Tagged Public Health

Pandemic Delays Federal Probe Into Medicare Advantage Health Plans

Federal health officials, citing a need to focus on the COVID-19 pandemic, have temporarily halted some efforts to recover hundreds of millions of dollars in overpayments made to Medicare Advantage health plans.

The Centers for Medicare & Medicaid Services says the decision will allow insurers and the agency to “focus on patient care,” and will last “until after the public health emergency has ended.”

Critics aren’t convinced that’s a wise idea.

“Some loosening of regulations during a crisis is necessary. But is this an abdication of oversight?” asked David Lipschutz, associate director and a senior policy attorney with the Center for Medicare Advocacy. “This is a serious concern we will have to grapple with at some point.”

Medicare Advantage plans are offered by private health insurers under contracts with Medicare. They treat more than 24 million Americans, most of them seniors at a relatively high risk of serious health complications from the pandemic.

The added costs these health plans will shoulder as a result remains unclear. Several plans have announced they will waive copayments for COVID-19 testing and care. In an April 3 letter to CMS Administrator Seema Verma, the industry advocacy group Better Medicare Alliance asked the agency to “monitor the unanticipated costs incurred as a result of the COVID-19 crisis, and work with Congress to put in place appropriate financial protections, such as excess loss protection for Medicare Advantage.”

CMS on Monday announced a 1.66% rate increase for the plans in 2021.

The trade group applauded CMS’ decision to relax auditing and other paperwork requirements. The CMS audits are designed to curb overcharging by Medicare Advantage plans, to which the government pays more than $200 billion a year. The audits are years behind schedule, largely because of industry opposition.

In July 2019, Kaiser Health News reported that the government had overpaid Medicare Advantage plans by nearly $30 billion in the past three years alone. In addition, as many as 20 whistleblower lawsuits ― the most recent filed late last month by the Justice Department against industry giant Anthem — have accused health plans of ripping off Medicare by exaggerating how sick their patients were.

The coronavirus emergency puts a unique strain on Medicare Advantage plans. Unlike standard Medicare, which pays medical providers for each service they render, Medicare Advantage plans are paid based on the health of members. That means they receive higher rates for sicker patients and less for those in robust health.

The insurers assess the health status of each member through face-to-face medical visits, which have been sharply curtailed by the crisis. The industry also argues that during the COVID-19 emergency, health plans and their doctors have little time to process paperwork.

“There’s a recognition that providers need to be focused on treating the epidemic,” said Thomas Kornfield, a senior consultant with the health care consulting firm Avalere Health and a former CMS official. Asking doctors and insurers to prepare medical records for review “when they face an unprecedented situation is not a good idea,” he said.

Still, concerns that some plans overcharge Medicare have been raised for years. In December, the Health and Human Services inspector general linked alleged schemes to $6.7 billion in questionable payments during 2017.

The March 26 Justice Department civil case accuses Anthem, whose holdings include several large Blue Cross Blue Shield plans, of illegally billing Medicare for diseases that were not supported by medical records. Anthem received more than $112 million in improper payments for 2015, according to the government.

Anthem denied wrongdoing. “We are confident that our health plans and associates have complied with Medicare Advantage regulations,” the company said in a statement.

The whistleblower cases have emerged as a primary tool for holding health plans accountable largely because the CMS audit program has foundered amid fierce protests from the industry. The industry argues the audits, called risk adjustment data validation, or RADV, are flawed and the results unreliable.

The controversy has resulted in long delays in conducting audits and recouping overpayments. CMS officials say they have yet to complete audits for 2011, 2012 and 2013.

That’s years behind schedule. CMS officials had expected to finish the 2011 audits by the end of 2016, for instance. (KHN is suing CMS under the Freedom of Information Act to compel public release of the audit findings. The case is pending in federal court in San Francisco.)

CMS said it would continue reviewing some audit materials but suspend the collection of records for reviews of 2015 payments and beyond until “the public health emergency has ended.”

The CMS action also temporarily waives the collection of some data the government uses to rate the quality of health plans and patient satisfaction with them. Medicare uses this information to rate the health plans from one to five stars.

“CMS is committed to allowing health plans, providers, and physician offices to focus on caring for Medicare beneficiaries during this public health emergency and not put staff at health plans at risk by requiring travel or collection of data in offices that are overwhelmed by patients needing care,” the agency said.

CMS said it is “reprioritizing” its enforcement of regulations to focus on problems that could pose a danger to patients, such as “lack of access to critically needed health services or prescription drugs” and “complaints alleging infection control concerns, including COVID-19 or other respiratory illnesses.”

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To Curb Coronavirus, What’s Behind The Wearing Of A Mask?

The Centers for Disease Control and Prevention on Friday recommended wearing cloth face masks when going out, especially to places like grocery stores and pharmacies.

That’s because a “significant portion” of people with the virus lack symptoms or can transmit the disease through close contact before they show signs of illness, the CDC said. It is not recommending people try to purchase N95 or surgical masks, and the federal agency included online instructions on making masks out of materials at home.

The recommendation is optional. President Donald Trump, for instance, said he didn’t envision wearing one. But in recent days, the number of people sporting some type of protective face gear appears to have soared.

So what gives?

Many experts agree that wearing a mask probably won’t keep people from getting the coronavirus, but it might help prevent those with the disease — especially those without symptoms ― from spreading it.

The CDC’s announcement — which came after days of deliberation among White House officials, the coronavirus task force and other public health figures about the need for such a guideline — brings with it caution.

First, masks could give people a false sense of security.

“We don’t want people to feel like, ‘Oh, I’m wearing a mask. I’m protected and I’m protecting others,’” said Dr. Deborah Birx, during a White House briefing last week before the CDC issued its recommendation. Birx, a member of the president’s coronavirus task force, made clear that wearing a mask would not replace the need for frequent hand-washing and continued social distancing.

Another concern is that the recommendation could further strain the supply of medical-grade masks for health care workers, if consumers flooded the market to get their hands on one. Earlier statements from U.S. officials downplayed the use of face masks in public, in part for this reason.

But those messages ran counter to what other countries ― particularly in Asia — have recommended or required. Face masks have been ubiquitous in countries such as China, South Korea and Japan during the outbreak.

Before the CDC recommendation, residents in some hard-hit American cities, such as Los Angeles and New York, were encouraged to wear masks in public. Riverside County in Southern California mandated it.

Another issue: Homemade masks — and some store-bought ones ― don’t fit as tightly as medical masks.

“Virus can sneak around the edges,” said Melissa Perry, a professor of environmental and occupational health at George Washington University in Washington, D.C.

There’s also the matter of the fabric.

“What I see are people buying masks on the web that are fashionable, but the fabric is thin,” said John Lednicky, an aerovirologist at the University of Florida, who studies how viruses spread through the air. “If the weave is not tight enough, the virus will go right through them.”

Still, he said, a homemade mask “is better than nothing” if it could block some particles expelled by an infected person. But he cautioned that a mask protects only the nose and mouth areas. Another route of transmission is through the eyes. So, again, don’t touch your face or rub your eyes if possible.

Might eyeglasses add protection from particles?

“There’s some protection from eyeglasses, but there’s a lot of space around eyeglasses, so air currents can still hit your eyes,” he said.

And one more caution: “When putting it on and taking it off, you have to be careful. You might end up getting virus all over your hands,” said Marcus Plescia, chief medical officer with the Association of State and Territorial Health Officials. “Discard it carefully.”

If it’s made of fabric, wash it. If it’s paper or some other material, put it in a sealed plastic bag and throw it away. Wash your hands after.

Transmission Out Of Thin Air?

Researchers are debating whether simply talking or breathing can send tiny virus particles airborne ― and whether those bits would be in great enough quantity to allow for transmission to another person.

This critical question has no clear answer.

No doubt a cough or sneeze can shoot out droplets several feet, but those are relatively large and heavy and quickly fall to the ground, researchers say. Still, that’s a main route of transmission because the droplets can either land on a close contact — defined by the World Health Organization as within 1 meter ― or fall on surfaces, which other people then touch, possibly picking up the virus.

Staying 6 feet away from others and washing your hands a lot helps reduce the risk packed by droplets.

But what about smaller particles — those aerosols created simply by exhaling that can float in the air longer?

Evidence is not clear.

A special panel last week released a report reviewing studies from the U.S. and China, raising the possibility of airborne transmission. The studies’ findings suggest that normal breathing can release aerosolized virus, according to the letter from a special pandemic committee at the National Academy of Sciences to the head of the White House’s Office of Science and Technology Policy.

But, the committee added, “one must be cautious,” because what the studies found may not represent “viable virus in sufficient amounts to produce infection.”

The WHO, in a March 20 report, took a more cautious approach, saying there isn’t enough information to say such tiny particles are airborne outside of medical settings.

Aerosols containing the virus can occur during some medical procedures, such as ventilating a patient, the WHO said, which puts health care workers at risk. Further study is needed, the report concluded, to see if the virus shows up in air samples in patient rooms where no such procedures took place and “whether viable virus is found and what role it may play in transmission.”

Given the uncertainty, the bottom line, Lednicky and others said, is to avoid close contact and take other reasonable protective steps.

Masks are good to ensure that you are not transmitting the virus to others. But don’t forget about that 6-foot zone of personal space.

How Does This Translate To Everyday Life?

Experts agree that in the midst of this pandemic ― while people are encouraged to stay at home and isolate — it’s still important for physical and mental health to get exercise by walking or running. But what happens when you cross paths with another person, who may not be wearing a mask?

“More distance is better no matter what,” said Dr. Georges Benjamin, executive director of the American Public Health Association, who said there is only a small likelihood that you are running through a mist that might contain the virus.

“If you want to hold your breath [while passing near others], fine, but it’s probably not necessary,” he said.

And then there’s your neighbor’s friendly dog. Researchers don’t believe pets can transmit the disease. Still, to protect the pet, they suggest that those who are sick to avoid caring for or sharing their food with the animal, said Benjamin. Because keeping a proper distance from your neighbor is also key, it might be a good idea to skip the dog-petting.

“I would just say ‘Hi’ right now,” said Benjamin.

Overall, most health officials appear to consider masks a good idea. But they agree on three constants in this quickly changing matter: Keep your distance from others outside your household. Wash your hands ― often. And don’t touch your face.

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Pacientes de cáncer enfrentan retrasos en cirugías mientras COVID-19 paraliza hospitales

El gobierno federal ha alentado a los centros de salud a retrasar las cirugías no esenciales mientras evalúa la gravedad de las condiciones de los pacientes y la disponibilidad de equipos de protección, camas y personal en los hospitales.

Las personas con cáncer se encuentran entre los pacientes con alto riesgo de complicaciones si se infectan con el nuevo coronavirus. Se estima que 1.8 millones de personas serán diagnosticadas con cáncer en los Estados Unidos este año. Más de 600,000 reciben quimioterapia.

Eso significa que millones de estadounidenses pueden estar enfrentando desafíos imprevistos para obtener atención.

Christine Rayburn, en Olympia, Washington, fue diagnosticada con cáncer de seno a mediados de febrero. El nuevo coronavirus apareció en las noticias, pero la mujer de 48 años no imaginó que el brote la afectaría. Su médico dijo que Rayburn necesitaba comenzar el tratamiento de inmediato. El cáncer ya se había extendido a sus ganglios linfáticos.

“El tumor canceroso parecía haberse adherido a un nervio”, dijo Rayburn, quien fue maestra de escuela durante muchos años. “Siento dolor regularmente”.

Después de tener su diagnóstico y el plan de tratamiento de su equipo médico, la meta de Rayburn era someterse a una cirugía lo antes posible.

Mientras tanto, el brote de coronavirus estaba empeorando, y Seattle, a solo una hora al norte de donde vive Rayburn, se había convertido en uno de los focos nacionales.

El esposo de Rayburn, David Forsberg, comenzó a ponerse un poco nervioso sobre si el procedimiento de su esposa seguiría según lo planeado.

“Se me pasó por la mente”, dijo. “Pero no quería molestarme con esa posibilidad además de todo lo demás”.

Dos días antes de la intervención de Rayburn para extirpar el tumor, dijo Forsberg, el cirujano llamó, “bastante lívido” con malas noticias. “Le dijo: ‘la han cancelado indefinidamente’”, recordó Forsberg.

El procedimiento había sido programado en el Hospital Providence St. Peter en Olympia, una instalación administrada por Providence Health & Services. En todo Washington, los hospitales estaban suspendiendo las cirugías electivas, para conservar el suministro limitado de equipo de protección personal, o EPP, y para evitar que los pacientes y el personal se expusieran innecesariamente al nuevo coronavirus.

“Simplemente me sentí como en una de esas películas realmente malas, en las que me estaban sacrificando”, dijo Rayburn.

“Era como si nos hubieran separado de los expertos en los que confiamos”, dijo su esposo.

El hospital dijo que revisaría la decisión en unas pocas semanas. Pero el cirujano de Rayburn dijo que era demasiado tiempo para esperar y que tenían que pasar al Plan B, que era comenzar la quimioterapia.

Originalmente, se suponía que la quimioterapia debía ocurrir después de la cirugía tumoral de Rayburn. Y reorganizar el plan de tratamiento no era ideal porque no se ha demostrado que la quimioterapia reduzca significativamente los tumores en el tipo de cáncer de seno que ella tiene.

Aun así, la quimioterapia podría ayudar a detener la propagación del cáncer. Pero a medida que la pareja descubrió el nuevo plan de tratamiento, se toparon con más obstáculos.

“Necesitaba un ecocardiograma, excepto que habían cancelado todos los ecocardiogramas”, dijo Forsberg.

Pasaron días en el teléfono tratando de poner todas las piezas en su lugar para que ella pudiera comenzar la quimioterapia. Rayburn también comenzó a escribir a sus legisladores locales sobre su situación.

Hospitales priorizan casos urgentes

A mediados de marzo, el gobernador de Washington, Jay Inslee, prohibió la mayoría de los procedimientos electivos, pero estableció excepciones para ciertas situaciones urgentes y potencialmente mortales.

“En realidad decía que [la prohibición] excluía la extirpación de tumores cancerosos”, dijo Rayburn.

Los hospitales de Providence utilizan algoritmos y un equipo de médicos para determinar qué cirugías pueden retrasarse, dijo Elaine Couture, directora ejecutiva de Providence Health en la región de Washington-Montana.

“No hay decisiones perfectas en absoluto en nada de esto”, dijo Couture. “Ninguna”.

Couture no habló sobre pacientes específicos, pero dijo que supone que otros casos eran más urgentes que los de Rayburn.

“¿Hubo otros pacientes que incluso tenían cánceres más agresivos que se completaron [quirúrgicamente]?”, se preguntó Couture. “Tan enfermo como estés, puede haber otras personas que necesiten algo incluso antes que tú”.

Couture dijo que los hospitales están agotando suministros de máscaras, batas y guantes y que deben tomar decisiones difíciles sobre los procedimientos electivos.

“Tampoco me gusta, y no es la forma en que queremos que funcione nuestro sistema de atención médica”, dijo Couture.

En todo el sistema hospitalario de Providence, el equipo de protección personal se usa mucho más rápido de lo que se puede reponer, dijo.

Sin un único estándar

En la Sociedad Americana del Cáncer, su director adjunto, el doctor Len Lichtenfeld, está escuchando a pacientes de todo el país a quienes les retrasan la quimioterapia o cancelan la cirugía.

“A un paciente con un tumor cerebral le dijeron que no podría someterse a una cirugía, lo que parece ser una sentencia de muerte”, dijo Lichtenfeld.

Este es un territorio desconocido para la atención del cáncer, agregó. Los hospitales están tomando estas “decisiones sobre la marcha” en respuesta a cómo se desarrolla la pandemia en una comunidad en particular. “No existe una norma nacional única que pueda aplicarse. Me temo que esto se volverá mucho más común en las próximas semanas”.

La sociedad del cáncer recomienda que las personas pospongan sus exámenes de detección de cáncer de rutina, por ahora.

El American College of Surgeons ha publicado una guía sobre cómo clasificar la atención quirúrgica para pacientes con cáncer. Pero Lichtenfeld dijo que cada decisión depende en última instancia de la disponibilidad de recursos en el hospital y las presiones por COVID-19. En el estado de Washington, que ha sido golpeado fuertemente, los hospitales están cambiando el espacio quirúrgico y las camas lejos de otros tipos de tratamiento.

“Necesitamos pronosticar dos o tres semanas más adelante cuando haya más pacientes que estén enfermos”, dijo el doctor Steven Pergam, director médico de prevención de infecciones de Seattle Cancer Care Alliance. “Necesitamos asegurarnos de que haya una capacidad de camas adecuada”.

Pergam dijo que la alianza de atención está ajustando los planes de tratamiento y, a veces, evitando los procedimientos que mantendrían a los pacientes con cáncer en el hospital durante un período prolongado.

“Realmente depende del cáncer y la naturaleza agresiva del mismo”, dijo. “Hemos analizado administrar quimioterapia en el departamento ambulatorio y cambiar los regímenes particulares que las personas tienen para hacerlos menos tóxicos”.

Pero Pergam dijo que esperan seguir haciendo cirugías urgentes para pacientes con cáncer, incluso a medida que la pandemia empeora.

Christine Rayburn en Olympia se estaba preparando para los próximos meses de quimioterapia: quedarse en su casa e incluso evitar el contacto con sus hijas adultas, para prevenir cualquier posible exposición al coronavirus.

Luego, hace dos semanas, el cirujano volvió a llamar. Después de todo, había persuadido al hospital para que permitiera la cirugía, 10 días después de lo inicialmente planeado.

Rayburn y su esposo se preguntan qué habría pasado si no hubieran hablado o presionado para que su lumpectomía volviera al calendario de cirugías del hospital. Forsberg dijo que es posible que pudieran haber terminado sin la atención que Rayburn necesitaba.

“Si no hubiéramos dicho nada, tal vez no hubiera recibido la atención que necesita”, dijo. “Pero en nuestra mente, esa no era una opción”.

Esta historia es parte de una asociación entre NPR y Kaiser Health News.

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Nursing Homes Have Thousands Of Ventilators That Hospitals Desperately Need

As the number of COVID-19 patients climbs and health officials hunt for ventilators to treat them, nursing homes across the United States have a cache ― about 8,200 of the lifesaving machines, according to data from the Centers for Medicare & Medicaid Services.

Most of the machines are in use, often by people who’ve suffered a brain injury or stroke. Some of those residents are in a vegetative state and have remained on a ventilator for years.

State officials are working to consolidate ventilators where they are most urgently needed. But so far, the supply in nursing homes has not drawn the same attention.

Or course, commandeering those units would set up a monumental ethical dilemma: Do you remove life support for a long-term nursing care patient in order to give a COVID-19 patient a better chance of survival?

The highest number of machines, about 2,300, is in California, where the state has created designated nursing home units for people on life support, officially called subacute units but known pejoratively by some doctors as “vent farms.” New York has the second most, 1,822, according to state officials.

Already, one nursing home on Long Island has lent a nearby hospital 11 ventilators that were not being used, leaving just five for its residents.

“The hospital came to us last week and asked, ‘Do you have any ventilators?’” the nursing home assistant administrator said on the condition of anonymity because he was not authorized to speak to the news media.

“We left ourselves with the bare minimum,” he said. In all, three hospitals reached out to the nursing home for ventilators ― it had to say no to the other two.

New York Gov. Andrew Cuomo has announced an executive order that ventilators not in use by hospitals be redeployed to ICUs. And he’s calling in the New York National Guard to facilitate the order. “We know where every ventilator is,” Cuomo said Sunday.

Nursing home ventilators are not included in his order, but they are included in the state’s tally of the machines.

Dr. Michael Kalafer, a pulmonologist and the medical director at two San Diego subacute units, said he can’t imagine taking one of his patients off a ventilator because it’s needed for someone else.

“I severely doubt we’ll take [a hypothetical] Mrs. Smith off a ventilator because she’s 80 and has been on it for a few years and has not gotten better,” Kalafer said.

But these are precisely the decisions bioethicists are being asked to weigh in on as the country confronts the crush of COVID-19 patients overwhelming the health care system.

And in some cases, states have already decided to give people who are severely brain-injured a lower priority when it comes to access to ventilators. Disability advocates oppose such guidelines and filed complaints with the Department of Health and Human Services last month, according to ProPublica. And although states and health associations can draw up recommendations, they are not legally binding.

“From an ethical point of view, for people who are not conscious, if it’s a matter of removing people from a [ventilator] who are not going to recover, I think it’s a hard decision, but one that in an emergency has to be made,” said Ronald Bayer, a professor of sociomedical sciences at the Mailman School of Public Health at Columbia University.

Bayer has been a member of the World Health Organization and in 2011 served on an ethics subcommittee that advised the Centers for Disease Control and Prevention on the allocation of ventilators in the event of a severe pandemic.

He and several other ethicists said these decisions should not be made at the bedside but by triage committees or people in supervisory roles. And the guidelines ought to be uniform and transparent. That’s why the CDC, the state of New York and medical associations like the American College of Chest Physicians have drafted ethical recommendations for deciding how to ration lifesaving equipment like ventilators in the event of a pandemic.

The California Department of Public Health in 2008 released guidelines to follow during a health care surge: They don’t specifically address ventilator allocation, but rather resources in general. Doctors should consider the likelihood of survival and change in the quality of life as opposed to the ability to pay or the perception of a person’s worth when there are not enough medical resources to treat everyone in need.

When the New York State Task Force on Life and the Law updated its ventilator allocation guidelines in 2015, it considered the question of withdrawing ventilators from nursing home residents, or chronic ventilator patients, to save the lives of those who grow critically ill during a pandemic.

“Are we comfortable sacrificing this group in exchange for saving more lives?” asked Stuart Sherman, the executive director of the task force at the time.

That question drew much debate, but the group ultimately decided that “chronic” vent patients should not be included in the pool when considering how to allocate ventilators during a pandemic. The task force does recommend prioritizing ventilator therapy based on who is likely to survive using a SOFA ― Sequential Organ Failure Assessment ― score.

Cuomo, whose daily televised news conferences have made “ventilators” a household word, is not making decisions based on those guidelines. The task force report is not a binding policy document, according to a spokesperson from the governor’s office.

In the U.S., there are about 62,000 “full-featured ventilators,” the kind needed to treat the most severe cases of COVID-19. An additional 10,000 to 20,000 ventilators are in the government’s National Strategic Stockpile, and 98,000 basic models, the kind often in nursing homes, exist that could be used in a crisis.

In the simplest terms, ventilators push oxygen into the lungs. The machines in ICUs are more powerful and have better monitoring systems than those in a nursing home.

Kalafer’s patients need ventilators to do the work for respiratory muscles. He said they could be used in a pinch during the pandemic. But the real issue is finding enough staff trained to operate and monitor the machines.

Meanwhile, a group of bioethicists, physicians and public health experts are recommending that in a shortage, health care workers could disconnect people from ventilators who have little or no chance of recovery to put them in service of those who do.

The recommendation is the first of six listed in an article published in the New England Journal of Medicine last month.

It did not consider the people who’ve been on vents long term.

“Honestly, before you emailed me, I thought about those patients but never thought about the actual number and how important that might be,” said Dr. James Phillips, one of the paper’s authors and chief of disaster and operational medicine at George Washington University Hospital.

“For patients who have devastating neurological injury and are deemed to never recover and who require ventilation for the rest of their lives, I think it’s an ethical conversation to have with those families to determine if it’s a more appropriate use of resources,” Phillips said.

One ventilator can save multiple lives. The average time a person sick with COVID-19 who needed a ventilator was 11 days, according to an NEJM article that looked at critically ill patients in the Seattle region. Using that number, eight people could potentially be saved over three months.

It is an especially complex moral dilemma when considering the withdrawal of treatment from someone who has lived several years on a ventilator, said Govind Persad, an assistant professor at the University of Denver Sturm College of Law and one of the authors of the NEJM paper.

Persad offered a hypothetical scenario.

“A 78-year-old grandmother has been on ventilator support for 5 years in a subacute facility and is expected to remain on it for the foreseeable future. Covid-19 has reached a senior apartment complex nearby, and doctors are looking everywhere for more ventilators,” Persad wrote.

“They think one more ventilator would give them a chance of saving another 78-year-old grandmother in the senior apartments who is growing worse with viral pneumonia, and, once she is off the ventilator, to save some of her neighbors, who are not yet sick but who they expect to be sick in a few weeks.”

Who gets the ventilator?

Persad suggested it should go to the grandmother in the senior apartments because she is likely to need less time on the ventilator, enabling the ventilator to be used to save her neighbors later.

As he put it: “We save her in order to save more lives, not because of quality-of-life judgments.”

The real-life decision is more problematic and heart-wrenching.

Nancy Curcio’s daughter Maria, who was born with a disabling form of cerebral palsy, was on a ventilator as an adult in San Diego for about three months in 2004. She was eventually weaned off the machine but lived the remainder of her life in a nursing home with a breathing and feeding tube, unable to walk or talk. She died in 2017 at age 57.

“I would be very upset if a doctor said I have to take her ventilator away for someone to live,” Curcio said. “But I can understand in triage this is what a doctor has to do. Would I like it? No. I would want to run away with the ventilator.”

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Cancer Patients Face Treatment Delays And Uncertainty As Coronavirus Cripples Hospitals

The federal government has encouraged health centers to delay nonessential surgeries while weighing the severity of patients’ conditions and the availability of personal protective equipment, beds and staffing at hospitals.

People with cancer are among those at high risk of complications if infected with the new coronavirus. It’s estimated 1.8 million people will be diagnosed with cancer in the U.S. this year. More than 600,000 people are receiving chemotherapy.

That means millions of Americans may be navigating unforeseen challenges to getting care.

Christine Rayburn in Olympia, Washington, was diagnosed with breast cancer in mid-February. The new coronavirus was in the news, but the 48-year-old did not imagine the outbreak would affect her. Her doctor said Rayburn needed to start treatment immediately. The cancer had already spread to her lymph nodes.

“The cancer tumor seemed to have attached itself to a nerve,” said Rayburn, who was a schoolteacher for many years. “I feel pain from it on a regular basis.”

After getting her diagnosis and the treatment plan from her medical team, Rayburn was focused on getting surgery as fast as possible.

Meanwhile, the coronavirus outbreak was getting worse, and Seattle, just an hour north of where Rayburn lives, had become a national focal point.

Rayburn’s husband, David Forsberg, began to get a little nervous about whether his wife’s procedure would go forward as planned.

“It did cross my mind,” he said. “But I did not want to bother with that possibility on top of everything else.”

Two days before Rayburn’s lumpectomy to remove the tumor, Forsberg said, the surgeon phoned, “pretty livid” with bad news. “She said, ‘Look, they’ve canceled it indefinitely,’” Forsberg remembered.

The procedure had been scheduled at Providence St. Peter Hospital in Olympia, a facility run by Providence Health & Services. Across Washington, hospitals were calling off elective surgeries, in order to conserve the limited supply of personal protective equipment, or PPE, and to prevent patients and staffers from unnecessary exposure to the new coronavirus.

“It just felt like one of those really bad movies, and I was being sacrificed,” Rayburn said.

“It was like we just got cut off from the experts we were relying on,” her husband said.

The hospital said it would review the decision in a few weeks. But Rayburn’s surgeon said that was too long to wait, and they needed to move to Plan B, which was to begin chemotherapy.

Originally, chemotherapy was supposed to happen after Rayburn’s tumor surgery. And rearranging the treatment plan wasn’t ideal because chemotherapy isn’t shown to significantly shrink tumors in Rayburn’s type of breast cancer.

Still, chemotherapy could help stop the cancer from spreading further. But as the couple figured out the new treatment plan, they ran into more obstacles.

“She needed an echocardiogram, except they had canceled all echocardiograms,” said Forsberg.

They spent days on the phone trying to get all the pieces in place so she could start chemotherapy. Rayburn also started writing to her local lawmakers about her predicament.

Hospitals Prioritize Urgent Cases

In mid-March, Washington Gov. Jay Inslee banned most elective procedures, but he did carve out exceptions for certain urgent, life-threatening situations.

“It actually said that it [the ban] excluded removing cancerous tumors,” Rayburn said.

Providence hospitals use algorithms and a team of physicians to figure out which surgeries can be delayed, said Elaine Couture, chief executive of Providence Health in the Washington-Montana region.

“There are no perfect decisions at all in any of this,” said Couture. “None.”

Couture would not talk about specific patients but said she assumes other cases were more urgent than Rayburn’s.

“Were there other patients that even had more aggressive types of cancer that were [surgically] completed?” Couture said. “As sick as you are, there can be other people that are needing something even sooner than you do.”

Couture said hospitals are burning through supplies of masks, gowns and gloves and need to make tough calls about elective procedures.

“I don’t like that, either, and it’s not the way that we want our health care system to work,” Couture said.

Across the Providence hospital system, personal protective equipment is being used much faster than it can be replenished, she said.

No Single Standard

At the American Cancer Society, Deputy Chief Medical Officer Dr. Len Lichtenfeld is hearing from patients across the country who are having their chemotherapy delayed or surgery canceled.

“There was someone who had a brain tumor who was told they would not be able to have surgery, which was, basically, and appears to be a death sentence for that patient,” said Lichtenfeld.

This is uncharted territory for cancer care, he said. Hospitals are making these “decisions on the fly” in response to how the pandemic looks in a particular community. “There is no single national standard that can be applied. I am afraid this is going to become much more common in the coming weeks.”

The cancer society recommends that people postpone their routine cancer screenings — for now.

The American College of Surgeons has published guidance on how to triage surgical care for cancer patients. But Lichtenfeld said every decision ultimately depends on the availability of resources at the hospital and the pressures of COVID-19. In Washington state, which has been hit hard, hospitals are shifting surgical space and beds away from other kinds of treatment.

“We need to forecast two to three weeks down the line when there are more patients that are ill,” said Dr. Steven Pergam, medical director of infection prevention at the Seattle Cancer Care Alliance. “We need to make sure there’s adequate bed capacity.”

Pergam said the care alliance is adjusting treatment plans and, at times, avoiding procedures that would keep cancer patients in the hospital for a prolonged period.

“It really depends on the cancer and the aggressive nature of it,” he said. “We have looked at giving chemotherapy in the outpatient department and changing the particular regimens people get to make them less toxic.”

But Pergam said they expect to keep doing urgent surgeries for cancer patients, even as the pandemic grows worse.

Christine Rayburn in Olympia was steeling herself for the months of chemotherapy to come: staying inside her home and even avoiding contact with her adult daughters, to avoid any possible exposure to the coronavirus.

Then, two weeks ago, the surgeon called again. She had persuaded the hospital to allow the surgery after all, 10 days later than initially planned.

Rayburn and her husband wonder what would have happened if they hadn’t spoken up or pushed to get her lumpectomy back on the hospital’s surgical schedule. Forsberg said it’s possible they could have ended up without the care Rayburn needed.

“If we didn’t say anything, in my mind that may be where we would be at,” he said. “But in our minds, that was not an option.”

This story is part of a partnership between NPR and Kaiser Health News.

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Inside Meals On Wheels’ Struggle To Keep Older Americans Fed During A Pandemic

In the best of times, Meals on Wheels faces the herculean task of delivering 200 million meals annually to 2.4 million hungry and isolated older Americans.

But this is the time of the dreaded novel coronavirus.

With the pandemic bearing down, I wanted to get inside Meals on Wheels to see how it would gear up its services. After all, 79% of its existing clients are 75 or older. There would be more demand now that many more seniors — including those who probably never imagined they’d be stuck inside — are advised it is safest to remain housebound.

What I saw was that this agency, a mainstay in the lives of so many, was swamped. Its ideas of what was possible diminished by the hour, and it has had to improvise, sometimes successfully, to complete its mission.

When I reached out to its press office on March 12, I was optimistic I’d be able to see its local operation, meet its director and volunteers, and maybe even talk to a client or two. While the West Coast was already hunkering down, life was still fairly normal on the East Coast and near its national headquarters in Arlington, Virginia. It would be ideal, of course, to go on a delivery. That was probably too much to ask.

By the next afternoon, a publicist from the headquarters told me, “In an effort to minimize risk, they’re no longer allowing visitors or inviting them into facilities.”

But this, she said, could “illustrate how cautious they’re being and how quickly the situation is escalating.”

That’s OK, I thought.

Not an hour later, another email from a local program director in nearby Alexandria, Virginia: “Things are very dynamic. As a precaution, we are no longer having visitors go along on deliveries.”

He invited me to a meal pickup spot to talk with volunteers, so long as there was “no shaking hands, of course.”

Maybe we could even get a look at meal prep. On the next Monday, four days later, we’d go with a photographer to Jeffery’s Catering, a full-service catering company tucked away in one of Alexandria’s industrial sections.

The novel coronavirus marched on.

About five minutes after I pulled up that Monday, I got a text saying all in-person meetings were canceled. Instead of seeing the director, I drove home to interview him by phone. And I could talk to a volunteer by phone, too. But not a client.

What I couldn’t see, but what I learned, was that Meals on Wheels was desperately — though creatively — struggling to honor its mission. This is also an organization that depends on older volunteers, roughly two-thirds of whom are 65 and up. What if they prefer to stay home for their safety? Or worse, what if they had been struck by this nasty virus, which is particularly deadly for older folks?

The need was overwhelming. Most volunteers were taking shelter. All social norms were upended, with people social distancing and working from home.

By the next Thursday, Vinsen Faris, CEO of Meals on Wheels in San Antonio, was worried. The chapter serves 3,600 meals daily and had lost dozens of corporate volunteers as companies shut down.

With fewer volunteers, staff members would make home deliveries. Faris suspected they’d need to move on to shelf-stable food, like canned fruit and beans and boxed pasta.

He was haunted by the idea that they might not be able to deliver at all.

“I’m up at night wondering: How do we continue to be their lifeline?” Faris said.

Bracing for the worst, the San Antonio group has been providing five extra meals for clients to keep in their refrigerators. It will also distribute emergency meal boxes with four days’ worth of food that can be easily opened and requires little preparation.

In Raleigh, North Carolina, executive director Alan Winstead said that its group would soon scrap fresh, hot meals. They would do more with less: delivering frozen and shelf-stable food. He’d lost 75% of his volunteers.

“I have been with Meals on Wheels for seven years, and this experience — and the need to adapt — is unprecedented,” said Ellie Hollander, CEO of Meals on Wheels America.

But adapt it must. “We will need to provide even more meals than we previously had to,” she said, because requests nationally for new aid are mounting.

Meals on Wheels is informing folks calling for help right now that it can’t take on new applicants until after April 15.

Meal delivery is more complicated, too. Volunteers must wash hands or use sanitizer between stops. They will have their temperature taken, too.

They will place the bag of food on the doorknob, knock on the door and then step back at least 6 feet. Some clients who can’t walk — or who are blind — can’t navigate the trip to the front door. Others aren’t able to bend down to pick up the food. They must wait for the client to come to the door and retrieve the food before leaving.

Rule No. 1: no contact.

The food is critical. But Meals on Wheels offers something just as precious: human connection. Its volunteers offer a conversation. They check in on folks. They might be the first to know that someone’s struggles are getting the best of them. Staff will now reach out by phone to check in.

As Winstead, in Raleigh, puts it: “The social connection is equally important.”

The group’s need for financial assistance is dire. Its COVID-19 Response Fund has raised more than $5 million. Another silver lining: The government has committed $250 million in supplemental funding to feed the needy as part of the Families First Coronavirus Response Act.

With a boost from that, it will hire more drivers and reach out to ride-hailing companies to assist with delivery, said Hollander, the national CEO.

The real possibility of halting all home delivery has Winstead focused on getting as much food as possible to his clients in Raleigh.

“This is a food crisis. This is a community crisis. This crisis challenges every operating procedure we’ve ever had,” he said. “I’m scared.”

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Dispatch From A Country Doctor: Seeing Patients Differently In The Time Of Coronavirus

Patients would often stop by River Bend Family Medicine just to gab with staff at the front desk or bring baked goods to Dr. Matt Hahn.

“I’m a simple country doctor,” said Hahn, who has practiced in Hancock, Maryland, for 20 years ― the past decade at his River Bend office. “Our waiting room is like a social network in and of itself.” Hahn is also a candidate for West Virginia’s 2nd Congressional District though he has backed away from campaigning because of the coronavirus threat.

His waiting room is now closed for the same reason. But Hahn’s practice in this small town — pinned hard up against the borders with West Virginia and Pennsylvania, about 100 miles northwest of Washington, D.C. ― is not.

Patients who need an in-office appointment call when they get to the parking lot and wait there instead. A staff member escorts them in, opening all the doors, telling patients not to touch anything. Those who are ill use one specific entrance, which leads them upstairs where they are met by staff who follow strict infection-control measures. The rest, such as those coming in with a wound or a diabetes checkup, are treated downstairs.

Still, Hahn now sees most of his patients in telehealth appointments, linked to their computers or smartphones. He can do a lot over video and phone, he said. Some things present more of a challenge, though. With rashes, for example, “people are angling their bodies to show a body part to their camera,” said Hahn. “We’ve had some fun with that.”

Humor remains important during this coronavirus crisis. But, jokes aside, Hahn isn’t taking any of it lightly. As of April 6, 37 coronavirus cases were confirmed in Washington County, which encompasses Hancock, and the governor of Maryland on March 30 issued a statewide stay-at-home order.

On March 17, the Trump administration used emergency powers to expand Medicare payments for telemedicine so that more doctors, hospitals and clinics could be paid for such services. While the expansion applies only to Medicare, Hahn said other insurers moved quickly to do the same. Previously, telemedicine coverage was generally limited to people in remote or underserved areas. Even though it’s at least 30 minutes from the nearest hospital, Hancock is not considered remote.

“It’s something we really wanted to do — we didn’t want to shut our doors,” said Hahn, who trained at George Washington University School of Medicine, in Washington, D.C.

Across the country, practices large and small, like River Bend, are enlisting the help of such technological innovations. In addition to the changes to Medicare reimbursement rules, the administration has loosened privacy enforcement for medical providers making “good faith” efforts to use non-public video services: Facebook Messenger is OK, for example, but Facebook Live is not.

Still, online visits are not perfect.

For one thing, internet service can be spotty, Hahn and nurse practitioner Lora Cole said. Another concern: The new rules required the use of both audio and video in consults with patients. But on March 30, the Centers for Medicare & Medicaid Services took an additional step of further loosening telehealth restrictions to allow providers to conduct the telehealth exams for beneficiaries who have audio phones only.

Another concern is that some patients are not that familiar with computers or smartphones, making telehealth consults more challenging, according to Hahn. And a number of them don’t have access to the internet.

For those who do, the staff tries to help them download apps, go to websites, adjust their cameras or turn on the audio.

“The first few days were frustrating. We spent much of the day trying to get people to paste an address into the right line and put in a nine-digit code,” said Hahn.

Part of the problem was they were trying to use a wide variety of different websites or apps. Once they narrowed the choices, the process got easier. Hahn settled on using Google Duo on his phone, while Cole and the other nurses use the web service GoToMeeting in their virtual exam room.

“We give them the code. They click join. It’s a couple of steps that are very quick and easy,” said Cole.

Those who struggle aren’t having problems with the programs themselves, she said, but with maneuvering their smartphone or computer. She and the nurses in the office walk them through it when they can.

“We take a big deep breath,” said Cole. “With some of our patients, we have actually asked them to find someone ― a family member — who can help them.”

The visits themselves work out just fine, even if they are missing a certain, well, human element, both say.

“It has been very hard on my heart,” said Cole, who said her patients know she loves elephants, often bring her presents to add to her collection of pictures, figurines and other tchotchkes. “I miss my patients. I miss being able to see them and give them a hug.”

Clinically, it has limitations, as well.

“I can’t see the entire body. I can’t do a physical exam,” said Hahn. “But, this is a wonderful thing to have right now. Until we have some break in this situation, we want to keep people home. This gives us the opportunity to take care of patients and keep patients safe and staff safe. Under these circumstances, I am not complaining.”

Someday, Hahn and Cole hope things return to normal, whenever that will be.

And what will things look like at River Bend when it’s all over? Will they still rely heavily on video visits? It hasn’t come up yet.

“We just don’t have time to think or even discuss what the future may hold,” said Cole. “We’re just totally focused on what we have to do that day. Personally, I want it to go back. I want to see my patients again.”

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After COVID-19: Doctors Ponder Best Advice As Patients Recover From Coronavirus

When David Vega fell ill with the novel coronavirus in mid-March, fever, chills and nausea left the 27-year-old Indiana medical student curled up in bed for days.

After a test confirmed he had COVID-19, the disease caused by the coronavirus, his doctor advised Vega to isolate himself at home for an additional week. The week passed, and Vega improved. His doctor cleared him to get back to his regular routines without additional testing after he had gone three days without symptoms.

But getting an all-clear from his medical provider has not completely assuaged Vega’s fears. How can he be sure he no longer carries the virus? Is it safe for him to be with others? One of his roommates decided to move out, he said, and still acts cautiously around him.

“Even after the quarantine was over and I felt recovered,” he said in a message, “I felt paranoid and very [conscious] of the fact that I had COVID-19.”

As with so many other aspects of this novel coronavirus, determining when a patient has recovered is still fraught with uncertainties. Although federal officials have issued general guidelines, information about the disease is limited. Physicians said they can’t offer seemingly recovered patients who aren’t retested any guarantees about whether they will be able to transmit the virus.

“I feel that the public is kind of like my 91-year-old mom,” said Dr. Gary LeRoy, president of the American Academy of Family Physicians. The public is “asking these questions, and we as clinicians don’t have the answers like we’re used to.”

This predicament highlights how scientists still lack a complete picture of how COVID-19 is transmitted, doctors said. Generating more data on such mysteries as how much of the virus a person emits at different stages of infection could give doctors a clearer sense of a patient’s risk of sickening others.

The federal Centers for Disease Control and Prevention says doctors can verify whether a patient is healthy enough to leave home isolation in two ways. One method requires patients to test negative from samples taken at least 24 hours apart.

But the nationwide shortage of tests has made it difficult for doctors to vet patients in recovery with an exam, a fact the guidelines acknowledged. Several states including Minnesota have restricted testing to certain populations, such as hospitalized patients and health care workers.

“It’s still kind of an Easter egg hunt for the availability of testing materials and test kits to do COVID-19 tests,” said LeRoy.

The second method allows patients to come out of isolation at least seven days after symptoms begin or after being diagnosed and three days after they are symptom-free.

This option “will prevent most, but may not prevent all instances of secondary spread,” according to the CDC’s website. “The risk of transmission after recovery is likely very substantially less than that during illness.”

The agency declined a request for an interview.

Its recommendation gives state authorities and doctors the flexibility to amend their approach based on their circumstances.

“The guidelines are guidelines,” said Dr. Kathryn Edwards, a professor of pediatrics at Vanderbilt University who specializes in infectious diseases. “But they’re not the Ten Commandments.”

One vital piece of the recovery puzzle several doctors mentioned is figuring out when and how long people with COVID-19 are able to transmit the virus — particularly those who don’t develop symptoms at all.

David Vega, a medical student in Indianapolis who has recuperated from a COVID-19 infection, worries about how safe it is to be around others now, such as when he goes running or grocery shopping. “I think it’s still something in the back of my mind,” he says.(Courtesy of David Vega)

The number of asymptomatic patients could be sizable. CDC director Dr. Robert Redfield said in an interview with NPR that as many as 25% of those who test positive for the virus do not develop symptoms. And patients who eventually develop symptoms may be spreading the virus up to 48 hours before they start feeling ill, he added.

Early research has suggested that patients who have recovered from COVID-19 may also continue to spread the virus.

Even Vega, now symptom-free, said he hesitates to get close to others when he goes on a run or picks up groceries.

“I think it’s still something in the back of my mind,” he said. “I think that it’ll get better with time.”

The need to prevent transmission must be balanced against the benefit of the person returning to their daily life, said Edwards, especially if they are working in an essential industry like health care.

“We’re always between a rock and a hard place,” she said.

Other factors help determine when a patient is ready to leave isolation. A provider may choose to leave a person in home isolation longer if they work with a high-risk population, like the elderly, or if they have a spouse with preexisting conditions, said LeRoy.

Ultimately, medical providers will likely tailor their advice to the patient’s lifestyle, said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.

“These are difficult questions that would likely be dealt with on a case-by-case basis,” he said.

People worried about getting the virus from someone who has recovered or doesn’t have symptoms can reduce their risk by practicing social distancing and good hygiene, such as frequent hand-washing, said Plescia.

Despite the uncertainty, Plescia said, it is important not to ostracize those who have recovered. He is concerned they could become stigmatized.

“In the back of everyone’s mind, whether they want to acknowledge it or not, people are going to be fearful about something they don’t know,” said LeRoy.

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Second Time Around? Health Care Issues Trump Might Tackle If Reelected

If President Donald Trump wins a second term in the White House, what health care policies might the nation expect from his administration?

Julie Rovner, Kaiser Health News’ chief Washington correspondent, examines that issue in the new edition of Washington Monthly magazine.

Although changes in health care might not have ranked high on the president’s priorities for a second term ― particularly if Democrats retain a majority in the House of Representatives — external factors such as the coronavirus pandemic could force the White House and Congress to work together to improve the nation’s public health infrastructure. And the administration might move to weaken the Affordable Care Act through regulations. You can read the article here.

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Young People Weigh Pain Of Job Loss Against Risks Of Virus

Emilio Romero, 23, has mixed feelings about losing his job. It’s a major financial setback, but with two previous hospitalizations for pneumonia, a restaurant was not the safest place for the recent college graduate as the COVID-19 pandemic mushroomed.

“Working in a restaurant, there’s obviously exposure to a lot of people and dirty plates,” Romero said. “Even before I was officially laid off, I was getting pretty nervous about the way everything was playing out, for my own safety.”

Romero worked his last shift as a restaurant host in San Diego’s Little Italy on March 16, the same day San Diego County officials ordered all restaurants to switch to takeout and delivery only. Since then, COVID-19 cases in California have increased by more than 22 times, from 598 to 13,438 as of April 4. If his restaurant asked him back tomorrow, Romero said, he wouldn’t risk it.

Yet he worries about his bank balance, which is barely sufficient to cover one month’s rent and expenses.

He’s considering asking his landlord whether he can break his lease to move back in with his parents. But he hopes a government check from the recently passed $2 trillion stimulus package will allow him to stay put as he continues to study for his real estate license — though it’s another industry jeopardized by the virus-driven economic downturn.

As measures to slow the pandemic decimate jobs and threaten to plunge the economy into a deep recession, young adults such as Romero are disproportionately affected. An Axios Harris survey conducted through March 30 showed that 31% of respondents ages 18 to 34 had either been laid off or put on temporary leave because of the outbreak, compared with 22% of those 35 to 49 and 15% of those 50 to 64.

John Gerzema, CEO of the Harris Poll, said it was important to note that the latest survey data does not factor in the doubling of U.S. jobless claims to over 6.6 million in the past week. That number “would suggest further pain and dislocation to 18-34 years olds,” he said.

But the economic fears of many young people, even ones with uncomplicated medical histories, are increasingly counterbalanced by health worries as they grow more aware of the risks of COVID-19. After hearing for months that it threatens primarily seniors and people with chronic diseases, they are now seeing how it imperils their own age group, with consequences such as lung failure.

“It’s natural that as we learn more, it’ll become clear that there are substantial costs for young people, even if the risks are, in fact, much greater for the elderly,” said Jeffrey Clemens, a health and labor economist at the University of California-San Diego. “Whether people want to work depends in part on other qualities of the job, one of which is whether it comes with serious health, physical or other risks.”

Despite the harsh economic impact, “epidemiologists and economists agree that the isolation is necessary, at least for a short period of time, both to avoid the big spike and to have the number of cases go down ideally to low-enough levels,” said Philip Oreopoulos, a labor economist at the University of Toronto and researcher for the Cambridge, Massachusetts-based National Bureau of Economic Research.

However, long-term unemployment and lower wages, associated with entering the workforce during a prolonged down economy, also carry health risks, including higher mortality, said Oreopoulos, who co-authored a paper on recessions and wages.

“That’s the part that gets me restless at night.”

Quinn Stephens, a student at Santa Barbara City College, lost his job as a restaurant server in March as the COVID-19 pandemic spread. Under California’s statewide stay-at-home order, Stephens is spending his time in his apartment, taking his classes online. He plans to study engineering at California Polytechnic State University-San Luis Obispo in the fall.(Courtesy of Quinn Stephens)

A recent study of the recession of the early 1980s shows that people who entered the labor market at the time later suffered increased mortality, starting in their late 30s, due to causes that included lung cancer, liver disease and drug abuse.

About 20 million people age 24 and younger will either seek work or hold jobs in this pandemic-stricken economy, said UCLA economist Till von Wachter, a co-author of the study.

Economists say it’s too soon to predict how a pandemic-induced recession will affect young people. Nobody knows how long businesses will remain closed, and data on workers is still coming in, said Sarah Anzia, faculty director of the Berkeley Institute for Young Americans at UC-Berkeley’s Goldman School of Public Policy.

But a record-smashing 10 million people applied for unemployment benefits in the U.S. over the past two weeks, and Anzia said service industries such as leisure and hospitality — the first to be hit by the shutdowns — have a large share of young service workers who could feel the impact for years.

For now, many young people are just hunkering down, waiting for the COVID-19 storm to pass.

Quinn Stephens, a 22-year-old student at Santa Barbara City College, lost his job as a server at a hotel restaurant earlier this month. Before that, he had continued going to work even after his managers said employees could turn down shifts if they were nervous about COVID-19. He was trying to save money for tuition, and the gravity of the pandemic had not yet sunk in.

But he’s changed his mind now. “I’d lean toward staying home at this point, because I’m seeing how my actions can affect so many others,” and young people are also being “affected pretty severely” by the virus, Stephens said.

“Going outside and continuing life as normal, right now at least, would be a big mistake that could lead to a lot of people dying.”

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‘You Pray That You Got The Drug.’ Ailing Couple Gambles On Trial For COVID-19 Cure

Josie and George Taylor stand on the porch of their home in Everett, Washington, on March 24. They are two of the first people in the U.S. to recover from novel coronavirus infections after joining a clinical trial for the antiviral drug remdesivir.(Dan DeLong for KHN)

For 10 days last month, they lay in side-by-side isolation units in a Seattle-area hospital, tethered to oxygen and struggling to breathe as the coronavirus ravaged their lungs.

After nearly 52 years of marriage, that was the hardest thing: being apart in this moment, too weak to care for each other, each alone with their anxiety and anguish.

“I worried about my husband a lot,” recalled Josie Taylor, 74, who fell ill a few days before George, 76. “Yes, I was concerned about me, but I was more concerned about what was going to happen to him.”

Despite their personal uncertainty, when a doctor approached the Taylors at their bedsides to ask if they would consent to join a study of an experimental drug to help experts learn to treat the devastating infection, each agreed.

“My answer was absolutely yes,” Josie said. “My feeling was anything I can do to help. Even if you’re stuck in an isolation room, this is affecting so many people and we have to do everything we can.”

In late March, the Taylors were discharged from EvergreenHealth medical center, heading home a few days apart. They returned to their tidy white house in Everett, tired, worn — and wondering if the clinical trial they had joined is the reason they survived the deadly disease.

The couple are among the first patients in the U.S. to recover from COVID-19 after agreeing to participate in a National Institutes of Health randomized controlled trial of remdesivir, an antiviral drug made by Gilead Sciences that once aimed to treat another infectious disease, Ebola.

The study is part of a surge in efforts to beat back the virus that as of Sunday evening had sickened more than 337,000 people in the U.S. and led to more than 9,600 known deaths.

“You pray that you got the drug,” said Josie. “The fact that we both recovered so quickly? You hope that’s the reason why.”

But neither the Taylors nor Dr. Diego Lopez de Castilla, the 41-year-old physician heading the trial at the Kirkland, Washington, hospital, know now whether the couple received injections of remdesivir — or an identical-looking placebo.

Nor do they know whether the investigational drug, designed to stop the virus from replicating, is effective at halting the disease. There are a half-dozen studies in progress across the globe testing remdesivir as a COVID-19 treatment.

At the same time, more than two dozen Phase 3 clinical trials are recruiting participants to study interventions to prevent or treat COVID-19. They range from a tuberculosis vaccine being tested on health care workers to a cancer drug that could prevent the deadly fluid buildup occurring in the lungs of COVID-19 patients.

Other drugs, including those used to treat rheumatoid arthritis and even gout are being tested to see if they reduce the body’s inflammatory response to the infection. A few studies aim to confirm whether treatments touted by President Donald Trump, the antimalarial drugs chloroquine and hydroxychloroquine, are indeed effective against COVID-19.

If any of the trials show overwhelming evidence of benefit or harm, they could be called off, with the drug in question accelerated to general use or halted.

So far, no drug appears to be a certain treatment for COVID-19. Early results regarding remdesivir are expected in late April. Officials with the World Health Organization and many media accounts have suggested the treatment could hold promise. But it’s too soon to say, said Lopez de Castilla.

“I don’t think we have enough data to be commenting,” Lopez de Castilla said. “I think it’s very premature. We’re still enrolling patients in the trial.”

Lopez de Castilla is steering clear of the political turmoil that has surrounded remdesivir and Gilead. The firm in March sought and received federal Food and Drug Administration approval for so-called orphan drug designation, but then asked the agency to rescind the designation after critics accused company officials of unfairly seeking a lucrative monopoly for the drug.

Orphan drug designation gives a manufacturer seven years of market exclusivity, a period that essentially bars competition. Consumer advocates criticized the designation because orphan drug status is aimed at products that target rare diseases, those that affect 200,000 people or fewer. Gilead received the status when U.S. cases were still hovering near 40,000 but were expected to rise far higher.

In the past two weeks, Gilead officials announced that, because of “overwhelming demand,” the company would no longer provide the drug on an individual compassionate-use basis to patients not enrolled in clinical trials and was shifting to a broader-access program.

For now, Lopez de Castilla is focused on the science, working to follow strict protocols set by the National Institute of Allergy and Infectious Diseases study expected to enroll 440 patients across 75 sites.

The double-blind trial calls for participants to receive the active drug or placebo for 10 days, and then to evaluate how they do based on a scale that moves from fully recovered to death. The drugs are given free to hospitals and trial patients. In a public letter March 28, Gilead chief executive Daniel O’Day pledged that the company would work to “ensure affordability and access.”

Since Feb. 21, 40 U.S. sites have joined the Adaptive COVID-19 Treatment Trial, with Lopez de Castilla’s team enrolling among the most patients so far: at least 20 as of April 1.

“We are a community hospital,” he said. “Although we don’t have all the resources that bigger hospitals have, we do have amazing people here.”

Still, it hasn’t been easy. For weeks, EvergreenHealth was at the epicenter of the U.S. outbreak, treating dozens of patients from the Life Care Center nursing home in Kirkland, where nearly 40 patients have died. Overall, the hospital has treated nearly 300 COVID-19 patients since Feb. 28.

The patients enrolled in the trial are among the sickest, Lopez de Castilla said. They’re those who are moderately to critically ill, including some who are unconscious and on ventilators. Obtaining consent to participate in a clinical trial from patients or families grappling with an emergency has been “very challenging,” he said.

“One of the challenges is how to enroll a patient who is already intubated,” he said. “We do this through a family member, someone who can make medical decisions for the patient.”

It can take hours to explain the procedure, describe the side effects — which could include gastrointestinal problems or elevated liver enzymes — and provide detailed information so the patient or their legal representative can make an informed decision.

Patients must understand that they could receive an unproven therapy, he said. And they need to know that, because the trial calls for half of the patients to receive the drug and half to receive a placebo, there’s a 50% chance they won’t actually receive the active drug.

One barrier has been that the trial paperwork is available only in English, which is not the first language of some patients. EvergreenHealth is working with the NIH to create at least one translation in Spanish.

Overall, about half of the patients Lopez de Castilla approached have said no.

The Taylors both fell ill in early March and ended up in a Seattle-area hospital with COVID-19, before deciding to join a clinical trial for an experimental drug. For Josie Taylor, a former second-grade teacher who volunteers for social causes, the decision was easy. “It does have to be studied,” she says. “It can’t be a knee-jerk reaction of ‘Take any medication, without knowing what the results will be.’”(Dan DeLong for KHN)

For Josie Taylor, a former second-grade teacher who volunteers for social causes, the decision to join the trial was easy. “It does have to be studied,” she said. “It can’t be a knee-jerk reaction of ‘Take any medication, without knowing what the results will be.’”

She and her husband, a retired banker, fell ill in early March, just weeks after moving from their home of 40 years to a new community 30 miles north of Seattle. Josie got sick first.

“I went to the grocery store and came out, loaded the stuff in the car and realized I was very short of breath — weirdly so,” she recalled.

She ran a fever that night, called her doctor and went to the emergency room the next morning, where she was quickly placed in isolation.

George Taylor is a Vietnam War veteran who was affected by the defoliant Agent Orange used in that war. He has multiple health problems, including prostate cancer, heart disease and Parkinson’s disease. Within a couple of days, he also fell ill.

George was sent to the ER and then to an isolation room — next to his wife’s. For more than a week, they were both seriously ill, on oxygen, uncertain about the future. “It was 10 or 11 days,” Josie said, adding wryly: “Honestly, you lose track when you’re having fun.”

Contracting the novel coronavirus has been scary. But they were heartened by the support of family, friends, even people they barely knew. “I came home to a brand-new place with brand-new neighbors and our yard had been mowed and edged,” Josie said.

Now that they’re both home, the Taylors are gradually getting back to normal. Josie still speaks slowly, pausing to catch her breath between words. She said she hopes her experience underscores the seriousness of the crisis.

“I’m hoping and praying that this drug helps a lot of people,” she said. “It’s not an old person’s issue. It’s an every person’s issue.”

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