Today's News and Commentary

About pharma

Pharmacy reimbursement often lags for generics undergoing price hikes, jeopardizing patient access: “Of more than 4,300 instances in which pharmacies saw generic drug prices rise by 50% or more over a recent two-year period, the reimbursement from health plans and pharmacy benefit kept up with the price increases only 16% of the time… The findings underscore the fact that pharmacies are sometimes getting squeezed when their costs increase, which has contributed to an ongoing number of closures among retail pharmacies around the U.S. in recent years.” Read the research here.

Novo Nordisk offers free 90-day supply of insulin amid pandemic:”Patients in the U.S. who can prove they lost their healthcare benefits because of a job termination notice or job status change are eligible. In addition, the offer will be extended past 90 days for anyone who is denied Medicaid benefits.”

DEA eases some controlled-substances rules during pandemic: “The DEA, in a letter posted last week, said that ‘due to the extraordinary circumstances arising out of the COVID-19 pandemic,’ would allow a health care organization’s existing DEA registration to apply to a satellite hospital or clinic if it meets certain conditions…”

About the public’s health

COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU): A reminder about this dynamic website. It has many new features since I first listed it.

Projecting the transmission dynamics of SARS-CoV-2 through the postpandemic period: “Absent other interventions, a key metric for the success of social distancing is whether critical care capacities are exceeded. To avoid this, prolonged or intermittent social distancing may be necessary into 2022. Additional interventions, including expanded critical care capacity and an effective therapeutic, would improve the success of intermittent distancing and hasten the acquisition of herd immunity. Longitudinal serological studies are urgently needed to determine the extent and duration of immunity to SARS-CoV-2. Even in the event of apparent elimination, SARS-CoV-2 surveillance should be maintained since a resurgence in contagion could be possible as late as 2024.”

FDA tightens enforcement on Covid-19 antibody tests: “After loosening restrictions on antibody tests, the US Food and Drug Administration has decided government scientists will review data on lab tests that claim they can detect if someone has antibodies to Covid-19…”

Trump halts US funding for World Health Organization as it conducts coronavirus review: This move will affect developing countries who are still struggling with diseases other than COVID-19. For example, Ebola is still not wiped out. Further, these other diseases could pose a risk to the US.

Three reasons why Jacinda Ardern’s coronavirus response has been a masterclass in crisis leadership: A really good article on differences in crisis leadership.

Mediterranean diet slows cognitive impairment, studies say: Another reason for healthy eating.

Work for America: Here is the site for the federal government’s plan to resume work.

About health insurance

UnitedHealthcare reports 475K drop in commercial plan membership: “…the insurance giant says it's unlikely to make up that lost ground in 2020.”

Today's News and Commentary

About health insurance

Health Insurers Respond to COVID-19: A Survey: Contrary to previous reports: “Few insurers anticipate raising 2021 premiums due to coronavirus – 83% say they do not anticipate raising rates for 2021 in response to the crisis, while 17% anticipate raising rates no more than 5%. Eighty-seven percent of respondents offering Affordable Care Act (ACA) plans say it is unlikely they will leave the ACA market due to coronavirus.”

More than Half of Participants Likely to Leave Cost-Saving Medicare Program: “…almost 60 percent of respondents in risk-based models reporting they are likely to quit the ACO program to avoid financial losses stemming from the pandemic, and  77 percent of ACOs reporting they are “very concerned” about the impact of COVID-19 on their ACO’s 2020 performance.”

 CMS delays new payment model for emergency care: “CMS has delayed the start date of its Emergency Triage, Treat and Transport model from May 1 until this fall…Medicare now pays for emergency ambulance services when beneficiaries are transported to hospitals, skilled nursing facilities and dialysis centers. Most beneficiaries who call 911 with a medical emergency are taken to a hospital emergency department. Under the ET3 model, Medicare will reimburse for transport to an urgent care clinic or primary care office, or for providing care in place or using telehealth.”

About pharma

The top 10 drugs by sales increase in 2020: The article gives each drug’s story and some manufacturer background. Keytruda is at the top of the list.

Death penalty states hoarding drugs needed to ventilate COVID-19 patients: In addition to reduced supply of opioids (due to problems with that class of drugs), here is another cause for shortages of medications needed to treat ventilator patients. “Nineteen out of 28 death penalty states use midazolam, vecuronium bromide, rocuronium bromide and fentanyl for executions, all of which are listed as being in short supply in hospitals…”

About the public’s health

US clears first saliva test to help diagnose new virus: “Rutgers University researchers have received U.S. government clearance for the first saliva test to help diagnose COVID-19, a new approach that could help expand testing options and reduce risks of infection for health care workers.”

More than 117 million children at risk of missing out on measles vaccines, as COVID-19 surges: “As COVID-19 continues to spread globally, over 117 million children in 37 countries may miss out on receiving life-saving measles vaccine. Measles immunization campaigns in 24 countries have already been delayed; more will be postponed.”

Retail scripts of vaccines, acute drugs decline sharply amid COVID-19 pandemic: The above article applies to the US as well. “…total prescriptions for drugs for acute use have plummeted by 28% since February… In contrast, chronic disease therapies are doing well, with weekly scripts even growing 2% at the end of March as compared with early February.
Within the realm of branded products, vaccines saw the most decline, probably because people stopped going to public spaces to address a disease they don’t even have [emphasis added]. Meanwhile, the autoimmune market, HIV and anticoagulants have so far experienced no impact…”

.The Occupational Safety and Health Act [OSHA] at 50: Introduction to the Special Section: The American Journal of Public Health's May issue has a special section devoted to the 50th anniversary of OSHA.

About emerging science

Large-scale proteomic analysis of Alzheimer’s disease [AD] brain and cerebrospinal fluid reveals early changes in energy metabolism associated with microglia and astrocyte activation: “A protein network module linked to sugar metabolism emerged as one of the modules most significantly associated with AD pathology and cognitive impairment. This module was enriched in AD genetic risk factors and in microglia and astrocyte protein markers associated with an an(ti-inflammatory state, suggesting that the biological functions it represents serve a protective role in AD. Proteins from this module were elevated in cerebrospinal fluid in early stages of the disease. In this study of >2,000 brains and nearly 400 cerebrospinal fluid samples by quantitative proteomics, we identify proteins and biological processes in AD brains that may serve as therapeutic targets and fluid biomarkers for the disease [emphasis added].

Today's News and Commentary

About health insurance

FAQs About Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation- Part 42: This document is from CMS and has a lot of information for payers. A few key issues:

  • These laws apply to all payers including ERISA plans

  • Testing cannot have any out of pocket expenses for the patient or have utilization criteria applied except medical necessity (e.g., must have a physician’s order).

  • The rates insurers pay testing entities must be their contracted rates or the rates the entities are required to publish, e.g., online. Such published rates need not be reasonable, however.

  • See the document for answers to what is a covered visit.

Bundled-Payment Models Around the World: How They Work and What Their Impact Has Been: This study, from the Commonwealth Fund, found that: “Of the 35 studies retrieved, 32 reported effects on quality of care and 32 reported effects on medical spending. Twenty of 32 studies reported modest savings or a modest reduction in spending growth, while two studies (both based on the same initiative) demonstrated increased spending in the early years of the bundled-payment model’s implementation. Eighteen of 32 studies reported quality improvements for most evaluated measures, while other studies showed no difference in measured quality. Our study provides evidence that bundled-payment models have the potential to reduce medical spending growth while having either a positive impact or no impact on quality of care.”

About the public’s health

Coronavirus Resources & Tools (COVID-19): This resource site is sponsored by Walters Kluwer. Click on “Agency Guidance” or go here to compare state and federal regulations and laws.

Towards aerodynamically equivalent COVID19 1.5 m social distancing for walking and running: In Europe, the recommended social distance is 1.5 meters (almost 5 feet). This Belgian study, widely quoted in the media today, says that “this social distance has been defined for persons that are standing still. It does not take into account the potential aerodynamic effects introduced by person movement, such as walking fast, running and cycling. This aerodynamics study investigates whether a first person moving nearby a second person at 1.5 m distance or beyond could cause droplet transfer to this second person.” The result of the study is that: “In the absence of head wind, tail wind and cross-wind, for walking fast at 4 km/h this [safe] distance is about 5 m [16.4 feet] and for running at 14.4 km/h this distance is about 10 m [32.8 feet].” Another recommendation is running or cycling to the side of the person in front. The article has some interesting graphics on slipstream dynamics.

Aerosol and Surface Distribution of Severe Acute Respiratory Syndrome Coronavirus 2 in Hospital Wards, Wuhan, China, 2020: In a related article from the CDC: “To determine distribution of severe acute respiratory syndrome coronavirus 2 in hospital wards in Wuhan, China, we tested air and surface samples. Contamination was greater in intensive care units than general wards. Virus was widely distributed on floors, computer mice, trash cans, and sickbed handrails and was detected in air ≈4 m from patients.” The 6 feet rule may not be sufficient in hospital settings.

Coronavirus Tests Are Being Fast-Tracked by the FDA, but It’s Unclear How Accurate They Are: The headline is self-explanatory.

Diagnostic Testing for Severe Acute Respiratory Syndrome–Related Coronavirus-2: A Narrative Review: In a related article, this open-access review from the Annals of Internal Medicine is a good review of the topic.

Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A good update on the subject from JAMA (open access). Bottom line: “No therapies have been shown effective to date.”

Small Chloroquine Study Halted Over Risk of Fatal Heart Complications: “A small study in Brazil was halted early for safety reasons after coronavirus patients taking a higher dose of chloroquine developed irregular heart rates that increased their risk of a potentially fatal heart arrhythmia.”

Vital Signs: Newly Reported Acute and Chronic Hepatitis C Cases ― United States, 2009–2018: “The annual rate of reported acute hepatitis C tripled from 2009 to 2018 and was highest among persons aged 20–39 years. In 2018, the largest proportion of chronic hepatitis C cases occurred among persons aged 20–39 years and 50–69 years. Only 61% of adults with hepatitis C knew that they were infected…
All adults and pregnant women should be screened for hepatitis C according to CDC’s new screening recommendations.”

Weekly U.S. Influenza Surveillance Report: “Nationally, the percent of laboratory specimens testing positive for influenza at clinical laboratories continued to decrease and is now low… CDC estimates that so far this season there have been at least 39 million flu illnesses, 410,000 hospitalizations and 24,000 deaths from flu.” Reporting (from care-seeking) has increased because of heightened awareness of COVID-19.

FDA OKs on-site decontamination systems for reusing millions of N95 respirator masks: “The FDA greenlighted its second and third systems for decontaminating N95 respirators, both previously used on-site at many health systems nationwide. Together, the agency estimates this will allow nearly 5 million masks to be processed and reused per day.”

FDA quickly authorizes its second blood filtering device for COVID-19: ”Shortly after granting an emergency authorization to Terumo BCT’s blood filtering device for COVID-19, the FDA did the same for CytoSorbents’ system. Both are designed to strip out the immune system proteins that fuel the deadly cytokine-storm reactions associated with the disease.”

WHO investigating reports of coronavirus patients testing positive again: “The World Health Organization (WHO) confirmed on Saturday it is investigating reports of some recovered coronavirus patients testing positive for the illness after initially testing negative. 
The move is in response to a report from South Korea on Friday that 91 patients who had been cleared of COVID-19 and were being prepared for discharge tested positive again. Officials say that, rather than being reinfected, patients may be suffering from a ‘reactivated’ coronavirus. “

America's new opioid crisis:”A yearslong crackdown on opioid production is having an unintended consequence during the coronavirus crisis: Many of these same drugs are essential for people on ventilators, and now there’s a shortage.”

Today's News and Commentary

About the public’s health

CommonSpirit Health transforms cafes in some hospitals into grocery stores to help front-line workers: “CommonSpirit Health has converted the cafes in several of its hospitals in Arizona and the Pacific Northwest into grocery stores to help out overwhelmed physicians and staff members.
The 137-hospital system said that the stores will provide staples that are not available in most retail stores, such as toilet paper and disinfectant cleaner.”

Coronavirus in Mississippi: UMMC makes ventilators with basic hardware store supplies: MacGyver lives! “Made with "primarily a garden hose, a lamp timer and electronic valve, the ventilator, named the Robertson Ventilator [after inventor Dr. Charles Robertson, a UMMC pediatric anesthesiologist] , for less than $100, can be assembled in approximately 20 to 30 minutes, meaning a dedicated team of four to five could produce nearly 100 in a day if needed…”

Coronavirus Becomes Number One Cause of Death Per Day in U.S., Surpassing Heart Disease and Cancer:The headline speaks for itself.

Thousands of coronavirus tests are going unused in US labs: “A Nature investigation of several university labs certified to test for the virus finds that they have been held up by regulatory, logistic and administrative obstacles, and stymied by the fragmented US health-care system. Even as testing backlogs mounted for hospitals in California, for example, clinics were turning away offers of testing from certified academic labs because they didn’t use compatible health-record software, or didn’t have existing contracts with the hospital.” Read the article for more details about the need for central governmental coordination.

COVID-19 fallout could push half a billion people into poverty in developing countries: New research published by UNU-WIDER [United national University-WIDER]  today warns that the economic fallout from the global pandemic could increase global poverty by as much as half a billion people, or 8% of the total human population. This would be the first time that poverty has increased globally in thirty years, since 1990.” [Emphases in the original.] This economic impact will affect their ability to afford healthcare and increase the need for foreign aid.

Germany to run Europe’s first large-scale antibody test programme: “Germany is to carry out Europe’s first large-scale coronavirus antibody testing in an effort to help researchers assess infection rates and monitor the spread of the virus more effectively…
Germany has already emerged as a leader in testing for coronavirus itself, carrying out up to 100,000 tests per day, according to health minister Jens Spahn.” Recall that Germany developed a test early in the pandemic, but our federal government decided to develop its own via the CDC. Also recall that the test did not work.

About hospitals

Fitch puts 15 nonprofit hospitals on its watch list for ratings downgrade due to coronavirus: “The action by Fitch impacts $3.7 billion of total outstanding debt.” See the article for the list.

CMS sends $51B in advance payments to hospitals: “CMS announced April 9 that it has delivered more than $51 billion in payments to hospitals and other healthcare providers in the past week through the Accelerated and Advance Payment Program.”

About health insurance

White House says no ‘surprise’ bills for COVID-19 patients: “Hospitals taking money from the $2 trillion stimulus bill will have to agree not to send ‘surprise’ medical bills to patients treated for COVID-19, the White House said Thursday.”

46 telehealth services UnitedHealthcare covers during COVID-19 pandemic + their codes:The article provides a list of services, and their respective codes, that UnitedHealthcare will cover when provided via telehealth through June 18.

About healthcare personnel

AWS powers new platform to train one million volunteer healthcare workers: “Amazon Web Services (AWS) is supporting a new initiative launched by nonprofit consortium Volunteer Surge, Inc., to recruit, train, and deploy 1 million volunteer health workers. The initiative will offer communities across the U.S. volunteer support so doctors and nurses can focus on tending to the most critical needs. To become trained, volunteers will complete an approximately 30-hour, fully-online Community Health Worker Course developed by Cinematic Health Education in consultation with the Yale School of Public Health. AWS is powering the virtual learning platform to train volunteers before they head into the field.”

About pharma

Coronavirus fuels a surge in fake medicines: In addition to fake medications are masks that do not offer protection.

Covid-19 drugs could be made for $1 per day, say academics: For example, “sofosbuvir/daclatasvir combination, a Hepatitis C treatment… is on sale for $18,610 per treatment course in the US, and for $6 in Pakistan… [The academic study calculates] that it would cost $5 to produce a course of the medicine — or 39 cents a day.” The figures include a 10% profit! Here is a link to the journal article.

Today's News and Commentary

About the public’s health

How Safe Is It To Eat Takeout?: This NPR article collects expert opinions to answer the headline’s question. In summary: “… safe food-handling rules, required of any establishment that serves food, would also be protective against spreading the coronavirus…. These include wearing gloves, workers staying home when sick, frequent hand-washing and disinfecting of surfaces in the kitchen. 
And no food establishment can operate unless there's at least one person on the premises who is trained in food safety…
The FDA has produced guidance on food safety and COVID-19. The only significant change from standing guidance before the pandemic is the recommendation from the FDA to maintain a 6-foot distance between food workers when possible, to reduce the risk of transmission among them.”

The next pandemic is already coming, unless humans change how we interact with wildlife, scientists say: Fascinating article about the ecology of viral pandemics. Some 70 percent of emerging infectious diseases in humans are of zoonotic origin, scientists say, and nearly 1.7 million undiscovered viruses  may exist in wildlife. Many researchers are searching for the ones that could cause the next animal-to-human spillover. The likeliest hot spots have three things in common…: lots of people, diverse plants and animals, and rapid environmental changes…Late last year, a horseshoe bat coronavirus is thought to have leaped in China, scientists say, where commerce in exotic animals is driven by luxury tastes in game and demand for parts used for medicinal purposes.”

Coconut Oil’s Health Halo a Mirage, Clinical Trials Suggest: “Despite the rising popularity of coconut oil because of its purported health benefits, our results raise concerns about high coconut oil consumption. Coconut oil should not be viewed as healthy oil for cardiovascular disease risk reduction and limiting coconut oil consumption because of its high saturated fat content is warranted.”

US suicide rate climbs 35% since 1999, new report finds: “The suicide rate in the United States continues to rise, increasing 35% for almost two decades from 1999 through 2018, according to a new data brief released by the National Center for Health Statistics on Wednesday.” Age, sex and geographic differences are pronounced.

About health insurance

Centene Announces Provider Support Program To Assist Providers With Grant Writing, Small Business Loan Applications: This insurer introduced a program to help support providers.

About healthcare IT

Amidst a record $3.1B funding in Q1 2020, digital health braces for COVID-19 impact: From venture capital firm Rock Heal+h: “Digital health venture funding had its strongest start ever in 2020, with a prodigious $3.1B invested across Q1. In February the COVID-19 pandemic hit the US, sending an immediate shock through public markets. The twin crises of a global pandemic and massive economic shifts will rapidly impact all market sectors, including digital health. To assess the scale, direction, and timing of the impact, we surveyed twelve leading healthcare investors between March 16 and March 20, 2020 (and included our own response in the sample).” The survey is a really god in-depth look at this sector’s recent and immediate prospects.

A public data lake for analysis of COVID-19 data: From Amazon Web Services: “Today, we are making a public AWS COVID-19 data lake available – a centralized repository of up-to-date and curated datasets on or related to the spread and characteristics of the novel corona virus (SARS-CoV-2) and its associated illness, COVID-19.”

 About pharma

FDA clears first generic version of Merck & Co.'s Proventil HFA inhaler for bronchospasm: “The FDA on Wednesday said it approved Cipla's filing for the first generic version of Merck & Co.'s Proventil HFA (albuterol sulfate) metered-dose inhaler. The medicine is indicated to treat and prevent bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as to prevent exercise-induced bronchospasm in this age group.
Commissioner Stephen Hahn stated that the agency ‘recognises the increased demand for albuterol products during the novel coronavirus pandemic.’”

COVID-19: 90-Day Refills May Strain Supply Chain:”Across the country, pharmacies have been seeing a significant uptick in patients seeking to extend 30-day prescriptions to 90 days to ensure access to their medications amid the growing COVID-19 crisis. While stakeholders say they have been able to meet these requests, several indicate that it’s only a matter of time before the supply chain buckles under these new pressures.”

Today's News and Commentary

About the public’s health

As Wuhan’s lockdown ends, residents leave messages for the dead doctor who sounded the alarm on coronavirus: Many experts are concerned this relaxation might make a second wave much worse.

Neutralizing antibody [NAb]responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications [This article is a preprint and has not been peer-reviewed]:” Methods Plasma collected from 175 COVID-19 recovered patients with mild symptoms…SARS-CoV-2-specific NAbs were detected in patients from day 10-15 after the onset of the disease…The titers of NAbs were variable in different patients. Elderly and middle-age patients had significantly higher plasma NAb titers (P<0.0001) and spike-binding antibodies (P=0.0003) than young patients. Notably, among these patients, there were ten patients whose NAb titers were under the detectable level of our assay.” If this study is confirmed, it means we need far more information on the variability of antibody responses to make intelligent clinical decisions about who is infected and who has recovered.

Mysterious Heart Damage, Not Just Lung Troubles, Befalling COVID-19 Patients: The article is a discussion of how the COVID-19 illness may directly affect the heart.

COVIDView: A Weekly Surveillance Summary of U.S. COVID-19 Activity: The CDC has a weekly update on COVID-19 activity. Here is the first installment.

CDC removes unusual guidance to doctors about drug favored by Trump: “The U.S. Centers for Disease Control and Prevention has removed from its website highly unusual guidance informing doctors on how to prescribe hydroxychloroquine and chloroquine, drugs recommended by President Donald Trump to treat the coronavirus... Reuters …reported that the original guidance was crafted by the CDC after President Trump personally pressed federal regulatory and health officials to make the malaria drugs more widely available to treat the novel coronavirus, though the drugs in question had been untested for COVID-19.”

Hospitals say feds are seizing masks and other coronavirus supplies without a word: “Although President Trump has directed states and hospitals to secure what supplies they can, the federal government is quietly seizing orders, leaving medical providers across the country in the dark about where the material is going and how they can get what they need to deal with the coronavirus pandemic.
Hospital and clinic officials in seven states described the seizures in interviews over the past week. The Federal Emergency Management Agency is not publicly reporting the acquisitions, despite the outlay of millions of dollars of taxpayer money, nor has the administration detailed how it decides which supplies to seize and where to reroute them.”

Trouble in testing land: University of Oxford Professor Sir John Bell wrote in his blog that: “Multiple tests have been provided for evaluation, and a range of convalescent sera has been used to determine whether the tests can identify both low and high levels of antibodies. We have been very careful to test using gold standards checked against a sensitive enzyme-linked immunosorbent assay (Elisa) of the spike protein and other viral proteins. Sadly, the tests we have looked at to date have not performed well. [Emphasis added.] We see many false negatives (tests where no antibody is detected despite the fact we know it is there) and we also see false positives. None of the tests we have validated would meet the criteria for a good test as agreed with the MHRA. This is not a good result for test suppliers or for us.” As previously reported, the rapid proliferation of barely-tested diagnostics may not be helping public health efforts.

Walgreens Expanding Drive-Thru Testing To 15 New Locations in Seven States:”Walgreens is working to expand drive-thru testing to 15 new sites in seven states, the company announced today. The states included are Arizona, Florida, Illinois, Kentucky, Louisiana, Tennessee and Texas…Testing will be available at no cost to eligible individuals who meet criteria established by the Centers for Disease Control and Prevention (CDC). Patients will need to pre-register in advance in order to schedule an appointment for testing.”

About health insurance

UnitedHealth fast-tracks $2B in payments to providers: “UnitedHealth's initiative, announced April 7, will fast-track claim payments to medical and behavioral care providers in UnitedHealthcare's fully insured commercial, Medicare Advantage and Medicaid networks. The healthcare company will also provide up to $125 million in small business loans to OptumHealth's clinical operator partners.” I wonder if this insurer (and CMS) will slow down payments again when the crisis is over.

Estimated Cost of Treating the Uninsured Hospitalized with COVID-19: This Kaiser Family Fund analysis estimates “total payments to hospitals for treating uninsured patients under the Trump administration policy would range from $13.9 billion to $41.8 billion. At the top end of the range, payments on behalf of the uninsured would consume more than 40% of the $100 billion fund Congress created to help hospitals and others respond to the COVID-19 epidemic. Given the uncertainty of our estimates of the total funding that will be needed to reimburse hospitals, and the fact that infections may come in several waves over the next year, it is unclear whether the new fund will be able to cover the costs of the uninsured in addition to other needs, such as the purchase of medical supplies and the construction of temporary facilities.”

Relationship of a Claims-Based Frailty Index to Annualized Medicare Costs: A Cohort Study: “Medicare uses the Centers for Medicare & Medicaid Services Hierarchical Condition Category (CMS-HCC) model to predict patients' annualized Medicare costs in value-based payment programs. The CMS-HCC model does not include measures of frailty, and prior research shows that it systematically underpredicts costs for frail Medicare beneficiaries…The frailty index addition to the CMS-HCC model predicted on average an additional $2712, $7915, and $16 449 in costs for prefrail, mildly frail, and moderately to severely frail patients, respectively, beyond the CMS-HCC model alone. On average, the model with the frailty index addition resulted in more accurate predictions of costs for patients at all 4 levels of frailty. However, observed costs remained more widely distributed than predictions from the enhanced model at all levels of frailty.”

About pharma

Eli Lilly makes new $35 insulin copay available in US during coronavirus pandemic:  “Eli Lilly said Tuesday that in light of the crisis caused by the coronavirus pandemic, it is introducing a programme that caps the out-of-pocket cost for most of the company's insulin products, including all Humalog (insulin lispro) formulations, to $35 per month for anyone with commercial insurance, as well as those without insurance. However, patients with government insurance such as Medicaid, Medicare, Medicare Part D or any state patient or pharmaceutical assistance programme are not eligible for the scheme.” Like many other special plans, is it cheaper to pay out of pocket and not use insurance?

FDA Drug Approval: Application Review Times Largely Reflect FDA Goals: The “GAO was asked to examine NDA [New Drug Approval] review times across FDA's divisions. In this report, GAO examines (among other things) differences between FDA divisions in the key features of the NDAs they review and initial review times, as well as the extent to which key NDA features contribute to these differences…
GAO's analysis of 637 NDAs submitted from fiscal years 2014 through 2018 indicated that the proportion of NDAs …key features differed among FDA review divisions. For example, 6 percent of the NDAs reviewed by the dermatology and dental division had a priority designation, compared to 56 percent for the anti-infective division. FDA has reported that some divisions, such as the oncology divisions, generally regulate products for conditions that are more likely to be serious or life-threatening, and, therefore, those products may be more likely to qualify for priority designation and other expedited programs... Controlling for the effects of these target time frames and the number of expedited programs for which the NDA qualified, GAO found that most of the divisions' average review times were similar to (within 2 weeks of) each other.”

About healthcare IT

Diagnostic Category Prevalence in 3 Classification Systems Across the Transition to the International Classification of Diseases, Tenth Revision, Clinical Modification: Many were worried that the change from ICD 9 to ICD 10 would distort historical trend analysis by changing diagnostic classifications. This research is the first I have seen on the topic and shows that the concerns were warranted. “These findings suggest that the ICD-10-CM transition was associated with large prevalence changes for many diagnostic categories. Diagnostic classification systems developed using ICD-9-CM may need to be refined using ICD-10-CM data to avoid unintended consequences for disease surveillance, performance assessment, and risk-adjusted payments.” 

Today's News and Commentary

World Health Day!

About the public’s health

World Health Day: What does the WHO do?: “The Constitution of the World Health Organization, initially signed by 61 countries in New York in 1946, went into effect on April 7, 1948 — the day we now call World Health Day.” This article is an interesting, short piece about WHO- origin, funding and what it does.

How the U.S. Compares to Other Countries in Responding to COVID-19: Populations at Risk, Health System Capacity, and Affordability of Care: Interesting comparisons from the Commonwealth fund. Not only responses, but population differences are discussed.

How Will We Know When It’s Time to Reopen the Nation?: Aaron E. Carroll’s opinion piece in the New York Times. He sets these 4 conditions in answer to the headline’s question:

  • Hospitals in the state must be able to safely treat all patients requiring hospitalization, without resorting to crisis standards of care.

  • A state needs to be able to at least test everyone who has symptoms.

  • The state is able to conduct monitoring of confirmed cases and contacts.

  • There must be a sustained reduction in cases for at least 14 days.

COVID-19 vaccine packed into skin patch shows promise in mice: Fascinating technology. Researchers at the University of Pittsburgh School of Medicine say they’ve… developed a vaccine that can be delivered into the skin with a Band-Aid-like patch made of 400 tiny needles. When they tested it in mice, the vaccine produced antibodies to fend off the virus within two weeks.”

Researchers harness new technology for rapid COVID-19 vaccine development: “…scientists working for a spinoff of Massachusetts General Hospital called Voltron Therapeutics…formed a joint venture with Hoth Therapeutics, named HaloVax, and tasked it with using a vaccine technology developed at MGH to find a COVID-19 candidate…
The Voltron candidate came from a platform developed at MGH called VaxCelerate, which is designed to quickly generate and test ‘self-assembling’ vaccines that spark immune responses to viruses. The experimental COVID-19 vaccine uses a heat shock protein to activate the immune system, rather than one of the chemical adjuvants that are commonly employed by vaccine developers, the company said. The vaccine will also include a variable component that targets specific characteristics of COVID-19.”

WTO Reports Heavy Tariffs on Critical COVID-19 Supplies:”Tariffs on protective supplies used in the fight against the virus are as high as 27 percent in certain countries, with the average tariff being 11.5 percent, the WTO said.”

About healthcare IT

VA suspends Cerner EHR rollout amid COVID-19 pandemic:”The Department of Veterans Affairs is postponing its $16 billion Cerner EHR implementation in response to the COVID-19 pandemic.” Yet another of many delays.

About health insurance

2021 Medicare Advantage and Part D Rate Announcement Fact Sheet: This CMS Fact Sheet has details about rates for these programs for 2021. Overall, Medicare Advantage, PACE and Part D organizations will get a 1.66 percent raise. Here are more details: Announcement of Calendar Year (CY) 2021 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies.

The Potential National Health Cost Impacts to Consumers, Employers and Insurers Due to the Coronavirus (COVID-19): This analysis by Covered California projects (emphases in the article):

  • The one-year projected costs in the national commercial market range from $34 billion to $251 billion for testing, treatment and care specifically related to COVID-19 — with the potential that costs could be higher than the high end of the range.

  • Potential COVID-19 costs for 2020 could range from about 2 percent of premium to over 21 percent of premium if the full first-year costs of the epidemic had been priced into the premium.

  • Health carriers are in the process of setting rates for 2021. If carriers must recoup 2020 costs,
    price for the same level of costs next year, and protect their solvency, 2021 premium increases to individuals and employers from COVID-19 alone could range from 4 percent to more than 40 percent.

About hospitals

Quorum Health files for bankruptcy: “Brentwood, Tenn.-based Quorum Health, which operates 23 hospitals in 13 states, announced April 7 that it has filed for Chapter 11 bankruptcy. 
The company, a spinoff of Franklin, Tenn.-based Community Health Systems, said the bankruptcy filing is part of a plan to recapitalize the business and reduce its debt by about $500 million. Quorum said it reached an agreementon the plan with a majority of its noteholders and term loan lenders.”

Today's News and Commentary

About healthcare IT

New York is merging all its hospitals to battle the coronavirus: It takes a real crisis to advance interoperability. “Cuomo announced that he had met with New York hospital leaders and come up with a plan to, in effect, merge them into one operating system with many different locations. From Buffalo to NYC, hospitals will be sharing staff, patients, and supplies for the foreseeable future, with Albany overseeing the distribution of resources.”

About health insurance

The 27 telehealth services Aetna covers during COVID-19 and their codes: The headline speaks for itself.

Trump Says Hospitals Will Be Paid for Treating Uninsured Coronavirus Patients: “The Trump administration plans to use money from the recent stimulus bills to pay hospitals for treatment of uninsured coronavirus patients. It says the plan is more efficient than reopening enrollment in the Obamacare markets to achieve the same goal.”

About the public’s health

China sees rise in asymptomatic coronavirus cases: “The National Health Commission (NHC) said on Monday that 78 new asymptomatic cases had been identified as of the end of Sunday, compared with 47 the day before. 
Imported cases and asymptomatic patients, who show no symptoms but can still pass the virus to others, have become China’s chief concern after draconian containment measures succeeded in slashing the overall infection rate.”

The blame game: the origins of Covid-19 and the anatomy of a fake news story: This article is an interesting, in-depth telling of how China spread fake news that SARS-CoV-2 came from the US and was introduced into China.

How sewage could reveal true scale of coronavirus outbreak: “More than a dozen research groups worldwide have started analysing wastewater for the new coronavirus as a way to estimate the total number of infections in a community, given that most people will not be tested. The method could also be used to detect the coronavirus if it returns to communities, say scientists. So far, researchers have found traces of the virus in the Netherlands, the United States and Sweden.”

Ignoring Expert Opinion, Trump Again Promotes Use of Hydroxychloroquine: From the NY Times: “Standing alongside two top public health officials who have declined to endorse his call for widely administering the drug, Mr. Trump suggested that he was speaking on gut instinct and acknowledged that he had no expertise on the subject…When a reporter at Sunday’s briefing asked Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, to weigh in on the subject, Mr. Trump stopped him from answering. As the reporter noted that Dr. Fauci, who has been far more skeptical about the drug’s potential, was the president’s medical expert, Mr. Trump made it clear he did not want the doctor to answer.”

Fauci: no evidence anti-malaria drug Trump pushes works against virus: On the same topic: “Donald Trump’s top coronavirus adviser has warned again that there is no scientific evidence to support the use of an unproven anti-malaria drug the president has been pushing as a possible remedy for Covid-19.”

EU body backs compassionate use of Gilead's remdesivir for COVID-19: In a related article: “The European Medicines Agency (EMA) on Friday said its Committee for Medicinal Products for Human Use (CHMP) recommended compassionate use of Gilead Sciences' investigational antiviral remdesivir to treat COVID-19. However, the agency cautioned that while remdesivir has been shown to be active against SARS-CoV-2 and other types of coronavirus in laboratory studies, there are ‘currently only limited data’ on its use for COVID‑19 patients.”

Some pharmacist licensing rules relaxed to fight COVID-19: “Some of the biggest regulation changes include allowing remote work, giving pharmacists more autonomy to handle certain prescriptions and allowing pharmacists and pharmacy technicians to practice out-of-state.”

E-cigarette Product Characteristics and Subsequent Frequency of Cigarette Smoking: “Among baseline past-30-day e-cigarette users, participants who used mods [modifiable electronic cigarettes] (versus vape pens) smoked >6 times as many cigarettes at follow-up… Regulation of e-cigarette device type warrants consideration as a strategy to reduce cigarette smoking among adolescents and young adults who vape.”

Weekly U.S. Influenza Surveillance Report: While COVID-19 is on everyone’s minds, we should not forget the impact of influenza. The “CDC estimates that so far this season there have been at least 39 million flu illnesses, 400,000 hospitalizations and 24,000 deaths from flu.” The good news is that: “Almost all (>99%) of the influenza viruses tested this season are susceptible to the four FDA-approved influenza antiviral medications recommended for use in the U.S. this season.”

Today's News and Commentary

About the public’s health

White House moves toward promoting face masks to fight virus: “A person familiar with the White House coronavirus task force’s discussion said officials would suggest that nonmedical masks, T-shirts or bandannas be used to cover the nose and mouth people go outside — for instance, at the grocery store or pharmacy. Medical-grade masks, particularly short-in-supply N95 masks, would be reserved for those dealing directly with the sick.”

Australia Begins Testing COVID-19 Vaccines: “Australia’s Commonwealth Scientific and Industrial Research Organization (CSIRO) has begun pre-clinical research for potential COVID-19 vaccines.”

Trump to expand use of Defense Production Act to build ventilators: “Trump issued a memorandum allowing the secretary of Health and Human Services to use authority under the powerful Korean War-era law to help six companies, including General Electric and Medtronic, secure supplies to make ventilators.”

Experts tell White House coronavirus can spread through talking or even just breathing: On a related topic: “‘While the current [coronavirus] specific research is limited, the results of available studies are consistent with aerosolization of virus from normal breathing,’ according to the letter, written by Dr. Harvey Fineberg, chairman of a committee with the National Academy of Sciences.”

About healthcare personnel

43,000 healthcare jobs lost in March: “Healthcare lost 43,000 jobs in March, with job losses primarily in ambulatory healthcare services, according to the latest jobs report from the U.S. Bureau of Labor Statistics….The job losses…included offices of physicians (-12,000), dentists (-17,000) and other healthcare practitioners (-7,000). At the same time, hospitals added only 200 jobs last month, compared to the 7,800 positions they added to the U.S. economy in February.”

U.S. doctors on coronavirus frontline seek protection from malpractice suits: Concerns range from physicians: practicing outside of their specialties (to cover excess cases) to operating hastily constructed equipment to sending people home from ERs to make room for COVID-19 patients.

Inside America’s mask crunch: A slow government reaction and an industry wary of liability: In a related story, manufacturers are wary of the liability from adapting their products to healthcare uses. For example, 3M makes masks for construction use but they are not medical grade (like N95 masks).

About healthcare IT

‘Zoom is malware’: why experts worry about the video conferencing platform: We are using Zoom and other conferencing software as never before. “But security researchers have called Zoom ‘a privacy disaster’ and ‘fundamentally corrupt’ as allegations of the company mishandling user data snowball.”

About health insurance

New York requires insurers to defer premium payments until June for individuals, small businesses facing financial hardship: The headline speaks for itself.

COVID-19 Impact on Medicaid, Marketplace, and the Uninsured, by State: Here are five take-aways from the study:

  1. The number of people receiving coverage from an employer could decline by 12 to 35 million, including both workers and family members. 

  2. Medicaid enrollment could increase from 71 million to 82-94 million.

  3. Medicaid enrollment could grow by 5 million regardless of the number of people who lose their jobs. 

  4. Uninsured numbers could increase to 40 million, with bigger impacts in non-expansion states.

  5. Marketplaces will likely see both new entrants and attrition due to job loss. 

Association Between Financial Incentives in Medicare's Hospital Readmissions Reduction Program and Hospital Readmission Performance: With regard to readmissions and Medicare, are penalties or rewards more useful incentives? “The findings suggest that improvements in readmission avoidance are more strongly associated with incentives from the HRRP than with aggregate penalty amounts, suggesting that the program has elicited sizeable changes. Worsened performance among hospitals with small or no incentives may indicate the need for reconsideration of the program's lack of financial rewards for high-performing hospitals.”

About pharma

COVID-19 is bad news for new drug launches. Which will suffer most?: As previously mentioned, the attention to COVID-19 has displaced work on many other areas of healthcare. This article discusses which drug launches will be delayed because of the pandemic.

Today's News and Commentary

About health insurance

Anthem Waives Cost Share for COVID-19 Treatment: Insurance companies are expanding benefits for covered members beyond testing for coronavirus. This Anthem “expansion covers the waiver of cost share for COVID-19 treatment received through May 31, 2020. Anthem will reimburse health care providers at in-network rates or Medicare rates, as applicable, for Anthem’s affiliated health plan fully insured, Individual, Medicaid and Medicare Advantage members. Anthem is strongly encouraging participation by our self-funded employers and will work with them to ensure their employees’ needs are met.” Note the last sentence. Many insurers are only acting as third party administrators for self-insured businesses; so the choice of benefits is up to the employer. Here is a more complete list of insurers waiving COVID-19 costs. Click on the plan to see the company’s policies.

Blue Cross parent launches special enrollment period: As posted yesterday, the Trump administration withdrew its previous proposal to open up the health exchanges for a special enrollment period. This insurer-based action may act as a model for social action. “Blue Cross & Blue Shield of Illinois parent company Health Care Service Corp. is offering a special sign-up period to increase the number of people with health insurance during COVID-19.
The enrollment period, which runs from today through April 30, applies to people who previously declined group health insurance coverage through their employer, the Chicago-based insurer, which owns Blue Cross plans in five states, announced today. It does not extend to self-insured employer plans, in which employers bear the cost of claims.”

Insurers knew the damage a viral pandemic could wreak on businesses. So they excluded coverage: Not a health insurance issue but important, nevertheless. “The forced closure of businesses nationwide because of the novel coronavirus would seem to be the perfect scenario for filing a ‘business interruption’ insurance claim.
But most companies will probably find it difficult to get an insurance payout because of policy changes made after the 2002-2003 SARS outbreak, according to insurance experts and regulators.
…many insurers added exclusions to standard commercial policies for losses caused by viruses or bacteria. Now, the added policy language will potentially allow insurance companies to avoid hundreds of billions of dollars in business-interruption claims because of the covid-19 pandemic.”

About pharma

White House pressures FDA on unproven Japanese drug: I mentioned this drug in a previous posting. Trials are underway. “Japanese Prime Minister Shinzo Abe has championed the drug, Avigan, as a possible treatment, and clinical trials are now getting underway in Japan. Chinese scientists also have touted the drug, produced by Japan-based Fujifilm, as a potential coronavirus treatment, but global regulators and U.S. researchers have long expressed concern about the drug’s risks, such as birth defects, and have warned that the Chinese data is insufficient.”

Efficacy of hydroxychloroquine in patients with COVID-19: results of a randomized clinical trial: This reference is the article the White House is touting as evidence for the effectiveness of hydroxychloroquine. I posted another Chinese study showing a slight, but statistically insignificant, benefit in the control group. Note that it is a preprint that has not been peer reviewed.

Unlike FDA, European regulators refuse to clear chloroquine for COVID-19 without data: In a related story: “In guidance Wednesday, the European Medicines Agency restricted general use of the drugs—already approved to treat malaria and autoimmune diseases—to patients taking them for approved indications. COVID-19 patients can receive the drugs as part of clinical trials or through national emergency use programs, the EMA said.”

The Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes and Cardiovascular Disease: Insights from the COMPASS Trial: Yes, there really is non-COVID-19 news. This study could set treatment standards for diabetic patients with cardiovascular disease. “In stable atherosclerosis, the combination of aspirin plus rivaroxaban 2.5 mg twice daily provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral endpoints in patients with and without diabetes. Given their higher baseline risk, the absolute benefits appeared larger in those with diabetes, including a three-fold greater reduction in all-cause mortality.”

About the public’s health

China Concealed Extent of Virus Outbreak, U.S. Intelligence Says: “China has concealed the extent of the coronavirus outbreak in its country, under-reporting both total cases and deaths it’s suffered from the disease, the U.S. intelligence community concluded in a classified report to the White House, according to three U.S. officials.
The officials asked not to be identified because the report is secret, and they declined to detail its contents. But the thrust, they said, is that China’s public reporting on cases and deaths is intentionally incomplete. Two of the officials said the report concludes that China’s numbers are fake.”

Presymptomatic Transmission of SARS-CoV-2 — Singapore, January 23–March 16, 2020: This study emphasizes the need for mass testing. “Investigation of all 243 cases of COVID-19 reported in Singapore during January 23–March 16 identified seven clusters of cases in which presymptomatic transmission is the most likely explanation for the occurrence of secondary cases.”

‘We have no choice.’ Pandemic forces polio eradication group to halt campaigns: Treatment and prevention of other diseases do not stop because of COVID-19. “The COVID-19 pandemic is imperiling the worldwide, 3-decade drive to wipe out polio. In an unprecedented move, the Global Polio Eradication Initiative (GPEI) has recommended suspending polio vaccination campaigns to help stop the spread of the novel coronavirus.”

BD to offer fingerstick antibody blood test for COVID-19: This method tests for antibodies rather than nucleic acid fragments of the virus. It takes 15 minutes and is done with a finger stick.

Texas 'mom and pop' business flooded with orders for helmet ventilators amid coronavirus crisis: This small Texas- based company’s space-helmet device has been tested in Italy and the US. “ …using them required ventilation 18.2 percent of the time, compared to 61.5 percent for the masks, and had a better 90-day survival rate, according to the study, published in the Journal of the American Medical Association.” The device costs $160. Why is the federal government not funding and ramping up such effective technology?

Medical Device Company’s Israel Division to Provide Ventilator Blueprints for Free: In a related technology story, the “Israel division of the medical device company Medtronic will provide the blueprints for its ventilators for free to companies seeking to manufacture them.”

Governmental Public Health Powers During the COVID-19 Pandemic: The government has certain powers to impose public health measures. This is a very good article that gives the legal basis for governmental actions during such crises.

About healthcare IT

Microsoft warns hospitals of sophisticated ransomware attacks targeting remote workforce: With more people than ever before working remotely, the opportunity for hacking into companies has greatly increased. “As healthcare organizations move their nonessential employees to work remotely during the COVID-19 pandemic, ransomware operators are trying to find vulnerabilities in network devices like gateway and virtual private network (VPN) appliances.”

About hospitals

Hospitals margins fell as COVID-19 pandemic ramped up: “U.S. hospitals were already facing falling margins when the COVID-19 pandemic began to ramp up in the nation.
That’s according to the National Hospital Flash Report from Kaufman Hall, which provided a snapshot of the performance of U.S. hospitals in February 2020. COVID-19 is expected to have a significant impact on hospitals over the coming months, changing the outlook for healthcare providers in the U.S. 
EBITDA margins dropped 92.7 basis points year over year in February, while operating margin declined 73.2 basis points. Operating EBITDA margin dropped 162.9 basis points and operating margin fell 206.4 basis points.
Margins fell thanks to lower volumes from January 2020 and higher expenses.”

Today's News and Commentary

About the public’s health

FDA authorizes use of new two-minute test kit for coronavirus: “The U.S. Food and Drug Administration has authorized the emergency use of Bodysphere Inc’s test that can detect the coronavirus in nearly two minutes, the privately held company said on Tuesday.” The speed will rival Abbott’s rapid test.

FDA Creates Coronavirus Treatment Acceleration Program: “The FDA launched the Coronavirus Treatment Acceleration Program (CTAP), an emergency program for potential COVID-19 therapies…
The agency is currently monitoring 10 therapies in active trials and 15 others in planning stages.”

Industry Voices—Another enemy emerges in the COVID-19 fight: Antibiotic-resistant bugs: The headline speaks for itself.

BAT joins race to develop Covid-19 vaccine: “Cigarette maker’s biotech unit tests potential antigen in genetically engineered tobacco plants.” How ironic!

Coronavirus death rate is lower than previously reported, study says, but it's still deadlier than seasonal flu: “The research, published in the medical journal The Lancet Infectious Diseases, estimated that about 0.66% of those infected with the virus will die.
That coronavirus death rate, which is lower than earlier estimates, takes into account potentially milder cases that often go undiagnosed -- but it's still far higher than the 0.1% of people who are killed by the flu.”

About healthcare technology

Grail's cancer blood test tracks down over 50 types of early-stage disease in study: “Grail published new data showing that its cancer-screening blood test is now able to spot more than 50 types of the disease across all stages of their growth…The results were published in the Annals of Oncology.”

Comparison of the Effectiveness of Single-Component and Multicomponent Interventions for Reducing Radiation Doses in Patients Undergoing Computed Tomography: Long title, but the gist is that radiation doses from CT scans can be significantly reduced without affecting radiologists’ satisfaction with the quality of the scans.

About pharma

FDA Wants All Ranitidine Products Off the Market: “All ranitidine products should be pulled from shelves immediately, the FDA said Wednesday, including brand-name Zantac as well as generic versions of the prescription and over-the-counter antacid.
Notably, this was not because of direct evidence of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, being present in particularly high concentrations in the drug itself.”

India likely to soon ease some drug export curbs after U.S. pressure - sources: “India will likely relax some export restrictions on pharmaceutical products soon due to intense pressure from the United States which is worried about drug shortages as the number of coronavirus cases surge, two Indian government officials told Reuters.
India, which supplies more than a quarter of the world’s generic drugs, last month restricted exports of 26 pharmaceutical ingredients and the medicines made from them. The move was seen as an attempt to secure supplies for its domestic population after the outbreak played havoc with the industry’s supply chain globally.”

About healthcare insurance

Trump rejects Obamacare special enrollment period amid pandemic: “The Trump administration has decided against reopening Obamacare enrollment to uninsured Americans during the coronavirus pandemic, defying calls from health insurers and Democrats to create a special sign-up window amid the health crisis.”

Today's News and Commentary

About the public’s health

COVID-19 Projections: Projections from the University of Washington are that the peak hospital resource needs (beds, ventilators, etc.) will be on April 15. See the chart and “normal” distribution of dates.

Johnson & Johnson targets Phase I study in September after selecting lead COVID-19 vaccine candidate: “Johnson & Johnson announced Monday the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January. The company noted that it hopes to initiate a Phase I study at the latest by September, accelerated from a previous target of November, with data on safety and efficacy expected to be available by the end of the year.”

Older Americans Act Reauthorized with Funds for Hospice Family Caregivers, Social Determinants: “Congress has reauthorized the Older Americans Act, which provides funds to services for seniors, including those designed to help them age in place. Some provisions of the act allocate dollars to community-based programs that provide meals, transportation and other social determinants of health, allowing seniors to remain in their homes where they later may receive hospice care.

The law, which originally passed in 1965, established the U.S. Administration of Aging, which works in concert with state agencies on aging as well as local entities. The recently passed reauthorization bill extends the funds for another five years. The revised law increases spending by 35% and includes additional programs to address social determinants of health as well as social isolation among seniors.”

2020’s Most & Least Stressed States: Is your state more or less stressed than others in the country.? Check here to find out.

Good news for teaching hospitals: U.S. resumes visa processing for physicians: “…the State Department updated information on visas, signaling that it will resume processing of J and H visa applications for medical professionals seeking to enter the U.S.”

Moderate social distancing yields $8 trillion in economic benefits, study finds: The headline speaks for itself.

About health insurance 

Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19: Yesterday, CMS issued what it calls an “unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic.” Much of the announcement is what CMS will allow for telehealth services and how to bill for them. See, also, Hospital Safety Rules Are Relaxed to Fight Coronavirus.

About healthcare IT

The platforms physicians can and can't use to communicate with patients: The HHS Office of Civil Rights (which monitors and enforces HIPAA compliance) has relaxed its IT requirements for communicating with patients during the COVID-19 crisis. Here are the social media platforms that you can and cannot use. For example, no Tik Tok.

About pharma

FDA lets Novartis off the hook in Zolgensma data manipulation: “When Novartis’ Zolgensma data manipulation problem first went public last August, an angry FDA said it would consider civil or criminal penalties. But it looks like neither of those is going to happen.
In a statement shared with FiercePharma, an FDA spokesperson said the agency has decided it will not punish Novartis’ gene therapy unit AveXis for doctoring Zolgensma mice testing data in its drug application package.”

Today's News and Commentary

TODAY IS NATIONAL DOCTOR’S DAY
Read what AMA President Patrice A. Harris, MD, MA has to say about its special importance this year.

About the public’s health

This slideshow from the London Business School is the best overview of COVID-19 that I have seen.

Time Kinetics of Viral Clearance and Resolution of Symptoms in Novel Coronavirus Infection: This Chinese study (with 2 Yale Medical School pulmonologists) observed 16 patients with COVID-19 who were treated and released from the Treatment Center of PLA General Hospital in Beijing between January 28 and Feb. 9. Because of the small size they had particular characteristics (like an average age of 35.5). Researchers found shedding can last as long as 8 days after symptoms were gone but the virus could be detected up to 14 days. The “safe” recommendation is that those who are positively diagnosed should self quarantine 14 days after symptoms are gone.

Abbott launches 5-minute COVID-19 test: “The North Chicago medical device maker today announced the U.S. Food & Drug Administration has authorized the use of its new coronavirus test, which delivers positive results within five minutes and negative results within 13.”

US coronavirus cases top 139,000 as Trump extends social distancing guidelines until April 30: The headline speaks for itself.

'Project Airbridge' To Expedite Arrival Of Needed Supplies, White House Says: “A planeload of health care supplies arrived in New York City on Sunday from China, part of an effort the White House says will expedite the arrival of goods that are badly needed to fight the coronavirus pandemic…Sunday's shipment included 130,000 N95 masks, nearly 1.8 million other face masks and gowns, more than 10.3 million gloves and more than 70,000 thermometers, according to a White House statement. A handful of American health care distributors purchases the supplies, and the Federal Emergency Management Agency paid for the Shanghai-to-New York flight.”

Battelle deploys decontamination system for reusing N95 masks: “Battelle received an emergency go-ahead from the FDA over the weekend to deploy its decontamination system for personal protective equipment (PPE), allowing healthcare workers to clean and reuse scarce N95 respirator masks.
The system is currently operating at Battelle’s Ohio facility—capable of processing up to 80,000 masks per machine, per day…”

Mystery In Wuhan: Recovered Coronavirus Patients Test Negative ... Then Positive: “But some Wuhan residents who had tested positive earlier and then recovered from the disease are testing positive for the virus a second time. Based on data from several quarantine facilities in the city, which house patients for further observation after their discharge from hospitals, about 5%-10% of patients pronounced ‘recovered’ have tested positive again. 
Some of those who retested positive appear to be asymptomatic carriers — those who carry the virus and are possibly infectious but do not exhibit any of the illness's associated symptoms — suggesting that the outbreak in Wuhan is not close to being over.”
BUT…My former student Jie Wang, MD in Beijing wrote to me last week about the positive retesting issue: “The bright side is some scientist announced that, it is the broken fragment, not the alive virus, that lead to a positive result. So far, no infectivity was observed in these cases.” So the epidemiological significance of this phenomenon is not yet known.

Apple's New Tool Lets You Screen Yourself For COVID-19: “Apple's new COVID-19 website and app allow users to screen themselves for coronavirus symptoms and receive recommendations from the Centers for Disease Control and Prevention on what to do next. 
The tool was developed in partnership with the CDC, the White House's coronavirus task force and the Federal Emergency Management Agency. Both the website and the app were made publicly available on Friday.”

About health insurance

Medicare will accelerate payments to providers and suppliers, CMS announces:”Over the weekend, the Centers for Medicare & Medicaid Services (CMS) announced it is expanding its accelerated and advance payment program for Medicare (PDF) providers based on historical payments when there is a disruption in claims submission and/or claims processing to ensure they have the resources to fight COVID-19.”

Medicaid Block Grants and Per Capita Caps: The Coronavirus Highlights Risks to States: While block grants are used to control predictable costs. crises can cause harmful disruptions on funding of necessary services.

CPT reporting for COVID-19 Testing: This brief algorithm is an excellent summary of codes to use in billing for COVID-19 services.

Today's News and Commentary

About the public’s health

FDA Lifts Requirements for Masks, Respirators, Looks to Reprocessing to Ease Shortages: “FDA points out that face masks and respirators intended for general or industrial use and not intended for medical purposes are not considered medical devices and thus not subject to requirements under the Federal Food, Drug, and Cosmetic Act.
For face masks intended for a medical purpose that are not intended to provide liquid barrier protection, FDA says it is lifting major regulatory requirements to increase availability of the devices, including 510(k) submission, quality system regulation (QSR), registration and listing, and unique device identifier (UDI) requirements, so long as the devices do not create an undue risk for users.
 FDA says it will allow the distribution and use of surgical masks, which are Class II devices, without 510(k) clearance, given that the masks meet certain standards for fluid resistance and flammability and include accurate labeling.” Also, millions of N95 masks are being found with more diligent searching. Some are expired but will be used if needed.

U.S. agencies to collaborate on wide-scale 3D printing of ventilator parts and medical supplies: “Alongside the National Institutes of Health and the Department of Veterans Affairs—as well as America Makes, the national accelerator program for additive manufacturing managed by the Department of Defense—the collective framework will look to help hospitals and others furnish components close to the patient or at the point-of-care.”

About health insurance 

DOJ sues Anthem over Medicare Advantage fraud claims: “Anthem faces a federal lawsuit for submitting inaccurate diagnostic data to get a higher Medicare reimbursement.
The U.S. Attorney for the Southern District of New York said in the lawsuit filed late Thursday that Anthem failed to find and delete inaccurate diagnosis codes from 2014 to early 2018 through its ‘chart review program.’”

About pharma

Pfizer and Mylan Delay Merger Due to COVID-19: The headline speaks for itself.

Today's News and Commentary

About hospitals

Analysis: Large majority of hospitals could lose $2,800 for treating each COVID-19 patient: “The analysis released Tuesday from Strata Decision Technology, which offers financial planning software for hospitals and health systems, also found that a proposed stimulus from Senate Republicans won't be nearly enough to help hospitals.”

S&P changes nonprofit hospital outlook to negative: “Nonprofit hospitals' outlook dropped from stable to negative due to the increasing threat of the COVID-19 pandemic, according to S&P Global Ratings.”

Hospitals get $100B in massive stimulus deal as facilities face COVID-19:”Hospitals and community health centers could get $130 billion as part of a $2 trillion economic stimulus package to help meet the skyrocketing increases of COVID-19 cases.” The article has a breakdown of the healthcare support part of the stimulus.

About pharma

FDA grants Gilead request to drop orphan drug designation for potential COVID-19 treatment remdesivir See yesterday’s story. “The FDA on Wednesday withdrew an orphan drug designation it had granted Gilead Sciences a few days ago for its investigational antiviral remdesivir to treat COVID-19. The company, which had made the request, said it will waive all benefits that come with the designation, including an extra seven years of exclusivity for the medication, adding that it ‘recognises the urgent public health needs posed by the COVID-19 pandemic…[and is] confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir,’ without the special status.” In a related story: California Researchers Begin Recruitment for Phase 2 Remdesivir Trial.

Qiagen Ships Coronavirus Test Kits to U.S.; FDA Grants Emergency Use Authorization for bioMérieux’s COVID-19 Test; Novacyt’s COVID-19 Test Earns Emergency Use Authorization: It is encouraging to see the number of tests increase for COVID-19. However, which are best? I have not seen a comparison nor any metrics, such as positive and negative predictive values.

Medical societies blast physician stockpiling of COVID-19 drugs: “The American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists issued a joint statement March 25 in response to reports that some physicians and pharmacists have been stockpiling drugs to treat COVID-19 for themselves and their families.” And on a related note: FDA commissioner warns public against taking 'any form of chloroquine' unless prescribed.

FDA Move Opens Door to Biosimilar Insulins, Other Biologics: "‘Now, it is possible for manufacturers to submit, and the FDA to approve, marketing applications for biosimilar and interchangeable biological products that reference transitioned biological products, which will help drive competition in the market, and patients may have more affordable access to the medications they need,’ FDA spokesperson James McKinney told Medscape Medical News.
It's not yet clear to what extent the move will lower prices. Although the presence of even a single generic drug typically lowers the price of a compound by 31% to 39%, biosimilars marketed in the United States typically have launched with initial list prices from just 15% to 35% lower than comparative list prices of the reference products, according to an FDA statement.”

Chances for drug pricing, surprise billing action fade until November: “The chances of Congress passing legislation to lower drug prices and protect patients from surprise medical bills are fading, at least until after the November election.”

Walmart Was Almost Charged Criminally Over Opioids. Trump Appointees Killed the Indictment: According to Propublica Walmart pharmacists around the country sought corporate guidance when they wanted to refuse filling prescriptions from suspected “pill mills.” “In response to these alarms, Walmart compliance officials did not take corporate-wide action to halt the flow of opioids. Instead, they repeatedly admonished pharmacists that they could not cut off any doctor entirely. They could only evaluate each prescription on an individual basis. And they went further. An opioid compliance manager told an executive in an email, gathered during the inquiry and viewed by ProPublica, that Walmart’s focus should be on ‘driving sales.’” The investigators claim that efforts to prosecute Walmart were hampered by Trump-appointed Justice Department officials, including then-deputy attorney general, Rod Rosenstein.

About the public’s health

'Better than a bandana or scarf': Expired face masks from stockpile OK, CDC says: “Expired masks have a failure rate of 5 percent to 10 percent, meaning they may not protect against particles or droplets and the elastic band could disintegrate.”

Fighting COVID-19 with Epidemiology: A Johns Hopkins Teach-Out: Free Coursera course.

UK-Senegal partnership to trial 10-minute coronavirus test:”A 10-minute coronavirus test that costs less than $1 to produce is being rushed into testing by a Senegalese research institute working with a British company, offering a potential lifesaver for countries battling to contain the pandemic.” Many cheaper and faster innovations are coming from developing countries.

Is ventilator-sharing a good idea? [7] Pulmonology experts weigh in: The headline speaks for itself. It is still experimental and theoretically possible, but complicated to do.

Hospitals consider universal do-not-resuscitate orders for coronavirus patients: “Hospitals on the front lines of the pandemic are engaged in a heated private debate over a calculation few have encountered in their lifetimes — how to weigh the ‘save at all costs’ approach to resuscitating a dying patient against the real danger of exposing doctors and nurses to the contagion of coronavirus.”

About health insurance

7 healthcare-related items you may have missed in the $2T coronavirus stimulus package: Really good, short summary of items that mostly involve payment issues. For example, the long-standing 2% Medicare sequester will not be held back for the rest of the year.

Aetna to waive commercial members' cost-sharing for inpatient COVID-19 admissions: “The insurer said this new program targeting the virus outbreak would be available to commercial members admitted to any of its in-network hospitals through June 1. The waivers are immediately available. “

Cigna Makes It Easier For Hospitals To Focus On COVID-19 By Helping Accelerate Patient Transfers: “Cigna will waive prior authorizations for the transfer of its non-COVID-19 customers from acute inpatient hospitals to in-network LTACHs. In place of prior authorizations, Cigna will require notification from the LTACH on the next business day following the transfer.”

5 payers waiving telehealth visit costs during coronavirus pandemic: The headline speaks for itself.

CMS tells states to leave Medicaid recipients alone and cover testing if they want coronavirus aid: “The government specifically warned states that if they want to receive enhanced federal matching funds available through the aid package, they must not terminate anyone from the program as of March 18. They also must cover all testing and treatment related to COVID-19 without any cost-sharing.
The Families First Coronavirus Response Act injects a temporary 6.2 percentage point increase to the Federal Medical Assistance Percentage [FMAP] that states receive from the federal government. The enhanced FMAP is available for qualifying expenditures incurred between Jan. 1, 2020, and the end of the quarter in which a public health emergency, including any extensions, ends.”

Today's News and Commentary

About medical devices

FDA Warns of Possible Failure of EpiPen Injectors: “The FDA issued an alert about the potential failure of EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors and authorized generics.
Pfizer, the manufacturer of the EpiPen, and Mylan said the devices may activate prematurely if their blue safety release is removed using a sideways force. A limited number of devices may have a blue safety release that is slightly raised and this also could cause the device to activate prematurely. 
Additionally, some of the devices may not slide out of their carrier tube easily, or potentially at all, due to a slight deformation on the rim of the carrier tube, the companies said.”

About the public’s health

National Health Expenditure Projections, 2019–28: Expected Rebound In Prices Drives Rising Spending Growth: This article from the CMS Office of the Actuary is issued pre-publication in Health Affairs (Subscription required). Here is the Abstract:
”National health expenditures are projected to grow at an average annual rate of 5.4 percent for 2019–28 and to represent 19.7 percent of gross domestic product by the end of the period. Price growth for medical goods and services is projected to accelerate, averaging 2.4 percent per year for 2019–28, which partly reflects faster expected growth in health-sector wages. Among all major payers, Medicare is expected to experience the fastest spending growth (7.6 percent per year), largely as a result of having the highest projected enrollment growth. The insured share of the population is expected to fall from 90.6 percent in 2018 to 89.4 percent by 2028.” Note the rates of increase will be greater than projected economic growth.

Symptoms & Testing: This CDC website is a good reference for personal information and “what to look for.”

Project N95: This site enables healthcare providers who need access to PPE to connect with manufacturers who can fill their orders.

Economic cost of the 'cure' is not worse than the disease — here's why: President Trump opined that the government’s current public health measures may cause worse harm to the economy than lesser actions. Read why this statement is false.

The Society for Critical Care medicine has developed a Tiered Staffing Strategy to care for critically ill patients.

CDC says traces of coronavirus found on cruise ship surfaces after two weeks: The headline speaks for itself. The traces of virus may not be infectious but it stresses the need for strict hand washing protocols.

FDA to allow COVID-19 treatments with blood from survivors: These treatments are not guaranteed to work and will be allowed on a case-by-case basis.

About healthcare IT

Telehealth visits up 312% in New York, causing major lag times: The good thing about telehealth is its availability. However, when “everyone” is using the technology, increased waiting lines mitigate this advantage.

About pharma

Gilead’s Remdesivir Gets Orphan Drug Status: “The FDA has granted Gilead’s remdesivir orphan drug designation as a potential treatment for COVID-19.
The investigational antiviral compound is currently in clinical trials around the world in severe COVID-19 patients, including the World Health Organization’s multinational SOLIDARITY trial.”
This designation is VERY strange. First, the treatment is unproved. More importantly, if it is found to be effective, the exclusive market advantage that accompanies Orphan Status is supposed to be limited to rare diseases- those with not more than 200,000 afflicted. Read, also: Gilead under fire for declaring remdesivir an orphan drug 

4 more state pharmacy boards join Ohio in curbing prescriptions for experimental COVID-19 drugs: “Four more state pharmacy boards have followed Ohio's lead and taken steps to block pharmacists from excessively dispensing two drugs touted as possible COVID-19 treatments, as both drugs are already in shortage. 
Utah, Idaho, Texas and Nevada have all moved to block unnecessary prescriptions of chloroquine and hydroxychloroquine, both designed to treat malaria but commonly used to treat autoimmune diseases such as lupus and rheumatoid arthritis.”

FDA Clarifies Criteria for Competitive Generic Therapy Designation: “The FDA has clarified its criteria for granting a competitive generic therapy (CGT) designation. The agency can designate a generic as a CGT if there is no more than one approved drug listed in the active section of the Orange Book.
Once designated, a generic will remain designated a CGT even if there is no longer inadequate generic competition for that drug prior to the ANDA’s approval, the agency said.”

Today's News and Commentary

About the public’s health

The coronavirus isn’t mutating quickly, suggesting a vaccine would offer lasting protection: The headline speaks for itself.

COVID-19 Resource: From the COVID-19 Healthcare Coalition. Included is the link to the Johns Hopkins University interactive global map.

Trump signs executive order to prevent price gouging, hoarding of medical supplies: “The executive order signed by Trump on Monday gives Health and Human Services (HHS) Secretary Alex Azar the authority to designate certain supplies as critical, meaning those found to be hoarding or price gouging such equipment could face criminal action…”

About healthcare professionals

As coronavirus spreads, thousands of foreign doctors could be blocked from U.S. entry, group warns: This year more than 4,200 foreign physicians were chosen to do medical residencies in American teaching hospitals. However, because of COVID-19 concerns, the State Department has temporarily stopped issuing J-1 visas they need to work in the U.S.

About pharma

Eli Lilly pauses enrollment in ongoing trials, delays new study starts citing strain coronavirus placing on healthcare system: Another side-effect of the pandemic is that research into treatments for other conditions has slowed or stopped.

India investing $1.3B to cut dependence on Chinese APIs:”India, like other countries, has grown dependent on cheap active pharmaceutical ingredients [APIs] from China. With the COVID-19 outbreak having put pressure on prices and supplies, the country is now doing something to wean itself away from that API habit. 
The government is setting up a 100-billion-rupees ($1.3 billion) fund to produce more APIs in the country…”

HHS Gives Liability Cover for Coronavirus Countermeasures: “HHS is providing immunity from legal liability for any drug, biologic, device, or vaccine approved or cleared to treat, diagnose, cure, prevent, or mitigate COVID-19. 
Manufacturers, distributors, and healthcare providers will be exempt from claims of loss caused by or related to manufacturing, distributing, or using medical countermeasures, except in the case of ‘willful misconduct.’”

About health insurance

2020’s States with the Most and Least Medicaid Coverage: States are ranked using criteria of spending, quality, and eligibility and enrollment.

BCBS sues Walgreens, alleges 10+ years of overcharging for drugs: A group of Blue Cross Blue Shield plans in New York has sued Walgreens, alleging that, … since 2007… Walgreens inflated the prices by billing for inflated ‘usual and customary prices,’ or the cost the general public would pay for prescriptions without going through insurance, instead of using a lower rate that many customers can get through its discount program, called the Prescription Savings Club.”

Coronavirus could drive up insurance premiums for tens of millions of Americans, projection shows:  Peter Lee, director of California’s individual insurance marketplace, said his organizations’ actuaries estimated that medical care stemming from the coronavirus could generate between $29 billion and $216 billion in hospital costs nationally for patients on employer-sponsored or individual market coverage. “Actuaries for Covered California, the state's ACA marketplace, estimated that patients hospitalized because of coronavirus would stay an average of 12 days, generating an average bill of $72,000…California’s $72,000 estimate for a hospital stay for coronavirus is considerably larger than what other analysts have projected. Kaiser Family Foundation researchers found the average employer-sponsored plan pays an average of $20,292 for hospital admission of a patient with pneumonia and major complications. The average cost ranged from $11,533 to $24,178, depending on the area of the country.”

Today's News and Commentary

About the public’s health

Why the Coronavirus Has Been So Successful: This article from The Atlantic is a very clear explanation of the biology of coronaviruses and what makes COVID-19 especially deadly.

Fair Allocation of Scarce Medical Resources in the Time of Covid-19: Although this article was written to provide guidance for the current pandemic, the principles are much older. It can serve as an excellent template for future public health catastrophes when resources are scarce.

Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1: This research found that the coronavirus could last up to: three hours in aerosols (after sneezing or coughing), four hours on copper, 24 hours on cardboard, and two to three days on plastic and stainless steel. These findings stress the need for sanitizing surfaces, frequent hand washing and covering mouth and nose when sneezing or coughing.

New drug target found for COVID-19: “Scientists from Northwestern University Feinberg School of Medicine have mapped the atomic structure of two critical proteins in a complex, nsp10/16. These proteins modify the genetic material of the virus to make it look more like the host (human) cell RNA. 
This allows the virus to hide from the cells, giving it time to multiply. If a drug can be developed to inhibit nsp10/nsp16, the immune system should be able to detect the virus and eradicate it faster.”

FDA Issues Statement Regarding NSAID Use and COVID-19: “ According to the agency, there is not enough scientific evidence to link the use of NSAIDs to worsening symptoms of COVID-19.”

FDA clamps down on at-home coronavirus testing, citing fake products and bad actors: “In a statement Friday, FDA Commissioner Stephen Hahn and acting Associate Commissioner for Regulatory Affairs Judith McMeekin said the agency has not yet authorized any COVID-19 product for home testing.”

Virus Drug Touted by Trump, Musk Can Kill With Just Two Gram Dose: “China, where the deadly pathogen first emerged in December, recommended the decades-old malaria drug chloroquine to treat infected patients in guidelines issued in February after seeing encouraging results in clinical trials. But within days, it cautioned doctors and health officials about the drug’s lethal side effects and rolled back its usage.”

Exclusive: U.S. axed CDC expert job in China months before virus outbreak:”Several months before the coronavirus pandemic began, the Trump administration eliminated a key American public health position in Beijing intended to help detect disease outbreaks in China…the American expert, Dr. Linda Quick, was a trainer of Chinese field epidemiologists who were deployed to the epicenter of outbreaks to help track, investigate and contain diseases.”

About health insurance

How 10 years of the ACA have shaped the insurance business—and what’s next: The 10th anniversary of the ACA’s passage is easy to miss amongst the deluge of coronavirus information. This article provides a nice summary of what various stakeholders say about this milestone.

White House mulling reopening of ObamaCare enrollment: reports: “Multiple states that operate their own health insurance marketplaces have reopened enrollment, which would allow state residents without health insurance to purchase coverage during the outbreak. However, most states use the marketplace run by the federal government..” How ironic, given Republican actions over the past several years to repeal or cripple the ACA.

About pharma

Insulin Makers Support CMS Plan for $35 Copays: “The Centers for Medicare and Medicaid Services (CMS) unveiled a model program that will cap Medicare Part D out-of-pocket insulin costs for seniors at $35 per month, and all three manufacturers for the U.S. market — Eli Lilly, Sanofi and Novo Nordisk — said they will take part.
The agency predicts that beneficiaries who enroll in plans included in the program will save an average of $446 in yearly out-of-pocket costs on insulin — more than 66 percent of their average insulin costs currently covered by insurance.”

The top 15 biopharma licensing deals of 2019:  The 15 largest licensing deals in 2019 totaled $41.1 billion. The article details each of these top 15 deals.

Today's News and Commentary

About the public’s health

Why Covid-19 is worse than the flu, in one chart: A useful graphic display comparing the two infections.

National COVID-19 response: US raises health alert to highest level and 9 other note: This short article is a good summary of the past week’s significant events.

Biopharma's leading treatment hopes against COVID-19: This article provides a good summary of what individual companies are developing to treat COVID-19.

WHO to launch multinational trial to jumpstart search for coronavirus drugs:”Four drugs or drug combinations already licensed and used for other illnesses will be tested, said WHO Director-General Tedros Adhanom Ghebreyesus. Ten countries have already indicated they will take part in the trial.”

Today's News and Commentary

About the public’s health

Coronavirus COVID-19 Global Cases by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU): This site is the best source of international data on
COVID-19.

Japanese flu drug 'clearly effective' in treating coronavirus, says China: This story has appeared in several global media outlets: '“Zhang Xinmin, an official at China’s science and technology ministry, said favipiravir, developed by a subsidiary of [Japanese firm] Fujifilm, had produced encouraging outcomes in clinical trials in Wuhan and Shenzhen involving 340 patients.
’It has a high degree of safety and is clearly effective in treatment,’ Zhang told reporters on Tuesday.
Patients who were given the medicine in Shenzhen turned negative for the virus after a median of four days after becoming positive, compared with a median of 11 days for those who were not treated with the drug, [Japanese] public broadcaster NHK said.
In addition, X-rays confirmed improvements in lung condition in about 91% of the patients who were treated with favipiravir, compared to 62% or those without the drug.” Japan has 2 million doses. The drug is unsafe for fetuses.

A new app would say if you’ve crossed paths with someone who is infected: “An app that tracks where you have been and who you have crossed paths with—and then shares this personal data with other users in a privacy-preserving way—could help curb the spread of Covid-19, says Ramesh Raskar at the MIT Media Lab, who leads the team behind it. Called Private Kit: Safe Paths, the free and open-source app was developed by people at MIT and Harvard, as well as software engineers at companies such as Facebook and Uber, who worked on it in their free time. “

Severe Outcomes Among Patients with Coronavirus Disease 2019 (COVID-19) — United States, February 12–March 16, 2020: “This first preliminary description of outcomes among patients with COVID-19 in the United States indicates that fatality was highest in persons aged ≥85, ranging from 10% to 27%, followed by 3% to 11% among persons aged 65–84 years, 1% to 3% among persons aged 55-64 years, <1% among persons aged 20–54 years, and no fatalities among persons aged ≤19 years.” This article also includes the CDC’s usual precautions for staying healthy.

Trump to invoke Defense Production Act to boost medical supplies: “Invoking the law will allow the administration to direct factories to produce more face masks, gowns, gloves and other medical supplies.”

New 2020 County Health Rankings Data Added: This interactive site allows you to get health status rankings by each county in each state. Check the criteria fro the rankings. Do you agree or is something missing?

FDA Halts Domestic Surveillance Inspections:”The US Food and Drug Administration (FDA) said Wednesday that it has temporarily postponed all domestic routine surveillance facility inspections.” The foreign surveillance was already suspended. Now we have to rely on faith for the quality of our food and health products.

COVID-19 reduces economic activity, which reduces pollution, which saves lives: The author calculates the reduction in pollution from decreased activity caused by COVOD-19 could save 53-77k lives.

Trump ban on fetal tissue research blocks coronavirus treatment effort: “…Kim Hasenkrug, an immunologist at the National Institutes of Health’s Rocky Mountain Laboratories in Montana, has been appealing for nearly a month to top NIH officials, arguing that the pandemic warrants an exemption to a ban imposed last year prohibiting government researchers from using tissue from abortions in their work…The fetal tissue is donated by women undergoing elective abortions, and critics say that it is unethical to use the material and that taxpayer money should not be used for research that relies on abortion.”

Before Virus Outbreak, a Cascade of Warnings Went Unheeded: The Administration conducted a simulation very much like the COVID-19 outbreak from last January to August. But they did not act on the findings. This NY Times article is well worth reading, even if you do not subscribe. Among the conclusions of the federal report:

  • HHS ’regional staff lack clear guidance on the distribution of federal information management products to state and local partners.

  • The current medical countermeasure supply chain and production capacity cannot meet the demands imposed by nations during a global influenza pandemic.