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COVID-19 was the dominant — but not the only — health policy story of 2020. In this special year-in-review episode of KHN’s “What the Health?” podcast, panelists look back at some of the biggest non-coronavirus stories. Those included Supreme Court cases on the Affordable Care Act, Medicaid work requirements and abortion, as well as a year-end surprise ending to the “surprise bill” saga.

This week’s panelists are Julie Rovner of KHN, Joanne Kenen of Politico, Anna Edney of Bloomberg News and Sarah Karlin-Smith of Pink Sheet.

Among the takeaways from this week’s podcast:

• The coronavirus pandemic strengthened the hand of ACA supporters, even as the Trump administration sought to get the Supreme Court to overturn the federal health law. Many people felt it was an inopportune time to get rid of that safety valve while so many Americans were losing their jobs — and their health insurance — due to the economic chaos from the virus.
• Preliminary enrollment numbers released by federal officials last week suggest that more people were taking advantage of the option to buy coverage for 2021 through the ACA marketplaces than for 2020, even in the absence of enrollment encouragement from the federal government.
• The ACA’s Medicaid expansion had a bit of a roller-coaster ride this year. Voters in two more states — Oklahoma and Missouri — approved the expansion in ballot measures, but the Trump administration continued its support of state plans that require many adults to prove they are working in order to continue their coverage. The Supreme Court has agreed to hear a challenge to that policy. Although lower courts have ruled that the Medicaid law does not allow such restrictions, it’s not clear how the new conservative majority on the court will view this issue.
• Concerns are beginning to grow in Washington about the near-term prospect of the Medicare trust fund going insolvent. That can likely be fixed only with a remedy adopted by Congress, and that may not happen unless lawmakers feel a crisis is very near.
• The Trump administration has sought to bring down drug out-of-pocket expenses for Medicare beneficiaries. Among those initiatives is a demonstration project to lower the cost of insulin. About a third of Medicare beneficiaries will be enrolled in plans that offer reduced prices in 2021. But the effort could have a hidden consequence: higher insurance premiums.
• Many members of Congress began this session two years ago with grand promises of working to lower drug prices — but they never reached an agreement on how to do it.
• President Donald Trump, however, was strongly motivated by the issue and late this year issued an order to set many Medicare drug prices based on what is paid in other industrialized nations. Drugmakers detest the idea and have vowed to fight it in court. Although some Democrats endorse the concept, it seems unlikely that President-elect Joe Biden would want to spend much capital in a legal battle for a plan that hasn’t been carefully vetted.
• The gigantic spending and COVID relief bill that Congress finally approved Monday includes a provision to protect consumers from surprise medical bills when they are unknowingly treated by doctors or hospitals outside their insurance network. The law sets up a mediation process to resolve the charges, but the process favors the doctors. Insurers are likely to pass along any extra costs to consumers through higher premiums.

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

In late summer, as researchers accelerated the first clinical trials of COVID-19 vaccines for humans, a group of scientists in Colorado worked to inoculate a far more fragile species.

About 120 black-footed ferrets, among the most endangered mammals in North America, were injected with an experimental COVID vaccine aimed at protecting the small, weasel-like creatures rescued from the brink of extinction four decades ago.

The effort came months before U.S. Department of Agriculture officials began accepting applications from veterinary drugmakers for a commercial vaccine for minks, a close cousin of the ferrets. Farmed minks, raised for their valuable fur, have died by the tens of thousands in the U.S. and been culled by the millions in Europe after catching the COVID virus from infected humans.

Vaccinating such vulnerable species against the disease is important not only for the animals’ sake, experts say, but potentially for the protection of people. Some of the most pernicious human diseases have originated in animals, including the new coronavirus, which is believed to have spread from bats to an intermediary species before jumping to humans and sparking the pandemic.

The worry when it comes to animals like farmed minks, which are kept in crowded pens, is that the virus, contracted from humans, can mutate as it spreads rapidly in the susceptible animals, posing a new threat if it spills back to people. Danish health officials in November reported detecting more than 200 COVID cases in humans that had variants associated with farmed minks, including a dozen with a mutation scientists feared could undermine the effectiveness of vaccines. However, officials now say that variant appears to be extinct.

In the U.S., scientists have not found similar COVID mutations in the domestic farmed mink populations, though they recently noted with concern the discovery of the first case of the virus in a wild mink in Utah.

“For highly contagious respiratory viruses, it’s really important to be mindful of the animal reservoir,” said Dr. Corey Casper, a vaccinologist and chief executive of the Infectious Disease Research Institute in Seattle. “If the virus returns to the animal host and mutates, or changes, in such a way that it could be reintroduced to humans, then the humans would no longer have that immunity. That makes me very concerned.”

For the newly vaccinated ferrets, the main risk is to the animals themselves. They’re part of a captive population at the National Black-footed Ferret Conservation Center outside Fort Collins, Colorado, where there have been no cases of COVID-19 to date. But the slender, furry creatures — known for their distinctive black eye mask, legs and feet — are feared to be highly vulnerable to the ravages of the disease, said Tonie Rocke, a research scientist at the National Wildlife Health Center who is testing the ferret vaccine. They’re all genetically similar, having come from a narrow breeding pool, which weakens their immune systems. And they likely share many of the features that have made the disease so deadly to minks.

“We don’t have direct evidence that black-footed ferrets are susceptible to COVID-19, but given their close relationship to minks, we wouldn’t want to find out,” Rocke said.

Rocke began working on the experimental vaccine in the spring, as she and Pete Gober, black-footed ferret recovery coordinator for the U.S. Fish and Wildlife Service, watched reports about the new coronavirus with growing alarm. An exotic disease is “the biggest nemesis for ferret recovery,” said Gober, who has worked with black-footed ferrets for 30 years. “It can knock you right back down to zero.”

The ferrets are a native species that once roamed vast areas of the American West. Their ranks declined precipitously over many decades as populations of prairie dogs, the ferrets’ primary source of food and shelter, were decimated by farming, grazing and other human activity.

In 1979, black-footed ferrets were declared extinct — until a small population was discovered on a ranch in Wyoming. Most of those rare animals were then lost to disease, including sylvatic plague, the animal version of the Black Death that has plagued humans. The species survived only because biologists rescued 18 ferrets to form the basis of a captive breeding program, Gober said.

With the threat of new disease looming, Gober doubled-down on the strict infection prevention precautions at the center, which houses more than half of the 300 black-footed ferrets in captivity. An additional 400 have been reintroduced to the wild. Then he called Rocke, who previously created a vaccine shown to protect ferrets from sylvatic plague. It uses a purified protein from Yersinia pestis, the bacterium that causes the disease.

Would the same technique work against the virus that causes COVID-19? Under the research authority granted by the Fish and Wildlife Service, the scientists were free to try.

“We can do these sorts of things experimentally in animals that we can’t do in humans,” Rocke noted.

Rocke acquired purified protein of a key component of the SARS-CoV-2 virus, the spike protein, from a commercial producer. She mixed the liquid protein with an adjuvant, a substance that enhances immune response, and injected it under the animals’ skin.

The first doses were given in late spring to 18 black-footed ferrets, all male, all about a year old, followed by a booster dose a few weeks later. Within weeks of getting the second shots, tests of the animals’ blood showed antibodies to the virus, a good — and expected — sign.

By early fall, 120 of the 180 ferrets housed at the center were inoculated, with the rest remaining unvaccinated in case something went wrong with the animals, which generally live four to six years in captivity. So far, the vaccine appears safe, but there’s no data yet to show whether it protects the animals from disease. “I can tell you, we have no idea if it will work,” said Rocke, who plans to conduct efficacy tests this winter.

But Rocke’s effort makes sense, said Casper, who has created several vaccines for humans. Rocke’s approach — introducing an inactivated virus in an animal to stimulate an immune response — is the basis for many common vaccines, such as those that prevent polio and influenza.

Vaccines containing inactivated virus to prevent COVID-19 have been tested in certain animals — and in human vaccines, including CoronaVac, created by the Chinese firm Sinovac Life Sciences. But the effort in Colorado may be among the first aimed at preventing COVID-19 in a specific animal population, Rocke said.

Gober said he is optimistic that the ferrets are protected, but it will take a well-designed study to settle the question. Until then, he’ll work to keep the fragile ferrets free of COVID-19. “The price of peace is eternal vigilance, they say. We can’t let our guard down.”

The tougher task is doing the same for people, Gober observed.

“We’re just holding our breath, hoping we can get all the humans vaccinated in the country. That will give us all a sigh of relief.”

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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The recent rollout of two newly authorized COVID-19 vaccines is a bright ray of hope at the pandemic’s darkest hour.

We now have a path that can lead us to happier times — even as we watch and suffer from the horrible onslaught of new infections, hospitalizations and deaths that mark the end of this regrettable year.

Health care workers and nursing home residents have already begun to get shots in the first phase of the rollout. Vaccinations should start to be available to the general public sometime in the first few months of next year.

The two vaccines — one developed by Pfizer and BioNTech, the other by Moderna — use the same novel genetic approach. Their development in under a year, shattering all records, is a marvel of science. It’s also a cause for concern for millions of Americans who fear the uncertainty of an unknown technology.

The clinical trial data for the Pfizer and Moderna vaccines show that when both shots of the dual-injection immunization are taken, three weeks to a month apart, they are about 95% effective — at least at preventing severe COVID illness.

However, “a vaccine that remains in the vial is 0% effective no matter what the data show,” says Dr. Walter Orenstein, a professor of infectious diseases at the Emory University School of Medicine in Atlanta and associate director of the Emory Vaccine Center.

Hence, the imperative of persuading millions of people, across racial, cultural, religious, political and generational lines, to get immunized when a vaccine becomes available to them. A survey published this month showed 45% of respondents are taking a wait-and-see approach to vaccination.

Because the vaccines were developed under duress as the coronavirus exacted its deadly toll, the premium was on speed — “warp speed.” So although the number of people in the trials is as large as or larger than in previous vaccine trials, some key questions won’t be answered until millions more are vaccinated.

For example, we don’t know to what extent the vaccines will keep us from transmitting or contracting the virus — though the protection from potentially fatal illness they are likely to confer is in itself something of a miracle.

We don’t know whether irreversible side effects might emerge, or who is at higher risk from them. And we don’t know whether we’ll need to get vaccinated every year, every three years, or never again.

These unknowns add to the challenges faced by the federal government, local health authorities, medical professionals and private sector entities as they seek to persuade people across the broadest possible swath of the population to get a vaccine.

Skepticism resides in many quarters, including among African Americans, many of whom have a long-standing mistrust of the medical world; the vocal “anti-vaxxers”; and people of all stripes with perfectly understandable doubts. Not to mention communities with language barriers and immigrants without documents — more than 2 million strong in California — who may fear coming forward.

Here are answers to some questions you might be asking yourself about the new vaccines:

Q: How can I be sure they’re safe?

There’s no ironclad guarantee. But the federal Food and Drug Administration, in authorizing the Moderna and Pfizer vaccines, determined that their benefits outweighed their risks.

The side effects observed in trial participants were common to other vaccines: pain at the injection site, fatigue, headache, muscle pain and chills. “Those are minor side effects, and the benefit is not dying from this disease,” says Dr. George Rutherford, a professor of epidemiology at the University of California-San Francisco.

Saturday, the Centers for Disease Control and Prevention reported six cases of anaphylactic allergic reaction in the first 272,000 people who got the Pfizer vaccine outside the clinical trials. This has led the CDC to recommend that people receiving the vaccine be observed for up to 30 minutes afterward.

It’s possible other unexpected adverse effects could pop up down the road. “The chances are low, but they are not zero,” says Orenstein. There’s not enough data yet to know if the vaccines pose an elevated risk to pregnant or lactating women, for example, or to immunocompromised people, such as those with HIV. And we know very little about the effects in children, who were not in the initial trials and for whom the vaccines are not authorized.

Q: Why should my family and I take it?

First of all, because you will protect yourselves from the possibility of severe illness or even death. Also, by getting vaccinated you will be doing your part to achieve a vaccination rate high enough to end the pandemic. Nobody knows exactly what percentage of the population needs to get inoculated for that to happen, but infectious disease experts put the number somewhere between 60% and 70% — perhaps even a little higher. Think of it as a civic duty to get your shots.

Q: So, when can I get mine?

It depends on your health status, age and work. In the first phase, already underway, health care workers and nursing home residents are getting vaccinated. The 40 million Moderna and Pfizer doses expected to be available by year’s end should immunize most of them.

Next in line are people 75 and older and essential workers in various public-facing jobs. They will be followed by people ages 65-74 and those under 65 with certain medical conditions that put them at high risk. Enough vaccine could be available for the rest of the population by late spring, but summer or even fall is more likely. Already, some distribution bottlenecks have developed.

On the bright side, two other vaccines — one from Johnson & Johnson, the other from AstraZeneca and Oxford University — could win FDA authorization early next year, significantly increasing the supply.

Q: Once I’m vaccinated, can I finally stop wearing a mask and physical distancing?

No. Especially not early on, before a lot of people have been vaccinated. One reason for that is self-protection. The Moderna and Pfizer vaccines are 95% effective, but that means you still have a 5% chance of falling ill if you are exposed to someone who hasn’t been vaccinated — or who has been but is still transmitting the virus.

Another reason is to protect others, since you could be the one shedding virus despite the vaccination.

Q: I’ve already had COVID-19, so I don’t need the vaccine, right?

We don’t know for sure how long exposure to the virus protects you from reinfection. Protection probably lasts at least a few months, but public health experts say it’s a good idea to get vaccinated when your turn comes up — especially if it’s been many months since you tested positive.

There’s been some talk among health officials of pushing those who’ve been infected in the last 90 days or so toward the back of the line, to ensure adequate supply for those who might be at higher risk.

Q: How long before our lives get back to normal?

“If everything goes well, next Thanksgiving might be near normal, and we might be getting close to that by the summer,” says Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine in Nashville, Tennessee. ”But there would have to be substantial acceptance of the vaccine and data showing the virus moving in a downward direction.”

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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Lorraine Rogge and her husband, Michael Rogge, travel the country in a recreational vehicle, a well-earned adventure in retirement. This spring found them parked in Artesia, New Mexico, for several months.

This story also ran on NPR. It can be republished for free.

In May, Rogge, 60, began to feel pelvic pain and cramping. But she had had a total hysterectomy in 2006, so the pain seemed unusual, especially because it lasted for days. She looked for a local gynecologist and found one who took her insurance at the Carlsbad Medical Center in Carlsbad, New Mexico, about a 20-mile drive from the RV lot.

The doctor asked if Rogge was sexually active, and she responded yes and that she had been married to Michael for 26 years. Rogge felt she made it clear that she is in a monogamous relationship. The doctor then did a gynecological examination and took a vaginal swab sample for laboratory testing.

The only lab test Rogge remembered discussing with the doctor was to see whether she had a yeast infection. She wasn’t given any medication to treat the pelvic pain and eventually it disappeared after a few days.

Then the bill came.

The Patient: Lorraine Rogge, 60. Her insurance coverage was an Anthem Blue Cross retiree plan through her husband’s former employer, with a deductible of $2,000 and out-of-pocket maximum of $6,750 for in-network providers.

Total Bill: Carlsbad Medical Center billed $12,386.93 to Anthem Blue Cross for a vaginosis, vaginitis and sexually transmitted infections (STI) testing panel. The insurer paid $4,161.58 on a negotiated rate of $7,172.05. That left Rogge responsible for $1,970 of her deductible and $1,040.36 coinsurance. Her total owed for the lab bill was $3,010.47. Rogge also paid $93.85 for the visit to the doctor.

Service Provider: Carlsbad Medical Center in Carlsbad, New Mexico. It is owned by Community Health Systems, a large for-profit chain of hospital systems based in Franklin, Tennessee, outside Nashville. The doctor Rogge saw works for Carlsbad Medical Center and its lab processed her test.

Medical Service: A bundled testing panel that looked for bacterial and yeast infections as well as common STIs, including chlamydia, gonorrhea and trichomoniasis.

What Gives: There were two things Rogge didn’t know as she sought care. First, Carlsbad Medical Center is notorious for its high prices and aggressive billing practices and, second, she wasn’t aware she would be tested for a wide range of sexually transmitted infections.

The latter bothered her a lot since she has been sexually active only with her husband. She doesn’t remember being advised about the STI testing at all. Nor was she questioned about whether she or her husband might have been sexually active with other people, which could have justified broader testing. They have been on the road together for five years.

“I was incensed that they ran these tests, when they just said they were going to run a yeast infection test,” said Rogge. “They ran all these tests that one would run on a very young person who had a lot of boyfriends, not a 60-year-old grandmother that’s been married for 26 years.”

Although a doctor doesn’t need a patient’s authorization to run tests, it’s not good practice to do so without informing the patient, said Dr. Ina Park, an associate professor of family community medicine at the University of California-San Francisco School of Medicine. That is particularly true with tests of a sensitive nature, like STIs. It is doubly true when the tests are going to costs thousands of dollars.

Park, an expert in sexually transmitted infections, also questioned the necessity of the full panel of tests for a patient who had a hysterectomy.

Beyond that, the pricing for these tests was extremely high. “It should not cost $12,000 to get an evaluation for vaginitis,” said Park.

Charles Root, an expert in lab billing, agreed.

“Quite frankly, the retail prices on [the bill] are ridiculous, they make no sense at all,” said Root. “Those are tests that cost about $10 to run.”

In fall 2019, The New York Times and CNN investigated Carlsbad Medical Center and found the facility had taken thousands of patients to court for unpaid hospital bills. Carlsbad Medical Center also has higher prices than many other facilities — a 2019 Rand Corp. study found that private insurance companies paid Carlsbad Medical Center 505% of what Medicare would pay for the same procedures.

The bundled testing panel run on Rogge’s sample was a Quest Diagnostics SureSwab Vaginosis Panel Plus. It included six types of tests. Quest Diagnostics didn’t provide the cost for the bundled tests, but Kim Gorode, a company spokesperson, said if the tests had been ordered directly through Quest rather than through the hospital, it was likely “the patient responsibility would have been substantially less.”

According to Medicare’s Clinical Laboratory Fee Schedule, Medicare would have reimbursed labs only about $40 for each test run on Rogge’s sample. And Medicaid would reimburse hospitals in New Mexico similarly, according to figures provided by Russell Toal, superintendent of New Mexico’s insurance department.

But hospitals and clinics can — and do — add substantial markups to clinical tests sent out to commercial labs.

Although private health insurance doesn’t typically reimburse hospitals at Medicare or Medicaid rates, Root said, private insurance reimbursement rates are rarely much more than 200% to 300% of Medicare’s rates. Assuming a 300% reimbursement rate, the total private insurance would have reimbursed for the six tests would have been $720.

That $720 is less than what Carlsbad Medical Center charged Rogge for her chlamydia test alone: $1,045. And for several of the tests, the medical center charged multiple quantities — presumably corresponding to how many species were tested for — elevating the cost of the yeast infection test to over $4,000.

Toal, who reviewed Rogge’s bill, called the prices “outrageous.”

Resolution: Rogge contacted Anthem Blue Cross and talked to a customer service representative, who submitted a fraud-and-waste claim and an appeal contending the charges were excessive.

The appeal was denied. Anthem Blue Cross told Rogge that under her plan the insurance company had paid the amount it was responsible for, and that based on her deductible and coinsurance amounts, she was responsible for the remainder.

Anthem Blue Cross said in a statement to KHN all the tests run on Rogge were approved and “paid for in accordance with Anthem’s pre-determined contracted rate with Carlsbad Medical Center.”

By the time Rogge’s appeal was denied, she had researched Carlsbad Medical Center and read the stories of patients being brought to court for medical bills they couldn’t pay. She had also gotten a notice from the hospital that her account would be sent to a collection agency if she didn’t pay the $3,000 balance.

Fearing the possibility of getting sued or ruining her credit, Rogge agreed to a plan to pay the bill over three years. She made three payments of $83.63 each in September, October and November, totaling $250.89.

After a Nov. 18 call and email from KHN, Carlsbad Medical Center called Rogge on Nov. 20 and said the remainder of her account balance would be waived.

Rogge was thrilled. We “aren’t the kind of people who have payment plans hanging over our heads,” she said, adding: “This is a relief.”

“I’m going to go on a bike ride now” to celebrate, she said.

The Takeaway: Particularly when visiting a doctor with whom you don’t have a long-standing trusted relationship, don’t be afraid to ask: How much is this test going to cost? Also ask for what, exactly, are you being tested? Do not be comforted by the facility’s in-network status. With coinsurance and deductibles, you can still be out a lot.

If it’s a blood test that will be sent out to a commercial lab like Quest Diagnostics anyway, ask the physician to just give you a requisition to have the blood drawn at the commercial lab. That way you avoid the markup. This advice is obviously not possible for a vaginal swab gathered in a doctor’s office.

Patients should always fight bills they believe are excessively high and escalate the matter if necessary.

Rogge started with her insurer and the provider, as should most patients with a billing question. But, as she learned: In American medicine, what’s legal and in accordance with an insurance contract can seem logically absurd. Still, if you get no satisfaction from your initial inquiries, be aware of options for taking your complaints further.

Every state and U.S. territory has a department that regulates the insurance industry. In New Mexico, that’s the Office of the Superintendent of Insurance. Consumers can look up their state’s department on the National Association of Insurance Commissioners website.

Toal, the insurance superintendent in New Mexico, said his office doesn’t (and no office in the state does that he’s aware of) have the authority to tell a hospital its prices are too high. But he can look into a bill like Rogge’s if a complaint is filed with his office.

“If the patient wants, they can request an independent review, so the bill would go to an independent organization that could see if it was medically necessary,” Toal said.

That wasn’t needed in this case because Rogge’s bill was waived. And after being contacted by KHN, Melissa Suggs, a spokesperson with Carlsbad Medical Center, said the facility is revising their lab charges.

“Pricing for these services will be lower in the future,” Suggs said in a statement.

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

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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El reciente lanzamiento de dos vacunas para COVID-19 es una luz de esperanza en medio de la pandemia.

Ahora hay un camino que puede llevarnos a tiempos más felices, incluso mientras observamos y sufrimos la horrible avalancha de nuevas infecciones, hospitalizaciones y muertes que marcan el final de este año lamentable.

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Los trabajadores de salud y los residentes de hogares de adultos mayores ya han comenzado a recibir vacunas en la primera fase de la distribución. Y más deberían estar disponibles para el público en general en los primeros meses del próximo año.

Las dos vacunas, una desarrollada por Pfizer y BioNTech, la otra por Moderna, utilizan el mismo enfoque genético novedoso. Su desarrollo en menos de un año, rompiendo todos los récords, es una maravilla de la ciencia. También es motivo de preocupación para millones de estadounidenses que sienten incertidumbre ante una tecnología desconocida.

Los datos de los ensayos clínicos de Las vacunas de Pfizer y Moderna muestran que cuando se reciben las dos dosis necesarias, con un intervalo de tres semanas a un mes, tienen una eficacia de aproximadamente el 95%, al menos para prevenir la forma grave de COVID.

Sin embargo, “una vacuna que permanece en el frasco tiene un 0% de efectividad sin importar lo que muestren los datos”, dijo el doctor Walter Orenstein, profesor de enfermedades infecciosas en la Escuela de Medicina de la Universidad de Emory en Atlanta y director asociado del Centro de Vacunas Emory.

De ahí la importancia de persuadir a millones de personas, de todas las razas, culturas, religiones, simpatías políticas y edades, para que se vacunen cuando llegue el momento. Una encuesta publicada este mes mostró que el 45% de los encuestados están adoptando un enfoque de “esperar y ver qué pasa” con la vacunación.

Debido a que las vacunas se desarrollaron bajo la presión de una pandemia mortal, la clave fue la velocidad. Por lo que, aunque el número de personas en los ensayos es tan grande o mayor que en pruebas anteriores, algunas preguntas clave no se responderán hasta que se vacunen millones más.

Por ejemplo, no se sabe si podrían surgir efectos secundarios irreversibles o quién corre mayor riesgo de sufrirlos. Y tampoco si habrá que vacunarse todos los años, cada tres años o nunca más.

Estas incógnitas se suman a los desafíos que enfrentan el gobierno federal, autoridades de salud locales, profesionales médicos y entidades privadas mientras buscan persuadir a la mayor cantidad de personas posible para que se vacunen.

Hay escepticismo en muchos sectores, incluso entre los afroamericanos, que desconfían desde hace mucho tiempo del mundo médico; los ruidosos “anti-vacunas”; y gente con dudas perfectamente comprensibles. Sin mencionar las comunidades con barreras idiomáticas e inmigrantes indocumentados, más de 2 millones solo en California, que pueden temer ir al centro de vacunación.

A continuación, respuestas a algunas preguntas sobre las nuevas vacunas:

¿Cómo puedo saber si son seguras?

No hay una garantía absoluta. Pero al autorizar las vacunas de Pfizer y Moderna, la Administración de Drogas y Alimentos (FDA) determinó que sus beneficios superaban a sus riesgos.

Los efectos secundarios observados en los participantes delos ensayos fueron similares a los de otras vacunas: dolor en el lugar de la inyección, fatiga, dolor de cabeza, dolor muscular y escalofríos. “Esos son efectos secundarios menores y el beneficio es no morir a causa de esta enfermedad”, dijo el doctor George Rutherford, profesor de Epidemiología en la Universidad de California-San Francisco.

El sábado 19 de diciembre, los Centros para el Control y Prevención de Enfermedades (CDC) informaron seis casos de reacción alérgica anafiláctica en las primeras 272,000 personas que recibieron la vacuna de Pfizer por fuera de los ensayos clínicos. Esto ha llevado a los CDC a recomendar que se mantenga en observación a las personas que se vacunan por unos 30 minutos.

Es posible que aparezcan otros efectos adversos inesperados en el futuro. “Las posibilidades son bajas, pero no nulas”, dijo Orenstein. Por ejemplo, todavía no hay datos suficientes para saber si las vacunas representan un riesgo elevado para las mujeres embarazadas o lactantes, o para las personas inmunodeprimidas, como las que viven con VIH.

Y sabemos muy poco sobre los efectos en los niños, que no formaron parte de los ensayos iniciales y para quienes las vacunas no están autorizadas.

¿Por qué debería vacunarse una familia?

En primer lugar, porque se protegerán de la posibilidad de una enfermedad grave o incluso de la muerte. Además, al vacunarse estarán haciendo su parte para lograr una tasa de vacunación lo suficientemente alta como para poner fin a la pandemia. Nadie sabe exactamente qué porcentaje de la población necesita vacunarse para que eso suceda, pero expertos en enfermedades infecciosas sitúan la cifra entre el 60% y el 70%, quizás incluso un poco más. Hay que pensar en vacunarse como en un deber cívico.

Entonces, ¿cuando vacunarse?

Depende del estado de salud de la persona, edad y trabajo. En la primera fase, que ya está en marcha, se está vacunando a trabajadores de salud y a adultos mayores en hogares. Las 40 millones de dosis de Moderna y Pfizer que se espera estén disponibles para fin de año deberían inmunizar a la mayoría de ellos.

Los siguientes en la fila son las personas de 75 años o más y los trabajadores esenciales en varios trabajos públicos. Luego, personas de 65 a 74 años y menores de 65 con ciertas condiciones médicas que los ponen en alto riesgo.

Es posible que haya suficientes vacunas disponibles para el resto de la población a fines de la primavera, pero es más probable el verano o incluso el otoño. Ya se han desarrollado algunos cuellos de botella en la distribución.

En el lado positivo, otras dos vacunas, una de Johnson & Johnson, la otra de AstraZeneca y la Universidad de Oxford, podrían obtener la autorización de la FDA a principios del próximo año, aumentando significativamente el suministro.

Una vez que la persona se vacuna, ¿puede dejar de usar una máscara y el distanciamiento físico?

No. Especialmente al principio, antes de que muchas personas hayan sido vacunadas. Una de las razones es la autoprotección. Las vacunas de Moderna y Pfizer tienen una efectividad del 95%, pero eso significa que la persona aún tiene un 5% de posibilidades de enfermarse si está expuesta a alguien con COVID.

Si la persona ya tuvo COVID-19, ¿aún necesita vacunarse?

Todavía no se sabe con certeza cuánto tiempo dura la inmunidad luego de la infección, y si hay posibilidad de reinfección. Expertos en salud pública dicen que es buena idea vacunarse cuando llegue el turno, especialmente si han pasado muchos meses desde que la persona dio positivo.

Se ha hablado de que las personas que ya han tenido COVID estén últimos en la fila para recibir la vacuna, para garantizar un suministro adecuado para aquellos que podrían estar en mayor riesgo.

¿Cuánto tiempo pasará antes de que se vuelva a la normalidad?

“Si todo va bien, el próximo Día de Acción de Gracias podría ser casi normal y podríamos estar acercándonos a eso para el verano”, dice el doctor William Schaffner, profesor de enfermedades infecciosas en la Escuela de Medicina de la Universidad de Vanderbilt en Nashville, Tennessee. “Pero tendría que haber una aceptación sustancial de la vacuna y datos que muestren que el virus se mueve en una dirección descendente”.

WOLF POINT, Mont. — Fallen pine cones covered 16-year-old Leslie Keiser’s fresh grave at the edge of Wolf Point, a small community on the Fort Peck Indian Reservation on the eastern Montana plains.

Leslie, whose father is a member of the Fort Peck Assiniboine and Sioux Tribes, is one of at least two teenagers on the reservation who died by suicide this summer. A third teen’s death is under investigation, authorities said.

Leslie’s mother, Natalie Keiser, was standing beside the grave recently when she received a text with a photo of the headstone she had ordered.

She looked at her phone and then back at the grave of the girl who took her own life in September.

“I wish she would have reached out and let us know what was wrong,” she said.

In a typical year, Native American youth die by suicide at nearly twice the rate of their white peers in the U.S. Mental health experts worry that the isolation and shutdowns caused by the COVID-19 pandemic could make things worse.

“It has put a really heavy spirit on them, being isolated and depressed and at home with nothing to do,” said Carrie Manning, a project coordinator at the Fort Peck Tribes’ Spotted Bull Recovery Resource Center.

It’s not clear what connection the pandemic has to the youth suicides on the Fort Peck reservation. Leslie had attempted suicide once before several years ago, but she had been in counseling and seemed to be feeling better, her mother said.

Keiser noted that Leslie’s therapist canceled her counseling sessions before the pandemic hit.

“Probably with the virus it would have been discontinued anyway,” Keiser said. “It seems like things that were important were kind of set to the wayside.”

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Tribal members typically lean on one another in times of crisis, but this time is different. The reservation is a COVID hot spot. In remote Roosevelt County, which encompasses most of the reservation, more than 10% of the population has been infected with the coronavirus. The resulting social distancing has led tribal officials to worry the community will fail to see warning signs among at-risk youth.

So tribal officials are focusing their suicide prevention efforts on finding ways to help those kids remotely.

“Our people have been through hardships and they’re still here, and they’ll still be here after this one as well,” said Don Wetzel, tribal liaison for the Montana Office of Public Instruction and a member of the Blackfeet Nation. “I think if you want to look at resiliency in this country, you look at our Native Americans.”

Poverty, high rates of substance abuse, limited health care and crowded households elevate both physical and mental health risks for residents of reservations.

“It’s those conditions where things like suicide and pandemics like COVID are able to just decimate tribal people,” said Teresa Brockie, a public health researcher at Johns Hopkins University and a member of the White Clay Nation from Fort Belknap, Montana.

Montana has seen 231 suicides this year, with the highest rates occurring in rural counties. Those numbers aren’t much different from a typical year, said Karl Rosston, suicide prevention coordinator for the state’s Department of Public Health and Human Services. The state has had one of the highest suicide rates in the country each year for decades.

As physical distancing drags on, fatality numbers climb and the economic impacts of the pandemic start to take hold of families, Rosston said, and he expected to see more suicide attempts in December and January.

“We’re hoping we’re wrong in this, of course,” he said.

For rural teenagers, in particular, the isolation caused by school closures and curtailed or canceled sports seasons can tax their mental health.

“Peers are a huge factor for kids. If they’re cut off, they’re more at risk,” Rosston said.

Furthermore, teen suicides tend to cluster, especially in rural areas. Every suicide triples the risk that a surviving loved one will follow suit, Rosston said.

On average, every person who dies by suicide has six survivors. “When talking about small tribal communities, that jumps to 25 to 30,” he said.

Maria Vega, a 22-year-old member of the Fort Peck Tribes, knows this kind of contagious grief. In 2015, after finding the body of a close friend who had died by suicide, Vega attempted suicide as well. She is now a youth representative for a state-run suicide prevention committee that organizes conferences and other events for young people.

Vega is a nursing student who lives six hours away from her family, making it difficult to travel home. She contracted COVID-19 in October and was forced to isolate, increasing her sense of removal from family. While isolated, Vega was able to attend therapy sessions through a telehealth system set up by her university.

“I really do think therapy is something that would help people while they’re alone,” she said.

But Vega points out that this is not an option for many people on rural reservations who don’t have computers or reliable internet access. The therapists who offer telehealth services have long waitlists.

Frederick Lee presents a suicide prevention program called QPR (Question, Persuade, Refer) in Scobey, Montana. Organizations offering youth suicide intervention and prevention initiatives are struggling to sustain the same level of services during the pandemic. (Sara Reardon)

Other prevention programs are having difficulties operating during the pandemic. Brockie, who studies health delivery in disadvantaged populations, has twice had to delay the launch of an experimental training program for Native parents of young children. She hopes the program will lower the risk of substance abuse and suicide by teaching resiliency and parenting skills.

At Fort Peck, the reservation’s mental health center has had to scale down its youth events that teach leadership skills and traditional practices like horseback riding and archery, as well as workshops on topics like coping with grief. The events, which Manning said usually draw 200 people or more, are intended to take teenagers’ minds away from depression and allow them to have conversations about suicide, a taboo topic in many Native cultures. The few events that can go forward are limited now to a handful of people at a time.

Tribes, rural states and other organizations running youth suicide intervention and prevention initiatives are struggling to sustain the same level of services. Using money from the federal CARES Act and other sources, Montana’s Office of Public Instruction ramped up online prevention training for teachers, while Rosston’s office has beefed up counseling resources people can access by phone.

On the national level, the Center for Native American Youth in Washington, D.C., hosts biweekly webinars for young people to talk about their hopes and concerns. Executive Director Nikki Pitre said that on average around 10,000 young people log in each week. In the CARES Act, the federal government allocated $425 million for mental health programs, $15 million of which was set aside for Native health organizations.

Pitre hopes the pandemic will bring attention to the historical inequities that led to lack of health care and resources on reservations, and how they enable the twin epidemics of COVID-19 and suicide.

“This pandemic has really opened up those wounds,” she said. “We’re clinging even more to the resiliency of culture.”

In Wolf Point, Natalie Keiser experienced that resiliency and support firsthand. The Fort Peck community has come together to pay for Leslie’s funeral.

“That’s a miracle in itself,” she said.

One tray of COVID-19 vaccine from pharmaceutical giant Pfizer contains 975 doses — way too many for a rural hospital in Arkansas.

But with the logistical gymnastics required to safely get the Pfizer vaccine to rural health care workers, splitting the trays into smaller shipments has its own dangers. Once out of the freezer that keeps it at 94 degrees below zero, the vaccine lasts only five days and must be refrigerated in transit.

In Arkansas — where over 40% of its counties are rural and COVID infections are climbing — solving this distribution puzzle is urgently critical, said Dr. Jennifer Dillaha, the state’s epidemiologist.

“If their providers come down with COVID-19,” Dillaha said, “there’s no one there to take care of the patients.”

Such quandaries resonate with officials in Georgia, Kentucky, Utah, Indiana, Wisconsin and Colorado. The first push of the nation’s mass COVID vaccination effort has been chaotic, marked by a lack of guidance and miscommunication from the federal level.

With Washington punting most vaccination decisions, each state and county is left to weigh where to send vaccines first and which of two vaccines authorized by the Food and Drug Administration for emergency use makes the most sense for each nursing home, hospital, local health department and even school. And after warning for months that they lacked the resources to distribute vaccines, state officials are only now set to receive a major bump in funding — $8.75 billion in Congress’ latest relief bill, which lawmakers are likely to pass this week.

The feat facing public health officials has “absolutely no comparison” in recent history, said Claire Hannan, executive director of the Association of Immunization Managers.

Officials who thought the H1N1 swine flu shot in 2009 was a logistical nightmare say it now looks simple in comparison. “It was a flu vaccine. It was one dose. It came at refrigerator-stable temperatures,” Hannan said. “It was nothing like this.”

Within just a few days, the logistical barriers of the vaccine made by Pfizer and BioNTech were laid bare. Many officials now hang their hopes on Moderna, whose vaccine comes in containers of 100 doses, doesn’t require deep freezing and is good for 30 days from the time it’s shipped.

The federal government had divvied up nearly 8 million doses of Pfizer and Moderna’s vaccines to distribute this week, on top of roughly 3 million Pfizer shots that were sent last week, said Army Gen. Gustave Perna, chief operating officer of the Trump administration’s Operation Warp Speed effort.

Perna said he took “personal responsibility” for overstating how many Pfizer doses states would receive.

Federal delays have led to confusion, Dillaha said: “Sometimes we don’t have information from CDC or Operation Warp Speed until right before a decision needs to be made.”

Officials in other states painted a mixed picture of the rollout.

Georgia’s Coastal Health District, which oversees public health for eight counties and has offices in Savannah and Brunswick, spent more than $27,000 on two ultra-cold freezers for the Pfizer vaccine, which it’s treating “like gold,” said Dr. Lawton Davis, its health director. Health care workers are being asked to travel, some up to 40 minutes, to get their vaccinations, because shipping them would risk wasting doses, he said. Vaccination uptake has been lower than Davis would like to see. “It’s sort of a jigsaw puzzle and balancing act,” he said. “We’re kind of learning as we go.”

In Utah, sites to vaccinate teachers and first responders starting in January had no capability to store the Pfizer vaccine, although officials are trying to secure some ultra-cold storage, a state department of health spokesperson said. Very few of Kentucky’s local health offices could store the Pfizer shots, because of refrigeration requirements and the size of shipments, said Sara Jo Best, public health director of the Lincoln Trail District. Indiana’s state health department had to identify alternative cold storage options for 17 hospitals following changes in guidance for the vaccine thermal shippers.

And in New Hampshire, where the National Guard will help administer vaccines, officials last week were still finalizing details for 13 community-based sites where first responders and health care workers are due to get vaccinated later this month. Jake Leon, a state Health and Human Services spokesperson, said that while the sites will be able to administer both companies’ vaccines, most likely they’ll get Moderna’s because of its easier transport. Even as the earliest vaccines are injected, much remains up in the air.

“It’s day to day and even then hour by hour or minute by minute — what we know and how we plan for it,” Leon said Friday. “We’re building the plane while flying it.”

In all, the Trump administration has bought 900 million COVID vaccine doses from six companies, but most of the vaccines are still in clinical studies. Even the front-runners whose shots have received FDA emergency authorization— Pfizer and BioNTech on Dec. 11, Moderna on Dec. 18 — will require months to manufacture at that scale. The Trump administration plans to distribute 20 million vaccine doses to states by early January, Perna said Saturday.

By spring, officials hope to stage broader vaccine deployment beyond top-priority populations of health care workers, nursing home residents and staff, as well as first responders.

During the effort to vaccinate Americans against H1N1, Dillaha said, health departments set up mass vaccination clinics in their counties and delivered doses to schools. But hospitals are taking charge of parts of the initial COVID immunization campaign, both because health care workers are at highest risk of illness or death from COVID-19, and to pick up the slack from health departments overwhelmed by case investigations and contact tracing from an unending stream of new infections.

Best said her workforce is struggling to keep up with COVID infections alone, much less flu season and upcoming COVID vaccinations. Public health department personnel in Kentucky shrank by 49% from 2009 to 2019, according to state data she supplied. Across the country, 38,000 state and local health positions have disappeared since the 2008 recession. Per capita spending for local health departments has dropped by 18% since 2010.

Nationally, Pfizer and Moderna have signed contracts with the federal government to each provide 100 million vaccine doses by the end of March; Moderna is set to deliver a second tranche of 100 million doses by June. States were playing it safe last week, directing Pfizer vials mainly to facilities with ultra-cold freezers, Hannan said.

“A lot of that vaccine is destined for institutional facilities,” Sean Dickson, director of health policy for West Health Policy Center, said of the Pfizer shots. The center, with the University of Pittsburgh School of Pharmacy, found that 35% of counties have two or fewer facilities to administer COVID vaccines.

The analysis found tremendous variation in how far people would need to drive for the vaccine. Residents of North Dakota, South Dakota, Montana, Wyoming, Nebraska and Kansas face the longest drives, with more than 10% living more than 10 miles from the closest facility that could administer a shot.

Counties with long driving distances between sites and a low number of sites overall “are going to be the hardest ones to reach,” said Inmaculada Hernandez, an assistant professor at the University of Pittsburgh School of Pharmacy and lead author of the analysis.

Certain vaccines could be better suited for such places, including Johnson & Johnson’s potential offering, which is a single shot, and health departments could distribute in rural areas through mobile units, she said. The company is expected to apply for FDA emergency authorization in February, Operation Warp Speed chief scientific adviser Moncef Slaoui said this month.

Until then, Pfizer and Moderna are the companies supplying doses for the country, and they’re not considered equal even though each is more than 90% effective at reducing disease.

In Wisconsin, the Moderna vaccine “gives us many more options” and “allows for us to get doses to those smaller clinics, more-rural clinics, in a way that reduces the number of logistics” needed for ultra-cold storage, Dr. Stephanie Schauer, the state’s immunization program manager, told reporters Wednesday.

Alan Morgan, head of the National Rural Health Association, echoed that the Moderna vaccine is being looked to as a “rural solution.” But he said states including Kansas have shown that a Pfizer rural rollout can be done.

“It’s where these states put a priority — either they prioritize rural or they don’t,” he said. “It’s a cautionary tale of what we may see this spring, of rural populations perhaps being second-tier when it comes to vaccination.”

Virginia, too, has a plan for getting the Pfizer vaccine to far-flung places. It’s shipping the vaccines to 18 health facilities with ultra-cold freezers across the state. The hubs are distributed widely enough so vaccinators can bring shots from there to health workers even in thinly populated areas before they spoil, said Brookie Crawford, spokesperson for the Virginia Department of Health’s central region.

Washington, on the other hand, allows hospitals without ultra-cold freezers to temporarily store Pfizer vaccines in the thermal boxes they arrive in, said Franji Mayes, spokesperson for the state’s health department. That means a box needs to be used quickly, before doses expire. “We are also working on a policy that will allow hospitals who don’t expect to vaccinate 975 people to transfer extra vaccine to other enrolled facilities,” she said. “This will reduce wasted vaccine.”

This story is from a reporting partnership that includes WABE, NPR and KHN. It can be republished for free.

Vice President Mike Pence was the clear celebrity draw at a Nov. 20 campaign event for Georgia’s two incumbent U.S. senators, Kelly Loeffler and David Perdue. Both Republicans are fighting to keep their seats against two Democratic challengers in the runoff election set for Jan. 5.

People were so eager to see Pence at the rally in Canton, Georgia, that parking spots were scarce and a long line of cars snaked through the parking lot of a community college. Some drivers jumped the curb and parked in the grass.

Hundreds of people, many unmasked, were given temperature checks before boarding large coach buses for a short ride to the rally site. The venue was a large, open space outside the conference center, but few attendees maintained physical distance

The runoff in Georgia was triggered when no candidate in either Senate race won more than 50% of the vote in the general election on Nov. 3.

In the midst of the coronavirus pandemic and with the fate of the Affordable Care Act in question, Republicans hope the two incumbents will win reelection, thus preserving their party’s 50-48 control of the Senate.

But if the two challengers, Raphael Warnock and Jon Ossoff, win their runoffs, Democrats will gain narrow control of the Senate, with Vice President-elect Kamala Harris serving as the designated tie-breaker.

Yana De Moraes came to the rally from another Atlanta suburb, Buford. She is uninsured and, after a recent hospital stay, said the high cost of medical care was weighing on her mind.

“We would like our health care costs lowered, so it could be more affordable,” she said, with a rueful laugh. “So you don’t get another heart attack while you’re getting a bill!”

De Moraes added she’d also like to see better price controls on prescription drugs to stop pharmaceutical companies from “robbing American people.”

Others on their way to the rally said they were looking for any kind of change, ideally one that minimizes government involvement in health care.

Barry Brown made the 40-mile drive from his home in Atlanta for the rally. He’s retired but too young to qualify for Medicare, so he has ACA insurance, which he affords with the help of a federal subsidy.

“It sort of works. It’s better than nothing,” Brown said. “I would like to see an improved health care situation. I don’t know what that will be, so maybe they’ll mention that today. I’m hoping so.”

But at the rally, Loeffler only briefly mentioned her health care plan, which focuses on reducing drug prices and giving people access to insurance options that cost less but offer fewer benefits.

When it was his turn to speak, Perdue didn’t talk much about health care either, though he did take a shot at Obamacare, which he’s voted multiple times to overturn.

“Remember a little thing called the Affordable Care Act? You think that was done bipartisan?” Perdue asked the crowd. “No! It was done with a supermajority! Can you imagine what they’re gonna do if they get control of the Senate?”

As the two Republicans have campaigned throughout the state, they have consistently stoked fears about what Democrats will do, and health care policy has not led their messaging.

Their Democratic challengers, however, have been all over health care in their own speeches.

Warnock opened his runoff campaign to unseat Loeffler with a modestly attended Nov. 12 event devoted to health care. That’s also been a focus for Ossoff in his bid to win Perdue’s seat.

“This is why these Senate runoffs are so vital,” Ossoff explained at a small, physically distanced event in the shadow of the Georgia Capitol building in Atlanta on Nov. 10.

Ossoff and Warnock support adding a public insurance option to the Affordable Care Act. They also have emphasized the role Democrats will play in resurrecting key parts of the law if the U.S. Supreme Court decides to overturn it. The justices are set to make a ruling next year.

“If the Supreme Court strikes down the Affordable Care Act, it will be up to Congress to decide how to legislate such that preexisting conditions remain covered,” Ossoff said.

Voters like Janel Green, a Democrat, connect with that message. She’s from the nearby suburb of Decatur and is fighting breast cancer — for the second time. Green wondered whether her private health insurance might try to deny her coverage if the protections in the ACA disappear.

“I have to worry about whether or not next year in open enrollment that I won’t be discriminated against, that I won’t have limits that would then potentially end my life,” she said.

More than one-quarter of Georgians have preexisting conditions that could make it hard to get coverage if the ACA is struck down, according to an analysis by KFF. (KHN is an editorially independent program of KFF.)

That possibility also drove Atlanta resident Herschel Jones to support the runoff. On a recent weekday morning, he dropped by an Ossoff campaign office to pick up a yard sign.

Jones, who has diabetes, is insured through the Veterans Health Administration. He said everyone deserves access to health care.

“It’s a main issue, because the Affordable Care Act benefits all those individuals who might have preexisting conditions,” Jones said.

One likely reason Ossoff and Warnock are running so much harder on health care than Perdue and Loeffler is because that strategy paid off for Democrats in the general election, said Ken Thorpe, a health policy professor at Emory University.

President-elect Joe Biden can thank independent voters for his win in Georgia, Thorpe said, and they were drawn to him because of his promise to uphold Obamacare.

“The threat of potentially losing health insurance in the midst of this pandemic turned out to be probably the major defining issue in the election,” Thorpe said.

Polling in the days leading up to the Nov. 3 election showed Democrats were motivated on the issues of health care and the coronavirus pandemic.

For Democrats to win Georgia’s Senate seats, Thorpe said, they’ll need to stay focused on those issues. That emphasis could help them attract additional moderate voters, as well as entice those in the party base to cast ballots a second time.

“The health care issue is the probably main motivating factor that’s gonna get Democrats and independents to the polls,” he said.

Still, no Democrat has ever won a statewide runoff race in Georgia. That means that even with a strong health care message, it’ll be tough for Ossoff and Warnock to break that trend and unseat the Republicans, Thorpe said.

This story is from a reporting partnership that includes WABE, NPR and KHN, an editorially independent program of KFF.

Most Americans tell pollsters they’re worried about being able to afford an unexpected medical bill.

Late Monday, Congress passed a bill to allay some of those fears. The measure is included in a nearly 5,600-page package providing coronavirus economic relief and government funding for the rest of the fiscal year.

Specifically, the legislation addresses those charges that result from a long-running practice in which out-of-network medical providers — from doctors to air ambulance companies — send insured Americans “surprise bills,” sometimes for tens of thousands of dollars.

The legislation itself was a bit of a surprise, coming after two years of debate that featured high-stakes lobbying by all who stood to gain or lose: hospitals, insurers, patient advocacy groups, physicians, air ambulance companies and private equity firms, which own a growing number of doctor practices. A similar effort failed at the last minute a year ago after intense pressure from a range of interests, including those private equity groups.

This time around, no group got everything it wanted. Lawmakers compromised — mainly over how to determine how much providers will ultimately be paid for their services.

“No law is perfect,” said Zack Cooper, an associate professor of public health and economics at Yale who studies health care pricing. “But it fundamentally protects patients from being balance-billed,” he said, referring to out-of-network medical providers billing patients for amounts their insurer did not cover. “That’s a remarkable achievement.”

The bottom line: Patients may still be surprised by the high cost of health care overall. But they will now be protected against unexpected bills from out-of-network providers.

Here’s a rundown on what this legislation means for consumers:

Fewer Surprise Bills

Starting in 2022, when the law goes into effect, consumers won’t get balance bills when they seek emergency care, when they are transported by an air ambulance, or when they receive nonemergency care at an in-network hospital but are unknowingly treated by an out-of-network physician or laboratory.

Patients will pay only the deductibles and copayment amounts that they would under the in-network terms of their insurance plans.

Medical providers won’t be allowed to hold patients responsible for the difference between those amounts and the higher fees they might like to charge. Instead, those providers will have to work out with insurers acceptable payments. For the uninsured, for whom everything is out of network, the bill requires the secretary of Health and Human Services to create a provider-patient bill dispute resolution process.

The measure takes aim at situations in which patients have little choice about whether they are in network, including emergencies. A recent survey found 18% of emergency room visits, on average, resulted in at least one surprise bill. (A growing number of emergency rooms are staffed by private equity-owned agencies that sign few in-network agreements.)

The legislative agreement also applies to nonemergency care provided at in-network facilities, where patients receive care and services from out-of-network providers, such as anesthesiologists and laboratories.

Also included in the bar on balance billing is air ambulance transportation, which is among the most expensive medical services, often costing tens of thousands of dollars.

Still, the bill does not extend its consumer protections to the far more commonly used ground ambulance services. But it does call for an advisory committee to recommend how to take this step.

An Option for Consumers to Agree to Balance Billing

In some cases, physicians can balance-bill their patients, but they must get consent in advance.

This part of the bill is aimed at patients who want to see an out-of-network physician, perhaps a surgeon or obstetrician recommended by a friend.

In those cases, physicians must provide a cost estimate and get patient consent at least 72 hours before treatment. For shorter-turnaround situations, the bill requires that patients receive the consent information the day the appointment is made.

In a sense, though, this provision allows consumers to forfeit protection.

Health providers “have to give you a good-faith cost estimate. If you sign that, then you can be billed whatever that physician wants to bill you,” said Jack Hoadley, research professor emeritus in the Health Policy Institute at Georgetown University.

The legislation allows this only in nonemergency circumstances and bars many types of physicians from the practice. Anesthesiologists, for example, can’t seek consent to balance-bill for their services, nor can radiologists, pathologists, neonatologists, assistant surgeons or laboratories.

Payment Will Be Sorted Out in Negotiations

While lawmakers agreed that patients will be held harmless, the real fight was over how to decide what amounts providers would be paid by insurers.

Some groups — including hospitals and physicians — opposed any kind of benchmark or standard to which all bills would be held. On the other side, insurers, employers and consumer groups argued for a benchmark, warning that, without one, providers would angle for much higher payments.

The legislation carves out some middle ground.

It gives insurers and providers 30 days to try to negotiate payment of out-of-network bills. If that fails, the claims would go through an independent dispute resolution process with an arbitrator, who would have the final say.

The bill does not specify a benchmark, but it bars physicians and hospitals from using their “billed charges” during arbitration. Such charges are generally far higher than negotiated rates and bear little or no relation to the actual cost of providing the care.

That was considered a win for insurers, employers and consumer advocates, who argued that allowing billed charges would mean higher prices — potentially driving up premiums — in cases sent to arbitration.

Billed charges “are totally made up” by providers, said Cooper, at Yale. “So, the big deal is that arbitrators are not considering charges.”

But hospitals and doctors won a limit they sought, too.

In last-minute changes over the weekend, they succeeded in barring consideration of Medicare or Medicaid prices during arbitration. Those government payments are often far lower than the negotiated rates paid by insurers and self-insured employers.

Instead, the bill says negotiators can consider the median in-network prices paid by each insurer for the services in dispute. Other factors, too, can come into play, including whether the medical provider tried to join the insurers’ network, and how sick the patient was compared with others. It also allows consideration of network rates a provider may have agreed to during the previous four years, which might help some high-priced services, such as air ambulances, remain costly even in arbitration.

Overall, the legislation “did include some wins for provider groups,” said Loren Adler, associate director at the USC-Brookings Schaeffer Initiative for Health Policy.

Even so, he expects the legislation will help insurers contain some prices and provide “some downward pressure on premiums, even if relatively minor at the end of the day.”

State Laws May Change

More than 30 states have enacted some type of surprise billing protections, but only 17 are considered comprehensive, according to the Commonwealth Fund.

Comprehensive states — California, New York and New Mexico, for example — extend protections to cover nonemergency situations at in-network hospitals, but that isn’t the case in less comprehensive states, the fund noted.

And state laws have another limitation: They apply only to certain types of insurance, and often do not cover Americans who get their health insurance through self-insured employers, which tend to be midsize to large companies because they fall under federal rules.

But the new federal rules will cover most types of insurance plans, including those offered by self-insured employers.

“States can’t fully deal with these situations, but this covers it,” said Hoadley, at Georgetown.

Still, some provisions in state law, such as how to determine a payment, differ from the federal law. In such cases, the federal law defers to states.

Statehouse lawmakers may eventually alter their legislation or adopt new proposals to avoid confusion, said policy experts. If they don’t, they could be left with rules that affect people differently depending on whether their insurance comes through a large self-insured employer or directly from an insurance plan subject to state law. “I would be surprised if, over time, states don’t just glom onto the federal law,” said Adler.

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SACRAMENTO — Nearly six months since Gov. Gavin Newsom promised to target businesses that are flagrantly violating public health orders to control the spread of COVID-19, California regulators have issued just 424 citations and suspended two business licenses as of Monday, according to data from 10 state regulatory and law enforcement agencies.

Instead of strictly penalizing businesses for violations, the Democratic governor and businessman with a portfolio of wineries, bars and restaurants under the brand name PlumpJack, has relied on educating owners about infectious disease mandates. State agencies have contacted establishments primarily by email, sending them 1.3 million messages since July 1 to urge them to comply with state and local public health rules.

Enforcement at bars and restaurants where alcohol is served, identified by the Centers for Disease Control and Prevention as among the highest-risk environments for COVID transmission, has been limited, data shows. The state Department of Alcoholic Beverage Control, which can issue criminal misdemeanor citations, fine businesses and revoke liquor licenses, has issued just 45 citations against bars and 119 against restaurants since July. No fines have been issued or licenses revoked for the 94,000 businesses it regulates.

By comparison, the state of New York — with half the population of California and far fewer eating and drinking establishments — has issued 1,867 fines against bars and restaurants and temporarily suspended 279 business liquor licenses from June 18 to Dec. 8.

“The reality is it’s not enough to send an email and say ‘Wear a mask,’” said Dr. Kirsten Bibbins-Domingo, a professor of epidemiology and biostatistics at the University of California-San Francisco. “We see workplace violations that we know are major sources of transmission. We have to be willing to enforce or there’s no point in doing these things.”

Like much of the country, both California and New York, the nation’s two most populous Democratic-led states, have put primary responsibility for enforcing public health mandates on cities and counties. Newsom and New York Gov. Andrew Cuomo have bolstered local enforcement efforts by forming statewide task forces to go after businesses that repeatedly violate or ignore public health rules, such as mask mandates and business closures.

But California has been less aggressive than New York in targeting and penalizing bad actors. Newsom and state agencies have instead relied on tough talk and persuasion, emphasizing “personal responsibility,” informing businesses about their responsibilities — and giving them plenty of time to comply.

“I’m not coming out with a fist. We want to come out with an open heart,” Newsom said July 1. “We have, I think, a responsibility at the same time to go after people that are thumbing their nose, that are particularly being aggressive and reticent to do anything.”

The state’s lenient enforcement policy has put enormous responsibility and pressure on cities and counties struggling to gain compliance with COVID measures. Local government leaders are preparing for deep budget cuts and can’t find resources to undertake a coherent enforcement strategy of their own. Many are also fighting intense political battles over mask mandates, curfews and other COVID safety measures.

As a result, some counties enforce the rules and some don’t. And because the state hasn’t stepped in to assist with adequate enforcement, some local officials say, businesses are often free to ignore the rules, allowing the virus to run rampant.

“It would be nice to have some air support from the governor,” said Nevada City Councilman Doug Fleming, who backs the city’s new ordinance imposing fines for violating the state mask mandate. “He’s kind of forcing local jurisdictions to enforce his rules without any air support.”

California is experiencing a COVID surge as never before, setting records almost daily for infections and deaths. Hospitals across the state are running dangerously low on intensive care beds, with the state reporting 2.5% ICU capacity as of Monday.

Most of California is under a mandatory stay-at-home order, which prohibits indoor and outdoor dining and requires closure of a wide swath of businesses, from barbershops to wineries. Retail operations are limited to 20% capacity and churches must hold services outside.

Yet across the state, many people continue to flout the rules, keeping businesses open and refusing to wear masks in public. Pastors Jim and Cyndi Franklin, for instance, continue to hold indoor Sunday sermons at the Cornerstone Church in Fresno. Bars in Los Angeles County were packed with maskless football fans on a recent Sunday. And the owners of Calla Lily Crepes in Nevada City have repeatedly refused to close or require masks despite more than 20 warnings and attempts by Nevada County to gain compliance.

As ICUs run out of capacity, this Huntington Beach, CA scene was posted by a resident noting that today’s Green Bay/ Detroit game can be seen on overhead TVs. pic.twitter.com/Dcr3IlOOaS

— Margot Roosevelt (@margotroosevelt) December 14, 2020

“We are free thinkers. I hope I’m not stepping out too far by saying we strongly question the masks, but we do,” said Rebecca Sweet Engstrom, who owns the restaurant with her husband, Darren Engstrom. “We feel that it should be people’s choice.”

Newsom in July threatened to withhold money from cities and counties that refuse to enforce public health orders. To date, the state has withheld federal funding from two cities in the Central Valley, Atwater and Coalinga, for allowing businesses to remain open in defiance of state and local health orders.

The governor has also directed 10 state agencies to police egregious violators of state and local health orders, primarily businesses, to protect workers and the public. State enforcement officials have issued few harsh penalties, they argue, because most businesses are complying — and the state doesn’t want to be punitive.

In interviews, regulators described long hours of back-breaking work to inform business owners about the rapidly changing COVID restrictions and enforcement rules.

“We’re not trying to get into an adversarial situation here,” said Erika Monterroza, chief spokesperson for the state Department of Industrial Relations, which oversees Cal/OSHA, the agency responsible for regulating workplace safety and employer public health mandates.

Cal/OSHA issued 219 COVID-related citations to 90 employers from Aug. 25 to Dec. 14, accompanied by about $2.2 million in proposed fines, according to department data. The penalties ranged from $475 on Sept. 30 against a Taco Bell in Anaheim for failing to require employees to maintain 6 feet of physical distance, to $108,000 on Oct. 29 against Apple Bistro in Placerville for not requiring masks indoors and for not providing adequate physical distance between employees and guests. The department is investigating about 1,700 other cases.

The state Board of Barbering and Cosmetology, which regulates about 54,000 salons and barbershops, has levied just two citations and suspended two licenses, both held by Primo’s Barbershop in Vacaville, which has “very adamantly” opposed state health orders, said Matt Woodcheke, a spokesperson for the state Department of Consumer Affairs, which oversees the board.

No citations have been issued for COVID-related public health violations by California’s 280 state parks, nor by the California Highway Patrol.

Regulators said they have felt tremendous angst trying to get businesses to follow rapidly changing rules, but they aim for voluntary compliance and don’t want to cause businesses to go under.

“This is extremely difficult and we don’t want to do it,” said Luke Blehm, an acting supervising agent in charge for the state Department of Alcoholic Beverage Control. “We are all compassionate and empathetic and it’s a very hard thing to tell somebody that they’ve got to close and they may lose everything because of these rules they have to comply with.”

The state Department of Public Health, which is not one of the 10 task force agencies but assists them, has not issued fines or citations for health order violations, even though it is the primary agency responsible for issuing statewide mandates, according to spokesperson Corey Egel.

In New York, by contrast, Cuomo has leaned on political leaders and law enforcement agencies to aggressively police violations of COVID public health rules and has publicly admonished sheriffs who refuse to enforce violations. He ordered a statewide crackdown on bars and restaurants as cases surged this summer after contact-tracing data indicated drinking and dining were a major source of community spread, said Cuomo spokesperson Jack Sterne.

In hard-hit counties and towns where political leadership rebuffed enforcement, the Cuomo administration deployed COVID strike teams composed of state inspectors — in some cases, retrained Department of Motor Vehicles employees — to police business violations of public health rules. Cuomo argues it has made a difference.

“Compliance on bars has increased dramatically from when we started,” he said in September, “because if you know someone is going to check, if you know there’s monitoring, people tend to increase compliance.”

In California, some counties are enforcing COVID restrictions. San Diego County is dedicating six sheriff’s deputies to the cause and fines repeat violators up to $1,000.

“We’re supportive of enforcement here,” said San Diego County Sheriff’s Lt. Ricardo Lopez. “COVID-19 is exploding and our view is, let’s get this over with as fast as possible.”

But elsewhere, county health officers pushing for stricter enforcement face intense political opposition from their bosses and law enforcement agencies. Sacramento County, for example, dropped its plan to impose fines this month after confronting resistance from businesses. Sacramento County Sheriff Scott Jones also has refused to enforce mask and other public health mandates.

Dr. Georges Benjamin, executive director of the American Public Health Association, said the state, ideally, should develop a consistent statewide enforcement system that starts with warnings and a strong public messaging campaign, then moves to graduated fines if noncompliance continues.

Until that happens, local leaders say, the patchwork of rules and enforcement strategies is causing confusion and chaos.

“People are continuing to disobey,” said Dr. Olivia Kasirye, Sacramento County’s health officer. “Some people are outright angry with us, asking why aren’t we doing something, but all we can do is refer problems to the state enforcement agencies.”