Johnson & Johnson will offer its in-development coronavirus
vaccine around the world, making it first available to front-line
medical workers, Chief Scientific Officer Paul Stoffels told Nikkei.
The company will work with all governments around the globe — not
just in Europe and the U.S., but also countries including Japan, China
and South Korea — to “find ways to provide vaccines in every country,”
including poor nations, Stoffels said. New Jersey-based Johnson &
Johnson, the world’s largest health care company, has a presence nearly
everywhere in the world, he noted.
In Stoffels’ view, the focus is less on where the vaccine goes than
on who gets it. “The first people who need to get access are the people
at the highest risk,” such as “the health care workers who work in
hospitals — the nurses, the doctors and all the people who work with the
patients,” he said.
As for the price, Stoffels said it is “too early” in the development
process to say, but he stressed that it will be as low as possible and
that Johnson & Johnson considers the vaccine a not-for-profit
project. “We are committed to make it affordable [and] accessible,” he
said.
Asked how the drugmaker plans to produce its promised 1 billion
doses, Stoffels expressed confidence that the company can quickly find
peers to help. “We will do capital investment as well as collaborating
with partners,” he said, adding that the company has begun building a
new plant in the U.S. and has capacity in Europe that it can expand.
“We hope we will be able to get four plants in total to start with,”
he said, adding “Two plants are already in line and two more to come,
and we’ll work in the next few weeks and months to make sure two more
plants will come online.”
Clinical trials on the vaccine are slated to begin in early
September, and the company is working on scaling up production to make
it available early next year, Stoffels said.
https://asia.nikkei.com/Editor-s-Picks/Interview/Hospital-workers-to-be-first-up-for-Johnson-Johnson-vaccine
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Friday, April 3, 2020
UK ramps up coronavirus trials but results ‘a few months away’
Britain said on Friday it was launching the biggest clinical trial of
possible treatments for coronavirus in the world but a leading health
official cautioned that the results were likely a few months away.
Almost 1,000 patients from 132 hospitals had been recruited in 15
days and thousands more were expected to join in the coming weeks, the
health department said.
The trial is testing medicines more commonly used to treat malaria and HIV, and is designed so that when further medicines are identified, they can be added to the study within days.
England’s Deputy Chief Medical Officer Jonathan Van-Tam said the next round of clinical trials should include new medicines, including those that might be in development for other diseases and might “have a role to play”.
But he was cautious on the timeline for results of the trials.
“I know that there’ll be a question about when are we going to get some results from these clinical trials, and my straight answer to you is: ‘I don’t know.’ I think it’s going to be a few months,” he told a news conference.
Health Minister Matt Hancock said that until possible treatments for COVID-19, the disease caused by the coronavirus, were shown to be effective, the only protection against it was to stay at home.
He said that so far clinical trials had been focused on repurposing existing drugs and steroids for treatment of COVID-19.
“We’ve also set up an expert therapeutics taskforce to search for and
shortlist other candidate medicines for trials,” Hancock said.
“We need more patients to volunteer to be part of these trials because the bigger the trials, the better the data and the faster we can roll out the treatments, if – and only if -it’s proven to work.”
https://www.reuters.com/article/us-health-coronavirus-britain-trials/uk-ramps-up-coronavirus-trials-but-results-a-few-months-away-idUSKBN21L2KQ
The trial is testing medicines more commonly used to treat malaria and HIV, and is designed so that when further medicines are identified, they can be added to the study within days.
England’s Deputy Chief Medical Officer Jonathan Van-Tam said the next round of clinical trials should include new medicines, including those that might be in development for other diseases and might “have a role to play”.
But he was cautious on the timeline for results of the trials.
“I know that there’ll be a question about when are we going to get some results from these clinical trials, and my straight answer to you is: ‘I don’t know.’ I think it’s going to be a few months,” he told a news conference.
Health Minister Matt Hancock said that until possible treatments for COVID-19, the disease caused by the coronavirus, were shown to be effective, the only protection against it was to stay at home.
He said that so far clinical trials had been focused on repurposing existing drugs and steroids for treatment of COVID-19.
“We need more patients to volunteer to be part of these trials because the bigger the trials, the better the data and the faster we can roll out the treatments, if – and only if -it’s proven to work.”
https://www.reuters.com/article/us-health-coronavirus-britain-trials/uk-ramps-up-coronavirus-trials-but-results-a-few-months-away-idUSKBN21L2KQ
Emergent BioSolutions, Feds Partner to Speed Plasma Therapy for COVID-19
- BARDA to provide $14.5 million in funding to support development of COVID-Human Immune Globulin (COVID-HIG), a human plasma-derived therapy candidate being developed as a potential treatment for COVID-19 in severe hospitalized and high-risk patients
- NIAID to include COVID-HIG product candidate in one of its clinical studies for assessment of treatments for COVID-19 upon availability of clinical material
- Emergent will seek a path forward with the FDA for the development of COVID-HIG and possible use under Emergency Use Authorization (EUA)
COVID-HIG is a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.
https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-partners-us-government-comprehensive
NY insurers to defer premiums until June for individuals, small biz in money woes
New York’s state government has required insurers to not collect
premiums for the next two months from the state’s individuals and small
businesses experiencing financial hardship due to COVID-19.
The plans will still be required to pay claims for the individual and small group plans through June 1. Health plans also cannot report late payments to credit rating agencies during this period, according to the announcement made Thursday.
The government added it is prohibited under state law for insurers to impose late payment fees.
New York also announced a one-month extension of the special
enrollment period for Affordable Care Act plans through May 15. If
someone lost employer coverage, they have within 60 days of losing
coverage to apply.
The state’s Department of Financial Services will consider “any liquidity or solvency concerns of the health plans in giving effect to this directive.”
Major insurers have started to waive cost-sharing for COVID-19-related costs and tests.
https://www.fiercehealthcare.com/payer/new-york-requires-insurers-to-defer-premium-payments-till-june-for-individuals-small
The plans will still be required to pay claims for the individual and small group plans through June 1. Health plans also cannot report late payments to credit rating agencies during this period, according to the announcement made Thursday.
The government added it is prohibited under state law for insurers to impose late payment fees.
The state’s Department of Financial Services will consider “any liquidity or solvency concerns of the health plans in giving effect to this directive.”
Major insurers have started to waive cost-sharing for COVID-19-related costs and tests.
https://www.fiercehealthcare.com/payer/new-york-requires-insurers-to-defer-premium-payments-till-june-for-individuals-small
Healthcare lost 43K jobs in March
More than 43,000 healthcare jobs were lost in March, according to the latest federal data.
The Bureau of Labor Statistics reports total nonfarm payroll employment fell by 701,000 in March, and the unemployment rate rose to 4.4% as a result of the effects of COVID-19 and efforts to contain it.
Employment in hospitality and leisure saw the steepest declines last month, with employment falling by about 459,000 jobs.
However, employment in healthcare and social assistance felt the pain with a total loss of about 61,000 jobs in March.
Healthcare employment, specifically, dropped by 43,000 with about 12,000 job losses from doctors’ offices, about 17,000 job losses from dentists’ offices and about 7,000 job losses from the offices of other healthcare practitioners.
Physician practices across the country worry whether they can survive the cash crunch caused by the coronavirus pandemic.
A recent survey of primary care practices found 31% of respondents said they are running their offices without some employees and risk financial collapse as they are canceling face-to-face patient visits that generate the bulk of their revenue. They expressed helplessness with their situation.
Staffing outages due to illness are already hitting clinicians (20%), nursing staff (17%) and front desk support (13%), according to the survey.
In a bid to help support practices, the Centers for Medicare & Medicaid Services (CMS) last month agreed to pay for virtual visits at the same rate as in-person visits while the coronavirus emergency remains in effect. CMS also agreed to pay physicians for patient visits that take place by telephone to help practices stay open by providing them with needed revenue.
As a result of the coronavirus outbreak, a large number of insurers are also paying for telemedicine visits, and more are doing so. Doctors hope commercial insurance companies will also agree to pay for telephone visits.
Some health systems have also begun instituting furloughs including Trinity Health, Tenet Healthcare and Bon Secours.
https://www.fiercehealthcare.com/hospitals-health-systems/healthcare-lost-43k-jobs-march-latest-bureau-labor-statistics-report-shows
The Bureau of Labor Statistics reports total nonfarm payroll employment fell by 701,000 in March, and the unemployment rate rose to 4.4% as a result of the effects of COVID-19 and efforts to contain it.
Employment in hospitality and leisure saw the steepest declines last month, with employment falling by about 459,000 jobs.
Healthcare employment, specifically, dropped by 43,000 with about 12,000 job losses from doctors’ offices, about 17,000 job losses from dentists’ offices and about 7,000 job losses from the offices of other healthcare practitioners.
Physician practices across the country worry whether they can survive the cash crunch caused by the coronavirus pandemic.
A recent survey of primary care practices found 31% of respondents said they are running their offices without some employees and risk financial collapse as they are canceling face-to-face patient visits that generate the bulk of their revenue. They expressed helplessness with their situation.
Staffing outages due to illness are already hitting clinicians (20%), nursing staff (17%) and front desk support (13%), according to the survey.
In a bid to help support practices, the Centers for Medicare & Medicaid Services (CMS) last month agreed to pay for virtual visits at the same rate as in-person visits while the coronavirus emergency remains in effect. CMS also agreed to pay physicians for patient visits that take place by telephone to help practices stay open by providing them with needed revenue.
As a result of the coronavirus outbreak, a large number of insurers are also paying for telemedicine visits, and more are doing so. Doctors hope commercial insurance companies will also agree to pay for telephone visits.
Some health systems have also begun instituting furloughs including Trinity Health, Tenet Healthcare and Bon Secours.
https://www.fiercehealthcare.com/hospitals-health-systems/healthcare-lost-43k-jobs-march-latest-bureau-labor-statistics-report-shows
COVID-19 job losses could cut employer plan rolls by as much as 35M – report
As many as 35 million people could drop out of employer-sponsored coverage amid COVID-19, according to a new analysis.
Health Management Associates estimates that between 12 million and 25 million people will lose coverage through their employers as unemployment skyrockets nationwide. The Department of Labor reported that 6.6 million people filed for unemployment last week alone.
HMA projects enrollment changes in three scenarios depending on how much the unemployment rate increases: 10% unemployment, 17.5% unemployment or 25% unemployment. In the first scenario, enrollment in employer plans would decline from 163 million to 151 million.
In tandem, Medicaid enrollment would likely increase from 71 million
to 82 million. Marketplace coverage would likely stay on par with
between 12 million and 13 million enrollees and the number of uninsured
could increase from 29 million to between 30 million and 31 million.
Meanwhile, unemployment at 25% would lead to enrollment in employer coverage to drop to 128 million, while Medicaid enrollment would skyrocket to 94 million, HMA estimates.
High unemployment would also boost the number of uninsured to between 39 million and 40 million, according to the report.
“This is the first economic downturn since Medicaid expansion, and what we’re experiencing is unprecedented,” said Jay Rosen, founder and president of HMA, in a statement.
“With millions of Americans expected to enroll in Medicaid in the coming months, our COVID-19 impact estimates at the state level are critical for policymakers trying to begin the complex steps of implementing new laws and policies while navigating an array of financial implications,” Rosen said.
The potential impact on the exchanges should unemployment rise to 25% is more of a question, according to the report. Enrollment in individual market plans could rise to 15 million or more, but it could also stay flat or potentially decline as millions more drop out of exchange plans.
HMA said it will be updating its model and analysis as the pandemic continues.
https://www.fiercehealthcare.com/payer/covid-19-job-losses-could-drive-down-employer-plan-enrollment-by-as-much-as-35m-report-shows
Health Management Associates estimates that between 12 million and 25 million people will lose coverage through their employers as unemployment skyrockets nationwide. The Department of Labor reported that 6.6 million people filed for unemployment last week alone.
HMA projects enrollment changes in three scenarios depending on how much the unemployment rate increases: 10% unemployment, 17.5% unemployment or 25% unemployment. In the first scenario, enrollment in employer plans would decline from 163 million to 151 million.
Meanwhile, unemployment at 25% would lead to enrollment in employer coverage to drop to 128 million, while Medicaid enrollment would skyrocket to 94 million, HMA estimates.
High unemployment would also boost the number of uninsured to between 39 million and 40 million, according to the report.
“This is the first economic downturn since Medicaid expansion, and what we’re experiencing is unprecedented,” said Jay Rosen, founder and president of HMA, in a statement.
“With millions of Americans expected to enroll in Medicaid in the coming months, our COVID-19 impact estimates at the state level are critical for policymakers trying to begin the complex steps of implementing new laws and policies while navigating an array of financial implications,” Rosen said.
The potential impact on the exchanges should unemployment rise to 25% is more of a question, according to the report. Enrollment in individual market plans could rise to 15 million or more, but it could also stay flat or potentially decline as millions more drop out of exchange plans.
HMA said it will be updating its model and analysis as the pandemic continues.
https://www.fiercehealthcare.com/payer/covid-19-job-losses-could-drive-down-employer-plan-enrollment-by-as-much-as-35m-report-shows
3 keys for doctors to keep practices running in time of coronavirus
The coronavirus pandemic has left many physician practices struggling to stay afloat.
They’ve lost revenue as the number of patient visits have dropped dramatically as people stay home to avoid exposure to the highly contagious virus. Specialty practices have also put off revenue-producing elective surgeries and procedures.
“The big takeaway for us is that every primary care practice in the country is at significant risk right now because of the way we have paid primary care,” said Dan Bowles, senior vice president at Aledade, a company that partners with independent primary care practices across the country.
Bowles, who has been leading the company’s efforts to help doctors
navigate the coronavirus crisis financially, said some cash-strapped
practices are wondering if they will have to close their doors.
Some practices have only two to three weeks of cash on hand. Some are exploring layoffs or have already laid off staff. Some are talking about closing or at least shuttering their doors until the economic crisis resulting from coronavirus passes with the hopes of reopening.
But there are things practices can do to shore up their finances and keep their doors open, said Bowles.
There are three components practices need to look at, according to Bowles. Aledade, which works with 550 practices across the country in the transition to value-based care, has also been advising these practices on navigating the coronavirus crisis.
“By and large, this is the playbook: Bolster your revenues, manage your expenses and let’s help you find ways to get access to new capital,” he said.
So where to begin?
At least temporarily for the duration of the coronavirus emergency, the Centers for Medicare and Medicaid Services (CMS) and some states have eased many of the restrictions that made it difficult for practices to conduct telehealth visits.
CMS has also increased the reimbursement for these services to create a closer payment parity between virtual visits and traditional office visits. And on Monday, it moved to cover patient visits conducted over the telephone (PDF).
Most of Aledade’s partners did not have telehealth services in place, because it was so hard to bill for those services, Bowles said. Since the reimbursement changes, the company has helped 200 to 250 practices get set up on telehealth visits in about a week.
That was also the case for the practices that Elation Health works with, said Kyna Fong, CEO and co-founder of the company that works with practices and offers an electronic health records system. At the beginning of the outbreak, most of the practices were not set up for telehealth visits. “We’ve been working around the clock to get them on there,” she said. “Bandwidth and time is a challenge.”
Because of the COVID-19 outbreak, the government has made it possible for practices to use non-HIPAA compliant connections such as Facetime and Skype.
“If they can get themselves set up for telehealth and virtual visits, they can recover some of their lost revenue,” said Fong.
For many, it’s not so much the technology, but the challenge of letting patients know they now have telehealth appointments, she said.
“How do you communicate with patients you are open for business? There are all these complexities,” Fong said.
Practices are putting information about how to use telehealth visits on their web sites, using their patient portal to get the word out as well as mailing letters to patients and making phone calls.
Fong said one doctor she talked to was glad he tried it. “He loved it,” she said because it allowed him to have efficient, focused conservations with his patients and to keep more on time.
Consider the services where there are high-paying codes, particularly under Medicare, for telehealth services, said Bowles. These include transitions of care visits, which typically pay two to four times more under the Medicare physician fee schedule than for traditional evaluation and management (E/M) visits, he said.
Physicians also can patient visits for advanced care planning meetings via telehealth. These are end-of-life conversations and while it may sound harsh to talk about those issues in light of the mounting coronavirus deaths, now is the time for patients to make their wishes clear about what kind of care they want to receive.
For instance, some elderly or seriously ill patients may choose not to be put on a ventilator. There are other visits that pay reasonably well and can be delivered via telehealth, Bowles added.
File all claims for outstanding services. While it may sound obvious, if practices have any outstanding claims, file them now, Bowles said. “Bill for everything you’re already done immediately.”
Take on new patients. It’s also a time when practices that are accepting new patients can market themselves, said Fong. Many people, especially younger people, may not have a primary care doctor and have relied on urgent care. They may now be re-thinking whether they need a primary care doctor that they can call, she said.
You may find relief is available for your rent or mortgage payments. “That’s a big expense for a lot of practices,” he said.
On the personal side, physicians can consider the salary they are taking and whether they can defer student debt they accumulated as part of their medical education.
Consider how to reduce payroll. “The biggest expense for a lot of practices is payroll,” he said. While it may be painful, now may be the time practice leaders need to think about ways to structure their practices so they can keep their doors open. That may mean layoffs that ensure staff are eligible for unemployment assistance. Other practices are reducing staff hours, said Fong.
“The difficult thing is the process is really onerous,” Bowles said. “We found essentially it takes upwards of 20 hours to fill out the paperwork. Most of our practices don’t have 20 hours.” Other restrictions may include the need for a personal guarantee from the practice owner before becoming eligible for a loan. “It’s not as simple as it sounds on its face.”
Community health centers are in luck. Those federally-funded centers, which serve some of the country’s most vulnerable populations, will receive $100 million in federal funding to boost their role in responding to the coronavirus pandemic.
Check into assistance that may available from your state. Some
state-based payers may have funding as well, Bowles said. States may
have small business assistance or be able to advance shared savings
payments.
While it’s important that the nation’s hospitals receive assistance, “we can’t forget about primary care because if we do, it not only hurts the hospitals, it hurts us over the long-term from a system perspective,” said Bowles.
He fears some practices won’t survive the financial crunch.
“Frontline primary care practices are absolutely critical to the healthcare structure right now,” said Fong, noting these practices triage patients with coronavirus symptoms and care for those with chronic illness.
“That is the last thing we need at a time where we need more healthcare capacity is for these critical frontline practices to be shuttering their doors,” she said.
https://www.fiercehealthcare.com/practices/3-keys-for-physicians-to-keep-their-medical-practice-running-time-coronavirus
They’ve lost revenue as the number of patient visits have dropped dramatically as people stay home to avoid exposure to the highly contagious virus. Specialty practices have also put off revenue-producing elective surgeries and procedures.
“The big takeaway for us is that every primary care practice in the country is at significant risk right now because of the way we have paid primary care,” said Dan Bowles, senior vice president at Aledade, a company that partners with independent primary care practices across the country.
Some practices have only two to three weeks of cash on hand. Some are exploring layoffs or have already laid off staff. Some are talking about closing or at least shuttering their doors until the economic crisis resulting from coronavirus passes with the hopes of reopening.
But there are things practices can do to shore up their finances and keep their doors open, said Bowles.
There are three components practices need to look at, according to Bowles. Aledade, which works with 550 practices across the country in the transition to value-based care, has also been advising these practices on navigating the coronavirus crisis.
“By and large, this is the playbook: Bolster your revenues, manage your expenses and let’s help you find ways to get access to new capital,” he said.
So where to begin?
Find ways to bolster revenue.
For many practices, this begins with telehealth services. “If you are not on telehealth, get on telehealth immediately and bill for those visits,” he said.At least temporarily for the duration of the coronavirus emergency, the Centers for Medicare and Medicaid Services (CMS) and some states have eased many of the restrictions that made it difficult for practices to conduct telehealth visits.
CMS has also increased the reimbursement for these services to create a closer payment parity between virtual visits and traditional office visits. And on Monday, it moved to cover patient visits conducted over the telephone (PDF).
Most of Aledade’s partners did not have telehealth services in place, because it was so hard to bill for those services, Bowles said. Since the reimbursement changes, the company has helped 200 to 250 practices get set up on telehealth visits in about a week.
That was also the case for the practices that Elation Health works with, said Kyna Fong, CEO and co-founder of the company that works with practices and offers an electronic health records system. At the beginning of the outbreak, most of the practices were not set up for telehealth visits. “We’ve been working around the clock to get them on there,” she said. “Bandwidth and time is a challenge.”
Because of the COVID-19 outbreak, the government has made it possible for practices to use non-HIPAA compliant connections such as Facetime and Skype.
“If they can get themselves set up for telehealth and virtual visits, they can recover some of their lost revenue,” said Fong.
For many, it’s not so much the technology, but the challenge of letting patients know they now have telehealth appointments, she said.
“How do you communicate with patients you are open for business? There are all these complexities,” Fong said.
Practices are putting information about how to use telehealth visits on their web sites, using their patient portal to get the word out as well as mailing letters to patients and making phone calls.
Fong said one doctor she talked to was glad he tried it. “He loved it,” she said because it allowed him to have efficient, focused conservations with his patients and to keep more on time.
Consider the services where there are high-paying codes, particularly under Medicare, for telehealth services, said Bowles. These include transitions of care visits, which typically pay two to four times more under the Medicare physician fee schedule than for traditional evaluation and management (E/M) visits, he said.
Physicians also can patient visits for advanced care planning meetings via telehealth. These are end-of-life conversations and while it may sound harsh to talk about those issues in light of the mounting coronavirus deaths, now is the time for patients to make their wishes clear about what kind of care they want to receive.
For instance, some elderly or seriously ill patients may choose not to be put on a ventilator. There are other visits that pay reasonably well and can be delivered via telehealth, Bowles added.
File all claims for outstanding services. While it may sound obvious, if practices have any outstanding claims, file them now, Bowles said. “Bill for everything you’re already done immediately.”
Take on new patients. It’s also a time when practices that are accepting new patients can market themselves, said Fong. Many people, especially younger people, may not have a primary care doctor and have relied on urgent care. They may now be re-thinking whether they need a primary care doctor that they can call, she said.
Manage the expense side of the ledger.
Look at your fixed monthly expenses. What can you defer, delay or not pay this month?You may find relief is available for your rent or mortgage payments. “That’s a big expense for a lot of practices,” he said.
On the personal side, physicians can consider the salary they are taking and whether they can defer student debt they accumulated as part of their medical education.
Consider how to reduce payroll. “The biggest expense for a lot of practices is payroll,” he said. While it may be painful, now may be the time practice leaders need to think about ways to structure their practices so they can keep their doors open. That may mean layoffs that ensure staff are eligible for unemployment assistance. Other practices are reducing staff hours, said Fong.
Find access to new capital.
Consider a Small Business Administration loan. The Trump administration is making loans available for small businesses, which may be eligible for up to $2 million at relatively low-interest rates.“The difficult thing is the process is really onerous,” Bowles said. “We found essentially it takes upwards of 20 hours to fill out the paperwork. Most of our practices don’t have 20 hours.” Other restrictions may include the need for a personal guarantee from the practice owner before becoming eligible for a loan. “It’s not as simple as it sounds on its face.”
Community health centers are in luck. Those federally-funded centers, which serve some of the country’s most vulnerable populations, will receive $100 million in federal funding to boost their role in responding to the coronavirus pandemic.
While it’s important that the nation’s hospitals receive assistance, “we can’t forget about primary care because if we do, it not only hurts the hospitals, it hurts us over the long-term from a system perspective,” said Bowles.
He fears some practices won’t survive the financial crunch.
“Frontline primary care practices are absolutely critical to the healthcare structure right now,” said Fong, noting these practices triage patients with coronavirus symptoms and care for those with chronic illness.
“That is the last thing we need at a time where we need more healthcare capacity is for these critical frontline practices to be shuttering their doors,” she said.
https://www.fiercehealthcare.com/practices/3-keys-for-physicians-to-keep-their-medical-practice-running-time-coronavirus
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