Medicare, Medicaid Will Cover COVID-19 Tests, Pence Says

The Trump administration is making sure public and private insurers will pay for COVID-19 screening tests, Vice President Pence announced Thursday.
The Centers for Medicare & Medicaid Services (CMS) “has already made the changes necessary so that the coronavirus test is now eligible for coverage under Medicare and Medicaid,” Pence said at a press briefing at the Pierce County Readiness Center here. “We’re working with members of Congress to ensure coronavirus testing is included as an ‘essential health benefit’ and will therefore be covered by all private insurance in this country as well … We’re making great progress in ensuring this test is available broadly.”
The vice president also updated the official numbers on the outbreak, noting that the U.S. now has “at least” 150 COVID-19 cases, “including 70 confirmed cases in Washington state.” Among the 150 cases are 49 patients who were repatriated from China or from the Diamond Princess cruise ship. He advised people to go to the CDC’s coronavirus website to get more information on the epidemic.
“We have observed that seniors and Americans with underlying health conditions are particularly vulnerable to serious disease, especially following the heartbreaking loss of life at the nursing home in Kirkland,” said Pence. Ten residents at the Life Care residential facility in the Seattle suburb have died so far. “We have taken action to address that. This week at President Trump’s direction, we raised the standards for all nursing homes in America with regard to guidelines for preventing the spread of infectious disease.”
In addition, “all 8,000 inspectors at CMS nationwide will be focusing all of their inspection efforts at nursing homes on compliance with standards to prevent the spread of infectious disease,” he continued. “We want to make every effort to ensure seniors at nursing homes are as safe as possible from the spread of the coronavirus.”

Test kits are also a focus of the administration. Earlier in the day, Pence visited the 3M company in Minnesota, a manufacturer of the N95 respirators. During that visit, he admitted, “We don’t have enough test kits today to meet what we anticipate will be the demand going forward,” but at the Washington state press conference, he was upbeat.
“I’m happy to report the CDC has prioritized the delivery of test kits to Washington state and to California,” he said. “The CDC’s test supplier, a company known as IDT, will distribute kits across country that will enable 1.2 million Americans to be tested for coronavirus; those kits will be delivered in a matter of a few days. And by the end of next week, another 4 million tests will be available. We want to make sure testing is available broadly.”
In addition, “President Trump brought together leaders of the top commercial labs in the country, and as we speak, at the president’s urging they have formed a consortium,” said Pence. “They tell us in a matter of weeks, they could well be in position where in the not too distant future, your doctor and your local pharmacy will have access to COVID-19 tests.” He also commended Congress for passing an $8.3 billion supplemental funding bill to fight COVID-19; the president is expected to sign the bill on Friday.
Pence suggested that the mortality rate from COVID-19 may likely be lower than the current 3.4% estimated globally by the WHO. “I support the president’s judgment that we’re going to continue to learn more about this,” Pence said during a question-and-answer session. “As we learn how many people actually contract this disease, we may well arrive at a lower number.” He was referring to a theory offered Wednesday by President Trump, who said that the 3.4% mortality rate “is really a false number” and that “personally, I think the number is way below 1%” because many infected people have only mild symptoms and haven’t been tested.

Ambassador-at-Large Deborah Birx, MD, who recently was added to the White House’s Coronavirus Task Force, echoed those sentiments. “As we get numbers country by country, we’ve been able to see in countries like South Korea, they’re doing broad testing so they’re finding the mild disease, moderate disease, and severe disease,” she said. “Their mortality rate is in the 0.5% range, which is significantly less.”
Pence was in Washington state to see the progress being made against the outbreak there; he met with Washington Gov. Jay Inslee (D) and toured the state’s Emergency Operations Center; prior to his arrival in the state, he led a conference call of the coronavirus task force.
During the press briefing, Inslee said he spoke with Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, who “has provided very useful information.” As for the conflicting opinions on the mortality rate, “I don’t think we have the luxury of having debates of that nature right now,” he said. “We all agree we need to get more tests in the field, increase manufacturing for personal protective devices, and develop a vaccine as fast as humanly possible, I’m pleased we have good consensus about those things.”
https://www.medpagetoday.com/infectiousdisease/covid19/85269

CDC Outreach Call to Clinicians on COVAD-19 Practices, with Webcast Link

The CDC relaxed previous recommendations regarding ways healthcare workers can protect themselves from COVID-19 in revised interim guidance issued Wednesday.
“The time to prepare your healthcare facility for community transmission is now, ” Amber Vasquez, MD, MPH, CDC epidemic intelligence service officer and member of the COVID-19 Response Infection Control Team, explained during a Clinician Outreach and Communication Activity (COCA) call on Thursday.
“However, with community transmission of COVID-19 in the U.S. being reported in multiple areas, contact tracing and risk-assessment of all potentially exposed healthcare personnel has become impractical for implementation by healthcare facilities in those situations,” Vasquez said.

In areas of community transmission, all healthcare personnel are at “some risk” for exposure to COVID-19, whether at work or in the community. Dedicating resources to contact tracing and “retrospective risk assessment” takes resources away from other critical infection prevention and control measures, she explained.
Instead, the CDC recommends facilities to shift focus to more “routine practices,” Vasquez said, including “self-reporting” to their occupational health program any “recognized exposures” such as potential travel or community-related exposures as specified by a separate interim guidance.
Healthcare personnel should also regularly monitor themselves for fever and any signs of respiratory infection and not come to work if they’re ill.
“Facilities should develop a plan for how they will screen symptoms and evaluate ill health personnel,” Vasquez said, such as having staff confirm an absence of fever and symptoms before work each day.
But the revised guidance also states that for healthcare workers with low-risk exposure who are “self-monitoring” their health status “with delegated supervision,” the agency has eliminated the requirement that healthcare facilities “actively verify absence of fever and respiratory symptoms” for clinicians reporting to work.

“That’s now optional,” she said.
The CDC’s revised guidance also streamlines “risk exposure categories” which are based on several factors including the presence or absence of source control measures, the use of personal protective equipment (PPE) by the healthcare provider, and the level of contact with the patient.
In addition to this updated guidance, the CDC also released its “Interim Guidance for Healthcare Facilities: Preparing for Community Transmission of COVID-19 in the United States” the previous weekend, which Vasquez recommended healthcare facilities use to guide their own planning.
In addition to educating staff, this second set of guidance recommends: identifying alternatives to “face-to-face triage and visits,” optimizing healthcare facility’s supply of PPE, and “reviewing triage and management of patients with respiratory illness to ensure that all appropriate precautions are in place” and ensuring that staff understand the plan. The guidance also includes advice for healthcare facilities that are already experiencing community spread based on the setting: inpatient, outpatient, and long-term care.

CDC staff also emphasized the importance of PPE and highlighted additional guidance on “Strategies for Optimizing the Supply of N-95 Respirators.”
Capt. Lisa Delaney of the CDC’s COVID-19 Response Worker Heath and Safety Team warned healthcare organizations to plan for “increased demand and decreased supply of PPE.”
Members of CDC staff also answered questions from clinician viewers of the CDC’s webcast and listeners on the phone including:
Q: How can clinicians obtain remdesivir for patients who test positive for COVID-19?
Remdesivir, originally developed to treat Ebola, is the one drug with in vitro data showing that it inhibits replication of the virus in non-human cells, Angela Campbell, MD, MPH, a member of the CDC’s COVID-19 Response Clinical Team, said, but she stressed that there aren’t any human data on the drug yet.
It’s also not FDA-approved. There are no FDA-approved therapeutics for COVID-19 at this time.
A small number of patients have accessed remdesivir through “compassionate use” through emergency requests submitted to the manufacturer, Gilead Sciences, through its website or the number 1-866-MEDI-GSI. A second option is to participate in an NIH adaptive randomized double-blind, placebo-controlled trial, which will be used to look at remdesivir and other future products as they enter the pipeline, Campbell said. Two other open-label trials of Remdesivir announced Wednesday are being launched by Gilead for hospitalized patients.
Campbell also recommended against the use of cortical steroids, unless indicated for other problems such as COPD exacerbation, because of the “potential for prolonging viral replication.”
Q: Should patients who have traveled to Washington state’s King County be tested for COVID-19?
Answering broadly, Sue Gerber, MD, a member of CDC’s COVID-19 Response Epidemiology Task Force, said that clinicians could consider the “clinical picture” and whether it’s consistent with COVID-19. She recommended considering what other potential risk factors the patient might have experienced. For example “did that patient visit a healthcare facility … or other [places] where there might be COVID-19 patients?”

She also recommended that clinicians consult with their local and state public health department to determine what testing is appropriate.
Q: Is it safe to assume that a person who tests positive for the flu cannot also have COVID-19?
Campbell encouraged ruling out other diagnoses, but she said she had heard anecdotally, not in the published research, of “a couple of instances of co-infection,” not just with flu and COVID-19 but also with other respiratory illnesses.
She recommended that providers rely on their overall “index of suspicion for COVID-19 based on some of the epidemiological factors as well.”
Q : Can respirators that haven’t been FDA-approved be worn in a healthcare setting?
The FDA regulates the types of respirators used in surgical settings, such as N-95s, Delaney said. However, the CDC’s National Institute for Occupational Safety and Health (NIOSH) approves a “whole suite” of disposable respirators, used in construction and other settings, that are “at least as protective as N-95s.” These industrial respirators, which include non-surgical N-95s, R-99s, P-100s, and a few other masks, don’t receive FDA-approval.

Earlier in the week, the FDA approved a request from the CDC for an emergency use authorization allowing healthcare personnel to use certain industrial respirators during the COVID-19 outbreak in healthcare settings.
Q: What is the risk of transmission for surfaces?
There isn’t “definitive” data to answer this question, Vasquez said.
However, she emphasized the “paramount importance” of hand-washing, since “the main risk of transmission from surfaces is through contamination of one’s hands and subsequent self-inoculation from touching your mouth, nose, or eyes.”
Vasquez also emphasized the need for using EPA-registered, hospital-grade, disinfectant to clean all surfaces or “products with label claims against human coronavirus” and focus on ensuring those “high touch surfaces” are cleaned.
Q: Do children display different symptoms from COVID-19 compared with adults?
Based on limited data, the symptoms and clinical course of COVID-19 are similar to those in adults, appear more mild in children than in adults. Respiratory symptoms include sore throat, headache, cough, and nasal congestion. Some patients experience diarrhea and nausea, prior to fever and lower respiratory symptoms. And there are reports suggesting “clinical deterioration” in the second week of illness, Campbell said.

Of the 44,000 confirmed cases of COVID-19 in China, roughly 2% were younger than 20, and no deaths were reported in patients under age 10. Severe disease, requiring ICU admission or ventilator support seems to be “uncommon” in children with COVID-19, Campbell said.
She said she knew of one 13-month child who developed acute respiratory distress syndrome and septic shock and required ICU admission, and that child lived, Campbell said.
While risk factors haven’t yet been characterized for children, those with underlying medical conditions may be at higher risk of severe illness.
A recording of the full webcast is available on Facebook.
https://www.medpagetoday.com/infectiousdisease/covid19/85294

Ted Cruz to stay at home this week after interacting with coronavirus patient

Sen. Ted Cruz (R-Texas) said Sunday that he shook hands with a man now confirmed to be infected with the novel form of coronavirus during a recent interaction at the Conservative Political Action Conference (CPAC).
In a news release Sunday evening, Cruz said that based on medical advice he had received, he did not believe there was any current risk of him developing the disease, which has already infected more than 100,000 people globally.
“Last night, I was informed that 10 days ago at CPAC I briefly interacted with an individual who is currently symptomatic and has tested positive for COVID-19. That interaction consisted of a brief conversation and a handshake,” Cruz said.

“I’m not experiencing any symptoms, and I feel fine and healthy. Given that the interaction was 10 days ago, that the average incubation period is 5-6 days, that the interaction was for less than a minute, and that I have no current symptoms, the medical authorities have advised me that the odds of transmission from the other individual to me were extremely low,” he added.
“The physicians further advised that testing is not effective before symptoms manifest, and my brief interaction with the individual does not meet the CDC criteria for self-quarantine,” he added.
Nevertheless, Cruz said he will remain at his home in Texas this week “out of an abundance of caution.”
The GOP senator’s statement comes a day after CPAC officials announced that an attendee of the conference had tested positive for the virus, which has killed a handful of people in the U.S. and thousands more around the world, with the majority of deaths occurring in mainland China, where the virus is believed to have originated.
Matt Schlapp, chairman of the American Conservative Union, which hosts CPAC, confirmed that he too had interacted with the infected individual at one point before later shaking hands with President Trump.
“Our children, spouses, extended family, and friends attended CPAC,” read a statement from the event. “During this time, we need to remain calm, listen to our health care professionals, and support each other. We send this message in that spirit.”
https://thehill.com/policy/healthcare/486534-ted-cruz-shook-hands-with-infected-cpac-attendee

Fauci on shutting down coronavirus epicenters: ‘Anything’s possible’

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Sunday that he doubted the U.S. would have to impose measures as “draconian” as total shutdowns ordered in some regions in northern Italy to halt the spread of coronavirus, but said “anything is possible.”
“We have to be realistic. I don’t think it would be as draconian as nobody in or nobody out. But if we continue to get cases like this, particularly at the community level, there will be what we call ‘mitigation,’ where we have to essentially do social distancing, keep people out of crowded places, take a look at seriousness, do you really need to travel, and I think it’s particularly important among the most vulnerable,” Fauci said on “Fox News Sunday.”
“You don’t want to alarm people, but given the spread we’ve seen anything is possible and that’s why we’ve got to be prepared to take whatever action is appropriate to contain and mitigate the outbreak,” he added.
Fauci also addressed reports that health experts on the White House’s coronavirus task force had been overruled on the recommendation that elderly people refrain from air travel.
“Here’s the deal- no one overruled anybody about saying this so let me say it loud and clear now,” Fauci said. “Right now I’m telling the American people based on everything that’s agreed upon in the task force if you are an individual with an underlying condition, particularly an elderly person with an underlying condition, you should start to distance yourself from the risk and above all don’t get on a cruise ship.”
He also addressed the specific case of the Grand Princess cruise ship, which will dock in the port of Oakland after being turned away from San Francisco.
“I recommended very strongly in our meetings that we get those people off that ship, we don’t want to have a repeat of what we saw at the Diamond Princess [in the port of Yokohama] where the ship became almost a hotspot of transmission, I feel strongly about getting them off there,” Fauci said.
Appearing on NBC’s “Meet the Press,” Fauci emphasized the risk to elderly and otherwise vulnerable people, telling host Chuck Todd, “I think right now something that’s important that I hope the American people appreciate is that the risk of getting into trouble with this infection is overwhelmingly weighted towards people with underlying conditions and the elderly.
“You don’t want to go to a massive gathering, particularly if you’re a vulnerable person,” he added.
https://thehill.com/homenews/sunday-talk-shows/486492-fauci-on-idea-of-shutting-down-epicenters-of-coronavirus-anythings

Uber to compensate drivers exposed to Covid-19

People diagnosed with Covid-19 or placed in quarantine by a public health authority qualify for up to 14 days in compensation from Uber (NYSE:UBER), according to a company email seen by Bloomberg.

The email also said Uber was “working to implement mechanisms to do this worldwide.”

Many workers are continuing to work despite fears of catching the virus, with 41% changing their driving strategy, including reducing hours, refusing airport rides and halting driving entirely, according to a recent study.

https://seekingalpha.com/news/3549558-uber-to-compensate-drivers-exposed-to-covidminus-19

The coronavirus ‘tipping point’

Coronavirus causes little more than a cough if it stays in the nose and throat, which it does for the majority of people infected. Danger starts when it reaches the lungs, according to a report by the World Health Organization. At that point, one in seven patients develops difficulty breathing and other severe complications, and 6% become critical, suffering respiratory failure and/or failure of other vital systems, and possibly septic shock.

The progression from mild to severe can occur “very, very quickly,” said Bruce Aylward, a WHO assistant director-general.

10-15% of mild-to-moderate patients progress to severe. Of those, 15-20% progress to critical. Patients at highest risk include people age 60+, and those with pre-existing conditions such as hypertension, diabetes and cardiovascular disease.

“When you get a bad, overwhelming infection, everything starts to fall apart in a cascade. You pass the tipping point where everything is going downhill and, at some point, you can’t get it back,” David Morens, senior scientific adviser to the director of the National Institute of Allergy and Infectious Diseases, said. While that tipping point appears to occur earlier in older people, healthy young adults have also succumbed to the illness. It’s unclear whether some people are genetically more susceptible.

https://seekingalpha.com/news/3549586-coronavirus-tipping-point

CytoDyn Files for Phase 2 Trial for Treatment of Coronavirus

CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting the coronavirus disease 2019 (COVID-19).
Bruce Patterson M.D., CEO of IncellDX and advisor to CytoDyn explains: “Leronlimab inhibits migration of Tregs, which can inhibit the innate immune response against pathogens, into areas of inflammation.  Most importantly, the migration of macrophages and the release of inflammatory cytokines including TNF and IL-6 (cytokine storm) is what causes the profound damage in the lungs in some patients.  Leronlimab binding to CCR5 changes the macrophages migration and cytokine production. Taken together, these activities may reduce the morbidity and mortality in moderate to severe cases of COVID-19. IncellDx has developed a suite of diagnostics to monitor these effects of leronlimab on the immune system in these critical patients.”
“Coronavirus deaths are linked to patients’ immune systems that have an inflammatory response to the virus causing Acute Respiratory Distress Syndrome (ARDS). With ARDS, the entire lung is affected, unlike pneumonia where often only part of the lung is affected,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Our scientists believe that our data in cancer patients indicated that leronlimab’s role in blocking Tregs and macrophages demonstrates that leronlimab modulates the inflammatory response to more effectively provide effector function. With more than 840 patients treated with leronlimab in our clinical trials, we believe leronlimab could reduce the inflammation which contributes to ARDS, thereby potentially reducing morbidity and mortality rates in coronavirus patients. If we can show a similar response in our current Phase 2 trial, then leronlimab could have a powerful impact on improving the prognosis for coronavirus patients. With leronlimab’s Fast Track designation from the FDA for the treatment of HIV and mTNBC (triple-negative breast cancer), we are expediting the initiation of this trial to address the rapid spread of this disease and are eager to test this proof of concept in clinical trials as a potential treatment for coronavirus,” added Dr. Pourhassan.
https://www.marketscreener.com/CYTODYN-INC-163210/news/CytoDyn-Files-IND-and-Protocol-for-Phase-2-Clinical-Trial-for-Treatment-of-Patients-with-Coronavir-30127957/