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OCR Issues Guidance on Telehealth Remote Communications Following Its Notification of Enforcement Discretion

HHS Gov News - March 20, 2020

Today, the Office for Civil Rights (OCR) at the U.S Department of Health and Human Services (HHS) issued guidance on telehealth remote communications following its Notification of Enforcement Discretion during the COVID-19 nationwide public health emergency. 

The Notification, issued earlier this week, announced, effective immediately, that OCR is exercising its enforcement discretion to not impose penalties for HIPAA violations against healthcare providers in connection with their good faith provision of telehealth using communication technologies during the COVID-19 nationwide public health emergency. 

The new guidance is in the form of frequently asked questions (FAQs) and clarifies how OCR is applying the Notification to support the good faith provision of telehealth.  Some of the FAQs include:

  • What covered entities are included and excluded under the Notification?
  • Which parts of the HIPAA Rules are included in the Notification?
  • Does the Notification apply to violations of 42 CFR Part 2, the HHS regulation that protects the confidentiality of substance use disorder patient records?
  • When does the Notification expire?
  • Where can health care providers conduct telehealth?
  • What is a “non-public facing” remote communication product?

“We are empowering medical providers to serve patients wherever they are during this national public health emergency,” said Roger Severino, OCR Director.  “We are especially concerned about reaching those most at risk, including older persons and persons with disabilities,” Severino added.

The FAQs on telehealth remote communications may be found at:  https://www.hhs.govhttps://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf

The press release on telehealth remote communications may be found at: https://www.hhs.gov/about/news/2020/03/17/ocr-announces-notification-of-enforcement-discretion-for-telehealth-remote-communications-during-the-covid-19.html

The Notification of Enforcement Discretion on telehealth remote communications may be found at: https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html

For more information on HIPAA and COVID-19, see OCR’s February 2020 Bulletin:  https://www.hhs.govhttps://www.hhs.gov/sites/default/files/february-2020-hipaa-and-novel-coronavirus.pdf

Listen: Front-Line Health Care Workers Face Shortage Of Protective Gear

Kaiser Health News:States - March 20, 2020

California Healthline senior correspondent Anna Maria Barry-Jester appeared on KQED’s “Forum” on Friday to discuss how hospitals are grappling with a shortage of protective gear during the coronavirus pandemic.

Gov. Gavin Newsom on Thursday issued a statewide order for California residents to stay at home. He projected that 56% of the state’s population could be infected by COVID-19 over an eight-week period if mitigation efforts were ignored. In a worst-case scenario, the state would need nearly 20,000 additional hospital beds to deal with a surge in coronavirus patients. Meanwhile, health workers in some Bay Area hospitals are wiping down and reusing masks and other equipment that used to be discarded after each use.

As efforts are underway to ramp up hospital capacity, will health care workers be equipped to help patients?

Click here to listen on KQED’s website.

HHS, DOD coordinate international airlift of COVID-19 supplies

HHS Gov News - March 20, 2020

On Thursday, the Department of Health and Human Services (HHS) and the Department of Defense (DOD) coordinated an emergency international airlift of 500,000 swabs and sample kits used in the COVID-19 testing process in an effort to increase diagnostic testing for Americans.

Copan Diagnostics, Inc., located in Italy, recently informed U.S. government officials they were unable to ship their swabs and sample kits to distributors in the United States due to border closures and flight cancellations in Europe. Recognizing that the company is one of the major suppliers for the U.S. market for sample kits, and the risk this posed to creating a shortage of these critical supplies, the U.S. government took swift action.

Several agencies within the HHS, including the office of the Assistant Secretary for Preparedness and Response and the Food and Drug Administration (FDA), immediately worked in collaboration with the Department of Defense, including its Defense Threat Reduction Agency (DTRA), to airlift the products from Italy to Memphis, Tennessee, a major hub for FedEx. FedEx then shipped the products to multiple diagnostic companies, nationwide to support private sector COVID-19 testing. Copan Diagnostics, Inc. continues to produce COVID-19 testing swabs in sufficient quantity to satisfy Italian need and sell abroad.

“An emergency military delivery of 500,000 collection kits from a manufacturer in Italy who has enough supplies to sell outside Europe is exactly the kind of public-private cooperation and whole-of-government approach that has characterized the Trump Administration’s response to COVID-19,” said HHS Secretary Alex Azar. “Thanks to this quick coordination among agencies and the private sector, private diagnostic companies will have the ability to provide rapid tests for hundreds of thousands of more Americans.”

This kind of successful interagency cooperation is an example of how the Trump Administration’s response to COVID-19 will proceed going forward. Airlifts have now been established to bring swabs and collection kits for COVID-19 to the United States, allowing distribution without interruption.

HHS announces upcoming action to provide funding to tribes for COVID-19 response

HHS Gov News - March 20, 2020

Today, the Department of Health and Human Services (HHS) is announcing upcoming action by the Centers for Disease Control and Prevention (CDC) to provide $80 million in funding to tribes, tribal organizations, and Urban Indian Organizations for resources in support of our nation’s response to the 2019 novel coronavirus (COVID-19). This initial action will be followed by additional funding made available on Wednesday, when President Trump signed the Families First Coronavirus Response Act into law, providing additional funds to the Indian Health Service for COVID-19 testing.

“Our nation’s tribal health leaders are on the front lines of the COVID-19 outbreak and these additional resources will help increase public health capacity for Indian Country,” said CDC Director Robert Redfield.  “This virus presents new challenges and our nation’s public health infrastructure must have the flexibility to implement public health measures to respond aggressively to the outbreak and to protect all Americans.”

As part of this upcoming funding action, CDC will:

  • Supplement an existing CDC Cooperative Agreement to get resources quickly to nine regionally designated tribal organizations, including resources for sub-awards to tribes with the greatest burden and needs in their region and other direct funds to a number of large tribes.
  • Supplement existing funding to the National Council of Urban Indian Health, which will make sub-awards to 41 urban Indian health centers.
  • Supplement existing funding to the National Indian Health Board for COVID-19 communication activities.
  • Issue a new non-competitive grant Notice of Funding Opportunity to reach all Title I and Title V tribes that are eligible to apply for a Federal grant.

For more information about COVID-19, please visit CDC’s website: https://www.cdc.gov/coronavirus/2019-ncov/index.html

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Hoping That Insurance Expansion Will Help Tamp Outbreak, 9 States Reopen Marketplaces

At least nine states are offering their uninsured residents another opportunity to sign up for a health plan this year as they seek new ways to fight the novel coronavirus pandemic.

The states have reopened their health insurance exchanges this month to help ease consumers’ concerns about the cost of health care so that the sick will not be deterred from seeking medical attention and inadvertently spread the virus.

Generally, consumers who buy their own insurance must purchase a policy during the regular open enrollment period in the fall. If they do not buy a plan and do not qualify for a special enrollment period, they cannot obtain health insurance from the exchange until the next open enrollment.

The states that have reopened exchanges — Colorado, Connecticut, Maryland, Massachusetts, Nevada, New York, Rhode Island and Washington — have more flexibility than most states to create a special enrollment period because they run their own health exchanges.

California announced Friday that its exchange, which had been open for reasons unrelated to the outbreak, will continue to allow residents to enroll through June because of the upheaval caused by the coronavirus.

The District of Columbia is also allowing residents to sign up for coverage for reasons unrelated to the outbreak.

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Michael Marchand, chief marketing officer for the Washington Health Benefit Exchange, said uninsured residents who don’t get tested for the novel coronavirus because of the fear of costs for that and treatment would represent an “extremely weak link in the response chain and would make things much worse.”

“The bottom line is, in a pandemic situation, your response will only be as strong as the most vulnerable link in the chain,” he said.

As of 2:30 p.m. ET Friday, more than 16,000 cases of COVID-19 — the disease caused by the virus — had been identified in the United States and over 200 people had died, according to Johns Hopkins University researchers.

Nearly 28 million people in the United States do not have health insurance.

In most of the states, people enrolling now will get coverage starting April 1.

The federal government, which runs the marketplaces for 32 states on healthcare.gov, is not making a similar offer.

Twenty-five senators sent a letter to the Department of Health and Human Services on March 12, urging them to give consumers a special opportunity to enroll.

“It is imperative for patients to receive covered care, regardless of whether they test positive or negative for the virus,” the letter said.

In a statement, the Centers for Medicare & Medicaid Services, which runs the federal marketplaces, said it is not offering a special enrollment period but continues to evaluate options in light of the coronavirus outbreak. It encouraged people to check whether they qualify for a special enrollment period for other reasons, like a job loss that ends their health coverage.

All consumers are allowed to sign up for insurance anytime if they meet certain qualifying conditions, such as losing health coverage, getting married or having a baby.

Seth Merritt, 42, enrolled in a health plan Thursday in Providence, Rhode Island, after losing his job as a bartender when the brewpub closed because of concerns about the spread of the virus, he said.

He was uninsured and didn’t want to deal with medical expense concerns if he contracted COVID-19.

The night he lost his job, Merritt said, he went online to sign up for a plan and he was enrolled the next morning.

“I assumed it would be hard. I assumed it wouldn’t make sense,” he said, but he was pleased it didn’t take long.

Details of the special open enrollment period vary. Some states, like Nevada and Maryland, are making coverage available to people without insurance and those with short-term health insurance that does not offer comprehensive benefits. Massachusetts and Washington, on the other hand, allow enrollments only for people who have no coverage.

The response, state officials said, has been positive. In Rhode Island, nearly 175 people signed up for a plan within the first 72 hours of the special enrollment period, said Lindsay Lang, director of the state’s exchange. Michele Eberle, executive director of Maryland’s health exchange, said more than 1,500 people enrolled in 48 hours. Washington has had 2,970 applications, and 530 people have been enrolled.

“There are things beyond our control that may happen, such as the coronavirus,” said Eberle, “and it’s really helpful to have that peace of mind, such as health insurance.”

Renata Marinaro works with a population whose health insurance status is volatile even under ordinary circumstances: employees in the entertainment industry.

As the national director of health services for the Actors Fund, a nonprofit that offers support services for professional entertainers, Marinaro has seen requests for help skyrocket over the past week as businesses that employ artists are closing. Of the 2,000 calls the organization has received, she said, many are looking for financial help. But insurance is a major concern, too. Because many in the industry face inconsistent work hours and income, she said, they tend to switch plans often or go without coverage.

“We see them moving in and out of many different types of insurance, public and private,” said Marinaro. She said she fears more upheaval ahead.

Whether driven by unemployment or the virus, the demand for health insurance during the special enrollment period could pose a financial risk for insurers in these states, said Sabrina Corlette, a research professor and co-director of the Center on Health Insurance Reforms at Georgetown University. Insurers rely on covering a stable number of people — or risk pool — to calculate how much to charge for health coverage.

A run on health coverage now — after insurers have set prices for plans — could lead to insurers paying out more to cover the sick than they take in.

“The rules of the game changed on them in the middle of the plan year,” said Corlette.

Requests to the Association of Health Insurance Plans, an industry trade group, for comment on the states’ efforts were not returned.

State officials said insurers have been supportive of the move to create a special enrollment period to respond to COVID-19. Nevada has taken steps to mitigate the risk by prohibiting people who lost insurance because they did not pay for their plan on time, said Heather Korbulic, executive director of the state’s exchange. But those people can try to work with their insurer to resume coverage.

Despite the gamble, state officials said they don’t view reopening the exchanges as rewarding residents who ignored regular enrollment efforts. A second chance to get coverage may translate to healthier, younger people buying plans and offsetting the costs of the sick, some said.

However, only time will tell whether the healthy or sick will sign up, said Dr. Charlene Wong, a pediatrician and health care researcher at Duke University.

“It’s hard to know how people are going to behave right now,” Wong said, “because it’s an unusual time.”

California Healthline reporter Rachel Bluth contributed to this article.

Nueve estados reabren mercados de seguros de salud, para ayudar a frenar a COVID-19

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Al menos nueve estados están ofreciendo a sus residentes sin seguro otra oportunidad para inscribirse en un plan de salud para este año, a medida que los gobiernos locales buscan nuevas formas de combatir la pandemia de coronavirus.

Forma parte del grupo de Facebook de Kaiser Health News en español “KHN-Hablemos de Salud”.

KHN-Hablemos de Salud

Los estados han reabierto sus mercados de seguros para ayudar a calmar las preocupaciones de los consumidores sobre el costo de la atención médica, para que las personas que se sienten enfermas no dejen de ir al médico por los costos, y terminen propagando el virus sin darse cuenta.

En general, los consumidores que compran su propio seguro deben hacerlo durante el período regular en el otoño. Si no compran un plan y no califican para un período especial de inscripción, no pueden adquirir un plan en los mercados de seguros hasta la siguiente inscripción abierta.

Los estados que han reabierto los intercambios (Colorado, Connecticut, Maryland, Massachusetts, Nevada, Nueva York, Rhode Island y Washington) tienen más flexibilidad que la mayoría de los estados para crear un período de inscripción especial porque gerencias sus propios mercados de salud.

California anunció el viernes 20 de marzo que su mercado, que había estado abierto por razones ajenas al brote, continuará permitiendo que los residentes se inscriban hasta junio debido a la preocupación generada por el coronavirus.

El Distrito de Columbia también está permitiendo que los residentes se inscriban, pero por razones ajenas al brote.

Michael Marchand, director de marketing de Washington Health Benefit Exchange, uno de los estados que está tomando esta medida, dijo que los residentes sin seguro que no vayan a hacerse la prueba para coronavirus por temor a los costos médicos representarían un “vínculo extremadamente débil en la cadena de respuesta y empeorarían las cosas”.

“El resultado final será que, en una situación de pandemia, la respuesta solo será tan fuerte como el eslabón más vulnerable de la cadena”, dijo.

La Universidad Johns Hopkins tiene un mapa para monitorear el brote minuto a minuto.

Casi 28 millones de personas en los Estados Unidos no tienen seguro de salud.

En la mayoría de los estados, para las personas que se inscriban ahora la cobertura entrará en vigencia el 1 de abril.

El gobierno federal, que administra los mercados de 32 estados en cuidadodesalud.gov, no está haciendo una oferta similar.

Veinticinco senadores enviaron una carta al Departamento de Salud y Servicios Humanos (HHS) el 12 de marzo, instándolos a dar a los consumidores una oportunidad especial para inscribirse.

“Es imperativo que los pacientes reciban atención cubierta, independientemente de si dan positivo o negativo para el virus”, dice la carta.

En un comunicado, los Centros de Servicios de Medicare y Medicaid (CMS), que administran los mercados federales, dijeron que no están ofreciendo un período especial de inscripción, pero continúa evaluando las opciones a la luz del brote de coronavirus. Alentó a las personas a verificar si califican para un período especial de inscripción por lo que se llama “eventos de vida calificados” como la pérdida de cobertura por un despido, un casamiento o el nacimiento de un bebé.

Seth Merritt, de 42 años, se inscribió en un plan de salud el jueves 19 en Providence, Rhode Island, después de perder su trabajo como cantinero cuando el bar en el que trabajaba cerrara debido a las preocupaciones sobre la propagación del virus, contó.

No tenía seguro y no quería lidiar con los gastos médicos si llega a contraer COVID-19.

Merritt contó que, la noche en la que perdió su trabajo, se conectó en línea para inscribirse en un plan y se inscribió a la mañana siguiente.

“Asumí que sería difícil. Supuse que no tendría sentido “, dijo, pero se alegró de que no tomara mucho tiempo.

Los detalles del período especial de inscripción abierta varían. Algunos estados, como Nevada y Maryland, están brindando cobertura a las personas sin seguro y aquellas con seguro de salud a corto plazo que no ofrece beneficios integrales. Massachusetts y Washington, permiten inscripciones solo para personas que no tienen cobertura.

Funcionarios estatales dijeron que la respuesta ha sido positiva. En Rhode Island, casi 175 personas se inscribieron en un plan dentro de las primeras 72 horas del período especial de inscripción, dijo Lindsay Lang, directora del mercado de seguros estatal.

Michele Eberle, directora ejecutiva del intercambio de salud de Maryland, dijo que más de 1,500 personas se inscribieron en 48 horas. Washington ha tenido 2,970 solicitudes y se han inscrito 530 personas.

“Hay cosas más allá de nuestro control que pueden suceder, como el coronavirus”, dijo Eberle, “y es realmente útil tener una tranquilidad como el seguro de salud”.

Renata Marinaro trabaja con una población cuyo estatus de cobertura es volátil incluso en circunstancias normales: empleados en la industria del entretenimiento.

Como director nacional de servicios de salud para el Actors Fund, una organización sin fines de lucro que ofrece servicios de apoyo para artistas profesionales, Marinaro ha visto que las solicitudes de ayuda se disparan a medida que las empresas que emplean artistas están cerrando.

De las 2,000 llamadas que recibió la organización, muchas buscan ayuda financiera, explicó. Pero el seguro también es una preocupación importante. Debido a que muchos en la industria enfrentan horarios e ingresos inconsistentes, tienden a cambiar de planes con frecuencia o no tienen cobertura.

Ya sea impulsada por el desempleo o por el virus, la demanda de cobertura durante el período especial de inscripción podría representar un riesgo financiero para las aseguradoras en estos estados, dijo Sabrina Corlette, profesora de investigación y codirectora del Centro de Reformas de Seguros de Salud de la Universidad de Georgetown. Las aseguradoras confían en cubrir un número estable de personas, o grupo de riesgo, para calcular cuánto cobrar por la atención médica.

Estos consumidores extra también pueden representar una presión para las aseguradoras, que ya tenían los precios establecidos para el año. Funcionarios estatales dijeron que las aseguradoras han apoyado la medida de un período especial de inscripción para responder a COVID-19.

A pesar de la apuesta, los funcionarios estatales dijeron que no ven la reapertura de los mercados como una recompensa para los residentes que ignoraron los esfuerzos regulares de inscripción. Una segunda oportunidad de obtener cobertura puede traducirse en que las personas más jóvenes y saludables compren planes y compensen el gasto de las personas enfermas, dijeron algunos.

Sin embargo, solo el tiempo dirá si los sanos o los enfermos se inscribirán, dijo la doctora Charlene Wong, pediatra e investigadora de salud en la Universidad Duke.

“Es difícil saber cómo se va a comportar la gente en este momento”, dijo Wong, “porque es un momento inusual”.

La reportera de California Healthline Rachel Bluth colaboró con este informe.

Millions Of Older Americans Live In Counties With No ICU Beds As Pandemic Intensifies

More than half the counties in America have no intensive care beds, posing a particular danger for more than 7 million people who are age 60 and up ― older patients who face the highest risk of serious illness or death from the rapid spread of COVID-19, a Kaiser Health News data analysis shows.

This story also ran on USA Today. This story can be republished for free (details). Intensive care units have sophisticated equipment, such as bedside machines to monitor a patient’s heart rate and ventilators to help them breathe. Even in communities with ICU beds, the numbers vary wildly ― with some having just one bed available for thousands of senior residents, according to the analysis based on a review of data hospitals report each year to the federal government.

Consider the homes of two midsize cities: The Louisville area of Jefferson County, Kentucky, for instance, has one ICU bed for every 442 people age 60 or older, while in Santa Cruz, California, that number stands at one bed for every 2,601 residents.

Differences are vast within each state as well: San Francisco, with one bed for every 532 older residents, and Los Angeles, with 847 residents per bed, both have greater bed availability than does Santa Cruz.

Even counties that rank in the top 10% for ICU bed count still have as many as 450 older people potentially competing for each bed.

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The KHN findings put in stark relief a wrenching challenge hospitals in many communities — both urban and rural ― could face during the coronavirus pandemic: deciding how to ration scarce resources.

“This is just another example of geography determining access to health care,” Arthur Caplan, a bioethics professor at NYU Langone Medical Center, said when told of KHN’s findings.

Overall, 18 million people live in counties that have hospitals but no ICU, about a quarter of them 60 or older, the analysis shows. Nearly 11 million more Americans reside in counties with no hospital, some 2.7 million of them seniors.

Dr. Karen Joynt Maddox, a professor at Washington University School of Medicine in St. Louis, said that hospitals with larger numbers of ICU beds tend to cluster in higher-income areas where many patients have private health insurance.

“Hospital beds and ICU beds have cropped up where the economics can support them,” she said. “We lack capacity everywhere, but there are pretty big differences in terms of per capita resources.”

Doctors in rural counties are bracing for the possibility they may run out of critical care beds. Northern Light Sebasticook Valley Hospital, in central Maine, has one ventilator and 25 beds. Two of those are “special care” beds that don’t meet full requirements for intensive care but are reserved for the sickest people. Such patients are often transferred elsewhere, perhaps to the city of Bangor, by ambulance or helicopter.

But that may not be possible if COVID-19 surges across the state “because they’re going to be hit just as hard if not harder than we will be,” said Dr. Robert Schlager, chief medical officer at the hospital in rural Pittsfield. “Just like the nation, we probably don’t have enough, but we’re doing the best we can.”

Hospitals also say they can quickly devise plans to transfer cases they can’t handle to other facilities, though some patients may be too ill to risk the move.

Certainly, being in a county with few or no ICU beds may not be as dire as it seems if that county abuts another county with a more robust supply of such beds.

In Michigan, health planners have determined that rural counties with few ICU beds, such as Livingston and Ionia, in the central part of the state, would be served by major facilities in nearby Lansing or Detroit in a major crisis.

Dr. Peter Graham, executive medical director for Physicians Health Plan in Michigan, is affiliated with Sparrow Health System in Lansing. He is making no assumptions. It’s possible central Michigan could take overflow COVID-19 patients from Detroit if that’s where the disease clusters, he said. Or patients might have to be transferred hundreds of miles away.

“It’s just obvious people are going to need to move” if local facilities are overwhelmed, he said. “If we’re able to find a ventilator bed in Indianapolis, in Chicago or Minneapolis or wherever, it is go, get them there!”

Yet experts warn that even areas comparatively rich in ICU beds could be overwhelmed with patients struggling to breathe, a common symptom of seriously ill COVID-19 patients.

“No matter how you look at it, the numbers [of ICU beds] are too small,” said Dr. Atul Grover, executive vice president of the Association of American Medical Colleges. “It’s scary.”

Lenard Kaye, director of the University of Maine Center on Aging, a state with a large older population and relatively few ICU beds, agreed. “The implications are tremendous and very troubling,” he said. “Individuals are going to reach out for help in an emergency, and those beds may well not be available.”

Health workers might need to resort to “triaging and tough decisions,” Kaye said, “on who beds are allocated to.”

That concern isn’t lost on Linnea Olsen, 60, who has lung cancer and knows she is especially vulnerable to any respiratory virus.

Olsen worries about a potential shortage of ventilators and ICU beds, which could lead doctors to ration critical care. Given her fragile health, she fears she wouldn’t make the cut.

“I’m worried that cancer patients will be a low priority,” said Olsen, a mother of three adult children, who lives in Amesbury, Massachusetts.

Olsen, who was diagnosed with lung cancer almost 15 years ago, has survived far longer than most people with the disease. She is now being treated with an experimental medication — which has never been tested before in humans ― in an early-stage clinical trial. It’s her fourth early clinical trial.

“I’m no longer young, but I still would argue that my life is worthwhile, and my three kids certainly want to keep me around,” she said.

She said she has “fought like hell to stay alive” and worries she won’t be given a fighting chance to survive COVID-19.

“Those of us with lung cancer are among the most vulnerable,” Olsen said, “but instead of being viewed as someone to be protected, we will be viewed as expendable. A lost cause.”

Overall, 26 million people live in counties with hospitals but no ICU, about a quarter of them older than 60. Nearly 11 million more Americans reside in counties with no hospital, some 2.7 million of them seniors.

The total number of ICU beds nationally varies, depending on which source is consulted and which beds are counted. Hospitals reported 75,000 ICU beds in their most recent annual financial reports to the government, but that excludes Veterans Affairs’ facilities.

The United States has about three times as many ICU beds per capita as Italy and 10 times as many as China, two countries ravaged by COVID-19, according to a new report from the Society of Critical Care Medicine. The supply of ventilators also exceeds other developed countries, another study found. But as with ICU beds, “there is wide variation [in ventilators available] across states,” the study found.

Many experts predict that demand may soon exceed the supply. Over a period of months, the country may need 1.9 million ICU beds — 20 times the current supply ― to treat COVID-19 patients, according to the American Hospital Association.

Dr. Tia Powell, who co-chaired a 2007 New York State Department of Health group that set guidelines for rationing scarce ventilators, said preventing wildfire-like spread of disease is critical to keeping sick patients from overcrowding hospitals.

“If it spreads slowly, you’re much less likely to run short of critical supplies,” she said. “If you need all of your ventilators right now, this week, that’s what makes trouble.”

Even slowing the pandemic does not guarantee hospitals can cope. While some hospitals are planning to treat patients with less serious illness in tents, it’s far more difficult to create intensive care units or even expand existing ones, said Dr. Greg Martin, president-elect of the Society of Critical Care Medicine, which represents intensive care doctors.

Martin said ventilators need to be hooked up to oxygen and gas lines to supply the appropriate mix of air patients need. To convert a standard hospital unit to an ICU, “you would literally need to tear down the wall and run the piping in,” he said.

Few areas — such as operating rooms, emergency department and units used for post-anesthesia care ― have the hookups needed, according to Martin.

Intensive care units also require specially trained doctors, nurses and respiratory therapists. While nurses in other areas of the hospital may care for six patients, ICU nurses typically focus on one or two, Martin said.

“Mechanical ventilation of a fragile patient is rather dangerous if provided by someone other than these trained ICU professionals, which is why mechanical ventilation is not typically done outside of the ICU,” the group said.

Bob Atlas, president and CEO of the Maryland Hospital Association, noted that hospitals and government officials have been discussing ways to boost staffing levels, such as calling on doctors with expired medical licenses, or those licensed to practice in other states, to treat patients in viral hot spots.

Also up for discussion: loosening rules for “scope of practice,” regulations that spell out the duties medical professionals are permitted based on their training.

Atlas and others said they hope steps hospitals have taken to free up beds, such as deferring nonessential surgery, will keep the system from collapsing.

“It’s not as if every Medicare beneficiary will need an ICU bed,” he said. He also said hospitals could wind up treating only the sickest patients.

Greg Burel, the former director of the Strategic National Stockpile, said he hoped that hospitals lacking ICU beds could quickly iron out transfer agreements to move critically ill patients.

“Let’s hope we don’t get there,” he said.

Novant Health Brunswick Medical Center, on North Carolina’s coast, ordered additional ventilators two months ago in case COVID-19 went global. It has six and expects four more, said Shelbourn Stevens, its president. But it has only five intensive care beds among its 74-bed total.

Drawing on decades of experience with emergency care after hurricanes, the hospital’s staff is decreasing elective-surgery cases and preparing to rapidly increase screening for the new coronavirus.

“I’m very comfortable with our plans right now,” Stevens said. “Disaster planning is in our bones, so to speak. Our team knows how to react.”

But the hospital’s critical-care capacity is limited. North Carolina’s Brunswick County, where it is located, has one bed for every 2,436 residents 60 and older. Such a population could overwhelm the facility in a COVID-19 surge.

If necessary, patients could be transferred to the larger New Hanover Regional Medical Center, a short helicopter ride away, in Wilmington, North Carolina, Stevens said. But with 57 intensive care beds, New Hanover County, which includes Wilmington, still ranks in the lower two-thirds of counties for ICU beds per senior residents.

If the pandemic becomes severe, no amount of critical-care beds will be enough, experts say.

“I liken it to sitting on a Gulf shore when a hurricane is offshore,” said Dr. Graham, from Michigan. “It’s a question of how soon and how hard.”

KHN senior correspondent JoNel Aleccia contributed to this report.

METHODOLOGY

Kaiser Health News evaluated the capacity of intensive care unit (ICU) beds around the nation by first identifying the number of ICU beds each hospital reported in its most recent financial cost report, filed annually to the Centers for Medicare & Medicaid Services. KHN included beds reported in the categories of intensive care unit, surgical intensive care unit, coronary care unit and burn intensive care unit.

KHN then totaled the ICU beds per county and matched the data with county population figures from the Census Bureau’s American Community Survey. KHN focused on the number of people 60 and older in each county because older people are considered the most likely group to require hospitalization, given their increased frailty and existing health conditions compared with younger people.
For each county, KHN calculated the number of people 60 and older for each ICU bed. KHN also calculated the percentage of county population who were 60 or older.

KHN’s ICU bed tally does not include Veterans Affairs hospitals, which are sure to play a role in treating coronavirus victims, because VA hospitals do not file cost reports. The total number of the nation’s ICU beds in the cost reports is less than the number identified by the American Hospital Association’s annual survey of hospital beds, which is the other authoritative resource on hospital characteristics. Experts attributed the discrepancies to different definitions of what qualifies as an ICU bed and other factors, and told KHN both sources were equally credible.

The Final Cut

Kaiser Health News:States - March 20, 2020

Antoine Dow cuts a customer’s hair as others wait in line at his barbershop in the Druid Heights neighborhood of West Baltimore.(Nate Palmer for KHN)

This story also ran on The New York Times. This story can be republished for free (details). BALTIMORE — The barber had with him his tools of trade: a black leather smock, a razor, clippers, scissors and tufts of black locks he had collected from the floor of his shop.

He would use them to try to cover the bullet hole that tore through his client’s head.

Antoine Dow owns a barbershop in the Druid Heights neighborhood of West Baltimore and has often been called upon to provide clients who have been gunned down with their final haircut. It’s a ritual that he says helps bring some dignity to the young black men whose lives are disproportionately affected by gun violence, many of whom Dow knew and serviced while they were still alive.

“When I walked into the room and saw his body, I didn’t recognize him because the trauma to the skull was so bad,” Dow said of Deontae Taylor, 20, a young man who was killed last fall. “The entry wound was a hole and the exit wound was sewed up in the back like a football,” he said.

After he finished, he called Taylor’s mother. “I did the best I could do.”

Antoine Dow has been cutting hair for 24 years. Dow, who owns a barbershop in West Baltimore, gives many of his clients their last haircut at local funeral homes, after losing them to gun violence.(Nate Palmer for KHN)

The decline in gun deaths in some major cities across the country has made headlines, but in places like Baltimore, the numbers remain high. There were 348 homicides in Baltimore last year, up more than 12% from the year before, and only five fewer than the record set in 1993. Firearms were involved in 312 of the 348 killings, according to an analysis of the latest numbers in the Baltimore Police Department Crime Stats Open Data database by Kaiser Health News.

Dow has been cutting hair for 24 years. He started when he was 19, giving haircuts to friends in his father’s basement. In 2001, at age 27, he found a small shop with a reasonable rent that had only enough room for one barber. He had the shop remodeled and has been open ever since. On Saturdays, he can be found cutting hair for as many as 70-odd clients, his barber chair positioned at the shop entrance, where he can greet each person as they enter.

On Saturdays, the busiest day at Antoine Dow’s barbershop in the Druid Heights neighborhood of West Baltimore, Dow can be found cutting hair from 6:30 a.m. to as late as 9 p.m., cutting the hair of roughly 72 clients in a single day.(Nate Palmer for KHN)

Tufts of hair lay at the feet of assistant barber Quant’e Boulware inside Antoine Dow’s barbershop in the Druid Heights neighborhood of West Baltimore. Dow has collected and incorporated such hair samples in some postmortem haircuts for his clients.(Nate Palmer for KHN)

“I always wanted my own barbershop. I pretty much knew what I wanted to do, because I enjoyed it, and people would pay me for it,” he said.

The issue of gun violence has followed Dow for years. In 2000, at a barbershop on the corner of Lafayette and Division streets in West Baltimore where he worked, Dow was shot in the leg after he tried to intervene in an argument between a client and another man. His client, Howard Robinson, 35, was shot in the back and died later that day.

Typically, funeral homes dress the bodies of the deceased and cut their hair, if necessary. But sometimes a favored barber is brought in.

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Dow was 26 when he performed his first haircut for a deceased client. In that case, it was an older man who had died of natural causes, circumstances that Dow said are much easier to manage than a shooting victim. He has continued to take on the difficult task of providing haircuts for clients who have been killed, for a straightforward reason, as he sees it — “because I cut their hair while they were alive.”

And as his business has expanded, Dow has hired other barbers who have also learned the trade of post-mortem hair cutting.

Quant’e Boulware, 24, has worked for Dow the past four years and has cut the hair of two customers no longer alive. One was a 2-year-old child who died in a car crash — his godson. “I rather me cut his hair than somebody else,” he said softly.

Quant’e Boulware combs the hair of Davonte Robinson before cutting his hair.(Nate Palmer for KHN)

When clients leave Dow’s shop, he said he tells them to “please be safe,” but he knows that can be hard in a city like Baltimore. He estimates that as many as eight of his clients were murdered in the last year alone.

Dontae Breeden, one of Dow’s younger clients, said that he and his peers often feel invisible in a city where violence is so common and that some young men turn to gun violence out of desperation. “People just want to be known for something,” said Breeden, 22. “They just want recognition.”

Rashad Jones has been a client of Dow’s for three years. In March 2019, he was shot at a bus stop on East Northern Parkway after work. Not only has Jones lost two of his best friends to gun violence this year, but in 2013 his brother was shot and paralyzed from the waist down at age 25.

The barbershop is one of the few places in West Baltimore where Jones, 29, said he feels safe and Dow has tried to provide that comfort to his clients, both in life and in death.

He talks to his clients while cutting their hair, even those who have passed away, like the young man who had been shot in the head.

“I was talking to him while I was cutting his hair, like I do a lot of my deceased clients,” said Dow. “I just said, you know, ‘I hope you rest well.’”

Antoine Dow (center) stands outside his West Baltimore barbershop with one of his assistant barbers, Quant’e Boulware (left), and Dow’s daughter, Akerah Dow, who runs a hair salon across the street from her father’s barbershop.(Nate Palmer for KHN)

KHN reporter Victoria Knight contributed to this article.

Mask Shortage Straps Pharmacists Who Need Them To Keep Medicines Pure

Pharmacy staff who prepare IV drugs inside hospitals are the latest health care workers decrying a shortage of masks as they scramble to prepare medications for patients with everything from cancer to COVID-19.

The staffers wear surgical masks while preparing liquid medications injected into patients’ veins to avoid breathing any droplets of saliva into the formulas, a crucial step in ensuring the medication remains sterile. Pharmacists are also in need of N95 masks to protect them as they counsel patients at hospitals — but tend to be behind front-line medical providers in line for protective gear.

The American Society of Health-System Pharmacists surveyed about 400 members about the shortages.

“I can tell you we had some very concerned members who indicated that they’re in danger of running out,” says Michael Ganio, a pharmacist and director of pharmacy practice and quality with the pharmacists’ group. “Over half said their institution has implemented a conservation plan. It’s something that’s very concerning.”

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Medications that require sterile preparation include those needed for treating COVID-19 patients, such as medications to calm, sedate or paralyze patients on a mechanical ventilator. Other such medications could supply IV nutrition or boost the blood pressure of patients who develop sepsis or shock.

Geriatric and pediatric patients are also frequent recipients of sterile compounded medications because they need doses tailored to their weight or have age-related health problems that require specially made medicine they can tolerate.

The survey of hospital pharmacists, released Thursday, found that 15% of them have already seen a “major or moderate” disruption in surgical mask supplies. That meant they went without masks or used alternatives with “mixed or poor” results.

Nearly 20% of them reported that mask prices were marked up compared with December 2019. And 70% of pharmacists said their organizations had already implemented plans to conserve masks.

To be sure, these conservation efforts are more optimal for pharmacists, who use masks to preserve a sterile environment, than they are for front-line COVID-19 clinicians working in a contaminated environment.

University of Utah Health Hospitals are still receiving masks. But pharmacists are reusing masks for sterile drug preparation to conserve them for other staff members and patients who need them during the outbreak, said Erin Fox, senior director of drug information and support services at the University of Utah Health Hospitals.

“That will allow more PPE [personal protective equipment] to be available for front-line emergency department folks that need it way more than we do,” she said, adding that there’s guidance on how to safely reuse masks.

A tornado that cut through Tennessee this month is making things even more complicated in the state, said Mark Sullivan, the executive director of pharmacy operations for Vanderbilt University Hospital and Clinics in Nashville. That’s because it damaged a warehouse that held hospital supplies.

“We are able to get masks,” he said. “Given the tornado and coronavirus situation, they are obviously in short supply in our area.”

Vanderbilt University Hospital and Clinics are also following guidelines for conserving masks and other personal protective equipment, like gowns and gloves, as demand has spiked, Sullivan said.

“It’s just a tough situation we’re all in, trying to make sure front-line folks have what they all need,” he said. “And behind the scenes, we’re just trying to make sure we have what we need to make safe products for patients.”

Before coronavirus became a reality, pharmacists at NYU Langone Health used to change masks and gowns when they went out on break. Now, if that gear isn’t soiled, they hang it up in a clean room and reuse it, said Arash Dabestani, the hospital’s senior director of pharmacy. His team is also keeping all personal protective equipment in an electronically locked cabinet to control use.

For weeks, hospitals have been getting fewer masks than they ask for from their suppliers. Health care facilities were getting only 44% of the N95 masks and 82% of the surgical masks they ordered, according to a survey released March 2 by Premier, a group-purchasing organization that procures supplies for 4,000 U.S. hospitals and health systems.

Most of the masks sitting in hospitals are redirected to front-line staff who care for patients, said Soumi Saha, a pharmacist who is senior director of advocacy for Premier Inc.

Saha said many state laws require pharmacists to wear masks when mixing sterile compounds. Her fear, she said, is that if the mask shortage is dire enough, hospitals will move to an unregulated way to get those crucial medications to patients: bedside compounding.

That means that clinicians such as nurses would mix the medications right in the patient’s room and put them straight into an IV, she said. She worries such a sudden shift means “we could start seeing a surge in unfortunate patient medication errors and patient harm.”

Premier has asked the federal government to waive the state requirements on pharmacists wearing medical masks to mix compounds or allow them to use industrial masks or expired ones, Saha said.

For now, the choice is up to individual states, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy. He said the national standards-setting organization that advises state boards, called USP, has urged states to make their own risk assessments when weighing whether to waive rules.

So far, California, Iowa and Connecticut have made moves to relax the rules for pharmacists’ personal protective equipment.

Secretary Azar hosts call with counterparts of G7 countries on COVID-19 response

HHS Gov News - March 19, 2020

On Thursday, March 19, Secretary Azar hosted the latest in a series of teleconferences with counterparts from the G7 core countries. The senior officials continued their sharing of information on measures being taken to combat COVID-19, as cases increase in every G7 country. They discussed some of the similar measures that are being taken, including social distancing, travel restrictions, plans for maintaining the availability of necessary medical supplies, optimizing testing procedures, and work on possible vaccines and treatments. The senior officials expressed their hope that these measures and the sharing of outcomes will help slow the spread of the disease, while new capabilities and tools become available to help manage the disease across all countries.

Participants in the call included representatives of:

  • United States of America
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • United Kingdom

Gig Economy Workers Hurt By Coronavirus Eye New Federal Funds For Relief

Kaiser Health News:Insurance - March 19, 2020

Being your own boss can mean missing out on benefits that many employees get on the job: paid leave when you’re sick or caring for a family member. That is scheduled to change under an emergency law enacted Wednesday that would provide financial relief for a broad swath of people affected by the novel coronavirus, including people who are self-employed.

And a few states already offer paid leave programs that can help consultants, gig workers and other self-employed people in times like these. But they won’t provide immediate help for those who haven’t yet signed up.

Provisions in the law signed by President Donald Trump only hours after it got final approval from the Senate would not directly give self-employed people paid leave if they or their families are hit by the virus or their kids can’t go to school because of it. But it would provide a refundable tax credit to help make up for the lost income.

Advocates for self-employed people welcome the proposed changes.

“Self-employed people don’t always get the coverage they need,” said John Arensmeyer, CEO of the Small Business Majority, an advocacy group for small businesses, including self-employed entrepreneurs. “We’re very glad that a number of the federal proposals address them.”

Three states — California, New York and Washington ― offer paid family and medical leave benefit programs that self-employed people can opt into, said Vasu Reddy, a senior policy counsel at the National Partnership for Women & Families, an advocacy group. These plans generally replace some portion of people’s income if they can’t work because of an illness or injury that’s not related to their job, or if they have to care for an ill family member, among other things. Participants generally pay regular premiums to be part of the plan.

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A number of other states, including Massachusetts, Connecticut, Oregon, and the District of Columbia are setting up family and medical leave programs that will cover self-employed individuals, Vasu said. The district will begin paying benefits in July, while the others take effect in subsequent years.

The requirements of these programs vary by state, but people aren’t generally eligible to collect benefits immediately after signing up. The programs, therefore, won’t help people who seek to join now, while their lives are being upended by the coronavirus.

Aruna Lee is one of them. Lee makes and sells several types of kimchi and salsa at San Francisco farmers markets, health food stores and through a grocery delivery service. With restaurants closed and people ordered to stay in as the coronavirus sweeps the city, they’re cooking more at home and driving demand for Lee’s Volcano Kimchi products, she said.

If she became sick with the coronavirus, she would be in trouble.

“I am basically a one-woman operation,” Lee said. “I do the production, sales, delivery, communications, accounting, everything. If I get sick, there is no Volcano Kimchi. I would have to suspend business until I recover.”

But she has not joined California’s benefits program.

In California, self-employed workers enrolled in the program who are sick or quarantined with COVID-19 or those who are caring for a family member affected by the virus can file a disability insurance claim to replace part of their lost income. Weekly benefits range from $50 to $1,300. But in order to collect benefits, self-employed people or an employer must have paid into the program for at least five to 18 months, according to information from the state.

They also have to be aware of the benefits in the first place. Lee said she had no idea such a program existed in California.

Not surprising, said Reddy, since the state hasn’t done much outreach.

“There was a really low awareness of the program until very recently,” she said.

Self-employed people in all parts of the country can buy a private disability insurance policy, but they typically have a three-month waiting period after someone becomes ill or injured before policies begin to pay out, said Carol Harnett, a health and disability consultant in the Raleigh-Durham area of North Carolina.

“The challenge of being a gig worker, freelancer, or consultant is we are so focused on making our business work that we don’t plan all that well for times when we can’t work,” Harnett said.

The latest federal relief law — part of a package of measures designed to help stimulate the economy and aid consumers following the havoc from the coronavirus outbreak ― could provide much-needed financial support during this uncertain time to the roughly 16 million people who are self-employed in the United States.

The law passed Wednesday will make self-employed people who are unable to work or telework because of COVID-19 eligible for a tax credit equal to up to 10 days this year of lost self-employment income, up to $511 per day, if they are subject to a government quarantine, advised by a health care provider to self-quarantine or have symptoms of COVID-19 and are seeking a diagnosis. If they’re caring for someone who is similarly quarantined or are caring for their child whose school has closed, or if their child care provider is unavailable because of COVID-19, they could receive a credit of two-thirds of their lost income, up to $200 per day, for up to 50 days.

Consumer advocates say that the third legislative package aimed at mitigating the economic effects of the novel coronavirus, which is being drafted, should speed up reimbursements for lost income for self-employed people and small businesses.

“These businesses are struggling financially now, and may not be able to wait for a quarterly tax credit for relief,” said Reddy.

In the meantime, companies such as Google and Microsoft have announced that they’ll pay vendors and other hourly workers even if they’re unable to do their jobs because the businesses are closed.

KHN’s ‘What The Health?’: The Affordable Care Act Turns 10

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Read The Interview

Sebelius, Looking Back At ACA, Says The Country’s Never ‘Seen This Kind Of Battle’

Read The Interview Julie Rovner

Kaiser Health News

@jrovner

Read Julie's Stories Mary Agnes Carey

Kaiser Health News

@MaryAgnesCarey

Read Mary Agnes' Stories Joanne Kenen

Politico

@JoanneKenen

Read Joanne's Stories

The Affordable Care Act on March 23 will reach a milestone many thought unlikely — it turns 10.

The past decade for the health law has been filled with controversy and several near-death experiences. But the law also brought health coverage to millions of Americans and laid the groundwork for a shift to a health system that pays for quality rather than quantity.

Yet the future of the law remains in doubt. Many progressive Democrats would like to scrap it in favor of a “Medicare for All” system that would be fully financed by the federal government. Republicans would still like to repeal or substantially alter it. And the Supreme Court recently accepted another case that could invalidate the law in its entirety.

In this special episode of KHN’s “What the Health?” host Julie Rovner interviews Kathleen Sebelius, who was secretary of Health and Human Services during the development, passage and implementation of the health law.

Then Rovner, Joanne Kenen of Politico and Mary Agnes Carey of Kaiser Health News, who have all covered the law from the start, discuss the ACA’s past, present and future.

Among the takeaways from this week’s podcast:

  • Although the creation of the ACA is often attributed to the Obama administration and the Democratic Congress at the time, work on a health care plan actually began well before then with small-group meetings among stakeholders, congressional hearings across the country and efforts by Sen. Ted Kennedy to galvanize interest. Much of those interactions were bipartisan and included industry leaders too.
  • Despite the vehement Republican opposition to the ACA and its many critical junctures (the death of Kennedy and his replacement by Republican Scott Brown; two tight Supreme Court decisions; and the calamitous debut of the marketplace website, among other issues), the law has proved popular. When Republicans gained control of the White House and Congress, their efforts to repeal the law helped focus consumers’ interest on the law and safeguard it.
  • How will the November election affect the law? If President Donald Trump is reelected, he is unlikely to renew the effort to repeal the law, but that doesn’t mean the assault on the law is over. Efforts to change the ACA could continue through the courts and through administrative rulemaking.
  • If a Democrat is elected, modifications to the law are generally expected to be incremental and perhaps deal with changes such as expanding the number of people getting subsidies and fix some glitches in the law.

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcherGoogle PlaySpotify, or Pocket Casts.

Sebelius, Looking Back At ACA, Says The Country’s Never ‘Seen This Kind Of Battle’

KHN’s ‘What The Health?'

The Affordable Care Act Turns 10

Listen to the podcast

Kathleen Sebelius, who served as secretary of Health and Human Services under President Barack Obama, helped lead the administration’s negotiations with Congress over the Affordable Care Act and implementation of the law.

Sebelius, who is also a member of the Kaiser Family Foundation board of directors, recently joined Julie Rovner, Kaiser Health News’ chief Washington correspondent, for a special edition of the “What the Health?” podcast dedicated to the ACA’s 10th anniversary. (Kaiser Health News is an editorially independent program of the foundation.)

Here is a condensed, edited text of that conversation. You can listen to the entire podcast here.

Rovner: How would you describe the U.S. health system’s biggest problems prior to the passage of the ACA?

Sebelius: Well, I think the problems were that we had way too many people who had no insurance coverage at all. So they weren’t accessing preventive care. They didn’t have a regular doctor, often using emergency rooms or no health care at all and finding conditions and diseases at a very late stage. We also had lots of people who are struggling with cost. That was problematic. And I think, as a country, we spent very little focus on preventive health.

Rovner: Remembering back to 2009, what did you see as the most important thing the administration could do to move the debate forward?

Sebelius: First of all, there was a great interest in not repeating what people saw as the mistakes of the Clinton health plan, not holding this legislation closely at the White House and then springing it on Congress. We knew Congress had to own it. There were people in Congress who had been working on health issues for a very long time. They needed to be a part of the conversation.

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And we also had a pretty good state template for improving access to coverage of individuals who didn’t have affordable employer-based coverage in Massachusetts. They had raised the Medicaid income eligibility to almost 300% of poverty and then created a large pool for individuals to buy individual coverage with tax help from the state but made sure that you didn’t have an adverse selection in a risk pool everybody was in.

President Obama didn’t want to start all over again from scratch, didn’t want to disrupt the whole market, but wanted to really fill the gap. And the gap was, what do you do for the lowest income workers? Expand Medicaid. And what do you do for people who are out in the marketplace buying their own coverage, who either need financial help or need insurance companies to play by a different set of rules because everybody in the individual market was medically underwritten? So healthy, well, folks were fine. Other people were either locked out entirely or at least the conditions that they wanted covered were locked out.

Rovner: So previous health proposals had been at least partly bipartisan. But there was a GOP blockade of this entire effort. Did you anticipate that? And how did you have to change your strategy to work around it?

Sebelius: I continued to believe first that we would be able to secure Republican votes in either the House or the Senate. That turned out to be not accurate.

So I kept thinking that once the bill was signed, we would then get Republican support. And the day that the president signed the bill, Republican attorneys general sued on constitutionality. I thought once the Supreme Court made a ruling on constitutionality, we would have broad-based support only to then have the election over the horizon. And that was a major debate in the reelection of President Obama.

I still continued to believe that once you crossed that threshold in November 2012, that then it would be settled. And here we are, days from the 10th anniversary and it’s still being litigated and challenged and fought about. So I don’t think anybody ever has seen this kind of battle over a major piece of legislation that has now been the law for 10 years and has never even been able to secure a technical correction for any of the language glitches. So I’m just totally baffled.

Rovner: Is there anything you wish you’d done differently during the congressional debate?

Sebelius: If we knew we only were going to have Democratic support, I think the bill could have been more progressive. Secondly, I think that President Obama was very convinced that one of the ways to get Republican support and get the country to buy in was assuring people that this would be entirely paid for. And there was a financial ceiling of pay-fors.

That really hindered some of the components of the bill. For instance, I think we would have had more generous subsidies with more money. We would have had a different look at who qualified for unaffordable insurance. It would have been a family picture, not just an individual. All of those decisions were made about money, not about policy.

Rovner: So we know that the bill nearly died at several stages along the way. Was there a moment that you almost gave up hope? And what was the moment where you actually knew it was going to happen?

Sebelius: Well, one of the most interesting rooms I was in during this entire tenure, 5½ years at HHS, was a sort of conference committee, although it was all Democrats, it was the leadership from the House and the leadership of the Senate. We had two very different bills, one that passed the House, one that passed the Senate. And, for about a six-day period, Democratic leadership from the House and the Senate sat in a room and went line by line through the bill with the president as the chief negotiator and rewrote what would have been a compromise bill. And I always found it really outrageous when people would suggest that President Obama didn’t know what was in the bill. I can guarantee you he read every line of both bills. So he knew everything that was in the bill.

We made a deal. We had a great bill and then lost the Massachusetts election [to replace the late Sen. Ted Kennedy] and lost the 60th senator [meaning Republicans had enough senators to stage a filibuster on any action]. At that point, things seemed pretty bleak.

Rovner: In retrospect, how sorry are you that the public option didn’t make it in because of the odd way the bill had to become law?

Sebelius: I think missing the public option was a huge blow, mostly because it would have been a cost lever. It would have forced the private companies to actually compete with what we knew would be a lower-administrative-cost, lower-priced public plan.

Rovner: So if passing a law was hard, implementing the law was harder still. Most people looking from the outside would guess that your worst day was when healthcare.gov crashed on takeoff in October 2013. Was that it or was there something we never even knew about?

Sebelius: Well, between Oct. 1 and Dec. 1 was a very, very, very long eight weeks. It seemed like eight years. The scariest part of that eight weeks was about a three-day period. The initial thought was there was just too much traffic on Day One and people couldn’t get through. By about Day Three it was clear that there were some very fundamental flaws throughout the system, not just at the gateway.

So there was kind of an emergency call for a team of, you know, top-notch tech analysts. And there was probably a three-day period where they were going through from start to finish making an assessment of whether the site could be saved or not, or we would have to start all over again. That was probably the most terrifying moment, because I kept thinking, how in the world would we go back to the president and say, Oh, by the way, we have to start over again?

The good news was they came back and said it can be fixed. It’s going to take eight weeks. We think you could go out in public and say by Dec. 1, we’ll have a functional website, not beautiful, but functional. And that was a pretty terrifying moment because I thought we don’t have two bites at this apple. If we’re wrong again, if it doesn’t work on Dec. 1, we are toast.

Rovner: Now it’s 10 years later, the law is more popular than ever. And yet there are still some big problems in the nation’s health care system, including levels of cost sharing, surprise bills, so that even people who do have insurance are worried about costs when accessing care. Why didn’t the Affordable Care Act fix everything?

Sebelius: Frankly, it probably would have been better to be a government takeover of health care. We got blamed for it. And yet we really didn’t do that. We ran most of this through the private system. So costs are still blossoming out of control. We’ve talked about how the public option would have been a lever for that, which we don’t have. Surprise billing wasn’t even an issue until investment bankers began buying specialty practices and figuring out, Oh, there’s a new way to make money.

And, I also think, often the Affordable Care Act is blamed for employers shifting massive costs onto their employees in employer-based health care plans, which weren’t really tampered with by the Affordable Care Act. That was always to be left alone. So we own all the bad.

Having said that, there are millions of people who have coverage today. Insurers cannot discriminate against people with preexisting health conditions. That’s very good news. I think there is much more universal agreement in the country that health care is a right not tied to your job or your geography. So there has been significant progress made.

Rovner: What are you most proud of having worked on this and having it part of your legacy?

Sebelius: Well, certainly I get stopped every day. I get stopped on airplanes and in grocery stores. And the stories are always very personal. People say to me, aren’t you that health lady? My husband lost his job and we had to buy coverage in the market. And then he could get surgery. And because of you, we could get that coverage. They are breathtaking and heartbreaking stories where people say my life is very different.

One of my favorites is there’s a great little diner on Massachusetts Street in Lawrence, Kansas, where I live. And Meg, who owns the diner, the Lady Bird Diner, said to me a couple of years ago, “You know, this is your diner.” And I said, “Really cool. I’ll take it. What does that mean?” She said, “Well, I was a waitress. I always wanted to have my own place. My husband and I had enough cash set aside,” but she said, “I have a preexisting health condition. He’s a carpenter. So he didn’t have insurance. I had to work in a different job so I could get insurance coverage. And,” she said, “your bill, the Affordable Care Act, made it possible that I could open this business. And now I serve pie every day. And I’m just happy as a clam.”

And I thought: Now that’s a very positive step forward. That’s a great legacy to have.

Amid Pandemic, Programs Struggle To Reach Vulnerable Seniors Living At Home

Kaiser Health News:States - March 19, 2020

Close down group meals for seniors. Cancel social gatherings.

The directive, from the Illinois Department on Aging, sent shock waves through senior service organizations late last week.

Overnight, Area Agencies on Aging had to figure out how to help people in their homes instead of at sites where they mingle and get various types of assistance.

This is the new reality as the COVID-19 virus barrels into communities across America. Older adults — the demographic group most at risk of dying if they become ill ― are being warned against going out and risking contagion. And programs that serve this population are struggling to ensure that seniors who live in the community, especially those who are sick and frail, aren’t neglected.

This vulnerable population far outstrips a group that has received more attention: older adults in nursing homes. In the U.S., only 1.4 million seniors reside in these institutions; by contrast, about 47 million older adults are aging in place. An additional 812,000 seniors make their homes at assisted living facilities.

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While some of these seniors are relatively healthy, a significant portion of them are not. Outside of nursing homes, 15% of America’s 65-and-older population (more than 7 million seniors) is frail, a condition that greatly reduces their ability to cope with even minor medical setbacks. Sixty percent have at least two chronic conditions, such as heart disease, lung disease or diabetes, that raise the chance that the coronavirus could kill them.

But the virus is far from the only threat older adults face. The specter of hunger and malnutrition looms, as sites serving group meals shut down and seniors are unable or afraid to go out and shop for groceries. An estimated 5.5 million older adults were considered “food insecure” — without consistent access to sufficient healthy food ― even before this crisis.

As the health care system becomes preoccupied with the new coronavirus, non-urgent doctors’ visits are being canceled. Older adults who otherwise might have had chronic illness checkups may now deteriorate at home, unnoticed. If they don’t go out, their mobility could become compromised — a risk for decline.

Furthermore, if older adults stop seeing people regularly, isolation and loneliness could set in, generating stress and undermining their ability to cope. And if paid companions and home health aides become ill, quarantined or unable to work because they need to care for children whose schools have closed, older adults could be left without needed care.

Yet government agencies have not issued detailed guidance about how to protect these at-risk seniors amid the threat of the COVID-19 virus.

“I’m very disappointed and surprised at the lack of focus by the CDC in specifically addressing the needs of these high-risk patients,” said Dr. Carla Perissinotto, associate chief for geriatrics clinical programs at the University of California-San Francisco, referring to the Centers for Disease Control and Protection.

In this vacuum, programs that serve vulnerable seniors are scrambling to adjust and minimize potential damage.

Meals on Wheels America CEO Ellie Hollander said “we have grave concerns” as senior centers and group dining sites serving hot meals to millions of at-risk older adults close. “The demand for home-delivered meals is going to increase exponentially,” she predicted.

That presents a host of challenges. How will transportation be arranged, and who will deliver the meals? About two-thirds of the volunteers that Meals on Wheels depends on are age 60 or older ― the age group now being told to limit contact with other people as much as possible.

In suburban Cook County just outside Chicago, AgeOptions, an Area Agency on Aging that serves 172,000 older adults, on Thursday shuttered 36 dining sites, 21 memory cafes for people with dementia and their caregivers, and programs at 30 libraries after the Illinois Department on Aging recommended that all such gatherings be suspended.

Older adults who depend on a hot breakfast, lunch or dinner “were met at their cars with packaged meals” and sent home instead of having a chance to sit with friends and socialize, said Diane Slezak, AgeOptions president. The agency is scrambling to figure out how to provide meals for pickup or bring them to people’s homes.

With Mather, another Illinois organization focused on seniors, AgeOptions plans to expand “Telephone Topics” — a call-in program featuring group discussions, lectures, meditation classes and live performances — for seniors now confined at home and at risk of social isolation.

In New York City, Mount Sinai at Home every day serves about 1,200 older adults who are homebound with serious illnesses and disabilities — an extraordinarily vulnerable group. A major concern is what will happen to clients if home care workers become sick with the coronavirus, are quarantined or are unable to show up for work because they have to care for family members, said Dr. Linda DeCherrie, Mount Sinai at Home’s clinical director and a professor of geriatrics at Mount Sinai Health System.

With that in mind, DeCherrie and her colleagues are checking with every patient on the program’s roster, evaluating how much help the person is getting and asking whether they know someone ― a son or daughter, a friend, a neighbor — who could step in if aides become unavailable. “We want to have those names and contact information ready,” she said.

If caregivers aren’t available, these frail, homebound patients could deteriorate rapidly. “We don’t want to take them to the hospital, if at all possible,” DeCherrie said. “The hospitals are going to be full and we don’t want to expose them to that environment.”

In San Francisco, UCSF’s Care at Home program serves about 400 similarly vulnerable older adults. “Testing [for the coronavirus] is even more of a problem for people who are homebound,” said Perissinotto, who oversees the program. And adequate protective equipment ― gloves, gowns, masks, eye shields — is extremely difficult to find for home-based providers, Perissinotto said, a concern voiced by other experts as well.

To the extent possible, UCSF program staff are trying to do video visits so they can assess whether patients are symptomatic ― feverish or coughing — before going out to their homes. But some patients don’t have the technology that makes that possible or aren’t comfortable using it. And others, with cognitive impairments who don’t have family at home, may not be able to respond appropriately.

At UCSF’s general medicine clinic, nonessential medical visits have been canceled. “I have a lot of older patients with chronic pain or diabetes who otherwise would come in for three-month visits,” said Dr. Anna Chodos, a geriatrician and assistant professor of medicine who practices in the clinic. “Now, I’m talking to them over the phone.”

“I’m less worried about people who can answer the phone and report on what they’re doing,” she said. “But I have a lot of older patients who are living alone with mild dementia, serious hearing issues and mobility impairments who can’t work their phones.”

Funeral Homes, Families Ponder Deaths In The Age Of COVID-19

Kaiser Health News:States - March 19, 2020

As COVID-19 cases spread across the nation, disrupting daily routines for the living, growing numbers of U.S. businesses and families are changing how they deal with the dead.

Funeral homes — already well-versed in ways to prevent disease — are implementing even stricter protocols to handle bodies infected with the novel coronavirus.

Families of people who die from any cause, not just COVID-19, are being asked to scale back how they memorialize their loved ones by changing or postponing funeral services, limiting the number of people who can attend and increasingly using online tools.

“The overwhelming majority of families understand,” said Matt Levinson, president of a Maryland funeral home that is limiting private graveside services to 10 people or fewer to comply with federal guidelines. “They’re not happy about it, but they understand that safety is more important.”

More than 7,700 cases of COVID-19 have been confirmed in the U.S., and more than 115 deaths, although infectious-disease experts say those figures are likely vast undercounts.

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In Washington state, where more than 1,100 people have been infected by the virus and more than 65 have died from the disease, funeral homes in the Seattle area and beyond are bracing for more bodies.

“Once the medical system gets overwhelmed, who’s next?” said Sandra Walker, president of the Washington Cemetery, Cremation and Funeral Association. “That would be us.”

Across the U.S., about 7,800 people die each day from any cause, a number that is only expected to increase. It’s impossible to predict how many people will die from COVID-19 disease, with U.S. estimates ranging from tens of thousands to more than 2 million in a worst-case scenario.

That’s expected to fuel a grim rise in business for mortuaries and crematoriums, said Barbara Kemmis, executive director of the Cremation Association of North America. Nearly 55% of people in the U.S. opt for cremation, with about 40% choosing traditional burials.

“We’ve come out of the flu season and, for much of the U.S., the winter weather, where death rates are usually higher,” Kemmis said. “What a lot of funeral businesses are preparing for now is no slowdown.”

Federal government guidelines banning gatherings of more than 10 people, plus state and local directives ordering residents to shelter in place, will curtail all but the most basic rituals.

In Washington, D.C., Arlington National Cemetery is closed to the general public to stem the spread of infection. Though funerals can still be held there, at least three dozen have been postponed in the past week, said Barbara Lewandrowski, the site’s director of public affairs.

“Each individual family has a personal reason for waiting,” she said.

Jack Mitchell, a spokesman for the National Funeral Directors Association and director of a Baltimore funeral home, had a service scheduled for Thursday at a local retirement center. Amid coronavirus concerns, the center abruptly canceled the reception and post-cremation burial ceremony.

“I’m going to hold the urn and they’ll have the service at a later time,” Mitchell said.

As funeral workers handle more bodies potentially infected with the COVID-19 virus, they’re doubling down on their usual precautions to avoid disease, said Rob Goff, executive director of the Washington State Funeral Directors Association.

“We’re not sure how long the virus will last on deceased human tissue at this point,” he said.

Workers transporting bodies are advised by health officials to place masks over the mouths and noses of those who have died because bodies can exhale the virus when moved. Workers also should use double body bags to contain them, Goff said. Guidelines from the Centers for Disease Control and Prevention call for disinfecting the outside of body bags and following embalming precautions for hard-to-kill viruses.

Funeral homes are discouraging touching or kissing the bodies of people who have died of COVID-19, said Bob Achermann, executive director of the California Funeral Directors Association.

“Those cultures where you may have different customs, such as bathing the body or a shroud, you may think about whether that’s advisable when COVID-19 was the diagnosis,” he said.

More funerals — and the arrangements for them — are being conducted online, Achermann added, to protect staff, families and guests from potential infections.

As a result, demand is surging for virtual funeral webcasts and other online services. Funeral-related websites, including eCondolence.com and shiva.com, have seen a “tremendous increase” in online traffic, said Michael Schimmel, chief executive of Sympathy Brands, an online marketplace.

“People just want to make sure they do the right thing,” he said.

David Lutterman, the chief executive of OneRoom, an international firm that has specialized in livestreaming funerals for the past decade, said the company’s 100,000 weekly views have spiked about 60%.

“It’s almost like the ability to stream a service has suddenly become the most important thing a funeral home can do,” said Lutterman.

Still, the crisis is difficult for families who may not be able to mourn in their usual way. At the Sol Levinson & Bros. funeral home in Pikesville, Maryland, staff members are advising Jewish clientele to forgo the traditional sitting shiva ritual that invites mourners to gather at the family’s home, Levinson said.

In Hayward, California, where a shelter-in-place order is in effect, in-person viewings continue at Chapel of the Chimes, a 61-acre cemetery and funeral home complex. But visitors there are being asked to stagger their arrivals to keep groups smaller than 10, and to follow social-distancing and hygiene guidelines.

“Our families are being incredibly gracious,” said General Manager David Madden, noting that funeral homes are considered essential businesses that can remain open.

Many funeral directors in Washington state are limiting the number of family members allowed in waiting rooms and offices, or they’re conducting business using email, remote document signing and other electronic tools. That means less in-person support for families.

“Typically, when people are grieving, they like to console each other,” Walker said. “It’s already a tough time for families, and this kind of compounds their grief.”

Walker and others are watching closely as public health experts work to slow growing numbers of COVID-19 cases. She’s seen the frightening reports from Italy, where traditional funerals have been outlawed and bodies are piling up in hospital morgues.

She wouldn’t speculate about whether that scenario could happen in the U.S.

“I don’t want to say we’re going to be Italy,” she said. “I just think we have to do one day at a time. I told my team today, It might be one hour at a time.”

A View From The Front Lines Of California’s COVID-19 Battle

On Tuesday, Dr. Jeanne Noble devoted time between patient visits to hanging clear 2-gallon plastic bags at each of her colleagues’ workstations. Noble is a professor of emergency medicine and director of the UC-San Francisco medical center response to the novel coronavirus that has permeated California and reached into every U.S. state.

The bags were there to hold personal protective equipment — the masks, face shields, gowns and other items that health care providers rely on every day to protect themselves from the viruses shed by patients, largely through coughs and sneezes. In normal times, safety protocols would require these items be disposed of after one use. But just weeks into the COVID-19 pandemic, supplies of protective gear at UCSF are already so low that doctors and nurses are wiping down and reusing almost everything except gloves.

“It is not a foolproof strategy at all; we all realize the risk we are taking,” Noble said. But as supplies dwindle, she increasingly finds herself asking the folks in charge of infection control at the hospital if they can make changes to protocols. “As days go by, one regulation after the other goes out,” she said.

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Noble is among the Bay Area physicians applauding the decision this week by seven Bay Area counties and multiple others across California to order residents to shelter in place for the foreseeable future, directives that are upending life for millions of people and shuttering schools and businesses across the state. Without swift and dramatic changes to curb transmission of the virus, hospital officials say, it is just a matter of time before their health systems are overwhelmed.

Interviews with California physicians on the front lines of COVID-19 offer a sobering portrait of a health care system preparing for the worst of a pandemic that could be months from peaking. In the Bay Area, the battle is being waged hospital by hospital, with wide variations in resources.

The tent where Noble tended to patients this week was set up to deal with a recent rise in people showing up with respiratory illness. Even without the coronavirus threat, UCSF’s emergency room is a busy one, and doctors frequently see patients in hallways and other spaces. But the current outbreak makes that close contact unsafe. So instead, everyone who comes to the hospital is being triaged. Most people with fever, cough or shortness of breath are diverted to the tent, which is heated and has negative air pressure to prevent the spread of infection. For now, the pace is manageable, but Noble fears what’s ahead.

Farther south, in Palo Alto, Stanford Medical Center was testing patients with respiratory problems in its parking garage. The private university hospital has more protective gear than the public one in San Francisco; a global scavenger hunt several weeks ago bolstered supplies, though Stanford, too, has adapted protocols to be more sparing with some items.

“We don’t have an unlimited supply,” said Dr. Andra Blomkalns, professor and chair of the Stanford School of Medicine’s Department of Emergency Medicine. “But at least we’re not looking at our last box.”

The entire country is short on protective gear, a result of both the surging demand for such equipment as the virus spreads and the implosion of supply chains from China, where much of the equipment is manufactured.

Noble believes some equipment will need to be made locally. “If the [federal] government doesn’t step in and force manufacturing of these products here now, we are going to run out,” she said.

Empty supply closets affect everyone who needs care, including heart attack victims and people in need of emergency surgery, said Dr. Vivian Reyes, president of the California chapter of the American College of Emergency Physicians and a practicing emergency physician in the Bay Area.

“I know it’s really hard for us Americans because we’re never told no,” she said of the shortfall of supplies. “But we’re not in normal times right now.”

And protective equipment isn’t the only thing in short supply.

Until a few days ago, UCSF had to rely on the San Francisco Department of Public Health for coronavirus testing, and a shortage of test kits meant clinicians could test only the most critically ill. The situation improved March 9, when the university started running tests created in its own lab. First, there were 40 tests a day. By Tuesday, there were 60 to 80. But a new shortage looms: The hospital has just 500 testing swabs left.

Stanford pathologist Benjamin Pinsky built an in-house test that has been approved for use by the federal Food and Drug Administration. Since March 3, Stanford has used it to test more than 500 patients, 12% of whom had tested positive as of Tuesday. The university has been running tests for other hospitals as well, including UCSF. It’s a dramatic improvement from a few weeks ago, when Stanford relied on its county lab.

Blomkalns saw a sick patient in mid-February, before the hospital had its own test kits, who had symptoms of COVID-19 but didn’t qualify for testing under the narrow federal guidelines in place at the time. He went home, only to return to the hospital after his condition deteriorated. This time, he was tested and it came back positive.

In Santa Clara County, home to Stanford, 175 people have tested positive for COVID-19 and six have died. Late last week, the medical center’s emergency department saw the highest number of patients in one day in its history. Blomkalns doubts it’s because there are more cases in her area. “If you don’t test, you don’t have any cases,” she said.

Blomkalns worries about staffing shortages as health care workers are inevitably exposed to the virus. As of Tuesday, one doctor in the Stanford ER had tested positive. At UCSF, six health care providers had.

Not all Bay Area hospitals are seeing a flood of patients. In fact, some have fewer patients than usual, as they have canceled elective surgeries in anticipation of a COVID-19 surge.

The doctors treating COVID-19 patients say nearly all who test positive have a cough. They complain of fatigue, body aches, headaches, runny noses and sore throats. While most people are well enough to recover at home, those who get critically ill tend to do so in their second week of symptoms, and can deteriorate very quickly, several doctors noted. “We are recommending that patients get intubated a little earlier than they might otherwise,” said Reyes.

In general, officials are asking people who have mild cases of COVID-19 to treat their symptoms at home, as they would a cold or flu, and refrain from seeking care at hospitals. People experiencing shortness of breath, however, should definitely go to the emergency room, said Blomkalns.

For children, the criteria may be a bit different. Shortness of breath should trigger a visit, as should altered mental state, excessive irritability, or an inability to eat or drink, said Dr. Nicolaus Glomb, a pediatric emergency care physician at UCSF Benioff Children’s Hospital.

Gov. Gavin Newsom said Tuesday that rough projections suggest the state could need anywhere from 4,000 to 20,000 additional beds to treat patients with serious cases of COVID-19.

The testing problems worry Noble, as do the equipment shortages, but not nearly as much as the potential for a lot of sick people. “I’m mostly worried about a tsunami of very ill patients that we’re not equipped to take care of,” said Noble.

Blomkalns isn’t sure whether or when Stanford might exceed capacity, saying the caseload trajectory may hinge on how aggressively state and national authorities move to cut off routes of community transmission. “It all depends on what happens in the coming weeks and days,” she said. “We know what we need to do, and we’re doing the job.”

KHN Senior Correspondents JoNel Aleccia and Jenny Gold contributed to this report.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Secretary Azar Statement on President Trump’s Invoking the Defense Production Act

HHS Gov News - March 18, 2020

On Wednesday, President Trump signed an executive order invoking the Defense Production Act and delegating to the Secretary of Health and Human Services authority, if necessary, to order the production and distribution of healthcare supplies as they are most needed. HHS Secretary Alex Azar issued the following statement:

“HHS has been working since January with American manufacturers to prepare for responding to the COVID-19 outbreak. We are coordinating closely with private suppliers, healthcare purchasers, and our federal partners like the Commerce Department to ensure that resources are going where they’re needed. President Trump’s bold invocation of the Defense Production Act gives his administration the necessary power to allocate healthcare supplies in the event that such a step is necessary. Through measures like a February notice of procurement for 500 million respirators, the Trump Administration is taking every step necessary to help American industry ramp up production of the products we will need to save lives.”

HHS Announces New Public-Private Partnership to Develop U.S.-Based, High-Speed Emergency Drug Packaging Solutions

HHS Gov News - March 18, 2020

The U.S. Department of Health and Human Services (HHS) has launched a public-private partnership to create a U.S.-based, high-speed, high-volume emergency drug packaging solution using low-cost prefilled syringes.

Working with HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR), the new consortium for Rapid Aseptic Packaging of Injectable Drugs, or RAPID, will enable the Strategic National Stockpile (SNS) to fill and finish, on a rapid basis, hundreds of millions of prefilled syringes to respond quickly and efficiently to widespread health emergencies, such as the novel coronavirus outbreak. Projects are under evaluation to expedite this process and could yield results within six months.

"The ability to deliver vaccines and therapeutic drugs when they are needed the most is among our top priorities. As vaccines and therapeutics become available, we must not be caught short on our capacity to deliver emergency drugs to Americans in need," said HHS Secretary Alex Azar. "The creation of RAPID is the right move at the right time, both for immediate and longer-term national public health emergency needs."

The RAPID consortium is being launched to build a surge capacity network of up to eight domestic facilities for the manufacture of prefilled syringes using a well-established process called Blow-Fill-Seal (BFS). The BFS process features a low cost, high volume, sterile plastic container that holds a pre-filled volume of medicines. This technology is already used for the delivery of billions of doses annually of sterile medicines such as eye drops, nasal sprays, and rotavirus oral vaccines. The RAPID consortium will combine well-established BFS technology with an innovative interlocking needle hub that eliminates the inefficiencies and difficulties of drawing medicines from glass vials. This will help the SNS to reduce its reliance on existing glass vial manufacturing and filling technology with very limited surge capacity.

HHS Assistant Secretary for Preparedness and Response Robert Kadlec commented, "We have been working over the past year on the creation of the RAPID consortium as an essential element of our nation's ability to deliver medicines quickly to large and wide-spread populations affected by a health emergency."

ASPR awarded Apiject Systems America, the public benefit corporation leading RAPID, with an award valued up to $456 million for research and development of BFS prefilled syringes, rapid prototyping and stability testing of select medical countermeasures from the SNS in these devices. Apiject Systems America will recruit the private and philanthropic investment necessary to create year-round domestic manufacturing facilities of aseptic BFS prefilled syringes for population-scale surge response capacity during health emergencies.

About HHS, ASPR and SNS

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. ASPR leads the federal government's healthcare and public health preparedness, response, and recovery efforts.

The SNS is the nation's largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency severe enough to cause local supplies to run out. When state, local, tribal, and territorial responders request federal assistance to support their response efforts, the stockpile ensures that the right medicines and supplies get to those who need them most during an emergency. Organized for scalable response to a variety of public health threats, this repository contains enough supplies to respond to multiple large-scale emergencies simultaneously.

Take A Deep Breath: Making Risk-Based Decisions In The Coronavirus Era

Kaiser Health News:States - March 18, 2020

Just last week, it seemed OK to have lunch out or maybe meet up with friends for a game of pickup soccer.

Now, in the fast-moving world of the coronavirus response, that’s no longer the case. More and better social distancing is required. But what’s still acceptable?

We reached out to public health experts, who, admittedly, vary in their recommendations. But their main message remains: The better individuals are now at social distancing to slow transmission of the virus, the better off we’ll all be eventually.

Already, California has told people 65 and older to stay at home. In the San Francisco Bay Area, where community spread is a growing concern, just about everyone else has been ordered to do so, too. California is also among the states that have ordered restaurants, gyms and other facilities to close. And the Trump administration has instructed Americans to avoid gatherings of more than 10 people for the next 15 days and avoid sit-down meals in bars, restaurants and food courts. More restrictions from states, localities and the federal government could follow.

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In the coming days, those rules and recommendations may expand as federal, state and local health officials weigh conditions on the ground. So what to do now?

“We ought to make risk-based decisions,” said Dr. Georges Benjamin, executive director of the American Public Health Association.

Expect change. Maybe daily. But also take a deep breath. Some things are still all right.

“At the end of the day, we have to take care of our kids, our family, we have to eat,” said Benjamin. “What people ought to do is think about how best to reduce risk and do as many less risky things as they can.”

So what about walking around the neighborhood?

“Yes, but not in groups,” said Benjamin, who added that he would wave at his neighbors while out for a stroll but “would not have a long conversation.”

If you do chat outside, maintain 6 feet of separation.

Dinner parties? Food for those shut in their homes?

“Inviting people over depends on whether or not they have symptoms, whether they have traveled overseas,” Benjamin suggested. “I would not have a BBQ on my deck with a bunch of people.”

If you bring food to a shut-in or a neighbor, “leave it on the porch,” he said, and always, always make sure you wash your hands before preparing the meal.

In a blog post titled “Social distancing: This is not a snow day,” Dr. Asaf Bitton, an assistant professor at the T.H. Chan School of Public Health at Harvard, takes a hard line, recommending no play dates or sleepovers for children. No sharing of toys with other families. Even playing outside with other kids is a no-go “if that means direct physical contact” such as in basketball or soccer.

Limit trips to stores. Cooking food at home, he wrote, is less risky than takeout. Don’t have other families over for dinner.

School closings won’t slow transmission if parents allow close play dates, or even activity on playgrounds, said Elizabeth Stuart, a professor of mental health, biostatistics and health policy at Johns Hopkins Bloomberg School of Public Health, in an interview with KHN.

Playgrounds are a problem because they put children, and their watching parents, in close proximity. There is also a chance the virus could remain on surfaces.

But some people need more flexible guidelines, especially those with young children or those who can’t work from home, such as health care workers.

For them, a “closed-network strategy” might work, Stuart, two epidemiologists and a health policy expert wrote in a piece that ran in USA Today.

That means a small, trusted circle can continue to interact while creating social distance from outsiders. If any member of an individual family within that circle, however, exhibits symptoms, the entire family should isolate — and let everyone else in their circle know.

“The ideal situation is everyone stays home, but that’s just not a reality for a lot of people,” Stuart said in an interview with KHN.

She said friends have asked what to do in specific situations, such as deciding whether a teenager should babysit for another family.

The key, she said, “is to think of the number of unique people you come in contact with.”

Each case involves a judgment call — and an element of risk. Maybe two families share child care, or a teenager babysits for one family. But the teen does not sit for 10 families, she said.

Bitton, in his column, took a tougher stance.

“Even if you choose only one friend to have over, you are creating new links and possibilities for the type of transmission that all of our school/work/public event closures are trying to prevent,” he wrote.

Do get outside every day, he wrote, as “it will be important during these strange times,” but “stay physically away from others.”

Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, agreed.

“We encourage people to go out and exercise, but in a solitary way. Your pickup soccer game, because of a lot of close contact, no. But maybe tennis because there’s a big distance from you and another player,” he said.

Maintain that 6-foot distance, whether outside or if you invite someone into your home, he said. If people come over, wipe down surfaces after they leave. And always wash your hands.

These recommendations — and the stricter ones being imposed in some cities, like San Francisco — are vitally important, Plescia said.

“Social distancing works. If we do it, we can keep the spread from going up. We can get ahead of this and slow it down,” he said.

HHS Supports Mesa Biotech to Develop a Rapid Diagnostic to Detect Novel Coronavirus Infections

HHS Gov News - March 18, 2020

In response to the now global pandemic, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), continues to work with its public-private partners to find solutions to mitigate the public health impact of the coronavirus disease 2019 (COVID-19). Part of this landscape is the immediate need for diagnostics tests that can quickly and accurately diagnose COVID-19 infections in order to identify the virus and mitigate the spread of the disease.

BARDA will provide Mesa Biotech, Inc. of San Diego, California, with technical expertise and $561,330 in immediate funding to pursue eventual Food and Drug Administration (FDA) approval or clearance of its diagnostic test. With BARDA’s support, the company can complete the development work necessary to request Emergency Use Authorization (EUA) from the FDA for the Accula COVID-19 point-of-care test within two months of the award. The Accula COVID-19 diagnostic test requires minimal sample handling, and a 30-minute sample-to-result time.

“Diagnostics are a critical need in the overall strategy to fight this newest global public health threat. We need increased testing capacity in the U.S to rapidly identify, isolate, and treat those infected with COVID-19 in order to limit transmission of the virus, and we need those tests as close to the patients as possible,” said BARDA Director Rick A. Bright, Ph.D. “This partnership is the latest example of our strong commitment to make diagnostic tests available as quickly and broadly as possible for Americans. We are working tirelessly to advance multiple diagnostics to EUA status so healthcare providers can rapidly diagnose and treat patients with COVID-19.”

The Accula COVID-19 test will leverage Mesa Biotech’s Accula Dock instrument that is used with several 510(k)-cleared tests; FDA has categorized the Accula Dock influenza point-of-care test as Clinical Laboratory Improvement Amendments (CLIA) waived. Utilizing the Accula Dock, the new test will provide molecular results indicating the presence of the virus based on nasopharyngeal (back of the nose and throat) swab samples. The diagnostic test is intended for use in clinical and hospital laboratories.

Mesa Biotech’s test is the fourth COVID-19 molecular diagnostic to receive development funding from BARDA. The project was selected through a business-friendly EZ-BAA application process that streamlines the way BARDA collaborates with industry and entrepreneurs. BARDA’s EZ-BAA is open for molecular diagnostic tests that utilize platforms already cleared by the FDA, point-of-care tests to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and tests that detect COVID-19 disease; all submissions require a viable plan to meet the FDA’s EUA requirements.

In addition to the EZ-BAA, BARDA expanded its standard broad agency announcement to accept proposals for advanced development of diagnostics, vaccines, therapeutics and other medical products for use in the current COVID-19 public health emergency response and future coronavirus outbreaks.

There are currently no FDA approved or cleared diagnostics, vaccines, or treatments for COVID-19. However, the FDA authorized emergency use of a several diagnostic tests under its EUA authority. HHS continues to work across the U.S. government to review potential products from public and private sectors to identify promising candidates that could detect, protect against or treat COVID-19 for development and FDA approval/clearance. HHS divisions, including the National Institutes of Health (NIH) and ASPR, are also supporting the development of multiple vaccines and therapeutic treatments for COVID-19.

To obtain information about products in development in the private sector that could be used in responding to COVID-19, the U.S. government launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies being developed for COVID-19.

To shorten the time to apply for product licensure and to reduce the spread of COVID-19, federal agencies are particularly interested in identifying products and technologies that have progressed beyond non-clinical studies, have established domestic large-scale manufacturing capability with commercial Good Manufacturing Practices (cGMP), and have utilized a platform used to manufacture a product already cleared by the FDA.

About HHS, ASPR, and BARDA

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, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance.

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