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

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

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

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

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

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

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

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

Impact of Inflation Reduction Act Will Take Many Years

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

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

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

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

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

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

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

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

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

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

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

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

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

Our Ruling

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

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

We rate this statement Half True.

Sources

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

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

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

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

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

White House, statement to PolitiFact, March 8, 2024

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

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

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

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

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

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

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There’s a long-running battle between insurers and drugmakers over financial assistance programs that purport to help patients afford expensive drugs. And lately, insurers have been losing ground as lawmakers, regulators and courts weigh in.

The issue is whether coupons and other copay aid many patients get from drugmakers should count toward annual insurance deductibles and out-of-pocket spending limits, enabling them to more quickly get fuller coverage for their medicines or other care. Insurers and employers gripe that the assistance is just a marketing ploy, intended to keep patients on costlier drugs even when cheaper alternatives are available.

But caught in the middle are people like Jennifer Hepworth of Eagle Mountain, Utah, who uses drugmaker assistance programs to pay for multiple prescriptions for herself and her daughter. Patients “are the ones losing out every time in this war between these two mega-industries,” Hepworth said.

Hepworth’s family used to be able to almost immediately hit their annual deductible by using drugmaker coupons for co-payments. By midyear, they’d hit their out-of-pocket maximum of $10,000 and no longer have any co-payments at all.

Then the insurance plan managing her husband’s employer coverage made a key change: It adopted a practice called “co-payment accumulator” that prevented those drug coupons from being counted toward deductibles.

All of a sudden, Hepworth’s family had to pay thousands of dollars out-of-pocket toward their deductible.

“Everything went on credit cards,” she said. And it took a lot longer to hit the out-of-pocket maximum.

The insurance industry says it can’t allow drugmaker financial assistance to count toward deductibles without affecting monthly premiums. It’s “a vital tool in keeping health insurance affordable,” the Blue Cross Blue Shield Association said in a recent letter to regulators.

The majority of insured people are in plans that use these kinds of programs, according to Avalere, a consulting firm. But some politicians aren’t buying it. Nineteen states now limit copay accumulator programs for some insurance plans — though not those of large employers that cover most workers..

And bipartisan legislation introduced in both chambers of Congress would require drugmaker financial assistance to be counted toward insurer deductibles and out-of-pocket limits.

Called the Help Ensure Lower Patient Co-pays Act, it would apply to most plans, including those exempt from state rules, such as those of large employers.

On top of all that, patient advocacy groups won a favorable ruling last December against copay accumulator programs in the U.S. District Court for D.C.

Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said the court decision essentially overturns a provision of a Centers for Medicare and Medicaid Services rule started late in the Trump administration that allowed insurers to expand the practice to almost any drug. Previous rules from 2020 would now be in effect, Schmid said, requiring copay assistance to count toward the deductible for all drugs for which there is no medically appropriate generic alternative available.

Even so, changes for many insured patients may take a while.

The Biden administration dropped an appeal of the decision on the Trump-era regulation in January, but it has filed motions saying that “it does not intend to take any enforcement action against issuers or plans” until regulators draw up new rules, according to Ellen Montz, deputy administrator and director of the Center for Consumer Information and Insurance Oversight at CMS.

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Durante el boom de la telemedicina por la pandemia de covid-19, surgieron tiendas online que promocionaban la testosterona como remedio para las afecciones masculinas relacionadas con la edad, a pesar de las normas de la Administración de Drogas y Alimentos (FDA) emitidas hace años que restringen este tipo de publicidad sobre “testosterona baja”.

En anuncios de Google, Facebook y otros medios, los sitios web de telemedicina sobre testosterona pueden prometer una solución rápida para la “lentitud” y la libido baja en los hombres. Pero los médicos dicen que no hay pruebas de su eficacia, y que es más probable que las causas del decaimiento masculino para el que se promociona la testosterona como solución sean las afecciones crónicas, una dieta inadecuada o un estilo de vida sedentario.

De hecho, los médicos piden precaución, y la FDA recomienda que todos los suplementos de testosterona lleven la advertencia de que pueden aumentar el riesgo de infarto de miocardio y accidente cerebrovascular.

Existen razones médicas válidas para tratar a algunos hombres con testosterona. La hormona existe como medicamento desde hace décadas, y entre los pacientes actuales se encuentran hombres con hipogonadismo, algunos transexuales que la utilizan para facilitar la transición física y, en ocasiones, mujeres con síntomas menopáusicos. También ha sido utilizada durante décadas por fisicoculturistas y atletas para aumentar su fuerza.

Sin embargo, los dispensarios en internet pueden exagerar la idea de lo que a veces se denomina “menopausia masculina”, para impulsar las ventas de inyectables potenciadores de la testosterona, muy rentables, ignorando a menudo las directrices de seguridad que deberían impedir el uso de la hormona en hombres sanos. Algunos de los sitios web se dirigen a veteranos militares.

“He visto anuncios en Internet que se pasan de la raya”, afirmó Steven Nissen, médico y director académico del Heart, Vascular, and Thoracic Institute de la Clínica Cleveland. “Para el estado de ánimo y la baja energía, recetar testosterona aporta poco o ningún beneficio. Están promoviendo la testosterona para indicaciones que no figuran en la etiqueta”.

Casi todos los sitios web sobre testosterona citan un estudio publicado en 2002 por científicos de los New England Research Institutes, que descubrieron que los niveles de testosterona caen un 1% al año en hombres mayores de 40 años. Stefan Schlatt, director del Centro de Medicina Reproductiva y Andrología de la Universidad de Muenster, en Alemania, dijo que los datos que respaldaban la estadística incluían a hombres mayores con una salud deteriorada cuyos niveles disminuían a causa de enfermedades.

“Los hombres sanos no muestran ese descenso”, señaló.

Ese estudio de 2002 dio lugar a una avalancha de anuncios de “baja T” en la televisión estadounidense, anuncios que más tarde fueron prohibidos por la FDA, en una sentencia de 2015 que acusaba a la industria farmacéutica de exagerar el fenómeno de la baja T para asustar a los hombres y hacerles comprar medicamentos.

Según otro estudio, el mercado de suplementos de testosterona se situó en $1,850 millones en 2023.

El diluvio de anuncios “ha alimentado la demanda de un producto en gran parte no cubierto, lo que permite altos márgenes de beneficio”, explicó Geoffrey Joyce, director de políticas de salud en el USC Schaeffer Center for Health Policy & Economics e investigador del National Bureau of Economic Research. “El motor principal es la demanda fabricada”.

Barbara Mintzes, profesora de política farmacéutica basada en la evidencia en el Centro Charles Perkins de la Universidad de Sydney, Australia, dijo que el bajo nivel de testosterona debería considerarse realmente como un signo de una enfermedad que necesita tratamiento. Mintzes dijo que la diabetes, las cardiopatías, la hipertensión, la obesidad, la exposición a sustancias químicas tóxicas como los PFAS y el estrés pueden reducir los niveles de testosterona.

Varios de los sitios web analizados por KFF Health News se presentan como revistas de noticias y fitness, con anuncios insertados en los artículos que dirigen a los lectores hacia formularios para pedidos de terapia de sustitución de testosterona, abreviada como TRT.

Los precios de la TRT oscilan entre $120 y $135 al mes, sin incluir los análisis de sangre iniciales por correo, que cuestan unos $60. Algunos sitios prometen aumentar la libido y reducir la grasa del estómago.

Por ejemplo, los anuncios de Male Excel en Google dicen que la TRT “mejora el estado de ánimo” y “restaura la vitalidad”. Y su sitio dice que el tratamiento con testosterona proporcionará “definición muscular”, “pérdida de peso”, “impulso explosivo”, “sueño más profundo” y “energía restaurada” por encima de un enlace a una evaluación gratuita en su plataforma de telesalud en línea.

Craig Larsen, director general de la empresa, no respondió a varios intentos de establecer contacto por teléfono y correo electrónico.

Tanto Male Excel como Hone Health se encuentran entre los sitios que se dirigen a los veteranos militares. Hone Health incluía un video de un veterano que afirmaba que un hospital del Departamento de Asuntos de Veteranos le había denegado el tratamiento con testosterona.

Saad Alam, CEO y cofundador de Hone, afirmó que su empresa es “conservadora” en el mercado. Dijo que Hone receta sólo a los hombres que son hipogonadales y les hace pruebas cada 90 días, a diferencia de otras empresas que operan sitios web de telesalud a las que calificó de “cazadoras de dinero”.

“Estoy de acuerdo en que los pacientes deben ser tratados por sus médicos. Pero el sistema de salud estadounidense no está en condiciones de atender a los hombres que tienen este problema, y algunos endocrinólogos prefieren tratar a pacientes que proporcionan mayores beneficios”, dijo Hone. “Por eso la gente acude a nosotros”.

Una forma popular de TRT es el cipionato de testosterona inyectable. Según la base de datos de precios de venta de Medicare, cuesta $0,027 por miligramo. Los proveedores en internet que venden el fármaco directamente a los consumidores en viales de 200 mg/mL por un precio medio de $129 al mes están cobrando el equivalente a $1,55 por miligramo, un margen de beneficio de más de 50 veces el precio promedio de Medicare.

Según un estudio de 2022, los sitios web de telesalud de TRT crean una forma de eludir a los médicos que se niegan a recetar la hormona. En ese estudio, Justin Dubin, urólogo del Memorial Healthcare System de Florida, se hizo pasar por un consumidor. Declaró tener un nivel de testosterona por encima de lo normal y manifestó su deseo de formar una familia, a pesar de que este tipo de terapia puede frenar la producción de esperma. Sin embargo, seis de las siete clínicas online de TRT le recetaron testosterona a través de un profesional médico.

“Y eso es preocupante”, afirmó Dubin. “La telemedicina ayuda a los hombres con hipogonadismo que podrían sentirse demasiado avergonzados para hablar de disfunción eréctil. Pero tenemos que hacer un mejor trabajo para entender lo que es una atención apropiada”.

Aun así, aunque la FDA no permite la comercialización off-label (la práctica de recetar medicamentos para un uso distinto par el que han sido aprobados), sí permite las recetas off-label.

El uso off-label de reemplazo de testosterona se ha convertido en algo común entre los veteranos. Y entre los militares masculinos que recibieron TRT en 2017, menos de la mitad cumplieron con las pautas de práctica clínica, según un informe del ejército estadounidense.

Phil Palmer, veterano del Cuerpo de Marines, de 41 años, que vive en las afueras de Charleston, Carolina del Sur, dijo que paga de su bolsillo los análisis de sangre y las recetas para una forma de testosterona de implante cutáneo y para el clomifeno, un medicamento que puede ayudar a contrarrestar la infertilidad masculina que es un efecto secundario del tratamiento con testosterona.

Palmer explicó que el tratamiento es algo que le atrae tanto a él como a otros veteranos que se enfrentan a las secuelas de haber servido en las fuerzas armadas.

“El entorno en el que servimos y los niveles de estrés tienen mucho que ver”, afirmó Palmer. “Estuvimos expuestos a pozos de quema tóxicos. El ejército no te enseña a comer bien: comíamos mucha comida procesada”.

En el ámbito médico, la TRT puede acelerar la recuperación de los soldados que tienen problemas de densidad ósea o lesiones de la médula espinal, indicó Mark Peterson, profesor de medicina física y rehabilitación en la Facultad de Medicina de la Universidad de Michigan. Pero, agregó, “para los hombres en el rango normal de T, el uso de una receta en línea para comprar testosterona para reducir la grasa del estómago puede ser contraproducente”.

Quienes la utilizan también se arriesgan a tener que tomar medicación de testosterona indefinidamente, porque la TRT puede hacer que el cuerpo deje de producir su propia hormona.

Palmer, que fundó una organización sin fines de lucro que ayuda a los veteranos a recuperarse a través del ejercicio, la nutrición y la tutoría, dijo que la medicación le ha sido útil, pero insta a sus compañeros veteranos a recibir atención médica en lugar de lo que él llamó sitios web de “bro science” que promocionan la testosterona. (La “bro science” surge cuando los relatos anecdóticos de personas que practican fisicoculturismo en el gimnasio se consideran más creíbles que la investigación científica)

“No se trata de una píldora mágica”, concluyó.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

He outlined simple steps that clinicians and parents can follow:

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

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

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

“Every child, every time,” he said.

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

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

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

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

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

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

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

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

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

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

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

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Luego de año crucial en el movimiento para desechar el término “delirio excitado”, en varios estados hay un impulso para prohibir el diagnóstico médico desacreditado en los certificados de defunción, la capacitación policial, los informes de incidentes policiales y el testimonio en los tribunales civiles.

En enero, California se convirtió en el primer estado en prohibir el término médico en muchos procedimientos oficiales. Ahora, legisladores de Colorado, Hawaii, Minnesota y Nueva York están considerando proyectos de ley que también limitarían cómo se utiliza el concepto de “delirio excitado”.

La nueva ola de propuestas estatales, impulsada por familias que perdieron familiares después de enfrentamientos con la policía, marca un paso importante para desterrar un término que los críticos dicen que incita a la policía a usar fuerza letal en exceso.

“Lo que queremos es ver es la ley siguiendo a la ciencia”, dijo Joanna Naples-Mitchell, abogada que trabajó en una influyente revisión de Physicians for Human Rights sobre cómo el término “delirio excitado” se convirtió en un concepto cuya legitimidad es en gran parte rechazada por la comunidad médica.

Pero el impulso inicial en las legislaturas estatales se encuentra con una resistencia renovada por parte de las agencias del orden y otros defensores, incluidos algunos que están de acuerdo en que el “delirio excitado” es un diagnóstico fraudulento.

Los proyectos de ley “claramente infringen la Primera Enmienda” y violan la libertad de expresión, dijo Bill Johnson, director ejecutivo de la National Association of Police Organizations. También argumentó que los agentes encuentran síntomas y comportamientos asociados con el “delirio excitado”.

El delirio excitado es una teoría diagnóstica de cuatro décadas que se ha utilizado para explicar cómo una persona que experimenta agitación grave puede morir repentinamente mientras está siendo controlada por la fuerza.

El año pasado, el American College of Emergency Physicians retiró un informe de 2009 que había sido el último pilar médico oficial de apoyo a la teoría utilizada cada vez más en los últimos 15 años para explicar la falta de responsabilidad de la policía en muchas muertes ocurridos bajo su custodia.

El “delirio excitado” se citó como defensa legal en las muertes de George Floyd en Minneapolis en 2020; Daniel Prude en Rochester, Nueva York; y Angelo Quinto en Antioch, California, entre otras. La teoría proponía que las personas en crisis de salud mental, a menudo bajo la influencia de drogas o alcohol, pueden exhibir una fuerza sobrehumana cuando la policía intenta controlarlas, y luego mueren repentinamente por la condición, no por la respuesta policial.

En 2021 y 2022, el Departamento de Policía de la Ciudad de Nueva York (NYPD) publicó materiales de capacitación que dicen a los oficiales que restrinjan y dejen sin sentido a las personas que encuentren y que muestren signos de “delirio excitado”, como “temperaturas corporales elevadas, aumento de la fuerza física y falta de fatiga física”, según New York Focus, una redacción sin fines de lucro. El NYPD no respondió a las solicitudes de comentarios sobre su capacitación o el nuevo proyecto de ley estatal.

“Siguen teniendo esto en los registros”, dijo Jessica González-Rojas, asambleísta estatal demócrata por Nueva York, quien presentó el proyecto de ley que pide prohibir el término en los certificados de defunción, autopsias, capacitación policial, informes de incidentes y procedimientos judiciales. “Y es bastante preocupante el tipo de restricciones que están recomendando, dada la falta de evidencia de que este sea un síndrome médico real”.

El Departamento de Policía de Minneapolis, que según el Star Tribune utilizó el término en capacitaciones, se negó a comentar sobre sus materiales de capacitación y la legislación estatal pendiente. Ese proyecto de ley prohibiría que el “delirio excitado” y términos similares se citen como causa de muerte, se utilicen como diagnóstico médico o se incluyan en el entrenamiento policial.

Sin embargo, la presencia de la teoría en los materiales de capacitación también puede estar comenzando a cambiar. En Colorado, donde el término se usó, en parte, para justificar la muerte en 2019 de Elijah McClain en Aurora, una junta estatal eliminó el término de la capacitación policial desde enero de este año. Los agentes de la ley inmovilizaron al joven de 23 años, y los paramédicos le inyectaron una dosis letal de ketamina.

Este año, los legisladores de Colorado están debatiendo una medida que se parece en gran medida al proyecto de ley de California, pero permite que el término permanezca en los procedimientos judiciales civiles.

En la audiencia del proyecto de ley ante el Comité Judicial de la Cámara de Representantes de Colorado el 6 de febrero, Rebecca De Luna describió la angustia de su familia por la muerte en 2017 del padre de su hija, Alejandro Gutiérrez, bajo custodia policial en Thornton. Dijo que se determinó que el “delirio excitado” había sido la causa de su muerte.

“Su rostro estaba magullado con la huella de un zapato. Su aspecto era irreconocible”, testificó De Luna. “El término se ha utilizado durante demasiado tiempo como una excusa para que las fuerzas del orden se protejan cuando alguien muere bajo su custodia, francamente, como resultado de una fuerza excesiva y lo que considero brutalidad policial que resulta en muerte”.

Varios proveedores de servicios médicos y educadores testificaron en contra.

John Seward, gerente del programa de servicios médicos de emergencia de la Universidad de Denver, dijo al comité que no se oponía a prohibir “delirio excitado” en certificados de defunción y capacitación policial, ya que los policías no son profesionales de la salud. Pero prohibir el uso del término en la capacitación del personal médico sería legislar la medicina y obstaculizar la libertad académica, apuntó.

“Si no podemos estudiar y aprender del pasado, incluso cuando ese pasado es doloroso, ahora estamos condenándonos a repetirlo”, dijo Seward a los legisladores.

Julia Sherwin, abogada de derechos civiles de California que testificó a favor del proyecto de ley de Colorado, se sorprendió por los argumentos de los opositores de que dichos proyectos de ley podrían limitar la libertad de expresión y el debate sobre la historia de la idea.

“Eso para mí pareció un poco ridículo”, dijo Sherwin, quien fue coautora el informe de Physicians for Human Rights. Estos proyectos de ley impiden que una teoría desacreditada se utilice falsamente para responder a una crisis y mantienen la “pseudociencia” fuera de los registros oficiales, enfatizó.

El proyecto de ley de Colorado fue aprobado por la Cámara de Representantes estatal en una votación de 42-19 a mediados de febrero y ahora está ante el Senado estatal. Se enmendó para aclarar que se puede utilizar “delirio excitado” al enseñar sobre la historia del término y que se permiten cursos de Servicios Médicos de Emergencia (EMS) sobre “interacción médica segura y eficaz con personas que exhiben un estado mental alterado”, que presentan síntomas que incluyen agitación y agresión, o violencia.

Parte del impulso para esta legislación proviene de familias cuyos seres queridos murieron a causa del “delirio excitado”, en lugar de por el uso de la fuerza durante un encuentro policial.

El proyecto de ley de Hawaii se presentó después que William y Verdell Haleck supieran del esfuerzo de California y comenzaran a contactar a legisladores en el estado. Su hijo Sheldon murió allí en 2015 después de ser rociado con gas pimienta, electrocutado y restringido por la policía de Honolulu. En un juicio civil que los Haleck perdieron, los oficiales culparon de su muerte al “delirio excitado”.

El proyecto de ley de Hawaii prohibiría que se use el “delirio excitado” en los certificados de defunción, informes de incidentes policiales y casos civiles. Hasta mediados de marzo, no se había programado una audiencia del comité legislativo, pero los Haleck tienen la esperanza de que eventualmente sea aprobado.

“Nos daría cierto tipo de cierre y justicia”, dijo William Haleck.

El Departamento de Policía de Honolulu está monitoreando el proyecto de ley y no ha tomado una posición al respecto, dijo Michelle Yu, vocera del departamento. Y el proyecto tendría poco impacto en el Departamento de Medicina Forense de Honolulu, dijo su director, Masahiko Kobayashi, porque los médicos allí no usan el “delirio excitado” como causa de muerte.

Una razón por la que estos proyectos de ley siguen siendo importantes es porque evitan que las políticas fluctúen con cada cambio de liderazgo, dijo David Siffert, director legal del Surveillance Technology Oversight Project, que ayudó a redactar una legislación modelo que prohíbe el “delirio excitado” y está presionando por el proyecto de ley de Nueva York.

“Incluso si estás haciendo todo bien, no sabes si tu sucesor lo hará”, dijo Siffert. “Históricamente hemos visto esos altibajos en nuestras agencias”.

Los partidarios de la legislación estatal dicen que prohibir el término “delirio excitado” es solo un primer paso hacia la reducción de las muertes bajo custodia policial.

“El contexto subyacente no cambia solo con la legislación”, dijo Naples-Mitchell. “Va a tomar mucho tiempo abordar las causas profundas”.

El editor de KFF Health News, Matt Volz, colaboró con este artículo.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Change healthcare cyber attack

ST. LOUIS — In early February, abortion rights supporters gathered to change Missouri history at the Pageant — a storied club where rock ’n’ roll revolutionary Chuck Berry often had played: They launched a signature-gathering campaign to put a constitutional amendment to voters this year to legalize abortion in the state.

“We have fought long for this moment,” the Rev. Love Holt, the emcee, told the crowd. “Just two years after Missouri made abortion illegal in virtually all circumstances, the people of our state are going to forever protect abortion access in Missouri’s constitution.”

The ballot measure — which would allow abortions until fetal viability — outlasted 16 other related proposals and months of litigation with Republican state officials. Next, its supporters must gather more than 171,000 valid signatures by May 5.

Missouri is one of 13 states weighing abortion-related ballot measures, most of which would protect abortion rights. Abortion rights supporters hope to build on prior ballot wins in seven politically diverse states — California, Kansas, Kentucky, Michigan, Montana, Ohio, and Vermont — since the Supreme Court in 2022 overturned federal abortion protections, handing authority back to states.

In a presidential election year, national strategy also steers the money. The success of initiatives could hinge on a state’s relevance to broader party ambitions. Democrats are focused on where anger over the abortion rollback could propel voter turnout and spur party victories up and down the ballot, including in key races for the Senate and White House. Those wins would help guard against what Democrats see as a bigger threat: a national abortion ban.

Republicans are quieter about their national strategy around abortion. But at the state level, the groups mounting opposition campaigns are putting foot soldiers on the streets to deter people from signing ballot petitions.

Abortion rights supporters have raised millions more for ballot campaigns than have opponents, according to a KFF Health News review of campaign finance records in multiple states.

Still, they “don’t have unlimited resources,” said Craig Burnett, an associate professor of political science at Hofstra University and expert on ballot initiatives. They must consider, “Where am I going to get the best bang for my buck here?”

Think Big America, a nonprofit founded by J.B. Pritzker, the billionaire Democratic governor of Illinois, is giving money to abortion rights initiatives in Arizona and Nevada and plans to do so in Montana, senior adviser Mike Ollen said. All are states where abortion remains legal to varying points in pregnancy, but each could have an outsize impact on the national political balance.

Arizona and Nevada are presidential swing states viewed as crucial for President Joe Biden to win reelection. They and Montana all have races that could flip control of the U.S. Senate from Democrats to Republicans in 2025.

Ollen said electoral consequences are “part of the calculus” for Think Big America. “We want to make sure that we protect abortion in the states that we’re going into,” Ollen said. “But we’re also not naive to the threat of a national abortion ban.”

About a fifth of key voter groups — Democratic women, women who live in states where abortion is banned, women who plan to vote for Biden, and women of reproductive age — identify as abortion voters, according to new polling from KFF.

Anti-abortion groups have pressured Republican candidates to support a national ban. Presumptive GOP presidential nominee Donald Trump quietly supports a 16-week ban with some exceptions, The New York Times reported.

Susan B. Anthony Pro-Life America, one of the nation’s largest anti-abortion groups, said it plans to spend “$92 million and reach 10 million voters” to back candidates in the political battleground states of Arizona, Georgia, Michigan, Montana, North Carolina, Ohio, Pennsylvania, and Wisconsin who would “protect life across America.” It will focus on “low turnout and persuadable voters to win the presidency and a majority in Congress.”

Ballot initiatives are one way for voters to assert their power over the political whims of state legislatures or courts. They are often viewed as more stable and harder to undo.

Abortion rights supporters must fend off statehouse maneuvers by Republicans to thwart ballot initiatives, such as proposals to change how ballot measures are approved or to buttress rules on collecting signatures. Politicians are appealing to the courts to beat back abortion rights.

In Montana, abortion is legally protected as a fundamental privacy right by a 1999 court ruling. Still, supporters are seeking to enshrine abortion access in the state constitution with a ballot measure.

Republican Attorney General Austin Knudsen, who has unsuccessfully asked the courts to overturn the 1999 precedent, rejected the draft initiative because it places “multiple distinct political choices into a single initiative.” The initiative’s backers, led by Planned Parenthood of Montana’s chief medical officer, Samuel Dickman, have asked the state Supreme Court to overturn Knudsen’s ruling and allow them to start gathering signatures.

Democrats hope the ballot question will drive voter turnout and boost reelection chances for incumbent U.S. Sen. Jon Tester against the likely Republican candidate, Tim Sheehy.

Tides Foundation, a social-justice-focused charity based in California, is monitoring ballot campaigns in Montana, Arizona, and Missouri, said Beth Huang, its program officer for civic engagement and democracy. It has granted funds in Florida and is in the process of approving funds for Colorado and Nevada, she said.

As a public charity, the group “legally cannot consider the partisan implications on any set of candidate elections” in funding decisions, she said. It will fund only ballot measures that would allow abortions at least until fetal viability — generally about 24 weeks — the standard under Roe v. Wade. A proposed initiative in Arkansas is off the table because access would go to 20 weeks.

“We are not interested in policies that do less than reestablish Roe,” Huang said.

In South Dakota, Dakotans for Health wants to reinstate abortion rights in the state. But an anti-abortion campaign says out-of-state money pays for signature drives that pressure people to sign the petitions without providing sufficient information on the measure. The Republican-dominated legislature passed a bill to let people remove their signatures from such ballot petitions. An emergency clause would put the bill into effect immediately if the governor signs it — ahead of the deadline to place the abortion question on the November ballot.

Critics of other states’ measures see other avenues for defeat.

Gregg Keller, a St. Louis-based Republican political strategist, said Missouri’s proposed amendment goes further than the measure passed last year in Ohio. For example, abortions could be allowed after fetal viability to protect the mental health of a pregnant person.

If opponents can get out the word that this goes further than what was done in Ohio and other states, “we have a chance of actually beating this thing,” Keller said. “If they are able to raise money. That’s a big if.”

Ballot supporters here raised $4.2 million as of March 12, according to campaign finance records. Money has come from national groups including the American Civil Liberties Union and the Fairness Project, which has supported ballot efforts on various progressive causes. Kansas City-based Health Forward Foundation has also donated.

So far opponents of the Missouri measure have raised $55,000, nearly half of which comes from the Catholic Church, according to campaign finance records.

“We went into this knowing that we were going to be outspent,” said Missouri Catholic Conference Executive Director Jamie Morris, who said he didn’t know whether the church would spend more. “We’re still going to be out trying to educate the faithful as best as we can, with the resources we have.”

Abortion Action Missouri Executive Director Mallory Schwarz said the coalition backing the state’s abortion measure is confident it will hit the signature goal by the May deadline.

If that happens, it will be up to outgoing Republican Gov. Mike Parson, who supports Missouri’s near-total abortion ban, to decide whether to put the measure before voters in the state’s August primary or the November general election.

Keller, the GOP strategist, said the governor will face tremendous pressure to put it on the August ballot. Five of six statewide offices are on the November ballot, as is Republican Josh Hawley’s U.S. Senate seat. An abortion ballot measure could overshadow those campaigns — just based on the war chests in play: Hawley’s 2018 campaign spent about $11.5 million, for example, while the three political action committees backing Ohio’s abortion amendment last year spent over $50 million.

“I am telling anyone who is running as a Republican this year that if you want to be able to make your case about how and why you deserve to be elected, and you want to be able to get your story out,” Keller said, “then clearly you would not want to have a $50 million ballot initiative on in November.”

KFF Health News rural health care correspondent Arielle Zionts and Mountain States editor Matt Volz contributed to this report.

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

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Four years after hospitals in New York City overflowed with covid-19 patients, emergency physician Sonya Stokes remains shaken by how unprepared and misguided the American health system was.

Hospital leadership instructed health workers to forgo protective N95 masks in the early months of 2020, as covid cases mounted. “We were watching patients die,” Stokes said, “and being told we didn’t need a high level of protection from people who were not taking these risks.”

Droves of front-line workers fell sick as they tried to save lives without proper face masks and other protective measures. More than 3,600 died in the first year. “Nurses were going home to their elderly parents, transmitting covid to their families,” Stokes recalled. “It was awful.”

Across the country, hospital leadership cited advice from the Centers for Disease Control and Prevention on the limits of airborne transmission. The agency’s early statements backed employers’ insistence that N95 masks, or respirators, were needed only during certain medical procedures conducted at extremely close distances.

Such policies were at odds with doctors’ observations, and they conflicted with advice from scientists who study airborne viral transmission. Their research suggested that people could get covid after inhaling SARS-CoV-2 viruses suspended in teeny-tiny droplets in the air as infected patients breathed.

But this research was inconvenient at a time when N95s were in short supply and expensive.

Now, Stokes and many others worry that the CDC is repeating past mistakes as it develops a crucial set of guidelines that hospitals, nursing homes, prisons, and other facilities that provide health care will apply to control the spread of infectious diseases. The guidelines update those established nearly two decades ago. They will be used to establish protocols and procedures for years to come.

“This is the foundational document,” said Peg Seminario, an occupational health expert and a former director at the American Federation of Labor and Congress of Industrial Organizations, which represents some 12 million active and retired workers. “It becomes gospel for dealing with infectious pathogens.”

Late last year, the committee advising the CDC on the guidelines pushed forward its final draft for the agency’s consideration. Unions, aerosol scientists, and workplace safety experts warned it left room for employers to make unsafe decisions on protection against airborne infections.

“If we applied these draft guidelines at the start of this pandemic, there would have been even less protection than there is now — and it’s pretty bad now,” Seminario said.

In an unusual move in January, the CDC acknowledged the outcry and returned the controversial draft to its committee so that it could clarify points on airborne transmission. The director of the CDC’s National Institute for Occupational Safety and Health asked the group to “make sure that a draft set of recommendations cannot be misread to suggest equivalency between facemasks and NIOSH Approved respirators, which is not scientifically correct.”

The CDC also announced it would expand the range of experts informing their process. Critics had complained that most members of last year’s Healthcare Infection Control Practices Advisory Committee represent large hospital systems. And about a third of them had published editorials arguing against masks in various circumstances. For example, committee member Erica Shenoy, the infection control director at Massachusetts General Hospital, wrote in May 2020, “We know that wearing a mask outside health care facilities offers little, if any, protection from infection.”

Although critics are glad to see last year’s draft reconsidered, they remain concerned. “The CDC needs to make sure that this guidance doesn’t give employers leeway to prioritize profits over protection,” said Jane Thomason, the lead industrial hygienist at the union National Nurses United.

She’s part of a growing coalition of experts from unions, the American Public Health Association, and other organizations putting together an outside statement on elements that ought to be included in the CDC’s guidelines, such as the importance of air filtration and N95 masks.

But that input may not be taken into consideration.

The CDC has not publicly announced the names of experts it added this year. It also hasn’t said whether those experts will be able to vote on the committee’s next draft — or merely provide advice. The group has met this year, but members are barred from discussing the proceedings. The CDC did not respond to questions and interview requests from KFF Health News.

A key point of contention in the draft guidance is that it recommends different approaches for airborne viruses that “spread predominantly over short distances” versus those that “spread efficiently over long distances.” In 2020, this logic allowed employers to withhold protective gear from many workers.

For example, medical assistants at a large hospital system in California, Sutter Health, weren’t given N95 masks when they accompanied patients who appeared to have covid through clinics. After receiving a citation from California’s occupational safety and health agency, Sutter appealed by pointing to the CDC’s statements suggesting that the virus spreads mainly over short distances.

A distinction based on distance reflects a lack of scientific understanding, explained Don Milton, a University of Maryland researcher who specializes in the aerobiology of respiratory viruses. In general, people may be infected by viruses contained in someone’s saliva, snot, or sweat — within droplets too heavy to go far. But people can also inhale viruses riding on teeny-tiny, lighter droplets that travel farther through the air. What matters is which route most often infects people, the concentration of virus-laden droplets, and the consequences of getting exposed to them, Milton said. “By focusing on distance, the CDC will obscure what is known and make bad decisions.”

Front-line workers were acutely aware they were being exposed to high levels of the coronavirus in hospitals and nursing homes. Some have since filed lawsuits, alleging that employers caused illness, distress, and death by failing to provide personal protective equipment.

One class-action suit brought by staff was against Soldiers’ Home, a state-owned veterans’ center in Holyoke, Massachusetts, where at least 76 veterans died from covid and 83 employees were sickened by the coronavirus in early 2020.

“Even at the end of March, when the Home was averaging five deaths a day, the Soldiers’ Home Defendants were still discouraging employees from wearing PPE,” according to the complaint.

It details the experiences of staff members, including a nursing assistant who said six veterans died in her arms. “She remembers that during this time in late March, she always smelled like death. When she went home, she would vomit continuously.”

Researchers have repeatedly criticized the CDC for its reluctance to address airborne transmission during the pandemic. According to a new analysis, “The CDC has only used the words ‘COVID’ and ‘airborne’ together in one tweet, in October 2020, which mentioned the potential for airborne spread.’”

It’s unclear why infection control specialists on the CDC’s committee take a less cautious position on airborne transmission than other experts, industrial hygienist Deborah Gold said. “I think these may be honest beliefs,” she suggested, “reinforced by the fact that respirators triple in price whenever they’re needed.”

Critics fear that if the final guidelines don’t clearly state a need for N95 masks, hospitals won’t adequately stockpile them, paving the way for shortages in a future health emergency. And if the document isn’t revised to emphasize ventilation and air filtration, health facilities won’t invest in upgrades.

“If the CDC doesn’t prioritize the safety of health providers, health systems will err on the side of doing less, especially in an economic downturn,” Stokes said. “The people in charge of these decisions should be the ones forced to take those risks.”

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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