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KFF Health News' 'What the Health?': Abortion — Again — At the Supreme Court

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.

Some justices suggested the Supreme Court had said its piece on abortion law when it overturned Roe v. Wade in 2022. This term, however, the court has agreed to review another abortion case. At issue is whether a federal law requiring emergency care in hospitals overrides Idaho’s near-total abortion ban. A decision is expected by summer.

Meanwhile, the Centers for Medicare & Medicaid finalized the first-ever minimum staffing requirements for nursing homes participating in the programs. But the industry argues that there are not enough workers to hire to meet the standards.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins University’s nursing and public health schools and Politico Magazine, Tami Luhby of CNN, and Alice Miranda Ollstein of Politico.

Panelists Joanne Kenen Johns Hopkins University and Politico @JoanneKenen Read Joanne's articles. Tami Luhby CNN @Luhby Read Tami's stories. Alice Miranda Ollstein Politico @AliceOllstein Read Alice's stories.

Among the takeaways from this week’s episode:

  • This week’s Supreme Court hearing on emergency abortion care in Idaho was the first challenge to a state’s abortion ban since the overturn of the constitutional right to an abortion. Unlike previous abortion cases, this one focused on the everyday impacts of bans on abortion care — cases in which pregnant patients experienced medical emergencies.
  • Establishment medical groups and doctors themselves are getting more vocal and active as states set laws on abortion access. In a departure from earlier political moments, some major medical groups are campaigning on state ballot measures.
  • Medicaid officials this week finalized new rules intended to more closely regulate managed-care plans that enroll Medicaid patients. The rules are intended to ensure, among other things, that patients have prompt access to needed primary care doctors and specialists.
  • Also this week, the Federal Trade Commission voted to ban most “noncompete” clauses in employment contracts. Such language has become common in health care and prevents not just doctors but other health workers from changing jobs — often forcing those workers to move or commute to leave a position. Business interests are already suing to block the new rules, claiming they would be too expensive and risk the loss of proprietary information to competitors.
  • The fallout from the cyberattack of Change Healthcare continues, as yet another group is demanding ransom from UnitedHealth Group, Change’s owner. UnitedHealth said in a statement this week that the records of “a substantial portion of America” may be involved in the breach.

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

Julie Rovner: NBC News’ “Women Are Less Likely To Die When Treated by Female Doctors, Study Suggests,” by Liz Szabo.  

Alice Miranda Ollstein: States Newsroom’s “Loss of Federal Protection in Idaho Spurs Pregnant Patients To Plan for Emergency Air Transport,” by Kelcie Moseley-Morris.  

Tami Luhby: The Associated Press’ “Mississippi Lawmakers Haggle Over Possible Medicaid Expansion as Their Legislative Session Nears End,” by Emily Wagster Pettus.  

Joanne Kenen: States Newsroom’s “Missouri Prison Agency To Pay $60K for Sunshine Law Violations Over Inmate Death Records,” by Rudi Keller.  

Also mentioned on this week’s podcast:

Credits Francis Ying Audio producer Emmarie Huetteman Editor

To hear all our podcasts, click here.

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

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

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Medicare Stumbles Managing a Costly Problem — Chronic Illness

Kaiser Health News:Insurance - April 24, 2024

Nearly a decade ago, Medicare launched a program to help the two-thirds of beneficiaries with chronic conditions by paying their doctors an additional monthly fee to coordinate their care.

The strategy has largely failed to live up to its potential; only about 4 percent of potentially eligible beneficiaries in the traditional Medicare program are enrolled, according to a Mathematica analysis.

But thousands of physicians have boosted their pay by participating, and auxiliary for-profit businesses have sprung up to help doctors take advantage of the program. An analysis of federal data by my KFF Health News colleague Holly K. Hacker shows that about 4,500 physicians received at least $100,000 each in chronic care management pay in 2021.

“This program had potential to have a big impact,” said Kenneth Thorpe, an Emory University health policy professor and an expert on chronic diseases. “But I knew it was never going to work from the start because it was put together wrong.”

Centers for Medicare and Medicaid Services spokespeople didn’t respond to questions about the program’s low participation rate, and it’s not clear whether the agency will address the issue.

Under the CCM program, Medicare pays physicians to develop a patient care plan, coordinate treatment with specialists and regularly check in with beneficiaries. Doctors receive an average of $62 per patient per month for at least 20 minutes of work, according to companies in the business.

Without the program, providers often have little incentive to spend time coordinating care for their patients because they can’t bill Medicare for the work.

A host of factors limit participation in the program, according to Thorpe and other experts. Chief among them is that both doctors and patients must opt into participating.

Doctors may not have the capacity to regularly monitor patients outside office visits. Some also worry about meeting strict Medicare documentation requirements for reimbursement and are reluctant to ask patients to join a program that may require a monthly co-payment, if they don’t have a supplemental policy.

“This is very time-intensive and not something physicians are used to doing or have time to do,” Thorpe said.

There’s evidence that wider uptake could generate savings ― as well as happier patients. A federally funded study by Mathematica in 2017 found the CCM program saved Medicare about $888 per patient per year ― owing mostly to decreasing hospital care.

Carrie Lester, 73, looks forward to a phone call every Thursday from her doctors’ medical assistant, who asks how she’s doing and if she needs prescription refills. The assistant counsels her on dealing with anxiety and other health issues.

Lester credits the chats for keeping her out of the hospital and reducing the need for clinic visits to manage chronic conditions including depression, fibromyalgia and hypertension.

“Just knowing someone is going to check on me is comforting,” said Lester, who lives with her dogs, Sophie and Dolly, in Independence, Kan.

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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Tire Toxicity Faces Fresh Scrutiny After Salmon Die-Offs

Kaiser Health News:States - April 24, 2024

For decades, concerns about automobile pollution have focused on what comes out of the tailpipe. Now, researchers and regulators say, we need to pay more attention to toxic emissions from tires as vehicles roll down the road.

At the top of the list of worries is a chemical called 6PPD, which is added to rubber tires to help them last longer. When tires wear on pavement, 6PPD is released. It reacts with ozone to become a different chemical, 6PPD-q, which can be extremely toxic — so much so that it has been linked to repeated fish kills in Washington state.

The trouble with tires doesn’t stop there. Tires are made primarily of natural rubber and synthetic rubber, but they contain hundreds of other ingredients, often including steel and heavy metals such as copper, lead, cadmium, and zinc.

As car tires wear, the rubber disappears in particles, both bits that can be seen with the naked eye and microparticles. Testing by a British company, Emissions Analytics, found that a car’s tires emit 1 trillion ultrafine particles per kilometer driven — from 5 to 9 pounds of rubber per internal combustion car per year.

And what’s in those particles is a mystery, because tire ingredients are proprietary.

“You’ve got a chemical cocktail in these tires that no one really understands and is kept highly confidential by the tire manufacturers,” said Nick Molden, CEO of Emissions Analytics. “We struggle to think of another consumer product that is so prevalent in the world and used by virtually everyone, where there is so little known of what is in them.”

Regulators have only begun to address the toxic tire problem, though there has been some action on 6PPD.

The chemical was identified by a team of researchers, led by scientists at Washington State University and the University of Washington, who were trying to determine why coho salmon returning to Seattle-area creeks to spawn were dying in large numbers.

Working for the Washington Stormwater Center, the scientists tested some 2,000 substances to determine which one was causing the die-offs, and in 2020 they announced they’d found the culprit: 6PPD.

The Yurok Tribe in Northern California, along with two other West Coast Native American tribes, have petitioned the Environmental Protection Agency to prohibit the chemical. The EPA said it is considering new rules governing the chemical. “We could not sit idle while 6PPD kills the fish that sustain us,” said Joseph L. James, chairman of the Yurok Tribe, in a statement. “This lethal toxin has no place in any salmon-bearing watershed.”

California has begun taking steps to regulate the chemical, last year classifying tires containing it as a “priority product,” which requires manufacturers to search for and test substitutes.

“6PPD plays a crucial role in the safety of tires on California’s roads and, currently, there are no widely available safer alternatives,” said Karl Palmer, a deputy director at the state’s Department of Toxic Substances Control. “For this reason, our framework is ideally suited for identifying alternatives to 6PPD that ensure the continued safety of tires on California’s roads while protecting California’s fish populations and the communities that rely on them.”

The U.S. Tire Manufacturers Association says it has mobilized a consortium of 16 tire manufacturers to carry out an analysis of alternatives. Anne Forristall Luke, USTMA president and CEO, said it “will yield the most effective and exhaustive review possible of whether a safer alternative to 6PPD in tires currently exists.”

Molden, however, said there is a catch. “If they don’t investigate, they aren’t allowed to sell in the state of California,” he said. “If they investigate and don’t find an alternative, they can go on selling. They don’t have to find a substitute. And today there is no alternative to 6PPD.”

California is also studying a request by the California Stormwater Quality Association to classify tires containing zinc, a heavy metal, as a priority product, requiring manufacturers to search for an alternative. Zinc is used in the vulcanization process to increase the strength of the rubber.

When it comes to tire particles, though, there hasn’t been any action, even as the problem worsens with the proliferation of electric cars. Because of their quicker acceleration and greater torque, electric vehicles wear out tires faster and emit an estimated 20% more tire particles than the average gas-powered car.

A recent study in Southern California found tire and brake emissions in Anaheim accounted for 30% of PM2.5, a small-particulate air pollutant, while exhaust emissions accounted for 19%. Tests by Emissions Analytics have found that tires produce up to 2,000 times as much particle pollution by mass as tailpipes.

These particles end up in water and air and are often ingested. Ultrafine particles, even smaller than PM2.5, are also emitted by tires and can be inhaled and travel directly to the brain. New research suggests tire microparticles should be classified as a pollutant of “high concern.”

In a report issued last year, researchers at Imperial College London said the particles could affect the heart, lungs, and reproductive organs and cause cancer.

People who live or work along roadways, often low-income, are exposed to more of the toxic substances.

Tires are also a major source of microplastics. More than three-quarters of microplastics entering the ocean come from the synthetic rubber in tires, according to a report from the Pew Charitable Trusts and the British company Systemiq.

And there are still a great many unknowns in tire emissions, which can be especially complex to analyze because heat and pressure can transform tire ingredients into other compounds.

One outstanding research question is whether 6PPD-q affects people, and what health problems, if any, it could cause. A recent study published in Environmental Science & Technology Letters found high levels of the chemical in urine samples from a region of South China, with levels highest in pregnant women.

The discovery of 6PPD-q, Molden said, has sparked fresh interest in the health and environmental impacts of tires, and he expects an abundance of new research in the coming years. “The jigsaw pieces are coming together,” he said. “But it’s a thousand-piece jigsaw, not a 200-piece jigsaw.”

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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Neumáticos tóxicos están matando a los peces. ¿Qué pasa con los humanos?

Kaiser Health News:States - April 24, 2024

Durante décadas, las preocupaciones sobre la contaminación automovilística se han centrado en lo que sale del tubo de escape. Ahora, investigadores y reguladores dicen que se necesita prestar más atención a las emisiones tóxicas de los neumáticos mientras los vehículos circulan por las carreteras.

Y primero en la lista de preocupaciones se encuentra un producto químico llamado 6PPD, que se agrega a los neumáticos para que duren más tiempo. Cuando los neumáticos se van desgastando por el roce con el pavimento, liberan 6PPD.

Al entrar en contacto con el ozono, esta sustancia reacciona y se convierte en un producto químico diferente, el 6PPD-q, que puede ser extremadamente tóxico, tanto que se ha relacionado con muertes de peces en el estado de Washington.

Pero los problemas no terminan ahí.

Los neumáticos están hechos principalmente de goma natural y goma sintética, pero contienen cientos de otros ingredientes, que a menudo incluyen acero y metales pesados como cobre, plomo, cadmio y zinc.

A medida que los neumáticos se desgastan, la goma desaparece en partículas, tanto trozos que se pueden ver a simple vista como micropartículas. Las pruebas realizadas por una empresa británica, Emissions Analytics, encontraron que los neumáticos de un automóvil emiten 1,000 millones de partículas ultrafinas por kilómetro conducido: entre 5 y 9 libras de goma por automóvil de combustión interna por año.

Y lo que hay en esas partículas es un misterio, porque los ingredientes de los neumáticos son de propiedad exclusiva.

“Tienes un cóctel químico en estos neumáticos que nadie realmente entiende y que los fabricantes de neumáticos mantienen en secreto”, dijo Nick Molden, CEO de Emissions Analytics. “Nos resulta difícil pensar en otro producto de consumo tan prevalente en el mundo y utilizado prácticamente por todos, donde se sepa tan poco sobre lo que contiene”.

Los reguladores apenas han comenzado a abordar el problema de la toxicidad en los neumáticos, aunque ha habido algunas acciones sobre el 6PPD.

El producto químico fue identificado por un equipo de investigadores, dirigido por científicos de la Universidad Estatal de Washington y de la Universidad de Washington, que estaban tratando de determinar por qué estaban muriendo masivamente los salmones coho que regresaban a arroyos del área de Seattle para desovar.

Trabajando para el Washington Stormwater Center, los científicos probaron alrededor de 2,000 sustancias para determinar cuál estaba causando las muertes, y en 2020 anunciaron que habían encontrado al culpable: 6PPD.

La Tribu Yurok en el norte de California, junto con otras dos tribus nativas de la costa oeste, han pedido a la Agencia de Protección Ambiental (EPA) que prohíba el producto químico. La EPA dijo que está considerando nuevas normas que lo regulen.

“No podríamos quedarnos de brazos cruzados mientras el 6PPD mata a los peces que nos sostienen”, dijo Joseph L. James, presidente de la Tribu Yurok, en un comunicado. “Esta toxina letal no tiene lugar en ninguna cuenca salmonera”.

California ha comenzado a tomar medidas para regular el producto químico. El año pasado comenzó a calificar a los neumáticos que lo contienen como un “producto prioritario”, lo que requiere que los fabricantes busquen y prueben sustitutos.

“El 6PPD juega un papel crucial en la seguridad de los neumáticos en las carreteras de California y, actualmente, no hay alternativas más seguras ampliamente disponibles”, dijo Karl Palmer, subdirector del Departamento de Control de Sustancias Tóxicas del estado. “Por esta razón, nuestro marco es ideal para identificar alternativas al 6PPD que sigan garantizado la seguridad de los neumáticos en las carreteras de California, protegiendo al mismo tiempo las poblaciones de peces y las comunidades que dependen de ellas”.

La Asociación de Fabricantes de Neumáticos de EE.UU. (USTMA) dice que ha movilizado un consorcio de 16 fabricantes para llevar a cabo un análisis de alternativas. Anne Forristall Luke, presidenta y CEO de la USTMA, dijo que “proporcionará la revisión más efectiva y exhaustiva posible de si existe una alternativa más segura al 6PPD en los neumáticos”.

Sin embargo, Molden dijo que hay un inconveniente. “Si no investigan, no se les permite vender en el estado de California”, dijo. “Si investigan y no encuentran una alternativa, pueden seguir vendiendo. No tienen que encontrar un sustituto. Y hoy no hay alternativa al 6PPD”.

California también está estudiando una solicitud de la California Stormwater Quality Association para clasificar los neumáticos que contienen zinc, un metal pesado, como un producto prioritario, lo que requeriría que los fabricantes busquen una alternativa. El zinc se utiliza en el proceso de vulcanización para aumentar la resistencia del caucho.

Sin embargo, cuando se trata de partículas de neumáticos, no ha habido ninguna acción, incluso cuando el problema empeora con la proliferación de automóviles eléctricos. Debido a su aceleración más rápida, los vehículos eléctricos desgastan los neumáticos más rápido y emiten aproximadamente un 20% más de partículas que los de un automóvil de gasolina promedio.

Un estudio reciente en el sur de California encontró que las emisiones de neumáticos y frenos en Anaheim representaban el 30% de PM2.5, un contaminante atmosférico de partículas pequeñas, mientras que las emisiones de escape representaban el 19%.

Las pruebas realizadas por Emissions Analytics han encontrado que los neumáticos producen hasta 2,000 veces más contaminación por partículas en masa que los tubos de escape. Estas partículas acaban en el agua y el aire y a menudo se ingieren. Los neumáticos también emiten partículas ultrafinas, incluso más pequeñas que PM2.5, que pueden ser inhaladas y viajar directamente al cerebro.

Nuevas investigaciones sugieren que las micropartículas de neumáticos deberían ser clasificadas como un contaminante de “alta preocupación”. En un informe el año pasado, investigadores del Imperial College de Londres dijeron que las partículas podrían afectar al corazón, los pulmones y los órganos reproductivos, y causar cáncer.

Las personas que viven o trabajan junto a carreteras, muchas veces de bajos ingresos, están expuestas a más de estas sustancias tóxicas.

Los neumáticos también son una fuente importante de microplásticos. Más de tres cuartas partes de los microplásticos que llegan al océano provienen de la goma sintética de los neumáticos, según un informe del Pew Charitable Trusts y la empresa británica Systemiq.

Y todavía hay muchas incógnitas sobre las emisiones de neumáticos, que pueden ser especialmente complejas de analizar porque el calor y la presión pueden transformar los ingredientes del neumático en otros compuestos.

Una pregunta pendiente de investigación es si el 6PPD-q afecta a las personas y qué problemas de salud, si los hay, podría causar. Un estudio reciente publicado en Environmental Science & Technology Letters encontró altos niveles del producto químico en muestras de orina de una región del sur de China, con niveles más altos en mujeres embarazadas.

Molden dijo que el descubrimiento del 6PPD-q ha generado un nuevo interés en el impacto sanitario y ambiental de los neumáticos, y espera una gran cantidad de nuevas investigaciones en los próximos años. “Las piezas del rompecabezas se están armando”, dijo. “Pero es un rompecabezas de mil piezas, no de doscientas”.

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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En Montana, investigan una nueva y poderosa vacuna contra la tuberculosis

Kaiser Health News:States - April 23, 2024

Un equipo de investigadores de Montana está jugando un papel clave en el desarrollo de una vacuna más efectiva contra la tuberculosis, una enfermedad infecciosa que ha matado a más personas que ninguna otra.

La BCG (Bacille Calmette-Guérin), desarrollada en 1921, sigue siendo la única vacuna contra la tuberculosis (TB). Si bien tiene una eficacia del 40% al 80% en niños pequeños, su efectividad es muy baja en adolescentes y adultos, lo que impulsó un esfuerzo mundial para encontrar una vacuna que sea más potente.

El Centro de Medicina Translacional de la Universidad de Montana está llevando a cabo una iniciativa en este sentido. El Centro se especializa en mejorar y crear vacunas, agregando los que se denominan “adyuvantes novedosos”.

Un adyuvante es una sustancia que se incluye en la vacuna, por ejemplo moléculas grasas o sales de aluminio, y que potencia la respuesta inmunitaria. Los adyuvantes novedosos son los que aún no se han utilizado en humanos. Los científicos están comprobando que estos adyuvantes generan una inmunidad más fuerte, precisa y duradera que los antígenos, que solo crean anticuerpos.

Provocar respuestas específicas del sistema inmunológico, y profundizar y ampliar su efectividad con adyuvantes, es algo que se conoce como “vacunación de precisión”.

“No es una solución única para todos, no se trata de una vacuna única”, explicó Ofer Levy, profesor de Pediatría de la Universidad de Harvard y director del Programa de Vacunas de Precisión del Hospital Infantil de Boston. “Una vacuna puede funcionar de forma diferente en un recién nacido, un adulto mayor o en una persona de mediana edad”, agregó.

Una vacuna de precisión definitiva, según Levy, brindaría protección de por vida contra una enfermedad con un solo pinchazo. “Una protección de una sola dosis que fuera efectiva contra la gripe o contra el covid sería el Santo Grial”, enfatizó Levy.

Jay Evans dirige el Centro de la Universidad de Montana y, a la vez, es cofundador y director científico y de estrategias, de Inimmune, una empresa privada de biotecnología de Missoula. Evans contó que su equipo lleva 15 años trabajando en una vacuna contra la tuberculosis y que aún faltan cinco años para que ésta pueda distribuirse ampliamente. La asociación público-privada está desarrollando vacunas e intentando mejorar las existentes, afirmó.

En el Centro no ha pasado inadvertido que este trabajo de investigación y producción de vacunas de vanguardia se realiza en Montana, el estado que aprobó una de las leyes antivacunas más extremas del país en 2021, durante la pandemia.

La ley prohíbe a empresas y gobiernos dar un trato diferente a las personas que no estén vacunadas contra covid u otras enfermedades. De hecho, prohíbe a los empleadores públicos y privados que les exijan a los trabajadores que se vacunen contra covid o cualquier otra enfermedad. Un juez federal dictaminó después que la ley no puede aplicarse en entornos sanitarios, como hospitales y consultas médicas.

A mediados de marzo, el Instituto de Investigación Médica Bill y Melinda Gates anunció que había iniciado en siete países la tercera y última fase de los ensayos clínicos de la nueva vacuna contra la tuberculosis. Los ensayos tardarán unos cinco años en completarse. La investigación y la producción se están llevando a cabo en varios lugares, incluida una planta de fabricación en Hamilton, propiedad de GSK, un gigante farmacéutico.

Conocida como “la pandemia olvidada”, la tuberculosis, a pesar de que se puede prevenir y tratar, mata hasta a 1,6 millones de personas al año, la mayoría en zonas empobrecidas de Asia y África.

En Estados Unidos se ha producido un aumento de esta enfermendad en la última década. Muchos inmigrantes tienen TB sin saberlo; en 2022 el número de casos aumentó un 16%. La tuberculosis es la principal causa de muerte entre las personas que viven con VIH, cuyo riesgo de contraer esta enfermedad es 20 veces mayor que el de las personas sin el virus.

“La tuberculosis es un patógeno complejo que ha acompañado a los seres humanos durante siglos”, dijo Alemnew Dagnew, que dirige el programa para la nueva vacuna en el Instituto de Investigación Médica Gates. “Debido a esta situación, ha evolucionado y ha podido desarrollar mecanismos para evadir al sistema inmunológico. Y la inmunología de la TB aún no se comprende completamente”.

En conjunto, el Centro de Medicina Translacional de la Universidad de Montana e Inimmune tienen 80 empleados especializados en la investigación de una variedad de adyuvantes con el propósito de comprender los detalles de las respuestas inmunitarias a diferentes sustancias. “Hay que adaptarlos al patógeno contra el que se vacuna, como si fueran un instrumento en una caja de herramientas”, dijo Evans. “Tenemos toda una biblioteca de moléculas y formulaciones de adyuvantes”.

Las vacunas se vuelven en gran medida más precisas mediante el uso de adyuvantes. Hay tres tipos básicos de adyuvantes naturales: sales de aluminio; escualeno, que se obtiene del hígado de tiburón; y algunos tipos de saponinas, que son moléculas grasas. No se sabe muy bien cómo estimulan el sistema inmunitario. El Centro de Missoula también ha creado y patentado un adyuvante sintético, el UM-1098, que induce un tipo específico de respuesta inmunitaria y que se añadirá a las nuevas vacunas.

Una de las moléculas más prometedoras que se están utilizando para potenciar la respuesta del sistema inmunológico a las vacunas es una molécula de saponina de la corteza del árbol de quillay, recolectada en Chile de árboles que tienen por lo menos una década.

Estas moléculas fueron utilizadas por Novavax en su vacuna contra covid y por GSK en Shingrix, su vacuna contra la culebrilla (shingles), de uso generalizado. Estas moléculas también son un componente clave en la nueva vacuna contra la tuberculosis, conocida como la vacuna M72.

Pero hay margen para mejorar.

“La vacuna muestra una eficacia del 50%, lo que no parece mucho, pero como actualmente se carece de otra vacuna más efectiva, el 50% es bastante mejor que lo que hay”, sostuvo Evans. “Buscamos aprovechar lo que aprendimos de ese desarrollo de la vacuna con adyuvantes adicionales para tratar de mejorarla y llevar ese índice desde el 50% hasta el 80% o más”.

Las vacunas contra el sarampión, en cambio, han alcanzado una efectividad del 95%.

Según el sitio web Medscape, en este momento se están desarrollando alrededor de 15 vacunas que son candidatas a reemplazar la BCG, y tres de ellas se encuentran en la fase 3 de ensayos clínicos.

Una alternativa que el Centro de Evans está investigando para mejorar la eficacia de la nueva vacuna es tomar una parte de la bacteria que causa la tuberculosis, sintetizarla y combinarla con el adyuvante QS-21, elaborado a partir del árbol de quillay. “Estimula el sistema inmunológico de una manera específica para la tuberculosis y genera una respuesta inmune que se acerca aún más a lo que obtenemos de las infecciones naturales”, dijo Evans.

Por su parte, el Centro de la Universidad de Montana está investigando el tratamiento de varias afecciones que generalmente no se consideran susceptibles de ser abordadas mediante vacunación. Por ejemplo, están ingresando en la primera fase de ensayos clínicos para una vacuna contra las alergias y para otra, contra el cáncer.

Avanzado este año, comenzarán los ensayos clínicos para obtener vacunas capaces de bloquear los efectos de opioides como la heroína y el fentanilo. La Universidad de Montana recibió la mayor subvención de su historia, $33 millones, para investigar una vacuna contra los opioides. Funciona creando un anticuerpo que se une a la droga en el torrente sanguíneo, evitando que entre al cerebro y produzca el efecto de euforia.

Por ahora, sin embargo, los expertos en salud de todo el mundo tienen sus ojos puestos en los ensayos de las nuevas vacunas contra la tuberculosis, que, si tienen éxito, podrían ayudar a salvar innumerables vidas en las regiones más pobres del mundo.

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 Finalizes Rule to Strengthen Services and Protections for Unaccompanied Children in Its Care

HHS Gov News - April 23, 2024
Services and Protections for Unaccompanied Children in Its Care

FTC Chief Says Tech Advancements Risk Health Care Price Fixing

New technologies are making it easier for companies to fix prices and discriminate against individual consumers, the Biden administration’s top consumer watchdog said Tuesday.

Algorithms make it possible for companies to fix prices without explicitly coordinating with one another, posing a new test for regulators policing the market, said Lina Khan, chair of the Federal Trade Commission, during a media event hosted by KFF.

“I think we could be entering a somewhat novel era of pricing,” Khan told reporters.

Khan is regarded as one of the most aggressive antitrust regulators in recent U.S. history, and she has paid particular attention to the harm that technological advances can pose to consumers. Antitrust regulators at the FTC and the Justice Department set a record for merger challenges in the fiscal year that ended Sept. 30, 2022, according to Bloomberg News.

Last year, the FTC successfully blocked biotech company Illumina’s over $7 billion acquisition of cancer-screening company Grail. The FTC, Justice Department, and Health and Human Services Department launched a website on April 18, healthycompetition.gov, to make it easier for people to report suspected anticompetitive behavior in the health care industry.

The American Hospital Association, the industry’s largest trade group, has often criticized the Biden administration’s approach to antitrust enforcement. In comments in September on proposed guidance the FTC and Justice Department published for companies, the AHA said that “the guidelines reflect a fundamental hostility to mergers.”

Price fixing removes competition from the market and generally makes goods and services more expensive. The agency has argued in court filings that price fixing “is still illegal even if you are achieving it through an algorithm,” Khan said. “There’s no kind of algorithmic exemption to the antitrust laws.”

By simply using the same algorithms to set prices, companies can effectively charge the same “even if they’re not, you know, getting in a back room and kind of shaking hands and setting a price,” Khan said, using the example of residential property managers.

Khan said the commission is also scrutinizing the use of artificial intelligence and algorithms to set prices for individual consumers “based on all of this particular behavioral data about you: the websites you visited, you know, who you had lunch with, where you live.”

And as health care companies change the way they structure their businesses to maximize profits, the FTC is changing the way it analyzes behavior that could hurt consumers, Khan said.

Hiring people who can “help us look under the hood” of some inscrutable algorithms was a priority, Khan said. She said it’s already paid off in the form of legal actions “that are only possible because we had technologists on the team helping us figure out what are these algorithms doing.”

Traditionally, the FTC has policed health care by challenging local or regional hospital mergers that have the potential to reduce competition and raise prices. But consolidation in health care has evolved, Khan said.

Mergers of systems that don’t overlap geographically are increasing, she said. In addition, hospitals now often buy doctor practices, while pharmacy benefit managers start their own insurance companies or mail-order pharmacies — or vice versa — pursuing “vertical integration” that can hurt consumers, she said.

The FTC is hearing increasing complaints “about how these firms are using their monopoly power” and “exercising it in ways that’s resulting in higher prices for patients, less service, as well as worse conditions for health care workers,” Khan said.

Policing Noncompetes

Khan said she was surprised at how many health care workers responded to the commission’s recent proposal to ban “noncompete” clauses — agreements that can prevent employees from moving to new jobs. The FTC issued its final rule banning the practice on Tuesday. She said the ban was aimed at low-wage industries like fast food but that many of the comments in favor of the FTC’s plan came from health professions.

Health workers say noncompete agreements are “both personally devastating and also impeded patient care,” Khan said.

In some cases, doctors wrote that their patients “got really upset because they wanted to stick with me, but my hospital was saying I couldn’t,” Khan said. Some doctors ended up commuting long distances to prevent the rest of their families from having to move after they changed jobs, she said.

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

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Para frenar las muertes por fentanilo, reparten kits para revertir las sobredosis puerta por puerta

Kaiser Health News:States - April 23, 2024

En una estrecha calle de townhouses y un taller mecánico en el vecindario Kensington, en el norte de Philadelphia, Marsella Elie subió los escalones y golpeó fuerte las puertas de las casas.

Un hombre de mediana edad abrió, con mirada cautelosa.

“Hola, señor, ¿cómo está hoy?”, le preguntó Elie, que tenía puesta una chaqueta con el logo de la Campana de la Libertad, del gobierno de la ciudad. “Mi nombre es Marsella. Estoy trabajando con la ciudad. ¿Ha oído hablar de las sobredosis que están ocurriendo en el vecindario, verdad?”.

El hombre asintió. Elie señaló los folletos que tenía sobre sobredosis de drogas y programas de tratamiento para la adicción. Levantó una caja de Narcan, una marca de naloxona, que puede revertir una sobredosis de opioides.

“Lo que estamos tratando de hacer es que esto llegue a todos los hogares. ¿Alguna vez ha oído hablar de esto antes?”, preguntó Elie antes de entregarle al hombre una bolsa de tela llena de folletos, tiras de prueba de fentanilo y la caja de Narcan.

Elie y otros trabajadores de medio tiempo de la ciudad y voluntarios forman parte de una campaña puerta a puerta a gran escala en Philadelphia que tiene como objetivo equipar los hogares con naloxona y otros suministros para prevenir sobredosis de drogas.

Los funcionarios de la ciudad esperan que este enfoque proactivo transforme a la naloxona en un artículo que esté en los botiquines, para evitar que las personas mueran por sobredosis, especialmente los residentes negros.

En Philadelphia, en 2022, según datos de la ciudad, un récord de 1,413 personas murieron por sobredosis de drogas. Entre los residentes negros, las muertes aumentaron un 20% respecto al año anterior, y muchas ocurrieron en casas.

“Lo mejor que podemos hacer para que estos productos sean más accesibles es simplemente dárselos a las personas”, dijo Keli McLoyd, subdirectora de la Unidad de Respuesta a Opioides de la ciudad, hablando sobre la bolsa de tela con naloxona y otros suministros.

“No le estamos preguntando si está usando drogas. El objetivo aquí es realmente construir una responsabilidad colectiva. Como personas de comunidades minoritarias, como vimos durante la epidemia de covid, nadie viene a salvarnos. Para nosotros, esta es una herramienta que podemos usar para salvarnos a nosotros mismos”.

Esta iniciativa de distribución tiene como objetivo llevar suministros de prevención directamente a personas que de otro modo no los buscarían por sí mismas, y concientizar sobre las sobredosis más allá de Kensington, el epicentro de la epidemia de adicción de la ciudad.

Los encuestadores planean golpear más de 100,000 puertas en los “puntos calientes” de Philadelphia, códigos postales con tasas crecientes de sobredosis de opioides, muchos en comunidades minoritarias.

El aumento de las disparidades raciales en las muertes por sobredosis es una de las consecuencias a largo plazo de la guerra contra las drogas, dijo McLoyd. Las políticas de esa campaña nacional llevaron a décadas de tácticas policiales agresivas, perfil racial y largas condenas de prisión, afectando de manera desproporcionada a personas de color y a sus comunidades.

La investigación muestra que los afroamericanos siguen representando un número desproporcionado de arrestos por drogas y servicios de protección infantil.

“Por eso, está muy claro por qué las personas de minorías podrían ser reacias a levantar la mano y decir: ‘Soy una persona que usa drogas, necesito esos recursos'”, dijo McLoyd.

Otras comunidades han distribuido naloxona y otros suministros, aunque en menor escala que Philadelphia. Lo que está haciendo Philadelphia podría convertirse en un modelo para otros lugares densamente poblados, dijo Daliah Heller, vicepresidenta de iniciativas sobre el uso de drogas en Vital Strategies, una organización de salud pública que trabaja con gobiernos locales en siete estados para abordar la epidemia de opioides.

“Hay algo intensamente personal en un compromiso humano”, dijo Heller. “Y que alguien toque a tu puerta para hablar sobre el uso de drogas y el riesgo de sobredosis y que haya algo que se pueda hacer, creo que es realmente poderoso”.

A lo largo de los años, la naloxona se ha vuelto más accesible que nunca, apuntó Heller. Ahora se puede pedir por internet y se puede recibir por correo, está disponible en máquinas expendedoras especializadas y algunas farmacias ahora venden el spray nasal de Narcan sin receta.

Pero decenas de miles de estadounidenses siguen muriendo por sobredosis de opioides cada año.

Eso significa que los esfuerzos de prevención y los mensajes sobre la crisis aún no llegan a algunas personas, dijo Heller. Y para Heller, llegar a las personas significa ir donde están. “Tenemos que pensar así cuando pensamos en la distribución de naloxona”.

El proyecto de divulgación en Philadelphia está financiado en parte por los pagos de acuerdos de demandas nacionales contra fabricantes y distribuidores de opioides, parte de los cuales recibió la ciudad.

Se espera que la ciudad reciba alrededor de $200 millones en aproximadamente 18 años de acuerdos con AmerisourceBergen, Cardinal Health, McKesson y Johnson & Johnson.

De la iniciativa forman parte muchas de las mismas personas que comenzaron a hacer divulgación como parte del censo de 2020.

No todos responden a la puerta. Algunos no están en casa. En esos casos, los trabajadores dejan un volante en el picaporte de la puerta que ofrece información sobre los riesgos de las sobredosis, y contactos para obtener más recursos.

Los equipos de encuestadores, a menudo con intérpretes de idiomas, hacen una segunda ronda de visitas en el vecindario para llegar a las personas que no vieron la primera vez.

En un jueves reciente, los encuestadores de Philadelphia estaban tocando puertas en los vecindarios de Franklinville y Hunting Park. Según datos de la ciudad, en este código postal, aproximadamente 85 personas murieron por sobredosis de drogas en 2022. Eso es menos que las 193 personas que murieron por sobredosis en Kensington el mismo año, pero mucho más que las pocas muertes vistas en los vecindarios más ricos de la ciudad.

Los encuestadores se acercaron a una residente, Katherine Camacho, en la acera, cuando salía de su garage. Camacho les dijo que estaba al tanto del problema de las sobredosis en su comunidad y luego aceptó con entusiasmo una caja de Narcan. “Voy a llevar esto conmigo, porque, como dije, a veces estás en la calle conduciendo a algún lugar y podrías salvar una vida”, les dijo Camacho.

En cuanto al esfuerzo de divulgación de Philadelphia, Camacho dijo que cree que “Dios está poniendo a estas personas para ayudar”. Mientras entraba en su casa llevando la caja de Narcan, agregó que quería hacer su parte para ayudar.

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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Unsheltered People Are Losing Medicaid in Redetermination Mix-Ups

Kaiser Health News:Insurance - April 23, 2024

KALISPELL, Mont. — On a cold February morning at the Flathead Warming Center, Tashya Evans waited for help with her Medicaid application as others at the shelter got ready for the day in this northwestern Montana city.

Evans said she lost Medicaid coverage in September because she hadn’t received paperwork after moving from Great Falls, Montana. She has had to forgo the blood pressure medication she can no longer pay for since losing coverage. She has also had to put off needed dental work.

“The teeth broke off. My gums hurt. There’s some times where I’m not feeling good, I don’t want to eat,” she said.

Evans is one of about 130,000 Montanans who have lost Medicaid coverage as the state reevaluates everyone’s eligibility following a pause in disenrollments during the covid-19 pandemic. About two-thirds of those who were kicked off state Medicaid rolls lost coverage for technical reasons, such as incorrectly filling out paperwork. That’s one of the highest procedural disenrollment rates in the nation, according to a KFF analysis.

Even unsheltered people like Evans are losing their coverage, despite state officials saying they would automatically renew people who should still qualify by using Social Security and disability data.

As other guests filtered out of the shelter that February morning, Evans sat down in a spare office with an application counselor from Greater Valley Health Clinic, which serves much of the homeless population here, and recounted her struggle to reenroll.

She said that she had asked for help at the state public assistance office, but that the staff didn’t have time to answer her questions about which forms she needed to fill out or to walk her through the paperwork. She tried the state’s help line, but couldn’t get through.

“You just get to the point where you’re like, ‘I’m frustrated right now. I just have other things that are more important, and let’s not deal with it,’” she said.

Evans has a job and spends her free time finding a place to sleep since she doesn’t have housing. Waiting on the phone most of the day isn’t feasible.

There’s no public data on how many unhoused people in Montana or nationwide have lost Medicaid, but homeless service providers and experts say it’s a big problem.

Those assisting unsheltered people who have lost coverage say they spend much of their time helping people contact the Montana Medicaid office. Sorting through paperwork mistakes is also a headache, said Crystal Baker, a case manager at HRDC, a homeless shelter in Bozeman.

“We’re getting mail that’s like, ‘Oh, this needs to be turned in by this date,’ and that’s already two weeks past. So, now we have to start the process all over again,” she said. “Now, they have to wait two to three months without insurance.”

Montana health officials told NPR and KFF Health News in a statement that they provided training to help homeless service agencies prepare their clients for redetermination.

Federal health officials have warned Montana and some other conservative states against disenrolling high rates of people for technicalities, also known as procedural disenrollment. They also warned states about unreasonable barriers to accessing help, such as long hold times on help lines. The Centers for Medicare & Medicaid Services said if states don’t reduce the rate of procedural disenrollments, the agency could force them to halt their redetermination process altogether. So far, CMS hasn’t taken that step.

Charlie Brereton, the director of the Montana health department, resisted calls from Democratic state lawmakers to pause the redetermination process. Redetermination ended in January, four months ahead of the federal deadline.

“I’m confident in our redetermination process,” Brereton told lawmakers in December. “I do believe that many of the Medicaid members who’ve been disenrolled were disenrolled correctly.

Health industry observers say that both liberal-leaning and conservative-leaning states are kicking homeless people off their rolls and that the redetermination process has been chaotic everywhere. Because of the barriers that unsheltered people face, it’s easy for them to fall through the cracks.

Margot Kushel, a physician and a homeless researcher at the University of California-San Francisco, said it may not seem like a big deal to fill out paperwork. But, she said, “put yourself in the position of an elder experiencing homelessness,” especially those without access to a computer, phone, or car.

If they still qualify, people can usually get their Medicaid coverage renewed — eventually — and it may reimburse patients retroactively for care received while they were unenrolled.

Kushel said being without Medicaid for any period can be particularly dangerous for people who are homeless. This population tends to have high rates of chronic health conditions.

“Being out of your asthma medicine for three days can be life-threatening. If you have high blood pressure and you suddenly stop your medicine, your blood pressure shoots up, and your risk of having a heart attack goes way up,” she said.

When people don’t understand why they’re losing coverage or how to get it back, that erodes their trust in the medical system, Kushel said.

Evans, the homeless woman, was able to get help with her application and is likely to regain coverage.

Agencies that serve unhoused people said it could take years to get everyone who lost coverage back on Medicaid. They worry that those who go without coverage will resort to using the emergency room rather than managing their health conditions proactively.

Baker, the case manager at the Bozeman shelter, set up several callbacks from the state Medicaid office for one client. The state needed to interview him to make sure he still qualified, but the state never called.

“He waited all day long. By the fifth time, it was so stressful for him, he just gave up,” she said.

That client ended up leaving the Bozeman area before Baker could convince him it was worth trying to regain Medicaid.

Baker worries his poor health will catch up with him before he decides to try again.

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

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

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California Legislators Debate Froot Loops and Free Condoms

Kaiser Health News:Insurance - April 23, 2024

SACRAMENTO, Calif. — California state lawmakers this year are continuing their progressive tilt on health policy with dozens of proposals including a ban on a Froot Loops ingredient and free condoms for high schoolers.

As states increasingly fracture along partisan lines, California Democrats are stamping their supermajority on legislation that they will consider until they adjourn at the end of August. But the cost of these proposals will be a major factor given the enormity of the state’s deficit, currently estimated at between $38 billion and $73 billion.

Health Coverage

Lawmakers are again considering whether to create a government-run, single-payer health care system for all Californians. AB 2200 is Democratic Assembly member Ash Kalra’s second such attempt, after a similar bill failed in 2022. The price tag would be enormous, though proponents say there would also be related savings. The high potential cost left Assembly Speaker Robert Rivas and others skeptical it could become law while the state faces a deficit.

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AB 4 would require Covered California, the state’s health insurance exchange, to offer health insurance policies to people who are otherwise not able to obtain coverage because of their immigration status, to the extent it can under federal law. That could eventually lead to subsidized insurance premiums similar to those offered in Colorado and Washington.

Medical Debt

Health care providers and collection agencies would be barred from sharing patients’ medical debt with credit reporting agencies under SB 1061. The bill would also prohibit credit reporting agencies from accepting, storing, or sharing any such information without consumer consent. Last year, the Biden administration announced plans to develop federal rules barring unpaid medical bills from affecting patients’ credit scores. California would be the third state to remove medical bills from consumer credit reports.

Medi-Cal

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The Medi-Cal program, which provides health care for low-income people, would be required to cover medically supportive food and nutrition starting July 1, 2026, under AB 1975. The bill builds on an existing but limited pilot program. The legislation says Californians of color could benefit from adequate food and nutrition to combat largely preventable chronic health conditions, and it’s one of 14 measures sought by the California Legislative Black Caucus as part of reparations for racial injustice.

More than 1.6 million California residents, disproportionately Latinos, have been kicked off Medi-Cal since the state resumed annual eligibility checks that were halted during the covid-19 pandemic. AB 2956 would have the state seek federal approval to slow those disenrollments by taking steps such as letting people 19 and older keep their coverage automatically for 12 months.

Violence Prevention

An increase in attacks on health workers is prompting lawmakers to consider boosting criminal penalties. In California, simple assault against workers inside an ER is considered the same as simple assault against almost anyone else, and carries a maximum punishment of a $1,000 fine and six months in jail. In contrast, simple assault against emergency medical workers in the field, such as an EMT responding to a 911 call, carries maximum penalties of a $2,000 fine and a year in jail. AB 977 would set the same maximum penalties for assaulting emergency health care workers on the job, whether they are in the field or an ER.

California could toughen penalties for interfering with reproductive health care services. Posting personal information or photographs of a patient or provider would be a felony if one of them is injured as a result. AB 2099 also boosts penalties for intimidation or obstruction.

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Under SB 53, gun owners would have to lock up their weapons in state-approved safes or lockboxes where they would be inaccessible to anyone but the owner or another lawfully authorized user. Democratic Sen. Anthony Portantino, the bill’s author, says that would make it tougher for anyone, including children, to use guns to harm themselves or others or use the weapons to commit crimes. Critics say it would make it harder to access the weapon when it’s needed, such as to counter a home invasion. Relatedly, AB 2621 and AB 2917 address gun violence restraining orders.

Substance Use

The spike in drug overdoses has prompted several responses: AB 3073 would require the state’s public health department to partner with local public health agencies, wastewater treatment facilities, and others to pilot wastewater testing for traces of dangerous drugs in an effort to pinpoint drug hot spots and identify new drugs. AB 1976 would require workplace first-aid kits to include naloxone nasal spray, which can reverse opioid overdoses. And senators have proposed at least nine bills aimed at curbing overdose deaths, particularly from the deadly synthetic opioid fentanyl.

Youth Welfare

Under AB 2229, backed by a “Know Your Period” campaign, school districts’ sex education curricula would have to include menstrual health. There was no registered opposition.

Public schools would have to make free condoms available to all pupils in grades nine to 12 under SB 954, which would help prevent unwanted pregnancies and sexually transmitted infections, according to the author, Democratic Sen. Caroline Menjivar. Democratic Gov. Gavin Newsom vetoed a similar bill last year.

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Reality show star Paris Hilton is backing a bipartisan bill to require more reporting on the treatment of youth in state-licensed short-term residential therapeutic programs. SB 1043 would require the state Department of Social Services to post information on the use of restraints and seclusion rooms on a public dashboard.

California would expand its regulation of hemp products, which have become increasingly popular among youths as a way to bypass the state’s adults-only restrictions on legal cannabis. AB 2223 would build on a 2021 law that Assembly member Cecilia Aguiar-Curry said in hindsight didn’t go far enough.

Public schools would, under AB 2316, generally be barred from providing food containing red dye 40, titanium dioxide, and other potentially harmful substances, which are currently used in products including Froot Loops and Flamin’ Hot Cheetos. It’s Democratic Assembly member Jesse Gabriel’s follow-up to his legislation last year that attempted to ban a chemical used in Skittles.

Women’s Health

AB 2515 would ban the sale of menstrual products with intentionally added PFAS, also known as “forever chemicals.” PFAS, short for perfluoroalkyl and polyfluoroalkyl substances, have been linked to serious health problems. Newsom vetoed a previous attempt.

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Public grade schools and community colleges would, under AB 2901, have to provide 14 weeks of paid leave for pregnancies, miscarriages, childbirth, termination of pregnancies, or recovery. Newsom vetoed a similar bill in 2019.

AB 2319 would improve enforcement of a 2019 law aimed at reducing the disproportionate rate of maternal mortality among Black women and other pregnant women of color.

Social Media

Social media companies could face substantial penalties if they don’t do enough to protect children, under AB 3172. The measure would allow financial damages of up to $1 million for each child under age 18 who proves in court they were harmed, or three times the amount of the child’s actual damages. The industry opposes the bill, calling it harmful censorship.

Cyberbullies could face civil liabilities up to $75,000 under SB 1504, and those damages could be sought by anyone. Under current law, damages are capped at $7,500 and may be pursued only by the state attorney general.

Wellness

Bosses could be fined for repeatedly contacting employees after working hours under AB 2751, a “right to disconnect” bill patterned after similar restrictions in 13 countries. The bill’s author, Democratic Assembly member Matt Haney, said despite the advent of smartphones that “have blurred the boundaries between work and home life,” employees shouldn’t be expected to work around the clock. The measure is opposed by the California Chamber of Commerce.

Finally, Democrat Anthony Rendon, a long-serving state Assembly speaker, is spending his last year in the chamber leading a first-in-the-nation Select Committee on Happiness and Public Policy Outcomes. The committee isn’t planning any legislation but intends to issue a report after lawmakers adjourn in August.

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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Biden Administration Sets Higher Staffing Mandates. Most Nursing Homes Don’t Meet Them.

The Biden administration finalized nursing home staffing rules Monday that will require thousands of them to hire more nurses and aides — while giving them years to do so.

The new rules from the Centers for Medicare & Medicaid Services are the most substantial changes to federal oversight of the nation’s roughly 15,000 nursing homes in more than three decades. But they are less stringent than what patient advocates said was needed to provide high-quality care.

Spurred by disproportionate deaths from covid-19 in long-term care facilities, the rules aim to address perennially sparse staffing that can be a root cause of missed diagnoses, severe bedsores, and frequent falls.

“For residents, this will mean more staff, which means fewer ER visits potentially, more independence,” Vice President Kamala Harris said while meeting with nursing home workers in La Crosse, Wisconsin. “For families, it’s going to mean peace of mind in terms of your loved one being taken care of.”

When the regulations are fully enacted, 4 in 5 homes will need to augment their payrolls, CMS estimated. But the new standards are likely to require slight if any improvements for many of the 1.2 million residents in facilities that are already quite close to or meet the minimum levels.

“Historically, this is a big deal, and we’re glad we have now established a floor,” Blanca Castro, California’s long-term care ombudsman, said in an interview. “From here we can go upward, recognizing there will be a lot of complaints about where we are going to get more people to fill these positions.”

The rules primarily address staffing levels for three types of nursing home workers. Registered nurses, or RNs, are the most skilled and responsible for guiding overall care and setting treatment plans. Licensed practical nurses, sometimes called licensed vocational nurses, work under the direction of RNs and perform routine medical care such as taking vital signs. Certified nursing assistants are supposed to be the most plentiful and help residents with daily activities like going to the bathroom, getting dressed, and eating.

While the industry has increased wages by 27% since February 2020, homes say they are still struggling to compete against better-paying work for nurses at hospitals and at retail shops and restaurants for aides. On average, nursing home RNs earn $40 an hour, licensed practical nurses make $31 an hour, and nursing assistants are paid $19 an hour, according to the most recent data from the Bureau of Labor Statistics.

CMS estimated the rules will ultimately cost $6 billion annually, but the plan omits any more payments from Medicare or Medicaid, the public insurers that cover most residents’ stays — meaning additional wages would have to come out of owners’ pockets or existing facility budgets.

The American Health Care Association, which represents the nursing home industry, called the regulation “an unreasonable standard” that “creates an impossible task for providers” amid a persistent worker shortage nationwide.

“This unfunded mandate doesn’t magically solve the nursing crisis,” the association’s CEO, Mark Parkinson, said in a statement. Parkinson said the industry will keep pressing Congress to overturn the regulation.

Richard Mollot, executive director of the Long Term Care Community Coalition, a New York City-based advocacy nonprofit, said “it is hard to call this a win for nursing home residents and families” given that the minimum levels were below what studies have found to be ideal.

The plan was welcomed by labor unions that represent nurses — and whom President Joe Biden is counting on for support in his reelection campaign. Service Employees International Union President Mary Kay Henry called it a “long-overdue sea change.” This political bond was underscored by the administration’s decision to have Harris announce the rule with SEIU members in Wisconsin, a swing state.

The new rules supplant the vague federal mandate that has been in place since the 1980s requiring nursing homes to have “sufficient” staffing to meet residents’ needs. In practice, inspectors rarely categorized inadequate staffing as a serious infraction resulting in possible penalties, federal records show.

Starting in two years, most homes must provide an average of at least 3.48 hours of daily care per resident. About 6 in 10 nursing homes are already operating at that level, a KFF analysis found.

The rules give homes breathing room before they must comply with more specific requirements. Within three years, most nursing homes will need to provide daily RN care of at least 0.55 hours per resident and 2.45 hours from aides.

CMS also mandated that within two years an RN must be on duty at all times in case of a patient crisis on weekends or overnight. Currently, CMS requires at least eight consecutive hours of RN presence each day and a licensed nurse of any level on duty around the clock. An inspector general report found that nearly a thousand nursing homes didn’t meet those basic requirements.

Nursing homes in rural areas will have longer to staff up. Within three years, they must meet the overall staffing numbers and the round-the-clock RN requirement. CMS’ rule said rural homes have four years to achieve the RN and nurse aide thresholds, although there was some confusion within CMS, as its press materials said rural homes would have five years.

Under the new rules, the average nursing home, which has around 100 residents, would need to have at least two RNs working each day, and at least 10 or 11 nurse aides, the administration said. Homes could meet the overall requirements through two more workers, who could be RNs, vocational nurses, or aides.

Homes can get a hardship exemption from the minimums if they are in regions with low populations of nurses or aides and demonstrate good-faith efforts to recruit.

Democrats praised the rules, though some said the administration did not go nearly far enough. Rep. Lloyd Doggett (D-Texas), the ranking member of the House Ways and Means Health Subcommittee, said the changes were “modest improvements” but that “much more is needed to ensure sufficient care and resident safety.” A Republican senator from Nebraska, Deb Fischer, said the rule would “devastate nursing homes across the country and worsen the staffing shortages we are already facing.”

Advocates for nursing home residents have been pressing CMS for years to adopt a higher standard than what it ultimately settled on. A CMS-commissioned study in 2001 found that the quality of care improved with increases of staff up to a level of 4.1 hours per resident per day — nearly a fifth higher than what CMS will require. The consultants CMS hired in preparing its new rules did not incorporate the earlier findings in their evaluation of options.

CMS said the levels it endorsed were more financially feasible for homes, but that assertion didn’t quiet the ongoing battle about how many people are willing to work in homes at current wages and how financially strained homes owners actually are.

“If states do not increase Medicaid payments to nursing homes, facilities are going to close,” said John Bowblis, an economics professor and research fellow with the Scripps Gerontology Center at Miami University. “There aren’t enough workers and there are shortages everywhere. When you have a 3% to 4% unemployment rate, where are you going to get people to work in nursing homes?”

Researchers, however, have been skeptical that all nursing homes are as broke as the industry claims or as their books show. A study published in March by the National Bureau of Economic Research estimated that 63% of profits were secretly siphoned to owners through inflated rents and other fees paid to other companies owned by the nursing homes’ investors.

Charlene Harrington, a professor emeritus at the nursing school of the University of California-San Francisco, said: “In their unchecked quest for profits, the nursing home industry has created its own problems by not paying adequate wages and benefits and setting heavy nursing workloads that cause neglect and harm to residents and create an unsatisfactory and stressful work environment.”

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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