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Las quejas sobre deficiencias en Medicare Advantage son comunes, pero la supervisión federal es rara

Además de los dolores ocasionales, envejecer puede traer sorpresas desagradables y enfermedades graves. Las relaciones de largo plazo con doctores de confianza suelen hacer que incluso las malas noticias sean más llevaderas.

Perder ese respaldo —especialmente en medio de una crisis de salud— puede ser aterrador. Por eso, existen requisitos federales poco conocidos que, se supone, protegen a las personas con cobertura de Medicare Advantage, operada por aseguradoras privadas, cuando las disputas contractuales hacen que los proveedores de salud y las aseguradoras se separen.

Pero documentos gubernamentales obtenidos por KFF Health News muestran que la agencia que supervisa Medicare Advantage no se esfuerza por hacer cumplir normas vigentes desde hace tiempo para garantizar que unos 35 millones de afiliados puedan, primero que nada, acceder a sus médicos.

En respuesta a una solicitud de información pública (Freedom of Information Act) que cubre la última década, los Centros de Servicios de Medicare y Medicaid (CMS) entregaron cartas enviadas a solo cinco aseguradoras entre 2016 y 2022, después de que siete de sus planes no cumplieran con los requisitos mínimos de la red de proveedores. Estas fallas podrían, en algunos casos, afectar la atención de los pacientes.

Según las cartas, los funcionarios de la agencia señalaron que algunos planes no contaban con suficientes médicos de atención primaria, especialistas u hospitales. Y advirtieron que el incumplimiento de esos requisitos podría resultar en la suspensión de la promoción e inscripción de nuevos afiliados, multas o incluso el cierre del plan.

Los CMS no explicaron por qué encontraron tan pocos planes con infracciones en la red durante esos 10 años. “El número de infracciones identificadas refleja los resultados de revisiones específicas, no de una auditoría completa de todos los planes en todos los años”, dijo Catherine Howden, vocera de los CMS.

Funcionarios en estados con infracciones de la red en planes Advantage afirman que los CMS no los notificaron, incluidos los directores del Programa Estatal de Asistencia de Seguros de Salud (SHIP), que ayuda a las personas a navegar Medicare y que cuenta con financiación gubernamental.

“Me cuesta creer que solo siete planes de Medicare Advantage hayan violado las reglas de la red”, dijo David Lipschutz, codirector del Centro de Defensa de Medicare (Center for Medicare Advocacy), una organización sin fines de lucro. “Frecuentemente escuchamos de personas —sobre todo en zonas rurales— que deben recorrer largas distancias para encontrar proveedores contratados”.

Medicare Advantage es una alternativa cada vez más popular al programa de Medicare tradicional, administrado por el gobierno, que cubre a personas mayores de 65 años y algunas personas con discapacidades. De los 63 millones de estadounidenses elegibles para unirse a planes Advantage en lugar de Medicare tradicional, el 54% lo hizo este año.

Estos planes usualmente ofrecen costos más bajos de bolsillo y beneficios adicionales, como cobertura para la vista, servicios dentales y auditivos, pero por lo general requieren que sus afiliados utilicen redes específicas de doctores, hospitales y otros proveedores. El año pasado, el gobierno federal pagó unos $494.000 millones a los planes Advantage por la atención a sus afiliados.

En comparación, Medicare tradicional no tiene red y es aceptado por casi todos los doctores y hospitales del país.

Es habitual que haya conflictos entre planes de Medicare Advantage y los doctores, hospitales y otros proveedores que atienden a sus afiliados. Solo este año, al menos 38 sistemas hospitalarios en 23 estados dejaron de trabajar con unos 11 planes Advantage, al no llegar a un acuerdo sobre pagos y otros temas, según una revisión de comunicados de prensa y reportes periodísticos. En los últimos tres años, las rupturas entre planes Advantage y sistemas de salud aumentaron un 66%, según FTI Consulting, una consultora que monitorea estos conflictos.

Después de marzo, los afiliados de Medicare Advantage por lo general deben permanecer en su plan hasta el próximo período de inscripción abierta, que está en curso y se extiende hasta el 7 de diciembre, para cobertura que comienza a partir del 1 de enero. Pero los hospitales, doctores, farmacias y otros proveedores de salud pueden salir de los planes en cualquier momento.

Cuando se produce una separación entre proveedores y aseguradoras, los afiliados pueden perder el acceso a sus doctores de confianza o a sus hospitales preferidos a mitad de año. En respuesta, los CMS a veces ofrecen a los afiliados de Advantage una opción poco conocida: un “período especial de inscripción” (SEP), para cambiar de plan o pasar a Medicare tradicional a mitad de año.

Cómo deciden los CMS quién califica para un SEP es un misterio incluso para reguladores estatales experimentados y senadores que supervisan los programas federales de salud. El senador Ron Wyden, demócrata de Oregon y miembro del Comité de Finanzas del Senado, y el senador Mark Warner, demócrata de Virginia, citaron reportes previos de KFF Health News sobre Medicare Advantage en una carta del 30 de octubre donde solicitaron una explicación a Mehmet Oz, el administrador de los CMS.

“A pesar del impacto significativo de los SEP sobre los afiliados y el mercado, el proceso para determinar quién califica es opaco, dejando a los afiliados y a los reguladores estatales en la oscuridad”, escribieron.

“Los adultos mayores merecen saber que su plan de Medicare no los va a abandonar a mitad de año”, dijo Wyden a KFF Health News.

“Ayúdennos”

Oz habló ante representantes de aseguradoras de Medicare Advantage el 15 de octubre en una conferencia organizada por Better Medicare Alliance, un grupo del sector privado, y las animó a ayudar a los CMS a combatir el fraude en el programa.

“Sean nuestro sistema de alerta temprana”, les dijo. “Dígannos qué problemas están viendo. Ayúdennos a encontrar mejores formas de abordarlos”.

Al terminar, se sentó junto a Mary Beth Donahue, presidenta y directora ejecutiva del grupo, y posó para fotos.

En seis cartas obtenidas por KFF Health News, funcionarios de CMS informaron a cinco aseguradoras que las violaciones en el desempeño de sus redes podrían afectar el acceso de los afiliados a la atención médica. Cinco cartas enumeraban la cantidad o los tipos de especialistas o centros médicos ausentes en sus redes. En tres casos, los CMS señalaron que los planes podrían haber solicitado excepciones a las normas, pero no lo hicieron. En una carta, los CMS solicitaron que se permitiera a los afiliados recibir atención fuera de la red sin costo adicional. Cuatro cartas exigían pasos concretos para resolver las deficiencias, como presentar evidencia de que se habían agregado más médicos a las redes.

Tres cartas requerían un “plan de acción correctiva”, establecían plazos para solucionar los problemas y advertían que no cumplir podría resultar en la suspensión de inscripciones y promoción, multas o cierre del plan. Las otras tres cartas eran “avisos de incumplimiento”, que instaban a las aseguradoras a cumplir con los requisitos legales.

Aunque los CMS consideran estas cartas como el primer paso en su proceso de supervisión, la agencia no ofreció información sobre si las infracciones se resolvieron ni si derivaron en sanciones.

La Comisión Asesora de Pagos de Medicare (Medicare Payment Advisory Commission), un grupo creado por el Congreso para supervisar el programa, señaló en un informe de junio de 2024 que “CMS tiene la autoridad para imponer sanciones intermedias o multas por incumplimiento de los estándares del desempeño adecuado de la red, pero nunca lo ha hecho”.

Una de las cartas sobre estas infracciones se envió en noviembre de 2020 a Vitality Health Plan of California. Eso ocurrió después de que cinco hospitales y 13 residencias de adultos mayores en un condado y cuatro hospitales en otro condado salieran de su red, según la carta firmada por Timothy Roe, entonces director de la División de Cumplimiento, Supervisión y Promoción de los CMS. Dos meses antes de enviar esa carta, los CMS concedieron a los afiliados del plan Vitality un período especial de inscripción.

Los beneficiarios agradecieron esa oportunidad, según Marcelo Espiritu, director del Programa de Asesoría y Defensa del Seguro de Salud en el condado de Santa Clara, California. Pero Espiritu no sabía en ese momento que la escasa red de Vitality violaba los requisitos de CMS, que, según Roe, “ponía en riesgo la salud de los beneficiarios de Vitality”.

“Al no tener suficientes proveedores en la red, es muy probable que los beneficiarios no reciban los servicios necesarios de forma oportuna, o que no los reciban en absoluto”, escribió Roe.

Esa es información que los pacientes necesitan saber, dijo Espiritu.

“La gente no recibiría los beneficios prometidos, habría demoras en la atención y mucha frustración al tratar de encontrar un nuevo plan”, señaló. “Sin duda que alertaríamos a las personas sobre ese plan y lo eliminaríamos de nuestro material”.

Representantes de Commonwealth Care Alliance, que adquirió Vitality en 2022, no respondieron a solicitudes de comentarios.

Mínimos de la red

La ley federal exige que los planes de Medicare Advantage incluyan en sus redes un mínimo de 29 tipos de proveedores de salud y 14 tipos de centros médicos, que los beneficiarios puedan visitar dentro de ciertas distancias y tiempos de traslado. Las normas, que varían según la población y densidad de cada condado, también establecen cuánto tiempo debe esperar un paciente para una cita médica. La agencia revisa el cumplimiento cada tres años, o más seguido si recibe quejas.

Las redes pueden variar considerablemente incluso dentro de un mismo condado, porque los requisitos mínimos se aplican a la aseguradora, no a cada plan que ofrece, según un informe de KFF. Una aseguradora puede ofrecer la misma red a afiliados de varios planes en uno o más condados, o crear una red distinta para cada plan.

En el condado de Maricopa, Arizona, investigadores de KFF encontraron que, en 2022, UnitedHealthcare ofrecía 12 planes con 12 redes diferentes. Según el plan, los clientes de la aseguradora tenían acceso a entre el 37% y el 61% de los médicos disponibles para los afiliados de Medicare tradicional en esa zona.

A principios de 2016, los CMS permitieron que 900 personas afiliadas a un plan Advantage en Illinois, operado por Harmony —una subsidiaria de WellCare en ese momento— se salieran del plan después de que Christie Clinic, un gran centro médico, dejara la red. El plan de WellCare siguió funcionando sin la clínica. Pero en junio de 2016, los CMS informaron al plan, en una de las cartas obtenidas por KFF Health News, que la pérdida de Christie Clinic implicaba que la red restante ya no cumplía con los requisitos federales.

Fue “un cambio significativo en la red con un impacto considerable para los beneficiarios”, decía la carta.

Claudia Lennhoff dijo que su grupo no supo de la carta en ese momento. Lennhoff es directora ejecutiva de Champaign County Health Care Consumers, un servicio gubernamental de asesoría sobre Medicare que ayudó a los afiliados de WellCare.

“No divulgar esa información es una traición a la confianza”, dijo Lennhoff. “Podría llevar a alguien a tomar una decisión que le perjudique o de la que luego se arrepienta profundamente”.

Centene Corp. compró WellCare en 2020, y representantes de la empresa, con sede en St. Louis, declinaron comentar sobre hechos ocurridos antes de esa adquisición.

Los CMS enviaron dos cartas por infracciones a Provider Partners Health Plan de Ohio, en 2019 y 2022. El Departamento de Seguros de Ohio no estaba al tanto, según su vocero Todd Walker quien dijo que tampoco se notificó al Programa de Información sobre Seguros de Salud para Personas Mayores del estado, un servicio gratuito de asesoría.

En 2021, los CMS también enviaron una carta de infracción a Liberty Advantage, de Carolina del Norte. Pero no informó sobre esta carta al Programa de Información sobre Seguros de Salud para Personas Mayores del estado, dijo su directora, Melinda Munden.

Representantes de Liberty no respondieron a solicitudes de comentarios.

Los CMS enviaron una carta en 2016 a CareSource sobre deficiencias en la red de algunos de sus planes Advantage vendidos en Kentucky e Indiana. La agencia pidió a la empresa corregir los problemas, incluyendo reembolsar a cualquier afiliado que hubiera recibido facturas por servicios de doctores fuera de la red.

“En respuesta a las infracciones de 2016, implementamos de inmediato un Plan de Acción Correctiva, que incluyó una revisión exhaustiva de nuestra red de proveedores para asegurar que se cumplieran los estándares de desempeño adecuado”, dijo Vicki McDonald, vocera de CareSource. “Los CMS aprobaron nuestro plan y no fue necesaria ninguna otra acción”.

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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US Cancer Registries, Constrained by Trump Policies, To Recognize Only ‘Male’ or ‘Female’ Patients

The top authorities of U.S. cancer statistics will soon have to classify the sex of patients strictly as male, female, or unknown, a change scientists and advocates say will harm the health of transgender people, one of the nation’s most marginalized populations.

Scientists and advocates for trans rights say the change will make it much harder to understand cancer diagnoses and trends among the trans population. Certain studies have shown that transgender people are more likely to use tobacco products or less likely to receive routine cancer screenings — factors that could put them at higher risk of disease.

The change is a consequence of Trump administration policies recognizing only “male” and “female” sexes, according to cancer researchers.

Scientists said the change will affect all cancer registries, in every state and territory, because they receive federal funding. Starting in 2026, registries funded through the Centers for Disease Control and Prevention and the National Cancer Institute will categorize cancer patients as male, female, or not stated/unknown. And federal health agencies will receive data only on cancer patients classified that way.

Registries currently specify whether a cancer patient’s sex is “male,” “female,” “other,” various options for “transsexual,” or that the patient’s sex is not stated or unknown.

President Donald Trump in January issued an executive order stating that the government would recognize only male and female sexes. Cancer registry officials said the federal government directed them to revise how they collect data on cancer patients.

“In the U.S., if you’re receiving federal money, then we, essentially, we weren’t given any choice,” Eric Durbin, director of the Kentucky Cancer Registry and president of the North American Association of Central Cancer Registries, told KFF Health News. NAACCR, which receives federal funds, maintains cancer reporting standards across the U.S. and Canada.

Officials will need to classify patients’ sex as unknown when a “patient’s sex is documented as other than male or female (e.g., non-binary, transsexual), and there is no additional information about sex assigned at birth,” the new standard says.

Missing the Big Picture

Researchers said they do not have high-quality population-level data on cancer incidence in transgender people but had been making inroads at improving it — work now at risk of being undone.

“When it comes to cancer and inequities around cancer, you can use the cancer registries to see where the dirtiest air pollution is, because lung cancer rates are higher in those areas. You can see the impact of nuclear waste storage because of the types of cancers that are higher in those ZIP codes, in those areas of the country,” said Shannon Kozlovich, who is on the executive committee of the California Dialogue on Cancer.

“The more parts of our population that we are excluding from this dataset means that we are not going to know what’s happening,” she said. “And that doesn’t mean that it’s not happening.”

For decades, cancer registries have been the most comprehensive U.S. surveillance tool for understanding cancer incidence and survival rates and identifying troubling disease trends. Each year, cancer cases are reported by hospitals, pathology labs, and other health facilities into regional and statewide cancer registries. The compiled data documents cancer and mortality rates among regions, races, sexes, and age groups.

Two federal programs serve as the top authorities on cancer statistics, with information on tens of millions of cases. The CDC’s National Program of Cancer Registries provides funding to organizations in 46 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the U.S. Pacific Island territories. Its data represents 97% of the U.S. population. The National Cancer Institute’s Surveillance, Epidemiology, and End Results program, known as SEER, collects and publishes data from registries covering nearly half the U.S. population.

The information published by cancer registries has led to changes in treatment and prevention, and the enactment of other policies designed to reduce diagnosis rates and mortality.

For example, data collected by cancer registries was essential in identifying rising rates of colorectal cancer among people younger than 50. As a result, U.S. guidelines now recommend that adults start screenings at age 45 rather than 50.

States have enacted their own measures. Lara Anton, spokesperson for the Texas Department of State Health Services, said epidemiologists with the Texas Cancer Registry in 2018 found that the state had the nation’s highest incidence rates of hepatocellular carcinoma, a liver cancer more common in men than women. The Cancer Prevention and Research Institute of Texas initiated a statewide effort aimed at reversing rising rates of liver cancer. The Texas Cancer Registry joined SEER in 2021.

“Once a cancer patient is entered into a cancer registry, we follow those patients for the rest of their lives. Because we really need to know, do patients survive for different types of cancer and different stages of cancer?” Durbin said. “That’s incredibly important for public policies.”

The North American Association of Central Cancer Registries maintains national standards outlining what kind of data registries collect for each diagnosis. It develops the list in partnership with the CDC, the National Cancer Institute, and other organizations.

For any given patient, under NAACCR’s standards, Durbin said, registries collect more than 700 pieces of information, including demographics, diagnosis, treatment, and length of survival. CDC and NCI-funded registries must specify the sex of each patient.

The NAACCR definitions and accompanying data standards are designed to ensure that registries collect case data uniformly. “Everyone essentially follows the standards” that NAACCR develops, Durbin said. Although registries can collect state-specific information, researchers said they need to follow those standards when sending cancer data to the federal government.

In an emailed statement, Department of Health and Human Services spokesperson Andrew Nixon said, “HHS is using biological science to guide policy, not ideological agendas that the Biden administration perpetrated.”

‘Backwards’ Progress

NAACCR routinely publishes updated guidelines. But the change to the “sex” category to remove transgender options in 2026 was an emergency move due to Trump administration policies, Kozlovich said. She was among a group that had pushed for changes in cancer data collection to account for sex and gender identity as separate data points.

According to an analysis of CDC data by the Williams Institute at the UCLA School of Law, 2.8 million people age 13 and older identify as transgender.

Scientists and trans rights advocates said in interviews that there are troubling signs that may make transgender people more likely to develop cancer or experience worse health outcomes than others.

“Without evidence of our health disparities, you take away any impetus to fix them,” said Scout, executive director of the LGBTQIA+ Cancer Network.

A study published in 2022 found that transgender and gender-diverse populations were two to three times as likely as cisgender people to report active use of cigarettes, e-cigarettes, or cigars. Tobacco use is a leading cause of cancer and death from cancer.

A Canadian study concluded in 2019 that transgender patients were less likely to receive recommended screenings for breast, cervical, and colorectal cancers. And a 2023 study from researchers at Stanford Medicine found that LGBTQ+ patients were nearly three times as likely to experience breast cancer recurrence as cisgender heterosexual people.

Scarlett Lin Gomez, an epidemiologist at the University of California-San Francisco and the director of the Greater Bay Area Cancer Registry, said that for at least 10 years the NCI had been interested in improving its ability to monitor cancer burden across patient populations with different sexual orientations and gender identities. Cancer registries are a logical place to start because that is what they’re set up to do, she said.

There’s been “slow but good progress,” Gomez said. “But now we’ve completely, personally, I think, regressed backwards.”

The decision not to capture transgender identity in cancer patients is just one change registries have confronted under the Trump administration, according to scientists leading surveillance efforts and state health agencies. An HHS mandate to reduce spending on contracts led to funding cuts for cancer registries in NCI’s SEER program. Scientists said CDC funds for registries haven’t been cut; however, the White House’s proposed fiscal 2026 budget aims to eliminate funding for the National Program of Cancer Registries.

Among the Trump administration’s other actions targeting trans people are canceling research grants for studies on LGBTQ+ health, dismantling the National Institutes of Health’s office for sexual and gender minority health, and stopping specialized services for LGBTQ+ youth on the 988 national suicide prevention hotline.

Without data, researchers can’t make a case to fund research that may help trans patients, Gomez said. “It’s erasure.”

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Complaints About Gaps in Medicare Advantage Networks Are Common. Federal Enforcement Is Rare.

Along with the occasional aches and pains, growing older can bring surprise setbacks and serious diseases. Longtime relationships with doctors people trust often make even bad news more tolerable. Losing that support — especially during a health crisis — can be terrifying. That’s why little-known federal requirements are supposed to protect people with privately run Medicare Advantage coverage when contract disputes lead their health care providers and insurers to part ways.

But government documents obtained by KFF Health News show the agency overseeing Medicare Advantage does little to enforce long-standing rules intended to ensure about 35 million plan members can see doctors in the first place.

In response to a Freedom of Information Act request covering the past decade, the Centers for Medicare & Medicaid Services produced letters it sent to only five insurers from 2016 to 2022 after seven of their plans failed to meet provider network adequacy requirements — lapses that could, in some cases, harm patient care.

Agency officials said some plans lacked enough primary care clinicians, specialists, or hospitals, according to the letters. And they warned that failure to meet the requirements could result in a freeze on marketing and enrollment, fines, or closure of the plan.

CMS declined to detail why it found so few plans with network violations over the 10 years. “The number of identified violations reflects the outcomes of targeted reviews, not a comprehensive audit of all plans in all years,” said Catherine Howden, a CMS spokesperson.

Officials in states with Advantage network violations say CMS didn’t notify them, including directors of the government-funded State Health Insurance Assistance Program, which helps people navigate Medicare.

“It’s hard for me to believe that only seven Medicare Advantage plans violated network rules,” said David Lipschutz, a co-director of the Center for Medicare Advocacy, a nonprofit group. “We often hear from folks — particularly in more rural areas — who have to travel significant distances in order to find contracted providers.”

Medicare Advantage is an increasingly popular alternative to the government-run Medicare program, which covers adults 65 and older and some people with disabilities. Of the 63 million Americans who were eligible to join Advantage plans instead of traditional Medicare, 54% did so for this year. The plans usually offer lower out-of-pocket costs and extra benefits, like coverage for vision, dental, and hearing care, but typically require their members to stick to select networks of doctors, hospitals, and other providers. Last year, the federal government paid Advantage plans an estimated $494 billion to care for patients.

Traditional Medicare, by comparison, has no network and is accepted by nearly all doctors and hospitals in the nation.

Conflicts between Medicare Advantage plans and the doctors, hospitals, and other providers that serve their members are common. Just this year, at least 38 hospital systems serving all or parts of 23 states have cut ties with at least 11 Advantage plans after failing to agree on payment and other issues, according to a review of news releases and press reports. Over the past three years, separations between Advantage plans and health systems have increased 66%, said FTI Consulting, which tracks reports of the disputes.

After March, Medicare Advantage beneficiaries are generally locked into their plans for the year until the annual open enrollment period happening now through Dec. 7, for coverage beginning Jan. 1. But hospitals, doctors, pharmacies, and other health providers can leave plans anytime.

When providers and insurers separate, Advantage members can lose access to longtime doctors or preferred hospitals in the middle of the year. In response, CMS sometimes gives Advantage customers a little-known escape hatch called a “special enrollment period” to change plans or enroll in traditional Medicare midyear.

How CMS decides who gets an SEP is a mystery even to well-versed state insurance regulators and U.S. senators who oversee federal health programs. Oregon Sen. Ron Wyden, the senior Democrat on the Senate Finance Committee, and Sen. Mark Warner (D-Va.) cited previous KFF Health News reporting on Medicare Advantage in an Oct. 30 letter asking CMS Administrator Mehmet Oz for an explanation.

“Despite the serious impacts of SEPs on enrollees and the market, the process of SEP determinations is opaque, leaving enrollees and state regulators in the dark,” they wrote.

“Seniors deserve to know their Medicare plan isn’t going to pull the rug out from under them halfway through the year,” Wyden told KFF Health News.

‘Help Us’

Oz spoke to Medicare Advantage insurers Oct. 15 at a conference organized by the Better Medicare Alliance, a trade group, and encouraged them to help CMS police fraud in the program.

“Be our early-warning system,” he told them. “Tell us about problems you’re witnessing. Help us figure out better ways of addressing it.”

When he finished speaking, he took a seat in the audience next to the president and chief executive of the group, Mary Beth Donahue, and smiled for photos.

In six letters KFF Health News obtained, CMS officials told five insurers that their network adequacy violations could affect Advantage members’ access to care. Five letters listed the number or types of medical specialists or facilities missing from the networks. In three cases, CMS noted that plans could request exceptions to the rules but didn’t. In one letter, CMS requested the plan allow members to receive out-of-network care at no additional cost. Four letters required specific steps to address deficiencies, including submitting evidence that more clinicians were added to networks.

Three letters required a “corrective action plan,” set deadlines for fixing problems, and warned that failure to comply with the rules could result in enrollment and marketing suspensions, fines, or forced plan closure. The other three letters were a “notice of non-compliance,” which urged insurers to comply with legal requirements.

Although CMS regards the letters as the first step in its enforcement process, the agency did not provide information about whether these violations were resolved or if they resulted in penalties.

The Medicare Payment Advisory Commission, a group created by Congress to monitor the program, said in a June 2024 report that “CMS has the authority to impose intermediate sanctions or civil monetary penalties for noncompliance with network adequacy standards, but it has never done so.”

One of the network adequacy violation letters went to Vitality Health Plan of California in November 2020. That came after five hospitals and 13 nursing homes in one county and four hospitals in another all left the insurer’s network, according to the letter from Timothy Roe, then-director of CMS’ Division of Compliance, Surveillance, and Marketing. Two months before sending its letter, CMS granted Vitality plan members a special enrollment period.

Beneficiaries welcomed the opportunity, said Marcelo Espiritu, program manager of the Santa Clara County office of California’s Health Insurance Counseling & Advocacy Program. But Espiritu didn’t know at the time that Vitality’s depleted network violated CMS requirements, which Roe said put “the health of Vitality’s beneficiaries at risk.”

“By not having enough network providers, beneficiaries may not be able to receive necessary services timely, or at all,” Roe wrote.

That’s information patients need to know, Espiritu said.

“People would not be able to receive promised benefits and there would be delays in care and a lot of frustration in trying to find a new plan,” he said. “We would certainly warn people about the plan and remove it from our materials.”

Representatives from Commonwealth Care Alliance, which acquired Vitality in 2022, did not respond to requests for comment.

Network Minimums

Federal law requires Medicare Advantage plans to include in their networks a minimum of 29 types of health care providers and 14 kinds of facilities that members can access within certain distances and travel times. The rules, which vary depending on a county’s population and density, also limit how long patients should wait for appointments. The agency checks compliance every three years, or more often if it receives complaints.

Networks can vary widely even within a county because the provider minimums apply to the insurer, not each plan it sells, according to a report from KFF, a health information nonprofit that includes KFF Health News. The company can offer the same network to members of multiple plans in one or more counties or create a separate network for each plan.

In Arizona’s Maricopa County, KFF researchers found, UnitedHealthcare offered 12 plans with 12 different networks in 2022. Depending on the plan, the company’s customers had access to 37% to 61% of the physicians in the area available to traditional Medicare enrollees.

In early 2016, CMS allowed 900 people in an Advantage plan in Illinois run by Harmony, then a WellCare subsidiary, to leave after the Christie Clinic, a large medical practice, left its provider network. The WellCare plan continued to operate without the clinic. But in June 2016, CMS told the plan in one of the letters KFF Health News obtained that losing the Christie Clinic meant the remaining provider network violated federal requirements.

It was “a significant network change with substantial enrollee impact,” the letter said.

Claudia Lennhoff, executive director at Champaign County Health Care Consumers, a government-funded Medicare counseling service that helped the WellCare members, said her group didn’t know about the letter at the time.

“Not disclosing such information is a violation of trust,” Lennhoff said. “It could lead someone to make a decision that will be harmful to them, or that they will deeply regret.”

Centene Corp. bought WellCare in 2020, and representatives for the St. Louis-based company declined to comment on events that occurred before the acquisition.

Two violation letters KFF Health News obtained from CMS went to Provider Partners Health Plan of Ohio in 2019 and 2022. The Ohio Department of Insurance was unaware of the violations, spokesperson Todd Walker said. He said CMS also did not notify the Ohio Senior Health Insurance Information Program, the state’s free counseling service.

Rick Grindrod, CEO and president of Provider Partners Health Plans, which is based in Maryland, said that after CMS reviewed its 2019 network, “we proactively reduced our service area and deferred enrollment in the plan until 2021.”

But Grindrod said the plan enrolled only a small number of members in one county in 2021 and decided to withdraw from the Ohio market entirely at the end of that year.

After Provider Partners withdrew from Ohio, CMS sent it another letter in March 2022 saying its network in 2021 had gaps in four counties for four types of providers and facilities. CMS asked the plan to comply with network rules by adding more providers.

“We believe CMS’ network adequacy standards are generally clear and appropriate for ensuring beneficiary access,” Grindrod said. “While the standards are not difficult to understand, as a provider-sponsored plan with a small footprint, we sometimes face challenges securing contracts with large systems that prioritize larger Medicare Advantage plans.”

In 2021, CMS also sent a violation letter to North Carolina’s Liberty Advantage. CMS didn’t tell the state’s free counseling service, the Seniors’ Health Insurance Information Program, about the letter, said its director, Melinda Munden.

Liberty representatives did not respond to requests for comment.

CMS sent a letter in 2016 to CareSource about network deficiencies in some of its Medicare Advantage plans sold in Kentucky and Indiana. The agency asked the company to fix the problems, including by reimbursing any members billed for services from doctors who were not in the plans’ networks.

“In response to the 2016 violations, we promptly implemented a Corrective Action Plan, which included a thorough review of our provider network to ensure adequacy standards were met,” said Vicki McDonald, a CareSource spokesperson. “CMS approved our plan, and no further action was required.”

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A Small Texas Think Tank Cultivated Covid Dissidents. Now They’re Running US Health Policy.

Martin Kulldorff, chair of the Trump administration’s reconstituted CDC vaccine panel, made a shocking — and misleading — statement as the group met in September. Referring to a clinical trial, Kulldorff, a biostatistician and former professor at Harvard Medical School, said eight babies born to women who received Pfizer’s covid vaccine while pregnant had birth defects, compared with two born to unvaccinated women.

“It is very concerning to have a fourfold excess risk of birth defects in these pregnant women,” Kulldorff then said.

Scientists criticized Kulldorff’s questions and remarks in that meeting because they suggested that the vaccine caused birth defects, which is not supported by evidence. The birth defects would have occurred before the women received the vaccine, the scientists said. They say it was one of several scientifically unsubstantiated claims by newly appointed members of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, an influential panel that guides which vaccines millions of people receive and whether insurance covers their cost.

Many of the new panel members share a connection to a little-known think tank making its mark in President Donald Trump’s Washington: the Brownstone Institute.

Libertarian author Jeffrey Tucker created the nonprofit institute in 2021, fueled by backlash against covid lockdowns and other pandemic-era policies. “You cannot do something like that to the world and expect people just to sit by and go, ‘OK, that’s normal,’” Tucker said in an interview.

Tucker has endorsed child labor; said of covid shots that “there is no evidence at all that the vaccines saved millions,” contradicting numerous studies showing the opposite; and opposes vaccine mandates.

His institute’s covid contrarians seek to limit the government’s role in protecting Americans from disease. The Austin, Texas-based think tank has received millions from donors whose identities are shielded in tax filings. And in recent months, its associates have catapulted to the highest levels of government.

At least eight people with ties to the Brownstone Institute hold or recently held senior positions at federal health agencies or key roles advising the government, exercising significant authority over access to vaccines and scientific research.

They include Jay Bhattacharya, director of the National Institutes of Health, which has been racked by funding cuts and firings under the Trump administration, as well as senior Food and Drug Administration officials Vinay Prasad and Tracy Beth Høeg. Prasad has been involved in restricting the use of covid vaccines. Høeg has voiced skepticism about vaccine mandates and some childhood immunizations.

Bhattacharya was a senior scholar for the organization. Brownstone has published Bhattacharya’s and Prasad’s writings on its website. Høeg has reported receiving payment from the group.

The institute has compensated Kulldorff and published his articles. Tucker wrote in October that 2020 marked “the beginning of a long friendship” with Kulldorff “that continues to this day.” Three other ACIP members share connections with the organization: MIT operations management professor Retsef Levi, who has spoken as part of at least one Brownstone event; physician Robert Malone, who speaks at its events and whose articles appear on its website; and Case Western Reserve University professor and epidemiologist Catherine Stein, who in 2022 authored an article calling for an end to vaccine mandates at universities.

Thomas Buckley, a public relations professional who wrote for the institute, accepted a political appointment as a top NIH spokesperson after thousands of workers at the biomedical research agency were fired. Buckley noted on Substack that his Brownstone writings “led to my new job.”

“That’s maybe his judgment,” Tucker said.

Buckley, when asked to elaborate, said in an email that he interviewed Bhattacharya “for a story that was later published on Brownstone — it was simply me being polite.” He said he resigned from the NIH on Sept. 30. NIH spokesperson Laci Williams declined to confirm his departure date.

Despite the ascendence of those with ties to his group, Tucker said that “anybody who thinks that somehow Brownstone is some big plot, it’s crazy.” He said he is not in regular contact with Health and Human Services Secretary Robert F. Kennedy Jr., whose department oversees the CDC, FDA, and NIH.

“I don’t have any influence,” Tucker said.

Sowing Vaccine Doubt

People with ties to the institute have sown doubt about covid vaccines or routine childhood immunizations, dismissing widespread evidence that they are safe and the benefits outweigh the risks.

“They’ve successfully placed their ideology inside the mechanism that determines U.S. vaccine policy,” said Jake Scott, a physician at Stanford Medicine who specializes in infectious diseases. “It’s very, very troubling.”

Tucker said that Brownstone “doesn’t have any operational impact on the ACIP committee at all” and that “if somebody wasn’t troubled by Brownstone, there’s probably no reason for us to exist.”

Tucker and Brownstone’s associates express libertarian views and promote distrust of government, including public health authorities.

“The evidence is mounting and indisputable that MRNA vaccines cause serious harm including death, especially among young people. We have to stop giving them immediately!” Levi posted on social media in 2023, referring to vaccines based on messenger RNA technology, which Pfizer-BioNTech and Moderna used to develop their covid shots. Stein wrote that covid vaccine mandates are “unethical” and not scientifically justified. Bhattacharya asserted on a podcast with Trump ally Stephen Bannon that mRNA technology for vaccines is “no longer viable,” and he has overseen mass terminations of NIH grants for scientific research.

Kennedy in June fired all 17 members of the CDC’s vaccine panel and has replaced them with 12 people so far, including individuals with connections to the Brownstone Institute. Tucker said that he did not propose to the White House or HHS that they be appointed and that Brownstone has not paid them over the past year.

During the September ACIP meeting, several new panel members expressed skepticism of vaccines and dismissed evidence — including the CDC’s own data — demonstrating that they are safe and effective.

That included Kulldorff’s questions and remarks about covid vaccines and birth defects.

In a Pfizer clinical trial, hundreds of pregnant women were given covid vaccines or a placebo during the second and third trimesters of pregnancy. But the birth defects Pfizer reported in its clinical study typically would have formed long before the vaccine was given, said Jeffrey Morris, a biostatistics and public health professor at the University of Pennsylvania Perelman School of Medicine.

“To say that this is a major safety risk,” Morris said, “is beyond a stretch.”

“This one really upsets me because it’s just so misleading,” he said.

Multiple large studies have shown no association between covid vaccines and miscarriage, stillbirth, or birth defects.

In response to questions for this article, Kulldorff said: “In the randomized trial, there were four times as many birth defects in children born to mothers receiving the Pfizer covid vaccine during pregnancy compared to the placebo-receiving control group. To ensure vaccine confidence, it is the responsibility of ACIP to note and inquire about such discrepancies, and it is the manufacturer’s responsibility to thoroughly examine it through additional follow-up studies.”

Kulldorff said he is “not affiliated with the Brownstone Institute” but declined to respond to additional questions, including whether he is currently compensated by the organization or has donated to it. The Brownstone Institute paid Kulldorff $108,333 in 2022, according to tax filings.

Levi said he heard about the Brownstone Institute from social media. He said he is in contact with Tucker “once in a while” but said Tucker has not advised him on vaccines since he was named to the CDC’s vaccine panel. Levi said he has “never received any compensation,” “never had any affiliation,” and “never donated or given any money” to the group.

Bhattacharya did not respond to questions. Williams, the NIH spokesperson, who had earlier declined to respond, citing the federal government shutdown, did not respond to a query seeking comment after the shutdown ended Nov. 12.

Stein declined to comment and referred questions to HHS. Department spokesperson Andrew Nixon said in a statement that Stein’s ACIP appointment “reflects the Administration’s commitment to independent, evidence-based science. Her professional record speaks for itself.”

The Brownstone Institute’s website says it works “to support writers, lawyers, scientists, economists, and other people of courage who have been professionally purged and displaced during the upheaval of our times.”

“There’s a danger associated with a state-imposed orthodoxy,” Tucker said in the interview. “I think Brownstone has a moral obligation to care for dissidents and create settings in which they’re able to test their ideas against people with whom they disagree.”

He said that “there’s never harm that comes from open debate and open distribution of information and views.” But Brownstone’s critics say its associates make extreme claims about vaccines and promote anti-vaccine messages.

“They kind of position themselves as defending freedom, but they consistently platform covid minimizers and vaccine skeptics,” Scott said.

Tucker took issue with the description, saying “it presumes that we know exactly with scientific precision the severity of covid, and so anybody who falls short of explaining that with amazing precision is a minimizer.”

In early September, Scott testified at a Senate subcommittee hearing on vaccines alongside Toby Rogers, a political economist and Brownstone Institute fellow who doesn’t list any medical credentials. Rogers wrote last year in his Substack newsletter that “vaccines are a civilization-destroying technology” and has promoted the debunked idea that vaccines cause autism. “My belief is that the autism and chronic disease epidemics are primarily caused by toxicants — mostly from vaccines and about a dozen additional toxicants,” Rogers said at the Senate hearing. Numerous studies have shown there is no link between vaccines and autism.

Days later, members of Kennedy’s handpicked panel of CDC vaccine advisers “spent hours elevating these theories” about vaccines “that are not really based in solid evidence or high-quality studies,” Scott said. “They manufactured doubt about established vaccines, entertained all this speculation without any evidence — that’s the real damage.”

Levi, responding to that criticism, said: “For the first time in a long time we are issuing objective, evidence-based immunization recommendations through ACIP with honest and transparent discussion of the benefits, risks, and uncertainties.”

As the panel weighed whether to delay the hepatitis B shot given to most newborns, Høeg, a senior adviser for clinical sciences at the FDA, questioned whether the vaccine is safe. “We should have some humility and consider that we may not know all of the potential safety issues,” she said to the CDC panel.

Widespread evidence shows that the hepatitis B newborn dose is safe and that the shot has very few side effects. Starting in 1991, the CDC recommended that the first of three shots of hepatitis B vaccine be given to infants shortly after birth. The move virtually eliminated the potentially fatal disease among American children. Babies infected with the virus at birth have a 90% chance of developing chronic hepatitis B.

In academic journals, Høeg has disclosed receiving payment from the Brownstone Institute but did not specify the amount. She has described Tucker as “a good friend.” Høeg did not respond to a request for comment for this article.

In an email, the FDA’s Prasad said that he “has received no money from Brownstone or any person(s) affiliated” and that all his content published on its website “was republished from his own personal Substack.”

Tucker said he has not advised Prasad or Høeg on vaccines since they became FDA officials. He described the latest CDC vaccine panel meeting as “a breath of fresh air.”

The Covid Contrarian Clubhouse

The Brownstone Institute, on its website, previously called itself “the spiritual child of the Great Barrington Declaration,” the controversial pandemic treatise Bhattacharya, Kulldorff, and Oxford University epidemiologist Sunetra Gupta co-authored in October 2020 that argued against lockdown measures to prevent the covid virus from spreading.

They proposed that widespread immunity against covid could be achieved by allowing healthy people to get infected, known as herd immunity, with protective measures instituted for medically vulnerable people.

The proposal was criticized at the time by many public health experts and high-ranking government officials, including then-NIH Director Francis Collins, who called its authors “fringe epidemiologists,” according to emails the American Institute for Economic Research obtained through a Freedom of Information Act request. (Tucker was AIER editorial director from 2017 to 2021.)

“They’ve been willing to publish articles of some very extreme anti-vaccine people,” Dorit Reiss, a professor at University of California Law-San Francisco focused on vaccine-related legal and policy issues, said of the Brownstone Institute. “They’re trying to give a more respectable veneer to the result of the Great Barrington Declaration,” she added.

In response, Tucker said: “I don’t think being an extremist is a good basis on which to shut somebody’s thoughts down. We need provocations.”

Tucker said he did not propose that Bhattacharya — who was a senior scholar at the institute and wrote 29 articles from July 2021 through October 2024 — be nominated to lead the NIH. More than one-third of the articles were co-authored with Kulldorff, who became Brownstone’s senior scientific director in November 2021.

Kulldorff told National Review he was fired from the Harvard-affiliated Mass General Brigham hospital system and placed on leave at the university that month after he refused to be vaccinated against covid, saying he had natural immunity. Kulldorff said he was hospitalized for a covid infection in early 2021.

The Brownstone Institute reported nearly $7.4 million in contributions, grants, and other payments between 2021 and 2024, with about 35% coming from tax-exempt foundations and donor-advised funds, according to an analysis of tax filings. Donor-advised funds allow people to secure tax deductions for anonymous charitable contributions. Tucker said the organization has 17,000 donors, most of them small, but declined to elaborate on funders.

The filings show the institute has also received funding from foundations run by people with backgrounds in business, including in tech, finance, law, and banking. According to a review of tax records, many of them have also given to anti-vaccine organizations; groups such as the Independent Medical Alliance, which promoted ineffective treatments for covid; or prominent organizations in conservative politics, such as the Federalist Society, the Alliance Defending Freedom, and the Heritage Foundation. Brownstone in 2023 received $67,350 from Donors Trust Inc., which funds conservative causes.

As of 2024, the Brownstone Institute’s board included David Stockman, a White House budget chief under President Ronald Reagan; libertarian economist Donald Boudreaux; and Roger Ver, an investor known as “Bitcoin Jesus.”

Ver’s website said he gave more than $1 million to the institute.

In 2024, Ver was indicted by a federal grand jury for allegedly committing tax fraud costing the IRS at least $48 million. On Oct. 14, the Justice Department announced that Ver had entered into a deferred prosecution agreement to resolve federal tax charges against him and has paid the IRS nearly $50 million. The government has moved to dismiss the indictment against him.

‘People Are Very Skeptical’

Other than publishing posts on its website, the institute awards fellowships and convenes conferences and retreats. Its associates testify in front of Congress. And it holds a “Supper Club” series in cities throughout the country.

“The goal of Brownstone is to make possible wide-ranging conversations about the failure of the system and the solutions to it,” Tucker said.

Ashley Grogg, a registered nurse and founder of Hoosiers for Medical Liberty, spoke at a Supper Club in August on “informed decision-making,” primarily about vaccines.

“People are very skeptical,” Grogg said in an interview. “How do we trust people moving forward? Do we really think that we can trust the new leadership that’s coming in to do the right thing?”

She said she was connected to Brownstone through one of her members. Grogg said she does not think newborns should universally be given the hepatitis B vaccine shortly after birth and opposes vaccine mandates. “I don’t want to take anything away from anybody,” but people who refuse to be vaccinated should not be “withheld from society,” Grogg said.

In September, as the CDC’s vaccine advisers met, Tucker took to the social media platform X to amplify statements questioning vaccines, including from panel members with ties to the group he created. One was Malone saying, “It’s clear that a significant population in the United States has significant concerns about vaccine policy and about vaccine mandates.” Another was from Levi, who, referring to covid vaccines, said, “Most of us are extremely concerned about the safety and the lack of robust evidence both on safety and efficacy for not only pregnant women, but their babies.”

There is strong evidence that mRNA and non-mRNA covid vaccines are safe for pregnant women. A mother’s vaccination while pregnant also helps protect newborns. CDC data that drew upon medical records in 12 states found that nearly 90% of babies who were hospitalized with covid had mothers who did not get the vaccine while pregnant.

In response to questions for this article, Levi said in an email that “the claim that there is strong evidence for the efficacy and safety of covid vaccination during pregnancy in the absence of appropriate clinical trials is not consistent with fundamental regulatory principles” and that panel members “were also concerned by the potential safety signal in the single (small) clinical trial that was conducted, and other research.” Malone did not respond to questions for this article.

Kulldorff, the ACIP chair, said the panel will review vaccines given during pregnancy, childhood, and adolescence.

Less than a week after the ACIP meeting in Atlanta, Levi gave a Brownstone Institute talk about artificial intelligence systems.

Brownstone was a sponsor this month when Children’s Health Defense, a leading anti-vaccine nonprofit founded by Kennedy, held its annual conference in Austin.

And during the institute’s own annual conference recently in Utah, Bhattacharya was one of three people who received its first “Brownstone Prize.”

“I would think it represents a kind of integrity and courage in public life,” Tucker said, “and stand up for what you believe is the truth, even at some degree of personal risk.”

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El ICE puede estar en el hospital con un paciente bajo custodia. Pero los detenidos tienen derechos

En julio, agentes federales de inmigración llevaron a Milagro Solís-Portillo al Glendale Memorial Hospital, en las afueras de Los Ángeles, luego que sufriera una emergencia médica estando detenida. Nunca se fueron del hospital.

Durante dos semanas, contratistas del Servicio de Inmigración y Control de Aduanas (ICE) hicieron guardia en el vestíbulo del hospital las 24 horas del día. Se tomaron turnos para vigilar sus movimientos, contó Ming Tanigawa-Lau, la abogada de Solís-Portillo.

Luego, el ICE trasladó a la mujer salvadoreña al Anaheim Global Medical Center, en contra de las indicaciones médicas y sin dar ninguna explicación, según dijo la abogada.

Tanigawa-Lau contó que allí les permitieron a los agentes del ICE quedarse dentro de la habitación de Solís-Portillo todo el tiempo, escuchando conversaciones entre la paciente y el personal médico que deberían haber sido privadas.

Solís-Portillo le dijo a su abogada que los agentes la presionaron para que dijera que estaba lo suficientemente bien como para salir del hospital, advirtiéndole que no podría comunicarse ni con su familia ni con su abogada hasta que aceptara irse.

“Me lo describió como una situación en la que sentía que la estaban torturando”, enfatizó Tanigawa-Lau.

Expertos legales explican que los agentes del ICE pueden estar en áreas públicas de un hospital, como el vestíbulo, y pueden acompañar a pacientes que ya están detenidos mientras reciben atención médica, lo que refleja el alcance de la autoridad federal.

Sin embargo, los pacientes detenidos tienen derechos y pueden tratar de defenderse por sí mismos o buscar ayuda legal.

Este año, California destinó $25 millones para financiar servicios legales para inmigrantes, y algunas jurisdicciones locales —incluidos el condado de Orange, Long Beach y San Francisco— también han asignado fondos para iniciativas de ayuda legal. El Departamento de Servicios Sociales de California enumera algunas organizaciones sin fines de lucro que han recibido estos fondos.

Sophia Genovese, abogada supervisora y profesora clínica en la Facultad de Derecho de Georgetown, explicó que los agentes del orden, incluidos los agentes federales de inmigración, pueden custodiar e incluso mantener esposada a una persona bajo su custodia mientras recibe atención médica.

Pero deben cumplir con las leyes constitucionales y de privacidad médica, sin importar el estatus migratorio del paciente. Según esas normas, los pacientes pueden pedir hablar en privado con los proveedores médicos y tener acceso confidencial a asesoría legal, explicó Genovese.

“ICE debe ubicarse fuera de la habitación o fuera del alcance auditivo durante cualquier conversación entre el paciente y su doctor o proveedor de salud”, dijo Genovese, y agregó que lo mismo aplica a las comunicaciones con abogados. “Eso es lo que se supone que deben hacer”.

Guías de ICE

En cuanto a la comunicación y las visitas, las normas del ICE establecen que los detenidos deben tener acceso a un teléfono y poder recibir visitas de familiares y amigos, “dentro de las limitaciones operativas y de seguridad”. Sin embargo, Genovese dijo que esas pautas no se exigen por ley.

Si los agentes de inmigración arrestan a una persona sin una orden judicial, deben informarle el motivo de la detención y, por lo general, no pueden retenerla más de 48 horas sin tomar una decisión formal sobre su custodia.

Un juez federal concedió recientemente una orden de restricción temporal en un caso en el que un hombre llamado Bayron Rovidio Marín fue vigilado por agentes de inmigración en un hospital de Los Ángeles durante 37 días sin que se le presentaran cargos.

En el pasado, si se percibían violaciones por parte de los agentes, se podían reportar a las oficinas locales del ICE, a la sede de la agencia o a organismos de supervisión, explicó Genovese.

Pero este año el Departamento de Seguridad Nacional (DHS) redujo el personal de las oficinas del ombudsman que investigan denuncias por violaciones a los derechos civiles, argumentando que esas oficinas “obstruían la aplicación de las leyes migratorias al agregar trabas burocráticas”.

Tricia McLaughlin, secretaria adjunta de asuntos públicos del DHS, dijo que los agentes arrestaron a Marín por estar en el país ilegalmente y que él mismo admitió su estatus migratorio ante los agentes del ICE. McLaughlin dijo que lo llevaron al hospital luego de que se lastimara una pierna mientras intentaba escapar de los oficiales federales durante una redada.

McLaughlin señaló que los agentes no le impidieron comunicarse con su familia ni usar el teléfono.

“Todos los detenidos tienen acceso a teléfonos que pueden usar para comunicarse con sus familias y abogados”, agregó.

McLaughlin calificó como “activista” a la jueza que emitió la orden de restricción temporal. No respondió a preguntas sobre los recortes de personal en las oficinas del ombudsman.

El DHS también dijo que Solís-Portillo estaba en el país sin autorización. Según el departamento, había sido expulsada de Estados Unidos en dos ocasiones y había sido arrestada por los delitos de uso de identificación falsa, robo y entrada en una vivienda ilegalmente.

“El ICE se toma muy en serio su compromiso de ofrecer entornos seguros, protegidos y humanos para quienes están bajo nuestra custodia”, dijo McLaughlin. “Desde que una persona entra bajo custodia del ICE, es práctica de larga data proveer atención médica integral, lo que incluye acceso a citas médicas y atención de emergencia las 24 horas”.

Protecciones en California

El Anaheim Global Medical Center no respondió a un pedido de comentarios.

En un comunicado, Dignity Health, que opera el Glendale Memorial Hospital, afirmó que “legalmente no puede restringir la presencia de personal de seguridad o agentes del orden en áreas públicas, lo que incluye el vestíbulo o las salas de espera del hospital”.

En septiembre, California aprobó una ley que prohíbe a los establecimientos médicos permitir la entrada de agentes federales a áreas privadas —incluyendo espacios donde los pacientes reciben atención o discuten temas de salud— si no presentan una orden de cateo o un mandato judicial válido.

Sin embargo, muchas de las noticias más destacadas sobre la presencia de agentes de migración en centros de salud han involucrado a pacientes detenidos que fueron trasladados para recibir atención.

Erika Frank, vicepresidenta de asesoría legal de la California Hospital Association, dijo que los hospitales siempre han recibido personas detenidas que necesitan atención médica por parte de las autoridades, incluidos agentes federales.

Según Jan Emerson-Shea, vocera de la asociación, son las autoridades quienes deciden si un paciente necesita ser vigilado todo el tiempo. Si un agente del orden escucha información médica mientras está presente en el hospital, eso no constituye una violación de la privacidad del paciente, agregó.

“Legalmente, no es diferente de que otro paciente o visitante escuche información sobre alguien en una cama cercana o en una sala de emergencias”, dijo Emerson-Shea en un comunicado.

No respondió si los pacientes pueden exigir privacidad con el personal médico o con sus abogados, y señaló que los hospitales no informan a familiares o amigos sobre la ubicación del paciente detenido, por razones de seguridad.

Sandy Reding, presidenta de la California Nurses Association, visitó las instalaciones de Glendale cuando Solís-Portillo estuvo internada. Contó que tanto enfermeras como pacientes se sintieron intimidados al ver agentes de inmigración con máscaras en el vestíbulo del hospital. Dijo que los vio sentados detrás del escritorio donde se registran los pacientes, desde donde podían escuchar conversaciones sobre información médica privada.

“Los hospitales solían ser un lugar seguro, y ahora ya no lo son”, dijo. “Y parece que el ICE actúa sin restricciones”.

La Junta de Supervisores del Condado de Los Ángeles tiene previsto votar el 18 de noviembre una propuesta para brindar mayor protección a las personas detenidas en centros de salud administrados por el condado. Estas medidas incluyen limitar la capacidad de los funcionarios de inmigración para ocultar la identidad de los pacientes, permitir que estos den su consentimiento para la divulgación de información a familiares y abogados, e instruir al personal para que exija que los agentes de inmigración abandonen la habitación en determinados momentos para proteger la privacidad de los pacientes. El condado también defenderá a los empleados que intenten hacer cumplir sus políticas.

La abogada de Solís-Portillo, Tanigawa-Lau, dijo que su clienta finalmente decidió regresar voluntariamente a El Salvador en lugar de pelear su caso, porque sentía que no podía recibir la atención médica que necesitaba mientras estuviera bajo la custodia del ICE.

“Aunque el caso de Milagro es realmente terrible, me alegra que ahora haya más conciencia sobre este tema”, afirmó Tanigawa-Lau.

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FDA’s Plan To Boost Biosimilar Drugs Could Stall at the Patent Office

While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer, and other diseases, the U.S. patent office is making it harder for the cheaper medicines to get on the market, industry officials say.

These officials were thrilled Oct. 29 when FDA Commissioner Marty Makary announced the agency’s plan, which he said would halve the time and money needed to get what are called “biosimilar” drugs to market. Biosimilars are essentially generic versions of biologics — such as Humira, Keytruda, and Xolair — which are made from living organisms. Biosimilars can cost up to 90% less.

Under the guidance the FDA proposed, the agency would begin overseeing biosimilars similarly to the way it regulates generics, which are copies of simpler molecules, usually pills. This change in approach could allow companies to save up to $100 million for each drug they develop, enabling them to make more products for underserved patients, said Stefan Glombitza, CEO of Formycon AG, a maker of biosimilars based in Germany.

But President Donald Trump’s patent office is working at cross-purposes with the FDA, biosimilar makers charge, by narrowing the opportunities for companies that try to challenge the throngs of patents that brand-name drugmakers file to protect their products from competition.

In the past, biosimilar makers have been able to invalidate some of those patents through a sped-up process called “inter partes review,” or IPR. But the new administration has denied most IPR requests and issued a proposed rule in October that makes IPRs harder to get.

Heavyweights on Pricing

Biosimilars have the potential to nibble or even gouge away at a major U.S. health care cost. Only 5% of prescriptions are for biologic drugs, but they account for more than half of the $600 billion the nation annually spends on medicines.

“Generic and biosimilar competition is the crucial way that we bring down prescription drug prices,” said William Feldman, a pharmaceuticals policy researcher at UCLA.

The FDA announcement “is a good thing that may ease barriers,” he added, “but there are a lot of caveats.”

In fact, biosimilar industry officials say, FDA regulation is often the least of the three major hurdles they face in marketing their products.

To protect their market share, brand-name biologics makers file scores or even hundreds of patents, continuing to do so long after their drugs hit the market. The “patent dance” that occurs when biosimilar makers seek to launch competitor drugs can drag on for many years.

For example, the FDA approved the first biosimilar of the rheumatoid arthritis drug Humira in 2016, but legal battles delayed competitors from entering the market — until nine FDA-approved products were launched in 2023. At his Oct. 29 news conference, Makary blamed FDA “red tape” for the delay, but it was mostly due to the baffling patent machinery, industry officials say.

The new rules, which could take effect next year, would formalize recent FDA practices aimed at speeding along approval for biosimilars. For example, the FDA has recently allowed drugmakers to waive expensive clinical testing contemplated under a 2009 law. The agency now lets companies employ less costly analytical tests, if they can show that the biosimilar has no clinically meaningful differences from the brand-name drug.

A ‘Switching’ Burden

Because biologic drugs are large molecules produced from live cells, copies of them cannot be chemically identical. So the FDA had required biosimilars to go through clinical studies like the ones required for the original drugs. But research has shown that analytic techniques can replace the need to test biosimilars on large numbers of patients.

The new rules would also confirm the FDA’s move away from requiring what are known as “switching” tests, in which patients first go on the brand-name drug and then the biosimilar, or vice versa, to see if their responses are the same. Such tests are required in many states for the biosimilar to obtain “interchangeable” status, which enables pharmacists to substitute an often cheaper version for the prescribed brand-name drug.

In short, the new rules would mean biosimilar makers would spend less money getting drugs to market, said Sean Tu, a law professor at the University of Alabama. “What that won’t do is get you on the market earlier,” he added.

After biosimilars launch, it can take years for them to gain a foothold. In 2023, Humira biosimilars made barely a dent in the market, and in 2024 they accounted for only about a quarter of sales, though they cost as little as 10% of the roughly $6,500 monthly price tag for the brand-name drug.

That’s because brand-name drug companies offer lucrative rebates for sales of their drugs to the go-between companies that design formularies — tiered lists that tell doctors and pharmacies which drugs are covered by insurance. These middlemen, pharmacy benefit managers, pass along some of that money to health plans.

Essentially, the insurance plans are “charging higher costs to people who require expensive drugs as a way to subsidize the whole population,” said Wayne Winegarden, an economist at the Pacific Research Institute.

The Patent Thicket Thickens

Biosimilar makers are particularly worried about the direction the U.S. Patent and Trademark Office has taken under Trump.

Patent challenges are already 10 to 20 times as expensive in the United States as in Europe, and restricting inter partes reviews is making it worse, said Formycon’s Glombitza.

The FDA recently gave his company a waiver from conducting a costly clinical trial of its biosimilar substitute for Keytruda, a blockbuster cancer drug. But Merck & Co., which got about half of its $17 billion third-quarter revenue from Keytruda, is expected to fight tooth and nail to protect its many patents on the drug. The Trump administration’s new obstacles to challenge them “counteract the waiver,” Glombitza said.

Merck protects its innovations, said spokesperson Julie Marie Cunningham. However, noting that Merck is touting a new, injectable Keytruda formulation, she said the company does not expect it to affect “the potential marketing” of biosimilars for the older, intravenous form of the drug.

The Pharmaceutical Research and Manufacturers of America, or PhRMA, the industry group representing most large brand-name companies, “welcomes the administration’s focus on increasing biosimilar access and affordability,” said spokesperson Alex Schriver.

But Big Pharma companies favor the patent office’s swing toward more protection of filed patents, according to attorneys who work in intellectual property litigation.

“I don’t think the Trump administration has any kind of coherent plan here,” said Mark Lemley, director of the Stanford Program in Law, Science & Technology. While Trump officials want to bring drug costs down, “they also want to make it more expensive to figure out whether patents are valid by effectively eliminating IPRs,” he said.

The patent office did not respond to repeated phone calls and emails.

Patents and patent litigation are the biggest impediments to getting biosimilars onto the market, UCLA’s Feldman said.

For instance, the FDA licensed Sandoz’s biosimilar for Enbrel, a popular drug to treat autoimmune disorders, in 2016, but Sandoz won’t be able to market its competitor in the U.S. until 2029 at the earliest because of patent challenges. Without insurance, Enbrel costs about $7,000 to $9,000 a month.

A Patient’s Perspective

Judy Aiken, a retired Portland, Maine, nurse who has taken Enbrel since 2007 to treat psoriatic arthritis, would be interested in trying the copycat if it costs her less. After retiring in 2019 and going on Medicare, she has spent thousands each year on the drug.

The Biden-era Inflation Reduction Act capped her out-of-pocket drug costs at $2,000 this year, and Aiken and her husband used the savings to replace their roof and furnace. But with health care changes on the horizon, “now I’m scared the other shoe is going to drop,” she said.

Only about 10% of the 118 biologics set to come off patent in the next decade have biosimilars in development, reflecting poor incentives in a system that biosimilar makers and patient advocates say is stacked against them.

But lower costs could enable companies like Formycon to expand their product lines — focused now on cancer and autoimmune diseases — to less common or even rare conditions, said CEO Glombitza.

“People have talked about the promise of biosimilars reducing out-of-pocket costs and creating more choices for consumers, and I feel like we’re still waiting,” said Anna Hyde, chief of advocacy and access for the Arthritis Foundation, which lobbies for research and treatment.

Although biosimilars could save everyone money, patients generally don’t care whether they get one or not, Hyde noted. Some don’t want to switch if they’ve found a brand-name drug that works for them, since the search can be grueling for people suffering from autoimmune diseases, she said.

“Generally, they can’t access them anyway,” she said, “because they are not available on the formulary.”

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Conflicting Advice on Covid Shots Likely To Ding Already Low Vaccine Rates, Experts Warn

More than three-quarters of American adults didn’t get a covid shot last season, a figure that health care experts warn could rise this year amid new U.S. government recommendations.

The covid vaccine was initially popular. About 75% of Americans had received at least one dose of the first versions of the vaccine by early 2022, Centers for Disease Control and Prevention data shows. But only about 23% of American adults got a covid shot during the 2024-25 virus season, well below the 47% of American adults who got a flu shot. The vaccination rates for flu, measles, and tetanus are also going down.

Yet covid remains a serious, potentially deadly health risk, listed as the primary cause of death on roughly 31,400 death certificates last year. By comparison, flu killed about 6,500 people and pneumonia, a common complication of the flu, killed an additional 41,600, CDC data shows.

As millions of Americans decide whether to get a covid shot this season, public health researchers worry vaccination rates will slide further, especially because Hispanic and Black Americans and those under 30 have lower rates, exposing them to serious complications such as long covid. Under the Trump administration and Health and Human Services Secretary Robert F. Kennedy Jr., the federal government has narrowed its recommendations on the covid vaccine, leading to a hodgepodge of rules on pharmacy access, with Americans living in Republican states often facing more barriers to getting a shot.

“A lot of misinformation is going around regarding covid,” said Alein Haro-Ramos, an assistant professor of health, society, and behavior at the University of California-Irvine. “Vaccine hesitancy is going to increase.”

In August, the FDA narrowed approval for covid vaccines to those 65 or older and to adults and children with at least one underlying condition that puts them at high risk for serious complications from covid.

A month later, the CDC’s Advisory Committee on Immunization Practices voted to recommend “shared clinical decision-making” on the vaccine, pulling back from advising all adults to get vaccinated. The committee advised doctors to emphasize to adults under 65 and children that the benefits of the vaccine are greatest for those with underlying health conditions.

The guidance is rebutted by infectious disease experts who say most adults and children should get both the flu and covid vaccines, which are safe, effective, and prevent serious illness. Several independent medical organizations like the American Academy of Family Physicians and the American Academy of Pediatrics have reiterated their support for broad adoption of covid vaccines.

More than two dozen states have taken steps to ensure most people can get a covid shot at the pharmacy without a prescription, with many states tying their policies to the advice given by medical organizations. And many of those states require insurers to cover vaccines at no cost, according to a KFF analysis. In several other states, predominantly Republican-led, pharmacy access to vaccines may require a prescription.

Among the most commonly cited reasons for covid vaccine hesitation are fears about side effects, long-term health consequences, and the effectiveness of the vaccine, and mistrust of pharmaceutical corporations and government officials, according to a 2024 review of multiple studies, published in the journal Vaccines.

Covid vaccine hesitancy in the 2024-25 virus season was higher among Latinos, African Americans, men, uninsured people, and people living in Republican-leaning states, CDC data shows.

Latino adults were significantly less likely than adults from most other racial and ethnic groups to get a covid shot last season, with a vaccination rate around 15%.

Some of that may be due to age: A disproportionate share of Latinos are young. But public policy actions may also be a factor. The first Trump administration, for example, tied Medicaid to “public charge,” a rule allowing the federal government to deny an immigrant a green card or visa based on their dependence on taxpayer-funded programs. Some Latinos may be afraid to sign up for social services even after the Biden administration reversed those first-term Trump actions.

Haro-Ramos co-authored a study published in 2024 that found many Latinos were hesitant to get vaccinated because of fears about their immigration status, and that experiencing health discrimination, like care denials or delays, increased their vaccine hesitancy.

“Do you trust the health care system, broadly speaking? Do you want to provide your information — your name, your address?” Haro-Ramos said. “Trust is critical.”

Haro-Ramos said the problem has likely worsened since her study was published. The Trump administration revealed this summer that it would give the personal information of Medicaid enrollees to Immigration and Customs Enforcement. Many Latinos are canceling doctor appointments to head off possible confrontation with immigration enforcement officials.

“People are avoiding leaving their homes at all costs,” Haro-Ramos said.

Janani Rajbhandari-Thapa, an associate professor at the University of Georgia College of Public Health, recently co-authored a study of covid vaccination among nearly 1,500 African Americans living in south Georgia. The study found that participants were more likely to listen to their health care providers than faith leaders or co-workers when seeking advice on getting vaccinated.

More than 90% of those studied had received at least one dose of the vaccine, but those who were unvaccinated were more likely to agree with false statements that tied vaccines to miscarriages, to components’ remaining in the body for a long time, or even to the conspiracy that they implant a computer chip in the body.

“It's the clinicians who can take the messages about vaccination — that these are myths,” Rajbhandari-Thapa said.

Even though covid hospitalization and death rates have fallen dramatically since the worst days of the pandemic, fatal complications related to covid remain most common among older people. Around 89% of U.S. covid deaths last year were among people 65 and older, compared with about 81% of flu and pneumonia deaths.

As the pandemic falls into the rearview, young people have developed a sense of invincibility. Only 11% of Americans ages 18 to 29 received a vaccine during the 2024-25 virus season, the lowest vaccination rate among adult age groups. That’s far below the 70% of young adults who got at least one dose of the initial covid vaccines by November 2023.

While many people get covid after receiving a covid shot, because the vaccine’s ability to prevent infection wears off pretty fast, some misunderstand the purpose of the shot, said Otto Yang, an infectious disease specialist at UCLA Health.

“They think, ‘Well, the vaccine didn’t prevent me from getting covid, so the vaccine didn’t work,’” Yang said. “And what they're not seeing is that the vaccine prevented them from getting severely ill, which is ultimately the most important thing.”

And the vaccine can help prevent long covid, which is a problem for all ages, Yang said. A recent Northwestern University study found that younger adults suffer worse symptoms of long covid than older adults.

Ultimately, Yang said, it is not a consistent choice to get a flu vaccine but forgo a covid vaccine, since both are safe, effective, and prevent serious illness. It is clear, he added, that people with compromised immune systems and those at higher risk should get a covid shot. The decision is “a little bit less clear” for others, but “probably most adults should be getting vaccinated, just like it’s recommended for the flu vaccine, as well as most children.”

Phillip Reese is a data reporting specialist and an associate professor of journalism at California State University-Sacramento.

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