Even without a Covid-19 vaccine, there’s reason for hope – CNN

Even without a Covid-19 vaccine, there’s reason for hope – CNN

India will be key for developing and scaling up production of Covid-19 vaccine: PM Modi – Livemint

India will be key for developing and scaling up production of Covid-19 vaccine: PM Modi – Livemint

July 9, 2020

"Today also our companies are active in international efforts for development and production of Covid-19 vaccine," Modi said.

The prime minister was speaking at the India Global Week 2020's inaugural session Wednesday, a virtual conference organised in UK. It will also feature a performance "Atmanirbhar Bharat" by Madhu Nataraj and a special 100 birth anniversary concert in tribute to the sitar maestro Ravi Shankar by three of his most eminent students.

In the inaugural speech, Modi also said vaccines made in India are responsible for two-third of the vaccine needs of the world's children.

Earlier this week, the process of conducting clinical trials for Covaxin, the first possible vaccine candidate for Covid-19 rom India, began at the Nizams Institute of Medical Sciences (NIMS) here, a top official of the state-run medical facility said. "We will select healthy individuals and draw blood and send the blood samples to designated labs in New Delhi. They will give the green signal. Then the medicine people will examine and the first shot of the vaccine will be given due observation," NIMS director Dr K Manohar told PTI.

Besides, Indian Council of Medical Research (ICMR) has identified 12 clinical trial sites such as medical institutions and hospitals, including NIMS, and has asked their principal investigators to ensure that the subject enrolment is initiated no later than 7 July.

PM Modi also said, "The pandemic has once again shown that India's pharma industry is an asset not just for India but for the entire world. It has played a leading role in reducing the cost of medicines, especially for developing countries."

He also spoke on this year's performance. He said Aatmanirbhar Bharat is not about being self-contained or closed to the world; it is about being self-sustaining, self-generating:

The India Global Week 2020 is a three-day virtual conference, being held from July 9 to July 11, themed 'Be The Revival: India and a Better New World', and will have 5,000 global participants from 30 nations being addressed by 250 global speakers across 75 sessions.

The other speakers at the three-day event include Dr S Jaishankar, Union External Affairs Minister, PiyushGoyal, Union Minister of Railways, and Commerce and Industry, Lt Gen of JK, GC Murmu, Isha Foundation founder Sadhguru, spiritual leader Sri Sri Ravi Shankar, along with UK's Foreign Secretary Dominic Raab and Home Secretary Priti Patel, US Ambassador to India Ken Juster, among others.

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Coronavirus: Bed Bath & Beyond to close 200 stores as pandemic weighs on sales  as it happened – Financial Times
Novavax Gets $1.6 Billion for Coronavirus Vaccine From Operation Warp Speed – The New York Times

Novavax Gets $1.6 Billion for Coronavirus Vaccine From Operation Warp Speed – The New York Times

July 7, 2020

The federal government will pay the vaccine maker Novavax $1.6 billion to expedite the development of a coronavirus vaccine. Its the largest deal to date from Operation Warp Speed, the sprawling federal effort to make coronavirus vaccines and treatments available to the American public as quickly as possible.

The deal would pay for Novavax to produce 100 million doses of its new vaccine by the beginning of next year if the vaccine is shown to be effective in clinical trials. Thats a significant bet on Novavax, a Maryland company that has never brought a product to market.

With this deal, the federal government has now invested nearly $4 billion in companies pursuing vaccines, but has provided little information about how Operation Warp Speed is spending money, which agencies the funding is coming from or how decisions are being made.

That money has gone to six companies with varying track records and, in many cases, promising but untested technologies. British drugmaker AstraZeneca has received $1.2 billion in federal assistance for its vaccine, which uses a harmless virus to provoke an immune response. Moderna Therapeutics, which has received more than $500 million, also has never brought a product to market and is using a genetic technology that is valued for its speed but has never led to a successful human vaccine.

Some say the administrations strategy backing a variety of approaches, including some that are cutting-edge but may not work is the best way to move quickly in the middle of a deadly pandemic. But critics say the public deserves to know more about how taxpayer money is being spent at this critical moment.

Its a black box, said Peter Maybarduk, the director of the global access to medicines program at Public Citizen, a public interest group. This could be one of the most important medical technologies of our time, and we know very little about how that money is being spent, and what conditions are being placed on it.

Officials have given varying estimates of how many treatments and vaccines are part of Operation Warp Speed, and have declined to give the full list of which companies are participating. Congress has appropriated nearly $10 billion to support development of a coronavirus treatment or vaccine, but Trump administration officials have said that billions more could ultimately be spent, without providing additional details. A flurry of contracts with vaccine and drug manufacturers were recently made public, but the documents were heavily redacted and provided little information about the arrangements with the companies.

Operation Warp Speed leaders analyze all possible therapeutics and vaccine partners, select the most promising candidates, and then follow standard protocol on contract awards and spending, said Michael Caputo, assistant secretary for public affairs at the department of health and human services. While these experts are moving quickly and focused on safety, were putting a lot of effort into assuring transparency while not tangling them up in constant media inquiries.

In an interview on Sunday, Novavaxs president and chief executive, Stanley C. Erck, initially said he was not sure where in the government the $1.6 billion was coming from. A Novavax spokeswoman later said the money was coming from a collaboration between the Health and Human Services Department and the Defense Department.

Adding Novavaxs candidate to Operation Warp Speeds diverse portfolio of vaccines increases the odds that we will have a safe, effective vaccine as soon as the end of this year, Alex M. Azar II, the health and human services secretary, said in a statement.

Until now, new vaccines have taken years to develop, and many vaccines fail in clinical trials when they turn out to be ineffective or to cause serious side effects. Many experts have said the aggressive timelines set by companies and government officials for a coronavirus vaccine are overly optimistic.

Mr. Erck said Novavaxs coronavirus vaccine uses the same technology as its other experimental vaccines, such as one for the flu, that have been tested in late-stage clinical trials. Novavax has recently brought in senior executives from established manufacturers like AstraZeneca and GlaxoSmithKline, he said.

The risk theyre taking is that a company like ours which doesnt have a pipeline of already commercialized products can we get to the big leagues and scale up? he said. And I think theyre placing the bet that we can.

The U.S. investment comes after an international group, the Coalition for Epidemic Preparedness Innovations, awarded up to $388 million to Novavax in May to make its coronavirus vaccine available globally.

Several vaccine experts said Novavaxs vaccine would help diversify the federal portfolio by including another candidate that uses a protein-based vaccine that has worked against other pathogens, like hepatitis B. The Novavax vaccine uses microscopic particles that carry fragments of the coronavirus, prompting the bodys immune system to respond. Sanofi, which has received nearly $31 million in government funding, is also developing a vaccine that is based on viral proteins.

This is a sort of diversification from other approaches, which makes a certain amount of sense, said John P. Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York City. You dont want all of your eggs in one basket.

Mr. Erck said the deal with the United States would allow Novavax to begin manufacturing the vaccines before the company concludes late-stage clinical trials, expected by the end of the year. The company would ensure that 100 million doses enough for 50 million people to receive an initial shot and a booster are delivered by the first quarter of 2021, if its coronavirus vaccine is proved safe and effective. In June, Novavax secured a $60 million contract from the Defense Department to guarantee the delivery of 10 million doses to vaccinate American troops for the coronavirus.

Novavax began early-stage safety trials in Australia in May, and the company has said it expects to make the results available this month. It said it planned to begin so-called Phase 3 efficacy trials by the fall of this year and could release interim data by the end of 2020.

Through its deal with the Coalition for Epidemic Preparedness Innovations, Novavax is also setting up manufacturing in other sites around the world, including in Europe and Asia, to serve populations outside the United States. The company is using its own facilities to scale up manufacturing and will also contract with outside companies, Mr. Erck said.

He and others have noted that more than one vaccine will need to succeed in order to vaccinate the entire world. Right now, we need and want everybodys to work, he said.

Noah Weiland contributed reporting.


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Novavax Gets $1.6 Billion for Coronavirus Vaccine From Operation Warp Speed - The New York Times
A New Generation of Coronavirus Tests Is Coming. Here’s What to Expect. – The New York Times

A New Generation of Coronavirus Tests Is Coming. Here’s What to Expect. – The New York Times

July 7, 2020

Still, the quick tests available now are frequently inaccurate. Although they ensure we can get an answer faster, said Dr. Ibukun Akinboyo, a pediatrician and infectious disease specialist at Duke Universitys School of Medicine, you lose some sensitivity, she said. Its hard to win at both.

In May, a swab-based point-of-care test called Abbott ID Now made headlines when an analysis found that it might miss infections up to 48 percent of the time, despite being promoted by President Trump as highly accurate.

Sensitivity issues also plague antigen tests, which detect pieces of proteins made by the virus, rather than its genes. Antigen tests have been used to detect other airway infections, such as the flu, in less than an hour, and are easy to manufacture en masse. But the convenience comes at a cost: Unlike genetic material, antigens cant be amplified easily. Some antigen tests, including a few that search for influenza viruses, fail to pick up on active infections around 50 percent of the time.

If a Covid antigen test performs like an influenza antigen test, I dont think they will have much utility, said Dr. David Alland, the director of the Center for Emerging Pathogens at Rutgers New Jersey Medical School. Still, he noted, if improved, they could be very promising.

Even imprecise tests have their place in this pandemic, as long as theyre easy to use and distributed widely enough. Should a test miss someone on Monday, maybe youll get them a day or two later, Dr. Wyllie said.

So far, only two companies have received emergency authorization from the F.D.A. for coronavirus antigen tests. One is Quidel, which is, according to a representative, producing millions of tests each month, many of which have been distributed to urgent care centers and medical clinics in the United States. On Monday, a second firm, Becton Dickinson & Company, also entered the fray with a point-of-care antigen test that can reportedly produce results in 15 minutes. While speedy, both Quidels and BDs tests may produce false negatives between 15 and 20 percent of the time.


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A New Generation of Coronavirus Tests Is Coming. Here's What to Expect. - The New York Times
Pooled Testing For Coronavirus Gets Another Look : Shots – Health News – NPR

Pooled Testing For Coronavirus Gets Another Look : Shots – Health News – NPR

July 7, 2020

Specimens collected from multiple people can be combined into one batch to test for the coronavirus. A negative result would clear all the specimens. Nati Harnik/AP hide caption

Specimens collected from multiple people can be combined into one batch to test for the coronavirus. A negative result would clear all the specimens.

Federal health officials are hoping to stretch the supplies used to test for the coronavirus by combining samples from a number of people and running a single test. Chinese health officials used that strategy to rapidly test large populations in Wuhan and Beijing.

The technique, called pooled testing, won't resolve the testing bottlenecks in the United States. But it could help.

The idea is simple. Instead of running a coronavirus test on every specimen that arrives in a lab, take a sample of that specimen and combine it with samples from other specimens. Then run a single test on that pooled sample.

If it comes back negative, you can assume that all of the original samples are negative. A single test has done the work of five or 10, compared with testing the samples individually.

If the pooled test comes back positive, it's then necessary to test each of the original specimens individually and that takes more time and more material. But on the whole, if a lab is testing samples that will be negative at least 90% of the time, the lab comes out ahead using the pooled approach.

"It can be used in any of a number of circumstances, at a community level or even in schools if you wanted to do that," Anthony Fauci said at a recent Senate hearing. Fauci, the nation's top infectious disease doctor, heads the National Institute of Allergy and Infectious Diseases.

This strategy has been used in screening for other viruses, such as HIV, and has already been put to use for COVID-19 in Nebraska.

"The reason why it came up in Nebraska was that we were running out of reagents [testing ingredients] back in mid-March, to be able to run COVID-19 testing in the public health lab," says Peter Iwen, director of the Nebraska Public Health Laboratory.

After convincing himself the technique would work, he got permission from the governor to use this method. He pooled five tests at a time and found that he could run more than twice as many tests with the same materials.

Some health officials have suggested that this technique can vastly increase testing, though unless the virus is rarely present, the savings won't be that substantial.

The Nebraska lab, for example, was able to run more than twice as many tests by pooling five samples. "You can save 50%-60% of the reagents," Iwen says. "You might only be saving 25%-30% of the labor, but you still are saving labor."

There are substantial logistics involved in running these tests. Labs have to keep track of the original specimens and keep track of test results, Iwen says. But large and organized labs can handle these additional steps.

Nebraska actually stopped pooled testing a few weeks ago. An outbreak in meatpacking plants led to a spike in positive test results. It no longer made sense to pool results, since so many of those pools were positive and had to be retested. Iwen says he's developing a method to select groups of samples where positive results will be rare and reserve pooled testing for those cases.

There's another trade-off as well. When labs combine samples, they increase the risk of getting negative results from people who are actually infected.

"That specimen in the pool has been diluted by the rest of the specimens," says Dr. Chris Pilcher, a professor of medicine at the University of California, San Francisco. "So, there's a decrease in the amount of stuff you want to detect in the specimen. And that results in a corresponding decrease in the sensitivity of detection for the test."

Pilcher recently ran an analysis and found it appears to be a manageable problem. He was looking at how quickly viruses arise in samples taken from infected individuals. It turns out that viruses are usually present at high levels, even early in the course of the disease. That means there are relatively few samples with low levels of virus, where concerns about dilution would be greatest.

"You will always lose some proportion of the cases that you could find [if you tested each] individually," he says. But he says the trade-off is worth it if pooling lets you test a lot more people, for example to survey a community or a group of workers or students.

Pilcher explored a system in which samples were pooled in groups of five, and then four or five of those groups were pooled together. If the largest pool tested positive, each of the smaller pools would then be tested. Any that were positive would then require the lab to test all the original specimens.

U.S. Assistant Secretary for Health Adm. Brett Giroir, who is the federal official responsible for wrangling coronavirus testing, says the government is ramping up its efforts to allow pooled testing. He says the initial pooled test could be conducted by a laboratory that hasn't been federally certified, as long as the follow-up testing is performed in a lab that's allowed to run diagnostic tests.

The Food and Drug Administration is developing guidelines for this practice.

Despite the enthusiasm for pooled testing, efficient use of laboratory materials is only one of the challenges in coronavirus testing. Collection swabs and vials can be hard to come by at some labs, and people who want testing can end up in long lines at overworked collection stations. So, pooling alone won't solve the nation's testing woes.

You can contact NPR Science Correspondent Richard Harris at rharris@npr.org.


Here is the original post: Pooled Testing For Coronavirus Gets Another Look : Shots - Health News - NPR
Despite Coronavirus, Federal Workers Head to the Office – The New York Times

Despite Coronavirus, Federal Workers Head to the Office – The New York Times

July 7, 2020

WASHINGTON As coronavirus cases surge around the country and epidemiologists urge caution, the federal government is heading back to work, jeopardizing pandemic progress in one of the few regions where confirmed infections continue to decline: the nations capital.

At the Energy Departments headquarters, 20 percent of employees possibly as many as 600 have been authorized to return on a full- or part-time basis. The Interior Department said in a statement last month that it anticipated about 1,000 workers to soon return daily to its main office near the White House.

The Defense Department has authorized up to 80 percent of its work force to return to office spaces, which could result in as many as 18,000 employees inside the Pentagon building, according to a spokeswoman. Many of them are already there.

Private-sector employers remain hesitant to put workers back in their seats. Restaurant and bar owners around the country are shutting their doors anew. But agency chiefs at the nations largest employer, the 2.1 million-strong federal government, are taking their cues from an impatient President Trump and summoning employees to their desks.

Federal employees have been working throughout the entire pandemic, said Everett Kelley, the national president of the American Federation of Government Employees, the largest union representing federal workers in the District of Columbia. To move them to a work site so the administration can say they reopened the government is irresponsible.

Governments in the capital region are less than enthusiastic about a rush back. Coronavirus cases in Washington, Maryland and Virginia are now holding steady, but just days ago, cases in Washington had been declining.

A panel of public health experts chosen to inform Mayor Muriel E. Bowsers reopening strategy in Washington recommended initially capping office buildings at 25 percent capacity, a threshold some federal agencies will soon exceed. In April, Gov. Ralph Northam of Virginia, Gov. Larry Hogan of Maryland and Ms. Bowser signed a letter urging the Trump administration to continue encouraging telework for the federal work force as much as possible.

And many private employers in the region, like Capital One, have closed their offices to nonessential workers until at least Labor Day.

But federal back-to-work orders are not changing. And that has local epidemiologists worried.

You dont want to negate all of the hard work that the D.C., Maryland, Virginia regions have done to reduce the number of cases of coronavirus in our region, by then returning everyone to work and potentially reversing the trends, said Amanda Castel, an epidemiology professor at George Washington University.

Several agencies are still encouraging some telework while pressing supervisors and managers to identify employees to bring back to offices immediately.

The Energy Department began that process last week. According to a back-to-work order obtained by The New York Times, employees asked to report to the departments offices will be questioned about flulike symptoms or contacts with coronavirus patients. The document did not say whether workers would undergo temperature screenings. It did say that while masks would be provided, employees would be encouraged, but not required, to wear them.

Employees with reservations but without heightened risk factors such as age or pre-existing conditions would still be required to return. Those tapped to come in could be given as little as a weeks notice to prepare.

Beyond the Interior Departments Washington headquarters, which are stirring back to life, department leaders said its bureaus and offices should begin bringing employees back to office spaces to better satisfy operational needs, according to agency work orders.

The department said it was working to provide face coverings but stopped short of requiring them. Employees were asked to voluntarily observe signs stating new occupancy limits in certain rooms and urged to wear masks in crowded spaces where social distancing could not be maintained.

At the I.R.S., we were told that employees were going to be coming back into buildings that had been cleaned, and Ive gotten a number of reports recently where employees have gone back into buildings that were in no way cleaned, said Tony Reardon, the national president of the National Treasury Employees Union, which represents 150,000 federal workers.

I think employees simply feel like the agency doesnt care about them personally, Mr. Reardon said. It is taking a morale that was already low in the federal workplace and driving it even lower.

In returning to normal operations, most federal agencies have chosen to follow the three-phase reopening plan for employers laid out under the Trump administrations Opening Up America Again guidelines. The recommendations provide few details relative to those adopted by many states, which announced a four-phased approach with more surgical regulations for different business sectors resuming daily operations.

The White House plan advises employers to begin reopening in areas where coronavirus cases have fallen for 14 days and where hospitals have not been overwhelmed. In the Washington region, only the District of Columbia can claim continued progress.

Just last week, when daily new cases topped 50,000 nationwide, the governments top infectious disease expert, Dr. Anthony S. Fauci, warned that increases across the South and West threatened regions that were still relatively secure.

When you have an outbreak in one part of the country, even though in other parts of the country they are doing well, they are vulnerable, Dr. Fauci told a Senate committee last Tuesday.

But the government appears undeterred. The Defense Department, which moved to a Phase 2 plan on June 29, could have up to 18,000 employees in their Pentagon seats, according to a spokeswoman. The departments re-entry guide states that random temperature screenings will be given at entrances, all workers must wear a cloth face covering inside the Pentagon, and gatherings must be limited to 50 people or fewer.

In planning for workers to return, agencies are navigating sometimes conflicting guidance from the White House, the Centers for Disease Control and Prevention, the Office of Personnel Management and state and city leaders. The result is a patchwork of plans.

The Department of Homeland Security, for example, is still stressing telework; the United States Citizenship and Immigration Services has given employees the option to extend work from home as late as September.

This is the fallout of not having a countrywide plan for how to go about this and having certain standards that everyone has to meet and adhere to, Professor Castel said.

Many federal agencies operate field offices, bases and satellite centers across states and territories, forcing them to manage reopening in regions with widely differing conditions.

The State Department moved forward in June with Phase 1 guidelines, in part to resume passport processing in some offices outside Washington. But four of its foreign posts had already fully reopened. The department declined to say which missions were fully operational.

For other agencies such as the Department of Veterans Affairs, which operates health centers and offices across all 50 states, a unified reopening strategy is all but impossible.

A central planning solution for resuming regular operations makes no sense here because some areas of the country will take longer to recover, while other areas have seen minimal cases, Robert L. Wilkie, the secretary of veterans affairs, said in a statement in May. Thats why were letting local conditions dictate our next steps.

Spokesmen for several agencies said they were closely monitoring the different postures taken by Virginia and Maryland, from which many federal employees commute.

On Wednesday, Virginia entered the final phase of its reopening plan, even allowing gatherings of up to 250 people. But a spokeswoman for the governor said the state continues to strongly encourage office workers to telework.

Federal officials appear ready to ignore that encouragement.

We think this rush to reopen is very hazardous, said Mr. Kelley, the union president. Employees health should be the No. 1 priority of the agencies, not scoring political points for rushing employees back.

Concerns about the risks facing federal employees have been brewing for months. On April 27, Democrats on the Senate governmental affairs committee sent a letter to the Office of Personnel Management, saying the office had not given federal employees clear advice on how and when to return to office work.

That is still true.

Environmental Protection Agency officials said their reopening plans were devised by local officials in each state, and all E.P.A. facilities and will be evaluated weekly by agency scientists using C.D.C. data. As of last week, the Washington office was still in Phase 1, and the agencys New York-based office began the process of reopening on June 30.

But federal workers noted that since each phase lasts only 14 days, the third and final phase in which the agency will expect employees to return to their offices could occur in August if downward trends continue.

Its just too fast, said Antony Tseng, the president of American Federation of Government Employees Local 3911, the labor union for employees in the E.P.A.s New York office.

The inspector general for the E.P.A. announced on Wednesday an investigation into how the agency was carrying out the Trump administrations reopening plan and the measures it had taken to protect employees.

Without a vaccine, there are still a lot of scared employees, Mr. Tseng said. Its making us feel like we are lab rats.

Mikayla Bouchard, Lisa Friedman, Lara Jakes and Zolan Kanno-Youngs contributed reporting.


The rest is here:
Despite Coronavirus, Federal Workers Head to the Office - The New York Times
Early Coronavirus Testing Restrictions Led To Some Big ER Bills – NPR

Early Coronavirus Testing Restrictions Led To Some Big ER Bills – NPR

July 7, 2020

It wasn't easy in early March to get a test in the U.S. confirming you had the coronavirus scarce availability of tests meant patients had to meet strict criteria linked to a narrow set of symptoms and particular travel history. Ted S. Warren/AP hide caption

It wasn't easy in early March to get a test in the U.S. confirming you had the coronavirus scarce availability of tests meant patients had to meet strict criteria linked to a narrow set of symptoms and particular travel history.

Fresh off a Caribbean cruise in early March, John Campbell developed a cough and fever of 104 degrees. He went to his primary care physician and got a flu test, which came up negative.

Then things got strange. Campbell says the doctor then turned to him and said, "I've called the ER next door, and you need to go there. This is a matter of public health. They're expecting you."

It was March 3, and no one had an inkling yet of just how bad the COVID-19 pandemic would become in the United States.

At the JFK Medical Center near his home in Boynton Beach, Fla., staffers met him in protective gear, then ran a battery of tests including bloodwork, a chest X-ray and an electrocardiogram before sending him home. Because he had not traveled to China a leading criterion at the time for coronavirus testing Campbell was not swabbed for the coronavirus.

When John Campbell developed his first symptoms in early March of what turned out to be COVID-19, doctors didn't give him a confirmatory swab test because he hadn't traveled to China. Because of a loophole in federal rules, that meant his insurer didn't have to cover the diagnostic exams and tests he underwent in the ER at the time. John Campbell hide caption

When John Campbell developed his first symptoms in early March of what turned out to be COVID-19, doctors didn't give him a confirmatory swab test because he hadn't traveled to China. Because of a loophole in federal rules, that meant his insurer didn't have to cover the diagnostic exams and tests he underwent in the ER at the time.

A $2,777 bill for the emergency room visit came the next month.

Now Campbell, 52, is among those who say they were wrongly billed for the costs associated with seeking a COVID-19 diagnosis.

Why insurers aren't paying

While most insurers have promised to cover the costs of testing and related services and Congress passed legislation in mid-March enshrining that requirement there's a catch. The law requires the waiver of patient cost-sharing only when a coronavirus test is ordered or administered.

And therein lies the problem. In the early weeks of the pandemic and through mid-April in many places, testing was often limited to those with specific symptoms or situations, likely excluding thousands of people who had milder cases of the virus or had not traveled overseas.

"They do pay for the test, but I didn't have the test," says Campbell, who appealed the bill to his insurer, Florida Blue. More on how that turned out later.

"These loopholes exist," says Wendell Potter, a former insurance industry executive who is now an industry critic. "We're just relying on these companies to act in good faith."

Exacerbating the problem, many of these patients were directed to go to hospital emergency departments the most expensive place to get care which can result in huge bills for patients.

Insurers say they fully cover costs when patients are tested for the coronavirus, but what happens with enrollees who sought a test but were not given one is less clear.

Kaiser Health News asked nine national and regional insurers for specifics about how they are handling these situations.

Responses to those queries have been mixed. Three UnitedHealthcare, Kaiser Permanente and Anthem say they do some level of automatic review of potential COVID-19-related claims from earlier in the pandemic, while a fourth, Quartz, says it will investigate and waive cost sharing for suspected COVID-19 patients if the member asks for a review. Humana says it is reviewing claims made in early March, but only those showing confirmed or suspected COVID-19. Florida Blue, similarly, says it is manually reviewing claims, but only those involving COVID tests or diagnoses. The remaining insurers point to other efforts, such as routine audits that look for all sorts of errors, along with efforts to train hospitals and doctors in the proper COVID billing codes the providers should use to ensure that their patients aren't incorrectly hit with a bill. Those were Blue Cross Blue Shield of Michigan, CIGNA and the Health Care Services Corp., which operates Blue Cross plans in Illinois, Montana, New Mexico, Oklahoma and Texas.

All nine insurers say patients should reach out to them or appeal a claim if they suspect an error.

To be sure, it would be a complex effort for insurers to go back over claims from March and April, looking for patients who might qualify for a more generous interpretation of the cost waiver because they were unable to get a coronavirus test. And there's nothing in the CARES Act passed by Congress or subsequent guidance from regulatory agencies about what to do in such situations.

Still, insurers could review claims, for example, by looking for patients who received chest X-rays and diagnoses of pneumonia or high fever and cough, checking to see if any might qualify as suspected COVID-19 cases, even if they were not given a diagnostic test, Potter says.

One thing is clear from the responses from insurers to our questions: Much of the burden falls on patients who think they've been wrongly billed it's left to them to call that to the attention of the insurer and the hospital, urgent care center or doctor's office where they were treated.

Some states have broader mandates that could be read to require the waiver of cost sharing even if a COVID-19 test was not ordered or administered, says Sabrina Corlette, a research professor and co-director of the Center on Health Insurance Reforms at Georgetown University.

But no matter where you live, she says, patients who get bills they think are incorrect should contest them.

"I've heard a lot of comments that claims are not coded properly," says Corlette. "Insurers and providers are on a learning curve. If you get a bill, ask for a review."

Scarce tests, rampant virus

In some places, including the state of Indiana, the city of Los Angeles and St. Louis County, Mo., a test is now offered to anyone who seeks one. Until recently, tests were scarce and essentially rationed, even though more comprehensive testing could have helped health officials battle the epidemic.

But even in the early weeks, when Campbell and many others sought a diagnosis, insurers nationwide were promising to cover the cost of testing and related services. That was good public relations and good public health: Removing cost barriers to testing means more people will seek care and thus could prevent others from being infected. Currently, the majority of insurers offering job-based or Affordable Care Act insurance say they are fully waiving copays, deductibles and other fees for testing, as long as the claims are coded correctly. (The law does not require short-term insurance plans to waive cost sharing.) Some insurers have even promised to fully cover the cost of treatment for COVID-19, including hospital care.

But getting stuck with a sizable bill has become commonplace.

"I only went in because I was really sick and I thought I had it," says Rayone Moyer, 63, of La Crosse, Wis., who was extra concerned because she has diabetes. "I had a hard time breathing when I was doing stuff."

On March 27, she went to Gundersen Lutheran Medical Center, which is in her Quartz insurance network, complaining of body aches and shortness of breath. Those symptoms could be COVID-19 related, but could also signal other conditions. While there, she was given an array of tests, including bloodwork, a chest X-ray and a CT scan.

She was billed in May: $2,421 by the hospital, plus more than $350 in doctor bills.

"My insurance applied the whole thing to my deductible," Moyer says. "Because they refused to test me, I've got to pay the bill. No one said, 'Hey, we'll give you $3,000 worth of tests instead of the $100 COVID test,'" she says.

Quartz spokesperson Christina Ott says patients with concerns like Moyer's should call the insurance company's customer service number and ask for an appeals specialist. The insurer, she says, will waive cost sharing for some members who sought a diagnosis.

"During the public health emergency, if the member presented with similar symptoms as COVID, but didn't receive a COVID-19 test and received testing for other illnesses on an outpatient basis, then cost sharing would be waived," she says.

Moyer says she has filed an appeal and was notified by the insurer of a review expected in mid-July. Back in Florida, Campbell filed an appeal of his bill with Florida Blue on April 22 but didn't hear anything until the day after a KHN reporter called the insurer in June to ask about his case.

Then, Campbell received phone calls from Florida Blue representatives. A supervisor apologized, saying the insurer should not have billed him and that 100% of his costs would be covered.

"Basically they said, 'We've changed our minds,'" Campbell says. "Because I was there so early on, and the bill was coded incorrectly."

KHN is a nonprofit, editorially independent program of Kaiser Family Foundation. KHN is not affiliated with Kaiser Permanente.


Link: Early Coronavirus Testing Restrictions Led To Some Big ER Bills - NPR
Coronavirus Cases in U.S. Are Rising, Even as Death Rates Trend Down – The New York Times

Coronavirus Cases in U.S. Are Rising, Even as Death Rates Trend Down – The New York Times

July 7, 2020

Mr. Abbott, a Republican, had previously opposed attempts by Democratic mayors and other local officials to require everyone in their cities to wear masks in public.

In Chicago, Mayor Lori Lightfoot said Thursday that travelers from 15 states with large outbreaks would have to quarantine for two weeks or face up to $7,000 in fines. In Los Angeles County, Calif., where there are more than 2,000 new cases most days, the top public health official said we urgently need to make a change in the trajectory. And in Northern California, where the outlook is also bad, leaders in several counties urged residents to celebrate the Fourth of July at home and not test the limits of the law.

Just because you can does not mean it is safe or that you should rush to do it, said Dr. Matt Willis, the Marin County public health officer.

President Trump plans to celebrate the Independence Day holiday with a fireworks display on Friday at the Mount Rushmore National Memorial in South Dakota. About 7,500 people are expected to attend the outdoor event, where masks will be available but not required.

As the United States headed into the Fourth of July weekend, officials were telling people to hold the partying until next year. The coronavirus has exploded in large parts of the nation: On Thursday, the U.S. set a single-day case record for the sixth time in nine days, with more than 50,000 new cases reported for the first time, according to a New York Times database. The figure topped 55,000 by the end of the day.

Thursdays daily new case total represented an increase of more than 85 percent since two weeks ago, when states were reopening after extensive lockdowns tempered the outbreak, particularly in the hard-hit Northeast. Until last week, the country had not surpassed a record daily total for two months, since 36,738 new cases were reported on April 24.

In a reversal, Gov. Greg Abbott of Texas, one of the worst-hit states in the past week, on Thursday ordered residents in counties with 20 or more virus cases to wear masks in public.


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Ron DeSantis, on the coronavirus: I think weve stabilized at where were at’ – Tampa Bay Times

Ron DeSantis, on the coronavirus: I think weve stabilized at where were at’ – Tampa Bay Times

July 7, 2020

TALLAHASSEE Gov. Ron DeSantis said the growing coronavirus case numbers in Florida are not necessarily a reflection of the outbreak, which he said has stabilized.

I want us to be in May. I want us to be in early June, DeSantis said, referring to the states low rate of positive test results from earlier in the pandemic. We want to get back to that for sure. I think weve stabilized at where were at.

The state reported more than 6,300 new positive cases Monday out of about 44,600 total tests, for a positive test rate of about 14 percent. Thats where the positive rate has remained for about a week as Floridas new reported case numbers continue to climb.

The growing case numbers have coincided with increasing coronavirus-related hospitalizations in the state, as well as a slight uptick in the average weekly death toll.

The state likely wont know the ultimate toll of this recent spike in cases for a few more weeks, public health experts say.

Deaths are a trailing indicator of cases, said Marc Lipsitch, a professor of epidemiology at Harvard Universitys T.C. Chan School of Public Health. Thats because it takes a long time for people to die, relative to when they got infected.

At Mondays news conference in The Villages, DeSantis noted that Floridas positive rate is much lower than the 50 percent rates reported by states such as New York earlier in the outbreak. However, when those New York numbers were reported, the total testing pool was much more limited than it is today in Florida. At the beginning of the coronavirus outbreak, only those people with symptoms could get tested because of a lack of national testing resources.

Thats much different than today. Florida has for weeks encouraged even the asymptomatic to get tested a public health measure that experts say helps officials know the extent of the outbreak.

DeSantis said that although the percent positive figure remains concerning, Floridians can safely go about their lives if they take a few extra health precautions.

Doing the moderate social distancing, doing the basic things will go a long way, the governor said. We need to keep people working, keep society functioning and combat it that way.


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Ron DeSantis, on the coronavirus: I think weve stabilized at where were at' - Tampa Bay Times
Coronavirus Updates: President Trump Wants Nation’s Schools Fully Reopened in the Fall – The Weather Channel

Coronavirus Updates: President Trump Wants Nation’s Schools Fully Reopened in the Fall – The Weather Channel

July 7, 2020

Despite a surging number of new coronavirus cases, President Donald Trump said Tuesday afternoon that he will be putting a lot of pressure on governors to get schools open this fall.

We hope that most schools are going to be open in the fall, Trump said at a White House event called a "National Dialogue on Safely Reopening America's Schools."

We dont want people to make political statements or do it for political reasons. They think its going to be good for them politically, so they keep the schools closed, he said. No way. Were very much going to put pressure on governors and everybody else to open the schools, to get them open.

And its very important. Its very important for our country, its very important for the well being of the student and the parents. So were going to be putting a lot of pressure on you to open your schools in the fall, he said.

Earlier in the day, U.S. Education Secretary Betsy DeVos also told the nation's governors the administration wants schools to reopen fully in the fall.

On a call that included Vice President Mike Pence, DeVos said "a couple of hours of week of online school is not OK."

She also said, "Ultimately, it's not a matter of if it needs to open, it's a matter of how and they must be fully operational and how that happens is best left to education and community leaders."

Their calls to reopen schools came despite Dr. Anthony Fauci, the top U.S. expert on infectious disease and member of the White House Coronavirus Task Force, warned on Monday, "We are still knee-deep in the first wave of this."

In a live-streamed interview with his boss, National Institutes of Health Director Francis Collins, Fauci said circumstances associated with states and cities trying to open up "has led to a situation where we now have record breaking cases.

So within a period of a week and a half, we've almost doubled the number of cases," Fauci said.

In Europe, countries saw cases go up and then come back down to a baseline. But in the U.S., Fauci said, "We went up, never came down to baseline, and now it's surging back up. So it's a serious situation that we have to address immediately.

In the U.S., there have been 2.97 million confirmed cases, according to data compiled by Johns Hopkins University. There have been more than 130,900 deaths in the U.S.

Worldwide, more than 11.7 million infections have been reported with more than 540,157 deaths.

United States:

-The Trump administration has informed the United Nations it is withdrawing the United States from the World Health Organization over its handling of the coronavirus pandemic, The Washington Post reported. The notice was delivered in a letter to UN Secretary General Antonio Guterres, according to the Post.

-On Tuesday, Fauci said he does not foresee the government mandating a coronavirus vaccine for the general public. "I don't see it on a national level, merely because of all the situations you have encroaching upon a person's freedom to make their own choice of their own health, Fauci told Sen. Doug Jones during a Facebook Live event.

-Florida Education Commissioner Richard Corcoran issued a sweeping order saying school districts and charter school governing boards must provide the full array of services that are required by law so that families who wish to educate their children in a brick and mortar school full time have the opportunity to do so. The only option for schools to not be physically open in August is if local Department of Health officials say schools cannot open, according to the emergency order.

-Mississippis Lt. Governor Delbert Hosemann tested positive for the new coronavirus hours after Gov. Tate Reeves announced his own test for the highly contagious virus had come back negative. Over the weekend, House Speaker Philip Gunn, 57, announced he had tested positive for COVID-19.

-Dr. Peter Hotez, dean of tropical medicine at Baylor College of Medicine, told CNN cases of COVID-19 are rising so quickly across parts of the South and Southwest, contact tracing is no longer possible.

-Five people who work in California's state Assembly have tested positive for the coronavirus. Assembly Speaker Anthony Rendon said the Assembly will stay in recess until further notice.

-Maryland biotech company Novavax has been awarded a $1.6 billion contract as part of the government's "Operation Warp Speed" COVID-19 vaccine program. It is the fourth company to receive federal funds to conduct large-scale Phase 3 clinical trials and manufacturing of the vaccine. The others are AstraZeneca, Moderna and Johnson & Johnson.

-Immigration and Customs Enforcement announced that international students who are pursuing degrees in the United States will have to leave the country or risk deportation if their universities switch to online-only courses.

-Atlanta Mayor Keisha Lance Bottoms announced she, her husband, and one of her children have tested positive for the new coronavirus. She told CNN on Monday that she had no idea how the family was exposed.

Worldwide:

-A six-week Stage 3 lockdown of the Australian city of Melbourne begins at 11:59 p.m. Wednesday, Victoria State Premier Daniel Andrews announced. People will be allowed to leave their homes only to buy food, go to work, receive or give care, and do exercise, Andrews said.

-South Africas health ministry reported 8,971 new cases on Monday, bringing the total to 205,721.

-India's rate of new virus infections and deaths are now rising at their fastest pace. The country reported 467 new deaths in the last 24 hours, taking the toll to 20,160. It also recorded 22,252 new infections, increasing the total to 719,665.

-Brazil's President Jair Bolsonaro has tested positive for COVID-19, CNN reported. Bolsonaro, who has repeatedly downplayed the seriousness of the virus, went to a hospital for a lung scan after developing symptoms, including a fever and an abnormal blood oxygen level. His press office said he was being treated with hydroxychloroquine and azithromycin.

For the latest coronavirus information in your county and a full list of important resources to help you make the smartest decisions regarding the disease, check out our dedicated COVID-19 page.


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