Rebecca Grapevine, Healthbeat, Author at KFF Health News https://kffhealthnews.org Thu, 06 Feb 2025 10:06:15 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.2 https://kffhealthnews.org/wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Rebecca Grapevine, Healthbeat, Author at KFF Health News https://kffhealthnews.org 32 32 161476233 Biden Rule Cleared Hurdles to Lifesaving HIV Drug, but in Georgia Barriers Remain https://kffhealthnews.org/news/article/prep-hiv-drug-biden-rule-access-georgia-barriers-remain/ Thu, 06 Feb 2025 10:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1981428 ATLANTA — Latonia Wilkins knows she needs to be on PrEP due to her non-monogamous lifestyle. But the 52-year-old Atlanta mother has faced repeated challenges getting the lifesaving drug that can prevent new HIV infections.

Years ago, Wilkins was dating a man newly diagnosed with HIV and went to get tested, she said, but was not offered PrEP.

Since then, Wilkins said, doctors either have told her she doesn’t need the drug or were reluctant to prescribe it. Her insurance through work would not cover a long-acting injectable form that tends to have better results than the original pill form. Getting to appointments across Atlanta for the pills was a challenge. She is now enrolled in a drug trial for a promising PrEP injection but worries about future access and cost.

Preexposure prophylaxis, known as PrEP, reduces the risk of new HIV infections through sex by 99% and among injectable drug users by at least 74%, according to the Centers for Disease Control and Prevention.

Among states, Georgia has the highest rate of new HIV infections, but residents — especially women and Black patients like Wilkins — are often not getting PrEP, data shows.

A rule enacted by the Biden administration that took effect for many Affordable Care Act plans on Jan. 1 should make it easier for people like Wilkins to get long-acting PrEP injectable drugs.

A new Trump administration adds an X factor to this and other federal health programs. On Jan. 27, the White House announced a federal funding freeze, which sent shudders through health agencies and nonprofits. By Jan. 29, it had reversed the order.

Federal initiatives like the Ryan White HIV/AIDS Program and HIV prevention funding seemed to be affected — and “blocking access to PrEP would have deadly consequences,” said Wayne Turner, a senior attorney at the National Health Law Program.

Georgia has big racial and gender discrepancies in PrEP uptake, said Patrick Sullivan, who is an epidemiology professor at Emory University and leads AIDSVu and PrEPVu, which track HIV data and access to the drug — work that is backed by Gilead Sciences, a PrEP drug manufacturer.

Public health experts use what’s called a “PrEP-to-need ratio” to measure how many people at risk of HIV are getting the drug. A higher number is better. In Georgia for 2023, the statewide ratio was 6, while it was nearly 167 in Vermont, according to PrEPVu.

While the ratio for white people in Georgia was roughly 22, it was about 3 for Black people and just over 3 for Hispanic people. And while it was 7 for men, it was just over 2 for women.

“Black people generally are underserved by PrEP, and women are underserved by PrEP relative to men,” Sullivan said.

Increasing PrEP uptake would help the state cut its new HIV diagnoses, said Dylan Baker, associate medical director at Grady Health’s HIV Prevention Program.

Georgia’s rate of new HIV diagnoses was 27 per 100,000 in 2022, according to the most recent available data. That’s second only to Washington, D.C., and more than double the national rate of 13 per 100,000. That amounts to about 2,500 new cases diagnosed in Georgia in a year.

Globally about 3.5 million people used PrEP in 2023, up from 200,000 in 2017 but short of the United Nations’ 2025 target of 21.2 million people, according to a 2024 report by the United Nations Program on HIV/AIDS.

PrEP users in Atlanta report many challenges in getting the drug, including cost, medical providers who don’t prescribe it, stigma, a lack of inclusive marketing, and transportation. Wilkins said she has run up against all of those.

“Here I am telling you that I’m here to get tested because I have come into contact with someone who was living with HIV, and we had a sexual relationship, and you’re not even mentioning PrEP to me,” Wilkins said. “That was a disservice.”

Insurers Now Required To Cover PrEP

Cost has long been a barrier. The Biden administration last fall issued guidance requiring most insurers to cover the full cost of all forms of PrEP, without prior authorization, along with certain lab work and other services. This includes pills as well as Apretude, an injection given every two months.

That means insured PrEP users should not face out-of-pocket costs, said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, which lobbied for the rule.

It applies to those on the federal marketplace plans and most large private health plans. A similar rule exists for Medicare and Medicare Advantage plans.

Schmid said he does not think the Trump administration will repeal the rule, but he is concerned the U.S. Supreme Court could end coverage for preventive services, including PrEP, when it issues a decision in Braidwood Management v. Becerra, anticipated this summer.

The rule will not help the uninsured. In Georgia, which did not expand Medicaid under the ACA, about 1 million adults under age 65 are uninsured.

“The cost is also a struggle, especially given different people are part of the gig economy, a lot of folks don’t always have access to health insurance,” said Maximillian Boykin, an Atlanta PrEP user.

Expanding Medicaid would help. States that have done so, Sullivan said, “have higher levels of PrEP uptake.”

Winning the PrEP Lottery

Since getting on PrEP in 2019, Wilkins has encountered two doctors who did not want to prescribe it.

One female OB-GYN told her “‘Girl, at our age, we should know better.’” Wilkins said she “fired” that doctor, telling her that such comments are stigmatizing.

When Wilkins moved, she looked for a nearby primary care provider so she would not have to pay for transportation to get PrEP.

But the doctor she found, Wilkins said, told her to find an infectious disease specialist for PrEP.

“‘You’re not treating an infectious disease,’ I say. ‘This is preventive care,’” Wilkins recalled.

Wilkins’ fortunes turned when she was selected to join a study for a twice-yearly injectable form of PrEP.

Lenacapavir, already approved for HIV treatment, showed promising results for HIV prevention in two earlier Gilead trials. Wilkins is part of a trial in Atlanta including about 250 cisgender women nationally who have sex with men.

It’s much better than a daily pill or even a shot once every two months, Wilkins said.

She hopes to stay on the drug, but the U.S. list price for lenacapavir as an HIV treatment averages about $40,000 a year.

Gilead last year announced it signed royalty-free licensing agreements with six manufacturers to make generic lenacapavir for 120 primarily low- and lower-middle-income countries.

It’s not clear where it falls with the Biden rule. “We believe it should be covered,” Schmid said, “but want the federal government to state that clearly.”

For many patients, challenges remain. Most people are willing to travel about 30 minutes for routine health care, Sullivan said, but in cities like Atlanta, those relying on public transportation may face longer commutes to PrEP providers. Some who need PrEP have unstable housing without firm mailing addresses.

Privacy is another concern. “Everybody should be able to find a place that's comfortable,” Sullivan said. “More of that can go on in primary health care.”

Others agree that public health messaging around PrEP services should target more diverse audiences. Dázon Dixon Diallo is the founder of SisterLove, an HIV, sexual, and reproductive health organization focused on Black women in the Southeast.

“You’re not going to get to us by giving us a 3-second cameo in a commercial about PrEP,” she said. “There’s no story in there for me, right?”

Healthbeat is a nonprofit newsroom covering public health published by Civic News Company and KFF Health News. Sign up for its newsletters here.

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

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The New Covid Vaccine Is Out. Why You Might Not Want To Rush To Get It. https://kffhealthnews.org/news/article/new-covid-vaccine-shot-approved-fda-timing-mrna/ Mon, 26 Aug 2024 09:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1903143 The FDA has approved an updated covid shot for everyone 6 months old and up, which renews a now-annual quandary for Americans: Get the shot now, with the latest covid outbreak sweeping the country, or hold it in reserve for the winter wave?

The new vaccine should provide some protection to everyone. But many healthy people who have already been vaccinated or have immunity because they’ve been exposed to covid enough times may want to wait a few months.

Covid has become commonplace. For some, it’s a minor illness with few symptoms. Others are laid up with fever, cough, and fatigue for days or weeks. A much smaller group — mostly older or chronically ill people — suffer hospitalization or death.

It’s important for those in high-risk groups to get vaccinated, but vaccine protection wanes after a few months. Those who run to get the new vaccine may be more likely to fall ill this winter when the next wave hits, said William Schaffner, an infectious disease professor at Vanderbilt University School of Medicine and a spokesperson for the National Foundation for Infectious Diseases.

On the other hand, by late fall the major variants may have changed, rendering the vaccine less effective, said Peter Marks, the FDA’s top vaccine official, at a briefing Aug. 23. He urged everyone eligible to get immunized, noting that the risk of long covid is greater in the un- and undervaccinated.

Of course, if last year’s covid vaccine rollout is any guide, few Americans will heed his advice, even though this summer’s surge has been unusually intense, with levels of the covid virus in wastewater suggesting infections are as widespread as they were in the winter.

The Centers for Disease Control and Prevention now looks to wastewater as fewer people are reporting test results to health authorities. The wastewater data shows the epidemic is worst in Western and Southern states. In New York, for example, levels are considered “high” — compared with “very high” in Georgia.

Hospitalizations and deaths due to covid have trended up, too. But unlike infections, these rates are nowhere near those seen in winter surges, or in summers past. More than 2,000 people died of covid in July — a high number but a small fraction of the at least 25,700 covid deaths in July 2020.

Partial immunity built up through vaccines and prior infections deserves credit for this relief. A new study suggests that current variants may be less virulent — in the study, one of the recent variants did not kill mice exposed to it, unlike most earlier covid variants.

Public health officials note that even with more cases this summer, people seem to be managing their sickness at home. “We did see a little rise in the number of cases, but it didn’t have a significant impact in terms of hospitalizations and emergency room visits,” said Manisha Juthani, public health commissioner of Connecticut, at a news briefing Aug. 21.

Unlike influenza or traditional cold viruses, covid seems to thrive outside the cold months, when germy schoolkids, dry air, and indoor activities are thought to enable the spread of air- and saliva-borne viruses. No one is exactly sure why.

“Covid is still very transmissible, very new, and people congregate inside in air-conditioned rooms during the summer,” said John Moore, a virologist and professor at Cornell University’s Weill Cornell Medicine.

Or “maybe covid is more tolerant of humidity or other environmental conditions in the summer,” said Caitlin Rivers, an epidemiologist at Johns Hopkins University.

Because viruses evolve as they infect people, the CDC has recommended updated covid vaccines each year. Last fall’s booster was designed to target the omicron variant circulating in 2023. This year, mRNA vaccines made by Moderna and Pfizer and the protein-based vaccine from Novavax — which has yet to be approved by the FDA — target a more recent omicron variant, JN.1.

The FDA determined that the mRNA vaccines strongly protected people from severe disease and death — and would do so even though earlier variants of JN.1 are now being overtaken by others.

Public interest in covid vaccines has waned, with only 1 in 5 adults getting vaccinated since last September, compared with about 80% who got the first dose. New Yorkers have been slightly above the national vaccination rate, while in Georgia only about 17% got the latest shot.

Vaccine uptake is lower in states where the majority voted for Donald Trump in 2020 and among those who have less money and education, less health care access, or less time off from work. These groups are also more likely to be hospitalized or die of the disease, according to a 2023 study in The Lancet.

While the newly formulated vaccines are better targeted at the circulating covid variants, uninsured and underinsured Americans may have to rush if they hope to get one for free. A CDC program that provided boosters to 1.5 million people over the last year ran out of money and is ending Aug. 31.

The agency drummed up $62 million in unspent funds to pay state and local health departments to provide the new shots to those not covered by insurance. But “that may not go very far” if the vaccine costs the agency around $86 a dose, as it did last year, said Kelly Moore, CEO of Immunize.org, which advocates for vaccination.

People who pay out-of-pocket at pharmacies face higher prices: CVS plans to sell the updated vaccine for $201.99, said Amy Thibault, a spokesperson for the company.

“Price can be a barrier, access can be a barrier” to vaccination, said David Scales, an assistant professor of medicine at Weill Cornell Medicine.

Without an access program that provides vaccines to uninsured adults, “we’ll see disparities in health outcomes and disproportionate outbreaks in the working poor, who can ill afford to take off work,” Kelly Moore said.

New York state has about $1 million to fill the gaps when the CDC’s program ends, said Danielle De Souza, a spokesperson for the New York State Department of Health. That will buy around 12,500 doses for uninsured and underinsured adults, she said. There are roughly one million uninsured people in the state.

CDC and FDA experts last year decided to promote annual fall vaccination against covid and influenza along with a one-time respiratory syncytial virus shot for some groups.

It would be impractical for the vaccine-makers to change the covid vaccine’s recipe twice every year, and offering the three vaccines during one or two health care visits appears to be the best way to increase uptake of all of them, said Schaffner, who consults for the CDC’s policy-setting Advisory Committee on Immunization Practices.

At its next meeting, in October, the committee is likely to urge vulnerable people to get a second dose of the same covid vaccine in the spring, for protection against the next summer wave, he said.

If you’re in a vulnerable population and waiting to get vaccinated until closer to the holiday season, Schaffner said, it makes sense to wear a mask and avoid big crowds, and to get a test if you think you have covid. If positive, people in these groups should seek medical attention since the antiviral pill Paxlovid might ameliorate their symptoms and keep them out of the hospital.

As for conscientious others who feel they may be sick and don’t want to spread the covid virus, the best advice is to get a single test and, if positive, try to isolate for a few days and then wear a mask for several days while avoiding crowded rooms. Repeat testing after a positive result is pointless, since viral particles in the nose may remain for days without signifying a risk of infecting others, Schaffner said.

The Health and Human Services Department is making four free covid tests available to anyone who requests them starting in late September through covidtest.gov, said Dawn O’Connell, assistant secretary for preparedness and response, at the Aug. 23 briefing.

The government is focusing its fall vaccine advocacy campaign — which it’s calling “Risk Less. Do More.” — on older people and nursing home residents, said HHS spokesperson Jeff Nesbit.

Not everyone may really need a fall covid booster, but “it’s not wrong to give people options,” John Moore said. “The 20-year-old athlete is less at risk than the 70-year-old overweight dude. It’s as simple as that.”

KFF Health News correspondent Amy Maxmen contributed to this report.

Healthbeat is a nonprofit newsroom covering public health published by Civic News Company and KFF Health News. Sign up for its newsletters here.

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

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Ya está disponible la nueva vacuna contra covid, pero piensa bien cuándo conviene vacunarte https://kffhealthnews.org/news/article/ya-esta-disponible-la-nueva-vacuna-contra-covid-pero-piensa-bien-cuando-conviene-vacunarte/ Mon, 26 Aug 2024 08:55:00 +0000 https://kffhealthnews.org/?post_type=article&p=1905389 La Administración de Drogas y Alimentos (FDA) ha aprobado una vacuna actualizada contra covid para todas las personas de 6 meses en adelante, lo que renueva un dilema que ahora es anual: ¿Recibir la vacuna ya, con el brote de covid aún por todo el país, o reservarla para la ola invernal?

La nueva vacuna debería proporcionar cierta protección a todos. Pero muchas personas saludables que ya han sido vacunadas o tienen inmunidad porque han estado expuestas al covid varias veces pueden querer esperar unos meses.

El covid se ha vuelto común. Para algunos, es una enfermedad leve con pocos síntomas. Otros están postrados con fiebre, tos y fatiga durante días o semanas. Un grupo mucho más pequeño, principalmente personas mayores o con enfermedades crónicas, sufre hospitalización o muerte.

Es importante que aquellos en grupos de alto riesgo se vacunen, pero la protección de la vacuna disminuye después de unos meses. Los que se apresuren a recibir la nueva vacuna pueden ser más propensos a enfermarse este invierno cuando llegue la próxima ola, dijo William Schaffner, profesor de enfermedades infecciosas en la Escuela de Medicina de la Universidad de Vanderbilt y vocero de la Fundación Nacional para Enfermedades Infecciosas.

Por otro lado, para finales del otoño, las principales variantes pueden haber cambiado, lo que podría hacer que la vacuna sea menos efectiva, dijo Peter Marks, el principal funcionario de vacunas de la FDA, en una conferencia el 23 de agosto. Instó a todos los elegibles para vacunarse, remarcando que el riesgo de covid prolongado es mayor en los no vacunados o los que no tienen todas sus vacunas.

Si el lanzamiento de la vacuna contra covid del año pasado sirve de guía, pocos estadounidenses seguirán su consejo, a pesar de que el aumento de casos de este verano ha sido inusualmente intenso, con niveles del virus en aguas residuales que sugieren que las infecciones son tan extendidas como en invierno.

Ahora, los Centros para el Control y Prevención de Enfermedades (CDC) observan las aguas residuales, ya que menos personas están informando los resultados de las pruebas a las autoridades de salud. Los datos de las aguas residuales muestran que la epidemia es peor en los estados del oeste y sur del país. En Nueva York, por ejemplo, los niveles se consideran “altos”, en comparación con “muy altos” en Georgia.

Las hospitalizaciones y muertes por covid también han aumentado. Pero a diferencia de las infecciones, estas tasas no se acercan a las vistas en las oleadas invernales, o en veranos anteriores. Más de 2,000 personas murieron a causa de covid en julio, una cifra alta pero una pequeña fracción de las al menos 25,700 muertes que hubo en julio de 2020.

La inmunidad parcial acumulada a través de vacunas e infecciones previas merece crédito por este alivio. Un nuevo estudio sugiere que las variantes actuales pueden ser menos virulentas; en el estudio, una de las variantes recientes no mató a ratones expuestos, a diferencia de la mayoría de las variantes anteriores de covid.

Funcionarios de salud pública indican que, incluso con más casos este verano, la gente parece estar manejando su enfermedad en casa. “Vimos un pequeño aumento en el número de casos, pero no tuvo un impacto significativo en términos de hospitalizaciones y visitas a las salas de emergencias”, dijo Manisha Juthani, comisionada de salud pública de Connecticut, en una conferencia de prensa el 21 de agosto.

A diferencia de la influenza o los virus tradicionales del resfriado, covid parece prosperar fuera de los meses fríos, cuando se cree que los niños escolares, el aire seco y las actividades en interiores facilitan la propagación de virus transmitidos por el aire y la saliva. Nadie está exactamente seguro de por qué.

“El covid sigue siendo muy transmisible, muy nuevo, y la gente se congrega en habitaciones con aire acondicionado durante el verano”, dijo John Moore, virólogo y profesor en el Colegio de Medicina Weill Cornell de la Universidad Cornell.

O “tal vez el covid sea más tolerante a la humedad u otras condiciones ambientales en el verano”, dijo Caitlin Rivers, epidemióloga de la Universidad Johns Hopkins.

Dado que los virus evolucionan a medida que infectan a las personas, los CDC han recomendado vacunas actualizadas contra covid cada año. El refuerzo del otoño pasado se diseñó para atacar a la variante ómicron que circulaba en 2023. Este año, las vacunas de ARNm de Moderna y Pfizer, y la vacuna basada en proteínas de Novavax —que aún no ha sido aprobada por la FDA—, están dirigidas a una variante más reciente de ómicron: JN.1.

La FDA determinó que las vacunas de ARNm protegían fuertemente a las personas contra enfermedades graves y la muerte, y lo harían aunque las primeras variantes de JN.1 ahora fueran superadas por otras.

El interés público en las vacunas contra covid ha bajado, con solo 1 de cada 5 adultos vacunándose desde septiembre pasado, en comparación con cerca del 80% que recibió la primera dosis. Los neoyorquinos han estado ligeramente por encima de la tasa nacional de vacunación, mientras que en Georgia solo alrededor del 17% recibió la última vacuna.

La aceptación de la vacuna es menor en los estados donde la mayoría votó por Donald Trump en 2020 y entre aquellos que tienen menos dinero y educación, menos acceso a atención médica o menos tiempo libre del trabajo. Estos grupos también tienen más probabilidades de ser hospitalizados o morir por la enfermedad, según un estudio de 2023 publicado en The Lancet.

Aunque las vacunas recién formuladas atacan mejor a las variantes del covid que circulan, los estadounidenses que no tienen seguro, o tienen una cobertura insuficiente pueden tener que apresurarse si esperan obtener dosis gratuitas. Un programa de los CDC que proporcionó refuerzos a 1.5 millones de personas durante el último año se quedó sin dinero y terminará el 31 de agosto.

La agencia reunió $62 millones en fondos no utilizados para pagar a los departamentos de salud estatales y locales para que ofrezcan las nuevas vacunas a aquellos que no están cubiertos por un seguro. Pero “eso puede no alcanzar mucho” si la vacuna cuesta a la agencia alrededor de $86 por dosis, como el año pasado, dijo Kelly Moore, CEO de Immunize.org, que aboga por la vacunación.

Las personas que pagan de su bolsillo en las farmacias enfrentan precios más altos: CVS planea vender la vacuna actualizada por $201.99, dijo Amy Thibault, vocera de la compañía.

“El precio puede ser una barrera, el acceso puede ser una barrera” para la vacunación, dijo David Scales, profesor asistente de medicina en el Colegio de Medicina Weill Cornell.

Sin un programa de acceso que proporcione vacunas a adultos no asegurados, “veremos disparidades en los resultados de salud y brotes desproporcionados entre los trabajadores pobres, que no pueden permitirse faltar al trabajo”, dijo Kelly Moore.

El estado de Nueva York tiene alrededor de $1 millón para llenar los vacíos cuando termine el programa de los CDC, dijo Danielle De Souza, portavoz del Departamento de Salud estatal. Con eso se comprarán alrededor de 12,500 dosis para adultos sin cobertura y con seguro insuficiente, dijo. En el estado, hay aproximadamente un millón de personas sin seguro.

El año pasado, expertos de los CDC y la FDA decidieron promover la vacunación anual contra covid y la influenza en otoño junto con una vacuna única contra el virus respiratorio sincitial para algunos grupos.

Sería poco práctico que los fabricantes cambiaran la receta de la vacuna contra covid dos veces al año, y ofrecer las tres vacunas durante una o dos visitas al médico parece ser la mejor manera de aumentar su aceptación, dijo Schaffner, quien es consultor para el Comité Asesor de Prácticas de Inmunización, que establece las políticas de los CDC.

En su próxima reunión, en octubre, el comité probablemente instará a las personas vulnerables a recibir una segunda dosis de la misma vacuna contra covid en la primavera, para protegerse contra la próxima ola de verano, dijo.

Si perteneces a una población vulnerable y estás esperando para vacunarte hasta más cerca de la temporada navideña, Schaffner dijo que tiene sentido usar máscara y evitar grandes multitudes, y hacerse una prueba si crees que tienes covid. Si el resultado es positivo, las personas en estos grupos deben buscar atención médica ya que la píldora antiviral Paxlovid podría mejorar sus síntomas y mantenerlas fuera del hospital.

En cuanto a otras personas conscientes, que sienten que pueden estar enfermos y no quieren propagar el virus, el mejor consejo es hacerse una prueba única y, si el resultado es positivo, intentar aislarse durante unos días y luego usar máscara durante varios días mientras evitan habitaciones concurridas. Repetir las pruebas después de un resultado positivo no tiene sentido, ya que las partículas virales en la nariz pueden permanecer durante días sin indicar un riesgo de infectar a otros, dijo Schaffner.

El Departamento de Salud y Servicios Humanos (HHS) está ofreciendo cuatro pruebas gratuitas de covid a cualquier persona que las solicite a partir de finales de septiembre a través de covidtest.gov, dijo Dawn O’Connell, secretaria adjunta de preparación y respuesta, en la conferencia del 23 de agosto.

El gobierno está centrando su campaña de promoción de vacunas para el otoño, que está llamando “Arriesga menos, vive más”, en las personas mayores y los residentes de hogares de adultos mayores, dijo Jeff Nesbit, vocero del HHS.

No todos pueden necesitar realmente un refuerzo de covid en otoño, pero “no está mal darle opciones a las personas”, dijo John Moore. “El atleta de 20 años tiene menos riesgo que la persona de 70 años con sobrepeso. Es tan simple como eso”.

Amy Maxmen, corresponsal de KFF Health News, colaboró con este informe

Healthbeat es una redacción sin fines de lucro que cubre temas de salud pública, publicada por Civic News Company y KFF Health News. Suscríbete a sus newsletters aquí.

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