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Friday, April 3, 2020

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

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

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?

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.

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

Encephalitis Linked to COVID-19 Reported

Clinicians from Henry Ford Health System in Detroit, Michigan, have reported the first presumptive case of acute necrotizing hemorrhagic encephalopathy associated with COVID-19.
“As the number of patients with COVID-19 increases worldwide, clinicians and radiologists should be watching for this presentation among patients presenting with COVID-19 and altered mental status,” the clinicians advise in a report published online March 31 in Radiology.
“This is significant for all providers to be aware of and looking out for in [COVID-19] patients who present with an altered level of consciousness. This complication is as devastating as severe lung disease,” Elissa Fory, MD, a neurologist with Henry Ford who was part of the team of medical experts that made the diagnosis, said in a statement.
“We need to be thinking of how we’re going to incorporate patients with severe neurological disease into our treatment paradigm,” Fory added.
Brent Griffith, MD, radiologist with Henry Ford and senior author of the case report, said the case shows “the important role that imaging can play in COVID-19 cases.”

Diagnosed via Neuroimaging

The 58-year-old woman presented with a 3-day history of fever, cough, and muscle aches ― symptoms consistent with COVID-19. She was transported by ambulance to the emergency department and showed signs of confusion, lethargy, and disorientation.
The woman tested negative for influenza, but a rapid COVID-19 test confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) infection. She was later diagnosed with acute hemorrhagic necrotizing encephalopathy.
“The team had suspected encephalitis at the outset, but then back-to-back CT and MRI scans made the diagnosis,” Fory said in the statement.
Noncontrast head CT revealed “symmetric hypoattenuation within the bilateral medial thalami with a normal CT angiogram and CT venogram,” the team reports in their article. Brain MRI showed “hemorrhagic rim enhancing lesions within the bilateral thalami, medial temporal lobes, and subinsular regions.”
The patient was started on intravenous immunoglobulin but not high-dose steroids, because of concern for respiratory compromise. As of April 1, the patient was hospitalized in serious condition. Henry Ford Hospital has not provided an update.
Acute necrotizing encephalopathy (ANE) is a rare complication of viral infections, but until now, it has not been known to have occurred as a result of COVID-19 infection. ANE has been associated with intracranial “cytokine storms,” and a recent report in the Lancet suggested that a subgroup of patients with severe COVID-19 might develop a cytokine storm syndrome.
Commenting for Medscape Medical News, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University in St. Louis, Missoui, said, “Since this is just one report of one patient, the findings are the most preliminary we can conceive, and more research is needed to determine the extent to which COVID-19 may affect the central nervous system.”
Fory, Griffith, and Raji have disclosed no relevant financial relationships.
Radiology. Published online March 31, 2020. Full text
https://www.medscape.com/viewarticle/928069

COVID-19: Maybe Just Say NO?

I’ve just submitted a hypothesis paper to The Lancet calling for an urgent multicenter prospective randomized controlled trial of arginine and citrulline supplementation for the purposes of pre- and post-exposure prophylaxis against the “novel coronavirus” (SARS-CoV-2). Whether or not that gets accepted, let alone, implemented, however, I feel compelled to put my thoughts forward here, possibly to a broader audience that might benefit. Right off the bat, however, let me give the disclaimer that this does not constitute medical advice — only medical hypothesis.
Here’s what we know so far:
1. Women do better than men with COVID-19. We saw that in the original SARS epidemic in 2003, where being male carried a 67% greater mortality, and we are seeing it again with data from many countries supporting similar gender-inequality. Women, of course, have a lot more estrogen, and estrogen results in increased nitric oxide (NO).
2. Laboratory research from that first SARS epidemic showed that NO not only inhibits the ability of coronavirus to attach to cells (by decreasing the adherence capability of its S or “spike” proteins to the ACE2 receptor) but also inhibits viral replication.
3. Stem cells are being actively researched right now with eight clinical trials underway at the time of this writing. Their activity is complex but seems to have a lot to do with using NO to suppress immune cell hyperreactivity.
4. Lastly, of course, there are also a handful of trials underway looking directly at the effect of nitric oxide in advanced respiratory disease from coronavirus.
So why not just give people NO? It’s a little complicated; first of all, it’s a gas (literally). Hence the inhaled trials in advanced pulmonary disease. Also for the record, it should be noted that NO is extremely complex in terms of its activities, with different and even contradictory effects in many situations depending on concentration, stage of disease, etc.
In other words, NO is potentially quite dangerous. It can have detrimental effects on the immune system or turn the immune system against a person (which is part of the issue, we think, in severe, advanced COVID-19). There is some very limited and again contradictory evidence that in some situations it may promote cancer.
Probably more pertinent from a population risk standpoint, however, is the fact that NO can really mess with blood pressure and put people’s hearts, brains and kidneys at risk if they have a lot of comorbid cardiovascular disease. That’s one reason they teach everybody in ACLS courses to ask about use of “the blue pill” before offering nitroglycerin in angina.
Speaking of sildenafil (and probably tadalafil); since they increase NO, why not try these to ward off coronavirus? First of all, there’s the whole social distancing thing (sorry). In all seriousness, it appears that those drugs may work primarily on one of the NO-synthesizing enzymes that doesn’t really have much to do with the immune system, and in fact may even suppress the important “inducible” NO synthase enzyme that seems to play a much bigger role in immune functions.
Which brings me to my main point and idea here; probably the best way to increase NO is to adopt a healthy lifestyle including regular and consistent exercise. But with time being of the essence now, supplementation with arginine and/or citrulline, two amino acids you can buy over-the-counter (or preferably online nowadays), might be the smartest way to increase NO.
Arginine is the only precursor to NO, meaning NO doesn’t get created in the body except via the transformation of arginine. Many studies over the years have shown that increasing arginine does increase NO, and also improves immune function, and I’m most familiar with that work in the context of surgery. We put a lot of people on arginine before their operation to reduce the risk of wound infections — what we call “immunonutrition.” However, arginine is poorly absorbed by the body, whereas citrulline is much more readily absorbed and serves as a precursor for arginine. In fact, some 60% or so of the NO created by the body is thought to come from citrulline.
All that to say, since I’m not a premenopausal female, I’ve started supplementing with arginine at 2 g per day and citrulline at 1.5 g per day. I’ve got my family and friends, and my staff at the office doing the same thing. I’m NOT saying everyone should do this — again, there are some risks depending on someone’s underlying health status, and those need to be taken into consideration, with consultation preferably from your physician. To reiterate — this does not constitute medical advice.
What I am doing is calling for urgent research into this simple, universally available, inexpensive means of potentially preventing this virus from replicating within hosts. If you happen to decide the potential benefit outweighs the potential risk for yourself, that’s on you. Just don’t buy up and hoard all the stock on Amazon, please.
Heath McAnally, MD, MSPH, is a board-certified anesthesiologist, pain physician, and addictionologist practicing in Alaska (the military sent him there and he decided to stay). If he wasn’t trying to guide people in improving their own lives, teaching medical students to do the same, or writing about it, he’d probably be outdoors right now slogging up a mountain with a good friend or two.
https://www.medpagetoday.com/infectiousdisease/covid19/85770

JPMorgan’s plan delay led to virus outbreak on trading floor

JPMorgan Chase (NYSE:JPM) had planned to have staff at its stock-trading operation split among three separate sites around New York City on March 9 in response to the COVID-19 outbreak.
But the technology wasn’t ready and management told many traders to report to its Manhattan headquarters as usual, the Wall Street Journal reports.
The firm traded a record number of shares in the bank’s history on that day. But one of the employees that showed up that day was sick and turned out to have COVID-19.
In three weeks, some 20 employees who worked on that floor tested positive for the virus and 65 more were quarantined.
A company spokesman said that more than 80% of its traders are working remotely, those who are in the office are more than six feet apart, and employees at risk of infection are sent home.
But salespeople and traders say they feel pressured to come into the office, and managers remind staff that their performance in recent weeks will help determine their compensation.
One manager, the firm’s global head of equities, told employees that the company’s business would suffer if too many employees worked from home. With rivals lagging, he saw the situation as an opportunity to gain market share.
https://seekingalpha.com/news/3558400-jpmorgans-plan-delay-led-to-virus-outbreak-on-trading-floor-wsj

The long path to an effective coronavirus vaccine

What is biopharma doing to develop vaccines against Covid-19, and what are the properties of each approach? Vantage takes a look.
While efforts to develop treatments for Covid-19 continue, it will probably not be possible to declare the pandemic truly over until an effective vaccine exists. Here numerous companies are also active, and a Vantage analysis reveals nearly 25 projects that should be of special interest.
Among these an mRNA vaccine has seized the early lead, courtesy of Moderna, though Johnson & Johnson’s promise to develop an AAV vector-based approach on a non-profit basis might have the most promise. However, despite understandable enthusiasm, the road to having a vaccine approved is long and treacherous.
The need to build sufficient manufacturing infrastructure is just one aspect that will slow the process, and that is before a vaccine with a sufficient efficacy is developed. It could also take a while to find a product with the right mix of safety and ability to generate antibodies that offer sufficient protection.
A recent article by the Coalition for Epidemic Preparedness Innovation (CEPI) in the NEJM pointed to the industry’s ability to respond quickly to the need for pandemic flu vaccines, but said those against Sars had not followed a similar path. Additionally, Covid-19 is an RNA virus, and the industry’s vaccine efforts against this type of pathogen, notably RSV, have underwhelmed.
Early attention
It might surprise that in the coronavirus pandemic Moderna’s mRNA-1273, rather than more traditional vaccine approaches, has seized early attention. One key advantage of RNA (and DNA) vaccines is that they use synthetic processes and do not require culture or fermentation, offering much faster manufacturing.
Moderna itself claims that mRNA vaccines are better at mimicking natural infection, and highlights the “agility” of its manufacturing system. Production for a phase II trial could begin in a few months, and ultimately could allow millions of doses to be made.
Pfizer, which through a deal with Biontech hopes to enter the clinic with another mRNA vaccine this month, told Vantage: “We are working at record pace. While the development process can generally take years, we are working with partners and government agencies to find opportunities to save time wherever we can.”
Unique antigens
Mechanistically, a prophylactic vaccine works by exposing the immune system to antigens unique to the virus in question, seeking to prime the immune system for the quick generation of large amounts of antibodies in the event of an actual infection.
An mRNA vaccine, for instance, comprises mRNA that codes for expression of such a protein antigen. Different vaccines have different properties in terms of whether they generate humoral (B cell and antibody) versus cellular (effector T cell) immunity, and at which sites this is elicited.
Beyond the modality that each vaccine approach uses, and whether adjuvanting is needed to potentiate the immune response, a key consideration is clearly the choice of antigen.
By far the most popular approach has been to target epitopes on Covid-19’s spike protein, a structure found on the surface of the virus. Ideally, antibodies raised against this could bind the virus immediately and stop the infection of host cells. Some vaccines target other so far undisclosed epitopes or proteins.
Selected vaccines in development for Covid-19
Company/org Vaccine Type Target Detail
Moderna/NIAID mRNA-1273 mRNA vaccine SARS-CoV-2 spike protein First clinical subjects dosed
Cansino Biologics Ad5-nCoV AAV5 vaccine SARS-CoV-2 spike protein China study under way
Shenzhen Genoimmune LV-SMENP-DC Synthetic minigene vaccine Multiple antigens Clinical trial started Mar 2020
University of Oxford COV001 Chimp AAV vaccine SARS-CoV-2 spike protein Clinical trial was to have started Mar 2020
Biontech/Pfizer BNT162 mRNA vaccine ? Clinical trial starting Apr 2020
Inovio INO-4800 DNA vaccine SARS-CoV-2 spike protein Clinical trial starting Apr 2020
Johnson & Johnson ? AAV26 vaccine ? Clinical trial starting Sep 2020
Altimmune AdCOVID AAV vaccine SARS-CoV-2 spike protein Clinical trial starting Q3 2020
Emergent/Vaxart ? Undisclosed non-replicating virus ? Clinical trial starting H2 2020
Geovax ? VLP vaccine ? Clinicl trial starting by end 2020
Arcturus LUNAR-COV19 mRNA vaccine ? Partnership with Duke-NUS Medical School
Sanofi ? DNA vaccine Viral surface proteins Collaboration with BARDA
Translate Bio/Sanofi ? mRNA vaccine ? Deal signed
Dynavax/Clover/GSK COVID-19 S-Trimer Trimerised fusion protein SARS-CoV-2 spike protein Deals signed
Greffex ? AAV5 vaccine ? Preparing for animal testing
Akers ? ? Major structural proteins Licensed candidate from Premas
Curevac ? mRNA vaccine ? Denies that US offered exclusive vaccine deal
AJ Vaccines ? Protein subunit vaccine SARS-CoV-2 spike protein Started precelinical development
Heat Biologics ? gp96-based vaccine Multiple antigens/epitopes Started precelinical development
Anges/Takara Bio ? DNA vaccine ? Collaboration with Osaka University
Epivax ? Protein subunit vaccine SARS-CoV-2 spike protein Collaboration with Uni of Georgia
Generex/Epivax ? Protein subunit vaccine Multiple epitopes To develop Ii-key peptide vaccines
Ibio ? Protein subunit vaccine ? Filed patent
Applied DNA/Takis ? DNA vaccine SARS-CoV-2 spike protein Collaboration to identify candidates
Source: WHO list, EvaluatePharma & company statements.
The CEPI has outlined how carrying out multiple activities simultaneously rather than linearly could curtail development times in a pandemic, and J&J says an accelerated timeline could see its lead vaccine being ready for emergency use in 2021.
That would represent an extraordinarily fast turnaround, but even so a vaccine of some sort might be needed even sooner. Thus even a suboptimal vaccine with moderate efficacy that could merely reduce the severity of Covid-19 infection might be a viable way of protecting people as next winter approaches, some think.
“It is hard to imagine fully returning to a pre-Covid-19 life until we have an effective vaccine, most of the population has been infected, or we have therapies that can turn nearly 100% of severe cases into nothing more than the annual ‘flu’,” says Dan Chen, chief medical officer of IGM Biosciences and a coronavirus expert by virtue of his PhD thesis.
This will require global governments to follow through on funding promises. The NEJM paper’s authors caution that the Sars and Zika epidemics ended before vaccine development was complete, at which point federal funding dried up and developers were left nursing losses.
Biopharma obviously wants to play its role in the pandemic, but it will be acutely aware that all too often vaccine development represents an economic black hole.
Traditional and pandemic vaccine development paradigms. Source: CEPI & NEJM.