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Colorado Dropped Medicaid Enrollees as Red States Have, Alarming Advocates for the Poor

Kaiser Health News:States - July 11, 2024

Colorado stands out among the 10 states that have disenrolled the highest share of Medicaid beneficiaries since the U.S. government lifted a pandemic-era restriction on removing people from the health insurance program.

It’s the only blue state in a cluster of red states with high disenrollment rates — a group that includes Idaho, Montana, Texas, and Utah — in the Medicaid “unwinding” underway since spring 2023.

Colorado also is the only state that had all the policy ingredients in place to cushion the fallout from the unwinding, according to Medicaid policy analysts at KFF.

But it seems the cushion hasn’t been deployed.

“There’s really a divide in Colorado between our progressive policies and our underfunded and fragmented administration,” said Bethany Pray, chief legal and policy officer at the Colorado Center on Law and Policy, a Denver-based legal aid group.

According to KFF data, during the unwinding Colorado has seen a bigger net drop in enrollment in Medicaid and the Children’s Health Insurance Program than any state except Utah.

Advocates for health care access, researchers, and county administrators — the administrators handling the bulk of the Medicaid redeterminations in Colorado — say that the major issues involve outdated technology and low rates of automatic renewals. Both create obstacles to enrollment that undercut the state’s progressive policies.

State officials have a rosier view. They say the drop in enrollment is a sign that they did a good job enrolling people at the height of the covid-19 pandemic. Secondly, they say Colorado’s economy is doing well, so more people can get insurance through their jobs.

“When we have a really stellar unemployment rate, not as many people need safety-net programs, and we’re proud of that. Our people are rising and thriving,” said Kim Bimestefer, who leads the Department of Health Care Policy and Financing and is the state’s top Medicaid official. Her department has also said that some people choose not to fill out their eligibility paperwork because they know their incomes are too high to qualify.

Bureau of Labor Statistics data shows that while it’s true Colorado’s unemployment rate is lower than the nation’s as a whole, it’s higher than it was before the pandemic.

State officials say they believe Medicaid enrollments dropped because many of those people found jobs, as reflected by the lower unemployment rates. But that scenario happened in fewer than half of the state’s counties, a KFF Health News analysis found. Notably, in 11 counties where unemployment stagnated or increased from January 2020 to April 2024, the share of the population covered by Medicaid shrank. A low unemployment rate does not necessarily mean there is less of a need for Medicaid coverage, because many employed people earn wages low enough to still qualify for the program.

Colorado increased enrollment in Medicaid and the related Children’s Health Insurance Program by 35% during the covid public health emergency, compared with about 30% nationally and among Medicaid expansion states.

“We grew more, which means, logically, we’re going to disenroll more,” said Bimestefer. “We went up higher, we’re going to come down lower, because our economy is stellar.”

Her department’s website initially claimed Colorado’s Medicaid enrollment grew more than any other Medicaid expansion state except Hawaii. But data from the Centers for Medicare & Medicaid Services shows pandemic enrollment growth in other states, including Indiana, North Dakota, Virginia, and Nevada, also exceeded that of Colorado.

Even if it had grown the most, the argument that what comes up must come down doesn’t hold water, Medicaid policy analysts said.

“A counterargument to that is we know that there was never a full participation in Medicaid prior to the pandemic,” said Jennifer Tolbert, deputy director of the KFF Program on Medicaid and the Uninsured.

Tolbert said she was surprised by the extent of Colorado’s Medicaid enrollment losses, given it was the one state in the nation that met all the criteria that KFF expected would cushion the effects of the unwinding. Those policies include adopting the Affordable Care Act’s Medicaid expansion and the automatic processing of renewals.

Tolbert was among several policy researchers who said that even if unemployment returned to pre-pandemic levels, they would expect a higher, not lower, share of Coloradans to be enrolled in safety-net coverage.

Ally Sullivan, a spokesperson for Gov. Jared Polis, a Democrat, said one complicating factor in Colorado’s system is that it’s among the handful of states where most of the eligibility verification work falls on counties, “which added complexity to the state’s unwind process.”

“Colorado is committed to ensuring that Coloradans who no longer qualify for Medicaid coverage are connected to other affordable sources of coverage as soon as possible, and the state is going to great lengths to do so,” the statement said.

Minnesota is another state where verifying eligibility is largely left to the counties. Yet it disenrolled just 26% of its Medicaid population in the unwinding, compared with Colorado’s 48%. Like Colorado, Minnesota is led by a Democratic governor. Minnesota also mirrors Colorado in its population, pandemic-era increase in enrollment, the percentage of its residents living in prosperous areas, and its better-than-national unemployment rate. But Bimestefer dismissed any comparison.

“I don’t care about Minnesota,” Bimestefer said. “This is Colorado. I don’t care what Minnesota did.”

Advocates for health care access and researchers said a cluster of technological and administrative issues have contributed to Colorado’s high disenrollment rate.

First, Colorado’s eligibility database, the Colorado Benefits Management System, is outdated and clunky, according to people who use it or are familiar with systems in other states.

“It’s like still using the old flip phone where you’re trying to play Snake,” said Sarah Grusin, an attorney at the National Health Law Program. “We have better stuff.”

Grusin and Pray’s organizations filed a civil rights complaint with several federal agencies saying that the system issues that terminated disabled Coloradans’ coverage amounted to discrimination.

“It took many months to fix something that doesn’t sound that complicated,” Pray said.

Bimestefer said her department is working on a plan to improve the system, which is managed by Deloitte under a $354.4 million contract that lasts until 2027. A recent KFF Health News investigation of eligibility systems managed by Deloitte found widespread problems. In Colorado, a state-commissioned audit in 2020 found that many Medicaid beneficiaries were sent incorrect notices and deadlines.

Kenneth Smith, a Deloitte executive who leads its national human services division, said that Deloitte is one player among many who together administer Medicaid benefits, and that the states own the technology and make the decisions about their implementation.

Colorado’s technology woes have also weakened its ability to use a powerful tool in enrollment: automatic renewal.

Last fall, Bimestefer said, her agency had to choose between fixing the system so that it would stop disenrolling children who shouldn’t lose coverage, or start automatically renewing people with no income or with income below the federal poverty level. It couldn’t do both, she said.

Experts such as Tricia Brooks, a research professor with the Center for Children and Families at Georgetown University, said it’s especially important to increase automatic renewals in states like Colorado where most of the renewal work falls on county government staff.

“What happens when you’re not getting a high rate of automated renewals? You’re sending out those renewal forms,” Brooks said — meaning more disenrollments. “They didn’t get the mail. The notice was confusing. They tried to get help through the call center. The list goes on as to why people don’t renew.”

Indeed, two-thirds of disenrolled Coloradans lost coverage for procedural reasons. That’s in line with the national average, according to KFF. But paired with Colorado having disenrolled so many people overall, that means more than 500,000 Coloradans, or about 9% of the state’s people, were disenrolled for procedural reasons — more than the population of its second-largest city, Colorado Springs.

At least a third of those disenrolled were later determined to be eligible for Medicaid.

Officials at Colorado community health centers and mental health centers say they’re seeing a rise in uninsured patients coming through their doors — a sign, they say, that Coloradans dropped from Medicaid aren’t necessarily moving on to greener health insurance pastures.

Fifty-eight percent of those who were disenrolled have returned to Medicaid, or now have another form of insurance. But the state doesn’t yet know what happened to the remaining 42% of people who were dropped and said it would conduct a survey to find out.

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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Finland Is Offering Farmworkers Bird Flu Shots. Some Experts Say the US Should, Too.

Kaiser Health News:States - July 11, 2024

As bird flu spreads among dairy cattle in the U.S., veterinarians and researchers have taken note of Finland’s move to vaccinate farmworkers at risk of infection. They wonder why their government doesn’t do the same.

“Farmworkers, veterinarians, and producers are handling large volumes of milk that can contain high levels of bird flu virus,” said Kay Russo, a livestock and poultry veterinarian in Fort Collins, Colorado. “If a vaccine seems to provide some immunity, I think it should be offered to them.”

Among a dozen virology and outbreak experts interviewed by KFF Health News, most agree with Russo. They said people who work with dairy cows should be offered vaccination for a disease that has killed roughly half of the people known to have gotten it globally over the past two decades, has killed cats in the U.S. this year, and has pandemic potential.

However, some researchers sided with the Centers for Disease Control and Prevention in recommending against vaccination for now. There’s no evidence that this year’s bird flu virus spreads between people or causes serious disease in humans. And it’s unclear how well the available vaccine would prevent either scenario.

But the wait-and-see approach “is a gamble,” said Jennifer Nuzzo, director of the Pandemic Center at Brown University. “By the time we see severe outcomes, it means a lot of people have been infected.”

“Now is the time to offer the vaccines to farmworkers in the United States,” said Nahid Bhadelia, director of the Boston University Center on Emerging Infectious Diseases. Even more urgent measures are lagging in the U.S., she added. Testing of farmworkers and cows is sorely needed to detect the H5N1 bird flu virus, study it, and extinguish it before it becomes a fixture on farms — posing an ever-present pandemic threat.

Demetre Daskalakis, director of the CDC’s National Center for Immunization and Respiratory Diseases, said the agency takes bird flu seriously, and the U.S. is stockpiling 4.8 million doses of the vaccine. But, he said, “there’s no recommendation to launch a vaccine campaign.”

“It’s all about risk-benefit ratios,” Daskalakis said. The benefits are blurry because there hasn’t been enough testing to understand how easily the virus jumps from cows into people, and how sick they become. Just four people in the United States have tested positive this year, with mild cases — too few to draw conclusions.

Other farmworkers and veterinarians working on dairy farms with outbreaks have reported being sick, Russo said, but they haven’t been tested. Public health labs have tested only about 50 people for the bird flu since the outbreak was detected in March.

Still, Daskalakis said the CDC is not concerned that the agency is missing worrisome bird flu infections because of its influenza surveillance system. Hospitals report patients with severe cases of flu, and numbers are normal this year.

Another signal that puts the agency at ease is that the virus doesn’t yet have mutations that allow it to spread rapidly between people as they sneeze and breathe. “If we start to see changes in the virus, that’s another factor that would be part of the decision to move from a planning phase into an operational one,” Daskalakis said.

On July 8, researchers reported that the virus may be closer to spreading between people than previously thought. It still doesn’t appear to do so, but experiments suggest it has the ability to infect human airways. It also spread between two laboratory ferrets through the air.

In considering vaccines, the agency takes a cue from a 1976 outbreak of the swine flu. Officials initially feared a repeat of the 1918 swine flu pandemic that killed roughly half a million people in the United States. So they rapidly vaccinated nearly 43 million people in the country within a year.

But swine flu cases turned out to be mild that year. This made the vaccine seem unnecessarily risky as several reports of a potentially deadly disorder, Guillain-Barré Syndrome, emerged. Roughly one of every million people who get influenza vaccines may acquire the disorder, according to the CDC. That risk is outweighed by the benefits of prevention. Since Oct. 1, as many as 830,000 people have been hospitalized for the seasonal flu and 25,000 to 75,000 people have died.

An after-action report on the 1976 swine flu situation called it a “sobering, cautionary tale” about responding prematurely to an uncertain public health threat. “It’s a story about what happens when you launch a vaccine program where you are accepting risk without any benefit,” Daskalakis said.

Paul Offit, a virologist at the Children’s Hospital of Philadelphia, sides with the CDC. “I’d wait for more data,” he said.

However, other researchers say this isn’t comparable to 1976 because they aren’t suggesting that the U.S. vaccinate tens of millions of people. Rather they’re talking about a voluntary vaccine for thousands of people in close contact with livestock. This lessens the chance of rare adverse effects.

The bird flu vaccine on hand, made by the flu vaccine company CSL Seqirus, was authorized last year by the European equivalent of the FDA. An older variety has FDA approval, but the newer variety hasn’t gotten the green light yet.

Although the vaccine targets a different bird flu strain than the H5N1 virus now circulating in cows, studies show it triggers an immune response against both varieties. It’s considered safe because it uses the same egg-based vaccine technology deployed every year in seasonal flu vaccines.

For these reasons, the United States, the United Kingdom, the Netherlands, and about a dozen other countries are stockpiling millions of doses. Finland expects to offer them to people who work on fur farms this month as a precaution because its mink and fox farms were hit by the bird flu last year.

In contrast, mRNA vaccines being developed against the bird flu would be a first for influenza. On July 2, the U.S. government announced that it would pay Moderna $176 million for their development, and that the vaccines may enter clinical trials next year. Used widely against covid-19, this newer technology uses mRNA to teach the immune system how to recognize particular viruses.

In the meantime, Florian Krammer, a flu virologist at Mount Sinai’s Icahn School of Medicine, said people who work on dairy farms should have the option to get the egg-based vaccine. It elicits an immune response against a primary component of the H5N1 bird flu virus that should confer a degree of protection against infection and serious sickness, he said.

Still, its protection wouldn’t be 100%. And no one knows how many cases and hospitalizations it would prevent since it hasn’t been used to combat this year’s virus. Such data should be collected in studies that track the outcomes of people who opt to get one, he said.

Krammer isn’t assuaged by the lack of severe bird flu cases spotted in clinics. “If you see a signal in hospitals, the cat is out of the bag. Game over, we have a pandemic,” he said. “That’s what we want to avoid.”

He and others stressed that the United States should be doing everything it can to curb infections before flu season starts in October. The vaccine could provide an additional layer of protection on top of testing, wearing gloves, and goggles, and disinfecting milking equipment. Scientists worry that if people get the bird flu and the seasonal flu simultaneously, bird flu viruses could snag adaptations from seasonal viruses that allow them to spread swiftly among humans.

They also note it could take months to distribute the vaccines after they’re recommended since it requires outreach. People who work beside dairy cows still lack information on the virus, four months into this outbreak, said Bethany Boggess Alcauter, director of research at the National Center for Farmworker Health.

Health officials have talked with dairy farm owners, but Boggess’ interviews with farmworkers suggest those conversations haven’t trickled down to their staff. One farmworker in the Texas Panhandle told her he was directed to disinfect his hands and boots to protect cows from diseases that workers may carry. “They never told us if the cow could infect us with some illness,” the farmworker said in Spanish.

The slow pace of educational outreach is a reminder that everything takes time, including vaccine decisions. When deciding whether to recommend vaccines, the CDC typically seeks guidance from its Advisory Committee on Immunization Practices, or the ACIP. A consultant to the group, infectious disease researcher William Schaffner, has repeatedly asked the agency to present its thinking on Seqirus’ bird flu vaccine.

Rather than fret about the 1976 swine flu situation, Schaffner suggested the CDC consider the 2009-10 swine flu pandemic. It caused more than 274,000 hospitalizations and 12,000 deaths in the U.S. within a year. By the time vaccines were rolled out, he said, much of the damage had been done.

“The time to discuss this with ACIP is now,” said Schaffner, before the bird flu becomes a public health emergency. “We don’t want to discuss this until the cows come home in the middle of a crisis.”

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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Finlandia ofrece vacunas contra la gripe aviar a sus trabajadores agrícolas. Estados Unidos debería hacer lo mismo, dicen expertos

Kaiser Health News:States - July 11, 2024

A medida que la gripe aviar se propaga entre las vacas lecheras en Estados Unidos, veterinarios e investigadores han tomado nota de la decisión de Finlandia de vacunar a los trabajadores agrícolas que corren el riesgo de infectarse. Y se preguntan por qué su gobierno no se hace lo mismo.

“Los trabajadores agrícolas, veterinarios y productores están manejando grandes volúmenes de leche que pueden contener altos niveles del virus de la gripe aviar”, dijo Kay Russo, veterinaria de ganado y aves de corral en Fort Collins, Colorado. “Si una vacuna parece proporcionar algo de inmunidad, creo que también habría que ofrecérsela a ellos”.

La mayoría de una docena de expertos en virología y brotes epidémicos entrevistados por KFF Health News, está de acuerdo con Russo.

Dijeron que a las personas que trabajan en tambos se les debería ofrecer la vacuna contra una enfermedad que ha matado a aproximadamente la mitad de las personas que se sabe que la han contraído en todo el mundo durante las últimas dos décadas, que ha matado a gatos en Estados Unidos este año, y que tiene potencial pandémico.

Sin embargo, otros investigadores están de acuerdo con la posición de los Centros para el Control y Prevención de Enfermedades (CDC), que recomiendan no vacunar por ahora. Consideran que no hay evidencia de que el virus de la gripe aviar de este año se propague entre personas, o cause enfermedad grave en humanos. Y que tampoco está lo suficientemente claro qué tan eficaz es la vacuna disponible a la hora de prevenir cualquiera de estos escenarios.

Sin embargo, para Jennifer Nuzzo, directora del Centro Pandémico de la Universidad Brown, la táctica de esperar y ver “es una apuesta”. “Para cuando tengamos consecuencias graves, muchas personas ya se habrán contagiado”, aseguró.

“Ahora es el momento de ofrecer las vacunas a los trabajadores agrícolas en Estados Unidos”, dijo Nahid Bhadelia, directora del Centro de Enfermedades Infecciosas Emergentes de la Universidad de Boston. Agregó que en el país hasta las medidas más apremiantes están retrasadas.  Bhadelia considera que es urgente realizar análisis tanto a los trabajadores agrícolas como a las vacas para detectar la presencia del virus de la gripe aviar H5N1, estudiarlo y erradicarlo antes de que se establezca en las granjas, lo que representaría una amenaza pandémica constante.

Demetre Daskalakis, director del Centro Nacional de Inmunización y Enfermedades Respiratorias de los CDC, explicó que la agencia se toma muy en serio a la gripe aviar y que se están almacenando 4.8 millones de dosis de la vacuna. Pero admitió que “no hay ninguna recomendación para lanzar una campaña de vacunación”.

“Se trata de la relación riesgo-beneficio”, comentó Daskalakis. Los beneficios todavía son inciertos porque no contamos con suficientes testeos como para entender con qué facilidad el virus pasa de las vacas a las personas, y tampoco sabemos cuán grave puede ser la enfermedad.

Este año, en Estados Unidos, solo cuatro personas han dado positivo y fueron casos leves. Es un número muy limitado, que no permite sacar conclusiones definitivas.

También informaron que han estado enfermos otros trabajadores agrícolas y veterinarios que trabajan en granjas lecheras donde se han detectados casos de gripe aviar. Sin embargo, no se les hicieron los análisis correspondientes. Desde que se detectó el brote en marzo, los hospitales públicos han examinado solo a unas 50 personas que podrían haberse contagiado.

De todos modos, Daskalakis aseguró que los CDC no están preocupados por la posibilidad de que la agencia esté pasando por alto infecciones significativas de gripe aviar debido a su sistema de vigilancia de la influenza. Los hospitales reportan pacientes con casos graves de gripe y este año los números se mantienen normales.

Otro indicio que tranquiliza a la agencia es que el virus aún no ha desarrollado mutaciones que le permitan propagarse rápidamente cuando la gente estornuda o respira. “Si comenzáramos a ver cambios en el virus, ese sería un factor que incidiría en la decisión de pasar de una fase de planificación a una fase operativa”, explicó Daskalakis.

Para evaluar si administrar o no las vacunas, la agencia se basó en el brote de gripe porcina de 1976. En aquel momento, los funcionarios temían que se pudiera repetir la pandemia de gripe porcina de 1918, que mató aproximadamente a medio millón de personas en Estados Unidos. Por lo tanto, en un año vacunaron rápidamente a casi 43 millones de personas.

Pero ese año los casos de gripe porcina resultaron ser leves. Esto hizo que la campaña de vacunación se considerara innecesariamente riesgosa ya que surgieron varios informes de un trastorno potencialmente mortal, el síndrome de Guillain-Barré.

Hay que tener en cuenta que, según los CDC, aproximadamente una persona de cada millón que son vacunadas contra la influenza puede desarrollar ese síndrome. En el balance, el beneficio de la prevención supera al riesgo. Desde el 1 de octubre por lo menos 830,000 personas han sido hospitalizadas por la gripe estacional y entre 25,000 y 75,000 han muerto.

Un informe elaborado tiempo después respecto de las acciones frente a la gripe porcina de 1976 habló de una “experiencia aleccionadora y con moraleja” sobre qué pasa si se responde prematuramente a una amenaza incierta para la salud pública.

“Es una historia sobre lo que sucede cuando lanzas un programa de vacunación en el que se está aceptando correr riesgos sin que haya un beneficio demostrado”, señaló Daskalakis.

Paul Offit, virólogo del Hospital Infantil de Philadelphia, se alinea con la decisión que tomaron los CDC. “Esperaría a tener más datos”, dijo.

Sin embargo, otros investigadores dicen que el escenario de 1976 fue distinto. Nadie está sugiriendo vacunar a decenas de millones de personas: se está hablando de una vacuna totalmente voluntaria para los miles de trabajadores que están en contacto cotidiano con el ganado, lo que reduce la posibilidad de efectos adversos raros.

La vacuna contra la gripe aviar que está disponible, fabricada por la empresa de vacunas contra la gripe CSL Seqirus, fue autorizada el año pasado por el equivalente europeo de la Administración de Drogas y Alimentos (FDA). Una versión previa tiene la aprobación de la FDA, pero la más reciente aún no recibió la luz verde.

Aunque la vacuna está dirigida a una cepa diferente de gripe aviar que la H5N1, que es la que circula actualmente entre las vacas, los estudios muestran que desencadena una respuesta inmune contra ambas variantes. Se considera segura porque utiliza la misma tecnología en base a huevo que se despliega cada año en las vacunas contra la gripe estacional.

Por estas razones, Estados Unidos, el Reino Unido, Holanda y otra docena de países están almacenando millones de dosis. Finlandia espera ofrecérselas este mes también a quienes trabajan en granjas peleteras, como precaución porque sus granjas de visones y zorros fueron golpeadas por la gripe aviar el año pasado.

En contraste, las vacunas de ARNm que se están desarrollando contra la gripe aviar serían las primeras de su tipo también para la influenza. El 2 de julio, el gobierno de Estados Unidos anunció que pagaría a la farmacéutica Moderna $176 millones por su desarrollo y que las vacunas podrían entrar en la etapa de ensayos clínicos el próximo año.

Utilizadas ampliamente contra covid-19, esta nueva tecnología emplea ARNm para enseñar al sistema inmune cómo reconocer virus particulares.

Mientras tanto, Florian Krammer, virólogo especializado en gripe en la Escuela de Medicina Icahn de Mount Sinai, señaló que las personas que trabajan en tambos deberían tener la opción de recibir la vacuna basada en huevo. Esta vacuna desencadena una respuesta inmunitaria contra un componente principal del virus H5N1 de la gripe aviar, lo que debería brindar un grado de protección contra la infección y la enfermedad grave, explicó.

Aun así, la protección no sería del 100%. Y nadie sabe cuántos contagios y hospitalizaciones podría prevenir esta vacuna, ya que no se ha utilizado para combatir el virus de este año. Esos datos deben recopilarse en estudios que rastreen qué resultado tuvo en las personas que opten por ser vacunadas, agregó.

A Krammer no lo tranquiliza que no se hayan detectado casos graves de gripe aviar en las clínicas. “Porque cuando los indicios llegan a los hospitales, significa que la situación ya se encuentra fuera de control, que estamos frente a una pandemia”, dijo. “Y eso es lo que queremos evitar”.

El virólogo y otros especialistas enfatizaron que Estados Unidos debería estar haciendo todo lo posible para frenar las infecciones antes de octubre, cuando comienza la temporada de gripe. La vacuna podría proporcionar una capa adicional de protección, que se sumaría a las evaluaciones, el uso de guantes y gafas, y la desinfección del equipo de ordeñe.

Algunos científicos temen que, si las personas contraen la gripe aviar y la gripe estacional simultáneamente, los virus de la gripe aviar podrían generar adaptaciones de los virus estacionales que les permitieran propagarse rápidamente entre humanos.

También dicen que podría llevar meses distribuir las vacunas después que se recomiende oficialmente, ya que ese tipo de campaña requiere grandes esfuerzos de divulgación.

Bethany Boggess Alcauter, directora de investigación del National Center for Farmworker Health, comentó que las personas que trabajan con vacas lecheras aún carecen de información sobre el virus, cuatro meses después del inicio de este brote.

Los funcionarios de salud han hablado con los propietarios de tambos, pero las entrevistas de Boggess con los trabajadores agrícolas permiten pensar que esas conversaciones no han llegado a su personal.

Un trabajador agrícola en el Panhandle de Texas le contó a Boggess que en su trabajo le dijeron que se desinfectara las manos y las botas para proteger a las vacas de enfermedades que los trabajadores puedan transmitir. “Nunca nos dijeron que la vaca podría infectarnos con alguna enfermedad”, dijo el hombre en español.

El ritmo siempre lento en que se divulga la información es un recordatorio de que todo lleva tiempo, incluidas las decisiones sobre vacunación. Para resolver si recomendar las vacunas, los CDC normalmente buscan orientación de su Comité Asesor sobre Prácticas de Inmunización, o ACIP. Un consultor del grupo, el investigador de enfermedades infecciosas William Schaffner, ha pedido repetidamente a la agencia que presente su opinión sobre la vacuna contra la gripe aviar de Seqirus.

En lugar de preocuparse por la situación de la gripe porcina de 1976, Schaffner sugirió que los CDC consideren la pandemia de gripe porcina de 2009-10. Esta pandemia causó más de 274,000 hospitalizaciones y 12,000 muertes en Estados Unidos en un año. Para cuando comenzó la vacunación, dijo, gran parte del daño ya estaba hecho.

“El momento de discutir esto con ACIP es ahora”, sostuvo Schaffner. Es decir, antes de que la gripe aviar se convierta en una emergencia de salud pública. “No queremos que se comience a discutir cuando ya sea demasiado tarde”.

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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HHS Proposes Physician Payment Rule to Drive Whole-Person Care and Improve Health Quality for All Individuals with Medicare

HHS Gov News - July 10, 2024
The proposed rule reflects the Administration’s vision for affordable, high-quality care for all Americans while driving innovation in the Medicare program.

HHS Proposes HTI-2 Rule to Improve Patient Engagement, Information Sharing, and Public Health Interoperability

HHS Gov News - July 10, 2024
HTI-2 proposed rule reflects ONC’s focused efforts to advance interoperability and improve information sharing.

Retratos convierten a muertes por armas de fuego en historias imborrables

Kaiser Health News:States - July 10, 2024

Philadelphia. — Zarinah Lomax es una documentalista poco común. Ha diseñado vestidos con las cintas amarillas de escenas de crimen y abrigos con leyendas pintadas a mano que dicen: “No Disparen”, en dorado, negro y púrpura. Cada pocos meses, transporta docenas de retratos de habitantes de Philadelphia —caras vibrantes, audaces y más grandes que la vida misma— a galerías temporales para alertar sobre la violencia armada en su ciudad natal, y en América.

En un depósito, Lomax estima que tiene unos mil lienzos, en su mayoría de jóvenes que murieron por disparos, y otros de madres, hermanas, amigos y dolientes que se preguntan por qué.

“El propósito no es hacer llorar a la gente”, dijo Lomax, una nativa de Philadelphia que ha viajado a Nueva York, Atlanta y Miami para colaborar en exhibiciones similares sobre este trauma. “Es para que las familias y las personas que han pasado por esto sepan que no son olvidadas”.

Cada persona “no es un número. Este es el hijo de alguien. La hija de alguien que estaba trabajando en algo”, dijo. “Los retratos no son solo retratos. Nos están diciendo cuáles son las consecuencias de lo que está sucediendo en nuestras ciudades”.

Las armas de fuego en 2020 se convirtieron en la causa número uno de muerte en niños y adolescentes menores de 18 años —tanto por suicidios como por agresiones— y una nueva investigación sobre la crisis de salud pública del Instituto Blavatnik de la Escuela de Medicina de Harvard muestra cómo esas pérdidas se extienden a través de familias y vecindarios, con costos económicos y psicológicos significativos.

El 25 de junio, Vivek Murthy, cirujano general de Estados Unidos, declaró a la violencia armada como una crisis de salud pública, remarcando: “Cada día que pasa perdemos más niños por la violencia armada. Cuantos más niños presencian episodios de violencia armada, más niños que son heridos por disparos y sobreviven están lidiando con impactos físicos y mentales de por vida”.

Philadelphia ha registrado más de 9,000 tiroteos fatales y no fatales desde 2020, con aproximadamente el 80% de las víctimas identificadas como negras no hispanas, según el controlador de la ciudad. Entre los heridos o muertos, aproximadamente el 60% tenía 30 años o menos.

Lomax ha sido una fuerza singular para que las estadísticas no se olviden. Desde 2018, cuando un joven amigo que estaba a punto de graduarse de la Universidad Estatal de Pennsylvania fue asesinada a tiros un domingo por la tarde en Philadelphia, Lomax se propuso apoyar la sanación entre aquellos que experimentan violencia.

Lanzó un programa en PhillyCAM, un canal de medios de acceso comunitario, para alentar a las personas a hablar sobre armas, opioides y el duelo. Organizó desfiles de moda con artistas locales y familias que se centraron en dar testimonio del sufrimiento. Se centró en el retrato, contactando a artistas locales para conmemorar las vidas, no las muertes, de los jóvenes de Philadelphia.

Comenzó a rastrear tiroteos en las redes sociales, en las noticias y a veces de boca en boca. En 2022, el Ayuntamiento abrió tres pisos para una notable exhibición de vidas perdidas, organizada por Lomax y creada por docenas de artistas.

Recientemente compartió los retratos en una cumbre patrocinada por la organización sin fines de lucro Brady: United Against Gun Violence y CeaseFirePA. La reunión ofreció orientación sobre la aplicación de regulaciones para prevenir compras de armas que impulsan el crimen y proporcionó datos sobre el tráfico de armas a través de las fronteras estatales.

Lomax sabía que el arte, exhibido a lo largo del escenario, ponía en evidencia la importancia del tema.

Miren estas caras, dijo ella. Estas personas eran prometedoras. ¿Qué pasó? ¿Qué se puede hacer?

Lomax, ahora de 40 años, dijo que las conversaciones que inicia tienen un propósito. Algunos cuadros los regala a las familias. Otros los guarda para futuras exhibiciones.

“Esto no es lo que me propuse hacer en la vida”, dijo ella. “Cuando estaba creciendo, pensé que sería enfermera. Pero supongo que de esta forma estoy cuidando a las personas”.

En lo que va del año, Philadelphia ha visto una disminución en el número de asesinatos, según una base de datos en línea de AH Datalytics, pero se encuentra entre las cinco ciudades principales en conteo de asesinatos. El año pasado, los investigadores de Harvard establecieron que las comunidades y familias quedan vulnerables por las lesiones con armas de fuego.

El estudio de 2023 dirigido por Zirui Song, profesor asociado de política de atención médica en Harvard, examinó datos relacionados con recién nacidos hasta los 19 años. La investigación documentó un costo económico “masivo”, con un aumento promedio de $35,000 en el gasto en atención médica para los sobrevivientes en el año posterior a un tiroteo, y desafíos de salud mental que alteran la vida.

Los sobrevivientes de tiroteos y sus cuidadores, ya sea lidiando con lesiones físicas o miedo generalizado, a menudo luchan con “lesiones invisibles y duraderas, incluidos trastornos psicológicos y de uso de sustancias”, según Song, quien también es internista general en el Hospital General de Massachusetts.

Su estudio encontró que los padres de niños heridos experimentaron un aumento del 30% en trastornos psiquiátricos en comparación con los padres cuyos hijos no sufrieron heridas de bala.

Desiree Norwood, quien pinta con acrílicos, ha estado ayudando a Lomax desde 2021. Como a todos los artistas, Lomax le paga. Ha completado unos 30 retratos, siempre después de sentarse con la familia de la víctima. “Obtengo una historia de fondo para poder incorporarla en el retrato”, dijo. “A veces lloramos. A veces rezamos. A veces tratamos de animarnos mutuamente. Es difícil de hacer”.

“Espero que un día no tenga que pintar otro retrato”, dijo Norwood, madre de cinco hijos. “La idea de que Zarinah haya tenido tantas exhibiciones, con numerosas personas que han muerto, es aterradora y desgarradora”.

Mike Doughty, un artista digital autodidacta, fue uno de los que querían ayudar a “honrar y ofrecer una mejor mirada de quiénes eran estas personas”. Doughty, un empleado de la ciudad que trabaja en un juzgado, puede ser mejor conocido Philadelphia por una serie de murales en los que ha agrupado a famosos nacidos en la ciudad como Will Smith, Grace Kelly y Kevin Hart.

Ha producido unos 150 retratos en su iPad y laptop, trabajando con el grupo sin fines de lucro de Lomax, The Apologues, para ponerle rostro a una frase, incrustada en una escena, que transmite el potencial perdido de la juventud.

“Al principio fue difícil de hacer,” dijo Doughty, quien trabaja a partir de fotografías familiares. “Miro y pienso: Son niños. Solo niños”.

Una vez, recibió un mensaje de texto de Lomax buscando un retrato de un rapero que reconoció de espectáculos de arte y música. Otro día, abrió un correo electrónico y encontró una foto de un hombre que conocía de la escuela secundaria. En mayo, Doughty compartió en Instagram su proceso de trabajo para un retrato de Derrick Gant, un rapero con el nombre artístico Phat Geez, que fue asesinado a tiros en marzo.

El asesinato ocurrió unas semanas después que el rapero lanzara “No Gunzone”, un video musical que hace referencia a una cuenta de Instagram que promueve esfuerzos contra la violencia en la ciudad.

Doughty, de 33 años, que creció en la sección Nicetown del norte de Philadelphia, señaló irónicamente: “No era tan agradable”. Las exhibiciones de Lomax, dijo, permiten a las familias, incluso a los vecindarios, procesar el dolor y el sufrimiento.

“Fui a la última y una madre se acercó y dijo, ‘¿Dibujaste el retrato de mi hijo?’ Simplemente cayó en mis brazos, llorando. Fue un momento tan emotivo”, contó. “Y un recordatorio de por qué hacemos lo que hacemos”.

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Why the Election May Slow Plans To Replace Lead Pipes

Kaiser Health News:States - July 10, 2024

With the Environmental Protection Agency’s latest — and strictest — plan to minimize the risk of Americans drinking lead-contaminated water on the horizon, the debate over whether the rules go too far or not nearly far enough is reaching a tipping point.

Although lead was banned from new water service lines in 1986, it’s estimated that more than 9 million such lines still carry drinking water to homes and businesses throughout the country. Under the EPA’s Lead and Copper Rule Improvements proposal, water utilities would be required to replace all lead-containing lines within 10 years.

The proposal from the Biden administration builds on different rules put out in the waning days of the Trump term that allowed up to 30 years for service line replacement, triggered only when lead levels test higher than 15 parts per billion. The new proposal, which would largely supplant the Trump rules, calls for stricter monitoring, enhanced public education, and the 10-year pipe replacement mandate regardless of lead levels.

An October deadline looms for the new rules to be adopted; otherwise, enforcement of the less-stringent Trump administration rules will begin. And complicating matters more: November’s election results could shake up whose rules the nation must follow.

While many cities and states have begun to replace their lead pipes, some utilities and officials say the 10-year time frame is unfeasible and too expensive. They say it would be difficult for water utilities to follow the rules while dealing with new EPA limits on five PFAS contaminants, known as “forever chemicals,” and failing pipes, among other issues.

“Nobody will tell you that having lead in contact with water is a great idea,” said Steve Via, director of federal relations for the American Water Works Association, the country’s largest nonprofit water utility industry group. “The question becomes: How urgent a matter is it, and at what pace does it need to be done?”

Already, 15 Republican state attorneys general have argued that the proposed rules infringe on states’ rights and chase “speculative” benefits. On the other side, 14 Democratic attorneys general said that the EPA should find more ways to ensure pipes are quickly replaced in low-income areas.

To be sure, no amount of lead is considered safe to consume. Lead is a neurotoxin known to cause irreversible long-term organ damage, lower IQs, higher risk for miscarriage, asthma, cardiovascular disease, impotence, and elevated blood pressure.

Public health advocates say societal costs — in health care, social services, and lost productivity — far outweigh the cost of replacement. They say corrosion controls that have limited lead exposure can and do fail, pointing to human and systemic errors that prompted the water crisis in Flint, Michigan, where thousands of people were exposed to high lead levels in their drinking water.

“That’s the whole thing about lead pipes: They unexpectedly release lead into drinking water,” said Roya Alkafaji, who manages an initiative focused on reducing lead exposure from water with the Environmental Defense Fund, a national advocacy group. “I don’t think kicking the can down the road is the solution.”

According to a 2023 analysis by Ronnie Levin, an instructor at Harvard’s T.H. Chan School of Public Health, the benefit of replacing lead pipes outweighs the costs by a 35:1 ratio.

Using the EPA’s estimated $335 million annual costs from the Trump rules, which include water sampling, corrosion control treatments, inventorying and replacement of lead service lines, and educational outreach, Levin’s analysis shows that $9 billion in annual health care costs could be avoided. An additional $2 billion in spending — through upgraded infrastructure and reduced corrosion damage to appliances — could be saved. The broad spectrum of health-related costs has historically been ignored in analyzing the actual costs of leaving lead service lines in place, said Levin, a former EPA scientist.

Estimates of the cost to replace the nation’s lead pipes range from $46 billion to more than $90 billion, far higher than the $15 billion set aside in the Bipartisan Infrastructure Law. The Biden administration has framed those funds as a down payment, 49% of which will be grants or principal forgiveness loans allocated on the basis of the estimated number of lead pipes per state. Other funding programs can also be tapped.

Replacement costs vary widely by location, with average costs ranging from the EPA’s 2019 estimate of $4,700 per service line to $12,500 from Via’s utilities trade group.

Carolyn Berndt, legislative director for sustainability at the National League of Cities, said funding challenges could render the EPA’s 10-year timeline unrealistic. While her organization is encouraging local leaders to secure as much funding as possible, what’s available won’t be enough to cover replacement costs for some localities — especially low-income areas, which often have older infrastructure and more lead pipes.

Some direct costs could fall to property owners, such as replacing the lines connecting their water meters to their homes. And people could face indirect costs if utilities increase customer rates to offset the expense.

Still, some communities, such as Olathe, Kansas, are finding ways to move forward with a patchwork of funding. Out of 37,000 service lines there, 266 galvanized pipes were found serving downtown properties, where many of the city’s most vulnerable residents live. The coating for galvanized pipes typically contains lead.

Workers will replace the lines at no cost to property owners in the city of 147,000 people outside Kansas City, said Megan Spence, who is overseeing the city project. It is expected to cost around $2.3 million, paid for with a loan from the Kansas Department of Health and Environment and about $1.2 million in federal infrastructure funding. About $500,000 for lawn restoration is included.

“We’re really looking at this as an opportunity and another way to protect public health,” said Spence. “There shouldn’t be any lead lines in any drinking water distribution systems.”

Elsewhere, some Republicans, such as Indiana state Sen. Eric Koch, are leading the charge to replace the pipes despite historical pushback in conservative states against federal mandates. He said lawmakers should consider the harm — and long-term costs — caused by delaying the cleanup of lead from drinking water.

In March, Indiana’s Republican Gov. Eric Holcomb signed a unanimously approved bill, which Koch authored, designed to lower costs for replacing customer-owned lead service lines. Under the law, landlords are required to enroll in a state-approved program to have their lead pipes removed at no cost by their water utility or pay for replacement themselves.

Koch said estimates for replacing customer-owned service lines are around $8,000, though the cost could be significantly higher for some properties. But by starting the work now, Koch said, utilities can avoid price inflation and ultimately remove pipes more cost efficiently.

Meanwhile, time is running out to publish the Biden administration’s proposed rules in the Federal Register. Water utilities will be required to comply with the Trump rules as of Oct. 16 unless the EPA publishes the newer rules before then, said Erik Olson, a senior strategic director of the National Resources Defense Council, an advocacy group. It remains unknown what the June 28 Supreme Court ruling on agency rulemaking, known as the “Chevron deference” decision, will mean for either set of rules.

A deadline is also looming for the 60-day “look-back” period under the Congressional Review Act, during which a regulation can be repealed. If control of Congress or the White House flips with the November election, the Biden administration’s rules could be repealed under an emboldened Congress even before the January swearing in of new officeholders.

“Depending on how the election goes, it could become a hot issue,” said Tom Neltner, national director of the advocacy organization Unleaded Kids.

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These Vibrant, Bigger-Than-Life Portraits Turn Gun Death Statistics Into Indelible Stories

Kaiser Health News:States - July 10, 2024

PHILADELPHIA — Zarinah Lomax is an uncommon documentarian of our times. She has designed dresses from yellow crime-scene tape and styled jackets with hand-painted demands like “Don’t Shoot” in purple, black, and gold script. Every few months, she hauls dozens of portraits of Philadelphians — vibrant, bold, bigger-than-life faces — to pop-up galleries to raise an alarm about gun violence in her hometown and America.

In a storage unit, Lomax has a thousand canvasses, she estimates, mostly of young people who died from gunfire, and others of the mothers, sisters, friends, and mourners left to ask why.

“The purpose is not to make people cry,” said Lomax, a Philadelphia native who has traveled to New York, Atlanta, and Miami to collaborate on similar exhibitions on trauma. “It is for families and for people who have gone through this to know that they are not forgotten.”

Each person “is not a number. This is somebody’s child. Somebody’s son, somebody’s daughter who was working toward something,” she said. “The portraits are not just portraits. They are telling us what the consequences are for what’s happening in our cities.”

Firearms in 2020 became the No. 1 cause of death for children and teens under 18 — from both suicides and assaults — and fresh research on the public health crisis from Harvard Medical School’s Blavatnik Institute show how those losses ripple through families and neighborhoods with significant economic and psychological costs.

On June 25, U.S. Surgeon General Vivek Murthy declared gun violence a public health crisis, noting: “Every day that passes we lose more kids to gun violence. The more children who are witnessing episodes of gun violence, the more children who are shot and survive that are dealing with a lifetime of physical and mental health impacts.”

Philadelphia has recorded more than 9,000 fatal and nonfatal shootings since 2020, with about 80% of the victims identified as Black, according to the city controller. Among those injured or dead, about 60% were age 30 or younger.

Lomax has been a singular, and perhaps unlikely, force in making the statistics unforgettable. Since 2018, when a young friend poised to graduate from Penn State University was shot to death on a Sunday afternoon in Philadelphia, Lomax has set out to support healing among those who experience violence.

She launched a show on PhillyCAM, a community access media channel, to encourage people to talk about guns and opioids and grief. She organized fashion shows with local artists and families that focused on bearing witness to distress. She seized on portraiture, reaching out to local artists to memorialize the lives, not the deaths, of Philadelphia’s young. She began tracking shootings on social media, in news accounts, and sometimes by word of mouth. In 2022, City Hall opened three floors to a remarkable exhibition of lost lives, organized by Lomax and created by dozens of artists.

She recently shared the portraits at a summit sponsored by the nonprofit Brady: United Against Gun Violence and CeaseFirePA. The meeting offered guidance on enforcing regulations to prevent straw gun purchases that propel crime and provided data on weapon trafficking across state lines. Lomax knew the art, displayed along the stage, brought home the stakes.

Look at these faces, she said. These people had promise. What happened? What can be done?

Lomax, now 40, said the conversations she starts have purpose. Some paintings she gives to families. Others she stores for future exhibits.

“This is not what I set out to do in life,” she said. “When I was growing up, I thought I’d be a nurse. But I guess I am kind of nursing people this way.”

So far this year, Philadelphia has seen a drop in the number of murders, according to an online database by AH Datalytics, but ranks among the top five cities in murder count. Last year, the Harvard researchers established that communities and families are left vulnerable by gun injuries.

The 2023 study led by Zirui Song, an associate professor of health care policy at Harvard Medical School, examined data related to newborns through age 19. The research documented a “massive” economic toll, with health care spending increasing by an average of $35,000 for survivors in the year after a shooting, and life-altering mental health challenges.

Survivors of shootings and their caregivers, whether dealing with physical injuries or generalized fear, often struggle with “long-lasting, invisible injuries, including psychological and substance-use disorders,” according to Song, who is also a general internist at Massachusetts General Hospital. His study found that parents of injured children experienced a 30% increase in psychiatric disorders compared with parents whose children did not sustain gunshot injuries.

Desiree Norwood, who paints with acrylics, has been helping Lomax since 2021. Like all the artists, she’s paid by Lomax. She has completed about 30 portraits, always after sitting down with the subject’s family. “I get a backstory so I can incorporate that in the portrait,” she said. “Sometimes we cry. Sometimes we pray. Sometimes we try to uplift each other. It is hard to do.”

“I hope one day I would not have to paint another portrait,” said Norwood, a mother of five children. “The idea that Zarinah has had so many exhibits, with numerous people who have died, is scary and heartbreaking.”

Mike Doughty, a self-taught digital artist, was among those who wanted to help to “honor and to offer a better look at who these people were.” Doughty, a city employee who works at a courthouse, may be best known within Philadelphia for a series of fanciful murals in which he has grouped famous natives such as Will Smith, Grace Kelly, and Kevin Hart.

He has produced about 150 portraits on his iPad and laptop, working with Lomax’s nonprofit group, The Apologues, to best match a face with a phrase, embedded in the scene, that telegraphs the lost potential of youth.

“At the beginning it was hard to do,” said Doughty, who works from family photographs. “I look and I think: They are kids. Just kids.”

One time, he received a text from Lomax seeking a portrait of a rapper he recognized from art and music shows. Another day, he opened an email to find a photo of a man he knew from high school. In May, Doughty shared on Instagram his work process for a portrait of Derrick Gant, a rapper with the stage name Phat Geez, who was gunned down in March. The killing happened a few weeks after the rapper released “No Gunzone,” a music video referring to an Instagram account that promotes anti-violence efforts in the city.

Doughty, 33, who grew up in the Nicetown section of north Philadelphia, wryly noted: “It wasn’t so nice.” Lomax’s exhibitions, he said, allow families, even neighborhoods, to sort through sorrow and pain.

“I went to the last one and a mother came up and said, ‘Did you draw my child’s portrait?’ She just fell into my arms, crying. It was such a moment,” he said. “And a reminder on why we do what we do.”

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When Hospital Cyberattacks Compromise Care, Not Just Data

When hospitals are hit by cyberattacks that compromise crucial technology systems for managing patient care, the stakes are staggering.

“We’ve started to think about these as public health issues and disasters on the scale of earthquakes or hurricanes,” said Jeff Tully, a co-director of the Center for Healthcare Cybersecurity at the University of California at San Diego.

Many hospitals are unprepared for long outages, cybersecurity experts say. And the federal government has offered little in the way of required protocols or standards to protect patient safety in attacks on the health sector, which have risen precipitously in recent years.

Long-held concerns about protecting patients’ sensitive health information have been overtaken by fears of harm to patients themselves. Kate Wells and I dug into one of the latest and biggest examples for the news organization Michigan Public and KFF Health News: the ransomware attack against Ascension that for weeks locked clinicians out of electronic health records, medication systems and other technology at one of the nation’s largest health systems.

The federal government requires hospitals to protect patient data, according to cybersecurity experts. Yet there are no requirements for hospitals to have basic cybersecurity protocols in place, which could include things like multifactor authentication, email controls and basic cybersecurity training for employees. The Biden administration, however, has indicated it will soon attempt to institute some mandatory measures.

When Denise Anderson, president of the Health Information Sharing and Analysis Center, began working in the health sector, federal officials were focused mostly on data privacy and the Health Insurance Portability and Accountability Act (HIPAA), the landmark 1996 patient privacy law.

“We weren’t pairing cybersecurity and health care in the same sentence,” said Anderson, whose organization works to protect the health sector from physical and cyberthreats.

Lawmakers have taken notice. “It is clear that HHS’ current approach to healthcare cybersecurity — self-regulation and voluntary best practices — is woefully inadequate and has left the health care system vulnerable to criminals and foreign government hackers,” Sen. Ron Wyden (D-Ore.) wrote in a June 5 letter to Health and Human Services Secretary Xavier Becerra.

Clinicians working for Ascension hospitals say the cyberattack led to harrowing lapses, including delayed or lost lab results, medication errors and an absence of routine safety checks via technology to prevent potentially fatal mistakes. More than a dozen doctors and nurses who work for the sprawling health system told Michigan Public and KFF Health News that patient care at its hospitals was compromised in the fallout of the cyberattack.

Ascension declined to answer questions about claims that care has been affected by the ransomware attack. “We are confident that our care providers in our hospitals and facilities continue to provide quality medical care,” Sean Fitzpatrick, Ascension’s vice president of external communications, said last month.

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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GOP’s Tim Sheehy Revives Discredited Abortion Claims in Pivotal Senate Race

Kaiser Health News:States - July 09, 2024

“Elective abortions up to and including the moment of birth. Healthy, 9-month-year-old baby killed at the moment of birth. That’s what Jon Tester and the Democrats have voted for.”

Tim Sheehy, Montana GOP candidate for U.S. Senate, said in a June 8 debate

Tim Sheehy, the Republican candidate seeking to unseat Democratic Sen. Jon Tester of Montana and give U.S. Senate control to the GOP, is campaigning on what he calls Tester’s and Democrats’ “extreme” position on abortion. 

In a televised debate June 8, Sheehy accused Tester and Democrats of voting for “elective abortions up to and including the moment of birth.” That statement prompted Tester to respond: “To say we’re killing babies at 40 weeks is total BS.”

Sheehy has made this accusation on his campaign website, which says, “Jon Tester supports elective abortion on demand up until the moment of birth. Think about that again: Jon Tester supports aborting a healthy, full-term baby the day before it’s due. That is the extreme position here.” Similar statements have been made in the campaign’s social media posts.

Painting the Democratic candidate with, in Sheehy’s words, an “extreme” position on abortion is a familiar conservative campaign strategy and campaign talking point this election cycle. But how does it hold up? 

Some Recent History

Asked for evidence to support Sheehy’s accusations, Sheehy’s campaign spokesperson, Katie Martin, said the Republican candidate was referring to Tester’s vote for the Women’s Health Protection Act, which failed to pass the Senate in 2022. She cited the bill’s provisions that said health providers and patients would have the right to perform and receive abortion services without certain limitations or requirements impeding access.

Anti-abortion advocates say the measure, which has been reintroduced in the current Congress, would create a loophole eliminating any limits to aborting a fetus later in pregnancy. And, rather than define when a fetus is viable during pregnancy, the bill would leave the question of viability to the health provider, who is financially motivated to perform abortions, according to Susan B. Anthony Pro-Life America, a nonprofit group supporting anti-abortion candidates, including Sheehy.

It would impose no-limits abortion on demand in all 50 states at any point in pregnancy,” said Marjorie Dannenfelser, president of SBA Pro-Life America.

In 2022, the legislation failed two votes in the Senate before the U.S. Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision removed federal protections for abortion access and left the issue to the states to decide. Tester voted for the measure both times, but the bill failed to advance after votes of 46-48 and 49-51.

Alina Salganicoff, director of the Women’s Health Policy Program at KFF, said nothing in the Women’s Health Protection Act supports an abortion up to the moment of birth. Rather, the legislation would allow a health provider to perform abortions without obstacles such as waiting periods, tests deemed medically unnecessary, unnecessary in-person visits, or other restrictions imposed by states.

The bill would explicitly allow an abortion after a fetus is viable when, according to the legislation, “in the good-faith medical judgment of the treating health care provider, continuation of the pregnancy would pose a risk to the pregnant patient’s life or health.”

“This is not abortion on demand until the moment of birth,” Salganicoff said. “Even if politicians and anti-abortion activists make this claim, there are no clinicians that provide ‘abortions’ moments before birth.”

Besides the Women’s Health Protection Act, the Sheehy campaign cited Tester’s opposition to “born-alive” legislation meant to protect babies who survive botched abortions.

“At what week does he think it’s inappropriate for medical providers to perform an abortion?” Martin said of Tester. “That would clear up his stance on the issue. Based on his voting record, it suggests he does, in fact, support abortion on demand up until the moment of birth.”

In 2002, Congress passed a “born-alive” law that gave legal protections to infants who survive abortions. A stalled 2022 bill sought to expand that law to add criminal penalties to health professionals who do not take steps to preserve the life of any child born. Montana voters rejected a similar ballot question in 2022.

Tester was elected to the Senate four years after the first bill passed and a vote was not taken on the 2022 measure.

Looking at the Data

Instances of fetuses surviving abortions are rare. So are abortions performed later in pregnancy: Just 1% of all abortions in the U.S. happen at or after 21 weeks of gestation. (The percentage of abortions that occur when the fetus is presumed to be viable, 24 weeks or later, is presumably lower, but the Centers for Disease Control and Prevention does not break out abortion rates for that period.)

An analysis by SBA Pro-Life America’s research arm, the Charlotte Lozier Institute, concluded that 6% of abortions performed in 2020, or an estimated 55,800 abortions, happened at or after 15 weeks of pregnancy.

“Most late-term abortions are elective, performed on healthy women with healthy babies for the same reasons given for first-trimester abortions,” Dannenfelser said.

SBA Pro-Life cites abortions at 15 weeks and later because that is the stage of development at which a fetus can feel pain, according to the group. That is the same rationale behind Republican Sen. Lindsay Graham’s 15-week abortion ban legislation introduced in 2022.

But the American College of Obstetricians and Gynecologists says “the science conclusively establishes” that a fetus does not have the capacity to feel pain until 24 or 25 weeks.

“Every medical organization that has examined this issue and peer-reviewed studies on the matter have consistently reached the conclusion that abortion before this point does not result in the perception of pain in a fetus,” according to the OB-GYN medical group.

Katrina Kimport, a professor in the University of California-San Francisco’s Department of Obstetrics, Gynecology & Reproductive Sciences, said “born-alive” laws are trying to regulate something that doesn’t happen.

Kimport, whose research involved interviewing 30 people in 2018 who had abortions after 24 weeks of pregnancy, and 10 more from 2021 to 2022, also criticized Sheehy’s use of “elective abortion.” In her view, that terminology reflects a political colloquialism that’s come to mean an abortion that is optional. That’s different from the medical definition, she said, in which an elective procedure is one that may be necessary but is not an emergency and can be scheduled for a particular date, such as knee surgery.

Women have abortions later in pregnancy either because they find out new information or because of economic or political barriers, Kimport said.

“I have never spoken to somebody whose abortion decision was not informed by deep thought and consideration,” she said.

Trying to Change the Debate

Mary Ziegler is a University of California-Davis law professor who specializes in the law, history, and politics of reproduction, health care, and conservatism. She said Sheehy’s argument reprises a Republican talking point that abortion opponents have made for decades.

Similar arguments are being heard nationwide as 10 states consider ballot measures to constitutionally protect abortion this election cycle.

Republicans such as Sheehy are accusing Democrats of being extreme on abortion partly to steer the discussion away from their own uncertain position, Ziegler said. The anti-abortion bloc is a key part of the GOP base, but since the Dobbs ruling, voters in seven states, including Montana, have added or upheld abortion rights in elections.

“They can’t really disavow what pro-life groups want as extreme because many of their base voters would be horrified by that,” Ziegler said. “But they can’t embrace it because then many swing voters would be horrified by that.”

Kimport said Sheehy’s statement “reveals a blatant misunderstanding of pregnancy care.”

“What people don’t understand about third-trimester abortions is that there aren’t very many, but for the people who do need abortions later in pregnancy, the circumstances are often desperate and intense,” she said. “And these are the people who are being maligned in these political conversations.”

Our Ruling

Sheehy’s description of Tester’s “extreme” position that would allow abortion “up until the moment of birth” simply doesn’t hold up.

These statements are rooted in Tester’s support for the Women’s Health Protection Act. That bill, however, doesn’t open the door to abortion on demand later in pregnancy. Instead, it allows for the role of medical judgment. In addition, CDC data indicates that late-term pregnancies are rare. Also, the term “elective abortion” is a political rather than medical phrasing.

We rate this claim False.

sources:

NBC Montana, “WATCH: Incumbent U.S. Senator Tester debates challenger Tim Sheehy,” July 9, 2024

X social platform, post by @SheehyforMT, June 9, 2024

Tim Sheehy’s U.S. Senate campaign website, accessed June 9, 2024

Email interview with Katie Martin, Tim Sheehy’s spokesperson, June 11, 2024

Susan B. Anthony Pro-Life America, “SBA Pro-Life America’s Candidate Fund Endorses Tim Sheehy for U.S. Senate,” Jan. 30, 2024

Marjorie Dannenfelser, president of SBA Pro-Life America, in a statement, June 26, 2024

Email interview with Alina Salganicoff, KFF senior vice president and director of the nonprofit’s Women’s Health Policy Program, June 12, 2024

Phone interview with Katrina Kimport, University of California-San Francisco professor, June 12, 2024

Phone interview with Mary Ziegler, University of California-San Diego professor, June 12, 2024 

Email interview with Rachel Kingery, American College of Obstetricians and Gynecologists spokesperson, June 12, 2024

KFF, “Status of Abortion-Related State Constitutional Amendment Measures for the 2024 Election,” updated June 28, 2024

KFF, ”Abortions Later in Pregnancy in a Post-Dobbs Era,” Feb. 21, 2024

Julie Rovner, KFF Health News, “Abortion ‘Until the Day of Birth’ Is Almost Never a Thing,” Nov. 15, 2023

American College of Obstetricians and Gynecologists, “ACOG Guide to Language and Abortion,” accessed June 11, 2024

American College of Obstetricians and Gynecologists, “Facts Are Important: Understanding and Navigating Viability,” accessed June 11, 2024 

American College of Obstetricians and Gynecologists, “Facts Are Important: Gestational Development and Capacity for Pain,” accessed June 11, 2024

Charlotte Lozier Institute, Fact Sheet: “Abortions at 15 Weeks in the United States,” updated Jan. 12, 2023

PolitiFact, “Ron DeSantis’ False Claim That Some States Allow ‘Post-Birth Abortions. None Do,” July 21, 2023

Women’s Health Protection Act of 2021, accessed June 11, 2024

Women’s Health Protection Act of 2022, accessed June 11, 2024

Women’s Health Protection Act of 2023, accessed July 2, 2024

Born-Alive Infants Protection Act of 2002, accessed June 11, 2024 

Born-Alive Abortion Survivors Act of 2022, accessed June 11, 2024 

Montana Free Press, “How Montana’s LR-131 ‘Born Alive’ Referendum Failed,” Nov. 15, 2022 

Ballotpedia, “History of Abortion Ballot Measures,” accessed June 13, 2024

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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If Lawsuit Ends Federal Mandates on Birth Control Coverage, States Will Have the Say

David Engler had been pretty sure he didn’t want children. Then a frustrating school day two years ago helped seal the deal for the now 43-year-old substitute teacher.

“It was wild. I had to call the office seven times to get kids pulled out,” he said. “The next day, I called Kaiser and said, ‘I’d like to know how much a vasectomy is.’”

A representative with Engler’s insurer, Kaiser Permanente, told him the procedure would be free because it was a form of birth control, he said. But after undergoing the vasectomy last winter, he received a bill for $1,080.

“I felt defeated, tricked, and frustrated,” said Engler, who lives in Portland, Oregon.

Engler’s experience highlights how a labyrinthine patchwork of insurance coverage rules on reproductive health care creates confusion for patients. Oregon requires that vasectomies be covered for most people who work in the public sector. But the federal Affordable Care Act — which mandates that most health plans cover preventive health services, such as contraception, at no cost to the consumer — does not require vasectomies to be covered.

And that perplexity surrounding coverage may get more complicated.

An ongoing federal lawsuit aims to strike down the ACA’s preventive care coverage requirements for private insurers. If the case knocks out the mandates, state-level laws — which vary widely across the country — would carry more weight, a change that would resume the “wild West” dynamic from before Obamacare, said Zachary Baron, a health policy researcher at Georgetown Law.

It would create an environment “in which insurers and employers pick and choose which services they want to cover or which services they want to charge for,” Baron said. “It would certainly threaten access to care for millions of Americans.”

Studies have shown the requirements to cover preventive care have reduced consumers’ out-of-pocket costs and increased their use of short- and long-term birth control methods.

The job of defining which contraceptive services should be covered falls to the Health Resources and Services Administration, or HRSA. Two other groups — the U.S. Preventive Services Task Force, or USPSTF, and the Advisory Committee on Immunization Practices, or ACIP — make recommendations on other kinds of care that the ACA requires insurers to cover.

The plaintiffs in the lawsuit, a group of individuals and Christian-owned businesses, argue the members of these three panels haven’t been properly appointed by Congress. They also say the recommendations for insurance plans to cover medication for HIV prevention violate their religious rights.

On June 21, the U.S. Court of Appeals for the 5th Circuit issued what it called a “mixed bag” opinion in the case. It said one group — the USPSTF — had not been properly appointed, and therefore its recommendations made after the ACA was signed into law were unconstitutional. The plaintiffs had asked for a nationwide ruling, but the court said only the plaintiffs’ organizations could be exempted from its recommendations.

The court then sent the plaintiffs’ challenges to the recommendations made by HRSA and ACIP — including those on contraception — back to a lower court to consider.

The case is likely headed to Reed O’Connor, a federal judge in Texas who has issued decisions undermining the ACA — including a ruling striking down the entire law that the U.S. Supreme Court later overturned.

“O’Connor is a judge notoriously hostile to the Affordable Care Act,” said Gretchen Borchelt, vice president of reproductive rights and health at the National Women’s Law Center. “He is someone who is willing to impose remedies where he takes access to care away from everybody in the country based on what’s happening in one situation.”

A win for the plaintiffs, she worried, could create confusion about what kind of contraception is covered and how much it costs, which would ultimately lead to more unintended pregnancies — all at a time when women have less access to abortions.

Nearly two dozen organizations — including the American Medical Association, the American Public Health Association, and the Blue Cross Blue Shield Association — have joined Borchelt’s group in filing briefs warning about the potential disruptions a ruling for the plaintiffs could cause.

Jay Carson, an attorney with the Buckeye Institute, a conservative think tank, said he’s happy with the court’s ruling. His group, along with the state of Texas, filed briefs in support of the plaintiffs.

“Unelected bureaucrats” shouldn’t have the power to decide what insurance plans should be required to cover, said Carson. “We’ve gotten so far afield of Congress actually making the laws and, instead, relying on Congress to just empower some agency to do the heavy lifting.”

What power agencies do have is likely to be curtailed in the wake of a June 28 U.S. Supreme Court decision that overturned a decades-old precedent dictating that courts should defer to federal agencies when it comes to regulatory or scientific decisions.

“Courts are going to be more able to scrutinize experts,” said Richard Hughes, a health care regulatory attorney with the firm Epstein, Becker, and Green. “It’s a vibe shift — we’re moving in the direction of the administrative state being curtailed.”

Eliminating federal coverage requirements for contraception would leave it up to states to determine what services health insurance plans would be required to provide.

Fourteen states and Washington, D.C., currently protect the right to contraception. But states can go only so far with those rules, said Baron, because a federal statute prevents them from regulating self-funded health plans, which cover about 65% of workers.

“It would leave significant gaps in coverage,” Baron said.

A group of Democratic-led states made such an argument in a court brief last year, arguing for the mandates to be upheld to discourage self-funded plans from declining to offer preventive services, as they often did before the ACA.

Even when states can regulate what health plans cover, people still fall through the cracks. “I see denials all the time in instances where the treatment clearly is covered,” said Megan Glor, a health insurance attorney in Oregon.

Patients can appeal their insurers’ decisions, but that’s not easy. And if a patient’s appeals fail, litigation is generally the only option — but that’s a long, complicated, costly process, Glor said. Likely, the best outcome for a patient is an insurer covering what should have been covered in the first place.

When Engler called Kaiser Permanente about his vasectomy charge, he said a representative told him the bill was sent by mistake. Still, he said, the insurer kept asking for money. Engler filed and lost multiple appeals and eventually settled the charge for $540.

Engler’s vasectomy likely should have been free, Glor said. As a teacher, Engler is a public sector employee, which means his insurance would be subject to an Oregon law that mandates no-cost coverage for vasectomies.

Kaiser Permanente told KFF Health News that state law does not apply because of a federal rule for high-deductible health plans paired with health savings accounts. That rule requires patients to cover out-of-pocket costs until their deductible is met.

However, after KFF Health News contacted Kaiser Permanente about Engler’s situation, he said the company promised to issue a full refund for the $540 he had paid to settle his case.

“Although we administered the benefit correctly, an employee who spoke with Mr. Engler told him incorrectly that he would not have” to share the cost, said Debbie Karman, a Kaiser Permanente spokesperson.

Engler said he’s happy with the outcome, though he’s still unsure how Kaiser Permanente’s staff was confused about his insurance coverage.

He worries that others don’t have the means he had to advocate for himself.

“It’s scary,” he said. “So many people are limited in their resources or their understanding of how to fight — or even who to fight.”

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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From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA

In 2013, the FDA approved an implantable device to treat leaky heart valves. Among its inventors was Mehmet Oz, the former television personality and former U.S. Senate candidate widely known as “Dr. Oz.”

In online videos, Oz has called the process that brought the MitraClip device to market an example of American medicine firing “on all cylinders,” and he has compared it to “landing a man on the moon.”

MitraClip was designed to spare patients from open-heart surgery by snaking hardware into the heart through a major vein. Its manufacturer, Abbott, said it offered new hope for people severely ill with a condition called mitral regurgitation and too frail to undergo surgery.

“It changed the face of cardiac medicine,” Oz said in a video.

But since MitraClip won FDA approval, versions of the device have been the subject of thousands of reports to the agency about malfunctions or patient injuries, as well as more than 1,100 reports of patient deaths, FDA records show. Products in the MitraClip line have been the subject of three recalls. A former employee has alleged in a federal lawsuit that Abbott promoted the device through illegal inducements to doctors and hospitals. The case is pending, and Abbott has denied illegally marketing the device.

The MitraClip story is, in many ways, a cautionary tale about the science, business, and regulation of medical devices.

Manufacturer-sponsored research on the device has long been questioned. In 2013, an outside adviser to the FDA compared some of the data marshaled in support of its approval to “poop.”

The FDA expanded its approval of MitraClip to a wider set of patients in 2019, based on a clinical trial in which Abbott was deeply involved and despite conflicting findings from another study.

In the three recalls, the first of which warned of potentially deadly consequences, neither the manufacturer nor the FDA withdrew inventory from the market. The company told doctors it was OK for them to continue using the recalled products.

In response to questions for this article, both Abbott and the FDA described MitraClip as safe and effective.

“With MitraClip, we’re addressing the needs of people with MR who often have no other options,” Abbott spokesperson Brent Tippen said. “Patients suffering from mitral regurgitation have severely limited quality of life. MitraClip can significantly improve survival, freedom for hospitalization and quality of life via a minimally invasive, now common procedure.”

An FDA spokesperson, Audra Harrison, said patient safety “is the FDA’s highest priority and at the forefront of our work in medical device regulation.”

She said reports to the FDA about malfunctions, injuries, and deaths that the device may have caused or contributed to are “consistent” with study results the FDA reviewed for its 2013 and 2019 approvals.

In other words: They were expected.

Inspiration in Italy

When a person has mitral regurgitation, blood flows backward through the mitral valve. Severe cases can lead to heart failure.

With MitraClip, flaps of the valve — known as “leaflets” — are clipped together at one or more points to achieve a tighter seal when they close. The clips are deployed via a catheter threaded through a major vein, typically from an incision in the groin. The procedure offers an alternative to connecting the patient to a heart-lung machine and repairing or replacing the mitral valve in open-heart surgery.

Oz has said in online videos that he got the idea after hearing a doctor describe a surgical technique for the mitral valve at a conference in Italy. “And on the way home that night, on a plane heading back to Columbia University, where I was on the faculty, I wrote the patent,” he told KFF Health News.

A patent obtained by Columbia in 2001, one of several associated with MitraClip, lists Oz first among the inventors.

But a Silicon Valley-based startup, Evalve, would develop the device. Evalve was later acquired by Abbott for about $400 million.

“I think the engineers and people at Evalve always cringe a little bit when they see Mehmet taking a lot of, you know, basically claiming responsibility for what was a really extraordinary team effort, and he was a small to almost no player in that team,” one of the company’s founders, cardiologist Fred St. Goar, told KFF Health News.

As of 2019, the MitraClip device cost $30,000 per procedure, according to an article in a medical journal. According to the Abbott website, more than 200,000 people around the world have been treated with MitraClip.

Oz filed a financial disclosure during his unsuccessful run for the U.S. Senate in 2022 that showed him receiving hundreds of thousands of dollars in annual MitraClip royalties.

Abbott recently received FDA approval for TriClip, a variation of the MitraClip system for the heart’s tricuspid valve.

Endorsed ‘With Trepidation’

Before the FDA said yes to MitraClip in 2013, agency staffers pushed back.

Abbott had originally wanted the device approved for “patients with significant mitral regurgitation,” a relatively broad term. After the FDA objected, the company narrowed its proposal to patients at too-high risk for open-heart surgery.

Even then, in an analysis, the FDA identified “fundamental” flaws in Abbott’s data.

One example: The data compared MitraClip patients with patients who underwent open-heart surgery for valve repair — but the comparison might have been biased by differences in the expertise of doctors treating the two groups, the FDA analysis said. While MitraClip was implanted by a highly select, experienced group of interventional cardiologists, many of the doctors doing the open-heart surgeries had performed only a “very low volume” of such operations.

FDA “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered,” the FDA said in a review prepared for a March 2013 meeting of a committee of outside advisers to the agency.

Some committee members expressed misgivings. “If your right shoe goes into horse poop and your left shoe goes into dog poop, it’s still poop,” cardiothoracic surgeon Craig Selzman said, according to a transcript.

The committee voted 5-4 against MitraClip on the question of whether it proved effective. But members voted 8-0 that they considered the device safe and 5-3 that the benefits of the device outweighed its risks.

Selzman voted yes on the last question “with trepidation,” he said at the time.

In October 2013, the FDA approved the MitraClip Clip Delivery System for a narrower group of patients: those with a particular type of mitral regurgitation who were considered a surgery risk.

“The reality is, there is no perfect procedure,” said Jason Rogers, an interventional cardiologist and University of California-Davis professor who is an Abbott consultant. The company referred KFF Health News to Rogers as an authority on MitraClip. He called MitraClip “extremely safe” and said some patients treated with it are “on death’s door to begin with.”

“At least you’re trying to do something for them,” he said.

Conflicting Studies

In 2019, the FDA expanded its approval of MitraClip to a wider set of patients.

The agency based that decision on a clinical trial in the United States and Canada that Abbott not only sponsored but also helped design and manage. It participated in site selection and data analysis, according to a September 2018 New England Journal of Medicine paper reporting the trial results. Some of the authors received consulting fees from Abbott, the paper disclosed.

A separate study in France reached a different conclusion. It found that, for some patients who fit the expanded profile, the device did not significantly reduce deaths or hospitalizations for heart failure over a year.

The French study, which appeared in the New England Journal of Medicine in August 2018, was funded by the government of France and Abbott. As with the North American study, some of the researchers disclosed they had received money from Abbott. However, the write-up in the journal said Abbott played no role in the design of the French trial, the selection of sites, or in data analysis.

Gregg Stone, one of the leaders of the North American study, said there were differences between patients enrolled in the two studies and how they were medicated. In addition, outcomes were better in the North American study in part because doctors in the U.S. and Canada had more MitraClip experience than their counterparts in France, Stone said.

Stone, a clinical trial specialist with a background in interventional cardiology, acknowledged skepticism toward studies sponsored by manufacturers.

“There are some people who say, ‘Oh, well, you know, these results may have been manipulated,'” he said. “But I can guarantee you that’s not the truth.”

‘Nationwide Scheme’

A former Abbott employee alleges in a lawsuit that after MitraClip won approval, the company promoted the device to doctors and hospitals using inducements such as free marketing support, the chance to participate in Abbott clinical trials, and payments for participating in “sham speaker programs.”

The former employee alleges that she was instructed to tell referring physicians that if they observed mitral regurgitation in their patients to “just send it” for a MitraClip procedure because “everything can be clipped.” She also alleges that, using a script, she was told to promote the device to hospital administrators based on financial advantages such as “growth opportunities through profitable procedures, ancillary tests, and referral streams.”

The inducements were part of a “nationwide scheme” of illegal kickbacks that defrauded government health insurance programs including Medicare and Medicaid, the lawsuit claims.

The company denied doing anything illegal and said in a court filing that “to help its groundbreaking therapy reach patients, Abbott needed to educate cardiologists and other healthcare providers.”

Those efforts are “not only routine, they are laudable — as physicians cannot use, or refer a patient to another doctor who can use, a device that they do not understand or in some cases even know about,” the company said in the filing.

Under federal law, the person who filed the suit can receive a share of any money the government recoups from Abbott. The suit was filed by a company associated with a former employee in Abbott’s Structural Heart Division, Lisa Knott. An attorney for the company declined to comment and said Knott had no comment.

Reports to the FDA

As doctors started using MitraClip, the FDA began receiving reports about malfunctions and cases in which the product might have caused or contributed to a death or an injury.

According to some reports, clips detached from valve flaps. Flaps became damaged. Procedures were aborted. Mitral leakage worsened. Doctors struggled to control the device. Clips became “entangled in chordae” — cord-like structures also known as heartstrings that connect the valve flaps to the heart muscle. Patients treated with MitraClip underwent corrective operations.

As of March 2024, the FDA had received more than 17,000 reports documenting more than 22,000 “events” involving mitral valve repair devices, FDA data shows. All but about 200 of those reports mention one iteration of MitraClip or another, a KFF Health News review of FDA data found.

Almost all the reports came from Abbott. The FDA requires manufacturers to submit reports when they learn of mishaps potentially related to their devices.

The reports are not proof that devices caused problems, and the same event might be reported multiple times. Other events may go unreported.

Despite the reports’ limitations, the FDA provides an analysis of them for the public on its website.

MitraClip’s risks weren’t a surprise.

Like the rapid-fire fine print in television ads for prescription drugs, the original product label for the device listed more than 60 types of potential complications.

Indeed, during clinical research on the device, about 6% of patients implanted with MitraClip died within 30 days, according to the label. Almost 1 in 4 — 23.6% – were dead within a year.

The FDA spokesperson, Harrison, pointed to a study originally published in 2021 in The Annals of Thoracic Surgery, based on a central registry of mitral valve procedures, that found lower rates of death after MitraClip went on the market.

“These data confirmed that the MitraClip device remains safe and effective in the real-world setting,” Harrison said.

But the study’s authors, several of whom disclosed financial or other connections to Abbott, said data was missing for more than a quarter of patients one year after the procedure.

A major measure of success would be the proportion of MitraClip patients who are alive “with an acceptable quality of life” a year after undergoing the procedure, the study said. Because such information was available for fewer than half of the living patients, “we have omitted those outcomes from this report,” the authors wrote.

If you’ve had an experience with MitraClip or another medical device and would like to tell KFF Health News about it, click here to share your story with us.

KFF Health News audience engagement producer Tarena Lofton 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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Planned Parenthood enfrenta a los republicanos y espera captar el apoyo de los votantes

Kaiser Health News:States - July 08, 2024

Planned Parenthood está preparando una campaña millonaria con el objetivo de desalojar de sus bancas a los congresistas republicanos de California.

Esta ofensiva estratégica es parte de un esfuerzo nacional más amplio del grupo de derechos reproductivos, que se propone evitar que una mayoría republicana apruebe restricciones al derecho al aborto, incluida una prohibición nacional.

Planned Parenthood Affiliates of California ha puesto la mira en ocho distritos en los que los votantes apoyaron mayoritariamente a los republicanos en 2022, aunque antes habían respaldado una enmienda constitucional que consagraba el acceso al aborto y a los anticonceptivos.

La estrategia publicitaria adoptó un enfoque negativo porque se centra en los antecedentes de cada uno de los congresistas que votaron contra el acceso al aborto y a métodos anticonceptivos en general.

En campañas anteriores, el grupo usó la idea del “Burn Book” de la comedia de 2004 “Mean Girls”, donde las protagonistas escribían rumores sobre sus compañeros de escuela.

Oficiales del Partido Republicano respondieron que confiaban en que los votantes de esos distritos considerarían el panorama general y mantendrían a los republicanos en sus bancas. Y uno de los candidatos rechazó la imputación de que el acceso a la atención reproductiva estuviera amenazado en el estado.

“El acceso al aborto y a otros servicios de salud reproductiva no van a desaparecer en California”, dijo Calvin Moore, vocero del congresista republicano Ken Calvert, del condado de Riverside. “El congresista Calvert cree que se trata de una cuestión profundamente personal que debe dejarse a criterio de los estados y se opone a una prohibición nacional del aborto”.

Con 52 escaños, la liberal California podría jugar un papel crucial en el control de la Cámara de Representantes de Estados Unidos este otoño.

Pero Planned Parenthood tiene mucho trabajo por delante, ya que siete de los escaños a los que aspira están ocupados actualmente por republicanos y sólo uno —el que dejará vacante la demócrata Katie Porter tras su fallida candidatura al Senado— quedará libre.

Según The Cook Political Report, cuatro de las contiendas electorales serán muy reñidas. El distrito de la representante Michelle Steel, ubicado principalmente en el condado de Orange, se inclina por los republicanos. Además, tienen buenas probabilidades de ganar tanto Kevin Kiley, cuyo distrito está situado a lo largo de la frontera oriental de California, como Young Kim, que representa al que está ubicado al este de Anaheim.

Para muchos votantes, el aborto ha resultado ser un tema más importante de lo que los analistas políticos habían previsto inicialmente. “Creo que en muchos de estos lugares los votantes se preocupan por sus libertades reproductivas y se identifican con nuestro mensaje, esa es la razón por la que creemos que vamos a ganar”, afirmó Jodi Hicks, directora ejecutiva y presidenta de Planned Parenthood Affiliates of California.

Aunque Planned Parenthood centró su trabajo en las elecciones a la Cámara de Representantes, Hicks mencionó que también están atentos a lo que sucede en los estados vecinos. Una filial de California, Planned Parenthood Mar Monte, se extiende hasta Reno, Nevada, y su equipo de defensa ha estado apoyando activamente una iniciativa electoral que protegería constitucionalmente el derecho al aborto de la población del estado.

En el nivel nacional, el grupo planea gastar  $40 millones en por lo menos ocho estados: Arizona, Georgia, Montana, New Hampshire, Nueva York, Carolina del Norte, Pennsylvania y Wisconsin.

En California, Planned Parenthood pretende poner de relieve los antecedentes de congresistas como Kiley, que votó a favor de imponer penas de prisión a los médicos que practicaran abortos.

Calvert, Kim, Steel y los representantes Mike García, del norte del condado de Los Ángeles, y David Valadao, del Valle Central, votaron en contra del acceso a los anticonceptivos. Y García, Valadao y Steel patrocinaron juntos un proyecto de ley para prohibir efectivamente los abortos en todo el país.

James Gallagher, líder republicano de la Asamblea, que forma parte de la junta del Partido Republicano de California, dijo que muchos californianos no confían en que los demócratas protejan sus derechos de salud, incluso si los líderes políticos apoyan que el aborto sea legal.

Gallagher señaló que bajo el mandato de los demócratas cerraron salas de maternidad y hospitales se han declarado en quiebra.

“En estos momentos, los demócratas no tienen un gran historial en California en lo que respecta a la atención médica de las mujeres”, afirma Gallagher. “Así que creo que suenan muy poco creíbles”.

Según una encuesta de KFF realizada en febrero sobre el aborto como una cuestión que incida en las elecciones de este año, cerca de la mitad de los votantes republicanos que apoyan que la interrupción del embarazo sea legal confían más en su propio partido sobre el tema, mientras que el 8% cree más en el Partido Demócrata. Uno de cada tres dijo que no confía en ninguno de los dos partidos políticos respecto de esta cuestión.

Ivy Cargile, profesora asociada de Ciencias Políticas en la Universidad Estatal de California en Bakersfield, consideró que puede ser difícil movilizar a los votantes sobre este tema, ya que muchos californianos consideran que sus derechos reproductivos se encuentran protegidos en este estado tan azul. “Los votantes podrían pensar que California es tan progresista que los derechos reproductivos están a salvo”, dijo Cargile. “Pero la ley federal prevalece sobre la estatal”.

Planned Parenthood intentará convencer a los votantes del Valle Central y del sur de California de que si permanecen leales a los candidatos republicanos corren el riesgo de que se prohíba el aborto en todo el país.

Planned Parenthood convencerá a los votantes del Valle Central y del Sur de California de que permaneciendo leal a los republicanos se corre el riesgo de una prohibición nacional del aborto.

Gran parte de su campaña publicitaria se centrará en conectar puntos para los votantes, argumentando que el apoyo a los derechos reproductivos requiere votar por candidatos demócratas.

“California es fundamental para garantizar que ganemos a nivel nacional”, explicó Hicks.

Gallagher dijo que la posición del Partido Republicano respecto de la inflación y de la seguridad pública tendrá impacto entre los votantes de los distritos más conservadores de California.

Tanto él como Calvert predicen que las elecciones reflejarán lo que sucedió en 2022: aunque los electores respaldaron la enmienda constitucional que garantiza la vigencia de los derechos reproductivos, apoyaron a los republicanos que estaban buscando la reelección, incluso a aquellos que se pronunciaron en contra del aborto.

KFF Health News habló con seis votantes en el distrito de García que dicen que apoyan el acceso al aborto, pero que normalmente votan por candidatos republicanos. Los seis planeaban votar por la reelección de García.

Rose Large, de Santa Clarita, dijo que si bien apoya el derecho al aborto, tiene preocupaciones más profundas con el liderazgo del Partido Demócrata en temas como la economía y el control fronterizo. Otros mencionaron el temor al aumento de la delincuencia y el deseo de proteger los derechos de la Segunda Enmienda.

Cuando se le preguntó si creía que la campaña de Planned Parenthood podría influir en ella o en los votantes de su vecindario, Large respondió: “Personalmente, no. No”.

Esta historia fue producida por KFF Health News, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

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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Planned Parenthood to Blitz GOP Seats, Betting Abortion Fears Can Sway Voters

Kaiser Health News:States - July 08, 2024

Planned Parenthood is preparing a seven-figure campaign blitz to oust GOP incumbents from California congressional seats, part of a larger national effort by the reproductive rights group to prevent a Republican majority from passing abortion restrictions, including a national ban.

Planned Parenthood Affiliates of California is targeting eight districts where voters largely backed Republicans in 2022 even as they endorsed a constitutional amendment enshrining access to abortion and contraceptives. The advertising plan goes negative by focusing on each incumbent’s record of voting against access to abortion and contraceptives. In the past, the group riffed on the “Burn Book” from the 2004 comedy “Mean Girls.”

GOP party officials said they were confident voters in those districts would look at the bigger picture and return Republicans to office. And one incumbent dismissed the notion that there’s a threat to reproductive care in the Golden State.

“Access to abortion and other reproductive care aren’t going anywhere in California,” said Calvin Moore, a spokesperson for Rep. Ken Calvert of Riverside County. “Congressman Calvert believes this is a deeply personal issue that should be left up to the states and opposes a national abortion ban.”

With 52 seats, liberal California could tip the scales for control of the U.S. House this fall. But Planned Parenthood has its work cut out for it since seven of the seats it is targeting are currently held by Republicans and only one — to be vacated by Democrat Katie Porter after an unsuccessful bid for U.S. Senate — is open.

According to The Cook Political Report, four are toss-up races; Rep. Michelle Steel’s district, mostly in Orange County, leans Republican; and Reps. Kevin Kiley, who represents a district along California’s eastern border, and Young Kim, who represents a district east of Anaheim, are likely to win.

Abortion has proved to be a bigger issue for many voters than political analysts may have anticipated. “In many of these seats, I think voters care about their reproductive freedoms and they resonate with our message, so we think we’re going to win,” said Jodi Hicks, CEO and president of Planned Parenthood Affiliates of California.

While Planned Parenthood is focused on House races, Hicks said it is also monitoring neighboring states. One California branch, Planned Parenthood Mar Monte, stretches into Reno, Nevada, and its advocacy arm has been actively supporting a Nevada ballot initiative that would constitutionally protect Nevadans’ right to abortion.

Nationally, the group plans to spend $40 million in at least eight states: Arizona, Georgia, Montana, New Hampshire, New York, North Carolina, Pennsylvania, and Wisconsin.

In California, Planned Parenthood aims to highlight the record of members of Congress like Kiley, who voted to potentially impose prison sentences on doctors who provide abortions. Calvert, Kim, Steel, and Reps. Mike Garcia, of northern Los Angeles County, and David Valadao, of the Central Valley, voted against access to birth control. And Garcia, Valadao, and Steel co-sponsored a bill to effectively ban abortions nationwide.

Assembly Republican leader James Gallagher, who is on the California Republican Party board, said many Californians don’t trust Democrats to protect their health care rights even if political leaders support abortion being legal, pointing out that under Democrats maternity wards have closed and hospitals have filed for bankruptcy.

“Democrats don’t really have a great record in California right now on women’s health care issues,” Gallagher said. “So I think it just rings a little bit hollow.”

According to a February KFF poll on abortion as a 2024 election issue, about half of Republican voters who support it being legal trust their own party more on the issue, while 8% trust the Democratic Party more. One in three said they don’t trust either political party on the issue.

Ivy Cargile, an associate professor of political science at California State University-Bakersfield, said it may be tricky to galvanize voters on the issue since many Californians are confident their reproductive rights are protected in the deep-blue state. “Voters might be thinking that California is so progressive, so reproductive rights are safe,” Cargile said. “But federal law does trump state law.”

Planned Parenthood will impress upon Central Valley and Southern California voters that remaining loyal to Republicans risks a national abortion ban. A large part of its advertising campaign will focus on connecting the dots for voters, arguing support for reproductive rights requires voting for Democratic candidates.

“California is so pivotal to ensure that we’re winning at the national level,” Hicks said.

Gallagher said the GOP’s focus on inflation and public safety will resonate with voters in California’s more conservative districts. He and Calvert predict the races will mirror what happened in 2022: Though voters backed the constitutional amendment for reproductive rights, they supported incumbent Republicans, even those who were anti-abortion.

California Healthline spoke to six voters in Garcia’s district who say they support access to abortion but typically vote for Republican candidates. All six planned to vote for Garcia’s reelection.

Rose Large of Santa Clarita said that while she supports abortion rights, she has deeper concerns with Democratic Party leadership on issues such as the economy and border control. Others mentioned fears of rising crime and wanting to protect Second Amendment rights.

Asked if she believed Planned Parenthood’s campaign would sway her or voters in her neighborhood, Large replied, “Personally, I don’t. No.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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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Falsa terapeuta engañó a cientos de pacientes en Internet, y solo se supo porque murió

Cientos de estadounidenses pueden haber recibido terapia, sin saberlo, de una impostora sin formación que se hizo pasar por terapeuta en sesiones por internet, posiblemente durante dos años. El engaño sólo se descubrió cuando murió, según registros de departamentos de salud estatales.

Peggy A. Randolph, trabajadora social con licencia en Florida y Tennessee, quien trabajaba para Brightside Health, una empresa nacional de terapia en línea, está acusada de ayudar a su esposa a hacerse pasar por ella en sesiones de internet, según el informe de una investigación del Departamento de Salud de Florida.

El informe de Florida indica que la pareja “estafaba” a los pacientes mediante un “esfuerzo coordinado”: mientras Randolph trataba a pacientes en persona, su esposa se hacía pasar por ella en sesiones de telesalud con pacientes de Brightside. El engaño se descubrió después que la esposa impostora muriera el año pasado, y un paciente se diera cuenta de que había estado hablando con la persona equivocada, según un acuerdo de conciliación del Departamento de Salud de Tennessee.

Los registros de ambos estados identifican a la esposa de Randolph sólo por sus iniciales, T.R., pero su nombre completo figura en su obituario: Tammy G. Heath-Randolph. Tradicionalmente, se espera que los terapeutas tengan al menos una maestría, pero la esposa de Randolph “no tenía licencia ni formación para prestar ningún tipo de servicios de consejería”, según revela el acuerdo de Tennessee.

Según consta en el acuerdo: “[Randolph] niega saber que T.R. estuviera utilizando sus credenciales de acceso al portal de terapeutas de Brightside Health o tratando a clientes con su cuenta. Sin embargo, [ella] recibió compensación por las sesiones realizadas”.

La presunta artimaña no había sido denunciada anteriormente y sus detalles y alcance salieron a la luz recientemente en las páginas de unos documentos públicos divulgadas por los agencias estatales.

El acuerdo de Tennessee, publicado en mayo, indica que Randolph debió haber proporcionado terapia en línea a “cientos de clientes” mientras trabajaba para Brightside Health desde enero de 2021 hasta febrero de 2023. Sin embargo, una investigación interna de Brightside descubrió que en realidad era Heath-Randolph quien “veía a todos los pacientes y lo estuvo haciendo durante mucho tiempo”, según el informe de la investigación de Florida.

Randolph declinó hacer comentarios.

Los registros de Florida y Tennessee dicen que Randolph renunció voluntariamente a sus licencias de trabajadora social en ambos estados. Esto dio lugar a que los departamentos de salud abandonaran sus investigaciones, lo que limitó los detalles del caso y los documentos disponibles en el registro público.

El informe de la investigación interna de Brightside no se ha divulgado.

Brightside Health, una empresa de San Francisco que ofrece sesiones de psiquiatría y terapia en línea en todo el país, declinó hacer ningún tipo de declaración por medio de una entrevista.

La vocera de la empresa, Hannah Changi, dijo en un correo electrónico que en cuanto Brightside se enteró de las acusaciones, hizo una auditoría de su seguridad, despidió a Randolph y la denunció ante las autoridades estatales que concede las licencias. Changi señaló que Brightside no puede decir cuántos pacientes fueron atendidos por la esposa de Randolph “debido a la naturaleza del incidente y los procedimientos legales en curso”, pero aseguró que la compañía notificó y reembolsó a todos los “pacientes potencialmente afectados”.

“Nos tomamos muy en serio la experiencia de nuestros pacientes y tenemos un elevado código ético de conducta”, dijo Changi. “Nos decepciona profundamente que uno de nuestros proveedores haya traicionado la confianza que Brightside y, más importante, sus pacientes habían depositado en ella”.

Además, Brightside se vio obligada a alertar al Departamento de Salud y Servicios Humanos de Estados Unidos, que investiga la filtración de datos que exponen información médica privada. En esta filtración, un “individuo no autorizado” accedió a la información de 767 personas, incluidos números de seguro social y diagnósticos, según la base de datos en línea de la agencia.

Ni las autoridades de salud de Florida ni las de Tennessee respondieron a las preguntas sobre el caso.

Dean Flener, vocero del Departamento de Salud de Tennessee, dijo que los detalles del caso de Randolph siguen siendo confidenciales en virtud de la ley estatal.

Jae Williams, vocero del Departamento de Salud de Florida, señaló que no se llevó a cabo una investigación completa porque Randolph renunció a su licencia, lo que tiene el mismo efecto que la revocación por parte del estado, pero le permitió conservar “la dignidad que le quedaba”.

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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FEMA and HHS Announce Resources and Tips to Address Extreme Heat Sweeping the Nation

HHS Gov News - July 03, 2024
The agencies are monitoring the risk of extreme heat and providing tips and resources for how to stay safe.

KFF Health News' 'What the Health?': SCOTUS Term Wraps With a Bang

Kaiser Health News:Medicaid - July 03, 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.

It was a busy year for health-related cases at the Supreme Court. Among other issues, the justices grappled with two abortion cases, a separate case touching on the opioid epidemic, and a case challenging whether localities can bar homeless people from sleeping in public spaces. Also, the court struck down a decades-old precedent that could dramatically change how the federal government oversees health care and other types of policy.

In this special episode of “What the Health?”, Sarah Somers, legal director of the National Health Law Program, joins KFF Health News’ chief Washington correspondent, Julie Rovner, to discuss how the justices disposed of the term’s health-related cases and what those decisions could mean going forward.

A Summary of the Cases

On the functioning of government:

Loper Bright Enterprises v. Raimondo, challenging the “Chevron doctrine” that required courts to defer in most cases to the expertise of federal agencies in interpreting laws passed by Congress.

Corner Post Inc. v. Board of Governors of the Federal Reserve System, challenging the statute of limitations for bringing a case against a federal agency’s actions.

On abortion:

Food and Drug Administration v. Alliance for Hippocratic Medicine, challenging the FDA’s approval of the abortion pill mifepristone.

Moyle v. United States and Idaho v. United States, about whether the federal Emergency Medical Treatment and Active Labor Act requirement that hospitals participating in Medicare provide the care needed to stabilize a patient’s condition overrides Idaho’s near-complete abortion ban when a pregnant patient experiences a medical emergency.

On other health issues:

Harrington v. Purdue Pharma, about whether federal bankruptcy law can shield an entity from future claims without the consent of all claimants.

City of Grants Pass v. Johnson, about whether banning sleeping in public subjects those with no other place to sleep to “cruel and unusual punishment” under the U.S. Constitution.

Previous “What the Health?” coverage of these cases:

click to open the transcript Transcript: SCOTUS Term Wraps With a Bang

KFF Health News’ ‘What the Health?’Episode Title: ‘SCOTUS Term Wraps With a Bang’Episode Number: 354Published: July 3, 2024

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.] 

Mila Atmos: The future of America is in your hands. This is not a movie trailer and it’s not a political ad, but it is a call to action. I’m Mila Atmos and I’m passionate about unlocking the power of everyday citizens. On our podcast “Future Hindsight,” we take big ideas about civic life and democracy and turn them into action items for you and me. Every Thursday we talk to bold activists and civic innovators to help you understand your power and your power to change the status quo. Find us @futurehindsight.com or wherever you listen to podcasts.

Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Tuesday, July 2, at 11 a.m. As always, news happens fast and things might have changed by the time you hear this, so here we go.

If you’re a regular listener, you’ll remember that the week of Memorial Day we did a roundup of the health policy-related Supreme Court cases whose decisions we expected to come in June. Well, now it’s the week of July Fourth, and we’re going to follow up and talk about how those cases got resolved. We are pleased to welcome back to the podcast Sarah Somers, legal director of the National Health Law Program. Last winter, Sarah helped us understand what was at stake in perhaps the most significant health-related case of the term. Sarah, welcome back to “What the Health?”

Sarah Somers: Hello, Julie. Thank you so much for having me.

Rovner: So let’s talk about the big kahuna first, or should I say the big herring? Tell us about the court’s decision in Loper Bright Enterprises v. Raimondo. Technically, this was a case about herring fishing and who should pay for government observers on fishing boats. But the reverberations from this will be felt all over the federal government, right?

Somers: Absolutely. This is yet another example of the kind of case that can sneak up out of nowhere for those of us who are interested in health policy, because it doesn’t have anything to do with health policy or our usual subjects. What this had to do with is a Department of Commerce regulation that required fishing boats to pay for observers to the extent to which they were fishing. And so this was something that normally would not concern us, but the parties introduced a much broader question, which is whether they should overturn a case called Chevron, which deals with the extent to which courts should defer to agency interpretations. Chevron was decided in 1984, and what it’s meant is that if a statute is clear, then a court needs to follow the statute. But if it’s ambiguous, then the court needs to defer to a reasonable interpretation by the administrative agency.

And so this is a particularly troubling case because the regulation at issue had been withdrawn and the fishermen involved in the case had been reimbursed for any fees that they’d paid. So this wasn’t really a live issue. And it just shows the extent to which the court was really eager to get to this question. Conservative lawyers and scholars and judges have had Chevron in their sights for a good while — and have been critical of it saying that it gives agencies too much power. Now, those of us who work in health policy think it actually gives the agencies an appropriate amount of power. The agencies are the ones who have the expertise, who have the time, and who have the official function of interpreting what a statute means. In the case, the work that we do, Medicaid is the statute that we’re most interested in. Medicaid, a notoriously hypertechnical and confusing statute, and just one of hundreds that agencies are interpreting all over the federal government.

What administrative agencies do touches on the lives of every American in so many ways: environmental, transportation, health, I could go on and on, but it’s all-encompassing. Yeah, the war on Chevron has finally culminated in this final battle, and now the court has ruled that the court doesn’t have to give particular deferences to agencies anymore. They can take a fresh look at everything and say, “I don’t care what you say, accountable experts, with all of your time and your know-how, we’re going to take a look at this and see if we agree or not. And if we don’t, then it’s a whole new day.”

Rovner: So what kind of health issues are we most concerned about here that we would now not necessarily be giving deference to the administrative agency?

Somers: I was thinking about this as falling into two categories. There are sort of the high-profile, more controversial, or ideological issues. Issues like bans on discrimination and treatment for LGBTQ people; protections for discrimination for people with disabilities; regulations that ensure access to services for people with limited English proficiency; anything to do with abortion; a lot of things to do with family planning. These are the kind of things that draw controversy and are always vulnerable to challenge. But then there’s a whole ’nother world of things that people don’t really think about, which is the complexities of how rates are determined for hospitals; how rates are determined for managed-care plans; how patient billing is conducted; all the myriad regulations that govern how hospitals function. And these are the kind of things that just grind along and keep the wheels of the health care industry turning. And what this does is it throws a lot of sand in those gears and sometimes can bring things to a halt.

And so it can influence these high-profile issues where people might be more vulnerable to discrimination, not have access to services in their language. But also the kind of invisible things that you don’t see — but you just know as a patient, as a provider that the works are being gummed up and it’s not working efficiently and quickly the way it’s supposed to.

Rovner: I’ve seen a few people write that they’re worried about agencies getting more timid in light of this. That they might be less inclined to regulate on things that they wouldn’t normally regulate about.

Somers: I think that’s absolutely true. And I already think the agencies are quite cautious because they’re always vulnerable to challenge under the Administrative Procedure Act. But this is just going to turn up the heat several notches and keep them out of areas that they really are very much needed, where their expertise and their experience is needed. I think that’s absolutely true. If you want to talk about the other decision that goes hand in hand with this one then …

Rovner: We’ll get there in a second, but before that, I’ve also seen commentary about the concern that this will give an advantage to businesses, or basically entities that have enough money to continue to go to court. Because those are the ones who’ll be able to file and complain about regulations. Whereas people who might be affected by other regulations will not have as much access to the courts.

Somers: Absolutely. This is a deep-pocket industry, and it’s just going to open the floodgates to more litigation for the well-resourced and connected among us — these big agencies, big corporations. It’s true that from the beneficiary side, or the patient side, you also may want to argue with an interpretation of a regulation, but it’s much less likely that you will have the resources and the time and really the knowledge to be able to do it. So the deck is really stacked in favor of industry after this.

Rovner: So one of the things that was in this decision or that [Chief] Justice [John] Roberts wrote was that this did not open the floodgates to go back and look at previous regulations. You couldn’t go backwards. I know that was a big concern. But there was another case that kind of said, “Well, maybe you can tell us about that other case.”

Somers: Yes. And let me just comment for a second on what Justice Roberts said, which is that, oh, this doesn’t mean that cases decided under Chevron aren’t good law anymore. In order to disrupt that you’d need some kind of special factors or special consideration. As Justice [Elena] Kagan pointed out, we don’t know what that would look like and anybody can come up with a special reason, an important reason it should be overturned. And it also, more importantly, forget the ones that are settled, the ones that have never been challenged because industry might’ve thought, well, it’s not worth it. Well, now it is worth it, right? And that bleeds to the next case, which is about Corner Post v. Board of Governors of [the] Federal Reserve [System]. And I will say, speaking for myself, this one snuck up on me a little bit. We’ve been watching Loper Bright for a long time. Our organization filed an amicus brief in the case.

The Corner Post kind of snuck up. And it’s about, once again something very far removed from health policy, about debit card fees that get passed on to merchants, and they hate it. And so two big industry groups came after this regulation, saying even though the statute of limitations had passed, we’re challenging it. Normally it’s six years after a regulation is final you have to challenge it. But they said that’s not fair, we didn’t even exist. And so now that we’re harmed by it, we should be able to challenge it. And sure enough, six out of the three justices said, “Yeah, that’s right.” And so what that means is everybody can look around and take a fresh look at things that have been on the books seven years, 10 years, 20 years, who knows? Including as Justice [Ketanji Brown] Jackson pointed out, cases about drug approval like approving mifepristone, the drug that’s used in abortions. So it all just weaves together into a web that is going to tangle up health advocates, patients, providers, and it’s really scary.

Rovner: Well, let’s move on to the abortion cases. There were two this term. One of the two was challenging the FDA’s approval of the abortion pill mifepristone. The other was asking whether a federal law that requires hospitals to provide emergency stabilizing care for pregnant women and others — including potentially abortion — overrides Idaho’s near-total ban on the procedure. In both cases, the court avoided reaching the merit. So we don’t really know what the justices think or what they might’ve ruled, but let’s take them one at a time. Let’s talk about what happened with the abortion pill case. That was the one brought by a group of conservative health professionals in Texas.

Somers: Right. These providers, doctors, and dentists said that it violated their religious beliefs to have to have anything to do with abortion. And even though they were not going to ever prescribe it, they argued, What if somehow we had to be burdened by treating somebody who had taken this pill? Well, they didn’t actually have any evidence that that had happened. And so what the court said was, you actually don’t have a stake in this other than a political one. And we’re not here to get into political questions like that. That’s not what the courts are for. You have to have what’s called standing, meaning, what’s your stake in this? How are you going to be harmed? Which is absolutely true and kind of a mark in contrast to Loper Bright, where really was the standing of these groups that were suing. But anyway, what goes on here in this case is that the court said you don’t have standing, but that doesn’t mean nobody could have standing. Who knows?

And so, sure enough, the states are waiting in the wings to bring it up themselves and argue anew that they’re the ones who are being harmed by it. So it’s an undead kind of issue, and it’s almost certain to come back and haunt us.

Rovner: You already mentioned that drugmakers in general have been kind of freaked out by the idea of judges making scientific decisions that overrule the FDA. That could still happen, right?

Somers: Absolutely. And the FDA is barraged by lawsuits. They have so many fronts on which already they have to defend themselves. And in addition to agencies being timid, there long have been concerns about industry capture in different parts of the agency. And so there already are so many areas on which they’re vulnerable in trying to regulate drugs. This is just one new blow.

Rovner: So the other case, as I said, pits Idaho’s abortion ban against the Federal Emergency Medical Treatment and Active Labor Act, EMTALA. Remind us again what EMTALA is and how it could relate to abortion.

Somers: What EMTALA is is a very important federal law that says that hospitals have to provide necessary stabling treatment to people who arrive in an emergency medical condition. And this means not just treatment to save somebody’s life, but also to prevent any kind of serious impairment to bodily functions or great pain or serious dysfunction or other types of jeopardy. So what that meant is EMTALA is requiring hospitals in every state to provide certain kinds of treatment that are banned by Idaho’s abortion ban. For example, Idaho’s abortion ban says you can’t provide any kind of abortion care unless someone is at the verge of death. And so there are a lot of situations — and they’ve already been happening in Idaho, while this law has been in effect — where you might have devastation to your reproductive organs, you might be in horrible pain. The pregnancy isn’t viable and you’re suffering because of this law that is conflicting with EMTALA.

And so the argument is: Federal law is superior to state law, and federal law has to rule if there’s a conflict with state law. And so in this case, the district court in Idaho said, “Yeah, this violates EMTALA.” And the court ended up taking it away from the 9th Circuit Court of Appeals, the Supreme Court did, and lifting the stay. And now what that meant was that the law was in effect, pregnant people were suffering horribly, having to be airlifted out of the state. And what does the court do at the end of the day but come back and say, “Yeah, we shouldn’t have done that. We’re going to let this go back and they’re going to figure this out more fully.” And the stay is going to stay in effect. That’s all fine and good in Idaho, for now. But then you already have the 5th Circuit, which has similar laws that are in effect. And so those people down there and the doctors who are trying to treat them are still in limbo.

And that’s what Justice Jackson said in her dissent, which is like you’re just leaving all these people in the lurch and doctors don’t know what to do. They’re scared of getting prosecuted, and so you should have just decided this instead of saving it for another day. And the majority kind of gave a roadmap to the court of appeals like, here’s how you can show that this actually doesn’t conflict with EMTALA.

Rovner: Which, I mean, the general rule is that federal laws are supreme to conflicting state laws, right? That’s a kind of …

Somers: Exactly. Federal law preempts state law, and it shouldn’t be a hard question. It’s the kind of thing that 10 years ago, regardless of Dobbs [v. Jackson Women’s Health Organization] would not have been a closed question.

Rovner: And technically the court just kind of said, “Oops, we shouldn’t have taken this case, or at least we shouldn’t have taken it now.” I read that as being they could not come to an agreement that they were likely, like, split 3-3-3. Is that your reading, too?

Somers: That’s the speculation. We never really know what goes on behind those closed doors. But it did seem like a real punt and a throwing up of the hands like, well, we don’t know what to do. So we’re just going to call this whole thing off. It was interesting too, to see Justice Jackson along with Justice [Clarence] Thomas and [Samuel] Alito saying, “We should decide this.” But they wanted to decide it very differently. They wanted to just call the question once and for all, but that’s not what happened.

Rovner: In both of these abortion cases, if Donald Trump is returned to office, his administration could likely just do itself what the plaintiffs are seeking here, right?

Somers: Yeah. A federal law could be passed if Congress was all Republican and Trump was president. There are all kinds of things that they could do through this. They could try to amend EMTALA. Who knows the mischief they could get into, the policymakers?

Rovner: But even if Congress remains, or at least one house of Congress remains in Democratic hands, one presumes that the administration would be pushed to both alter its interpretation of EMTALA and perhaps revoke the approval of mifepristone. Those are both theoretical things that the administration could do, right?

Somers: Absolutely. There’s executive action that could endanger access to abortion. Of course legislative action. And then there are these legal issues looming in the courts that could just come back again.

Rovner: So none of these cases are over. The court in the past few weeks also ruled in a couple of cases I call health care-adjacent. In one, the justices overturned a bankruptcy settlement reached between state governments and families of people who died of opioid overdoses, and Purdue Pharma, the company that made OxyContin and lied about how addictive it was. What happened in this case? What was the Supreme Court doing in a bankruptcy case?

Somers: Yes, questions were raised about the settlement. This is a huge settlement, billions of dollars on behalf of all the people who died and suffered from addiction because of the drugs that were being prescribed at a time when people weren’t aware of how addictive they were. The majority said that the settlement was not adequate to protect debtors or even the creditors and other victims. And all this work had gone into, all this time to try to come up with the settlement, but the majority was saying, this just gets the defendants too much off the hook. They still have too much of themselves protected from bankruptcy and from debtors and from creditors.

Rovner: One of the terms of the settlement was that it would basically eliminate any future claims against the Sackler family, the people who own Purdue Pharma.

Somers: Exactly. It really arguably let them off the hook. But at the same time, the dissent in this case said, “Look, this has been so hard-fought. It’s been so difficult to get everybody on the same page. There’s so much money at stake. And some of these people are in really dire straits and they need the money now.” So it was a real trade-off between are you really letting the bad actors off the hook, and what do you take today so that you can get the most relief for people as quickly as possible? Definitely not something as a health advocate I thought I’d have to think about bankruptcy, but think about it I did.

Rovner: And it was not decided ideologically.

Somers: Not at all.

Rovner: It was a very odd breakdown of justices with liberals and conservatives on both sides.

Somers: Exactly. And you can see the liberal and conservative arguments on both. You know what I mean?

Rovner: Let’s put it this way, I was glad I wasn’t being asked to decide that case.

Somers: 100%, oh my gosh, yes.

Rovner: Finally, the court ruled in a case out of Grants Pass, Oregon, that cities can enforce bans against sleeping in public even if the sleepers have no homes and no other access to shelter. This is also kind of health care-adjacent but could have repercussions, right?

Somers: Yeah, it’s health care-adjacent in two senses. One is the arguments that the local governments were making, which is that having people camping in public places is a public health problem. There’s a lot of attendant problems that the local governments say they have to deal with that affect the health of the community. But it’s also an important health issue from the perspective of the people who are unhoused, who are forced to sleep in their cars or in public, because housing is one of the primary drivers of health. And we know there’s a horrible housing crisis in this country. It’s not just people who have limited income who can’t find housing. People at higher and higher income levels are struggling to find housing now. And so it just seemed like the ultimate cruelty to say to people, yes, we know you don’t have housing. We know it’s impossibly unaffordable. We know there’s a shortage. And the same time, too bad for you.

The underpinning of this decision is for years they had said it’s a cruel and unusual punishment under the Eighth Amendment to have criminal penalties against people because of their status. Like you can’t have criminal penalties for being an addict. You can’t have criminal penalties for someone being homeless. But what they split this hair and said, well, it’s not for being homeless it’s because they’re camping. And Justice [Sonia] Sotomayor in her dissent sort of said, “Oh, come on. That’s really a distinction without a difference.” And it’s the real concern on the part of Justice [Neil] Gorsuch — writing for the majority — was for the local governments and how hard this was on them and how difficult. And OK, but it’s really hard on the people who are going to be forced to stay awake or go to jail.

Rovner: And it’s not like a lot of these people can just move on. Many of them have jobs in the community. They just don’t pay enough for them to be able to afford housing.

Somers: They have jobs and they have families and their kids can be in school. There’s all kinds of reasons they want to stay there. And there was also discussion of, well, there really is shelter space but people don’t want to go because they don’t want to be forced to go to religious services, because they don’t want to be in a sober house. Well, I don’t know. That was subject to dispute in the record. But also there’s other reasons of safety and concern not going to shelters. And something that looks available on paper may not actually be available. So, it’s very cruel.

Rovner: To wrap up, which of these cases do you think is going to have the most lasting significance when it comes to health care?

Somers: That’s a really good question. Right now, because of the potential chaos it can unleash, I would say sort of the one-two punch of Loper Bright and Corner Post. It seems like that could be a real shock to the system and cause a real upheaval in administrative law. Sometimes these things don’t shake out as badly as we think they do. It may be that most judges who are faced with these cases that aren’t ideological may be like, “You know what? I do want to defer to the agency because I don’t know anything about the Two-Midnight Rule in Medicare. I don’t know anything about actuarial soundness and Medicaid managed care, so why don’t I let the agency do that?” But at least in the short term it’s going to be pretty disruptive.

Rovner: Yeah. And to be clear, the ruling didn’t say they can’t defer to the agency. The ruling just said they don’t have to defer to the agency.

Somers: Exactly. And Justice Roberts in his majority opinion cited a case called Skidmore [doctrine], which is a level of deference to the agency that’s like a step below Chevron [doctrine]. And it just says you need to give it respectful deference based on how reasonable it is. And sometimes in practice, Chevron and Skidmore may not look that different. And so I remain hopeful that courts will still show respectful deference to the civil servants who really know what’s going on.

Rovner: We shall keep an eye on it. Sarah Somers, thank you so much for this Supreme Court wrap-up.

Somers: Sure. I’m happy to do it.

Rovner: So, OK, that is our show for this holiday week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks as always to our technical guru, Francis Ying, and our editor, Emmarie Huetteman. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X, @jrovner. We will be back in your feed next week. Have a lovely holiday. And until then, be healthy.

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Two Rival Hospitals Want To Join Forces. Will Patients Lose?

In Terre Haute, Ind., two rival hospitals want to merge, a move that supporters say will save patients money and help people live longer.

But similar hospital consolidations in Tennessee, Virginia and North Carolina have resulted in government reports documenting diminished care.

In more than a dozen states, certificates of public advantage (COPAs) permit deals like the one on the table in Indiana, even though the Federal Trade Commission otherwise considers them illegal because they reduce competition. As a result, the FTC has warned states to avoid COPAs and the mergers they create.

In Terre Haute, state regulators will decide whether to allow Union Hospital to purchase the surrounding county’s only other acute care facility, Terre Haute Regional Hospital. The merger would be the first deal under the state’s 2021 COPA law. Aside from the FTC’s concerns about the anti-competitive nature of these deals, there’s another, potentially bigger question: Does allowing hospitals to combine forces improve patient care?

The largest COPA-created hospital system in the country, Tennessee-based Ballad Health, has reported that the time patients spend in its ERs in Virginia and Tennessee before being hospitalized has more than tripled, reaching nearly 11 hours, in the six years since that monopoly of 20 hospitals formed.

The FTC has been closely examining the effects mergers have on prices, quality and even employee wages. In 2019, the FTC ordered multiple insurers and COPA-created health systems, including Ballad, to turn over information. The FTC declined to provide an update on the status of its findings.

To mitigate the negative effects of a monopoly, merged hospitals typically agree to conditions imposed by state regulators. Still, Tennessee has awarded Ballad top marks even when certain quality metrics, including its ER speed, fall below its established benchmarks.

Ballad Health spokesperson Molly Luton said the system’s performance has improved since statistics were collected for its 2023 fiscal year, which ended June 30, 2023, and that ER wait times have shortened.

COPA arrangements have also led to fallout in nearby North Carolina. When the state repealed its 2015 COPA law, it removed state oversight of Asheville’s Mission Health system, which was required as part of the merger. That meant the local monopoly remained but none of the COPA’s conditions applied when a subsidiary of HCA Healthcare bought the system for $1.5 billion in 2019.

Last year, government inspectors found “deficiencies” at Mission Health that contributed to four patient deaths and posed an “immediate jeopardy” to patients’ health and safety, according to the 384-page federal inspection report.

North Carolina Attorney General Joshua Stein sued HCA’s subsidiary, alleging that the ER was “significantly degraded” and that the company did not maintain certain critical services, including oncology care, a violation of a purchase agreement Stein’s office negotiated because the company acquired a nonprofit.

HCA said it promptly addressed the issues found in the inspections and denied Stein’s allegations in its response to the ongoing lawsuit, arguing that it has expanded services. HCA also contended the agreement is silent about maintaining the quality of care.

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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