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High stakes and big challenges await as the U.S. prepares to roll out vaccines against COVID-19, with front-line health care workers and vulnerable nursing home residents recommended as the top priority.

Doses could be on their way very soon. An independent advisory committee to the Food and Drug Administration on Thursday gave a green light to the first vaccine candidate, made by Pfizer in conjunction with the German company BioNTech — a recommendation expected to be approved by the agency within days. The committee is scheduled to consider a second candidate, made by Moderna, Dec. 17.

On tap is an initial stockpile of vaccines made during the approval process, with federal officials hoping to distribute at least 20 million doses by year’s end.

While that will go a long way toward reaching the top-priority groups — the nation’s 21 million health care workers and 3 million long-term care residents — there won’t be enough to inoculate everyone on Day One, or even the first week.

In Ohio, for example, the governor expects an initial delivery of 98,000 doses, with the state allocating 88,000 of those to long-term care facilities, said Pete Van Runkle, executive director of the Ohio Health Care Association, which represents long-term care facilities.

“It’s more than a drop in the bucket, but it’s not all that’s needed,” said Van Runkle, who estimated there are between 150,000 and 175,000 residents and staff members in long-term care centers in the state.

Consequently, the doses will be distributed in waves, with the centers and hospitals not chosen for the first wave getting them in the coming weeks, he said.

Facilities will have to divvy up the supplies to best address the needs of patients and employees.

For hospitals, first up are likely to be “workers with the greatest exposure” to the virus, said Anna Legreid Dopp, a senior director at the American Society of Health-System Pharmacists, a trade group representing more than 55,000 pharmacists who work for hospitals and health systems.

Then who? Perhaps those with personal medical conditions putting them at higher risk. And there may be other considerations specific to individual hospitals. What if, for example, only two people are trained to run a specialized treatment system in the ICU needed to care for patients seriously ill with COVID-19?

“Are they at the top of the list?” asked Dopp.

Nursing homes have a slightly different calculation because they have fewer employees than hospitals, said Van Runkle.

“It’s more a question of choosing which facilities” will get the initial doses, he said. “Once those are chosen, they’ll vaccinate everyone there [who consents], not pick and choose among people.”

Even so, there may be some selectivity because most nursing home employees are women and many are of child-bearing age. Because the vaccines have not yet been tested on pregnant women, those who are pregnant or breastfeeding may not be eligible in the initial rollout.

Which long-term care facilities get the vaccine first may come down to where they are located in relation to two large pharmacy chains: CVS and Walgreens.

In October, the federal government signed an agreement with CVS and Walgreens to store and administer the vaccines. Most long-term care facilities opted to join the partnership.

Under the agreement, the pharmacist teams will make at least three trips to each nursing home over a couple of months to administer the vaccines, which must be given in two doses, set several weeks apart.

One big hurdle in distributing the two vaccines seeking FDA approval is keeping them cold. The Pfizer vaccine is stored at around 94 degrees below zero, while the Moderna option is kept at minus 4 degrees. CVS expects to keep the vaccine at 1,100 locations around the country that have the required refrigeration technology, said Mike DeAngelis, senior director of corporate communications at CVS Health. From those hubs, teams of pharmacists and pharmacy technicians will take thawed doses of the vaccines to the long-term care facilities and administer them to staff and residents. About 30,000 homes have signed on with CVS for the clinics.

Walgreens expects to administer the vaccinations in more than 23,000 long-term care locations, according to a written statement.

While there’s no charge to the nursing homes or residents, Medicare will pay an administrative fee to CVS and Walgreens of $16.94 for the first shot and $28.39 for the second.

Yet there’s a flip side to the supply equation: What if no one wants to go first?

“That’s what keeps me up at night,” said Dr. Michael Wasserman, the immediate past president of the California Association of Long Term Care Medicine, a group of physicians, nurses, social workers and others who provide care to seniors.

That’s key because a good portion of America must be vaccinated to get to the much-sought-after “herd immunity,” in which most people are protected and the virus finds it difficult to spread.

“What if government and pharmacies do a great job in getting vaccine to the front door, then no one takes it?” Wasserman worries.

Nursing home residents are particularly vulnerable to COVID-19 and account for 40% of all reported deaths.

With COVID-positive test results on the rise in almost every state, vaccinating nursing home workers is crucial to protecting not only themselves, but also their patients.

That reality meets a reluctance among many front-line nursing home workers to take the vaccine, said Lori Porter, co-founder and CEO of the National Association of Health Care Assistants, which represents certified nursing assistants who work in long-term care.

Their distrust stems from many things, she said, including politicization around the vaccines, fueled by misinformation on social media.

Educational campaigns and personal endorsements from trusted organizations could help counter the falsehoods, she said. A nationwide event planned for next week by her organization will allow certified nursing assistants to ask questions directly of physician experts and hear from a panel of their peers.

“I’m asked 100 times a day if I’m going to be taking it,” said Porter, who definitely will, hoping to do so in a live webcast, to further convince her members it’s safe.

Despite the need to vaccinate staff to protect residents, Wasserman, a former regulator and nursing home executive, does not think mandates are appropriate for workers, many of whom are low-paid and people of color. “As a society, are we prepared to force this group of folks to get a brand-new vaccine?” he asked.

A better approach, he said, is the type of educational programs that Porter mentioned, so that workers can weigh the evidence and decide whether they want to get vaccinated.

Although employers may have the authority to mandate vaccination, many experts don’t think that policy will be widespread in the nursing home industry, given a shortage of workers and a fear of losing staffers who choose not to comply.

“I can tell you our members are not going to do that,” said Van Runkle, with the Ohio trade group. “If they were to try a mandate, some number of workers would say, ‘Sorry, this is the last straw. I’m leaving.’”

Instead of a mandate, Porter said, a few nursing homes are offering prizes or financial incentives — with at least one talking about offering a drawing for a new car among those who participate. Others, however, may take the opposite approach: ending supplemental hazard pay for workers who refuse.

As for residents, there is no debate. They will not get the vaccine unless they agree, often in writing, said Van Runkle.

For those with dementia or other health problems that prevent making such a decision, family members or others with legal authority must sign, which could slow down the vaccination process considerably.

“During a pandemic, it may be difficult to get hold of them or get their handwritten signature on a document,” said Van Runkle. “We’ve got to sort all this out in the next couple of weeks.”

With front-line health workers and nursing home residents and staff expected to get the initial doses of COVID vaccines, the thornier question is figuring out who goes next.

The answer will likely depend on where you live.

While an influential federal advisory board is expected to make its recommendations later this month, state health departments and governors will make the call on who gets access to a limited number of vaccines this winter.

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As a result, it’s been a free-for-all in recent weeks as manufacturers, grocers, bank tellers, dentists and drive-share companies all jostle to get a spot near the front of the line.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 this month to give first vaccination priority to health care workers and residents of long-term care facilities once the Food and Drug Administration approves one or more COVID-19 vaccines for emergency use. The advisory committee is expected to provide further details of its list of prioritized recipients before year’s end.

Its next recommendations are likely to focus on prioritizing people who keep society functioning, like workers in food and agriculture, public safety and education. Older people and those with chronic diseases are also considered high on the list.

But because early supplies of vaccine are limited, tough choices lie ahead, such as: Is it more important to prioritize teachers who come into contact with many people each day, or farmworkers, who can’t work remotely and provide the country’s food?

“We have to be mindful of equity issues, comorbidities and the likelihood of death versus survival, even within these essential workers,” said Mitch Steiger, a legislative advocate for the California Labor Federation. There will be “a lot of really tough conversations and a lot of different competing principles.”

Initially, states won’t get enough vaccine doses to cover even their top-ranked groups.

In California, a state of 40 million residents, the initial shipments of around 1 million doses won’t come close to covering everyone at the front of the line. More than 2 million people fall into the Phase 1a category of vaccine distribution, which covers only those at risk of getting sick at a health care or long-term care setting.

Even within that health worker category, there’s jockeying to get to the front of the line, with pharmacists and dentists arguing for priority.

Dr. Laurie Forlano, deputy commissioner for population health at the Virginia Department of Health, said the state has been hearing from numerous parties via letters, phone calls and virtual meetings as it decides which “critical workers” will follow the initial bunch in getting vaccinated. “It is complex,” she said of the undertaking. “But it is not new for public health to make these decisions.”

States have already signaled different priorities.

Florida Gov. Ron DeSantis said that after nursing home residents and front line health workers are inoculated, the state will try to vaccinate people 65 and over and residents with significant illnesses.

Kentucky Gov. Andy Beshear said grade school teachers should be next in line after health care workers and nursing home residents, along with first responders and adults with significant illnesses.

Pennsylvania will include “critical workers” and people with high-risk conditions at the top of its priority list, along with health workers, nursing home residents and staff and first responders, according to state health department spokesperson Rachel Kostelac.

Nationally, disease advocacy groups point out that people with some preexisting conditions are at a greater risk of death if they become infected with the coronavirus. The American Diabetes Association published an opinion piece advocating for its patients; the National Renal Administrators Association wrote to federal regulators saying kidney patients should be prioritized.

Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, said he expects states to largely follow the committee’s priority list. But it’s unclear how much detail the CDC committee will provide in its next round of recommendations — such as which “high-risk individuals” and critical workers to include.

Leaving some flexibility for states is good, Plescia said, because they may differ on ways to vaccinate people efficiently. For example, some states may be home to large factories where people are at higher risk and could get vaccinated on-site.

That’s also where lobbying comes into play.

“Priority 1a for us is getting our employees into that ‘priority 1b’ priority group,” said Bryan Zumwalt, executive vice president of public affairs for the Consumer Brands Association, which represents companies that make thousands of household products, from toilet paper to soda. Of the membership’s 2.3 million employees, 1.7 million are considered essential, he said.

“Workers at our companies are making life-sustaining products,” Zumwalt said. The association is reaching out with letters to state health departments, but Zumwalt said the process would be easier if there were a uniform national priority order for the vaccine, instead of letting states have final say.

These companies are dealing with absenteeism rates averaging 10%, he said, which could cause delays in producing food and other key products.

“When one worker tests positive, an additional five to 10 workers have to be taken off the production lines,” he said.

In Idaho, a COVID-19 advisory board decided this month that after health workers and nursing home residents and staff, first responders such as police and firefighters, and grade school teachers and staff should get the shots, followed by correctional facility staff, then food-processing workers, grocery workers and the Idaho National Guard.

Dr. Elizabeth Wakeman, an associate professor of philosophy at the College of Idaho, and a member of the board, had told her colleagues that it made more sense to vaccinate with the aim of slowing virus transmission rather than ranking groups on their value to society.

That would put food-processing workers ahead of grocery clerks, because there’s more room to maintain distance and better ventilation in a grocery store, Wakeman said.

There’s also pressure to quickly protect food service and farmworkers. Diana Tellefson Torres, executive director of the United Farm Workers Foundation, said farmworkers are both essential and deeply at risk. They may work outdoors where transmission risk is lower, but they often live and ride to work with many people outside their immediate families, she said.

Most farmworkers are undocumented immigrants who lack health insurance and “might not even know they have underlying health conditions,” said Tellefson Torres, who sits on California’s Community Vaccine Advisory Committee. “There’s a lot of vulnerability.”

It’s almost time for the winter citrus crops to be harvested in California, and the lettuce needs to be picked in Arizona.

“It’s important to ensure that the community of individuals who provide food for this country, the food at each one of our tables, is also taken into consideration as a top priority,” said Tellefson Torres.

In the opening week of California’s legislative session, one of the first pieces of legislation to be introduced argued that the food-supply workforce should be first in line for vaccines and rapid tests.

The International Association of Fire Fighters, a union representing 322,000 firefighters and emergency medical personnel, is pushing to include its members as among the first to get access to the vaccine, arguing that firefighters provide emergency medical services that bring them into people’s homes and other closed spaces.

Airline employees also want to be quickly vaccinated.

Pharmacists, too, have also been making their case. While the ACIP included pharmacists in its Phase 1a health worker category, each state interprets the recommendations differently based on its vaccine supply, noted Mitchel Rothholz, chief of governance and state affiliates for the American Pharmacists Association, which is urging states to keep its members atop the list. “It’s a race for who gets the vaccine first,” he said. “Everybody wishes there was enough supply for everyone right out of the gate, but that’s not the situation.”

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Vivek Kaliraman, que vive en Los Angeles, ha celebrado todas las navidades desde 2002 con su mejor amigo, que vive en Houston. Pero, este año, por el riesgo de COVID, en lugar de ir en avión, manejó y piensa quedarse varias semanas.

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El viaje, que le llevaría 24 horas, era demasiado largo para hacerlo en un día, así que Kaliraman llamó a siete hoteles en Las Cruces, Nuevo México —que está a medio camino— para preguntar cuántas habitaciones ofrecían y cuáles eran sus protocolos de limpieza y entrega de alimentos.

“Llamaba por la noche y hablaba con una persona de la recepción y luego volvía a llamar durante el día”, dijo Kaliraman, de 51 años, que es empresario en el sector de la salud digital. “Quería estar seguro de que las dos personas me dieran la misma respuesta”.

Cuando llegó al hotel elegido, pidió una habitación que hubiera estado desocupada la noche anterior. Y aunque esa noche hacía frío, dejó la ventana abierta.

Precauciones por estadísticas aterradoras

Muchos estadounidenses, como Kaliraman, que finalmente llegó a Houston, todavía piensan viajar en diciembre, a pesar de que las cifras de coronavirus en el país empeoran día a día.

La primera semana de diciembre, los Centros para el Control y Prevención de Enfermedades (CDC) informaron que la tasa de hospitalización semanal por COVID estaba en su punto más alto desde el comienzo de la pandemia.

Más de 283,000 estadounidenses han muerto a causa de COVID-19. Los funcionarios de salud pública se preparan para un aumento de casos como resultado de los millones de personas que, desoyendo el consejo de los CDC, viajaron para celebrar el Día de Acción de Gracias, incluyendo los 9 millones que pasaron por los aeropuertos del 20 al 29 de noviembre.

Los hospitales están colmados. Por eso, de nuevo, expertos en salud recomiendan a los estadounidenses que se queden en casa durante las fiestas.

Para muchos, sin embargo, los viajes se reducen a una cuestión de riesgo-beneficio.

Según David Ropeik, autor del libro “How Risky Is It, Really?” y experto en psicología de la percepción de riesgos, es importante recordar que lo que está en juego en este tipo de situaciones no puede ser cuantificado con exactitud.

Nuestro cerebro percibe el riesgo al observar primero la amenaza —en este caso, contraer o transmitir COVID-19— y luego el contexto de nuestra propia vida, que a menudo involucra emociones, explicó.

Si conoces personalmente a alguien que murió por COVID-19, eso es un contexto emocional agregado. Si quieres asistir a una boda, es escenario.

“Piensa en ello como una balanza. A un lado están todos los datos sobre COVID-19, como el número de muertes”, dijo Ropeik. “Y del otro lado están todos los factores emocionales. Las vacaciones son un gran peso en el lado emocional”.

Las personas que entrevistamos para esta historia dijeron que entienden el riesgo que implica. Y sus razones para viajar difieren. Kaliraman comparó su viaje para ver a su amigo con un ritual importante: no se ha perdido esta visita en 19 años.

Lo que está claro es que muchos no se toman la decisión de viajar a la ligera.

Para Annette Olson, de 56 años, el riesgo de volar desde Washington, D.C., a Tyler, Texas, valía la pena porque necesitaba ayudar a cuidar de sus padres, ya muy mayores, durante las vacaciones.

“Desde mi punto de vista, yo represento un riesgo menor para ellos que el que supondría tener a una enfermera viniendo a la casa, que entra y sale, y va a otras casas”, comentó Olson. “En cuanto llego yo, estoy en cuarentena”.

Ahora que está con sus padres, lleva una máscara facial en las zonas comunes de la casa hasta que reciba los resultados de la prueba de COVID.

Otros piensan ponerse en cuarentena semanas antes de ver a sus familiares; aunque, como en el caso de Chelsea Toledo, la familia que va a visitar esté a sólo una hora en auto.

Toledo, de 35 años, vive en Clarkston, Georgia, y trabaja desde su casa. Sacó a su hija, de 6 años, de la escuela en persona después del Día de Acción de Gracias, con la esperanza de ver a su mamá y a su padrastro en Navidad.

Madre e hija harán cuarentena durante varias semanas y pedirá que les envíen las compras del mercado para no entrar en contacto con nadie antes del viaje. Toledo no sabe si seguirá con este plan. Todo puede cambiar basado en base a los casos de COVID en su área.

“Estamos tomando las cosas semana a semana, o realmente día a día”, contó Toledo. “No hay un plan para ver a mi madre; está la esperanza de verla”.

Para los jóvenes adultos que viven solos, ver a los padres en las fiestas es una recarga de energía en este año difícil. Rebecca, de 27 años, vive en Washington, D.C., y condujo con una amiga con la que vive, a Nueva York para ver a sus padres y a su abuelo en Hanukkah. (Rebecca le pidió a KHN que no publicara su apellido porque temía que la publicidad pudiera afectar negativamente su trabajo, que es en la salud pública).

“Estoy bien, pero creo que tener una ilusión ayuda. No quería cancelar mi viaje”, dijo Rebecca. “Soy la única hija y nieta que no tiene hijos. Puedo controlar, más que nadie, lo que hago y con quién entro en contacto”.

Ella, y las dos amigas con las que vive, estuvieron en cuarentena durante dos semanas antes del viaje y se hicieron la prueba de COVID-19 dos veces durante ese tiempo. Ahora que Rebecca está en Nueva York, se ha puesto en auto cuarentena durante 10 días y se hará la prueba de nuevo antes de ver a su familia.

“Creo que, con lo que he hecho, voy segura”, comentó Rebecca. “Aunque sé que lo más seguro es no verlos, así que me siento un poco nerviosa”.

Porque el mejor plan siempre puede fallar. Las pruebas pueden dar falsos negativos y los familiares pueden pasar por alto la posible exposición o no creer en la gravedad de la situación.

Para entender mejor las consecuencias potenciales del riesgo que se está corriendo, Ropeik aconseja tener pensamientos “personales y viscerales” sobre lo peor que podría pasar.

“Imagina que la abuela se enferma y muere” o “que la abuela está en la cama del hospital y no puedes visitarla”, dijo Ropeik. Eso equilibrará la atracción emocional positiva de las fiestas y te ayudará a tomar una decisión más fundamentada.

¿Reducción de daños?

Todos los entrevistados para esta historia reconocieron que muchas de las precauciones que están tomando son posibles sólo porque disfrutan de ciertos privilegios, incluyendo la posibilidad de trabajar desde casa, poder aislarse o hacer que les envíen los comestibles; opciones que pueden no estar al alcance de todos, incluyendo los trabajadores esenciales y aquellos con bajos ingresos.

Aun así, los estadounidenses viajarán durante las vacaciones de diciembre.

Y al igual que con la enseñanza de prácticas sexuales seguras en las escuelas, en lugar de un enfoque basado únicamente en la abstinencia, es importante dar estrategias de mitigación de riesgos para que “si se va a hacer, se piense en cómo hacerlo de forma segura”, recomendó el doctor Iahn Gonsenhauser, del Centro Médico Wexner de la Universidad Estatal de Ohio.

En primer lugar, Gonsenhauser aconseja observar los números de casos de COVID en tu área, considerar si viajas de una comunidad de alto riesgo a una de bajo riesgo y hablar con tus familiares sobre los riesgos. Además, comprueba si el estado al que viajas tiene requisitos de cuarentena o de pruebas que debes hacerte al llegar.

Y ponte en cuarentena antes del viaje, las recomendaciones van de siete a 14 días.

Otra cosa que hay que recordar, dijo Gonsenhauser, es que una prueba de COVID negativa antes de viajar no es una garantía, y sólo funciona si se hace en combinación con el período de cuarentena.

También se debe considerar el medio de transporte: conducir es más seguro que volar.

Por último, una vez que hayas llegado a tu destino, prepárate para lo que podría ser la parte más difícil: continuar el distanciamiento físico, usar máscara y lavarte las manos. “Es fácil bajar la guardia durante las vacaciones, pero hay que mantenerse alerta”, concluyó Gonsenhauser.

Esta historia fue producida por Kaiser Health News, un programa editorial independiente de la Kaiser Family Foundation.

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The first vaccine to protect against COVID-19 could be approved in the U.S. within days, but legislation to help fund its distribution remains mired in Congress.

And President-elect Joe Biden has tapped California Attorney General Xavier Becerra as his secretary of Health and Human Services. The choice of Becerra, who served 12 terms in the House of Representatives, is being criticized by Republicans for his support of single-payer health care.

This week’s panelists are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Kimberly Leonard of Business Insider and Mary Ellen McIntire of CQ Roll Call.

Among the takeaways from this week’s podcast:

• Despite indications that both Republican and Democratic lawmakers are eager to push out a new COVID relief bill, they are having trouble finding common ground on the issue of liability protections for employers whose workers or customers may get sick. And the party leaders, notably Senate Majority Leader Mitch McConnell, have not tipped their hands on whether they will go along with the effort.
• Complicating the COVID relief bill talks is Congress’ inability thus far to come to terms on a spending bill for the government for the fiscal year that began Oct. 1.
• Some of the delay in getting deals on spending and COVID relief is linked to the uncertainty over which party will control the Senate after the January special elections in Georgia, which will determine two Senate seats. Although many observers expect the Republicans to win at least one, if not both, of those races, McConnell can’t be sure. He likely aims to use what political muscle he has now with the majority and an ally in the White House to get deals favorable to his causes.
• Despite the grumbling by some Republican senators over Becerra’s nomination, it is still too early to suggest that he won’t win approval. The outcome may also depend on whether McConnell remains majority leader and whether Republicans determine that this is a nomination they want to take a stand on — or whether they save the gunpowder for another nominee.
• Dr. Vivek Murthy, chosen by Biden to be the next surgeon general, is likely to have a broader portfolio than that office typically has because of his strong relationship with Biden.
• An advisory committee for the Food and Drug Administration is meeting to consider an application for Pfizer’s COVID vaccine. If the request is approved, consumers should still anticipate there could be glitches in distribution and some unforeseen issues with the vaccine, such as the side effects noted in Britain this week in people with strong allergies. Nevertheless, this vaccine and others can be expected to make significant progress in the battle against the coronavirus. 
• The clinical trials for the COVID vaccine have shown it reduces the severity of the disease, but it’s not clear whether the vaccine will stop disease transmission.

Also this week, Rovner interviews Michael Mackert, director of the Center for Health Communication at the University of Texas-Austin and a professor both at the Dell Medical School and the Stan Richards School of Advertising and Public Relations.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:

Julie Rovner: Politico’s “How Biden Aims to Covid-Proof His Administration,” by Alice Miranda Ollstein and Daniel Lippman

Kimberly Leonard: Business Insider’s “Here’s How the GSA Plans to Disinfect the White House Between Trump’s Departure and Biden’s Arrival,” by Robin Bravender and Kimberly Leonard

Mary Ellen McIntire: The Atlantic’s “The Danger of Assuming That Family Time Is Dispensable,” by Julia Marcus

Joanne Kenen: The New Yorker’s “How Will We Tell the Story of the Coronavirus?” by Andrew Dickson

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunes, Stitcher, Google Play, Spotify, or Pocket Casts.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

The Trump administration wants to require the Department of Health and Human Services to review most of its regulations by 2023 — and automatically void those not assessed in time.

A proposed rule would require HHS to analyze within 24 months about 2,400 regulations — rules that affect tens of millions of Americans on everything from Medicare benefits to prescription drug approvals.

The move has met a fierce backlash from health providers and consumer advocates who fear it would hamstring federal health officials while they seek to control the COVID-19 pandemic, which has killed more than 250,000 Americans.

The HHS proposal appears designed to tie up the incoming Biden administration, say critics. They note the timing of the proposal, which was issued Nov. 4 — the day after Election Day, when it appeared President Donald Trump would likely lose his bid for a second term.

“The cynical part of me thinks this is a perfectly designed way to bring the department to a standstill in the next administration,” said Mary Nelle Trefz, health policy associate at Common Good Iowa, a consumer advocacy group.

She said HHS does not have the bandwidth to review all these regulations during the next two years while running its many programs, including Medicaid and Medicare.

If the proposal is finalized before Jan. 20, it is likely to be undone by the incoming Biden administration. But the chore would add to duties of HHS officials trying to attack the pandemic, she said.

HHS officials deny their proposal was aimed at the Biden administration. Brian Harrison, chief of staff at the department, said he first sought legal review of the proposal in April. “Our lawyers moved as fast as they could,” he said, and the rule was written with the expectation it would be implemented during Trump’s second term.

“The outcome of the election had nothing to do with it,” he said.

Democrats and Republicans for the past 40 years have failed to review existing regulations, leaving unnecessary and irrelevant rules on the books, Harrison said.

But Andy Schneider, a research professor at the Center for Children and Families at Georgetown University who has written about the proposal, said he fears the sunset provision will be one of many actions the Trump team will take to distract the incoming administration.

“It speaks volumes that they waited until the end of the fourth year of the administration to decide that the regulatory process needs to be improved,” he said.

Incoming administrations have typically frozen new rules that were pending but have not taken effect before Inauguration Day. That gives new administrations time to unwind them.

Efforts to enact reviews of funding bills and other legislation, known as sunset clauses, have been popular among conservatives for years. The federal government has occasionally used sunset provisions in legislation, such as the tax cuts enacted during the George W. Bush administration, but it is rare to make department regulations subject to these types of mandatory deadlines.

The option is more popular among states, which have adopted varying procedures for measures passed by the legislatures or regulatory boards. Those efforts run the gamut from requiring most initiatives to be reviewed to identifying specific agencies or legislation that must be reconsidered on a regular timetable.

HHS accepted public comments on the proposal though Dec. 4, except on part of the rule affecting Medicare regulations, which has a Jan. 4 deadline. A final rule is expected before Biden becomes president on Jan. 20.

HHS officials don’t point to any specific regulations they say are outdated. However, in their supporting material for the proposal, they note in part:

“An artificial-intelligence-driven data analysis of HHS regulations found that 85 percent of department regulations created before 1990 have not been edited; the Department has nearly 300 broken citation references in the Code of Federal Regulations, meaning CFR sections that reference other CFR sections that no longer exist.”

Harrison said the scarcity of reviews is due to “inertia” and “lack of an incentive mechanism.”

“Many presidents have formally ordered their agencies to review existing regulations, and it has been existing law for 40 years, so simply asking the divisions to review these regulations has been tried for decades and proven to be ineffective,” Harrison said.

“We need to incentivize their behaviors,” he said.

With more than 80,000 employees, the department should be able to complete the review of 2,400 rules in 24 months, he added.

Harrison said the proposal is authorized by a law signed by President Jimmy Carter in the late 1970s requiring federal agencies to review existing rules. But that law has no provision that calls for cutting regulations that are not reviewed within a certain time frame, Schneider said.

The proposal says the HHS secretary would have flexibility to stop some regulations from being eliminated “on a case by case basis.”

HHS estimates the reviews would cost up to $19 million over two years. Regulations would have to be reviewed every 10 years under the proposal.

When he took office in 2017, Trump vowed that for every regulation his administration issued, it would remove two. In July, he said his administration had more than exceeded that goal.

“For every one new regulation added, nearly eight federal regulations have been terminated,” he said in a Rose Garden speech. The Washington Post Fact Checker said that claim was based on “dubious math and values each regulation as having equal weight.”

One of the few groups to endorse the HHS proposal is the National Federation of Independent Business. The group said the proposal would alleviate regulatory burdens on small businesses.

But other groups, such as the American Academy of Neurology, suggest the proposed rule would limit input from interest groups on changes to existing regulations, because it would not follow the usual process of seeking public comments when altering rules. “The AAN is highly supportive of the current process to modify and rescind regulations through the notice and comment period, as it affords stakeholders the necessary opportunity to provide feedback on proposed regulations prior to changes being implemented,” the group told HHS.

The Medicaid and CHIP Payment and Access Commission, which advises Congress, opposes the proposal. “MACPAC questions the need for a proposed rule that creates a duplicative and administratively burdensome new process that is likely to create confusion for beneficiaries, states, providers, and managed care plans,” the group said in a letter to HHS. “The new requirements will create additional unnecessary work that will distract the department and CMS from the critical roles they play in our health care system, Medicaid and CHIP amid the pandemic and its resulting economic challenges.”

It’s unclear how the proposed rule would affect long-standing regulations for product safety and standards, said Betsy Booren, senior vice president of the food lobbying group Consumer Brands Association. “The idea that these regulations would be sunset because a regulations timer went too long is not acceptable,” she wrote in comments on the proposed rule.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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As hospitals across the country weather a surge of COVID-19 patients, in Seattle — an early epicenter of the outbreak — nurses, respiratory therapists and physicians are staring down a startling resurgence of the coronavirus that’s expected to test even one of the best-prepared hospitals on the pandemic’s front lines.

After nine months, the staff at Harborview Medical Center, the large public hospital run by the University of Washington, has the benefit of experience.

In March, the Harborview staff was already encountering the realities of COVID-19 that are now familiar to so many communities: patients dying alone, fears of getting infected at work and upheaval inside the hospital.

This forced the hospital to adapt quickly to the pressures of the coronavirus and how to manage a surge, but all these months later it has left staff members exhausted.

“This is a crisis that’s been going on for almost a year — that’s not the way humans are built to work,” said Dr. John Lynch, an associate medical director at Harborview and associate professor of medicine at the University of Washington.

“Our health workers are definitely feeling that strain in a way that we’ve never experienced before,” he said.

Until the late fall, the Seattle area had mostly kept the virus in check. But now cases are rising faster than ever, and Washington Gov. Jay Inslee has warned a “catastrophic loss of medical care” could be on the horizon.

“This is the very beginning, to be honest, so thinking about what that looks like in December and January has got me very concerned,” Lynch said.

Lessons Learned From Spring Surge

When the outbreak first swept through western Washington, hospitals were in the dark on many fronts. It was unclear how contagious the virus was, how widely it had spread and how many intensive care beds would be needed.

Intensive care unit nurse Whisty Taylor remembers the moment she learned one of her colleagues — a young, active nurse — was hospitalized on their floor and intubated.

“That’s really when it hit — that could be any of us,” Taylor said.

Concerns over infection control and conserving personal protective equipment meant nurses were delegated all sorts of unusual tasks.

“The nurses were the phlebotomists and physical therapists,” said nurse Stacy Van Essen. “We mopped the floors and we took the laundry out and made the beds, plus taking care of people who are extremely, extremely sick.”

A lot has changed since those early days.

Staff members besides just nurses are now trained to go into COVID rooms and be near patients, and the hospital has ironed out the thorny logistics of caring for these highly contagious patients, said Vanessa Makarewicz, Harborview’s manager of infection control and prevention.

How to clean the rooms? Who’s going to draw the blood? What’s the safest way to move people around?

“We’ve grown our entire operation around it,” Makarewicz said.

The physical layout of the hospital has changed to accommodate COVID patients, too.

“It’s still busy and chaotic, but it’s a lot more controlled,” said Roseate Scott, a respiratory therapist in the ICU.

Harborview has also learned how to stretch its supplies of PPE safely. And as cases started to rise significantly last month, the hospital quickly reimposed visitor restrictions.

“In the past, we’ve had visitors who then call us two days later and say, ‘Oh, my gosh, I just came up positive,’” said nurse Mindy Boyle.

Boyle said months of caring for COVID patients — and all the steps the hospital has taken, including having health care workers observed as they don and doff their PPE — has tamped down the fears of catching the virus at work.

“It still scares me somewhat, but I do feel safe, and I would rather be here than out in the community, where we don’t know what’s going on,” said Boyle.

‘We’re All Tired of This’

Preparation can go only so far, though. The hospital still runs the risk of running low on PPE and staff, just like so much of the country.

During the spring, the hospital cleared out beds and recruited nurses from all over the nation, but that is unlikely to happen this time, with so many hospitals under pressure at once.

“All things point to what could be an onslaught of patients on top of a very tired workforce and less staff to go around,” said Nate Rozeboom, a nurse manager on one of the COVID units. “We’re all tired of this, tired of taking care of COVID patients, tired of the uncertainty.”

Already, COVID’s footprint at Harborview is expanding and bringing the hospital close to where it was at its previous peak.

“The fear I have personally is overwhelming the resources, using up all the staff — and the numbers are still going to go up,” said Scott.

And she said the realities of caring for these desperately ill patients have not changed.

“When they’re on their belly, laying down with all the tubes and drains and all these extra lines hanging off of them, it takes about four to five people to manually flip them over,” Scott said. “It feels intense every time. It doesn’t matter how many times you’ve done it.”

Hospitalized patients are faring better than in the spring, but there are still no major breakthroughs, said Dr. Randall Curtis, an attending physician in the COVID ICU and a professor of medicine at the University of Washington.

“The biggest difference is that we have a better sense of what to expect,” Curtis said.

The few treatments that have shown promise, including the steroid dexamethasone and the antiviral remdesivir, have “important but marginal effects,” he said.

“They’re not magic bullets. … People are not jumping out of bed and saying, ‘I feel great. I’d like to go home now,’” Curtis said.

Taylor said nursing has never quite felt the same since she started in the COVID ICU.

“These people are in the rooms for months. Their families can only see them through Zoom. The only interaction they have is with us through our mask, eyewear, plastic,” Taylor said. “We’re just giving their body a runaround trying to keep them alive.”

This story is from a reporting partnership that includes NPR and KHN. 

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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SACRAMENTO — President-elect Joe Biden didn’t back “Medicare for All” during his campaign.

Yet his choice of California Attorney General Xavier Becerra to serve in the nation’s top health care post is fueling California lawmakers’ most progressive health care dreams, including pursuing a government-run single-payer system at the state level.

“Now it’s much more real, and it energizes me in terms of pushing for single-payer now,” said state Assembly member Ash Kalra (D-San Jose), who is considering spearheading a new single-payer campaign next year — a move he argues is more plausible under the Biden-Harris administration, with Becerra at the helm of the U.S. Department of Health and Human Services.

“It’s not good enough to just say that we believe health care is a human right. We’re now obligated to act,” Kalra said.

Across California, Democrats are changing their political calculus for what could be possible if Becerra, 62, is confirmed to the powerful position. After nearly four years of battling President Donald Trump and federal policies they view as unfriendly, Gov. Gavin Newsom and other Democratic leaders welcome a strong ally who could help make California a laboratory for progressive ideas. He would set the agenda for key federal health care agencies, which have broad authority to steer more money to states and approve their ambitious health care proposals.

Becerra, whose mother emigrated from Mexico, would be the first Latino to serve in the position. He would lead a massive $1.3 trillion federal health care apparatus that oversees agencies responsible for Medicare, Medicaid, vaccines, prescription drug approval and the U.S. public health response to the coronavirus pandemic.

“It’s a game changer for us — the stale era of normalcy versus the fresh era of progress,” Newsom said Monday. “We’re going to take advantage of this moment and these relationships — not unfairly.”

A native Californian with 30 years of political experience, 24 of them in Congress, Becerra has long backed a progressive health care agenda, including single-payer, environmental justice and protecting immigrants’ access to safety-net care. He has fiercely defended the Affordable Care Act and fought to preserve reproductive rights. He has gone after deep-pocketed pharmaceutical companies, and successfully sued a large health system in California for anti-competitive practices.

Newsom said he’s already spoken to Becerra about California’s health care priorities and is “accelerating” a dramatic transformation of the state’s Medicaid program to better serve the chronically sick and those suffering from untreated mental illness.

Immigrant advocates, who are deploying a new strategy to expand the state’s Medicaid program to all income-eligible unauthorized immigrants, plan to lobby Becerra and the Biden administration for additional federal money that could help fast-track it. They also want Becerra to agree to allow young unauthorized immigrants known as “Dreamers” to purchase insurance through Covered California, the state exchange. And California Senate President Pro Tem Toni Atkins said she’s “excited” to seek renewed approval to use federal Medicaid dollars for nontraditional uses, such as combating homelessness and providing emergency housing assistance.

“We’ve had a lot less money to bank on under Trump, but Becerra at HHS bodes well for us,” said Cathy Senderling-McDonald, incoming executive director for the County Welfare Directors Association of California. “We can rethink and possibly open up more federal funding.”

Democrats are also seizing on Becerra’s past support for single-payer, which dates back to his early congressional career in the 1990s. He has described himself as a lifelong single-payer advocate, and when a reporter asked him last year whether the idea is too costly and “pie in the sky,” Becerra responded, “I love pie.”

A young XAVIER BECERRA, Biden’s pick to run HHS, lays out his health care principles as a congressman in 1994.

“We must have universal coverage. We must have portability. We must have choice of provider,” Becerra says, endorsing single-payer. pic.twitter.com/fkJVNV0DYQ

— Dan Diamond (@ddiamond) December 7, 2020

But it’s unclear whether Becerra as HHS secretary would embrace progressive — and expensive — health care ideas like single-payer. In his first public remarks on his nomination Tuesday, he touted his work helping to pass the Affordable Care Act and said on Twitter he would “build on our progress to ensure every American has access to quality, affordable health care.”

Some congressional Republicans are raising red flags about Becerra’s nomination, which must be confirmed by the U.S. Senate. They cite his anti-Trump stance and opposition to some federal policies, such as a Trump-era Obamacare rule that allows private employers with religious objections to deny workers contraceptive coverage. Becerra has sued the Trump administration 107 times, including 13 times on health care.

Although Becerra has no direct health care experience, “the court has become the arbiter of health policy, and he certainly got experience there,” said Trish Riley, executive director of the National Academy for State Health Policy.

In announcing Becerra as his Cabinet pick Tuesday, Biden described him as someone who is unafraid to take on special interests and has spent his career working to expand health care access and reduce racial health disparities. California, under Becerra’s leadership, led the defense of the federal health care law before the U.S. Supreme Court last month.

“No matter what happens in the Supreme Court, he’ll lead our efforts to build on the Affordable Care Act, to work to dramatically expand coverage and take bold steps to lower health care prescription drug costs,” Biden said at the news briefing.

In Congress, I helped pass the Affordable Care Act. As California’s Attorney General, I defended it. As Secretary of Health and Human Services, I will build on our progress and ensure every American has access to quality, affordable health care—through this pandemic and beyond.

— Xavier Becerra (@XavierBecerra) December 7, 2020

At the outset, however, Becerra would be consumed by managing the U.S. response to the coronavirus pandemic. In his new role, he would oversee the Centers for Disease Control and Prevention and the National Institutes of Health.

“The No. 1 task he’s going to be completely absorbed with is getting this pandemic under control. We need a consistent message,” said Bruce Pomer, a public health expert and chief lobbyist for the California Association of Public Health Laboratory Directors. “It’s going to be critical for the Biden administration to show people that it can be effective at keeping the American people safe.”

Becerra’s public comments Tuesday indicated the pandemic would be his top priority. “The COVID pandemic has never been as vital or as urgent as it is today,” Becerra said, adding that the economic fallout has “thrust families into crisis. Too many Americans are sick or have lost loved ones, too many have lost their jobs.”

But liberal California lawmakers and advocates say the pandemic has made their ambitious health care goals all the more urgent. And should Becerra back a progressive health agenda in California, similar proposals could follow from other states, said Mark Peterson, a professor of public policy, political science and law at UCLA.

“California has pushed the envelope on health care beyond where other states are,” he said. “And that gives more capacity for California sensibilities and ideas to get into the mix in Washington.”

This story was produced by KHN (Kaiser Health News), which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN is not affiliated with Kaiser Permanente.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Vaccines that protect against COVID-19 are on the way. What should older adults expect?

The first candidates, from Pfizer and Moderna, could arrive before Christmas, according to Alex Azar, who heads the Department of Health and Human Services.

Both vaccines are notably effective in preventing illness due to the coronavirus, according to information released by the companies, although much of the data from clinical trials is still to come. Both have been tested in adults age 65 and older, who mounted a strong immune response.

Seniors in nursing homes and assisted living centers will be among the first Americans vaccinated, following recommendations last week by a federal advisory panel. Older adults living at home will need to wait a while longer.

Many uncertainties remain. Among them: What side effects can older adults anticipate and how often will these occur? Will the vaccines offer meaningful protection to seniors who are frail or have multiple chronic illnesses?

Here’s a look at what’s known, what’s not and what lies ahead.

Decision-making timetable. Pfizer’s vaccine will be evaluated by a 15-member Food and Drug Administration advisory panel on Thursday. Moderna’s vaccine is expected to go before the panel Dec. 17.

At least two days before each meeting, an analysis by FDA staff will be made public. This will be the first opportunity to see extensive data about the vaccines’ performance in large phase 3 clinical trials, including more details about their impact on older adults.

So far, summary results disclosed in news releases indicate that Pfizer’s vaccine, produced in partnership with BioNTech, has an overall efficacy rate of 95% and efficacy of 94% in people 65 and older. Moderna’s overall efficacy is 94%, with 87% efficacy in preventing moderate disease in older adults, according to Moncef Slaoui, chief science adviser to Operation Warp Speed, the government’s COVID-19 vaccine development program.

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If the advisory panel gives a green light, the FDA will decide within days or weeks whether to authorize the Pfizer and Moderna vaccines for emergency use. Distribution of the vaccine has already begun, and health care providers are expected to begin administering it immediately after the FDA acts.

Allocation framework. At a Dec. 1 meeting of the Advisory Commission on Immunization Practices (ACIP), which guides the Centers for Disease Control and Prevention on vaccines, experts recommended that people living in long-term care (primarily nursing homes and assisted living facilities) and health care workers be the first groups to get COVID-19 vaccines.

This recognizes the extraordinary burden of COVID-19 in long-term care facilities. Although their residents represent fewer than 1% of the U.S. population, they account for 40% of COVID deaths — more than 100,000 deaths to date.

The commission’s decision comes despite a lack of evidence that Pfizer’s and Moderna’s vaccines are effective and safe for frail, vulnerable seniors in long-term care. Vaccines were not tested in this population. Federal officials insist side effects will be carefully monitored.

Next in line likely would be essential workers who cannot work from home, such as police, firefighters, teachers and people employed in food processing and transportation, according to commission deliberations Nov. 23 that have not come to a formal vote.

Then would be adults with high-risk medical conditions such as diabetes, cancer, kidney disease, obesity, heart disease and autoimmune diseases and all adults age 65 and older.

Although states typically follow ACIP guidelines, some states may choose, for instance, to vaccinate high-risk older adults before some categories of essential workers.

Left off the list are family caregivers, who provide essential support to vulnerable older adults living in the community — an unpaid workforce of tens of millions of people. “If someone is providing day-to-day care, it makes sense they should have access to the vaccine, too, to keep everyone safe,” said Beth Kallmyer, vice president of care and support for the Alzheimer’s Association.

Further prioritization. The priority groups constitute nearly half of the U.S. population — 21 million health care workers, 3 million long-term care residents, 66 million essential workers, more than 100 million adults with high-risk conditions and 53 million adults age 65 and older.

With initial supplies of vaccines limited, setting priorities will be inevitable. Practically, this means that hospitals and physicians may try to identify older adults who are at the highest risk of becoming seriously ill from COVID-19 and offer them vaccines before other seniors.

A study of more than 500,000 Medicare beneficiaries age 65 and older provides new evidence that could influence these assessments. It found the conditions that most increase older adults’ chances of dying from COVID-19 are sickle cell disease, chronic kidney disease, leukemias and lymphomas, heart failure, diabetes, cerebral palsy, obesity, lung cancer and heart attacks, in that order.

“Out of all Medicare beneficiaries, we identified just under 2,500 who had no medical problems and died of COVID-19,” said Dr. Martin Makary, co-author of the study and a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health in Baltimore. “We knew risk was skewed toward comorbidity [multiple underlying medical conditions], but we didn’t realize it skewed this much.”

Supplies available. Both the Pfizer and Moderna vaccines require two doses, administered three to four weeks apart. The companies have said about 40 million doses of their vaccines should be available this year, enough to fully vaccinate about 20 million people.

After that, 50 million doses might become available in January, followed by 60 million doses in both February and March, according to Dr. Larry Corey, a virologist who heads the COVID-19 Prevention Trials Network.

That translates into enough vaccine for another 85 million people and should be sufficient to vaccinate older adults in addition to medical personnel on the front lines and many other at-risk individuals, Corey suggested at a recent panel on COVID-19 sponsored by the National Academy of Medicine and American Public Health Association.

He acknowledged these were estimates, based on information he has been given. Pfizer and Moderna have not yet specified how much vaccine will be delivered and when. Nor is it clear when other vaccines under investigation will become available — 13 are in phase 3 clinical trials — or what their monthly production capacity might be.

Distribution issues. As Pfizer’s and Moderna’s vaccines are rolled out, a very vulnerable group may have difficulty getting them: 2 million seniors who are homebound and another 5.3 million with physical impairments who have problems getting around.

The reason: handling and cold storage requirements.

Pfizer’s vaccine needs to be stored at minus 70 degrees Celsius, calling for special equipment not available in small hospitals, clinics or doctors’ offices. Moderna’s vaccine needs long-term storage at minus 20 degrees Celsius.

Landmark Health provides in-home medical care to more than 120,000 frail, chronically ill homebound seniors in 15 states. “We don’t have the capabilities to store and distribute these vaccines to our population,” said Dr. Michael Le, the company’s co-founder and chief medical officer.

Instead, he said, Landmark is working to arrange transportation for its patients to centers where COVID-19 vaccines will be administered and educating them about the benefits of the vaccines. “Given the trust, the bond we have with our patients, we can play a big role as advocates,” Le said.

Addressing mistrust. Advocates have a big job ahead of them. According to a recent poll from the University of Michigan, only 58% of older adults (ages 50 to 80) said they were very or somewhat likely to get a COVID-19 vaccine. A significant number of older adults, 46%, thought they’d get the vaccine eventually but wanted others to go first. Only 20% wanted to get it as soon as possible.

Most important in making decisions is knowing how well the vaccine works, according to 80% of the 1,556 older adults surveyed. Just over half (52%) said a recommendation from their doctor would be influential.

Dr. Sharon Inouye, a geriatrician at Hebrew Senior Life in Boston and a professor of medicine at Harvard Medical School, is among the physicians impatiently awaiting the publication of data from Pfizer’s and Moderna’s phase 3 clinical trials.

Among the things she wants to know: How many older adults with chronic health conditions participated? How many participants were 75 and older? Did side effects differ for older adults?

“What I worry about most is the side effects,” she said. “We may not be able to know about serious but rare side effects until millions of people take them.”

But that’s a gamble she’s willing to take. Not only will Inouye get a vaccine, she just told her 91-year-old mother, who lives in assisted living, to say “yes” when one is offered.

“My whole family lives in fear that something will happen to her every day,” Inouye said. “Even though there’s a lot we still don’t know about these vaccines, it’s compelling that we protect people from this overwhelming illness.”

With his state reeling amid one of the worst COVID-19 outbreaks in the nation, the last thing South Dakota Speaker of the House Steven Haugaard wants to be dealing with during the upcoming legislative session is marijuana. But the state’s voters haven’t left the Republican much choice.

This fall, South Dakota became the first state in the U.S. to legalize both medical marijuana and recreational marijuana in the same election. Haugaard, who long opposed any form of marijuana legalization, now must participate in the creation of a medical marijuana program.

South Dakota voters enshrined legal marijuana in the state’s constitution. So if Haugaard had any thoughts about reversing the initiative once lawmakers reconvene on Jan. 12, they’ve been dashed.

“With a constitutional amendment, there’s really not much we can do about it. It’s written in stone until it’s repealed,” Haugaard said.

South Dakota is one of a handful of states in which voters both approved marijuana ballot questions and elected Republicans to lead state governments. Montana and Arizona, two other states in which Republicans control (or will soon control) the governor’s office and legislature, also backed recreational marijuana at the ballot box. Mississippi passed a measure legalizing medical marijuana.

New Jersey, which has a Democratic governor and Democratic-majority legislature, also passed a recreational marijuana ballot question.

Many conservative lawmakers oppose the legalization of marijuana, an illegal drug under federal law. But they are discovering obstacles to simply passing bills to reverse the initiatives when state legislatures return to work in January. Some marijuana opponents, realizing the limitations to altering a constitutional amendment, are turning to the courts or local officials to undo the measures or at least blunt the effects of legal pot.

Before the November election, 11 states and Washington, D.C., had legalized recreational marijuana, most of them left-leaning states, with exceptions like Alaska. An additional 21 states allow medical marijuana. In the wake of the election, 15 states will have legalized recreational marijuana and 35 will allow medical marijuana.

In conservative states like Montana, where passage of a bill can change or negate a ballot initiative, one thing giving lawmakers pause is that many voters who elected them also approved the legalization of marijuana use for adults 21 and up.

In Montana, 57% of voters approved the recreational marijuana initiative — the same share received by President Donald Trump. In South Dakota, 54% voted for recreational marijuana and a whopping 70% approved medical marijuana. In Arizona, the recreational pot proposition also passed easily.

Those kinds of margins are what caused state Rep. Derek Skees to reconsider a bill he was drafting to repeal the Montana ballot measure in anticipation of its passage.

Skees told the Missoulian the day after the election that after it became clear voters supported it — while also supporting Republican candidates for office up and down the ballot — he decided to shelve it.

“There’s no way I’m going to try to overturn the will of Montana,” Skees told the newspaper.

Haugaard said opposition to the South Dakota measure was derailed by the pandemic and voters never got the message from opponents about the potential negative impacts of legalization.

Proponents of legalization spent nearly $800,000 on their campaign in South Dakota — most of it coming from the New Approach Political Action Committee, a pro-legalization group that works across the country — and five times what opponents of ballot measures raised.

Colorado, the first state to allow recreational use of marijuana in 2014, is often held up as the poster child for what can happen. Proponents say the state has benefited from increased tax income and economic activity. But opponents, including Haugaard, point to studies about increased traffic deaths in Colorado since legalization to explain why they think it’s a bad idea.

“That side of the story wasn’t told and had it been told I think this vote would have gone differently,” Haugaard said.

Marijuana opponents aren’t waiting to see what state lawmakers do, if anything — they’re going to court. The Pennington County, South Dakota, sheriff and the superintendent of the South Dakota Highway Patrol have filed a lawsuit challenging the constitutionality of the marijuana amendment. The Rapid City Journal reported the suit had the backing of Gov. Kristi Noem, and that the state was paying for part of the suit. Noem was a vocal opponent of legalization during the campaign.

Should the legal challenge fail, the amendment is scheduled to take effect July 1 and, according to the governor’s office, it will be up to the state health department to implement it. The legislature will have more control over how the medical marijuana program will work. Haugaard said that will be a big focus of the 37-day session.

Opponents in Montana are also asking the courts to disallow recreational marijuana. Steve Zabawa, a Billings car dealer who has campaigned against legalized marijuana for years, said in his lawsuit that what the voters passed would illegally take power from state lawmakers by designating where tax revenue will go.

Zabawa blamed its passage at the ballot box on pro-marijuana advocacy groups that so outraised and outspent opponents of the measure that he compared it to David and Goliath.

“They candy-coated this deal. They lied to the entire state of Montana by saying that this would benefit veterans and fish and wildlife,” Zabawa said. “They crossed a line and we’re calling them on it.”

Zabawa said that if the courts don’t block recreational marijuana, he’s hopeful that Montana’s Republican-controlled Statehouse will stymie its implementation.

“I just don’t think there’s a lot of love for marijuana in Montana,” Zabawa said.

In Arizona, a recreational marijuana ballot measure was rejected by voters just four years ago. This year it passed by a wide margin. The state’s voters also chose Joe Biden over President Donald Trump, the first time a Democrat won the presidential election in the state since 1996.

It’s unlikely Arizona’s Republican-led legislature can do anything to stop implementation because of a 1998 law that prohibits lawmakers from changing a voter-approved initiative without a three-quarters majority.

State lawmakers’ hands may be tied, but the initiative did give municipalities some power to restrict its use. The day after the initiative passed, Oro Valley Town Council approved an emergency declaration that would limit which type of businesses could sell marijuana and prohibited its use in public places.

The declaration was based on language written by the League of Arizona Cities and Towns and given to members prior to Election Day.

One of the major backers of the state ballot measures is the Marijuana Policy Project, a Washington, D.C.-based organization that supports sweeping marijuana policy changes across the country. Deputy Director Matthew Schweich said this election showed how the public’s opinion on marijuana is rapidly evolving.

Schweich said he believes the results of the 2020 election bode well for future legalization efforts in states and even at the federal level. Because of that growing support, he dismissed any chance Montana or South Dakota could derail recreational legalization but added that his organization will do whatever it can to fight those efforts.

“This is a bipartisan issue [and] I think we’re at a tipping point. We’ve passed it in big states and small states, liberal states and conservative states,” he said. “We’re feeling pretty good. We believe that 2021 is our year.”

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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I still remember exactly where I was sitting decades ago, during the short film shown in class: For a few painful minutes, we watched a woman talking mechanically, raspily through a hole in her throat, pausing occasionally to gasp for air.

This story also ran on The New York Times. It can be republished for free.

The public service message: This is what can happen if you smoke.

I had nightmares about that ad, which today would most likely be tagged with a trigger warning or deemed unsuitable for children. But it was supremely effective: I never started smoking and doubt that few if any of my horrified classmates did either.

When the government required television and radio stations to give $75 million in free airtime for antismoking ads between 1967 and 1970 — many of them terrifyingly graphic — smoking rates plummeted. Since then, numerous smoking “scare” campaigns have proved successful. Some even featured celebrities, like Yul Brynner’s posthumous offering with a warning after he died from lung cancer: “Now that I’m gone, don’t smoke, whatever you do, just don’t smoke.”

As the United States faces out-of-control spikes from COVID-19, with people refusing to take recommended, often even mandated, precautions, our public health announcements from governments, medical groups and health care companies feel lame compared with the urgency of the moment. A mix of clever catchphrases, scientific information and calls to civic duty, they are virtuous and profoundly dull.

The Centers for Disease Control and Prevention urges people to wear masks in videos that feature scientists and doctors talking about wanting to send kids safely to school or protecting freedom.

Quest Diagnostics made a video featuring people washing their hands, talking on the phone, playing checkers. The message: “Come together by spending time apart.”

As cases were mounting in September, the Michigan government produced videos with the exhortation, “Spread Hope, Not Covid,” urging Michiganders to put on a mask “for your community and country.”

Forget that. Mister Rogers-type nice isn’t working in many parts of the country. It’s time to make people scared and uncomfortable. It’s time for some sharp, focused, terrifying realism.

“Fear appeals can be very effective,” said Jay Van Bavel, associate professor of psychology at New York University, who co-authored a paper in Nature about how social science could support COVID response efforts. (They may not be needed as much in places like New York, he noted, where people experienced the constant sirens and the makeshift hospitals.)

I’m not talking fear-mongering, but showing in a straightforward and graphic way what can happen with the virus.

From what I could find, the state of California came close to showing the urgency: a soft-focus video of a person on a ventilator, featuring the sound of a breathing machine, but not a face. It exhorted people to wear a mask for their friends, moms and grandpas.

But maybe we need a PSA featuring someone actually on a ventilator in the hospital. You might see that person “bucking the vent” — bodies naturally rebel against the machine forcing pressurized oxygen into the lungs, which is why patients are typically sedated.

(Because I had witnessed this suffering as a practicing doctor, I was always upfront about the trauma with loved ones of terminally ill patients when they were trying to decide whether to consent to a relative being put on a ventilator. It sounds as easy as hooking someone to an IV. It’s not.)

Another message could feature a patient lying in an ICU bed, immobile, tubes in the groin, with a mask delivering 100% oxygen over the mouth and nose — eyes wide with fear, watching the saturation numbers rise and dip on the monitor over the bed.

Maybe some PSAs should feature a so-called COVID long hauler, the 5% to 10% of people for whom recovery takes months. Perhaps a professional athlete like the National Football League’s Ryquell Armstead, 24, who has been in and out of the hospital with serious lung issues and missed the season.

These PSAs might sound harsh, but they might overcome our natural denial. “One consistent research finding is that even when people see and understand risks, they underestimate the risks to themselves,” Van Bavel said. Graphs, statistics and reasonable explanations don’t do it. They haven’t done it.

Only after Chris Christie, an adviser to President Donald Trump, experienced COVID, did he start preaching about mask-wearing: “When you have seven days in isolation in an ICU, though, you have time to do a lot of thinking,” Christie said, suggesting that people, “follow CDC guidelines in public no matter where you are and wear a mask to protect yourself and others.”

We hear from many who resist taking precautions. They say, “I know someone who had it and it’s not so bad.” Or, “It’s just like the flu.”

Sure, most longtime smokers don’t end up with lung cancer — or tethered to an oxygen tank — either. (That, in fact, was the justification of smokers like my father, whose two-pack-a-day habit contributed to his death at 47 of a heart attack.)

These new ads will seem hard to watch. “We live in a Pixar era,” Van Bavel reflected, with traditional fairy tales now stripped of their gore and violence.

But studies have shown that emotional ads featuring personal stories about the effects of smoking were the most effective at persuading folks to quit. And quitting smoking is much harder than maintaining physical distance and mask-wearing.

Once a vaccine has proved successful and enough people are vaccinated, the pandemic may well be in the rearview mirror. In the meantime, the creators of public health messaging should stop favoring the cute, warm and dull. And — at least sometimes — scare you.