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Feeling Anxious and Depressed? You’re Right at Home in California.

Kaiser Health News:States - August 26, 2020

It’s official, California: COVID-19 has left us sick with worry and increasingly despondent. And our youngest adults — ages 18 to 29 — are feeling it worst.

Weekly surveys conducted by the U.S. Census Bureau from late April through late July offer a grim view of the toll the pandemic has taken on the nation’s mental health. By late July, more than 44% of California adult respondents reported levels of anxiety and gloom typically associated with diagnoses of generalized anxiety disorder or major depressive disorder, a stunning figure that rose through the summer months alongside the menacing spread of the coronavirus.

America at large has followed a similar pattern, with about 41% of adult respondents nationwide reporting symptoms of clinical anxiety or depression during the third week of July. By comparison, just 11% of American adults reported those symptoms in a similar survey conducted in early 2019.

The July responses showed a marked geographic variance, with residents of Western and Southern states, where the virus remains most virulent, registering greater mental distress, on average.

The findings reflect a generalized sense of hopelessness as the severity of the global crisis set in. Most adults have been moored at home in a forced stasis, many in relative isolation. The unemployment rate hit its highest rate since the Great Depression of the 1930s. Thousands of families across California and tens of thousands across the U.S. have lost people to the virus. There is no clear indication when — or even if — life will return to normal.

“The pandemic is the first wave of this tsunami, and the second and third waves are really going to be this behavioral health piece,” said Jessica Cruz, executive director of the National Alliance on Mental Illness (NAMI) California.

The surveys were part of a novel partnership between the National Center for Health Statistics and the Census Bureau to provide relevant statistics on the coronavirus’s impact. In weekly online surveys over three months, the Census Bureau asked about 900,000 Americans questions to quantify their levels of anxiety or depression. The four survey questions are a modified version of a common screening tool physicians use to diagnose mental illness.

Respondents were asked how often during the previous seven days they had been bothered by feeling hopeless or depressed; had felt little interest or pleasure in doing things; had felt nervous or anxious; or had experienced uncontrolled worry. They were scored based on how often they had experienced those symptoms in the previous week, ranging from never to nearly every day. High scores on the anxiety questions indicated symptoms associated with generalized anxiety disorder. High scores on the depression questions indicated symptoms of major depressive disorder.

In both California and the nation, symptoms of depression and anxiety were more pronounced among young adults, and generally decreased with age. For example, nearly 3 in 4 California respondents between ages 18 and 29 reported “not being able to stop or control worrying” for at least several of the previous seven days. And 71% reported feeling “down, depressed or hopeless” during that time.

Interestingly, respondents 80 and older — an age group far more likely to suffer and die from COVID-19 — reported nowhere near the same levels of distress. Just 40% reported feeling down or hopeless for at least several days in the previous week, and 42% reported uncontrollable worry.

Cruz said that may be because young adults are more comfortable expressing worry and sadness than their parents and grandparents, adding that such openness is a good thing. However, even before the pandemic, suicide rates among teens and young adults had been on a yearslong climb nationwide, and California emergency rooms had registered a sharp rise in the number of young adults seeking care for mental health crises.

Some researchers have cited the ubiquitous reach of social media — and with it an increased sense of inferiority and alienation — as factors in the rise in mental health struggles among younger generations. COVID-19 could be exacerbating those feelings of isolation, Cruz said.

The Census surveys also found higher rates of depression and anxiety among those who have lost jobs during the pandemic. Young adults in the service sector have been hit particularly hard by the wide-scale economic shutdowns. In July, the unemployment rate among U.S. workers ages 20 to 24 was 18%, compared with 9% among workers 25-54, according to the U.S. Bureau of Labor Statistics.

Others noted that many other young adults who would normally be immersed in college life are stuck on the couch in their parents’ home, staring at a professor on Zoom, with little social life and no paid work after class.

“Some of the things that generally help improve mood have been more difficult and more challenging now,” said Paul Kim, director of counseling services at the University of California-Davis. “So I think some of our counselors’ work is to help them think through, ‘How is it, for example, you stay socially connected while socially distant?’”

Californians with lower incomes also reported higher levels of anxiety or depression. About 72% of California respondents with household incomes below $35,000 reported “little interest or pleasure in doing things” for at least several of the previous seven days, according to an average of survey results from July 2 through July 21.

“People have had a lot of trouble accessing unemployment benefits — that has not been an easy path,” said Jo Campbell, a therapist and integrated operations director at Hill Country Community Clinic, which provides services to clients, many of them economically disadvantaged, in Shasta County.

Some experts said they worry that the tumble toward depression and anxiety could outlast the pandemic itself, particularly if the economy lapses into a prolonged recession.

“The pandemic will likely have short- and long-term implications on mental health and substance use,” said Laura Pancake, a vice president at Pacific Clinics, one of the largest mental health service providers in Southern California. The pandemic, she added, “has only exacerbated existing challenges that many face, including unemployment, poor health and other barriers.”

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

This KHN story first published on California Healthline, a service of the 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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LA Hospital Seeks Vaccine Trial Participants Among Its Own High-Risk Patients

The patients at Dr. Eric Daar’s hospital are at high risk for serious illness from COVID-19, and he’s determined to make sure they’re part of the effort to fight the disease.

He also hopes they can protect themselves in the process.

When Daar and his colleagues at Harbor-UCLA Medical Center on Wednesday announce the start of enrollment for a trial to test a COVID-19 vaccine produced by AstraZeneca, they will also unveil the hospital’s community-based recruitment strategy.

Harbor-UCLA wants to recruit most, if not all, of the trial’s 500 participants from among the high-risk patients it already treats: people over 65, those with chronic illnesses and members of underserved racial and ethnic groups. Hospital officials also expect that the recruitment task will not be easy.

“It’s a priority and obligation to make sure our community is well represented in these trials,” said Daar, chief of HIV medicine at Harbor-UCLA and a researcher at the UCLA-affiliated Lundquist Institute, who dropped his other research projects last spring to focus on a COVID-19 vaccine.

The safety-net hospital in Torrance, California, serves patients in the South Bay area of Los Angeles County who are predominantly Black, Latino and Pacific Islander. Many live in crowded homes and do “essential” work that requires them to expose themselves to the virus to make a living: They’re orderlies and cooks and house cleaners, day laborers and bus drivers and sanitation workers.

The area has high rates of heart disease and stroke.

“If you don’t have a community represented in the trial, it’s hard to extrapolate your results to the community,” said Dr. Katya Corado, one of Daar’s colleagues. “We want to find something to protect our patients and loved ones.”

Latinos and Blacks in the United States are nearly three times more likely than non-Hispanic whites to be diagnosed with COVID-19 and nearly five times more likely to be hospitalized with the disease. In Los Angeles County, Latinos in particular have been disproportionately stricken by the virus.

Eight of 10 COVID-19 deaths nationwide occur among people 65 and older, according to the Centers for Disease Control and Prevention.

Historically, Blacks and Latinos have been less likely to be included in clinical trials for disease treatment, despite federal guidelines that urge minority and elder participation.

The National Institutes of Health and the Food and Drug Administration have urged infectious disease researchers to focus on these vulnerable populations in the large phase 3 trials that will test how well vaccines prevent COVID-19.

Harbor-UCLA, a public teaching hospital owned and operated by Los Angeles County, is one of roughly 100 sites nationwide testing the AstraZeneca vaccine candidate, which was developed in collaboration with Oxford University in Britain. Phase 3 trials of about the same size for vaccine candidates produced by Moderna and Pfizer are already underway. Each of the three companies seeks to recruit 30,000 people, 20,000 of whom will get the vaccine and 10,000 a placebo, or harmless saline solution, to test whether the vaccine prevents coronavirus disease.

Recruitment at Harbor-UCLA will include patients with well-controlled chronic diseases such as diabetes and hypertension, and people with HIV who’ve kept the virus under control with medication, Daar said.

According to the AstraZeneca trial protocol, patients will get up to $100 for each of 15 to 20 visits during the two-year trial. The Harbor-UCLA team will also offer car services to bring people to the hospital through L.A. traffic.

To reach its targeted recruits, the hospital will distribute leaflets to clinics and community organizations and create targeted social media campaigns, in addition to taking any free publicity it can get, Daar said.

Recruitment of high-risk patients in other COVID-19 trials so far has been mixed. Moderna, which began the first phase 3 trial of the experimental vaccines on July 27, announced Friday that 18% of its 13,000-plus enrollees so far were Black, Latino or Native American — a high percentage as clinical trials go, but only about one-third of the goal set by NIH officials.

Other AstraZeneca trial sites have also publicized their efforts to reach those most at risk from the virus. The University of Southern California’s Keck School of Medicine placed one of its AstraZeneca recruitment sites in Vernon, south of downtown Los Angeles in an area with many factories and meatpacking plants, which have experienced high COVID-19 infection rates.

Clinicians suspect that the higher rates of disease and hospitalization in minority groups are due both to health conditions — such as undertreated diabetes and heart disease — and to higher exposure to the virus in workplaces and crowded housing. Environmental factors like polluted neighborhoods may also have an impact.

While there’s little evidence that vaccines affect Blacks or Latinos differently than white people, the subject hasn’t really been studied, said Dr. Akilah Jefferson Shah, an allergist/immunologist and bioethicist at the University of Arkansas for Medical Sciences. That’s another reason for making sure these groups are well represented in trials, she said.

“We know now there are subgroup responses to drugs by sex, but no one figured it out until they started including women in these studies,” Jefferson Shah said. “Race is not genetic. It’s a social construct. But there are genetic variants more prevalent in certain populations. We won’t know until we look.”

Perhaps most important, diversity in the research will be needed to build trust and uptake of the vaccine, Corado said. In a May poll from the Associated Press-NORC Center for Public Affairs Research, just 25% of Blacks and 37% of Hispanics said they would definitely seek vaccination against the coronavirus, compared with 56% of whites.

In July, the Harbor-UCLA vaccine team began holding weekly Zoom meetings with about 25 activists and clergy members to learn what their communities were saying about the vaccine and get tips on how to design educational materials for the trial.

What they’ve heard suggests they’ll have an uphill recruitment battle.

One member of the community council, HIV activist Dontá Morrison, noted that people frequently say on social media that the vaccine is designed to give them COVID-19 as part of a plot to get rid of Black voters. (None of the vaccines contains infectious COVID virus.)

“It may seem far-fetched, but those are the conversations because we have an administration that has not shown itself to be trustworthy,” Morrison said.

He noted that the first challenge UCLA researchers face is to convince community leaders, particularly clergy members, of the vaccine’s safety. Church leaders worry they’ll be blamed for supporting the trial if the vaccine ends up making their congregants sick, he said.

If done right, the trial could build trust in medical science while helping minorities help themselves — and the rest of us — find a way out of the current mess, Morrison said.

Dr. Raphael Landovitz, another UCLA scientist working on the trial, agreed.

“We’re hoping that people understand this is a chance — if we succeed — to take back some power and control in this situation that has made so many of us feel so powerless,” he said.

This KHN story first published on California Healthline, a service of the 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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Trump Administration to Release 1.5 Million N95 Respirators from the Strategic National Stockpile for Distribution to Nursing Homes

HHS Gov News - August 25, 2020

Under the leadership of President Trump, the Department of Health and Human Services (HHS) today announced the release of 1.5 million N95 respirators from the Strategic National Stockpile (SNS) for distribution to approximately 3,336 nursing home facilities across the United States.

Beginning Aug. 28, 2020, the Defense Logistics Agency will direct shipments of N95 respirators to select nursing homes that recently reported having enough supplies for only zero to three days of operations. These respirators are meant to supplement existing supplies of personal protective equipment (PPE) and will provide a seven-day supply for each nursing home to support an entire shift before discarding used products.

“President Trump and Secretary Azar remain fully committed to caring for our nation’s most vulnerable citizens, and that means ensuring nursing homes have the equipment and supplies they need to treat patients safely during the pandemic,” said HHS Assistant Secretary for Preparedness and Response (ASPR) Robert Kadlec, M.D., who oversees the SNS. “This additional federal supplement of N95 respirators from the SNS will immediately help those nursing homes prevent the spread of COVID-19 and keep the patients they care for safe during this pandemic.”

“Through the use of the Defense Production Act, the federal government has increased the domestic production of N95 respirators and has allowed the SNS to grow,” said Rear Admiral John Polowczyk, HHS Supply Chain Task Force lead. “This increase has allowed us to use our existing surge-capacity built up in the stockpile to distribute 1.5 million masks to meet the needs of front-line healthcare workers caring for one of our most-affected populations. Our goal is to enable our states to provide longer term support in the fight against COVID-19.”

Certified by the National Institute of Occupational Safety and Health (NIOSH), these N95 respirators are produced by O&M Halyard and made in the United States. Each shipment will contain a 4:1 mix of size regular and small respirators as validated by historical distribution ratios from the medical distributors.

The quantity of respirators distributed to each nursing home will be based on the number of medical staff employed at the facility, as reported to the Centers for Medicare and Medicaid Services database. Each state’s governor was notified of the pending shipments during the Vice President’s call with governors on Aug. 18, 2020. 

These shipments support only Medicare and Medicaid-approved nursing homes and are in addition to prior shipments of PPE distributed in order to safeguard our most vulnerable populations during the COVID-19 pandemic.

About HHS, ASPR, and the Strategic National Stockpile:

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, the Strategic National Stockpile supplements state and local supplies during public health emergencies. The supplies, medicines, and devices for life-saving care contained in the stockpile can be used as a short-term, stopgap buffer when supplies may not be immediately available or sufficient. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.

Los incendios forestales son otra razón para usar máscaras

Kaiser Health News:States - August 25, 2020

Si te has negado a usar una máscara facial durante la crisis de COVID-19, tal vez deberías reconsiderarlo, ya que el humo de más de 300 incendios forestales está asfixiando a mucha gente en el centro y norte de California.

Pero vas a tener que evaluar cuál es el mejor tipo de máscara.

Los incendios han esparcido sustancias tóxicas, haciendo llover cenizas por toda la región y cubriéndola de una neblina acre de color gris. La calidad del aire en gran parte del Área de la Bahía fue la peor del mundo, durante unos días, la semana del 17 de agosto. Y la temporada de incendios apenas comienza.

El mayor riesgo para la salud: partículas diminutas, de menos de 2,5 micrones de diámetro, que constituyen el 80% del humo de los incendios forestales. Pueden penetrar en el flujo sanguíneo a través de los pulmones, dañando las vías respiratorias y el corazón. Los riesgos son mayores para los adultos mayores y los más pequeños, y para aquéllos con condiciones cardíacas y pulmonares preexistentes.

La mejor defensa contra el humo es simplemente quedarse en casa. “Si no tienes que salir, no salgas”, dijo la doctora Mary Prunicki, directora de investigación sobre contaminación del aire y salud del Centro Sean N. Parker sobre Asma y Alergias de la Universidad de Stanford. Prunicki aconseja mantener puertas y ventanas cerradas y usar un purificador de aire para filtrar las partículas de humo.

Además, hay que abstenerse de hacer ejercicios extenuantes. “Tienes permiso para quedarte en el sofá”, recomendó Anthony Wexler, director del Centro de Investigación de la Calidad del Aire de la Universidad de California-Davis.

Si tienes que salir por un período prolongado, debes cubrirte la cara, y es ahí donde la convergencia de COVID-19 y los incendios forestales plantea desafíos, aunque no insuperables.

Las cubiertas de tela relativamente sueltas y las mascarillas azules de tipo quirúrgico que muchos usamos en público para evitar la propagación del coronavirus no son particularmente útiles contra el humo, aunque pueden proporcionar cierta protección, según demuestran los estudios. Las máscaras de tela redujeron las partículas en el aire en un 57%, según un estudio. Otra investigación demostró que las máscaras quirúrgicas redujeron cuatro veces las concentraciones de partículas y las caseras tres veces.

En comparación, los respiradores con filtro N95, comúnmente conocidos como N95s, proporcionan una reducción del 95% de las partículas.

“Las N95 son geniales, si puedes conseguir una”, señaló Wexler.

Y ahí está el problema. La enorme demanda de máscaras N95 entre los trabajadores de la salud en primera línea contra COVID-19 llevó a restricciones de suministro, en primavera, que continúan este verano.

“Nos preocupa la disponibilidad de las máscaras N95”, expresó Gail Blanchard-Saiger, una de las vicepresidentes de la Asociación de Hospitales de California. Los administradores de un hospital le dijeron recientemente que no habían recibido ni un solo envío de N95 desde marzo. Otro reportó que su hospital tenía 350,000 N95s en pedido pendiente y que tenían suerte de recibir 200 al mes.

Realicé una encuesta (muy poco científica) por mi cuenta, llamando a cuatro ferreterías y cinco tiendas de suministros médicos en el sur de California, donde vivo, para preguntar si vendían N95s. Las ferreterías no las tenían y sólo dos de las tiendas de suministros médicos las vendían.

Si consigues algunas N95, ten en cuenta que funcionan correctamente sólo con un ajuste apretado contra tu piel, proporcionando un sello que minimiza las fugas. Es probable que sean demasiado grandes para los niños, y si tienes vello facial interferirá con el ajuste.

El ajuste apretado de una N95 que funciona correctamente significa que es incómodo, “así que no lo vas a usar por mucho tiempo, porque va a ser muy molesto”, advirtió Wexler.

Si sufres de una condición respiratoria como asma o enfermedad pulmonar obstructiva crónica (EPOC), consulta con tu médico antes de usar una mascarilla.

Gina Spadafori, residente de West Sacramento que ha padecido de asma toda su vida, compró una caja de N95 durante el incendio (Paradise) de finales de 2018 y le quedaba uno de los respiradores. En agosto, cuando su vecindario fue engullido por el humo de una multitud de incendios forestales en la región.

Se lo puso antes de salir a cuidar de sus cabras y pollos una mañana reciente. “Inmediatamente sentí una opresión en el pecho y algunos problemas para respirar”, contó Spadafori, de 62 años. “Así que creo que salir al granero sin él habría sido un grave error”.

Dada la importancia de la conservación de las máscaras durante la pandemia, es aceptable reutilizar las N95, apuntó el doctor Nicholas Kenyon, jefe de la división de medicina pulmonar, de cuidados críticos y del sueño de UC Davis Health. “Si no están sucias y húmedas, y todavía están intactas, puedes usarlas durante varios días, con la esperanza de llegar al fin de todo esto”.

Si no puedes conseguir los N95, no te preocupes. Tienes otras opciones. Una es un tipo de N95 alternativo, conocido como KN95, que es fácil de conseguir. Ocho de las nueve tiendas a las que llamé las tenían en stock.

Las KN95, producidos principalmente por fabricantes chinos, filtran el 95% de las partículas en el aire, como las N95. Pero cuidado: No siempre funcionan como se anuncia. La Administración de Alimentos y Medicamentos (FDA) rescindió su autorización de emergencia para algunas marcas de KN95 después de que un estudio encontrara que no cumplían con el objetivo del 95%.

El sitio web de los Centros para el Control y Prevención de Enfermedades (CDC) proporciona informes de eficiencia de filtración para un gran número de respiradores N95 y KN95.

También puedes insertar filtros PM2.5, diseñados para máscaras de tela o quirúrgicas. Se pueden comprar en línea; hay muchos y son baratos. La desventaja es que puede ser difícil conseguir un ajuste apretado, por lo que podría haber fugas.

“No son tan buenos como los de verdad, pero es mejor que nada”, apuntó Wexler.

Si quieres parecer Darth Vader, y ser más sofisticado, puedes gastar un poco más de dinero y echar un vistazo a los respiradores elastoméricos: máscaras de goma o silicona ajustadas que vienen con cartuchos de filtración y ofrecen una protección al menos equivalente a la de un N95 y, en algunos casos, mejor.

También tienen válvulas de exhalación, lo que facilita la respiración. Pero hay un problema con eso: Expulsas gotas respiratorias. Genial para lidiar con el humo, pero potencialmente riesgoso para aquellos que se encuentran en medio de una pandemia. Como el N95, su ajuste puede hacer que sea difícil de usar durante largos períodos de tiempo, especialmente en altas temperaturas.

Sea lo que sea que decidas, una cosa parece ineludible: Con una sociedad que se ha vuelto germofóbica por la pandemia y con los incendios forestales como una amenaza cada vez mayor, las máscaras se están convirtiendo rápidamente en una parte indispensable de nuestro vestuario.

“Creo que esta es la nueva normalidad del siglo XXI”, aseguró el doctor Richard Jackson, profesor emérito de la Escuela de Salud Pública Fielding de la UCLA y ex jefe del Departamento de Salud Pública de California bajo el gobierno de Arnold Schwarzenegger. “Guardas las baterías de las linternas en casa, y tienes máscaras de buena calidad”.

Esta historia de KHN se publicó primero en California Healthline, un servicio 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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HHS Awards $117 Million to Support Health Center Quality Improvement

HHS Gov News - August 25, 2020

Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced over $117 million in quality improvement awards to 1,318 health centers across all U.S. states, territories and the District of Columbia. HRSA-funded health centers will use these funds to further strengthen quality improvement activities and expand quality primary health care service delivery.

“These quality improvement awards support health centers across the country in delivering care to nearly 30 million people, providing a convenient source of quality care that has grown even more important during the COVID-19 pandemic,” said HHS Secretary Alex Azar. “These awards help ensure that all patients who visit a HRSA-funded health center continue to receive the highest quality of care, including access to COVID-19 testing and treatment.”

Health centers deliver comprehensive care to people who are low-income, uninsured or face other obstacles to getting health care. On top of the safety-net that they provide, health centers have been on the front lines preventing and responding to the COVID-19 public health emergency, including providing over 3 million COVID-19 tests. Health centers continue to provide essential services for our nation’s most vulnerable and medically underserved populations, including those who often do not have access to care, before, during and after the COVID-19 pandemic.

HRSA’s quality improvement awards recognize the highest performing health centers nationwide as well as those health centers that have made significant quality improvements from the previous year.

Health centers are recognized for achievements in various areas:

  • Improving cost-efficient care delivery;
  • Increasing quality of care;
  • Reducing health disparities;
  • Increasing both the number of patients served;
  • Increasing patients’ ability to access comprehensive services;
  • Advancing the use of health information technology; and
  • Achieving patient-centered medical home recognition.

“Nearly all HRSA-funded health centers have demonstrated improvement in their clinical quality measures reflecting HRSA’s strong commitment to providing high value health care,” said HRSA Administrator Tom Engels. “Health centers serve approximately 1 in 11 people nationally. These awards will support health centers as they continue to be a primary medical home for  communities around the country. Today, nearly 1,400 health centers operate nearly 13,000 service delivery sites nationwide.”

For a list of today’s award recipients, visit: https://bphc.hrsa.gov/programopportunities/fundingopportunities/qualityimprovement/index.html   

To locate a HRSA-funded health center, visit: https://findahealthcenter.hrsa.gov/.

Republican Convention, Day 1: A Campaign-Style Trump Speech and More

Kaiser Health News:Insurance - August 25, 2020

Before the prime-time GOP showcase began, President Donald Trump took to the podium Monday afternoon and delivered an approximately one-hour campaign-style speech to delegates after he was officially renominated by the Republican Party as its candidate for president.

His comments were wide-ranging, and our partners at PolitiFact found many to be either wrong, misleading, premature or in need of clarification. Here is the complete rundown from that speech and a wrap-up story detailing the rest of the evening. (PolitiFact also fact-checked former Vice President Joe Biden’s acceptance speech during the Democratic National Convention.)

Monday’s evening broadcast was full of platitudes. Amy Ford, a West Virginia nurse, applauded Trump’s steps during the pandemic to expand telemedicine, saying these policies are “essential” and will “continue to aid many that are unable to find transportation or a way to the doctor for regular checkups. This is especially true in rural America.” Dr. G.E. Ghali, a Louisiana oral surgeon and chancellor of a medical research center, spoke as both a clinician and a patient about how the administration’s efforts to provide emergency-use authorization for emerging treatments saved lives.

Video vignettes heralded Trump’s leadership during the coronavirus, focusing on things like Operation Warp Speed, the administration’s initiative to speed vaccine development, rather than the statistics: nearly 6 million Americans who have contracted COVID-19 or the more than 177,000 who have died. Trump also spoke with a group of first responders — including nurses, postal workers and a police officer from Colorado who said she had contracted COVID-19 in late March and has since recovered. “That means we don’t have to be afraid of you at all, right?” Trump said to her. “Once you’re recovered, we have the whole thing with plasma happening. That means your blood is very valuable, you know that, right?”

What follows are some of Trump’s statements from his afternoon speech geared to health policy issues:

Trump has repeatedly claimed that President Barack Obama left him with an empty national stockpile of emergency supplies. But this is an exaggeration.

The stockpile had a shortage of N95 masks, which were depleted as a result of the H1N1 outbreak in 2009 and not substantially replenished during the Obama or Trump administrations.

ProPublica found that the budget battles during Obama’s tenure after the Republicans won the 2010 election also hurt the stockpile’s budget.

Budget figures going back to 2009 show overall funding for the stockpile dropped to its lowest level in 2013, to about $477 million. Allocations have grown steadily since then to a 2020 budget of $705 million.

“We eliminated Obamacare’s horrible and very unfair individual mandate, which basically knocked out Obamacare. We knocked out Obamacare.”

Saying Republicans “knocked out Obamacare” is a stretch. Trump did sign legislation to eliminate the requirement that Americans have health insurance or pay a tax penalty, but eliminating this requirement did not get rid of Obamacare, or the Affordable Care Act, as it is officially known.

The administration supports a lawsuit by a group of Republican state attorneys general that argues that the ACA should be ruled unconstitutional. The lawsuit’s argument focuses on the Supreme Court’s previous ruling that the ACA was constitutional because it was based on a tax, which Congress has the authority to levy. With the tax penalty now eliminated, the lawsuit argues, the law should be scrapped entirely. The Supreme Court has agreed to hear the case.

In the meantime, much of the health law’s key provisions remain in force. In 2020, at least 11.4 million Americans have purchased insurance through the online marketplaces created under the act. More than 10 million others have signed up for Medicaid under the expanded eligibility requirements passed as part of the law. And people who have private insurance have benefited from new rules enacted by the law, from the ability to keep young adults on a parent’s policy to an end to out-of-pocket payments for certain preventive measures.

“So we protected your preexisting conditions, very strongly protected.”

We rated a similar claim as Pants on Fire. Protections for preexisting conditions under Obamacare remain on the books, but it’s not for lack of trying by the Trump administration.

For starters, the administration backs the lawsuit that would eliminate protections for preexisting conditions by getting rid of Obamacare.

In addition, the administration has not put forth any plan that might keep those guarantees in place. Every replacement health bill the administration has endorsed has offered protections less generous than those offered by the ACA.

Finally, the administration has issued a rule loosening restrictions on the length of so-called short-term health plans. While such plans could be more affordable for individuals in the market for insurance, they are not required to provide preexisting condition protections.

PolitiFact’s Louis Jacobson, Amy Sherman, Samantha Putterman and Miriam Valverde contributed to this story.

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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Wildfires Provide Another Reason to Mask Up

Kaiser Health News:States - August 25, 2020

If you have declined to wear a face mask during the COVID-19 crisis, you might want to reconsider, as the smoke from over 300 wildfires chokes people across central and Northern California.

But you are going to have to think a little more about what kind of mask is best.

The fires have spewed toxic substances far and wide, raining ash across the region and leaving an acrid brownish-gray haze. Air quality in much of the Bay Area was the worst in the world for a few days last week. And fire season is only just beginning.

The biggest health risk: tiny particles, less than 2.5 microns in diameter, that make up 80% of wildfire smoke. They can enter the bloodstream through the lungs, damaging the airways and the heart. The risks are greatest for the old and very young, and those with preexisting heart and lung conditions.

The best defense against the smoke is simply to stay inside. “If you don’t have to go out, don’t go out,” says Dr. Mary Prunicki, director of air pollution and health research at Stanford University’s Sean N. Parker Center for Asthma and Allergy Research. She advises keeping doors and windows shut and using an air purification device to filter out the smoke particles.

And refrain from strenuous exercise. “You have permission to be a couch potato,” says Anthony Wexler, director of the Air Quality Research Center at the University of California-Davis.

If you must be outside for any extended period, you should cover your face — and that’s where the convergence of COVID-19 and wildfires poses challenges, though not insurmountable ones.

The relatively loose-fitting cloth face coverings and blue surgical-style masks that many of us wear in public to prevent spreading the coronavirus are not particularly useful against smoke, though they can provide some protection, research has shown. Cloth masks reduced airborne particles by 57%, according to one study. Another study showed that surgical and homemade masks reduced particle concentrations fourfold and threefold, respectively.

That compares with a hundredfold reduction by N95 filtering facepiece respirators, commonly known as N95s. The number 95 signifies that they filter out 95% of particles.

“The N95s are great, if you can get your hands on one,” says Wexler.

And therein lies the rub. Huge demand for N95 masks among health care workers on the front lines of COVID-19 led to supply constraints in the spring that continue this summer.

“We are extremely concerned about the availability of N95 masks,” says Gail Blanchard-Saiger, vice president of labor and employment at the California Hospital Association. Administrators at one hospital recently told her they had not received a single shipment of N95s since March. Another said their hospital had 350,000 N95s on back order and were lucky to get 200 a month.

I conducted a (very unscientific) survey of my own, calling four hardware stores and five medical supply stores in Southern California, where I live, to ask if they carried N95s. None of the hardware stores and only two of the medical supply stores did.

If you do get hold of some N95s, be aware that they work properly only with a tight fit against your skin, providing a seal that minimizes leakage. They will likely be too big for children, and if you have facial hair it will interfere with the fit.

The tight fit of a properly functioning N95 means it is uncomfortable, “so you’re not going to wear it a really long time, because it’s going to be really annoying,” Wexler says.

If you have a chronic respiratory condition such as asthma or COPD, check with your doctor before wearing a mask.

Gina Spadafori, a West Sacramento resident who’s had asthma all her life, bought a box of N95s during the Camp Fire in late 2018 and had one left this month when her neighborhood was engulfed by smoke from a multitude of wildfires burning in the region.

She put it on before she went out to check on her goats and chickens one recent morning. “I still immediately got tightness in my chest and some problems breathing,” says Spadafori, 62. “So I can imagine that going out to the barn without it would have been a pretty bad mistake.”

Given the importance of conserving masks during the pandemic, it’s OK to reuse N95s, says Dr. Nicholas Kenyon, division chief of pulmonary, critical care, and sleep medicine at UC Davis Health. “If they are not soiled and wet, and they are still intact, you can use them for several days, hopefully to get through this.”

If you can’t get hold of N95s, don’t fret. You have other options. One is a kind of alternative N95, known as the KN95, which is abundantly available. Eight of the nine stores I called had them in stock.

The KN95s, produced mainly by Chinese manufacturers, are meant to filter out 95% of airborne particles, like the N95s. But beware: They do not always perform as advertised. The Food and Drug Administration rescinded its emergency authorization for some KN95 brands after a study this year found they did not meet the 95% target.

The Centers for Disease Control and Prevention website provides filtration efficiency reports on a large number of N95 and KN95 respirators.

You might also consider insertable PM2.5 filters, designed to fit inside cloth or surgical masks. You can buy them online; they are abundant and inexpensive. The downside is that it may be difficult to get a tight fit, so there could be leakage.

They are “not as good as the real thing, but way better than nothing,” says Wexler.

If you want to go Darth Vader, and a bit more upscale, check out elastomeric respirators — tight-fitting rubber or silicone masks that come with filtration cartridges and offer protection at least equivalent to an N95 and, in some cases, better.

They also have exhalation valves, which makes it easier to breathe. But here’s the problem with that: You expel respiratory droplets. Great for coping with smoke, but potentially risky for those you encounter in the midst of a pandemic. Like the N95s, their tight fit can make them hard to wear for long periods of time — especially in high heat.

Whatever you decide, one thing seems inescapable: With a society rendered germophobic by the pandemic and with wildfires an ever-increasing threat, masks are fast becoming an indispensable part of our wardrobe.

“I think this is the new normal for the 21st century,” says Dr. Richard Jackson, a professor emeritus at UCLA’s Fielding School of Public Health and former head of California’s Department of Public Health under Gov. Arnold Schwarzenegger. “You keep flashlight batteries in your house, and you keep good quality masks.”

This KHN story first published on California Healthline, a service of the 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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Veteran’s Appendectomy Launches Excruciating Months-Long Battle Over Bill

Kaiser Health News:States - August 25, 2020

In late August 2019, Shannon Harness awoke to serious pain in the lower right side of his abdomen — a telltale sign of appendicitis.

He booked it to the emergency room of the only hospital in the county: Heart of the Rockies Regional Medical Center in Salida, Colorado. After a CT scan, doctors told Harness he had acute appendicitis and required immediate surgery.

A surgeon performed an appendectomy that night and released Harness the next day.

But a couple of days later, Harness felt sharp pains where his appendix had been. The pain grew until he was on the floor screaming.

“It was disturbing,” said Eliza Novick-Smith, his partner. “He has a pretty high pain tolerance,” given previous injuries from military service and mountain biking.

Harness went back to the hospital, where another CT scan revealed a blood clot the size of a brick floating in his pelvic area, a rare complication that most likely came from clipping and stapling the appendix tissue in the first surgery, said his surgeon. He would need another operation to check for the source of bleeding and to remove the clot.

After four more days in the hospital, he went home. It took him a couple of months to fully recover.

Then the bill came.

Patient: Shannon Harness, 39, an operations manager for a company that builds mountain bike trails across the country and a Marine Corps veteran. At the time of this incident, Harness had no insurance.

Total Owed: The original hospital bill was $80,232 for both surgeries — the first surgery cost $35,906 and the clot surgery cost $44,326. These amounts do not include payments to the surgeon, anesthesiologist, pathologist or radiologist.

Service Provider: Heart of the Rockies Regional Medical Center, a nonprofit critical access hospital in Colorado, where the surgeries were performed. Anesthesia, radiology and pathology were performed by other providers.

Medical Services: Laparoscopic appendectomy, followed by a second surgery a few days later, to resolve complications.

What Gives: Uninsured patients are extremely vulnerable to exorbitant hospital bills. It’s difficult to negotiate with a hospital without the leverage and bargaining power of an insurance company. Worse, uninsured patients are often billed three or four times what an insurer or government program would pay for the same service, said Anthony Wright, executive director of Health Access California, an organization advocating for affordable health care in California.

“As somebody who’s uninsured, you are getting an unnegotiated rate,” Wright said, derived from the hospital’s master price list. Insurers typically pay a rate that is a tiny fraction of that cost.

Harness was uninsured for seven years before this incident. His employer didn’t offer insurance, and the Affordable Care Act plan he qualified for cost $350 a month — an amount he didn’t have.

One option for uninsured patients is a hospital’s financial assistance program, a requirement in some states. In Colorado, every hospital is supposed to have a comprehensive charity care program for uninsured patients who earn less than 250% of the federal poverty level.

Heart of the Rockies hospital determines financial assistance on a sliding scale of family size and income. They also offer a self-pay discount of 15% to uninsured patients. Harness said the hospital’s financial services office initially told him he was ineligible for their assistance program as well as the Colorado Indigent Care Program. Harness had worked overtime the previous month and missed the qualification by around $200. The hospital would use only his past two pay stubs to verify his income, he said.

The hospital wouldn’t answer any questions about Harness’ care or bills, even though he gave it permission to do so.

Another quirk of the U.S. health care system that Harness encountered is that when surgeries don’t go as planned, and need revision with another operation, the patient (or his insurer) typically pays again. Medicare and some insurers have experimented with “bundled payments,” through which the hospital gets a set fee for the surgery and any follow-up care for 90 days thereafter.

Resolution: Harness filed a grievance with the hospital with the help of Novick-Smith, who is a lawyer, to push back on the bills for the two surgeries — $35,906 for the first and $44,326 more for the second —and express concerns with the quality of care.

Healthcare Bluebook, which estimates costs based on insurers’ claims data, says a fair price for an appendectomy in Salida is around $12,600. Dr. Gina Adrales, director of minimally invasive surgery at Johns Hopkins Medicine in Baltimore, said the complication Harness experienced is not common. The complication rate for an appendectomy is fairly low, she said.

In November, the hospital decided to give Harness a 30% discount for both surgeries, leaving him with a still hefty bill of $56,162.40.

The couple followed up repeatedly with the hospital for months, often finding representatives “hard to reach.” More than six months later, in March, the hospital told Harness he would have to pay for the second surgery because it was a risk he accepted by agreeing to the appendectomy.

Adam Fox, director of strategic engagement at Colorado Consumer Health Initiative, said it’s “especially important” to push back on bills resulting from surgical complications. “It usually indicates that something didn’t go right in the first surgery and at least that second surgery should be provided at a substantially reduced cost to the individual,” he said.

By May, the hospital gave in. Lesley Fagerberg, Heart of the Rockies’ vice president of financial services, wrote a response to Harness’ grievance, reducing the total bill by roughly the amount charged for the second surgery. But she didn’t explain how the hospital had come to that decision.

“Unfortunately, there was a complication in your appendectomy surgery,” Fagerberg wrote. “As explained in the consent to treat, a surgery/procedure has inherent risk. Your case has been reviewed and the total bill has been reduced by $31,218.60.”

Harness’ final bill from the hospital, Fagerberg wrote, stands at $22,304.17 after adjustments that included a self-pay discount.

Harness and Novick-Smith said that still seemed too high to them, and after some research, offered to pay the hospital $12,000 upfront. The hospital rejected this offer.

Now, Harness is working out a payment plan with the hospital. The hospital offers an interest-free payment plan if he can pay it off in two years, but for Harness, those monthly payments would be more than his rent.

“I would not be able to do it by myself, like, I wouldn’t have another choice other than taking out a loan,” Harness said. “Before the appendectomy, I was looking for property and homes to purchase, and that is pretty much completely off the table right now.”

Novick-Smith said she’s glad the hospital ultimately wrote off the bill for the second surgery. But she still feels angry with the hospital.

“What feels particularly hard is that the hospital markets itself in our community as this vital community resource and they provide a lot of jobs,” she said. “Their lack of transparency and lack of communication with us made this all a whole lot worse especially because there’s nowhere else to go.”

The Takeaway: The United States health care system is not forgiving to the uninsured, who, paradoxically, often face the highest bills of all patients. The benefit of having insurance is in part that your plan pays much of the bill, but also that you get the benefit of being charged the plan’s highly discounted rates. If your employer doesn’t provide health insurance, check whether you’re eligible for a public program, said Wright.

Harness now has VA Health Care. He initially avoided looking into VA Health Care because he felt “other vets needed it more.”

If you’re uninsured and stuck with a huge bill, Fox said, the first step is to ask for an itemized bill to ensure it reflects the actual service you received. The next step is to check the hospital’s charity care policy. Another resource uninsured patients can turn to are organizations like the Colorado Consumer Health Initiative.

“It’s by no means a perfect solution because there’s only so much that we can do to help consumers advocate for themselves in these cases, but we do our best,” Fox said.

If all else fails, Wright said, it’s best to put pressure on the hospital before they sell the bill to a collections agency. There’s less room for negotiation once a bill goes to collections, Wright said. And if all else really fails, you could try calling the press.

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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Is Cuomo Directive to Blame for Nursing Home COVID Deaths, as US Official Claims?

Kaiser Health News:States - August 24, 2020

On the first night of the Democratic National Convention, New York Gov. Andrew Cuomo was among the first in a weeklong parade of speakers to issue scathing critiques of the Trump administration’s coronavirus response.

Cuomo’s criticisms drew a quick reply in a tweet from Michael Caputo, an assistant secretary for public affairs at the Department of Health and Human Services.

“Does the #DemConvention know @NYGovCuomo forced nursing homes across NY to take in COVID positive patients and planted the seeds of infection that killed thousands of grandmothers and grandfathers?” he wrote.

It was an easy jab: Cuomo has been dogged by criticism for months over his March advisory directing nursing homes in the state to accept patients who had or were suspected of having COVID-19. As long as they were medically stable, the notice said, it was appropriate to move patients in. Further, nursing homes were prohibited from requiring that medically stable prospective residents be tested for the virus before they arrived.

Between March 25 and May 8, approximately 6,326 COVID-positive patients were admitted to nursing homes, according to a state health department report.

While experts say this policy was flawed, is it fair to say that the governor’s directive “forced” nursing homes to take patients who were sick with COVID-19? And to what extent did that strategy sow the seeds of disease and death? When we examined the evidence, we found it was less clear-cut than the statement makes it seem. The policy likely had an effect, but epidemiologists identified additional factors that fed the problem. What’s more, the policy did not “force” nursing homes to accept COVID-positive patients. Nursing homes interpreted it this way.

We checked with HHS to find the basis for Caputo’s comment but got no response.

The Back Story

As the virus tore through nursing homes, killing dozens at some of them, Cuomo came under withering censure. His administration’s policy, implemented with an eye toward freeing up hospital beds for an onslaught of COVID patients, seemed to disregard the risks to frail and elderly nursing home residents who were especially vulnerable to the disease.

According to the COVID Tracking Project, 6,624 people have died of COVID-19 in nursing homes and other long-term care facilities in New York, accounting for 26% of the state’s 25,275 COVID deaths. Some say the true number of deaths is much higher because, unlike many states, New York does not count the deaths of former nursing home residents who are transferred to hospitals and die there as nursing home deaths.

Cuomo’s explanation for the policy — that he was simply following guidance from the federal Centers for Disease Control and Prevention — didn’t cut it. A recent PolitiFact piece examining his claim rated it “Mostly False.”

In May, the governor amended the March order, prohibiting hospitals from discharging patients to nursing homes unless they tested negative for COVID-19.

A Misguided Approach

In the early days of the COVID-19 pandemic, when New York was the epicenter and more than a thousand people were being hospitalized daily, there was a genuine fear that hospitals would not be able to accommodate the influx of desperately ill patients.

Moving people out of the hospitals and into nursing homes was one strategy to help hospitals meet these needs.

According to the CDC guidance cited in the earlier PolitiFact story, there were two factors to consider when deciding whether to discharge a patient with COVID-19 to a long-term care facility: whether the patient was medically ready, and whether the facility could implement the recommended infection-control procedures to safely care for a patient recovering from the virus.

A document from the federal Centers for Medicare & Medicaid Services said nursing homes should accept only patients they were able to care for.

Long-standing state guidance is based on the same condition.

Still, nursing homes didn’t believe turning away patients with COVID-19 was an option.

“On its face, it looked like a requirement,” said Christopher Laxton, executive director of the Society for Post-Acute and Long-Term Care Medicine, which represents medical professionals in nursing homes and other long-term care facilities. “The nursing homes we spoke to felt it was a mandate, and a number of them felt they had no choice but to take COVID patients.”

While the overarching guidance not to take patients in unless they could be safely cared for may have been clear, nursing homes’ experience was often different, said.

Richard Mollot, executive director of the Long-Term Care Community Coalition, an advocacy group for elderly and disabled people. “There was little reason for nursing homes to think they should only take in patients if they have the ability to do so safely because those rules are not generally enforced on a regular basis.”

Bottom line: State and federal rules didn’t force nursing homes to accept COVID-positive patients, but many of them believed they had no other choice.

A Lethal Result?

How much of the blame for the deaths of thousands of people in nursing homes from COVID-19 can be attributed to Cuomo’s March advisory?

That is the 6,000-person question.

In a July analysis of COVID-19 nursing home deaths, the state concluded that the deadly virus was introduced by nursing home staff members rather than sick patients.

It noted that peak nursing home resident mortality from COVID-19 on April 8 preceded the peak influx of COVID patients on April 14. In addition, it found that nearly 1 in 4 nursing home workers — 37,500 people — were infected with the virus between March and early June.

Based on these and other factors, the report concluded that the state admissions policy could not have been a driver of nursing home infections or fatalities.

Epidemiologists and nursing home advocates beg to differ.

“To say that introducing patients [to nursing homes] who had COVID did not cause problems is ridiculous,” said Laxton.

Calling the study’s approach “pretty flawed,” Denis Nash, an epidemiologist at City University of New York School of Public Health, said he didn’t agree with the report’s conclusion that the policy had nothing to do with deaths.

Others had the same view. “I didn’t think they showed data to say [the policy] is not a ‘driver,’” said Rupak Shivakoti, an assistant professor of epidemiology at the Mailman School of Public Health at Columbia University.

But Gary Holmes, assistant commissioner at the New York State Department of Health, had a different take. Critics of the report, he said, must be deliberately ignoring the rising death tolls in nursing homes in hot spots across the country.

“Public health officials in those states are experiencing (and acknowledging) what NY’s report indicated weeks ago: these facilities are microcosms of the community and transmission is occurring unknowingly by asymptomatic spread among staff members,” Holmes said, in an email.

While public health experts quibbled with the report’s self-serving claim that the governor’s policy wasn’t a factor in COVID-19 nursing home deaths, they nevertheless agreed with the report’s broader conclusion that nursing home staffers as well as visitors, before they were banned, were likely the main drivers of COVID-19 infection and death in nursing homes.

“Based on the timeline of the policy and deaths in the city, it is very unlikely that policy contributed to thousands of deaths,” said Shivakoti.

Infection control is a long-standing problem at nursing homes, Nash said, and the COVID deaths were a basic failure of infection control. That said, “it’s unclear how many of the deaths the policy might have caused.”

Also unclear: how many of the dead were grandmothers and grandfathers.

Our Ruling

In a tweet, the HHS assistant secretary for public affairs said that New York Gov. Andrew Cuomo “forced” nursing homes across the state to admit COVID-positive patients and that this policy fueled the spread of COVID-19 that led to thousands of deaths in the nursing home population.

Although nursing homes felt pressure to accept COVID-positive patients, they were not actually forced to do so. State regulations require nursing homes to accept patients only if they can care for them, and they could have refused them on those grounds.

In addition, it’s unclear the extent to which the governor’s policy was responsible for nursing home COVID-19 deaths. Infection control is a long-standing problem in nursing homes, predating the pandemic, and a report showed peak numbers of nursing home deaths came prior to the peak influx of patients as a result of Cuomo’s advisory. While the introduction of COVID-19 positive patients into nursing homes no doubt had an effect on infection spread, Caputo’s statement suggests it was solely responsible. That’s not what the evidence shows.

We rate this Mostly False.

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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Cómo Florida drenó su sistema de salud pública y le abrió la puerta a COVID

Kaiser Health News:States - August 24, 2020

Jacksonville, Florida. – En una sofocante mañana de julio, Rose Wilson luchaba por respirar mientras estaba sentada en su cama, con un tubo de oxígeno en su nariz, la luz de su computadora iluminando su rostro.

Wilson, de 81 años, jubilada que trabajó como supervisora de enfermería del departamento de salud pública en el condado de Duval durante 35 años, acababa de ser diagnosticada con neumonía inducida por COVID-19.

Era su cita de telemedicina y al otro lado de la pantalla estaba el doctor Rogers Cain, quien dirige una pequeña clínica familiar en el norte de Jacksonville, un área predominantemente de raza negra donde el coronavirus está impactando fuerte. Cain ya había atendido virtualmente a siete pacientes con COVID durante la mañana.

Cain y Wilson están nerviosos. Durante años, ambos fueron testigos de como el departamento de salud del condado se quedaba sin dinero y personal, lo que fue dificultando la capacidad de Duval para responder a brotes.

Y ahora enfrentan a COVID-19 en uno de los estados que lidera el alza de casos en los Estados Unidos.

Florida es tanto un microcosmos como una advertencia para el país. A medida que la nación empezó a drenar su sistema de salud pública, la dotación de personal y los fondos cayeron más rápidamente en este estado, dejándolo especialmente desprotegido para la peor crisis de salud en un siglo.

Aunque la población de Florida creció en 2,4 millones desde 2010, el estado redujo drásticamente la dotación de personal de sus departamentos de salud locales, de 12,422 trabajadores de tiempo completo a 9,125 en 2019, según observó una investigación conjunta de KHN y The Associated Press.

Los departamentos de salud locales, administrados por el estado, gastaron un 41% menos por residente en 2019 comparado con 2010, según un análisis de datos estatales, cayendo de $57 a $34. Los departamentos de todo el país también han recortado gasto, pero menos de la mitad, según datos de la Asociación Nacional de Funcionarios de Salud del Condado y la Ciudad.

Incluso antes que iniciara la pandemia, ya había menos investigadores disponibles para rastrear y contener enfermedades como la hepatitis. Cuando la ola de COVID-19 inundó Florida, sus principales líneas de defensa ya habían sido diezmadas.

Ahora, los casos confirmados han superado los 588.000 y las muertes superaron las 10.000. La preocupación por el virus hizo que los republicanos cancelaran los planes para la convención nacional en persona en Jacksonville, esta semana.

Expertos en salud culpan por los recortes de fondos a la Gran Recesión y a una serie de gobernadores que quisieron transferir los servicios estatales financiados con fondos públicos a empresas con fines de lucro.

Y, dicen que, cuando la pandemia recrudeció, el gobernador republicano Ron DeSantis y otros líderes políticos enviaron mensajes contradictorios sobre estrategias de prevención como el uso de máscaras. Las voces dentro de los departamentos de salud estaban amordazadas.

“Lamentablemente, la realidad es que la gente va a morir por la irresponsabilidad de las decisiones que toman las personas que elaboran los presupuestos”, dijo Ron Bialek, presidente de la Public Health Foundation, una organización sin fines de lucro en Washington, DC, que ofrece recursos y formación para mejorar la salud pública.

Los funcionarios estatales no respondieron a preguntas específicas de The Associated Press y KHN sobre cambios en la financiación de la salud pública, ni pusieron a disposición personal para explicaciones más profundas.

El doctor Leslie Beitsch, ex subsecretario del departamento de salud del estado de Florida, dijo que no prepararse para un desastre previsible “es negligencia gubernamental”.

Dado que el virus no respeta fronteras, otros estados sienten los efectos de las fallas de Florida.

A pesar de un movimiento hacia la privatización en la década de 1990, el gasto por persona en salud pública local fue aumentando, alcanzando un máximo de $59 cifra ajustada por la inflación al dólar de 2019.

Beitsch dijo que la tendencia a disminuir continuó bajo los ex gobernadores republicanos Charlie Crist y Rick Scott, impulsada por una creciente creencia en la contracción del gobierno. Scott, ahora senador nacional, dijo a través de un vocero que no se disculpaba por los recortes del departamento de salud, a los que caracterizó como acciones para “que el gobierno fuera más eficiente”.

La capacidad de manejar los brotes de enfermedades se ha visto obstaculizada en algunas comunidades de Florida más que en otras debido a esta reducción.

Los departamentos que atienden al menos a medio millón de residentes gastaron solo $29 en salud pública por persona en promedio en 2019, en comparación con $90 por persona en aquellos que atienden a 50,000 o menos, una diferencia más marcada que la brecha típica entre departamentos más grandes y más pequeños a nivel nacional, según el análisis de KHN-AP.

El gasto del departamento de salud del condado de Duval fue el equivalente a $34 por persona, un 63% menos que en 2008. Por lo general, alrededor de 22 trabajadores, o el 5% del personal total, se han dedicado a prepararse y rastrear brotes de enfermedades.

“Los acontecimientos actuales demuestran qué malas fueron las decisiones de realizar profundos recortes a la salud pública”, dijo la doctora Marissa Levine, profesora de salud pública y medicina familiar en la Universidad del Sur de Florida. “Realmente han regresado para vengarse”.

Florida tiene ahora más de medio millón de casos de COVID y 35,000 hospitalizaciones. Aunque DeSantis todavía no ha emitido un mandato de usar máscaras faciales, algunos gobiernos locales, como el de Jacksonville, sí lo han hecho.

Chad Neilsen, director de prevención de infecciones en la Universidad de Florida-Jacksonville, elogió al alcalde de la ciudad por el requisito de usar cubrebocas, pero señaló que otros condados tienen reglas diferentes y que el mensaje inconsistente genera confusión.

“Tenemos que tener una sola voz y un liderazgo constante si queremos que la gente cambie su comportamiento”, dijo el doctor Jonathan Kantor, epidemiólogo y dermatólogo de Jacksonville.

En cambio, expertos en Florida dijeron que los trabajadores de salud pública han sido silenciados o los altos funcionarios estatales les han indicado qué decir. A los funcionarios de salud locales “se les dice sin rodeos: ‘Cállate'”, dijo Patrick Bernet, profesor asociado de administración de salud en la Florida Atlantic University. “Literalmente, no pueden hablar”.

Beitsch, quien ahora preside el departamento de ciencias del comportamiento y medicina social en la Universidad Estatal de Florida, dijo que esto, y una dinámica similar a nivel nacional, alimenta la politización de la salud pública y el debilitamiento de la ciencia.

Mientras tanto, el número de casos de COVID aumenta.

Con un sistema de salud pública que no está equipado, Wilson, la enfermera de salud pública jubilada, dijo que es responsabilidad de todos sacar a Jacksonville, y a Florida, de la crisis.

“Mi esperanza es que todos comiencen a tomarse este virus en serio, usen su máscara y mantengan el distanciamiento social”, dijo Wilson, cuya condición ha mejorado. “Eventualmente habrá una vacuna. Pero hasta entonces, depende de nosotros ayudar. Y si no lo tomamos en serio, estamos condenados”.

Dearen es reportero de The Associated Press, y Ungar y Recht son reporteras de KHN.

Esta historia es una colaboración entre The Associated Press y KHN, un servicio de noticias sin fines de lucro que cubre temas de salud. Es un programa editorialmente independiente de la Kaiser Family Foundation que no está afiliado a 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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Trump Administration Adds Health Plans to June 2020 Plasma Donation Guidance

HHS Gov News - August 24, 2020

Today, under the leadership of President Trump, the Office for Civil Rights (OCR) at the U.S Department of Health and Human Services (HHS) issued amended guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule permits covered health care providers (e.g., hospitals, pharmacies, laboratories) and health plans to contact their patients and beneficiaries who have recovered from COVID-19 to inform them about how they can donate their plasma containing antibodies (known as "convalescent plasma") to help treat others with COVID-19.

OCR added health plans to the June 2020 guidance that explains how HIPAA permits covered health care providers and health plans to identify and contact patients and beneficiaries who have recovered from COVID-19 for individual and population-based case management or care coordination. The guidance also emphasizes that, without individuals' authorization, the providers and health plans cannot receive any payment from, or on behalf of, a plasma donation center in exchange for such communications with recovered individuals.

This announcement builds upon President Trump's call to action and existing partnership with commercial labs, insurers, providers, and pharmacies to send communications to individuals who have recovered from COVID-19 encouraging them to donate their convalescent plasma. This guidance to health care providers and health plans also complements the Food and Drug Administration's (FDA) recent issuance of an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in some hospitalized patients. The FDA has concluded this product may be effective in treating COVID-19.

"In response to the President's call for Americans who have recovered from COVID-19 to donate their plasma, OCR clarified how HIPAA permits health plans to contact their beneficiaries about plasma donation opportunities," said Roger Severino, OCR Director. "We will continue to use every tool at our disposal to beat this virus and keep Americans healthy," he added.

The amended guidance may be found at: https://www.hhs.govhttps://www.hhs.gov/sites/default/files/guidance-on-hipaa-and-contacting-former-covid-19-patients-about-blood-and-plasma-donation.pdf.

For more information related to HIPAA and COVID-19, please visit: https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-covid19/index.html.

‘An Arm and a Leg’: How to Fight Bogus Medical Bills Like a Bulldog

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After Izzy Benasso had knee surgery, she and her dad received a letter from a surgical assistant giving notice that he “had been present” at the procedure.

The surgical assistant was out-of-network and seemed to be laying the groundwork to get the Benassos to pay his fee.

Steve Benasso wrote a letter right back, basically telling the guy to buzz off: He had no intention of paying the surgical assistant. Because the bill was a surprise, Benasso suggested that the surgical assistant try to get the money from the insurance company, or negotiate for some part of the knee surgeon’s payment.

Benasso first shared his story with KHN and NPR for the Bill of the Month series.

There are two explanations for Benasso’s chutzpah.

One: “Steve is the kind of person to check every receipt twice and argue over any discrepancies he finds,” his daughter said.

Two: He had lots of experience haggling over medical bills in particular. As a human resources director, he specializes in defending his colleagues against bogus bills and unfair insurance denials.

“I am a bulldog on this stuff,” he said. “I do it every month.”

In this episode, learn how Steve became such a bulldog, and the tips he has for the rest of us.

“An Arm and a Leg” is a co-production of KHN and Public Road Productions.

To keep in touch with “An Arm and a Leg,” subscribe to the newsletter. You can also follow the show on Facebook and Twitter. And if you’ve got stories to tell about the health care system, the producers would love to hear from you.

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And subscribe to “An Arm and a Leg” on iTunesPocket CastsGoogle Play or Spotify.

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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Florida’s Cautionary Tale: How Gutting and Muzzling Public Health Fueled COVID Fire

Kaiser Health News:States - August 24, 2020

JACKSONVILLE, Fla. — On a sweltering July morning, Rose Wilson struggled to breathe as she sat in her bed, the light from her computer illuminating her face and the oxygen tubes in her nose.

Wilson, a retiree who worked as a public health department nurse supervisor in Duval County for 35 years, had just been diagnosed with COVID-19-induced pneumonia. She had a telemedicine appointment with her doctor.

Staring back from her screen was Dr. Rogers Cain, who runs a tidy little family medical clinic a couple of blocks from the Trout River in north Jacksonville, a predominantly Black area where the coronavirus is running roughshod. Wilson, 81, was one of Cain’s patients who’d tested positive — he had seven other COVID patients that morning before noon. Three of her grown children had contracted the virus, too.

“It started as a drip, drip, drip in May,” said Cain, his voice muffled by his mask. “Now it’s more like a faucet running.”

Cain and Wilson are nervous. Over the past two decades, both watched as the county health department was gutted of money and people, hampering Duval’s ability to respond to outbreaks, including a small cluster of tuberculosis cases in 2012. And now they face the menace of COVID-19 in a city once slated to host this week’s Republican National Convention, in one of the states leading the latest U.S. surge.

Florida is both a microcosm and a cautionary tale for America. As the nation starved the public health system intended to protect communities against disease, staffing and funding fell faster and further in the Sunshine State, leaving it especially unprepared for the worst health crisis in a century.

Although Florida’s population grew by 2.4 million since 2010 to make it the nation’s third-most-populous state, a joint investigation by KHN and The Associated Press has found, the state slashed its local health departments’ staffing — from 12,422 full-time equivalent workers to 9,125 in 2019, the latest data available.

According to an analysis of state data, the state-run local health departments spent 41% less per resident in 2019 than in 2010, dropping from $57 to $34 after adjusting for inflation. Departments nationwide have also cut spending, but by less than half as much ― an average of 18%, according to data from the National Association of County and City Health Officials.

Even before the pandemic hit, that meant fewer investigators to track, trace and contain diseases such as hepatitis. It meant fewer public health nurses to teach people how to protect themselves from HIV/AIDS or the flu. When the wave of COVID-19 inundated Florida, the state was caught flat-footed when it mattered most, its main lines of defense eviscerated.

Now, confirmed cases have soared past 588,000 and deaths have risen to more than 10,000. Concerns over the virus prompted Republicans to cancel plans for an in-person convention in Jacksonville, opting for a pared-down version in North Carolina.

Health experts blame the funding cuts on the Great Recession and choices by a series of governors who wanted to move publicly funded state services to for-profit companies.

And when the pandemic took hold, they say, residents got mixed messages about prevention strategies like wearing masks from Republican Gov. Ron DeSantis and other political leaders. Voices within the health departments were muzzled.

“The reality, unfortunately, is people are going to die because of the irresponsibility of the decisions being made by the people crafting the budgets,” said Ron Bialek, president of the Public Health Foundation, a nonprofit in Washington, D.C., offering tools and training. “Public health can’t help us get out of this situation without our elected officials giving us the resources.”

State officials neither answered specific, repeated questions from KHN and The Associated Press about changes in public health funding, nor made staffers available for deeper explanations.

Dr. Leslie Beitsch, a former deputy secretary of Florida’s state health department, said failing to prepare for a foreseeable disaster “is governmental malpractice.” The nation’s pandemic response is only as good as the weakest link, he said. Since the virus respects no borders, other states feel the ripples of Florida’s failings.

Those failings are clear in Duval County, which had employed the equivalent of 852 full-time workers and spent $91 per person in 2008 but in 2019 had only 422 workers and spent just $34 per resident, according to the KHN-AP analysis of state data. That’s less than the typical list price of a single COVID test. Former county health director Dr. Jeff Goldhagen said the county’s team has been “dismantled to the extent that it could not really manage an outbreak.”

Yet it must.

Cain’s private north Jacksonville medical clinic alone has had about 60 confirmed COVID cases and eight deaths. “We are all on fire right now,” he said. “You have to have a fire department that is adequately equipped to put out the fire. ”

Dwindling Budgets

Florida faced similar shortcomings around the time of the last great pandemic, the 1918 flu. Back then, according to a 1924 state report, public health workers faced too many demands and their efforts were “to some extent scattered and transitory.” The state could have used at least three more district health officers, the report said: “It is a source of regret and a matter of grave concern to public health workers that the funds available are not sufficient.”

County-based health departments began in 1930, providing more robust services closer to home. About 50 years later, legislation created state-administered primary care programs in which county health departments provided low-income Floridians with the type of basic health care and treatment most people now get at private doctors’ offices.

The 1990s saw a move toward privatization, particularly as Medicaid managed care took hold, said a 2004 paper in the Florida Public Health Review. Still, per-person spending on local public health rose until the late 1990s, when adjusted for inflation to 2019 dollars, peaking at $59.

Wilson, the retired public health nurse stricken with COVID-19, recalled how Duval County’s department started feeling the financial pain during former Republican Gov. Jeb Bush’s administration in the early 2000s and kept losing nurses and other staff until they were “very, very short.”

Beitsch, who worked for the state health department in the 1990s, said the downward trend continued under former Republican governors Charlie Crist and Rick Scott, fueled by a growing belief in shrinking government that flourished in many states. Florida’s leaders exerted more control over public health, Beitsch said, and “the amount of local autonomy has been diminishing with successive administrations.”

The recession that began in late 2007 sparked public health reductions across the nation that were especially harsh in Florida. By 2011, budget cuts and lack of money were the most frequently cited challenges in a Florida public health workforce survey, which pointed to growing needs. In the following years, the state had some of the nation’s highest rates of heart disease and diabetes.

Squeezed departments struggled and sometimes stumbled. A report from the state health department’s inspector general for the 2018-19 fiscal year, for example, found a series of lost and inconsistent shipments of lab specimens from county health departments to the state lab — not long before the pandemic would make labs more important than ever.

As governor, Scott presided over the state from 2011 to 2019, when funding and staffing dropped most. Now a U.S. senator, he said through a spokesperson that he was unapologetic for health department cuts, which he characterized as a move toward “making government more efficient” without endangering public health.

“I’m sure that he had no problem with the cuts that were being made,” said Patrick Bernet, an associate professor in health administration at Florida Atlantic University. “To put it all on him is not fair because a bunch of little henchmen from the counties had to vote that way. … We keep voting in people who undervalue public health.”

Democratic state Sen. Janet Cruz, a legislator who has represented the Tampa region for a dozen years and sat on health care committees, said she watched lawmakers systematically cut money for health departments. When she questioned it, she said, some colleagues claimed the need wasn’t as great because the state was moving toward private family health care centers. “Public health in Florida has been wholly underfunded,” she said.

Some places have suffered more than others. Departments serving at least half a million residents spent $29 per person in 2019 on average, compared with $90 per person in departments serving 50,000 or fewer — a difference starker than the typical gap between larger and smaller departments nationally, according to an KHN-AP analysis. Experts can’t say exactly why the gap is wider in Florida, which has a state-run system, but point to politics and historical decisions about budgets.

Duval County’s health department spending was the equivalent of $34 per person, down 63% since 2008. Typically, about 22 workers, or 5% of the total staff, have been dedicated to preparing for and tracking disease outbreaks.

But when the pandemic hit, many there and elsewhere were diverted to fight the coronavirus, leaving little time for their typical duties such as mosquito abatement and tracking sexually transmitted infections such as syphilis.

“Current events demonstrate how bad a decision” the deep cuts to public health were, said Dr. Marissa Levine, a professor of public health and family medicine at the University of South Florida. “It’s really come back to haunt us.”

Mixed and Muzzled Messages

The pandemic caught fire in Florida this summer as the state’s rapid reopening allowed people to flock to beaches, Disney World, movie theaters and bars.

The state has had more than half a million confirmed cases ― among them, players and workers for baseball’s Miami Marlins ― and 35,000 hospitalizations, yet DeSantis still hasn’t issued a mask mandate. Some local governments have. Jacksonville adopted one in late June, and about a week later Republican Mayor Lenny Curry announced he and his family were self-quarantining because he’d been exposed to someone who tested positive for the virus.

Chad Neilsen, director of infection prevention at the University of Florida-Jacksonville, lauded the mayor for the mask requirement, saying, “We know that masking works.” But he pointed out that other counties have different rules and that the inconsistent messaging breeds confusion.

St. Johns County began requiring masks in late July but only in county facilities. And DeSantis has appeared in public without a mask numerous times, including at an Aug. 13 coronavirus update briefing during which some other speakers wore them.

“One voice is so critical during a pandemic,” said Dr. Jonathan Kantor, a Jacksonville epidemiologist and dermatologist. “We have to have one voice, and consistent leadership that is modeling behavior if we want to get people to change their behaviors.”

Instead, experts in Florida said, public health workers have been silenced or told by top state officials what to say. For example, The Palm Beach Post reported that state leaders told school boards they needed health department approval to keep schools closed, then instructed health directors not to give it.

“All the communication is directed by the state, and localities are very limited in what they can do,” said Levine, the University of South Florida professor. “Anything to do with a mandate, there’s resistance to do at a state level. This includes the hot debate on masks. The locals have to extend the state messaging.” Local health officials “are being told bluntly: ‘Shut up,’” Bernet said. “They literally cannot speak.”

Beitsch, who now chairs the department of behavioral sciences and social medicine at Florida State University, said such limitations ― and similar mixed messages and silencing of medical experts at the national level ― fuels the politicization of public health and undermining of science.

“People think they should be listening to politicians and state legislative leaders about their health care. They’re not listening to health experts and the epidemiologists who say if you just wear a mask and if you just wash your hands, we can really, really reduce the spread of the virus,” said Cruz, the state senator. “People are confused, and they think this is a hoax and it’s nothing more than the flu.”

Meanwhile, the COVID caseload continues to rise, surpassing 25,000 in Duval County, with minorities stricken disproportionately, as elsewhere in the nation. In a county that’s 29% Black and 60% white, Black residents with COVID have been hospitalized at more than double the rate of white residents. Rates are also high for Floridians grouped together as “other,” including Native American, Asian and multiracial residents.

Duval County’s overall caseload is rising so fast that Goldhagen, the former health department director, said the agency has given up on contact tracing, which means trying to curb the virus by identifying and warning people who have been exposed.

“It’s impossible,” Goldhagen said. “Dismantling the system was a complete disregard for the health and well-being of the citizens of Florida.”

With an unequipped public health system, Wilson, the retired public health nurse, said it falls to everyone to lead Jacksonville, and Florida, out of the coronavirus crisis.

“My hope is that everybody begins to take this virus seriously, and wear their mask and stay social distancing. It can work if we do that,” said Wilson, whose condition has improved. “So, that’s my hope. Eventually there will be a vaccine that will curtail this virus. But until then, it’s up to us to help do that. And if we’re not serious about it, then we’re doomed.”

This story is a collaboration between KHN and The Associated Press.

Methodology

Spending and staffing data for Florida’s local health departments is from the Florida Department of Health. Florida Atlantic University professor Patrick Bernet provided additional state data on staffing by program area. KHN-AP adjusted spending data for inflation using the Bureau of Economic Analysis’ state and local government deflator.

COVID-19 data by race is from the Florida Department of Health. KHN-AP calculated rates per 10,000 people using data on race, regardless of ethnicity, from the U.S. Census Bureau’s 2018 American Community Survey. Statewide COVID-19 cases per day are from Johns Hopkins University.

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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Inside the Race to Build a Better $500 Emergency Ventilator

As the coronavirus crisis lit up this spring, headlines about how the U.S. could innovate its way out of a pending ventilator shortage landed almost as hard and fast as the pandemic itself.

The New Yorker featured “The MacGyvers Taking on the Ventilator Shortage,” an effort initiated not by a doctor or engineer but a blockchain activist. The University of Minnesota created a cheap ventilator called the Coventor; MIT had the MIT Emergency Ventilator; Rice University, the ApolloBVM. NASA created the VITAL, and a fitness monitor company got in the game with Fitbit Flow. The price tags varied from $150 for the Coventor to $10,000 for the Fitbit Flow — all significantly less than premium commercially available hospital ventilators, which can run $50,000 apiece.

Around the same time, C. Nataraj, a Villanova College of Engineering professor, was hearing from front-line doctors at Philadelphia hospitals fearful of running out of ventilators for COVID-19 patients. Compelled to help, Nataraj put together a volunteer SWAT team of engineering and medical talent to invent the ideal emergency ventilator. The goal: build something that could operate with at least 80% of the function of a typical hospital ventilator, but at 20% or less of the cost.

For decades, Nataraj has worked on medical projects — like finding a better way to diagnose a potentially deadly brain injury in premature infants — primarily with doctors at Children’s Hospital of Philadelphia and the Geisinger Health system in rural Pennsylvania, so key clinical players came together swiftly. By March 23, he had approached engineering faculty about collaborating on a monthslong effort to build the NovaVent, a basic, low-cost ventilator with parts that cost about $500. The schematics would be open-sourced, so others could use them free of charge to mass-manufacture the device.

The New Yorker wasn’t alone in referencing the ’80s TV series “MacGyver,” whose protagonist was a Swiss Army knife-carrying secret agent who got the job done with wits and whatever was at hand. The suggestion was that these ventilators were simple enough to throw together with parts from a medical supply closet or your neighborhood hardware store. “Everybody can make it,” one headline read, enticingly. These miracle machines, the thinking went, could be helpful in U.S. hospitals facing critical shortages, perhaps in cities surging with sick patients.

To understand the potential utility and true costs of these emergency ventilators, KHN followed Villanova’s team for three months as it developed, tested and prepared to submit the NovaVent for Food and Drug Administration approval.

The team tapped a maker of car parts, along with roboticists. It gathered input from anesthesiologists as well as electrical, mechanical, fluid systems and computer engineers. It tapped nurses to help ensure that users would immediately know how to operate the ventilator. Local manufacturers 3D-printed pieces of the machine.

Nataraj and his team realized that some of the other ultra-bare-bones machines wouldn’t meet the standards of the modern U.S. health care system. But they also believed there was a lot of room for Villanova’s team to innovate between those and the high-end, expensive devices from corporations like Philips or Medtronic.

One thing is clear: The $500 ventilator is something of a unicorn.

While the parts for the NovaVent cost about that much, the brainpower and people hours added uncounted value. In the early phases, the core group — all volunteers — worked 20 to 25 hours a week, Nataraj said, mainly via Zoom calls from home on top of their day jobs.

Teams of two or three were allowed into the lab to work — virtually the only people on campus. The effort, after all, was in line with the university’s Augustinian mission, which values the pursuit of knowledge, stewardship and community over the individual.

By the time they realized what they could achieve with the $500 model, the first wave of crisis had passed. Yet in those weeks, an alarm resounded across the land about the dismal state of America’s public health system.

So the NovaVent mission pivoted: build better low-cost vents for hospitals in poor and rural U.S. communities that have few, if any, ventilators.

One immediate legacy of the innovation happening at Villanova and elsewhere is the public-spirited nature of the effort, said Dr. Julian Goldman, an anesthesiologist at Massachusetts General Hospital who helps set standards for medical devices: “People from different walks of life in terms of their skills — engineers, clinicians, pure scientists — all thinking and working to try to figure out how to move very quickly to solve a national emergency with many dimensions: How do we make the patient safer? How do we make the caregiver safer? How do we deal with supply chain limitations?”

From other ventures, new designs have already been used as a jumping-off point to build emergency ventilators overseas. They’ve also bolstered New York City’s stockpile and could add to state and national reserves as well.

The early, urgent concerns about a looming ventilator shortage were well founded: On March 13, the U.S. had about 200,000 ventilators, according to the Society of Critical Care Medicine. But because of the surge of COVID patients, it was predicted the country could soon need as many as 960,000.

In early April, New York Gov. Andrew Cuomo said the state would run out of ventilators in six days, leaving doctors with the sort of grim calculation they’d heard about from hard-hit northern Italy: “If a person comes in and needs a ventilator and you don’t have a ventilator, the person dies.”

In Philadelphia, 12 miles east of Villanova, hospital administrators braced for shortages and reported short supplies of the drugs required to sedate patients on ventilators.

President Donald Trump invoked the Defense Production Act to get major manufacturers to make ventilators, though GM was already working on it. When GM signed a $500 million contract to deliver 30,000 ventilators to the U.S. government by August, the NovaVent team wondered whether its own efforts would be futile.

“We said, ‘Well, GM is making it. Why are we making it?’” Nataraj said. “But there was a lot of uncertainty with the epidemiological models. We didn’t know how bad it was going to get. Or [the curve] could completely collapse and there’d be no need at all.”

And for a few weeks, it did seem the worst was over. The rate of new cases began to slow in the nation’s early epicenters. Hot spots flared in nearly every pocket of the country, but those too were mostly contained.

People spilled back into normal life, gathering in backyards, beaches and bars. In June, news coverage moved on to the calls for racial justice and mass protests after the videotaped killing of George Floyd in the custody of Minneapolis police.

In the background, the highly contagious coronavirus tore across the South, through Florida, Georgia, Texas and Arizona, and surged in California. Some states reported ICU beds were quickly at or above capacity. This mercurial virus had proved uncontrollable, and the prospect of ventilator shortages had bubbled up once again.

***

Past pandemics have been mothers of innovation. Progress in mechanical ventilation began in earnest after a 1952 polio outbreak in Copenhagen, Denmark. According to the American Journal of Respiratory and Critical Care Medicine, 50 patients a day arrived at the Blegdams Infectious Disease Hospital. Many had paralyzed respiratory muscles; nearly 90% died.

An anesthesiologist at the hospital realized patients were dying from respiratory failure rather than renal failure, as was previously believed, and recommended forcing oxygen into the lungs of patients. This worked — mortality dropped to 40%. But one big problem remained: Patients had to be “hand-bagged,” with more than 1,500 medical students squeezing resuscitator bags for 165,000 total hours.

“They’d recruit nurses and medical students to stand there and squeeze a bag,” says Dr. S. Mark Poler, a Geisinger Health system anesthesiologist on the NovaVent team. “Sometimes they were just so exhausted that they would fall asleep and stop ventilating. It was obviously a catastrophe, so that was the motivation for creating mechanical ventilators.”

The first ones were simple machines, much like the basic emergency-use ventilators created during the COVID crisis. But those came with hazards such as damaging the lungs by forcing in too much air. More sophisticated machines would deliver better control. These engineering marvels — the monitors, the different modes of ventilation, the slick touch-screen controls designed to minimize the risk of injury or error — improved patient treatment but also drove costs sky-high.

The emergency ventilators of 2020 focused on models that, typically, used an Ambu bag and some sort of mechanical “arm” to squeeze it. Most people are familiar with Ambu bags from scenes in TV programs like “ER” where paramedics compress the manual resuscitator bags to help patients breathe as they’re rushed inside from an ambulance. The bags are already widely available in hospitals, cost $30 to $40 and are FDA-approved.

But making machines that are that simple could render them effectively useless (or, worse, dangerous). Medical experts watching university and hospital teams coalesce across the country this spring to develop low-cost emergency ventilators took notice — and worried.

***

Goldman, the Massachusetts General anesthesiologist, was among the medical experts nervous about all the slapped-together ventilators.

“We had the maker community being stood up very quickly, but they don’t know what they don’t know,” said Goldman, chair of the COVID-19 working group for the Association for the Advancement of Medical Instrumentation, the primary source of standards for the medical device industry. “There were videos of harebrained ideas for building ventilators online by people who don’t know any better, and we were very concerned about that.”

The general public doesn’t really understand the nuances required to build a safe medical device, Goldman said.

“They look at something and think, well, this can’t be that hard to build. It just blows air,” he said. “‘I’ll take a vacuum cleaner and turn it on reverse. … It’s a ventilator!’”

AAMI wanted to encourage innovation, but also safety. So Goldman assembled a meeting of 38 engineers, regulators and clinicians to quickly write boiled-down guidelines for emergency-use ventilators.

The simplest ventilators were based on the idea of a piston in a car engine, Poler said: Put a piston on a crankshaft, hook it up to a motor and use a paddle or “arm” to compress the Ambu bag.

“It’s better than no ventilator at all, but it goes at one speed. It doesn’t really have any controls,” Poler said — not ideal when patients need to be monitored for changes in how their lungs are responding, or not, to treatment.

Villanova’s team of engineers, doctors and nurses realized that the simplest ventilators, the ones that AAMI was concerned about, seemed to ignore some basic, practical considerations: What sort of hospitals would these be used in, and under what conditions? What sorts of patients would be put on these ventilators? For how long? Would they be used as backups for higher-end ventilators? What about error alarms?

All good questions, Poler said, but the answer to all of them essentially is “we hope to never use these.”

Their best use? “A surge situation where you simply don’t have enough of the sophisticated ventilators.”

***

Rather than go totally bare-bones, the Villanova team designed the devices as though they would one day be deployed in modern health care.

Flow sensors, which monitor patient ventilation, cost several hundred dollars, so the team designed its own in the lab and 3D-printed it at a cost of 50 cents, Nataraj said, enabled by strides in 3D-printing technology that have vastly cut the price of so many devices. Southco, a Pennsylvania-based global manufacturer that makes parts like the latch on your car’s glove box, was tapped to use its 3D printers to make airflow tubes and couplings for the ventilator.

Garrett Clayton, director of Villanova’s Center for Nonlinear Dynamics and Control, was the day-to-day keeper of the prototype. He was particularly excited about the addition of a handle, which made it easier for him, and eventually others, to lug the 20-pound device from the lab to home and back.

Clayton’s computerized control system measures the flow rate of air going into the patient and converts it into volume, much as commercial ventilators do. That controls how hard and fast the Ambu bag is squeezed; it’s made of a hobby-grade Arduino microcontroller board. A direct-current motor attached to a linear actuator with a fist-shaped piece of PVC on the end pushes the bag in and out. The operator of the ventilator can control the respiratory rate (the number of breaths per minute), as well as the ratio between inspiration and expiration and the volume of air going in.

While traditional ventilators have many control methods, Clayton’s team focused on just one: how much volume is forced into the airway. “We have a set point so we don’t damage the lung,” he said.

Polly Tremoulet, a research psychologist and human factors consultant for ECRI and Children’s Hospital of Philadelphia, was pulled in to focus on error messages and make sure the ventilators’ buttons and displays “spoke the user’s language,” whether that user was an anesthesiologist in New Jersey or a nurse in India pulled into an ICU COVID ward.

Graduate student Emily Hylton and other nursing students were brought in to provide feedback about using the NovaVent and ask questions such as: Would all the controls and monitors look familiar to nurses at the bedside?

The very prospect of these low-cost devices is relatively new, Nataraj said, because of the price of microcontrollers with any real capacity: “Twenty years ago, they cost, oh gosh, $20,000 — and now they’re $20.”

By May 30, the first NovaVent prototype was complete. It was successfully tested on an artificial lung at Children’s Hospital of Philadelphia on June 12. Villanova has applied for a patent for the NovaVent, to help ensure it won’t be commercialized by others.

“If you make it free without having a patent, other people can take it and charge for it,” Clayton said. “A patent protects the open-source nature of it.”

Once a provisional patent is received, the team will submit the ventilator for Emergency Use Authorization from the FDA — hewing to the guidelines set up by AAMI.

***

Within weeks of kicking off the NovaVent project, the curve in the East Coast had indeed flattened, and states had enough standard ventilators to treat every patient. The life-threatening ventilator shortage had not materialized. Some of the emergency-use ventilators based on designs by other teams, like the one at MIT, did go into production — but even those didn’t end up in hospitals, and instead went into city stockpiles meant to reduce potential future reliance on the federal government. So the Villanova team seized on a new, global mission.

“We thought if it wasn’t useful in the U.S. market,” Nataraj said, “we know the developing world, especially sub-Saharan Africa, Latin America and Central America, they don’t have the same kind of facilities that we do here.”

Where the ventilators might end up remains to be seen. Early on, Pennsylvania showed interest in helping Villanova find manufacturing partners. The team has spoken with engineers in India, Cambodia and Sudan (which reportedly has only 80 ventilators in the entire country) who are interested in possibly finding a way to manufacture the NovaVent.

Six thousand emergency ventilators based on the design by the University of Minnesota have been manufactured in the U.S., according to Dr. Stephen Richardson, a cardiac anesthesiologist who worked on that project. Three thousand were made by North Dakota aviation and agricultural manufacturer Appareo for state emergency stockpiles in North Dakota and South Dakota. UnitedHealth Group provided $3 million in funding to manufacture another 3,000 units made by Boston Scientific, which were donated to countries like Peru and Honduras through U.S. organizations; others were sent to the U.S. government.

Like the Villanova team, Richardson said he thinks the most promising potential for these ventilators is in developing countries.

“When we were arranging to get these donated to Honduras, we were speaking with a physician who was telling me that [at] his hospital right now, the med students are just hand-ventilating patients. For everything, and for COVID specifically,” Richardson said. “Right now, in Pakistan or in any low-resource country, a family member is hand-ventilating a toddler. Before COVID and after COVID, this is a problem.”

For Poler, the project was a reminder that the country needs to tend to its stockpiles. “People were thinking about [ventilator reserves] in the ’90s, and then they basically quit thinking about it,” he said. “COVID is a shocking reminder that we shouldn’t have stopped thinking about it.”

Goldman said the national efforts may not result in a flood of cheap ventilators in U.S. hospitals. International use could also be tricky. In countries with few resources, even very low-cost ventilators may not be feasible because of lack of electricity or compressed oxygen, though there is “potentially a sweet spot of need and capability where these things could be deployed.”

On the upside, he said, the pandemic kicked off a nearly unprecedented global engineering effort to share information and solve the problem.

“If there’s going to be a magic bullet to come out of this, it’s going to be the capability of our communities and our infrastructure,” he said. “People stood up, put in the appropriate processes and spirit, worked hard, made it happen. We’ve added resilience to the health care sector. That’s the outcome here.”

As for the NovaVent, team members were relieved they didn’t have to rush it into manufacturing as COVID-19 was ripping through the Northeast this spring, thanks to aggressive efforts to flatten the curve. “We ended up without a ventilator shortage, which is excellent,” Clayton said. “But with the increase in cases now, it’s very possible some of them may get used.”

To build on the project, Villanova is raising money for a laboratory for affordable medical technologies called NovaMed. The lab formalizes the process of making inexpensive medical equipment that follows the 80-20 function-to-cost rule. The university says the lab is “motivated by the belief that income should not determine who has access to lifesaving care.”

The effort to prevent a ventilator shortage, Nataraj said, made him think more critically about the American health care system overall.

“How come we haven’t built the technology, the economic and social systems that are able to handle a situation like this — especially when something like this was predicted?” he said. “It’s absolute nonsense. Why should a single person die because we weren’t prepared?”

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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One College’s Pop-Up COVID Test: Stop and ‘Smell the Roses’ (Or the Coffee)

Kaiser Health News:States - August 24, 2020

If all goes according to plan, Penn State University students who opt for an on-campus experience this fall will start in-person classes on Aug. 24 under the banner of a “Mask Up or Pack Up” campaign.

By returning to campus, students are agreeing to wear masks, adhere to social distancing practices and submit to random testing for COVID-19.

But “Mask Up or Pack Up” also offers a less traditional, more proactive approach to virus containment: the smell test.

“Our message is, ‘If you have sudden-onset smell loss, in the absence of other explanatory history like a head injury, the chance of you being infected is high,’” said John Hayes, a professor in the department of food science at Penn State and director of the Sensory Evaluation Center in the College of Agricultural sciences. “This is about raising awareness that smell loss is an early symptom of COVID-19.”

Hayes’ department plans to send scented scratch-and-sniff postcards to students, asking them to monitor their sense of smell. There will be other reminders throughout campus, such as flower arrangements that invite people to “smell the roses” before entering a lecture hall.

Bottom line, said Hayes: “We’re telling our community if you lose your sense of smell, you should self-isolate and immediately get tested.”

It’s advice that might help people throughout the world contain the spread of the COVID virus.

According to Danielle Reed, associate director of the Monell Chemical Senses Center in Philadelphia, the loss of the sense of smell is one of the best and earliest indicators of COVID-19.

“More COVID patients have loss of sense of smell than have a fever,” Reed said. “Yet fever is often first on the checklist of COVID symptoms and sense of smell is at the bottom, like an afterthought. We think it should be near or at the top.”

A recent study based on a worldwide survey of 25,000 patients by the Global Consortium for Chemosensory Research found that COVID-19 is more strongly associated with smell and taste than with fever, cough or shortness of breath, though the latter are the “cardinal symptoms currently highlighted by the US Centers for Disease Control and Prevention (CDC).” The study has not yet been peer-reviewed.

Several other studies have linked the loss of smell to the virus. Researchers at the Mayo Clinic reported in June that patients with COVID-19 were 27 times more likely to lose their sense of smell than people without the virus, while less than three times as likely to report fever and/or chills. Another analysis of medical records by Mayo researchers suggested that routine screening for those changes “could contribute to improved case detection in the ongoing COVID-19 pandemic.”

Proteus Duxbury, former chief technology officer for the Colorado health insurance exchange, now lives in Northern Ireland and heads service delivery for a National Health Service trust. Suffering from what seemed a mild cold in early March, Duxbury noticed he couldn’t smell or taste his meal. Luckily, a colleague passed along the then-brand-new hypothesis that COVID affected these senses, and Duxbury isolated, though he had no other disease symptoms.

“I didn’t have cough, headache, fever or shortness of breath,” said Duxbury. “But everything tasted like cardboard. The first thing I did every morning was put my head in the coffee jar and take a real deep breath. Nothing.”

Two weeks later, his sense of smell began to return; three months after that, he had a positive antibody test. Today, nearly six months after his recovery from COVID-19, Duxbury reports his senses are back but slightly dulled.

Scientists have hypothesized that the loss of smell is caused by damage to olfactory sensory neurons. The COVID virus actively attacks neighboring cells in the nasal cavity that express ACE2, a protein that acts as a receptor for the virus. In doing so, the olfactory cells may also become inflamed and “paralyzed.” Thus, the sudden inability to smell.

Because the loss of smell is an early symptom, it may be helpful in screening otherwise asymptomatic and pre-symptomatic COVID carriers, according to researchers. It is often the only symptom present in people who otherwise feel fine and don’t think of themselves as sick, leading them to unwittingly spread the virus. Though only 50% of COVID-19-positive patients list smell loss as a complaint, specific questioning leads to a significantly higher rate of around 70% to 75%, according to a study recently submitted by the Monell research team to the NIH.

Loss of smell has been tied to other upper respiratory ailments in the past, so it is not a foolproof exercise. Still, E. John Wherry, chair of the department of systems pharmacology at the University of Pennsylvania and director of the university’s Institute for Immunology, is cautiously optimistic about the potential for smell tests to help in the fight against COVID — while noting results can be misinterpreted.

“The idea is very attractive because we need testing any way we can get it and there’s just not enough to go around,” Wherry said. “The other side of the equation is that people who wake up with allergies or a hangover and can’t smell the coffee as well as they did yesterday might panic and run to urgent care for a test. It would be good to understand the costs.”

That’s why researchers stress that the loss of smell associated with COVID is not subtle. “It’s not a matter of degrees of discrimination,” Reed said. “This isn’t something you miss.”

The smell loss associated with COVID-19 is swift and utter. It could involve waking up one morning and not being able to smell your shampoo, aftershave or coffee. And it may be disorienting because it’s not typically accompanied by nasal congestion, which is how most people have experienced smell reduction in the past.

It’s also an extremely strong indicator, so there should be no second-guessing. Anyone who experiences an abrupt, unexplained loss of smell should take it seriously: Self-isolate and get tested for COVID-19.

Johan Lundström, a Swedish-based biologist with the Monell Chemical Senses Center, is using the evidence uncovered by the global consortium report to help track incipient COVID-19 outbreaks before they take hold.

Working with the Edith Wolfson Medical Center and the Weizmann Institute of Science, both in Israel, Lundström created smelltracker.org — a website that provides users with a simple daily smell test they can self-administer using five household items. Once they have chosen their set of odorants — such as cinnamon, peanut butter, mustard and coffee — respondents rate the odors with respect to pleasantness and strength.

Rather than collect personal data, smelltracker.org aggregates the responses in a neighborhood, region or city, so researchers see only trends. When an increasing number of people in those areas report they have a reduced, impaired or no sense of smell, public officials can move in with widespread PCR testing.

“This test is quick and very cheap, people like doing it, and it gives them some awareness and reassurance about their own health,” Lundström said. “It’s also very good at helping public health officials decide how and where to spend their resources to implement widespread testing using the proper COVID regime.”

Currently, smelltracker.org is being used by health officials in regions of Israel and in Italy, where citizens are encouraged to sign up. But the website is available worldwide, with instructions in 15 languages. Interest from other countries is beginning to grow.

No one is recommending that smell tests replace traditional swab or saliva testing. But Reed, Hayes and Lundström all believe that better education around this unique COVID-19 symptom will lead to greater engagement and care on the part of people who don’t feel sick themselves.

Perhaps the best part of smell testing is that it doesn’t involve discomfort or stigma, and it can easily be turned into a game. Soon, Reed said, instead of being zapped with a digital thermometer, individuals who are entering a meeting or store may be handed a card with three peel-off stickers and asked which one has a scent.

“I’m an optimist and I believe people do not want to spread this disease,” Hayes said. “Our students don’t want to. If we give them the tools to know when they might be sick, they’ll help us keep our campus safe.”

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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Trump Is Sending Fast, Cheap COVID Tests to Nursing Homes — But There’s a Hitch

Kaiser Health News:Medicaid - August 24, 2020

The Trump administration’s latest effort to use COVID-19 rapid tests — touted by one senior official as a “turning point” in arresting the coronavirus’s spread within nursing homes — is running into roadblocks likely to limit how widely they’ll be used.

Federal officials are distributing point-of-care antigen tests — which are cheaper and faster than tests that must be run by a lab — to 14,000 nursing homes to increase routine screening of residents and staff. The initial distribution targets nursing homes in hot spots and those with at least three COVID-19 cases, senior Trump administration officials said in July, hailing it as a tool that could root out asymptomatic carriers who might still infect others.

But there’s a hitch: Two manufacturers that have received Food and Drug Administration authorization and whose instruments are being delivered — Becton, Dickinson and Co., known as BD, and Quidel — say their antigen tests are intended for patients with symptoms, calling into question how valuable the tests would be for broad screening purposes. The Centers for Disease Control and Prevention estimates 40% of infected people may be asymptomatic.

“It’s important always to use a diagnostic in the way that it has been designed to be used,” said Elizabeth Talbot, New Hampshire’s deputy state epidemiologist. “We simply don’t know how [the tests] will perform in persons who are asymptomatic.”

Perhaps the highest-profile example of the problem occurred in Ohio this month, when Gov. Mike DeWine had no symptoms and tested positive for COVID-19 with Quidel’s antigen test. Within hours, the Republican governor’s diagnosis was reversed after he got a PCR test.

“People should not take away from my experience that testing is not reliable or doesn’t work,” DeWine said on CNN after his false-positive diagnosis. “The antigen tests are fairly new,” he said. “We’re going to be very careful in how we use it.”

The bigger problem is false-negative results, which show someone isn’t infected when they actually are. BD’s false-negative rate — how often a test incorrectly says someone isn’t infected — is about 15%; Quidel’s is 3%.

Quidel and BD say their tests are intended to be used for people within the first five days of showing symptoms. A spokesperson for BD said its test should not be used on asymptomatic individuals. Quidel through a spokesperson deferred to FDA guidelines, which allow asymptomatic testing in certain scenarios.

“For routine surveillance, this is a great tool and these are our best tools that we have available,” said Adm. Brett Giroir, assistant secretary for health at the Department of Health and Human Services, on a July call with nursing home officials, according to a recording obtained by KHN. Seema Verma, the administrator of the federal Centers for Medicare & Medicaid Services, on the call referred to the effort as a “turning point” in the fight against the virus.

A month after the initial announcement, the Trump administration invoked the Defense Production Act to bump its contracts with the two companies to the front of the line and expedite shipments. BD will send roughly 11,000 devices and 3.75 million tests to nursing homes; Quidel and HHS declined to answer questions about its volume.

As states and the federal government move to mandate COVID testing inside nursing homes, whose patients are deemed highly vulnerable to infection and severe complications, several industry officials have said they hoped to use the tests on asymptomatic people. But many states restrict the use of antigen tests or still require lab-based testing because of accuracy concerns.

If a person with a negative test result has to default to getting a more accurate PCR test, “then we simply have just added time and cost,” Talbot said. “That’s a problem.”

Officials said the antigen test announcement caught them by surprise, underscoring the administration’s chaotic testing strategy. Separate from the federal effort, 10 states have banded together through the Rockefeller Foundation to secure 5 million tests from the two companies in hopes of curbing the virus’s spread this fall.

After nursing homes receive an initial batch of tests — each facility gets between 150 and 900 — they would have to buy future supplies. Medicare will cover the costs of diagnostic tests but not expenses for routine surveillance.

“I just have a lot of skepticism,” said Brendan Williams, president of the New Hampshire Health Care Association, which represents nursing homes and assisted living facilities in the state. “Basically you’re giving some lousy tests for nursing homes and you’re making them pay for them. I don’t see that as a win; I see that as a risk.”

Public health experts have become increasingly vocal that frequent rapid testing is the best tool for stopping the virus — which has killed more than 174,000 Americans including tens of thousands in nursing care — rather than relying on more accurate lab-based tests that have been plagued by delays and shortages. In a call this month with the industry, Verma estimated that half of the country’s nursing homes have experienced cases.

“I don’t see an avenue where these will not help to stop transmission chains, and I don’t see another option on the table for us,” said Dr. Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health and a proponent of rapid tests. “It is what we need to be doing right now.”

“This is better for the folks in our buildings, without a doubt,” added Jason Belden, director of emergency preparedness and physical plant services for the California Association of Health Facilities.

In theory, antigen tests can serve dual purposes — diagnosing a person with a suspected infection or screening a group of people to more quickly identify sick individuals. The tests by Quidel and BD, under their FDA authorizations, can be used on certain asymptomatic individuals, including those suspected of having COVID-19 after exposure to an infected person. The companies would need additional FDA authorization to screen any asymptomatic person regardless of whether they’re suspected of being sick, according to agency guidelines.

The CDC has suggested antigen tests could be useful in high-risk settings if performed repeatedly. It said there was limited data to guide using them to screen asymptomatic people.

Nonetheless, HHS recommends universal screening of nursing home residents at least once and regular screening of staff regardless of symptoms, said agency spokesperson Mia Heck, citing the fact that COVID-19 viral loads are similar between patients with and without symptoms. “Only one test in the U.S. is authorized for asymptomatic individuals,” she said, referring to a PCR test from LabCorp, “yet the overwhelming majority of testing is being done on asymptomatic individuals.”

“If the world were ideal we’d say, ‘Oh, we want the more accurate test.’ But the more accurate test takes forever to get the results back,” said Peter Van Runkle, executive director of the Ohio Health Care Association, which represents the state’s nursing homes.

All targeted nursing homes will receive tests by the end of September, according to federal officials, who recently announced that facilities in states with a positivity rate of at least 5% must test staff each week.

“I don’t see this as a federal strategy so much as a stopgap method to bring a little relief to nursing homes,” said Katie Smith Sloan, president of LeadingAge, which represents nonprofit nursing homes. “It’s really tragic that we are where we are right now.”

Boosted by $71 million in federal funds for Quidel and $24.3 million for BD, Quidel plans to produce 1.8 million tests weekly by September; BD will produce similar volumes by October.

“The situation is much too urgent to wait a few months so we can put bows and lipstick on the program. So we’re going to build this plane a little bit while we’re flying it,” Giroir told nursing homes in July. “Just work with us. We want to get you what you need. And then in September, October you can get what you want.”

States take different approaches in deploying antigen tests in nursing homes; in at least seven — including California, Illinois and Maryland — officials say PCR tests should still be used to confirm results or to screen patients without symptoms. In Massachusetts, nursing homes must use PCR tests to meet surveillance requirements.

In Maryland, “our goal is to screen out staff who are positive as quickly as possible, particularly asymptomatic folks,” said Dennis Schrader, chief operating officer of the health department.

Maryland nursing homes can use antigen tests for weekly staff testing if there isn’t an outbreak. But if at least one person tests positive for the coronavirus, all staff and residents must be tested with PCR tests.

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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