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Maker of Device To Treat Addiction Withdrawal Seeks Counties’ Opioid Settlement Cash

LOUISVILLE, Ky. — In the early 2000s, Michelle Warfield worked at a factory, hauling heavy seats for Ford trucks on and off an assembly line. To suppress daily aches in her back and hips, her doctor prescribed opioid painkillers.

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 billions in opioid settlement cash 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. NET Recovery, which makes the device, said it has signed about $1.2 million in contracts with more than a dozen counties and cities in Kentucky. 

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 high-dose overdose reversal medications 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 serious questions arose 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 Tricia Christensen, 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 — published a road map 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 cleared the NET device for a specific use: reducing drug withdrawal symptoms. It has not approved the device to treat addiction.

That’s a crucial distinction, said Eric Hulsey, executive director of the Institute for Research, Education and Training in Addictions. He co-authored a recent report 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 Joe Winston 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 an October study 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.) Kelly Dycus, 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 awarded $75,000 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 Vocal-KY, 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 — the gold standard for treating opioid addiction. National data shows 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. There’s also discrimination 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 Derran Broyles — whom the company considers a key champion for its device — said in a public meeting to other county officials that medication treatment is just “swapping one drug for another.” It’s a common refrain from critics that many researchers and clinicians refute.

Winston told KFF 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 Mark Greenwald has led studies for NET Recovery and consults for Indivior, 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 increase their risk of dying. 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.”

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

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Lost in Transmission: Changes in Organ Donor Status Can Fall Through Cracks in the System

When Raven Kinser walked into a Virginia Department of Motor Vehicles office two summers ago, she completed a driver’s license application that included the option to register as an organ donor. The form provides a checkbox to opt in, but not one to opt out. Kinser left the donor registration box unchecked, reflecting her decision to reverse an earlier donor registration. Six months later, after she was declared dead at Riverside Regional Medical Center in Newport News, Virginia, her parents say, they learned that her decision did not prevent organ procurement.

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 held a hearing 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 is rated 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 policy can be fraught, 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?” Jamie 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 Uniform Anatomical Gift Act, and queries applicable state donor registries, relying on time stamps and governing law to determine the most recent, 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 place.”

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 over $5 billion industry 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 position paper 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 Association of Organ Procurement Organizations 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.) proposed legislation 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 new guidance 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 National Donate Life Registry, 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.”

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

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

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