But Republican lawmakers in some states think the new rules — part of the GOP’s One Big Beautiful Bill Act, signed last July by President Donald Trump — don’t go far enough.

Indiana is leading that charge, with a new law that requires applicants to prove they’ve been working or participating in a similar activity for three consecutive months to get benefits.

Meanwhile, residents in many other states will have to show they’ve been working just one month, the least cumbersome option under Trump’s signature tax-and-domestic-spending law. It instructs states to decide whether to require one, two, or three months of work history.

As in Indiana, Republican Idaho lawmakers approved a three-month requirement, and the state’s governor signed the bill into law on April 10.

The efforts, along with similar moves in Arizona, Missouri, and Kentucky, are aimed at restricting flexibility to implement the federal law at the state level.

“Normally, you would not see state legislators weighing in on these decisions,” said Lucy Dagneau, a senior official with the American Cancer Society’s advocacy arm.

The nonpartisan Congressional Budget Office estimated 18.5 million adults will be subject to the new rules, which will be enforced across 42 states and the District of Columbia. In Indiana, work rules will target about 33% of the state’s Medicaid population. The rules generally wouldn’t apply to children, people 65 or older, or people with disabilities or serious health issues.

Typically, state administrators — not lawmakers — detail how they plan to comply with new federal standards, and they often look to federal regulators for guidance. But officials at the Centers for Medicare & Medicaid Services have yet to tell states how to comply with many aspects of the sweeping budget law, leaving state lawmakers to intervene.

Gov. Mike Braun, a Republican, signed the Indiana bill into law on March 4, making his state the first to set the Medicaid work requirement at three months — the longest period allowed under the federal law.

Republican state Sen. Chris Garten introduced a bill in January, saying it was needed to “align” state law with the new federal Medicaid rules. He also pitched the bill as a way to crack down on “waste, fraud, and abuse” in public programs.

When ineligible people get enrolled, it robs “the truly vulnerable Hoosier who actually needs the help,” Garten said during a January committee hearing.

Democratic state Sen. Fady Qaddoura expressed skepticism during the hearing and questioned the necessity of the legislation. Qaddoura asked Indiana Family and Social Services Administration Secretary Mitch Roob to provide an estimate of the number of ineligible people who enrolled in Medicaid in the state.

“I think very few,” Roob replied. “It’ll never be none.”

After hearing Roob’s answer, Qaddoura said there is no evidence of a widespread problem in Indiana. He accused Republicans of using waste, fraud, and abuse as justification to deny health benefits and food aid to vulnerable Hoosiers.

Garten later called Qaddoura’s accusation a “fundamental mischaracterization” of the bill.

Republicans have said imposing these limits protects the Medicaid program’s longevity.

“We believe in a safety net for our most vulnerable, not a hammock for able-bodied adults that choose not to work,” Garten said. “By tightening these screws, we ensure that our safety net remains sustainable.”

Indiana’s Medicaid enrollment is expected to decrease because of Garten’s legislation, according to an analysis from Indiana’s nonpartisan Legislative Services Agency.

Medicaid helps keep people healthy, so they can continue to work, said Adam Mueller, executive director of the Indiana Justice Project, a nonpartisan legal advocacy organization focusing on health, housing, and food insecurity.

Mueller worries that people will struggle to prove their work history, especially those with nontraditional jobs.

“If the point is to get people engaged, the one month would do it,” Mueller said.

Ultimately, he fears the law will harm Hoosiers with the greatest need for assistance. “They’re going to get tripped up by the bureaucratic hurdles.”

An analysis by the Center on Budget and Policy Priorities predicted that work rules will and that how states choose to implement the rules will “significantly affect the number of people who lose coverage.” State policy decisions will determine just “how intense the burden is,” the left-leaning think tank found, and opting for a shorter look-back period “will enable more people to enroll.”

Lawmakers in multiple states considered limits. And the same right-leaning lobbying group, the Foundation for Government Accountability, testified in favor of these measures in Arizona, Indiana, and Missouri.

In Missouri, FGA lobbyist James Harris said the measure intends to “move people from dependency and give them back that dignity and pride of work.”

Missouri state Rep. Darin Chappell proposed requiring a three-month look-back period like the measure in Indiana. But the latest version of the bill he sponsored would require applicants to show they were working for only one month before enrolling.

Chappell, a Republican, said his initiative would encourage a “working mindset.”

Anna Meyer, owner of a small bakery in Columbia, Missouri, said the implication is that she and others on Medicaid are lazy. “I have been working since I was 15 years old,” she said. “I’m 43 now.”

Meyer, who voiced her opposition, said she previously had problems submitting information to the state Medicaid agency. She fears new reporting requirements will put her and others at risk of losing coverage, even if they meet the work rule.

She has fibromyalgia, a chronic condition that increases overall sensitivity to pain. She also has food allergies. Medicaid helps pay for medications and doctor visits that keep her healthy and allow her to keep working.

“I work very hard,” Meyer said.

In St. Louis, Jessica Norton, an OB-GYN, treats many Medicaid patients at an Affinia Healthcare clinic. She said they struggle to remain insured even though Missouri extends a full year of Medicaid coverage to eligible women after they give birth. Some of her patients are inexplicably kicked off that coverage by the time of their checkups six weeks after birth. She fears red tape from the new work requirements will make it harder to hang on to insurance, even though pregnant women and new mothers are supposed to be exempt.

Norton criticized lawmakers for the message this policy sends to vulnerable patients. They are saying, “Oh, actually, health care is a privilege, and you have to earn it,” she said.

of adults ages 19 to 64 on Medicaid already work, according to KFF. The reason many of the remaining adults on Medicaid are not working is that they are retired, serving as a caregiver, or too sick, KFF has found.

Some states are not only setting the strictest requirements but also blocking out the optional leniency built into the federal rules.

For example, states may adopt additional exemptions from work rules, such as allowing people to claim a “short-term hardship,” designed to provide continued Medicaid coverage to people with medical conditions that prevent them from working.

Missouri lawmakers are seeking a constitutional amendment to bar their state from offering such optional exemptions. But patient advocates warn these limits would harm the state’s vulnerable residents when they need coverage the most, particularly Missouri’s rural cancer patients.

Often, rural Missouri patients must travel to Kansas City or St. Louis for treatment, disrupting their ability to work, Emily Kalmer, a lobbyist for the American Cancer Society’s advocacy arm, testified at the January hearing. Recognizing this, the federal law provides certain exemptions for this kind of scenario.

But this short-term hardship exemption would be off the table in Missouri.

Time is “very important in the life of a cancer patient or a cancer survivor,” Kalmer said.

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State governments rely on such companies to design and operate computer systems that assess whether low-income people qualify for Medicaid or food aid through the Supplemental Nutrition Assistance Program, commonly known as food stamps. Those state systems have a history of errors that can cut off benefits to eligible people, a Ñî¹óåú´«Ã½Ò•îl Health News investigation showed.

States are now racing to update their eligibility systems to adhere to President Donald Trump’s sweeping tax-and-spending law. The changes will add red tape and restrictions. They are coming at a steep price ― both in the cost to taxpayers and coverage losses ― according to state documents obtained by Ñî¹óåú´«Ã½Ò•îl Health News and interviews.

The documents showÌýgovernment agenciesÌýwill spend millionsÌýto saveÌýconsiderablyÌýmoreÌýbyÌýremovingÌýpeople fromÌýhealth benefits.ÌýWhile statesÌýsignÌýeligibility system contracts with companiesÌýandÌýwork with them to manageÌýupdates, the federal governmentÌýfootsÌýmost of the bill.

The law’s Medicaid policies will causeÌýÌýtoÌýbecome uninsuredÌýby 2034, according to the nonpartisan Congressional Budget Office.ÌýRoughlyÌýÌýwill loseÌýaccess toÌýmonthly cashÌýassistanceÌýforÌýfood, including those with children.Ìý

In five statesÌýalone,ÌýÌýfor state officialsÌýand reviewed by Ñî¹óåú´«Ã½Ò•îl Health NewsÌýshow that changesÌýwill cost at least $45.6ÌýmillionÌýcombined.Ìý

The lawÌýrequires most statesÌýtoÌýtieÌýMedicaid coverageÌýfor some adultsÌýtoÌýhavingÌýaÌýjob,ÌýandÌýimposes other restrictions that will make it harder forÌýpeopleÌýwith low incomesÌýto stay enrolled.ÌýSNAP restrictions began to take effect in 2025. Major Medicaid provisionsÌýbeginÌýlater this year.Ìý

DocumentsÌýprepared by consulting company DeloitteÌýestimateÌýthat a pair ofÌýcomputer systemÌýchangesÌýforÌýMedicaid work requirementsÌýin WisconsinÌýwillÌýÌý. Two other changesÌýrelatedÌýto the state’s SNAP program will cost an additional $4.2Ìýmillion, according to the documents, which for the Wisconsin Department of Health Services.

In Iowa, changes to its Medicaid system are expected to cost at least $20 million, , a consulting company thatÌýoperatesÌýthe state’sÌýeligibility system.Ìý

OptumÌý—ÌýwhichÌýoperatesÌýthe platform Vermont residents useÌýfor Medicaid and marketplaceÌýhealthÌýplans under the Affordable Care ActÌý—ÌýÌýÌýÌýÌýtoÌýevaluate andÌýincorporateÌýnewÌýhealthÌýcoverage restrictions.Ìý

Initial changes in Kentucky, which has had a contract with Deloitte since 2012,ÌýÌýÌýÌýÌý. And in Illinois,ÌýÌýwill cost at least $12 million.

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Six months after a West Virginia man died following a protracted battle with his health insurer over doctor-recommended cancer care, the state’s Republican governor signed a bill intended to curb the harm of insurance denials.

West Virginia’s Public Employees Insurance Agency enrolls nearly 215,000 people — state workers, as well as their spouses and dependents. The new law, which will take effect June 10, will allow plan members who have been approved for a course of treatment to pursue an alternative, medically appropriate treatment of equal or lesser value without the need for another approval from the state-based health plan.

“This legislation is rooted in a simple principle: if a treatment has already been approved, patients should be able to pursue a medically appropriate alternative without being forced to start the process over again — especially when it does not cost more,” Gov. Patrick Morrisey said in a statement after signing the bill into law on March 31.

“This is about common sense, compassion, and trusting patients and their doctors to make the best decisions for their care,” he said.

Delegate Laura Kimble, the Republican from Harrison County who introduced the legislation, told Ñî¹óåú´«Ã½Ò•îl Health News the measure offers “a rational solution” for patients facing “the most irrational and chaotic time of their lives.”

From Arizona to Rhode Island, at least half of all state legislatures have taken up bills this year related to prior authorization, a process that requires patients or their medical team to seek approval from an insurer before proceeding with care. These state efforts come as patients across the country await relief from prior authorization hurdles, as promised by dozens of major health insurers in a pledge announced by the Trump administration last year.

The West Virginia law was inspired by Eric Tennant, a coal-mining safety instructor from Bridgeport who died on Sept. 17 at age 58. In early 2025, the Public Employees Insurance Agency of a $50,000 noninvasive cancer treatment, called histotripsy, that would have used ultrasound waves to target, and potentially shrink, the largest tumor in his liver. His family didn’t expect the procedure to eradicate the cancer, but they hoped it would buy him more time and improve his quality of life. The insurer said the procedure wasn’t medically necessary and that it was considered “experimental and investigational.”

Becky Tennant, Eric’s widow, told members of a West Virginia House committee in late February that she submitted medical records, expert opinions, and data as part of several attempts to appeal the denial. She also reached out to “almost every one of our state representatives,” asking for help.

Nothing worked, she told lawmakers, until Ñî¹óåú´«Ã½Ò•îl Health News and NBC News got involved and posed questions to the Public Employees Insurance Agency about Eric’s case. Only then did the insurer reverse its decision and approve histotripsy, Tennant said.

“But by then, the delay had already done its damage,” she said.

Within one week of the reversal in late May, Eric Tennant was hospitalized. His health continued to decline, and by midsummer he was no longer considered a suitable candidate for the procedure. “The insurance company’s decision did not simply delay care. It closed doors,” his wife said.

Had the new law been in effect, Kimble said, Tennant could have undergone histotripsy without preapproval, because it was a less expensive alternative to chemotherapy, which his insurer had already authorized. The bill was passed unanimously by the state legislature in March.

U.S. health insurers argue that most prior authorization requests are quickly, if not instantly, approved. AHIP, the health insurance industry trade group, says prior authorization acts as an important guardrail in preventing potential harm to patients and reducing unnecessary health care costs. But denials and delays tend to affect patients who need expensive, time-sensitive care, .

The practice has come under intense scrutiny in recent years, particularly after the in New York City in late 2024. Americans rank prior authorization as their biggest burden when it comes to getting health care, according to a by KFF, a health information nonprofit that includes Ñî¹óåú´«Ã½Ò•îl Health News.

Samantha Knapp, a spokesperson for the West Virginia Department of Administration, would not answer questions about the law’s financial impact on the state. “We prefer to avoid any speculation at this time regarding potential impact or actions,” Knapp said.

In a fiscal note attached to the bill, Jason Haught, the Public Employees Insurance Agency’s chief financial officer, said the law would cost the agency an estimated $13 million annually and “cause member disruption.”

West Virginia isn’t an outlier in targeting prior authorization. By late 2025, 48 other states, in addition to the District of Columbia and Puerto Rico, already had some form of a prior authorization law — or laws — on the books, according to a by the National Association of Insurance Commissioners.

Many states have set up “gold carding” programs, which allow physicians with a track record of approvals to bypass prior authorization requirements. Some states establish a maximum number of days insurance companies are allowed to respond to requests, while others prohibit insurance companies from issuing retrospective denials after a service has already been preauthorized. There are also a crop of new state laws seeking to regulate the use of artificial intelligence in prior authorization decision-making.

Meanwhile, prior authorization bills introduced this year across the country, including in Kentucky, Missouri, and New Jersey, have been supported by politicians from both parties.

“Republicans in conservative states see health care as a vulnerability for the midterm elections, and so, unsurprisingly, you’ll see some action on this,” said Robert Hartwig, a clinical associate professor of risk management, insurance, and finance at the University of South Carolina. “They realize that they’re not really going to get much action at the federal level given the degree of gridlock we’ve already seen.”

Last summer, the Trump administration announced a pledge signed by dozens of health insurers vowing to reform prior authorization. The insurers promised to reduce the scope of claims that require preapproval, decrease wait times, and communicate with patients in clear language when denying a request.

Consumers, patient advocates, and medical providers that companies will follow through on their promises.

Becky Tennant is skeptical, too. That’s why she advocated for the West Virginia bill.

“Families should not have to beg, appeal, or go public just to access time-sensitive care,” she told lawmakers. Tennant, who sees the bill’s passage as bittersweet, said she thought her husband would have been proud.

During Eric’s final hospital stay, Tennant recalled, right before he was discharged to home hospice care, she asked him whether he wanted her to keep fighting to change the state agency’s prior authorization process.

“‘Well, you need to at least try to change it,’” she recalled her husband saying. “‘Because it’s not fair.’”

“I told him I would keep trying,” she said, “at least for a while. And so I am keeping that promise to him.”

NBC News health and medical unit producer Jason Kane and correspondent Erin McLaughlin contributed to this report.

Do you have an experience with prior authorization you’d like to share? to tell Ñî¹óåú´«Ã½Ò•îl Health News your story.

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State governments rely on such companies to design and operate computer systems that assess whether low-income people qualify for Medicaid or food aid through the Supplemental Nutrition Assistance Program, commonly referred to as food stamps. Those state systems have a history of errors that can cut off benefits to eligible people, a Ñî¹óåú´«Ã½Ò•îl Health News investigation showed.

These benefits, provided to the poorest Americans, can mean the difference between someone obtaining medical care and having enough to eat — or going without.

States are now racing to update their eligibility systems to adhere to President Donald Trump’s sweeping tax and domestic spending law. The changes will add red tape and restrictions. They are coming at a steep price — both in the cost to taxpayers and coverage losses — according to state documents obtained by Ñî¹óåú´«Ã½Ò•îl Health News and interviews.

The documents show government agencies will spend millions to save considerably more by removing people from health benefits. While states sign eligibility system contracts with companies and work with them to manage updates, the federal government foots most of the bill.

The law’s Medicaid policies will cause to become uninsured by 2034, according to the nonpartisan Congressional Budget Office. Roughly will lose access to monthly cash assistance for food, including those with children.

In five states alone, for state officials and reviewed by Ñî¹óåú´«Ã½Ò•îl Health News show that changes will cost at least $45.6 million combined.

“This is a pretty big payday,” said Adrianna McIntyre, an assistant professor of health policy and politics at Harvard’s T.H. Chan School of Public Health.

The law, which grants tax breaks to the nation’s wealthiest people, requires most states to tie Medicaid coverage for some adults to having a job, and imposes other restrictions that will make it harder for people with low incomes to stay enrolled. SNAP restrictions began to take effect in 2025. Major Medicaid provisions begin later this year.

Documents prepared by consulting company Deloitte estimate that a pair of computer system changes for Medicaid work requirements in Wisconsin will . Two other changes related to the state’s SNAP program will cost an additional $4.2 million, according to the documents, which for the Wisconsin Department of Health Services.

In Iowa, changes to its Medicaid system are expected to cost at least $20 million, , a consulting company that operates the state’s eligibility system.

Optum — which operates the platform Vermont residents use for Medicaid and marketplace health plans under the Affordable Care Act — to evaluate and incorporate new health coverage restrictions.

Initial changes in Kentucky, which has had a contract with Deloitte since 2012, . And in Illinois, will cost at least $12 million.

A Historic Mandate

For six decades after President Lyndon Johnson created the government insurance program in 1965, Congress had never mandated that Medicaid enrollees have a job, volunteer, or go to school.

That will change next year. The tax and spending law enacted by Trump and congressional Republicans requires millions of Medicaid enrollees in 42 states and the District of Columbia to prove they’re working or participating in a similar activity for 80 hours a month, unless they qualify for an exemption. The CBO projected, based on an early version of the bill, that 18.5 million adults would be subject to the new rules — .

Vermont Medicaid officials expect it will cost $5 million in fiscal 2027 to implement changes in response to the federal law, said Adaline Strumolo, deputy commissioner of the Department of Vermont Health Access. About $1.8 million is for Optum to make eligibility system adjustments. Optum is a subsidiary of UnitedHealth Group.

The One Big Beautiful Bill Act will subject nearly 55,000 Vermont Medicaid recipients to work requirements — about a third of the state’s enrollees.

The law forced the state “to essentially drop everything else we were doing,” Strumolo said in an interview. “This is a big, big lift.”

Optum’s contract with the state was as of October.

of adult Medicaid enrollees nationally are already working, according to KFF. Advocacy groups for Medicaid recipients say work requirements will nonetheless cause significant coverage losses. Enrollees will face added red tape to prove they’re complying. And eligibility systems already prone to error will have to account for employment, job-related activities, and any exemptions.

An estimated 5.3 million enrollees will become uninsured by 2034 due to work requirements, the .

In Wisconsin, state officials estimate could lose coverage after work requirements take effect. Not covering those people would in Medicaid spending for one year.

Wisconsin’s eligibility system for Medicaid and SNAP — known as CARES — in 1994, and initially was a transfer system from Florida, according to a 2016 state document.

Deloitte submitted its cost estimates for Medicaid and SNAP changes to the state in September and December. Elizabeth Goodsitt, a spokesperson for the Wisconsin Department of Health Services, declined to answer questions about whether additional changes will be needed, how much it will cost to make all eligibility system changes to comply with the new federal law, and whether the state negotiated prices with Deloitte.

Bobby Peterson, executive director of the public interest law firm ABC for Health, said Wisconsin has invested “very little” to help people navigate the Medicaid eligibility process, which soon will become more difficult.

“But they’re very willing to throw $6 million to their contractors to create the bells and whistles,” Peterson said. “That’s where I feel a sense of frustration.”

New Hurdles for Vets and Homeless People

Medicaid work requirements are only one change required by Trump’s tax law that will make it harder to obtain safety-net benefits.

Starting in October, the law prohibits several immigrant populations from accessing Medicaid and ACA coverage, including people who have been granted asylum, refugees, and certain survivors of domestic violence or human trafficking. Beginning Dec. 31, states must verify eligibility twice a year for millions of adults — doubling state officials’ workload. And the law restricts SNAP benefits by requiring more adult recipients to work and by removing work exemptions for veterans, homeless people, and former foster youth.

Days after Trump signed the bill in July, Kentucky health officials raced to make changes to the state’s integrated eligibility system, which verifies eligibility for Medicaid, SNAP, and other programs. Deloitte operates the system under a five-year . , initial changes costing $1.6 million were labeled a “high priority” and approved on an “emergency” basis, with some of the changes to the nation’s largest food aid program going into effect almost immediately.

Officials with Kentucky’s Cabinet for Health and Family Services declined to answer a detailed list of questions, including how much it will cost to make all the modifications needed.

Deloitte spokesperson Karen Walsh said the company is working with states to implement new requirements but declined to answer questions about cost estimates in several states. “We are delivering the value and investments we committed to,” Walsh said.

In most states, government agencies rely on contractors to build and run the systems that determine eligibility for Medicaid. Many of those states also use such computer systems for SNAP. But the federal government — that is, taxpayers — to develop and implement state Medicaid eligibility systems and pays 75% of ongoing maintenance and operations expenses, according to federal regulations.

“Five, 10 years ago, I’m not sure if you would hear much mention of SNAP from a Medicaid director,” Melisa Byrd, Washington, D.C.’s Medicaid director, said in November at an annual conference of Medicaid officials. “And particularly for those with integrated eligibility systems — as D.C. is —­ I’m learning more about SNAP than I ever thought.”

The federal law was the topic du jour at last year’s gathering in Maryland, held at the Gaylord National Resort and Convention Center, the largest hotel between New Jersey and Florida.

Consulting companies had taken notice. Gainwell, an eligibility contractor and one of the conference’s corporate sponsors, emblazoned its logo on hotel escalators. Companies set up booths with materials promoting how they could help states and handed out snacks and swag.

“Conduent helps agencies work smarter by simplifying operations, cutting costs and driving better outcomes through intelligent automation, analytics, and innovation in fraud prevention,” read one such handout from another contractor. “Together, we can better serve residents at every step of their health journeys.” Conduent holds Medicaid eligibility and enrollment contracts in Mississippi and New Jersey, their Medicaid agencies confirmed to Ñî¹óåú´«Ã½Ò•îl Health News.

In handouts, Deloitte touted its role in “building a new era in state health care” and as “a national leader in Medicaid program and technology transformation, building a strong track record across the federal, state, and commercial health care ecosystem.” Ñî¹óåú´«Ã½Ò•îl Health News found that Deloitte, a global consultancy that generated in revenue in fiscal 2025, dominates this slice of government business.

“With Medicaid Community Engagement (CE) requirements, states are tasked with adding a new condition of Medicaid eligibility to support state and federal objectives,” added another brochure. “Deloitte offers strategic outreach and responsive support to help states engage communities, lower barriers, and address access to coverage.”

A $20.3 Million Bill in Iowa

Before Trump signed the One Big Beautiful Bill Act, Iowa lawmakers wanted to impose their own version of work requirements. They would have applied to 183,000 people before any exemptions. The new law would necessitate a change to Iowa’s Medicaid eligibility system, according to documents prepared by Accenture, which operates Iowa’s system through a .

Adding the ability to verify work status would cost up to $7 million, . By July, the cost to implement the One Big Beautiful Bill Act’s work requirements and other Medicaid provisions . Accenture’s analysis said the federal law necessitated . Making employment a condition of Medicaid benefits could cause an estimated 32,000 Iowans to lose coverage, according to a

Cutting 32,000 people from coverage in one year, a fraction of the Iowa and the federal government spend on Medicaid in a given year.

In Cedar Rapids, most of Eastern Iowa Health Center’s patients rely on Medicaid, CEO Joe Lock said. He questioned the government’s logic of spending tens of millions of dollars on a policy to remove Iowans from Medicaid.

Most of the health center’s patients live at or below the federal poverty level — currently .

“There is no benefit to this population,” Lock said.

Danielle Sample, a spokesperson for Iowa’s Department of Health and Human Services, did not answer questions about how much it will cost to implement changes to the state’s separate SNAP eligibility system.

In Illinois, the state’s work this year is largely focused on meeting major provisions of the One Big Beautiful Bill Act. The state estimates that as many as 360,000 residents could lose Medicaid, largely due to the work requirements, said Melissa Kula, a spokesperson for the Illinois Department of Healthcare and Family Services.

Kula confirmed that — priced at $12 million — is related to Trump’s law. The estimate also mentions other work. Kula said Deloitte is charging the state a $2 million fixed fee related to work requirements.

The Trump administration has acknowledged that the work is coming at a cost. In January, top officials for the Centers for Medicare & Medicaid Services said government contractors, including Deloitte, Accenture, and Optum, have and reduced rates through 2028 to help states incorporate system changes.

“The companies were extremely excited to do this,” , the top CMS Medicaid official. “Everyone’s really focused on getting to work.”

CMS spokesperson Catherine Howden declined to answer questions about the discounts.

Goodsitt, the Wisconsin Medicaid spokesperson, declined to answer questions about whether Deloitte has discounted its rates. Officials with Kentucky’s Cabinet for Health and Family Services did not answer a detailed list of questions, including whether Deloitte extended discounts to make these changes.

It’s unclear what discounts, if any, Deloitte and Accenture have offered to individual states. Walsh, the Deloitte spokesperson, declined to answer detailed questions about the discounts the Trump administration announced this year. Accenture did not respond to repeated requests for comment.

Strumolo, the Vermont health official, said state officials discussed the announcement with Optum “in detail.”

Optum for a specific module related to Medicaid work requirements. That product is unworkable for Vermont because it would mean “moving to a new system when we don’t have to.” When asked about whether the company offered discounts, Strumolo said “not explicitly.”

In a statement, UnitedHealth Group spokesperson Tyler Mason said Optum supports state implementation of new federal requirements “with a range of options to meet their unique cost and policy needs.”

He declined to specify whether Optum discounted Vermont’s rates and how it calculated the costs of doing its work. “Optum is helping mitigate upfront implementation expenses so states can focus on approaches that reduce duplication, accelerate implementation, and manage costs over time — supporting better outcomes for individuals covered by Medicaid,” Mason said.

Strumolo said Optum’s initial changes in Vermont cover items that take effect this year and in 2027 — Medicaid work requirements, checking eligibility every six months, and prohibiting certain immigrants from qualifying for health programs.

“There’s a lot more that could come,” she said.

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The upshot, : Babies fed rival Mead Johnson Nutrition’s acidified liquid human milk fortifier — a nutritional supplement used in neonatal intensive care units — developed certain complications at higher rates than those given an Abbott fortifier, a researcher at the University of Nebraska had found.

At least one of those complications .

The Abbott scientist, Bridget Barrett-Reis, described the results in the email to colleagues, using two exclamation points. Then she proposed that Abbott test the Mead Johnson fortifier, acidified for sterilization, against another Abbott product.

The clinical trial among preterm infants that Abbott subsequently sponsored, , is a case study of corporate warfare in the high-stakes business of infant nutrition, wherein preemies have been coveted like commodities; their anxious, vulnerable parents have been — whether they know it or not — targets of calculated commercial pursuit; and scientific research has been used as a marketing tool.

In hospitals around the country, dozens of babies born an average of 11 weeks early were fed Mead Johnson’s fortifier. Dozens of others were fed an Abbott fortifier that wasn’t acidified.

The clinical trial became a boon for Abbott, which to wrest market share from Mead Johnson. But for some of the babies enrolled, it didn’t turn out so well, a Ñî¹óåú´«Ã½Ò•îl Health News investigation found.

Far more infants given Mead Johnson’s product developed a buildup of acid in the blood called metabolic acidosis than those fed Abbott’s product — 19 versus four, according to results published in the journal .

Two outside doctors monitoring infants in the study became so alarmed that they refused to enroll any more babies, according to an April 2016 email one of them sent to Abbott.

In a related email to Abbott, neonatologist Robert White of Memorial Hospital in South Bend, Indiana, and Pediatrix Medical Group — an investigator in the study — .

“We had another SAE” — serious adverse event — “today in which a child developed profound metabolic acidosis while on the study fortifier,” White wrote. The severity was “unlike what we would see in most children with these issues.”

A manager at Abbott replied that the company was “taking your concerns very seriously.”

The study continued for almost a year.

At least some of the consent forms used to inform parents about risks did not mention metabolic acidosis or the often-fatal necrotizing enterocolitis, another condition identified in the 2013 email that led to the study.

In a November response to questions for this article, Abbott spokesperson Scott Stoffel said the clinical trial “was safe and ethical” and that the fortifiers it compared were “on the market and widely used.”

The study was “led by 20 non-Abbott investigators,” Stoffel said.

According to a federal website, chaired the study.

Stoffel added that the study was approved “by 14 independent safety review boards at hospitals” and “published in a leading peer-reviewed scientific journal.”

“It is reckless and not credible to suggest that these doctors and institutions conducted and then published the results of an unsafe or unethical study,” Stoffel said.

A spokesperson for Mead Johnson, Jennifer O’Neill, did not comment on Abbott’s clinical trial but said in a November statement to Ñî¹óåú´«Ã½Ò•îl Health News that existing studies “cannot responsibly support” any connection between the acidified fortifier and conditions such as necrotizing enterocolitis or metabolic acidosis.

Mead Johnson executive Cindy Hasseberg argued in a deposition that Abbott waged a “smear campaign” against the acidified fortifier that was “very hard to come back from.”

In 2024, Mead Johnson discontinued the product.

Winning the ‘Hospital War’

Behind their warm-and-fuzzy marketing, industry giants Abbott, maker of Similac products, and Mead Johnson, maker of the Enfamil line, have turned neonatal intensive care units into arenas of brutal competition.

This article quotes from and is based largely on records from three lawsuits against formula manufacturers that went to trial in 2024 and are now on appeal. The cases are , , and The records include emails, internal presentations, and other company documents used as exhibits in litigation, as well as court transcripts and witness testimony from depositions.

The records provide an inside view of the business of infant formula and fortifier, a nutritional supplement added to a mother’s milk. For example, a Mead Johnson slide deck for a 2020 national sales meeting — later used in the Whitfield trial — outlined a plan for “Branding NICU Babies.”

Urging employees to win more sales from neonatal intensive care units, the document said: “’”

In internal documents and other material from litigation reviewed by Ñî¹óåú´«Ã½Ò•îl Health News, formula makers described hospitals as gateways to the much larger retail market because parents are likely to stick with the brand their babies started on. Products used in the NICU help win hospital contracts, and hospital contracts help establish brand loyalty, according to court records.

Manufacturers vie for contracts that can be “exclusive” or nearly so, according to records from the litigation, including company documents and testimony by people who have worked in management for the companies.

An undated Abbott presentation used in the Gill case, apparently referring to inroads with hospitals in its rivalry with Mead Johnson, boasted of “MJ Strongholds Broken!”

It saluted two employees who “Own 27K Babies Exclusively,” and said another “Stole 600 formula feeders from MJ.”

Still others were praised for “Playing in Mom’s mailbox” or “kicking … and ‘taking names.’”

In July 2024, Abbott CEO Robert Ford said in a conference call for investors that formula and fortifier for preterm infants generated total annual revenue of about $9 million — a small portion of Abbott’s total sales of $42 billion in 2024 and its $2.2 billion of sales in the United States from pediatric nutritional products.

Industry documents cited in litigation provide a different perspective.

“‘,” stated an Abbott training presentation from about a decade ago used in the Gill and Whitfield trials.

That described a baby’s first formula feeding in the hospital, the document said. Over 74% of the time, an infant fed formula in the hospital stays on that brand at home, the document said.

Abbott’s goal was that the first-bottle-fed strategy , the document showed. A staff training slide displayed during the Whitfield trial showed how that momentum could pay off in bonuses for Abbott sales representatives, leading to a “Happy Rep.”

Mead Johnson has espoused a similar strategy.

The company rolled out a with cash rewards for flipping hospitals from Abbott, according to a 2019 document marked for internal use by Mead Johnson and its parent company, England-based Reckitt Benckiser Group, and admitted into evidence in the Watson case.

“ is critical to contract gains and acquisition,” stated a company plan for 2022 that was cited in the Whitfield case.

One Abbott document shown in the Whitfield trial said more than half of first feedings happen at night, adding, “.”

A “Mead Johnson University” training document described a scenario in which a sales rep overhears patient information in a NICU and encouraged the rep to promote the company’s products. The document, titled “,” was admitted as evidence in the Watson case.

“[Y]ou are walking back into your most important NICU,” it said. “You overhear the HCP’s” — health care providers, apparently — “stating all of the notes,” it said. “There may be some information that may help you to position your products as a resource for this patient and to handle any objections that the HCP may present you with.”

To win parents’ business, companies have supplied formula to hospitals free or at a loss, court records show. That has resulted in such curiosities as a Mead Johnson “purchasing agreement” cited in the Watson case, listing the price for product after product as “no charge.”

In a 2017 strategy document prepared for Mead Johnson, a consulting firm laid out a plan “to win hospital war.”

Why focus on hospitals? “,” it explained.

The document was displayed in the Whitfield case.

In the market for preterm nutrition, Abbott and Mead Johnson compete with each other, not against the use of human milk, the companies told Ñî¹óåú´«Ã½Ò•îl Health News.

“Thus, references in documents about wanting to ‘win’ or ‘own’ the NICU refer to out-performing Mead Johnson by offering the highest-quality products,” Abbott’s Stoffel said in February.

Asked specific questions about business strategies and internal documents, Mead Johnson’s O’Neill said the company was “concerned that you are presenting a misleading and incomplete picture.”

Mead Johnson’s products “are safe, effective, and recommended by neonatologists when clinically appropriate,” O’Neill added.

On the Defensive

In courthouses around the country, Abbott and Mead Johnson are on the defensive — and have been for years.

In hundreds of lawsuits, parents of sickened or deceased preterm infants have alleged that formula designed for preemies has caused necrotizing enterocolitis, or NEC, a devastating condition in which immature intestinal tissue can become infected and die, spreading infection through the body.

Lawsuits also accuse the manufacturers of failing to warn parents of the risk.

One of the cases on which this article is based, , resulted in a against Mead Johnson. , Gill v. Abbott Laboratories, et al., resulted in a against Abbott. , Whitfield v. St. Louis Children’s Hospital, et al., resulted in a , but the judge found errors and misconduct on the part of defense counsel, faulted his own performance, and .

The cases have involved children like Robynn Davis, who was born at 26 weeks, lost 75% to 80% of her intestine to NEC, suffered brain damage — and, at almost 3 years old, couldn’t walk, couldn’t really talk, and was eating through a tube, as Jacob Plattenberger, an attorney representing her, in 2024.

An attorney for Abbott, James Hurst, that Robynn suffered a catastrophic brain injury at birth, 10 days before she received any Abbott formula, and that her NEC resulted not from formula but from many health problems.

In at least three cases, a federal judge has in favor of Abbott — ruling for the company before the lawsuits even reached trial.

The formula makers have repeatedly denied fault.

Addressing stock analysts in 2024, as “without merit or scientific support” the theory that preterm infant formula or milk fortifier caused NEC.

In a issued in 2024, the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health said there was “no conclusive evidence that preterm infant formula causes 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.

Neonatologists use the products routinely, O’Neill said.

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,” adding that trial evidence “demonstrated, at a minimum, uncertainty as to the magnitude of the risk, as well as the causal role of various feeding options in the development of NEC.”

Manufacturers say formula is needed when mother’s milk or human donor milk isn’t an option. Fortifier, a product tailored to preemies, is meant to augment mother’s milk when babies are born prematurely and a mother’s milk alone doesn’t deliver enough nutrition. The Mead Johnson fortifier used in the head-to-head clinical trial sponsored by Abbott was acidified to prevent bacterial contamination.

In March 2025, Health and Human Services Secretary Robert F. Kennedy Jr. announced that his department, which encompasses the FDA, was undertaking a review of infant formula, dubbed “Operation Stork Speed.” It includes and increasing testing for heavy metals and other contaminants, HHS said.

However, is limited. The agency doesn’t approve the products or their labeling. Whether to report adverse events — illnesses or deaths potentially related to the products — to the FDA is largely at manufacturers’ discretion.

The business of infant formula further spotlights a central contradiction in the Trump administration’s health policies. When it comes to food and medical products, the administration has criticized industry-funded research as unworthy of trust. Yet under Kennedy, it has disrupted, defunded, or sought to cut government-funded research, which could leave industry-funded research with a larger and more influential role.

It “is entirely appropriate for the Department to scrutinize research design, conflicts of interest, and funding sources, particularly when research is used to inform public policy,” HHS spokesperson Andrew Nixon said.

‘At the Table’

Company emails cited in litigation shed light on the industry’s approach to research.

In a 2015 email, when Mead Johnson was considering supplying some of its formula to a researcher for a study, a company neonatologist expressed concern that the results could be spun to make the preemie product look unsafe.

“However, we are more likely to have control over final language if we provide the small support and are ‘at the table’ with him,” Mead Johnson’s Timothy Cooper added in the email, which was cited in the Watson trial.

In 2017, Abbott with researchers at Johns Hopkins University about a study on how the composition of infant formula might affect NEC in mice. The email thread became an exhibit in the Whitfield case.

Abbott was both funding and collaborating on the work, shows.

Forwarding a draft of the resulting paper to Abbott, David Hackam, chief of pediatric surgery at the Johns Hopkins University School of Medicine, said in one of the emails, “We hope you like it.” He also requested help from Abbott in filling in information.

“The manuscript looks great!” Abbott’s Tapas Das , after a back-and-forth.

But Abbott had some changes, the email thread shows.

“We (VM & DT) made some edits in the text especially to soften a bit with the statement ‘infant formula seems responsible for developing NEC,’” Das wrote.

“Instead, we thought if we could state as ‘infant formula is linked to severity of NEC’. So we made changes throughout the text emphasizing on severity of NEC by infant formula rather than development of NEC by infant formula,” Das wrote.

Das wrote that “other factors are involved for NEC development as described in the text.”

Hackam did not respond to questions Ñî¹óåú´«Ã½Ò•îl Health News sent by email.

Efforts to reach Das and Cooper — including by phoning numbers and sending letters to addresses that appeared to be associated with them — were unsuccessful.

When Mead Johnson provided support to scientific researchers, the company would want to make sure they reported the results “in an honest way,” Cooper said in a deposition played in the Watson trial.

The Abbott co-authors “proposed routine edits to the article for scientific accuracy and for the consideration of the other authors, some of the most well-respected NEC researchers in the world,” Abbott’s Stoffel said.

“Abbott regularly collaborates with and publishes studies with leading NEC scientists for the benefit of both premature infants and the entire scientific community,” Stoffel said.

“The research studies Mead Johnson supports are conducted independently and appropriately, with full transparency,” said O’Neill, the Mead Johnson spokesperson.

‘In the Wrong Direction’

Transparency can be subjective.

More than a decade ago, Mead Johnson sponsored a clinical trial testing what was then a new acidified liquid fortifier against a powdered fortifier already on the market.

In the study, which enrolled 150 babies, 5% of infants fed the acidified liquid developed NEC compared with 1% of infants fed the powder, according to deposition testimony and a record of the clinical trial used in the Watson case.

That information was not included in a 2012 that reported the study results.

The article, in the journal Pediatrics, whose authors included two Mead Johnson employees, concluded it was safe to use the new liquid fortifier instead of the powdered one. The article also said that, comparing babies fed the liquid with those fed the powder, the study observed no difference in the incidence of NEC.

The unpublished finding of 5% to 1% represented so few babies that it was not statistically significant.

Nonetheless, retired neonatologist Victor Herson, who ran a NICU in Connecticut and has studied fortifiers, said in an interview he would have wanted to see those numbers.

“The trend was in the wrong direction,” Herson said, “and would have, I think, alerted the typical neonatologist that, well, maybe not to rush in and adopt” the new fortifier.

It’s common for study publications to include tables showing complications even if they aren’t statistically significant so that readers can draw their own conclusions, Herson said.

Neonatologist Fernando Moya, a co-author of the Pediatrics article, had a different perspective.

“You may not be very familiar with medical literature but when there are no ‘statistically significant’ differences, we do not comment on whether something was increased or decreased,” Moya said by email. He referred questions to Mead Johnson.

Mead Johnson’s O’Neill gave several reasons why “the data you cite was not included in the publication.” She said the study was designed to examine infant nutrition and growth, NEC was a “secondary outcome,” the NEC numbers weren’t statistically significant, and the size of the study, “while appropriate, was not powered to draw any conclusions with respect to any potential differences in NEC.”

In a deposition used in the Watson trial, Carol Lynn Berseth — a co-author of the paper and Mead Johnson’s director of medical affairs for North America when the study was completed — testified that the article was peer-reviewed and that no reviewer asked for additional data.

“Had they asked for it, we would have shown it,” Berseth testified.

Berseth did not respond to a phone message or to an email or letter sent to addresses apparently associated with her.

‘It Should Not Be in a NICU’

The Abbott scientist who flagged research on Mead Johnson’s acidified fortifier in 2013, Bridget Barrett-Reis, was later of AL16, the follow-up clinical trial Abbott sponsored, and of .

In a deposition, she was asked why she conducted the study.

“I conducted that study because I thought [the acidified fortifier] could be dangerous,” she said, “and I thought it would be a good idea to find out if it really was because nobody was doing anything about it.”

Elaborating on the thinking behind the study, she testified: “It should not be in a NICU in the United States. That product should not be anywhere for preterm infants.”

In her 2013 email recommending that Abbott conduct a study, Barrett-Reis cited findings by “an independent investigator,” Ann Anderson-Berry, that showed, compared with preterm infants fed an Abbott powder, those on Mead Johnson’s acidified liquid “had slower growth, higher incidence of metabolic acidosis and NEC!!”

Asked about the exclamation points, Barrett-Reis testified in a January 2024 deposition used in the Gill case that she wasn’t excited about the findings. “I am known to put exclamation points instead of question marks and everything anywhere, so I have no idea at the time what those meant,” she testified.

The research that caught her eye in 2013 reviewed patient records from the Nebraska Medical Center. The institution had switched to the acidified fortifier with high hopes but stopped using it after four months because it was concerned about patient outcomes, Anderson-Berry and Nebraska co-authors .

In an interview, Anderson-Berry said she set out to analyze why, during those four months, babies’ growth “fell apart in our hands.”

Abbott was “very pleased” with Anderson-Berry’s findings and paid her to go around the country discussing them, she said.

Metabolic acidosis can be fatal, Anderson-Berry said. But typically it can be managed, she said, adding that she didn’t know of deaths from metabolic acidosis caused by the acidified fortifier.

Research has found that metabolic acidosis “is associated with poor developmental and neurologic outcomes in very low birth weight infants,” according to . In addition, it is “a risk factor for neonatal necrotizing enterocolitis,” the paper said.

Barrett-Reis did not respond to inquiries for this article, including a message sent via LinkedIn and a letter sent to an address that appeared to be associated with her.

In court, Abbott representative Robyn Spilker testified that metabolic acidosis and that nobody should knowingly put kids at risk for getting NEC in an effort to make money.

Before infants were enrolled in the AL16 study, their parents or guardians had to sign consent forms disclosing, among other things, the risks that clinical trial subjects would face.

International ethical principles for medical research on humans, known as the , say each participant must be adequately informed of the “potential risks.”

Questioning Abbott’s Spilker in litigation, plaintiff’s attorney Timothy Cronin said, “Ma’am, despite the hypothesis going in, are you aware Abbott on the informed consent form given to parents that signed their kids up for that study?” Spilker, who identified herself in court as a senior brand manager, said she didn’t know what was on the consent forms.

Through a request under a Kentucky open-records law, Ñî¹óåú´«Ã½Ò•îl Health News obtained an informed consent form for the AL16 study used at a public institution, the University of Louisville. The form mentioned risks such as diarrhea, constipation, gas, and fussiness. It did not mention metabolic acidosis or NEC.

Ñî¹óåú´«Ã½Ò•îl Health News also reviewed an informed consent form for the AL16 study used at Memorial Hospital of South Bend. It was largely identical to the one used in Louisville and did not mention metabolic acidosis or NEC.

Cronin, the plaintiff’s attorney, said in an interview that Abbott showed disregard for the health and safety of premature babies participating in the AL16 clinical trial.

“I think it’s unethical to do a study if you know you are subjecting participants in the study to an increased risk of a potentially deadly disease and you don’t at least tell them that,” Cronin said.

Anderson-Berry told Ñî¹óåú´«Ã½Ò•îl Health News that Abbott was “ethically well positioned” to conduct the AL16 clinical trial because her paper was not definitive.

Yet she said she was unwilling to enroll any of her patients in the Abbott clinical trial because she didn’t want to take the chance that they would be given the acidified liquid.

White, the neonatologist who stopped enrolling patients in the study, defended the decision to conduct it. In an interview, he said it was appropriate to conduct a large, properly controlled clinical trial to see whether concerns raised in earlier research were borne out. The two babies whose serious adverse events he reported to Abbott ended up doing fine, he said.

But White, who went on to be listed as a co-author of the study, told Ñî¹óåú´«Ã½Ò•îl Health News that parents should have been informed that the risks included metabolic acidosis and NEC.

“In retrospect, obviously, that is something that we, I think, should have informed parents of,” he said.

Abbott did not directly answer questions about the consent forms.

The results of AL16 were in 2018. The conclusion: Infants fed the acidified product — in other words, the Mead Johnson fortifier — had higher rates of metabolic acidosis and poorer feeding tolerance. Plus, poorer “initial weight gain.”

The title of the article trumpeted “Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier” — in other words, the Abbott product.

Eight of the 78 infants receiving the Mead Johnson fortifier were treated for metabolic acidosis, compared with none of the 82 receiving the Abbott product, the article said. Four infants on Mead Johnson’s product experienced serious adverse events, compared with one on the Abbott product, the article reported.

One infant receiving the Mead Johnson product died — from sepsis, the article said. One had a case of NEC, and infants on Mead Johnson’s fortifier “had significantly more vomiting,” the article said.

However, in a pair of letters to the editor published in the Journal of Pediatrics, the article as hyped. Writers said the article emphasized findings that were .

In its business battle with Mead Johnson, Abbott deployed the study. It produced an annotated copy for its sales force, which was shown in the Whitfield trial.

Abbott’s use of AL16 as a marketing tool worked.

In 2019, when Barrett-Reis applied for a promotion at Abbott, she wrote that the results of the study had been “leveraged to secure whole hospital contracts which have increased hospital share to > 70%.”

Her letter was displayed in a deposition video filed in the Gill litigation.

Internally, Mead Johnson conceded it had been beaten in the fight over fortifiers. In the slide deck for a 2020 national sales meeting, the company said, “Abbott won the narrative.”

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They worked for a bit. But by 2011, Warfield struggled to walk.

And “by that time, I was addicted,” said Warfield, now living in Shelbyville, Kentucky.

After she lost her health insurance, Warfield started buying pills on the street. She tried to quit several times, but the debilitating withdrawal — so bad she couldn’t get out of bed, she said — kept driving her back to drug use.

Until last year.

Through her church, Warfield learned about the NET device. It’s a cellphone-sized pack connected to gel electrodes placed near the ear that deliver low-level electrical pulses to the brain.

“Once I got set up on the device, within 30 minutes, I didn’t have any cravings” for opioids, Warfield said.

After three days on the device in August, she stopped using drugs altogether, she said.

Warfield’s treatment was paid for with her county’s opioid settlement dollars — money from pharmaceutical companies accused of fueling the overdose crisis.

State and local governments nationwide are receiving over nearly two decades and are meant to spend it treating and preventing addiction.

Warfield wants them to allot a good chunk to the NET device, which costs counties about $5,500 a person. The pitch is gaining traction. , which makes the device, said it has signedÌýaboutÌý$1.2 million in contracts withÌýmore than a dozen counties and citiesÌýin Kentucky.Ìý

But some researchers and recovery advocates say the company’s rapid consumption of opioid dollars raises red flags. They see the NET device as the latest in a series of products that have been overhyped as the solution to the addiction crisis, preying on people’s desperation and capitalizing on the windfall of opioid settlements. Many of these products — from to body scanners for jails — have little evidence to back their lofty promises. That has not stopped sales representatives from repeatedly pitching elected officials or circulating ready-made templates to request settlement money for the companies’ products.

In fact, a device similar to NET called the Bridge gained popularity several years ago, receiving more than $215,000 in opioid settlement cash nationwide. But about the study backing its effectiveness, and the device is currently off the market.

NET Recovery’s activity “fits the national trends of these industry money grabs,” said , a national expert on opioid settlements based in Tennessee. The device “could be helpful for some,” she said. “But it’s being sold as a silver bullet.”

This year, 237 organizations working to end overdose — including Christensen’s consulting company — to guide officials in charge of opioid settlement money. In it, they called the NET device an example of problematic spending on unproven treatment.

Treating Withdrawal or Addiction

The FDA has for a specific use: reducing drug withdrawal symptoms. It has not approved the device to treat addiction.

That’s a crucial distinction, said , executive director of the Institute for Research, Education and Training in Addictions. He co-authored evaluating the evidence on neuromodulation devices like NET.

“The term ‘treatment’ becomes confusing,” Hulsey said. “These devices were cleared to treat opioid withdrawal symptoms, not to treat an opioid use disorder.”

NET Recovery CEO said the company adheres to FDA rules and advertises the device only for withdrawal management. But “we are finding that physicians are prescribing this to folks for long-term behavior based on the results of our study.”

He’s referring to that he co-authored and the company funded, in which researchers followed two groups of addiction patients in Kentucky for 12 weeks. The first group received the NET device for up to seven days, while the second group received a sham treatment.

The study found no significant difference between the groups’ outcomes. Participants who got the NET device were similarly likely to use illicit drugs after treatment as those who got the fake.

Hulsey, who was not affiliated with the study, said the takeaway is clear: “They didn’t find that was effective.”

A subgroup of participants who chose to use the device for more than 24 hours consecutively, however, went on to use illicit drugs less often than other participants.

As the researchers acknowledged in their paper, that subgroup might simply have been more motivated to engage with any form of treatment. The results don’t necessarily show that the device is making a difference, Hulsey said.

Rapid Growth

Winston had a different take. He said the success of the subgroup is “intriguing and outstanding.”

So outstanding, in fact, that the company this month is opening a brick-and-mortar location in Miami, where the device will be available to anyone who can pay $8,000 out-of-pocket. (The cost is higher for individuals than for county governments.) It has also applied for opioid settlement dollars from the state of Kentucky to conduct a larger research study and aims to bring the NET device into metro areas such as Louisville and Lexington.

Last year, NET Recovery hired a magistrate in Franklin County, Kentucky, to head up its operations in the state. (Magistrates function as county commissioners.) , who is also a mental health clinician, travels to different counties, extolling the benefits of the device and encouraging officials to contract with the company.

Her county to NET Recovery prior to her joining the company. Moving forward, Dycus said, she would recuse herself from any contract votes in her county.

Christensen, the national expert on opioid settlements, called Dycus’ new role “extremely strategic” for the company and “an obvious conflict of interest” for a public official.

Giving People Choice

More options for people to enter recovery is generally good, said Jennifer Twyman, who has a history of opioid addiction and now works with , a nonprofit that advocates to end homelessness and the war on drugs.

But settlement funds are finite, she said, and when counties invest in the NET device, that leaves less money to support options like mental health treatment, housing, and transportation programs — critical for many people who use drugs.

“People slip through these big, huge gaps we have and they die,” Twyman said, pointing to photos of dead friends that line her office wall.

She added that people should have the option of taking medications such as methadone and buprenorphine — for treating opioid addiction. only 1 in 4 people with opioid addiction get them.

Many people can’t afford them, find a doctor willing to prescribe them, or get transportation to appointments, Twyman said. against those who use medications, with detractors saying they’re not truly abstinent or clean.

Companies like NET Recovery sometimes lean into that stigma, Twyman said.

For instance, Scott County, Kentucky, jailer — whom the company considers a key champion for its device — to other county officials that medication treatment is just “swapping one drug for another.” It’s a common refrain from critics that .

Winston told Ñî¹óåú´«Ã½Ò•îl Health News his company is supportive of all types of recovery but that the NET device can help the “underserved population” of people who don’t want medication.

Longtime addiction researcher has led studies for NET Recovery and consults for , one of the leading producers of medications for opioid use disorder. He said he sees value in both approaches. It just depends on whom you’re trying to treat.

For people injecting drugs or accustomed to high doses of fentanyl, who are more likely to return to using drugs after residential treatment, “I would hesitate to recommend the device,” he said. Abstinence-based approaches can . But for people who are “highly motivated to stay abstinent,” the NET device may be a good fit.

“Giving people choices is the right thing to do,” he said.

Community as Part of Recovery

Warfield, who has not used opioids since August, credits not just the NET device with her recovery but her community too.

“It’s not a miracle cure,” she said of the device. “You still have to manage your triggers, but it’s easier.”

She regularly attends individual and group therapy to address childhood trauma. She’s found close friends within her church and has reconnected with her daughter. She installed a car seat in her vehicle so she can drive her grandson to preschool.

Warfield explained her hope for opioid settlement money to reach others in her community simply: “I want people to get as much help as they can.”

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 .

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Miller, quien es neurocientífica, dijo que consultó a varios psiquiatras y recibió receta tras receta de distintos medicamentos. Durante dos años, probó cuatro antidepresivos y dos antipsicóticos. Nada de eso ayudó hasta que su doctor de atención primaria notó niveles altos de un marcador autoinmune en su sangre.

Un especialista luego le hizo “todas las pruebas posibles”, dijo Miller. Finalmente, la diagnosticaron con la enfermedad autoinmune lupus y le recetaron un esteroide para reducir la inflamación. Algunos de sus síntomas mejoraron en cuestión de horas. Su depresión disminuyó poco después.

“Estaba convencida de que era un efecto placebo”, dijo Miller, “pero luego siguió funcionando”.

¿Había contribuido la inflamación a sus problemas de salud mental todo el tiempo? Miller cree que sí, aunque no puede saberlo con certeza. Sus psiquiatras nunca mencionaron esa posibilidad, dijo.

En la mayoría de las especialidades médicas, los doctores pueden confirmar si deben seguir un tipo de tratamiento mediante pruebas, como análisis de sangre, estudios de imagen y biopsias. Sin embargo, los trastornos mentales históricamente se han diagnosticado y tratado en base a síntomas visibles. Eso podría cambiar.

En la Asociación Americana de Psiquiatría incluyó ideas sobre cómo podría incorporar biomarcadores —indicadores biológicos de enfermedad mental que pueden aparecer en pruebas diagnósticas— en futuras versiones de su Manual Diagnóstico y Estadístico de los Trastornos Mentales (DSM, por sus siglas en inglés).

El DSM, a veces llamado por su influencia en el campo, proporciona criterios de diagnóstico. Lo utilizan clínicos que evalúan a pacientes y aseguradoras para decidir si cubren la atención.

Se necesita investigación “coordinada”

Los biomarcadores psiquiátricos aún no están listos para un uso generalizado, enfatiza el documento. Los científicos han investigado el tema por décadas, con pocos resultados. Se necesita más investigación para demostrar que estas mediciones son lo suficientemente válidas y confiables para usarse en la atención de pacientes, señala el documento de la asociación, y otros investigadores han planteado dudas sobre cómo su uso podría afectar los costos de la atención médica, la cobertura y la privacidad de los pacientes.

Agregar biomarcadores al DSM sería “algo muy importante”, dijo Jonathan Alpert, autor del documento de enero y vicepresidente del Comité Estratégico del Futuro del DSM de la asociación profesional.

El acceso a resultados de pruebas, junto con los síntomas, podría agilizar las decisiones de cobertura de seguros y ayudar a los clínicos a hacer diagnósticos y recomendaciones de tratamiento más rápidos y precisos, dijo. Si la biología de los pacientes sugiere que responderán mejor a un tratamiento que a otro, el doctor podría comenzar de inmediato con esa opción.

Actualmente, recetar medicamentos psiquiátricos puede ser “algo incierto”, ya que los clínicos no pueden predecir si funcionarán en un paciente en particular, dijo Matthew Eisenberg, director del Centro de Políticas de Salud Mental y Adicciones de la Escuela de Salud Pública Bloomberg de la Universidad Johns Hopkins.

En de principios de la década de 2000 financiado por el Instituto Nacional de Salud Mental, alrededor del 30% de los participantes con depresión vieron desaparecer sus síntomas con su primer tratamiento antidepresivo. Ese estudio sigue siendo uno de los ensayos más sólidos realizados sobre antidepresivos, aunque investigadores que menos personas se curan con estos medicamentos de lo que sugieren sus resultados.

Este enfoque de prueba y error puede llevar a recetas ineficaces e innecesarias, un tema criticado por defensores del movimiento Make America Healthy Again, encabezado por el secretario del Departamento de Salud y Servicios Humanos (HHS), Robert F. Kennedy Jr.

Kennedy ha sido especialmente , al vincularlos con la violencia después de sin evidencia y culpar a los doctores por recetar en exceso medicamentos a niños.

El HHS está analizando tendencias en diagnósticos y recetas psiquiátricas y evaluando enfoques alternativos de tratamiento en salud mental, con especial atención en niños, dijo la vocera Emily Hilliard en un comunicado. Hilliard no respondió a una pregunta sobre comentarios previos de Kennedy.

Los biomarcadores ya se utilizan para guiar tratamientos en otras áreas médicas, como la oncología. Arizona, Georgia, Kentucky, Texas y exigen que las aseguradoras cubran este tipo de pruebas. También se utilizan análisis de sangre y estudios de imagen para ayudar a diagnosticar la enfermedad de Alzheimer.

La Asociación Americana de Psiquiatría incluyó en su artículo varias formas en que los biomarcadores psiquiátricos podrían usarse en el futuro, como pruebas de actividad cerebral, perfiles genéticos o marcadores inmunológicos asociados con ciertas condiciones psiquiátricas, incluidas la esquizofrenia y las adicciones.

En la depresión, por ejemplo, alrededor de una cuarta parte de los pacientes tiene niveles elevados de una proteína inflamatoria llamada proteína C reactiva, que puede detectarse mediante un análisis de sangre. Las que las personas con niveles altos de esta proteína parecen responder mejor cuando reciben medicamentos que modifican los niveles de dopamina en el cerebro, en lugar de usar solo inhibidores selectivos de la recaptación de serotonina (ISRS), un tipo común de antidepresivo.

La proteína C reactiva aún necesita ser “validada de manera sólida” como biomarcador, según el documento de la APA, pero es una de las opciones más prometedoras bajo estudio.

Se necesita un esfuerzo de investigación “coordinado y bien financiado” para lograr esa validación, escribió la asociación, lo cual es incierto ya que la administración Trump recortó el financiamiento para investigación.

Solo al Instituto Nacional de Salud Mental se le cancelaron en 2025 al menos 128 subvenciones, por un valor de casi $173 millones, según en la revista JAMA. Aunque desde entonces algunas subvenciones han sido restauradas, los investigadores que dependen de fondos federales aún temen recortes.

“Hay una gran necesidad de financiamiento continuo y activo para la investigación relacionada con la salud mental”, dijo Alpert, pero los científicos tendrán que enfrentar “incertidumbres en el panorama de financiamiento”.

Efectos en cobertura y costos

Los costos de la atención médica entre pacientes con enfermedades mentales mal controladas, como hospitalizaciones, consultas ambulatorias y medicamentos. Algunas investigaciones sugieren que las pruebas de biomarcadores podrían ahorrar dinero al encontrar tratamientos adecuados más rápido y evitar algunos de estos costos.

Unestimó que las pruebas para identificar componentes genéticos que pueden influir en la efectividad de un medicamento podrían ahorrar al sistema de salud de Canadá $956 millones en 20 años si se aplican en adultos con depresión mayor en British Columbia., de investigadores españoles, encontró que estas pruebas redujeron costos para la mayoría de los 188 participantes con enfermedad mental grave.

No se sabe si ocurriría lo mismo en el sistema de salud de Estados Unidos. A corto plazo, dijo Eisenberg, un enfoque que use biomarcadores podría aumentar el gasto en atención médica debido al costo de las pruebas.

Las aseguradoras podrían negarse a cubrir pruebas de biomarcadores costosas, agregó. “Toma tiempo demostrar que la nueva evidencia científica es segura y efectiva”, dijo Eisenberg. “Y una vez que lo es, las aseguradoras no la cubren de inmediato”.

Algunos investigadores han expresado preocupación de que aseguradoras o empleadores puedan discriminar a personas cuyos perfiles biológicos sugieren riesgo de desarrollar afecciones neuropsiquiátricas graves.

Es un “momento crítico” para considerar enfoques legislativos que protejan a los pacientes y capaciten a los clínicos sobre cómo usar estas herramientas de manera adecuada, dijo Gabriel Lázaro-Muñoz, miembro del Centro de Bioética de la Escuela de Medicina de Harvard.

“No creo que el campo de la psiquiatría esté listo en este momento para manejar esto”, dijo.

El sistema de salud mental no está listo para “avanzar por completo”, dijo Andrew Miller, profesor de psiquiatría y ciencias del comportamiento en la Facultad de Medicina de la Universidad Emory, quien estudia la depresión relacionada con la inflamación. Pero la adopción de biomarcadores por parte de la asociación de psiquiatría marca “el inicio de una revolución”, dijo.

“Esto es un reconocimiento… de que lo que hemos hecho hasta ahora no ha sido suficiente”, dijo Miller. “Y podemos hacerlo mejor”.

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Miller, a neuroscientist, said she saw several psychiatrists and got prescriptions for drug after drug. Over two years, she tried four antidepressants and two antipsychotics. None of that helped — until her primary care doctor noticed high levels of an autoimmune marker in her blood.

A specialist then ran “every test in the book,” Miller said. Eventually, she was diagnosed with the autoimmune disease lupus and prescribed an inflammation-lowering steroid. Some of her symptoms let up within hours. Her depression subsided not long after.

“I was convinced it was a placebo effect,” Miller said, “but then it kept working.”

Had inflammation been contributing to her mental health problems all along? Miller thinks so, although she can’t know for sure. Her psychiatrists never raised that possibility, she said.

In most medical specialties, doctors can confirm whether to pursue a type of treatment through tests, such as blood work, imaging, and biopsies. Mental illnesses, however, have historically been diagnosed and treated based on outward symptoms. That could change.

The American Psychiatric Association included ideas for how it might incorporate biomarkers — biological indicators of mental illness that could show up on diagnostic tests — into future versions of its Diagnostic and Statistical Manual of Mental Disorders.

The DSM, sometimes because of its influence in the field, provides criteria for diagnoses. It’s used by clinicians assessing patients and by insurance companies deciding whether to cover care.

‘Coordinated’ Research Needed

Psychiatric biomarkers are not ready for widespread use yet, the paper emphasized. Scientists have researched the topic for decades, with little to show for it. More research is needed to prove these metrics are valid and reliable enough to be used in patient care, the APA’s paper said, and other researchers have raised questions about how their use could affect health care costs, insurance coverage, and patient privacy.

Adding biomarkers to the DSM would be “a very big deal,” said Jonathan Alpert, an author of the January paper and vice chair of the APA’s Future DSM Strategic Committee.

Access to test results, along with symptoms, could streamline insurance coverage decisions and help clinicians make faster and more accurate diagnoses and treatment recommendations, he said. If patients’ biology suggested they’d respond better to one treatment than another, their doctor could waste no time in starting there.

Currently, prescribing psychiatric medications can be “a bit of a crapshoot,” with clinicians unable to predict whether they will work for a particular patient, said Matthew Eisenberg, director of the Center for Mental Health and Addiction Policy at the Johns Hopkins University Bloomberg School of Public Health.

In a funded by the National Institute of Mental Health, about 30% of the study’s participants with depression saw symptoms disappear with their first antidepressant treatment. That study is still one of the most robust antidepressant trials conducted — although researchers have that fewer people are cured by these medications than its results suggest.

Such a trial-and-error approach can lead to ineffective and unnecessary prescriptions, a topic of attack by proponents of the Make America Healthy Again movement, spearheaded by Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy has been especially , having linked them to violence after a without evidence and blaming doctors for overprescribing medications for children.

HHS is analyzing psychiatric diagnosis and prescription trends and evaluating alternative mental health treatment approaches, with a particular focus on children, spokesperson Emily Hilliard said in a statement. Hilliard did not respond to a question about Kennedy’s previous comments.

Biomarkers are already used to guide treatment in other medical disciplines, such as oncology. Arizona, Georgia, Kentucky, Texas, and require insurers to cover such testing. Blood and imaging tests are now used to help diagnose Alzheimer’s disease as well.

The APA included in its article a variety of ways psychiatric biomarkers could be used in the future — such as testing for brain activity, genetic profiles, or immune markers associated with certain psychiatric conditions, including schizophrenia and substance use disorders.

In depression, for example, about a quarter of patients have elevated levels of an inflammatory protein, called C-reactive protein, that can be found through a blood test. that people with high levels of this protein seem to respond better when given drugs that alter dopamine levels in the brain, rather than using only selective serotonin reuptake inhibitors, or SSRIs, a common type of antidepressant. C-reactive protein still needs to be “robustly validated” as a biomarker, according to the APA’s paper, but it’s among the most promising currently under investigation.

A “coordinated, well-funded” research effort is needed to achieve such validation, the APA wrote — a tenuous prospect since the Trump administration slashed funding for research.

The National Institute of Mental Health alone had at least 128 grants, worth almost $173 million, canceled in 2025, according to a . Though some grants have since been restored, researchers relying on federal money still fear their work is vulnerable to cuts.

“There’s a great need for continued, active funding of research related to mental health,” Alpert said, but scientists will have to grapple with “uncertainties of the funding landscape.”

Ripple Effects on Coverage, Costs

Health care costs among patients with poorly controlled mental illnesses, like hospital visits, outpatient appointments, and prescriptions. Some research suggests biomarker testing could save money by landing on the right treatments faster and avoiding some of these costs.

estimated that testing to look for genetic components that may influence a drug’s effectiveness could save the Canadian health system $956 million over 20 years if used among adults with major depression in British Columbia. , by Spanish researchers, found that such testing reduced costs for most of the 188 participants with serious mental illness.

Whether the same would be true in the U.S. health care system is unknown. In the short term, Johns Hopkins’ Eisenberg said, an approach that uses biomarkers could raise health care spending due to the costs of testing.

Insurers may decline to cover pricey biomarker tests, he added. “It takes a while for new science to be proven safe and effective,” Eisenberg said. “And once it is, insurance companies don’t cover it immediately.”

Some researchers have raised concerns that insurers or employers could discriminate against people whoseÌýbiological profiles of developing serious neuropsychiatric conditions.

It’s a “critical moment” to consider legislative approaches to protect patients and train clinicians about how to appropriately use these tools, said Gabriel Lázaro-Muñoz, a member of Harvard Medical School’s Center for Bioethics.

“I do not think that the field of psychiatry is currently ready to manage this,” he said.

The mental health system isn’t ready to “jump in with both feet,” said Andrew Miller, a professor of psychiatry and behavioral sciences at the Emory University School of Medicine, who studies inflammation-related depression. But the APA’s embrace of biomarkers signals “the beginning of a revolution,” he said.

“This is a recognition … that what we’ve done up to this point has not been good enough,” Miller said. “And we can do better.”

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Raven’s case reveals a little-known gap in the U.S. donation system: There is no clear, nationally binding way to opt out — or to ensure a later “no” overrides an earlier “yes” in a different state.

This gap, along with a range of other issues related to the organ procurement system, has become a point of bipartisan congressional concern. Late last year, the House Ways and Means subcommittee on oversight examining what members described as shortcomings, including alleged consent failures.

The panel’s scrutiny of organ procurement organizations, or OPOs, and their consent practices is a first step toward a more meaningful accountability plan that could help maintain trust across the system, according to some committee staff members.

The trust in our organ procurement and transplant system “has been eroded,” said Rep. Terri Sewell of Alabama, the panel’s senior Democrat, calling for stronger transparency and oversight to rebuild public confidence.

“Respect for autonomy — our ability to make our own decisions (self-determination) — allows for both ‘yes’ and ‘no’ decisions and for changing one’s mind,” Margaret McLean, a bioethicist at Santa Clara University, said in an email.

“Medical decision-making is not well served in a context of ambiguity,” she said.

And if a donor revokes consent, she added, “revocation by that person should carry the same ethical and procedural weight as the initial authorization, perhaps more.”

Raven Kinser Changed Her Mind

Raven was 25 when she died. Her parents, Jeff and Jaime Kinser, were at home in Michigan when they received the phone call that shattered their world. They drove through the night to the Newport News hospital, where they learned Raven’s disposition had been referred to LifeNet Health, the region’s federally designated OPO. LifeNet a failing OPO by the Centers for Medicare & Medicaid Services, meaning it doesn’t meet the government’s standards for how well it finds donors and recovers usable organs for transplant compared with other organizations.

Under federal law, hospitals are required to refer deaths and imminent deaths to OPOs, which take responsibility for donation-related decisions and discussions.

OPOs occupy a hybrid position in the health care system, as private nonprofit entities that hold exclusive, federally authorized contracts to recover organs within defined regions. They are regulated by CMS and overseen by the Health Resources and Services Administration, but that oversight occurs primarily through certification standards, performance metrics, and periodic audits rather than routine public disclosure requirements. With donor registries largely managed at the state level and no unified federal reporting requirement for removals, comprehensive national data on revocations is elusive.

OPOs are meant to separate bedside care from organ procurement decisions — to help prevent conflicts of interest and preserve the trust that decisions about life-sustaining treatment are made solely in the dying patient’s interest. But the , leaving families unsure who is in control if and when conflicts arise.

The Kinsers, for instance, felt their daughter would not have wanted to go through the donation process, but, at the time, had no evidence. Jaime remembers telling her husband that Raven would have been mad at them for letting it happen. In an effort to stop it, Jaime inquired about whether she would be asked to sign a consent form. But a LifeNet staff member told her that wasn’t an option because donation was Raven’s “living will,” Jaime said. Meanwhile, Raven’s parents said, her personal effects, including her Virginia driver’s license, which bore no donor designation, had not yet been turned over to the family, leaving them no meaningful way to challenge LifeNet’s determination in real time.

Jaime struggled with this outcome, even mentioning in Raven’s obituary that she was an organ donor. “How would you try to make peace with something that you felt was so wrong but had no proof?” Jaime said.

Two months passed before the Kinsers gained possession of the license, which, as they had expected, showed that Raven had not opted to be an organ donor.

According to the Kinsers, LifeNet staff told them that Raven’s status as a registered donor was established by her designation on her older Michigan license.

An emailed statement attributed to Douglas Wilson, LifeNet executive vice president, said the OPO follows federal law on organ donation, the , and queries applicable state donor registries, relying on time stamps and governing law to determine the , legally valid expression of intent. Under that framework, a prior donor authorization remains enforceable unless a valid revocation is recorded in the regional OPO’s donor registry.

Because of privacy laws, Wilson said, LifeNet could not comment on the specifics of any individual case.

Raven Kinser’s choice not to be a donor when she applied for a Virginia license in July 2024 was not reflected in the registry LifeNet consulted, according to her parents, who said that is what the organization told them. According to Lara Malbon, executive director of Donate Life Virginia, which manages the state’s organ donor registry, if someone changes their donor status while completing a Virginia driver’s license or ID transaction, “that information is sent to our registry, and the registry is updated daily to reflect those changes.” Malbon also said Virginia’s registry includes only people who have “affirmatively said ‘yes’ to becoming an organ, eye, and tissue donor, and it retains records solely for those who have made that decision.”

The Kinsers said they were never told why Raven’s Virginia DMV record was insufficient, or how an older yes from Michigan could outweigh a newer no in Virginia.

In December, the Kinsers filed a complaint with the Health Resources and Services Administration, urging federal regulators to investigate LifeNet’s actions and require OPOs to provide families with documented proof of the donor’s current status at the time of referral. They also called for OPOs, which operate as federally designated regional monopolies but are structured as private nonprofits, to be made subject to public records laws.

When Opting Out Doesn’t Stick

Such confusion is not unique to the Kinser family. It is a consequence of the organ donation consent process in the United States.

“I have also wondered that: why there’s not just one” registry for organ donation, Jaime said. If you go to get a firearm, you have one federal registry, she said.

Here’s how the system works: Americans typically register their organ donation intentions when they apply for driver’s licenses through state DMVs, and that decision remains governed largely by state law. That has led to 50 different sets of rules and very little federal regulation of what has become an in the U.S.

In some states, a donor checkbox is a binding legal document. In other states, the same choice may have different rules about when it takes effect, what it covers, and how it can be revoked.

Those differences can be big. State rules determine whether a person’s “gift” is limited to transplantation or also includes research and education. They determine whether the donation authorization includes tissue. And they can determine what counts as a valid revocation and when it is legally recognized.

Because of the system’s fragmentation, though, signals can cross when someone changes their mind, like Raven; it’s not always reflected from one state system to another.

Under state versions of the Uniform Anatomical Gift Act, a donor’s most recent legally valid expression of intent is meant to control.

“Personal autonomy is paramount to everything,” said Adam Schiavi, a neurointensivist who studies end-of-life decision-making. “If I say I want to be a donor, or if I say I don’t want to be a donor, that has to take precedence over everything else.”

But states differ in how revocation must be recorded and which registry is considered authoritative if someone has lived in more than one state. Those inconsistencies can create uncertainty when records conflict across jurisdictions.

“It has to be the most recent expression, not the most recent yes,” Schiavi said.

In Michigan, a change to someone’s donor status is reflected immediately in the secretary of state’s system, but only affirmative “yes” registrations appear in the registry. Removal information remains in internal motor vehicle records. In Virginia, the state registry includes only those who have affirmatively said “yes,” retaining records solely of donors, creating potential gaps if someone believes a DMV change alone is sufficient.

Elsewhere, processes and volumes differ sharply. New Mexico updates driver records in real time but does not transmit status changes to its donor registry. Instead, donor services receive restricted search access. The state logged nearly 15,000 removals in late 2021 and almost 30,000 in 2022. Florida, which maintains formal removal records through weekly DMV data files, reported 356,161 removals in 2020, more than 1.5 million in 2023, and over 1.2 million in 2025. Kentucky processed 847,371 donor registrations from 2020 to 2025, but only 16,043 icon removals, with registry withdrawal handled separately. In 2025, more than 570,000 Texans opted into the registry, while over 31,000 individuals requested removal.

According to a federal official who asked not to be identified for fear of professional repercussions, OPOs have been highly effective at lobbying states to broaden the definition of consent and authorization — shaping how those terms are applied, whether those statuses must be renewed, and how easy or difficult it is for someone to opt out.

In subsequent correspondence with federal officials, the Kinsers have urged reforms to prevent OPOs from relying on older registry entries when a more recent state DMV record exists, and they have called for criminal penalties in cases in which consent is knowingly misrepresented. Federal regulators have not indicated whether such proposals are under consideration.

Congress Takes a Closer Look

Ethicists have long cautioned that consent must be more than a checkbox and must remain grounded in respect for the donor-patient. In an October on organ transplantation, the American College of Physicians emphasized that clinicians’ primary duty is to the patient in their care, and that maintaining trust requires transparency and safeguards to prevent conflicts of interest from blurring that “bright line.”

Advocates say those steps leave unresolved the core problem raised by the Kinser family: the lack of a clear, legally binding way for people to say “no” and for that decision to follow them across state lines.

The said it “supports strengthening donor registries and enhancing registry interoperability to ensure that an individual’s documented donation decision is honored.” But OPOs have also argued that current policies protect donation as a legally enforceable gift and prevent families from overriding a loved one’s “yes” in the midst of grief. They argue that stronger, more durable consent helps reduce missed donations and saves lives.

Congress and federal regulators are considering changes to the nation’s organ donation system, including how consent is recorded and what should happen when a donor changes their mind.

Sen. Ron Wyden (D-Ore.) last year to create new federal standards for patient safety, transparency, and oversight of organ transplants, including a formal authorization for hospital or OPO staff to pause harvesting if there is any “clinical sign of life.”

HHS press secretary Emily Hilliard said the agency is “committed to holding organ procurement organizations accountable” and to “restoring integrity and transparency” to organ donation policy, calling reforms essential to informed consent and protecting donor rights. CMS issued related March 11, but it does not address the problems highlighted by the Kinsers’ case.

Critics of the organ transplant system say it is difficult for families to obtain documentation or independently verify how consent determinations were made in disputed cases.

HRSA has launched a sweeping modernization of the Organ Procurement and Transplantation Network, the national system that oversees organ allocation and transplant policy. Federal officials have described the overhaul as the most significant restructuring of the transplant system in decades, aimed at breaking up a long-standing contractor monopoly, strengthening patient safety oversight, and replacing aging technology infrastructure.

Central to that effort is modernizing the OPTN’s data systems: improving interoperability, audit trails, and transparency in how decisions are documented and reviewed. A more modern federal data architecture could make it easier to trace which registry was queried, what time stamp controlled, and how a consent determination was reached in disputed donations that span multiple states. But the modernization effort would not change the underlying state-by-state legal framework for donor authorization and what counts as a valid “no.”

Meanwhile, Donate Life America, a national nonprofit that supports state donor registries, also runs the , a central database that allows people to sign up as organ donors directly. Unlike many DMV systems, the national registry lets people log in at any time to view, update, or remove their registration and print proof of their decision. The group is also starting a project to let participating states send registrations directly into the national system, creating one place to track donor sign-ups and removals across state lines.

Each of the proposals comes with trade-offs, and both advocates and OPOs have raised concerns about how they would work in practice.

“Just doing a dump truck dump of information is not going to do much unless you really apply it through checking and auditing,” said Arthur Caplan, a professor of bioethics at New York University’s Grossman School of Medicine. “It could be like the IRS. They don’t have to audit everybody. Just do a spot audit once in a while.”

The Kinsers aren’t opposed to organ donation itself. They celebrated Raven’s donation in her obituary, and in their complaint to federal regulators, they wrote, “We are NOT anti-organ donation, and we will never take away the gift of life our oldest daughter gave to others. However, that was not LifeNet’s choice to make.”

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Within a few days, Reynolds became so desperate that she and her husband had to physically restrain Jonah, dumping pain medication down his throat as he screamed in pain.

“It broke our hearts,” said Reynolds, who lived in Georgetown, Kentucky, at the time. “And I remember just thinking that it shouldn’t have to come to that.”

Reynolds couldn’t find a dentist with an opening who could treat Jonah, who is autistic and often resists dental exams due to hypersensitivity and anxiety. Over the course of five days, Reynolds took Jonah twice to a nearby emergency room as he struggled with persistent pain and a fever due to a likely infected tooth with an exposed nerve. The ER had no dentists; both times, the family was sent home with only pain medication and an ice pack.

Across the nation, more children are entering ERs for preventable tooth problems. Dentists, hygienists, and researchers attributed that trend to a shortage of pediatric dental care professionals in rural areas and worsening oral hygiene since the covid-19 pandemic. Tens of thousands of kids end up in the hospital for dental emergencies each year, according to Melissa Burroughs, senior director of policy and advocacy at the national health nonprofit CareQuest Institute for Oral Health.

ER visits for tooth problems unrelated to physical injuries for children under 15 years old from 2019 to 2022, according to a report released late last year by CareQuest. And local data reflects that national trend: At Children’s Hospital Colorado in the Denver area, nontraumatic dental cases, such as cavities or gum infections, in its ER increased 175% from 2010 to 2025, according to hospital spokesperson Sarah Bonar. In Kentucky, where Jonah lives, children’s visits to the ER for dental problems rose 72% from 2020 to 2024, according to the state.

Policy changes under the Trump administration are poised to worsen the trend. President Donald Trump’s 2025 federal budget reconciliation law, known as the One Big Beautiful Bill Act, called for billions in cuts from Medicaid, which may force states to limit or drop dental coverage from the public insurance program for those with low incomes or disabilities. New eligibility requirements for Medicaid in some states could affect kids’ access to dental care, even though children are guaranteed dental coverage under the program. Research shows that when parents lose Medicaid, even kids with coverage are more likely to have and to go to a dentist.

The Trump administration has also promoted skepticism about fluoride. show that fluoride in drinking water and topical fluoride treatments dramatically reduce tooth decay and prevent cavities. In recent months, the Food and Drug Administration against the use of fluoride supplements and the Environmental Protection Agency of “potential health risks of fluoride in drinking water.” Health and Human Services Secretary Robert F. Kennedy Jr. has called fluoride a “” and “.” A 2025 study in JAMA Pediatrics linked high levels of fluoride with lower IQ in children — but only at concentrations the recommended level in public drinking water.

, a pediatric dentist at the University of Washington who studies fluoride hesitancy, worries that these anti-fluoride stances will further erode trust in fluoride treatment. Since the start of 2026, lawmakers in at least 15 states have introduced bills prohibiting or limiting fluoride in public drinking water. Utah and Florida in 2025 became the first states to enact fluoride bans.

“Will that have an effect on cavity rates?” Chi asked. “Absolutely.”

Severe Dental Cases Rise

Pediatric dentists Katherine Chin and Chaitanya Puranik said they are treating more patients like Jonah at Children’s Hospital Colorado. More severe cases have become more common, too. Puranik said he used to typically see patients with only one cavity, but now his patients are often coming in with tooth decay throughout their mouth.

During the pandemic, many dental offices , and studies show children also increased , a major risk factor for cavities. Severe cavities that lead to tooth extraction can affect , sometimes causing long-term problems with or .

Millions of people live in in the U.S., with scant dentists within driving distance. On top of that, only treat Medicaid patients, due to low reimbursement rates, which are on average of their typical dental charges, according to the American Dental Association.

Children with intellectual or developmental disabilities may especially struggle to access quality dental care. Few general dentists have sufficient pediatric training to care for kids with disabilities such as Jonah, who are easily overwhelmed or need to be sedated for an exam, , a health information nonprofit that includes Ñî¹óåú´«Ã½Ò•îl Health News. Over have special health care needs, and those children are to have unmet dental needs. Their parents are also to finding a dentist.

When he was younger, Jonah would not let his parents brush his teeth, which led to cavities in his baby teeth, his mother said. After Jonah’s first visit to the ER, Reynolds found a general dentist with an opening. But unlike a trained pediatric dentist, she said, the dentist did not know how to examine Jonah in a way he could tolerate and wasn’t prepared to provide sedation. Jonah left without treatment and was soon back in the ER when his fever returned.

ERs Rarely Provide Solutions

, a pediatrician in Washington County, Maine, said he is fielding “the most horrifying cavities” at Down East Community Hospital.

ERs are often ill-equipped to treat dental concerns, Weitz said. Similar to the ER Jonah went to in Kentucky, Down East has no dentists on staff. Weitz often finds himself prescribing antibiotics as a temporary measure.

“But a month later, they’re back again because it’s flaring up again,” Weitz said.

As a potential solution, states such as Maine and Alaska are proposing to use money from the $50 billion to develop the oral health workforce or to create specialized dental care centers, which can better serve children with special health care needs on short notice. But those initiatives won’t address the loss of coverage anticipated from Medicaid cuts. California last year in state grants to develop or expand over 120 dental facilities to serve patients with special health care needs.

Jonah’s dental emergency cost Reynolds a week of work from her job as a dog groomer and Jonah three days of third grade, plus hundreds of dollars in out-of-pocket costs.

Eventually, Reynolds found an oral surgeon who extracted the tooth. But even that went poorly, she said. When Jonah became upset over a needle stick, the surgeon threatened to hold him down, Reynolds said. She said the surgeon left quickly after the procedure and never gave her a clear diagnosis of what caused Jonah’s pain. The procedure did resolve his toothache, but Reynolds said more professionals should know how to handle cases like Jonah’s, with sensitivity to the families. Four years later, forcing Jonah to take his pain meds still lives fresh in her memory.

“That will never leave my mind,” Reynolds said.

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