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Saturday, April 11, 2020

Trump orders U.S. government to help Italy in coronavirus fight

U.S. President Donald Trump on Friday ordered top U.S. administration officials to help Italy in fighting the novel coronavirus by providing medical supplies, humanitarian relief and other assistance.
In a memo to several Cabinet ministers, Trump ordered a variety of measures to help Italy, including making U.S. military personnel in the country available for telemedicine services, helping set up field hospitals, and transporting supplies.
“The Italian Republic (Italy), one of our closest and oldest Allies, is being ravaged by the COVID-19 pandemic, which has already claimed more than 18,000 lives, brought much of the Italian healthcare system to the brink of collapse, and threatens to push Italy’s economy into a deep recession,” Trump said in the memo.
Italy has recorded the biggest number of deaths from COVID-19, the respiratory disease caused by the novel coronavirus, followed by the United States.

Trump ordered his commerce secretary to encourage U.S. suppliers to sell products requested by Italian authorities and healthcare providers, except those required for the United States’ own response to the pandemic.
The memo said the secretary of state, the head of the U.S. Agency for International Development and the president of the U.S. Export-Import Bank “may use available authorities to support the recovery of the Italian economy.”
https://www.reuters.com/article/us-health-coronavirus-usa-italy/trump-orders-u-s-government-to-help-italy-in-coronavirus-fight-idUSKCN21T01V

CytoSorbents’ EBP device wins emergency OK to treat COVID-19 patients

The Food and Drug Administration says it granted Emergency Use Authorization for CytoSorbent’s (NASDAQ:CTSO) CytoSorb device to treat patients with confirmed Covid-19 admitted to the ICU with confirmed or imminent respiratory failure.
Based on bench performance testing and reported clinical experience, the FDA concludes the CytoSorb device – also referred to as an Extracorporeal Blood Purification device – may be effective at treating certain patients with confirmed Covid-19 by removing various pro-inflammatory cytokines from their blood.
The FDA believes the removal of pro-inflammatory cytokines may ameliorate cytokine storm due to the overabundance of pro-inflammatory cytokines and thus provide clinical benefit.
https://seekingalpha.com/news/3559968-cytosorbents-ebp-device-wins-emergency-ok-to-treat-covidminus-19-patients

Coronavirus patients can suffer lasting bodily damage, even after recovery

Patients who survive COVID-19 can still suffer lasting bodily damage, including to the liver and heart, researchers are finding.
Multiple studies of recovered patients from China, where the disease first emerged in November, showed impaired liver and heart function, according to the Los Angeles Times.
“COVID-19 is not just a respiratory disorder,” Dr. Harlan Krumholtz, a cardiologist at Yale University, told the paper.
“It can affect the heart, the liver, the kidneys, the brain, the endocrine system and the blood system.”
Inflammation from the body’s immune response has been linked to strokes and heart attacks.
Researchers also wonder if the coronavirus that causes COVID-19 might lie dormant in the body for years or even decades — and then spring back to life, in the same way, that the herpes virus that causes chickenpox can reemerge as shingles.
Nearly 400,000 people across the globe have recovered from COVID-19.
https://nypost.com/2020/04/11/coronavirus-patients-can-suffer-lasting-bodily-damage/

COVID-19 Might Cost Health Insurers Over $550 Billion: Report

The cost to US health insurers of the COVID-19 pandemic might be anywhere between $56 billion and $556 billion in 2020 and 2021 combined, depending on how many people are infected, according to a new report prepared for America’s Health Insurance Plans (AHIP), the industry trade association.
The report, by the Wakely Consulting Group, modeled healthcare utilization and costs on the basis of published studies for infection rates ranging from 20% to 60% of the population. The researchers also calculated the costs if only 10% of the population — half of the lower bound of infection rates in the studies — was infected with the coronavirus.
The report evaluated these scenarios for a population of 255 million insured people, including members of commercial, Medicare Advantage, and Medicaid managed care plans.
If just 10% of this population was infected, insurance-allowed costs would range from $56.2 billion to $92.7 billion during the 2-year period. If 20% of the people were infected, the cost range would be $112.5 billion to $185.4 billion. If 60% caught the virus, it would cost insurers from $337.5 billion to $556.1 billion.
Wakely also estimated that plan enrollees would pay 14% to 18% of the annual allowed costs. Thus, copayments and deductibles would cost plan members $10 billion to $78 billion in 2020 and 2021, again depending on the infection rate.
For each person admitted into intensive care, the costs — on average — could exceed $30,000, according to an AHIP news release.
The researchers modeled the costs and utilization of COVID-19 patients on data for patients who had been treated for seasonal influenza and pneumonia.
To estimate inpatient costs, they used the 75th percentile of admission costs for patients with ICU admissions and the 25th percentile of admission costs for non-ICU cases. Other cost figures came from claims databases.
The researchers assumed that 75% of total costs would be incurred in 2020, and 25% of costs would occur in 2021, after the pandemic waned. It’s notable, however, that such a high cost was projected for the second year of the disease.
While experts disagree on how long the pandemic might last, there is a consensus that only a vaccine will knock it out completely. Such a vaccine may be available in a year to 18 months, but it may take longer, some experts say, according to a report by CNN.

Baseline Scenario

In the baseline scenario of a 20% infection rate, the report said, 51 million Americans would be infected, and the number of confirmed cases would be 35.6 million. These estimates indicate that 43% more people would be infected than would have positive test results.
About 5.5 million people, or 11% of the 51 million infected, would be hospitalized with COVID-19, the report said. Of these individuals, 1.3 million would be transferred to the ICU.
Outpatient hospital services would be required by 21.4 million people, and the same number would require professional services. (Professional services in the hospital were apparently included in inpatient costs.) Drugs would be prescribed to 15.9 million patients, and 380,000 would require other services such as skilled nursing and home health care.
Inpatient costs outweighed all other expenses in the infection rate scenarios. At the high cost estimate for each of the three models, inpatient costs were 85% of total spending. At the low cost estimates, they comprised 79% of total costs.
Although the elderly are more vulnerable than younger people to COVID-19, the projections in the Wakely report show that Medicare patients would generate much lower spending in every scenario than commercial patients did, simply because the latter were more numerous. Medicaid managed-care organizations patients accounted for slightly lower costs than the Medicare patients did.

Limitations of the Report

The researchers acknowledged a number of limitations in their study. Whereas they made adjustments for age and gender, they didn’t risk-adjust for individuals with higher-risk conditions.
They also didn’t account for patients who delayed various kinds of care because of social distancing guidelines and other factors. This might save insurers some money in the short run but could drive costs up later if the deferrals in care led to complications, the report authors note.
The modeling also did not adjust for potential out-of-network costs or the waiving of COVID-19 testing and treatment costs by some health plans. Because the analysis was completed just before the passage of the CURES Act, it did not take into account that law’s increase in Medicare payments for COVID-19 care.
Moreover, the study did not adjust for changes in coverage status and utilization patterns as a result of potential job or income losses related to the crisis.
https://www.medscape.com/viewarticle/928564#vp_1

COVID-19 and Diabetes: Patterns Emerge

The data that we have suggest that people with diabetes are actually not at increased risk for catching the novel coronavirus, but once they become infected, they may do less well, particularly if they’re in an ICU setting.
However, we don’t know if there are any differences between people with type 1 versus type 2 diabetes, or between people whose diabetes is well controlled versus less well controlled. We do know that younger people as a whole do better than older people. The more comorbidities present, such as cardiovascular disease and chronic kidney disease, the higher the risk for mortality and doing poorly.
Historically, we’ve believed that people with higher glucose levels are likely to be at greater risk for infection than those with more normal glucose levels. This is because high glucose levels can inhibit white cell function. We obviously want our patients to be as well controlled as possible in order to help them do better.

Some Patterns Emerge

I have now seen patients with diabetes who have been infected with COVID-19 and heard cases of many others. No one in my personal practice with type 1 diabetes has developed COVID-19, but I have seen a number of people with type 2 diabetes who have had it.
What I know for sure is that I can’t predict this virus. I have had people with every known risk factor for a poor outcome do incredibly well, and those with fewer risk factors do worse than I expected. I’ve seen families in whom everybody was infected, and families where only one member became ill.
However, some patterns have emerged. Unscientifically, I divide my patients into three groups of illness severity: mild, moderate, and severe. Mild is when COVID-19 is a slightly annoying head cold and nothing more. Moderate is where people feel miserable; they’re feverish, they have muscle pain, they have headaches, their lungs hurt, they cough, and they feel wretched—but they don’t need to be in the hospital and they survive. Then there are the severe cases; these patients are hospitalized, and some of them end up in the ICU.
In terms of diabetes management, it’s the moderate category where we really have to do our most aggressive outpatient care. We don’t want these patients to end up in the hospital. The biggest issue I deal with is dehydration. My patients are febrile and they’re often anorexic, not wanting to eat or drink much, so I really have to encourage hydration.
I’ve also seen patients with glucose levels lower than normal, which is different from what I’m used to seeing in patients with infection. Glucose monitoring is incredibly important in patients with COVID-19.

Changes to Medications

My first step in all patients who are on an SGLT2 inhibitor is to stop the drug at the first sign of symptoms. I’ve had a lean person with type 2 diabetes on an SGLT2 inhibitor go into diabetic ketoacidosis (DKA) when they developed COVID-19, so this is very important. This patient had already stopped their SGLT2 inhibitor for a day when they became quite ill.
Other practitioners, such as my dear friend, Dr Irl Hirsch, suggest that we stop SGLT2 inhibitor therapy in all people with type 1 diabetes who are using them off-label because it increases the risk for DKA. I haven’t done that in my patients except for those who I feel are on too low a dose of insulin or who seem to be at higher risk for DKA than others. For my patients who are able to test for ketones and connect with me, I’ve kept them on their SGLT2 inhibitor, but I suggest monitoring this on a case-by-case basis.
In my patients with type 1 diabetes, I make sure that they are prepared with glucose-containing fluids at home, and that they’re able to give injected insulin. I also make sure that they have ketone test strips at home and some sort of antiemetic so they can keep down fluids.

Preparing a Hospital Kit

There has been an issue in hospitals where patients on insulin drips can’t get hourly blood glucose readings because the staff doesn’t have enough personal protective equipment to go in and out of patient rooms to do the testing. Patients must be prepared to do self-monitoring of glucose levels in the hospital if they happen to end up hospitalized. I encourage patients with type 1 diabetes and those with type 2 diabetes on insulin to prepare a kit that they could bring with them to the hospital. This kit includes testing supplies (if people are doing self-monitoring of blood glucose) and sensors (if people are on a sensor).
People need to remember such details as bringing charger cables for their iPhones, iPads, and anything else they may need to help self-monitor their glucose levels if hospitalized. This is particularly important now because family members aren’t allowed into hospitals to bring the pieces that someone may have forgotten at home.
In people with type 2 diabetes who are on insulin secretagogues and/or insulin, I have needed to lower the dose of medication, and in some cases, to stop it. Again, self-monitoring is important.
As patients recover from their COVID-19 infections, they may still not feel much like eating and have relative anorexia. There have been some cases where I have held the GLP-1 receptor agonist therapy for a week or two after the illness has resolved to make sure my patients return to their fully normal baseline state.
The most important advice I give patients is to reach out to us, their healthcare team, if they need us. None of us want anyone to go to the hospital, but there are patients who develop DKA and can’t keep down fluids, and they need to be hospitalized. Patients shouldn’t wait, because the DKA may become even more severe by the time they’re admitted.
We all need to keep in mind that most people are going to be okay, with or without diabetes—although, tragically, some will die. As a healthcare provider, I am encouraging my patients to use this time to take extra good care of themselves, to learn to optimize their diabetes control when not being distracted by going out to social events, dinner, or work.
I think we are helping our patients establish a new baseline that will hopefully translate into sustained health over time. Please be sure to take care of yourselves, your families, and your patients. Be well.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California (USC) Keck School of Medicine and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts, and three books, on diabetes, and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations.
https://www.medscape.com/viewarticle/928425#vp_1

CMS Loosens Telehealth, Clinician Scope-of-Practice Rules for COVID-19 Crisis

To boost the capacity of frontline clinicians and facilities to fight COVID-19, the Centers for Medicare & Medicaid Services (CMS) on Thursday announced it is temporarily suspending rules to allow physicians to provide telehealth services across state lines, and will permit midlevel practitioners to provide as much care as their state licenses allow.
Physicians can now care for patients at rural hospitals across state lines via phone, radio, or online communications without having to be physically present.
“Remotely located physicians, coordinating with nurse practitioners at rural hospitals, will provide staffs at such facilities additional flexibility to meet the needs of their patients,” a CMS news release said.
At skilled nursing facilities, nurse practitioners will now be able to perform some medical exams that doctors normally conduct on Medicare patients, whether they are COVID-19-related or not, CMS said.
Occupational therapists from home health agencies can now perform initial assessments on certain homebound patients, allowing home health services to start sooner and freeing home health nurses to do more direct patient care.
In addition, hospice nurses will be relieved of hospice aide in-service training tasks so they can spend more time with patients.
“It’s all hands on deck during this crisis,” said CMS Administrator Seema Verma in the press release. “All frontline medical professionals need to be able to work at the highest level they were trained for. CMS is making sure there are no regulatory obstacles to increasing the medical workforce to handle the patient surge during the COVID-19 pandemic.”
The announcement did not directly address the question of whether CMS’ new telemedicine and scope-of-practice policies override state laws. The agency said, “CMS sets and enforces essential quality and safety standards that supplement state scope-of-practice and licensure laws for healthcare workers. CMS has continuously examined its regulations to identify areas where federal requirements may be more stringent than state laws and requirements.”
On March 20, Vice President Pence announced that physicians would be allowed to practice across state lines during the COVID-19 crisis, as reported by Medscape Medical News. Until now, however, CMS had not changed its regulations to allow doctors to conduct telehealth consultations in states other than the ones in which they are licensed.

Other Changes

As part of other rule changes to support the healthcare workforce, CMS said on March 30 that it will pay for more than 80 additional services when furnished via telehealth.
These include emergency department visits, initial skilled nursing facility and discharge visits, and home visits. In addition, the agency said it would cover phone visits with Medicare beneficiaries.
Moreover, while virtual “check-in” visits had previously been limited to established patients, CMS said that doctors would be able to provide these services to both new and established patients.
Among its other regulatory changes in recent weeks, CMS has also temporarily:
  • Permitted physicians whose privileges will expire to continue practicing at a hospital, and allowed new physicians to begin working prior to full hospital medical staff/governing body review and approval
  • Lifted regulatory requirements regarding hospital personnel qualified to perform specific respiratory care procedures, allowing these professionals to operate to the fullest extent of their licensure
  • Waived federal minimum personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants so they can work at rural hospitals as long as they meet state licensure requirements
  • Allowed physicians and nonphysician practitioners to use telehealth to care for patients at long-term care facilities, rather than having to treat patients at those facilities in person
  • https://www.medscape.com/viewarticle/928541

NYC Hospitals: Healthcare Workers to Report in Person, Even Phone, Telehealth

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.
The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.
“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.
Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other healthcare workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.
“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”
There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.
In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”
Recently, many medical associations have issued statements supporting the rights of healthcare workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.
During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.
“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”
He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”
Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.
At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.
https://www.medscape.com/viewarticle/928550