their families of depression, anxiety, post-traumatic stress disorder, and other mental health problems.

Throughout U.S. history, local governments have pushed industrial plants, , and highways through Black neighborhoods even as to increased risks of cardiovascular and respiratory diseases, cancer, preterm births, and gun violence.

But the Florida Department of Health does not focus on gun violence as a public health threat, Goldhagen said, despite its being the nation’s for children and teens.

The , a set of goals developed by the health department and an advisory committee, does not mention guns, the toll they take on children, or efforts to reduce firearm deaths and injuries to young people.

Instead, its goals include preventing or reducing sudden unexpected infant deaths and youth drownings, emergency room visits for motor vehicle crashes, and hospitalizations for traumatic brain injuries.

And yet, no one with the authority to address this public health crisis would agree to talk to Ñî¹óåú´«Ã½Ò•îl Health News about gun violence and its toll on Jacksonville’s children — not the Florida health department, Gov. Ron DeSantis, Mayor Donna Deegan, or 18 of 19 members of the Jacksonville City Council.

()

Only Council member Jimmy Peluso responded. Peluso said the city has long ignored the needs of neighborhoods with high rates of firearm injuries among children.

“A lot of these neighborhoods have just felt like the wealth has left them,” he said, “and the city didn’t come in to put in the amount of work they needed to.”

DeSantis, a Republican, in public comments has called for few limits on how people purchase or carry firearms. He to allow Floridians to carry concealed weapons without a permit.

When then-U.S. Surgeon General Vivek Murthy declared firearm violence a public health crisis in 2024, DeSantis called the advisory an “.”

DeSantis said Florida would not follow the advisory, which recommended policies including universal background checks for gun purchases and requirements for secure storage.

DeSantis spokesperson Molly Best declined an interview request and to answer questions about the governor’s gun policies.

“There isn’t an agenda to end gun violence in the state of Florida,” said Jean Francis, a former pediatric nurse who leads the Jacksonville chapter of Moms Demand Action, part of a nonprofit that advocates for stronger firearm laws.

Research has linked increases in pediatric gun deaths from 2011 to 2023 to state-level gun policies.

States with permissive gun policies, such as “stand your ground” and open carry laws, reported higher rates of firearm deaths among children than states with strict regulations, such as weapon and age restrictions, according to a .

The study ranked Florida among a group of 30 states with the most permissive gun policies. Four states with comparatively strict gun laws — California, Maryland, New York, and Rhode Island — saw a decrease in pediatric gun deaths over the same time period.

prevents cities and counties from enacting stricter gun safety measures.

kids in disadvantaged neighborhoods are up to 20 times more likely to suffer firearm injuries than their peers in the most advantaged areas.

“It’s disheartening,” Madbak said. UF Health Jacksonville treated 255 patients for gunshot wounds in 2024, including 32 who were 17 or younger, he said.

A zip code choropleth map of Florida shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21,21-44,44-79,79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

In Some Florida Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of Florida shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21,21-44,44-79,79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Broward County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of the Fort Lauderdale area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21, 21-44, 44-79, 79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Duval County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of the Jacksonville area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21,21-44,44-79,79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Miami-Dade County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A ZIP code choropleth map of the Miami area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21,21-44,44-79,79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Orange County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of the Orlando area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21,21-44,44-79,79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Palm Beach County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of the Palm Beach area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21, 21-44, 44-79, 79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with fewer than 10 hospitalizations are suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Escambia County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of the Pensacola area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21, 21-44, 44-79, 79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Manatee and Sarasota County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of the Sarasota area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21, 21-44, 44-79, 79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Pinellas County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of the Saint Petersburg area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21, 21-44, 44-79, 79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Leon County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of the Tallahassee area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21, 21-44, 44-79, 79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In Some Hillsborough County Neighborhoods,<br>Child Gunshot Hospitalizations Are Common

A zip code choropleth map of the Tampa area shaded in blue by gunshot hospitalizations per 100k children. Shade buckets are: No cases, 0-7, 7-21, 21-44, 44-79, 79-140, Population too small. Click the city names to visit those regions and see zip codes with smaller geographic areas.

ZIP codes with 1-10 hospitalizations have data suppressed or represented as ranges to comply with privacy laws. <br><br>GSW = gunshot wound<br><br>

Florida Agency for Health Care Administration

In 2025, the hospital treated 269 patients for firearm injuries, including 22 who were under 18, according to Dan Leveton, a hospital spokesperson. As of Aug. 19, the hospital has treated 137 patients for gunshot wounds this year, including 18 who were 17 or younger.

Preventing gun violence “shouldn’t be a political issue, even though it is,” Madbak said, adding that there is a lot of room for more effective advocacy for violence prevention.

“It’s really an American issue,” Madbak said, “and our state has been impacted tremendously by this kind of violence.”

The Pain of Mothers, Grandmothers, and Aunts

A white woman stands outside by a tree surrounded with flowers.
Kim Crow, grandmother of Bryce Williams, who died at age 17 from being shot in a neighborhood park in an Orlando suburb in 2018. Crow says her grandson’s death has left a void in her life. “I’m not me anymore,” she says. (WFTV)

In Orlando, one ZIP code — 32805 — had the state’s highest rate of children under 18 hospitalized for a gunshot wound from 2018 through 2024, with a total of 25 children, or 125.8 per 100,000.

On New Year’s Day 2018, Bryce Williams, 17, was in Casselberry, an Orlando suburb. He was found dead after crashing his blue Kia into a home near the park.

Williams’ death devastated his family, his grandmother Kim Crow told WFTV in Orlando.

“First off, you can’t believe that someone is taken from you so violently,” Crow said. “It’s heartbreaking.”

In April, Daesean Moctezuma Orland, 18, was while attending a house party outside Orlando. Two others wounded in the shooting were taken to the hospital. Police arrested a 16-year-old boy about a month after the shooting and charged him with Moctezuma Orland’s death.

Moctezuma Orland’s grandmother Iveliz Moctezuma told WFTV that a friend of her grandson’s called her and daughter Noemi Moctezuma to tell them that he had been shot. The women drove to four hospitals, including one in Tampa, searching for him.

A Latina woman sits for a television interview in her home. She is tearing up.
Iveliz Moctezuma, grandmother of Daesean Moctezuma Orland, who was shot and killed at age 18 at a house party in Davenport, Florida, in April. “It was the hardest night of my life,” she says. “They ripped him away from us.” (Keary Croskrey/WFTV)

“My every day is crumbled,” Iveliz Moctezuma said. “It’s hard to work. You sit there and you watch the news. You’re like, oh my God, there goes another kid getting killed by gun violence.”

“It’s a hole in my chest, a hole in my mind,” Noemi Moctezuma said. “It’s like the biggest void that you could ever possibly imagine, that not even the happiest moments can fill a void like that.”

Jacksonville, a city of about 1 million, is particularly treacherous for children living in areas north and west of downtown.

The victims include a gunned down while playing in front of a house, a fatally wounded coming home from a football tryout, and a killed by a stray bullet as she sat in a parked car.

Advocates for victims said that gun violence has ripped any sense of normalcy from families and entire neighborhoods. Grieving mothers fear fireworks and other loud noises that sound like gunshots. Grappling with their own emotions, they said, they sometimes struggle to help their surviving children cope with the loss.

“When you hear their stories, you think, ‘This is the worst thing I have ever heard,’” Francis said, “until you hear the next one.”

Hours after graduating from Jacksonville’s Raines High School in May 2022, , 18, was shot and killed while arriving at a friend’s celebration. Fields was walking into the party when a car pulled up and opened fire, his mother, Yvonne Fields, told Action News Jax in an interview.

A defensive lineman on his high school football team, Fields had been offered a full scholarship to play for Keiser University in West Palm Beach. His parents were planning a party for the following day to celebrate his graduation.

“Everybody loved him,” Yvonne Fields said of her youngest son, calling him “the life of the party.”

A Black woman sits for a TV interview indoors.
Yvonne Fields of Jacksonville talks about the death of her son, Rashaud Fields, 18, who was shot and killed in May 2022 at a high school graduation party. (Kevin Jordan/Action News Jax)

“Rashaud loved to dance. He was a joke teller. He was funny,” Fields said.

At the time, Rashaud Fields was at least the ninth 17- to 19-year-old homicide victim in the city that year, according to the , the local newspaper. Yvonne Fields said she has kept her son’s room exactly as he left it the day he was killed. She smells his shirt every day.

“I know he’s not coming back,” she said, “but I can feel the spirit.”

Two days after celebrating his 18th birthday, Maurice Hobbs was fatally shot in January 2017 as he waited for his mother to pick him up.

“I was not even a block away,” Latasha Hobbs said to Action News Jax.

A photo shows a white woman being hugged outside in the evening at a gathering.
Latasha Hobbs receives a hug at a gathering to end gun violence in Jacksonville on Aug. 27, 2018. Her son, Maurice Hobbs, was shot and killed two days after celebrating his 18th birthday in January 2017. (Joe Raedle/Getty Images)

A singer, rapper, and poet, Maurice Hobbs wanted to perform and launch a clothing line. He dreamt of making enough money to give homes to everyone in his family so they could all live on the same street.

His mom recalled celebrating his birthday with cake and dancing in the kitchen and his reaction to turning 18.

“He was like, ‘Oh my God, Mom, I made it to 18,’” Latasha Hobbs said. “So it’s hard to swallow knowing that my baby didn’t make it to 19. It’s not fair. My baby deserves to be here.”

Pamela Howard has struggled for nearly two decades with the pain of the killing of her son Derrell Baker at age 17.

Howard, a mother of five, called her son energetic and an anchor for his younger siblings. Baker excelled at football, she said, and was on track to graduate high school despite having severe attention-deficit/hyperactivity disorder.

Someone shot Baker in September 2008 as he walked to school. A passerby found him by the road.

A Black woman sits outside as she holds two framed photos of her son.
Pamela Howard has spent nearly two decades trying to help police find the person who killed her son Derrell Baker, 17, as he walked to school in 2008. (Malcolm Jackson for Ñî¹óåú´«Ã½Ò•îl Health News)

Howard said she thought Baker was at school and later football practice. The family learned something might be wrong only when a sibling heard that Baker had been shot.

Howard called area hospitals in search of her son. By the time she found him at UF Health Jacksonville, it was too late, she said: He had died hours earlier.

“I don’t remember anything after they told me” he was dead, Howard said. “My friends say they just heard me scream.”

For the mothers Fields, Hobbs, and Howard, the sudden, unexpected death of their children cut deep. The lack of closure is painful. Police have not made an arrest in any of the cases.

“When I get justice,” Yvonne Fields said, “maybe I’ll be a little at peace.”

()

Leading Cause of Death

, chief of pediatric surgery and trauma at Children’s Hospital of Philadelphia, said there has to be an appetite in state capitals to regulate firearms and protect children from gun violence.

Nance co-authored a in JAMA Pediatrics finding that the number of states where guns were the leading cause of death for children and teens increased from zero over the period 2004 to 2008 to 24 from 2019 to 2023.

Motor vehicle deaths among children, once the leading cause of death in that group, have declined primarily because of safety interventions undertaken by governments and car manufacturers, he said, from seat belt laws and speed limits to air bags and antilock brakes.

“That progress has been pretty universal across the U.S.,” he said, “but firearm stuff is just all over the map.”

Guns don’t have federal safety standards, Nance noted. They aren’t regulated by the Consumer Product Safety Commission, a federal agency that protects the public from dangerous products, and they can’t be recalled the way unsafe toys or cars can be.

“We’ve really done almost nothing to change the trajectory of firearm injuries in kids,” Nance said.

Goldhagen, the UF Health pediatrician, said Jacksonville leaders tried to address gun violence through the Jacksonville Journey, an initiative launched in 2008 — when Duval County was the murder capital of Florida — under former Mayor John Peyton.

The program for children at risk of violence provided mentorship, summer camps, job training, and nonpolice strategies such as neighborhood beautification projects and community center programs. The Journey also partnered with the Jacksonville Sheriff’s Office on gang intervention focused on young people.

Officials credited the effort with a nearly 40% reduction in homicides in Duval County in its first four years.

After Peyton left office in 2011, program spending of about $15 million was slashed to $8.6 million in 2012 and about $2.3 million in 2014. The scaled-back program was eventually combined with another children’s initiative to form the , which uses city, state, and federal grants to fund youth services and intervention programs.

Duval County is the only large county in Florida that does not have a child services tax dedicated to programs for children, including efforts to reduce youth crime.

City leaders believe “public safety is about fire and police, but not social services,” said Vicki Waytowich, executive director of the , a nonprofit funded through grants and contracts that provides health and juvenile justice services for children and families in Jacksonville.

“There is absolutely zero political will to do anything that remotely resembles a child services tax,” she said.

In 2024, on a gun violence prevention program called Cure Violence, which tried to squash beefs between youths before they escalated to shootings. A city Office of Inspector General report and sound financial practices.

“We have a public health system that doesn’t focus on this as a public health or population health issue,” Goldhagen said.

Waytowich said crime is a symptom of much deeper problems on the north side of Jacksonville, from neighborhood decay to generational trauma and lack of job opportunities.

“We don’t really have the funds to address the root causes,” she said. “What we’re doing is slapping a band-aid on things.”

Unlike in Mandarin, a predominantly white neighborhood on the south side of Jacksonville with easy access to about seven grocery stores, children of the city’s north side have poor nutrition, Waytowich said, and many walk more than a mile to get to school.

“We can see that kids don’t have hope,” Waytowich said. “When kids believe they’re going to die at 21, then what’s the use of goal-setting and résumé-building workshops?”

In 2025, Jacksonville Mayor Deegan launched a program to address gun violence called .

But like its predecessor, Journey Forward does not have a dedicated, ongoing source of funding.

Hard Memory

On March 22, Ladonna Johnson said, she broke up with Dodson because she saw that he was sharing location information with other women on his cellphone.

She said she went into a bedroom where A’mahri and his sister were watching television and put her son on her lap. Dodson followed Johnson into the room, she said, then went into a closet and retrieved the gun.

“He just kept asking me, ‘What are we doing?’” Johnson said.

Moments later, Johnson said, she heard a loud bang. Her daughter started to cry.

They will both need therapy, she said. She is dedicated to preserving A’mahri’s memory: “I want people to know how adorable and sweet my son was.”

Still, she said, “I feel like I will never be OK.”

Methodology

To find that more than 4,000 children under 18 had been treated in Florida hospitals for gunshot wounds from 2018 to 2024, The Trace and Ñî¹óåú´«Ã½Ò•îl Health News analyzed two datasets obtained from the Florida Agency for Health Care Administration via a data request:

  • In the emergency department file, which contained records of 67,565,314 ER visits that did not result in an inpatient admission, we identified 37,415 gunshot wound cases using the Centers for Disease Control and Prevention’s .
  • In the inpatient file, which contained records of 21,857,664 hospital visits in which patients were admitted, we identified 28,149 gunshot wound cases using the CDC definition.

We defined children as 17 and under and filtered the patient age column to find that 2,340 children had been treated in ERs and 1,684 admitted to hospitals with gunshot wounds. To avoid double-counting, we excluded patients from the emergency department file whose records indicated that they were transferred to a different inpatient facility.

Demographic breakdowns were generated using the race and ethnicity columns in the datasets.

To examine the geographic distribution of the burden of gun violence, we grouped child gunshot wound victims by the ZIP code provided. Importantly, this ZIP code is the location not of the shooting but of the child’s residence. A small number of children in the data had out-of-state ZIP codes, or placeholder ZIP codes indicating they were homeless or from a foreign country. These children are included in statewide totals as children treated in Florida hospitals but not in ZIP-level results.

This data does not include children who were shot but died at the scene or before reaching the hospital or who never received medical treatment.

Ñî¹óåú´«Ã½Ò•îl Health News data editor Holly K. Hacker contributed to this report.

This report was produced by Ñî¹óåú´«Ã½Ò•îl Health News, The Trace, Action News Jax in Jacksonville, and WFTV in Orlando.

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2278230
Budget Battle Erupts in Nation’s Capital Over Opioid Settlement Money /public-health/washington-dc-opioid-settlements-medicaid-budget-supplantation/ Fri, 07 Aug 2026 09:00:00 +0000 /?p=2268191 Your browser does not support the audio element.

Can’t see the audio player? Visit kffhealthnews.org to listen.

For years, Washington, D.C., has paid for Medicaid — the state-federal health insurance program for low-income people — out of its general budget. But next year, the city is shifting part of that recurring multimillion-dollar cost to a new funding source: opioid settlement dollars.

That’s raising red flags for addiction recovery advocates, people directly affected by the crisis, and the commission in charge of recommending how the city uses its share of the settlement money.

The come from a host of companies that made or distributed prescription painkillers and were accused of fueling the overdose crisis. State and local governments nationwide are set to receive more than $50 billion over almost two decades. Washington, D.C.’s cut is expected to .

The money is meant to remediate the addiction crisis, often by increasing services or funding new programs.

But many states are facing increasing fiscal pressures as they are squeezed by inflation, federal funding cuts, and rising costs. Some officials have been tempted to turn to opioid settlement cash as a budget stopgap — an idea that can trigger opposition and outrage from recovery advocates and people who have struggled with opioid addiction and their family members.

“These funds were awarded to D.C. for very specific reasons and with a specific mandate, which are to remediate issues related to the opioid crisis in new and innovative ways,” said Queen Adesuyi, a partner at , a consulting group for community-based organizations, who is crying foul over the proposed fiscal year 2027 budget.

A document provided to Ñî¹óåú´«Ã½Ò•îl Health News shows line items in the district’s fiscal 2027 budget that would direct about $2.3 million in opioid settlement funds to help pay for the city’s Medicaid contribution and at least $5.5 million to support addiction treatment centers previously funded through the general budget. Substituting opioid settlement dollars for general funding keeps overall spending on treatment flat instead of increasing.

“Opioid settlement dollars are not meant to be a rainy-day fund for existing government obligations,” said , associate director of the Center on Addiction and Public Policy at Georgetown Law’s O’Neill Institute.

More than 80 individuals and 30 city organizations protesting this use of settlement dollars, saying the district’s planned to spend opioid cash to “pay off its own debts.” The letter was sent to DBH Director Barbara Bazron; the chair of the D.C. Council’s Committee on Health, ; and Attorney General .

Chad Jackson, himself in recovery, chairs the district’s , which was created to advise the city on how to spend its settlement dollars. Jackson called the latest move supplantation, a budgeting tactic that shifts money from one fund to another to free up dollars.

“If the opioid settlement funds were not there, I feel pretty confident that these things would have been funded, because they have to be funded,” Jackson said.

What’s happening now is against the district’s opioid litigation law, he said.

The that money from the district’s opioid abatement fund “shall supplement, and not supplant.”

“It’s a pretty tightly written law where the intent is very clear: Do not supplant,” Weizman said.

Adesuyi, an advocate for programs that help people who use drugs, said the council is flouting that law and that it’s a “slap in the face.”

A woman speaks into a microphone. In front of her are people sitting at tables in a U formation.
Queen Adesuyi is a Washington, D.C.-based harm reduction advocate and partner at Reframe Health and Justice, a consulting group for community-based organizations. At the July 15 meeting of the Opioid Abatement Advisory Commission, they speak against the city’s use of opioid settlement dollars to fill budget holes. (Aneri Pattani/Ñî¹óåú´«Ã½Ò•îl Health News)

Councilmember Henderson and Attorney General Schwalb weighed in too.

“We are also concerned that DBH may be using the settlement monies for other unauthorized purposes,” they wrote in a to the department. They highlighted the $2.3 million used to cover the city’s Medicaid contribution and asked the department to explain by July 31 how it determined that was legal.

It’s unclear whether the Department of Behavioral Health met that deadline. DBH, Henderson’s office, and the attorney general’s office did not respond to that specific question.

However, DBH spokesperson said in a statement that the department is “committed to compliance with all statutory requirements governing opioid settlement funds.” The department’s general position has been that its budget was approved by the council, and that the funding supports efforts that counter opioid addiction.

The council “passed a legally-certified budget for the next fiscal year that makes the best use of all local resources, including the opioid settlement fund, to award grants to 17 community-based providers who last year served nearly 9,800 residents including 3,500 in medication-assisted treatment for opioid addiction,” Reed told Ñî¹óåú´«Ã½Ò•îl Health News.

The district’s budget is pending a 30-day “congressional review,” which is the last step in its .

Still, some residents like Adesuyi want more accountability for how the opioid money is spent.

“The drug supply is getting a lot more unpredictable, which calls for some nimbleness, and it calls for interventions that are more courageous. Unfortunately, DBH is not meeting the mark when it comes to that,” Adesuyi said, adding, “It’s frustrating, it’s disappointing, and it’s enraging because people are dying unnecessarily in the district to overdose.”

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2268191
Uninsured but Undaunted, a Surgical Patient Searched the Globe for a Deal /health-care-costs/hernia-surgery-search-globe-for-deal-bill-of-the-month-july-2026/ Wed, 29 Jul 2026 09:00:00 +0000 /?p=2266609 Around the end of last year, Ronmel Rangel, 63, began to feel a familiar discomfort in his lower abdomen. Twenty-five years earlier, while living in his native Venezuela, he had undergone surgery to repair a hernia on the right side of his groin.

Now, the same pain had returned — on the left.

This time, Rangel was in the U.S. and lacked health insurance. In 2019, he moved to Portland, Maine, where one of his daughters lives.

As a green-card holder, he qualified to purchase health insurance through the Affordable Care Act marketplace. But he quickly realized that the premiums for someone his age were beyond his budget. He decided to go without insurance, even though it had been a priority for him.

Instead, Rangel signed up for a plan at a concierge practice where patients pay as little as $70 a month for services, including unlimited office visits and minor procedures such as stitches and biopsies.

But when Rangel was diagnosed with a hernia, surgery became unavoidable. Ben Hagopian, his primary care physician, helped him compile a list of hospitals and surgical centers to consider. Rangel has a PhD in management, a field he pursued while serving in the navy in Venezuela. Armed with that knowledge and a naturally inquisitive mind, he began researching prices.

His efforts paid off when the bill came.

The Medical Service

Rangel had what is called an , which occurs when the contents of the abdomen bulge through a weak spot in the lower abdominal wall. The condition is relatively common, particularly among older adults.

In most cases, surgery is required to fix the muscle wall and can be performed . There are three main surgical approaches to repair an inguinal hernia: open, laparoscopic, and robot-assisted. Studies have shown that the three approaches have similarly low rates of hernia recurrence and are .

Rangel underwent an open repair, an approach often preferred by physicians for recurrent hernias. He said his operation lasted less than two hours, and he walked out of the surgical center shortly afterward.

The Bill

$2,900: The flat rate Rangel ultimately paid for his hernia repair at an outpatient surgery center in Maryland, including the surgeon’s fee and anesthesia. He said he also paid around $1,800 to travel to the surgery center from his home in Maine, including airfare, meals, and lodging for him and his wife.

The Billing Problem: No Insurance — But Time To Shop

Because Rangel did not have insurance, he had no protections from high costs — except time and his ability to shop for an acceptable price for his procedure.

Rangel’s first stop was a nonprofit hospital close to home. He scheduled a consultation with a surgeon with MaineHealth, the state’s largest health system, and received an estimate showing it would cost approximately $23,000 to repair his hernia laparoscopically.

Laparoscopic procedures generally cost more because surgeons use more advanced tools. Still, the average laparoscopic inguinal hernia repair costs nearly twice as much at a hospital as it does at an ambulatory surgery center for a patient , which pays $5,280 for the hospital-based option.

“I wasn’t going to mortgage my life just to have surgery and spend the next 30 years paying off the debt,” said Rangel, now 64.

So, he kept shopping. He considered a surgical center in Oklahoma that was far cheaper, but he ultimately ruled it out because it was so far away. He also explored traveling to Universidad de los Andes in Santiago, Chile, where another of his daughters lives. There, his hernia repair would have cost about $7,000, but once he added thousands of dollars in travel expenses, that option no longer made financial sense.

Gerard Anderson, a professor who analyzes healthcare spending at the Johns Hopkins Bloomberg School of Public Health, said patients without health insurance are often the ones hit hardest by wide price variations.

A closer look at any hospital bill helps explain why. “Every hospital is different,” he said, “but generally about half of the total charge is the facility fee,” a charge added to hospital care to help cover overhead costs.

Anderson said hospitals often mark up prices far more than smaller facilities do.

Medical billing researchers say the price gap between hospitals and ambulatory surgery centers partially reflects the higher overhead costs of operating a hospital.

Hagopian, Rangel’s physician, acknowledged that hospitals have higher administrative expenses. “But that doesn’t explain the high costs.”

MaineHealth declined to comment to Ñî¹óåú´«Ã½Ò•îl Health News, directing questions about the hospital-based procedure’s cost to Jeffrey Austin, president of the Maine Hospital Association.

Austin said that, unlike surgery centers, hospitals must absorb the costs of providing “money-losing” services, such as behavioral healthcare and care for Medicaid patients. He added that revenue generated by large hospitals in a health system supports other facilities, improving access to care.

Hospital prices, which can vary widely, are also driven by negotiations with insurers and market concentration. For uninsured patients, those list prices can become the starting point for negotiations — or the full amount owed.

Anderson noted that standardized payment rates exist for Medicare and Medicaid but not for most privately priced medical services. “In the private sector, providers can charge whatever they want.”

A photo of Ronmel Rangel standing in an area with green shrubbery outside his home.
Rangel collected estimates from facilities near and far from his home in Portland, Maine, including some outside the United States. “I wasn’t going to mortgage my life just to have surgery and spend the next 30 years paying off the debt,” he says. (Brianna Soukup for Ñî¹óåú´«Ã½Ò•îl Health News)

The Resolution

Rangel has another daughter in Argentina, a son in Venezuela, and other family in Spain. But he decided to stop looking around the globe for a good price, because he finally found what he was looking for in Maryland.

In April, he traveled to the Affordable Hernia Surgery center in Rockville, where he said “an efficient, well-coordinated system” guided him through the entire process.

“I received professional and very human care,” Rangel said. He was fully recovered within two weeks, as his surgeon predicted, he said.

The surgery center charged Rangel a flat fee for his hernia repair. The added travel expenses for the two-day trip with his wife went toward airline tickets, transportation, meals, and one night in a hotel.

Rangel said he paid about $4,700 total.

Alan Kravitz, the surgeon who performed Rangel’s operation, said the price difference uninsured patients face compared with insured patients is far from fair. “In the predatory and strategic world of U.S. healthcare pricing, uninsured patients generally get charged more than providers would accept from Medicare or commercial insurance.”

Kravitz then pulled out an estimate another patient had received for an inguinal hernia repair from a different large health system. The price: $37,000.

The Takeaway

Without insurance, many patients are on their own to negotiate.

“With the help of their primary physicians, patients can dig into prices and compare their options to avoid falling into medical debt,” Rangel said.

That approach, however, is most feasible for elective procedures with several surgical options offering comparable outcomes.

Patients facing medical emergencies do not have the luxury of comparing prices before seeking care, though many hospitals offer cash-pay discounts or charity care for those paying without insurance.

Billing analysts say patients who do have time to shop should look beyond cost alone. They recommend checking the quality of hospitals and surgical centers by reviewing publicly available ratings and patient reviews. that higher prices do not necessarily translate into a better quality of care, but it’s also important to select a reputable care provider.

Comparison shopping for medical care can be time-consuming. But for patients facing elective procedures, the effort can pay off — sometimes saving thousands of dollars.

“This was a learning experience for me,” Rangel said, “and I hope it will be for other people, too.”

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

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2266609
Tracking State Rural Health Transformation Plans /rural-health/tracking-state-rural-health-transformation-plans/ Mon, 27 Jul 2026 09:00:00 +0000 /?p=2253259 The five-year, $50 billion Rural Health Transformation Program was created as part of the One Big Beautiful Bill Act to expand access to healthcare. States competed to win funding with first-year allocations ranging from $147 million for New Jersey to $281 million for Texas. Find links to available public documents for each state below.

Choropleth map

Source: <a href=”; target=_”blank”>Centers for Medicare & Medicaid Services</a>


Table

Ñî¹óåú´«Ã½Ò•îl Health News will update this database as more states respond to emails and public records requests for their documents.

Note: Data collected as of Sept. 11, 2026. Ñî¹óåú´«Ã½Ò•îl Health News reporters searched state websites, requested documents, and filed public records requests. Ñî¹óåú´«Ã½Ò•îl Health News continues to collect documents.

Sources: Documents publicly posted online or released in response to Ñî¹óåú´«Ã½Ò•îl Health News requests; <a href=”; target=_”blank”>Centers for Medicare & Medicaid Services</a>

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2253259
Leadership Vacuum: Agencies in New York and Beyond Pass the Buck on Opioid Cash Oversight /public-health/opioid-settlement-funds-leadership-vacuum-disbursement-oversight-new-york/ Tue, 21 Jul 2026 09:00:00 +0000 /?p=2258516 Companies accused of recklessly marketing and distributing prescription opioid painkillers are paying to settle lawsuits over their role in fueling the addiction crisis. It’s a pot of gold eyed by addiction treatment providers, companies creating the latest opioid-related products, and government officials struggling to balance budgets.

Nearly half of that money is , to be distributed by county commissioners and city councilors. The idea is that local leaders know their communities best and can do justice to these payouts, often described as “blood money” by people who’ve lost loved ones to an overdose.

But many local leaders have little to no training in addiction policy and may lack robust local health departments and policy guardrails to assist them.

That has resulted in spending decisions that many clinicians, researchers, and addiction recovery advocates say are unlikely to save lives or treat substance use disorders.

In New York, where is directly controlled by local governments, counties have spent tens of thousands of dollars on surveillance cameras, technology to help police access data on locked cellphones, and goggles that simulate being drunk, according to public records obtained by the nonprofit advocacy group and shared exclusively with Ñî¹óåú´«Ã½Ò•îl Health News. Though the purchases were likely legal, many people consider them a slap in the face because they don’t directly help people struggling with addiction or their families.

Without oversight, counties have the chance “to go rogue” with this money, said , director of drug policy at VOCAL-NY, an advocacy organization that is tracking settlement money as part of its mission to serve people affected by the war on drugs.

When advocates and families of overdose victims raise concerns to the various state agencies that could hold localities accountable, those agencies often punt to one another, Budnella and other local advocates said.

It feels “like the where it’s like everybody’s pointing at each other,” Budnella said. “Somebody needs to be able to have the stick and slam their hand on the table and be like, ‘You’re doing this wrong and this is the consequence.’”

The experience in New York provides a microcosm of regulators evading oversight responsibility nationwide while varied interests vie for the financial windfall.

Years of data collected by Ñî¹óåú´«Ã½Ò•îl Health News, the Johns Hopkins Bloomberg School of Public Health, and the addiction nonprofit Shatterproof have found that settlement money was spent on law enforcement gear, such as night-vision goggles and bulletproof vests; unproven prevention initiatives, such as a drug-awareness magician for kids; and budget stopgaps.

It’s unclear who should — or will — take action on such expenditures that many people harmed by the crisis consider questionable.

In each state, control of the money is split among various entities, creating a leadership vacuum. The federal government . Advocates and families who’ve lost loved ones have pushed for accountability but have limited power. A few states have passed new laws, but change is slow and uneven.

The require the majority of the money to be spent on “opioid remediation,” with . But the list is broad and open to interpretation. Further complicating the issue, many states — including New York — designate some portion of the settlement dollars as unrestricted, which allows for general spending.

Meanwhile, federal budget cuts have threatened addiction-related services and created more demand for funding. And though overdose deaths have decreased since , they still claim about 186 lives per day.

“We really are wasting this opportunity to use these funds to turn the epidemic around,” said , a Binghamton, New York, resident, whose 28-year-old son, Jeff Dugon, died of a heroin overdose in 2014.

Three men and a woman stand outside an pose for a photo together.
Jeff Dugon (right) spent Easter with his mother, Alexis Pleus, and brothers in 2014. He died four months later of a heroin overdose. Now, Pleus is fighting to ensure opioid settlement money is spent in ways that can spare other families such heartache. (Mitchell Sosnicki)

He was a chef who loved to rib Pleus about her bad knife skills. She thinks of him and smiles every time she peels garlic the way he taught her. If the money could spare other families such heartache, that would give her solace.

“We need oversight,” said Pleus, who runs a nonprofit that is receiving opioid settlement cash from her county to serve people who use drugs and provide support groups for families.

In New York, there are three prime watchdog contenders: the Office of Addiction Services and Supports, the attorney general, and the comptroller.

The Lead State Agency

New York’s opioid settlement documents designate the as the “.”

It distributes a portion of settlement dollars via grants, according to recommendations from the state’s . It also has the power to “engage in oversight and audits of projects and programs” funded by settlement cash and “may withhold future funds” from local governments that do not comply with certain requirements, according to the agreement.

Agency spokesperson Jerry Gretzinger told Ñî¹óåú´«Ã½Ò•îl Health News the office has not yet exercised its power to withhold funds but understands its oversight role.

“OASAS has a duty to ensure these funds are used responsibly and strategically to build programs that will have a lasting impact in reversing this crisis,” Gretzinger wrote in a statement.

The office is currently auditing 19 local governments’ use of the money to ensure compliance with “reporting and recordkeeping requirements,” he said. However, that may not encompass the broader question of whether money was spent on appropriate uses, which many advocates want addressed.

Some people are frustrated with the narrow role OASAS has carved out.

For example, required local governments for the first time to publicly report how they spent settlement money. OASAS on its site. But it does not review the accuracy or detail of that data, instead relying on “the information as it is provided” by localities, Gretzinger said.

“That doesn’t feel like oversight,” said , a deputy director at the Legal Action Center, which obtained public records about local spending in New York.

Members of the state’s Opioid Settlement Fund Advisory Board have also to provide more data and evaluation of how dollars are being used. But at a , OASAS Commissioner Chinazo Cunningham deflected.

“OASAS has no oversight over these portions of dollars,” she said of the 46% of settlement money that goes directly to counties and cities. “In terms of what kind of data each county collects,” she added, “we cannot dictate exactly what that information is.”

Click for Examples of spending decisions Local Spending That’s Fueling Calls for Oversight in New York

To uncover how opioid settlement cash is being spent, the nonprofit advocacy group filed public records requests with 56 New York counties and New York City, all of which are to disburse as they see fit.

Many of the responses showed spending on addiction treatment, recovery, and prevention initiatives that researchers and clinicians agree are a good use of money. Others surfaced questionable expenditures.

, for example, showed $150,000 in settlement cash directed to “Sheriff Jail” with no further description. The county did not respond to repeated inquiries for more details.

Sullivan County spent more than $30,000 on Cellebrite technology, used to extract data from cellphones, and more than $37,000 on Tasers. Though county officials didn’t respond to requests for comment, explained that those purchases came from unrestricted funds.

Such justifications rankle some families affected by the crisis, who say even if there aren’t legal restrictions on those dollars, there should be moral ones.

“Anything that is not directly tied to people who are struggling with opioid addiction or the loss of someone is a poor use of funds,” said , who lost a son to an overdose and now runs a nonprofit aimed at helping families dealing with addiction. Her organization has received settlement funds from Broome County, New York.

A woman in a pink dress and a teenage boy in a white polo shirt dance together under a blue and white striped awning. They both look at the camera and smile.
Alexis Pleus is pictured with her son Jeff Dugon in 2003, when he was 17. She thinks of him every time she sees a sunrise or sunset. He loved them and would often send her photos, she says. (Jason Dugon)

Records also revealed that many jurisdictions have yet to spend a significant portion of their money — a other .

Local officials say thoughtful planning takes time. But some advocates suspect ulterior motives. Millions of settlement dollars in bank accounts can generate sizable interest.

In March, it came to light that Nassau County had in interest accrued from unused opioid settlement funds to the county’s general fund, where it could be used for any purpose. County officials didn’t respond to requests for comment. The money was following public backlash.

Advocates suspect such attempts are happening elsewhere but are difficult to identify within complex budgeting documents.

It feels like “it’s up to us all — the organizers, the advocates, the service providers” — to be constantly watching, said , director of drug policy at the advocacy organization VOCAL-NY. “It’s frustrating.”

That’s why state agencies are being called on to step into an oversight role.

The Top Law Enforcement Officer

New York has been one of the leading national voices on prosecuting pharmaceutical companies that fueled the overdose crisis. Her office has issued on the topic, touting her role in securing billions of opioid settlement dollars for the state.

But when asked about the attorney general’s role in ensuring this windfall is spent appropriately, her office passed the buck to other agencies.

“While our partners in state and local governments distribute and oversee these funds, we will continue our work to hold accountable the companies responsible for fueling the spread of addictions and overdoses,” spokesperson Grant Fox wrote in a statement.

That stance contrasts starkly with many people’s views of the office’s responsibility.

A state senator, a member of the opioid settlement advisory board, and several advocates named the attorney general’s office as a key enforcement entity.

“The money is here because of their efforts,” said Democratic state , who chairs the committee on alcoholism and substance use disorders and has introduced of related to settlement funds. “I believe it is under the Office of the Attorney General to enforce.”

Budnella, the advocate with VOCAL-NY, agreed, saying, “It would be a shame for all of their work that they have done to secure all this funding for it to be misspent.”

A man speaks in the middle of a group of people protesting. Behind him, several people hold a banner that is had to read because words are obscured. Another person to the left of the man holds a cardboard sign that reads, "Mourn the dead, fight for the living."
VOCAL-NY is a statewide advocacy organization that tracks opioid settlement money as part of its mission to serve people affected by the war on drugs. The group is calling on state agencies to hold city and county officials accountable to ensure the money is spent on services that help people with substance use disorders and their families. (VOCAL-NY)

Attorneys general in and have taken more active roles, issuing lists of ways opioid settlement money cannot be spent. The lists include many law enforcement expenditures that have raised concerns for advocates in New York.

James’ office did not respond to a specific question about whether she’d consider creating a similar list.

The Fiscal Watchdog

Some people have suggested that the state comptroller, as a steward of New York’s finances, could play an oversight role, perhaps by conducting or requiring audits.

Early this year, the Reason Foundation, a libertarian think tank, that would create audit requirements for organizations receiving settlement cash. The blueprint suggests recipients of more than $1 million in opioid settlements be required to undergo an independent review of financial statements and transaction testing to determine whether funds were used for their intended purpose. Smaller grantees, receiving less than $1 million, could simply provide an unaudited accounting of the funds.

It’s “not telling states what is and what isn’t an appropriate use,” said , a co-author of the Reason Foundation plan. “We’re simply trying to ensure recipients follow through with their promises.”

No state has adopted the model law yet. But the office of New York told Ñî¹óåú´«Ã½Ò•îl Health News it is already conducting an audit.

The process, which began in February, “is looking at OASAS’ oversight” of the opioid settlement money, said spokesperson Mary Mueller. It includes settlement money controlled by the state and local governments.

Mueller said any future enforcement action “will depend on the results of our current work and our ongoing monitoring.”

The office is following in the footsteps of comptrollers and auditors in , , and , Tennessee, who have taken action on settlement cash.

These initial steps have given some advocates and researchers hope for the future of opioid settlement dollars, which are expected to flow for more than a decade.

“We’re already years in and we’ve seen the craziest stories” of this money and a , said , a co-author of the Reason Foundation’s model law. “If we can prevent that at least a little and have these funds be a bit more focused, I don’t think it’s too late.”

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2258516
A Deloitte-Run System Denied Medicaid Benefits for Michigan’s Disabled. Now Trump’s Law Piles On. /health-industry/deloitte-medicaid-eligibility-system-denials-michigan-trump-policy-piles-on/ Tue, 21 Jul 2026 09:00:00 +0000 /?p=2258559 Marie Noon takes eight medications a day. One keeps her heart rate from spiking to avoid a stroke. One prevents debilitating headaches. Another ensures she doesn’t retain excess fluid.

More than a decade ago, Noon said, she was diagnosed with adult-onset Still’s disease, a rare type of inflammatory arthritis that can cause rashes, debilitating pain, and fevers. The disease upended her life.

She had been living a typical suburban life in Michigan, shuttling her two kids to activities like cheerleading, choir practice, and track. She was active in the PTA. She managed a bank.

She went from that to crawling to the bathroom because she was in so much pain, “just crying all day long” from being so sick.

Noon, who is disabled, said she couldn’t work for eight years — a time marked by hospital stays that stretched for weeks.

“I honestly thought I was going to die,” Noon said.

So it was a shock when Michigan denied her application for Medicaid benefits last year after she lost private insurance. Worse yet, it came down to an IT error, according to an attorney who helped Noon overturn the denial.

“I can’t afford my medical care. I have to have insurance,” said Noon, who has returned to working.

Deloitte, a multibillion-dollar global consulting firm, has operated Michigan’s Medicaid eligibility system under contracts worth roughly $768 million since 2006, according to contracts reviewed by Ñî¹óåú´«Ã½Ò•îl Health News. Nationwide, Deloitte dominates this important slice of government business: At least 25 states have awarded the company contracts to build or run computer systems that control access to safety net benefits such as Medicaid.

Michigan’s system has incorrectly directed people with disabilities into skimpier benefits that cover limited care or has denied coverage completely, a Ñî¹óåú´«Ã½Ò•îl Health News investigation found. Similar problems were at the center of a class-action suit in Tennessee, , and have occurred in Texas, according to interviews and state records.

The Ñî¹óåú´«Ã½Ò•îl Health News investigations are based on statements from state officials, allegations and declarations in court documents, emails obtained through public records requests, state government information provided to Medicaid enrollees and applicants, and interviews with attorneys and patients or their caregivers.

In an emailed statement, Deloitte spokesperson Karen Walsh said it found “no system anomalies causing routine denials of Medicaid for people with disabilities.”

“There are many reasons why someone may no longer be eligible for a benefit they once received or believe they deserve,” Walsh said. “All of the eligibility systems we support are owned by the states and built to their unique specifications. We will continue to work at the direction of our state clients.”

Lynn Sutfin, a spokesperson for Michigan’s Department of Health and Human Services, said it “is not aware of any widespread or systemic issues” within Bridges, Michigan’s eligibility system for Medicaid, SNAP, and other benefits, “related to disability‑based eligibility pathways.” 

Since 2006, Deloitte’s contracts with the state have said the company is responsible for development, implementation, maintenance, operations, and enhancements to the Michigan system.

Computer system problems foreshadow trouble as states prepare to roll out the most significant and complicated changes to their Medicaid programs in years. Those changes, dictated by President Donald Trump’s landmark One Big Beautiful Bill Act, have states rushing to update their Medicaid computer systems.

Nationwide, on Medicaid have a disability, according to KFF.

“When these administrative systems get overloaded, everyone gets impacted,” said Pamela Herd, a University of Michigan professor who researches bureaucratic obstacles to accessing government benefits. “The systems are going to be really, really strained.” 

In Michigan, Noon was eligible for Medicaid through a program that provides coverage to disabled adults who work. But the state’s computer system didn’t register that she is disabled and said she earned too much to qualify, according to documents reviewed by Ñî¹óåú´«Ã½Ò•îl Health News and interviews with Noon and Anastassia Kolosova, a disability rights attorney who helped her.

Without Medicaid coverage, Noon paid hundreds of dollars out-of-pocket for prescriptions, after scrounging for discount coupons. She takes some of the drugs twice a day.

Without them, “I’m toast,” she said. It was stressful “not knowing if my medicine’s going to be $50 or $500 this month, because it changes constantly.”

Noon said her doctor agreed to fewer visits to avoid medical bills.

“It was kind of a nightmare,” Noon said.

‘I Just Wanted To Give Up’

Medicaid, a safety net health program jointly run by the federal government and states, people with low incomes or disabilities. State governments rely on companies like Deloitte to design and operate computer systems that assess whether people qualify for Medicaid or food aid through the Supplemental Nutrition Assistance Program, commonly known as food stamps.

That technology has a history of errors that deprive eligible people of benefits, earlier Ñî¹óåú´«Ã½Ò•îl Health News investigations have shown. As reported previously, Kenneth Smith, a Deloitte executive who leads its national human services division, said Medicaid eligibility technology is state-owned and agencies “direct their operation” and “make decisions about the policies and processes that they implement.”

“They’re not Deloitte systems,” he said, noting Deloitte is one player among many who together administer Medicaid benefits.

States are under immense pressure to update their eligibility systems on a tight schedule to adhere to requirements in the Republicans’ sweeping 2025 tax and spending law. Companies including Deloitte, Accenture, and Optum are being paid millions in taxpayer funds to make the changes, which are projected to strip Medicaid from roughly 7.5 million people and SNAP from 2.4 million people by 2034.

Many coverage restrictions in the new federal law don’t apply to seniors, children, or people who are disabled, such as Noon. Nonetheless, the law’s demands on state agencies and the computer systems they oversee will disrupt benefits, advocates for Medicaid enrollees and other healthcare experts said in interviews.

The same systems also need to correctly classify why someone is eligible for Medicaid — and therefore which rules and restrictions apply.

The law’s SNAP restrictions began to take effect in 2025, and major Medicaid provisions begin later this year, generally after the midterm elections.

Kolosova is a supervising attorney with Disability Rights Michigan, a legal advocacy organization for people with disabilities. She said she has been unable to get a meeting with Michigan officials to understand the underlying problem that deprived Noon of health coverage.

A woman stands in a stairwell. She wears a shirt that says "Disability Rights Michigan"
Anastassia Kolosova, a supervising attorney with Disability Rights Michigan, helped Noon navigate the complicated process to obtain safety net health insurance through Medicaid. Kolosova says she has seen multiple wrongful coverage denials and fears problems will soon get worse because of changes required by federal law. (Kate Wells/Ñî¹óåú´«Ã½Ò•îl Health News)

State records show Deloitte has held contracts for at least 14 years for Bridges, Michigan’s eligibility system for Medicaid, SNAP, and other benefits. In its attempts to secure more business, the company often cites its nationwide footprint in Medicaid operations.

“Deloitte understands Bridges,” and its history in Michigan makes the company “the ideal vendor,” the firm said in its . Given Deloitte’s work on similar systems in 31 other states, , “Michigan benefits from our technical expertise drawn from across the nation.”

But advocates who work with people with disabilities say Michigan’s computer system has failed to recognize when certain adults should receive Medicaid benefits.

Problems aren’t unique to the Great Lakes State. Medicaid beneficiaries who brought a against Tennessee in 2020 said the state’s Deloitte-built system “does not reliably test for eligibility” for several categories of people with disabilities. The firm’s is worth $1.12 billion over a decade.

A federal judge in 2024 , ruling that Tennessee violated federal law and the U.S. Constitution. The lawsuit does not name Deloitte as a defendant.

In Michigan, a from the state’s Office of the Auditor General said government agencies “did not provide effective project administration” and failed to ensure that the state could “independently maintain and operate Bridges” because “the contractor did not transfer knowledge and skills” to state officials, according to the audit.

The auditor’s report said that, as a result, Deloitte’s original contract — valued at roughly $70 million — ballooned by $50 million over the initial cost, a 71% increase. State records show Michigan would go on to add millions more, bumping the cost of Deloitte’s initial contract to $124.1 million.

The audit said maintaining the contract would result “in significant additional costs.”

Sutfin said that “the state is now fully capable of operating and maintaining Bridges independently.”

Deloitte’s in Michigan — worth $197.4 million — is set to expire in 2030.

Noon applied for Medicaid in August, she and Kolosova said. In September, the Michigan Department of Health and Human Services sent a notice denying her coverage, citing incorrect income information and stating she wasn’t disabled, according to Kolosova and state documents reviewed by Ñî¹óåú´«Ã½Ò•îl Health News.

Noon said that when she called the state for help, state workers “didn’t know anything about” the Medicaid program she had applied to, Freedom to Work.

“I can’t tell you how many times I just wanted to give up,” she said.

For some people with disabilities, Medicaid is supposed to count only half their earnings when assessing whether they should receive benefits. That didn’t happen. Kolosova said she thinks Michigan’s eligibility system didn’t identify Noon as disabled, even though the state “already had all the information they needed” to show she was.

By failing to recognize her disability, the state used the wrong income formula and said Noon earned too much to qualify for Medicaid, she added. Deloitte and Michigan declined to respond to a detailed list of questions about Noon’s experience.

Kolosova said Disability Rights Michigan has seen a growing number of calls from people about Freedom to Work benefit denials. “Maybe two or three a month,” she said.

“There’s something wrong with the system if they’re relying on individual caseworkers to catch this,” Kolosova said. “The system needs to work.”

Marie Noon holds her dog as they stand by a window.
Noon at home with her dog, Ziggy. Despite being eligible for Medicaid, she was denied coverage in 2025 because of an error with the state’s benefits system. It took months of pushback before the state reversed its mistake. Even as a “tech-savvy” former bank manager, she says, she wanted to give up several times along the way. (Kate Wells/Ñî¹óåú´«Ã½Ò•îl Health News)

Enrolled in the Wrong Coverage

Noon’s experience isn’t the first time in recent years that people with disabilities have been denied benefits by Deloitte-run eligibility systems.

In Texas in 2023, Lilly Livingston, who has Down syndrome and is now 22, was abruptly cut off from Medicaid benefits, according to Livingston’s mother, Marie. She has undergone numerous surgeries to reconstruct her severely misaligned jaw, which caused sleep apnea and impaired her speech and chewing ability. She relied on an array of Medicaid services, including speech and occupational therapy.

When Livingston lost benefits, she was wrongly enrolled in Healthy Texas Women, a limited program that provides breast and cervical cancer screenings and family planning services.

“Trying to fix that was a nightmare,” Marie Livingston said.

Terry Anstee, an attorney with Disability Rights Texas, intervened.

In a September 2023 email with the subject line “URGENT,” Anstee begged a Texas Medicaid eligibility worker for help.

Some unknown “error” had occurred and stripped Livingston of her benefits, Anstee said in an email he sent to a state Medicaid staffer. “Lilly has had 2 major surgeries, and her recovery is contingent on Medicaid.”

It was clear that Livingston qualified for Medicaid through multiple paths, Anstee said: “It never made any sense.”

Deloitte declined to respond to a detailed list of questions about Livingston’s case. Jennifer Ruffcorn, a spokesperson for Texas Health and Human Services, confirmed that Livingston was erroneously enrolled in Healthy Texas Women. However, Ruffcorn said, Livingston did not experience a lapse in Medicaid coverage in 2023.

Anstee disputed the state’s characterization: “A glance in the system by a Texas HHS press officer or other staff 3 years after the fact may not tell the full story or show the issues that Ms. Livingston endured in August and September 2023. Ms. Livingston experienced lapses in coverage.”

The problem Livingston encountered in Texas was also reported in Michigan.

In 2024, mental health services advocates in Michigan raised red flags about a similar error: People with disabilities were being enrolled in a limited Medicaid program covering sexual health and family planning services. Plan First covers only services and treatment for sexually transmitted infections. It doesn’t provide the comprehensive coverage that people with disabilities require.

But some enrollees were “being automatically enrolled in Plan First,” Malcolm Kletke, a lobbyist representing the Community Mental Health Association of Michigan and other mental health providers, wrote to a Michigan health official, according to emails obtained by Ñî¹óåú´«Ã½Ò•îl Health News through a public records request.

These enrollees had “long received Medicaid due to their disability,” and getting enrolled in the wrong plan meant losing access to “services essential to their recovery and quality of life,” Kletke wrote in September 2024 to Amy Epkey, a senior deputy director of the Michigan Department of Health and Human Services.

In fact, the state’s own records show that Medicaid enrollment for those with disabilities did decline.

Over roughly four years, enrollment in the Medicaid category that includes people with disabilities , according to the Michigan House Fiscal Agency, which provides nonpartisan analysis to lawmakers. The drop was unusual given people generally leave the program because of death or having recovered from a temporary disability, and it’s unlikely those numbers would balloon, said Robert Sheehan, who was the mental health association’s CEO at the time.

Sutfin said the state examined the decline in enrollment and found “several contributing factors, including post‑covid renewal patterns, changes in beneficiary circumstances and movement to other coverage categories.”

After inquiries from Ñî¹óåú´«Ã½Ò•îl Health News, the Michigan health department acknowledged in April that it had made changes to “address concerns raised by advocates.”

Michigan’s computer system now prevents approval of Plan First benefits until all other coverage options are evaluated, Sutfin told Ñî¹óåú´«Ã½Ò•îl Health News. Sutfin said the changes were implemented but “not to correct system errors.”

Sutfin said the state submitted a change request to Deloitte to address this problem. The fix was implemented in January 2025.

Until presented with Kletke’s email, the state had denied there were problems related to Plan First.

Even after the state addressed that issue, other problems persisted.

Noon’s coverage denial notice arrived in September. She fought with the state for months to reverse its decision, “paying cash for all of the medicines through these appeals over and over and over again.”

It was only in January that she was approved.

“I literally cried,” Noon said. “It was a really big deal.”

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2258559
A Mom Said Infant Formula Killed Her Baby. The Manufacturer Closed the File. /health-industry/infant-formula-adverse-events-nec-baby-deaths-fda-reporting/ Thu, 02 Jul 2026 09:00:00 +0000 /?p=2236395 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 and .

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 , 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 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, Ñî¹óåú´«Ã½Ò•îl 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.

Ñî¹óåú´«Ã½Ò•îl 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 under any regulation for preterm infant formula.

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, .

A screenshot of a video hosted by CVN where a balding man in a suit and tie sits behind a microphone. The words "Whitfield v. St. Louis Children's Hospital, et al." and "2024-10-28" are underneath the video.
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. (CVN courtroom video from the Whitfield trial.)

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 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 , according to a Ñî¹óåú´«Ã½Ò•îl Health News analysis of a 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 .

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 and the , have said that, when nutritional needs can’t be met with human milk, formula is vital.

One of the cases, , led to a against Mead Johnson. , Gill v. Abbott, led to a against Abbott. , 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 .

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

On May 5, a Missouri appeals court 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 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 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, Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 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.

Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 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 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 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. Ñî¹óåú´«Ã½Ò•îl 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 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 for reporting infant deaths.

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

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 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 and 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 not just deaths but also “serious injuries” that the product “may have caused or contributed to.”

Drugmakers are required to report any “” adverse event, “.” That fatal or life-threatening events.

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

Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 last year and being named acting head of the agency in May, Kyle Diamantas in the and 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’

Ñî¹óåú´«Ã½Ò•îl 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.

Ñî¹óåú´«Ã½Ò•îl 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 from 2005 through 2022 that contained the search term “NEC.”

When Wallingford went through the files, he found 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 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. Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl Health News reporting team.

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2236395
She Struggled To Get a Lifesaving Drug Even After Insurers Vowed To Help /health-care-costs/prior-authorization-medicare-advantage-humana-missouri-bill-of-the-month-june-2026/ Mon, 29 Jun 2026 09:00:00 +0000 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, . 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, 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 Ñî¹óåú´«Ã½Ò•îl 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.

At least 50 medalls attached to ribbons hang from hooks mounted above a picture window.
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/Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl Health News and that dissects and explains medical bills. Since 2018, this series has helped many patients and readers get their medical bills reduced, and it has been cited in statehouses, at the U.S. Capitol, and at the White House. Do you have a confusing or outrageous medical bill you want to share? !

Ñî¹óåú´«Ã½Ò•îl 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 .

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

]]>
2254875