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The Trump administration released $1.4 billion to almost 80 children’s hospitals that have been impacted by the COVID-19 pandemic...The money comes out of a $175 billion fund Congress passed a few months ago to help providers that have been slammed by a financial crisis caused by the COVID-19 pandemic...“Children’s hospitals have seen decreasing patient visits and increased costs,” the Department of Health and Human Services said...“This distribution will help to ensure children’s hospitals receive relief funding proportional to other hospitals across the nation and providers caring for children are able to continue operating safely in some of our most vulnerable communities.”...HHS already gave out nearly $15 billion to safety hospitals and $11 billion to rural healthcare providers. The agency is also allocating funding to hospitals that have seen a high number of COVID-19 cases...READ MORE

The good news: The United States has a window of opportunity to beat back Covid-19 before things get much, much worse...The bad news: That window is rapidly closing. And the country seems unwilling or unable to seize the moment...Winter is coming. Winter means cold and flu season, which is all but sure to complicate the task of figuring out who is sick with Covid-19 and who is suffering from a less threatening respiratory tract infection. It also means that cherished outdoor freedoms that link us to pre-Covid life — pop-up restaurant patios, picnics in parks, trips to the beach — will soon be out of reach, at least in northern parts of the country...Unless Americans use the dwindling weeks between now and the onset of “indoor weather” to tamp down transmission in the country, this winter could be Dickensianly bleak, public health experts warn...READ MORE

...Moderna will begin the first clinical trial of its kind, a massive placebo-controlled study to definitively determine whether an experimental vaccine can thwart the disease caused by the novel coronavirus...four other like-sized trials from other coronavirus vaccine developers are also expected to begin in the U.S. Combined, they are looking for a specific group of about 150,000 total volunteers, and aiming to amass enough information from them within months to back potential approvals for emergency use...Other, similarly large trials have been run before to test vaccines. But never have so many been done, simultaneously, for the same disease during a pandemic. Those factors make for one of the most logistically challenging research initiatives in history...READ MORE

Nevada on Saturday reported a record daily increase of additional confirmed COVID-19 cases. But health officials later said the bulge largely resulted from laboratory data entry errors that delayed the posting of hundreds of cases from two previous days...The state Department of Health and Human Services reported an additional confirmed 1,099 cases, mostly from metro Las Vegas...The number of additional cases reported Saturday was more than double the previous record of 507 reported Thursday. Bur the Southern Nevada Health Agency said the reported daily increase included over 600 cases that should have been reported earlier in the week but were not...READ MORE

Potential accuracy issues with a widely used coronavirus test could lead to false results for patients, U.S. health officials warned...The Food and Drug Administration issued the alert...to doctors and laboratory technicians using Thermo Fisher’s TaqPath genetic test. Regulators said issues related to laboratory equipment and software used to run the test could lead to inaccuracies. The agency advised technicians to follow updated instructions and software developed by the company to ensure accurate results...Dr. Albert Ko of Yale’s School of Public Health said the potential accuracy problems have “pretty serious implications” given that Thermo Fisher’s test is used widely both in the U.S. and around the world to screen for coronavirus...The FDA has used its emergency powers to OK more than 200 tests for coronavirus since February. No test is perfect and all are expected to give at least a small percentage of false negatives and false positives...READ MORE

Never before have prospective vaccines for a pathogen entered final-stage clinical trials as rapidly as candidates for Covid-19...The colossal impact of the coronavirus is motivating the speed, opening a spigot of funding and inspiring research teams around the world to join the hunt. But the astonishing pace of the progress is also a consequence of the virus itself: It is, scientifically speaking, an easier target for potential vaccines than other pathogens, and a prime candidate for cutting-edge vaccine platforms new to scientists’ toolkits...Vaccines typically take years, if not decades, to reach people; the record now is four years for the mumps vaccine. Here’s what has propelled the Covid-19 endeavor to eclipse prior efforts so far...READ MORE
A familiar family
An acute, not chronic infection
Cutting-edge approaches
Money, money, money
Regulatory nimbleness
The challenges ahead

Leading health IT groups are criticizing the Trump administration's move to abruptly change how hospitals report COVID-19 data, saying it jeopardizes public trust and hampers the industry's ability to respond to the pandemic...the Trump administration directed hospitals to sidestep the Centers for Disease Control and Prevention and send critical information about COVID-19 hospitalizations and equipment to a different federal database set up by the Department of Health and Human Services...The American Medical Informatics Association and the American College of Medical Informatics wrote an open letter claiming this shift in reporting will create data gaps, "hindering efforts to recognize, understand, and evaluate important trends related to COVID-19."...READ MORE

A New Jersey medical office has filed suit against Cigna, alleging that the insurer failed to pay for diagnostic testing and treatment related to COVID-19 in violation of the CARES Act...Open MRI and Imaging of RP Vestibular Diagnostics claims that Cigna owes it nearly $400,000 in unpaid claims for care related to the novel coronavirus, and that the decisions to decline coverage were "arbitrary."..."The explanations given by [Cigna] for its refusal to make payment include unelaborated denials that the services were rendered as billed, or matched the services billed, as well as the occasional contention that the billing was duplicative," according to the lawsuit. "The grounds for rejecting plaintiff's claims were, upon information and belief, false and invalid."...READ MORE

The National Institutes of Health is preparing to launch a “flurry” of large clinical trials to test new approaches to treating Covid-19, according to the agency’s director, hoping to expand what for now remains a limited arsenal of therapies to help people with the disease...Among the trials, he said: studies of antiviral monoclonal antibodies to treat Covid-19 in both hospitalized patients and patients who can be treated at home; studies of drugs to quell overreaction of the immune system that the agency has picked from dozens of approved treatments; and studies of blood thinners in very sick Covid-19 patients to prevent problems caused by blood clots. Those treatment studies will be on top of the work that the NIH is also doing on vaccines...READ MORE

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development...under the umbrella of the International Coalition of Medicines Regulatory Authorities...Emphasis was placed upon the requirement for Phase III clinical trials...should include those with underlying medical conditions so that relevant data can be generated. Additionally...clinical studies should be designed with stringent success criteria to ensure there is convincing demonstration of efficacy...READ MORE