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Updated: 1 hour 10 min ago

Programas de inteligencia artificial diagnostican retinopatía diabética en minutos

March 27, 2024

Christian Espinoza, director de operaciones de una red de clínicas de tratamiento del sur de California, comenzó recientemente a emplear un nuevo asistente poderoso: un algoritmo de inteligencia artificial (IA) que puede realizar exámenes de la vista con imágenes tomadas por una cámara retinal.

Realiza diagnósticos rápidos, sin la presencia de un médico.

Sus clínicas, Tarzana Treatment Centers, son de las primeras en adoptar un sistema de IA que promete expandir drásticamente la detección de retinopatía diabética, la principal causa de ceguera entre adultos en edad laboral y una amenaza para muchos de los cerca de 38 millones de estadounidenses con diabetes.

“Ha sido una bendición para nosotros”, dijo Espinoza, citando los beneficios de un examen rápido y fácil que puede realizarse con poco entrenamiento y que brinda resultados inmediatos.

Y a sus pacientes también les gusta. Joseph Smith, quien tiene diabetes tipo 2, recordó la engorrosa tarea de tomar el autobús hasta el oftalmólogo, dilatar sus pupilas, y luego esperar una semana por los resultados. “Era horrible”, dijo. “Ahora, toma solo unos minutos”.

En medio de todo el revuelo en torno a la inteligencia artificial en la atención médica, la tecnología de exámenes de la vista está surgiendo como uno de los primeros casos de uso probados de diagnósticos basados en IA en un entorno clínico.

Si bien la Administración de Drogas y Alimentos (FDA) ha aprobado cientos de dispositivos médicos basados en la IA, la adopción ha sido lenta mientras los proveedores navegan por el proceso regulatorio, la cobertura del seguro, los obstáculos técnicos, las preocupaciones sobre la equidad y los desafíos de integrarlos en los sistemas de proveedores.

Los exámenes de la vista muestran que la capacidad de la IA para proporcionar resultados inmediatos, así como el ahorro de costos y la conveniencia de no necesitar hacer una cita adicional, pueden tener grandes beneficios tanto para los pacientes como para los proveedores.

De unos 700 exámenes de la vista realizados durante el último año en las clínicas de Espinoza, casi una cuarta parte detectaron retinopatía, y los pacientes fueron remitidos a un especialista para recibir atención adicional.

La retinopatía diabética se produce cuando el alto nivel de azúcar en la sangre daña los vasos sanguíneos en la retina. Si bien el control de la diabetes de un paciente a menudo puede prevenir esta afección, y existen tratamientos para etapas más avanzadas, los médicos dicen que las evaluaciones regulares son cruciales para detectar los síntomas temprano.

Las tres compañías con exámenes de la vista con IA aprobados por la FDA para retinopatía diabética —Digital Diagnostics, con sede en Coralville, Iowa; Eyenuk, de Woodland Hills, California; y la empresa de software israelí AEYE Health— han vendido sistemas a cientos de consultorios en todo el país.

Unas pocas docenas de compañías han realizado investigaciones en este campo específico, y algunas han obtenido autorización regulatoria en otros países, incluyendo gigantes tecnológicos como Google.

Digital Diagnostics, antes Idx, recibió la aprobación de la FDA para su sistema en 2018, después de décadas de investigación y un ensayo clínico que involucró a 900 pacientes diagnosticados con diabetes. Fue el primer sistema de IA totalmente autónomo en cualquier campo médico, lo que hizo que su aprobación fuera “un momento histórico en la historia de la medicina”, dijo Aaron Lee, especialista en retina y profesor asociado de la Universidad de Washington.

Al sistema, utilizado por Tarzana Treatment Centers, puede operarlo alguien con un diploma de escuela secundaria y unas horas de entrenamiento, y solo lleva unos minutos generar un diagnóstico, sin dilatación de los ojos la mayoría de las veces, dijo John Bertrand, CEO de Digital Diagnostics. Se puede instalar en cualquier habitación poco iluminada, y los pacientes apoyan su barbilla en un soporte, y miran fijo a la cámara mientras un técnico toma imágenes de cada ojo.

La Asociación Americana de Diabetes (ADA) recomienda que las personas con diabetes tipo 2 se hagan exámenes de la vista cada uno o dos años; sin embargo, solo alrededor del 60% de las personas con diabetes se los realizan cada año, dijo Robert Gabbay, director científico y médico de la ADA.

Las tasas pueden ser tan bajas como el 35% para los menores de 21 años con diabetes. En grandes áreas del país, la escasez de optometristas y oftalmólogos puede dificultar la programación de citas, por las que a veces hay que esperar meses. Además, las barreras de viajar a una cita adicional para dilatar los ojos —lo que significa tomar tiempo libre del trabajo o la escuela, y tener transporte— pueden ser particularmente difíciles para pacientes de bajos ingresos, quienes también tienen un mayor riesgo de diabetes tipo 2.

“El 90% de nuestros pacientes son trabajadores manuales y de fábricas”, dijo Espinoza sobre sus clínicas del sur de California, que atienden principalmente a poblaciones minoritarias. “Si no trabajan, no comen”.

Un posible inconveniente de no tener un médico que realice el examen es que el algoritmo solo busca retinopatía diabética, por lo que podría pasar por alto otras enfermedades de cuidado, como el melanoma coroideo, dijo Lee. También los algoritmos generalmente “pecan de precavidos” y mandan demasiado a los pacientes a ver a especialistas.

Pero esta tecnología ha mostrado un gran beneficio: es tres veces más probable que el paciente haga un seguimiento después de un resultado positivo con el sistema de IA, según un estudio reciente realizado por Universidad de Stanford.

Eso se debe a la “proximidad del mensaje”, dijo David Myung, profesor asociado de Oftalmología en el Instituto de Ojos Byers en Stanford. Cuando el resultado se entrega de inmediato, en lugar de en semanas o incluso meses, es mucho más probable que el paciente tome acciones.

Myung lanzó el programa de teleoftalmología automatizado de Stanford en 2020, enfocándose originalmente en telemedicina y luego cambiando a IA en sus clínicas del área de la Bahía.

Ese mismo año, el National Committee for Quality Assurance amplió su estándar  de detección de retinopatía diabética para incluir los sistemas de IA. Myung dijo que llevó alrededor de un año filtrar los sistemas de ciberseguridad y TI del sistema de salud de Stanford para integrar la nueva tecnología.

También se aprendió a tomar fotos de calidad que la IA pueda descifrar, dijo Myung. “Incluso alcanzando nuestro ritmo, siempre hay algo que mejorar”, agregó.

La prueba de IA ha sido reforzada por un código de reembolso de los Centros de Servicios de Medicare y Medicaid (CMS), que puede ser difícil y llevar mucho tiempo obtener para dispositivos innovadores. Pero los proveedores de atención médica necesitan esa aprobación gubernamental para obtener reembolsos.

En 2021, los CMS establecieron la tasa de pago nacional para exámenes de retinopatía diabética con IA en $45.36: bastante por debajo de la tasa promedio  negociada de manera privada, que es de $127.81, según un estudio reciente del New England Journal of Medicine sobre IA.

Cada empresa tiene un modelo de negocio ligeramente diferente, pero en general cobran a los proveedores tarifas de suscripción o licencia por su software. Las compañías no quisieron compartir cuánto cobran por el programa.

Las cámaras pueden costar hasta $20,000 y se compran por separado o se alquilan como parte de la suscripción del software.

El mayor cumplimiento de las recomendaciones, junto con las referencias a especialistas, hace que valga la pena, dijo Lindsie Buchholz, líder de informática clínica de Nebraska Medicine, que a mediados de diciembre comenzó a usar el sistema de Eyenuk. “De alguna manera, ayuda a que la cámara se pague por sí sola”, dijo.

Hoy en día, el sistema de Digital Diagnostics se encuentra en alrededor de 600 sitios en todo el país, según la compañía. AEYE Health dijo que a su examen de la vista lo utilizan cientos de proveedores en el país. Eyenuk se negó a compartir detalles sobre su alcance.

La tecnología continúa avanzando, con estudios clínicos para cámaras adicionales —incluyendo un dispositivo portátil que puede examinar a los pacientes fuera de las clínicas— y diagnosticar otras enfermedades oculares, como el glaucoma.

Estas innovaciones ponen a la oftalmología, junto con la radiología, la cardiología y la dermatología, como especialidades en las que la innovación en IA está ocurriendo rápidamente.

“En un futuro cercano va a haber cámaras que se pueden usar en la medicina de calle, y van a ayudar a mucha gente”, dijo Espinoza.

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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The Burden of Getting Medical Care Can Exhaust Older Patients

March 27, 2024

Susanne Gilliam, 67, was walking down her driveway to get the mail in January when she slipped and fell on a patch of black ice.

Pain shot through her left knee and ankle. After summoning her husband on her phone, with difficulty she made it back to the house.

And then began the run-around that so many people face when they interact with America’s uncoordinated health care system.

Gilliam’s orthopedic surgeon, who managed previous difficulties with her left knee, saw her that afternoon but told her “I don’t do ankles.”

He referred her to an ankle specialist who ordered a new set of X-rays and an MRI. For convenience’s sake, Gilliam asked to get the scans at a hospital near her home in Sudbury, Massachusetts. But the hospital didn’t have the doctor’s order when she called for an appointment. It came through only after several more calls.

Coordinating the care she needs to recover, including physical therapy, became a part-time job for Gilliam. (Therapists work on only one body part per session, so she has needed separate visits for her knee and for her ankle several times a week.)

“The burden of arranging everything I need — it’s huge,” Gilliam told me. “It leaves you with such a sense of mental and physical exhaustion.”

The toll the American health care system extracts is, in some respects, the price of extraordinary progress in medicine. But it’s also evidence of the poor fit between older adults’ capacities and the health care system’s demands.

“The good news is we know so much more and can do so much more for people with various conditions,” said Thomas H. Lee, chief medical officer at Press Ganey, a consulting firm that tracks patients’ experiences with health care. “The bad news is the system has gotten overwhelmingly complex.”

That complexity is compounded by the proliferation of guidelines for separate medical conditions, financial incentives that reward more medical care, and specialization among clinicians, said Ishani Ganguli, an associate professor of medicine at Harvard Medical School.

“It’s not uncommon for older patients to have three or more heart specialists who schedule regular appointments and tests,” she said. If someone has multiple medical problems — say, heart disease, diabetes, and glaucoma — interactions with the health care system multiply.

Ganguli is the author of a new study showing that Medicare patients spend about three weeks a year having medical tests, visiting doctors, undergoing treatments or medical procedures, seeking care in emergency rooms, or spending time in the hospital or rehabilitation facilities. (The data is from 2019, before the covid pandemic disrupted care patterns. If any services were received, that counted as a day of health care contact.)

That study found that slightly more than 1 in 10 seniors, including those recovering from or managing serious illnesses, spent a much larger portion of their lives getting care — at least 50 days a year.

“Some of this may be very beneficial and valuable for people, and some of it may be less essential,” Ganguli said. “We don’t talk enough about what we’re asking older adults to do and whether that’s realistic.”

Victor Montori, a professor of medicine at the Mayo Clinic in Rochester, Minnesota, has for many years raised an alarm about the “treatment burden” that patients experience. In addition to time spent receiving health care, this burden includes arranging appointments, finding transportation to medical visits, getting and taking medications, communicating with insurance companies, paying medical bills, monitoring health at home, and following recommendations such as dietary changes.

Four years ago — in a paper titled “Is My Patient Overwhelmed?” — Montori and several colleagues found that 40% of patients with chronic conditions such as asthma, diabetes, and neurological disorders “considered their treatment burden unsustainable.”

When this happens, people stop following medical advice and report having a poorer quality of life, the researchers found. Especially vulnerable are older adults with multiple medical conditions and low levels of education who are economically insecure and socially isolated.

Older patients’ difficulties are compounded by medical practices’ increased use of digital phone systems and electronic patient portals — both frustrating for many seniors to navigate — and the time pressures afflicting physicians. “It’s harder and harder for patients to gain access to clinicians who can problem-solve with them and answer questions,” Montori said.

Meanwhile, clinicians rarely ask patients about their capacity to perform the work they’re being asked to do. “We often have little sense of the complexity of our patients’ lives and even less insight into how the treatments we provide (to reach goal-directed guidelines) fit within the web of our patients’ daily experiences,” several physicians wrote in a 2022 paper on reducing treatment burden.

Consider what Jean Hartnett, 53, of Omaha, Nebraska, and her eight siblings went through after their 88-year-old mother had a stroke in February 2021 while shopping at Walmart.

At the time, the older woman was looking after Hartnett’s father, who had kidney disease and needed help with daily activities such as showering and going to the bathroom.

During the year after the stroke, both of Hartnett’s parents — fiercely independent farmers who lived in Hubbard, Nebraska — suffered setbacks, and medical crises became common. When a physician changed her mom’s or dad’s plan of care, new medications, supplies, and medical equipment had to be procured, and new rounds of occupational, physical, and speech therapy arranged.

Neither parent could be left alone if the other needed medical attention.

“It wasn’t unusual for me to be bringing one parent home from the hospital or doctor’s visit and passing the ambulance or a family member on the highway taking the other one in,” Hartnett explained. “An incredible amount of coordination needed to happen.”

Hartnett moved in with her parents during the last six weeks of her father’s life, after doctors decided he was too weak to undertake dialysis. He passed away in March 2022. Her mother died months later in July.

So, what can older adults and family caregivers do to ease the burdens of health care?

To start, be candid with your doctor if you think a treatment plan isn’t feasible and explain why you feel that way, said Elizabeth Rogers, an assistant professor of internal medicine at the University of Minnesota Medical School. 

“Be sure to discuss your health priorities and trade-offs: what you might gain and what you might lose by forgoing certain tests or treatments,” she said. Ask which interventions are most important in terms of keeping you healthy, and which might be expendable.

Doctors can adjust your treatment plan, discontinue medications that aren’t yielding significant benefits, and arrange virtual visits if you can manage the technological requirements. (Many older adults can’t.)

Ask if a social worker or a patient navigator can help you arrange multiple appointments and tests on the same day to minimize the burden of going to and from medical centers. These professionals can also help you connect with community resources, such as transportation services, that might be of help. (Most medical centers have staff of this kind, but physician practices do not.)

If you don’t understand how to do what your doctor wants you to do, ask questions: What will this involve on my part? How much time will this take? What kind of resources will I need to do this? And ask for written materials, such as self-management plans for asthma or diabetes, that can help you understand what’s expected.

“I would ask a clinician, ‘If I chose this treatment option, what does that mean not only for my cancer or heart disease, but also for the time I’ll spend getting care?’” said Ganguli of Harvard. “If they don’t have an answer, ask if they can come up with an estimate.”

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care, and advice you need in dealing with the health care system. Visit kffhealthnews.org/columnists to submit your requests or tips.

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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As AI Eye Exams Prove Their Worth, Lessons for Future Tech Emerge

March 27, 2024

Christian Espinoza, director of a Southern California drug-treatment provider, recently began employing a powerful new assistant: an artificial intelligence algorithm that can perform eye exams with pictures taken by a retinal camera. It makes quick diagnoses, without a doctor present.

His clinics, Tarzana Treatment Centers, are among the early adopters of an AI-based system that promises to dramatically expand screening for diabetic retinopathy, the leading cause of blindness among working-age adults and a threat to many of the estimated 38 million Americans with diabetes.

“It’s been a godsend for us,” said Espinoza, the organization’s director of clinic operations, citing the benefits of a quick and easy screening that can be administered with little training and delivers immediate results.

His patients like it, too. Joseph Smith, who has Type 2 diabetes, recalled the cumbersome task of taking the bus to an eye specialist, getting his eyes dilated, and then waiting a week for results. “It was horrible,” he said. “Now, it takes minutes.”

Amid all the buzz around artificial intelligence in health care, the eye-exam technology is emerging as one of the first proven use cases of AI-based diagnostics in a clinical setting. While the FDA has approved hundreds of AI medical devices, adoption has been slow as vendors navigate the regulatory process, insurance coverage, technical obstacles, equity concerns, and challenges of integrating them into provider systems.

The eye exams show that the AI’s ability to provide immediate results, as well as the cost savings and convenience of not needing to make an extra appointment, can have big benefits for both patients and providers. Of about 700 eye exams conducted during the past year at Espinoza’s clinics, nearly one-quarter detected retinopathy, and patients were referred to a specialist for further care.

Diabetic retinopathy results when high blood sugar harms blood vessels in the retina. While managing a patient’s diabetes can often prevent the disease — and there are treatments for more advanced stages — doctors say regular screenings are crucial for catching symptoms early. An estimated 9.6 million people in the U.S. have the disease.

The three companies with FDA-approved AI eye exams for diabetic retinopathy — Digital Diagnostics, based in Coralville, Iowa; Eyenuk of Woodland Hills, California; and Israeli software company AEYE Health — have sold systems to hundreds of practices nationwide. A few dozen companies have conducted research in the narrow field, and some have regulatory clearance in other countries, including tech giants like Google.

Digital Diagnostics, formerly Idx, received FDA approval for its system in 2018, following decades of research and a clinical trial involving 900 patients diagnosed with diabetes. It was the first fully autonomous AI system in any field of medicine, making its approval “a landmark moment in medical history,” said Aaron Lee, a retina specialist and an associate professor at the University of Washington.

The system, used by Tarzana Treatment Centers, can be operated by someone with a high school degree and a few hours of training, and it takes just a few minutes to produce a diagnosis, without any eye dilation most of the time, said John Bertrand, CEO of Digital Diagnostics.

The setup can be placed in any dimly lit room, and patients place their face on the chin and forehead rests and stare into the camera while a technician takes images of each eye.

The American Diabetes Association recommends that people with Type 2 diabetes get screened every one to two years, yet only about 60% of people living with diabetes get yearly eye exams, said Robert Gabbay, the ADA’s chief scientific and medical officer. The rates can be as low as 35% for people with diabetes age 21 or younger.

In swaths of the U.S., a shortage of optometrists and ophthalmologists can make appointments hard to schedule, sometimes booking for months out. Plus, the barriers of traveling to an additional appointment to get their eyes dilated — which means time off work or school and securing transportation — can be particularly tricky for low-income patients, who also have a higher risk of Type 2 diabetes.

“Ninety percent of our patients are blue-collar,” said Espinoza of his Southern California clinics, which largely serve minority populations. “They don’t eat if they don’t work.”

One potential downside of not having a doctor do the screening is that the algorithm solely looks for diabetic retinopathy, so it could miss other concerning diseases, like choroidal melanoma, Lee said. The algorithms also generally “err on the side of caution” and over-refer patients.

But the technology has shown another big benefit: Follow-up after a positive result is three times as likely with the AI system, according to a recent study by Stanford University.

That’s because of the “proximity of the message,” said David Myung, an associate professor of ophthalmology at the Byers Eye Institute at Stanford. When it’s delivered immediately, rather than weeks or even months later, it’s much more likely to be heard by the patient and acted upon.

Myung launched Stanford’s automated teleophthalmology program in 2020, originally focusing on telemedicine and then shifting to AI in its Bay Area clinics. That same year, the National Committee for Quality Assurance expanded its screening standard for diabetic retinopathy to include the AI systems.

Myung said it took about a year to sift through the Stanford health system’s cybersecurity and IT systems to integrate the new technology. There was also a learning curve, especially for taking quality photos that the AI can decipher, Myung said.

“Even with hitting our stride, there’s always something to improve,” he added.

The AI test has been bolstered by a reimbursement code from the Centers for Medicare & Medicaid Services, which can be difficult and time-consuming to obtain for breakthrough devices. But health care providers need that government approval to get reimbursement.

In 2021, CMS set the national payment rate for AI diabetic retinopathy screenings at $45.36 — quite a bit below the median privately negotiated rate of $127.81, according to a recent New England Journal of Medicine AI study. Each company has a slightly different business model, but they generally charge providers subscription or licensing fees for their software.

The companies declined to share what they charge for their software. The cameras can cost up to $20,000 and are either purchased separately or wrapped into the software subscription as a rental.

The greater compliance with screening recommendations that the machines make possible, along with a corresponding increase in referrals to specialists, makes it worthwhile, said Lindsie Buchholz, clinical informatics lead at Nebraska Medicine, which in mid-December began using Eyenuk’s system.

“It kind of helps the camera pay for itself,” she said.

Today, Digital Diagnostics’ system is in roughly 600 sites nationwide, according to the company. AEYE Health said its eye exam is used by “low hundreds” of U.S. providers. Eyenuk declined to share specifics about its reach.

The technology continues to advance, with clinical studies for additional cameras — including a handheld imager that can screen patients in the field — and looking at other eye diseases, like glaucoma. The innovations put ophthalmology alongside radiology, cardiology, and dermatology as specialties in which AI innovation is happening fast.

“They are going to come out in the near future — cameras that you can use in street medicine — and it’s going to help a lot of people,” said Espinoza.

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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Some Medicaid Providers Borrow or Go Into Debt Amid ‘Unwinding’ Payment Disruptions

March 27, 2024
https://kffhealthnews.org/wp-content/uploads/sites/2/2024/03/Montana-Medicaid_WithIntro-1.mp3

George said the company didn’t have enough money to pay its employees. When he called state health and public assistance officials for help, he said, they told him they were swamped processing a high load of Medicaid cases, and that his residents would have to wait their turn.

“I’ve mentioned to some of them, ‘Well what do we do if we’re not being paid for four or five months? Do we have to evict the resident?’” he asked.

Instead, the company took out bank loans at 8% interest, George said.

Montana officials finished their initial checks of who qualifies for Medicaid in January, less than a year after the federal government lifted a freeze on disenrollments during the height of the covid-19 pandemic. More than 127,200 people in Montana lost Medicaid with tens of thousands of cases still processing, according to the latest state data, from mid-February.

Providers who take Medicaid have said their state payments have been disrupted, leaving them financially struggling amid the unwinding. They’re providing care without pay, and sometimes going into debt. It’s affecting small long-term care facilities, substance use disorder clinics, and federally funded health centers that rely on Medicaid to offer treatment based on need, not what people can pay.

State health officials have defended their Medicaid redetermination process and said they have worked to address public assistance backlogs.

Financial pinches were expected as people who legitimately no longer qualify were removed from coverage. But the businesses have said an overburdened state workforce is creating a different set of problems. In some cases, it has taken months for people to reapply for Medicaid after getting dropped, or to access the coverage for the first time. Part of the problem, providers said, are long waits on hold for the state’s call center and limited in-person help.

The problem is ongoing: George said two Guardian residents were booted from Medicaid in mid-March, with the state citing a lack of information as the cause.

“I have proof we submitted the needed information weeks ago,” he said.

Providers said they’ve also experienced cases of inconsistent Medicaid payments for people who haven’t lost coverage. It can be hard to disentangle why payments suddenly stop. Patients and providers are working within the same overstretched system.

Jon Forte is the head of the Yellowstone County health department in Billings, which runs health centers that provide care regardless of patients’ ability to pay. He said that at one point some of the clinics’ routine Medicaid claims went unpaid for up to six months. Their doctors are struggling to refer patients out for specialty care as some providers scale back on clientele, he said.

“Some have honestly had to stop seeing Medicaid patients so that they can meet their needs and keep the lights on,” Forte said. “It is just adding to the access crisis we have in the state.”

Payment shortfalls especially hurt clinics that base fees on patient income.

David Mark, a doctor and the CEO of One Health, which has rural clinics dotted across eastern Montana and Wyoming, said the company anticipated making about $500,000 in profit through its budget year so far. Instead, it’s $1.5 million in the red.

In Yellowstone County, Forte said, the health department, known as RiverStone Health, is down $2.2 million from its anticipated Medicaid revenue. Forte said that while state officials have nearly caught up on RiverStone Health’s direct Medicaid payments, smaller providers are still seeing delays, which contributes to problems referring patients for care.

Jon Ebelt, a spokesperson for the Montana Department of Public Health and Human Services, said Medicaid can retroactively pay for services for people who have lost coverage but are then found eligible within 90 days. He said the state’s average redetermination processing time is 34 days, the average processing time for applications is 48 days, and, when processing times are longer, it’s often due to ongoing communication with a client.

Ebelt didn’t acknowledge broader Medicaid payment delays, but instead said a provider may be submitting claims for Medicaid enrollees who aren’t eligible. He rejected the idea that individual examples of disruptions amount to a systemic problem.

“We would caution you against using broad brush strokes to paint a picture of our overall eligibility system and processes based on a handful of anecdotal stories,” Ebelt said in an emailed response to a KFF Health News query.

Ebelt didn’t directly answer questions about continued long waits for people seeking help but instead said continued coverage depends on individual beneficiaries submitting information on time.

Federal data shows Montana’s average call center wait time is 30 minutes — putting it among states with the highest average wait times. Mike White, co-owner of Caslen Living Centers, which has six small assisted living facilities across central and southwestern Montana, said some family members allowed the company to manage residents’ Medicaid accounts to help avoid missing deadlines or paperwork. Even so, he said, the company is waiting for about $30,000 in Medicaid payments, and it’s hard to reach the state when problems arise.

When they do get through to the state’s call center, the person on the other end can’t always resolve their issue or will answer questions for only one case at a time.

“You don’t know how long it’s going to take — it could be two months, it could be six months — and there’s nobody to talk to,” White said.

Ebelt said long-term care facilities were provided information on how to prepare for the unwinding process. He said new Medicaid cases for long-term care facilities are complicated and can take time.

Stan Klaumann lives in Ennis and has power of attorney for his 94-year-old mom, who resides in one of Guardian’s assisted living homes. Klaumann said that while she never lost coverage, the state didn’t make Medicaid payments toward her long-term care for more than four months and he still doesn’t know why.

He said that since last fall the state hasn’t consistently mailed him routine paperwork he needs to fill out and return in exchange for Medicaid payments to continue. He tried the state’s call center, he said, but each time he waited on hold for more than two hours. He made four two-hour round trips to his closest office of public assistance to try to get answers.

Sometimes the workers told him that there was a state error, he said, and other times that he was missing paperwork he’d already submitted, such as where money from selling his mom’s car went.

“Each time I went, they gave me a different answer as to why my mother’s bills weren’t being paid,” Klaumann said.

Across the nation, people have reported system errors and outdated contact information that led states to drop people who qualify. At least 28 states paused procedural disenrollments to boost outreach to people who qualify, according to federal data. Montana stuck to its original time frame and has a higher procedural disenrollment rate than most other states, according to KFF.

Stephen Ferguson, executive director of Crosswinds Recovery in Missoula, said the substance use disorder program doesn’t have a full-time person focused on billing and sometimes doesn’t realize clients lost Medicaid coverage until the state rejects thousands of dollars in services that Crosswinds submits for reimbursement. After that, it can take months for clients to either get reenrolled or learn they truly no longer qualify.

Ferguson said he’s writing grant proposals to continue to treat people despite their inability to pay.

“We’re riding by the seat of our pants right now,” he said. “We are unsure what next month or the next quarter looks like.”

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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This State Isn’t Waiting for Biden To Negotiate Drug Prices

March 26, 2024

As the federal government negotiates with drugmakers to lower the price of 10 expensive drugs for Medicare patients, impatient legislators in some states are trying to go even further. Leading the pack is Colorado, where a new Prescription Drug Affordability Review Board is set to recommend an “upper payment limit” for drugs it deems unaffordable.

In late February the board selected Enbrel, Amgen’s blockbuster drug for autoimmune conditions (list price $1,850 per week), as the first medication that would go through its processNovartis’s Cosentyx and Johnson & Johnson’s Stelara (both treat autoimmune conditions) will undergo affordability reviews later this year.

Enbrel and Stelara are also on the list of drugs whose prices the federal government is negotiating — but only for Medicare patients. Prices may be published Sept. 1 — in time for President Biden to cheer the results in his reelection campaign. But they won’t take effect until 2026, while the drug industry pursues a raft of lawsuits to stop the initiative.

Colorado’s plan is, in many ways, both broader and more prescriptive than the feds’, covering all patients and potentially fixing an upper price limit rather than squabbling with the industry over an acceptable figure.

Colorado’s government said it anticipates similar litigation. A spokesperson for the state’s Division of Insurance, which oversees the program, declined to make anyone available for an interview.

The Pharmaceutical Research and Manufacturers of America, the industry’s main trade group, said in a blog post: “Policymakers in Colorado have created a system in which patients may face significant barriers to lifesaving medicines because of government price setting.”

The state has already said 604 drugs met the first criteria to undergo an affordability review. The full list of drugs is linked from the board’s webpage, along with a list — in order — of those it has slated for priority review.

The Colorado board will spend the summer setting upper payment levels for drugs selected for price reviews. Drugmakers can then appeal.

The board plans to examine how manufacturers price — and raise prices — for drugs. For generics, the board’s director, Lila Cummings, said at a Feb. 23 meeting, the criteria could include whether the price paid by wholesalers before discounts has increased at least 200 percent in the past year and whether a 30-day supply costs more than $100. Branded drugs that cost more than $30,000 a year or whose wholesale price has increased at least 10 percent in the past year could land in the board’s sights, as could biosimilars that aren’t at least 15 percent cheaper than the brand-name biologics they’re intended to replace, Cummings said.

The five-member board, appointed by Gov. Jared Polis (D), includes two medical doctors, two pharmacists and a hospital executive. A 15-member advisory council includes patient advocates, insurers, pharmacists and representatives of drug manufacturers.

The Colorado law creating the board set out a lengthy process for any drugmaker that decides to withdraw its product from the state over the price caps. (Note that the state is also exploring importing cheaper drugs from Canada, without much success so far.)

More than a dozen states are attempting to rein in drug prices through a variety of tactics. It’s early in U.S. regulators’ work to control drug prices, and it’s unclear whether the federal or state efforts will prevail. 

What is clear is that patients need some relief: Over 30 percent of adults report not taking medications as prescribed because of costs, and 1 in 5 didn’t fill a prescription, according to KFF survey results published in August.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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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Overdosing on Chemo: A Common Gene Test Could Save Hundreds of Lives Each Year

March 26, 2024

One January morning in 2021, Carol Rosen took a standard treatment for metastatic breast cancer. Three gruesome weeks later, she died in excruciating pain from the very drug meant to prolong her life.

Rosen, a 70-year-old retired schoolteacher, passed her final days in anguish, enduring severe diarrhea and nausea and terrible sores in her mouth that kept her from eating, drinking, and, eventually, speaking. Skin peeled off her body. Her kidneys and liver failed. “Your body burns from the inside out,” said Rosen’s daughter, Lindsay Murray, of Andover, Massachusetts.

Rosen was one of more than 275,000 cancer patients in the United States who are infused each year with fluorouracil, known as 5-FU, or, as in Rosen’s case, take a nearly identical drug in pill form called capecitabine. These common types of chemotherapy are no picnic for anyone, but for patients who are deficient in an enzyme that metabolizes the drugs, they can be torturous or deadly.

Those patients essentially overdose because the drugs stay in the body for hours rather than being quickly metabolized and excreted. The drugs kill an estimated 1 in 1,000 patients who take them — hundreds each year — and severely sicken or hospitalize 1 in 50. Doctors can test for the deficiency and get results within a week — and then either switch drugs or lower the dosage if patients have a genetic variant that carries risk.

Yet a recent survey found that only 3% of U.S. oncologists routinely order the tests before dosing patients with 5-FU or capecitabine. That’s because the most widely followed U.S. cancer treatment guidelines — issued by the National Comprehensive Cancer Network — don’t recommend preemptive testing.

The FDA added new warnings about the lethal risks of 5-FU to the drug’s label on March 21 following queries from KFF Health News about its policy. However, it did not require doctors to administer the test before prescribing the chemotherapy.

The agency, whose plan to expand its oversight of laboratory testing was the subject of a House hearing, also March 21, has said it could not endorse the 5-FU toxicity tests because it’s never reviewed them.

But the FDA at present does not review most diagnostic tests, said Daniel Hertz, an associate professor at the University of Michigan College of Pharmacy. For years, with other doctors and pharmacists, he has petitioned the FDA to put a black box warning on the drug’s label urging prescribers to test for the deficiency.

“FDA has responsibility to assure that drugs are used safely and effectively,” he said. The failure to warn, he said, “is an abdication of their responsibility.”

The update is “a small step in the right direction, but not the sea change we need,” he said.

Europe Ahead on Safety

British and European Union drug authorities have recommended the testing since 2020. A small but growing number of U.S. hospital systems, professional groups, and health advocates, including the American Cancer Society, also endorse routine testing. Most U.S. insurers, private and public, will cover the tests, which Medicare reimburses for $175, although tests may cost more depending on how many variants they screen for.

In its latest guidelines on colon cancer, the Cancer Network panel noted that not everyone with a risky gene variant gets sick from the drug, and that lower dosing for patients carrying such a variant could rob them of a cure or remission. Many doctors on the panel, including the University of Colorado oncologist Wells Messersmith, have said they have never witnessed a 5-FU death.

In European hospitals, the practice is to start patients with a half- or quarter-dose of 5-FU if tests show a patient is a poor metabolizer, then raise the dose if the patient responds well to the drug. Advocates for the approach say American oncology leaders are dragging their feet unnecessarily, and harming people in the process.

“I think it’s the intransigence of people sitting on these panels, the mindset of ‘We are oncologists, drugs are our tools, we don’t want to go looking for reasons not to use our tools,’” said Gabriel Brooks, an oncologist and researcher at the Dartmouth Cancer Center.

Oncologists are accustomed to chemotherapy’s toxicity and tend to have a “no pain, no gain” attitude, he said. 5-FU has been in use since the 1950s.

Yet “anybody who’s had a patient die like this will want to test everyone,” said Robert Diasio of the Mayo Clinic, who helped carry out major studies of the genetic deficiency in 1988.

Oncologists often deploy genetic tests to match tumors in cancer patients with the expensive drugs used to shrink them. But the same can’t always be said for gene tests aimed at improving safety, said Mark Fleury, policy director at the American Cancer Society’s Cancer Action Network.

When a test can show whether a new drug is appropriate, “there are a lot more forces aligned to ensure that testing is done,” he said. “The same stakeholders and forces are not involved” with a generic like 5-FU, first approved in 1962, and costing roughly $17 for a month’s treatment.

Oncology is not the only area in medicine in which scientific advances, many of them taxpayer-funded, lag in implementation. For instance, few cardiologists test patients before they go on Plavix, a brand name for the anti-blood-clotting agent clopidogrel, although it doesn’t prevent blood clots as it’s supposed to in a quarter of the 4 million Americans prescribed it each year. In 2021, the state of Hawaii won an $834 million judgment from drugmakers it accused of falsely advertising the drug as safe and effective for Native Hawaiians, more than half of whom lack the main enzyme to process clopidogrel.

The fluoropyrimidine enzyme deficiency numbers are smaller — and people with the deficiency aren’t at severe risk if they use topical cream forms of the drug for skin cancers. Yet even a single miserable, medically caused death was meaningful to the Dana-Farber Cancer Institute, where Carol Rosen was among more than 1,000 patients treated with fluoropyrimidine in 2021.

Her daughter was grief-stricken and furious after Rosen’s death. “I wanted to sue the hospital. I wanted to sue the oncologist,” Murray said. “But I realized that wasn’t what my mom would want.”

Instead, she wrote Dana-Farber’s chief quality officer, Joe Jacobson, urging routine testing. He responded the same day, and the hospital quickly adopted a testing system that now covers more than 90% of prospective fluoropyrimidine patients. About 50 patients with risky variants were detected in the first 10 months, Jacobson said.

Dana-Farber uses a Mayo Clinic test that searches for eight potentially dangerous variants of the relevant gene. Veterans Affairs hospitals use a 11-variant test, while most others check for only four variants.

Different Tests May Be Needed for Different Ancestries

The more variants a test screens for, the better the chance of finding rarer gene forms in ethnically diverse populations. For example, different variants are responsible for the worst deficiencies in people of African and European ancestry, respectively. There are tests that scan for hundreds of variants that might slow metabolism of the drug, but they take longer and cost more.

These are bitter facts for Scott Kapoor, a Toronto-area emergency room physician whose brother, Anil Kapoor, died in February 2023 of 5-FU poisoning.

Anil Kapoor was a well-known urologist and surgeon, an outgoing speaker, researcher, clinician, and irreverent friend whose funeral drew hundreds. His death at age 58, only weeks after he was diagnosed with stage 4 colon cancer, stunned and infuriated his family.

In Ontario, where Kapoor was treated, the health system had just begun testing for four gene variants discovered in studies of mostly European populations. Anil Kapoor and his siblings, the Canadian-born children of Indian immigrants, carry a gene form that’s apparently associated with South Asian ancestry.

Scott Kapoor supports broader testing for the defect — only about half of Toronto’s inhabitants are of European descent — and argues that an antidote to fluoropyrimidine poisoning, approved by the FDA in 2015, should be on hand. However, it works only for a few days after ingestion of the drug and definitive symptoms often take longer to emerge.

Most importantly, he said, patients must be aware of the risk. “You tell them, ‘I am going to give you a drug with a 1 in 1,000 chance of killing you. You can take this test. Most patients would be, ‘I want to get that test and I’ll pay for it,’ or they’d just say, ‘Cut the dose in half.’”

Alan Venook, the University of California-San Francisco oncologist who co-chairs the National Comprehensive Cancer Network, has led resistance to mandatory testing because the answers provided by the test, in his view, are often murky and could lead to undertreatment.

“If one patient is not cured, then you giveth and you taketh away,” he said. “Maybe you took it away by not giving adequate treatment.”

Instead of testing and potentially cutting a first dose of curative therapy, “I err on the latter, acknowledging they will get sick,” he said. About 25 years ago, one of his patients died of 5-FU toxicity and “I regret that dearly,” he said. “But unhelpful information may lead us in the wrong direction.”

In September, seven months after his brother’s death, Kapoor was boarding a cruise ship on the Tyrrhenian Sea near Rome when he happened to meet a woman whose husband, Atlanta municipal judge Gary Markwell, had died the year before after taking a single 5-FU dose at age 77.

“I was like … that’s exactly what happened to my brother.”

Murray senses momentum toward mandatory testing. In 2022, the Oregon Health & Science University paid $1 million to settle a suit after an overdose death.

“What’s going to break that barrier is the lawsuits, and the big institutions like Dana-Farber who are implementing programs and seeing them succeed,” she said. “I think providers are going to feel kind of bullied into a corner. They’re going to continue to hear from families and they are going to have to do something about it.”

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

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After Appalachian Hospitals Merged Into a Monopoly, Their ERs Slowed to a Crawl

March 25, 2024

In the small Appalachian city of Bristol, Virginia, City Council member Neal Osborne left a meeting on the morning of Jan. 3 and rushed himself to the hospital.

Osborne, 36, has Type 1 diabetes. His insulin pump had malfunctioned, and without a steady supply of this essential hormone, Osborne’s blood sugar skyrocketed and his body was shutting down.

Osborne went to the nearest hospital, Bristol Regional Medical Center. He said he settled into a wheelchair in the emergency room waiting area, where over the next few hours he drifted in and out of consciousness and retched up vomit, then bile, then blood. After 12 hours in the waiting room, Osborne said, he was moved to an ER bed, where he stayed until he was sent to the intensive care unit the next day. In total, the council member was in the ER for about 30 hours, he said.

Osborne said his ordeal echoes stories he’s heard from constituents for years. In his next crisis, Osborne said, he plans to leave Bristol for an ER about two hours away.

“I want to go to Knoxville or I want to go to Roanoke, because I do not want to further risk my life and die at a Ballad hospital,” he said. “The wait times just to get in and see a doctor in the ER have grown exponentially.”

Ballad Health, a 20-hospital system in the Tri-Cities region of Tennessee and Virginia, benefits from the largest state-sanctioned hospital monopoly in the United States. In the six years since lawmakers in both states waived anti-monopoly laws and Ballad was formed, ER visits for patients sick enough to be hospitalized grew more than three times as long and now far exceed the criteria set by state officials, according to Ballad reports released by the Tennessee Department of Health.

Tennessee and Virginia have so far announced no steps to reduce time spent in Ballad ERs. The Tennessee health department, which has a more direct role in regulating Ballad, has each year issued a report saying the agreement that gave Ballad a monopoly “continues to provide a Public Advantage.” Department officials have twice declined to comment to KFF Health News on Ballad’s performance.

According to Ballad’s latest annual report, which was released this month and spans from July 2022 to June 2023, the median time that patients spend in Ballad ERs before being admitted to the hospital is nearly 11 hours. This statistic includes both time spent waiting and time being treated in the ER and excludes patients who weren’t admitted or left the ER without receiving care.

The federal government once tracked ER speed the same way. When compared against the latest corresponding federal data from 2019, which includes more than 4,000 hospitals but predates the covid-19 pandemic, Ballad ranks among the 100 hospitals with the slowest ERs. More current federal data is not available because the Centers for Medicare & Medicaid Services retired this statistic in 2020 in favor of other measurements.

Newer data tells a similar story. The Joint Commission, a nonprofit that accredits health care organizations, collected this same measurement for 2022 from about 250 hospitals that volunteered the data, finding a median ER speed of five hours and 41 minutes — or about five hours faster than Ballad’s latest annual report.

Ballad Health spokesperson Molly Luton said in an email statement that, by holding patients in the ER, where they are observed while waiting for a bed, Ballad avoids “overwhelming” its staff. Luton said ER delays are also caused by two nationwide crises: a nursing shortage and fewer admissions at nursing homes and similar facilities, which can create a backlog of patients awaiting discharge from the hospital.

Luton added that Ballad’s ER time for admitted patients has dropped to about 7½ hours in the months since the company’s latest annual report.

“On those issues Ballad Health can directly control, our performance has rebounded from 2022, and is now among the best in the nation,” Luton said.

Luton also noted that Ballad performs better than or close to the national average on several other measurements of ER performance, including having fewer patients who leave without being treated. CMS data shows the national average is about 3%. Ballad reported 1.4% in its latest annual report.

Osborne, the Bristol council member, attributed this statistic to Ballad’s monopoly.

“Just because they aren’t leaving the ER doesn’t mean they are happy where they are,” he said. “It just means they don’t have anywhere else they could be.”

Ballad’s Big Monopoly

Ballad Health was formed in 2018 after state officials approved the nation’s biggest hospital merger based on a so-called Certificate of Public Advantage, or COPA, agreement. COPAs have been used in about 10 hospital mergers over the past three decades, but none has involved as many hospitals as Ballad’s.

State lawmakers in Tennessee and Virginia waived federal anti-monopoly laws so rival hospital systems — Mountain States Health Alliance and Wellmont Health System — could merge into a single company with no competition. Ballad is now the only option for hospital care for most of about 1.1 million residents in a 29-county region at the nexus of Tennessee, Virginia, Kentucky, and North Carolina.

The Federal Trade Commission warns that hospital monopolies lead to increased prices and decreased quality of care. To offset the perils of Ballad’s monopoly, officials required the new company to commit to a long list of special conditions, including dozens of quality-care metrics spelled out with specific benchmarks.

In its latest annual report, Ballad improved on many quality-of-care metrics over the prior year, including several that the company prioritized, but still fell short on 56 of 75 benchmarks.

ER time for admitted patients is one of those. The benchmark was set at three hours and 47 minutes in the original COPA agreement. Ballad met or nearly met this goal for three years, according to its annual reports. Then the ERs slowed.

In 2022, Ballad reported a median ER time for admitted patients of about six hours.

In 2023, it reported the same statistic at seven hours and 40 minutes.

In the latest report, ER time for admitted patients had reached 10 hours and 45 minutes.

CMS, which grades thousands of hospitals nationwide, warns on its website that timely ER care is “essential for good patient outcomes,” and that more time spent in the ER has been linked to higher complication rates and delays in patients getting pain medication and antibiotics.

Ben Harder, chief of health analysis for U.S. News & World Report, said extensive ER times can be a symptom of slowdowns throughout a hospital, including in the operating room.

“A long delay in getting patients admitted is both a risk in itself, in that a test may not get conducted as promptly,” Harder said. “But it’s also an indication that the hospital is backed up, and that there are problems getting patients moved from one unit to another.”

Bill Christian, a spokesperson for the Tennessee Department of Health, said Ballad’s rising ER times had been “noted” but did not say if the agency had taken or was considering any action. Christian directed questions about Ballad’s latest stats to the company itself.

‘A Nightmare for Community Members’

Ballad has also fallen short — by about $191 million over the past five years — of its obligation to Tennessee to provide charity care, which is free or discounted care for low-income patients, according to health department documents and Ballad’s latest report. The health department waived this obligation in each of the past four fiscal years. Ballad has said it would ask for another this year.

In a two-hour interview last year, Ballad CEO Alan Levine defended his company and said that because the Tri-Cities region could not support two competing hospital companies, the COPA merger had likely prevented at least three hospital closures. Levine attributed Ballad’s failure to meet quality benchmarks to the pressure of the covid pandemic and said charity care shortfalls were partly caused by Medicaid changes beyond Ballad’s control.

“Our critics say, ‘No Ballad. We don’t want Ballad.’ Well, then what?” Levine said. “Because the hospitals were on their way to being closed.”

Some residents see Ballad as a savior. John King, who runs a physical therapy clinic in the core of Ballad’s region, said at a public hearing last June that in multiple visits to Ballad ERs, including one for a stroke, he found their care to be quick and compassionate.

“If it weren’t for Ballad Health, I literally would not be here today,” King said, according to a hearing transcript.

Ballad’s failures to live up to the terms of the COPA agreement were detailed in a KFF Health News investigation last September, and the company faced a new wave of criticism in the months that followed.

Local leaders in Carter County, Tennessee, in October debated but did not pass a resolution calling for Ballad to be better regulated or broken up. Tennessee Attorney General Jonathan Skrmetti, a Republican, said in an interview with the Tennessee Lookout published in November that Ballad must be constantly monitored in light of community complaints. Earlier this month, Tennessee state Rep. David Hawk (R-Greeneville), who represents a region within Ballad’s monopoly, called for Levine’s resignation, according to wjhl.com.

In response, Ballad Health said in a statement it has “strong relationships with the majority of elected officials” in Carter County and welcomed scrutiny from the Tennessee attorney general. Ballad said Hawk’s “opinion certainly does not reflect our broader relationships” within the area. Tennessee lawmakers are also considering legislation to forbid future COPA mergers in the state, which Ballad said “risks putting more hospitals at risk for closure.”

The bill was introduced by state Sen. Heidi Campbell (D-Nashville) and state Rep. Gloria Johnson (D-Knoxville), who is running for the U.S. Senate. Johnson said the bill would end Ballad’s protection from antitrust laws.

“It’s just been a nightmare for community members out there,” Johnson said. “And they have no other option.”

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' 'What the Health?': The ACA Turns 14

March 21, 2024
The Host Julie Rovner KFF Health News @jrovner Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

The Affordable Care Act was signed into law 14 years ago this week, and Health and Human Services Secretary Xavier Becerra joined KFF Health News’ Julie Rovner on this week’s “What the Health?” podcast to discuss its accomplishments so far — and the challenges that remain for the health law.

Meanwhile, Congress appears on its way to, finally, finishing the fiscal 2024 spending bills, including funding for HHS — without many of the reproductive or gender-affirming health care restrictions Republicans had sought.

This week’s panelists are Julie Rovner of KFF Health News, Mary Agnes Carey of KFF Health News, Tami Luhby of CNN, and Alice Miranda Ollstein of Politico.

Panelists Mary Agnes Carey KFF Health News @maryagnescarey Read Mary Agnes' stories. Tami Luhby CNN @Luhby Read Tami's stories. Alice Miranda Ollstein Politico @AliceOllstein Read Alice's stories.

Among the takeaways from this week’s episode:

  • The Supreme Court will hear oral arguments next week in a case that could decide whether the abortion pill mifepristone will remain easily accessible. The case itself deals with national restrictions rather than an outright ban. But, depending on how the court rules, it could have far-reaching results — for instance, preventing people from getting the pills in the mail and limiting how far into pregnancy the treatment can be used.
  • The case is about more than abortion. Drug companies and medical groups are concerned about the precedent it would set for courts to substitute their judgment for that of the FDA regarding drug approvals.
  • Abortion-related ballot questions are in play in several states. The total number ultimately depends on the success of citizen-led efforts to collect signatures to gain a spot. Such efforts face opposition from anti-abortion groups and elected officials who don’t want the questions to reach the ballot box. Their fear, based on precedents, is that abortion protections tend to pass.
  • The Biden administration issued an executive order this week to improve research on women’s health across the federal government. It has multiple components, including provisions intended to increase research on illnesses and diseases associated with postmenopausal women. It also aims to increase the number of women participating in clinical trials.
  • This Week in Medical Misinformation: The Supreme Court heard oral arguments in the case Murthy v. Missouri. At issue is whether Biden administration officials overstepped their authority when asking companies like Meta, Google, and X to remove or downgrade content flagged as covid-19 misinformation.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: The Washington Post’s “Arizona Lawmaker Tells Her Abortion Story to Show ‘Reality’ of Restrictions,” by Praveena Somasundaram. (Full speech here.)

Alice Miranda Ollstein: CNN’s “Why Your Doctor’s Office Is Spamming You With Appointment Reminders,” by Nathaniel Meyersohn.

Tami Luhby: KFF Health News’ “Georgia’s Medicaid Work Requirement Costing Taxpayers Millions Despite Low Enrollment,” by Andy Miller and Renuka Rayasam.

Mary Agnes Carey: The New York Times’ “When Medicaid Comes After the Family Home,” by Paula Span, and The AP’s “State Medicaid Offices Target Dead People’s Homes to Recoup Their Health Care Costs,” by Amanda Seitz.

Also mentioned on this week’s podcast:

Credits Francis Ying Audio producer Stephanie Stapleton Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ “What the Health?” on SpotifyApple PodcastsPocket Casts, or wherever you listen to podcasts.

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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Social Security Chief Testifies in Senate About Plans to Stop ‘Clawback Cruelty’

March 21, 2024

The new chief of the Social Security Administration outlined for senators Wednesday a plan to tackle overpayments and clawbacks, which affect millions of beneficiaries and, he said, have caused “grave injustices” and left people “in dire financial straits.”

As a joint investigation by KFF Health News and Cox Media Group television stations reported in September, the agency has harmed people it is supposed to help by reducing or halting benefit checks to recoup billions of dollars in payments it sent them but later said they should never have received.

Testifying at two Senate hearings on March 20, Social Security Commissioner Martin O’Malley said he is taking several steps to address the problem.

Starting next week, O’Malley said, the agency will stop “that clawback cruelty” of intercepting 100% of a beneficiary’s monthly Social Security check if they fail to respond to a demand for repayment.

Instead, the agency will default to withholding 10% of the recipient’s monthly benefits to recoup the debt, he said.

That would have helped Denise Woods, a Savannah, Georgia, woman who ended up living in her car after the SSA clawed back her entire monthly benefit to recoup a $58,000 overpayment. The agency restored some of her benefits after KFF Health News-CMG reported her story in December.

“People like Denise and others shouldn’t be penalized for situations they did not create,” Sen. Raphael Warnock (D-Ga.) said during one of the hearings. “I think it’s always important that we center the people as we discuss policy, remember the human face of the issues we talk about.”

On the question of who caused an overpayment — the beneficiary or someone at the agency — the burden of proof will shift from the beneficiary to the agency, O’Malley said.

The agency will make it much easier for people who believe they weren’t at fault or can’t repay the debt to seek a waiver, O’Malley said, which he later clarified means simplifying the form people must submit.

(WPXI-TV, Pittsburgh)

(WSB-TV, Atlanta)

O’Malley’s plan also includes making notices to beneficiaries easier to understand. Now, they’re “like Mad Libs designed by mad lawyers,” he testified.

In addition, the agency recently changed a policy to allow most beneficiaries to arrange repayment plans of as long as five years, up from three years, he said.

Millions of people a year have been hit with clawbacks, including retirees, people receiving Social Security disability benefits, and the poorest of the poor. The alleged debts can stretch back years or decades and reach tens of thousands of dollars or more.

At the end of the last fiscal year, uncollected overpayments totaled $23 billion.

In December, KFF Health News and Cox Media Group television stations obtained an internal agency document showing that more than 2 million Americans each year are subjected to overpayment demands, out of about 70 million beneficiaries.

O’Malley, a former Maryland governor who was sworn in as commissioner in December, had previewed his planned changes in a recent interview with KFF Health News.

On Wednesday, he appeared before the Senate Special Committee on Aging in the morning and the Finance Committee in the afternoon.

In hours of testimony, O’Malley said nothing about one of the reforms he heralded in the interview: limiting how far back in time the agency can reach to recover overpayments.

In an interview between the hearings, O’Malley said, “That’s still being unpacked and may well require a change in regulation.” He said he expected an announcement within a few months.

O’Malley said he didn’t know how far back the limit would go but noted that other agencies tend to have a look-back period of four years.

Establishing a statute of limitations is one of the most important steps the government can take to address overpayments, Boston University economist Laurence Kotlikoff, who has studied and written about clawbacks, said in an interview.

“If Social Security can’t figure out its mistakes within 18 months, it should be on them,” Kotlikoff said.

Having to repay a year and a half of benefits could cost people their homes, Kotlikoff said.

Rebecca Vallas, who has helped beneficiaries navigate overpayments as a legal aid attorney and has called for reform of clawbacks, said the steps O’Malley announced “are nothing short of historic.”

Shifting the burden of proof “is a dramatic change,” said David Camp, chief executive of the National Organization of Social Security Claimants’ Representatives. While a lot is riding on the details and how O’Malley’s plans are implemented, that change alone should lead to “a very different experience” for anyone challenging a clawback, Camp added.

(WSOC-TV, Charlotte)

In the past, there has been a gap between what the agency says and what it does. O’Malley said 10% has been the default withholding rate in one of the Social Security programs, Supplemental Security Income. But KFF Health News and Cox Media Group have found people whose entire SSI benefit checks were suspended on account of alleged overpayments.

The changes announced won’t apply automatically to people already on a repayment plan or whose monthly benefits are already being docked, O’Malley said outside the hearings. To take advantage of the new terms, beneficiaries would have to contact the agency and request relief, he said. The agency will notify people that they have that option, he added.

O’Malley implored lawmakers to increase funding for the agency. On average, customers trying to reach the agency by phone wait 38 minutes, he said. Most who call the 800 number “hang up in disgust after waiting far too long,” he said in written testimony.

Trouble getting through to anyone at the agency can contribute to overpayments and make it harder for recipients to resolve them.

Sen. Bob Casey (D-Pa.), chair of the Special Committee on Aging, said that unless Congress provides adequate funding for the agency, fixing problems “will be really difficult.”

Sen. Mike Braun of Indiana, the top Republican on that committee, called for looking at how the agency is run “before we throw more money at it.” He suggested focusing on what can be done to prevent overpayments “rather than forgiving them once they occur” or trying to claw them back, “which is insult on top of injury.”

O’Malley noted that the Social Security Administration recently sought public comment on a long-delayed plan to reduce overpayments by automatically obtaining monthly wage and employment data on beneficiaries.

Finance Committee Chairman Ron Wyden (D-Ore.) praised O’Malley for tackling what Wyden called “the scourge of overpayments.”

“I think you’re really off to a strong start in terms of righting wrongs,” Wyden said.

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Biden Said Medicare Drug Price Negotiations Cut the Deficit by $160B. That’s Years Away.

March 21, 2024

We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices to Big Pharma.

President Joe Biden in his State of the Union address, March 7, 2024

President Joe Biden has been making his case for reelection to voters by telling them he is good for their pocketbooks, including at the pharmacy counter.

During his State of the Union address, Biden said legislation he signed gave Medicare the power to negotiate lower prescription drug prices.

“That’s not just saving seniors money and taxpayers money,” Biden said, a reference to the Inflation Reduction Act, which passed in 2022. “We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices to Big Pharma.” 

Biden added, “This year, Medicare is negotiating lower prices for some of the costliest drugs.” He called for giving Medicare the power to negotiate prices for 500 drugs over the next decade.

In August, the federal government announced the first 10 drugs that it will negotiate for lower prices as part of the Inflation Reduction Act. A respected source of legislation analysis projects the change will save the government a lot of money, but those dollars haven’t been realized.

There is a reason Biden touted this legislation during his address: Polling by KFF shows that people, regardless of their political leanings, overwhelmingly support the idea of allowing Medicare to negotiate drug prices. But most people don’t know that such negotiations are underway.

Impact of Inflation Reduction Act Will Take Many Years

In August 2022, Biden signed the Inflation Reduction Act, which will allow the federal government to negotiate prices with drugmakers for Medicare. Biden kept his promise to repeal the law that barred Medicare from negotiating prices. 

The nonpartisan Congressional Budget Office projects a 10-year cumulative savings of $161.7 billion from two provisions of the Iaw: a phased-in effort to negotiate with drugmakers for lower prices and a rebate for price increases above the overall inflation rate. (The White House has previously pointed to this analysis.)

However, not all the savings will be permanent. About $44.3 billion over 10 years will be funneled into related provisions that expand access and lower out-of-pocket costs for Medicare beneficiaries.

“Negotiations are still ramping up, so the savings generated by the Inflation Reduction Act negotiation provisions are still in the future,” said Matthew Fiedler, a Brookings Institution expert on the economy and health studies. “The Congressional Budget Office did expect the inflation rebate provisions of the IRA (which are encompassed in the $160 billion) to begin generating modest savings during 2023 and 2024, but there, too, most of the savings are in the future.”

The legislation involves price negotiations for 10 brand-name medications that lack generic equivalents. Those drugs include the blood thinners Eliquis and Xarelto; the diabetes drugs Januvia, Jardiance, and NovoLog; Enbrel, for rheumatoid arthritis; the blood-cancer drug Imbruvica; Entresto, for heart failure; Stelara, for psoriasis and Crohn’s disease; and Farxiga, a drug for diabetes, heart failure, and chronic kidney disease.

The CBO has estimated that the negotiated prices will translate to nearly $100 billion in federal savings from 2026 to 2031.

“Biden is jumping the gun on claiming savings for seniors,” said Joe Antos, an expert on health care at the conservative American Enterprise Institute. “Price negotiations haven’t been completed; the new prices for selected drugs aren’t in place until 2026.”

Biden said the legislation is “saving seniors money and taxpayers money,” which could be interpreted to mean it is saving them money now on prescription drugs. But the negotiations for these drugs would define the prices to be paid for prescriptions starting in 2026. For 2027 and 2028, 15 more drugs per year will be chosen for price negotiations. Starting in 2029, 20 more will be chosen a year. 

That said, other provisions in the legislation have already led to savings for seniors, said Tricia Neuman, a senior vice president at KFF:

  • Certain recommended adult vaccines covered under Medicare Part D, such as shingles, are covered at no cost. 
  • The act established a cap on Part D spending that begins phasing in this year. This year, Part D enrollees will pay no more than $3,300 on brand-name drugs. In 2025, the cap for all covered Part D drugs drops to $2,000.
  • The Inflation Reduction Act included the $35-a-month insulin cap, improvements in coverage for low-income beneficiaries, and the inflation rebate.

When we pressed the White House to provide examples of savings that have already occurred, a spokesperson pointed to the insulin cap.

Meanwhile, Antos said that although the Part D rebate has kicked in, the savings come from a small subset of Part D drugs taken by older Americans and that the government reaps the savings, not older Americans.  

“There is no reason to expect that seniors will see significant savings since there’s no obligation for the feds to distribute savings to Part D enrollees,” Antos said.

Our Ruling

Biden said, “We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices to Big Pharma.”

Biden’s statement omits the time frame; the savings have not been realized. The CBO projected 10-year cumulative savings of $161.7 billion from two provisions of the legislation. And as for saving older Americans money on their prescriptions, that hasn’t happened yet. The federal government is negotiating the first 10 drugs with the new prices set to take effect in 2026.

We rate this statement Half True.

Sources

KFF, “3 Charts: Medicare Drug Price Negotiations,” Jan. 31, 2024

White House, “Budget Cuts Wasteful Spending on Big Pharma, Big Oil, and Other Special Interests, Cracks Down on Systemic Fraud, and Makes Programs More Cost Effective,” March 9, 2023

Email interview, Matthew Fiedler, senior fellow in economic studies, Center on Health Policy at The Brookings Institution, March 8, 2024

Email interview, Tricia Neuman, a senior vice president of KFF and the executive director of its Program on Medicare Policy, March 8, 2024

Email interview, Joe Antos, a senior fellow at the American Enterprise Institute, March 8, 2024

White House, statement to PolitiFact, March 8, 2024

President Joe Biden, remarks on health care costs, Aug. 29, 2023

Congressional Budget Office, “Estimated Budgetary Effects of Public Law 117-169, to Provide for Reconciliation Pursuant to Title II of S. Con. Res. 14,” Sept. 7, 2022

Congressional Budget Office, “How CBO Estimated the Budgetary Impact of Key Prescription Drug Provisions in the 2022 Reconciliation Act,” February 2023

KFF, “Explaining the Prescription Drug Provisions in the Inflation Reduction Act,” Jan. 24, 2023

NBC News, “Medicare Names First 10 Drugs up for Price Negotiations With the Government,” Aug. 29, 2023

PolitiFact, “Democrats’ Inflation Reduction Act Will Allow Medicare to Negotiate Drug Prices,” Aug. 10, 2022

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Georgia’s Medicaid Work Requirements Costing Taxpayers Millions Despite Low Enrollment

March 20, 2024

Georgia Gov. Brian Kemp’s plan for a conservative alternative to Obamacare’s Medicaid expansion has cost taxpayers at least $26 million so far, with more than 90% going toward administrative and consulting costs rather than medical care for low-income people.

Kemp’s Georgia Pathways to Coverage offers government health insurance to people earning up to the federal poverty level — $15,060 for an individual adult — if they can document that they’re working, in school, or performing other qualifying activities.

Since July, when the program began, about 3,500 people have signed up, according to state officials. That’s a small fraction of the Georgians who could enroll if the state expanded Medicaid without such requirements.

Republican leaders in several states have sought to require that people who are eligible for Medicaid through expansion work, arguing the health program for low-income Americans shouldn’t be a handout. Kemp’s experiment, aimed at single adults with low incomes who aren’t already eligible for Medicaid, is the only current effort to survive legal challenges. But critics say it creates obstacles for people in need of health care while wasting taxpayer dollars on technology, consultants, and attorney’s fees.

The Pathways program is “fiscally foolish and anti-family,” said Joan Alker, executive director and co-founder of Georgetown University’s Center for Children and Families. She noted that full-time caregiving does not qualify someone for eligibility into the program. “A lot of taxpayer money has been wasted,” she said, “and not on health care for people who need it.”

The state projected that administrative costs will increase to $122 million over four years, mostly in federal spending, as it rolls out key features of the program, including the collection of premiums and verifying enrollees’ eligibility, according to an internal planning document dated December 2022 obtained by KFF Health News. The primary consultant for the project is Deloitte, which is collecting hefty fees.

Georgia’s GOP-led state legislature has rejected what Democrats say would be a far simpler way to cover the state’s low-income workers: expanding Medicaid under the Affordable Care Act. That could make at least 359,000 uninsured people in Georgia newly eligible for Medicaid, according to KFF data. In addition, Georgia could reduce state spending by $710 million over two years, according to KFF research from 2021.

Despite Georgia’s rocky implementation experience, state Republican leaders have put off considering a full Medicaid expansion. And such conservative states as Mississippi, Idaho, and South Dakota are weighing similar work requirements.

“You’re spending money, primarily here, to put people through an extra set of hoops before they get coverage,” said Benjamin Sommers, a professor of health care economics at Harvard T.H. Chan School of Public Health.

The low enrollment for Pathways has disappointed supporters, as the state projected more than 25,000 residents would enroll during its first year and 52,000 by the end of five years, according to its application to the federal government.

Chris Denson, director of policy and research at the conservative Georgia Public Policy Foundation, which supports Pathways, said the low enrollment numbers are “just part of the ramping up.”

The program was intended to start in July 2021 but was delayed two years due to legal wrangling. In December 2022, Georgia officials told the federal Centers for Medicare & Medicaid Services that it would cost at least $51 million over two years to design, develop, and implement an eligibility system, funds that would largely be channeled to Deloitte Consulting, according to the documents KFF Health News obtained.

About 45% of Pathways applications were still waiting to be processed, based on the state’s most recent monthly reports, said Leah Chan, director of health justice at the Georgia Budget and Policy Institute, a nonprofit research organization that supports full Medicaid expansion.

The eligibility system, she said, “the thing that we’ve spent the most money on, is actually one of the things standing in the way of the program seeing higher enrollment.”

The state Department of Community Health reported $26.6 million in Pathways spending through Dec. 31, of which more than 80% was paid for using federal funds. Deloitte was paid $2.4 million to prepare and submit the application to the federal government. Just $2 million was paid to insurers to cover medical care. In the fourth quarter, administrative costs alone rose by more than $6 million.

The total costs do not include legal fees for defending the Pathways program. The state attorney general’s office said that as of Feb. 7 those costs surpass $230,000.

In striking contrast, North Carolina has enrolled 380,000 beneficiaries in its Medicaid expansion as of March 1, according to that state’s Department of Health and Human Services. North Carolina became the 40th state to expand Medicaid under the ACA on Dec. 1, a move that has prompted fresh debate over expansion in a handful of other Southern holdout states.

Georgia, which has one of the highest uninsured rates among states, is currently the only state that requires people in its Medicaid expansion population to prove they are working or doing other qualifying activities to gain health coverage.

A spokesperson for Kemp, Carter Chapman, told KFF Health News that the governor “remains committed to implementing Georgia Pathways, an innovative program expanding coverage to tens of thousands of otherwise ineligible, low-income Georgians, despite the Biden administration’s continued efforts to disrupt its rollout.”

In February, citing the delays in implementation, Georgia filed a suit against the federal government to ensure the work requirement program could continue running through 2028 instead of 2025, when it was originally scheduled to end. CMS refused to comment because of pending litigation.

Georgia’s cost estimates are in line with what other states anticipated for administrative spending for Medicaid work requirement programs, including Kentucky’s projected spending of $272 million, according to a 2019 report from the Government Accountability Office, a federal agency that recommended CMS consider administrative costs in such applications.

In Arkansas, administrative costs for the state’s work requirement program were nearly 30% higher than costs of running standard Medicaid in 2016, according to a report from the Arkansas Center for Health Improvement, a nonpartisan health policy group in the state. People struggled to prove they qualified because setting up online accounts was difficult and confusing and many had limited access to the internet, said Robin Rudowitz, a vice president at KFF and director of the Program on Medicaid and the Uninsured. Arkansas’ work requirement program ended in 2019 after a judge blocked it, but not before 18,000 people lost coverage. Unlike Arkansas, which placed a work requirement on a population already receiving Medicaid expansion benefits, Georgia is offering coverage to new people who qualify. But the program’s expense may not be worth sustaining it, Sommers said.

Typically, in Medicaid, administrative costs range from 12% to 16% of overall program spending, said Laura Colbert, executive director of the advocacy group Georgians for a Healthy Future, which supports full Medicaid expansion.

“It’s reasonable to expect that at least 80% of costs of a public or private health insurance plan to go toward health care and services,” she said.

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Needle Pain Is a Big Problem for Kids. One California Doctor Has a Plan.

March 20, 2024

Almost all new parents go through it: the distress of hearing their child scream at the doctor’s office. They endure the emotional torture of having to hold their child down as the clinician sticks them with one vaccine after another.

“The first shots he got, I probably cried more than he did,” said Remy Anthes, who was pushing her 6-month-old son, Dorian, back and forth in his stroller in Oakland, California.

“The look in her eyes, it’s hard to take,” said Jill Lovitt, recalling how her infant daughter Jenna reacted to some recent vaccines. “Like, ‘What are you letting them do to me? Why?’”

Some children remember the needle pain and quickly start to internalize the fear. That’s the fear Julia Cramer witnessed when her 3-year-old daughter, Maya, had to get blood drawn for an allergy test at age 2.

“After that, she had a fear of blue gloves,” Cramer said. “I went to the grocery store and she saw someone wearing blue gloves, stocking the vegetables, and she started freaking out and crying.”

Pain management research suggests that needle pokes may be children’s biggest source of pain in the health care system. The problem isn’t confined to childhood vaccinations either. Studies looking at sources of pediatric pain have included children who are being treated for serious illness, have undergone heart surgeries or bone marrow transplants, or have landed in the emergency room.

“This is so bad that many children and many parents decide not to continue the treatment,” said Stefan Friedrichsdorf, a specialist at the University of California-San Francisco’s Stad Center for Pediatric Pain, speaking at the End Well conference in Los Angeles in November.

The distress of needle pain can follow children as they grow and interfere with important preventive care. It is estimated that a quarter of all adults have a fear of needles that began in childhood. Sixteen percent of adults refuse flu vaccinations because of a fear of needles.

Friedrichsdorf said it doesn’t have to be this bad. “This is not rocket science,” he said.

He outlined simple steps that clinicians and parents can follow:

  • Apply an over-the-counter lidocaine, which is a numbing cream, 30 minutes before a shot.
  • Breastfeed babies, or give them a pacifier dipped in sugar water, to comfort them while they’re getting a shot.
  • Use distractions like teddy bears, pinwheels, or bubbles to divert attention away from the needle.
  • Don’t pin kids down on an exam table. Parents should hold children in their laps instead.

At Children’s Minnesota, Friedrichsdorf practiced the “Children’s Comfort Promise.” Now he and other health care providers are rolling out these new protocols for children at UCSF Benioff Children’s Hospitals in San Francisco and Oakland. He’s calling it the “Ouchless Jab Challenge.”

If a child at UCSF needs to get poked for a blood draw, a vaccine, or an IV treatment, Friedrichsdorf promises, the clinicians will do everything possible to follow these pain management steps.

“Every child, every time,” he said.

It seems unlikely that the ouchless effort will make a dent in vaccine hesitancy and refusal driven by the anti-vaccine movement, since the beliefs that drive it are often rooted in conspiracies and deeply held. But that isn’t necessarily Friedrichsdorf’s goal. He hopes that making routine health care less painful can help sway parents who may be hesitant to get their children vaccinated because of how hard it is to see them in pain. In turn, children who grow into adults without a fear of needles might be more likely to get preventive care, including their yearly flu shot.

In general, the onus will likely be on parents to take a leading role in demanding these measures at medical centers, Friedrichsdorf said, because the tolerance and acceptance of children’s pain is so entrenched among clinicians.

Diane Meier, a palliative care specialist at Mount Sinai, agrees. She said this tolerance is a major problem, stemming from how doctors are usually trained.

“We are taught to see pain as an unfortunate, but inevitable side effect of good treatment,” Meier said. “We learn to repress that feeling of distress at the pain we are causing because otherwise we can’t do our jobs.”

During her medical training, Meier had to hold children down for procedures, which she described as torture for them and for her. It drove her out of pediatrics. She went into geriatrics instead and later helped lead the modern movement to promote palliative care in medicine, which became an accredited specialty in the United States only in 2006.

Meier said she thinks the campaign to reduce needle pain and anxiety should be applied to everyone, not just to children.

“People with dementia have no idea why human beings are approaching them to stick needles in them,” she said. And the experience can be painful and distressing.

Friedrichsdorf’s techniques would likely work with dementia patients, too, she said. Numbing cream, distraction, something sweet in the mouth, and perhaps music from the patient’s youth that they remember and can sing along to.

“It’s worthy of study and it’s worthy of serious attention,” Meier said.

This article is from a partnership that includes KQED, NPR, and KFF Health News.

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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Under Fire for Massive Health System Hack, Biden Team Leans on Insurers

March 19, 2024

The Biden administration has hit on a strategy to deal with the massive, industry-paralyzing cyberattack on a UnitedHealth Group unit: pressuring insurers to fix it.

Federal officials have been in constant conversation with senior leaders at UnitedHealth and across the industry, including at a Monday meeting where Department of Health and Human Services and White House officials again pressed UnitedHealth to be more transparent about its timeline for restoring services.

Many insurers have committed to “making accelerated or advance payments,” an HHS official told reporters on a media call after yesterday’s meeting, declining to specify which plans had done so. The plans have also committed to making interim payments to Medicaid providers, a second official added, as well as providing other support, including payment for pending claims, loans and assistance switching to other electronic clearinghouses when needed.

“We have seen significant improvement between last week and this week,” a third official told reporters, but “we have a last mile to go — we are still hearing from small, rural safety-net providers who need cash assistance.”

UnitedHealth’s Change Healthcare is still struggling to recover from a ransomware attack by hackers believed to be part of a Russia-based group called ALPHV, or Blackcat. Change, little known outside the health-care industry, processes billions of transactions a year on behalf of hospitals, physician practices, pharmacies and the insurers that pay them.

Both UnitedHealth and the federal government have come under fire from health-care providers and lawmakers for being unprepared for the attack and too slow to respond. 

“Neither UnitedHealth Group nor federal agencies were prepared for the attack on Change Healthcare and its fallout,” Senate Finance Committee Chairman Ron Wyden, an Oregon Democrat, said last Thursday.

The byzantine structure of the U.S. health-care system has created obstacles for regulators to navigate as they help the industry recover. For example, said Chip Kahn, president of the Federation of American Hospitals, which represents for-profit hospitals: Because hospitals and doctors receive many payments from commercial insurers operating Medicare Advantage plans, over which HHS has limited authority, the agency can’t necessarily force those payers to make the providers whole.

Instead, the administration is applying public pressure — including a tense White House meeting with UnitedHealth CEO Andrew Witty and other insurers last week. (HHS’ Office for Civil Rights, which enforces some of the agency’s privacy and security regulations, has also announced an investigation of the hack.)

HHS has “taken the actions they can, within the constraints of the law,” Kahn said in an interview.

Accelerated payments from Medicare may also make a difference. Brad van Pelt, president of the Palm Beach Institute of Sports Medicine, a physical therapy group in South Florida, told me those patients are about half his caseload.

The payments “will make us a little bit whole,” he said, though he took out a loan on Monday to cover payroll. The federal money hadn’t yet arrived.

Longer-term, HHS has signaled it wants mandatory cybersecurity standards imposed through Medicare and Medicaid. That’s not popular with hospitals.

“The trouble with penalties is that at the end of the day, you could penalize institutions that are mission-critical to a community,” Kahn said.

Wyden floated his own more populist approaches on Thursday. Health-care companies, he argued, have become too large.

A federal judge appointed by then-President Donald Trump ruled in September 2022 that UnitedHealth’s $13 billion acquisition of Change could proceed over the Biden administration’s opposition.

“Negligent CEOs” should be held accountable for the mess, Wyden said.

The Washington Post’s Dan Diamond contributed to this report.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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Cuando tu cobertura de salud dentro de la red… simplemente se esfuma

March 18, 2024

Sarah Feldman, de 35 años, recibió las primeras cartas amenazantes del Centro Médico Mount Sinai en noviembre pasado. El sistema hospitalario de Nueva York le advirtió que tenía problemas para negociar un acuerdo de precios con UnitedHealthcare, que incluye los planes de salud de Oxford, la aseguradora de Feldman.

“Estamos trabajando de buena fe con Oxford para alcanzar un nuevo acuerdo justo”, decía la carta, continuando con la frase tranquilizadora: “Sus médicos seguirán siendo parte de la red y debería mantener sus citas con sus proveedores”.

En los meses siguientes, llegaron una avalancha de comunicaciones sobre la disputa tanto del hospital como de la aseguradora. Pasaban de “tienes que preocuparte” a “no tienes que preocuparte'”, contó Feldman.

A fines de febrero, finalmente cayó la bomba: desde el 1 de marzo, el Mount Sinai ya no estaría en la red de la aseguradora de Feldman.

“De repente tuve que cambiar todos mis médicos, gran estrés”, dijo Feldman. Eso incluía no solo a un querido médico de atención primaria, sino también a un ginecólogo, un ortopedista y un fisioterapeuta.

Uno de los aspectos más injustos del seguro médico, en un sistema que a menudo parece diseñado para la frustración, es este: los pacientes solo pueden cambiar de seguro durante los períodos de inscripción abierta al final del año o cuando experimentan “eventos de vida” que califican para una inscripción especial, como un divorcio o un cambio de trabajo.

Pero los contratos de las aseguradoras con médicos, hospitales y farmacéuticas (o sus intermediarios, los llamados administradores de beneficios farmacéuticos) pueden cambiar abruptamente de la noche a la mañana.

Esto es particularmente irritante para los pacientes porque, ya sea que tengan cobertura a través de un empleador o compren un seguro en el mercado, generalmente eligen un plan en función de si cubre a sus médicos y hospitales preferidos, o a un medicamento costoso que necesitan.

Resulta que esa cobertura particular podría desaparecer en cualquier momento durante el término de la póliza.

Los consumidores están en riesgo, según un informe reciente de la Robert Wood Johnson Foundation, en la creciente guerra de precios entre grandes sistemas hospitalarios y mega aseguradoras en un mercado despiadado.

Estas disputas de contratos están aumentando rápidamente, el sitio web Becker’s Hospital Review cita 21 enfrentamientos entre aseguradoras y proveedores en el tercer trimestre de 2023, un aumento del 91% comparado con el mismo período el año anterior.

Por ejemplo, en septiembre pasado, los médicos de Baptist Health en Kentucky cortaron abruptamente la relación con los pacientes inscritos en los planes de Medicare Advantage de Humana, y los médicos de Vanderbilt Health en Tennessee rompieron los contratos lo hicieron con varios planes de Humana, en abril.

En ambos casos los pacientes desesperados tuvieron que buscar frenéticamente nuevos médicos dentro de la red en otros sistemas hospitalarios.

Y expertos predicen más cancelaciones de contratos en un mercado cruel. (las cancelaciones que ocurren dentro del período de inscripción, generalmente entre noviembre y enero por lo menos permite que los pacientes abandonados busquen un nuevo plan que cubra sus médicos y medicamentos).

“La respuesta humana correcta es que esto es horrible”, dijo Allison Hoffman, profesora de derecho de la Universidad de Pennsylvania, incluso si la práctica, por ahora, es “probablemente legal”.

Hoffman dijo que encontró una cláusula “enterrada” en la página 32 de su propio plan médico, de 60 páginas, que sugería que los contratos entre proveedores y aseguradoras pueden cambiar en cualquier momento.

Los reguladores estatales y federales tienen la autoridad para regular las redes de aseguradoras y podrían poner fin a la práctica, dijo Hoffman. Pero hasta ahora “no ha habido regulación federal sobre la continuidad de la cobertura”, especialmente sobre cómo definirla. Sospecha que el aparente aumento en disputas de contratos entre aseguradoras y proveedores se deriva de las regulaciones sobre la transparencia de los precios hospitalarios, que entraron en vigencia en 2022 y han permitido a los hospitales comparar tasas de reembolso entre sí.

De hecho, el Mount Sinai dijo que exigía un mejor reembolso de UnitedHealthcare porque descubrió que estaba recibiendo pagos considerablemente más bajos que otras “instituciones similares”.

Muchas aseguradoras dicen que continuarán pagando por un período después de que termine un contrato —en general de entre 60 a 90 días— o para completar un “episodio de atención” particular, como un embarazo.

Pero, por ejemplo, con el cáncer, ¿eso significaría una ronda de quimioterapia o el curso completo de un tratamiento, que podría durar muchos años? ¿Es continuidad de cobertura si un paciente debe cambiar de oncólogo en medio de una terapia, o si tiene que dejar a un terapeuta eficaz?

Erin Moses, que trabaja para una pequeña organización sin fines de lucro, encontró a un nuevo terapeuta que le gustó después que ella y su esposo se mudaron a la Costa Central de California en febrero del año pasado. En septiembre, recibió una factura de la práctica que decía que había terminado su contrato con Anthem porque la aseguradora era lenta con sus reembolsos. Esto la dejó con una factura de $814.

“No es que no pudiéramos pagarlo, pero mi esposo y yo estamos tratando de ahorrar para una casa, y eso es mucho dinero”, dijo.

A menudo, a los pacientes los toma desprevenidos, sin saber qué hacer. Cuando Laura Alley se cayó de una escalera en septiembre de 2020 y necesitó cirugía para reparar su pelvis quebrada, el hospital y el cirujano estaban en la red.

Alley escribió al proyecto “Bill of the Month” de KFF Health News y NPR y dijo: “Lo que no podía saber de ninguna manera era que el grupo que proporcionaba la anestesia estaba en disputa con el proveedor de seguros de nuestra firma, y que desde el 30 de julio de 2020, ya no estaban en la red”.

Se sintió “como un títere”, dijo. “Mientras trabajo para recuperarme de una lesión traumática, estoy atrapada en medio de una disputa entre una enorme compañía de seguros y un gran grupo de médicos”.

Alley es dueña de una pequeña firma de arquitectura con su esposo, y terminaron pagando “casi $10,000” por servicios de anestesia fuera de la red. (Este tipo de factura fuera de la red para el paciente ahora estaría prohibido por el No Surprises Act, vigente desde 2022).

Nada de esto será noticia para Feldman, la paciente del Mount Sinai que fue una inocente espectadora en la disputa del sistema hospitalario con Oxford Health Plans. Los padres de Feldman la llamaron recientemente, diciendo que recibieron una carta de su aseguradora, Anthem, diciendo que el 1 de mayo podría terminar su contrato con el Hospital NewYork-Presbyterian, en donde la madrastra de Feldman recibe tratamiento por un cáncer de mama.

Es malo para la salud —y para la cordura— de los pacientes que las promesas percibidas de atención en sus planes de seguro puedan desaparecer repentinamente a mitad de año. Y los reguladores pueden hacer algo al respecto: obligar a los proveedores y aseguradoras a mantener sus contratos entre sí durante todo el término de las pólizas de los pacientes, para que ninguno quedé atrapado en una guerra con la que no tienen nada que ver.

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' 'What the Health?': Maybe It’s a Health Care Election After All

March 14, 2024
The Host Julie Rovner KFF Health News @jrovner Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

The general election campaign for president is (unofficially) on, as President Joe Biden and former President Donald Trump have each apparently secured enough delegates to become his respective party’s nominee. And health care is turning out to be an unexpectedly front-and-center campaign issue, as Trump in recent weeks has suggested he may be interested in cutting Medicare and taking another swing at repealing and replacing the Affordable Care Act.

Meanwhile, the February cyberattack of Change Healthcare, a subsidiary of insurance giant UnitedHealth Group, continues to roil the health industry, as thousands of hospitals, doctors, nursing homes, and other providers are unable to process claims and get paid.

This week’s panelists are Julie Rovner of KFF Health News, Anna Edney of Bloomberg News, Joanne Kenen of Johns Hopkins University and Politico Magazine, and Margot Sanger-Katz of The New York Times.

Panelists Anna Edney Bloomberg @annaedney Read Anna's stories. Joanne Kenen Johns Hopkins Bloomberg School of Public Health and Politico @JoanneKenen Read Joanne's articles. Margot Sanger-Katz The New York Times @sangerkatz Read Margot's stories.

Among the takeaways from this week’s episode:

  • It is unclear exactly what Trump meant in his recent remarks about possible cuts to Medicare and Social Security, though his comments provided an opening for Biden to pounce. By running as the candidate who would protect entitlements, Biden could position himself well, particularly with older voters, as the general election begins.
  • Health care is shaping up to be the sleeper issue in this election, with high stakes for coverage. The Biden administration’s expanded subsidies for ACA plans are scheduled to expire at the end of next year, and the president’s latest budget request highlights his interest in expanding coverage, especially for postpartum women and for children. Plus, Republicans are eyeing what changes they could make should Trump reclaim the presidency.
  • Meanwhile, Republicans are grappling with an internal party divide over access to in vitro fertilization, and Trump’s mixed messaging on abortion may not be helping him with his base. Could a running mate with more moderate perspectives help soften his image with voters who oppose abortion bans?
  • A federal appeals court ruled that a Texas law requiring teenagers to obtain parental consent for birth control outweighs federal rules allowing teens to access prescription contraceptives confidentially. But concerns that if the U.S. Supreme Court heard the case a conservative-majority ruling would broaden the law’s impact to other states may dampen the chances of further appeals, leaving the law in effect. Also, the federal courts are making it harder to file cases in jurisdictions with friendly judges, a tactic known as judge-shopping, which conservative groups have used recently in reproductive health challenges.
  • And weeks later, the Change Healthcare hack continues to cause widespread issues with medical billing. Some small providers fear continued payment delays could force them to close, and it is possible that the hack’s repercussions could soon block some patients from accessing care at all.

Also this week, Rovner interviews Kelly Henning of Bloomberg Philanthropies about a new, four-part documentary series on the history of public health, “The Invisible Shield.”

Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: The Washington Post’s “Navy Demoted Ronny Jackson After Probe Into White House Behavior,” by Dan Diamond and Alex Horton.

Joanne Kenen: The Atlantic’s “Frigid Offices Might Be Killing Women’s Productivity,” by Olga Khazan.

Margot Sanger-Katz: Stat’s “Rigid Rules at Methadone Clinics Are Jeopardizing Patients’ Path to Recover From Opioid Addiction,” by Lev Facher.

Anna Edney: Scientific American’s “How Hospitals Are Going Green Under Biden’s Climate Legislation,” by Ariel Wittenberg and E&E News.

Also mentioned on this week’s podcast:

Credits Francis Ying Audio producer Emmarie Huetteman Editor

To hear all our podcasts, click here.

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Exclusive: Social Security Chief Vows to Fix ‘Cruel-Hearted’ Overpayment Clawbacks

March 13, 2024

The Social Security Administration’s new chief is promising to overhaul the agency’s system of clawing back billions of dollars it claims was wrongly sent to beneficiaries, saying it “just doesn’t seem right or fair.”

In an interview with KFF Health News, SSA Commissioner Martin O’Malley said that in the coming days he would propose changes to help people avoid crushing debts that have driven some into homelessness and caused financial hardships for the nation’s most vulnerable — the poorest of the poor and people with disabilities or persistent medical conditions or who are at least age 65.

O’Malley, who took office in December, said that “addressing the injustice we do to too many Americans because of overpayments, the rather cruel-hearted and mindless way that we recover those overpayments,” is among his top priorities.

He said he has concrete steps in mind, such as establishing a statute of limitations, shifting the burden of proof to the agency, and imposing a 10% cap on clawbacks for some beneficiaries.

“We do have the ability and we do have the authority to address many of these injustices,” he said, suggesting that the SSA won’t have to wait for congressional action.

The pledge comes after an investigation by KFF Health News and Cox Media Group television stations revealed that SSA routinely reduces or halts monthly benefit checks to reclaim billions of dollars in payments it sent to beneficiaries then later said they should not have received.

In some cases, years passed before the government discovered its mistake and then imposed debts that sometimes have reached tens of thousands of dollars on people who cannot afford to pay. KFF Health News and Cox Media Group discovered that more than 2 million people a year have been hit with overpayment demands.

Most overpayments are linked to the Supplemental Security Income program, which provides money to people with little or no income, who are disabled, blind, or at least age 65. Others are connected to the Social Security Disability Insurance program, which aids disabled workers and their dependents.

O’Malley said the agency plans to cease efforts to claw back years-old overpayments and halt the practice of terminating benefits for disabled workers who don’t respond to overpayment notices because they did not receive them or couldn’t make sense of them.

“We’re not fulfilling congressional intent by putting seniors out of their homes and having them live under a bridge when they didn’t understand our notice,” O’Malley said.

Denise Woods lives in her Chevy, seeking a safe place to sleep each night at strip malls or truck stops around Savannah, Georgia. Woods said she became homeless in 2022 after the SSA — without explanation — determined it had overpaid her and demanded she send back roughly $58,000. Woods didn’t have that amount on hand, so the agency cut off her monthly disability benefits to recoup the debt.

The agency later restored some of her benefit allowance: She gets $616 a month. That’s not enough to cover rent in Savannah, where even modest studio apartments can run $1,000 a month.

In January, she fell ill and landed in intensive care with pneumonia. “I signed a [Do Not Resuscitate form] and a nurse asked, ‘Do you know what this means?'” Woods said. “I told her there was no reason to revive me if my heart stops. They have already ruined my life. I’m beyond exhausted.”

After KFF Health News and Cox Media Group published the series “Overpayment Outrage,” hundreds of disability beneficiaries came forward with troubling accounts, including how the government sent them overpayment notices without explanation and threatened to cut off their main source of income with little warning.

Members of Congress publicly demanded that SSA fix the problems. Democratic Sen. Ron Wyden of Oregon said he would meet monthly with agency officials “until it is fixed.”

Sens. Gary Peters and Debbie Stabenow, both Michigan Democrats, sent a letter dated Feb. 29 to the SSA, saying many overpayments were caused by the agency. They asked officials to explain what is causing the problems.

“It’s absolutely critical that the agency is accurately administering these benefits,” Peters said in written response to an interview request. “I’ve heard from too many people across Michigan who have faced financial hardship after the agency sent them incorrect payments.”

The agency recovered $4.9 billion of overpayments during the 2023 fiscal year, with an additional $23 billion in overpayments still uncollected, according to its latest annual financial report.

O’Malley said he wants to address overpayment clawbacks as part of a larger effort to address SSA’s “customer service crisis.” He did not provide specifics but said he anticipated plans would be implemented this year.

Officials have long acknowledged that the federal disability system is dogged by lengthy delays and dysfunction. Some people become homeless or grow sicker while waiting for an initial decision on an application, which took an average of over seven months in 2023, according to a letter signed by dozens of members of Congress.

O’Malley said the agency terminates disability benefits for some people who don’t contact the SSA after receiving a clawback letter.

“To be honest, a lot of problems [are caused by] our notices being hard to read,” O’Malley said. “In fact, one might argue that the only thing that’s really clear about the notice is to call the 800 number.”

The agency’s toll-free number, O’Malley said, is on his fix-it list, too.

Callers complain of lengthy hold times and often are unable to reach an agent for help, according to congressional members, disability attorneys, and others.

O’Malley pointed to a 27-year low in staffing. “We’ve been unpacking many of these customer service challenges,” he said. “There’s not one of them that hasn’t been made worse by the short staff.”

Still, he said, the overpayment process is unfair. Beneficiaries often must produce evidence to show they did not receive extra money, O’Malley noted.

“One would assume that in a country where people are innocent until proven guilty,” he said, “that the burden should fall more on the agency than on the unwitting beneficiary.”

Advocates for the poor and disabled said they are hopeful O’Malley will stick to his commitments.

“Overpayments have long plagued our clients and caused severe hardship,” said Jen Burdick, an attorney with Community Legal Services of Philadelphia, which represents clients who have received overpayment notices. “We are heartened to see that SSA’s new commissioner is taking a hard look at overpayment policy reforms and optimistic and hopeful his administration will provide these folks some long-needed relief.”

Mike Pistorio is worried that change won’t come fast enough for him.

A letter dated Sept. 21, 2023, that he received from the Social Security Administration says he was overpaid $9,344. The letter alleges Pistorio — a disabled 63-year-old who said he has four stents in his heart — received too much money on behalf of his children, who are now adults.

Pistorio said that he doesn’t understand why he owes the government money and that the SSA has not answered his questions. He said he and his wife live in fear of being evicted from their home because they depend on his $1,266 monthly disability benefits to pay rent.

“What makes me mad is none of this is my fault,” said Pistorio, who lives in Middletown, Pennsylvania, and worked as a plumber until his health faltered. “The stress of this has made my diabetes go up.”

Pistorio said the agency has offered to deduct $269 a month from his benefits to pay off his debt — an amount he says he cannot afford.

“I have told them ‘I will lose my housing,’” Pistorio said.

David Hilzenrath of KFF Health News and Jodie Fleischer of Cox Media Group contributed to this report.

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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Ya hay una droga oral para la depresión postparto… pero cuesta $16,000

March 13, 2024

En diciembre se lanzó al mercado zuranolona, un tratamiento muy esperado para la depresión postparto, con la promesa de que iba a ser un medicamento accesible y de acción rápida para una enfermedad debilitante.

Pero la mayoría de los seguros de salud privados aún no han determinado cómo, y si, la cubrirán, según un nuevo análisis de planes médicos.

La falta de orientación podría limitar el uso del medicamento, que es tanto novedoso —alivia los síntomas apuntando a la función hormonal y no a la serotonina cerebral como lo hacen los antidepresivos tradicionales— como costoso: $15,900 por un régimen de pastillas de 14 días.

Abogados, defensores y reguladores están observando de cerca cómo las aseguradoras diseñarán las normas para cubrirla.

Para su predecesora, una forma intravenosa del mismo medicamento llamada brexanolona que salió al mercado en 2019, muchas aseguradoras requirieron que las pacientes probaran otros medicamentos más baratos primero antes de aprobar su uso.

En los primeros ensayos clínicos revisados por la Administración de Drogas y Alimentos (FDA) la droga mostró que ofrecía alivio en cuestión de días. Los antidepresivos tradicionales tardan de cuatro a seis semanas en hacer efecto.

“Tendremos que ver si las aseguradoras cubren este medicamento y qué requisitos de ‘intentar primero con otro’ establecen para la zuranolona”, dijo Meiram Bendat, psicoterapeuta y abogado que representa a pacientes.

La mayoría de los planes de salud aún no han emitido ninguna guía para la zuranolona, y defensores de la salud materna se preocupan de que los pocos que lo han hecho estén adoptando un enfoque restrictivo.

Algunas pólizas requieren que los pacientes prueben primero, y fracasen, con un antidepresivo estándar antes que la aseguradora pague por la zuranolona.

En otros casos, las directrices requieren que los psiquiatras lo receten, en lugar de los obstetras, lo que podría retrasar el tratamiento, ya que los gineco-obstetras  suelen ser los primeros proveedores médicos en detectar signos de depresión posparto.

Los defensores están más preocupados por la falta de orientación sobre la cobertura.

“Si no tienes una norma publicada, se tomarán decisiones que tal vez no sean justas y sean menos eficientes. La transparencia es realmente importante”, dijo Joy Burkhard, directora ejecutiva del Centro de Política para la Salud Mental Materna, que encargó el estudio.

Con la brexanolona, que se vendía a $34,000 para un régimen de tratamiento de tres días, la aseguradora más grande de California, Kaiser Permanente, tenía criterios tan rigurosos para recetarla que expertos dijeron que la política equivalía a una denegación general para todos los pacientes, según una investigación de NPR de 2021.

Las directrices escritas de Kaiser Permanente requerían que los pacientes probaran y fallaran con cuatro medicamentos, y terapia electroconvulsiva, antes de ser elegibles para la brexanolona. Debido a que el medicamento estaba aprobado solo para los primeros seis meses postparto, y los ensayos de antidepresivos típicos toman de cuatro a seis semanas cada uno, el tiempo se agotaba antes que un paciente tuviera tiempo de probar la brexanolona.

Un análisis de NPR de una docena de otros planes de salud en ese momento mostró que la política de KP sobre la brexanolona era atípica. Algunos sí requerían que los pacientes fallaran con uno o dos medicamentos antes, pero KP fue el único que recomendó cuatro.

Miriam McDonald, quien desarrolló una grave depresión postparto e ideas suicidas después de dar a luz a finales de 2019, luchó contra Kaiser Permanente durante más de un año para encontrar un tratamiento efectivo.

Sus médicos la pusieron bajo una catarata de medicamentos que no funcionaron y que a menudo tenían efectos secundarios intolerables, dijo. Se negaron a recetarle brexanolona, el único medicamento aprobado por la FDA específicamente para la depresión postparto en ese momento.

“Ninguna mujer debería sufrir como yo después de tener un hijo”, dijo McDonald. “La política fue completamente injusta. Estaba en el purgatorio”.

Un mes después que NPR publicara su investigación, Kaiser Permanente revisó completamente sus criterios para recomendar que las mujeres probaran solo un medicamento antes de ser elegibles para la brexanolona.

Luego, en marzo de 2023, después que el Departamento de Trabajo federal lanzara una investigación contra la aseguradora —citando la investigación de NPR—, Kaiser revisó nuevamente sus directrices sobre brexanolona, eliminando todas las recomendaciones de intentar primero con otra droga, según documentos internos obtenidos recientemente por NPR. Los pacientes solo necesitan rechazar una prueba con otro medicamento.

“Desde que brexanolona fue aprobada por primera vez para su uso, más experiencia e investigación ha sumado información sobre su eficacia y seguridad”, dijo la aseguradora en un comunicado. “Kaiser Permanente se compromete a garantizar que brexanolona esté disponible cuando los médicos y los pacientes determinen que es un tratamiento apropiado”.

“Básicamente, Kaiser pasó de tener la política más restrictiva a la más sólida”, dijo Burkhard, del Centro de Política para la Salud Mental Materna. “Ahora es un estándar de oro para el resto de la industria”.

McDonald tiene la esperanza de que su disposición a hablar y las posteriores acciones regulatorias y cambios en las políticas para brexanolona lleven a Kaiser Permanente y a otros planes de salud a establecer normas favorables a los pacientes para la zuranolona.

“Esto evitará que otras mujeres tengan que pasar por un año de depresión para encontrar algo que funcione”, dijo.

Los médicos estaban emocionados cuando la FDA aprobó la zuranolona en agosto pasado, creyendo que en forma de pastilla, tomada una vez al día en casa durante dos semanas, sería más accesible para las mujeres en comparación con tres días de estadía en el hospital para la infusión intravenosa.

Muchos psiquiatras perinatales le dijeron a NPR que es imperativo tratar la depresión posparto lo antes posible para evitar efectos negativos, incluidos problemas cognitivos y sociales en el bebé, ansiedad o depresión en el padre o pareja, o la muerte de la madre por suicidio, que representa hasta el 20% de las muertes maternas.

Hasta ahora, solo una de las seis mayores aseguradoras privadas del país, Centene, ha establecido una política para la zuranolona. No está claro qué criterios establecerá Kaiser Permanente para la nueva pastilla. El programa de Medicaid de California, conocido como Medi-Cal, aún no ha establecido criterios de cobertura.

Las políticas de las aseguradoras para la zuranolona se escribirán en un momento en el que el entorno regulatorio en torno al tratamiento de la salud mental está cambiando.

El Departamento de Trabajo de Estados Unidos está tomando medidas enérgicas contra las violaciones del Mental Health Parity and Addiction Equity Act de 2008, que requiere que las aseguradoras cubran los tratamientos psiquiátricos de la misma manera que los tratamientos físicos.

Ahora, las aseguradoras deben cumplir con requisitos de informes y auditorías más estrictos destinados a aumentar el acceso de los pacientes a la atención de salud mental, los defensores esperan que los planes de salud sean más cuidados al determinar las normas de uso.

En California, desde 2021, las aseguradoras también deben cumplir con una ley de paridad de salud mental estatal aún más amplia, que requiere que se utilicen criterios y directrices basadas en la clínica y reconocidas por expertos para tomar decisiones médicas.

La ley fue diseñada para limitar los rechazos arbitrarios o impulsados por el costo de los tratamientos de salud mental y ha sido celebrada como un modelo para el resto del país. Se espera que se publiquen regulaciones muy esperadas para la ley esta primavera, que podrían ofrecer más orientación para las aseguradoras en California que establecen políticas para la zuranolona.

Mientras tanto, Burkhard dijo que las pacientes que sufren de depresión postparto no deberían dejar de preguntar a sus médicos sobre la zuranolona. Las aseguradoras aún pueden otorgar acceso al medicamento basándose en cada caso antes de formalizar sus criterios de cobertura.

“Los proveedores no deberían sentirse desalentados de recetar zuranolona”, dijo Burkhard.

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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Concerns Grow Over Quality of Care as Investor Groups Buy Not-for-Profit Nursing Homes

March 13, 2024

Shelly Olson’s mother, who has dementia, has lived at the Scandia Village nursing home in rural Sister Bay, Wisconsin, for almost five years. At first, Olson said, her mother received great care at the facility, then owned by a not-for-profit organization, the Evangelical Lutheran Good Samaritan Society.

Then in 2019, Sanford Health — a not-for-profit, tax-exempt hospital system — acquired the nursing home. The covid-19 pandemic struck soon after. From then on, the facility was regularly short of staff, and residents endured long wait times and other care problems, said Olson, a registered nurse who formerly worked at the facility.

Now Scandia Village has a new, for-profit owner, Continuum Healthcare. Olson said she was reassured when Continuum hired two locals as the facility’s new administrator and nursing director.

But Kathy Wagner, a former Scandia Village nursing director, is not optimistic. “The for-profit owner will face the same problems,” said Wagner, who is now retired and serves on an informal task force that monitors the facility’s quality of care. “No one has articulated what the for-profit owner will bring to the table to change the picture.”

The sale of Scandia Village this year is part of a trend of for-profit companies, including private equity groups and real estate investment trusts, snapping up struggling not-for-profit nursing homes, many of which were operated for decades by Lutheran, Catholic, Jewish, and other faith-based organizations.

The pace of sales has ticked up, reaching a high last year, according to Ziegler Investment Banking. Since 2015, 900 not-for-profit nursing homes and senior living communities nationwide have changed hands, with more than half of them acquired by for-profit operators.

For-profit groups own about 72% of the roughly 15,000 nursing homes in the United States, which serve more than 1.3 million residents.

While overall for-profit ownership percentage hasn’t notably increased in recent years, the type of for-profit companies that own these facilities has shifted toward private equity, real estate investment trusts, and complicated ownership structures, said David Grabowski, a professor of health care policy at Harvard Medical School.

Consumer advocates, researchers, and regulators are leery about this trend. They point to studies showing that nursing homes owned by for-profit companies — particularly investors in private equity and real estate — tend to have skimpier staffing, lower quality ratings, and more regulatory violations. Motivated by these concerns, the Biden administration issued a rule last fall that requires nursing homes to disclose more information about their owners and management firms.

Executives at not-for-profit organizations, as well as researchers who study nursing homes, wonder how for-profit companies can accomplish what the previous not-for-profit owners could not: reviving financially struggling nursing homes.

“I don’t know where these investor groups can see savings without cutting back on the level of quality,” Grabowski said.

Part of the problem is that to boost profits, many for-profit operators set up a network of related companies to provide fee-based services such as management, physical therapy, and staffing. They also may sell a nursing home’s real estate to a sister company, which then charges high rent. These payments cut into the available operating funds to provide adequate staffing and quality care.

Last year, New York Attorney General Letitia James sued the for-profit owners of four nursing homes for financial fraud and resident neglect, alleging that they used more than $83 million in public funds to enrich themselves through a complex network of related companies while providing horrendous care.

“When nonprofits are sold, you start to see a precipitous decline in quality,” said Sam Brooks, director of public policy for National Consumer Voice for Quality Long-Term Care. “Nonprofits generally staff well above for-profits. When churches and nonprofits divest these homes, for-profits move in, and the care gets really bad.”

The leaders of not-for-profits that have sold facilities to for-profit operators cite a variety of reasons for exiting or downsizing. Those reasons include state Medicaid payment rates that are too low to cover operating costs and a shortage of nursing and other staffers that makes it hard to maintain quality care. In addition, they say their facilities have seen fewer admissions, at least partly because Medicare Advantage plans have tightened coverage policies for rehabilitation care in nursing homes.

Susan McCrary, chief executive of St. Ignatius Community Services in Philadelphia, said her organization sold its nursing home because it was losing money. She said low state Medicaid rates forced their hand, even after the state bolstered its Medicaid payments by 17.5% in January 2023.

McCrary said the St. Ignatius board worried the losses would jeopardize the organization’s ability to continue its mission of serving low-income seniors, for whom it also operates three independent-living and assisted living buildings.

At the same time, “our board definitely had concerns about selling to a for-profit because we’re aware of the research that shows the quality of care is not the same as with a nonprofit,” McCrary said. “But we knew we needed to move forward with this process to continue our services in West Philadelphia.”

Nate Schema, CEO of the Evangelical Lutheran Good Samaritan Society, said his organization decided to sell some of its long-term care facilities to Continuum Healthcare, a New Jersey-based corporation, and a second company, Idaho-based Cascadia Healthcare, as part of its strategy to better serve its communities. Good Samaritan now operates in seven Midwestern states, down from 22 states. Consolidating markets better enables his organization to launch programs for nursing home residents in conjunction with Sanford’s hospitals and clinics.

“We’ve been very intentional about finding quality partners to carry on our mission,” Schema said. “Unfortunately, we haven’t seen a lot of nonprofit providers coming to us.”

Continuum, which took over Scandia Village nursing home in January, will address staffing shortages by improving wages, benefits, and career opportunities, said Tim Hodges, the corporation’s communications director. Continuum, which is owned by private investors and commercial lenders, owns eight nursing homes in four states.

Similarly, Steve LaForte, Cascadia’s executive vice president, said his company has revived the finances of the nine Good Samaritan nursing homes it took over in the Pacific Northwest partly by attracting more patient referrals and strengthening relationships with state policymakers, in the hope it “leads to more realistic Medicaid rates.” He said Cascadia has also focused on workplace culture — such as by not using workers from staffing agencies — and on empowering those who run the individual facilities to select vendors for pharmacy, rehabilitation, and other services.

Cascadia, he said, does not use tactics like contracting with sister vendors to boost its profits. “That type of organization gives the whole industry a bad name,” LaForte said.

The overall perception of for-profit corporations is unfair, said Zach Shamberg, CEO of the Pennsylvania Health Care Association, because all nursing homes are struggling under inadequate Medicaid rates and high labor costs due to a shortage in workers.

He said he hopes that Pennsylvania’s Medicaid rate increase — plus a new minimum staffing requirement and a mandate that 70% of total costs be dedicated to resident care — will address the financial and quality issues. Nursing homes in Pennsylvania and across the country are also lobbying state lawmakers and the federal government to offer extra payments tied to quality outcomes for residents.

“If there aren’t for-profit entities to buy these facilities, these facilities are closing, which would exacerbate the existing access to care crisis as the population gets older,” Shamberg said.

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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Movimientos en contra de las vacunas perjudican a los niños más vulnerables

March 12, 2024

Gayle Borne ha cuidado a más de 300 niños en Springfield, Tennessee. Niños que rara vez han visto a un médico y que han sido tan descuidados que ni siquiera pueden hablar.

Una ley que este estado aprobó en 2023 que requiere el consentimiento de los padres biológicos o tutores legales para que los niños reciban vacunas de rutina— vuelve a estos niños aún más vulnerables.

Los padres temporales, trabajadores sociales y otros cuidadores no pueden otorgar ese permiso.

En enero, Borne llevó a una bebé que estaba cuidando, que nació con poco apenas 2 libras, a su primera cita médica. Los proveedores de salud dijeron que sin el consentimiento de la madre de la niña, no podían vacunarla contra enfermedades como la neumonía, la hepatitis B y la polio.

La madre no ha sido localizada, por lo que un trabajador social tuvo que solicitar una orden judicial para poder vacunarla. “Estamos esperando”, dijo Borne. “Nuestras manos están atadas”.

La ley de Tennessee también impide que las abuelas y otros cuidadores que acompañan a los niños a citas de rutina cuando los padres están trabajando, en rehabilitación, o simplemente no pueden ir, otorguen ese permiso.

La ley pretende “devolverles a los padres el derecho a tomar decisiones médicas para sus hijos”.

Enmarcada en la retórica de la elección y el consentimiento, esta ley es una de más de una docena de propuestas recientes y pendientes en todo el país que usan la libertad para decidir de los padres en contra de la salud comunitaria y de los niños.

En realidad, crean obstáculos para la vacunación, el fundamento de la atención pediátrica. Siembran dudas sobre la seguridad de las vacunas en un clima lleno de desinformación médica.

Esta tendencia ha explotado a medida que políticos e influencers en las redes sociales hacen afirmaciones falsas sobre los riesgos de las vacunas, a pesar de los estudios que muestran lo contrario.

Los médicos tradicionalmente brindan información sobre vacunas a los cuidadores y obtienen su permiso antes de administrar más de una docena de inmunizaciones infantiles que protegen contra el sarampión, la polio y otras enfermedades debilitantes.

Pero ahora, la ley de Tennessee exige que los padres biológicos asistan a citas de rutina y firmen formularios de consentimiento para cada vacuna administrada durante dos años o más.

“Los formularios podrían tener un efecto disuasorio”, opinó el doctor Jason Yaun, pediatra de Memphis y ex presidente del capítulo de Tennessee de la Academia Americana de Pediatría. “Las personas que promueven los derechos parentales sobre las vacunas tienden a minimizar los derechos de los niños”, dijo Dorit Reiss, investigadora de políticas de vacunas en la Facultad de Derecho de la Universidad de California en San Francisco.

Baja en la tasa de vacunación de rutina

La desinformación, junto con un movimiento por el derecho de los padres que aleja la toma de decisiones de la salud pública, ha contribuido a las tasas de vacunación infantil más bajas en una década.

Este año, legisladores en Arizona, Iowa y West Virginia han presentado proyectos de ley relacionados con el consentimiento.

Una enmienda del Parent’s Bill of Rights en Oklahoma busca asegurar que los padres sepan que pueden eximir a sus hijos de los mandatos de vacunación escolar junto con las lecciones sobre educación sexual y el SIDA.

En Florida, el escéptico médico que lidera el Departamento de Salud del estado recientemente desafió las recomendaciones de los Centros para el Control y la Prevención de Enfermedades (CDC) diciéndoles a los padres que podían enviar a los niños no vacunados a la escuela durante un brote de sarampión.

El año pasado, Mississippi comenzó a permitir exenciones de los requisitos de vacunación escolar por motivos religiosos debido a una demanda financiada por la Informed Consent Action Network (ICAN), que está catalogada como una de las principales fuentes de desinformación antivacunas por el Center for Countering Digital Hate.

Aunque algunos proyectos de ley fracasen, Reiss teme que el resurgimiento del movimiento por los derechos de los padres pueda llevar a abolir leyes que requieren vacunas de rutina para asistir a la escuela.

En un reciente mitín de campaña, el candidato presidencial republicano Donald Trump dijo: “No daré ni un centavo a ninguna escuela que tenga un mandato de vacunación”.

Este movimiento se remonta a la pandemia de influenza de 1918, cuando algunos padres se opusieron a reformas progresistas que volvieron obligatorio asistir a la escuela y prohibieron el trabajo infantil. Desde entonces, las tensiones entre las medidas estatales y la libertad de los padres han estallado ocasionalmente sobre una variedad de temas.

Las vacunas se convirtieron en un tema prominente en 2021, cuando el movimiento encontró puntos en común con personas escépticas sobre las vacunas contra covid.

“El movimiento de derechos parentales no comenzó con las vacunas”, dijo Reiss, “pero el movimiento antivacunas se ha aprovechado, ampliando su alcance”.

Cuando legisladores callan a expertos

En Tennessee, los activistas antivacunas y las organizaciones de tendencia libertaria arremetieron contra el Departamento de Salud del estado en 2021 cuando recomendó vacunas contra covid a menores, siguiendo la orientación de los CDC.

Gary Humble, director ejecutivo del grupo conservador Tennessee Stands, pidió a los legisladores que criticaran al departamento por aconsejar el uso de máscaras y la vacunación.

También hubo repercusiones después que Michelle Fiscus, entonces directora de inmunización del estado, envió un aviso a los médicos. Les recordó que no necesitaban el permiso de los padres para vacunar a adolescentes de 14 años o más que dieran su consentimiento, según una regla estatal de décadas llamada Doctrina del Menor Maduro (Mature Minor Doctrine).

En las semanas siguientes, los legisladores estatales amenazaron con retirarle al departamento su financiamiento, y lo presionaron para que redujera la promoción de la vacuna contra covid, según reveló The Tennessean.

Fiscus fue despedida abruptamente. “Hoy me convertí en la vigésimo quinta de los 64 directores de programas de inmunización estatales y territoriales en dejar su puesto durante esta pandemia”, escribió en un comunicado. “Eso es casi el 40% de nosotros”.

La tasa de mortalidad por covid en Tennessee aumentó, convirtiéndose en una de las más altas del país a mediados de 2022.

Para cuando dos legisladores estatales presentaron un proyecto de ley para revertir la doctrina, el departamento de salud guardó silencio sobre la propuesta. A pesar de los obstáculos para los niños en hogares temporales que requerirían de una orden judicial para vacunas de rutina, el Departamento de Servicios Infantiles de Tennessee tampoco dijo nada.

El representante republicano John Ragan, quien presentó el proyecto en abril de 2023, dijo: “Los niños pertenecen a sus familias, no al estado”.

El representante demócrata Justin Pearson habló en contra del proyecto de ley. “No tiene en cuenta a las personas y niños que son descuidados”, le dijo a Ragan. “Estamos legislando desde un lugar de privilegio y no reconociendo a las personas que no tienen estos privilegios”, agregó.

El proyecto de Ragan obtuvo la mayoría y el gobernador republicano Bill Lee lo firmó en mayo, haciéndolo efectivo de inmediato.

Deborah Lowen, entonces subcomisionada de salud infantil en el Departamento de Servicios Infantiles, recibió decenas de llamadas de médicos que ahora enfrentan pena de cárcel y multas por vacunar a menores sin un consentimiento adecuado. “Me sentí, y me siento, muy descorazonada”, dijo.

Derecho a la salud

Yaun, el pediatra de Memphis, dijo que se sintió conmocionado cuando se negó a administrar una primera serie de vacunas a un bebé acompañado por un trabajador social. “Ese niño está entrando en una situación en donde está rodeado de otros niños y adultos”, dijo, “donde podría estar expuesto a algo y fracasamos en protegerlo”.

“Hemos tenido muchos abuelos enojados en nuestra sala de espera que traen a sus nietos a las citas porque los padres están trabajando o pasando por un mal momento”, dijo Hunter Butler, pediatra en Springfield, Tennessee. “Una vez llamé a una instalación de rehabilitación para encontrar a una madre y hablar con ella por teléfono para obtener su consentimiento verbal para vacunar a su bebé”, dijo. “Y no está claro si eso estuvo bien”.

Las tasas de vacunación infantil han disminuido por tres años consecutivos en Tennessee. A nivel nacional, las tendencias en baja de la vacunación contra el sarampión llevaron a los CDC a estimar que un cuarto de millón de niños de jardín de infantes están en riesgo de contraer la enfermedad altamente contagiosa.

Las comunidades con tasas bajas de vacunación son vulnerables a medida que el sarampión aumenta a nivel internacional. Los casos confirmados de sarampión en 2023 fueron casi el doble que en 2022, un año en el que la Organización Mundial de la Salud (OMS) estima que más de 136,000 personas murieron por la enfermedad en todo el mundo.

Cuando los viajeros infectados en el extranjero llegan a comunidades con bajas tasas de vacunación infantil, el virus altamente contagioso puede propagarse rápidamente entre personas no vacunadas, así como entre bebés demasiado pequeños para ser vacunados y personas con sistemas inmunes debilitados.

“Existe un aspecto de libertad en el otro lado de este argumento”, dijo Caitlin Gilmet, directora de comunicaciones del grupo de defensa de vacunas SAFE Communities Coalition and Action Fund. “Deberías tener el derecho de proteger a tu familia de enfermedades prevenibles”.

A finales de enero, Gilmet y otros defensores de la salud infantil se reunieron en una sala del Capitolio de Tennessee en Nashville y ofrecieron un desayuno gratuito. Distribuyeron folletos mientras los legisladores y sus asistentes llegaban a comer. Un folleto describía el costo de un brote de sarampión en 2018-19 en el estado de Washington que enfermó a 72 personas, la mayoría de las cuales no estaban vacunadas. El brote costó $76,000 en atención médica, $2,3 millones para la respuesta de salud pública y aproximadamente $1 millón en pérdidas económicas debido a la enfermedad, cuarentena y atención.

Barb Dentz, defensora del grupo de base Tennessee Families for Vaccines, repitió que la mayoría de los constituyentes del estado apoyan políticas sólidas a favor de las vacunas. De hecho, siete de cada 10 adultos estadounidenses sostuvieron que las escuelas públicas deberían exigir la vacunación contra el sarampión, las paperas y la rubéola, en una encuesta del Pew Research Center realizada el año pasado.

Pero las cifras han estado disminuyendo. “Proteger a los niños debería ser algo tan obvio”, le dijo Dentz al representante republicano Sam Whitson. Whitson estuvo de acuerdo y reflexionó sobre una explosión de desinformación antivacunas. “El Dr. Google y Facebook han sido un desafío tan grande”, dijo. “Combatir la ignorancia se ha convertido en un trabajo de tiempo completo”.

Whitson fue uno de los pocos republicanos que votaron en contra de la enmienda de vacunas de Tennessee del año pasado. “La cuestión de los derechos de los padres realmente se ha afianzado”, dijo, “y puede ser utilizada a nuestro favor y en nuestra contra”.

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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How the Anti-Vaccine Movement Pits Parental Rights Against Public Health

March 12, 2024

Gayle Borne has fostered more than 300 children in Springfield, Tennessee. She’s cared for kids who have rarely seen a doctor — kids so neglected that they cannot speak. Such children are now even more vulnerable because of a law Tennessee passed last year that requires the direct consent of birth parents or legal guardians for every routine childhood vaccination. Foster parents, social workers, and other caregivers cannot provide permission.

In January, Borne took a foster baby, born extremely premature at just over 2 pounds, to her first doctor’s appointment. The health providers said that without the consent of the child’s mother, they couldn’t vaccinate her against diseases like pneumonia, hepatitis B, and polio. The mother hasn’t been located, so a social worker is now seeking a court order to permit immunizations. “We are just waiting,” Borne said. “Our hands are tied.”

Tennessee’s law has also stymied grandmothers and other caregivers who accompany children to routine appointments when parents are at work, in drug and alcohol rehabilitation clinics, or otherwise unavailable. The law claims to “give parents back the right to make medical decisions for their children.”

Framed in the rhetoric of choice and consent, it is one of more than a dozen recent and pending pieces of legislation nationwide that pit parental freedom against community and children’s health. In actuality, they create obstacles to vaccination, the foundation of pediatric care.

Such policies have another effect. They seed doubt about vaccine safety in a climate rife with medical misinformation. The trend has exploded as politicians and social media influencers make false claims about risks, despite studies showing otherwise.

Doctors traditionally give caregivers vaccine information and get their permission before delivering more than a dozen childhood immunizations that defend against measles, polio, and other debilitating diseases.

But now, Tennessee’s law demands that birth parents attend routine appointments and sign consent forms for every vaccine given over two or more years. “The forms could have a chilling effect,” said Jason Yaun, a Memphis pediatrician and past president of the Tennessee chapter of the American Academy of Pediatrics.

“People who promote parental rights on vaccines tend to downplay the rights of children,” said Dorit Reiss, a vaccine policy researcher at the University of California Law-San Francisco.

Drop in Routine Vaccination Rates

Misinformation coupled with a parental rights movement that shifts decision-making away from public health expertise has contributed to the lowest childhood vaccine rates in a decade.

This year, legislators in Arizona, Iowa, and West Virginia have introduced related consent bills. A “Parents’ Bill of Rights” amendment in Oklahoma seeks to ensure that parents know they can exempt their children from school vaccine mandates along with lessons on sex education and AIDS. In Florida, the medical skeptic leading the state’s health department recently defied guidance from the Centers for Disease Control and Prevention by telling parents they could send unvaccinated children to a school during a measles outbreak.

Last year, Mississippi began allowing exemptions from school vaccine requirements for religious reasons because of a lawsuit funded by the Informed Consent Action Network, which is listed as a leading source of anti-vaccine disinformation by the Center for Countering Digital Hate. A post on ICAN’s website said it “could not be more proud” in Mississippi to “restore the right of every parent in this country to have his or her convictions respected and not trampled by the government.”

Even if some bills fail, Reiss fears, the revived parental rights movement may eventually abolish policies that require routine immunizations to attend school. At a recent campaign rally, Republican presidential candidate Donald Trump said, “I will not give one penny to any school that has a vaccine mandate.”

The movement dates to the wake of the 1918 influenza pandemic, when some parents pushed back against progressive reforms that required school attendance and prohibited child labor. Since then, tensions between state measures and parental freedom have occasionally flared over a variety of issues. Vaccines became a prominent one in 2021, as the movement found common ground with people skeptical of covid-19 vaccines.

“The parental rights movement didn’t start with vaccines,” Reiss said, “but the anti-vaccine movement has allied themselves with it and has expanded their reach by riding on its coattails.”

When Lawmakers Silence Health Experts

In Tennessee, anti-vaccine activists and libertarian-leaning organizations railed against the state’s health department in 2021 when it recommended covid vaccines to minors, following CDC guidance. Gary Humble, executive director of the conservative group Tennessee Stands, asked legislators to blast the health department for advising masks and vaccination, suggesting the department “could be dissolved and reconstituted at your pleasure.”

Backlash also followed a notice sent to doctors from Michelle Fiscus, then the state’s immunization director. She reminded them that they didn’t need parental permission to vaccinate consenting adolescents 14 or older, according to a decades-old state rule called the Mature Minor Doctrine.

In the weeks that followed, state legislators threatened to defund the health department and pressured it into scaling back covid vaccine promotion, as revealed by The Tennessean. Fiscus was abruptly fired. “Today I became the 25th of 64 state and territorial immunization program directors to leave their position during this pandemic,” she wrote in a statement. “That’s nearly 40% of us.” Tennessee’s covid death rate climbed to one of the nation’s highest by mid-2022.

By the time two state legislators introduced a bill to reverse the Mature Minor Doctrine, the health department was silent on the proposal. Despite obstacles for foster children who would require a court order for routine immunizations, Tennessee’s Department of Children’s Services was silent, too.

Notably, the legislator who introduced the bill, Republican Rep. John Ragan, was among those simultaneously overseeing a review of the agency that would determine its leadership and budget for the coming years. “Children belong to their families, not the state,” said Ragan as he presented the bill at a state hearing in April 2023.

Democratic Rep. Justin Pearson spoke out against the bill. It “doesn’t take into account people and children who are neglected,” he told Ragan. “We are legislating from a point of privilege and not recognizing the people who are not privileged in this way.”

Rather than address such concerns, Ragan referenced a Supreme Court ruling in favor of parental rights in 2000. Specifically, judges determined that a mother had legal authority to decide who could visit her daughters. Yet the Supreme Court has also done the opposite. For instance, it sided against a legal guardian who removed her child from school to proselytize for the Jehovah’s Witnesses.

Still, Ragan swiftly won the majority vote. Tennessee Gov. Bill Lee, a Republican, signed the bill in May, making it effective immediately. Deborah Lowen, then the deputy commissioner of child health at the Department of Children’s Services, was flooded with calls from doctors who now face jailtime and fines for vaccinating minors without adequate consent. “I was and remain very disheartened,” she said.

A Right to Health

Yaun, the Memphis pediatrician, said he was shaken as he declined to administer a first series of vaccines to an infant accompanied by a social worker. “That child is going into a situation where they are around other children and adults,” he said, “where they could be exposed to something we failed to protect them from.”

“We have had numerous angry grandparents in our waiting room who take kids to appointments because the parents are at work or down on their luck,” said Hunter Butler, a pediatrician in Springfield, Tennessee. “I once called a rehabilitation facility to find a mom and get her on the phone to get verbal consent to vaccinate her baby,” he said. “And it’s unclear if that was OK.”

Childhood immunization rates have dropped for three consecutive years in Tennessee. Nationwide, downward trends in measles vaccination led the CDC to estimate that a quarter million kindergartners are at risk of the highly contagious disease.

Communities with low vaccination rates are vulnerable as measles surges internationally. Confirmed measles cases in 2023 were almost double those in 2022 — a year in which the World Health Organization estimates that more than 136,000 people died from the disease globally. When travelers infected abroad land in communities with low childhood vaccination rates, the highly contagious virus can spread swiftly among unvaccinated people, as well as babies too young to be vaccinated and people with weakened immune systems.

“There’s a freedom piece on the other side of this argument,” said Caitlin Gilmet, communications director at the vaccine advocacy group SAFE Communities Coalition and Action Fund. “You should have the right to protect your family from preventable diseases.”

In late January, Gilmet and other child health advocates gathered in a room at the Tennessee Statehouse in Nashville, offering a free breakfast of fried chicken biscuits. They handed out flyers as legislators and their aides drifted in to eat. One pamphlet described the toll of a 2018-19 measles outbreak in Washington state that sickened 72 people, most of whom were unvaccinated, costing $76,000 in medical care, $2.3 million for the public health response, and an estimated $1 million in economic losses due to illness, quarantine, and caregiving.

Barb Dentz, an advocate with the grassroots group Tennessee Families for Vaccines, repeated that most of the state’s constituents support strong policies in favor of immunizations. Indeed, seven in 10 U.S. adults maintained that public schools should require vaccination against measles, mumps, and rubella, in a Pew Research Center poll last year. But numbers have been dropping.

“Protecting kids should be such a no-brainer,” Dentz told Republican Rep. Sam Whitson, later that morning in his office. Whitson agreed and reflected on an explosion of anti-vaccine misinformation. “Dr. Google and Facebook have been such a challenge,” he said. “Fighting ignorance has become a full-time job.”

Whitson was among a minority of Republicans who voted against Tennessee’s vaccine amendment last year. “The parental rights thing has really taken hold,” he said, “and it can be used for and against us.”

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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