Huge Gaps in Vaccine Data Make It Next to Impossible to Know Who Got the Shots

As they rush to vaccinate millions of Americans, health officials are struggling to collect critically important information — such as race, ethnicity and occupation — of every person they jab.

The data being collected is so scattered that there’s little insight into which health care workers, or first responders, have been among the people getting the initial vaccines, as intended — or how many doses instead have gone to people who should be much further down the list.

The gaps — which experts say reflect decades of underfunding of public health programs — could mean that well-connected people and health personnel who have no contact with patients are getting vaccines before front-line workers, who are at much higher risk for illness. Federal and state officials prioritized health workers plus residents and staffs of nursing homes for the first wave of shots.

Although officials leading President Joe Biden’s covid response have pledged to tackle racial inequities as they seek to control the pandemic, lapses in reporting race or ethnicity could hinder efforts to identify and track whether minorities hit especially hard by the pandemic are getting shots at a high-enough rate to achieve hoped-for levels of herd immunity. So far, limited data in multiple states shows Black residents are getting vaccinated at lower rates than whites.

“Every state knows where they’ve sent vaccine, and every provider has to report inventory. But as far as who is being vaccinated, that one is a little more tricky,” said Claire Hannan, executive director of the Association of Immunization Managers.

Data that eventually makes its way to the Centers for Disease Control and Prevention and other federal systems is “only going to be as good as whatever you can get out of the vaccine registries” that vary by state, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials. “They’re all different and, going into this, they were all at different stages of how robust they were.”

There are 64 immunization registries in the United States that gather information for states, territories and a handful of large cities — and they aren’t connected. Meanwhile, real-time data in the U.S. public health system is virtually nonexistent, Plescia said.

Reporters at KHN examined the data being gathered versus what the CDC says is supposed to be collected for every person vaccinated, which includes: name, address, sex, date of birth, race and ethnicity, the date and location where they were vaccinated, and the shot they received (currently only two products are available, from Pfizer-BioNTech and Moderna). Not on its list: occupation, even though initial vaccine distribution largely hinges on place of work, prioritizing health care personnel, long-term care facilities and then other essential workers such as teachers, grocery store workers and firefighters.

Dr. Katherine Poehling, a pediatrician at the Wake Forest School of Medicine who’s on the CDC advisory committee that issued vaccine priority recommendations, declined to comment on whether occupation should have been a required element for reporting to the CDC.

“I think you can always wish for more data, but really what we’re going for is vaccinating everybody that wants to be vaccinated,” she said. “The fact that there was something available on day one was really remarkable,” she said, referring to a database that could track vaccine shipments and allocations by state.

Still, gaps are evident, including holes in CDC rules for reporting race and ethnicity. Race and ethnicity information are missing from at least hundreds of thousands of vaccine doses that have already been administered and reported to state public health authorities.

Texas’ vaccine data on Wednesday showed that race or ethnicity was unknown for more than 700,000 people. Virginia’s dashboard shows that data was missing for nearly 300,000 vaccinations, or 52% of vaccine doses, as of Tuesday. The same was true for tens of thousands of vaccinations in Colorado and Maryland.

In Minnesota, state law prohibits the sharing of data on race and ethnicity.

“It is important how many shots are administered, but it is critical that we get good race and ethnicity information about who is receiving it so we can identify disparities and other problems,” said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

The CDC declined to say how many of the vaccine records it had received were missing the information. In response to questions, CDC spokesperson Kristen Nordlund said the agency plans to publish race, ethnicity and other demographic data next week.

The Department of Health and Human Services did not respond to multiple requests for comment.

Dr. Marcella Nunez-Smith, chair of the Biden administration’s covid-19 health equity task force, on Wednesday conceded that the racial and ethnicity data is “incomplete” but said it wasn’t the only way to gauge progress of the vaccine rollout on the ground.

“We can think about things like neighborhoods and communities as metrics and ways to track as well,” she said. “We’re building our equity dashboard right now, and we’ll rely on government sources as well as sources of data external to government.”

The ongoing struggle for complete data shows how little has changed for the CDC since the virus appeared in the U.S. one year ago and its early efforts to collect data identifying covid-infected people were widely panned.

So far, the CDC has publicly stated how many vaccines have been distributed nationwide and how many doses administered. Its dashboard includes a breakdown of how many shots have been given by state and in long-term care facilities. Walgreens and CVS together have given more than 2.5 million doses in nursing homes and other long-term care facilities, though neither company has released data on race or whether the shots were given to patients or staffers.

State and federal health officials know where vaccines go as officials must track inventory by facility. Several states have released breakdowns of doses administered by the type of institution, providing a window into how many shots are being used in hospitals, nursing homes, pharmacies, primary care practices, public health departments and tribal health sites. And when signing up for an appointment, individuals may be asked to provide their occupation to attest they qualify for a shot under a state’s rules at a given time.

Maryland and Ohio require providers to submit data on the occupations of vaccine recipients, in a break with CDC practice. But several states contacted by KHN said they do not collect that information, such as Idaho, Michigan, Minnesota, Texas and Virginia.

Electronic health records manufacturers that provide software to hospitals and other facilities said they are scrambling to modify the software to accommodate data reporting requirements that vary by state.

Occupation is one example. Another: Texas law requires the state to collect information on all medications given “in response to a declared disaster or public health emergency,” said State Health Services spokesperson Chris Van Deusen.

Leigh Burchell, vice president of policy and government affairs at the EHR firm Allscripts, said these variations are “obstacles none of us has tackled before,” though she thinks that, overall, “successes outweigh failures” as companies have had to adjust quickly during the pandemic.

EHR systems can connect to state registries, which ultimately send vaccine tracking data to the CDC. A lack of “a coordinated, national public health infrastructure” continues to be a problem that “forces everyone to work less efficiently than would be optimal,” Burchell said.

Health IT consultant Reed Gelzer said the situation reflects the 30-year-plus failure of the public health system to modernize data collection. He said officials need look no further than chronic problems tracking childhood immunizations, handled in some states at the county level, and in others at the state level, often poorly. A national system to track immunizations has never existed, which he argues should have been discussed before the vaccine rollout.

“As far as I know, even in the earliest days of the pandemic, nobody did stress-testing of the information system,” Gelzer said.

Cerner, a major electronic health records company, says that some hospitals are using an existing workplace health system to track employees who have been vaccinated while others create a patient record for vaccinated employees as well as for patients. The systems can capture demographic details, but the data fields to do that have to be turned on and it’s unclear whether its client hospitals have done so.

The CDC and other federal agencies rely on a complicated web of systems to get data about who’s been vaccinated. State and local vaccine registries, known as immunization information systems, are the most comprehensive source of records and the “source of truth,” Hannan said.

Those registries have long-standing connections to providers’ electronic health records, said Rebecca Coyle, executive director of the American Immunization Registry Association. But they aren’t meant to capture certain information, such as a patient’s medical history and occupation.

Those state and local registries transmit data to an HHS-owned clearinghouse, where personal details are redacted.

The clearinghouse gets data from other sources, too. These include a new CDC vaccination clinic mobile app called VAMS, as well as pharmacies, prisons and federal agencies like the Department of Veterans Affairs and the Indian Health Service.

A limited slice of the data then moves to another CDC repository known as the “Data Lake,” where it can be analyzed and reported to the CDC and Tiberius, a separate software platform developed by federal contractor Palantir for former President Donald Trump’s Operation Warp Speed effort. The Data Lake also receives information on shipment and vaccine orders from the CDC’s VTrckS system.

On top of that dizzying array of tools, many states use another, third-party software system, PrepMod, to manage vaccine inventory, appointments and reporting.

When asked whether not having data on occupations could hinder tracking whether priority groups have received their shots, Nordlund of the CDC said it’s unnecessary to vaccinate all individuals in one phase before initiating the next.

“This means ideally hitting a sweet spot that maximizes getting vaccine into arms while also being mindful of the priority groups,” Nordlund said, “especially because these are people who are higher risk for complications from covid-19 or are more likely to be exposed to the virus because of their jobs.”

Lawmakers recently attempted to address the nation’s antiquated public health data infrastructure, partly by appropriating $500 million under the CARES Act to the CDC. In an August letter to Rep. Lucy McBath (D-Ga.), former CDC director Dr. Robert Redfield said the agency would use the funds to update how state and health departments report data to federal officials, improve the CDC’s own data infrastructure, and develop new standards for public health reporting.

Additionally, tucked into the massive year-end spending bill Congress passed in late December was a requirement that HHS expand and improve public health data systems used by the CDC and award grants to state and local health departments to upgrade their infrastructure.

The Biden administration has made promises to strengthen the federal government’s approach to data collection on vaccination efforts.

KHN data reporter Hannah Recht and KHN correspondent Lauren Weber contributed to this report.

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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4 Vital Health Issues — Not Tied to Covid — That Congress Addressed in Massive Spending Bill

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Late last month, before President Joe Biden took office and proposed his pandemic relief plan, Congress passed a nearly 5,600-page legislative package that provided some pandemic relief along with its more general allocations to fund the government in 2021.

While the $900 billion that lawmakers included for urgent pandemic relief got most of the attention, some even bigger changes for health care were buried in the other parts of that huge legislative package.

The bundle included a ban on surprise medical bills, for example — a problem that key lawmakers had been wrestling with for two years. Starting in 2022, because of the new law, patients generally will not pay more for out-of-network care in emergencies and at otherwise in-network facilities.

But surprise bills weren’t the only health care issue Congress addressed as it ended a tumultuous year. Lawmakers also answered pleas from strained health facilities in rural areas, agreed to cover the cost of training more new doctors, sought to strengthen efforts to equalize mental health coverage with that of physical medicine and instructed the federal government to collect data that could be used to rein in high medical bills.

Here are some details about those big changes Congress made in December.

Rural Hospitals Get a Boost

Throwing a lifeline to struggling rural health systems — and, it appears, a bone to an outgoing congressional committee chairman — lawmakers gave rural hospitals a way to get paid by Medicare for their services regardless of whether they have patients in beds.

The law creates a new category of provider, known as a “rural emergency hospital.” Starting in 2023, some hospitals will qualify for this designation by maintaining full-time emergency departments, among other criteria, without being required to provide in-patient care. The Department of Health and Human Services will determine how the program is implemented and which services are eligible.

Medicare, the federal insurance program that covers more than 61 million Americans 65 and older or with certain disabilities, currently does not reimburse hospitals for emergency or hospital outpatient services unless the hospital also offers in-patient care.

That requirement has exacerbated financial problems for rural hospitals, many of which balance serving communities with fewer patients and less need for full in-patient services with the need for emergency and outpatient services. One study last year found 120 rural hospital facilities had closed in the past 10 years, with more at risk.

Hospital groups have praised the change, which was introduced by Sen. Chuck Grassley (R-Iowa), who has championed rural health issues and ended his term as chairman of the Senate Finance Committee this month. “I worked to ensure rural America would not go overlooked,” he said in a statement.

Medicare Invests in More Doctors

Hoping to address a national shortage of doctors that has reached critical levels during the pandemic, Congress created an additional 1,000 residency positions over the next five years.

Medicare will fund the positions, which involve supervised training to medical school graduates going into specialties like emergency medicine and are distributed among hospitals most in need of personnel, including rural hospitals.

Critics like The Wall Street Journal’s editorial board have noted this is Congress’ attempt to fix a problem it created in the late 1990s, when lawmakers capped the number of Medicare-funded residency positions in the United States, fearing too many doctors would inflate the cost of Medicare.

While Medicare is not the only source of educational funding and hospitals may add their own residency slots as needed, Medicare generally will reimburse hospitals for the number of residents they had at the end of 1996. Among other consequences of that 1996 cap, most Medicare-funded residencies are clumped at Northeastern hospitals, a 2014 study showed.

In contrast to the 1,000 positions created as part of the stimulus package, one bipartisan proposal in 2019 that was never enacted would have added up to 15,000 positions over five years.

Strengthening Mental Health Parity

The legislative package strengthens protections for mental health coverage, requiring federal officials to study the limitations insurance companies place on coverage for mental health and substance use disorder treatments.

In 1996 Congress passed the first law barring health insurers from passing along more of the cost for mental health care to patients than they would for medical or surgical care. The Affordable Care Act, building on earlier laws, made mental health and substance use disorder treatments an “essential health benefit” — in other words, it required most health insurance plans to cover mental health care.

But enforcing that standard has been a challenge, in part because violations can be hard to spot and the system has often relied on patients to notice — and report — them.

In December, lawmakers approved a measure requiring insurers to analyze their coverage and provide their findings to state and federal officials upon request.

They also instructed federal officials to request the findings from at least 20 plans per year that may have violated mental health parity laws and tell insurers how to correct any problems they find — under penalty of having insurer violations reported to their customers if they do not comply.

The law requires federal officials to publish an annual report summarizing the analyses they collect.

More Transparency in Cost and Quality

Americans often do not know how much they will be expected to pay when they enter a doctor’s office, an ambulance or an emergency room.

Taking another modest step toward transparency, Congress banned so-called gag clauses in contracts between health insurers and providers.

Among other things, these sorts of “gag” restrictions previously have prevented insurers and group health plans from sharing with patients and others — such as employers — information about a provider’s prices or quality. The December legislation also prohibited insurers from agreeing to contracts that prevent them from getting access electronically to claims and other information from providers on behalf of the insurer’s enrollees.

In 2018, Congress banned gag clauses in contracts between pharmacies and insurers or pharmacy benefit managers. Those gag clauses had prevented pharmacists from sharing cost information with patients, like whether they could pay a lower price for a prescription by paying out-of-pocket rather than using their insurance coverage.

The proposal approved in December’s legislation came from a big, bipartisan package of health care cost fixes passed in 2019 by the Senate Health, Education, Labor and Pensions Committee, but not by the rest of Congress. The committee’s Republican chairman, Sen. Lamar Alexander of Tennessee, retired from Congress this month. His Democratic partner on that package, Sen. Patty Murray of Washington, will take over the chairmanship as Democrats assume control of the Senate and has vowed to focus on health care affordability.

Consumers First, a health consumer-focused alliance of health professionals, labor unions and others, led by Families USA, praised the ban. The change is “a significant step forward” to stop “the abusive practices from hospitals and health systems and other segments of the health care sector that are driving up health care costs and making health care unaffordable for our nation’s families, workers, and employers,” it said in a statement.

KHN senior correspondent Sarah Jane Tribble contributed to this report.

New Covid Cases Plunge 25% or More As Behavior Changes

A dozen states are reporting drops of 25% or more in new covid-19 cases and more than 1,200 counties have seen the same, federal data released Wednesday shows. Experts say the plunge may relate to growing fear of the virus after it reached record-high levels, as well as soaring hopes of getting vaccinated soon.

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Nationally, new cases have dropped 21% from the prior week, according to Department of Health and Human Services data, reflecting slightly more than 3,000 counties. Corresponding declines in hospitalization and death may take days or weeks to arrive, and the battle against the deadly virus rages on at record levels in many places.

Health officials, data modeling experts and epidemiologists agreed it’s too early to see a bump from the vaccine rollout that started with health care workers in late December and has, in many states, moved on to include older Americans.

Instead, they said, the factors involved are more likely behavior-driven, with people settling back home after the holidays, or reacting to news of hospital beds running out in places like Los Angeles. Others are finding the resolve to wear masks and physically distance with the prospect of a vaccine becoming more immediate.

A single reason is hard to pinpoint, said Adriane Casalotti, chief of government and public affairs for the National Association of County and City Health Officials. She said it may be due in part to people hoping to avoid the new, more contagious variants of the virus, which some experts say appear to be deadlier as well.

She also said so many people got sick in the last surge that more people may be taking precautions: “There’s a better chance you know someone who had it,” Casalotti said.

Eva Lee, a mathematician and engineering professor at the Georgia Institute of Technology, works on models predicting covid patterns. She said in an email that the decline reflects the natural course of the virus as it infects a social web of people, exhausts that cluster, dies down and then emerges in new groups.

She also said the national trend, with even steeper drops in California, also reflects restrictions in that state, which included closing indoor dining and a 10 p.m. curfew in hard-hit regions. She said those measures take a few weeks to show up in new-case data.

“It is a very unstable equilibrium at the moment,” Lee wrote in the email. “So any premature celebration would lead to another spike, as we have seen it time and again in the US.”

Four California counties were among the five large U.S. counties seeing the steepest case drops, including Los Angeles County, where new cases declined nearly 40% in the week ending Jan. 25, compared with the week before.

Dr. Karin Michels, chair of epidemiology at the UCLA Fielding School of Public Health, said the lower numbers in L.A. after the virus infected 1 in 8 county residents likely mirror what happened after New York City’s surge: People got very scared and changed their behavior.

“People are beginning to understand we really need to get our act together in L.A., so that helps,” she said. “The big fear [now] is ‘Is it really going in this direction, is it plateauing, or where is it going to go?’ We need to go further down, because it is really high.”

Michels said herd immunity would not explain the declines, since we’re nowhere near the level of 70% of the population having had the disease or been vaccinated. She said the declines may also reflect a drop in testing, as Dodger Stadium has been converted from a mass testing site to a mass vaccination center.

Officials with the California Department of Public Health acknowledged that testing has fallen off, but overall rates of positive covid tests are falling, suggesting the change is real.

New cases also fell significantly in Wyoming, Oregon, South Dakota and Utah, with each state recording at least 30% fewer new cases. Each of those states reported having vaccinated 8% or more of their adult population by Tuesday, putting them among the top 20 states in terms of vaccination rate.

Alaska leads the states currently, at nearly 15%, according to HHS. It’s also logged a new-case drop of 24% in recent days.

Yet experts aren’t willing to say yet that the vaccines are driving cases down.

“Most people in public health don’t think we’ll see the benefit of the vaccine until a few months from now,” said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.

The number of deaths continues to remain high weeks after high case rates as the virus variably attacks the heart, kidneys, lungs and nervous system. Many patients remain unconscious and on a ventilator for weeks as doctors search for signs of improvement.

The death rate fell by only 5% in the data posted Wednesday, reflecting 21,790 patients who died of the virus Jan. 19-25.

Anxiety about new strains of the virus from the U.K., Brazil and South Africa remains high in Portland’s Multnomah County, Oregon, which saw a drastic 43% new-case decline in recent days.

“The concern is that everything could change,” said Kate Yeiser, spokesperson for the Multnomah County Health Department.

Shoshana Dubnow contributed to this story.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation) that 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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At Colorado’s Rural Edges, Vaccines Help Assisted Living Homes Crack Open the Doors

Bingo is back in the dining room. In-person visits have returned, too, though with masks and plexiglass. The Haven Assisted Living Facility’s residents are even planning a field trip for a private movie screening once they’ve all gotten their second round of covid-19 vaccines.

Such changes are small but meaningful to residents in the Hayden, Colorado, long-term care home, and they’re due mostly to the arrival of the vaccine.

While the vaccine rollout has hit snags across the U.S., including in many large urban areas, some rural counties — with their smaller populations and well-connected communities — have gotten creative about getting the doses out quickly to long-term care facilities. They are circumventing bogged-down Walgreens and CVS, the pharmacy chains contracted for the campaign, and instead are inoculating their older residents with the counties’ shares of doses.

It’s clear why the counties are trying their own path. Federal data provided by the state of Colorado shows that, as of Jan. 21, dozens of long-term care facilities in Colorado were enrolled to receive vaccines from Walgreens or CVS but still did not have any vaccination dates scheduled. Among assisted living facilities in particular, rural locations tended to have later start dates than non-rural ones. By mid-January, over 90 facilities had opted out of the program that has been beset by cumbersome paperwork and corporate policies.

When Roberta Smith, who directs the Routt County Public Health Department, learned in December that The Haven and another facility in the county hadn’t gotten any dates from Walgreens for their shots, she diverted about 100 doses from the county’s allotment. The vaccines would likely have gone to health care workers, she said, but she couldn’t let the most vulnerable in the county wait.

Fourteen of the 19 people who died of covid in the county, after all, had been residents of those two long-term care facilities.

The county received a shipment of Moderna vaccines the following week to continue with its health care workers, Smith said.

The health department ensured that all able and willing residents of the county’s two long-term care facilities received their first doses before 2021 began. Smith suspects such reprioritization and fast deployment — despite the department’s reliance on spreadsheets and sticky notes to schedule visits — is easier in small communities.

“There is a sense of community in our smaller, rural counties that we’re all kind of looking out for each other. And when you tell someone, ‘Hey, we need to vaccinate these folks first,’ they’re quick to say, ‘Oh, yeah,’” Smith said.

Hayden, a town of about 2,000 in northwestern Colorado, is the kind of place where, within hours of Haven staffers posting online that they were looking for a grill, workers from the hardware store delivered one at no charge. It’s the kind of town where locals have come throughout the pandemic to serenade Haven residents with guitar, flute and violin performances outside the windows. When the virus hit The Haven, eventually killing two of its 15 residents, locals paraded past the facility in their cars, taped with balloons and signs that said “We love you” and “Get well soon.”

After all the heartache, isolation and waiting, newly vaccinated resident Rosa Lawton, 70, is ready to bust out of The Haven. She said she expected to get her second vaccine dose Jan. 28.

“I hope to be able to go shopping at Walmart and City Market and go to the bank, the library, the senior center. … I won’t stop,” she said, laughing. “Right now, we’re restricted to the building.”

Even after getting everyone vaccinated, though, assisted living locations won’t be able to fling open the doors quite yet. State and federal officials need to give the OK, said Doug Farmer, president and CEO of the Colorado Health Care Association, which represents long-term care facilities in the state. Still, the combination of vaccines, repeated negative covid tests and a lower level of virus spread in the community is allowing some facilities the peace of mind to crack the doors open just a bit in the meantime.

Until recently, Lawton and others at The Haven were playing bingo perched in their doorways, with a staff member moving down the hallway calling out numbers. Lawton said she could see about four others from her door, but not her friends Sally, Ruth or Louise. Now, they’re back in the dining room, with one person to a table and playing with sanitized chips.

“We can see each other and we’re closer together and we can hear the caller better,” said Lawton. “It’s just more of a group experience.”

Residents can now gather in the common areas, wearing masks, to play the piano and do target practice with foam dart guns. And the excursion to a movie theater next month will be the first field trip in nearly a year. (Lawton is rooting for watching “The Sound of Music.”)

“It just feels overall lighter,” said Adrienne Idsal, director of The Haven, hours before receiving her second vaccine dose.

Fraser Engerman, a spokesperson with Walgreens, confirmed that some counties moved ahead with vaccinations before the company received its allocation, and said the company is on track to complete vaccinations at all Colorado long-term care facilities that they were responsible for by the end of January. Monica Prinzing, a CVS Health spokesperson, said that her company has completed first doses for all 119 skilled-nursing facilities in Colorado and more than half the assisted living sites it partnered with, adding that their team is working closely with facilities to “remain on track to meet our program commitments.”

Along the state’s eastern edge, where Colorado meets Kansas, a pair of counties is already done vaccinating long-term care residents, according to Meagan Hillman, the public health director for Prowers and Kiowa counties.

In December, Hillman and her colleagues started to wonder just how Walgreens was going to get the shots to their four local long-term care facilities.

“Out here, I’m two-plus hours from the closest Walgreens, and I don’t even know where a CVS is,” she said. “It’s such a huge operation and we just were worried, you know. Oftentimes the little guy gets left out or left for last.”

Hillman said she and her colleagues managed to secure Pfizer vaccines from a local hospital.

“We have been so beat down in public health that I actually went and did the vaccination clinic,” said Hillman, who is also a physician assistant. “We just needed that — a good, heart-swelling thing to do.”

She said it indeed helped boost her spirits to give the shots herself. “Finally, I feel like the light at the end of the tunnel is not a train,” she said.

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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Nuevos casos de Covid caen un 25% o más a medida que cambian conductas

Una docena de estados están reportando caídas del 25% o más en nuevos casos de covid-19, y más de 1,200 condados también observan esta baja, según muestran datos federales publicados esta semana.

Expertos dicen que la caída puede estar relacionada con el creciente temor al virus después que alcanzara niveles récord, así como con la esperanza de vacunarse pronto.

A nivel nacional, los casos nuevos han caído un 21% con respecto a la semana anterior, indican datos del Departamento de Salud y Servicios Humanos (HHS), que reflejan los números de unos 3,000 condados.

Las bajas correspondientes en hospitalizaciones y muertes pueden tardar días o semanas en registrarse, y la batalla contra el mortal virus continúa a niveles récord en muchas áreas.

Funcionarios de salud, expertos en estadísticas y epidemiólogos acordaron que es demasiado pronto para ver una baja generada por la vacunación, que comenzó con los trabajadores de salud a fines de diciembre y, en muchos estados, ya incluye a los adultos mayores.

En cambio, dijeron, es más probable que los factores involucrados en la disminución de casos estén impulsados ​​por el comportamiento, con las personas reaccionando  con susto a las noticias de que ya no hay camas libres en hospitales, en lugares como Los Ángeles, por ejemplo.

Con la cercanía de la vacuna, otros han decidido respetar a rajatabla el uso de máscaras y el distanciamiento físico.

Es difícil precisar una sola razón, dijo Adriane Casalotti, jefa de asuntos públicos y de gobierno de la Asociación Nacional de Funcionarios de Salud de Condados y Ciudades.

Agregó que puede deberse en parte a que las personas busan evitar las nuevas variantes más contagiosas del virus, que según algunos expertos también parecen ser más letales.

También dijo que son tantas las personas que se enfermaron en la última oleada que es posible que más gente esté tomando precauciones: “Hay más posibilidades de que conozcas a alguien que haya tenido covid”, dijo Casalotti.

Eva Lee, matemática y profesora de ingeniería en el Instituto de Tecnología de Georgia, trabaja en modelos que predicen patrones de covid. Lee dijo en un correo electrónico que la disminución refleja el curso natural del virus, ya que infecta una red social de personas, agota ese grupo, se “apaga” y luego emerge en nuevos grupos.

También dijo que la tendencia nacional, con caídas aún más pronunciadas en California, también refleja las restricciones en ese estado, que incluyeron el cierre de las comidas en interiores de restaurantes, y toques de queda a las 10pm en las regiones más afectadas. Dijo que el efecto de estas medidas tardan unas semanas en aparecer en los datos de nuevos casos.

“Es un equilibrio muy inestable en este momento”, escribió Lee en su mensaje. “Entonces, cualquier celebración prematura conduciría a otro pico, como lo hemos visto una y otra vez en los Estados Unidos”.

De los cinco condados a nivel nacional con más caída de casos, cuatro son de California, incluido el condado de Los Ángeles, donde los nuevos casos disminuyeron casi un 40% en la semana que terminó el 25 de enero, en comparación con la semana anterior.

La doctora Karin Michels, jefa de epidemiología de la Escuela de Salud Pública Fielding de la UCLA, dijo que las cifras más bajas en Los Ángeles, después que el virus infectara a 1 de cada 8 residentes del condado, probablemente reflejan lo que sucedió después del aumento repentino de la ciudad de Nueva York: la gente se asustó mucho y cambió su comportamiento .

“En LA, la gente está empezando a comprender que realmente necesitamos actuar juntos, así que eso ayuda”, dijo.

Michels dijo que la inmunidad colectiva no explicaría las disminuciones, ya que no estamos ni cerca del nivel del 70% de la población que ha tenido la enfermedad o ha sido vacunada. Apuntó que estas caídas también pueden reflejar una baja en las pruebas, ya que el Dodger Stadium se ha convertido de un sitio de pruebas masivas en un centro de vacunación masiva.

Funcionarios del Departamento de Salud Pública de California reconocieron que las pruebas han disminuido, pero las tasas generales de pruebas positivas de covid están disminuyendo, lo que sugiere que el cambio es real.

Los casos nuevos también bajaron significativamente en Wyoming, Oregon, Dakota del Sur y Utah, y cada estado registró al menos un 30% menos de casos nuevos. Cada uno de esos estados informó haber vacunado al 8% o más de su población adulta hasta el martes 26 de enero, lo que los coloca entre los 20 estados con mayores tasas de vacunación.

Alaska lidera los estados actualmente, con casi un 15%, según el HHS. También registró una caída de casos nuevos del 24% en los últimos días.

Sin embargo, expertos no están dispuestos todavía a decir que las vacunas estén reduciendo los casos.

“La mayoría de las personas en salud pública cree que no veremos los beneficios de la vacuna hasta dentro de unos meses”, dijo el doctor Marcus Plescia, director médico de la Asociación de Funcionarios de Salud Estatales y Territoriales.

El número de muertes sigue siendo alto semanas después de las tasas récord de casos, ya que el virus ataca de forma variable el corazón, los riñones, los pulmones y el sistema nervioso. Muchos pacientes permanecen inconscientes y con un ventilador durante semanas mientras los médicos buscan signos de mejoría.

La tasa de mortalidad cayó solo un 5% en los datos publicados el miércoles 27, lo que refleja 21,790 pacientes que murieron por el virus del 19 al 25 de enero.

La ansiedad por las nuevas cepas del coronavirus del Reino Unido, Brasil y Sudáfrica sigue siendo alta en el condado de Multnomah de Portland, Oregon, que experimentó una drástica disminución del 43% en los casos nuevos en los últimos días.

“La preocupación es que todo podría cambiar”, dijo Kate Yeiser, vocera del Departamento de Salud del condado de Multnomah.

Shoshana Dubnow contribuyó a esta historia.

Esta historia fue producida por KHN, que publica California Healthline, un servicio editorialmente independiente de la California Health Care 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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Baby Blues: First-Time Parents Blindsided by ‘the Birthday Rule’ and a $207,455 NICU Bill

In the nine months leading up to her due date, Kayla Kjelshus and her husband, Mikkel, meticulously planned for their daughter’s arrival.


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Their long to-do list included mapping out their family’s health insurance plan and registering for baby gear and supplies. They even nailed down child care ahead of her birth.

“We put a deposit down to hold a spot at a local day care following our first ultrasound,” said Kayla Kjelshus, of Olathe, Kansas.

The first-time parents felt ready for their daughter’s debut on Feb. 15, 2019. But one of the happiest days of their lives turned out to be one of the scariest. Their daughter, Charlie, had a complication during delivery that caused her oxygen levels to drop and put her at risk for brain damage.

“We had a waiting room filled with family and friends,” Mikkel recalled. “To come out and say things aren’t well … it was really hard.”

Charlie was transferred from St. Luke’s Community Hospital to HCA Overland Park Regional Medical Center, where she received treatment in the neonatal intensive care unit, known as the NICU, for the next seven days.

Doctors sent Charlie home with a positive prognosis. The couple had decided that Kayla, a nurse practitioner, would carry Charlie on her insurance plan through Blue Cross and Blue Shield of Kansas City. Her plan offered better rates than Mikkel’s, and his plan was based in another state and carried a higher deductible. So when the hospital asked for insurance information, Kayla provided her policy number; Mikkel did not.

They expected things to work out fine between the insurance company and the hospitals.

Then the bills came.

The Patient: Charlie Kjelshus, an infant covered by her mother’s plan through Blue Cross and Blue Shield of Kansas City and, eventually, her father’s plan, CommunityCare of Oklahoma

Medical Service: Whole body cooling and other treatment in the NICU to prevent brain injury that may result from oxygen deprivation during birth

Service Provider: HCA Overland Park Regional Medical Center in Overland Park, Kansas

Total Bill: Multiple charges totaling $270,951, according to Mikkel Kjelshus, including a charge of $207,455 for the NICU stay

What Gives: Kayla Kjelshus filed a claim with Blue KC, and the insurer started paying for baby Charlie’s care. But then it canceled payments to the HCA Overland Park hospital, St. Luke’s Community Hospital and Charlie’s neurologist, pediatrician and other physicians.

“We thought, ‘This is crazy,’” Mikkel said. “‘We have insurance.’”

What was going on?

The Kjelshus family had slammed into something well known among insurance experts but little understood by the general public. “Coordination of benefits” and “the birthday rule” are the jargon terms for the red tape that snared them.

When a child is born into a family in which both parents have insurance through their jobs, the parents are supposed to “coordinate benefits” — meaning they must tell both insurers that their child is eligible for coverage under two plans. The parents might be forgiven for thinking they have some say in how their child will be insured. In most cases, they don’t.

Instead, a child with double health insurance eligibility must take as primary coverage the plan of the parent whose birthday comes first in the calendar year; the other parent’s insurance is considered secondary. This model regulation was set by the National Association of Insurance Commissioners and adopted by most states, including Kansas, said Lee Modesitt, director of government affairs with the Kansas Insurance Department.

For Charlie Kjelshus, the birthday rule meant her dad’s plan — with a $12,000 deductible, a high coinsurance obligation and a network focused in a different state — was primary. Her mom’s more generous plan was secondary.

Mom Kayla said Blue KC dispatched an investigator to discover that dad Mikkel had insurance through his job. The family had not been trying to hide Mikkel’s coverage; they merely weren’t aware of the birthday rule and that they may be subject to state laws that ensure babies are covered for the first 31 days of life.

“If these are the rules of engagement, you need to tell people upfront that these are the rules,” said Dr. Linda Burke, an OB-GYN and author of “The Smart Mother’s Guide to a Better Pregnancy.” “It’s a communication problem.”

After Blue KC informed Mikkel that his insurance had to serve as primary coverage, CommunityCare of Oklahoma did pay Charlie’s bills from the hospitals and other providers. It paid HCA Overland Park $16,505 on the $207,455 NICU charge. The insurer said its negotiated rate on the bill was $35,721. With Mikkel’s deductible and coinsurance, that left the family on the hook for more than $19,116, it seemed.

“When an insurance company finds out that a baby is in the NICU, then it’s a red flag,” Burke said. “They are going to look for ways to cut their losses.”

Resolution: The couple turned to the Kansas Department of Insurance to file a complaint about the bill, but the department declined to help because Kayla’s policy is self-funded by her employer, which means the company is subject to federal rather than state regulations.

After close to a year and a half of going back and forth with their insurance companies and the hospitals, Blue KC paid $19,116 of the Kjelshuses’ bill as a secondary insurer and said the Kjelshuses should not be responsible for a remaining balance of $7,504.51 from HCA Overland Park. But the family kept getting bills.

And, beginning in summer 2020, collections calls from the hospital rolled in daily, leaving the couple frustrated and confused.

Eventually, after a human resources officer at Kayla’s job stepped in to help, they received a statement with a zero balance. Their own calls to HCA Overland Park hospital billing department didn’t get them anywhere.

“We always got a different answer,” Kayla said. “It was so frustrating.”

A spokesperson for the hospital apologized for the deluge of calls from collections.

“We made an administrative error and an automated billing call system for payment occurred, causing the family undue frustration during an already stressful time, and we apologize,” the hospital wrote in a statement. “Once the issue was identified and resolved, the insurance companies processed the claim and we informed the family that there is a zero balance on the account. Again, we are sorry for the stress and inconvenience, and wish them well.”

In a statement, Blue KC acknowledged that coordination of benefits can be confusing for members, and that the company follows rules of state and federal regulators, modeled on standards set by the NAIC. It said the Kjelshuses’ future claims would continue to be paid and that a “dedicated service consultant” would continue to work with Kayla Kjelshus.

In the end, the insurers and hospitals settled Charlie’s bill as they were supposed to: The primary insurer paid first, and the secondary paid what had not been covered by the first. But it took more than a year of phone calls, appeals and complaints before the Kjelshus family had the matter settled. Charlie turns 2 next month.

The Takeaway: In theory, “the birthday rule” would be a fair, if random, way to figure out which insurance should be primary and which secondary for families with insurance from two employers. The presumption is that the premiums, deductibles and networks are roughly similar in both parents’ insurance plans — but that’s simply not the case for many families.

The Kjelshuses found out the hard way they didn’t have a choice about which parents’ insurance was primary. They might have avoided their quagmire if Mikkel had dropped his own coverage and gotten onto Kayla’s plan before Charlie was born.

It’s not clear whose responsibility it is to help families navigate these rules before a baby is born. It’s even more complicated for parents who are divorced or never married. Insurance companies don’t always offer the critical information families need about the coordination of benefits.

“Expecting parents should try to get in touch with their health plan before the baby is born to find out about the coverage rules,” said Karen Pollitz, a senior fellow at KFF, the Kaiser Family Foundation. (KHN is an editorially independent program of KFF.)

“Also figure out if they want to switch the entire family onto one plan once the baby is born.”

It’s also a good idea to speak to human resources representatives at both parents’ jobs. The birth of a baby is considered “a qualifying event” for insurance coverage in all group health plans, so families can make decisions about changing coverage at that time. Otherwise, families might have to wait for open enrollment to make coverage changes.

“It is ridiculous to me my wife and I faced so many issues since both parents have health insurance,” Mikkel Kjelshus wrote. His daughter, Charlie, now is covered only by his wife’s plan.

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!

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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Encuesta: casi la mitad de los adultos ahora quiere vacunarse contra covid lo antes posible

La renuencia de los estadounidenses a vacunarse contra covid-19 está disminuyendo, según una encuesta publicada el miércoles 27 de enero.

Casi la mitad de los adultos encuestados en enero dijeron que ya han sido vacunados o que quieren la vacuna tan pronto como puedan, en comparación con aproximadamente un tercio de los adultos encuestados en diciembre, según el último sondeo de KFF (Kaiser Family Foundation).

Aproximadamente 20 millones de estadounidenses han sido vacunados contra covid desde que comenzaron a distribuirse las primeras vacunas a mediados de diciembre. El ritmo también se ha acelerado en las últimas semanas, con un promedio de más de un millón de estadounidenses vacunándose cada día.

La encuesta encontró que a medida que más personas conocen a alguien cercano que ha sido vacunado, es más probable que quieran vacunarse.

Aproximadamente la mitad de los que quieren la inyección lo antes posible conocen a alguien que ya ha recibido una dosis, una proporción mucho mayor que entre los que dicen que solo la recibirán si es necesario (29%) o se negarán a recibirla (36%).

Casi la mitad (47%) de los adultos dicen que han recibido personalmente al menos una dosis de la vacuna o conocen a alguien que la ha recibido. Las personas que postean su estatus de vacunación en redes sociales como Facebook y Twitter han ayudado a correr la voz.

Sin embargo, persisten las disparidades raciales, étnicas y económicas.

Los adultos blancos no hispanos (51%) tienen más probabilidades que los encuestados de raza negra (38%) o hispanos, que pueden ser de cualquier raza (37%) de haber sido vacunados o conocer a alguien que lo haya hecho.

Aquellos con ingresos familiares anuales de al menos $90,000 tienen casi el doble de probabilidades de vacunarse, que aquellos con ingresos inferiores a $40, 000 (es decir, 65% frente a 33%).

Casi uno de cada tres adultos dice que quiere esperar hasta que la vacuna “haya estado disponible por un tiempo para ver cómo funciona en otros” antes de recibirla ellos mismos. Aproximadamente el 7% de los adultos dicen que recibirán la vacuna solo “si se requiere para el trabajo, la escuela u otras actividades”, y el 13% dice que “definitivamente no se pondrán” la vacuna.

La encuesta también encontró que aproximadamente uno de cada tres trabajadores de salud quiere esperar para ver cómo está funcionando la vacuna, o la recibiría solo si fuera necesario.

El porcentaje de personas que quieren la vacuna de inmediato ha aumentado entre todas las razas, aunque los adultos blancos no hispanos (53%) siguen siendo más propensos a decirlo que los adultos negros (35%) e hispanos (42%).

Los adultos de raza negra (43%) e hispanos (37%) son más propensos que los adultos blancos no hispanos (26%) a decir que quieren “esperar y ver” antes de vacunarse, según la encuesta.

Los demócratas e independientes también muestran un mayor entusiasmo, aunque las opiniones de los republicanos han cambiado poco desde diciembre.

Los republicanos siguen siendo el grupo menos entusiasta. Un 32% dijo que ya ha sido vacunado o quiere la vacuna tan pronto como puedan, un 33% dijo que quiere esperar y ver cómo funciona, y un 25% expresó que definitivamente no se vacunará.

La encuesta de KFF se realize entre 1,563 adultos, del 11 al 18 de enero y tuvo un margen de error de 3 +/- puntos porcentuales.

Esta historia fue producida por KHN, que publica California Healthline, un servicio editorialmente independiente de la California Health Care 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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If I Have Cancer, Dementia or MS, Should I Get the Covid Vaccine?

As public demand grows for limited supplies of covid-19 vaccines, questions remain about the vaccines’ appropriateness for older adults with various illnesses. Among them are cancer patients receiving active treatment, dementia patients near the end of their lives and people with autoimmune conditions.

Recently, a number of readers have asked me whether older relatives with these conditions should be immunized. This is a matter for medical experts, and I solicited advice from several. All strongly suggested that people with questions contact their doctors and discuss their individual medical circumstances.

Experts’ advice may be helpful since states are beginning to offer vaccines to adults over age 65, 70 or 75, including those with serious underlying medical conditions. Twenty-eight states are doing so, according to the latest survey by The New York Times.

Q: My 80-year-old mother has chronic lymphocytic leukemia. For weeks, her oncologist would not tell her “yes” or “no” about the vaccine. After much pressure, he finally responded: “It won’t work for you, your immune system is too compromised to make antibodies.” She asked if she can take the vaccine anyway, just in case it might offer a little protection, and he told her he was done discussing it with her.

First, some basics. Older adults, in general, responded extremely well to the two covid-19 vaccines that have received special authorization from the Food and Drug Administration. In large clinical trials sponsored by drugmakers Pfizer and Moderna, the vaccines achieved substantial protection against significant illness, with efficacy for older adults ranging from 87% to 94%.

But people 65 and older undergoing cancer treatment were not included in these studies. As a result, it’s not known what degree of protection they might derive.

Dr. Tobias Hohl, chief of the infectious diseases service at Memorial Sloan Kettering Cancer Center in New York City, suggested that three factors should influence patients’ decisions: Are vaccines safe, will they be effective, and what is my risk of becoming severely ill from covid-19? Regarding risk, he noted that older adults are the people most likely to become severely ill and perish from covid, accounting for about 80% of deaths to date — a compelling argument for vaccination.

Regarding safety, there is no evidence at this time that cancer patients are more likely to experience side effects from the Pfizer-BioNTech and Moderna vaccines than other people. Generally, “we are confident that these vaccines are safe for [cancer] patients,” including older patients, said Dr. Armin Shahrokni, a Memorial Sloan Kettering geriatrician and oncologist.

The exception, which applies to everyone, not just cancer patients: people who are allergic to covid-19 vaccine components or who experience severe allergic responses after getting a first shot shouldn’t get covid-19 vaccines.

Efficacy is a consideration for patients whose underlying cancer or treatment suppresses their immune systems. Notably, patients with blood and lymph node cancers may experience a blunted response to vaccines, along with patients undergoing chemotherapy or radiation therapy.

Even in this case, “we have every reason to believe that if their immune system is functioning at all, they will respond to the vaccine to some extent,” and that’s likely to be beneficial, said Dr. William Dale, chair of supportive care medicine and director of the Center for Cancer Aging Research at City of Hope, a comprehensive cancer center in Los Angeles County.

Balancing the timing of cancer treatment and immunization may be a consideration in some cases. For those with serious disease who “need therapy as quickly as possible, we should not delay [cancer] treatment because we want to preserve immune function and vaccinate them” against covid, said Hohl of Memorial Sloan Kettering.

One approach might be trying to time covid vaccination “in between cycles of chemotherapy, if possible,” said Dr. Catherine Liu, a professor in the vaccine and infectious disease division at Fred Hutchinson Cancer Research Center in Seattle.

In new guidelines published late last week, the National Comprehensive Cancer Network, an alliance of cancer centers, urged that patients undergoing active treatment be prioritized for vaccines as soon as possible. A notable exception:  Patients who’ve received stem cell transplants or bone marrow transplants should wait at least three months before getting vaccines, the group recommended.

The American Cancer Society’s chief medical and scientific officer, Dr. William Cance, said his organization is “strongly in favor of cancer patients and cancer survivors getting vaccinated, particularly older adults.” Given vaccine shortages, he also recommended that cancer patients who contract covid-19 get antibody therapies as soon as possible, if their oncologists believe they’re good candidates. These infusion therapies, from Eli Lilly and Co. and Regeneron Pharmaceuticals, rely on synthetic immune cells to help fight infections.

Q: Should my 97-year-old mom, in a nursing home with dementia, even get the covid vaccine?

The federal government and all 50 states recommend covid vaccines for long-term care residents, most of whom have Alzheimer’s disease or other types of cognitive impairment. This is an effort to stem the tide of covid-related illness and death that has swept through nursing homes and assisted living facilities — 37% of all covid deaths as of mid-January.

The Alzheimer’s Association also strongly encourages immunization against covid-19, “both for people [with dementia] living in long-term care and those living in the community, said Beth Kallmyer, vice president of care and support.

“What I think this question is trying to ask is ‘Will my loved one live long enough to see the benefit of being vaccinated?’” said Dr. Joshua Uy, medical director at a Philadelphia nursing home and geriatric fellowship director at the University of Pennsylvania’s Perelman School of Medicine.

Potential benefits include not becoming ill or dying from covid-19, having visits from family or friends, engaging with other residents and taking part in activities, Uy suggested. (This is a partial list.) Since these benefits could start accruing a few weeks after residents in a facility are fully immunized, “I would recommend the vaccine for a 97-year-old with significant dementia,” Uy said.

Minimizing suffering is a key consideration, said Dr. Michael Rafii, associate professor of clinical neurology at the University of Southern California’s Keck School of Medicine. “Even if a person has end-stage dementia, you want to do anything you can to reduce the risk of suffering. And this vaccine provides individuals with a good deal of protection from suffering severe covid,” he said.

“My advice is that everyone should get vaccinated, regardless of what stage of dementia they’re in,” Rafii said. That includes dementia patients at the end of their lives in hospice care, he noted.

If possible, a loved one should be at hand for reassurance since being approached by someone wearing a mask and carrying a needle can evoke anxiety in dementia patients. “Have the person administering the vaccine explain who they are, what they’re doing and why they’re wearing a mask in clear, simple language,” Rafii suggested.

Q: I’m 80 and I have Type 2 diabetes and an autoimmune disease. Should I get the vaccine?

There are two parts to this question. The first has to do with “comorbidities” — having more than one medical condition. Should older adults with comorbidities get covid vaccines?

Absolutely, because they’re at higher risk of becoming seriously ill from covid, said Dr. Abinash Virk, an infectious diseases specialist and co-chair of the Mayo Clinic’s covid-19 vaccine rollout.

“Pfizer’s and Moderna’s studies specifically looked at people who were older and had comorbidities, and they showed that vaccine response was similar to [that of] people who were younger,” she noted.

The second part has to do with autoimmune illnesses such as lupus or rheumatoid arthritis, which also put people at higher risk. The concern here is that a vaccine might trigger inflammatory responses that could exacerbate these conditions.

Philippa Marrack, chair of the department of immunology and genomic medicine at National Jewish Health in Denver, said there’s no scientifically rigorous data on how patients with autoimmune conditions respond to the Pfizer and Moderna vaccines.

So far, reasons for concern haven’t surfaced. “More than 100,000 people have gotten these vaccines now, including some who probably had autoimmune disease, and there’s been no systematic reporting of problems,” Marrack said. If patients with autoimmune disorders are really worried, they should talk with their physicians about delaying immunization until other covid vaccines with different formulations become available, she suggested.

Last week, the National Multiple Sclerosis Society recommended that most patients with multiple sclerosis — another serious autoimmune condition — get the Pfizer or Moderna covid vaccines.

“The vaccines are not likely to trigger an MS relapse or to worsen your chronic MS symptoms. The risk of getting COVID-19 far outweighs any risk of having an MS relapse from the vaccine,” it said in a statement.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.

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

Remdesivir, Given to Half of Hospitalized Covid Patients in U.S., Is Big Win for Gilead — Boosted by Taxpayers

It was the end of April — just as the U.S. confirmed its millionth covid-19 case and 50,000 deaths — when White House adviser Dr. Anthony Fauci announced “highly significant” news about a drug called remdesivir.

That was surprising because the antiviral drug, owned by Gilead Sciences and developed with investment from the federal government, had languished for years with no apparent commercial use. It had struck out as a treatment for hepatitis C and Ebola.

But early in 2020, when the first global cases of a new pneumonia-like viral illness emerged in China, Gilead resurfaced the compound, branded as Veklury, and shared it with scientists across the globe. From the Oval Office, Fauci, director of the National Institute of Allergy and Infectious Diseases, said remdesivir would be the “standard of care” for treating coronavirus disease.

Its emergency-use approval by the Food and Drug Administration immediately drew a storm of criticism. Clinical trials suggested it was only modestly helpful to covid patients. The World Health Organization recommended against its use. Politicians railed at its $3,120 price tag.

Yet, nine months later, it appears Fauci was right: As U.S. infections climb above 24 million, doctors with no other FDA-approved treatment options are now prescribing remdesivir to half the covid patients in U.S. hospitals.

“We want to shorten their hospital stay,” said Dr. Jade Le, an infectious diseases specialist with Access Physicians in Texas, where hospitals have been at capacity for weeks. Le prescribes remdesivir on average three to five times a day, always in concert with a low-cost steroid.

This month, Gilead chief executive Daniel O’Day raised the profit estimates of the company, headquartered in Foster City, California, noting that remdesivir alone would deliver about $2.8 billion in 2020 sales, bolstered by its use in U.S. and European markets. The company is proud of the role the treatment is playing during the pandemic, he said.

Still, controversies abound. Tension mounted last summer as shortages of remdesivir taxed the global medical community and raised urgent questions about how the federal government could step in. While doctors rationed the drug, politicians and advocates said U.S. taxpayers had invested enough in remdesivir’s development to merit a lower price.

“The remdesivir story is actually a story that is all too common,” said Zain Rizvi, law and policy researcher at the consumer advocacy group Public Citizen. Rizvi — and other advocates — say the drug would not have come to market if it wasn’t for federal grants and the help of U.S. scientists.

They said the rags-to-riches story of remdesivir, a losing prospect turned blockbuster, holds lessons in how Americans end up paying more for medicine than anyone else in the world. Remdesivir used taxpayer dollars to be developed but, in a public health emergency, patients have no option but to pay whatever the pharmaceutical giant demands.

Rizvi has estimated that federal grants of “at least” $70 million supported the scientific discovery of remdesivir. He pointed to early research done, including a collaboration between Gilead and university scientists, using federal grants, to test remdesivir’s antiviral compounds against coronaviruses, such as MERS and SARS. Others figure the investment could be much higher.

Kathryn Ardizzone, legal counsel for the patent rights group Knowledge Ecology International, is among those, though she agreed the amount is at least $70 million and declined to estimate the total amount of federal dollars used for remdesivir’s discovery. There is no publicly available database of how much the government has spent to develop any drug, including remdesivir.

The NIH said in an emailed statement that it “did not develop remdesivir.” The agency confirmed it funded research on the drug’s uses as well as providing money to institutions that worked with Gilead to develop the drug.

KEI filed a Freedom of Information Act request to view the grants and clinical trials related to remdesivir. In October, the group sued the National Institutes of Health because it had failed to respond. Ardizzone said she expects the records will counter Gilead’s justification of remdesivir’s price: “When the government has played such a critical role at every step of the way, that argument falls apart.”

Gilead, in an emailed statement, said its investment in the drug predates any government involvement and “disagrees with the premise that the government has any rights to Gilead’s remdesivir intellectual property.” No federal scientists are named on remdesivir’s patents.

The company has defended the price of the drug, saying it invested more than $1 billion in 2020 to support clinical trials as well as to manufacture and distribute remdesivir. Gilead priced it at $3,120 for a five-day course of treatment in the U.S. market, and $2,340 for other developed countries. Some smaller U.S. government entities, like the Indian Health Service, pay the lower price as well. Noting the price for developed countries, Gilead spokesperson Arran Attridge said the drug is priced “significantly below the potential value” it delivers.

But U.S. Sen. Ron Wyden, a top-ranking Democrat from Oregon on the Senate Finance Committee, said he has been concerned about Gilead’s price for a five-day course of treatment since it was announced. “My previous investigative work … has shown Gilead’s willingness to put profits over patients,” Wyden said. Wyden, along with Sen. Chuck Grassley (R-Iowa), released an investigation in 2015 of Gilead’s hepatitis C drug prices and marketing.

At its core, remdesivir is a simple, “small molecule” drug. Generics manufacturers in India have copied the design and priced it at $53.34 per vial, or $320 for a course of treatment.

The U.S. government, so far, has not exerted its intellectual property rights. But there are signals that could change.

In late summer, California Attorney General Xavier Becerra led a group of more than 30 attorneys general calling for the federal government to license remdesivir to another manufacturer, such as a lower-cost provider from overseas. President Joe Biden nominated Becerra to lead the Department of Health and Human Services.

Another Biden pick, Dr. Rochelle Walensky, an infectious diseases specialist who has been tasked to lead the Centers for Disease Control and Prevention, co-authored a New York Times opinion piece suggesting that HHS could buy the drug from another company (including a generics maker overseas) and pay royalties to Gilead. This fall, U.S. Rep. Lloyd Doggett (D-Texas) held a news conference supporting the approach Walensky and others proposed.

Neither maneuver, however, was meant as a lever to lower its price for patients, said Adam Mossoff, a law professor at George Mason University. Mossoff doubted that either of the strategies would hold up in court and noted there are plenty of congressional proposals to lower drug prices and sometimes “people get ahead of themselves.” They try to use the law to advocate for what should be a policy goal, he said.

Underlying Becerra’s and Walensky’s proposals is the deeper, nagging question of whether Gilead should fully own the rights to remdesivir if the U.S. funded research and its scientists worked with Gilead to discover the drug.

Doggett put it this way: “Gilead is overcharging on a drug that was saved from the scrap heap of failed drugs only because of taxpayer-funded research.”

Sen. Debbie Stabenow (D-Mich.) and Rep. Carolyn Maloney (D-N.Y.) have asked the government’s federal watchdog agency, the Government Accountability Office, to investigate “what legal rights do federal agencies have” in relation to remdesivir. Gilead said it is cooperating with the investigation; government officials expect the review to be completed this spring.

Gilead, in an emailed statement in response to a question about the GAO review, called the government’s involvement “limited.” In response to questions about the patents, Gilead said its own investments predate any government involvement and its inventors identified the drug’s antiviral activity, optimized the formula and scaled up the manufacturing process.

Gilead confirmed it has eight listed patents on remdesivir, with the last expiring in 2038.

In the abstracts of two patents, filed in 2014 and 2015, the CDC and USAMRIID, the U.S. Army Medical Research Institute of Infectious Diseases, are mentioned as places studies were conducted. Each patent emphasizes its focus on treating the Ebola virus and other filoviruses that cause fatal hemorrhagic fevers.

Christopher Morten, deputy director of technology law and policy clinic at New York University School of Law, said those two patents should list government scientists as co-inventors. Referring to one patent (No. 9,724,360), Morten said its earliest filing was October 2014. “Which makes perfect sense, because the U.S. government collaboration started in 2013 with Ebola and the CDC,” Morten said. While not attaching specific government investment dollars to its descriptions, Gilead confirms the collaboration, as well, saying it “worked with the U.S. government to confirm remdesivir’s preclinical activity against Ebola.”

Morten, who previously represented pharmaceutical companies as a patent lawyer, said he believes the question of inventorship should be raised in court, using the legal tactic proposed by CDC chief Walenksy. Morten co-authored a white paper on remdesivir with the HIV advocacy group PrEP4All.

Notably, PrEP4All also challenged Gilead’s patents for the HIV drug Truvada. In 2019, the U.S. Departments of Justice and Health and Human Services sued Gilead over patent rights for Truvada. The case is ongoing.

Back on the pandemic’s front lines, U.S. doctors administer remdesivir even after the World Health Organization recommended against the drug in November. The WHO’s recommendation, which referenced results from an international trial called Solidarity, found remdesivir did not improve a covid patient’s chance of survival.

The Food and Drug Administration gave remdesivir full regulatory approval in October, making it the only approved U.S. treatment for the deadly disease.

Dr. Rajesh Gandhi, a member of the Infectious Diseases Society of America’s panel on covid-19 treatment guidelines, pointed to another clinical trial of more than 1,000 hospitalized patients run by the National Institutes of Health. The trial, called ACTT-1, showed hospital stays of about 10 days for those who received remdesivir compared with 15 days for those who did not, he said.

“Many of us believe remdesivir has a role,” Gandhi said, “though we wish it had a greater effect.” He noted that the trial showed one group of patients saw the biggest benefit: those who need supplemental oxygen but are not yet on a ventilator. It’s clear, he said, “we need better drugs than remdesivir.”

Remdesivir — along with a steroid — was enough for Shirley Lewis.

The 69-year-old Florida resident said she was sick for about a week when she found herself unable to breathe and went to the hospital.

“I’m telling you, I was like half-dead and half-alive … all I could do was pray,” Lewis said. Doctors put her on supplemental oxygen and began IV bags of remdesivir paired with steroids. Lewis said she felt the difference right away.

“I said, Oh, thank God,” Lewis recalled about a month after being released from the hospital. “I thought it was some kind of miracle, I really did. So don’t let them say it doesn’t work, because it did.”

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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Poll: Nearly Half of American Adults Now Want the Covid Vaccine — ASAP

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Americans’ reluctance to get vaccinated for covid-19 is waning, according to a poll released Wednesday.

Nearly half of adults surveyed in January said they have either already been vaccinated or want the vaccine as soon as they can, up from about a third of adults polled in December, according to the latest KFF survey. (KHN is an editorially independent program of KFF.)

About 20 million Americans have been vaccinated for covid since distribution of the first vaccines began in mid-December. The pace has also picked up in recent weeks, with more than a million Americans on average getting vaccinated every day. The survey found that when people know someone close to them who has been vaccinated, they are more likely to want the shots.

About half of those who said they want the shot as soon as possible know someone who has already gotten a dose, a much larger share than among those who said they’ll get it only if required (29%) or will refuse to get it (36%).

Nearly half (47%) of adults said they have personally received at least one vaccine dose or know someone who has. People posting their vaccination status on social networks such as Facebook and Twitter has helped spread the word.

Racial, ethnic and economic disparities continue, however. White adults (51%) are more likely than Black (38%) or Hispanic (37%) respondents to have either been vaccinated or know someone who has, and those with annual household incomes of at least $90,000 are almost twice as likely as those with incomes under $40,000 to say so (64% vs. 34%). (Hispanics can represent any race or combination of races.)

About 3 in 10 adults said they want to wait until the vaccine “has been available for a while to see how it is working for others” before getting it themselves. About 7% of adults said they will get the vaccine only “if required to do so for work, school or other activities,” and just 13% said they will “definitely not get” the vaccine, not a significant change.

The poll also found about 1 in 3 health care workers planned to wait to see how the vaccine is working or would get it only if required to.

The percentage of people who said they want the vaccine immediately is up among the racial and ethnic groups surveyed, although white (53%) adults remained more likely to say so than Black (35%) and Hispanic (42%) adults. Black (43%) and Hispanic (37%) adults were more likely than white adults (26%) to say they want to “wait and see” before getting vaccinated, according to the poll.

Democrats and independents also showed increased enthusiasm, though Republicans’ views were little changed since December.

Republicans remained the least enthusiastic political group, with 32% saying they have already been vaccinated or want the vaccine as soon as they can, 33% saying they want to wait and see how it works for others, and 25% saying they will definitely not get the vaccine.

The KFF survey of 1,563 adults was conducted Jan. 11-18 and had a margin of error of +/-3 percentage points.

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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This story can be republished for free (details).