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Wednesday, April 1, 2020

Feds offer advice to providers on how to split use of ventilators

The Trump administration offered guidance to providers on how to properly split a ventilator to serve two patients at once but cautioned the modification should only be used as an “absolute last resort.”
The U.S. Public Health Service Corps sent out guidance and technical documents to providers Tuesday on how to split ventilators as well as a guide on the anticipated problems a hospital could face employing the strategy.
A lack of ventilators has been a major issue for providers as the number of COVID-19 cases has surged throughout the country, threatening to overwhelm many systems. Some hospitals and experts have floated the idea of having one ventilator take on two patients in order to shore up capacity, but the practice is controversial.

The administration cautioned that splitting ventilators should only be used as an “absolute last resort.”
“These decisions must be made on an individual institution, care-provider and patient level,” the guidance said. “However, we do know that many institutions are evaluating this practice and protocols are being developed and tested, and some places, preliminarily implemented.”
The guidance includes a statement by the Centers for Disease Control and Prevention that the infection control implications for splitting ventilators aren’t “firmly established since it would not meet general established standards for infection control for ventilated patients.”
However, if a facility employs the currently established infection control interventions needed to reduce ventilator-associated infections then any additional risk from splitting is “likely to be small and would likely be appropriate in a crisis standard of care,” the guidance said.
The Food and Drug Administration also added that it doesn’t object to creating a T-connector outlined in instructions to providers to split a ventilator.
But while the administration appears to be fine with splitting ventilators as a last resort to shore up capacity, not all providers are.

Adam Schlifke, M.D., a board-certified anesthesiologist and a clinical assistant professor at Stanford University in California, said sharing ventilators is a bad idea as patients cannot be properly monitored.
“I’ll tell you, it’s a Pandora’s box,” he said, with a preferred solution to re-purpose anesthesia machines from operating rooms or increasing the supply of ventilators.
Schlifke leads a group of anesthesiologists and other professionals called CovidVent that has called for turning operating rooms and surgery centers into critical care units for patients in order to free up hospital beds and ventilators.
“It is dangerous,” Schlifke said, about the idea of splitting ventilation between two patients. With only one way to monitor the split, there’s a risk of causing trauma or hypoventilating patients. “It’s a very hard thing to manage and it’s not something providers are used to doing because it’s never really been done before.”
“At the end of the day, of all the ways we could increase the supply of ventilation, that would be my last choice,” he said.
https://www.fiercehealthcare.com/hospitals-health-systems/trump-administration-offers-advice-to-providers-how-to-split-use

Amarin jumps 18% on possible patent win

Amarin (AMRN +18.0%) is up on massive turnover of over 63M shares in apparent reaction to a call between a patent lawyer and Jefferies’ Jared Holtz about the adverse patent ruling on Vascepa (icosapent ethyl) that caused the stock to plummet almost 71% yesterday.
The attorney said the company has an even-money chance to win on appeal citing a possible procedural error in the case.
https://seekingalpha.com/news/3557411-amarin-jumps-18-on-possible-patent-win

Stanford launches an accelerated test of AI to help care for Covid-19 patients

In the heart of Silicon Valley, Stanford clinicians and researchers are exploring whether artificial intelligence could help manage a potential surge of Covid-19 patients — and identify patients who will need intensive care before their condition rapidly deteriorates.
The challenge is not to build the algorithm — the Stanford team simply picked an off-the-shelf tool already on the market — but rather to determine how to carefully integrate it into already-frenzied clinical operations.
“The hardest part, the most important part of this work is not the model development. But it’s the workflow design, the change management, figuring out how do you develop that system the model enables,” said Ron Li, a Stanford physician and clinical informaticist leading the effort. Li will present the work on Wednesday at a virtual conference hosted by Stanford’s Institute for Human-Centered Artificial Intelligence.
The effort is primed to be an accelerated test of whether hospitals can smoothly incorporate AI tools into their workflows. That process, typically slow and halting, is being sped up at hospitals all over the world in the face of the coronavirus pandemic.
The machine learning model Li’s team is working with analyzes patients’ data and assigns them a score based on how sick they are and how likely they are to need escalated care. If the algorithm can be validated, Stanford plans to start using it to trigger clinical steps — such as prompting a nurse to check in more frequently or order tests — that would ultimately help physicians make decisions about a Covid-19 patient’s care.
The model — known as the Deterioration Index — was built and is marketed by Epic, the big electronic health records vendor. Li and his team picked that particular algorithm out of convenience, because it’s already integrated into their EHR, Li said. Epic trained the model on data from hospitalized patients who did not have Covid-19 — a limitation that raises questions about whether it will be generalizable for patients with a novel disease whose data it was never intended to analyze.
Nearly 50 health systems — which cover hundreds of hospitals — have been using the model to identify hospitalized patients with a wide range of medical conditions who are at the highest risk of deterioration, according to a spokesperson for Epic. The company recently built an update to help hospitals measure how well the model works specifically for Covid-19 patients. The spokesperson said that work showed the model performed well and didn’t need to be altered. Some hospitals are already using it with confidence, according to the spokesperson. But others, including Stanford, are now evaluating the model in their own Covid-19 patients.
In the months before the coronavirus pandemic, Li and his team had been working to validate the model on data from Stanford’s general population of hospitalized patients. Now, they’ve switched their focus to test it on data from dozens of Covid-19 patients that have been hospitalized at Stanford — a cohort that, at least for now, may be too small to fully validate the model.
“We’re essentially waiting as we get more and more Covid patients to see how well this works,” Li said. He added that the model does not have to be completely accurate in order to prove useful in the way it’s being deployed: to help inform high-stakes care decisions, not to automatically trigger them.
As of Tuesday afternoon, Stanford’s main hospital was treating 19 confirmed Covid-19 patients, nine of whom were in the intensive care unit; another 22 people were under investigation for possible Covid-19, according to Stanford spokesperson Julie Greicius. The branch of Stanford’s health system serving communities east of the San Francisco Bay had five confirmed Covid-19 patients, plus one person under investigation. And Stanford’s hospital for children had one confirmed Covid-19 patient, plus seven people under investigation, Greicius said.
Stanford’s hospitalization numbers are very fluid. Many people under investigation may turn out to not be infected, and many confirmed Covid-19 patients who have relatively mild symptoms may be quickly cleared for discharge to go home.
The model is meant to be used in patients who are hospitalized, but not yet in the ICU. It analyzes patients’ data — including their vital signs, lab test results, medications, and medical history — and spits out a score on a scale from 0 to 100, with a higher number signaling elevated concern that the patient’s condition is deteriorating.
Already, Li and his team have started to realize that a patient’s score may be less important than how quickly and dramatically that score changes, he said.
“If a patient’s score is 70, which is pretty high, but it’s been 70 for the last 24 hours — that’s actually a less concerning situation than if a patient scores 20 and then jumps up to 80 within 10 hours,” he said.
Li and his colleagues are adamant that they will not set a specific score threshold that would automatically trigger a transfer to the ICU or prompt a patient to be intubated. Rather, they’re trying to decide which scores or changes in scores should set off alarm bells that a clinician might need to gather more data or take a closer look at how a patient is doing.
“At the end of the day, it will still be the human experts who will make the call regarding whether or not the patient needs to go to the ICU or get intubated — except that this will now be augmented by a system that is smarter, more automated, more efficient,” Li said.
Using an algorithm in this way has potential to minimize the time that clinicians spend manually reviewing charts, so they can focus on the work that most urgently demands their direct expertise, Li said. That could be especially important if Stanford’s hospital sees a flood of Covid-19 patients in the coming weeks. Santa Clara County, where Stanford is located, had confirmed 890 cases of Covid-19 as of Monday afternoon. It’s not clear how many of them have needed hospitalization, though San Francisco Bay Area hospitals have not so far faced the crush of Covid-19 patients that New York City hospitals are experiencing.
That could change. And if it does, Li said, the model will have to be integrated into operations in a way that will work if Stanford has several hundred Covid-19 patients in its hospital.
‘Human experts will make the call’: Stanford launches an accelerated test of AI to help care for Covid-19 patients

Temperature checks at Home Depot

Home Depot (HD -3.5%) is distributing thermometers to associates in stores and distribution centers and asking them to perform health checks before reporting to work.
The retailer’s step is one of the aggressive approaches in the sector and arrives in front of what is typically the busy spring season.
https://seekingalpha.com/news/3557385-temperature-checks-home-depot

Insurers fret as company bosses face coronavirus legal claims

Insurers are increasingly worried about shareholders, employees or customers bringing coronavirus-related claims against company executives and are considering excluding the virus from policies which protect the bosses, industry sources say.

Two cases have been filed in the United States in recent weeks accusing companies of making misleading statements about the coronavirus or their coronavirus plans in order to sell products and boost their share price, while cruise operators, for example, are bracing for claims from passengers stuck on ships hit by the virus.
More such cases may follow in the U.S. and other parts of the world where class action suits can be filed, such as Britain, continental Europe, Australia and Canada, the sources said.
“An uptick in litigation targeting directors and officers across industry sectors is one likely, and unwelcome, consequence” of the coronavirus pandemic, said James Whitaker, partner at law firm Mayer Brown.
Companies who face legal action use directors & officers (D&O) insurance to pay their executives’ defence costs and any penalties awarded by the courts.
The global market for D&O insurance in London, the U.S. and Bermuda, provides for around $600-700 million in cover, said Christine Williams, Chief Operating Officer for broker Aon’s Financial Services Group.
But recent years have proved challenging as legal cases and awards mounted, pushing up premiums and reducing the amount of cover offered, and the coronavirus outbreak would likely exacerbate this, she said.
While many classes of insurance, such as business interruption and event cancellation, exclude epidemics, D&O insurance usually provides cover and brokers said this could be a rare avenue for companies to recoup costs triggered by the pandemic.
CLASS ACTIONS
A shareholder of Inovio Pharmaceuticals filed a class action complaint on March 16 against the company and its chief executive, citing “misstatements” that the company had developed a coronavirus vaccine in three hours.
An Inovio spokesman told Reuters that the firm developed a vaccine construct for its coronavirus vaccine within three hours from the viral sequence being publicly available, manufactured the vaccine and was in preclinical trials in January.
Meanwhile, a securities fraud class action was filed against Norwegian Cruise Line Holdings, its chief executive and chief financial officer on March 18, claiming the company made misleading statements about the virus to encourage customers to book cruises.
Norwegian Cruise Line Holdings did not respond to request for comment.
Carnival Corp also said this week that it had received, and expected to continue to receive, lawsuits from passengers aboard the coronavirus-stricken Princess cruises and additional lawsuits stemming from COVID-19.
“The pressure on insurers will be significant, while the legal costs…will also be huge,” said AFL Insurance Brokers Chairman Toby Esser.
That pressure means insurers are seeking to avoid covering such claims in future.
“We are starting to see insurers looking at the potential for specific COVID-19 exclusions going forward,” said Beth Thurston, head of management liability, UK & Ireland, for broker Marsh.
Ian Roberts, managing partner of law firm Clyde & Co Clasis Singapore, said D&O policies could exclude claims arising from bodily injury or illness, and insurers may be considering this.
Lloyd’s and other London commercial insurers account for the bulk of D&O business, brokers say.
“D&O insurers in London are trying to have a very broad exclusion of anything related to coronavirus,” a fourth broker said.
However, the International Underwriting Association, the trade body for London commercial insurers outside Lloyd’s, said feedback from its members showed few were applying exclusions so far.
“This is a developing situation and things may change in the future, but currently the market appears to be evaluating exposures by asking more questions rather than simply excluding,” an IUA spokesman said by email.
The Lloyd’s Market Association declined to comment.

https://www.marketscreener.com/INOVIO-PHARMACEUTICALS-I-17937428/news/Inovio-Pharmaceuticals-Insurers-fret-as-company-bosses-face-coronavirus-legal-claims-30290043/

Becton Dickinson, BioMedomics to Release Rapid Covid-19 Detection Test

Becton Dickinson & Co. and BioMedomics said Tuesday they will launch a new test that can detect current or past exposure to Covid-19, the illness caused by the new coronavirus, in nearly 15 minutes, part of a new wave of companies seeking to scale up testing and cut down wait times for results.
Clinical-diagnostics company BioMedomics has developed and manufactured the new test, which will be available through Becton Dickinson. The test will be exclusively distributed by Henry Schein Inc. Healthcare providers around the U.S. will be able to receive the tests.
The four-stage test won’t require special equipment, the companies said. It can be used in a laboratory or at a point-of-care facility.
The test will be able to detect antibodies in the blood that are produced in response to the coronavirus infection. The test can detect past exposure as well, which could help researchers pinpoint more precisely the occurrence of the infection in the population.
Though the test has been clinically validated at some hospitals and labs in the U.S. and China, it hasn’t been reviewed by the U.S. Food and Drug Administration. However, it is permitted for distribution and use under the fast-tracked emergency guidelines of the agency.

https://www.marketscreener.com/BECTON-DICKINSON-AND-COM-11801/news/Becton-Dickinson-and-BioMedomics-to-Release-Rapid-Covid-19-Detection-Test-30285169/

Henry Schein Exclusive Distributor of Point-of-Care Covid-19 Test

Henry Schein Inc. said Wednesday it will serve as the exclusive distributor in the U.S. of a second point-of-care rapid test kit that can detect antibodies associated with Covid-19 in as few as 15 minutes.
The health-care technology company said it is working with Becton Dickinson & Co. and BioMedomics, a privately held clinical diagnostics company, to make the test kits available to health-care professionals.
The BioMedomics test analyzes blood, serum or plasma samples for the presence of Immunoglobulin M and Immunoglobulin G antibodies associated with the coronavirus. The test is completed in four steps. The results can be read in 15 minutes.
The company said it is also a participant in the White House’s Covid-19 Supply Chain Task Force, and has worked with the Strategic National Stockpile to deliver personal protective equipment to Covid-19 testing sites, and is working with the Federal Emergency Management Agency to source and deliver critical supplies quickly.

https://www.marketscreener.com/HENRY-SCHEIN-INC-9582/news/Henry-Schein-Harry-Schein-Exclusive-Distributor-of-Point-of-Care-Covid-19-Test-30288558/